Q2 2026 Pfizer Inc Earnings Call
Speaker #1: Good day, everyone, and welcome to Pfizer's second quarter 2026 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Francesca DeMartino, Chief Investor Relations Officer and Senior Vice President.
Operator: Good day, everyone, and welcome to Pfizer's Q2 2026 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Francesca DeMartino, Chief Investor Relations Officer and Senior Vice President. Please go ahead, ma'am.
Speaker #1: Please go ahead, ma'am.
Speaker #2: Good morning, and welcome to Pfizer's earnings call. I'm Francesca DeMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us.
Francesca DeMartino: Good morning, welcome to Pfizer's earnings call. I'm Francesca DeMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us. This call is being made available via audio webcast at pfizer.com. Earlier this morning, we released our results for Q2 2026 via a press release that is available on our website at pfizer.com. I'm joined today by Dr. Albert Bourla, our Chairman and CEO, David Denton, our CFO, Cecile Guegan, our incoming interim CFO, and Chris Boshoff, our Chief Scientific Officer. After their prepared remarks, we will open the call for questions. Members of our leadership team will be available for the Q&A session. Before we get started, I want to remind you that we will be making forward-looking statements and discussing certain non-GAAP financial measures.
Francesca DeMartino: Good morning, welcome to Pfizer's earnings call. I'm Francesca DeMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us. This call is being made available via audio webcast at pfizer.com. Earlier this morning, we released our results for the Q2 of 2026 via a press release that is available on our website at pfizer.com. I'm joined today by Dr. Albert Bourla, our Chairman and CEO, David Denton, our CFO, Cecile Guegan, our incoming interim CFO, and Chris Boshoff, our Chief Scientific Officer. After their prepared remarks, we will open the call for questions. Members of our leadership team will be available for the Q&A session. Before we get started, I want to remind you that we will be making forward-looking statements and discussing certain non-GAAP financial measures.
Speaker #2: This call is being made available via audio webcast at Pfizer.com. Earlier this morning, we released our results for the second quarter of 2026 via a press release that is available on our website at Pfizer.com.
Speaker #2: I'm joined today by Dr. Albert Bourla, our Chairman and CEO, Dave Denton, our CFO, Cecile Gueguen, our incoming interim CFO, and Chris Boshoff, our Chief Scientific Officer.
Speaker #2: After their prepared remarks, we will open the call for questions. Members of our leadership team will be available for the Q&A session. Before we get started, I want to remind you that we will be making forward-looking statements and discussing certain non-GAAP financial measures.
Speaker #2: I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning, and the disclosures in our SEC filings, which are all available on the IR website on Pfizer.com.
Francesca DeMartino: I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning, and the disclosures in our SEC filings, which are all available on the IR website on pfizer.com. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements. With that, I will turn the call over to Albert.
Francesca DeMartino: I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning, and the disclosures in our SEC filings, which are all available on the IR website on pfizer.com. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements. With that, I will turn the call over to Albert.
Speaker #2: Forward-looking statements on the call are subject to substantial risks and uncertainties. Speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements.
Speaker #2: With that, I will turn the call over to Albert.
Speaker #3: Thank you Francesca. Good morning, everyone, and thank you for joining our call. We had another strong quarter of execution, driving continued strategic progress. Our revenues and adjusted diluted EPS in the second quarter once more exceeded expectations.
Albert Bourla: Thank you, Francesca. Good morning, everyone, thank you for joining our call. We had another strong quarter of execution, driving continued strategic progress. Our revenues and adjusted diluted EPS in Q2 once more exceeded expectations. This shows that our commercial teams are performing with excellence and precision, that we continue to operate with financial discipline. We also are building towards the future, advancing our R&D pipeline that provides multiple opportunities for success across our four therapeutic areas. Previously, we announced that David Denton would be leaving Pfizer soon for another opportunity. Since then, Dave has partnered closely with Cecile Guégan to prepare for this transition. Cecile is fully ready to serve as our interim CFO, including answering your financial questions during today's Q&A session. I want to thank Dave for his leadership, his dedication to Pfizer, all he has contributed to our company's success.
Albert Bourla: Thank you, Francesca. Good morning, everyone, thank you for joining our call. We had another strong quarter of execution, driving continued strategic progress. Our revenues and adjusted diluted EPS in Q2 once more exceeded expectations. This shows that our commercial teams are performing with excellence and precision, that we continue to operate with financial discipline. We also are building towards the future, advancing our R&D pipeline that provides multiple opportunities for success across our four therapeutic areas.
Speaker #3: This shows that our commercial teams are performing with excellence and precision, and that we continue to operate with financial discipline. We also are building towards the future, advancing our R&D pipeline that provides multiple opportunities for success across our four therapeutic areas.
Speaker #3: Previously, we announced that Dave Denton would be leading Pfizer soon for another opportunity. Since then, Dave has partnered closely with Cecile Gueguen, to prepare for this transition.
Albert Bourla: Previously, we announced that David Denton would be leaving Pfizer soon for another opportunity. Since then, Dave has partnered closely with Cecile Guégan to prepare for this transition. Cecile is fully ready to serve as our interim CFO, including answering your financial questions during today's Q&A session. I want to thank Dave for his leadership, his dedication to Pfizer, all he has contributed to our company's success.
Speaker #3: Cecile is fully ready to serve as our interim CFO, including answering your financial questions during today's Q&A session. I want to thank Dave for his leadership, his dedication to Pfizer, and all he has contributed to our company's success.
Speaker #3: With Cecile's leadership, I'm confident we are in very good hands. She has had a central role for years in shaping and driving Pfizer's financial and strategic direction.
Albert Bourla: With Cecile's leadership, I'm confident we are in very good hands. She has had a central role for years in shaping and driving Pfizer's financial and strategic direction. She's an expert in our industry and her field and knows our company well. She has worked closely with Dave and our leadership team in completing key transactions, developing our approach to capital allocation, driving efficiency and productivity improvements across our company. Now, I'm confident in the years ahead because we have been purposeful in establishing a foundation marked by strong execution across our business, alignment among our leadership team, a clear strategy to guide our colleagues in working toward meaningful future growth and impact. Let me go through our progress with our 2026 strategic priorities, starting with maximizing the value of key transactions.
Albert Bourla: With Cecile's leadership, I'm confident we are in very good hands. She has had a central role for years in shaping and driving Pfizer's financial and strategic direction. She's an expert in our industry and her field and knows our company well. She has worked closely with Dave and our leadership team in completing key transactions, developing our approach to capital allocation, driving efficiency and productivity improvements across our company. Now, I'm confident in the years ahead because we have been purposeful in establishing a foundation marked by strong execution across our business, alignment among our leadership team, a clear strategy to guide our colleagues in working toward meaningful future growth and impact. Let me go through our progress with our 2026 strategic priorities, starting with maximizing the value of key transactions.
Speaker #3: She's an expert in our industry and her field, and knows our company well. She has worked closely with Dave and our leadership team in completing key transactions, developing our approach to capital, allocation, and driving efficiency and productivity improvements across our company.
Speaker #3: Now, I'm confident in the years ahead because we have been purposeful in establishing a foundation marked by strong execution across our business, alignment among our leadership team, and a clear strategy to guide our colleagues in working toward meaningful future growth and impact.
Speaker #3: Let me go through our progress with our 2026 strategic priorities, starting with maximizing the value of key transactions. In the quarter, revenue for our acquired products grew 25% operationally, when excluding the impact of certain one-time items in the same quarter a year ago.
Albert Bourla: In the quarter, revenue for our acquired products grew 25% operationally when excluding the impact of certain one-time items in the same quarter a year ago. We view our Seagen, Metsera, Biohaven transactions as transformative opportunities for Pfizer. We are focused on execution and pleased with the progress we continue to make with each of them. With the addition of Seagen, we gained an innovative platform, deep expertise, a promising ADC pipeline central to our goal of growing our oncology list. We also acquired a commercial portfolio that is delivering ahead of expectations. In the quarter, we drove strong revenue growth with a 21% year-over-year increase across the legacy Seagen portfolio in the US after excluding the one-time stocking benefit that we had in Q2 of last year.
Albert Bourla: In the quarter, revenue for our acquired products grew 25% operationally when excluding the impact of certain one-time items in the same quarter a year ago. We view our Seagen, Metsera, Biohaven transactions as transformative opportunities for Pfizer. We are focused on execution and pleased with the progress we continue to make with each of them. With the addition of Seagen, we gained an innovative platform, deep expertise, a promising ADC pipeline central to our goal of growing our oncology list. We also acquired a commercial portfolio that is delivering ahead of expectations. In the quarter, we drove strong revenue growth with a 21% year-over-year increase across the legacy Seagen portfolio in the US after excluding the one-time stocking benefit that we had in Q2 of last year.
Speaker #3: We view our Seagen, Matera, and Biohaven transactions as transformative opportunities for Pfizer. We are focused on execution and pleased with the progress we continue to make with each of them.
Speaker #3: With the addition of Seagen, we gained an innovative platform, deep scientific expertise, and the promising ADC pipeline, central to our goal of growing our oncology leaders.
Speaker #3: We also acquired a commercial portfolio. That is delivering ahead of expectations. In the quarter, we drove strong revenue growth with a 21% year-over-year increase across the legacy Seagen portfolio, in the US, after excluding the one-time stocking benefit that we had in the second quarter of last year.
Speaker #3: With Matera, we believe we are on a path towards unlocking a differentiated profile for patients, with obesity and related conditions in a market expected to reach $150 billion.
Albert Bourla: With Metsera, we believe we are on a path towards unlocking a differentiated profile for patients with obesity and related conditions in a market expected to reach $150 billion. Data we served recently at the American Diabetes Association scientific session reinforce why we are excited about danuglipron, which is an investigational ultra-long-acting GLP-1 receptor agonist with the potential to be the first monthly GLP-1 peptide approved for the treatment of obesity and related comorbidities. We are targeting a first approval in 2028. This year alone, we expect to advance an extensive phase III program that includes 10 studies for chronic weight management and obesity-related conditions. Finally, the acquisition of Biohaven positioned our company as a leader in providing treatment options for migraine, a disease affecting an estimated 1.2 billion people worldwide.
Albert Bourla: With Metsera, we believe we are on a path towards unlocking a differentiated profile for patients with obesity and related conditions in a market expected to reach $150 billion. Data we served recently at the American Diabetes Association scientific session reinforce why we are excited about danuglipron, which is an investigational ultra-long-acting GLP-1 receptor agonist with the potential to be the first monthly GLP-1 peptide approved for the treatment of obesity and related comorbidities. We are targeting a first approval in 2028. This year alone, we expect to advance an extensive phase III program that includes 10 studies for chronic weight management and obesity-related conditions. Finally, the acquisition of Biohaven positioned our company as a leader in providing treatment options for migraine, a disease affecting an estimated 1.2 billion people worldwide.
Speaker #3: Data we shared recently at the American Diabetes Association Scientific Sessions reinforced why we are excited about Berobenadine. Which is an investigation ultra-long-acting GLP-1 receptor agonist with the potential to be the first monthly GLP-1 peptide approved for the treatment of obesity and related comorbidities.
Speaker #3: We are targeting a first approval in 2028, and this year alone, we expect to advance an extensive phase three program that includes 10 studies for chronic weight management and obesity-related conditions.
Speaker #3: Finally, the acquisition of Biohaven positioned our company as a leader in providing treatment options for migraine. A disease affecting an estimated 1.2 billion people worldwide.
Speaker #3: Nurtec delivered strong year-over-year growth, again this quarter, and continued to lead the oral CGRP class in total prescriptions. Looking ahead, we are working towards expansion opportunities that would further strengthen our impact for this patient.
Albert Bourla: NURTEC delivered strong year-over-year growth again this quarter and continued to lead the oral CGRP class in total prescriptions. Looking ahead, we are working towards expansion opportunities that would further strengthen our impact for this space. We have the phase III trial underway for menstrual migraine, an area of high unmet patient need, and another trial evaluating redosing for acute treatment of migraine. We also expect a pivotal trial start this year investigating NURTEC's use as a treatment for chronic migraine. Our pipeline progress through H1 reflects our discipline in prioritizing programs where strong science, clinical execution, and strategic investments can make the greatest impact for patients. Our R&D team already has been productive with our ambitious agenda, achieving critical milestones that included three regulatory approvals, six key data readouts, and eight pivotal study starts so far. Oncology is a clear area of strength.
Albert Bourla: NURTEC delivered strong year-over-year growth again this quarter and continued to lead the oral CGRP class in total prescriptions. Looking ahead, we are working towards expansion opportunities that would further strengthen our impact for this space. We have the phase III trial underway for menstrual migraine, an area of high unmet patient need, and another trial evaluating redosing for acute treatment of migraine. We also expect a pivotal trial start this year investigating NURTEC's use as a treatment for chronic migraine.
Speaker #3: We have the Phase 3 trial underway for menstrual migraine, an area of high unmet patient need, and another trial evaluating re-dosing for acute treatment of migraine.
Speaker #3: We also expect a pivotal trial start this year, investigating Nurtec's use as a treatment for chronic migraine. Our pipeline progress through the first half of the year reflects our discipline in prioritizing programs where strong science, clinical execution, and strategic investments can make the greatest impact for patients.
Albert Bourla: Our pipeline progress through H1 reflects our discipline in prioritizing programs where strong science, clinical execution, and strategic investments can make the greatest impact for patients. Our R&D team already has been productive with our ambitious agenda, achieving critical milestones that included three regulatory approvals, six key data readouts, and eight pivotal study starts so far. Oncology is a clear area of strength.
Speaker #3: Our R&D team has already been productive with our ambitious agenda, achieving critical milestones that include three regulatory approvals, six key data readouts, and eight pivotal study starts so far.
Speaker #3: Oncology is a clear area of strength. In the past two years, we have initiated a dozen late-stage studies across our core tumor areas, we have unveiled data from 21 late-stage readouts, and achieved six regulatory approvals.
Albert Bourla: In the past two years, we have initiated a dozen late-stage studies across our core tumor areas. We have unveiled data from 21 late-stage readouts and achieved six regulatory approvals. We also have clear line of sight to our aim of delivering a risk-adjusted, high single-digit revenue CAGR from year-end 2028 through year-end 2033. This is supported by our bottoms-up analysis that included assessing our base of growing in-line products and 20 key potential new medicines and vaccines within our pipeline. We continue to prioritize investment in R&D, both on internal programs and selective business development, with the potential to strengthen our position in key areas. Financial discipline and cost management is allowing us to continue investing in growth. We now expect an additional $1 billion in savings from our ongoing cost realignment program, powered in part by rapid advancements of technology.
Albert Bourla: In the past two years, we have initiated a dozen late-stage studies across our core tumor areas. We have unveiled data from 21 late-stage readouts and achieved six regulatory approvals. We also have clear line of sight to our aim of delivering a risk-adjusted, high single-digit revenue CAGR from year-end 2028 through year-end 2033. This is supported by our bottoms-up analysis that included assessing our base of growing in-line products and 20 key potential new medicines and vaccines within our pipeline.
Speaker #3: We also have clear line of sight to our aim of delivering a risk-adjusted, high single-digit revenue CAGR from year end 2028 through year end 2033.
Speaker #3: This is supported by our bottoms-up analysis that included assessing our base of growing inline products, and 20 key potential new medicines and vaccines within our pipeline.
Speaker #3: We continue to prioritize investment in R&D, both on internal programs and selective business development, with the potential to strengthen our position in key areas.
Albert Bourla: We continue to prioritize investment in R&D, both on internal programs and selective business development, with the potential to strengthen our position in key areas. Financial discipline and cost management is allowing us to continue investing in growth. We now expect an additional $1 billion in savings from our ongoing cost realignment program, powered in part by rapid advancements of technology.
Speaker #3: Financial discipline and cost management are allowing us to continue investing in growth. We now expect an additional $1 billion in savings from our ongoing cost realignment program, powered in part by rapid advancements in technology. Net cost savings from these programs are now expected to total $6.7 billion through 2029.
Albert Bourla: Net cost savings from these programs are now expected to total $6.7 billion through 2029. We are also moving forward with the next phase of our manufacturing optimization program. With additional savings, we now expect total net cost savings of approximately $3 billion from this program through 2029. With our strong performance through H1 and our ongoing productivity enhancement discipline, we remain confident in our business. Today, we are raising the midpoint of our revenue guidance for full year 2026 and are affirming guidance for adjusted diluted earnings per share. We remain committed to maintaining and over time, growing our dividend. We view AI as the structural transformation opportunity for driving substantial acceleration of our R&D pipeline, greater speed and productivity across our business, and an improved competitive position for Pfizer.
Albert Bourla: Net cost savings from these programs are now expected to total $6.7 billion through 2029. We are also moving forward with the next phase of our manufacturing optimization program. With additional savings, we now expect total net cost savings of approximately $3 billion from this program through 2029. With our strong performance through H1 and our ongoing productivity enhancement discipline, we remain confident in our business. Today, we are raising the midpoint of our revenue guidance for full year 2026 and are affirming guidance for adjusted diluted earnings per share. We remain committed to maintaining and over time, growing our dividend. We view AI as the structural transformation opportunity for driving substantial acceleration of our R&D pipeline, greater speed and productivity across our business, and an improved competitive position for Pfizer.
Speaker #3: We are also moving forward with the next phase of our manufacturing optimization program, and with additional savings, we now expect total net cost savings of approximately $3 billion from this program through 2029.
Speaker #3: With our strong performance through the first half of the year and our ongoing productivity enhancement discipline, we remain confident in our business. Today, we are raising the midpoint of our revenue guidance for full year 2026, and reaffirming guidance for adjusted diluted earnings per share.
Speaker #3: And we remain committed to maintaining and, over time, growing our dividend. We view AI as the structural transformation opportunity for driving substantial acceleration of our R&D pipeline, greater speed and productivity across our business, and an improved competitive position for Pfizer.
Speaker #3: We are already seeing benefits from AI in reducing cost and expanding yields in manufacturing. It's helping to make our commercial field force more effective and sharpening our commercial marketing approaches.
Albert Bourla: We are already seeing benefits from AI in reducing cost and expanding yields in manufacturing. It's helping to make our commercial field force more effective and sharpening our commercial marketing approach. Even greater opportunities are ahead as we apply AI to accelerate innovation in drug discovery and development. Our ambition is to build an AI-native R&D organization where every insight from target discovery through medical evidence continuously informs the next decision. In summary, I'm confident in how our business is positioned. We executed well and operated with continued financial discipline through H1 2026. With our performance in Q2, this is the ninth time we exceeded consensus expectations for revenues in the last 10 quarters, and we have beaten expectations for adjusted diluted EPS in all 10 of the 10 past quarters.
Albert Bourla: We are already seeing benefits from AI in reducing cost and expanding yields in manufacturing. It's helping to make our commercial field force more effective and sharpening our commercial marketing approach. Even greater opportunities are ahead as we apply AI to accelerate innovation in drug discovery and development. Our ambition is to build an AI-native R&D organization where every insight from target discovery through medical evidence continuously informs the next decision.
Speaker #3: Even greater opportunities are ahead as we apply AI to accelerate innovation in drug discovery and development. Our ambition is to build an AI-native R&D organization where every insight, from target discovery through medical evidence, continuously informs the next decision.
Speaker #3: In summary, I'm confident in how our business is positioned. We executed well and operated with continued financial discipline through the first half of 2026.
Albert Bourla: In summary, I'm confident in how our business is positioned. We executed well and operated with continued financial discipline through H1 2026. With our performance in Q2, this is the ninth time we exceeded consensus expectations for revenues in the last 10 quarters, and we have beaten expectations for adjusted diluted EPS in all 10 of the 10 past quarters. With that, what a better slide to turn it over to Dave and Cecile.
Speaker #3: With our performance in the second quarter, this is the ninth time we exceeded consensus expectations for revenues, in the last 10 quarters, and we have beaten expectations for adjusted diluted EPS in all 10 of the 10 past quarters.
Speaker #3: And with that, what a better slide to turn it over to Dave and Cecile.
Albert Bourla: With that, what a better slide to turn it over to Dave and Cecile.
Speaker #2: Great. Thank you, Albert, and good morning, everyone. Leaving Pfizer was a difficult decision, but it's the right one for me personally. I'm deeply proud of what we've accomplished together.
David Denton: Great. Thank you, Albert, and good morning, everyone. Leaving Pfizer was a difficult decision, but it's the right one for me personally. I'm deeply proud of what we've accomplished together, the team that we have built, and the vision for the future of Pfizer. The results for this quarter show how well our company is executing and why we are confident in the strategy for returning to growth post-2028. We anticipated that a substantial portion of today's call will focus on our outlook for the remainder of this year, as well as our strategy for creating long-term value for both patients and shareholders. With that in mind, we determined it would be best for you to hear directly from Cecile. I've worked closely with Cecile, seen firsthand how she leads effectively with her deep financial knowledge, her expertise, and the respect that she's earned from the entire organization.
Dave Denton: Great. Thank you, Albert, and good morning, everyone. Leaving Pfizer was a difficult decision, but it's the right one for me personally. I'm deeply proud of what we've accomplished together, the team that we have built, and the vision for the future of Pfizer. The results for this quarter show how well our company is executing and why we are confident in the strategy for returning to growth post-2028. We anticipated that a substantial portion of today's call will focus on our outlook for the remainder of this year, as well as our strategy for creating long-term value for both patients and shareholders.
Speaker #2: The team that we have built, and the vision for the future of Pfizer. The results of this quarter show how well our company is executing and why we are confident in the strategy for returning to growth post-2028.
Speaker #2: We anticipated that a substantial portion of today's call will focus on our outlook for the remainder of this year, as well as our strategy for creating long-term value for both patients and shareholders.
Speaker #2: So with that in mind, we determined it would be best for you here directly from Cecile. I've worked closely with Cecile, seeing firsthand how she leads effectively with her deep financial knowledge, her expertise, and the respect that she has earned from the entire organization.
Dave Denton: With that in mind, we determined it would be best for you to hear directly from Cecile. I've worked closely with Cecile, seen firsthand how she leads effectively with her deep financial knowledge, her expertise, and the respect that she's earned from the entire organization. I leave knowing that Cecile will guide Pfizer's financial and growth strategy with both rigor, discipline, and continuity. With that, I'm pleased to turn it over to Cecile.
Speaker #2: I leave knowing that Cecile will guide Pfizer's financial and growth strategy with both rigor, discipline, and continuity. And with that, I'm pleased to turn it over to Cecile.
David Denton: I leave knowing that Cecile will guide Pfizer's financial and growth strategy with both rigor, discipline, and continuity. With that, I'm pleased to turn it over to Cecile.
Speaker #4: Thank you. Albert and Dave, and good morning. Before I discuss second quarter results, I want to underscore Albert's comment. I believe Pfizer is well positioned to return to growth from 2029 onward, and create meaningful value for shareholders.
Cécile Guégan: Thank you, Albert and Dave, and good morning. Before I discuss Q2 results, I want to underscore Albert's comment. I believe Pfizer is well-positioned to return to growth from 2029 onwards and create meaningful value for shareholders. We will continue to execute a disciplined approach to capital allocation, making targeted investment today to drive revenue growth later in the decade and beyond. We intend to do this while maintaining and, over the long term, growing the dividend. Our business is performing well. Commercial execution is driving strong results, including 18% operational revenue growth in our launched and acquired products this quarter. We continue to strengthen and advance our pipeline. With the continued growth of our launched and acquired products, we are laying the groundwork for high single-digit revenue growth toward the end of the decade.
Cecile Guegan: Thank you, Albert and Dave, and good morning. Before I discuss Q2 results, I want to underscore Albert's comment. I believe Pfizer is well-positioned to return to growth from 2029 onwards and create meaningful value for shareholders. We will continue to execute a disciplined approach to capital allocation, making targeted investment today to drive revenue growth later in the decade and beyond. We intend to do this while maintaining and, over the long term, growing the dividend. Our business is performing well. Commercial execution is driving strong results, including 18% operational revenue growth in our launched and acquired products this quarter. We continue to strengthen and advance our pipeline. With the continued growth of our launched and acquired products, we are laying the groundwork for high single-digit revenue growth toward the end of the decade.
Speaker #4: We will continue to execute a disciplined approach to capital allocation, making targeted investments today to drive revenue growth later in the decade and beyond.
Speaker #4: We intend to do this while maintaining, and over the long term, growing the dividend. Our business is performing well. Commercial execution is driving strong results, including 18% operational revenue growth in our launch and acquired products this quarter.
Speaker #4: We continue to strengthen and advance our pipeline. With continued growth of our launch and acquired products, we're laying the groundwork for high single-digit revenue growth toward the end of the decade.
Speaker #4: Our second quarter adjusted earnings performance reflects disciplined execution across our strategic priorities, and continued progress towards building the foundation for durable, long-term value creation.
Cécile Guégan: Our Q2 adjusted earnings performance reflects disciplined execution across our strategic priorities and continued progress towards building the foundation for durable long-term value creation. I will review our results from the quarter, productivity enhancement initiatives, capital allocation priorities, and full-year guidance. We are raising the midpoints of our revenue guidance range despite lower-than-expected COVID revenues. We are also reaffirming adjusted diluted EPS guidance, which absorbs an approximately $0.10 impact related to the Innovent Biologics transaction that closed in Q1 2026. We delivered revenue growth in the quarter through disciplined execution across key brands in the US and select international markets. Q2 2026 revenue was $15 billion, ahead of our expectations and representing a year-over-year operational increase of 1%. Excluding COVID products, the underlying business delivered 5% operational revenue growth.
Cecile Guegan: Our Q2 adjusted earnings performance reflects disciplined execution across our strategic priorities and continued progress towards building the foundation for durable long-term value creation. I will review our results from the quarter, productivity enhancement initiatives, capital allocation priorities, and full-year guidance. We are raising the midpoints of our revenue guidance range despite lower-than-expected COVID revenues. We are also reaffirming adjusted diluted EPS guidance, which absorbs an approximately $0.10 impact related to the Innovent Biologics transaction that closed in Q1 2026. We delivered revenue growth in the quarter through disciplined execution across key brands in the US and select international markets. Q2 2026 revenue was $15 billion, ahead of our expectations and representing a year-over-year operational increase of 1%. Excluding COVID products, the underlying business delivered 5% operational revenue growth.
Speaker #4: I will review our results from the quarter, productivity enhancement initiatives, capital allocation priorities, and full year guidance. We are raising the midpoint of our revenue guidance range despite lower than expected COVID revenues.
Speaker #4: We are also reaffirming adjusted diluted EPS guidance, which absorbs an approximately 10 cents impact related to the innovant biologic transaction that closed in the third quarter of 2026.
Speaker #4: We delivered revenue growth in the quarter through disciplined execution across key brands in the U.S. and select international markets. Second quarter 2026 revenue was $15 billion, ahead of our expectations and representing a year-over-year operational increase of 1%.
Speaker #4: Excluding COVID products, the underlying business delivered 5% operational revenue growth. Progress leveraging data and scaling AI across the company supported our sales force in driving access and increasing uptake for new launches.
Cécile Guégan: Progress leveraging data and scaling AI across the company supported our sales force in driving access and increasing uptake for new launches. Our commercial performance has also helped mitigate the impact of currently low COVID infection levels. On the bottom line, Q2 adjusted diluted EPS was $0.77, also exceeding our expectations. This outperformance reflects continued cost discipline and productivity across the organization while we still advanced several phase III study starts across our pipeline. Our results this quarter demonstrate the effectiveness of our commercial strategy. We saw solid contribution across the portfolio, primarily driven by Eliquis, PAXLOVID, VYNDAQEL, XTANDI, and LORBRENA, each reflecting focused execution in key therapeutic areas.
Cecile Guegan: Progress leveraging data and scaling AI across the company supported our sales force in driving access and increasing uptake for new launches. Our commercial performance has also helped mitigate the impact of currently low COVID infection levels. On the bottom line, Q2 adjusted diluted EPS was $0.77, also exceeding our expectations. This outperformance reflects continued cost discipline and productivity across the organization while we still advanced several phase III study starts across our pipeline. Our results this quarter demonstrate the effectiveness of our commercial strategy. We saw solid contribution across the portfolio, primarily driven by Eliquis, PAXLOVID, VYNDAQEL, XTANDI, and LORBRENA, each reflecting focused execution in key therapeutic areas.
Speaker #4: Our commercial performance has also helped mitigate the impact of currently low COVID infection numbers. On the bottom line, second quarter adjusted diluted EPS was 77 cents, also exceeding our expectations.
Speaker #4: This outperformance reflects continued cost discipline and productivity across the organization, while we still advance several phase three study starts across our pipeline. Our results this quarter demonstrate the effectiveness of our commercial strategy.
Speaker #4: We saw solid contributions across the portfolio, primarily driven by Eliquis, Paxlovid, the Vindicare family, and Lorbrena. Each reflects focused execution in key therapeutic areas. We also expect post-2028 cash flow to benefit from the previously announced Vindamax patent settlement.
Cécile Guégan: We also expect H1 2028 cash flow to benefit from the previously announced VYNDAMAX patent settlement. Across international and US markets, our commercial team are focused on identifying patients, enabling access, and supporting duration of therapy based on clinical data. This as Optum maintain leadership position across oncology and vaccines and unlock new opportunities. We continue to drive value in key in-line products ahead of approaching LOEs. While our launched and acquired products delivered $3.2 billion in revenue and grew 18% operationally in the quarter. Of note, this growth rate was tempered by one-time items recorded in Q2 2025, mostly impacting the legacy Seagen in-line portfolio. Excluding this impact, the growth rate was 27%. We continue to invest behind in-line brands and launched and acquired products to support their growth trajectory and help offset incoming LOE headwinds over the next several years.
Cecile Guegan: We also expect H1 2028 cash flow to benefit from the previously announced VYNDAMAX patent settlement. Across international and US markets, our commercial team are focused on identifying patients, enabling access, and supporting duration of therapy based on clinical data. This as Optum maintain leadership position across oncology and vaccines and unlock new opportunities. We continue to drive value in key in-line products ahead of approaching LOEs. While our launched and acquired products delivered $3.2 billion in revenue and grew 18% operationally in the quarter.
Speaker #4: Across international and US markets, our commercial team are focused on identifying patients enabling access and supporting duration of therapy, based on clinical data. This has helped us maintain leadership position across oncology and vaccines, and unlocked new opportunities.
Speaker #4: We continue to drive value in key inline products approaching ahead of approaching LOEs, while our launch and acquired products delivered 3.2 billion dollars in revenue.
Speaker #4: And grew 18% operationally in the quarter. Of note, this growth rate was tempered by one-time items recorded in the second quarter of 2025, mostly impacting the legacy Seagen inline portfolio.
Cecile Guegan: Of note, this growth rate was tempered by one-time items recorded in Q2 2025, mostly impacting the legacy Seagen in-line portfolio. Excluding this impact, the growth rate was 27%. We continue to invest behind in-line brands and launched and acquired products to support their growth trajectory and help offset incoming LOE headwinds over the next several years.
Speaker #4: Excluding this impact, the growth rate was 27%. We continue to invest beyond inline brands and launch and acquired products, to support their growth trajectory, and help offset incoming LOE headwinds over the next several years.
Speaker #4: Financial discipline and strong cost management across our manufacturing footprint remain top priorities. Adjusted gross margin for the second quarter was 76%, primarily reflecting product mix and ongoing cost control measures.
Cécile Guégan: Financial discipline and strong cost management across our manufacturing footprint remain top priorities. Adjusted gross margin for Q2 was 76%, primarily reflecting product mix and ongoing cost control measures. We continue to expect $700 million in savings from phase one of our manufacturing optimization program this year, with $175 million realized in Q2. Total adjusted operating expenses were $6.1 billion for Q2 2026, an increase of 4% operationally versus Q2 last year. Looking at the components, adjusted SI&A expenses decreased 3% operationally, primarily reflecting lower spending in corporate enabling functions. Adjusted R&D expenses increased 12% operationally, primarily driven by an increase in spending in certain oncology and obesity product candidates. Q2 2026 adjusted operating margin was strong at 35%, reflecting effective cost management, strong non-COVID revenue performance, and higher R&D investment in the quarter.
Cecile Guegan: Financial discipline and strong cost management across our manufacturing footprint remain top priorities. Adjusted gross margin for Q2 was 76%, primarily reflecting product mix and ongoing cost control measures. We continue to expect $700 million in savings from phase one of our manufacturing optimization program this year, with $175 million realized in Q2. Total adjusted operating expenses were $6.1 billion for Q2 2026, an increase of 4% operationally versus Q2 last year. Looking at the components, adjusted SI&A expenses decreased 3% operationally, primarily reflecting lower spending in corporate enabling functions. Adjusted R&D expenses increased 12% operationally, primarily driven by an increase in spending in certain oncology and obesity product candidates. Q2 2026 adjusted operating margin was strong at 35%, reflecting effective cost management, strong non-COVID revenue performance, and higher R&D investment in the quarter.
Speaker #4: We continue to expect $700 million in savings from phase one of our manufacturing optimization program this year, with $175 million realized in Q2.
Speaker #4: Total adjusted operating expenses were 6.1 billion dollars for the second quarter of 2026, an increase of 4% operationally, versus second quarter last year. Looking at the components, adjusted SINA expenses decreased 3% operationally.
Speaker #4: Primarily reflecting lower spending in corporate enabling functions. Adjusted R&D expenses increased 12% operationally, primarily driven by an increase in spending in certain oncology and obesity product candidates.
Speaker #4: Second quarter 2026 adjusted operating margin was strong, at 35%. Reflecting effective cost management, strong non-COVID revenue performance, and higher R&D investment in the quarter.
Speaker #4: Turning to the bottom line, Q2 reported loss per share was negative 4 cents, and our adjusted diluted EPS was positive 77 cents, which benefited from our strong non-COVID revenues and efficient operating structure.
Cécile Guégan: Turning to the bottom line, Q2 reported loss per share was $-0.04, and our adjusted diluted EPS was +$0.77, which benefited from our strong non-COVID revenues and efficient operating structure. Our Q2 GAAP results reflect the impact of our recent phase III readout for SV in second-line plus non-small cell lung cancer and, to a lesser extent, the removal of revenue projection for OXBRYTA following recent discussion with the FDA. The updated forecast resulted in $4.3 billion in non-cash intangible asset impairments recorded in the quarter. For SV, we continue to forecast significant risk-adjusted revenue in other non-small cell lung cancer indications subject to technical and regulatory success. So far, Seagen revenue performance has exceeded our initial expectations, and we aim to continue delivering above initial expectations in the long term. We remain disciplined in operating expense management and focused on long-term margin improvement.
Cecile Guegan: Turning to the bottom line, Q2 reported loss per share was $-0.04, and our adjusted diluted EPS was +$0.77, which benefited from our strong non-COVID revenues and efficient operating structure. Our Q2 GAAP results reflect the impact of our recent phase III readout for SV in second-line plus non-small cell lung cancer and, to a lesser extent, the removal of revenue projection for OXBRYTA following recent discussion with the FDA. The updated forecast resulted in $4.3 billion in non-cash intangible asset impairments recorded in the quarter. For SV, we continue to forecast significant risk-adjusted revenue in other non-small cell lung cancer indications subject to technical and regulatory success.
Speaker #4: Our second quarter gap results reflect the impact of the recent phase three readout for SV in second line plus non-small cell lung cancer, and to a lesser extent, the removal of revenue projection for Oxbryta following recent discussion with the FDA.
Speaker #4: The updated forecast resulted in 4.3 billion dollars in non-cash intangible asset impairments, recorded in the quarter. For SV, we continue to forecast significant risk-adjusted revenue in other non-small cell lung cancer indications, subject to technical and regulatory success.
Speaker #4: So far, Seagen revenue performance has exceeded our initial expectations, and we aim to continue delivering above initial expectations in the long term. We remain disciplined in operating expense management and focused on long-term margin improvement.
Cecile Guegan: So far, Seagen revenue performance has exceeded our initial expectations, and we aim to continue delivering above initial expectations in the long term. We remain disciplined in operating expense management and focused on long-term margin improvement.
Speaker #4: We have made meaningful progress on our productivity enhancement initiatives, and remain on track to deliver most of the anticipated 7.2 billion dollars in total net cost 2026.
Cécile Guégan: We have made meaningful progress on our productivity enhancement initiatives and remain on track to deliver most of the anticipated $7.2 billion in total net cost savings by the end of 2026. Building on that momentum, today, we announce the expansion of our ongoing cost improvement programs, which are expected to generate approximately $2.5 billion in additional net cost savings from 2027 through 2029. We now expect $1 billion of additional net cost savings from our productivity enhancements from technology and simplification efforts designed to further reduce SI&A costs. Separately, the next phase of our multi-year manufacturing optimization program is designed to reduce cost of goods sold and deliver approximately $1.5 billion in additional net cost savings, and we expect to begin realizing a portion of this saving in 2027.
Cecile Guegan: We have made meaningful progress on our productivity enhancement initiatives and remain on track to deliver most of the anticipated $7.2 billion in total net cost savings by the end of 2026. Building on that momentum, today, we announce the expansion of our ongoing cost improvement programs, which are expected to generate approximately $2.5 billion in additional net cost savings from 2027 through 2029. We now expect $1 billion of additional net cost savings from our productivity enhancements from technology and simplification efforts designed to further reduce SI&A costs. Separately, the next phase of our multi-year manufacturing optimization program is designed to reduce cost of goods sold and deliver approximately $1.5 billion in additional net cost savings, and we expect to begin realizing a portion of this saving in 2027.
Speaker #4: Building on that momentum, today we announce the expansion of our ongoing cost improvement programs which are expected to generate approximately 2.5 billion dollars in additional net cost savings from 2027 through 2029.
Speaker #4: We now expect 1 billion dollars of additional net cost savings from our productivity enhancements from technology, and simplification efforts designed to further reduce SINA costs.
Speaker #4: Separately, the next phase of our multi-year manufacturing optimization program is designed to reduce cost of goods sold and deliver approximately $1.5 billion in additional net cost savings.
Speaker #4: And we expect to begin realizing a portion of these savings in 2027. This next phase focuses on network structure changes, product portfolio enhancement, and additional operational efficiency.
Cécile Guégan: This next phase focuses on network structure changes, product portfolio enhancements, and additional operational efficiencies. We now expect total net cost savings from this program of approximately $3 billion through 2029. In summary, we now expect approximately $9.7 billion in total net savings from this program through 2029. These initiatives are expected to enhance operating efficiency, support continued operating margin expansion, and strengthen our ability to invest in innovation and future growth opportunities. Let me now turn to capital allocation. Our strategy is designed to enhance long-term shareholder value while preserving flexibility. It includes reinvesting in the business at appropriate returns, maintaining and over time growing our dividend, and preserving optionality for future value-enhancing actions, including share repurchases. In H1 2026, we invested $5.5 billion in internal and external R&D and returned $4.9 billion to shareholders via our quarterly dividend.
Cecile Guegan: This next phase focuses on network structure changes, product portfolio enhancements, and additional operational efficiencies. We now expect total net cost savings from this program of approximately $3 billion through 2029. In summary, we now expect approximately $9.7 billion in total net savings from this program through 2029. These initiatives are expected to enhance operating efficiency, support continued operating margin expansion, and strengthen our ability to invest in innovation and future growth opportunities. Let me now turn to capital allocation. Our strategy is designed to enhance long-term shareholder value while preserving flexibility. It includes reinvesting in the business at appropriate returns, maintaining and over time growing our dividend, and preserving optionality for future value-enhancing actions, including share repurchases. In H1 2026, we invested $5.5 billion in internal and external R&D and returned $4.9 billion to shareholders via our quarterly dividend.
Speaker #4: We now expect total net cost savings from this program of approximately $3 billion through 2029. In summary, we now expect approximately $9.7 billion in total net savings from this program through 2029.
Speaker #4: This initiative are expected to enhance operating efficiency, support continued operating margin expansion, and strengthen our ability to invest in innovation and future growth opportunities.
Speaker #4: Let me now turn to capital allocation. Our strategy is designed to enhance long-term shareholder value while preserving flexibility. It includes reinvesting in the business at appropriate returns, maintaining and, over time, growing our dividends, and preserving optionality for future value-enhancing actions, including share repurchases.
Speaker #4: In the first half of 2026, we invested $5.5 billion in internal and external R&D, and returned $4.9 billion to shareholders via quarterly dividends.
Speaker #4: The Innovant Biologics deal closed in July, resulting in an initial $650 million fund payment to be recorded as acquired in-process R&D expense in the third quarter.
Cécile Guégan: The Innovent Biologics deal closed in July, resulting in an initial $650 million upfront payment to be recorded as acquired in-process R&D expense in Q3. Following this transaction, our BD capacity is approximately $6 billion. Q2 2026 operating cash flow was $3.45 billion, and leverage ended the quarter at 2.7x. Given the LOE impact over the next few years, we expect leverage to remain around current levels or modestly higher through this transition period. Earlier in the quarter, we made our final TCJA repatriation tax payment of approximately $2.6 billion and closed on our exit of these, providing approximately $1.65 billion in net cash proceeds. Based on our performance to date and continued execution, we are raising our full year 2026 guidance by $500 million at the midpoint to a range of $60.5 to 62.5 billion from $59.5 to 60.5 billion.
Cecile Guegan: The Innovent Biologics deal closed in July, resulting in an initial $650 million upfront payment to be recorded as acquired in-process R&D expense in Q3. Following this transaction, our BD capacity is approximately $6 billion. Q2 2026 operating cash flow was $3.45 billion, and leverage ended the quarter at 2.7x. Given the LOE impact over the next few years, we expect leverage to remain around current levels or modestly higher through this transition period.
Speaker #4: Following this transaction, our BD capacity is approximately 6 billion dollars. Second quarter 2026 operating cash flow was 3.45 billion dollars, and leverage ended the quarter at 2.7 times.
Speaker #4: Given the LOE impact over the next few years, we expect leverage to remain around the current level or modestly higher through this transition period. Earlier in the quarter, we made our final TCGA repatriation tax payment of approximately $2.6 billion and closed on our exit of these, providing approximately $1.65 billion in net cash proceeds.
Cecile Guegan: Earlier in the quarter, we made our final TCJA repatriation tax payment of approximately $2.6 billion and closed on our exit of these, providing approximately $1.65 billion in net cash proceeds. Based on our performance to date and continued execution, we are raising our full year 2026 guidance by $500 million at the midpoint to a range of $60.5 to 62.5 billion from $59.5 to 60.5 billion.
Speaker #4: Based on our performance to date, and continued execution, we are raising our full year 2026 guidance by 500 million dollars at the midpoint. To a range of 60.5 to 62.5, from 59.5 to 60.5 billion dollars.
Speaker #4: Our updated revenue guidance reflects strong non-COVID product performance, and revised revenue expectations of approximately 4 billion dollars down from 5 billion dollars for COVID-19 revenue.
Cécile Guégan: Our updated revenue guidance reflects strong non-COVID product performance and revised revenue expectations of approximately $4 billion, down from $5 billion for our COVID-19 revenue. We are reaffirming all other components of guidance, including adjusted diluted EPS guidance of $2.80 to $3. This EPS range now absorbs an unfavorable impact of approximately $0.10 related to the $650 million acquired in-process R&D charge from the Innovent Biologics transaction. This outlook reflects year-to-date performance, confidence in our business, progress with ongoing cost improvement initiatives, our expectation of adjusted gross margin in the mid-70s range, and continued investment to support growth by the end of the decade. Low COVID-19 incidents could continue to limit PAXLOVID utilization. Our plan also assumes that the majority of COMIRNATY sales will occur towards year-end, consistent with the vaccination season. As always, we will continue to monitor currency situation as the year progresses.
Cecile Guegan: Our updated revenue guidance reflects strong non-COVID product performance and revised revenue expectations of approximately $4 billion, down from $5 billion for our COVID-19 revenue. We are reaffirming all other components of guidance, including adjusted diluted EPS guidance of $2.80 to $3. This EPS range now absorbs an unfavorable impact of approximately $0.10 related to the $650 million acquired in-process R&D charge from the Innovent Biologics transaction. This outlook reflects year-to-date performance, confidence in our business, progress with ongoing cost improvement initiatives, our expectation of adjusted gross margin in the mid-70s range, and continued investment to support growth by the end of the decade.
Speaker #4: We are reaffirming all other components of guidance, including adjusted diluted EPS guidance of $2.80 to $3. This EPS range now absorbs an unfavored impact of approximately 10 cents related to the 650 million dollar acquired in-process R&D charge from the Innovant Biologics transaction.
Speaker #4: This outlook reflects year-to-date performance, confidence in our business, progress with ongoing cost improvement initiatives, our expectation of adjusted gross margin in the mid-70s range, and continued investment to support growth by the end of the decade.
Speaker #4: Low COVID-19 incidence could continue to limit Paxlovid utilization. Our plan also assumes that the majority of Comirnaty sales will occur toward year-end, consistent with the vaccination season.
Cecile Guegan: Low COVID-19 incidents could continue to limit PAXLOVID utilization. Our plan also assumes that the majority of COMIRNATY sales will occur towards year-end, consistent with the vaccination season. As always, we will continue to monitor currency situation as the year progresses.
Speaker #4: And as always, we will continue to monitor currency fluctuations as the year progresses. Now, I will wrap up with a few key points. Over the next several years, we will continue to position Pfizer for high single-digit revenue growth toward the end of the decade.
Cécile Guégan: I will wrap up with a few key points. Over the next several years, we will continue to position Pfizer for high single-digit revenue growth towards the end of the decade. We will invest in our business with focus and discipline, supporting continued progress with our R&D pipeline and driving commercial impact with our launched and acquired products. We remain committed to disciplined capital allocation with a continued focus on maintaining and, over the long term, growing our dividend while preserving balance sheet strength and flexibility. We will continue to operate with rigor and strategic focus, executing with discipline today while building a strong foundation for the future. I look forward to working with Albert and the entire executive leadership team as we help patients around the world and position Pfizer for long-term growth and shareholder value creation. With that, let me turn over to Chris.
Cecile Guegan: I will wrap up with a few key points. Over the next several years, we will continue to position Pfizer for high single-digit revenue growth towards the end of the decade. We will invest in our business with focus and discipline, supporting continued progress with our R&D pipeline and driving commercial impact with our launched and acquired products. We remain committed to disciplined capital allocation with a continued focus on maintaining and, over the long term, growing our dividend while preserving balance sheet strength and flexibility.
Speaker #4: We will invest in our business with focus and discipline, supporting continued progress with our R&D pipeline and driving commercial impact with our launched and acquired products.
Speaker #4: We remain committed to disciplined capital allocation, with a continued focus on maintaining—and, over the long term, growing—our dividends, while preserving balance sheet strength and flexibility.
Speaker #4: We will continue to operate with rigor and strategic focus, executing with discipline today, while building a strong foundation for the future. I look forward to working with Albert and the entire executive leadership team as we serve patients around the world and position Pfizer for long-term growth and shareholder value creation.
Cecile Guegan: We will continue to operate with rigor and strategic focus, executing with discipline today while building a strong foundation for the future. I look forward to working with Albert and the entire executive leadership team as we help patients around the world and position Pfizer for long-term growth and shareholder value creation. With that, let me turn over to Chris.
Speaker #4: With that, let me turn over to Chris.
Speaker #2: Thanks, Cecile. I will now provide additional color on the past quarter. Starting with the recent Phase 3 readout for Lutfullo in non-segmental vitiligo, a condition affecting more than a million adults in the US alone.
Chris Boshoff: Thanks, Cecile. I will now provide additional color on the past quarter, starting with the recent phase III readout for LITFULO in non-segmental vitiligo, a condition affecting more than 1 million adults in the US alone. In the TRANQUILLO program, both the 50 and 100 mg doses of LITFULO delivered significant, clinically meaningful improvements over placebo on co-primary endpoints for the facial and total body vitiligo area scoring index, or VASI. Specifically, the program measured the percentage of patients that achieve a 30% improvement from baseline, 75% for facial VASI and 50% for total VASI at week 52. On the right, data for LITFULO, an internally discovered molecule with unique mechanism of action targeting TEC family kinases and JAK3, alongside results from recent pivotal trials of oral JAK1 selective inhibitors. These data show placebo-adjusted percentages of participants achieving facial VASI 75%.
Chris Boshoff: Thanks, Cecile. I will now provide additional color on the past quarter, starting with the recent phase III readout for LITFULO in non-segmental vitiligo, a condition affecting more than 1 million adults in the US alone. In the TRANQUILLO program, both the 50 and 100 mg doses of LITFULO delivered significant, clinically meaningful improvements over placebo on co-primary endpoints for the facial and total body vitiligo area scoring index, or VASI. Specifically, the program measured the percentage of patients that achieve a 30% improvement from baseline, 75% for facial VASI and 50% for total VASI at week 52.
Speaker #2: In the Tranquilla program, both the 50 and 100 milligram doses of Lutfullo delivered significant clinically meaningful improvements, over placebo, on co-primary endpoints for the facial and total body vitiligo area scoring index, or VASI.
Speaker #2: Specifically, the program measured the percentage of patients that achieved a certain percent improvement from baseline—75% for facial VASI and 50% for total VASI—at week 52.
Speaker #2: On the right, data for Lutfullo and internally discovered molecule with unique mechanism of action targeting tech family kinases and JAK3, alongside results from recent pivotal trials of oral JAK1 selective inhibitors.
Chris Boshoff: On the right, data for LITFULO, an internally discovered molecule with unique mechanism of action targeting TEC family kinases and JAK3, alongside results from recent pivotal trials of oral JAK1 selective inhibitors. These data show placebo-adjusted percentages of participants achieving facial VASI 75%.
Speaker #2: These data show placebo-adjusted percentages of participants achieving facial VASI 75, at 100 milligram dose Lutfullo induced placebo-adjusted response rate of 19.5% at week 52, while cross-trial comparisons cannot support definitive conclusions we encouraged when viewing these facial VASI results alongside external comparative data.
Chris Boshoff: At 100-milligram dose, LITFULO induced a placebo-adjusted response rate of 19.5% at week 52. While cross-trial comparisons cannot support definitive conclusions, we are encouraged when viewing these facial VASI results alongside external comparator data. Management of vitiligo requires continued and durable treatment, which is why we are particularly encouraged by emerging data from our extension study demonstrating a sustained treatment effect with continued dosing at 100 milligrams out to 2 years. Moving to oncology. I will start with PADCEV, the transformative bladder cancer medicine from our Seagen transaction. Last month, the FDA expanded the approved indication of PADCEV plus pembrolizumab to muscle-invasive bladder cancer, regardless of cisplatin eligibility. The expansion was based on phase III results, showing a 35% reduction in the risk of death versus standard of care.
Chris Boshoff: At 100-milligram dose, LITFULO induced a placebo-adjusted response rate of 19.5% at week 52. While cross-trial comparisons cannot support definitive conclusions, we are encouraged when viewing these facial VASI results alongside external comparator data. Management of vitiligo requires continued and durable treatment, which is why we are particularly encouraged by emerging data from our extension study demonstrating a sustained treatment effect with continued dosing at 100 milligrams out to 2 years. Moving to oncology. I will start with PADCEV, the transformative bladder cancer medicine from our Seagen transaction. Last month, the FDA expanded the approved indication of PADCEV plus pembrolizumab to muscle-invasive bladder cancer, regardless of cisplatin eligibility. The expansion was based on phase III results, showing a 35% reduction in the risk of death versus standard of care.
Speaker #2: Management of vitiligo requires continued and durable treatment, which is why we are particularly encouraged by emerging data from our extension study demonstrating a sustained treatment effect with continued dosing at 100 milligrams out to two years.
Speaker #2: Moving to oncology, I'll start with Padcev, the transformative bladder cancer medicine from our Seagen transaction. Last month, the FDA expanded the approved indication of Padcev plus pembrolizumab to muscle invasive bladder cancer regardless of cisplatin eligibility.
Speaker #2: The expansion was based on Phase 3 results showing a 35% reduction in the risk of death versus standard of care. Together with prior data showing unprecedented survival benefits in the cisplatin ineligible muscle invasive and local advanced or metastatic settings, these results established Paxlovid as a potential practice-changing medicine for more than 42,000 patients in the US alone.
Chris Boshoff: Together with prior data showing unprecedented survival benefits in the cisplatin-ineligible muscle-invasive and locally advanced or metastatic settings, these results establish PADCEV as a potential practice-changing medicine for more than 42,000 patients in the US alone. This quarter, we also initiated a phase III trial in the bladder-sparing muscle-invasive bladder cancer setting, aiming to extend PADCEV transformative benefits even further and to offer an option for patients seeking to avoid cystectomy. Combined with our leading capabilities in small molecules and protein engineering, we are now advancing the next wave of potential ADC breakthroughs in the clinic, leveraging innovative linkers, payloads, and targets. Two I will highlight, GPS, which includes an auristatin S payload designed for improved tolerability, and IBI3028 from Innovent, a bispecific dual payload ADC integrating multiple clinically validated approaches.
Chris Boshoff: Together with prior data showing unprecedented survival benefits in the cisplatin-ineligible muscle-invasive and locally advanced or metastatic settings, these results establish PADCEV as a potential practice-changing medicine for more than 42,000 patients in the US alone. This quarter, we also initiated a phase III trial in the bladder-sparing muscle-invasive bladder cancer setting, aiming to extend PADCEV transformative benefits even further and to offer an option for patients seeking to avoid cystectomy. Combined with our leading capabilities in small molecules and protein engineering, we are now advancing the next wave of potential ADC breakthroughs in the clinic, leveraging innovative linkers, payloads, and targets. Two I will highlight, GPS, which includes an auristatin S payload designed for improved tolerability, and IBI3028 from Innovent, a bispecific dual payload ADC integrating multiple clinically validated approaches.
Speaker #2: This quarter, we also initiated a Phase 3 trial and the bladder sparing muscle invasive bladder cancer setting, aiming to extend Paxlovid transformative benefits even further and to offer an option for patients seeking to avoid cystectomy.
Speaker #2: Combined with our leading capabilities in small molecules and protein engineering, we are now advancing the next wave of potential ADC breakthroughs in the clinic, leveraging innovative linkers, payloads, and targets.
Speaker #2: Two I will highlight: GPS, which includes an Oristatin-S payload designed for improved tolerability; and 3028 from Innovent, a bispecific dual payload ADC integrating multiple clinically validated approaches.
Speaker #2: With these and other programs, we aim to cement Pfizer as a leading developer of ADCs, maximizing the value from recent transactions. In June, we announced the primary overall survival endpoint was not met in the intention to treat population, non-small cell, non-squamous, non-small cell lung cancer.
Chris Boshoff: With these and other programs, we aim to cement Pfizer as a leading developer of ADCs, maximizing the value from recent transactions. In June, we announced the primary overall survival endpoint was not met in the intention to treat population non-small cell, non-squamous lung cancer. Though a disappointing outcome, we were encouraged that the subgroup of patients who received only one prior line of therapy showed a median survival benefit of 2.5 months, 13.6 with SV versus 11.1 months with docetaxel. This suggests a survival benefit that is meaningful for patients. For context, standard of care ramucirumab plus docetaxel was approved based on a survival benefit of 1.4 months in its pivotal second-line trial, though no definitive conclusions can be drawn across studies.
Chris Boshoff: With these and other programs, we aim to cement Pfizer as a leading developer of ADCs, maximizing the value from recent transactions. In June, we announced the primary overall survival endpoint was not met in the intention to treat population non-small cell, non-squamous lung cancer. Though a disappointing outcome, we were encouraged that the subgroup of patients who received only one prior line of therapy showed a median survival benefit of 2.5 months, 13.6 with SV versus 11.1 months with docetaxel. This suggests a survival benefit that is meaningful for patients. For context, standard of care ramucirumab plus docetaxel was approved based on a survival benefit of 1.4 months in its pivotal second-line trial, though no definitive conclusions can be drawn across studies.
Speaker #2: Though a disappointing outcome, we were encouraged that the subgroup of patients who received only one prior line of therapy showed a median survival benefit of 2.5 months.
Speaker #2: 13.6 months with SV versus 11.1 months with docetaxel. This suggests a survival benefit that is meaningful for patients. For context, standard of care ramucirumab plus docetaxel was approved based on a survival benefit of 1.4 months in its pivotal second-line trial, though no definitive conclusions can be drawn across studies.
Speaker #2: Together with updated Phase 1 data, we are sharing today these results reinforce that SV has the potential to deliver meaningful activity in earlier lines of lung cancer.
Chris Boshoff: Together with updated phase I data we are sharing today, these results reinforce that SV has the potential to deliver meaningful activity in earlier lines of lung cancer. On the right are updated phase I data of SV plus pembrolizumab in first-line non-small cell lung cancer with high PD-L1 expression, the same regimen and indication as our ongoing phase III trial. These data show robust activity with an unconfirmed objective response rate of about 82%, including a complete response. This compares favorably to historical anti-PD-1 monotherapy. These data align with the ability of datopotamab deruxtecan ADCs to induce immunogenic cell death and thereby potentially synergize with anti-PD-1 agents such as pembrolizumab. We've seen meaningful activity when combining datopotamab deruxtecan with immune checkpoint blockers in our PADCEV, TIVDAK, and ADCETRIS programs, and we aim to extend this finding in SV's ongoing phase III trial.
Chris Boshoff: Together with updated phase I data we are sharing today, these results reinforce that SV has the potential to deliver meaningful activity in earlier lines of lung cancer. On the right are updated phase I data of SV plus pembrolizumab in first-line non-small cell lung cancer with high PD-L1 expression, the same regimen and indication as our ongoing phase III trial.
Speaker #2: On the right are updated Phase 1 data of SV plus pembrolizumab in first line non-small cell lung cancer with high PD-L1 expression. The same regimen and indication as our ongoing Phase 3 trial.
Speaker #2: These data show robust activity with an unconfirmed objective response rate of about 82%, including a complete response. This compares favorably to historical anti-PD-1 monotherapy.
Chris Boshoff: These data show robust activity with an unconfirmed objective response rate of about 82%, including a complete response. This compares favorably to historical anti-PD-1 monotherapy. These data align with the ability of datopotamab deruxtecan ADCs to induce immunogenic cell death and thereby potentially synergize with anti-PD-1 agents such as pembrolizumab. We've seen meaningful activity when combining datopotamab deruxtecan with immune checkpoint blockers in our PADCEV, TIVDAK, and ADCETRIS programs, and we aim to extend this finding in SV's ongoing phase III trial.
Speaker #2: These data align with the ability of certain ADCs to induce immunogenic cell death and thereby potentially synergize with anti-PD-1 agents such as pembrolizumab.
Speaker #2: We've seen meaningful activity when combining the dotant with immune checkpoint blockers in our Paxlovid, Tiftaq, and Acetraz programs, and we aim to extend this finding in SV's ongoing Phase 3 trial.
Speaker #2: Moving to 4404, our PD-1 VGF bispecific antibody that has the potential to be a next-generation backbone therapy. Of note, the ongoing Phase 1 dose escalation study of 4404 in combination with SV is showing early and encouraging response rates.
Chris Boshoff: Moving to 4404, our PD-1/VEGF bispecific antibody that has the potential to be a next-generation backbone therapy. Of note, the ongoing phase I dose escalation study of 4404 in combination with SV is showing early and encouraging response rates. Since in-licensing from 3SBio about a year ago, we started nine trials including two phase III studies. We have expanded the program's global reach with approximately 230 patients dosed outside of China to date, and are encouraged that the safety profile has remained consistent. Our goal is to develop 4404 as a potential best-in-class foundational therapy across multiple tumor types. Our ambitions with 4404 are supported by its differentiated profile recently presented at AACR, including in vitro data showing soluble VEGF-A affinity that is 30 to 60-fold higher than the PD-1 VEGF bispecific ivonescimab and the VEGF monoclonal antibody bevacizumab.
Chris Boshoff: Moving to 4404, our PD-1/VEGF bispecific antibody that has the potential to be a next-generation backbone therapy. Of note, the ongoing phase I dose escalation study of 4404 in combination with SV is showing early and encouraging response rates. Since in-licensing from 3SBio about a year ago, we started nine trials including two phase III studies. We have expanded the program's global reach with approximately 230 patients dosed outside of China to date, and are encouraged that the safety profile has remained consistent. Our goal is to develop 4404 as a potential best-in-class foundational therapy across multiple tumor types. Our ambitions with 4404 are supported by its differentiated profile recently presented at AACR, including in vitro data showing soluble VEGF-A affinity that is 30 to 60-fold higher than the PD-1 VEGF bispecific ivonescimab and the VEGF monoclonal antibody bevacizumab.
Speaker #2: Since in-licensing from 3S BioBody a year ago, we started nine trials, including two Phase 3 studies. We have expanded the program's global reach with approximately 230 patients dosed outside of China to date, and encouraged that the safety profile has remained consistent.
Speaker #2: Our goal is to develop 4404 as a potential best-in-class foundational therapy across multiple tumor types. Ambitions with 4404 are supported by its differentiated profile, recently presented at AACR, including in vitro data showing soluble VGF affinity that is 30- to 60-fold higher than the PD-1 VGF bispecific ivernosumab and the VGF monoclonal antibody bevacizumab.
Speaker #2: Our Phase 2 data remain encouraging, as a selected pivotal dose in first line PD-L1 positive non-small cell lung cancer, 4404 monotherapy generated a confirmed response rate of about 68% and median progressive free survival of about 12.4 months.
Chris Boshoff: Our phase II data remain encouraging at a selected pivotal dose in first-line PD-L1 positive non-small cell lung cancer, 4404 monotherapy generated a confirmed response rate of about 68% and median progressive free survival of about 12.4 months. As you can see on the right, these data compare favorably with ivonescimab's phase III results in this population, though cross-trial comparisons preclude definitive conclusions. Moving next to mevrometostat, our potential first-in-class internally discovered EZH2 inhibitor. EZH2 is the core catalytic subunit of the polycomb repressive complex 2, PRC2. Mevrometostat is currently in phase III development and the next potential breakthrough in our prostate franchise, including XTANDI and TALZENNA. Mevrometostat targets the underlying epigenetic mechanisms that drive resistance to androgen receptor pathway inhibitors such as XTANDI.
Chris Boshoff: Our phase II data remain encouraging at a selected pivotal dose in first-line PD-L1 positive non-small cell lung cancer, 4404 monotherapy generated a confirmed response rate of about 68% and median progressive free survival of about 12.4 months. As you can see on the right, these data compare favorably with ivonescimab's phase III results in this population, though cross-trial comparisons preclude definitive conclusions. Moving next to mevrometostat, our potential first-in-class internally discovered EZH2 inhibitor. EZH2 is the core catalytic subunit of the polycomb repressive complex 2, PRC2. Mevrometostat is currently in phase III development and the next potential breakthrough in our prostate franchise, including XTANDI and TALZENNA. Mevrometostat targets the underlying epigenetic mechanisms that drive resistance to androgen receptor pathway inhibitors such as XTANDI.
Speaker #2: As you can see on the right, these data compare favorably with Ivernosumab's Phase 3 results in this population, though cross-trial comparisons preclude definitive conclusions.
Speaker #2: Moving next to Macrometastat, our potential first-in-class internally discovered EZH2 inhibitor. EZH2 is the core catalytic subunit of the polychrome repressor complex 2 PRC2. Macrometastat is currently in Phase 3 development, and the next potential breakthrough in our prostate franchise including Xtandi and Talzenna.
Speaker #2: Macrometastat targets the underlying epigenetic mechanisms that drive resistance to androgen receptor pathway inhibitors such as Xtandi. We are encouraged by the randomized Phase 1 data in post-aberration hormone-resistant prostate cancer, showing radiographic progression-free survival more than doubling with Macrometastat plus Xtandi versus Xtandi alone.
Chris Boshoff: We are encouraged by the randomized phase I data in post-abiraterone hormone-resistant prostate cancer, showing radiographic progressive free survival more than doubling with mevrometostat plus XTANDI versus XTANDI alone. This translated to a 49% reduction in risk of disease progression or death. We are taking a comprehensive approach with mevrometostat's development, with three pivotal studies underway, including MEVPRO-1, evaluating mevrometostat plus XTANDI versus either XTANDI or docetaxel in post-abiraterone metastatic hormone-resistant prostate cancer. Each of these studies is event driven, with the first readout expected for MEVPRO-1 in Q4 based on the current event rate. In MEVPRO-1, our goal is to delay resistance to XTANDI, which has historically delivered radiographic progression-free survival of about 5 to 8 months in similar settings. Obesity is a core focus area for our R&D organization.
Chris Boshoff: We are encouraged by the randomized phase I data in post-abiraterone hormone-resistant prostate cancer, showing radiographic progressive free survival more than doubling with mevrometostat plus XTANDI versus XTANDI alone. This translated to a 49% reduction in risk of disease progression or death. We are taking a comprehensive approach with mevrometostat's development, with three pivotal studies underway, including MEVPRO-1, evaluating mevrometostat plus XTANDI versus either XTANDI or docetaxel in post-abiraterone metastatic hormone-resistant prostate cancer. Each of these studies is event driven, with the first readout expected for MEVPRO-1 in Q4 based on the current event rate. In MEVPRO-1, our goal is to delay resistance to XTANDI, which has historically delivered radiographic progression-free survival of about 5 to 8 months in similar settings. Obesity is a core focus area for our R&D organization.
Speaker #2: This translated to a 49% reduction in risk of disease progression or death. We are taking a comprehensive approach with Macrometastat's development with three pivotal studies underway, including Macro 1, evaluating Macrometastat plus Xtandi versus either Xtandi or dosetaxel in post-aberration metastatic hormone resistant prostate cancer.
Speaker #2: Each of these studies is event-driven, with the first readout expected for Macro 1 in the fourth quarter based on the current event rate. In Macro 1, our goal is to delay resistance to Xtandi, which has historically delivered radiographic progression-free survival of about 5 to 8 months in similar settings.
Speaker #2: Obesity is a core focus area for R&D organization. In June, we presented Phase 2B data supporting better benetized potential as a first-in-class monthly GLP-1 receptor agonist peptide and foundational metabolic medicine.
Chris Boshoff: In June, we presented phase II-B data supporting tirzepatide's potential as a first-in-class monthly GLP-1 receptor agonist peptide and foundational metabolic medicine. Shown here are phase II-B ADA data on monthly tirzepatide at 4.8 mg, which is our median phase III dose. At this dose, we achieved placebo-corrected weight loss of up to 12.3% in our VESPER-3 trial. Though cross-trial comparisons cannot support definitive conclusions, it is encouraging that tirzepatide achieved week 28 efficacy that was similar to tirzepatide's medium dose of 10 mg in the SURMOUNT-1 study, and potentially better than semaglutide's median approved dose of 2.4 mg in step one. We also presented the first results at our high phase III dose, 2.4 mg weekly or 9.6 mg monthly from phase II-B VESPA1 extension participants who escalated from placebo to 2.4 mg weekly tirzepatide. Participants achieved approximately 16% mean weight loss over 32 weeks of treatment.
Chris Boshoff: In June, we presented phase II-B data supporting tirzepatide's potential as a first-in-class monthly GLP-1 receptor agonist peptide and foundational metabolic medicine. Shown here are phase II-B ADA data on monthly tirzepatide at 4.8 mg, which is our median phase III dose. At this dose, we achieved placebo-corrected weight loss of up to 12.3% in our VESPER-3 trial. Though cross-trial comparisons cannot support definitive conclusions, it is encouraging that tirzepatide achieved week 28 efficacy that was similar to tirzepatide's medium dose of 10 mg in the SURMOUNT-1 study, and potentially better than semaglutide's median approved dose of 2.4 mg in step one.
Speaker #2: Shown here are Phase 2B ADA data on monthly berobenetide at 4.8 milligrams, which is our median Phase 3 dose. At this dose, we achieved placebo-corrected weight loss of up to 12.3% in our Phase 3 trial.
Speaker #2: Though cross-trial comparisons cannot support definitive conclusions, it is encouraging that berobenetide achieved week 28 efficacy that was similar to Tocepatide's medium dose of 10 milligrams in this amount one study, and potentially better than semaglutide's median approved dose of 2.4 milligrams in step one.
Speaker #2: We also presented the first results at our high Phase 3 dose, 2.4 milligram weekly or 9.6 milligrams monthly from Phase 2B Vesper 1 extension participants who escalated from placebo to 2.4 milligram weekly berobenetide.
Chris Boshoff: We also presented the first results at our high phase III dose, 2.4 mg weekly or 9.6 mg monthly from phase II-B VESPA1 extension participants who escalated from placebo to 2.4 mg weekly tirzepatide. Participants achieved approximately 16% mean weight loss over 32 weeks of treatment.
Speaker #2: Participants achieved approximately 16% mean weight loss over 32 weeks of treatment. Importantly, there were no treatment discontinuations due to treatment-emergent adverse events in any of the arms evaluating maintenance doses moving to Phase 3.
Chris Boshoff: Importantly, there were no treatment discontinuations due to treatment emergent adverse events in any of the arms evaluating maintenance doses moving to phase III. On the right is a model-based meta-analysis of data from over 32,000 participants to project 72-week weight loss for berobenatide's high monthly phase III dose relative to the highest approved doses of tirzepatide and semaglutide. As with our clinical data from VESPER-3 monthly study, the analysis suggests berobenatide can deliver weight loss comparable to tirzepatide and potentially better than semaglutide. We see high concordance between the high dose VESPER-1 extension study and the model's predictions, further increasing our confidence that berobenatide can potentially deliver robust efficacy and favorable GI tolerability with the convenience of a monthly therapy. Since closing the Metsera transaction about 8 months ago, we've advanced berobenatide towards the first of a series of potential approvals beginning in 2028.
Chris Boshoff: Importantly, there were no treatment discontinuations due to treatment emergent adverse events in any of the arms evaluating maintenance doses moving to phase III. On the right is a model-based meta-analysis of data from over 32,000 participants to project 72-week weight loss for berobenatide's high monthly phase III dose relative to the highest approved doses of tirzepatide and semaglutide.
Speaker #2: On the right is a model-based meta-analysis of data from over 32,000 participants to project 72-week weight loss for berobenetide's high monthly Phase 3 dose, relative to the highest approved doses of tocepatide and semaglutide.
Speaker #2: As with our clinical data from the Vesper 3-monthly study, the analysis suggests that berobenetide can deliver weight loss comparable to Tocepatide and potentially better than semaglutide.
Chris Boshoff: As with our clinical data from VESPER-3 monthly study, the analysis suggests berobenatide can deliver weight loss comparable to tirzepatide and potentially better than semaglutide. We see high concordance between the high dose VESPER-1 extension study and the model's predictions, further increasing our confidence that berobenatide can potentially deliver robust efficacy and favorable GI tolerability with the convenience of a monthly therapy. Since closing the Metsera transaction about 8 months ago, we've advanced berobenatide towards the first of a series of potential approvals beginning in 2028.
Speaker #2: We see high concordance between the high-dose VESPER 1 extension study and the model's predictions, further increasing our confidence that berobenetide can potentially deliver robust efficacy and favorable GI tolerability with the convenience of a monthly therapy.
Speaker #2: Since closing the Mecera transaction about eight months ago, we've advanced berobenetide toward the first of a series of potential approvals, beginning in 2028. Today, we have three ongoing Phase 3 trials.
Chris Boshoff: Today, we have three ongoing phase III trials. The now fully enrolled VESPER-4 and VESPER-5 studies of weekly berobenatide and the VESPER-6 study evaluating monthly dosing. We plan to advance 10 phase III studies in 2026, including one evaluating participants switching from approved weekly therapies to monthly berobenatide. Our obesity portfolio includes injectables with the potential for monthly or longer dosing, once-daily orals, and novel combinations. The most advanced combination is berobenatide plus the ultra long-acting amylin, AMYL-3945, which we are developing as potential first-in-category monthly medicine. We expect to report data from phase I/II-A studies of 3945 monotherapy and the berobenatide combination this year. As is typical for small, early-stage studies, these were designed to inform starting doses and potential escalation regimens for further evaluation in phase IIb. Our phase IIb SOLIS-1 study has already enrolled more than half of approximately 900 planned participants.
Chris Boshoff: Today, we have three ongoing phase III trials. The now fully enrolled VESPER-4 and VESPER-5 studies of weekly berobenatide and the VESPER-6 study evaluating monthly dosing. We plan to advance 10 phase III studies in 2026, including one evaluating participants switching from approved weekly therapies to monthly berobenatide. Our obesity portfolio includes injectables with the potential for monthly or longer dosing, once-daily orals, and novel combinations.
Speaker #2: The now fully enrolled Vesper 4 and 5 studies of weekly berobenetide and the Vesper 6 study evaluating monthly dosing. We plan to advance 10 Phase 3 studies in 2026, including one evaluating participants switching from approved weekly therapies to monthly berobenetide.
Speaker #2: Our obesity portfolio includes injectables with the potential for monthly or longer dosing. Once daily orals and novel combinations. The most advanced combinations berobenetide plus the ultra-long-acting amyline, amylog, 3945, which we are developing as potential first in category monthly medicine.
Chris Boshoff: The most advanced combination is berobenatide plus the ultra long-acting amylin, AMYL-3945, which we are developing as potential first-in-category monthly medicine. We expect to report data from phase I/II-A studies of 3945 monotherapy and the berobenatide combination this year. As is typical for small, early-stage studies, these were designed to inform starting doses and potential escalation regimens for further evaluation in phase IIb. Our phase IIb SOLIS-1 study has already enrolled more than half of approximately 900 planned participants.
Speaker #2: We expect to report data from Phase 1 and 2a studies of 3945 monotherapy and the berobenetide combination this year. As is typical for small, early-stage studies, these were designed to inform starting doses and potential escalation regimens for further evaluation in Phase 2b.
Speaker #2: Our Phase 2B SOLIS 1 study has already enrolled more than half of the approximately 900 planned participants. We expect data from SOLIS 1 in 2027, providing us with the first robust efficacy data from our amyline, monotherapy, and combination programs.
Chris Boshoff: We expect data from SOLIS-1 in 2027, providing us with the first robust efficacy data from our amylin monotherapy and combination programs. Looking ahead, our efforts in R&D will continue to be defined by focused execution. Here we provide visibility into the steady cadence of milestones expected over the next 12 months, including five regulatory decisions, eight key readouts, and 19 pivotal study starts. With that, I'll hand it over to Albert.
Chris Boshoff: We expect data from SOLIS-1 in 2027, providing us with the first robust efficacy data from our amylin monotherapy and combination programs. Looking ahead, our efforts in R&D will continue to be defined by focused execution. Here we provide visibility into the steady cadence of milestones expected over the next 12 months, including five regulatory decisions, eight key readouts, and 19 pivotal study starts. With that, I'll hand it over to Albert.
Speaker #2: Looking ahead, our efforts in R&D will continue to be defined by focused execution. Here, we provide visibility into the steady cadence of milestones expected over the next 12 months, including five regulatory decisions.
Speaker #2: Eight key readouts and 19 pivotal study starts. With that, I'll hand it over to Albert.
Speaker #1: Thank you, Chris. Very nice update. Let's move to Q&A. I'm sure there are a lot of questions. Operator, please assemble the queue.
Albert Bourla: Thank you, Chris. Very nice update. Let's move to Q&A. I'm sure there are a lot of questions. Operator, please assemble the queue.
Albert Bourla: Thank you, Chris. Very nice update. Let's move to Q&A. I'm sure there are a lot of questions. Operator, please assemble the queue.
Speaker #3: Thank you. If you'd like to ask a question, press star 1 on your keypad. To leave the queue at any time, press star 2.
Operator 2: Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. Our first question today will come from Evan Seigerman with BMO Capital Markets. Your line is now open.
Operator: Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. Our first question today will come from Evan Seigerman with BMO Capital Markets. Your line is now open.
Speaker #3: Once again, that is star 1 to ask a question. Our first question today will come from Evan Zegerman with BMO Capital Markets. Your line is now open.
Speaker #4: Hi all. Thank you so much for taking my question. Before I ask my question, I want to express my gratitude and congratulations to Dave.
Evan Seigerman: Hi, all. Thank you so much for taking my question. Before I ask my question, I want to express my gratitude and congratulations to Dave. You'll be missed. Cecile, we're looking forward to working with you. Ahead of the MEVPRO-1 data, Chris, I'd love it if you could help us define how you view success. Does this study need to reproduce the phase I magnitude of benefit, or demonstrating a clinically meaningful delay in AR pathway resistance be enough to validate the mechanism and potentially support broad adoption in a clinical setting? Thank you so much.
Evan Seigerman: Hi, all. Thank you so much for taking my question. Before I ask my question, I want to express my gratitude and congratulations to Dave. You'll be missed. Cecile, we're looking forward to working with you. Ahead of the MEVPRO-1 data, Chris, I'd love it if you could help us define how you view success. Does this study need to reproduce the phase I magnitude of benefit, or demonstrating a clinically meaningful delay in AR pathway resistance be enough to validate the mechanism and potentially support broad adoption in a clinical setting? Thank you so much.
Speaker #4: You'll be missed, Cecile, but we're looking forward to working with you. So, ahead of the MEVPRO 1 data, Chris, I'd love it if you could help us define how you view success.
Speaker #4: Does this study need to reproduce the Phase 1 magnitude of benefit? Would demonstrating it clinically meaningful delay in AR pathway resistance be enough to validate the mechanism and potentially support broad adoption in the clinical setting?
Speaker #4: Thank you so much.
Speaker #1: Thank you very much for the question. We continue to be excited about the potential of MEVPRO Metastat to become a breakthrough therapy in prostate cancer.
Chris Boshoff: Thank you very much for the question. We are continued to be excited about the potential of mevrometostat to become a breakthrough therapy in prostate cancer. I want to also address the Q4 readout and how we are thinking about it. Phase I data, as you've seen, showed a hazard ratio of 0.5, doubling radiographic progressive free survival, and our data are now validated by some competitors with EZH2 or PRC2 inhibitor data in prostate cancer, although these are obviously earlier studies. MEVPRO 1, 2, and 3 are event-driven studies, meaning control and experimental arm is where events could happen. However, the statistical analysis plan is based on a clinically meaningful benefit of approximately 30% over standard of care, because that'll be clinically meaningful.
Chris Boshoff: Thank you very much for the question. We are continued to be excited about the potential of mevrometostat to become a breakthrough therapy in prostate cancer. I want to also address the Q4 readout and how we are thinking about it. Phase I data, as you've seen, showed a hazard ratio of 0.5, doubling radiographic progressive free survival, and our data are now validated by some competitors with EZH2 or PRC2 inhibitor data in prostate cancer, although these are obviously earlier studies. MEVPRO 1, 2, and 3 are event-driven studies, meaning control and experimental arm is where events could happen. However, the statistical analysis plan is based on a clinically meaningful benefit of approximately 30% over standard of care, because that'll be clinically meaningful.
Speaker #1: I want to also address the Q4 readout and how we are thinking about it. Phase 1 data, as you've seen, showed a hazard ratio of 0.5, doubling radiographic progression-free survival.
Speaker #1: And our data are validated by some competitors with EZH2 or PRC2 inhibitor data in prostate cancer, although these are obviously earlier studies. MEVPRO 1, 2, and 3 are event-driven studies, meaning the control and experimental arms are where events could happen.
Speaker #1: However, the statistical analysis plan is based on a clinically meaningful benefit of approximately 30% over standard of care, because that will be clinically meaningful.
Chris Boshoff: It's hazard ratio-based, and as I pointed out, we expect the standard of care, the control arm, to perform at five to eight months in this setting. Altogether, we are confident in the performance of the experimental arm in MEVPRO 1, and we're looking forward to share update of a potential next breakthrough for prostate cancer later this year. Thank you.
Speaker #1: And its hazard ratio is based, and as I pointed out, we expect the standard of care for the control arm to perform at 5 to 8 months in this setting.
Chris Boshoff: It's hazard ratio-based, and as I pointed out, we expect the standard of care, the control arm, to perform at five to eight months in this setting. Altogether, we are confident in the performance of the experimental arm in MEVPRO 1, and we're looking forward to share update of a potential next breakthrough for prostate cancer later this year. Thank you.
Speaker #1: So altogether, we are confident in the performance of the experimental arm in MEVPRO 1, and we're looking forward to sharing an update on the potential next breakthrough for prostate cancer later this year.
Speaker #1: Thank you. Excellent. We can't wait to see the final results. Let's move to the next question, please.
Albert Bourla: Excellent. We can't wait to see the final results. Let's move to the next question, please.
Albert Bourla: Excellent. We can't wait to see the final results. Let's move to the next question, please.
Speaker #3: Our next question comes from Chris Schott with JPMorgan. Your line is now open.
Operator 2: Our next question comes from Chris Schott with J.P. Morgan. Your line is now open.
Operator: Our next question comes from Chris Schott with J.P. Morgan. Your line is now open.
Speaker #4: Great, thank you so much for the questions. Just two for me. First, I want to dig into the $1.5 billion increase in the non-COVID guidance.
Chris Schott: Great. Thanks so much for the questions. Just two from me. First, I wanted to dig into the $1.5 billion increase in the non-COVID guidance. Can you just comment on how much of this is coming from Eliquis versus the rest of the business? Specifically, what's in the guidance now for Eliquis growth? I think your partner's talking about 20% to 25% growth this year. Second question was just on Padcev. With the further label expansion, just talk a little bit about how we should think about growth for that asset from here going forward. Thanks so much.
Chris Schott: Great. Thanks so much for the questions. Just two from me. First, I wanted to dig into the $1.5 billion increase in the non-COVID guidance. Can you just comment on how much of this is coming from Eliquis versus the rest of the business? Specifically, what's in the guidance now for Eliquis growth? I think your partner's talking about 20% to 25% growth this year. Second question was just on Padcev. With the further label expansion, just talk a little bit about how we should think about growth for that asset from here going forward. Thanks so much.
Speaker #4: Can you just comment on how much of this is coming from Eliquis versus the rest of the business? And I guess specifically, what's in the guidance now for Eliquis growth?
Speaker #4: I think your partner is talking about 20% to 25% growth this year. Second question was just on Padcev. I guess with the further label expansion, just talk a little bit about how we should think about growth for that asset from here going forward.
Speaker #4: Thanks so much.
Speaker #1: All right. Why don't we start with Cecile on the guidance?
Albert Bourla: All right. Why don't we start with Cecile on the guidance?
Albert Bourla: All right. Why don't we start with Cecile on the guidance?
Speaker #5: Thank you, Chris, for your question. As I described, our performance on the non-COVID portfolio is definitely very strong, both in the U.S. and internationally.
Cécile Guégan: Thank you, Chris, for your question. As I described, our performance on the non-COVID portfolio is definitely very strong, both in the US and in international. That's not one single driver. It's definitely strong execution in both US and international businesses. The strength of our business led to the incremental $1.5 billion above the original guidance. It is a reflection of one, exceeding our expectation in Q1 and Q2 on non-COVID portfolio. It also reflects the confidence in the momentum across our overall business. It comes from our key products, Eliquis being one of them, with a driver that our partner BMS has described, but it's also coming from our launched and acquired products. As I mentioned earlier, 27% of growth, if you exclude the one-time impact that we had in 2025.
Cecile Guegan: Thank you, Chris, for your question. As I described, our performance on the non-COVID portfolio is definitely very strong, both in the US and in international. That's not one single driver. It's definitely strong execution in both US and international businesses. The strength of our business led to the incremental $1.5 billion above the original guidance. It is a reflection of one, exceeding our expectation in Q1 and Q2 on non-COVID portfolio. It also reflects the confidence in the momentum across our overall business. It comes from our key products, Eliquis being one of them, with a driver that our partner BMS has described, but it's also coming from our launched and acquired products. As I mentioned earlier, 27% of growth, if you exclude the one-time impact that we had in 2025.
Speaker #5: And that's not one single driver. It's definitely strong execution in both U.S. and international businesses. The strength of our business that led to the incremental $1.5 billion above the original guidance is a reflection of, one, exceeding our expectations in Q1 and Q2 on the non-COVID portfolio, but it also reflects the confidence in the momentum across our overall business.
Speaker #5: It comes from our it comes from our key products, Eliquis being one of them, with a driver that our partner BMS has described, but it's also coming from our large and acquired products.
Speaker #5: As I mentioned earlier, it's 27% gross if you exclude the one-time impact that we add in 2025. Some of the drivers you have seen where we are showing very strong performance are especially Nurtec and Padcev.
Cécile Guégan: Some of the drivers that you have seen where we have very strong performance, especially on NURTEC and PADCEV. I'll just comment on the COVID business. To say that obviously the performance that we have to date reflects the low infection level, mostly impacting PAXLOVID. We remain with our revenues for COMIRNATY in the later part of the year, consistent with the vaccination season. As a reminder also, our COMIRNATY business for international is mostly secured through the government contracts, including EC. Overall, very strong performance across the board on our non-COVID, which translates into the raise in revenue and also translates into EPS, which is then offset by the $0.10 linked to the AI IPR&D.
Cecile Guegan: Some of the drivers that you have seen where we have very strong performance, especially on NURTEC and PADCEV. I'll just comment on the COVID business. To say that obviously the performance that we have to date reflects the low infection level, mostly impacting PAXLOVID. We remain with our revenues for COMIRNATY in the later part of the year, consistent with the vaccination season. As a reminder also, our COMIRNATY business for international is mostly secured through the government contracts, including EC. Overall, very strong performance across the board on our non-COVID, which translates into the raise in revenue and also translates into EPS, which is then offset by the $0.10 linked to the AI IPR&D.
Speaker #5: I'll just comment on the COVID business, just to say that obviously the performance that we have to date reflects the low infection level, mostly impacting Paxlovid.
Speaker #5: But we remain with our revenues for Comirnaty in the later part of the year, consistent with the vaccination season. And, as a reminder, also our COVID or Comirnaty business internationally is mostly secured through government contracts, including ECT.
Speaker #5: So overall, very strong performance across the board on our non-COVID, which translates into the raise in revenue and also translates into EPS, which is then offset by the $0.10 linked to the AIPR, indeed.
Speaker #1: Thank you. Amir, we would like to take the second question.
Albert Bourla: Thank you. Aamir, would you like to take the second question?
Albert Bourla: Thank you. Aamir, would you like to take the second question?
Speaker #4: Sure. Chris, I think what's exciting on Padcev is if you think about the data Chris shared are indicated uses for Padcev and Pembro now span the entire continuum all the way from curative intent MIBC through to metastatic disease, all independent of cisplatin and eligibility.
Aamir Malik: Sure. Chris, I think what's exciting on PADCEV is if you think about the data Chris shared, our indicated uses for PADCEV and pembro now span the entire continuum, all the way from curative intent-MIBC through to metastatic disease, all independent of cisplatin and eligibility. We've executed really well against that in the growing patient population that we have. Q2 was really strong. We grew over 20%. A very big part of that is the terrific commercial execution from our PADCEV team. We've driven la/mUC new patient share to now above 60%.
Aamir Malik: Sure. Chris, I think what's exciting on PADCEV is if you think about the data Chris shared, our indicated uses for PADCEV and pembro now span the entire continuum, all the way from curative intent-MIBC through to metastatic disease, all independent of cisplatin and eligibility. We've executed really well against that in the growing patient population that we have. Q2 was really strong. We grew over 20%. A very big part of that is the terrific commercial execution from our PADCEV team. We've driven la/mUC new patient share to now above 60%.
Speaker #4: And we've executed really well against that in the growing patient population that we have. Q2 was really strong—we grew over 20%. A very big part of that is the terrific commercial execution from our Padcev team.
Speaker #4: We've driven LAMUC new patient share to now above 60%, and we're also really pleased with the uptake that we have in the MIBC setting.
Aamir Malik: We're also really pleased with the uptake that we have in the MIBC setting. So far, most of that prescribing is in the neoadjuvant setting, and obviously we expect those patients to reach adjuvant treatment over time. To your question about what to expect, we obviously think PAXLOVID is going to be a major growth engine for us going forward. We've had very accelerated growth to date. The pace of that growth, of course, is going to moderate from here as we reach the majority of eligible patients and prescribers in LA and UC, but we'll continue to drive that opportunity. The upside for us will come through MIBC and continue over time.
Aamir Malik: We're also really pleased with the uptake that we have in the MIBC setting. So far, most of that prescribing is in the neoadjuvant setting, and obviously we expect those patients to reach adjuvant treatment over time. To your question about what to expect, we obviously think PAXLOVID is going to be a major growth engine for us going forward. We've had very accelerated growth to date. The pace of that growth, of course, is going to moderate from here as we reach the majority of eligible patients and prescribers in LA and UC, but we'll continue to drive that opportunity. The upside for us will come through MIBC and continue over time.
Speaker #4: So far, most of that prescribing is in the neoadjuvant setting, and obviously, we expect those patients to reach adjuvant treatment over time. To your question about what to expect, we obviously think Padcev is going to be a major growth engine for us going forward.
Speaker #4: We've had very accelerated growth to date. The pace of that growth, of course, is going to moderate from here as we reach the majority of eligible patients and prescribers in LAMUC, but we'll continue to drive that opportunity.
Speaker #4: And then the upside for us will come through MIBC and continue over time.
Speaker #1: And I also want to emphasize that there is a very important study that we have initiated, which, if positive, would be very exciting. This study focuses on bladder-sparing opportunities, so that those patients will not have to go through this horrible operation.
Chris Boshoff: I want also to emphasize that there is a very important study that we have initiated that, if positive, would be very exciting. It is in bladder-sparing opportunities so that those patients will not have to go through this horrible operation. That would be really a big deal if we will achieve it. Next question, please.
Albert Bourla: I want also to emphasize that there is a very important study that we have initiated that, if positive, would be very exciting. It is in bladder-sparing opportunities so that those patients will not have to go through this horrible operation. That would be really a big deal if we will achieve it. Next question, please.
Speaker #1: That will really be a big deal if we achieve it. So, next question, please.
Speaker #3: Our next question comes from Umar Rafit with Evercore ISI. Your line is now open.
Operator 2: Our next question comes from Umer Raffat with Evercore ISI. Your line is now open.
Operator: Our next question comes from Umer Raffat with Evercore ISI. Your line is now open.
Speaker #4: Hi, guys. Thanks for taking my question. I just wanted to focus on the EZH2 for a quick second, and maybe a two-part question for Chris and for Amir, if I may.
Umer Raffat: Hi, guys. Thanks for taking my question. I just wanted to focus on the EZH2 for a quick second and maybe a two-part question for Chris and for Aamir, if I may. Chris, I appreciate the readout is not till Q4, but I just wanted to confirm that the trial was fully enrolled as of May, not as of last December, and that you have not hit those 302 PFS events yet. Aamir, in a scenario this trial hits, how large a commercial opportunity is this? Should we be thinking XTANDI-like? Thank you.
Umer Raffat: Hi, guys. Thanks for taking my question. I just wanted to focus on the EZH2 for a quick second and maybe a two-part question for Chris and for Aamir, if I may. Chris, I appreciate the readout is not till Q4, but I just wanted to confirm that the trial was fully enrolled as of May, not as of last December, and that you have not hit those 302 PFS events yet. Aamir, in a scenario this trial hits, how large a commercial opportunity is this? Should we be thinking XTANDI-like? Thank you.
Speaker #4: Chris, I appreciate the readout is not till Q4, but I just wanted to confirm that the trial was fully enrolled as of May, not as of last December, and that you have not hit those 302 PFS events yet.
Speaker #4: And Amir, in a scenario where this trial hits, how large a commercial opportunity is this? Should we be thinking Xtandi-like? Thank you.
Speaker #1: Thank you. Thank you very much. I'll start. Thank you for the question. This trial definitely fully enrolled and we have not reached the we have not reached the events.
Chris Boshoff: Thank you. Thank you very much. I'll start. Thank you for the question. This trial is definitely fully enrolled, and we have not reached the events for the study, just to confirm. Events not reached as outlined in the statistical analysis plan. Aamir?
Chris Boshoff: Thank you. Thank you very much. I'll start. Thank you for the question. This trial is definitely fully enrolled, and we have not reached the events for the study, just to confirm. Events not reached as outlined in the statistical analysis plan.
Speaker #1: For the study, just to confirm—so, events not reached as outlined in the statistical analysis plan. And, Amir?
Albert Bourla: Aamir?
Speaker #4: Yeah. Umar, thanks for the question. I think we're obviously very excited about this. If we are successful, I think the opportunity can scale across the entire disease continuum from post-abiraterone to earlier line settings.
Aamir Malik: Umer, thanks for the question. I think we're obviously very excited about this. If we are successful, I think the opportunity can scale across the entire disease continuum from post-abiraterone to early-line settings. I think that's exciting for us. The other thing I will point out is that MEVPRO will be a 100% global opportunity for Pfizer. We have the opportunity not only in the US, but to capture share and value in markets outside the US as well, which is distinct from our situation with XTANDI. Yes, we're very excited about this.
Aamir Malik: Umer, thanks for the question. I think we're obviously very excited about this. If we are successful, I think the opportunity can scale across the entire disease continuum from post-abiraterone to early-line settings. I think that's exciting for us. The other thing I will point out is that MEVPRO will be a 100% global opportunity for Pfizer. We have the opportunity not only in the US, but to capture share and value in markets outside the US as well, which is distinct from our situation with XTANDI. Yes, we're very excited about this.
Speaker #4: So I think that's exciting for us. The other thing that I will point out is that Mevro will be a 100% global opportunity for Pfizer.
Speaker #4: So, we have the opportunity not only in the US, but to capture share and value in markets outside the US as well, which is distinct from our situation with Xtandi.
Speaker #4: So yes, we're very excited about this.
Speaker #1: Thank you very much. Next question, please.
Chris Boshoff: Thank you very much. Next question, please.
Albert Bourla: Thank you very much. Next question, please.
Speaker #3: Our next question will come from Jeff Meacham with Citibank. Your line is now open.
Operator 2: Our next question will come from Geoff Meacham with Citi. Your line is now open.
Operator: Our next question will come from Geoff Meacham with Citi. Your line is now open.
Speaker #6: Hey everyone. Thanks so much for the question. I guess one for Chris on Verabenetide. What do you guys ultimately looking for in the combo studies?
Geoff Meacham: Hey, everyone. Thanks so much for the question. I guess one for Chris on berobenatide. What are you guys ultimately looking for in the combo studies? Is it quarterly dosing? Is it indications outside of diabetes? Is it tirzepatide-like efficacy? Just wanted to get some perspective on that, how are you looking at the tolerability bar from a competitive standpoint? Thank you.
Geoff Meacham: Hey, everyone. Thanks so much for the question. I guess one for Chris on berobenatide. What are you guys ultimately looking for in the combo studies? Is it quarterly dosing? Is it indications outside of diabetes? Is it tirzepatide-like efficacy? Just wanted to get some perspective on that, how are you looking at the tolerability bar from a competitive standpoint? Thank you.
Speaker #6: Is it quarterly dosing? Are there indications outside of diabetes? Is it retatrutide-like efficacy? I just wanted to get some perspective on that. And then, how are you looking at the tolerability bar from a competitive standpoint?
Speaker #6: Thank you.
Speaker #1: Thank you for the question. So as we pointed out, the Amilen is unique. It's ultra-long. It's a potential monthly therapy. So the ongoing phase one and two A study was really to determine the optimal dose that's tolerable to start the study, the safety, and the clinical pharmacology, the PK.
Chris Boshoff: Thank you for the question. As we pointed out, the amylin is unique. It's ultra-long. It's a potential monthly therapy. The ongoing phase I and II-A study was really to determine the optimal dose that's tolerable to start the study, the safety, and the clinical pharmacology, the PK. That informs the phase II-B study, which is now ongoing SOLIS-1, which is controlled with placebo for efficacy. Expect the SOLIS-1 study to read out in 2027. Monthly differentiated, we obviously want to see efficacy that's more than with berobenatide alone. What we've seen so far with the combination early on is obviously well-tolerated, we hope to report that later this year and early next year. Thank you. Thank you very much. Next question, please.
Chris Boshoff: Thank you for the question. As we pointed out, the amylin is unique. It's ultra-long. It's a potential monthly therapy. The ongoing phase I and II-A study was really to determine the optimal dose that's tolerable to start the study, the safety, and the clinical pharmacology, the PK. That informs the phase II-B study, which is now ongoing SOLIS-1, which is controlled with placebo for efficacy. Expect the SOLIS-1 study to read out in 2027. Monthly differentiated, we obviously want to see efficacy that's more than with berobenatide alone. What we've seen so far with the combination early on is obviously well-tolerated, we hope to report that later this year and early next year.
Speaker #1: And that then informed the two B study, which is now ongoing Solis 1, which is controlled for with placebo for efficacy. So expect the solid Solis 1 study to read out in 2027.
Speaker #1: Monthly differentiated, we obviously want to see efficacy that's more than with Verabenetide alone. And what we've seen so far with a combination early on is obviously well tolerated.
Speaker #1: So we hope to report that later this year and early next year. Thank you. Thank you very much. Next question, please.
Albert Bourla: Thank you. Thank you very much. Next question, please.
Speaker #3: Our next question comes from Akash Towari with Jefferies. Your line is now open.
Operator 2: Our next question comes from Akash Tewari with Jefferies. Your line is now open.
Operator: Our next question comes from Akash Tewari with Jefferies. Your line is now open.
Speaker #5: Hey, thanks so much. Can you talk about the efficacy advantages Atermo showed versus CDK4/6s in 4-Lite 1? Are we seeing signs of an early-onset PFS separation that we might not see with the other molecules?
Akash Tewari: Hey, thanks so much. Can you talk about the efficacy advantages atirmociclib showed versus CDK4/6s in FOURLIGHT-1? Are we seeing signs of an early onset PFS separation that we might not see with the other molecules? What's your current plan for first-line adjuvant with this molecule? What's really gating you from starting that first-line adjuvant trial? If I could sneak in another one, there's been a proposal from the CMS to cut reimbursement for 340B hospital payments from ASP +6 to ASP -33%. How would that affect your oncology portfolio, and what's your chances of this proposal ultimately getting enacted? Thank you.
Akash Tewari: Hey, thanks so much. Can you talk about the efficacy advantages atirmociclib showed versus CDK4/6s in FOURLIGHT-1? Are we seeing signs of an early onset PFS separation that we might not see with the other molecules? What's your current plan for first-line adjuvant with this molecule? What's really gating you from starting that first-line adjuvant trial? If I could sneak in another one, there's been a proposal from the CMS to cut reimbursement for 340B hospital payments from ASP +6 to ASP -33%. How would that affect your oncology portfolio, and what's your chances of this proposal ultimately getting enacted? Thank you.
Speaker #5: And what's your current plan for first-line adjuvant with this molecule? And what's really gating you from starting that first-line adjuvant trial? And then if I could sneak in another one, there's been a proposal from the CMS to cut reimbursement for 340B hospital payments from ASP plus 6 to ASP minus 33%.
Speaker #5: How would that affect your oncology portfolio? And what are your what's your chance of this proposal ultimately getting enacted? Thank you.
Speaker #1: All right. Therese and Amir?
Chris Boshoff: All right. Chris and Aamir.
Albert Bourla: All right. Chris and Aamir.
Speaker #6: Thank you. I'll start with atomic cycle. Just a reminder that the CDK4 gain, internally discovered and conceptualized, was very well tolerated, with very few patients discontinuing treatment, which partly may address your question.
Chris Boshoff: Thank you. I'll start with atirmociclib. Just a reminder that the CDK4, again, internally discovered and conceptualized, very well-tolerated with very few patients discontinuing treatment, which partly may address your question because of the tolerability profile. We'll share the full data later this year at a conference, but as you've seen before, we said the hazard ratio is 0.6, which is a 40% reduction in the risk of disease progression or death. It's clinically meaningful and statistic for that randomized phase II experience. For atirmociclib, we're focusing on two indications. First-line ER-positive breast cancer. To your point, the adjuvant setting. A reminder for second-line ER-positive breast cancer, we are focusing on CDK6, another potential breakthrough internally discovered, conceptualized medicine. For the early adjuvant setting, a significant opportunity.
Chris Boshoff: Thank you. I'll start with atirmociclib. Just a reminder that the CDK4, again, internally discovered and conceptualized, very well-tolerated with very few patients discontinuing treatment, which partly may address your question because of the tolerability profile. We'll share the full data later this year at a conference, but as you've seen before, we said the hazard ratio is 0.6, which is a 40% reduction in the risk of disease progression or death. It's clinically meaningful and statistic for that randomized phase II experience. For atirmociclib, we're focusing on two indications. First-line ER-positive breast cancer. To your point, the adjuvant setting. A reminder for second-line ER-positive breast cancer, we are focusing on CDK6, another potential breakthrough internally discovered, conceptualized medicine. For the early adjuvant setting, a significant opportunity.
Speaker #6: Because of the tolerability profile, we'll share the full data later this year at a conference. But as you've seen before, we say the hazard ratio is 0.6, which is a 40% reduction in the risk of disease progression or death.
Speaker #6: And it's clinically meaningful and statistically significant for that randomized Phase 2 experience. For atomic cycle, we're focusing on two indications: first-line positive breast cancer and, to your point, the adjuvant setting.
Speaker #6: A reminder for second-line positive breast cancer, we are focusing on CAT6, another potential breakthrough internally discovered conceptualized medicine. For the early adjuvant setting, a significant opportunity.
Speaker #6: We believe atomic cycle could be highly differentiated here because of the tolerability. And we should release later this year the clinical trial design for the adjuvant study that should start by the end of 2026.
Aamir Malik: We believe atirmociclib could be highly differentiated here because of the tolerability. We should release later this year the clinical trial design for the adjuvant study that should start by the end of 2026.
Chris Boshoff: We believe atirmociclib could be highly differentiated here because of the tolerability. We should release later this year the clinical trial design for the adjuvant study that should start by the end of 2026.
Speaker #1: Yes. Also, regarding your question on 340B, we have clearly articulated multiple times that there is a need. The current situation of the program has nothing to do with the intentions of the program when it was established.
Albert Bourla: Yes. For your question on 340B, clearly we have articulated multiple times that there is a need, saying the situation. The current situation of the program has nothing to do with the intentions of the program when it was established. We are very active in trying to explain that to regulators and legislators. There is a mobility right now on that topic. You have seen several announcements here and there, including some pilot programs that they are planning to implement. I don't think it's appropriate for me at this stage to comment, because we don't really know what will be the shape and form of all of that. Thank you, Akash. Next question.
Albert Bourla: Yes. For your question on 340B, clearly we have articulated multiple times that there is a need, saying the situation. The current situation of the program has nothing to do with the intentions of the program when it was established. We are very active in trying to explain that to regulators and legislators. There is a mobility right now on that topic. You have seen several announcements here and there, including some pilot programs that they are planning to implement. I don't think it's appropriate for me at this stage to comment, because we don't really know what will be the shape and form of all of that. Thank you, Akash. Next question.
Speaker #1: And we are very active in trying to explain that to regulators and legislators. There is a lot of mobility right now on that topic, and you have seen several announcements here and there, including some pilot programs that they are planning to implement.
Speaker #1: But I don't think it's for me appropriate at this stage to comment because we don't really know what will be the shape and form of all of that.
Speaker #1: Thank you, Akash. Next question.
Speaker #3: Our next question comes from Terrence Flynn with Morgan Stanley. Your line is now open.
Operator 2: Our next question comes from Terence Flynn with Morgan Stanley. Your line is now open.
Operator: Our next question comes from Terence Flynn with Morgan Stanley. Your line is now open.
Speaker #6: Great, thanks so much for taking the question. Albert, I recognize your recent remarks on maintaining the dividend and your aspiration to grow it in the future.
Terence Flynn: Great. Thanks so much for taking the question. Albert, recognize your recent remarks on maintaining the dividend and growing it in the future as an aspiration, just wondering what would have to transpire in order for you and the board to consider a cut to the dividend. When we look at your BD capacity, you mentioned $6 billion in the prepared remarks. Seems like that's somewhat constraining as you think about the opportunity set out there. Thank you very much.
Terence Flynn: Great. Thanks so much for taking the question. Albert, recognize your recent remarks on maintaining the dividend and growing it in the future as an aspiration, just wondering what would have to transpire in order for you and the board to consider a cut to the dividend. When we look at your BD capacity, you mentioned $6 billion in the prepared remarks. Seems like that's somewhat constraining as you think about the opportunity set out there. Thank you very much.
Speaker #6: But just wondering, what would have to transpire in order for you and the Board to consider a cut to the dividend? When we look at your BD capacity, you mentioned $6 billion in the prepared remarks.
Speaker #6: It seems like that's somewhat constraining as you think about the opportunity set out there. Thank you very much.
Speaker #1: No, thank you. We feel extremely confident that, even in the most stressed scenarios that we are running, we will be able to maintain our dividend.
Albert Bourla: No, thank you. We feel extremely confident that even the most stretched scenarios that we are running, we will be able to maintain our dividend. I want once and for all to make that clear to all that the dividend will be maintained, and eventually after the LOE period, we'll start again growing it. That's I think a fundamental statement that I need to reinforce. Thank you. Next question, please.
Albert Bourla: No, thank you. We feel extremely confident that even the most stretched scenarios that we are running, we will be able to maintain our dividend. I want once and for all to make that clear to all that the dividend will be maintained, and eventually after the LOE period, we'll start again growing it. That's I think a fundamental statement that I need to reinforce.
Speaker #1: So I want, once and for all, to make it clear to all that the dividend will be maintained. And eventually, after the LOE period, we’ll start growing it again.
Speaker #1: So that's, I think, a fundamental statement that I need to reinforce. Thank you. Next question, please.
Terence Flynn: Thank you.
Albert Bourla: Next question, please.
Speaker #3: We'll go next to Chung Huyen with RBC. Your line is now open.
Operator 2: We'll go next to Truong Nguyen with RBC. Your line is now open.
Operator: We'll go next to Truong Nguyen with RBC. Your line is now open.
Speaker #7: Hi, guys. Thanks for taking my questions. Just a couple on immunology, please. So, the vitiligo program—you've disclosed some of the TRANQUILO-2 data there in the slides.
Truong Nguyen: Hi, guys. Thanks for taking my questions. Just a couple on immunology, please. The vitiligo program, you've disclosed some of the TRANQUILO 2 data there in the slides. I didn't see the TRANQUILLO 1 findings. Perhaps you can summarize the data there. Is there a consistency between those two pivotal trials? It looks like you've listed four new potential starts for tilracabimab, the tri-specific, two in AD, one versus placebo, one versus DUPIXENT. There's an asthma one and a COPD one. Perhaps can you talk about your strategic thinking there? How quick can you start these, the trial designs, expected timelines, and perhaps can you remind us where you hope to differentiate? Thank you.
Trung Huynh: Hi, guys. Thanks for taking my questions. Just a couple on immunology, please. The vitiligo program, you've disclosed some of the TRANQUILO 2 data there in the slides. I didn't see the TRANQUILLO 1 findings. Perhaps you can summarize the data there. Is there a consistency between those two pivotal trials? It looks like you've listed four new potential starts for tilracabimab, the tri-specific, two in AD, one versus placebo, one versus DUPIXENT. There's an asthma one and a COPD one. Perhaps can you talk about your strategic thinking there? How quick can you start these, the trial designs, expected timelines, and perhaps can you remind us where you hope to differentiate? Thank you.
Speaker #7: I didn't see the Tranquilo-1 findings. Perhaps you can summarize the data there. Is there consistency between those two digital trials? And then it looks like you've listed four new potential starts for TIL recomic: the trispecific, two in AD—one versus placebo, one versus dupi.
Speaker #7: There's an asthma one and there's a COPD one. Perhaps can you talk about your strategic thinking there—how quickly can you start these, the trial designs, and expected timelines?
Speaker #7: And perhaps, can you remind us where you hope to differentiate? Thank you.
Speaker #1: Therese?
Albert Bourla: Chris?
Albert Bourla: Chris?
Speaker #5: Okay. Thank you very
Chris Boshoff: Okay. Thank you very much. First question on TRANQUILLO 1 and the TRANQUILLO study, and two, we obviously want to present later this year at a conference the full data set, we don't want to release all the data now. We focused on the TRANQUILLO data where 100 milligrams was the official co-primary endpoint and only shared that data today. We've seen, as we stated in the press release, for both 50 and 100 milligrams for both primary and co-primary endpoints, clinically meaningful and statistical data, which we hope to share at a conference later this year. To go on regarding tilracabimab, again, this is an internally discovered, conceptualized molecule. It's a tri-specific, so it's IL-4, IL-13, and TSLP. A reminder that one of the main competitors is IL-4 and IL-13, and there's also an IL-13-only medicine recently that you would've seen.
Chris Boshoff: Okay. Thank you very much. First question on TRANQUILLO 1 and the TRANQUILLO study, and two, we obviously want to present later this year at a conference the full data set, we don't want to release all the data now. We focused on the TRANQUILLO data where 100 milligrams was the official co-primary endpoint and only shared that data today. We've seen, as we stated in the press release, for both 50 and 100 milligrams for both primary and co-primary endpoints, clinically meaningful and statistical data, which we hope to share at a conference later this year.
Speaker #6: much. So first question on tacolo one and the tranquilo-study. And two, we obviously want to present later this year at a conference, the full data set.
Speaker #6: So, we don't want to release all the data now. We are focusing on the Tranquilo data, where 100 milligrams was the official co-primary endpoint, and only shared that data today.
Speaker #6: But we've seen, as we stated in the press release, that for both 50 and 100 milligrams and for both primary and co-primary endpoints, the data are clinically meaningful and statistically significant, which we hope to share at a conference later this year.
Speaker #6: To go on regarding tilzomic, again, this is an internally discovered, conceptualized molecule. It's trispecific—so it's IL-4, IL-13, and TSLP. A reminder that one of the main competitors targets IL-4 and IL-13, and there's also an IL-13-only medicine recently that you would have seen.
Chris Boshoff: To go on regarding tilracabimab, again, this is an internally discovered, conceptualized molecule. It's a tri-specific, so it's IL-4, IL-13, and TSLP. A reminder that one of the main competitors is IL-4 and IL-13, and there's also an IL-13-only medicine recently that you would've seen.
Speaker #6: So, tilremic also includes TSLP, which is shown to enhance activity in allergic conditions, including asthma and COPD. For IL-13 specifically, we believe we've got a best-in-class trispecific, especially if you look at the affinity for IL-13.
Chris Boshoff: tilracabimab also includes TSLP, which is shown to enhance activity in allergic conditions, including in asthma and COPD. For IL-13 specifically, we believe we've got a best-in-class tri-specific, especially if you look at the affinity for IL-13, the blockages of IL-13. Data previously released, which is the EASI-75 in atopic dermatitis for both the median and high dose, showed 52% and 50% EASI-75 placebo-adjusted results. For us, that's differentiated data. It's highly encouraging. As pointed out, we hope to start four phase III studies, one against placebo, one against DUPIXENT, and also programs in asthma and COPD.
Chris Boshoff: tilracabimab also includes TSLP, which is shown to enhance activity in allergic conditions, including in asthma and COPD. For IL-13 specifically, we believe we've got a best-in-class tri-specific, especially if you look at the affinity for IL-13, the blockages of IL-13. Data previously released, which is the EASI-75 in atopic dermatitis for both the median and high dose, showed 52% and 50% EASI-75 placebo-adjusted results. For us, that's differentiated data. It's highly encouraging. As pointed out, we hope to start four phase III studies, one against placebo, one against DUPIXENT, and also programs in asthma and COPD.
Speaker #6: The block is of IL-13. Data previously released, which is the EASI-75 in atopic dermatitis for both the median and high dose, showed 52% and 50% EASI-75.
Speaker #6: Placebo-adjusted results for us, I mean, that's differentiated data. It's highly encouraging. And as pointed out, we hope to start four Phase 3 studies.
Speaker #6: One against placebo, one against dupi, and also programs in asthma and COPD.
Speaker #1: Yeah, that's a very, very exciting asset for us. Next question, please.
Albert Bourla: Yeah, that's a very exciting asset for us. Next question, please.
Albert Bourla: Yeah, that's a very exciting asset for us. Next question, please.
Speaker #3: We'll go next to Steve Scholla with P.D. Cowen. Your line is now open.
Operator 2: We'll go next to Steve Scala with TD Cowen. Your line is now open.
Operator: We'll go next to Steve Scala with TD Cowen. Your line is now open.
Speaker #4: Thank you. I have two questions. First, on till recomic, can you confirm that the trial versus dupixent will be a true head-to-head trial powered for superiority on first line or in first line bio-native patients?
Steve Scala: Thank you. I have two questions. First, on tilracabimab, can you confirm that the trial versus DUPIXENT will be a true head-to-head trial powered for superiority on first line or in first-line bio-naive patients? Secondly, given small changes in the risks section language of the release, it looks like Pfizer signed the Pfizer voluntary agreement with the US government to lower drug costs. That occurred sometime in Q2 of this year. Just curious, were there any major changes in the final version versus earlier versions, and why did it take so long? Thank you.
Steve Scala: Thank you. I have two questions. First, on tilracabimab, can you confirm that the trial versus DUPIXENT will be a true head-to-head trial powered for superiority on first line or in first-line bio-naive patients? Secondly, given small changes in the risks section language of the release, it looks like Pfizer signed the Pfizer voluntary agreement with the US government to lower drug costs. That occurred sometime in Q2 of this year. Just curious, were there any major changes in the final version versus earlier versions, and why did it take so long? Thank you.
Speaker #4: And secondly, given small changes in the Risks section language of the release, it looks like Pfizer signed the Pfizer Voluntary Agreement with the US government to lower drug costs, and that occurred sometime in the second quarter of this year.
Speaker #4: Just curious, were there any major changes in the final version versus earlier versions? And why did it take so long? Thank you.
Speaker #1: Thanks. Let me take that one. That is the continuation of the memorandum of understanding that we had signed at the White House. You remember that memorable day when we resolved the MFM and tariffs issue altogether for the industry, I think.
Albert Bourla: Thanks. Let me take that one. That is the continuation of the memorandum of understanding that we had signed in the White House. You remember this memorable day that we resolved the MFN and tariffs all together for the industry, I think. No, the agreements are very consistent with what you have seen for other companies and for us, and we are very pleased with the agreements. Let me move to Chris about the studies with DUPIXENT and how you think about the protocol. Whatever you can tell us.
Albert Bourla: Thanks. Let me take that one. That is the continuation of the memorandum of understanding that we had signed in the White House. You remember this memorable day that we resolved the MFN and tariffs all together for the industry, I think. No, the agreements are very consistent with what you have seen for other companies and for us, and we are very pleased with the agreements. Let me move to Chris about the studies with DUPIXENT and how you think about the protocol. Whatever you can tell us.
Speaker #1: No, the agreements are very consistent with what you have seen for other companies and for us. We are very pleased with the agreements.
Speaker #1: Now, let me move to Chris about the studies with dupixent and how you think about the protocol. Whatever you can tell us.
Speaker #6: And yes, thank you for the question. Indeed, this will be one of the first Phase 3 trials that will be head-to-head against dupi and powered for superiority against dupi.
Chris Boshoff: Yes. Thank you for the question. Indeed, this will be one of the first phase III trials that will be head against DUPIXENT and powered for superiority against DUPIXENT.
Chris Boshoff: Yes. Thank you for the question. Indeed, this will be one of the first phase III trials that will be head against DUPIXENT and powered for superiority against DUPIXENT.
Speaker #1: All right. Thank you. And the last question, please.
Albert Bourla: All right. Thank you. The last question, please.
Albert Bourla: All right. Thank you. The last question, please.
Speaker #3: And our final question comes from Asad Haider with Goldman Sachs. Your line is now open.
Operator 2: Our final question comes from Asad Haider with Goldman Sachs. Your line is now open.
Operator: Our final question comes from Asad Haider with Goldman Sachs. Your line is now open.
Speaker #5: Great. Thanks for taking the question. For Albert or Cecile, just back to COVID, just given that the trend has continued to be lower than expected and understanding that the lowered 4 billion for 2026 is somewhat secured by contracts and your expectations for vaccination rates, just curious as to what you're expecting in terms of the long-term trajectory of the franchise since that will have an impact on the high single-digit growth algorithm post-2028 that you've highlighted.
Asad Haider: Great. Thanks for taking the question. For Albert or Cecile, just back to COVID, just given that the trend has continued to be lower than expected and understanding that the lower $4 billion for 2026 is somewhat secured by contracts and your expectations for vaccination rates. Just curious as to what you're expecting in terms of the long-term trajectory of the franchise, since that will have an impact on the high single-digit growth algorithm post-2028 that you've highlighted. Then just a quick follow-up, Albert, on BD. Just would be curious to hear any updated thoughts on how you're thinking about utilizing that lever in terms of size in the context of your remaining capacity as well as where you'd like to build out further. Thank you.
Asad Haider: Great. Thanks for taking the question. For Albert or Cecile, just back to COVID, just given that the trend has continued to be lower than expected and understanding that the lower $4 billion for 2026 is somewhat secured by contracts and your expectations for vaccination rates. Just curious as to what you're expecting in terms of the long-term trajectory of the franchise, since that will have an impact on the high single-digit growth algorithm post-2028 that you've highlighted. Then just a quick follow-up, Albert, on BD. Just would be curious to hear any updated thoughts on how you're thinking about utilizing that lever in terms of size in the context of your remaining capacity as well as where you'd like to build out further. Thank you.
Speaker #5: And then just a quick follow-up, Albert, on BD—just would be curious to hear any updated thoughts on how you're thinking about utilizing that lever in terms of size, in the context of your remaining capacity, as well as where you'd like to build out further.
Speaker #5: Thank you.
Speaker #1: Yes, on COVID, of course, we can also ask the commercial leaders and finance to comment on that. But let me give it at a very high level.
Albert Bourla: Yes. On the COVID, of course, we can ask also the commercial leaders and the finance to comment on that. Let me give at a very high level. We have this year a very low COVID season. For all respiratory seasonal diseases, this is something that we see constantly. Could be a year that the flu is more acute and more spread than years that it is not. It could be years with RSV is more acute and years that it is not. Why we don't see big variation in the sales of the products when this happens is because they are mainly vaccines, and vaccines tend to be more independent from the infection rates.
Albert Bourla: Yes. On the COVID, of course, we can ask also the commercial leaders and the finance to comment on that. Let me give at a very high level. We have this year a very low COVID season. For all respiratory seasonal diseases, this is something that we see constantly. Could be a year that the flu is more acute and more spread than years that it is not. It could be years with RSV is more acute and years that it is not. Why we don't see big variation in the sales of the products when this happens is because they are mainly vaccines, and vaccines tend to be more independent from the infection rates.
Speaker #1: This year, we have a very low COVID season. For all respiratory seasonal diseases, this is something that we see constantly. So, it could be a year when the flu is more acute and more widespread than in years when it is not.
Speaker #1: There could be years when RSV is more acute and years when it is not. The reason we don't see big variations in the sales of these products when this happens is because they are mainly vaccines.
Speaker #1: And vaccines tend to be more independent from the infection rates. It is based on the risk of infection, and people that are committed, or they are in vaccination, or they are feeling that they are at risk, will continue doing those vaccinations irrelevant of whether the season is high or low.
Albert Bourla: It is based on the risk of infection and people that they are committed, or they are in vaccination, or they are feeling that they are at risk, will continue doing those vaccinations irrelevant if the season is high or low. Clearly, when it is a high season, moves more people to vaccination, but the variation is very small. When it comes to PAXLOVID, this is now completely correlated with infection rates. If someone is not infected, he's not going to need PAXLOVID. This is what we see right now. What I want to say it is that the COVID revenue should split it into the vaccines and the PAXLOVID, the vaccines will see more stability irrelevant of the fluctuations of the infection rates. With the PAXLOVID, you will see high correlation if it is a high season or low season. That's now.
Albert Bourla: It is based on the risk of infection and people that they are committed, or they are in vaccination, or they are feeling that they are at risk, will continue doing those vaccinations irrelevant if the season is high or low. Clearly, when it is a high season, moves more people to vaccination, but the variation is very small. When it comes to PAXLOVID, this is now completely correlated with infection rates.
Speaker #1: Clearly, when it is high season, more people move to vaccination, but the variation is very small. When it comes to Paxlovid, this is now completely correlated with infection rates.
Speaker #1: If someone is not infected, it's not going to need Paxlovid. And this is what we see right now. So what I want to say is that the COVID revenues which should split it into the vaccines and the Paxlovid and the vaccines will see more stability irrelevant of the fluctuations of the infection rates.
Albert Bourla: If someone is not infected, he's not going to need PAXLOVID. This is what we see right now. What I want to say it is that the COVID revenue should split it into the vaccines and the PAXLOVID, the vaccines will see more stability irrelevant of the fluctuations of the infection rates. With the PAXLOVID, you will see high correlation if it is a high season or low season. That's now.
Speaker #1: With the Paxlovid, you will see high correlation if it is a high season or low season. So that's now. Can we predict what will be next year?
Albert Bourla: Can we predict what will be next year? It could be a very high season, or it could be equally low this season. That's something that you can't really predict very well. What I want to emphasize, though, it is that this year, where we have the lowest possible infections that we could imagine as we were setting our goals, still we were able to offset every shortfall of COVID with the super performance of the remaining of the business. I think that was the important thing. There was also another question I had.
Albert Bourla: Can we predict what will be next year? It could be a very high season, or it could be equally low this season. That's something that you can't really predict very well. What I want to emphasize, though, it is that this year, where we have the lowest possible infections that we could imagine as we were setting our goals, still we were able to offset every shortfall of COVID with the super performance of the remaining of the business. I think that was the important thing. There was also another question I had.
Speaker #1: It could be a very high season or it could be equally low. The season. So that's something that you can't really predict very well.
Speaker #1: What I want to emphasize, though, it is that this year where we have the lowest possible infections that we could imagine, as we were setting our goals, still we were able to offset every shortfall of COVID with a super performance of the remaining of the business.
Speaker #1: And I think that was the important thing. There was also another question.
Speaker #2: Business development.
Speaker #1: On the business development, also let me give a high level. Also, Terrence, before he had asked, you have only 7 billion dollars. Look, guys, Pfizer has placed the business development bets already.
[Company Representative] (Pfizer): Business development.
Cecile Guegan: Business development.
Albert Bourla: On the business development, also let me give a high level. Also, Terence, before he had asked, you have only $7 billion. Look, guys, Pfizer has placed the business development bets already. Right? We are executing on that. If you see how much we have invested in business development, it is outpacing everyone else right now. Since 2022, let's say, after we came back to the normality after the COVID years. We are having 80% of these investments that we did that exceeds $80 billion already been placed in three of the transactions, all three are performing very well. Still, though, we are executing because in season we are developing further the pipeline to realize much higher value. In NURTEC, we are developing new claims so that we can further finalize the value. In Metsera, we are moving with the speed of light.
Albert Bourla: On the business development, also let me give a high level. Also, Terence, before he had asked, you have only $7 billion. Look, guys, Pfizer has placed the business development bets already. Right? We are executing on that. If you see how much we have invested in business development, it is outpacing everyone else right now.
Speaker #1: Right? And we are executing on that. If you see how much we have invested in business development, it is outpacing everyone else—right now.
Speaker #1: Since 2022, let's say after we came back down from the high to normality following the COVID years, we are seeing 80% of this investment—amounting to over $80 billion.
Albert Bourla: Since 2022, let's say, after we came back to the normality after the COVID years. We are having 80% of these investments that we did that exceeds $80 billion already been placed in three of the transactions, all three are performing very well. Still, though, we are executing because in season we are developing further the pipeline to realize much higher value. In NURTEC, we are developing new claims so that we can further finalize the value. In Metsera, we are moving with the speed of light.
Speaker #1: Already been placed in three of the transactions and all three are performing very well. So still, though, we are executing because in Seagen, we are developing further the pipeline to realize much higher value.
Speaker #1: In Nurtec, we are developing new claims. So that you can further finalize the value. And in Mecera, we are moving with the speed of light as Chris said, two studies that we already initiated.
Albert Bourla: As Chris said, two studies that we already initiated are fully enrolled, and the other one it is about to be fully enrolled. We are moving with the speed of light. There is a lot that already we have done. With the $6 to 7 billion of remaining, we will be very strategic, of course, and you should expect something on the bolt-on with the size of these opportunities. The areas that we are looking are areas that we can make a difference, and clearly oncology is one of them, immunoinflammation is another one, primary care with obesity is another one, and vaccines clearly is another one. Although in vaccines you can't find much outside for business development. I think that we have invested a lot, and we will continue doing small pieces.
Albert Bourla: As Chris said, two studies that we already initiated are fully enrolled, and the other one it is about to be fully enrolled. We are moving with the speed of light. There is a lot that already we have done. With the $6 to 7 billion of remaining, we will be very strategic, of course, and you should expect something on the bolt-on with the size of these opportunities. The areas that we are looking are areas that we can make a difference, and clearly oncology is one of them, immunoinflammation is another one, primary care with obesity is another one, and vaccines clearly is another one. Although in vaccines you can't find much outside for business development. I think that we have invested a lot, and we will continue doing small pieces.
Speaker #1: They are fully enrolled. And the other one, it is about to be fully enrolled. So we are moving with the speed of light. So there is a lot that already we have done.
Speaker #1: With the $6–7 billion remaining, we will be very strategic, of course, and you should expect something on the bolt-on side with the size of these opportunities.
Speaker #1: The areas that we are looking are areas that we can make a difference and clearly oncology, it's one of them, immune inflammation is another one, primary care, with obesity, it's another one, and vaccines.
Speaker #1: Clearly, it's another one. Although, in vaccines, you can't find much outside for business development. So, I think that we have invested a lot, and we will continue doing small pieces.
Speaker #1: Those investments, we are confident, will drive high single-digit growth after the LOE period, which is in 2028. So that's my answer to that. And with that, I think it's time to close the call. Again, I want to emphasize: I'm very pleased with what we were able to achieve.
Albert Bourla: Those investments, we are confident will drive high single-digit growth after the LOE period, which is in 2028. That's my answer to that. With that, I think it's time to close the call. Again, I want to emphasize, I'm very pleased with what we were able to achieve. To start with, we really can prove that we know how to execute operationally. We are probably based on all these three years of results, one of the supreme companies in our ability to execute, reduce our cost base, and still perform and over-perform on our top line. I think with R&D, you will see the significant progress that we have. If you've noticed in the chart that Chris put together, in the next 12 months, we have significant catalysts that are coming, and we are remaining optimistic that they will be successful.
Albert Bourla: Those investments, we are confident will drive high single-digit growth after the LOE period, which is in 2028. That's my answer to that. With that, I think it's time to close the call. Again, I want to emphasize, I'm very pleased with what we were able to achieve.
Speaker #1: To start with, we really can prove that we know how to execute operationally. We are probably, based on all these three years of results.
Albert Bourla: To start with, we really can prove that we know how to execute operationally. We are probably based on all these three years of results, one of the supreme companies in our ability to execute, reduce our cost base, and still perform and over-perform on our top line. I think with R&D, you will see the significant progress that we have. If you've noticed in the chart that Chris put together, in the next 12 months, we have significant catalysts that are coming, and we are remaining optimistic that they will be successful. I want to thank my Pfizer colleagues for their dedication, and I want to wish you all a great day. Thank you.
Speaker #1: One of the supreme companies in our ability to execute, reduce our cost base, and still perform and overperform on our top line. I think with R&D, you will see the significant progress that we have.
Speaker #1: And if you've noticed in the chart that Chris put together in the next 12 months, we have significant catalysts that are coming and we are remaining optimistic that they will be successful.
Speaker #1: I want to thank my Pfizer colleagues for their dedication, and I want to wish you all a great day. Thank you.
Albert Bourla: I want to thank my Pfizer colleagues for their dedication, and I want to wish you all a great day. Thank you.
Operator 2: Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.
Operator: Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.