Johnson and Johnson Q4 2025 Johnson & Johnson Earnings Call | AllMind AI Earnings | AllMind AI
Q4 2025 Johnson & Johnson Earnings Call
Speaker #1: Good morning, and welcome to Johnson & Johnson's fourth quarter 2025 earnings conference call. All participants will be in listen-only mode until the question-and-answer session of the conference.
Operator: Good morning and welcome to Johnson & Johnson's Q4 2025 earnings conference call. All participants will be in a listen-only mode until the question-and-answer session of the conference. This call is being recorded. If anyone has any objections, you may disconnect at this time. If you experience technical difficulties during the conference, you may press *0 to reach the operator. I will now turn the conference call over to Johnson & Johnson. You may begin.
Operator: Good morning and welcome to Johnson & Johnson's Q4 2025 earnings conference call. All participants will be in a listen-only mode until the question-and-answer session of the conference. This call is being recorded. If anyone has any objections, you may disconnect at this time. If you experience technical difficulties during the conference, you may press *0 to reach the operator. I will now turn the conference call over to Johnson & Johnson. You may begin.
Speaker #1: This call is being recorded. If anyone has any objections, you may disconnect at this time. If you experience technical difficulties during the conference, you may press star zero to reach the operator.
Speaker #1: I will now turn the conference call over to Johnson & Johnson. You may proceed.
Speaker #1: begin. Hello,
Darren Snellgrove: Hello, everyone. This is Darren Snellgrove, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of business results for Q4 and Q2, and our financial outlook for 2026. First, a few logistics. As a reminder, today's presentation and associated schedules are available on the Investor Relations section of the Johnson & Johnson website at investor.jnj.com. Please note that this presentation contains forward-looking statements regarding, among other things, the company's future operating and financial performance, market position, and business strategy. You are cautioned not to rely on these forward-looking statements, which are based on the current expectations of future events using the information available as of the date of this recording and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected.
Darren Snellgrove: Hello, everyone. This is Darren Snellgrove, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of business results for Q4 and Q2, and our financial outlook for 2026. First, a few logistics. As a reminder, today's presentation and associated schedules are available on the Investor Relations section of the Johnson & Johnson website at investor.jnj.com. Please note that this presentation contains forward-looking statements regarding, among other things, the company's future operating and financial performance, market position, and business strategy. You are cautioned not to rely on these forward-looking statements, which are based on the current expectations of future events using the information available as of the date of this recording and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected.
Speaker #2: Everyone, this is Darren Snellgrove, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of business results for the fourth quarter and full year 2025, and our financial outlook for 2026.
Speaker #2: First, a few logistics. As a reminder, today's presentation and associated schedules are available on the Investor Relations section of the Johnson & Johnson website at investor.jnj.com.
Speaker #2: Please note that this presentation contains forward-looking statements regarding among other things the company's future operating and financial performance, market position, and business strategy. Your caution not to rely on these forward-looking statements which are based on the current expectations of future events using the information available as of the date of this recording and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected.
Speaker #2: The description of these risks and uncertainties and other factors can be found in our SEC filings, including our 2024 Form 10-K, which is available at investor.jnj.com and on the SEC's website.
Darren Snellgrove: The description of these risks, uncertainties, and other factors can be found in our SEC filings, including our 2024 Form 10-K, which is available at investor.jnj.com and on the SEC's website. Additionally, several of the products and compounds discussed today are being developed in collaboration with strategic partners or licensed from other companies. This slide acknowledges those relationships. Moving to today's agenda, Joaquin Duato, our Chairman and CEO, will discuss our business performance and growth drivers. I will then review the Q4 sales and P&L results, as well as Q4 2025 results for the enterprise. Joe Wolk, our CFO, will then close by sharing an overview of our cash position, capital allocation priorities, and guidance for 2026, as well as key milestones and qualitative considerations for 2026.
The description of these risks, uncertainties, and other factors can be found in our SEC filings, including our 2024 Form 10-K, which is available at investor.jnj.com and on the SEC's website. Additionally, several of the products and compounds discussed today are being developed in collaboration with strategic partners or licensed from other companies. This slide acknowledges those relationships. Moving to today's agenda, Joaquin Duato, our Chairman and CEO, will discuss our business performance and growth drivers. I will then review the Q4 sales and P&L results, as well as Q4 2025 results for the enterprise. Joe Wolk, our CFO, will then close by sharing an overview of our cash position, capital allocation priorities, and guidance for 2026, as well as key milestones and qualitative considerations for 2026.
Speaker #2: Additionally, several of the products and compounds discussed today are being developed in collaboration with strategic partners or licensed from other companies. This slide acknowledges those relationships.
Speaker #2: Moving to today's agenda, Joaquin Duato, our Chairman and CEO, will discuss our business performance and growth drivers. I will then review the fourth quarter sales and P&L results, as well as full-year 2025 results for the enterprise.
Speaker #2: Joe Wolk, our CFO, will then close by sharing an overview of our cash position, capital allocation priorities, and guidance for 2026, as well as key milestones and qualitative considerations for 2026.
Speaker #2: Jennifer Talbot, Executive Vice President, Worldwide Chairman, Innovative Medicine; John Reed, Executive Vice President, Innovative Medicine Research and Development; and Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, will be joining us for Q&A.
Darren Snellgrove: Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, John Reed, Executive Vice President, Innovative Medicine Research and Development, and Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, will be joining us for Q&A. To ensure we provide enough time to address your questions, we anticipate the webcast will last up to 75 minutes. With that, I will now turn the call over to Joaquin Duato.
Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, John Reed, Executive Vice President, Innovative Medicine Research and Development, and Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, will be joining us for Q&A. To ensure we provide enough time to address your questions, we anticipate the webcast will last up to 75 minutes. With that, I will now turn the call over to Joaquin Duato.
Speaker #2: To ensure we provide enough time to address your questions, we anticipate the webcast will last up to 75 minutes. With that, I will now turn the call over to
Speaker #2: Joaquin. Good morning,
Joaquin Duato: Good morning, everyone, and thank you for joining us. I'm excited to discuss our very strong full-year results. We said 2025 would be a catapult year for Johnson & Johnson, and that's exactly what it was. It was a year that launched us into a new era of accelerated growth. Fueled by the strongest portfolio and pipeline in our history, Johnson & Johnson today has a leading and expanding position in each of our six key businesses: oncology, immunology, neuroscience, cardiovascular, surgery, and vision. In each of these areas, we have multiple differentiated assets to drive growth and a strong competitive advantage, which you can see in the success of our recent launches. In recent years, we have increased our focus on areas of high growth and high unmet need, and we will continue this transformation with the planned separation of our orthopedics business.
Joaquin Duato: Good morning, everyone, and thank you for joining us. I'm excited to discuss our very strong full-year results. We said 2025 would be a catapult year for Johnson & Johnson, and that's exactly what it was. It was a year that launched us into a new era of accelerated growth. Fueled by the strongest portfolio and pipeline in our history, Johnson & Johnson today has a leading and expanding position in each of our six key businesses: oncology, immunology, neuroscience, cardiovascular, surgery, and vision. In each of these areas, we have multiple differentiated assets to drive growth and a strong competitive advantage, which you can see in the success of our recent launches. In recent years, we have increased our focus on areas of high growth and high unmet need, and we will continue this transformation with the planned separation of our orthopedics business.
Speaker #3: Everyone, thank you for joining us. I'm excited to discuss our very strong full-year results. We said 2025 would be a catapult year for Johnson & Johnson, and that's exactly what it was.
Speaker #3: It was a year that launched us into a new era of accelerated growth. Fueled by the strongest portfolio and pipeline in our history, Johnson & Johnson today has a leading and expanding position in each of our six key businesses.
Speaker #3: Oncology, immunology, neuroscience, cardiovascular, surgery, and vision—in each of these areas, we have multiple differentiated assets to drive growth and a strong competitive advantage, which you can see in the success of our recent launches.
Speaker #3: In recent years, we have increased our focus on areas of high growth and high unmet need, and we will continue this transformation with the planned separation of our Orthopedics business.
Speaker #3: In 2025, we invested over $32 billion in R&D and M&A, including the acquisitions of Intracellular Therapies and Halda Therapeutics. We also initiated billions of dollars in new state-of-the-art manufacturing facilities in the U.S., which will accelerate delivery of our next wave of innovation.
Joaquin Duato: In 2025, we invested over $32 billion in R&D and M&A, including the acquisitions of Intra-Cellular Therapies and Halder Therapeutics. We also initiated billions of dollars in new state-of-the-art manufacturing facilities in the US, which will accelerate the delivery of our next wave of innovation. These moves fuel our confidence that growth in 2026 will be faster than in 2025, and we have a line of sight to double-digit growth by the end of the decade, which is notable as Johnson & Johnson is the only healthcare company that will soon deliver more than $100 billion in annual revenue. How is that possible? It's possible because we have tremendous strength and depth both in innovative medicine and in medtech. We are different from other companies. We are not focused on one or two growth drivers.
In 2025, we invested over $32 billion in R&D and M&A, including the acquisitions of Intra-Cellular Therapies and Halder Therapeutics. We also initiated billions of dollars in new state-of-the-art manufacturing facilities in the US, which will accelerate the delivery of our next wave of innovation. These moves fuel our confidence that growth in 2026 will be faster than in 2025, and we have a line of sight to double-digit growth by the end of the decade, which is notable as Johnson & Johnson is the only healthcare company that will soon deliver more than $100 billion in annual revenue. How is that possible? It's possible because we have tremendous strength and depth both in innovative medicine and in medtech. We are different from other companies. We are not focused on one or two growth drivers.
Speaker #3: These moves fuel our confidence that growth in 2026 will be faster than in 2025. And we have line of sight to double-digit growth by the end of the decade, which is notable as Johnson & Johnson is the only healthcare company that will soon deliver more than $100 billion in annual revenue.
Speaker #3: How is that possible? It's possible because we have tremendous strength and depth, both in innovative medicine and in medtech. We are different from other companies.
Speaker #3: We are not focused on one or two growth drivers. In fact, we now have 28 platforms or products that generate at least $1 billion of revenue annually, and that makes our growth more sustainable.
Joaquin Duato: In fact, we now have 28 platforms or products that generate at least $1 billion of revenue annually, and that makes our growth more sustainable. This, together with our strong balance sheet and free cash flow, creates the resilience and durability that will power our future. Turning to our results, over the full year, we delivered 5.3% operational sales growth. The strength of our commercial execution and relentless focus on innovation drove strong momentum throughout the year, firmly placing the Stelara LOE in the rearview mirror. In innovative medicine, we reported operational sales growth for the year of 5.3%. Full-year sales for our pharmaceutical business exceeded $60 billion for the first time, with 13 brands growing double digits. The foundation for these results and for the acceleration we see ahead is our unrivaled portfolio and pipeline. In 2025 alone, we secured 51 approvals and filed 32 submissions across major markets.
In fact, we now have 28 platforms or products that generate at least $1 billion of revenue annually, and that makes our growth more sustainable. This, together with our strong balance sheet and free cash flow, creates the resilience and durability that will power our future. Turning to our results, over the full year, we delivered 5.3% operational sales growth. The strength of our commercial execution and relentless focus on innovation drove strong momentum throughout the year, firmly placing the Stelara LOE in the rearview mirror. In innovative medicine, we reported operational sales growth for the year of 5.3%. Full-year sales for our pharmaceutical business exceeded $60 billion for the first time, with 13 brands growing double digits. The foundation for these results and for the acceleration we see ahead is our unrivaled portfolio and pipeline. In 2025 alone, we secured 51 approvals and filed 32 submissions across major markets.
Speaker #3: This, together with our strong balance sheet and free cash flow, creates the resilience and durability that will power our future. Turning to our results, over the full year we delivered 5.3% operational sales growth.
Speaker #3: The strength of our commercial execution and relentless focus on innovation drove strong momentum throughout the year, firmly placing the Stelara LOE in the rearview mirror.
Speaker #3: In Innovative Medicine, we reported operational sales growth for the year of 5.3%. Full-year sales for our pharmaceutical business exceeded $60 billion for the first time, with 13 brands growing double digits.
Speaker #3: The foundation for these results and for the acceleration we see ahead is our unrivaled portfolio and pipeline. In 2025 alone, we secure $51 approvals and filed 32 submissions across major markets.
Speaker #3: We delivered positive readouts from 17 key studies and initiated 11 new Phase 3 programs. These milestones are not just numbers; they are the seeds of our best-in-class medicines that are improving and extending lives.
Joaquin Duato: We delivered positive readouts from 17 key studies and initiated 11 new phase III programs. These milestones are not just numbers. They are the seeds of our best-in-class medicines that are improving and extending lives. Let me now talk about our key areas of focus. In oncology, we are working to cure cancer, and our depth of expertise is unmatched. In 2025, we delivered 21% operational sales growth, and we expect to exceed $50 billion in annual sales by 2030. We are the number one company in multiple myeloma, where 80% of patients are treated with at least one of our four medicines over their treatment journey. Darzalex is the largest medicine by sales in our pharmaceutical portfolio and is considered the foundational gold standard treatment in multiple myeloma. With annual sales over $14 billion, Darzalex grew an impressive 22% across the full year.
We delivered positive readouts from 17 key studies and initiated 11 new phase III programs. These milestones are not just numbers. They are the seeds of our best-in-class medicines that are improving and extending lives. Let me now talk about our key areas of focus. In oncology, we are working to cure cancer, and our depth of expertise is unmatched. In 2025, we delivered 21% operational sales growth, and we expect to exceed $50 billion in annual sales by 2030. We are the number one company in multiple myeloma, where 80% of patients are treated with at least one of our four medicines over their treatment journey. Darzalex is the largest medicine by sales in our pharmaceutical portfolio and is considered the foundational gold standard treatment in multiple myeloma. With annual sales over $14 billion, Darzalex grew an impressive 22% across the full year.
Speaker #3: Let me now talk about our key areas of focus. In Oncology, we are working to cure cancer, and our depth of expertise is unmatched.
Speaker #3: In 2025, we delivered 21% operational sales growth, and we expect to exceed $50 billion in annual sales by 2030. We are the number one company in multiple myeloma, where 80% of patients are treated with at least one of our four medicines over their treatment journey.
Speaker #3: Darzalex is the largest medicine by sales in our pharmaceutical portfolio and is considered the foundational gold standard treatment in multiple myeloma. With annual sales over $14 billion, Darzalex grew an impressive 22% across the full year.
Speaker #3: Carvykti is the leading CAR-T cell therapy in multiple myeloma with more than 10,000 patients now treated across 14 markets. And we are not stopping there.
Joaquin Duato: Carvykti is the leading CAR-T cell therapy in multiple myeloma with more than 10,000 patients now treated across 14 markets, and we are not stopping there. Last month, we published and presented results for Tecvayli plus Darzalex that show reduced risk of progression or death by 83% in relapsed refractory multiple myeloma as early as the second line. We also recently announced top-line findings from a second phase III study, Majestic-9, which showed Tecvayli monotherapy reduced the risk of disease progression or death as early as first relapse in patients with multiple myeloma who are predominantly refractory to anti-CD38 and lenalidomide therapies. We are also seeing significant momentum in our solid tumor portfolio. In Q4, we received FDA approval for Rybrevant and Lazcluze as the first subcutaneous therapy for EGFR-mutated non-small cell lung cancer, reducing administration time from hours to minutes and improving patient experience.
Carvykti is the leading CAR-T cell therapy in multiple myeloma with more than 10,000 patients now treated across 14 markets, and we are not stopping there. Last month, we published and presented results for Tecvayli plus Darzalex that show reduced risk of progression or death by 83% in relapsed refractory multiple myeloma as early as the second line. We also recently announced top-line findings from a second phase III study, Majestic-9, which showed Tecvayli monotherapy reduced the risk of disease progression or death as early as first relapse in patients with multiple myeloma who are predominantly refractory to anti-CD38 and lenalidomide therapies. We are also seeing significant momentum in our solid tumor portfolio. In Q4, we received FDA approval for Rybrevant and Lazcluze as the first subcutaneous therapy for EGFR-mutated non-small cell lung cancer, reducing administration time from hours to minutes and improving patient experience.
Speaker #3: Last month, we published and presented results for Tecvayli, plus Darzalex, that show a reduced risk of progression or death by 83% in relapsed refractory multiple myeloma as early as the second line.
Speaker #3: We also recently announced the Majestic Nine study. Top-line findings from a second phase showed Tecvayli monotherapy reduced the risk of disease progression or death as early as first relapse in patients with multiple myeloma who are predominantly refractory to anti-CD38 and lenalidomide therapies.
Speaker #3: We are also seeing significant momentum in our solid tumor portfolio. In Q4, we received FDA approval for Rybrevant Faspro as the first subcutaneous therapy for EGFR-mutated non-small cell lung cancer, reducing administration time from hours to minutes and improving patient experience.
Speaker #3: We are making strong progress in bladder cancer with the introduction of INLEXO, our novel drug-releasing system, which received its initial FDA approval in September.
Joaquin Duato: We are making strong progress in bladder cancer with the introduction of Inlexo, our novel drug releasing system, which received its initial FDA approval in September. This is a revolutionary treatment that offers a life-changing alternative for patients who otherwise would have lost their bladders to radical surgery. Future approvals addressing larger patient populations are anticipated, and our Q4 acquisition of Halder Therapeutics added a promising clinical stage treatment for prostate cancer with potential across multiple tumor types. In immunology, we are focused on transforming the standard of care by increasing remission rates in immune-mediated disease. In 2025, Tremfya became the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen for both ulcerative colitis and Crohn's disease. It is now the fastest-growing IL-23 therapy in the US, delivering Q4 operational sales growth of 75% and 65% worldwide.
We are making strong progress in bladder cancer with the introduction of Inlexo, our novel drug releasing system, which received its initial FDA approval in September. This is a revolutionary treatment that offers a life-changing alternative for patients who otherwise would have lost their bladders to radical surgery. Future approvals addressing larger patient populations are anticipated, and our Q4 acquisition of Halder Therapeutics added a promising clinical stage treatment for prostate cancer with potential across multiple tumor types. In immunology, we are focused on transforming the standard of care by increasing remission rates in immune-mediated disease. In 2025, Tremfya became the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen for both ulcerative colitis and Crohn's disease. It is now the fastest-growing IL-23 therapy in the US, delivering Q4 operational sales growth of 75% and 65% worldwide.
Speaker #3: This is a revolutionary treatment that offers a life-changing alternative for patients who otherwise would have lost their bladders to radical surgery. Future approvals addressing larger patient populations are anticipated.
Speaker #3: And our Q4 acquisition of HALDA Therapeutics added a promising clinical-stage treatment for prostate cancer, with potential across multiple tumor types. In immunology, we are focused on transforming the standard of care by increasing remission rates in immune-mediated disease.
Speaker #3: In 2025, Tremfya became the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen for both ulcerative colitis and Crohn's disease. It is now the fastest-growing IL-23 therapy in the U.S., delivering Q4 operational sales growth of 75% and 65% worldwide.
Speaker #3: And with global full-year sales of Tremfya accelerating to more than $5 billion for the first time, we are increasingly confident that Tremfya will exceed $10 billion in peak year sales.
Joaquin Duato: With global full-year sales of Tremfya accelerating to more than $5 billion for the first time, we are increasingly confident that Tremfya will exceed $10 billion in peak year sales. But in healthcare, leadership means continually raising the bar, which is why we are focused on what's next in immunology. In the coming months, we look forward to the anticipated US approval of icotroquimab to be marketed as Icotide, which will expand our immunology innovation beyond injectable medicines. We believe Icotide positions Johnson & Johnson to lead the next wave of treatment for psoriasis and inflammatory bowel disease. Turning to neuroscience, where 2025 operational sales grew 10%, Spravato continues its strong trajectory with 57% growth in the year and more than 200,000 patients now treated worldwide.
With global full-year sales of Tremfya accelerating to more than $5 billion for the first time, we are increasingly confident that Tremfya will exceed $10 billion in peak year sales. But in healthcare, leadership means continually raising the bar, which is why we are focused on what's next in immunology. In the coming months, we look forward to the anticipated US approval of icotroquimab to be marketed as Icotide, which will expand our immunology innovation beyond injectable medicines. We believe Icotide positions Johnson & Johnson to lead the next wave of treatment for psoriasis and inflammatory bowel disease. Turning to neuroscience, where 2025 operational sales grew 10%, Spravato continues its strong trajectory with 57% growth in the year and more than 200,000 patients now treated worldwide.
Speaker #3: But in healthcare, leadership means continually raising the bar. Which is why we are focused on what's next in immunology. In the coming months, we look forward to the anticipated US approval of Icotroquinra, to be marketed as Icotide, which will expand our immunology innovation beyond injectable medicines.
Speaker #3: We believe Icotide positions Johnson & Johnson to lead the next wave of treatment for psoriasis and inflammatory bowel disease. Turning to neuroscience, where 2025 operational sales grew 10%.
Speaker #3: Spravato continues its strong trajectory with 57% growth in the year and more than 200,000 patients now treated worldwide. In November, we solidified our leadership with the US launch of Caplyta for adjunctive major depressive disorder, further strengthening our confidence in its $5 billion peak year sales potential.
Joaquin Duato: In November, we solidified our leadership with the US launch of Caplyta for adjunctive major depressive disorder, further strengthening our confidence in its $5 billion peak year sales potential. Now turning to MedTech, where operational sales for the year grew 5.4%. In 2025, we deliver nearly $34 billion in sales with strong performance in cardiovascular and accelerating momentum across surgery and vision. Our success over the last year was supported by 15 major launches and more than 40 regulatory approvals in major markets, and with more than 60 active clinical trials, we have significant momentum going into 2026. Johnson & Johnson today is a leader in three cardiovascular segments, with the portfolio delivering 15% operational sales growth in the year. Abiomed and Shockwave performed particularly well, delivering operational growth of approximately 18% and 23% in the quarter.
In November, we solidified our leadership with the US launch of Caplyta for adjunctive major depressive disorder, further strengthening our confidence in its $5 billion peak year sales potential. Now turning to MedTech, where operational sales for the year grew 5.4%. In 2025, we deliver nearly $34 billion in sales with strong performance in cardiovascular and accelerating momentum across surgery and vision. Our success over the last year was supported by 15 major launches and more than 40 regulatory approvals in major markets, and with more than 60 active clinical trials, we have significant momentum going into 2026. Johnson & Johnson today is a leader in three cardiovascular segments, with the portfolio delivering 15% operational sales growth in the year. Abiomed and Shockwave performed particularly well, delivering operational growth of approximately 18% and 23% in the quarter.
Speaker #3: Now turning to MedTech, where operational sales for the year grew 5.4%. In 2025, we delivered nearly $34 billion in sales, with strong performance in Cardiovascular and accelerating momentum across Surgery and Vision.
Speaker #3: Our success over the last year was supported by 15 major launches and more than 40 regulatory approvals in major markets. And with more than 60 active clinical trials, we have significant momentum going into 2026.
Speaker #3: Johnson & Johnson today is a leader in three cardiovascular segments with the portfolio delivering 15% operational sales growth in the year. AveoMed and Shockwave performed particularly well, delivering operational growth of approximately 18% and 23% in the quarter.
Speaker #3: We remain the market leader in electrophysiology, and we plan to expand our position in post-field ablation. Varipulse has now been used to treat nearly 40,000 atrial fibrillation patients globally.
Joaquin Duato: We remain the market leader in electrophysiology, and we plan to expand our position in pulsed field ablation. Varipulse has now been used to treat nearly 40,000 atrial fibrillation patients globally, and we look forward to submitting our dual-energy ThermoCool SmartTouch SF catheter for use in the US market in 2026. We are also seeing positive data for our Omnipulse catheter, which has the potential to further redefine pulsed field ablation. In fact, we anticipate launching a new catheter every year through the end of the decade as we build an industry-leading portfolio in PFA, complemented by at least two CARTO updates each year. In surgery, we are reinventing procedures through robotics and digital. This year, we will launch a first-of-its-kind robotics platform for urology with Monarch. The technology was first to market in bronchoscopy, helping diagnose and treat lung cancer.
We remain the market leader in electrophysiology, and we plan to expand our position in pulsed field ablation. Varipulse has now been used to treat nearly 40,000 atrial fibrillation patients globally, and we look forward to submitting our dual-energy ThermoCool SmartTouch SF catheter for use in the US market in 2026. We are also seeing positive data for our Omnipulse catheter, which has the potential to further redefine pulsed field ablation. In fact, we anticipate launching a new catheter every year through the end of the decade as we build an industry-leading portfolio in PFA, complemented by at least two CARTO updates each year. In surgery, we are reinventing procedures through robotics and digital. This year, we will launch a first-of-its-kind robotics platform for urology with Monarch. The technology was first to market in bronchoscopy, helping diagnose and treat lung cancer.
Speaker #3: And we look forward to submitting our dual energy thermocouple smart touch SF catheter for use in the US market in 2026. We are also seeing positive data for our OmniPulse catheter, which has the potential to further redefine post-field ablation.
Speaker #3: In fact, we anticipate launching a new catheter every year through the end of the decade, as we build an industry-leading portfolio in PFA, complemented by at least two CAR-T updates each year.
Speaker #3: In surgery, we are reinventing procedures through robotics and digital. We will launch, this year, a first-of-its-kind robotics platform for urology with Monarch. The technology was first to market in bronchoscopy, helping diagnose and treat lung cancer.
Speaker #3: And this year, we'll create another first with Monarch, becoming the only robotic endoluminal and percutaneous platform for the treatment of kidney stones and other renal conditions.
Joaquin Duato: This year, we'll create another first with Monarch, becoming the only robotic endoluminal and percutaneous platform for the treatment of kidney stones and other renal conditions. We also recently announced the FDA de novo submission of our Ottava robotic surgery system. With continued innovation in surgical instrumentation, including our recent launch of the Ethicon 4000 stapler, we anticipate continued growth as we reduce complications and elevate the surgical experience across specialties. Finally, Vision, which delivers robust annual operational sales growth of 5.3%, with particularly strong momentum in Surgical Vision. In 2025, we launched Acuvue Oasys MAX disposable lenses for astigmatism and presbyopia and completed the full market release of Tecnis Odyssey IOL, which is the fastest-growing intraocular lens in the US. Looking ahead, we're planning to launch Tecnis PureSee in the US later this year.
This year, we'll create another first with Monarch, becoming the only robotic endoluminal and percutaneous platform for the treatment of kidney stones and other renal conditions. We also recently announced the FDA de novo submission of our Ottava robotic surgery system. With continued innovation in surgical instrumentation, including our recent launch of the Ethicon 4000 stapler, we anticipate continued growth as we reduce complications and elevate the surgical experience across specialties. Finally, Vision, which delivers robust annual operational sales growth of 5.3%, with particularly strong momentum in Surgical Vision. In 2025, we launched Acuvue Oasys MAX disposable lenses for astigmatism and presbyopia and completed the full market release of Tecnis Odyssey IOL, which is the fastest-growing intraocular lens in the US. Looking ahead, we're planning to launch Tecnis PureSee in the US later this year.
Speaker #3: We also recently announced the FDA De Novo submission of our Octava robotic surgery system. And with continued innovation in surgical instrumentation, including our recent launch of the Ethicon 4000 stapler, we anticipate continued growth as we reduce complications and elevate the surgical experience across specialties.
Speaker #3: And finally, Vision, which delivers robust annual operational sales growth of 5.3%, with particularly strong momentum in Surgical Vision. In 2025, we launch Acuvue Oasys Max, disposable lenses for astigmatism and presbyopia, and completed the full market release of TECNIS Odyssey IOL, which is the fastest-growing intraocular lens in the US.
Speaker #3: Looking ahead, we're planning to launch Tecnis Purcy in the US later this year. As you can tell, we are starting the year from a position of strength.
Joaquin Duato: As you can tell, we are starting the year from a position of strength. You have heard me talk about the unmatched depth and strength of our business. In 2026, that will translate into accelerated growth and impact with game-changing innovation, reaching more patients more quickly than ever before. I will now turn the call back over to Darren. Thank you, Joaquin. Moving to our financial results. Unless otherwise stated, the percentages quoted represent operational results and therefore exclude the impact of currency translation. Starting with Q4 2025 sales results. Worldwide sales were $24.6 billion for the quarter. Sales increased 7.1% despite an approximate 650 basis point headwind from Stelara. Growth in the US was 7.5% and 6.6% outside of the US. Acquisitions and divestitures had a net positive impact on worldwide growth of 100 basis points, primarily driven by the Intra-Cellular acquisition. Turning now to earnings.
As you can tell, we are starting the year from a position of strength. You have heard me talk about the unmatched depth and strength of our business. In 2026, that will translate into accelerated growth and impact with game-changing innovation, reaching more patients more quickly than ever before. I will now turn the call back over to Darren.
Speaker #3: You have heard me talk about the unmatched depth and strength of our business. In 2026, that will translate into accelerated growth and impact with game-changing innovation reaching more patients, more quickly, than ever before.
Speaker #3: I will now turn the call back over to
Darren Snellgrove: Thank you, Joaquin. Moving to our financial results. Unless otherwise stated, the percentages quoted represent operational results and therefore exclude the impact of currency translation. Starting with Q4 2025 sales results. Worldwide sales were $24.6 billion for the quarter. Sales increased 7.1% despite an approximate 650 basis point headwind from Stelara. Growth in the US was 7.5% and 6.6% outside of the US. Acquisitions and divestitures had a net positive impact on worldwide growth of 100 basis points, primarily driven by the Intra-Cellular acquisition. Turning now to earnings.
Speaker #2: Thank you, Joaquin. Moving to our financial results. Unless otherwise stated, the percentages quoted represent operational results and, therefore, exclude the impact of currency translation.
Speaker #2: Starting with Q4 2025 sales results. Worldwide sales were $24.6 billion for the quarter. Sales increased 7.1%, despite an approximate 650 basis point headwind from Stelara.
Speaker #2: Growth in the US was 7.5% and 6.6% outside of the US. Acquisitions and divestitures had a net positive impact on worldwide growth of 100 basis points, primarily driven by the Intracellular acquisition.
Speaker #2: Turning now to earnings. For the quarter, net earnings were $5.1 billion and diluted earnings per share was $2.10, versus $1.41 a year ago. Adjusted net earnings for the quarter were $6.0 billion and adjusted diluted earnings per share was $2.46, representing an increase of 21.5% and 20.6%, respectively.
Joaquin Duato: For the quarter, net earnings were $5.1 billion, and diluted earnings per share was $2.10 versus $1.41 a year ago. Adjusted net earnings for the quarter were $6 billion, and adjusted diluted earnings per share of $2.46, representing an increase of 21.5% and 20.6% respectively compared to the fourth quarter of 2024. Items of note include a $0.22 IPR&D charge associated with the V-Wave acquisition in 2024 and $0.10 of dilution due to the acquisition of Halder Therapeutics in 2025. For the full year 2025, worldwide sales were $94.2 billion. Sales increased 5.3% despite an approximate 620 basis points headwind from Stelara. And if you do the math, Johnson & Johnson grew double digits for the full year excluding Stelara. Growth in the US was 6.9% and 3.4% outside the US.
For the quarter, net earnings were $5.1 billion, and diluted earnings per share was $2.10 versus $1.41 a year ago. Adjusted net earnings for the quarter were $6 billion, and adjusted diluted earnings per share of $2.46, representing an increase of 21.5% and 20.6% respectively compared to the fourth quarter of 2024. Items of note include a $0.22 IPR&D charge associated with the V-Wave acquisition in 2024 and $0.10 of dilution due to the acquisition of Halder Therapeutics in 2025. For the full year 2025, worldwide sales were $94.2 billion. Sales increased 5.3% despite an approximate 620 basis points headwind from Stelara. And if you do the math, Johnson & Johnson grew double digits for the full year excluding Stelara. Growth in the US was 6.9% and 3.4% outside the US.
Speaker #2: Compared to the fourth quarter of 2024, items of note include a $0.22 IPR&D charge associated with the V-Wave acquisition in 2024 and $0.10 of dilution due to the acquisition of Howder Therapeutics in 2025.
Speaker #2: For the full year 2025, worldwide sales were $94.2 billion; sales increased 5.3%, despite an approximate 620 basis point headwind from Stelara. And if you do the math, Johnson & Johnson grew double digits for the full year, excluding Stelara.
Speaker #2: Growth in the U.S. was 6.9%, and 3.4% outside the U.S. Acquisitions and divestitures had a net positive impact on worldwide growth of 110 basis points.
Joaquin Duato: Acquisitions and divestitures had a net positive impact on worldwide growth of 110 basis points, primarily driven by the Intra-Cellular and Shockwave Medical acquisitions. Turning now to earnings. Net earnings for full year 2025 were $26.8 billion, and diluted earnings per share was $11.03, including the $7 billion talc reserve reversal from Q1. This compares to diluted earnings per share of $5.79 a year ago, which included $0.67 of dilution due to acquired IPR&D charges on various transactions. Full year 2025 adjusted net earnings were $26.2 billion, and adjusted diluted earnings per share was $10.79, both representing an increase of 8.1% compared to full year 2024. I will now comment on business sales performance in the quarter, focusing on the six key areas where meaningful innovation is driving our performance and fueling our long-term growth. Beginning with innovative medicine.
Acquisitions and divestitures had a net positive impact on worldwide growth of 110 basis points, primarily driven by the Intra-Cellular and Shockwave Medical acquisitions. Turning now to earnings. Net earnings for full year 2025 were $26.8 billion, and diluted earnings per share was $11.03, including the $7 billion talc reserve reversal from Q1. This compares to diluted earnings per share of $5.79 a year ago, which included $0.67 of dilution due to acquired IPR&D charges on various transactions. Full year 2025 adjusted net earnings were $26.2 billion, and adjusted diluted earnings per share was $10.79, both representing an increase of 8.1% compared to full year 2024. I will now comment on business sales performance in the quarter, focusing on the six key areas where meaningful innovation is driving our performance and fueling our long-term growth. Beginning with innovative medicine.
Speaker #2: Primarily driven by the Intracellular and Shockwave acquisitions. Turning now to earnings. Net earnings for full year 2025 were $26.8 billion, and diluted earnings per share was $11.03, including the $7 billion TARC reserve reversal from Q1.
Speaker #2: This compares to diluted earnings per share of $5.79 a year ago, which included $0.67 of dilution due to acquired IPR&D charges on various transactions.
Speaker #2: Full-year 2025 adjusted net earnings were $26.2 billion, and adjusted diluted earnings per share was $10.79. Both represent an increase of 8.1% compared to full-year 2024.
Speaker #2: I will now comment on business sales performance in the quarter, focusing on the six key areas where meaningful innovation is driving our performance and fueling our long-term growth.
Speaker #2: Beginning with innovative medicine. Worldwide sales of $15.8 billion increased 7.9%, despite an approximate 1,110 basis point headwind from Stelara, illustrating the continued strength of our key brands and new launches.
Joaquin Duato: Worldwide sales of $15.8 billion increased 7.9% despite an approximate 1,110 basis point headwind from Stelara, illustrating the continued strength of our key brands and new launches. Growth both in the US and outside of the US was 7.9%. Acquisition and divestitures had a net positive impact of 170 basis points on worldwide growth, primarily due to the Intra-Cellular acquisition. In oncology, starting with multiple myeloma, Darzalex growth was 24.1%, primarily driven by strong share gains of 6.5 points across all lines of therapy and nearly 12 points in the front-line setting, as well as inventory dynamics and market growth. Carvykti achieved sales of $555 million with growth of 63.2%, driven by share gains and site expansion. Tecvayli and Talvey growth was 18.9% and 73.1% respectively, driven by continued expansion in the community setting.
Worldwide sales of $15.8 billion increased 7.9% despite an approximate 1,110 basis point headwind from Stelara, illustrating the continued strength of our key brands and new launches. Growth both in the US and outside of the US was 7.9%. Acquisition and divestitures had a net positive impact of 170 basis points on worldwide growth, primarily due to the Intra-Cellular acquisition. In oncology, starting with multiple myeloma, Darzalex growth was 24.1%, primarily driven by strong share gains of 6.5 points across all lines of therapy and nearly 12 points in the front-line setting, as well as inventory dynamics and market growth. Carvykti achieved sales of $555 million with growth of 63.2%, driven by share gains and site expansion. Tecvayli and Talvey growth was 18.9% and 73.1% respectively, driven by continued expansion in the community setting.
Speaker #2: Growth both in the U.S. and outside of the U.S. was 7.9%. Acquisitions and divestitures had a net positive impact of 170 basis points on worldwide growth, primarily due to the Intracellular acquisition.
Speaker #2: In oncology, starting with multiple myeloma, Darzalex growth was 24.1%, primarily driven by strong share gains of 6.5 points across all lines of therapy, and nearly 12 points in the frontline setting.
Speaker #2: As well as inventory dynamics and market growth. Carvykti achieved sales of $555 million, with growth of 63.2%, driven by share gains and site expansion.
Speaker #2: Tecvayli and TAR-V growth was 18.9% and 73.1%, respectively, driven by continued expansion in the community setting. In prostate cancer, Erleada delivered strong growth of 18% due to market growth and continued share gains, partially offset by the impact of Part D redesign.
Joaquin Duato: In prostate cancer, Erleada delivered strong growth of 18% due to market growth and continued share gains, partially offset by the impact of Part D redesign. In lung cancer, Rybrevant plus Lazcluze delivered sales of $216 million and growth of 76.5%, driven by continued launch uptake in all regions. We continue to see share gains in both first and second lines of therapy. Within immunology, Tremfya delivered remarkable growth of 65.4%. We continue to see share gains across all indications, with particularly strong momentum from our IBD launch as well as market growth. Stelara declined 48.6%, driven by share loss due to biosimilar competition and Part D redesign. In neuroscience, Spravato grew an impressive 67.8%, driven by continued strong demand from physicians and patients. Caplyta, which was acquired in Q2 as part of the Intra-Cellular acquisition, delivered sales of $249 million for the quarter.
In prostate cancer, Erleada delivered strong growth of 18% due to market growth and continued share gains, partially offset by the impact of Part D redesign. In lung cancer, Rybrevant plus Lazcluze delivered sales of $216 million and growth of 76.5%, driven by continued launch uptake in all regions. We continue to see share gains in both first and second lines of therapy. Within immunology, Tremfya delivered remarkable growth of 65.4%. We continue to see share gains across all indications, with particularly strong momentum from our IBD launch as well as market growth. Stelara declined 48.6%, driven by share loss due to biosimilar competition and Part D redesign. In neuroscience, Spravato grew an impressive 67.8%, driven by continued strong demand from physicians and patients. Caplyta, which was acquired in Q2 as part of the Intra-Cellular acquisition, delivered sales of $249 million for the quarter.
Speaker #2: In lung cancer, Rybrevant plus Lasclause delivered sales of $216 million and growth of 76.5%, driven by continued launch uptake in all regions. We continue to see share gains in both first- and second-line therapy.
Speaker #2: Within immunology, Tremfya delivered remarkable growth of 65.4%. We continue to see share gains across all indications, with particularly strong momentum from our IBD launch as well as market growth.
Speaker #2: Stelara declined 48.6%, driven by share loss due to biosimilar competition and Part D redesign. In neuroscience, Spravato grew an impressive 67.8%, driven by continued strong demand from physicians and patients.
Speaker #2: Caplyta, which was acquired in Q2 as part of the Intra-Cellular acquisition, delivered sales of $249 million for the quarter. Since AMDD approval in the U.S., Caplyta has had its highest-ever new patient start volumes across all indications.
Joaquin Duato: Since AMDD approval in the US, Caplyta has had its highest-ever new patient start volumes across all indications. Now moving to medtech. Worldwide sales of $8.8 billion increased 5.8%, with growth of 6.6% in the US and 4.9% outside of the US, driven by strong performance in our three focus areas: cardiovascular, surgery, and vision. Acquisitions and divestitures had a net negative impact of 10 basis points on worldwide growth. In cardiovascular, electrophysiology delivered growth of 6.5%, driven by procedure growth within our comprehensive portfolio, commercial execution, as well as Varipulse and other new products, partially offset by competitive pressures in PFA. Abiomed delivered growth of 18.3% with continued strong adoption of Impella technology. Shockwave delivered strong double-digit growth of 22.9%, driven by continued adoption of coronary and peripheral products, becoming our 13th billion-dollar medtech platform. Surgery grew 3.7% despite divestitures negatively impacting results by approximately 60 basis points.
Since AMDD approval in the US, Caplyta has had its highest-ever new patient start volumes across all indications. Now moving to medtech. Worldwide sales of $8.8 billion increased 5.8%, with growth of 6.6% in the US and 4.9% outside of the US, driven by strong performance in our three focus areas: cardiovascular, surgery, and vision. Acquisitions and divestitures had a net negative impact of 10 basis points on worldwide growth. In cardiovascular, electrophysiology delivered growth of 6.5%, driven by procedure growth within our comprehensive portfolio, commercial execution, as well as Varipulse and other new products, partially offset by competitive pressures in PFA. Abiomed delivered growth of 18.3% with continued strong adoption of Impella technology. Shockwave delivered strong double-digit growth of 22.9%, driven by continued adoption of coronary and peripheral products, becoming our 13th billion-dollar medtech platform. Surgery grew 3.7% despite divestitures negatively impacting results by approximately 60 basis points.
Speaker #2: Now moving to MedTech. Worldwide sales of $8.8 billion increased 5.8%, with growth of 6.6% in the US and 4.9% outside of the US, driven by strong performance in our three focus areas: cardiovascular, surgery, and vision.
Speaker #2: Acquisitions and divestitures had a net negative impact of 10 basis points on worldwide growth. In Cardiovascular, Electrophysiology delivered growth of 6.5%, driven by procedure growth within our comprehensive portfolio, commercial execution, as well as Varipulse and other new products.
Speaker #2: Partially offset by competitive pressures in PFA. Abiomed delivered growth of 18.3%, with continued strong adoption of Impella technology. Shockwave delivered strong double-digit growth of 22.9%, driven by continued adoption of coronary and peripheral products, becoming our 13th billion-dollar med tech platform.
Speaker #2: Surgery grew 3.7%, despite divestitures negatively impacting results by approximately 60 basis points. Growth was driven by accelerated launches of new products in biosurgery, technology penetration in wound closure, and strong commercial execution, partially offset by competitive pressures in energy and endocutters, as well as VBP in China across the portfolio.
Joaquin Duato: Growth was driven by accelerated launches of new products in biosurgery, technology penetration in wound closure, and strong commercial execution, partially offset by competitive pressures in energy and endocutters, as well as VBP in China across the portfolio. In vision, contact lenses and other products grew 5.3%, driven by category growth, strong performance in the Acuvue Oasys 1-Day family of products, and continued strategic price actions, further solidifying our leadership position. Surgical vision grew 10.8%, driven by new product innovations, robust demand for premium IOLs, and strong commercial execution. Orthopedics growth this quarter continued to gain momentum and increased to 3.5%, primarily driven by new product launches and strong commercial execution, partially offset by the orthopedics transformation and VBP in China.
Growth was driven by accelerated launches of new products in biosurgery, technology penetration in wound closure, and strong commercial execution, partially offset by competitive pressures in energy and endocutters, as well as VBP in China across the portfolio. In vision, contact lenses and other products grew 5.3%, driven by category growth, strong performance in the Acuvue Oasys 1-Day family of products, and continued strategic price actions, further solidifying our leadership position. Surgical vision grew 10.8%, driven by new product innovations, robust demand for premium IOLs, and strong commercial execution. Orthopedics growth this quarter continued to gain momentum and increased to 3.5%, primarily driven by new product launches and strong commercial execution, partially offset by the orthopedics transformation and VBP in China.
Speaker #2: In Vision, contact lenses and other products grew 5.3%, driven by category growth, strong performance in the Acuvue Oasys one-day family of products, and continued strategic price actions.
Speaker #2: Further solidifying our leadership position, Surgical Vision grew 10.8%, driven by new product innovations, robust demand for premium IOLs, and strong commercial execution. Orthopedics growth this quarter continued to gain momentum and increased to 3.5%.
Speaker #2: Primarily driven by new product launches and strong commercial execution, partially offset by the orthopedics transformation and VBP in China. Now, turning to our consolidated statement of earnings for the fourth quarter of 2025.
Joaquin Duato: Now turning to our consolidated statement of earnings for the fourth quarter of 2025, I'd like to highlight a few noteworthy items that have changed compared to the same quarter of last year. Cost of goods sold deleveraged by 80 basis points, driven by unfavorable product mix in innovative medicine and the impact of tariffs in medtech. This was partially offset by the one-time prior year fair value inventory step-up associated with the Shockwave acquisition. Selling, marketing, and administrative expense leveraged by 110 basis points, driven by lower administrative expense across the enterprise. Research and development leveraged by 620 basis points, primarily driven by prior year acquired IPR&D expense from the V-Wave acquisition in medtech, as well as pipeline investment timing in innovative medicine. Interest income and expense was a net income of $23 million as compared to $144 million of income in the fourth quarter of 2024.
Now turning to our consolidated statement of earnings for the fourth quarter of 2025, I'd like to highlight a few noteworthy items that have changed compared to the same quarter of last year. Cost of goods sold deleveraged by 80 basis points, driven by unfavorable product mix in innovative medicine and the impact of tariffs in medtech. This was partially offset by the one-time prior year fair value inventory step-up associated with the Shockwave acquisition. Selling, marketing, and administrative expense leveraged by 110 basis points, driven by lower administrative expense across the enterprise. Research and development leveraged by 620 basis points, primarily driven by prior year acquired IPR&D expense from the V-Wave acquisition in medtech, as well as pipeline investment timing in innovative medicine. Interest income and expense was a net income of $23 million as compared to $144 million of income in the fourth quarter of 2024.
Speaker #2: I'd like to highlight a few noteworthy items that have changed compared to the same quarter of last year. Cost of goods sold de-leveraged by 80 basis points, driven by unfavorable product mix in Innovative Medicine and the impact of tariffs in MedTech.
Speaker #2: The one-time prior year was partially offset by fair value inventory step-up associated with the Shockwave acquisition. Selling, marketing, and administrative expense leveraged by 110 basis points, driven by lower administrative expense across the enterprise.
Speaker #2: Research and development leveraged by 620 basis points, primarily driven by prior-year acquired IPR&D expense from the V-Wave acquisition in MedTech, as well as pipeline investment timing in Innovative Medicine.
Speaker #2: Interest income and expense was a net income of $23 million, as compared to $144 million of income in the fourth quarter of 2024.
Speaker #2: The decrease in income was primarily driven by a higher average debt balance. Other income and expense was a net expense of $483 million, as compared to $161 million of income in the fourth quarter of 2024.
Joaquin Duato: The decrease in income was primarily driven by a higher average debt balance. Other income and expense was a net expense of $483 million as compared to $161 million of income in the fourth quarter of 2024. This increase in net expense was driven by higher litigation costs of $0.9 billion, primarily related to the ORIS shareholder resolution, and a $0.2 billion non-recurring charge related to Halder employee equity awards. This was partially offset by a $0.3 billion contingent value right reduction associated with the Abiomed acquisition. Tax rate on a GAAP basis in the fourth quarter of 2025 was a benefit of 3% compared to an 11.7% cost in the fourth quarter of 2024. The decrease in the effective tax rate is primarily driven by a non-recurring tax benefit related to a loss on certain international subsidiaries. More information can be found in the company's forthcoming Form 10-K.
The decrease in income was primarily driven by a higher average debt balance. Other income and expense was a net expense of $483 million as compared to $161 million of income in the fourth quarter of 2024. This increase in net expense was driven by higher litigation costs of $0.9 billion, primarily related to the ORIS shareholder resolution, and a $0.2 billion non-recurring charge related to Halder employee equity awards. This was partially offset by a $0.3 billion contingent value right reduction associated with the Abiomed acquisition. Tax rate on a GAAP basis in the fourth quarter of 2025 was a benefit of 3% compared to an 11.7% cost in the fourth quarter of 2024. The decrease in the effective tax rate is primarily driven by a non-recurring tax benefit related to a loss on certain international subsidiaries. More information can be found in the company's forthcoming Form 10-K.
Speaker #2: This increase in net expense was driven by higher litigation costs of $0.9 billion, primarily related to the ORIS shareholder resolution, and a $0.2 billion non-recurring charge related to holder employee equity awards.
Speaker #2: This was partially offset by a $0.3 billion contingent value right reduction associated with the Abiomed acquisition. Tax rate on a GAAP basis in the fourth quarter of 2025 was a benefit of 3%, compared to an 11.7% cost in the fourth quarter of 2024.
Speaker #2: The decrease in the effective tax rate is primarily driven by a non-recurring tax benefit related to a loss on certain international subsidiaries. More information can be found in the company's forthcoming Form 10-K.
Speaker #2: Lastly, I'll direct your attention to the box section of the slide, where we have also provided our income before tax, net earnings, and earnings per share—adjusted to exclude the impact of intangible amortization expense and special items.
Joaquin Duato: Lastly, I'll direct your attention to the box section of the slide, where we have also provided our income before tax, net earnings, and earnings per share adjusted to exclude the impact of intangible amortization expense and special items. Now let's look at adjusted income before tax by segment for the quarter. Innovative medicine margin improved from 32.5% to 36.3%, primarily driven by administrative expense leveraging and phasing of R&D expense, partially offset by unfavorable mix in the cost of products sold. Medtech margin improved from 10.8% to 17.4%, primarily driven by prior year acquired IPR&D expense from the V-Wave acquisition, partially offset by the impact of tariffs and cost of products sold. As a result, adjusted income before tax for the enterprise as a percentage of sales increased from 24.1% to 28.7%.
Lastly, I'll direct your attention to the box section of the slide, where we have also provided our income before tax, net earnings, and earnings per share adjusted to exclude the impact of intangible amortization expense and special items. Now let's look at adjusted income before tax by segment for the quarter. Innovative medicine margin improved from 32.5% to 36.3%, primarily driven by administrative expense leveraging and phasing of R&D expense, partially offset by unfavorable mix in the cost of products sold. Medtech margin improved from 10.8% to 17.4%, primarily driven by prior year acquired IPR&D expense from the V-Wave acquisition, partially offset by the impact of tariffs and cost of products sold. As a result, adjusted income before tax for the enterprise as a percentage of sales increased from 24.1% to 28.7%.
Speaker #2: Now let's look at adjusted income before tax by segment for the quarter. Innovative Medicine margin improved from 32.5% to 36.3%, primarily driven by administrative expense leveraging and phasing of R&D expense.
Speaker #2: Partially offset by unfavorable mix in the cost of products sold. Med Tech margin improved from 10.8% to 17.4%, primarily driven by prior-year acquired IPR&D expense from the V-Wave acquisition.
Speaker #2: Partially offset by the impact of tariffs in cost of products sold. As a result, adjusted income before tax for the enterprise, as a percentage of sales, increased from 24.1% to 28.7%.
Speaker #2: This concludes the sales and earnings portion of the call, and I will now turn the call over to Joe. Thanks, Darren. Hello everyone, we appreciate you joining us today.
Joaquin Duato: This concludes the sales and earnings portion of the call, and I will now turn the call over to Joe.
This concludes the sales and earnings portion of the call, and I will now turn the call over to Joe.
Darren Snellgrove: Thanks, Darren. Hello everyone. We appreciate you joining us today. As you've heard from Joaquin and Darren, the employees of Johnson & Johnson delivered impressive results in 2025, driven by strong execution, important new launches, and significant pipeline progress that launched a new era of accelerated growth. Our performance demonstrates the depth and strength of Johnson & Johnson's business centered on six core areas: oncology, immunology, and neuroscience in innovative medicine, and cardiovascular, surgery, and vision in medtech. This has enabled us to exceed financial expectations that existed at the beginning of 2025 on both the top and bottom line. We enter 2026 with powerful momentum and anticipate another solid year ahead. Let me briefly address yesterday's Daubert rulings in the talc MDL. The special master correctly decided to exclude the opinions of certain plaintiffs' experts who preponderate junk science.
Joe Wolk: Thanks, Darren. Hello everyone. We appreciate you joining us today. As you've heard from Joaquin and Darren, the employees of Johnson & Johnson delivered impressive results in 2025, driven by strong execution, important new launches, and significant pipeline progress that launched a new era of accelerated growth. Our performance demonstrates the depth and strength of Johnson & Johnson's business centered on six core areas: oncology, immunology, and neuroscience in innovative medicine, and cardiovascular, surgery, and vision in medtech. This has enabled us to exceed financial expectations that existed at the beginning of 2025 on both the top and bottom line. We enter 2026 with powerful momentum and anticipate another solid year ahead. Let me briefly address yesterday's Daubert rulings in the talc MDL. The special master correctly decided to exclude the opinions of certain plaintiffs' experts who preponderate junk science.
Speaker #2: As you've heard from Joaquin and Darren, the employees of Johnson & Johnson delivered impressive results in 2025, driven by strong execution, important new launches, and significant pipeline progress that launched a new era of accelerated growth.
Speaker #2: Our performance demonstrates the depth and strength of Johnson & Johnson's business, centered on six core areas: oncology, immunology, and neuroscience in innovative medicine, and cardiovascular, surgery, and vision in med tech.
Speaker #2: This has enabled us to exceed financial expectations that existed at the beginning of 2025 on both the top and bottom line. We entered 2026 with powerful momentum and anticipate another solid year ahead.
Speaker #2: Let me briefly address yesterday's Daubert rulings in the talc MDL. The special master correctly decided to exclude the opinions of certain plaintiffs' experts who preponderated junk science.
Speaker #2: In other parts of the ruling, the court did not uphold its proper gatekeeping duty with respect to the reliability of plaintiff's experts' opinions, and we will appeal.
Darren Snellgrove: In other parts of the ruling, the court did not uphold its proper gatekeeping duty with respect to the reliability of plaintiff's expert's opinions, and we will appeal. The decision only serves to bolster our overall litigation strategy. We will continue to defend against these meritless claims at trial and through the appeals courts, where we have largely prevailed. Before we move into 2026 guidance, let's address cash and capital allocation. We ended 2025 with approximately $20 billion of cash and marketable securities and $48 billion of debt for a net debt position of approximately $28 billion. The company generated $19.7 billion of free cash flow during 2025, on par with 2024, despite increased capital investment in the US and the impact of tariffs. Our financial strength is a competitive advantage that allows us to both invest in our future and return value to our shareholders.
In other parts of the ruling, the court did not uphold its proper gatekeeping duty with respect to the reliability of plaintiff's expert's opinions, and we will appeal. The decision only serves to bolster our overall litigation strategy. We will continue to defend against these meritless claims at trial and through the appeals courts, where we have largely prevailed. Before we move into 2026 guidance, let's address cash and capital allocation. We ended 2025 with approximately $20 billion of cash and marketable securities and $48 billion of debt for a net debt position of approximately $28 billion. The company generated $19.7 billion of free cash flow during 2025, on par with 2024, despite increased capital investment in the US and the impact of tariffs. Our financial strength is a competitive advantage that allows us to both invest in our future and return value to our shareholders.
Speaker #2: The decision only serves to bolster our overall litigation strategy. We will continue to defend against these meritless claims at trial and through the appeals courts, where we have largely prevailed.
Speaker #2: Before we move into 2026 guidance, let's address cash and capital allocation. We ended 2025 with approximately $20 billion of cash and marketable securities, and $48 billion of debt, for a net debt position of approximately $28 billion.
Speaker #2: The company generated $19.7 billion of free cash flow during 2025, on par with 2024, despite increased capital investment in the US and the impact of tariffs.
Speaker #2: Our financial strength is a competitive advantage that allows us to both invest in our future and return value to our shareholders. As we move forward in 2026, we expect to elevate free cash flow generation to approximately $21 billion.
Darren Snellgrove: As we move forward in 2026, we expect to elevate free cash flow generation to approximately $21 billion. As it relates to the separation of our orthopedics business, we are making good progress towards a mid-2027 separation and look forward to providing updates later this year. Turning now to guidance for the full year 2026, we anticipate operational sales growth in the range of 5.7% to 6.7%, with a midpoint of $100 billion or 6.2%. Acquisitions and divestitures are expected to favorably impact operational growth by approximately 30 basis points, resulting in an adjusted operational sales growth midpoint of 5.9%. We do benefit in 2026 as our financial calendar includes a 53rd week, which is worth approximately 100 basis points. As you know, we do not speculate on future currency movements, and last quarter we utilized the euro spot rate relative to the US dollar of 1.17.
As we move forward in 2026, we expect to elevate free cash flow generation to approximately $21 billion. As it relates to the separation of our orthopedics business, we are making good progress towards a mid-2027 separation and look forward to providing updates later this year. Turning now to guidance for the full year 2026, we anticipate operational sales growth in the range of 5.7% to 6.7%, with a midpoint of $100 billion or 6.2%. Acquisitions and divestitures are expected to favorably impact operational growth by approximately 30 basis points, resulting in an adjusted operational sales growth midpoint of 5.9%. We do benefit in 2026 as our financial calendar includes a 53rd week, which is worth approximately 100 basis points. As you know, we do not speculate on future currency movements, and last quarter we utilized the euro spot rate relative to the US dollar of 1.17.
Speaker #2: As it relates to the separation of our orthopedics business, we are making good progress towards a mid-2027 separation and look forward to providing updates later this year.
Speaker #2: Turning now to guidance for the full year 2026. We anticipate operational sales growth in the range of 5.7% to 6.7%, with a midpoint of $100 billion, or 6.2%.
Speaker #2: Acquisitions and divestitures are expected to favorably impact operational growth by approximately 30 basis points, resulting in an adjusted operational sales growth midpoint of 5.9%.
Speaker #2: We do benefit in 2026, as our financial calendar includes a 53rd week, which is worth approximately 100 basis points. As you know, we do not speculate on future currency movements, and last quarter we utilized the Euro spot rate relative to the US dollar of 1.17.
Speaker #2: As of last week, the US dollar has stayed relatively flat to the Euro spot rate, and as a result, we expect reported sales growth between 6.2% to 7.2%, with a midpoint of $100.5 billion, or 6.7%.
Darren Snellgrove: As of last week, the US dollar has stayed relatively flat to the euro spot rate, and as a result, we expect reported sales growth between 6.2% to 7.2%, with a midpoint of $100.5 billion or 6.7%. 2026 sales growth across our innovative medicine business will be driven by Tremfya, Darzalex, Carvykti, Olyta, and Spravato, as well as new launches of Rybrevant plus Lazcluze in lung cancer and Caplyta as adjunctive therapy for major depressive disorder. In medtech, we expect growth to be driven by continued uptake and market expansion of new product launches across our cardiovascular, surgery, and vision portfolios, including Varipulse in electrophysiology, Ethicon 4000 in surgery, and the Oasys Max family in vision. Turning next to other items on the P&L.
As of last week, the US dollar has stayed relatively flat to the euro spot rate, and as a result, we expect reported sales growth between 6.2% to 7.2%, with a midpoint of $100.5 billion or 6.7%. 2026 sales growth across our innovative medicine business will be driven by Tremfya, Darzalex, Carvykti, Olyta, and Spravato, as well as new launches of Rybrevant plus Lazcluze in lung cancer and Caplyta as adjunctive therapy for major depressive disorder. In medtech, we expect growth to be driven by continued uptake and market expansion of new product launches across our cardiovascular, surgery, and vision portfolios, including Varipulse in electrophysiology, Ethicon 4000 in surgery, and the Oasys Max family in vision. Turning next to other items on the P&L.
Speaker #2: 2026 sales growth across our Innovative Medicine business will be driven by Tremfya, Darzalex, Carvykti, Erleada, and Spravato, as well as new launches of Rybrevant plus Lasclause in lung cancer, and Caplyta as adjunctive therapy for major depressive disorder.
Speaker #2: In MedTech, we expect growth to be driven by continued uptake and market expansion of new product launches across our cardiovascular, surgery, and vision portfolios, including Varipulse and electrophysiology, Ethicon 4000 in surgery, and the OASYS-MAX family in vision.
Speaker #2: Turning next to other items on the P&L. In 2026, we expect to drive continued operating efficiencies; the majority of which we plan to invest in our business to power our new product launches and pipeline with heavier investment at the outset of the year.
Darren Snellgrove: In 2026, we expect to drive continued operating efficiencies, the majority of which we plan to invest in our business to power our new product launches and pipeline with heavier investment at the outset of the year. Despite that increased investment, we are planning for our 2026 adjusted pre-tax operating margin to improve by at least 50 basis points. Our pre-tax operating margin guidance takes into account the costs from the 53rd week of operations and full year medtech tariffs of approximately $500 million, which is significantly above the 2025 amount. It also includes the impact of the recently announced voluntary agreement with the US government to improve access to medicines and lower costs to US patients. We expect net interest expense between $300 million and $400 million. We anticipate net other income to be $1 to $1.2 billion for 2026, relatively flat to last year.
In 2026, we expect to drive continued operating efficiencies, the majority of which we plan to invest in our business to power our new product launches and pipeline with heavier investment at the outset of the year. Despite that increased investment, we are planning for our 2026 adjusted pre-tax operating margin to improve by at least 50 basis points. Our pre-tax operating margin guidance takes into account the costs from the 53rd week of operations and full year medtech tariffs of approximately $500 million, which is significantly above the 2025 amount. It also includes the impact of the recently announced voluntary agreement with the US government to improve access to medicines and lower costs to US patients. We expect net interest expense between $300 million and $400 million. We anticipate net other income to be $1 to $1.2 billion for 2026, relatively flat to last year.
Speaker #2: Despite that increased investment, we are planning for our 2026 adjusted pre-tax operating margin to improve by at least 50 basis points. Our pre-tax operating margin guidance takes into account the costs from the 53rd week of operations and full-year med tech tariffs of approximately $500 million, which is significantly above the 2025 amount.
Speaker #2: It also includes the impact of the recently announced voluntary agreement with the US government to improve access to medicines and lower costs to US patients.
Speaker #2: We expect net interest expense between $300 million and $400 million. We anticipate net other income to be $1.0 to $1.2 billion for 2026, relatively flat to last year.
Speaker #2: Finally, we are projecting an effective tax rate in the range of 17.5% to 18.5%, with the increase largely due to a mix change with income in higher tax jurisdictions.
Darren Snellgrove: Finally, we are projecting an effective tax rate in the range of 17.5% to 18.5%, with the increase largely due to a mix change with income in higher tax jurisdictions. Turning to adjusted operational earnings per share, we expect growth of 5.5% at the midpoint for a range of $11.28 to $11.48. By utilizing the exchange rate we mentioned earlier for our reported adjusted earnings per share for the year, we estimate a positive impact of $0.15. As such, we expect reported adjusted earnings per share of $11.53 at the midpoint. Regarding our share count, due to the rapid share price appreciation in the second half of 2025 into early 2026, our diluted share count is increasing to approximately 2.44 billion shares based on US GAAP accounting rules for the diluted share count calculation, in line with how the fourth quarter of 2025 landed.
Finally, we are projecting an effective tax rate in the range of 17.5% to 18.5%, with the increase largely due to a mix change with income in higher tax jurisdictions. Turning to adjusted operational earnings per share, we expect growth of 5.5% at the midpoint for a range of $11.28 to $11.48. By utilizing the exchange rate we mentioned earlier for our reported adjusted earnings per share for the year, we estimate a positive impact of $0.15. As such, we expect reported adjusted earnings per share of $11.53 at the midpoint. Regarding our share count, due to the rapid share price appreciation in the second half of 2025 into early 2026, our diluted share count is increasing to approximately 2.44 billion shares based on US GAAP accounting rules for the diluted share count calculation, in line with how the fourth quarter of 2025 landed.
Speaker #2: Turning to adjusted operational earnings per share, we expect growth of 5.5% at the midpoint, for a range of $11.28 to $11.48. By utilizing the exchange rate we mentioned earlier for our reported adjusted earnings per share for the year, we estimate a positive impact of $0.15.
Speaker #2: As such, we expect reported adjusted earnings per share of $11.53 at the midpoint. Regarding our share count, due to the rapid share price appreciation in the second half of 2025 into early 2026, our diluted share count is increasing to approximately 2.44 billion shares, based on US GAP accounting rules for the diluted share count calculation.
Speaker #2: In line with how the fourth quarter of 2025 landed. The incremental diluted shares for next year are worth slightly more than $0.05 headwind versus 2025.
Darren Snellgrove: The incremental diluted shares for next year are worth slightly more than $0.05 headwind versus 2025. Relative to current analyst expectations, our EPS and margin outlooks absorb the previously referenced incremental tariffs, the impact of the voluntary US government agreement, and a higher share count. We will now shift to some 2026 phasing considerations to help inform your modeling. We are well positioned to build upon our accomplishments in 2025, continuing to make advancements across our innovative medicine and medtech portfolio and pipeline. We anticipate fairly consistent operational sales growth throughout the year, with a higher fourth quarter due to the benefit from the 53rd week referenced earlier. Regarding innovative medicine, we expect a more pronounced impact from newly launched products throughout the year. We anticipate Stelara to continue to follow the Humira erosion curve, which accelerated as we move through the second half of 2025 compared to the start.
The incremental diluted shares for next year are worth slightly more than $0.05 headwind versus 2025. Relative to current analyst expectations, our EPS and margin outlooks absorb the previously referenced incremental tariffs, the impact of the voluntary US government agreement, and a higher share count. We will now shift to some 2026 phasing considerations to help inform your modeling. We are well positioned to build upon our accomplishments in 2025, continuing to make advancements across our innovative medicine and medtech portfolio and pipeline. We anticipate fairly consistent operational sales growth throughout the year, with a higher fourth quarter due to the benefit from the 53rd week referenced earlier. Regarding innovative medicine, we expect a more pronounced impact from newly launched products throughout the year. We anticipate Stelara to continue to follow the Humira erosion curve, which accelerated as we move through the second half of 2025 compared to the start.
Speaker #2: Relative to current analyst expectations, our EPS and margin outlooks absorb the previously referenced incremental tariffs, the impact of the voluntary U.S. government agreement, and a higher share count.
Speaker #2: We will now shift to some 2026 phasing considerations to help inform your modeling. We are well positioned to build upon our accomplishments in 2025, continuing to make advancements across our innovative medicine and med tech portfolio and pipeline.
Speaker #2: We anticipate fairly consistent operational sales growth throughout the year, with a higher fourth quarter due to the benefit from the 53rd week referenced earlier.
Speaker #2: Regarding innovative medicine, we expect a more pronounced impact from newly launched products throughout the year. We anticipate Stelara to continue to follow the Humira erosion curve, which accelerated as we move through the second half of 2025 compared to the start.
Speaker #2: While not nearly as impactful as Stelara, we do anticipate generic impact for both Simponi and Upsummit to begin in 2026. Both of which are contemplated in our full year guidance.
Darren Snellgrove: While not nearly as impactful as Stelara, we do anticipate generic impact for both Simponi and Opsumit to begin in 2026, both of which are contemplated in our full year guidance. In medtech, we will continue to accelerate our newly launched products and expect normalized seasonality. The surgery transformation progress will accelerate throughout the year, and we anticipate some additional rounds of volume-based procurement in China, all of which has been incorporated into our 2026 guidance. Regarding the P&L, it is important to consider one-time items that impacted our EPS results in 2025. Specifically, in Q1 2025, the impact from Stelara biosimilars was less pronounced, given that the erosion accelerated starting in Q2. The Intra-Cellular acquisition anniversaries in Q2 and tariffs will be relatively linear in 2026, unlike last year, where the P&L cost was largely recorded in Q4 2025.
While not nearly as impactful as Stelara, we do anticipate generic impact for both Simponi and Opsumit to begin in 2026, both of which are contemplated in our full year guidance. In medtech, we will continue to accelerate our newly launched products and expect normalized seasonality. The surgery transformation progress will accelerate throughout the year, and we anticipate some additional rounds of volume-based procurement in China, all of which has been incorporated into our 2026 guidance. Regarding the P&L, it is important to consider one-time items that impacted our EPS results in 2025. Specifically, in Q1 2025, the impact from Stelara biosimilars was less pronounced, given that the erosion accelerated starting in Q2. The Intra-Cellular acquisition anniversaries in Q2 and tariffs will be relatively linear in 2026, unlike last year, where the P&L cost was largely recorded in Q4 2025.
Speaker #2: In med tech, we will continue to accelerate our newly launched products and expect normalized seasonality. The surgery transformation progress will accelerate throughout the year, and we anticipate some additional rounds of volume-based procurement in China; all of which has been incorporated into our 2026 guidance.
Speaker #2: Regarding the P&L, it is important to consider one-time items that impacted our EPS results in 2025. Specifically, in Q1 2025, the impact from Stelara biosimilars was less pronounced, given that the erosion accelerated starting in Q2.
Speaker #2: The intercellular acquisition anniversaries in Q2. And tariffs will be relatively linear in 2026, unlike last year where the P&L cost was largely recorded in Q4 2025.
Speaker #2: Given these factors, we expect higher earnings per share growth in the second half of the year versus the first half. We are excited about how our pipeline is anticipated to advance in 2026.
Darren Snellgrove: Given these factors, we expect higher earnings per share growth in the second half of the year versus the first half. We are excited about how our pipeline is anticipated to advance in 2026. For example, in innovative medicine, we expect regulatory approvals for Icotide in psoriasis, Tecvayli in combination with Darzalex in relapsed refractory multiple myeloma as early as second line, and Tremfya for the inhibition of structural joint damage for patients with psoriatic arthritis. As this chart indicates, we also have many important regulatory submissions and data presentations across oncology, immunology, and neuroscience. In medtech, we anticipate the following approvals and regulatory submissions: Ottava robotic surgical system, Aphysia in biosurgery, and the Dual Energy ThermoCool SmartTouch SF catheter in the US. Here too, we are also excited for new launches and continued expansion of new products as seen in the chart.
Given these factors, we expect higher earnings per share growth in the second half of the year versus the first half. We are excited about how our pipeline is anticipated to advance in 2026. For example, in innovative medicine, we expect regulatory approvals for Icotide in psoriasis, Tecvayli in combination with Darzalex in relapsed refractory multiple myeloma as early as second line, and Tremfya for the inhibition of structural joint damage for patients with psoriatic arthritis. As this chart indicates, we also have many important regulatory submissions and data presentations across oncology, immunology, and neuroscience. In medtech, we anticipate the following approvals and regulatory submissions: Ottava robotic surgical system, Aphysia in biosurgery, and the Dual Energy ThermoCool SmartTouch SF catheter in the US. Here too, we are also excited for new launches and continued expansion of new products as seen in the chart.
Speaker #2: For example, in innovative medicine, we expect regulatory approvals for Icotide in psoriasis, Tecvayli in combination with Darzalex in relapsed refractory multiple myeloma, as early as second line, and Tremfya for the innovation of structural joint damage for patients with psoriatic arthritis.
Speaker #2: As this chart indicates, we also have many important regulatory submissions and data presentations across oncology, immunology, and neuroscience. In MedTech, we anticipate the following approvals and regulatory submissions.
Speaker #2: Otava Robotics Surgical System, Athesia in biosurgery, and the Dual Energy ThermoCool SmartTouch SF catheter in the US. Here, too, we are also excited for new launches and continued expansion of new products, as seen in the chart.
Speaker #2: To close the prepared remarks, I hope it's evident that Johnson & Johnson is entering 2026 with significant momentum. We are positioned to lead where healthcare is going, to tackle areas of critical unmet need.
Darren Snellgrove: To close the prepared remarks, I hope it's evident that Johnson & Johnson is entering 2026 with significant momentum. We are positioned to lead where healthcare is going, to tackle areas of critical unmet need. Our strong financial position enables us to invest in our business and the next generation of scientific breakthroughs that will help improve patient outcomes while simultaneously delivering value for our shareholders. None of this would be possible without the hard work and dedication of our incredible colleagues worldwide, who always keep patients at the center of everything we do. With that, we are happy to take your questions, so I will now turn it to Kevin to provide instructions for those seeking to participate in the Q&A.
To close the prepared remarks, I hope it's evident that Johnson & Johnson is entering 2026 with significant momentum. We are positioned to lead where healthcare is going, to tackle areas of critical unmet need. Our strong financial position enables us to invest in our business and the next generation of scientific breakthroughs that will help improve patient outcomes while simultaneously delivering value for our shareholders. None of this would be possible without the hard work and dedication of our incredible colleagues worldwide, who always keep patients at the center of everything we do. With that, we are happy to take your questions, so I will now turn it to Kevin to provide instructions for those seeking to participate in the Q&A.
Speaker #2: Our strong financial position enables us to invest in our business and the next generation of scientific breakthroughs that will help improve patient outcomes while simultaneously delivering value for our shareholders.
Speaker #2: None of this would be possible without the hard work and dedication of our incredible colleagues worldwide, who always keep patients at the center of everything we do.
Speaker #2: With that, we are happy to take your questions. I will now turn it to Kevin to provide instructions for those seeking to participate in the Q&A.
Speaker #2: Thank you. Ladies and gentlemen, it's about time for questions at this time. Please press star, then one on your telephone keypad. If you'd like to withdraw your question, please press star, then two.
Joaquin Duato: Thank you, ladies and gentlemen. If you'd like to ask a question at this time, please press Star, then 1 on your telephone keypad. If you'd like to withdraw your question, please press Star, then 2. Please limit yourselves to one question only. Our first question is coming from Asad Haider from Goldman Sachs. Your line is now live.
Operator: Thank you, ladies and gentlemen. If you'd like to ask a question at this time, please press Star, then 1 on your telephone keypad. If you'd like to withdraw your question, please press Star, then 2. Please limit yourselves to one question only. Our first question is coming from Asad Haider from Goldman Sachs. Your line is now live.
Speaker #2: Please let me yourselves to one question only. Our first question is coming from Assad Haider from Goldman Sachs. Your line is now
Speaker #2: live.
Speaker #3: Great. Congrats on
[Analyst] (IRS): Great. Congrats on the quarter, and thanks for taking the question. Joaquin, maybe just a big picture question for you. You're entering this year in a clear position of strength following what's been one of the best performance years for the stock in about 20 years. You've had momentum in both business segments. You're generating tremendous free cash flow, and that you're saying is going to continue to elevate. And you've now started to talk more about double-digit revenue growth by the latter part of the decade, although Street consensus is currently modeling something in the 6% range.
Asad Haider: Great. Congrats on the quarter, and thanks for taking the question. Joaquin, maybe just a big picture question for you. You're entering this year in a clear position of strength following what's been one of the best performance years for the stock in about 20 years. You've had momentum in both business segments. You're generating tremendous free cash flow, and that you're saying is going to continue to elevate. And you've now started to talk more about double-digit revenue growth by the latter part of the decade, although Street consensus is currently modeling something in the 6% range.
Speaker #3: Thanks for taking the question. Joaquin, maybe just a big picture question for you. You’re entering this year in a clear position of strength following what’s been one of the best performance years for the stock in about 20 years.
Speaker #3: You've had momentum in both business segments. You're generating tremendous free cash flow, and that you're saying is going to continue to elevate. And you've now started to talk more about double-digit revenue growth by the latter part of the decade, although street consensus is currently modeling something in the 6% range.
Speaker #3: So if you could just maybe double-click a little bit more on what the key levers are to bridge to that double-digit growth profile from where we sit today, particularly in the context of the current revenue base that's now approaching $100 billion and remains sizable through the end of the decade, even with the author spin.
[Analyst] (IRS): If you could just maybe double-click a little bit more on what the key levers are to bridge to that double-digit growth profile from where we sit today, particularly in the context of the current revenue base that's now approaching $100 billion and remains sizable through the end of the decade, even with the auto spin. I guess what we're really trying to understand is how much of that acceleration comes from the organic pipeline versus acquisitions versus portfolio pruning. I guess related, what innings are we in of this strategic repositioning away from lower growth segments like you're doing with auto towards higher growth segments? Thank you.
If you could just maybe double-click a little bit more on what the key levers are to bridge to that double-digit growth profile from where we sit today, particularly in the context of the current revenue base that's now approaching $100 billion and remains sizable through the end of the decade, even with the auto spin. I guess what we're really trying to understand is how much of that acceleration comes from the organic pipeline versus acquisitions versus portfolio pruning. I guess related, what innings are we in of this strategic repositioning away from lower growth segments like you're doing with auto towards higher growth segments? Thank you.
Speaker #3: And I guess what we're really trying to understand is how much of that acceleration comes from the organic pipeline versus acquisitions versus portfolio pruning.
Speaker #3: And I guess related, what innings are we in of the strategic repositioning away from lower growth segments like you're doing with author towards higher growth segments?
Speaker #3: Thank you.
Tim Schmid: Thank you. Great question, and sure. I mean, we come out of a really successful 2025, leaving the Stelara biosimilars in the rearview mirror and initiating a cycle of accelerated growth for Johnson & Johnson. You have seen that we have provided guidance for 2026, which is strong and ahead of expectations. As I said before, we have line of sight to double-digit growth in the later part of the decade, which is especially remarkable for a company that, according to our guidance, would be $100 billion in sales in 2026. So what are the reasons to believe? The reasons to believe are focused on the strength of our portfolio and pipeline. Let me now take you through the six areas of focus that we are investing into the future. Let me start with oncology.
Tim Schmid: Thank you. Great question, and sure. I mean, we come out of a really successful 2025, leaving the Stelara biosimilars in the rearview mirror and initiating a cycle of accelerated growth for Johnson & Johnson. You have seen that we have provided guidance for 2026, which is strong and ahead of expectations. As I said before, we have line of sight to double-digit growth in the later part of the decade, which is especially remarkable for a company that, according to our guidance, would be $100 billion in sales in 2026. So what are the reasons to believe? The reasons to believe are focused on the strength of our portfolio and pipeline. Let me now take you through the six areas of focus that we are investing into the future. Let me start with oncology.
Speaker #4: Great question, thank you. And sure, I mean, we come out of a really successful 2025, leaving the Stelara biosimilars in the rearview mirror and initiating a cycle of accelerated growth for Johnson & Johnson.
Speaker #4: And you have seen that we have provided guideline guidance for 2026, which is strong. And ahead of expectations. And as I said, before, we have line of sight to double-digit growth in the later part of the decade, which is especially remarkable for a company that, according to our guidance, would be $100 billion in sales in 2026.
Speaker #4: what are the reasons to believe? So focused on the strength of our portfolio and pipeline. And let me now take you through the six areas of focus that we are investing into the future.
Speaker #4: Let me start with oncology. Our ambition with oncology is to become the number one oncology company, reaching $50 billion by the end of the decade.
Tim Schmid: Our ambition with oncology is to become the number one oncology company, reaching $50 billion by the end of the decade, sustained by our success in multiple myeloma and also in solid tumors with lung cancer, prostate cancer, and bladder cancer. We are very confident on our progress there and in our pipeline, and I'm sure we'll have some time to discuss that later in the call. In our second area in innovative medicine, which is immunology, we are focusing on three major blockbusters. One is Tremfya, which has been very successful in IBD. You have seen the growth in Q4, really spectacular, 65%. Tremfya and IBD launch is doing really well. And as a reminder, in the case of Stelara, IBD was 75% of the sales. So there's significant growth for Tremfya ahead of us. We see Tremfya more than a $10 billion asset.
Our ambition with oncology is to become the number one oncology company, reaching $50 billion by the end of the decade, sustained by our success in multiple myeloma and also in solid tumors with lung cancer, prostate cancer, and bladder cancer. We are very confident on our progress there and in our pipeline, and I'm sure we'll have some time to discuss that later in the call. In our second area in innovative medicine, which is immunology, we are focusing on three major blockbusters. One is Tremfya, which has been very successful in IBD. You have seen the growth in Q4, really spectacular, 65%. Tremfya and IBD launch is doing really well. And as a reminder, in the case of Stelara, IBD was 75% of the sales. So there's significant growth for Tremfya ahead of us. We see Tremfya more than a $10 billion asset.
Speaker #4: Sustained by our success in multiple myeloma, and also in solid tumors with lung cancer, prostate cancer, and bladder cancer. We are very confident on our progress there and in our pipeline, and I'm sure we'll have some time to discuss that later in the call.
Speaker #4: In our second area in innovative medicine, which is immunology, we are focusing on three major blockbusters. One is Tremfya, which has been very successful in IBD.
Speaker #4: You have seen the growth in the fourth quarter—really spectacular, 65%. Tremfya in IBD launch is doing really well, and as a reminder, in the case of Stelara, IBD was 75% of the sales.
Speaker #4: So there's significant growth for Tremfya ahead of us. We see Tremfya more than a $10 billion asset. The second one is Icotide. Icotide is the trademark of Icotrochinra, our oral IL-23 blocker.
Tim Schmid: The second one is Icotide. Icotide is the trademark of icotroquimab, our oral IL-23 blocker. We see the oral IL-23 blocker expanding the market, becoming a new blockbuster for us. We expect to have the launch of Icotide in 2026, initially in psoriasis. This is going to be a transformational change for the treatment of these diseases, and we plan to continue to develop Icotide too in IBD, in inflammatory bowel disease. And finally, the third blockbuster in which we will see data this year is our bispecific antibody therapeutic for patients that are refractory to biologics. I think that's a great solution for these patients, many of them relapse. So three major blockbusters in immunology, which are largely de-risked, some of them are approved file, or you're going to see data very, very soon.
The second one is Icotide. Icotide is the trademark of icotroquimab, our oral IL-23 blocker. We see the oral IL-23 blocker expanding the market, becoming a new blockbuster for us. We expect to have the launch of Icotide in 2026, initially in psoriasis. This is going to be a transformational change for the treatment of these diseases, and we plan to continue to develop Icotide too in IBD, in inflammatory bowel disease. And finally, the third blockbuster in which we will see data this year is our bispecific antibody therapeutic for patients that are refractory to biologics. I think that's a great solution for these patients, many of them relapse. So three major blockbusters in immunology, which are largely de-risked, some of them are approved file, or you're going to see data very, very soon.
Speaker #4: We see the oral IL-23 blocker expanding the market, becoming a new blockbuster for us. We expect to have the launch of Icotide in 2026, initially in psoriasis.
Speaker #4: This is going to be a transformational change for the treatment of these diseases, and we plan to continue to develop Icotide II in IBD, in inflammatory bowel disease.
Speaker #4: And finally, the third blockbuster in which we will see data this year is our co-antibody therapeutic for patients that are refractory to biologics. I think that's a great solution for these patients.
Speaker #4: Many of them relapse. So, three major blockbusters in immunology, which are largely de-risked—some of them are approved, and for others you'll see data very, very soon.
Speaker #4: To end in innovative medicine, we are very encouraged by the progress of Spravato, more than 60% growth, and also the very successful launch of Caplyta in adjunctive treatment of major depressive disorder.
Tim Schmid: To end in innovative medicine, we are very encouraged by the progress of Spravato, more than 60% growth, and also the very successful launch of Caplyta in adjunctive treatment of major depressive disorder. We're seeing the first data coming in, very, very encouraging. We see Caplyta, as we discussed, as additive to our growth and more than a $5 billion business. So all positives in our innovative medicine group, clearly driving this line of sight to double-digit growth by the end of the decade. If I move to our medtech business, our cardiovascular sector, very strong growth in 2025. Double-digit growth is reaching $9 billion. It's one of the largest cardiovascular franchises in the industry.
To end in innovative medicine, we are very encouraged by the progress of Spravato, more than 60% growth, and also the very successful launch of Caplyta in adjunctive treatment of major depressive disorder. We're seeing the first data coming in, very, very encouraging. We see Caplyta, as we discussed, as additive to our growth and more than a $5 billion business. So all positives in our innovative medicine group, clearly driving this line of sight to double-digit growth by the end of the decade. If I move to our medtech business, our cardiovascular sector, very strong growth in 2025. Double-digit growth is reaching $9 billion. It's one of the largest cardiovascular franchises in the industry.
Speaker #4: We're seeing the first data coming in very, very encouraging. We see Caplyta as we discuss as additive to our growth and more than a $5 billion business.
Speaker #4: So, all positives in our Innovative Medicine group, clearly driving this line of sight to double-digit growth by the end of the decade. If I move to our MedTech business—our cardiovascular sector—very strong growth in 2025; double-digit growth is reaching $9 billion.
Speaker #4: It's one of the largest cardiovascular franchises in the industry. We are in three major markets, which are specialty markets with high growth: cardiac ablation, where we are the leaders, and we plan to expand our leadership in PFA with a launch of a new catheter every year, a new cartoversions, a team will explain later.
Tim Schmid: We are in three major markets, which are specialty markets with high growth, cardiac ablation, where we are the leaders, and we plan to expand our leadership in PFA with the launch of a new catheter every year, a new CARTO version. A team will explain later. Our strong position both with Abiomed and Shockwave in heart recovery and in calcified arterial disease. So that's going to be a growth driver for us into the rest of the decade. In surgery, we have had strong results both in wound closure and in biosurgery, which are high single digit in both areas. We just filed for Ottava, which is going to make us a relevant player in the surgery robotics market, which is an area in which we have all the right to compete.
We are in three major markets, which are specialty markets with high growth, cardiac ablation, where we are the leaders, and we plan to expand our leadership in PFA with the launch of a new catheter every year, a new CARTO version. A team will explain later. Our strong position both with Abiomed and Shockwave in heart recovery and in calcified arterial disease. So that's going to be a growth driver for us into the rest of the decade. In surgery, we have had strong results both in wound closure and in biosurgery, which are high single digit in both areas. We just filed for Ottava, which is going to make us a relevant player in the surgery robotics market, which is an area in which we have all the right to compete.
Speaker #4: Our strong position, both with Abiomed and Shockwave in heart recovery and in calcified arterial disease, is going to be a growth driver for us into the rest of the decade.
Speaker #4: In surgery, we have had strong results both in wound closure and in biosurgery, which are high single-digit in both areas. We just filed for OTAVA, which is going to make us a relevant player in the surgery robotics market, which is an area in which we have all the right to compete.
Speaker #4: Let me remind all of you that we are in all hospitals in the world, and we already participate in all surgeries, and we plan to be a relevant player in robotic surgery.
Tim Schmid: Let me remind all of you that we are in all hospitals in the world, and we already participate in all surgeries, and we plan to be a relevant player in robotic surgery with Ottava and also with the launch of Monarch in urology, in which we are going to have a unique position. Then finally, in vision, you see our results in vision. It's a market with growth. We're gaining share, and it's an area of innovation in which we plan to invest. So we have about a dozen new product launches for the company. Some of them are already approved, most of them submitted. So I would say that in that sense, it's essentially what I would call de-risk.
Let me remind all of you that we are in all hospitals in the world, and we already participate in all surgeries, and we plan to be a relevant player in robotic surgery with Ottava and also with the launch of Monarch in urology, in which we are going to have a unique position. Then finally, in vision, you see our results in vision. It's a market with growth. We're gaining share, and it's an area of innovation in which we plan to invest. So we have about a dozen new product launches for the company. Some of them are already approved, most of them submitted. So I would say that in that sense, it's essentially what I would call de-risk.
Speaker #4: With OTAVA, and also with the launch of Monarch in Urology, we are going to have a unique position. Then finally, in Vision, you see our results—Vision is a market with growth.
Speaker #4: We're gaining share, and it's an area of innovation in which we plan to invest. So, we have about a dozen new product launches for the company.
Speaker #4: Some of them are already approved. Most of them submitted. So I would say that in that sense, it's essentially what I would call the risk.
Speaker #4: And some of you have called our story of growth in the second half of the decade as one of the cleanest, stories of growth for the healthcare sector for the healthcare entire sector overall.
Tim Schmid: And some of you have called our story of growth in the second half of the decade as one of the cleanest stories of growth for the healthcare sector, for the healthcare entire sector overall. So we feel very confident about our outlook. It's reflected in our guidance for 2026, and I can assure you that everybody here at Johnson & Johnson is focused on doing exactly what we do best, which is looking for innovation in medicines and medical technologies to improve the standard of care of the millions of patients that we serve. And we are convinced that will translate in strong business results.
And some of you have called our story of growth in the second half of the decade as one of the cleanest stories of growth for the healthcare sector, for the healthcare entire sector overall. So we feel very confident about our outlook. It's reflected in our guidance for 2026, and I can assure you that everybody here at Johnson & Johnson is focused on doing exactly what we do best, which is looking for innovation in medicines and medical technologies to improve the standard of care of the millions of patients that we serve. And we are convinced that will translate in strong business results.
Speaker #4: We feel very confident about our outlook. It's reflected in our guidance for 2026, and I can assure you that everybody here at Johnson & Johnson is focused on doing exactly what we do best—which is looking for innovation in medicines and medical technologies to improve the standard of care for the millions of patients that we serve.
Speaker #4: And we are convinced that that will translate into strong business.
Speaker #4: results. Thank
Speaker #1: Our next question is coming from Larry Beagleson from Wells Fargo. Your line is now open.
Joaquin Duato: Thank you. Our next question is coming from Larry Biegelsen from Wells Fargo. Your line is now live.
Operator: Thank you. Our next question is coming from Larry Biegelsen from Wells Fargo. Your line is now live.
Speaker #1: live.
Speaker #3: Good morning. Thanks for
[Analyst] (Wells Fargo): Good morning. Thanks for taking the question, and I'll echo my congratulations on a nice end to the year here. So Tim, there's some dynamics in the medtech market that you called out in the slides, as well as the loss of coverage in the US from the enhanced subsidies expiring. How are you thinking about the medtech market in 2026 relative to 2025? And how are you thinking about J&J's adjusted operational growth in 2026 versus 2025? Do you expect an acceleration? And it'd be helpful if you could touch upon the outlook for your EP business, which is growing below market. Thank you.
Larry Biegelsen: Good morning. Thanks for taking the question, and I'll echo my congratulations on a nice end to the year here. So Tim, there's some dynamics in the medtech market that you called out in the slides, as well as the loss of coverage in the US from the enhanced subsidies expiring. How are you thinking about the medtech market in 2026 relative to 2025? And how are you thinking about J&J's adjusted operational growth in 2026 versus 2025? Do you expect an acceleration? And it'd be helpful if you could touch upon the outlook for your EP business, which is growing below market. Thank you.
Speaker #3: Taking the question, and I'll echo my congratulations on a nice end to the year here. So, Tim, there are some dynamics in the MedTech market that you called out in the slides, as well as the loss of coverage in the U.S.
Speaker #3: From the enhanced subsidies expiring, how are you thinking about the medtech market in 2026 relative to 2025? And how are you thinking about J&J's adjusted operational growth in 2026 versus 2025?
Speaker #3: Do you expect an acceleration? And it would be helpful if you could touch upon the outlook for your EP business, which is growing below the market.
Speaker #3: Thank
Speaker #3: Larry, thank you for the question.
Tim Schmid: Larry, thank you for the question. Let me touch quickly on the first question around ACA subsidies and put that one to bed. Firstly, based on what we know today, we do not expect the loss of ACA subsidies or any potential policy changes under the one big beautiful bill to have a material impact on our MedTech performance. While we'll continue to monitor how coverage dynamics evolve, at this stage, we see no indication of an impact on our growth trajectory. The primary constraint, as you know, Larry, in our business is really more about clinical capacity, not coverage levels, and procedure demands remain very robust across our portfolio, which I think really speaks to the resilience of the businesses that we've decided to participate in. Turning to your question about the year, we do expect to see accelerate.
Tim Schmid: Larry, thank you for the question. Let me touch quickly on the first question around ACA subsidies and put that one to bed. Firstly, based on what we know today, we do not expect the loss of ACA subsidies or any potential policy changes under the one big beautiful bill to have a material impact on our MedTech performance. While we'll continue to monitor how coverage dynamics evolve, at this stage, we see no indication of an impact on our growth trajectory. The primary constraint, as you know, Larry, in our business is really more about clinical capacity, not coverage levels, and procedure demands remain very robust across our portfolio, which I think really speaks to the resilience of the businesses that we've decided to participate in. Turning to your question about the year, we do expect to see accelerate.
Speaker #2: Let me touch quickly on the first question around ACA subsidies and put that one to bed. Firstly, based on what we know today, we do not expect the loss of ACA subsidies or any potential policy changes under the big, the one big beautiful bill, to have a material impact on our MedTech performance.
Speaker #2: And while we'll continue to monitor how coverage dynamics evolve, at this stage, we see no indication of an impact on our growth trajectory. The primary constraint, as you know, Larry, in our business is really more about clinical capacity, not coverage levels, and procedure demands remain very robust across our portfolio, which I think really speaks to the resilience of the businesses that we've decided to participate in.
Speaker #2: Turning to your question about the year, we do expect to see acceleration. We expect the year to be better in 2026 than it was in 2025.
Tim Schmid: We expect the year to be better in 2026 than it was in 2025. I think it's important to maybe hedge this question on really our strategy. I think you know for the last couple of years, we've been very clear in articulating our strategy focused on shifting our portfolio into higher innovation, higher growth, and higher margin markets. As you just heard from Joaquin, we have deliberately chosen to focus on our three focus areas of CV, surgery, and vision. I think our results, Larry, speak for themselves. Our strategy is working. We said we would accelerate our performance in the back half of 2025, and we did exactly that, beating consensus for the third consecutive quarter. What we're most proud of, Larry, is that we saw acceleration across the board.
We expect the year to be better in 2026 than it was in 2025. I think it's important to maybe hedge this question on really our strategy. I think you know for the last couple of years, we've been very clear in articulating our strategy focused on shifting our portfolio into higher innovation, higher growth, and higher margin markets. As you just heard from Joaquin, we have deliberately chosen to focus on our three focus areas of CV, surgery, and vision. I think our results, Larry, speak for themselves. Our strategy is working. We said we would accelerate our performance in the back half of 2025, and we did exactly that, beating consensus for the third consecutive quarter. What we're most proud of, Larry, is that we saw acceleration across the board.
Speaker #2: And I think it's important to maybe hedge this question on really our strategy. And I think you know for the last couple of years, we've been very clear in articulating our strategy focused on shifting our portfolio into higher innovation, higher growth, and higher margin markets.
Speaker #2: And as you just heard from Joaquin, we have deliberately chosen to focus on our three focus areas of CV, surgery, and vision. And I think our results, Larry, speak for themselves.
Speaker #2: Our strategy is working. We said we would accelerate our performance in the back half of 2025, and we did exactly that—beating consensus for the third consecutive quarter.
Speaker #2: And what we're most proud of, Larry, is that we saw acceleration across the board. As you heard from Joaquin, cardiovascular is now one of our largest businesses at $9 billion.
Tim Schmid: As you heard from Joaquin, cardiovascular, now one of our largest businesses at $9 billion, grew 15.2% operationally in 2025, driven by success of Abiomed and Shockwave, both double-digit growers and increasing performance in EP, which I'll touch on a little later. Vision, strong, high to mid to high single digit performer, double-digit growth in surgical vision. Of course, we couldn't be more excited by the growth opportunity that will come with Ottava as we look to commercialize that first in the US, hopefully this year. We've also seen continued improvement of ortho. You would have expected maybe some distraction as a result of the announcement we made. We've seen exactly the opposite with sequential growth through the quarter and 3.5% in Q4. So I'll finally reinforce, Larry, that our portfolio transformation is working.
As you heard from Joaquin, cardiovascular, now one of our largest businesses at $9 billion, grew 15.2% operationally in 2025, driven by success of Abiomed and Shockwave, both double-digit growers and increasing performance in EP, which I'll touch on a little later. Vision, strong, high to mid to high single digit performer, double-digit growth in surgical vision. Of course, we couldn't be more excited by the growth opportunity that will come with Ottava as we look to commercialize that first in the US, hopefully this year. We've also seen continued improvement of ortho. You would have expected maybe some distraction as a result of the announcement we made. We've seen exactly the opposite with sequential growth through the quarter and 3.5% in Q4. So I'll finally reinforce, Larry, that our portfolio transformation is working.
Speaker #2: Grew 15.2% operationally in 2025, driven by the success of AbbVie and Shockwave, both double-digit growers, and increasing performance in EP, which I'll touch on a little later.
Speaker #2: Vision: strong, high mid- to high single-digit performer, double-digit growth in Surgical Vision, and of course, we couldn't be more excited by the growth opportunity that will come with OTAVA as we look to commercialize that first in the US, hopefully this year.
Speaker #2: We've also seen continued improvement of Ortho. You would have expected maybe some distraction as a result of the announcement we made, but we've seen exactly the opposite, with sequential growth during the quarter and 3.5% in Q4.
Speaker #2: And so I'll finally reinforce, Larry, that our portfolio transformation is working. If you look at the $34 billion business today, we have roughly half of our assets participating in higher-growth markets, growing north of 5%.
Tim Schmid: If you look at the $34 billion business today, we have roughly half of our assets participating in higher growth markets, growing north of 5%. That's compared to about 20% in 2018. And this will catapult to north of 70% following the ortho separation. And so as a result, we believe, frankly, that our best days are ahead, and we remain very confident in our ability to drive accelerated operational growth as we further push into higher areas of innovation, growth, and margins. Let me touch quickly on EP because I think that was another part of your question. The results speak for themselves, and they're speaking loud and clear. We're seeing continued acceleration in the markets that matter most, especially here in the US and in Europe. You will have seen that in Q4, our growth accelerated to 9.5%.
If you look at the $34 billion business today, we have roughly half of our assets participating in higher growth markets, growing north of 5%. That's compared to about 20% in 2018. And this will catapult to north of 70% following the ortho separation. And so as a result, we believe, frankly, that our best days are ahead, and we remain very confident in our ability to drive accelerated operational growth as we further push into higher areas of innovation, growth, and margins. Let me touch quickly on EP because I think that was another part of your question. The results speak for themselves, and they're speaking loud and clear. We're seeing continued acceleration in the markets that matter most, especially here in the US and in Europe. You will have seen that in Q4, our growth accelerated to 9.5%.
Speaker #2: That's compared to about 20% in 2018. And this will catapult to north of 70% following the Ortho separation. So as a result, we believe frankly that our best days are ahead, and we remain very confident in our ability to drive accelerated operational growth as we further push into higher areas of innovation, growth, and margins.
Speaker #2: Let me touch quickly on EP, because I think that was another part of your question. The results speak for themselves, and they're speaking loud and clear.
Speaker #2: We're seeing continued acceleration in the markets that matter most, especially here in the US and in Europe. You will have seen that in the fourth quarter, our growth accelerated to 9.5%.
Speaker #2: We're on the cusp of, once again, double-digit growth here in the United States, which is by far and away the most important market. We're seeing this driven by the success of Varipulse, and more than 40,000 cases today, Larry, with a benchmark safety profile.
Tim Schmid: We're on the cusp of once again double-digit growth here in the United States, which is by far and away the most important market. We're seeing this driven by the success of Varipulse in more than 40,000 cases today, Larry, with a benchmark safety profile. As you heard from Joaquin, we've made a commitment to an additional catheter each year for the foreseeable future, starting with dual energy STSF, followed by Omnipulse, which is a large-to-focal catheter. And we're also doubling down on our leadership position in mapping. And we now see really customers shifting back to CARTO based on the integration we have across our portfolio. And just to put a point on this, Larry, for example, our CARTO 3 system is widely recognized as the industry benchmark in mapping.
We're on the cusp of once again double-digit growth here in the United States, which is by far and away the most important market. We're seeing this driven by the success of Varipulse in more than 40,000 cases today, Larry, with a benchmark safety profile. As you heard from Joaquin, we've made a commitment to an additional catheter each year for the foreseeable future, starting with dual energy STSF, followed by Omnipulse, which is a large-to-focal catheter. And we're also doubling down on our leadership position in mapping. And we now see really customers shifting back to CARTO based on the integration we have across our portfolio. And just to put a point on this, Larry, for example, our CARTO 3 system is widely recognized as the industry benchmark in mapping.
Speaker #2: As you heard from Joaquin, we've made a commitment to an additional catheter each year for the placebo future, starting with dual energy STSF, followed by OmniPulse, which is a large two-focal catheter.
Speaker #2: And we're also doubling down on our leadership position in mapping. And we now see really customers shifting back to Cardo based on the integration we have across our portfolio.
Speaker #2: And just to put a point on this, Larry, for example, our Cardo 3 system is widely recognized as the industry benchmark in mapping. In fact, in a recent study, it found that patients treated with PFA devices, whether that be ours or the competition's using Cardo, were at 61%.
Tim Schmid: In fact, in a recent study, it found that patients treated with PFA devices, whether that be ours or the competition's using CARTO, were 61%, once again, 61% less likely to experience AFib-related readmissions, which I think further reinforces the competitive advantage we have in this portfolio. And so I've said this before, Larry, and I'll end by saying that we are not rolling over. J&J's strength lies in our comprehensive portfolio of integrated EP solutions, mapping, ablation, and cardiac imaging technologies combined with our best-in-class mappers. And we remain resolute and confident that our deep EP expertise earned over 30 years and our robust pipeline position us well to continue to drive global leadership in this important space. Thanks, Larry.
In fact, in a recent study, it found that patients treated with PFA devices, whether that be ours or the competition's using CARTO, were 61%, once again, 61% less likely to experience AFib-related readmissions, which I think further reinforces the competitive advantage we have in this portfolio. And so I've said this before, Larry, and I'll end by saying that we are not rolling over. J&J's strength lies in our comprehensive portfolio of integrated EP solutions, mapping, ablation, and cardiac imaging technologies combined with our best-in-class mappers. And we remain resolute and confident that our deep EP expertise earned over 30 years and our robust pipeline position us well to continue to drive global leadership in this important space. Thanks, Larry.
Speaker #2: Once again, 61% less likely to experience AFib-related readmissions, which I think further reinforces the competitive advantage we have in this portfolio. And so I've said this before, Larry, and I'll end by saying that we are not rolling over.
Speaker #2: J&J's strength lies in our comprehensive portfolio of integrated EP solutions, mapping, ablation, and cardiac imaging technologies, combined with our best-in-class mappers. And we remain resolute and confident that our deep EP expertise, earned over 30 years, and our robust pipeline position us well to continue to drive global leadership in this important space.
Speaker #2: Thanks,
Speaker #2: Larry. Thank
Speaker #3: you. Next question today is coming from Chris Schopp from JPMorgan Chase and Company. Your line is
Joaquin Duato: Thank you. Next question today is coming from Chris Schott from JPMorgan Chase & Co. Your line is now live.
Operator: Thank you. Next question today is coming from Chris Schott from JPMorgan Chase & Co. Your line is now live.
Speaker #3: now live. Hi, great.
[Analyst] (JPMorgan Chase & Co.): Hi, great. Thanks so much, and congrats on the results. Joe, can you just elaborate a little bit more on how to think about margin progression over time at J&J? You've obviously highlighted the potential for accelerating top-line growth over the next several years. Should we think about that higher level of top-line growth being associated with greater margin expansion, or is this kind of 50 basis point-year type improvement that you're seeing this year a reasonable proxy to think about margin expansion for J&J over time? Thank you.
Chris Schott: Hi, great. Thanks so much, and congrats on the results. Joe, can you just elaborate a little bit more on how to think about margin progression over time at J&J? You've obviously highlighted the potential for accelerating top-line growth over the next several years. Should we think about that higher level of top-line growth being associated with greater margin expansion, or is this kind of 50 basis point-year type improvement that you're seeing this year a reasonable proxy to think about margin expansion for J&J over time? Thank you.
Speaker #4: Thanks so much, and yeah, congrats on the results. Joe, can you just elaborate a little bit more on how to think about margin progression over time at J&J?
Speaker #4: You've obviously highlighted the potential for accelerating top-line growth over the next several years. Should we think about that higher level of top-line growth being associated with greater margin expansion, or is this kind of 50 basis point year type improvement that you're seeing this year a reasonable proxy to think about margin expansion for J&J over time?
Speaker #4: Thank you.
Speaker #5: Yeah, good morning, Chris. Thanks for the question. Yeah, it's a great question. As we look at the margin expansion, the idea would be to continue to improve our infrastructure.
Tim Schmid: Yeah, good morning, Chris. Thanks for the question. Yeah, it's a great question. As we look at the margin expansion, the idea would be to continue to improve our infrastructure. What gives me confidence with respect to 2026 outlook of at least 50 basis points is, as you know, with the orthopedic separation, much like we did with the consumer health separation, we're going to take this opportunity to look and see where there's areas of opportunity efficiency to eliminate stranded costs. While that will probably need to be in place for 2027, we're going to get a jumpstart on that in 2026. There's also, as you know from recent calls, efforts underway to improve our operating margins, our gross margins specifically in our manufacturing footprint, largely in the MedTech space.
Tim Schmid: Yeah, good morning, Chris. Thanks for the question. Yeah, it's a great question. As we look at the margin expansion, the idea would be to continue to improve our infrastructure. What gives me confidence with respect to 2026 outlook of at least 50 basis points is, as you know, with the orthopedic separation, much like we did with the consumer health separation, we're going to take this opportunity to look and see where there's areas of opportunity efficiency to eliminate stranded costs. While that will probably need to be in place for 2027, we're going to get a jumpstart on that in 2026. There's also, as you know from recent calls, efforts underway to improve our operating margins, our gross margins specifically in our manufacturing footprint, largely in the MedTech space.
Speaker #5: What gives me confidence with respect to the 2026 outlook of at least 50 basis points is, as you know, with the orthopedic separation—much like we did with the Consumer Health separation—we're going to take this opportunity to look and see where there are areas of opportunity, efficiency, to eliminate stranded cost.
Speaker #5: While that will probably need to be in place for 2027, we're going to get a jump start on that in 2026. There's also, as you know from recent calls, efforts underway to improve our operating margins—our gross margins specifically—in our manufacturing footprint.
Speaker #5: Largely in the med tech space. And then lastly, while we will have continued Stelara erosion, it'll be off a smaller base. So that will have less of an impact going forward.
Tim Schmid: And then lastly, while we will have continued Stelara erosion, it'll be off a smaller base, so that will have less of an impact going forward. And so I wouldn't want to give you a longer-term outlook. What I can say is I'll harken back to our last investor day where we said that earnings would be commensurate with sales growth. So you can expect that the margin profile will improve in conjunction with the sales growth profile as we move out to the next couple of years and to the back half of this decade.
And then lastly, while we will have continued Stelara erosion, it'll be off a smaller base, so that will have less of an impact going forward. And so I wouldn't want to give you a longer-term outlook. What I can say is I'll harken back to our last investor day where we said that earnings would be commensurate with sales growth. So you can expect that the margin profile will improve in conjunction with the sales growth profile as we move out to the next couple of years and to the back half of this decade.
Speaker #5: And so, I wouldn't want to give you a longer-term outlook. What I can say is, I'll harken back to our last Investor Day, where we said that earnings would be commensurate with sales growth.
Speaker #5: So you can expect that the margin profile will improve in conjunction with the sales growth profile as we move out to the next couple of years and to the back half of this decade.
Speaker #3: Thank you. Next question today is coming from Joanne Wundt from Citibank. Your line is now open.
Joaquin Duato: Thank you. Next question today is coming from Joanne Wuensch from Citibank. Her line is now live.
Operator: Thank you. Next question today is coming from Joanne Wuensch from Citibank. Her line is now live.
Speaker #3: live.
Speaker #6: Good morning. Thank you for
[Analyst] (Citibank): Good morning. Thank you for taking the question, and I'll add my congrats on the good quarter. I just want to spend a minute or two talking about vision care. You highlighted that as one of the three growth areas in medical technology. It looks like in your surgical business, it was a little bit slower during the quarter versus what we saw in the United States versus what we saw outside the United States. If you could tease that apart a little bit and your views on the health of the contact lens market would be really welcome? Thanks again.
Joanne Wuensch: Good morning. Thank you for taking the question, and I'll add my congrats on the good quarter. I just want to spend a minute or two talking about vision care. You highlighted that as one of the three growth areas in medical technology. It looks like in your surgical business, it was a little bit slower during the quarter versus what we saw in the United States versus what we saw outside the United States. If you could tease that apart a little bit and your views on the health of the contact lens market would be really welcome? Thanks again.
Speaker #6: Taking the question, and I'll add my congrats on the good quarter. I just want to spend a minute or two talking about the vision care.
Speaker #6: You highlighted that as one of the three growth areas in medical technology. It looks like in your surgical business, it was a little bit slower during the quarter versus what we saw in the United States versus what we saw outside the United States.
Speaker #6: If you could tease that apart a little bit, and your views on the health of the contact lens market would be really welcome. Thanks again.
Speaker #5: Joanne, thank you for your note and once again, we have doubled down and really focusing on vision as one of our three priority areas within med tech and as you highlighted, a strong fourth quarter at growth of just under 7%.
Tim Schmid: Joanne, thank you for your note. Once again, we have doubled down and really focusing on vision as one of our three priority areas within medtech. As you highlighted, a strong fourth quarter at growth of just under 7%. Strong underlying performance within our contact lens category. While we did see a little softness, Joanne, in Asia-Pacific, underlying demand is robust, and we saw tremendous growth at roughly 5.3% with share gains driven by the continued rollout of our Acuvue Oasys 1-Day family, which I think you probably know that we've added to with the addition of a product focused on multifocal astigmatism and only daily disposable available for patients suffering with both presbyopia and astigmatism. So we believe that's going to be a nice growth driver for the future. Turning to surgical vision, growth of close to 11% in the quarter.
Tim Schmid: Joanne, thank you for your note. Once again, we have doubled down and really focusing on vision as one of our three priority areas within medtech. As you highlighted, a strong fourth quarter at growth of just under 7%. Strong underlying performance within our contact lens category. While we did see a little softness, Joanne, in Asia-Pacific, underlying demand is robust, and we saw tremendous growth at roughly 5.3% with share gains driven by the continued rollout of our Acuvue Oasys 1-Day family, which I think you probably know that we've added to with the addition of a product focused on multifocal astigmatism and only daily disposable available for patients suffering with both presbyopia and astigmatism. So we believe that's going to be a nice growth driver for the future. Turning to surgical vision, growth of close to 11% in the quarter.
Speaker #5: Strong underlying performance within our contact lens category. While we did see a little softness, Joanne, in Asia Pacific, underlying demand is robust and we saw tremendous growth at roughly 5.3%, with share gains driven by the continued rollout of our Acuvue Oasys one-day family, which I think you probably know that we've added to with the addition of a product focused on multifocal astigmatism—and the only product, or only daily disposable, available for patients suffering with both presbyopia and astigmatism.
Speaker #5: And so we believe that's going to be a nice growth driver for the future. Turning to surgical vision, growth of close to 11% in the quarter and that's all driven by our doubling down of our focus on premium intraocular lenses both with Tecnis Odyssey launch here in the US last year and PureSee more broadly globally.
Tim Schmid: That's all driven by our doubling down of our focus on premium intraocular lenses, both with Tecnis Odyssey launch here in the US last year and PureSee more broadly globally. As you look to 2026, we're going to be further enhancing that performance by building out the portfolio specifically with the launch of PureSee here in the United States. You touched on our fourth quarter performance. Underlying performance of our premium IOLs here in the US was outstanding. We did see that offset somewhat by some ongoing market declines in some of the legacy categories, which we're working to address. We're confident that our surgical vision business can continue to be a strong double-digit growth for the foreseeable future.
That's all driven by our doubling down of our focus on premium intraocular lenses, both with Tecnis Odyssey launch here in the US last year and PureSee more broadly globally. As you look to 2026, we're going to be further enhancing that performance by building out the portfolio specifically with the launch of PureSee here in the United States. You touched on our fourth quarter performance. Underlying performance of our premium IOLs here in the US was outstanding. We did see that offset somewhat by some ongoing market declines in some of the legacy categories, which we're working to address. We're confident that our surgical vision business can continue to be a strong double-digit growth for the foreseeable future.
Speaker #5: As you look to 2026, we're going to be further enhancing that performance by building out the portfolio, specifically with the launch of PureSee here in the United States.
Speaker #5: You touched on our fourth quarter performance. Underlying performance of our premium IOLs here in the U.S. was somewhat impacted by some ongoing market headwinds. We did see that offset declines in some of the legacy categories, which we're working to address.
Speaker #5: But we're confident that our Surgical Vision business can continue to be a strong double-digit growth driver for the foreseeable future. A couple of other areas I'll focus on here is that we are expanding global market share, both in contact lenses and Surgical Vision—not just winning here in the United States, but more importantly, globally.
Tim Schmid: A couple of other areas I'll focus on here is that we are expanding global market share, both in contact lenses and surgical vision, not just winning here in the United States, but more importantly, globally. We're focusing very much on portfolio optimization. I do think the ortho separation enables greater capital allocation to vision, supporting both R&D, commercial execution, and digital transformation. So we're thrilled with the continued improvement in surgical vision and have great confidence in that continuing. Thank you.
A couple of other areas I'll focus on here is that we are expanding global market share, both in contact lenses and surgical vision, not just winning here in the United States, but more importantly, globally. We're focusing very much on portfolio optimization. I do think the ortho separation enables greater capital allocation to vision, supporting both R&D, commercial execution, and digital transformation. So we're thrilled with the continued improvement in surgical vision and have great confidence in that continuing. Thank you.
Speaker #5: We're focusing very much on portfolio optimization, and I do think the ortho separation enables greater capital allocation to Vision—supporting both R&D, commercial execution, and digital transformation.
Speaker #5: And so we're thrilled with the continued improvement in surgical vision and have great confidence in that continuing. Thank you.
Speaker #5: you. Thank you.
Joaquin Duato: Thank you. Next question is coming from Terence Flynn from Morgan Stanley. Your line is now live.
Operator: Thank you. Next question is coming from Terence Flynn from Morgan Stanley. Your line is now live.
Speaker #3: Next question is coming from Terrence Flynn from Morgan Stanley. Your line is now live.
Speaker #7: Great. Thanks for taking the question. Appreciate it. Congrats on the quarter. Obviously, multiple myeloma is another one of your key growth drivers here. I was wondering post a lot of the earlier stage data, earlier line data we've seen for Tech Valley, if you could speak to how you're thinking about positioning here of that franchise relative to Carvicti and then the related question is I know FDA published some final guidance regarding MRD negativity and CR's endpoint.
[Analyst] (Morgan Stanley): Great. Thanks for taking the question. Appreciate it. Congrats on the quarter. Obviously, multiple myeloma is another one of your key growth drivers here. I was wondering, post a lot of the earlier stage data, earlier line data we've seen for Tecvayli, if you could speak to how you're thinking about positioning here of that franchise relative to Carvykti. And then the related question is, I know FDA published some final guidance regarding MRD negativity and CR's endpoint. So just thinking about how you might implement that across your development portfolio and what that could mean for timelines. Thank you.
Terence Flynn: Great. Thanks for taking the question. Appreciate it. Congrats on the quarter. Obviously, multiple myeloma is another one of your key growth drivers here. I was wondering, post a lot of the earlier stage data, earlier line data we've seen for Tecvayli, if you could speak to how you're thinking about positioning here of that franchise relative to Carvykti. And then the related question is, I know FDA published some final guidance regarding MRD negativity and CR's endpoint. So just thinking about how you might implement that across your development portfolio and what that could mean for timelines. Thank you.
Speaker #7: So, just thinking about how you might implement that across your development portfolio and what that could mean for timelines. Thank you.
Speaker #8: Thanks for the question, Terrence. And good morning, everyone. Yeah, for multiple myeloma, we were absolutely thrilled with the data that we saw for Tecvayli plus Darzalex in the second-line-plus setting, as well as most recently the Tecvayli data in patients who are refractory to anti-CD38 and lenalidomide therapy.
John Reed: Thanks for the question, Terence, and good morning, everyone. Yeah, for multiple myeloma, we were absolutely thrilled with the data that we saw for Tecvayli, plus Darzalex in the second-line plus setting, as well as most recently, the Tecvayli data in patients who were refractory to anti-CD38 and lenalidomide therapy. And maybe if I take a step back, over the past 20 years, J&J therapies have dramatically improved survival for people with multiple myeloma, from 3- to 5-year survival rates to 10- to 15-year survival rates now or more. Yet, despite these advances, multiple myeloma is still a complex disease, a heterogeneous disease, and about 40% of patients are currently in the second-line and third-line settings. So how do all of these agents fit, and why do we see that this is such an extraordinary opportunity?
Thanks for the question, Terence, and good morning, everyone. Yeah, for multiple myeloma, we were absolutely thrilled with the data that we saw for Tecvayli, plus Darzalex in the second-line plus setting, as well as most recently, the Tecvayli data in patients who were refractory to anti-CD38 and lenalidomide therapy. And maybe if I take a step back, over the past 20 years, J&J therapies have dramatically improved survival for people with multiple myeloma, from 3- to 5-year survival rates to 10- to 15-year survival rates now or more. Yet, despite these advances, multiple myeloma is still a complex disease, a heterogeneous disease, and about 40% of patients are currently in the second-line and third-line settings. So how do all of these agents fit, and why do we see that this is such an extraordinary opportunity?
Speaker #8: And maybe if I take a step back, over the past 20 years, J&J therapies have dramatically improved survival for people with multiple myeloma. We've gone from three- to five-year survival rates to 10 to 15 years now, or more.
Speaker #8: Yet despite these advances, multiple myeloma is still a complex disease. Heterogeneous disease. And about 40% of patients are currently in the second line and third line settings.
Speaker #8: So how do all of these agents fit, and why do we see that this is such an extraordinary opportunity? Well, first, if we start off with the Tech DARA information.
John Reed: Well, first, if we start off with the Tecvayli/Darzalex information, plus Talvey and Carvykti, together, they really provide highly effective agents that allow treatment that's tailored to the treatment goals, the patient setting, access, the patient status, and the prior therapy. So there's a number of things that get taken into account. So we start off with Tecvayli plus Darzalex. This is really community-ready therapy that's proven an unprecedented efficacy rate in the second-line plus setting. The hazard ratio was 0.17. And so this is for patients who are CD38 naive or are CD38 experienced. And this is about 70% of the population in that second-line and third-line setting. If you take a look at Tecvayli/Darzalex, the data, again, extraordinarily impressive: 71% reduction in the risk of disease progression, 40% reduction in overall survival. And this is for patients who are refractory to anti-CD38 therapy and lenalidomide therapies.
Well, first, if we start off with the Tecvayli/Darzalex information, plus Talvey and Carvykti, together, they really provide highly effective agents that allow treatment that's tailored to the treatment goals, the patient setting, access, the patient status, and the prior therapy. So there's a number of things that get taken into account. So we start off with Tecvayli plus Darzalex. This is really community-ready therapy that's proven an unprecedented efficacy rate in the second-line plus setting. The hazard ratio was 0.17. And so this is for patients who are CD38 naive or are CD38 experienced. And this is about 70% of the population in that second-line and third-line setting. If you take a look at Tecvayli/Darzalex, the data, again, extraordinarily impressive: 71% reduction in the risk of disease progression, 40% reduction in overall survival. And this is for patients who are refractory to anti-CD38 therapy and lenalidomide therapies.
Speaker #8: As plus Tecvayli and Carvykti together, they really provide highly effective agents that allow treatment that's tailored to the treatment goals, the patient setting, access, the patient status, and the prior therapy.
Speaker #8: So there's a number of things that get taken into account. So we start off with Tech plus DARA. This is really community-ready therapy. That's proven with an unprecedented efficacy rate in the second line-plus setting.
Speaker #8: The hazard ratio was 0.17. And so this is for patients who are CD38-naive or are CD38-experienced. And this is about 70% of the population in that second-line and third-line setting.
Speaker #8: If you take a look at Tecvayli, the data again is extraordinarily impressive: a 71% reduction in the risk of disease progression, and a 40% reduction in overall mortality.
Speaker #8: And this is for patients who are refractory to anti-CD38 therapy and lenalidomide therapies. And so you can see the 70% Tech DARA and then the 30% for the Tech Nine data.
John Reed: And so you can see the 70% Tecvayli and then the 30% for the Talvey data. And then when you bring Carvykti in, Carvykti is really the most successful CAR-T therapy. We just announced we're over 10,000 patients who've been infused with this. And this is a single-dose therapy with really a tremendous shot at what we would count as cure. And we're the only CAR-T therapy that's got that superior overall survival versus the standard of care. And so really, when you take a look at what the goals are for that patient, what their prior lines of therapy would be, and what the practice setting is, J&J now has an option for really every one of those patients in that second-line, third-line setting. So we see a lot of growth potential ahead for these agents, as well as Darzalex in the front-line setting.
And so you can see the 70% Tecvayli and then the 30% for the Talvey data. And then when you bring Carvykti in, Carvykti is really the most successful CAR-T therapy. We just announced we're over 10,000 patients who've been infused with this. And this is a single-dose therapy with really a tremendous shot at what we would count as cure. And we're the only CAR-T therapy that's got that superior overall survival versus the standard of care. And so really, when you take a look at what the goals are for that patient, what their prior lines of therapy would be, and what the practice setting is, J&J now has an option for really every one of those patients in that second-line, third-line setting. So we see a lot of growth potential ahead for these agents, as well as Darzalex in the front-line setting.
Speaker #8: And then when you bring Carvykti in, Carvykti is really the most successful CAR-T therapy. We just announced we're over 10,000 patients who’ve been infused with this.
Speaker #8: And this is a single dose therapy with really a tremendous shot at what we would count as cure. And we're the only CAR T therapy that's got that superior overall survival versus the standard of care.
Speaker #8: And so really when you take a look at what the goals are for that patient, what their prior lines of therapy would be, and what the practice setting is, J&J now has an option for really every one of those patients in that second line, third line setting.
Speaker #8: So we see a lot of growth potential ahead for these agents as well as Darzalex in the front-line setting.
Speaker #9: Yeah, and maybe to get into your MRD, but first, just to supplement a little bit, I'd also note that the Tecvayli regimens, whether it's monotherapy in CD38-refractory patients or the combo with Darzalex in patients who are CD38-naive or have been exposed but still remain sensitive, these are dexamethasone-free regimens, which means the patients aren't on high-dose steroids, which really is an improvement in quality of life.
Joaquin Duato: Yeah, and maybe to get into your MRD, but first, just to supplement a little bit, I'd also note that the Tecvayli regimens, whether it's monotherapy in CD38 refractory patients or the combo with Darzalex in patients who are CD38 naive or have been exposed but still remain sensitive, these are dexamethasone-free regimens, which means the patients aren't on high-dose steroids, which really is an improvement on quality of life. The other thing I wanted to note is that the FDA, in fact, was so impressed with our MajesTEC-3 data that unsolicited, they contacted us and offered a priority review voucher to accelerate bringing this new regimen to patients. So really excited with that recent interaction with the FDA. Indeed, on MRD, that is exciting for us.
[Analyst] (Johnson & Johnson): Yeah, and maybe to get into your MRD, but first, just to supplement a little bit, I'd also note that the Tecvayli regimens, whether it's monotherapy in CD38 refractory patients or the combo with Darzalex in patients who are CD38 naive or have been exposed but still remain sensitive, these are dexamethasone-free regimens, which means the patients aren't on high-dose steroids, which really is an improvement on quality of life. The other thing I wanted to note is that the FDA, in fact, was so impressed with our MajesTEC-3 data that unsolicited, they contacted us and offered a priority review voucher to accelerate bringing this new regimen to patients. So really excited with that recent interaction with the FDA. Indeed, on MRD, that is exciting for us.
Speaker #9: The other thing I wanted to note is that the FDA, in fact, was so impressed with our MAJESTEC-3 data that, unsolicited, they contacted us and offered a priority review voucher.
Speaker #9: To accelerate bringing this new regimen to patients. So really excited with that recent interaction with the FDA. Indeed, on MRD, that is an exciting for us.
Speaker #9: Last year, there was an ODAC that endorsed that concept of using these biomarker, if you will, approach to finding those rare residual malignant cells.
Joaquin Duato: Last year, there was an ODAC that endorsed that concept of using this biomarker, if you will, approach to finding those rare residual malignant cells. Much of the evidence behind that, frankly, was pioneered by J&J over the years. So we're excited that that is an option. We are mindful, however, that it's only an option in the United States. So at this point, we'll still have to deliver progression-free and overall survival data for other territories. So I suspect that will continue to be an element of our protocols. But indeed, we will be speaking with the agents to be able to have opportunities to accelerate some of our development.
Last year, there was an ODAC that endorsed that concept of using this biomarker, if you will, approach to finding those rare residual malignant cells. Much of the evidence behind that, frankly, was pioneered by J&J over the years. So we're excited that that is an option. We are mindful, however, that it's only an option in the United States. So at this point, we'll still have to deliver progression-free and overall survival data for other territories. So I suspect that will continue to be an element of our protocols. But indeed, we will be speaking with the agents to be able to have opportunities to accelerate some of our development.
Speaker #9: Much of the evidence behind that, frankly, was pioneered by J&J over the years. So we're excited that that is an option. We are mindful, however, that it's only an option in the United States.
Speaker #9: So, at this point, we will still have to deliver progression-free and overall survival data for other territories. So, I suspect that will continue to be an element of our protocols.
Speaker #9: But indeed, we will be speaking with the agents to be at opportunities to accelerate some of our development and, in that regard, I think a place where this could be particularly apropos is with our new tri-specific antibody for myeloma, Remantomig, which brings the features of both Tech and Tal into a single molecule with unprecedented efficacy.
Joaquin Duato: And in that regard, I think a place where this could be particularly apropos is with our new trispecific antibody for myeloma, Ramantamig, which brings the features of both Tec and TAL into a single molecule with unprecedented efficacy, improved tolerability as well, fewer, for example, of the taste effects that you might see with TALV, less weight loss, et cetera, really improved tolerability. And then great convenience that makes it apropos for the community setting with only one step-up dose and Q4 week dosing for monthly dosing. Really excited about the pilot data we're seeing in newly diagnosed myeloma in combination with Dara, with that trispecific. And that could be a really apropos place to discuss with the FDA using MRD negativity. Thank you. Next question today is coming from Danielle Antalffy from UBS. Your line is now live.
And in that regard, I think a place where this could be particularly apropos is with our new trispecific antibody for myeloma, Ramantamig, which brings the features of both Tec and TAL into a single molecule with unprecedented efficacy, improved tolerability as well, fewer, for example, of the taste effects that you might see with TALV, less weight loss, et cetera, really improved tolerability. And then great convenience that makes it apropos for the community setting with only one step-up dose and Q4 week dosing for monthly dosing. Really excited about the pilot data we're seeing in newly diagnosed myeloma in combination with Dara, with that trispecific. And that could be a really apropos place to discuss with the FDA using MRD negativity.
Speaker #9: Improved tolerability as well. Fewer, for example, of the taste effects that you might see with TALVI. Less weight loss, etc. Really improved tolerability. And then great convenience that makes it apropos for the community setting with only one step up dose and Q4 week dosing for monthly dosing.
Speaker #9: Really excited about the pilot data we're seeing in newly diagnosed myeloma in combination with DARA, with that tri-specific, and that could be a really apropos place to discuss with the FDA using MRD.
Speaker #9: negativity. Thank you.
Operator: Thank you. Next question today is coming from Danielle Antalffy from UBS. Your line is now live.
Speaker #10: Next question today is coming from Danielle Antolfi from UBS. Your line is now
Speaker #10: live. Hey, good morning, guys.
[Analyst] (UBS): Hey, good morning, guys. Thanks so much for taking the question. I'll echo everyone's strong end to the year and happy new year. Just a question on this move to higher growth end markets. Appreciate that you've done a lot of and are doing a lot of portfolio pruning now. You mentioned the 70% in a few years here. I mean, ultimately, I guess it's two. Do you see that 70% moving higher, or do you think that's sort of the aspirational peak? That's the first part. And the second part is, what are some other growth markets, whether it's in innovative medicines or medtech, where you guys aren't participating today that you see to participate over that time frame, whether it's via organic or inorganic moves? Thanks so much for taking the question.
Danielle Antalffy: Hey, good morning, guys. Thanks so much for taking the question. I'll echo everyone's strong end to the year and happy new year. Just a question on this move to higher growth end markets. Appreciate that you've done a lot of and are doing a lot of portfolio pruning now. You mentioned the 70% in a few years here. I mean, ultimately, I guess it's two. Do you see that 70% moving higher, or do you think that's sort of the aspirational peak? That's the first part. And the second part is, what are some other growth markets, whether it's in innovative medicines or medtech, where you guys aren't participating today that you see to participate over that time frame, whether it's via organic or inorganic moves? Thanks so much for taking the question.
Speaker #11: Thanks so much for taking the question. I'll echo everyone's. Strong end to the year. And happy New Year. Just a question on this move to higher growth end markets.
Speaker #11: I appreciate that you've done a lot of, and are doing a lot of, portfolio pruning now. You mentioned the 70% in a few years here.
Speaker #11: I mean, ultimately, I guess it's two. Do you see that 70% moving higher, or do you think that's sort of the aspirational peak? That's the first part.
Speaker #11: And the second part is, what are some other growth markets, whether it's in Innovative Medicines or MedTech, where you guys aren't participating today that you see?
Speaker #11: to participate over that time frame, whether it's via organic or inorganic moves. Thanks so much for taking the
Speaker #11: question. Danielle, thank you.
Tim Schmid: Danielle, thank you. I mean, our aspiration is not to put a limit on the high-growth markets in which we participate. I think we can conservatively say that once we separate ortho, we'll be at least at 70%. There is tremendous opportunity, even just focused within the three business units we've decided to focus on within medtech, both in cardiovascular, in surgery, and in vision. I think we've built your confidence around cardiovascular continuing to be a strong double-digit grower. Surgery, one of our profitable businesses where we maintain leadership positions both in contact lens and surgical vision. We believe it's going to be a strong middle to high single-digit grower. Then surgery is the major opportunity to really catapult our growth. That comes down to our belief in Ottava.
Tim Schmid: Danielle, thank you. I mean, our aspiration is not to put a limit on the high-growth markets in which we participate. I think we can conservatively say that once we separate ortho, we'll be at least at 70%. There is tremendous opportunity, even just focused within the three business units we've decided to focus on within medtech, both in cardiovascular, in surgery, and in vision. I think we've built your confidence around cardiovascular continuing to be a strong double-digit grower. Surgery, one of our profitable businesses where we maintain leadership positions both in contact lens and surgical vision. We believe it's going to be a strong middle to high single-digit grower. Then surgery is the major opportunity to really catapult our growth. That comes down to our belief in Ottava.
Speaker #2: I mean, our aspiration is not to put a limit on the high growth markets, and which we participate in. I think we can conservatively say that once we separate Ortho we'll be at least at 70%.
Speaker #2: And there is tremendous opportunity even just focused within the three business units we've decided to focus on within med tech, both in cardiovascular, in surgery, and in vision.
Speaker #2: I think we've built your confidence around Cardiovascular continuing to be a strong double-digit grower. Surgery is one of our profitable businesses, where we maintain leadership positions both in contact lens and Surgical Vision.
Speaker #2: We believe it's going to be a strong middle- to high-single-digit grower. And then surgery is the major opportunity to really catapult our growth.
Speaker #2: And that comes down to our belief in Otava. As you heard from Joaquin, we are absolutely resolute in our commitment to play a bigger role beyond open and laparoscopic surgery in robotics with Otava.
Tim Schmid: As you heard from Joaquin, we are absolutely resolute in our commitment to play a bigger role beyond open and laparoscopic surgery in robotics with Ottava. What we are most confident about is that we have something that is unique and different, and something that surgeons and health system CEOs tell us every day that they need. So while we're excited by the recent milestone and the submission for approval, we're just getting started. What really highlights the fact that this is different is you'll recall that this is a very different regulatory pathway we chose. This is a de novo pathway. The reason we chose that pathway is that there is no predicate device, nothing that can be compared against. So this is a novel platform where there's no reference or predicate device.
As you heard from Joaquin, we are absolutely resolute in our commitment to play a bigger role beyond open and laparoscopic surgery in robotics with Ottava. What we are most confident about is that we have something that is unique and different, and something that surgeons and health system CEOs tell us every day that they need. So while we're excited by the recent milestone and the submission for approval, we're just getting started. What really highlights the fact that this is different is you'll recall that this is a very different regulatory pathway we chose. This is a de novo pathway. The reason we chose that pathway is that there is no predicate device, nothing that can be compared against. So this is a novel platform where there's no reference or predicate device.
Speaker #2: And what we are most confident about is that we have something that is unique and different and something that surgeons and health system CEOs tell us every day that they need.
Speaker #2: And so, while we're excited by the recent milestone and the submission for approval, we're just getting started. And what really highlights the fact that this is different is you'll recall that this is a very different regulatory pathway we chose.
Speaker #2: This is the de novo pathway, and the reason we chose that pathway is that there is no predicate device—nothing that can be compared against.
Speaker #2: And so, this is a novel platform where there's no reference or predicate device. And so, that, coupled with the fact that we're going after the U.S., should further reinforce our confidence in the fact that we believe we have something that is really different.
Tim Schmid: And so that, coupled with the fact that we're going after the US, should further reinforce our confidence in the fact that we believe we have something that is really different. Now, we're not stopping just in the US. We're building our submissions in a parallel path fashion outside of the US with a focus on Japan and some select US markets. You will have recalled from the announcement we made two weeks ago. We're also already expanding into our next IDE clinical study in the lower abdomen. Make no mistake that we believe that we can and will be a formidable player in surgical robotics.
And so that, coupled with the fact that we're going after the US, should further reinforce our confidence in the fact that we believe we have something that is really different. Now, we're not stopping just in the US. We're building our submissions in a parallel path fashion outside of the US with a focus on Japan and some select US markets. You will have recalled from the announcement we made two weeks ago. We're also already expanding into our next IDE clinical study in the lower abdomen. Make no mistake that we believe that we can and will be a formidable player in surgical robotics.
Speaker #2: Now, we're not stopping just in the US. We're building our submissions in a parallel path fashion outside of the US, with a focus on Japan and some select EU markets.
Speaker #2: And you will have recalled from the announcement we made two weeks ago, we're also already expanding into our next IDE clinical study in the lower abdomen.
Speaker #2: And so, make no mistake that we believe we can and will be a formidable player in surgical robotics. We don't take the current incumbent for granted by any means, but we do think that the presence we have in open, laparoscopic, and soon-to-be robotic surgery gives us a right to play and a tremendous opportunity to drive to those high levels of growth that we've committed to in the back half.
Tim Schmid: We don't take the current incumbent for granted by any means, but we do think that presence we have in open laparoscopic and soon-to-be robotic surgery gives us a right to play and a tremendous opportunity to drive to those high levels of growth that we've committed in the back half of the decade.
We don't take the current incumbent for granted by any means, but we do think that presence we have in open laparoscopic and soon-to-be robotic surgery gives us a right to play and a tremendous opportunity to drive to those high levels of growth that we've committed in the back half of the decade.
Speaker #2: of the decade. And
Speaker #3: then in innovative medicine, we are looking to expand in a number of really exciting areas. Right now, where we've got clinical work already underway.
John Reed: And then in innovative medicine, we are looking to expand in a number of really exciting areas right now where we've got clinical work already underway. So to give maybe a few examples, Rybrevant in head and neck cancer and colorectal cancer, of which there's clinical trials underway. Amave, which we haven't spoken about yet today, but areas such as Sjogren's disease and SLE, lupus, areas of really high unmet medical need. Atopic dermatitis, of which we made a number of key acquisitions and licensing at the end of 2024 that give us a stable of assets there that we're working towards. B-cell malignancies with our BICAR that's in development. And even Milvaxian that we're developing in partnership with Bristol Myers Squibb and that we're very, very excited about for atrial fibrillation and secondary stroke prevention.
[Analyst] (Johnson & Johnson): And then in innovative medicine, we are looking to expand in a number of really exciting areas right now where we've got clinical work already underway. So to give maybe a few examples, Rybrevant in head and neck cancer and colorectal cancer, of which there's clinical trials underway. Amave, which we haven't spoken about yet today, but areas such as Sjogren's disease and SLE, lupus, areas of really high unmet medical need. Atopic dermatitis, of which we made a number of key acquisitions and licensing at the end of 2024 that give us a stable of assets there that we're working towards. B-cell malignancies with our BICAR that's in development. And even Milvaxian that we're developing in partnership with Bristol Myers Squibb and that we're very, very excited about for atrial fibrillation and secondary stroke prevention.
Speaker #3: And so to give maybe a few examples, Ribravan in head and neck cancer and colorectal cancer of which there's clinical trials underway. Amave, which we haven't spoken about yet today, but areas such as Sjogren's disease and SLE, lupus, areas of really high unmet medical need.
Speaker #3: Atopic dermatitis of which we made a number of key acquisitions and licensing at the end of 2024 that give us a stable of assets there that we're working towards.
Speaker #3: B-cell malignancies, with our BICAR that's in development. And even Milveccian, which we're developing in partnership with Bristol Myers Squibb, and that we're very, very excited about for atrial fibrillation and secondary stroke prevention.
Speaker #3: So, a number of additional, really key diseases that could be growth drivers for us in the future.
John Reed: A number of additional really key diseases that could be growth drivers for us in the future.
A number of additional really key diseases that could be growth drivers for us in the future.
Speaker #10: Thank you. Next question today is coming from Vamodavan from Krugerheim Security. Your line is now open.
Joaquin Duato: Thank you. Next question today is coming from Vamil Divan from Guggenheim Securities. Your line is now live.
Operator: Thank you. Next question today is coming from Vamil Divan from Guggenheim Securities. Your line is now live.
Speaker #10: live. Great.
[Analyst] (UBS): Great. Thank you so much for taking the questions. I just want to ask on Inlexo. It's a couple of questions here, but just one: any sort of initial feedback you can share with us in terms of the initial launch and kind of what doctors and patients are saying? If there's any update on when you expect to get a permanent J code? And then finally, just I see you listed Sunrise 5 data and potential submission on your events list for 2026. So that's good to see. I'm curious if you can just talk about how that data and how that might impact the addressable population for the product. And then tied to that, Sunrise 3, I thought might come this year. You didn't include that one on the list. So I'm just curious if any update on timing when we might see data from Sunrise 3. Thanks.
Vamil Divan: Great. Thank you so much for taking the questions. I just want to ask on Inlexo. It's a couple of questions here, but just one: any sort of initial feedback you can share with us in terms of the initial launch and kind of what doctors and patients are saying? If there's any update on when you expect to get a permanent J code? And then finally, just I see you listed Sunrise 5 data and potential submission on your events list for 2026. So that's good to see. I'm curious if you can just talk about how that data and how that might impact the addressable population for the product. And then tied to that, Sunrise 3, I thought might come this year. You didn't include that one on the list. So I'm just curious if any update on timing when we might see data from Sunrise 3. Thanks.
Speaker #4: Thank you so much for taking the questions. I just want to ask on INLEXO. It's a couple of questions here, but just one: any sort of initial feedback you can share with us in terms of the initial launch and kind of what doctors and patients are saying?
Speaker #4: Is there any update on when you expect to get a permanent J-code? And then finally, I see you listed SunRISe-5 data and potential submission on your events list for 2026.
Speaker #4: So that's good to see. I'm curious if you can just talk about how that data and that population—how that might impact the addressable population for the product.
Speaker #4: And then tied to that, Sunrise 3—I thought it might come this year. You didn't include that one on the list, so I'm just curious if there's any update on timing, or when we might see data from Sunrise 3.
Speaker #4: Thanks.
Speaker #3: Great. Thanks so much for the question on INLEXO. So we are really pleased with the launch, and what we're seeing in terms of interest and receptivity by both urologists as well as the patients, who've had application of the device as you recall, we've really launched into the BCG unresponsive population.
John Reed: Great. Thanks so much for the question on Inlexo. So we are really pleased with the launch and what we're seeing in terms of interest and receptivity by both urologists as well as the patients who've had application of the device. As you recall, we've really launched into the BCG unresponsive population. And as you noted, we're actually looking to further expand that through SunRISe-5, the BCG-experienced, and then SunRISe-3 population on the BCG-naive population. So far, the interest and enthusiasm on this has been really, really robust. We are anticipating the permanent J code at the beginning of Q2, sort of in that April timeframe, which we think is going to be a really nice catalyst for utilization.
[Analyst] (Johnson & Johnson): Great. Thanks so much for the question on Inlexo. So we are really pleased with the launch and what we're seeing in terms of interest and receptivity by both urologists as well as the patients who've had application of the device. As you recall, we've really launched into the BCG unresponsive population. And as you noted, we're actually looking to further expand that through SunRISe-5, the BCG-experienced, and then SunRISe-3 population on the BCG-naive population. So far, the interest and enthusiasm on this has been really, really robust. We are anticipating the permanent J code at the beginning of Q2, sort of in that April timeframe, which we think is going to be a really nice catalyst for utilization.
Speaker #3: And as you noted, we're actually looking to further expand that through Sunrise 5, the BCG experienced, and then Sunrise 3 population, the BCG naive population.
Speaker #3: So so far, the interest and enthusiasm on this has been really, really robust. We are anticipating the permanent J-code at the beginning of the second quarter, sort of in that April timeframe, which we think is going to be a really nice catalyst for utilization.
Speaker #3: And so we do continue to believe strongly that this is one of our $5 5 billion plus assets. And really look forward to getting that permanent J-code in the second quarter.
John Reed: So we do continue to believe strongly that this is one of our $5 billion-plus assets and really look forward to getting that permanent J code in Q2. John, do you want to talk about, yeah?
So we do continue to believe strongly that this is one of our $5 billion-plus assets and really look forward to getting that permanent J code in Q2. John, do you want to talk about, yeah?
Speaker #3: John, do you want
Speaker #2: Yeah, we're making great progress with this lead product, INLEXO. But I would also remind you that we see a whole series of innovative products where we use these devices in the bladder to deliver different payloads.
Joaquin Duato: Yeah, just we're making great progress with this lead product, Inlexo, but I would also remind that we see a whole series of innovative products where we use these devices in the bladder to deliver different payloads. The next one on deck is containing erdafitinib. That's the same targeted therapy that is currently marketed as Balversa for metastatic bladder cancer, but here delivered through a unique device, a customized device. It's not the same one as Inlexo, but works in much the same way to deliver that targeted therapy. There we are focusing on the so-called intermediate risk population, whereas Inlexo is targeted for the high-risk population. So this broadens our coverage of patients with bladder cancer.
John Reed: Yeah, just we're making great progress with this lead product, Inlexo, but I would also remind that we see a whole series of innovative products where we use these devices in the bladder to deliver different payloads. The next one on deck is containing erdafitinib. That's the same targeted therapy that is currently marketed as Balversa for metastatic bladder cancer, but here delivered through a unique device, a customized device. It's not the same one as Inlexo, but works in much the same way to deliver that targeted therapy. There we are focusing on the so-called intermediate risk population, whereas Inlexo is targeted for the high-risk population. So this broadens our coverage of patients with bladder cancer.
Speaker #2: The next one on deck contains erdafitinib. That's the same targeted therapy that is currently marketed as Balversa for metastatic bladder cancer, but here it's delivered through a unique, customized device.
Speaker #2: It's not the same one as INLEXO, but it works in much the same way. To deliver that targeted therapy, there we are focusing on the so-called intermediate-risk population, whereas INLEXO is targeted for the high-risk population.
Speaker #2: So, this broadens our coverage of patients with bladder cancer. And just to remind people, localized bladder cancer represents about 600,000 new cases per year, and there are another 400,000 cases annually of patients who've relapsed and are looking for a solution that would allow them to save their bladder. So it's about 1 million patients a year.
Joaquin Duato: Just to remind people that localized bladder cancer represents about 600,000 new cases per year and another 400,000 cases annually of patients who've relapsed and are looking for a solution that would allow them to save their bladder. So it's about a million patients a year between Inlexo and now TAR-210, the erdafitinib carrying device. We'll be able to really address a very large percentage of these patients with these bladder-sparing technologies. With TAR-210, the success rate we've been seeing with complete responses has been north of 90%. And so we're super excited about that. And there'll be other devices with different payloads to come over time. So we see this as a platform that will address this incredible unmet need and that will be a big growth driver for J&J.
Just to remind people that localized bladder cancer represents about 600,000 new cases per year and another 400,000 cases annually of patients who've relapsed and are looking for a solution that would allow them to save their bladder. So it's about a million patients a year between Inlexo and now TAR-210, the erdafitinib carrying device. We'll be able to really address a very large percentage of these patients with these bladder-sparing technologies. With TAR-210, the success rate we've been seeing with complete responses has been north of 90%. And so we're super excited about that. And there'll be other devices with different payloads to come over time. So we see this as a platform that will address this incredible unmet need and that will be a big growth driver for J&J.
Speaker #2: Between INLEXO and now TAR-210, the erta-fitnib carrying device, we'll be able to really address a very large percentage of these patients with these bladder-sparing technologies.
Speaker #2: With TAR210, the success rate we've been seeing with complete responses has been north of 90%. And so we're super excited about that. And there'll be other devices with different payloads to come over time.
Speaker #2: So, we see this as a platform that will address this incredible unmet need, and that we'll be a big growth driver for J&J. I would finally close by just giving a shout-out to our colleagues in MedTech, because this is just a wonderful example of how innovative medicines and MedTech can come together—bringing devices and drugs together in an unprecedented way.
Joaquin Duato: I would finally close by just giving a shout-out to our colleagues in medtech because this is just a wonderful example of how innovative medicines and medtech can come together, bringing devices and drugs together in an unprecedented way. And we're looking for more ways to do that in the future. Thank you. Next question is coming from Shagun Singh from RBC Capital Markets. Your line is now live.
I would finally close by just giving a shout-out to our colleagues in medtech because this is just a wonderful example of how innovative medicines and medtech can come together, bringing devices and drugs together in an unprecedented way. And we're looking for more ways to do that in the future.
Speaker #2: And we're looking for more ways to do that in the future.
Operator: Thank you. Next question is coming from Shagun Singh from RBC Capital Markets. Your line is now live.
Speaker #10: Thank you. Next question is coming from Sugun Singh from RBC Capital Markets. Your line is now
Speaker #10: live. Great.
Speaker #11: Thank you so much. Joaquin and Joe, could you spend some time in elaborate on your next step with respect to the talc litigation implications of the initial Daubert decision?
[Analyst] (UBS): Great. Thank you so much. Joaquin and Joe, could you spend some time and elaborate on your next step with respect to the TALC litigation, implications of the initial Dover decision? I know you indicated it'll be appealed if reserves need to be stepped up. And then most importantly, what are your plans for an eventual resolution and risk mitigation here? I think this may be contributing to the modest talk down today, even though you reported strong results and you have a very strong outlook to the end of the decade. Thank you for taking the question.
Shagun Singh: Great. Thank you so much. Joaquin and Joe, could you spend some time and elaborate on your next step with respect to the TALC litigation, implications of the initial Dover decision? I know you indicated it'll be appealed if reserves need to be stepped up. And then most importantly, what are your plans for an eventual resolution and risk mitigation here? I think this may be contributing to the modest talk down today, even though you reported strong results and you have a very strong outlook to the end of the decade. Thank you for taking the question.
Speaker #11: I know you indicated it'll be appealed if reserves need to be stepped up. And then most importantly, what are your plans for an eventual resolution and risk mitigation here?
Speaker #11: I think this may be contributing to the modest top-down today, even though you reported strong results and you have a very strong outlook to the end of the decade.
Speaker #11: Thank you for taking the
Speaker #11: Thank you for taking the question. Yeah,
Tim Schmid: Yeah, I'll start, Shagun, and then Joaquin, I'll turn it over to you. So thank you very much for the question. And I want to thank you for acknowledging just the strong results and outlook of the business, which is really what is at the heart of Johnson & Johnson. So last night, the special master reviewing the Daubert motions in the TALC MDL issued what is known as a report and recommendation. So that really has no legal import until the judge actually accepts this recommendation. The recommendation itself excluded certain aspects of the plaintiff's expert witnesses and their opinions. And simultaneously, the recommendation also endorsed virtually all of our opinions of our experts.
Joe Wolk: Yeah, I'll start, Shagun, and then Joaquin, I'll turn it over to you. So thank you very much for the question. And I want to thank you for acknowledging just the strong results and outlook of the business, which is really what is at the heart of Johnson & Johnson. So last night, the special master reviewing the Daubert motions in the TALC MDL issued what is known as a report and recommendation. So that really has no legal import until the judge actually accepts this recommendation. The recommendation itself excluded certain aspects of the plaintiff's expert witnesses and their opinions. And simultaneously, the recommendation also endorsed virtually all of our opinions of our experts.
Speaker #3: I'll start. Sugun, and then Joaquin, I'll turn it over to you. So thank you very much for the question. And I want to thank you for acknowledging just the strong results and outlook of the business, which is really what is at the heart of Johnson & Johnson.
Speaker #3: So last night, the special master reviewing the Daubert motions in the talc MDL issued what is known as a report and recommendation. So that really has no legal import until the judge actually accepts this recommendation.
Speaker #3: The recommendation itself excluded certain aspects of the plaintiff's expert witnesses and their opinions, and, simultaneously, the recommendation also endorsed virtually all of our experts' opinions.
Speaker #3: However, there were other parts of the recommendation where the special master clearly failed to apply the new federal rules of evidence, known as Rule 702, which really reinforced, starting in December of 2023, the gatekeeping responsibilities that the special master should have had.
Tim Schmid: However, there were other parts of the recommendation where the special master clearly failed to apply the new federal rules of evidence known as Rule 702, which really reinforced, starting in December of 2023, the gatekeeping responsibilities that the special master should have had. We will certainly appeal those erroneous parts of the recommendation to the district court. Again, this recommendation from the special master has no legal consequence until the appeal is resolved. The bottom line is this is not going to change our strategy. We will continue to aggressively fight in the court system each and every one of these meritless claims. We will do so whether it's at original trial or through appeal.
However, there were other parts of the recommendation where the special master clearly failed to apply the new federal rules of evidence known as Rule 702, which really reinforced, starting in December of 2023, the gatekeeping responsibilities that the special master should have had. We will certainly appeal those erroneous parts of the recommendation to the district court. Again, this recommendation from the special master has no legal consequence until the appeal is resolved. The bottom line is this is not going to change our strategy. We will continue to aggressively fight in the court system each and every one of these meritless claims. We will do so whether it's at original trial or through appeal.
Speaker #3: We will certainly appeal those erroneous parts of the recommendation to the district court. Again, this recommendation from the special master has no legal consequence until the appeal is resolved.
Speaker #3: The bottom line is, this is not going to change our strategy. We will continue to aggressively fight in the court system each and every one of these meritless claims.
Speaker #3: We will do so whether it's at original trial or through appeal. And we will continue to really bring to light the actions of the plaintiffs' bar, the tactics that they use, the third-party litigation financing—all of which is really undermining U.S. business and U.S. competitiveness overall.
Tim Schmid: We will continue to really bring to light the actions of the plaintiff's bar, the tactics that they use, the third-party litigation financing, all which is really undermining US business and US competitiveness overall. Joaquin?
We will continue to really bring to light the actions of the plaintiff's bar, the tactics that they use, the third-party litigation financing, all which is really undermining US business and US competitiveness overall. Joaquin?
Speaker #3: Joaquin, thank you. Joe, Sugun, I would tell you and I would tell investors we have been navigating this talc issue already for a decade.
Darren Snellgrove: Thank you, Joe. So, Wuna, I would tell you and I would tell investors, we have been navigating this TALC issue already for a decade. We have been able to continue to deliver excellent results, invest in our business, and continue to return value to shareholders. So let's focus on the real story here. The real story is our successful 2025, the strong guidance for 2026, and what you said before, our line of sight for double-digit growth in the later part of the decade. This is a clean story for us, one of the cleanest stories in the entire healthcare sector. We are in a position of strength today. As Joe said, we are going to continue to fight these meritless claims, and we are going to continue with our strategy of litigating every single one.
Joaquin Duato: Thank you, Joe. So, Wuna, I would tell you and I would tell investors, we have been navigating this TALC issue already for a decade. We have been able to continue to deliver excellent results, invest in our business, and continue to return value to shareholders. So let's focus on the real story here. The real story is our successful 2025, the strong guidance for 2026, and what you said before, our line of sight for double-digit growth in the later part of the decade. This is a clean story for us, one of the cleanest stories in the entire healthcare sector. We are in a position of strength today. As Joe said, we are going to continue to fight these meritless claims, and we are going to continue with our strategy of litigating every single one.
Speaker #3: And we have been able to continue to deliver excellent results. Invest in our business and continue to return value to shareholders. So let's focus on the real story here.
Speaker #3: The real story is our successful 2025, the strong guidance for 2026, and, as you said before, our line of sight for double-digit growth in the later part of the decade.
Speaker #3: This is a clean story for us, one of the cleanest stories in the entire healthcare sector. And we are in a position of strength today.
Speaker #3: And as Joe said, we are going to continue to fight these meritless claims, and we are going to continue with our strategy of litigating every single one.
Speaker #3: What I can assure you and all investors is that every single employee of Johnson & Johnson does not get distracted. They wake up every day with the intent to bring new medicines, a medical technology that improves the standard of care of the millions of patients that we serve every day.
Darren Snellgrove: What I can assure you and all investors is that every single employee of Johnson & Johnson does not get distracted. They wake up every day with the intent to bring new medicines and medical technologies that improve the standard of care of the millions of patients that we serve every day. That's really our goal. Let's focus on what really matters. Let's not get distracted.
What I can assure you and all investors is that every single employee of Johnson & Johnson does not get distracted. They wake up every day with the intent to bring new medicines and medical technologies that improve the standard of care of the millions of patients that we serve every day. That's really our goal. Let's focus on what really matters. Let's not get distracted.
Speaker #3: And that's really our goal. Let's focus on what really matters. Let's not get distracted.
Speaker #10: Thanks, Sugun. And I think we probably have time for one more question.
Joaquin Duato: Thanks, Shagun. And I think we probably have time for one more question. So our final question today is coming from Alexandra Hammond from Wolfe Research. Your line is now live.
Operator: Thanks, Shagun. And I think we probably have time for one more question. So our final question today is coming from Alexandra Hammond from Wolfe Research. Your line is now live.
Speaker #4: So our final question today is coming from Alexandria Hammond from Wolf Research. Your line is now
Speaker #4: live. Thanks for taking
Operator: Thanks for taking the question. On Milvaxian, can you talk a little bit about your confidence in this asset? What do you think you'll need to show to be competitive in what's already a pretty crowded space with another potential next-generation Factor XI from Bayer? And I guess as a quick follow-up, how can you leverage your past experiences commercializing Xarelto to make another multi-billion dollar opportunity for J&J?
Alexandria Hammond: Thanks for taking the question. On Milvaxian, can you talk a little bit about your confidence in this asset? What do you think you'll need to show to be competitive in what's already a pretty crowded space with another potential next-generation Factor XI from Bayer? And I guess as a quick follow-up, how can you leverage your past experiences commercializing Xarelto to make another multi-billion dollar opportunity for J&J?
Speaker #11: The question. I'm no vaccine. Can you talk a little bit about your confidence in this asset? What do you think you'll need to show to be competitive?
Speaker #11: And what's already a pretty crowded space with another potential next-generation factor 11 from Bayer? And I guess as a quick follow-up, how can you leverage your past experiences commercializing Xarelto to make another multibillion-dollar opportunity for J&J?
Speaker #4: Yeah, so on Milvaxian, we're expecting data readouts later this year for both secondary stroke as well as atrial fibrillation. We often get asked about atrial fibrillation because the competitor molecule had failed in that indication and we cite a couple of things.
Joaquin Duato: Yeah, so on Milvaxian, we're expecting data readouts later this year for both secondary stroke as well as atrial fibrillation. We often get asked about atrial fibrillation because the competitor molecule had failed in that indication. We cite a couple of things. One is that Milvaxian, at least in vitro, is about 10 times more potent than the other molecule that is being developed by another company. We know from monitoring the APTT biomarker, the thromboplastin time, that we have very effective reductions in clotting at the dose that we have selected for atrial fibrillation, which is 100mg twice a day. We feel that we've got the right dose and the right study design. We'll be looking forward to those data later this year.
[Analyst] (Johnson & Johnson): Yeah, so on Milvaxian, we're expecting data readouts later this year for both secondary stroke as well as atrial fibrillation. We often get asked about atrial fibrillation because the competitor molecule had failed in that indication. We cite a couple of things. One is that Milvaxian, at least in vitro, is about 10 times more potent than the other molecule that is being developed by another company. We know from monitoring the APTT biomarker, the thromboplastin time, that we have very effective reductions in clotting at the dose that we have selected for atrial fibrillation, which is 100mg twice a day. We feel that we've got the right dose and the right study design. We'll be looking forward to those data later this year.
Speaker #4: One is that Milvaxian, at least in vitro, is about 10 times more potent than the other molecule that is being developed by another company.
Speaker #4: And we know from monitoring the APPTT biomarker, the thromboplastin time, that we have very effective reductions in clotting at the dose that we have selected for atrial fibrillation, which is 100 milligrams twice a day.
Speaker #4: So we feel that we've got the right dose and the right study design, so we'll be looking forward to those data later this year.
Speaker #4: year. And we're really excited about the
John Reed: And we're really excited about the opportunity with Milvaxian. And what we're really looking to show there is clear superiority in terms of safety and bleeding risk. We know from all of our experience in the market with Xarelto that there are a lot of patients that are not treated or are undertreated because of fear of safety risk. And so we think there's extraordinary need for a highly efficacious and highly safe with low bleeding risk product in the market, both for atrial fibrillation. And then we're very excited about the possibilities in secondary stroke as well. So we're looking forward to this product that we're developing in collaboration with Bristol Myers Squibb. It is absolutely one of our $5 billion plus assets on our list.
[Analyst] (Johnson & Johnson): And we're really excited about the opportunity with Milvaxian. And what we're really looking to show there is clear superiority in terms of safety and bleeding risk. We know from all of our experience in the market with Xarelto that there are a lot of patients that are not treated or are undertreated because of fear of safety risk. And so we think there's extraordinary need for a highly efficacious and highly safe with low bleeding risk product in the market, both for atrial fibrillation. And then we're very excited about the possibilities in secondary stroke as well. So we're looking forward to this product that we're developing in collaboration with Bristol Myers Squibb. It is absolutely one of our $5 billion plus assets on our list.
Speaker #3: opportunity with Milvaxian. And what we're really looking to show there is clear superiority in terms of safety and bleeding risk. We know from all of our experience in the market with Xarelto that there are a lot of patients that are not treated or are undertreated because of fear of safety risk.
Speaker #3: And so, we think there's extraordinary need for a highly efficacious and highly safe product with low bleeding risk in the market, both for atrial fibrillation, and then we're very excited about the possibilities in secondary stroke as well.
Speaker #3: So we're looking forward to this product that we're developing in collaboration with Bristol-Myers Squibb. It is absolutely one of our $5 5 billion plus assets on our list.
Speaker #4: Okay, thanks, Alex. And thanks to everyone for your questions and your continued interest in our company. I will now turn the call over to Joaquin for some brief closing remarks.
Joaquin Duato: Thanks, Alex. Thanks to everyone for your questions and your continued interest in our company. I will now turn the call over to Joaquin for some brief closing remarks.
Darren Snellgrove: Thanks, Alex. Thanks to everyone for your questions and your continued interest in our company. I will now turn the call over to Joaquin for some brief closing remarks.
Speaker #10: Thank you to all of you for joining the call today. As we have commented in the call, we are starting the year from a position of strength.
Darren Snellgrove: Thank you to all of you for joining the call today. As we have commented in the call, we are starting the year from a position of strength. We have the strongest portfolio and pipeline in our history. We have a leading and expanding position in our six key business areas of focus. 2026 will be a year of accelerated growth and expanded impact. I look forward to sharing our progress with you in the remaining of the year. Thank you very much. This finalizes the call.
Joaquin Duato: Thank you to all of you for joining the call today. As we have commented in the call, we are starting the year from a position of strength. We have the strongest portfolio and pipeline in our history. We have a leading and expanding position in our six key business areas of focus. 2026 will be a year of accelerated growth and expanded impact. I look forward to sharing our progress with you in the remaining of the year. Thank you very much. This finalizes the call.
Speaker #10: We have the strongest portfolio and pipeline in our history, and we have a leading and expanding position in our six key business areas of focus.
Speaker #10: 2026 will be a year of accelerated growth and expanded impact. I look forward to sharing our progress with you for the remainder of the year.
Speaker #10: Thank you very much. And this finalizes the
Speaker #10: call. Thank you.
Joaquin Duato: Thank you. This concludes today's Johnson & Johnson's Fourth Quarter 2025 earnings conference call. You may now disconnect.
Operator: Thank you. This concludes today's Johnson & Johnson's Fourth Quarter 2025 earnings conference call. You may now disconnect.
