Johnson & Johnson (JNJ) Q3 2026 earnings call transcript

Hello, everyone. This is Ryan Kors, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of business results for the third quarter of 2026 and our financial outlook for the full year.

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.

They are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected. The description of these risks, uncertainties, and other factors can be found in our SEC filings, including our 2025 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 Diwato, our chairman and CEO, will discuss our business performance and growth drivers. I will then review the third quarter sales and P&L results. Joe Walk, our CFO, will then close by sharing an overview of our capital allocation priorities and updated guidance for 2026. Tom Cavanaugh, 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 approximately 60 minutes. With that, I will now turn the call over to Joaquin.

Thank you, Ryan, and good morning, everyone. Our strong performance in the third quarter reinforces our confidence in 2026 as a year of accelerated growth and impact for Johnson & Johnson. In Q3, we reported operational sales growth of 6% ahead of analyst consensus and increased sequential growth compared to the second quarter. With six strategic focus areas, oncology, immunology, neuroscience, cardiovascular surgery, and vision, we are living in areas of high and med need where innovation can make the greatest difference for patients.

Our powerful combination of innovative medicine and med tech expertise strengthens our competitiveness. Twenty-nine of our products and platforms now generate at least $1 billion in annual sales. Our marketed portfolio continues to perform. Our launches are gaining significant traction, and we are advancing our new product pipeline that will sustain our growth into the next decade. With sales in the quarter of more than $25 billion, we are on track to meet our guidance and exceed $100 billion in annual revenue for the first time in our company's 140-year history.

As we advance our differentiated portfolio and pipeline, we have a clear path to double-digit growth by the end of the decade. In innovative medicine, we delivered operational sales growth of 7.9% with eight brands growing double digits. Let's start with oncology. We are making progress to redefine cancer care from treatment to cure. In the third quarter, our oncology business grew approximately 17%. Our multiple myeloma portfolio and pipeline are unmatched with 80% of patients receiving a Johnson & Johnson therapy as part of their treatment journey. And we continue to strengthen the body of evidence supporting our recently launched multiple myeloma therapies and combination regimens. New phase three results announced in July demonstrated that the combination of Tecvili plus Talve reduced the risk of disease progression or death by 89% as early as the second line of treatment.

In solid tumors, sales of Ribreban increased by 64%, reflecting its strength in lung cancer. And by the end of the year, we expect to receive US FDA approval for Ribreban FASPRO in advanced head and neck cancer, a disease with significant unmet needs. In bladder cancer, Inlexo has rapidly emerged as a market leader for new patient share, just one year after its launch. Nearly one in three eligible patients started on an Inlexo regimen in the third quarter, demonstrating its growing role in transforming care in high-risk, non-muscle invasive disease. During the quarter, we also invested to bolster our oncology pipeline. We completed our acquisition of Firefly Bio, adding a promising new degraded antibody conjugate platform that targets drivers of difficult to treat cancers, including Keras.

Our ambition is to become the number one oncology company by 2030 with sales projected to exceed $50 billion. Turning to immunology, we are building on our 25-year legacy to drive industry-leading innovation for patients. Trenfaia delivered exceptional sales growth of 68% in the quarter, reflecting strong momentum across its indications. In the U. S. , it is now the number one IL-23 inhibitor in new-to-brand share in Crohn's disease, ulcerative colitis, and psoriatic arthritis. And we continue to generate evidence that reinforces TREMFIA's clinical differentiation. Based on the landmark STARS study, TREMFIA is the first and only IL-23 inhibitor to demonstrate positive outcomes in axial disease clinical trials, including significant improvement in spinal pain, stiffness, and inflammation in patients with psoriatic arthritis.

This momentum reinforces our conviction in Trenfaya as a foundational medicine in inflammatory bowel and psoriatic diseases, and our belief that it can grow into a $10 billion plus franchise. IcoTide, our first-in-class targeted oral peptide for plaque psoriasis, continues to outpace the recent competitor's launches. More than 20,000 patients have initiated therapy through nearly 9,000 prescribers since Icotide's launch in the U. S. We continue to make strong progress on commercial access with Icotide now broadly covered across all national plans. Also this quarter, Imavi was approved as the first advanced treatment specifically for warm, autoimmune hemolytic anemia, a rare life-threatening disease that causes severe anemia and fatigue. This new indication builds on Imavi's momentum in generalized myasthenia gravis and reflects its broad potential across autoantibody diseases.

And we continue to pursue next-generation therapies. In July, we announced a collaboration with SAIL Biomedicines to advance in vivo CAR T approaches for immune-mediated diseases. Next, in neuroscience, we aim to transform the future of brain health by addressing complex nervous system disorders. Today, we are the definitive leader in neuropsychiatry. Kavlita reached $1 billion in year-to-date sales, making it our $29 billion platform. Driven by strong uptake as an adjunctive treatment for major depressive disorder, Kavlita is now the fastest growing oral branded therapy in this space. And last month, we presented pivotal phase 3 data that show cablita significantly and rapidly improved symptoms of bipolar mania. Spravato also delivered impressive growth of 36% this quarter, reflecting strong demand in treatment-resistant depression.

Now, let's turn to MedTech, where we deliver Q3 operational sales growth of 2.5%. While we fell short of our expectations for the segment, our conviction in our future direction has not changed. Starting with cardiovascular, we continue to invest in heart recovery, circulatory restoration, and heart rhythm disorders to address the leading global cause of death. This was another strong quarter for Shockwave, our circulatory restoration business, which grew 17%. The ongoing global launch of Subway C2 Arrow continues to broaden the reach of our intravascular lithothripsy platforms.

BodyPulse, our pulsed field ablation platform, reached a major milestone this quarter with more than 100,000 AFI patients treated worldwide. Body Pulse Pro, which delivers five times faster ablation speed, has been very well received in Europe, where it is driving double-digit growth. And just last week, we received approval for Body Pulse Pro in Japan. With increasing clinical experience, we are seeing differentiated benefits from Body Pulse. In a recent retrospective analysis, body pulse demonstrated a 68% lower risk of adverse cardiac events compared to a competing post-field ablation platform. And in hard recovery, while physician selectivity continued to affect the biomed performance, we remain confident in the technology and focused on supporting appropriate patient selection. In surgery, we are poised to shape the next era of care through robotics, digital innovation, and advanced instrumentation.

In July, the U. S. FDA granted the Novo Authorization for OTTAVA, the world's first stable integrated soft tissue robotic system. This is one of the most significant medtech innovations we will bring to market this decade. Otava's unique architecture, automated features, and next-generation robotic instruments help address surgeon needs for operating room space and better surgical workflows. Its connection to our open digital ecosystem, Polyphonic, turns procedure data into actionable insights for clinicians. We already signed our first commercial customer for Otava, and we are progressing our development program. Our investigational device exemption trial is already underway in inguinal hernia repair, with future plans for indication expansion into urology and gynecology.

Finally, in vision, we are advancing lifelong eye health to bring better sight to more than 40 million people each year. The recent U. S. launch of Technis PureSea further strengthened our portfolio of intraocular lenses. During the quarter, Technics Pure C and Technics Odyssey surpassed 1 million implants worldwide, reflecting continued surgeon adoption and our leadership in personalized vision solutions. We also received CE marking for AcuVue Oasis Max 2 Week reusable lenses, expanding our AcuVue portfolio in Europe. Overall, this quarter's strong results demonstrate the impact of the choices we have made to build a foundation for durable growth. We sharpened our portfolio to focus on innovation with the greatest potential to change lives. We proved our ability to grow through a significant loss of exclusivity.

Our strategic investments in high-growth areas are delivering results. And our innovation engine continues to drive breakthroughs for patients. That is why we have the confidence to say that we will finish 2026 strong and that 2027 will be an even better year for Johnson & Johnson. I will now turn the call back over to Ryan.

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 Q3 2026 sales results. Worldwide sales were $25.4 billion for the quarter, increasing 6%. Growth in the U. S. was 9.1% and 1.8% outside the U. S. Acquisitions and divestitures had a net negative impact on worldwide growth of 10 basis points.

Now turning to earnings. For the quarter, net earnings were $210 million, and diluted earnings per share were $0.09 versus $2.12 a year ago. Results in the quarter were impacted by the proposed TALK litigation resolution, as well as expenses associated with the Firefly biotransaction and Sale Biomedicine's collaboration, amounting to approximately $7 billion. Adjusted net earnings for the quarter were $6.3 billion, and adjusted diluted earnings per share were $2.59, representing a decrease of 6.8% and 7.5% respectively, compared to the third quarter of 2025. Adjusted earnings in the quarter were also impacted by expenses associated with the Firefly Biotransaction and Sale Biomedicine collaboration I will now comment on business sales results in the quarter focusing on the six key areas where meaningful innovation and strong commercial execution are driving our performance and fueling long growth Beginning with innovative medicine, where our financial results reflect the depth of our expertise and innovation in areas of high unmet need across oncology, immunology, and neuroscience.

Worldwide sales of $16.8 billion increased 7.9%, which underscores the continued strength of our key brands and new launches. Growth in the U. S. was 11.1% and 3% outside the U. S. Divestitures had a negative impact of 10 basis points on worldwide growth. In oncology, starting with multiple myeloma, Darzilek's growth was 15.6%, primarily driven by strong share gains of 5 points across all lines of therapy, with 10 points in the frontline setting, as well as continued market growth, partially offset by OUS pricing headwinds.

Parvicti achieved growth of 35.2%, driven by share gains across earlier lines of therapy and continued site expansion. Tick Veily growth was 77.3%, driven by launch uptake and share gains across earlier lines of therapy following last quarter's approval in the U. S. for Tick Veily plus Darzilex FastPro, with U. S. growth greater than 100%. Talve growth was 42.1%, driven by share gains due to increased depth of prescribing in the community setting. In lung cancer, Ribavant plus Lasklues delivered growth of 63.5%, with strong share gains in the first and second lines driven by continued launch uptake in all regions, along with rapid uptake in Ribavant FastPro.

In prostate cancer, Erlita delivered growth of 9.4%, with continued share gains and market growth, partially offset by unfavorable patient mix. Within immunology, Trimphia delivered impressive growth of 68.2%, driven by continued momentum from the IBD launch, with four points of share growth in both ulcerative colitis and Crohn's disease, alongside continued market growth.

Stelara declined 54%, which reflects continued competitive pressures from biosimilars and the ongoing shift towards novel classes. Growth in other immunology is driven by Amave and Icotide launch uptake in the U. S. In neuroscience, Spravato grew 36%, driven by continued share gains reflecting strong physician adoption and increased patient demand. Kaplita showed significant growth of 66.1%, driven by strong continued launch momentum in adjunctive major depressive disorder and continued demand increases across bipolar disorder and schizophrenia.

Now moving to MedTech. Worldwide sales of $8.6 billion increased 2.5%, with growth of 4.8% in the U. S. and 0.1% outside the U. S. Overall cardiovascular grew 4.1%, including 20 basis points related to acquisitions. Electrophysiology delivered growth of 4.4%, driven by procedure expansion, commercial execution, and new product performance, partially offset by competitive PFA pressures, which were more pronounced than ASPAC this quarter, as well as a lapping of prior year OUS inventory dynamics.

Abium Ed saw a decline of 1.5% due to lower patient volume. There are encouraging signals in the U. S. performance with improvement in the quarter, supported by acute myocardial infarction, cardiogenic shock, and Impella 5.5 continuing to gain adoption.

Shockwave grew double digits at 17.2%, driven by continued adoption of coronary and peripheral products as well as new product launches, and the reimbursement in the office-based lab setting within the U. S. Surgery saw a decline of 1%, including a negative impact of approximately 30 basis points from divestitures. The decline is more notably driven by ongoing expansion of EVP in China, surgery transformation program outcomes across the portfolio, and Middle East disruption, which impacted tender timing and ordering patterns. The decline was partially offset by portfolio strength, driven by recent innovations such as Ethicon 4000 and Dualto, as well as commercial execution and biosurgery.

Envision growth was 5.1%, driven by premium innovation, strong execution, and global reach. Contact lenses and other products grew 4.3%, driven by strong performance in the AccuView Oasis one-day family of products, further solidifying our leadership position, partially offset by U. S. inventory dynamics. Surgical vision delivered growth of 7.1%, driven by new product innovations, robust demand for premium IOLs, and strong commercial execution, partially offset by market-specific factors, such as disruptions in the Middle East. Orthopedics growth for the quarter was 3.4%, primarily driven by new product launches such as Volt and Trauma and Emphasis and Hips, including strong commercial execution and bellus pull-through and knees.

Now turning to our consolidated statement of earnings for the third quarter of 2026. 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 150 basis points, driven by unfavorable product sales mix and increased intangible asset amortization expense in the innovative medicine segment for intracellular, partially offset by the impact of tariff recoveries in the medtech business.

Selling, marketing, and administrative expenses were flat as a percent of sales, reflecting consistent commercial investments in the innovative medicine business. We continue to invest strategically in research and development, deploying approximately $4.7 billion or 18.3% of sales, which includes $1 billion related to the acquisition of Firefly Bio. In process, research and development impairment costs of $339 million in the quarter is related to the write-off of Precardia, a non-core asset acquired as part of the broader AbiumEd transaction. Other income and expense was a net expense of $5.8 billion as compared to $478 million of income in the third quarter of 2025, with the change primarily driven by the proposed talc litigation resolution and orthopedic separation-related costs.

The tax rate was a small net benefit in the quarter, primarily related to the positive tax effect associated with the accrual for the proposed talc litigation resolution. More information can be found in our upcoming 10Q for changes in taxes.

Lastly, I will 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 the adjusted income before tax by segment for the quarter. Another, innovative medicine margin declined from 44.3% to 35.4%, primarily due to acquired in-process research and development expense of approximately $1 billion related to the acquisition of Firefly Bio, transaction costs for sale biomedicine, and unfavorable product sales mix and cost of products sold. MedTech margin increased from 21% to 22.9%, driven by the impact of tariff recoveries, partially offset by increased strategic investments in commercial capabilities.

As a result, adjusted income before tax for the enterprise, as a percentage of sales, decreased from 35.2% to 30.2%. This concludes the sales and earnings portion of the call, and I will now turn the call over to Joe.

Thanks, Ryan. Hello everyone, and thank you for joining us today. As you heard from Joaquin and Ryan, our third quarter results were driven by the strength of our innovative medicine business. This performance more than offset headwinds in certain areas of MedTech, enabling us to exceed expectations on both the top and bottom line, while continuing to invest in our pipeline and future growth. We are clear on where MedTech performance needs to improve, specifically cardiovascular and surgery outside the U. S. , and are taking action to strengthen results. While disappointing, the underlying fundamentals of the MedTech business remain strong, supporting our confidence in the long term for that business.

Across Johnson & Johnson, the drivers underpinning our outlook remain firmly in place. As a result, we are raising our guidance for 2026 versus our most recent update in July. The depth of our portfolio, momentum from new product launches, and upcoming pipeline catalysts further reinforce our conviction in achieving double-digit growth by the end of this decade with sustainable growth beyond.

Turning to financial metrics and our cash position. We ended the third quarter with approximately $17 billion of cash and marketable securities and approximately $45 billion of debt for a net debt position of approximately $28 billion, generating more than $6 billion in free cash flow in the third quarter. We remain confident in our full-year free cash flow guidance of approximately $21 billion. During the quarter, we completed the $1 billion acquisition of Firefly Bio, deepening capabilities in oncology with next-generation antibody engineering to address complex tumor biology.

As Joaquin referenced earlier, we also entered into a collaboration with SAIL Biomedicines to advance in vivo CAR-T therapies for immune-mediated diseases. Our disciplined approach to capital allocation is principled on prioritizing investments that support key commercial launches, accelerating future innovation, increasing our annual dividend, and strengthening our pipeline through strategic value-creating inorganic opportunities. In July, we announced an agreement for a resolution of the Ovarian Talc litigation for $5.5 billion, which is reflected in our third-quarter gap results. The agreement is conditioned upon the express participation of at least 95% of the remaining ovarian claims. We are trending to meet the 95% threshold.

Let me now turn to full year 2026 guidance. As always, our outlook reflects what we know today regarding foreign exchange rates, the broader macroeconomic environment, and other external factors. Based on our year-to-date performance and expectations for the fourth quarter, we are raising the midpoint and tightening the range of our operational sales guidance. We now expect full-year operational sales growth in the range of 6.7% to 7.1%, which represents operational sales of $100.7 billion at the midpoint or growth of 6.9%. We do not speculate on future currency movements. As of last week, the euro spot rate to the U. S. dollar was 1.12. However, the average rate for the fiscal year stands at 1.15. Based on that average rate, we estimate reported sales growth of 7.2% to 7.6%, with a midpoint of $101.2 billion, or 7.4%.

Assuming the current spot rate holds into next year, you could expect currency to be a headwind. Turning now to other items of the P&L. Regarding operating margin, we now expect a decline of approximately 60 basis points. This is an improvement from the 75 basis points decline reflected in our updated July guidance that included the impact of the Firefly Bio and Sail Biomedicine's transactions, which had an unfavorable impact of 150 basis points. Absent those deals, we continue to deliver base margin improvement.

As a reminder, our pre-tax adjusted operating margin outlook also reflects the costs associated with the 53rd week of operations and our previously announced agreement with the U. S. government to improve access to medicines. For net interest expense, we are lowering our guidance to $150 million to $200 million. We are also tightening the range of our effective tax rate guidance. Based on our year-to-date results, we now expect a full-year effective tax rate of 17.0% to 17.5%. Given those updates, we now expect adjusted operational earnings per share in the range of $10.95 to $11.05, or 2% at the midpoint. We expect reported adjusted earnings per share of $11.05 to $11.15, with a midpoint of $11.10, or growth of 2.9%.

Excluding the impact of Firefly Bio and Sail Biomedicine's transactions of $0.64, reported EPS growth would approach 9%. As a reminder for your 2027 modeling, we expect Firefly Bio and Sail Biomedicines to have a combined dilutive impact of $1.36 per share on a full-year adjusted earnings per share next year. We will provide more details on our 2027 outlook later this year at our Enterprise Business Review.

Let me now highlight several upcoming developments that reinforce our growth outlook and performance for the remainder of the year. In oncology, we expect several important data readouts in the fourth quarter. These include data for passeritamig, a first-in-class bispecific antibody in patients with advanced prostate cancer who have progressed after multiple lines of therapy. We also expect data for J&J6143, an investigational first-in-class once-daily oral therapy for metastatic castration-resistant prostate cancer. We continue to see strong adoption for Alexo with year-to-date sales of approximately $200 million and expect to build on that momentum with a data readout in high-risk, non-muscle invasive bladder cancer later this year.

We also expect U. S. approval of Riborant FastPro in advanced head and neck cancer. In immunology, as Joaquin referenced earlier, icotide is off to a strong start, and we look forward to presenting data in psoriatic arthritis later this year. In MedTech, we expect U. S. approval of Varipulse Pro in the fourth quarter, further complementing last week's approval in Japan.

In heart recovery, we are taking corrective action to improve Abiomed's performance. We continue to invest in clinical evidence and expect results from the HRPCI Protect 4 trial in 2027. The trial will have 1,252 patients, four times more than the CHIP-BESIS-3 study. This large-scale study will evaluate the safety and efficacy of Abiomed's Impella CP pump during high-risk percutaneous coronary intervention.

In surgery, we are focused on commercializing Otava following its recent FDA de novo authorization. We expect adoption and revenue contribution to build over time, with the goal of establishing Otava as a significant pillar of our surgery portfolio by the end of the decade.

Regarding orthopedics, we remain on track for the planned separation of the Pew Synthes by mid-2027. I'm really proud of the team working to evaluate all separation vehicles, and all options are better positioned today than when we announced our intentions with this business. Given the way the Pew Synthes is performing and the momentum Nimal Nohanna and his team are generating, we are leaning towards a spin as being the best option to create long-term value for Johnson & Johnson shareholders. That has always been our base plan and we are confident that it can be successfully executed We will provide additional updates as appropriate and when there is more information to share Finally I am really looking forward to and hope you join management for the enterprise business review on December 8th At that event we will provide additional perspective on our 2027 outlook and the key drivers that reinforce our conviction in achieving double growth by the end of the decade Perhaps more importantly, we will highlight our earlier stage pipeline and how it represents the next wave of growth into the next decade.

Attendees will also have the opportunity to experience firsthand some of our latest innovations, such as Otava. Thank you for joining us today.

Thank you. Yes, thank you for your questions. On the first aspect, that is correct. Your interpretation of that being internal strategic investments is what will propel us to double-digit growth by the end of this decade in the coming years with increasing performance. So that is the correct interpretation. It does not assume any inorganic additions at this moment in time. We always are on the lookout for strategic drivers that could complement our business, that makes sense to be in our hands versus where the asset would currently reside, but also creates value for the risk we're bearing on behalf of shareholders. With respect to the urgency, it's an urgency to fix what we currently have. We like the portfolio and the construct that currently exists with the three focus areas of vision care, of surgery, as well as cardiovascular.

I think you're very familiar, and maybe I'll even hand it over to Tim to talk about some of the things we're doing in heart recovery specifically to address that.

What I would say is now a stable business, but we want to catalyze back to double-digit growth. We're very excited at what's on the horizon for surgery. With the addition of Otava over time, that will be a significant contributor to growth by the end of the decade. And then, as I mentioned earlier, vision seems to be functioning well, both on the surgery side as well as the contact lens side, where we are the market leader. But, Tim, maybe you want to offer a comment or two around Abiy Ahmed?

Sure, Joe. So, Asad, ultimately, Abiy Ahmed remained in a temporary headwind, as you saw in Q3, but our conviction in the long-term opportunity has not changed at all. You know, the slowdown we're seeing continues to be the same issue we highlighted in the quarter before, which is this study outside of the U. S. focused on high-risk PCI. And importantly, we do not view these challenges as structural in nature and ones that will drive a long-term impact on the business. We are not seeing any changes in the patient's need, nor to reimbursement access or any meaningful competitive pressures. We also have highlighted some questions we have around the study as to whether best practices were used in the study, and so our focus today is really on education and advancing the clinical evidence-based to show the incredible impact that Impella has in both saving and improving lives.

And so we believe it's a short-term headwind. It's It's important to recognize that in any emerging area of science, there's always going to be debate and discussion, and our responsibility is to continue to advance the evidence base to support what's in the best interest of patients. And in the case of Abiumet, we're doing exactly that. And so a short-term headwind, but we are very confident this is going to be a strong platform for growth for Johnson & Johnson for the future.

So for this year, the IPR&D dilution is $0.64, and for next year, the combination of those deals is $1.36. And the way I would think about that, Larry, and you've covered us long enough where you know that typically our income growth or EPS growth will be a little bit better than our sales growth. That's how you can think about that next year after adjusting for the $1.36 adjustment. So we'll continue to look at margin improvement as part of the orthopedic separation, looking more holistically at our business, some of the advances we're getting with technology and getting us more efficient across all parts of our business. But that's probably a good way to kind of frame in your thinking now for 2027.

But we'll be a little bit more explicit on December 8th at our investor day. We'll outline specifically kind of the components to that, and then even probably provide a pro forma with respect to the orthopedic separation should that occur at some point next year, as well as a longer-term outlook.

Great, Chris. It's Tom. Good to hear from you. First, I do want to start by recognizing Jennifer Talbert and thanking her for her tremendous leadership and partnership. Jennifer leaves Innovative Medicine incredibly well positioned, as you see from our quarterly earnings, with strong momentum, outstanding portfolio and pipeline, and most importantly, a great team. We're fortunate to build on that foundation she established, and I'm excited about what's ahead. And really what I'm excited about is what you're touching on right now is IcoTide. We do foresee IcoTide to be one of our biggest assets in innovative medicine, and it is off to an incredibly great start. As you highlighted, as Joaquin highlighted on the call this morning, I think getting into some of the launch performance, you heard it from Joaquin.

Already to date, we've seen over 20,000 patients initiated on therapy with over 8,000 prescribers, or nearly 9,000 prescribers, I would say. So absolutely tracking better than some of most all launches in psoriatic diseases. I think early prescribing trends is what you wanted to get at kind of as we think about, and we are expanding the systemic marketplace.

Approximately 60% of the patients are systemic naive, so they haven't received any systemic therapy. And roughly the 40 remaining, 20% are sourced from orals and 20% are sourced from other treatments, most likely biologics as we dig into the data. So I can say, as you're seeing with regards to the launch performance, earlier a bit of expansion of the marketplace and absolutely an opportunity to continue to drive that. Highlighted as well, as Joaquin highlighted earlier, I think it's important to point out we do have broad commercial access now And preferred access in place on all national commercial plans are actively engaged to expand that to the Medicare population. So I would say we're very excited about the launch to date, as equally as excited about the future.

And we do foresee this to be one of our largest assets, as I pointed out. We're excited about the upcoming data readouts, both with a PSA and Phase III data, as well as the head-to-head Stellar data for Ascend. And as we look to expand beyond that, and we'll get into more of this at the EBR and IBD and expansions into UC and CD, expecting similar results with regards to launch performance as we go into those other indications.

J. John, it's Tim. Thank you very much for the question. Let me start by really putting the overall MedTech Q3 results in context for you and all on the call. And to be clear, our performance is below the standard we have set internally and below the expectations we previously communicated to investors. Simply put, we can do better, and we absolutely will. And right now, we are focused solely on the actions needed to deliver stronger results in the fourth quarter and beyond.

And that said, when, to your question, you know, when we break down our results, you will see that the pressure was primarily concentrated actually in two very distinct areas. Firstly, our performance outside of the U. S. , and secondly, Abiumed globally, which we already touched on. And to put it in perspective, growth in the U. S. , which, as you know, is the most important market, was in fact robust in the quarter and accelerated to almost 5%. Our performance outside of the U. S. was a challenge, and it reflected a combination of mostly known headwinds, which we have discussed previously. For example, in surgery, the expected impact of the transformation program and the ongoing expansion of volume-based procurement in China.

And in electrophysiology, competitive intensity, especially in Asia-Pacific, which is a region that you know is still relatively early in the adoption of PFA. We did introduce a new headwind, which is really the incremental pressure that we're seeing on the business due to the conflict in the Middle East. But when you actually step back and you look deeper into these results, we're seeing several encouraging indicators which give us confidence in a stronger Q4 and outlook beyond that. For example, in electrophysiology, in markets like Europe, where we've already launched Varipulse Pro, which, by the way, is a faster and easier-to-use catheter, we're back to double-digit growth. And we will launch VariPulse Pro in Japan shortly after receiving regulatory approval last week.

You can also anticipate a U. S. launch by the end of this year. I think at Abiumid we've already touched on the study in Iris PCI, a study where we actually believe that the methodology employed did not follow well-established practices, an issue which we're addressing through education. We think we're going to get through that because the evidence base is so solid, especially in areas like AMI cardiogenic shock, and we're still seeing tremendous performance of 5.5. We did, by the way, already see some improvement sequentially throughout the quarter, and we do believe that that business will be back to growth in short order.

Now, while Q3 for MedTech was not a strong quarter, this should not distort the whole picture. As mentioned, the issues are primarily concentrated in the two areas I mentioned. It's also worth reinforcing to your question that the underlying procedure environment remains stable across our key markets. I know there's been a lot of debate about that. Our job now is to make sure that we convert that demand to more consistent performance. And so we remain confident in the combination of the momentum we're seeing in the U. S. and the moderation of these near-term headwinds, which will support improved performance in Q4 while positioning us for stronger performances in 2027 and beyond. And as you've already heard from Joaquin and Joe, we'll share more detail around what that looks like for 2027 and beyond, Specifically with a focus on new innovations like Otava when we come together on December 8th.

Hi, Richard. It's Tom addressing your question. A couple of things I'd point out, and I'd obviously turn it over to John if he has any further remarks with regards. So I'll say a couple of things. We absolutely know the space very well, whether it be in psoriasis or IBD, and you can tell by the launch that we had with Trimphia and IBD, it's off to an incredibly great start. As you can see, over 70% growth year over year and heavily penetrated into becoming actually the fastest growing biologic across all indications, in particular in IBD, new patient starts. So we know the space very well.

With that said, I will say there's still significant unmet need in a large amount of patients that are untreated or not treated earlier in the course of their diseases. And we do see that to be a great opportunity for not only market expansion, as we're seeing in psoriatic disease or psoriasis with icotide, but the profile of the product fits beautifully in that spot, I would say. And, you know, obviously the data will depend on how we look at it in the positioning once it becomes on the marketplace. But I will tell you we'll have early access as one of the other keys, and we'll see rapid uptake once we get the data results. John?

Yeah, maybe just to build on that a little bit, I think the reason that we've had such a great start in psoriasis is because of that trifecta of biologics-like efficacy, coupled with placebo-like safety, combined with the convenience of a once-a-day pill, and we think that'll play very well across all indications, including IBD, where, as Tom referenced, still a large percentage of patients are not on an advanced therapy.

You know the data in our Phase II study were quite encouraging and looked like IKOTI can deliver on par with the current monotherapies Of course we very aware that some patients need something more that they need a combination therapy and that's why we're developing 4804, which pairs our goselcomab, our IL-23 inhibitor, with gulivumab, our TNF inhibitor. And that is in phase three studies now after really compelling phase two data that show that in that refractory population that have failed two or more prior advanced therapies, this really delivers superior efficacy to the monotherapy. So we're actively pursuing that for those patients where a monotherapy is not enough and could see then, you know, that opportunity to migrate patients, if needed, beyond the monotherapies to the dual therapies with our co-antibody therapeutic 4804.

Yeah, obviously we haven't disclosed any sales for Icotide, but I'm confident we're going to be doing that next year, just based on the momentum and the progress that we're seeing with the launch of Icotide. Turning over to Enlexo, also another exciting product that we have, or even a platform as we think about TAR210 as well. We are off to an incredibly great start. Joe disclosed that we are nearly 200 million in net trade sales for a year to date. And quite honestly, we haven't reported quarterly sales, but I could say that Q3 was north of 90 million dollars. So we are seeing great sequential growth. This quarter we saw new patient inserts grow 45% versus the previous quarter.

And I wanted to point out that this is in a population in non-muscle invasive bladder cancer, high risk with carcinoma, The Johnson's SIT2 represents roughly 4,000 patients in totality, so relatively small in nature, and we're still seeing one in three patients being put on anlexo in this patient population. You touch on Sunrise 5, which is a broader patient population, roughly 15,000 patients, and what we call Sunrise 3, which is the BCG naive population, roughly 50,000. This is where we absolutely see a greater opportunity for us to live into the number of 5 billion-plus for the platform, And I do believe we will do just that and above that, given the unmet medical need, the simplicity of Alexo delivers and the high response, high durable complete remission rates that we are delivering with Alexo as we look to expand in the population.

Maybe I'll turn it to John to touch on a little bit of the clinical development program.

Indeed. As you know, the approval currently is for the cyst type of non-bustle invasive bladder cancer which spreads laterally. But the more common is the papillary, and in our so-called Sunrise I study, we had a cohort devoted to patients with papillary cancers where those lesions which project outward from the bladder wall are excised by the urologist, and then in Lexo is applied, and one tries to prevent recurrence. And we showed nearly 75% of patients had no recurrence after one year, and that over 95% had no progression of their disease. In other words, they did not progress to more invasive types of disease. So based on that, the use of Inlexo in that papillary form of the disease, which is by far the more common, is already in the NCCN guidelines.

And the FDA has invited us to submit for an expansion of our label into that population. Both IcoTide and Ilexo are going to be, together with Ribobank, key drivers of our growth acceleration, driving to double-digit growth. So they will become one of our largest products, both of them. Thank you. Our next question is coming from Michael Yee from UBS Security. Your line is now live.

Great. Thank you for the questions. Maybe two pipeline science questions. On IcoTide, obviously, you have great data, and psoriasis is a little bit lower than biologics, but great data. In IBD, the UC data was quite strong, and just wondering if you think that would be replicated to biologic-like efficacy as an oral, and that differentiation due to the release in the gut is a reason for the potentially stronger data in IBD, which could be a bigger driver. Second part question is on meldexian. I know you share in that partnership, but SSP data is coming up, and I just wanted to check in on your confidence that that should be similar to aslendexian, and that should be a fairly de-risk indication as a factor of 11.

Thank you. John Reed here. Thanks for your questions. I'll start off, and then maybe Tom will want to supplement. But on Iketide and IBD, we get that question all the time, asking might we see even greater efficacy with an oral because of the gut absorption. All I can say is to be determined, we were quite pleased with the phase 2 data and ulcerative colitis.

I would also say the phase 3 studies, as we saw with our psoriasis and psoriatic arthritis studies, are enrolling briskly in the prior studies. They enrolled in about a third the time that it normally takes us to enroll in those indications, reflecting, I think, the real enthusiasm that both physicians and patients have for this oral option. So, you know, that theory about oral absorption and improved efficacy is to be determined by the data.

Moving to Milvexian, we remain confident in the studies underway with the secondary stroke because of the Asundexian data. As we know in vitro, Milvexian is a more potent inhibitor of factor 11. We also have been able to have a safety margin that allows us to push that dose to ranges that we're confident are quite effective. So we remain confident in the results and expect that perhaps the secondary stroke data will be available even this year. It's event-driven, the study. I will now turn the call over to management for the atrial fibrillation. It will be exciting for us if we can prevail in both those indications because about 25% of patients who are candidates for secondary stroke have atrial fibrillation.

That's probably why they had the stroke in the first place. And so if we can benefit both of those populations, that will be exciting. We are competent in atrial fibrillations study as well. There we were able to push the dose four times higher given our safety margin in the drug and feel from monitoring of the anticoagulation status of the blood with laboratories that we're in the right range to benefit patients and prevent thrombosis. So thank you for the question.

Yeah, I just reinforced what John has said. There's an absolute need for highly effective oral anticoagulation therapy with a reduced bleeding risk. In AFib alone, approximately 40% of the patients eligible for oral anticoagulants are not receiving oral anticoagulants, typically due to the concerns on potential safety and the bleeding risk associated with the current ODACs.

Thank you.

Thank you, Jason. Let me try to get to all of those. Let me start with the Middle East, and clearly we've highlighted that as a new risk that has broadened over time, and really the effect is no longer limited to a handful of markets as we initially thought. We've seen increased disruption to ordering patterns, tender timing, and hospital spending decisions across a wider group of countries, unfortunately. And we've also seen governments and healthcare systems become more cautious in their spending priorities, with some funding and procurement decisions taking longer than what we normally would expect. That has created a more meaningful impact on purchasing behavior than we saw earlier in the year. That said, I think it's important that we see this really as a short-term factor.

I mean, the underlying issues have not changed. The clinical need remains intact, and we would expect many of these opportunities to be deferred rather than permanently lost. I think that's an important factor as it relates to any form of conflict and certainly what we're seeing in the Middle East. You know, on surgery, as I mentioned, we were actually really excited about the performance of the business in the U. S. Our issue really was outside of the U. S. , and as you know, primarily driven by factors we've discussed before, such as the transformation program and volume-based procurement.

And then, of course, the incremental pressure that we've just mentioned are out the Middle East. I will say that despite those headwinds, you know, we're focused on where we can have an impact, and we have a lot of opportunities. You know, wound closure growth continue to benefit. This is a category where we absolutely dominate, and that growth has been driven by innovation such as Stratafix and Plus Sutures. Biosurgery and other north of billion dollar platform delivered solid growth driven by key brands like Surgeaflow, Surgeacel, and VistaSeal. And we continue to see good traction with our endomechanical innovations such as Ethicon 4000 and Dualto. And so we are confident that we will see continued growth in the U. S. And to your question, we will see acceleration in EMEA and return to growth overall in the fourth quarter.

I do think it's also worth mentioning our confidence in this business going forward. This was the core to how we started Johnson & Johnson MedTech, and we are absolutely committed to it for the long term. I'd say the biggest reason for confidence is the fact that we will be entering the surgical robotic space, and combined with our leadership positions across wound closure, biosurgery, and advanced instrumentation, We believe that Otava gives us an opportunity to participate more fully in one of the most attractive and underpenetrated areas of surgery. And so, you know, as we continue to execute our portfolio transformation, advance innovation across the existing business, and prepare for the launch of Otava, we remain confident in the long-term trajectory of the surgery franchise.

We do get a lot of questions on Otava, and rest assured that when you come together for the meeting on December 8th, we will provide perspective on the outlook for that innovation and further build your confidence in what we believe will be a material contributor to Johnson & Johnson's growth over the long term.

Hi, Alex. It's Tom. Thanks for the question. I think first and foremost, yes, we're anxiously awaiting for those trials to read out. I would say we're already doing that right now with CAR-Titude 4 across the globe. CAR-VICTI is available in over 20 markets, and we're seeing substantial share growth in the earlier line settings. And I would say roughly in the U. S. , 50 percent of the utilization of CAR-VICTI lies in lines 2 and 3. So there's becoming more familiarity with the product and access to the product and excitement about it, predominantly due to the unmatched overall survival as early as line two of therapy that we see in versus standard of care. So we're already educating health care providers on the product and how they can utilize it earlier.

Some of the education that is centered around is appropriate patient selection, and the earlier the better, as well as proper bridging, getting the patients to the highest level MRD negativity. I will now turn the call over to management for the first time to be effectively treated with CARVICTI.

Just to remind on top of that, the recent myeloma meetings we showed five-year follow-up data from the CAR2 study that is in the second line showing that about half of those patients enjoyed complete remission out to five years with no further treatment.

Thank you for your questions and your engagements in today's call. As you can see, we continue to build momentum. Growth improves sequentially in the third quarter. We expect further acceleration to increase the growth of the growth of the market. We will be in the next generation in 2027 with a clear path to double-digit growth by the end of the decade. In innovative medicine, growth will come from both our existing portfolio, including Darsalex and Trenfaya, and newer products such as IcoTite, Ribreban, and Ilexo as they begin to contribute more meaningfully. We see similar opportunities in MedTech, the potential from our cardiovascular launches, including next-generation PFA and IVL catheters. Additional data supporting Impela and Otava in robotic surgery are not yet fully reflected in our growth.

Taken together, these drivers position Johnson & Johnson as one of the cleanest growth stories in healthcare. We will provide more details about our portfolio and later stage pipeline at our Enterprise Business Review later in December. Thank you very much, and enjoy the rest of your day.