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F500-2023-040-Johnson-and-Johnson

The health care company is best known for household items like baby shampoo and Tylenol, but pharmaceuticals and medical technology are its big revenue drivers, bringing in $52.5 billion and $27.4 billion respectively, compared to $14.9 billion in the consumer health segment. 
<ul> 
 	<li>Revenue inched up 1.2% to $94.9 billion in 2022, but profits fell 14.1% to $17.9 billion.</li> 
 	<li>The U.S. government phased out Johnson &amp; Johnson’s one-shot COVID vaccine, hurting the company’s pharmaceutical division.</li> 
 	<li>In April 2023, the company settled a decade-long legal dispute in which consumers accused J&amp;J’s iconic baby powder of causing cancer. The company agreed to pay $8.9 billion to tens of thousands of plaintiffs but has not admitted wrongdoing. Before the settlement is final, a court must accept a controversial bankruptcy filing by a subsidiary that Johnson &amp; Johnson created to shield its corporate assets from litigation. A court rejected an earlier bankruptcy filing aimed at reaching a settlement, which allowed thousands of related cases against J&amp;J to go ahead.</li> 
</ul>

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WMAC-2022-17-Johnson and Johnson

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WMAC 2021-15-Johnson & Johnson

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G500-2021-094-Johnson & Johnson

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F500-2021-36-Johnson & Johnson

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G500-2020-104-JJ

The sprawling 134-year-old health conglomerate eked out 0.6% sales growth in 2019 thanks to the strong performance of its pharmaceutical business, and particularly its immunology and oncology drugs. J&amp;J’s consumer business—with a portfolio that includes Neutrogena, Tylenol, and Listerine—was boosted by the acquisition of Zarbee’s, a purveyor of naturally based over-the-counter remedies. The company continued its push into the robotic surgery market in an effort to revive its struggling medical device business. J&amp;J is also mired in litigation surrounding its opioid and baby powder products. (In May, it announced it would stop selling talc-based baby powder.) While COVID-19 has dinged sales of some of its products—like contact lenses and artificial knees and hips—the company is one of the frontrunners in the race for a vaccine; J&amp;J has said it hopes to begin late-stage human trials by the end of September.

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F500-2020-035-Johnson and Johnson

The sprawling 134-year-old health conglomerate eked out 0.6% sales growth in 2019 thanks to the strong performance of its pharmaceutical business, and particularly its immunology and oncology drugs. J&amp;J’s consumer business—with a portfolio that includes Neutrogena, Tylenol, and Listerine—was boosted by the acquisition of Zarbee’s, a purveyor of naturally based over-the-counter remedies. The company continued its push into the robotic surgery market in an effort to revive its struggling medical device business. J&amp;J is also mired in litigation surrounding its opioid and baby powder products. No surprise, the company has been impacted by COVID-19 in various ways; while its pharma division is racing to develop a vaccine, sales of products like artificial knees and hips are down due to the cancellation of elective surgeries during the pandemic.

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Global business is back. After limping through a worldwide financial crisis and economic slowdown, the 500 largest companies ranked by revenues shattered all sorts of performance records in 2013: They racked up combined revenues of $31.1 trillion, up 2.5% from 2012, and profits soared 27% to nearly $2 trillion. China’s 95 companies (up from 89 last year) posted $5.8 trillion in revenues. The U.S. has four fewer companies on the list than last year but remains (for now) the country leader, with 128 corporations on the list—including No. 1 Wal-Mart Stores—reporting $8.6 trillion in revenues. 

Wal-Mart stayed on top as its sales crept closer to half-a-trillion dollars. Apple moved into the top five. And UnitedHealth Group continued its steady climb. 

Best Companies To Work For Europe

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Johnson &amp; Johnson, founded in 1886, is among the world’s largest and most influential health care companies. It is involved in the research, development, manufacture, and distribution of innovative medicines and medical technologies. The company’s innovative medicine business operates in areas including oncology, immunology, neuroscience, and cardiopulmonary treatment. In medtech, the company is focused on developing and delivering cardiovascular, orthopedics, surgery, and vision solutions.

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Johnson & Johnson (JNJ): Company Profile, Stock Price, News, Rankings

legacy

Johnson & Johnson

johnson & johnson

Good morning, and welcome to Johnson & Johnson's third quarter 2026 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 any technical difficulties during the conference, you may press star zero to reach the operator. I will now turn the conference call over to Johnson & Johnson. You may begin.

Hello, everyone. This is Ryan Koors, 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 Duato, 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 Wolk, 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 leading in areas of high unmet need where innovation can make the greatest difference for patients. Our powerful combination of innovative medicine and MedTech expertise strengthens our competitiveness. 29 of our products and platforms now generate at least $1 billion in annual sales. Our marketed portfolio continued 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 a match with 80% of patients receiving a Johnson & Johnson therapy as part of their treatment journey. We continue to strengthen the body of evidence supporting our recently launched multiple myeloma therapies and combination regimens.

New phase III results announced in July demonstrated that the combination of TECVAYLI plus TALVEY reduced the risk of disease progression or death by 89% as early as the second line of treatment. In solid tumors, sales of RYBREVANT increased by 64%, reflecting its strength in lung cancer. By the end of the year, we expect to receive U.S. FDA approval for RYBREVANT FASPRO in advanced head and neck cancer, a disease with significant unmet needs. In bladder cancer, INLEXZO 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 INLEXZO 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 degrader antibody conjugate platform that targets drivers of difficult-to-treat cancers, including KRAS. 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. TREMFYA 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. We continue to generate evidence that reinforces TREMFYA's clinical differentiation. Based on the landmark STAR study, TREMFYA 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 TREMFYA as a foundational medicine in inflammatory bowel and psoriatic diseases, and our belief that it can grow into a $10 billion+ franchise. ICOTYDE, our first-in-class targeted oral peptide for plaque psoriasis, continues to outpace the recent competitors' launches. More than 20,000 patients have initiated therapy through nearly 9,000 prescribers since ICOTYDE's launch in the U.S. We continue to make strong progress on commercial access, with ICOTYDE now broadly covered across all national plans. Also this quarter, IMAAVY 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 IMAAVY's momentum in generalized myasthenia gravis and reflects its broad potential across autoantibody diseases. 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. CAPLYTA reached $1 billion in year-to-date sales, making it our 29th billion-dollar platform. Driven by strong uptake as an adjunctive treatment for major depressive disorder, CAPLYTA is now the fastest-growing oral branded therapy in this space. Last month, we presented pivotal phase III data that show CAPLYTA significantly and rapidly improves 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 delivered 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 Shockwave C2 Aero continues to broaden the reach of our intravascular lithotripsy platforms. VARIPULSE, our pulsed field ablation platform, reached a major milestone this quarter with more than 100,000 AFib patients treated worldwide. VARIPULSE Pro, which delivers five times faster ablation speed, has been very well received in Europe, where it is driving double-digit growth. Just last week, we received approval for VARIPULSE Pro in Japan. With increasing clinical experience, we are seeing differentiated benefits from VARIPULSE. In a recent retrospective analysis, VARIPULSE demonstrated a 68% lower risk of adverse cardiac events compared to a competing pulsed field ablation platform.

In heart recovery, while physician selectivity continued to affect Abiomed performance, we remain confident in the technology and focused on supporting appropriate patient selection. In surgery, we're poised to shape the next era of care through robotics, digital innovation, and advanced instrumentation. In July, the U.S. FDA granted De Novo authorization for OTTAVA, the world's first table integrated soft tissue robotic system. This is one of the most significant MedTech innovations we will bring to market this decade. OTTAVA'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 OTTAVA, 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 TECNIS PureSee further strengthened our portfolio of intraocular lenses. During the quarter, TECNIS PureSee and TECNIS Odyssey surpassed 1 million implants worldwide, reflecting continued surgeon adoption and our leadership in personalized vision solutions. We also received CE marking for ACUVUE OASYS 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. 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 talc litigation resolution, as well as expenses associated with the Firefly Bio transaction and Sail Biomedicines 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 Bio transaction and Sail Biomedicines 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-term growth. Beginning with Innovative Medicine, where our financial results reflect the depth of our expertise in 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, DARZALEX 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. CARVYKTI achieved growth of 35.2%, driven by share gains across earlier lines of therapy and continued site expansion. TECVAYLI 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 TECVAYLI plus DARZALEX FASPRO, with U.S. growth greater than 100%. TALVEY growth was 42.1%, driven by share gains due to increased depth of prescribing in the community setting.

In lung cancer, RYBREVANT plus LAZCLUZE 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 RYBREVANT FASPRO. In prostate cancer, ERLEADA delivered growth of 9.4%, with continued share gains and market growth partially offset by unfavorable patient mix. Within immunology, TREMFYA delivered impressive growth of 68.2% driven by continued momentum from the IBD launch, with 4 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 IMAAVY and ICOTYDE launch uptake in the U.S. In neuroscience, SPRAVATO grew 36%, driven by continued share gains reflecting strong physician adoption and increased patient demand.

CAPLYTA 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 in ASPAC this quarter, as well as the lapping of prior year OUS inventory dynamics. Abiomed 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 VBP 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 strengths driven by recent innovations such as Ethicon 4000 and DUALTO, as well as commercial execution in biosurgery. In Vision, 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 ACUVUE OASYS 1-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 in trauma and EMPHASYS in hips, including strong commercial execution in VELYS pull through in 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 Intra-Cellular, 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 Abiomed 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 10-Q for changes in taxes. 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 the adjusted income before tax by segment for the quarter. 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 Sail Biomedicines, 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 GAAP 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%-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%-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 Biomedicines 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-$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%-17.5%. Given those updates, we now expect adjusted operational earnings per share in the range of $10.95-$11.05 or 2% at the midpoint.

We expect reported adjusted earnings per share of $11.05-$11.15 with a midpoint of $11.10 or growth of 2.9%. Excluding the impact of Firefly Bio and Sail Biomedicines 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 pasritamig, 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 JNJ-6143, an investigational first-in-class, once-daily oral therapy for metastatic castration-resistant prostate cancer. We continue to see strong adoption for ERLEADA 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 RYBREVANT FASPRO in advanced head and neck cancer. In immunology, as Joaquin Duato referenced earlier, ICOTYDE 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 IV trial in 2027.

The trial will have 1,252 patients, four times more than the CHIP-BCIS3 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 OTTAVA following its recent FDA De Novo authorization. We expect adoption and revenue contribution to build over time, with the goal of establishing OTTAVA 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 DePuy 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 DePuy Synthes is performing and the momentum Namal Nawana 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 us 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-digit 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 OTTAVA. 2026 is on track for another successful year, exceeding expectations set at the beginning of the year. We look forward to closing out 2026 strong and setting up 2027 for continued success. Thank you to our colleagues whose dedication and commitment continue to advance innovation, improve patient outcomes, and create long-term value for shareholders. With that, we are ready to answer your questions. Kevin, can you please open the call for Q&A?

Certainly. We will now be conducting a question and answer session. Ladies and gentlemen, if you would like to ask a question at this time, please press star then one on your telephone keypad. If you would like to withdraw your question, please press star then two. We ask you please limit yourselves to one question only. Our first question today is coming from Asad Haider from Goldman Sachs. Your line is now live.

Great. Thanks for taking the question and congrats on all the progress. Just one point of clarification. On the double-digit growth by the end of the decade, the vocabulary in the press release references the progress in the underlying business, quote, "Together with strategic investments." Just want to be clear that that refers to internal investments and not M&A. That is a question we are getting this morning. Joe, on your comments that you are not satisfied with MedTech performance and are taking action to strengthen that growth, is the implication there that you now feel more urgency to add to higher growth areas via M&A in MedTech? Or do you think that you have the product portfolio today to drive the improved performance you are looking for? Thank you.

Yeah, Asad, 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. 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 are bearing on behalf of shareholders. With respect to the urgency, it is 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 are very familiar, and maybe I will even hand it over to Tim to talk about some of the things we are 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 are very excited at what is on the horizon for surgery with the addition of OTTAVA over time. That will be a significant contributor to growth by the end of the decade. 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 Abiomed?

Sure, Joe. Asad, ultimately, Abiomed remained in a temporary headwind, as you saw in Q3. But our conviction in the long-term opportunity has not changed at all. The slowdown we are 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. 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 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 base to show the incredible impact that Impella has.

It is saving and improving lives. So we believe it is a short-term headwind. It is important to recognize that in any emerging area of science, there is always going to be debate and discussion, and our responsibility is to continue to advance the evidence base to support what is in the best interest of patients. In the case of Abiomed, we are doing exactly that. 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. Thank you.

Thank you. Our next question today is coming from Larry Biegelsen from Wells Fargo. Your line is now live.

Good morning. Thanks for taking the question. Joe, I wanted to ask about the 2027 comments you made at Deutsche Bank. On the top line, you said you expect reported sales growth to be similar to 2026 after adjusting 100 basis points for the extra week in both years, which I think would mean about 5.4% reported growth next year. On EPS, how should we think about your ability to grow earnings excluding IP R&D? Just remind us of how much the Firefly and Sail dilution is IP R&D this year and next year. Thank you.

For this year, the IP R&D dilution is $0.64. For next year, the combination of those deals is $1.36. The way I would think about that, Larry, and you've covered us long enough where you know that typically our income growth or our 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. 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. That's probably a good way to kind of frame in your thinking now for 2027. We'll be a little bit more explicit on December 8th at our Investor Day.

We will 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.

Thank you. Our next question is coming from Chris Schott from JPMorgan Chase. Your line is now live.

Great. Thanks so much. Just wanted to touch base on ICOTYDE. Just two-part question here. First, can you just give us an update in terms of what you're seeing in terms of patient uptake as we think about new to biologic versus oral switches versus injectable switches? Then bigger picture for the drug. You're talking about this as a $10 billion+ asset, but when you think about this very strong launch we've seen so far in psoriasis, you got a number of additional indications pending. I guess, how do you think about could this be a much larger asset than $10 billion as you think about the peak sales opportunity for ICOTYDE? Thanks so much.

Great, Chris, it's Tom. Good to hear from you. First, I do want to start by recognizing Jennifer Taubert 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. Really what I'm excited about is what you're touching on right now is ICOTYDE. We do foresee ICOTYDE to be one of our biggest assets in Innovative Medicine, and it is off to an incredibly great start.

As you highlighted, and 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. 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. 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.

I can say, as you are seeing with regards to the launch performance earlier, a big expansion of the marketplace and absolutely an opportunity to continue to drive that. Highlighted as Joaquin highlighted earlier, I think it is important to point out we do have broad commercial access now and preferred access in place on all national commercial plans and are actively engaged to expand that to the Medicare population. I would say we are very excited about the launch to date as equally as excited about the future. We do foresee this to be one of our largest assets. As I pointed out, we are excited about the upcoming data readouts, both with the PsA phase III data, as well as the head-to-head STELARA data for ICONIC-ASCEND that we should be releasing in the coming months.

As we look to expand beyond that, and we will 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.

Thank you. Our next question is coming from Joanne Wuensch from Citi. Your line is now live.

Good morning, and thank you for taking the question. I want to focus a little bit on MedTech here. When you use the phrase underlying fundamentals in MedTech are solid, I want to confirm that you are thinking about all the good stuff, the patient volumes, the CapEx spending from the hospitals, and then what you are seeing in terms of just general flows. As a sister question to that, how do you or what do you think needs to be done to improve the J&J franchise? Thank you.

Joanne, 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.

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. Right now, we are focused solely on the actions needed to deliver stronger results in the fourth quarter and beyond. That said, to your question, when we break down our results, you will see that the pressure was primarily concentrated in two very distinct areas. Firstly, our performance outside of the U.S., and secondly, Abiomed globally, which we already touched on. 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. 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 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. 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 Abiomed, we've already touched on the study in high-risk 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 Impella 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 is also worth reinforcing to your question that the underlying procedure environment remains stable across our key markets. I know there has been a lot of debate about that. Our job now is to make sure that we convert that demand into more consistent performance. We remain confident in the combination of the momentum we are 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.

As you have already heard from Joaquin and Joe, we will share more detail around what that looks like for 2027 and beyond, specifically with a focus on new innovations like OTTAVA when we come together on December 8th. Thank you.

Thank you. Next question today is coming from Jason Gerberry from Bank of America. Your line is now live.

Hello. This is Richard Wagner for Jason. I had a question regarding the ICOTYDE psoriasis launch. Are there lessons that can be learned that would be useful when ICOTYDE launches in IBD? Specifically, in IBD, competitors are developing high efficacy combination programs and wondering how that could affect the efficacy perception by physicians of ICOTYDE. Thank you.

Hi, Richard. This is Tom addressing your question. A couple of things I would point out, and I would obviously turn it over to John if he has any further remarks with regards. I will say a couple of things. We absolutely know the space very well, whether it be in psoriasis or IBD. You can tell by the launch that we had with TREMFYA in IBD, it is off to an incredibly great start. As you can see, over 70% growth year-over-year, and heavily penetrated in 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 is still significant unmet need in a large amount of patients that are untreated or not treated earlier in the course of their diseases.

We do see that to be a great opportunity for not only market expansion as we are seeing in psoriatic disease or psoriasis with ICOTYDE, but the profile of the product fits beautifully in that spot, I would say. Obviously, the data will depend on how we look at it in the positioning once it becomes on the marketplace. I will tell you, we will have early access as one of the other keys, and we will 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 have had such a great start in psoriasis is because of that trifecta biologics-like efficacy, coupled with placebo-like safety, combined with the convenience of a once-a-day pill. We think that will play very well across all indications, including IBD, whereas Tom referenced still a large percentage of patients are not on an advanced therapy. The data in our phase II study were quite encouraging and look like ICOTYDE can deliver on par with the current monotherapies. Of course, we are very aware that some patients need something more, that they need a combination therapy, and that is why we are developing JNJ-4804, which pairs our guselkumab, our IL-23 inhibitor, with golimumab, our TNF inhibitor.

That is in phase III studies now after really compelling phase II data that show that in that refractory population that have failed two or more prior really delivers superior efficacy to the monotherapy. We are actively pursuing that for those patients where a monotherapy is not enough and could see then that opportunity to migrate patients if needed beyond the monotherapies to the dual therapies with our co-antibody therapeutic JNJ-4804.

Thank you. Our next question is coming from Vamil Divan from Guggenheim Securities. Your line is now live.

Great. Thanks for taking the question. Maybe one just follow-up and then one actual question. Following up on the ICOTYDE, i appreciate the comments you have made so far. I am just curious if you would be willing to provide any commentary around the actual net sales in the quarter or kind of how it compares to where consensus was. We are just getting some questions from investors on that specifically. My other question is just around INLEXZO. So I appreciate the comments there you made around the sales so far. I am wondering if you can just quantify, I know you have the data coming up later this year as well, how you see the market opportunity for that expanding based on the current indication, and then what the SUNRISe-5 data, what the size of that opportunity is relative to what you have currently? Thank you.

Yeah. Obviously, we have not disclosed any sales for ICOTYDE, but I am confident we are going to be doing that next year, just based on the momentum and the progress that we are seeing with the launch of ICOTYDE. Turning over to INLEXZO, also another exciting product that we have or even a platform as we think about TAR-210 as well, and the opportunity that exists for us. We are off to an incredibly great start. Joe disclosed that we are nearly $200 million in net trade sales for year to date. Quite honestly, we have not reported quarterly sales, but I could say that Q3 was north of $90 million. So we are seeing great sequential growth. This quarter, we saw new patient inserts grow 45% versus the previous quarter. I wanted to point out that this is in a population in non-muscle invasive bladder cancer, high risk with carcinoma in situ.

It represents roughly 4,000 patients in totality, so relatively small in nature. We are still seeing one in three patients being put on INLEXZO 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+ for the platform. I do believe we will do just that and above that given the unmet medical need, the simplicity of INLEXZO delivers and the high durable complete remission rates that we are delivering with INLEXZO as we look to expand in the population. Maybe I will 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 CIS type of non-muscle invasive bladder cancer, which spreads laterally. The more common is the papillary, and in our so-called SUNRISe-1 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 INLEXZO is applied, and one tries to prevent recurrence. 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. Based on that, the use of INLEXZO 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 expansion of our label into that population.

Both ICOTYDE and INLEXZO are going to be, together with RYBREVANT, key drivers of our growth acceleration, driving to double-digit growth. They will become one of our largest products, both of them.

Thank you. Our next question is coming from Michael Yee from UBS Securities. Your line is now live.

Great. Thank you for the questions. Maybe two pipeline science questions. On ICOTYDE, obviously you have great data in psoriasis, 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 there 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 milvexian. 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 asundexian, and that should be a fairly de-risked indication as a Factor XI. Thank you.

John Reed here. Thanks for your questions. I will start off, and then maybe Tom will want to supplement. On ICOTYDE 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 II data in ulcerative colitis. I would also say the phase III 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, that theory about oral absorption and improved to be determined by the data.

Moving to milvexian, we remain confident in the studies underway, particularly with the secondary stroke, because of the asundexian data. As we know, in vitro, milvexian is a more potent inhibitor of Factor XI. We also have been able to have a safety margin that allows us to push that dose to ranges that we are confident are quite effective. We remain confident in the results and expect that perhaps the secondary stroke data will be available even this year. It is event-driven, the study. The atrial fibrillation, the larger population, will be next year. 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 is probably why they had the stroke in the first place. If we can benefit both of those populations, that will be exciting.

Johnson & Johnson (JNJ) Q3 2026 Earnings Call Transcript

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