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WMAC 2023-Johnson and Johnson

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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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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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Q4 2024

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

legacy

Johnson & Johnson

johnson & johnson

Good morning and welcome to Johnson & Johnson's fourth quarter 2025 earnings conference call. All participants will be in a listen-only mode until the question-and-answer session of the conference. This call is being recorded. If anyone has any objections, you may disconnect at this time. If you experience technical difficulties during the conference, you may press star zero to reach the operator. I will now turn the conference call over to Johnson & Johnson. You may begin.

Hello everyone. This is Darren Snellgrove, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of business results for the fourth quarter and full year 2025, and our financial outlook for 2026. First, a few logistics. As a reminder, today's presentation and associated schedules are available on the Investor Relations section of the Johnson & Johnson website at investor.jnj.com. Please note that this presentation contains forward-looking statements regarding, among other things, the company's future operating and financial performance, market position, and business strategy. You are cautioned not to rely on these forward-looking statements, which are based on the current expectations of future events using the information available as of the date of this recording, and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected.

The description of these risks, uncertainties, and other factors can be found in our SEC filings, including our 2024 Form 10-K, which is available at investor.jnj.com and on the SEC's website. Additionally, several of the products and compounds discussed today are being developed in collaboration with strategic partners or licensed from other companies. This slide acknowledges those relationships. Moving to today's agenda, Joaquin Duato, our Chairman and CEO, will discuss our business performance and growth drivers. I will then review the fourth quarter sales and P&L results, as well as full year 2025 results for the enterprise. Joe Wolk, our CFO, will then close by sharing an overview of our cash position, capital allocation priorities, and guidance for 2026, as well as key milestones and qualitative considerations for 2026.

Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, John Reed, Executive Vice President, Innovative Medicine Research and Development, and Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, will be joining us for Q&A. To ensure we provide enough time to address your questions, we anticipate the webcast will last up to 75 minutes. With that, I will now turn the call over to Joaquin.

Good morning everyone, and thank you for joining us. I'm excited to discuss our very strong full year results. We said 2025 would be a catapult year for Johnson & Johnson, and that's exactly what it was. It was a year that launched us into a new era of accelerated growth. Fueled by the strongest portfolio and pipeline in our history, Johnson & Johnson today has a leading and expanding position in each of our six key businesses: oncology, immunology, neuroscience, cardiovascular, surgery, and vision. In each of these areas, we have multiple differentiated assets to drive growth and a strong competitive advantage, which you can see in the success of our recent launches. In recent years, we have increased our focus on areas of high growth and high unmet need, and we will continue this transformation with the planned separation of our Orthopaedics business.

In 2025, we invested over $32 billion in R&D and M&A, including the acquisitions of Intra-Cellular Therapies and Halda Therapeutics. We also initiated billions of dollars in new state-of-the-art manufacturing facilities in the U.S., which will accelerate the delivery of our next wave of innovation. These moves fuel our confidence that growth in 2026 will be faster than in 2025, and we have a line of sight to double-digit growth by the end of the decade, which is notable as Johnson & Johnson is the only healthcare company that will soon deliver more than $100 billion in annual revenue. How is that possible? It's possible because we have tremendous strength and depth, both in Innovative Medicine and in MedTech. We are different from other companies. We are not focused on one or two growth drivers.

In fact, we now have 28 platforms or products that generate at least $1 billion of revenue annually, and that makes our growth more sustainable. This, together with our strong balance sheet and free cash flow, creates the resilience and durability that will power our future. Turning to our results, over the full year, we delivered 5.3% operational sales growth. The strength of our commercial execution and relentless focus on innovation drove strong momentum throughout the year, firmly placing the Stelara LOE in the rearview mirror. In Innovative Medicine, we reported operational sales growth for the year of 5.3%. Full year sales for our pharmaceutical business exceeded $60 billion for the first time, with 13 brands growing double digits. The foundation for these results and for the acceleration we see ahead is our unrivaled portfolio and pipeline.

In 2025 alone, we secured 51 approvals and filed 32 submissions across major markets. We delivered positive readouts from 17 key studies and initiated 11 new phase III programs. These milestones are not just numbers. They are the seeds of our best-in-class medicines that are improving and extending lives. Let me now talk about our key areas of focus. In oncology, we are working to cure cancer, and our depth of expertise is unmatched. In 2025, we delivered 21% operational sales growth, and we expect to exceed $50 billion in annual sales by 2030. We are the number one company in multiple myeloma, where 80% of patients are treated with at least one of our four medicines over their treatment journey. Darzalex is the largest medicine by sales in our pharmaceutical portfolio and is considered the foundational gold standard treatment in multiple myeloma.

With annual sales over $14 billion, Darzalex grew an impressive 22% across the full year. Carvykti is the leading CAR-T cell therapy in multiple myeloma, with more than 10,000 patients now treated across 14 markets, and we are not stopping there. Last month, we published and presented results for Tecvayli plus Darzalex that showed reduced risk of progression or death by 83% in relapsed refractory multiple myeloma, as early as the second line. We also recently announced top-line findings from a second phase III study, MajesTEC-9, which showed Tecvayli monotherapy reduced the risk of disease progression or death as early as first relapse in patients with multiple myeloma who are predominantly refractory to anti-CD38 and lenalidomide therapies. We are also seeing significant momentum in our solid tumor portfolio.

In Q4, we received FDA approval for Rybrevant plus Lazcluze as the first subcutaneous therapy for EGFR-mutated non-small cell lung cancer, reducing administration time from hours to minutes and improving patient experience. We are making strong progress in bladder cancer with the introduction of Inlexo, our novel drug release system, which received its initial FDA approval in September. This is a revolutionary treatment that offers a life-changing alternative for patients who otherwise would have lost their bladders to radical surgery.

Future approvals addressing larger patient populations are anticipated, and our Q4 acquisition of Halda Therapeutics added a promising clinical stage treatment for prostate cancer with potential across multiple tumor types. In immunology, we are focused on transforming the standard of care by increasing remission rates in immune-mediated disease. In 2025, Tremfya became the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen for both ulcerative colitis and Crohn's disease.

It is now the fastest-growing IL-23 therapy in the U.S., delivering Q4 operational sales growth of 75% and 65% worldwide. And with global full year sales of Tremfya accelerating to more than $5 billion for the first time, we are increasingly confident that Tremfya will exceed $10 billion in peak year sales. But in healthcare, leadership means continually raising the bar, which is why we are focused on what's next in immunology. In the coming months, we look forward to the anticipated U.S. approval of icotrokinra to be marketed as Icotide, which will expand our immunology innovation beyond injectable medicines. We believe Icotide positions Johnson & Johnson to lead the next wave of treatment for psoriasis and inflammatory bowel disease. Turning to neuroscience, where 2025 operational sales grew 10%, Spravato continues its strong trajectory with 57% growth in the year and more than 200,000 patients now treated worldwide.

In November, we solidified our leadership with the U.S. launch of Caplyta for adjunctive major depressive disorder, further strengthening our confidence in its $5 billion peak year sales potential. Now turning to MedTech, where operational sales for the year grew 5.4%. In 2025, we delivered nearly $34 billion in sales, with strong performance in cardiovascular and accelerating momentum across surgery and vision. Our success over the last year was supported by 15 major launches and more than 40 regulatory approvals in major markets, and with more than 60 active clinical trials, we have significant momentum going into 2026. Johnson & Johnson today is a leader in three cardiovascular segments, with the portfolio delivering 15% operational sales growth in the year. Abiomed and Shockwave performed particularly well, delivering operational growth of approximately 18% and 23% in the quarter.

We remain the market leader in electrophysiology, and we plan to expand our position in pulsed field ablation. VARIPULSE has now been used to treat nearly 40,000 atrial fibrillation patients globally, and we look forward to submitting our dual-energy ThermoCool SmartTouch SF catheter for use in the U.S. market in 2026. We are also seeing positive data for our OMNIPULSE catheter, which has the potential to further redefine pulsed field ablation. In fact, we anticipate launching a new catheter every year through the end of the decade, as we build an industry-leading portfolio in PFA, complemented by at least two CARTO updates each year. In surgery, we are reinventing procedures through robotics and digital. This year, we will launch a first-of-its-kind robotics platform for urology with Monarch. The technology was first to market in bronchoscopy, helping diagnose and treat lung cancer.

This year, we'll create another first with Monarch, becoming the only robotic endoluminal and percutaneous platform for the treatment of kidney stones and other renal conditions. We also recently announced the FDA De Novo submission of our Ottava robotic surgery system. With continued innovation in surgical instrumentation, including our recent launch of the ECHELON 4000 stapler, we anticipate continued growth as we reduce complications and elevate the surgical experience across specialties. Finally, vision, which delivers robust annual operational sales growth of 5.3%, with particularly strong momentum in Surgical Vision. In 2025, we launched Acuvue Oasys MAX disposable lenses for astigmatism and presbyopia and completed the full market release of Tecnis Odyssey IOL, which is the fastest-growing intraocular lens in the U.S. Looking ahead, we're planning to launch Tecnis PureSee in the U.S. later this year.

As you can tell, we are starting the year from a position of strength. You have heard me talk about the unmatched depth and strength of our business. In 2026, that will translate into accelerated growth and impact with game-changing innovation, reaching more patients more quickly than ever before. I will now turn the call back over to Darren.

Thank you, Joaquin. Moving to our financial results. Unless otherwise stated, the percentages quoted represent operational results and therefore exclude the impact of currency translation. Starting with Q4 2025 sales results. Worldwide sales were $24.6 billion for the quarter. Sales increased 7.1% despite an approximate 650 basis point headwind from Stelara. Growth in the U.S. was 7.5% and 6.6% outside of the U.S. Acquisitions and divestitures had a net positive impact on worldwide growth of 100 basis points, primarily driven by the Intra-Cellular acquisition. Turning now to earnings.

For the quarter, net earnings were $5.1 billion, and diluted earnings per share was $2.10 versus $1.41 a year ago. Adjusted net earnings for the quarter were $6 billion, and adjusted diluted earnings per share of $2.46, representing an increase of 21.5% and 20.6% respectively, compared to the fourth quarter of 2024. Items of note include a $0.22 IPR&D charge associated with the V-Wave acquisition in 2024 and $0.10 of dilution due to the acquisition of Halda Therapeutics in 2025. For the full year 2025, worldwide sales were $94.2 billion. Sales increased 5.3% despite an approximate 620 basis point headwind from Stelara, and if you do the math, Johnson & Johnson grew double digits for the full year excluding Stelara. Growth in the U.S. was 6.9% and 3.4% outside the U.S.

Acquisitions and divestitures had a net positive impact on worldwide growth of 110 basis points, primarily driven by the Intra-Cellular and Shockwave acquisitions. Turning now to earnings. Net earnings for full year 2025 were $26.8 billion, and Diluted Earnings Per Share was $11.03, including the $7 billion talc reserve reversal from Q1. This compares to Diluted Earnings Per Share of $5.79 a year ago, which included $0.67 of dilution due to acquired IPR&D charges on various transactions. Full year 2025 adjusted net earnings were $26.2 billion, and adjusted Diluted Earnings Per Share was $10.79, both representing an increase of 8.1% compared to full year 2024. I will now comment on business sales performance in the quarter, focusing on the six key areas where meaningful innovation is driving our performance and fueling our long-term growth. Beginning with Innovative Medicine.

Worldwide sales of $15.8 billion increased 7.9% despite an approximate 1,110 basis point headwind from Stelara, illustrating the continued strength of our key brands and new launches. Growth both in the U.S. and outside of the U.S. was 7.9%. Acquisition and divestitures had a net positive impact of 170 basis points on worldwide growth, primarily due to the Intra-Cellular acquisition. In oncology, starting with multiple myeloma, Darzalex growth was 24.1%, primarily driven by strong share gains of 6.5 points across all lines of therapy and nearly 12 points in the front-line setting, as well as inventory dynamics and market growth. Carvykti achieved sales of $555 million with growth of 63.2%, driven by share gains and site expansion. Tecvayli and Talvey growth was 18.9% and 73.1% respectively, driven by continued expansion in the community setting.

In prostate cancer, ERLEADA delivered strong growth of 18% due to market growth and continued share gains, partially offset by the impact of Part D redesign. In lung cancer, Rybrevant plus Lazcluze delivered sales of $216 million and growth of 76.5%, driven by continued launch uptake in all regions. We continue to see share gains in both first and second lines of therapy. Within immunology, Tremfya delivered remarkable growth of 65.4%. We continue to see share gains across all indications, with particularly strong momentum from our IBD launch as well as market growth. Stelara declined 48.6%, driven by share loss due to biosimilar competition and Part D redesign. In neuroscience, Spravato grew an impressive 67.8%, driven by continued strong demand from physicians and patients. Caplyta, which was acquired in Q2 as part of the Intra-Cellular acquisition, delivered sales of $249 million for the quarter.

Since MDD approval in the U.S., Caplyta has had its highest-ever new patient start volumes across all indications. Now moving to MedTech. Worldwide sales of $8.8 billion increased 5.8%, with growth of 6.6% in the U.S. and 4.9% outside of the U.S., driven by strong performance in our three focus areas: cardiovascular, surgery, and vision. Acquisitions and divestitures had a net negative impact of 10 basis points on worldwide growth. In cardiovascular, electrophysiology delivered growth of 6.5%, driven by procedure growth within our comprehensive portfolio, commercial execution, as well as VARIPULSE and other new products, partially offset by competitive pressures in PFA. Abiomed delivered growth of 18.3%, with continued strong adoption of Impella technology. Shockwave delivered strong double-digit growth of 22.9%, driven by continued adoption of coronary and peripheral products, becoming our 13th billion dollar MedTech platform. Surgery grew 3.7% despite divestitures negatively impacting results by approximately 60 basis points.

Growth was driven by accelerated launches of new products in Biosurgery, technology penetration in wound closure, and strong commercial execution, partially offset by competitive pressures in energy and Endocutters, as well as VBP in China across the portfolio. Vision Contact Lenses and other products grew 5.3%, driven by category growth, strong performance in the Acuvue Oasys 1-Day family of products, and continued strategic price actions, further solidifying our leadership position. Surgical Vision grew 10.8%, driven by new product innovations, robust demand for premium IOLs, and strong commercial execution. Orthopaedics growth this quarter continued to gain momentum and increased to 3.5%, primarily driven by new product launches and strong commercial execution, partially offset by the Orthopaedics transformation and VBP in China.

Now turning to our consolidated statement of earnings for the fourth quarter of 2025, I'd like to highlight a few noteworthy items that have changed compared to the same quarter of last year. Cost of goods sold deleveraged by 80 basis points, driven by unfavorable product mix in Innovative Medicine and the impact of tariffs in MedTech. This was partially offset by the one-time prior year fair value inventory step-up associated with the Shockwave acquisition. Selling, marketing, and administrative expense leveraged by 110 basis points, driven by lower administrative expense across the enterprise. Research and development leveraged by 620 basis points, primarily driven by prior year acquired IPR&D expense from the V-Wave acquisition in MedTech, as well as pipeline investment timing in Innovative Medicine. Interest income and expense was a net income of $23 million as compared to $144 million of income in the fourth quarter of 2024.

The decrease in income was primarily driven by a higher average debt balance. Other income and expense was a net expense of $483 million as compared to $161 million of income in the fourth quarter of 2024. This increase in net expense was driven by higher litigation costs of $0.9 billion, primarily related to the Auris shareholder resolution, and a $0.2 billion non-recurring charge related to HALDA employee equity awards. This was partially offset by a $0.3 billion contingent value right reduction associated with the Abiomed acquisition. Tax rate on a GAAP basis in the fourth quarter of 2025 was a benefit of 3% compared to an 11.7% cost in the fourth quarter of 2024. The decrease in the effective tax rate is primarily driven by a non-recurring tax benefit related to a loss on certain international subsidiaries. More information can be found in the company's forthcoming Form 10-K.

Lastly, I'll direct your attention to the box section of the slide, where we have also provided our income before tax, net earnings, and earnings per share adjusted to exclude the impact of intangible amortization expense and special items. Now let's look at adjusted income before tax by segment for the quarter. Innovative Medicine margin improved from 32.5% to 36.3%, primarily driven by administrative expense leveraging and phasing of R&D expense, partially offset by unfavorable mix in the cost of product sold. MedTech margin improved from 10.8% to 17.4%, primarily driven by prior year acquired IPR&D expense from the V-Wave acquisition, partially offset by the impact of tariffs and cost of product sold. As a result, adjusted income before tax for the enterprise as a percentage of sales increased from 24.1% to 28.7%.

This concludes the sales and earnings portion of the call, and I will now turn the call over to Joe.

Thanks, Darren. Hello everyone. We appreciate you joining us today. As you've heard from Joaquin and Darren, the employees of Johnson & Johnson delivered impressive results in 2025, driven by strong execution, important new launches, and significant pipeline progress that launched a new era of accelerated growth. Our performance demonstrates the depth and strength of Johnson & Johnson's business centered on six core areas: oncology, immunology, and neuroscience in Innovative Medicine, and cardiovascular, surgery, and vision in MedTech. This has enabled us to exceed financial expectations that existed at the beginning of 2025 on both the top and bottom line. We enter 2026 with powerful momentum and anticipate another solid year ahead. Let me briefly address yesterday's Daubert rulings in the Talc MDL.

The special master correctly decided to exclude the opinions of certain plaintiff's experts who preponderate junk science. In other parts of the ruling, the court did not uphold its proper gatekeeping duty with respect to the reliability of plaintiff's expert's opinions, and we will appeal. The decision only serves to bolster our overall litigation strategy. We will continue to defend against these meritless claims at trial and through the appeals courts, where we have largely prevailed. Before we move into 2026 guidance, let's address cash and capital allocation. We ended 2025 with approximately $20 billion of cash and marketable securities and $48 billion of debt for a net debt position of approximately $28 billion. The company generated $19.7 billion of free cash flow during 2025, on par with 2024, despite increased capital investment in the U.S. and the impact of tariffs.

Our financial strength is a competitive advantage that allows us to both invest in our future and return value to our shareholders. As we move forward in 2026, we expect to elevate free cash flow generation to approximately $21 billion. As it relates to the separation of our Orthopaedics business, we are making good progress towards a mid-2027 separation and look forward to providing updates later this year. Turning now to guidance for the full year 2026, we anticipate operational sales growth in the range of 5.7%-6.7%, with a midpoint of $100 billion or 6.2%. Acquisitions and divestitures are expected to favorably impact operational growth by approximately 30 basis points, resulting in an adjusted operational sales growth midpoint of 5.9%. We do benefit in 2026 as our financial calendar includes a 53rd week, which is worth approximately 100 basis points.

As you know, we do not speculate on future currency movements, and last quarter we utilized the euro spot rate relative to the U.S. dollar of 1.17. As of last week, the U.S. dollar has stayed relatively flat to the euro spot rate, and as a result, we expect reported sales growth between 6.2%-7.2%, with a midpoint of $100.5 billion or 6.7%. 2026 sales growth across our Innovative Medicine business will be driven by Tremfya, Darzalex, Carvykti, ERLEADA, and Spravato, as well as new launches of Rybrevant plus Lazcluze in lung cancer and Caplyta as adjunctive therapy for major depressive disorder. In MedTech, we expect growth to be driven by continued uptake and market expansion of new product launches across our cardiovascular, surgery, and vision portfolios, including VARIPULSE in electrophysiology, ECHELON 4000 in surgery, and the Acuvue Oasys MAX family in vision.

Turning next to other items on the P&L. In 2026, we expect to drive continued operating efficiencies, the majority of which we plan to invest in our business to power our new product launches and pipeline with heavier investment at the outset of the year. Despite that increased investment, we are planning for our 2026 adjusted pre-tax operating margin to improve by at least 50 basis points. Our pre-tax operating margin guidance takes into account the costs from the 53rd week of operations and full year MedTech tariffs of approximately $500 million, which is significantly above the 2025 amount. It also includes the impact of the recently announced voluntary agreement with the U.S. government to improve access to medicines and lower costs to U.S. patients. We expect net interest expense between $300 million and $400 million.

We anticipate net other income to be $1 billion-$1.2 billion for 2026, relatively flat to last year. Finally, we are projecting an effective tax rate in the range of 17.5%-18.5%, with the increase largely due to a mixed change with income in higher tax jurisdictions. Turning to adjusted operational earnings per share, we expect growth of 5.5% at the midpoint for a range of $11.28-$11.48. By utilizing the exchange rate we mentioned earlier for our reported adjusted earnings per share for the year, we estimate a positive impact of $0.15. As such, we expect reported adjusted earnings per share of $11.53 at the midpoint.

Regarding our share count, due to the rapid share price appreciation in the second half of 2025 into early 2026, our diluted share count is increasing to approximately 2.44 billion shares based on U.S. GAAP accounting rules for the diluted share count calculation, in line with how the fourth quarter of 2025 landed. The incremental diluted shares for next year are worth slightly more than $0.05 headwind versus 2025. Relative to current analyst expectations, our EPS and margin outlooks absorb the previously referenced incremental tariffs, the impact of the voluntary U.S. government agreement, and a higher share count. We will now shift to some 2026 phasing considerations to help inform your modeling. We are well positioned to build upon our accomplishments in 2025, continuing to make advancements across our Innovative Medicine and MedTech portfolio and pipeline.

We anticipate fairly consistent operational sales growth throughout the year, with a higher fourth quarter due to the benefit from the 53rd week referenced earlier. Regarding Innovative Medicine, we expect a more pronounced impact from newly launched products throughout the year. We anticipate Stelara to continue to follow the Humira erosion curve, which accelerated as we move through the second half of 2025 compared to the start. While not nearly as impactful as Stelara, we do anticipate generic impact for both Simponi and Opsumit to begin in 2026, both of which are contemplated in our full-year guidance. In MedTech, we will continue to accelerate our newly launched products and expect normalized seasonality. The surgery transformation progress will accelerate throughout the year, and we anticipate some additional rounds of volume-based procurement in China, all of which has been incorporated into our 2026 guidance.

Regarding the P&L, it is important to consider one-time items that impacted our EPS results in 2025. Specifically, in Q1 2025, the impact from Stelara biosimilars was less pronounced, given that the erosion accelerated starting in Q2. The Intra-Cellular acquisition anniversaries in Q2 and tariffs will be relatively linear in 2026, unlike last year, where the P&L cost was largely recorded in Q4 2025. Given these factors, we expect higher earnings per share growth in the second half of the year versus the first half. We are excited about how our pipeline is anticipated to advance in 2026. For example, in Innovative Medicine, we expect regulatory approvals for Icotide in psoriasis, Tecvayli in combination with Darzalex in relapsed refractory multiple myeloma as early as second line, and Tremfya for the inhibition of structural joint damage for patients with psoriatic arthritis.

As this chart indicates, we also have many important regulatory submissions and data presentations across oncology, immunology, and neuroscience. In MedTech, we anticipate the following approvals and regulatory submissions: Ottava Robotic Surgical System, ETHIZIA in Biosurgery, and the dual-energy ThermoCool SmartTouch SF catheter in the U.S. Here too, we are also excited for new launches and continued expansion of new products as seen in the chart. To close the prepared remarks, I hope it's evident that Johnson & Johnson is entering 2026 with significant momentum. We are positioned to lead where healthcare is going, to tackle areas of critical unmet need. Our strong financial position enables us to invest in our business and the next generation of scientific breakthroughs that will help improve patient outcomes while simultaneously delivering value for our shareholders.

None of this would be possible without the hard work and dedication of our incredible colleagues worldwide, who always keep patients at the center of everything we do. With that, we are happy to take your questions, so I will now turn it to Kevin to provide instructions for those seeking to participate in the Q&A.

Thank you, ladies and gentlemen. If you'd like to ask a question at this time, please press Star, then One on your telephone keypad. If you'd like to withdraw your question, please press Star, then Two. Please limit yourselves to one question only. Our first question is coming from Asad Haider from Goldman Sachs. Your line is now live.

Great. Congrats on the quarter, and thanks for taking the question. Joaquin, maybe just a big picture question for you.

You're entering this year in a clear position of strength following what's been one of the best performance years for the stock in about 20 years. You've had momentum in both business segments. You're generating tremendous free cash flow that you're saying is going to continue to elevate. And you've now started to talk more about double-digit revenue growth by the latter part of the decade, although street consensus is currently modeling something in the 6% range. So if you could just maybe double-click a little bit more on what the key levers are to bridge to that double-digit growth profile from where we sit today, particularly in the context of the current revenue base that's now approaching $100 billion and remains sizable through the end of the decade, even with the ortho spin?

And I guess what we're really trying to understand is how much of that acceleration comes from the organic pipeline versus acquisitions versus portfolio pruning. And I guess related, what innings are we in of this strategic repositioning away from lower growth segments like you're doing with ortho towards higher growth segments? Thank you.

Thank you. Great question and sure. I mean, we come out of a really successful 2025, leaving the Stelara biosimilars in the rearview mirror and initiating a cycle of accelerated growth for Johnson & Johnson. And you have seen that we have provided guidance for 2026, which is strong and ahead of expectations. And as I said before, we have line of sight to double-digit growth in the later part of the decade, which is especially remarkable for a company that, according to our guidance, would be $100 billion in sales in 2026.

What are the reasons to believe? The reasons to believe are focused on the strength of our portfolio and pipeline. Let me now take you through the six areas of focus that we are investing into the future. Let me start with oncology. Our ambition with oncology is to become the number one oncology company, reaching $50 billion by the end of the decade, sustained by our success in multiple myeloma and also in solid tumors with lung cancer, prostate cancer, and bladder cancer. We are very confident on our progress there in our pipeline, and I'm sure we'll have some time to discuss that later in the call. In our second area in Innovative Medicine, which is immunology, we are focusing on three major blockbusters. One is Tremfya, which has been very successful in IBD. You have seen the growth in the fourth quarter, really spectacular, 65%.

Tremfya and IBD launch is doing really well. And as a reminder, in the case of Stelara, IBD was 75% of the sales. So there's significant growth for Tremfya ahead of us. We see Tremfya more than a $10 billion asset. The second one is Icotide. Icotide is the trademark of Icotrokinra, our oral IL-23 blocker. We see the oral IL-23 blocker expanding the market, becoming a new blockbuster for us. We expect to have the launch of Icotide in 2026, initially in psoriasis. This is going to be a transformational change for the treatment of these diseases, and we plan to continue to develop Icotide too in IBD, in inflammatory bowel disease. And finally, the third blockbuster in which we will see data this year is our co-antibody therapeutic for patients that are refractory to biologics. I think that's a great solution for these patients, many of them relapse.

So three major blockbusters in Immunology, which are largely de-risked, some of them are approved, filed, or you're going to see data very, very soon. Turning to Innovative Medicine, we are very encouraged by the progress of Spravato, more than 60% growth, and also the very successful launch of Caplyta in adjunctive treatment of major depressive disorder. We're seeing the first data coming in, very, very encouraging. We see Caplyta, as we discussed, as additive to our growth and more than a $5 billion business. So all positives in our Innovative Medicine group, clearly driving this line of sight to double-digit growth by the end of the decade. If I move to our MedTech business, our cardiovascular sector, very strong growth in 2025. Double-digit growth is reaching $9 billion. It's one of the largest cardiovascular franchises in the industry.

We are in three major markets, which are specialty markets with high growth, cardiac ablation, where we are the leaders, and we plan to expand our leadership in PFA with the launch of a new catheter every year, a new CARTO version. A team will explain later. Our strong position both with Abiomed and Shockwave in heart recovery and in calcified arterial disease. So that's going to be a growth driver for us into the rest of the decade. In surgery, we have had strong results both in wound closure and in biosurgery, which are high single-digit in both areas. We just filed for Ottava, which is going to make us a relevant player in the surgery robotics market, which is an area in which we have all the right to compete.

Let me remind all of you that we are in all hospitals in the world, and we already participate in all surgeries, and we plan to be a relevant player in robotic surgery with Ottava and also with the launch of Monarch in urology, in which we are going to have a unique position. Then finally, in vision, you see our results in vision. It's a market with growth. We're gaining share, and it's an area of innovation in which we plan to invest. So we have about a dozen new product launches for the company. Some of them are already approved, most of them submitted. So I would say that in that sense, it's essentially what I would call de-risk.

Some of you have called our story of growth in the second half of the decade as one of the cleanest stories of growth for the healthcare sector, for the healthcare entire sector overall. So we feel very confident about our outlook. It's reflected in our guidance for 2026, and I can assure you that everybody here at Johnson & Johnson is focused on doing exactly what we do best, which is looking for innovation in medicines and medical technologies to improve the standard of care of the millions of patients that we serve. And we are convinced that will translate in strong business results.

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

Good morning. Thanks for taking the question, and I'll echo my congratulations on a nice end to the year here.

Tim, there are some dynamics in the MedTech market that you called out in the slides, as well as the loss of coverage in the U.S. from the enhanced subsidies expiring. How are you thinking about the MedTech market in 2026 relative to 2025? And how are you thinking about J&J's adjusted operational growth in 2026 versus 2025? Do you expect an acceleration? And it would be helpful if you could touch upon the outlook for your EP business, which is growing below market. Thank you.

Larry, thank you for the question. Let me touch quickly on the first question around ACA subsidies and put that one to bed. Firstly, based on what we know today, we do not expect the loss of ACA subsidies or any potential policy changes under the one big beautiful bill to have a material impact on our MedTech performance.

While we'll continue to monitor how coverage dynamics evolve, at this stage, we see no indication of an impact on our growth trajectory. The primary constraint, as you know, Larry, in our business is really more about clinical capacity, not coverage levels, and procedure demands remain very robust across our portfolio, which I think really speak to the resilience of the businesses that we've decided to participate in. Turning to your question about the year, we do expect to see accelerate. We expect the year to be better in 2026 than it was in 2025. I think it's important to maybe hedge this question on really our strategy. I think you know for the last couple of years, we've been very clear in articulating our strategy focused on shifting our portfolio into higher innovation, higher growth, and higher margin markets.

As you just heard from Joaquin, we have deliberately chosen to focus on our three focus areas of CV, surgery, and vision. I think our results, Larry, speak for themselves. Our strategy is working. We said we would accelerate our performance in the back half of 2025, and we did exactly that, beating consensus for the third consecutive quarter. What we're most proud of, Larry, is that we saw acceleration across the board. As you heard from Joaquin, cardiovascular, now one of our largest businesses at $9 billion, grew 15.2% operationally in 2025, driven by success of Abiomed and Shockwave, both double-digit growers and increasing performance in EP, which I'll touch on a little later. Vision, strong, mid- to high-single-digit performer, double-digit growth in Surgical Vision.

And of course, we couldn't be more excited by the growth opportunity that will come with Ottava as we look to commercialize that first in the U.S., hopefully this year. We've also seen continued improvement of ortho. You would have expected maybe some distraction as a result of the announcement we made. We've seen exactly the opposite with sequential growth through the quarter and 3.5% in Q4. And so I'll finally reinforce, Larry, that our portfolio transformation is working. If you look at the $34 billion business today, we have roughly half of our assets participating in higher growth markets, growing north of 5%. That's compared to about 20% in 2018. And this will catapult to north of 70% following the ortho separation.

And so as a result, we believe, frankly, that our best days are ahead, and we remain very confident in our ability to drive accelerated operational growth as we further push into higher areas of innovation, growth, and margins. Let me touch quickly on EP because I think that was another part of your question. The results speak for themselves, and they're speaking loud and clear. We're seeing continued acceleration in the markets that matter most, especially here in the U.S. and in Europe. You will have seen that in the fourth quarter, our growth accelerated to 9.5%. We're on the cusp of once again double-digit growth here in the United States, which is by far and away the most important market. We're seeing this driven by the success of VARIPULSE, more than 40,000 cases today, Larry, with a benchmark safety profile.

As you heard from Joaquin, we've made a commitment to an additional catheter each year for the foreseeable future, starting with dual-energy STSF, followed by OMNIPULSE, which is a large-focal catheter. We're also doubling down on our leadership position in mapping. We now see really customers shifting back to CARTO based on the integration we have across our portfolio. Just to put a point on this, Larry, for example, our CARTO 3 system is widely recognized as the industry benchmark in mapping. In fact, in a recent study, it found that patients treated with PFA devices, whether that be ours or the competition's using CARTO, were 61%, once again, 61% less likely to experience AFib-related readmissions, which I think further reinforces the competitive advantage we have in this portfolio.

And so I've said this before, Larry, and I'll end by saying that we are not rolling over. J&J's strength lies in our comprehensive portfolio of integrated EP solutions, mapping, ablation, and cardiac imaging technologies combined with our best-in-class mappers. And we remain resolute and confident that our deep EP expertise earned over 30 years and our robust pipeline position us well to continue to drive global leadership in this important space. Thanks, Larry.

Thank you. Next question today is coming from Chris Schott from JPMorgan Chase & Company. Your line is now live.

Great. Thanks so much, and congrats on the results. Joe, can you just elaborate a little bit more on how to think about margin progression over time at J&J? You've obviously highlighted the potential for accelerating top-line growth over the next several years.

Should we think about that higher level of top-line growth being associated with greater margin expansion, or is this kind of 50 basis point per year type improvement that you're seeing this year a reasonable proxy to think about margin expansion for J&J over time? Thank you.

Yeah. Good morning, Chris. Thanks for the question. Yeah, it's a great question. As we look at the margin expansion, the idea would be to continue to improve our infrastructure. What gives me confidence with respect to 2026 outlook of at least 50 basis points is, as you know, with the orthopedic separation, much like we did with the consumer health separation, we're going to take this opportunity to look and see where there's areas of opportunity efficiency to eliminate stranded cost. While that will probably need to be in place for 2027, we're going to get a jumpstart on that in 2026.

There's also, as you know from recent calls, efforts underway to improve our operating margins, our gross margins specifically in our manufacturing footprint, largely in the MedTech space. And then lastly, while we will have continued Stelara erosion, it'll be off a smaller base, so that will have less of an impact going forward. And so I wouldn't want to give you a longer-term outlook. What I can say is I'll harken back to our last investor day where we said that earnings would be commensurate with sales growth, so you can expect that the margin profile will improve in conjunction with the sales growth profile as we move out to the next couple of years and to the back half of this decade.

Thank you. Next question today is coming from Joanne Wuensch from Citibank. Your line is now live.

Thank you for taking the question, and I'll add my congrats on the good quarter. I just want to spend a minute or two talking about Vision Care. You highlighted that as one of the three growth areas in medical technology. It looks like in your surgical business, it was a little bit slower during the quarter versus what we saw in the United States versus what we saw outside the United States. If you could tease that apart a little bit and your views on the health of the contact lens market would be really welcome. Thanks again.

Joanne, thank you for your note. And once again, we have doubled down and really focusing on vision as one of our three priority areas within MedTech. And as you highlighted, a strong fourth quarter at growth of just under 7%. Strong underlying performance within our contact lens category.

While we did see a little softness, Joanne, in Asia-Pacific, underlying demand is robust, and we saw tremendous growth at roughly 5.3% with share gains driven by the continued rollout of our Acuvue Oasys 1-Day family, which I think you probably know that we've added to with the addition of a product focused on multifocal astigmatism and only daily disposable available for patients suffering with both presbyopia and astigmatism. And so we believe that's going to be a nice growth driver for the future. Turning to Surgical Vision, growth of close to 11% in the quarter, and that's all driven by our doubling down of our focus on premium intraocular lenses, both with Tecnis Odyssey launch here in the U.S. last year and PureSee more broadly globally.

As you look to 2026, we're going to be further enhancing that performance by building out the portfolio specifically with the launch of PureSee here in the United States. You touched on our fourth quarter performance. Underlying performance of our premium IOLs here in the U.S. was outstanding. We did see that offset somewhat by some ongoing market declines in some of the legacy categories which we're working to address, but we're confident that our Surgical Vision business can continue to be a strong double-digit growth for the foreseeable future. A couple of other areas I'll focus on here is that we are expanding global market share, both in contact lenses and Surgical Vision, not just winning here in the United States, but more importantly, globally.

We're focusing very much on portfolio optimization, and I do think the ortho separation enables greater capital allocation to vision, supporting both R&D, commercial execution, and digital transformation. And so we're thrilled with the continued improvement in Surgical Vision and have great confidence in that continuing. Thank you.

Thank you. Next question is coming from Terence Flynn from Morgan Stanley. Your line is now live.

Great. Thanks for taking the question. Appreciate it. Congrats on the quarter. Obviously, multiple myeloma is another one of your key growth drivers here. I was wondering, post a lot of the earlier stage data, earlier line data we've seen for Tecvayli, if you could speak to how you're thinking about positioning here of that franchise relative to Carvykti. And then the related question is, I know FDA published some final guidance regarding MRD negativity and CR's endpoint.

Just thinking about how you might implement that across your development portfolio and what that could mean for timelines. Thank you.

Thanks for the question, Terence, and good morning, everyone. Yeah, for multiple myeloma, we were absolutely thrilled with the data that we saw for Tecvayli plus Darzalex in the second-line plus setting, as well as most recently, the Tecvayli data in patients who are refractory to anti-CD38 and lenalidomide therapy. And maybe if I take a step back, over the past 20 years, J&J therapies have dramatically improved survival for people with multiple myeloma from three- to five-year survival rates to 10-15 years now or more. Yet, despite these advances, multiple myeloma is still a complex disease, a heterogeneous disease, and about 40% of patients are currently in the second-line and third-line settings.

So how do all of these agents fit, and why do we see that this is such an extraordinary opportunity? Well, first, if we start off with the Tecvayli DARA information, plus Tecvayli 9 and Carvykti, together, they really provide highly effective agents that allow treatment that's tailored to the treatment goals, the patient setting, access, the patient status, and the prior therapy. So there's a number of things that get taken into account. So we start off with Tecvayli plus DARA. This is really community-ready therapy that's proven an unprecedented efficacy rate in the second-line plus setting. The hazard ratio was 0.17. And so this is for patients who are CD38 naive or are CD38 experienced. And this is about 70% of the population in that second-line and third-line setting.

Johnson & Johnson (JNJ) Q4 2025 Earnings Call Transcript

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