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JNJ
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2025-01-22 08:00:00
Johnson & Johnson
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Jennifer Taubert: Maybe hot off the press last night. The team was very excited to come tell me. We've actually completed and reached our 5000th patient infused with CARVYKTI, both across the clinical and commercial settings. And it is the most successful cell therapy launched in the industry. Operator: Thank you. Our next question today is coming from Josh Jennings from TD Cowen. Your line is now live Joshua Jennings: Hi. Good morning. Thanks for taking the questions. I was hoping to just ask about the medical device or the sector, the business, excuse me, and just the acquisition strategy. You've had a couple of pre-revenue swings with Laminar and V-Wave and some other more established more established businesses under the roof. Can you just talk about the strategy on a go-forward basis? I mean is it going to continue to be a mix between pre-revenue companies and formally more fully established business or are you going to be -- is there going to be a shift in that strategy? Thanks for taking the question.
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Joaquin Duato: Thank you, Josh. It's Joaquin, and good morning, everyone. External innovation has always been a very important part of our capital allocation strategy for Johnson & Johnson for the enterprise. And in fact, we are one of the top investors not only in M&A, but also in R&D. We are always looking for opportunities to be able to enhance our portfolio and our pipeline. And in 2024 alone, we completed more than 40 business development transactions. Some of them were big, some of them were small, but all of them complement both our Innovative and MedTech portfolio. Many of these smaller acquisitions were also in our MedTech portfolio. You have to think that larger acquisitions like the case of Shockwave or in the Innovative Medicine side, Intra-Cellular are more outliers. Our go-forward, it's always been focused on these smaller opportunities like the ones you mentioned like Laminar or V-Wave or some of the ones we have completed the Innovative Medicines like TARIS or our IL-23 blocker, which are more than $5 billion opportunities. That's where we are able to create value, larger opportunities have to be seen more like outliers. And finally, I want to underline that both Abiomed and Shockwave are progressing really well ahead of the deal model, delivering on our financial commitments there and that we are looking forward upon closure to start working on the Intra-Cellular acquisition, which is an opportunity to reinforce our position of leadership in the Neuroscience space, which has been always a strength of Johnson & Johnson and also an opportunity overall to fortify revenue projections that you have looking today and also into the future. Thank you.
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Joseph Wolk: And Josh maybe just building on Joaquin's comments relative to MedTech. While the big acquisitions get a lot of attention, to Joaquin's point, we have a tremendous amount of business development activity across all of our businesses. I think most notably evidenced by almost 40 transactions just in '24 alone. I did want to point to the excitement we have around the significant investments we've made both in Abiomed and Shockwave. Abiomed grew 15% for full year 2024 and we are seeing constant acceleration driven by firstly, the tremendous portfolio we have. I think we could not be more excited about the danger shock results, which really bring more validity to the evidence base around this portfolio. This is the first study in 20 years to actually demonstrate a survival benefit, in fact, a 12.7% mortality improvement versus the standard of care. We also, while not a big commercial opportunity, received FDA approval in the fourth quarter of last year for the use of Impella in pediatric community, which I think is just further evidence of the building confidence around the safety profile of this product. We also mentioned earlier that we are excited to be planning our submission for ECP to the FDA in the first half of this year. This will, Josh, be the first and actually the smallest pump in the world. This is a 9-French at insertion, which expands to about 21-French inside the heart, a lower profile, which we believe that along with its ease of use, reduce further barriers to adoption. And then finally, a smaller transaction, but certainly important to our goal to play a bigger role in heart failure is the acquisition of V-Wave, which reinforces our commitment to building leadership in heart failure and really allows for the active shunting of blood across the intraatrial septum. A quick couple of comments on Shockwave. It's our latest acquisition. We closed that in May of last year. This delivered $564 million of growth last year. It is the leading and first-to-market pioneer in IVL technology. And
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year. This delivered $564 million of growth last year. It is the leading and first-to-market pioneer in IVL technology. And we're confident that while certainly, there's a lot of excitement around this category, we have at least a five to eight year first-mover advantage. And this comes down to the fact that we have an easy-to-use system with now six available catheters. We've also recently announced the addition of two additional catheters, our E8 catheter, which is our workhorse within peripheral as well as Javelin, which is a novel non-balloon based IVL catheter designed to modify calcium and cross extremely narrowed vessels. And so we feel enormously confident that while big investments, they will make tremendous impact on patients and continue to drive our business. Thank you, Josh.
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Operator: Thank you. Next question today is coming from Alexandria Hammond from Wolfe Research. Your line is now live. Alexandria Hammond: Thanks so much for taking the question and congrats on the Intra-Cellular deal last week. For CAPLYTA, how should we be thinking about the cadence of sales growth to the forecasted sales of $5 billion? And I guess on the acquisition, should we expect a deprioritization of seltorexant and aticaprant? Thank you so much. Jennifer Taubert: Good morning. Thanks so much for the question. And we are so excited to be able to welcome the Intra-Cellular colleagues to Johnson & Johnson. They have done such an extraordinary job, both in developing CAPLYTA and their pipeline, but also commercializing and bringing CAPLYTA to patients currently for schizophrenia as well as for bipolar I and bipolar II depression. I think you can take a look at their current sales trajectory, which is a really nice growth curve and then also take into account the filing that has done for AMDD, major depressive disorder. The filing has been done with the regulatory authorities that we anticipate approval for later in the year. AMDD, we believe to ultimately be the largest of those three indications for CAPLYTA. And so we think that, that will be an additional catalyst for growth. So you can factor that into your thinking. We're really excited about CAPLYTA. I know the company had guided to it being a $5 billion plus asset. We definitely think that it will be as well and think that together we're going to be able to do even more for patients with mental health issues. We're also really excited about their pipeline and 1284 and potential in Alzheimer's psychosis, general anxiety disorder and others. So we see Intra-Cellular as both in near-term as well as long-term growth catalyst for us.
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John Reed: Yes. About your question, though, around whether we'll deprioritize other things in the portfolio, absolutely not. Let me just remind everyone that depression is a very heterogeneous disorder and it's not a disease that accommodates to a one size fits all. We see each of these molecules that we're developing, having unique mechanisms that can play in different subpopulations. And we're developing those aticaprant, seltorexant, for example, using a precision neuroscience strategy. So we see this broad portfolio, which includes, of course, SPRAVATO as a repertoire of different mechanisms we can bring to bear. The 260 million people worldwide that suffer from chronic depression. It's the leading cause of disability and more than 30% of those do not get relief from the ongoing medicines. The other thing that I really like about our portfolio is the side effect profiles are so benign compared to the standard of care. With all four of the mechanisms, whether it's CAPLYTA, which we hope to welcome into the portfolio, whether its aticaprant, seltorexant or SPRAVATO, you don't have weight gain, you don't have sexual dysfunction, you don't have the tardive dyskinesia or extrapyramidal effects that are so common with many of the medicines today. So this is really exciting for us. Maybe also while I am talking about our depression portfolio, I would just acknowledge and congratulate the team on the recent approval of SPRAVATO in the monotherapy context. This indeed allows us to offer SPRAVATO as a solution for patients with treatment resistant depression without necessity to use it on top of standard of care and therefore avoiding those side effects that I just mentioned that the standard of care medicines often bring. Very excited about that approval. We had received priority review from the FDA for that submission. That's the second time SPRAVATO had received a prior review, the only antidepressant ever to do so. And SPRAVATO is also the only antidepressant to ever receive breakthrough designation from the FDA.
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ever to do so. And SPRAVATO is also the only antidepressant to ever receive breakthrough designation from the FDA. So great momentum and a long-term commitment to patients suffering with depression.
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Operator: Thank you. Next question today is coming from Tim Anderson from Bank of America. Your line is now live. Tim Anderson: Thank you very much. I have a question on immunology franchise and TREMFYA. So with STELARA facing biosimilars, I'm wondering if it might play out like how it has with AbbVie. So in the case of AbbVie they said that biosimilar HUMIRA is actually driven the volume shifts in favor of other brands like Skyrizi. I'm wondering if you expect that could occur with TREMFYA on the volume side. And then on the price side, can you talk about incremental price erosion in 2025 to maintain access relative to whatever the price erosion was in 2024.
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Jennifer Taubert: Thank you very much for the question. And we're really excited about the great progress that we're making with TREMFYA. In psoriasis and psoriatic arthritis, but really particularly with inflammatory bowel diseases coming up with the launch in ulcerative colitis now and Crohn's upcoming. We've guided maybe just back on STELARA, we've talked about the HUMIRA erosion curve being probably the best thing to model. Specific to your question about should there or will there be patient switches. I think there are a lot of patients in the immunology market right now that are in need of both advanced therapies or are in need of better therapies than they are on now. And so we do see across the board, shifting of patients and movement into the newer and the better products. I would put TREMFYA squarely in that camp. We've got lots of reasons. We focus in on IBD and the potential growth for TREMFYA. We've got a lot of reasons for great optimism there and differentiation. It's the only dual-acting IL-23 agent in IBD, acts on both IL-23 as well as CD64. We think it's got the potential to really set the next bar in efficacy and we know there are a lot of patients who need more and are ready for switch. And we think with our subcu induction dose, we're going to have unrivaled flexibility. So the ability for fully subcu induction and maintenance as well as the opportunity for IV. So the launch right now is going very well in UC and we're very excited and optimistic really looking forward to the upcoming launch in Crohn's and subcu. And we've invested appropriately, last part of the question, I think, was on pricing. We've invested appropriately to make sure that we've got the right access for patients with TREMFYA so that as we launch, we've got the abilities when prescribers want to write for patients. We've got the access to be able to do so. And we're seeing that right now with strong frontline commercial coverage for TREMFYA in UC as well as a permanent J-code. So that is in and sort of factored into what
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frontline commercial coverage for TREMFYA in UC as well as a permanent J-code. So that is in and sort of factored into what we're seeing now.
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Operator: Thank you. Next question is coming from Larry Biegelsen from Wells Fargo. Your line is now live. Lawrence Biegelsen: Good morning. Thanks for taking the question. Tim, how are you thinking about the growth of the MedTech market in 2025 and J&J relative to the market? And what are you assuming for the EP business and VARIPULSE? Thanks for taking the question.
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Tim Schmid: Thank you, Larry, and appreciate your continued interest in our business. Let me start with the market, Larry. We communicated that the Enterprise Business Review that we saw our end markets growing roughly 5% to 7%. As we look at procedures within the year to come, we believe that they have, for the most part, normalized. You will recall that in the first half of last year, we expected some tailwinds on the back of clearing of the backlog, specifically in orthopedic procedures. We believe that for the most part around the world, procedures have normalized to pre-COVID levels and we expect the same as we now move into 2025. Specific to electrophysiology, I did want to firstly acknowledge that out of an abundance of caution, we recently announced a temporary pause of all US VARIPULSE cases while we investigate the root cause of four reported neurovascular events. And, Larry, while disappointing, this is an easy decision for us aligned to Our Credo. Patient safety is always an absolute priority for us. And frankly given that we are collaborating now with the FDA on this matter, this is all we will be sharing at this time. We will proactively provide further updates when we have additional information to share. I do have I think it's important to remind everyone that this announcement is specific to the US and there is no expected impact to VARIPULSE cases outside of the US where the rollout of the technology has been successful with approximately 3,000 commercial cases completed. I do think important, it's important to reinforce that while we are facing a headwind today, we have tremendous opportunity in the electrophysiology space. It's an exciting market, as you know, with relatively low global penetration well under 5%, as you know, and an expanding market size due to aging populations. Today, we have a $5 billion market leading position in electrophysiology, which grew 14% in 2024 driven by commercial execution and a significant portfolio of new product introductions from QDOT to Ultrasound, CARTO
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in 2024 driven by commercial execution and a significant portfolio of new product introductions from QDOT to Ultrasound, CARTO and more recently, VARIPULSE, partially offset by competitive PFA pressures, most notably here in the US. Now we've been market leader, as you know, Larry, for 20 years and have an entrenched footprint with an installed base of over 5,000 CARTO systems, which is widely recognized that the benchmark in mapping software and a broad network of highly trained mappers. And building on our success in navigation catheters and RF ablation in 2024, we launched our first PFA catheter VARIPULSE with strong initial feedback in Europe, Japan and Canada. Additionally, similar to our success in our RF portfolio, we are expanding beyond that. And we recently announced EU approval of the Dual Energy STSF catheter which is modeled on the RF STSF catheter, which historically is the most widely used ablation catheter in the world. We're also building on this and working on an Omnipulse large tip focal catheter demonstrating commitment to bring to market a comprehensive portfolio in PFA. And so I will also say, Larry, it's not just in EP, we're also moving beyond AFib and we're working to enter the Left Atrial Appendage closure market through the acquisition of Laminar which we announced in the fourth quarter of 2023. In summary, Larry, while we're facing short-term headwinds, as you know, especially here in the US, we are absolutely confident in our ability to retain our global market leadership position over the long-term. Thank you.
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Operator: Thank you. Next question is coming from Chris Schott from JPMorgan. Your line is now live. Chris Schott: Great. Thanks so much. I just had a two-parter on operating margins. I think you mentioned in the remarks about 150 basis points of improvement this year in process R&D. Can you just elaborate a little bit more on what's enabling that despite the lower top line growth and some of the negative product mix from STELARA. I guess, I'm trying to get at, should we be expecting OpEx to be down this year embedded in that guide? And the second part was just beyond this year. Just help us think about the cadence of margin expansion as we think about 2026 and beyond and top line reaccelerates? Thank you.
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Joseph Wolk: Yes. Thanks for the question, Chris. With respect to the 150 basis improvement that wasn't related to year-on-year comparison from IPR&D. I would say that's really part and parcel to what we've been doing for a couple of years now when we had a chance to separate the consumer health business out into its own company, we did take a look at the corporate infrastructure. And as you know, we also prioritized our investments in Innovative Medicine and MedTech, specifically within those portfolios as well. So we came much more focused and you're starting to see the culmination of that this year. You might have noticed in MedTech last year, we did have some restructuring charges related to some orthopedic moves that we made, getting out of certain markets that were less profitable, improving our infrastructure around manufacturing. Those are starting to come home to roost, so to speak, in Innovative Medicine, obviously, prioritizing most of our investment into what I would call our thoroughbreds within the stable, so oncology, immunology, neuroscience, as you can tell. And we have invested in technology over the last few years in a pretty significant way. There's still more investment to come, but that's starting to yield some benefits as well in terms of efficiency around the organization. So we knew for a few years now that STELARA would face biosimilar competition. And so we had to be prepared and this is kind of how the organization has gone about it. As far as 2026 and beyond, I think, I'd go back to the comments I made with respect to operating margin and probably EPS growth overall that, that will be commensurate with sales. So that should be a positive outlook. As you know, this year, we're calling for 3% operational growth despite a multibillion dollar headwinds. Most organizations would be looking to contract both probably top and bottom line. Here we are growing 3% on the top line operationally and about 9% on the bottom line. I think you could look for maybe a little bit better equilibrium in
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the top line operationally and about 9% on the bottom line. I think you could look for maybe a little bit better equilibrium in 2026 and beyond, but with an expectation that we'd have some higher sales growth.
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Operator: Thank you. Next question is coming from Matt Miksic from Barclays. Your line is now live. Perhaps your phone is on mute, Matt. Matt, your line is now live. Our next question is coming from David Risinger from Leerink Partners. Your line is now live. Pardon me, just make sure you hear my audio. Jessica Moore: The next analyst, please. Operator: Our next question is coming from David Roman from Goldman Sachs. Your line is now live. David Roman: Thank you. Good morning, everybody. I'm on behalf of Christopher Bhutani and myself here. I wanted to come back to just the overall MedTech strategy. And I appreciate that you exited the year over the 7% number that you had previously communicated as the high end of the range. But when you pick that apart a little bit, clearly, a big percentage of that does come from M&A, I think with ex M&A, the organic number being below the 5% to 7%. So can you maybe just walk through a little bit how you think about the organic investment in the business versus inorganic contribution to that number long-term, especially when you start to look at some of the more established franchises of that surgery, orthopedics, your end market? And then if I could just sneak in accounting one in here. I just want to confirm there is no revenue recognition reversal charges in the EP numbers this quarter for VARIPULSE?
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Joseph Wolk: David, thank you for the question. And we could not be more thrilled with the performance that we delivered in 2024. And while there are opportunities, we delivered almost $32 billion of sales at an operational growth rate of 6.2%. When you take out impact of Shockwave, that's 4.7%. And let me be very clear that we remain very confident in our expectations communicated at the EBR. And as a reminder, we expect our end markets to grow between 5% and 7% on a weighted average basis between 22% and 27%. And we expect to deliver an operational CAGR in the upper end of the range over that period. In 2024, 6.2%, as I mentioned and we're pleased with the continued double-digit growth in cardiovascular, both within our core electrophysiology business and our new acquisitions in Abiomed and Shockwave, which I referenced earlier. We're also proud of the continuous improvements in Ortho. This is a business that historically was a laggard for MedTech, but tremendous improvements especially with the mid-single-digit growth in hips and knees and continued innovation with our enabling technologies and specifically in VELYS. We're also encouraged by the continuous improvements in vision, another core business. And as you know, we had a slower start to 2024, but we saw that improve throughout the year, culminating in operational growth rate in the fourth quarter of 9.1%. That said, as you know too well, we do have some short-term headwinds near-term competitive pressures in US. EP as one and secondly continued headwinds in China, which we've mentioned in 2025 will continue to be a headwind and we have included that in our estimates. As we look to the year ahead, we don't provide guidance by sector, as you know, but we're confident that continued growth will be driven by our tremendous portfolio of new products, specifically VARIPULSE, our TECNIS premium IOLs, ACUVUE OASYS MAX and Contact Lens, VELYS portfolio in Ortho, our STRATAFIX portfolio in barbed sutures and our broad-based hemostats in surgery. We also believe
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VELYS portfolio in Ortho, our STRATAFIX portfolio in barbed sutures and our broad-based hemostats in surgery. We also believe that our recent acquisitions of Shockwave and Abiomed, as I mentioned earlier, will continue to perform exceptionally well fueled by multiple new products, new indications and a rapidly growing body of clinical evidence. I will say that it's important as you think about 2025 to recognize, as Joe mentioned earlier, that we expect to see an acceleration in the back half. We are seeing some tough comparators when we compare to 2024. A couple of factors will be a positive one-time change in revenue recognition in our Ortho business. Inventory builds outside of the US and electrophysiology and finally headwinds related to selling days versus prior year. And so we would recommend that you encourage you to consider these in your statements for the year ahead. And maybe, David, just to cap off, you asked a specific question around accounting reversal and whether that had any impact on the quarter. There was none related to VARIPULSE.
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Jessica Moore: Thanks, David, and thanks to everyone for your questions and your continued interest in our company. We apologize to those we couldn't get to because of time, but don't hesitate to reach out to the Investor Relations team with any remaining questions that you may have. I'll now turn the call over to Joaquin for some brief closing remarks. Joaquin Duato: Thank you. Thank you, Jessica, and thank you, everyone, for joining the call today. As you have heard, we are ready for 2025, a year that will solidify our strength and lead to elevated performance for the balance of the decade. Enjoy the rest of the day. Operator: Thank you. This concludes today's Johnson & Johnson's Fourth Quarter 2024 Earnings Conference Call. You may now disconnect.
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Operator: Good morning, and welcome to Johnson & Johnson's Third Quarter 2024 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. [Operator Instructions] I would now like to turn the conference call over to Johnson & Johnson. You may begin.
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Jessica Moore: Hello, everyone. This is Jessica Moore, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of the third quarter results and our full year financial outlook for 2024. A few logistics before we get into the details. As a reminder, you can find additional materials, including today's presentation and associated schedules 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 risk and uncertainties that may cause the company's actual results to differ materially from those projected. A description of these risks, uncertainties and other factors can be found in our SEC filings, including our 2023 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 kick us off with opening remarks and highlight key catalysts within the segments. I will review the third quarter sales and P&L results for the enterprise, as well as highlights related to our two businesses. Joe Wolk, our CFO, will then provide an overview of our pipeline advancements, cash position, capital allocation priorities and guidance for 2024, as well as qualitative considerations for 2025. Jennifer Taubert, John Reed and Tim Schmid, our Innovative Medicine and MedTech leaders, will be joining us for Q&A. To ensure we provide enough time to address your questions, we
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Medicine and MedTech leaders, 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. I will now turn the call over to Joaquin.
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Joaquin Duato: Thank you, Jess, and hello, everyone. As you will hear, we delivered strong results in the third quarter with 6.3% operational sales growth. Our performance, once again, reflects the unique breadth of our business and our commitment to delivering the next wave of healthcare innovation to patients around the world. It also reflects the work we have done to shift our pipeline and portfolio to high innovation and high growth markets. That work continues, which you saw with the recently completed acquisitions of Shockwave and V-Wave in MedTech and Ambrx, Proteologix and NM26 bispecific antibody in Innovative Medicine. And we are pleased with the progress we are making. In Innovative Medicine, we reported a second consecutive quarter of sales exceeding $14 billion with 11 key brands growing double-digits. DARZALEX became the first product in our portfolio to reach $3 billion in sales in a single quarter. And as you will hear, our pipeline of high innovation, high growth potential assets is advancing rapidly with five major U.S. and EC approvals in the quarter. This includes FDA approval of RYBREVANT plus LAZCLUZE as first line treatment for EGFR-mutated advanced lung cancer, a transformational step forward for patients, and FDA approval of TREMFYA for active ulcerative colitis, which represents a significant opportunity for Johnson & Johnson, given 75% of STELARA sales today come from inflammatory bowel disease. And with filings and reviews underway for many of our innovative medicines that have the potential to generate $5 billion in peak year sales, we are increasingly confident in our near- and long-term growth trajectory. In MedTech, you can see the impact of our portfolio shift to high innovation, high growth markets, particularly in Cardiovascular. With the recent acquisitions of Shockwave and Abiomed, we are now category leaders in four of the largest and highest growth cardiovascular intervention medtech markets, which in Q3 translated to another quarter of double-digit growth across the
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growth cardiovascular intervention medtech markets, which in Q3 translated to another quarter of double-digit growth across the Cardiovascular portfolio. And with the full market launch of Shockwave E8 peripheral IVL catheter, we are seeing an immediate impact of the Shockwave acquisition. In Vision, growth is accelerating, and we expect that to continue with the recent full market release of TECNIS Odyssey in the U.S. and ACUVUE OASYS MAX 1-Day contact lenses. We are also excited about the future of our surgery business. As you will recall, in November 2023, we committed to submitting the OTTAVA robotic surgical system for an investigational device exemption, or IDE, to the U.S. FDA in the second half of 2024 to initiate clinical trials. I'm pleased to announce that we have met that milestone with the IDE application submitted in Q3. Looking across the enterprise, our high innovation, high growth strategy is working and our progress this quarter speaks to the strength of our commercial and innovation capabilities. We have increased adjusted operational EPS guidance pre-M&A for the third quarter in a row. We have invested $18 billion in high innovation, high growth M&A this year. Based on this quarter's results, we are confident in our expectations for 2025 through the end of the decade and beyond. And with that, I will turn the call back to Jess.
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Jessica Moore: Thank you, Joaquin. Moving to our financial results for the quarter. Unless otherwise stated, the financial results and guidance highlighted today reflect the continuing operations of Johnson & Johnson. Furthermore, the percentages quoted represent operational results and, therefore, exclude the impact of currency translation. Worldwide sales were $22.5 billion for the third quarter of 2024. Sales increased 6.3%, with growth of 7.6% in the U.S. and 4.6% outside of the U.S. Acquisitions and divestitures positively impacted worldwide growth by 90 basis points. Turning now to earnings. For the quarter, net earnings were $2.7 billion and diluted earnings per share was $1.11 versus diluted earnings per share of $1.69 a year ago. Results in the quarter were impacted by the updated talc litigation settlement proposal, as well as acquired IPR&D expense associated with the NM26 bispecific antibody. Excluding after-tax intangible asset amortization expense and special items for both periods, adjusted net earnings for the quarter were $5.9 billion and adjusted diluted earnings per share was $2.42, representing decreases of 13.3% and 9%, respectively, compared to the third quarter of 2023. Results were impacted by the acquired IPR&D expense of $1.25 billion or approximately 1,900 basis points associated with the NM26 bispecific antibody. I will now comment on business sales performance in the quarter. Beginning with Innovative Medicine. Worldwide sales of $14.6 billion increased 6.3%, with growth of 7.5% in the U.S. and 4.4% outside of the U.S. Innovative Medicine growth was driven by our key brands and continued uptake from recently launched products, with 11 assets delivering double-digit growth. Results across the portfolio continue to be positively impacted by price increases associated with Argentina hyperinflation, consistent with market practice. We continue to drive strong sales growth across our multiple myeloma portfolio. DARZALEX growth was 22.9%, primarily driven by share gains of 4 points across
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growth across our multiple myeloma portfolio. DARZALEX growth was 22.9%, primarily driven by share gains of 4 points across all lines of therapy, with 7.7 points of growth in the front line setting as well as market growth. CARVYKTI achieved sales of $286 million, with growth of 87.6%, driven by share gains, continued capacity expansion and manufacturing efficiencies. This reflects sequential growth of 53.2% aligned with our expectations of accelerating growth in the back half of the year. TECVAYLI sales were $135 million in the quarter with growth of 21.4%, reflecting a strong launch in the relapsed refractory setting. Demand remained strong, while sequential growth was flat due to continued adoption of longer duration dosing intervals. Finally, within our multiple myeloma portfolio, TALVEY continued its launch trajectory with another quarter of strong growth. We anticipate disclosing TALVEY sales in the first quarter of 2025, which are currently reported in other oncology. ERLEADA continues to deliver strong growth of 26.3%, primarily driven by share gains in metastatic castrate sensitive prostate cancer and favorable inventory dynamics. RYBREVANT, our bispecific antibody for non-small cell lung cancer, contributed to growth in other oncology as we expand approved indications. We also anticipate disclosing RYBREVANT sales in the first quarter of 2025. Within immunology, we saw sales growth in TREMFYA of 14.3%, driven by strong market growth and share gains in PsO and PsA, partially offset by unfavorable patient mix. STELARA declined 5.7%, driven by unfavorable net patient mix and share loss, partially offset by market growth. As a reminder, biosimilar competition has entered Europe as of July, and we anticipate U.S. biosimilar entry in January 2025. In neuroscience, SPRAVATO growth of 55.3% continues to be driven by increased physician and patient confidence. In pulmonary hypertension, OPSUMIT and UPTRAVI grew 17.4% and 15.2%, respectively, driven by market growth, share gains and patient mix. As mentioned
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OPSUMIT and UPTRAVI grew 17.4% and 15.2%, respectively, driven by market growth, share gains and patient mix. As mentioned last quarter, REMICADE and SIMPONI realized limited sales in Europe as we prepare for the return of distribution rights in Q4. I'll now turn your attention to MedTech. Worldwide sales of $7.9 billion increased 6.4% with growth in the U.S. of 7.8% and 5% outside of the U.S. Acquisitions and divestitures had a net positive impact of 270 basis points on worldwide growth, 360 basis points in the U.S. and 180 basis points outside of the U.S. Overall, MedTech growth was driven by commercial execution and strength of new product introductions, partially offset by continued headwinds in Asia Pacific, specifically in China. In Cardiovascular, electrophysiology delivered double-digit growth of 10.7%. Performance was driven by global procedure growth, new product uptake and commercial execution, partially offset by competitive PFA ablation catheter uptake in the U.S., as well as prior year trade inventory dynamics and VBP in China. Abiomed delivered growth of 16.3%, driven by strong growth in all regions and continued adoption of Impella 5.5 and Impella RP technology. Cardiovascular results also included $229 million associated with the acquisition of Shockwave. Contact lenses and other performance improved to 4.7%, driven by continued strategic price actions, strong performance in ACUVUE OASYS 1-Day family of products, a one-time benefit from a change in U.S. contract shipping terms worth approximately 150 basis points, as well as lapping prior year impacts from Russia sanctions. Surgical Vision grew 1.9%, driven by TECNIS PureSee and TECNIS Eyhance, partially offset by China VBP and softness in the U.S. Surgery declined 0.7%, with the Acclarent divestiture negatively impacting results by approximately 110 basis points. Performance was driven primarily by competitive pressures in energy and endocutters, as well as VBP and the anticorruption campaign in China. This was partially offset by commercial
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in energy and endocutters, as well as VBP and the anticorruption campaign in China. This was partially offset by commercial execution, strength of new products across wound closure and biosurgery and continued price increases associated with Argentina hyperinflation consistent with market practice. Orthopaedics growth of 1.3% was primarily driven by success of recent product launches and commercial execution, partially offset by competitive pressures, impacts of China VBP and revenue disruption from the previously announced Orthopaedics transformation. Now, turning to our consolidated statement of earnings for the third quarter of 2024. I'd like to highlight a few noteworthy items that have changed compared to the same quarter of last year. We continue to invest strategically in research and development at competitive levels, investing nearly $5 billion or 22% of sales, which includes a $1.25 billion payment to secure the global rights to NM26 bispecific antibody. Even when excluding this investment, R&D as a percent of sales increased 30 basis points. Selling, marketing and administrative expense as a percent of sales was leveraged 100 basis points, driven by the realization of optimization efforts following the Kenvue separation. Interest income was $99 million as compared to $182 million of income last year, driven by a higher net debt position primarily related to the financing impacts of the Shockwave acquisition. Other income and expense was a net expense of $1.8 billion compared to an expense of $0.5 billion in the prior year. The increase in expense was driven by a $1.75 billion charge related to the talc litigation settlement proposal, partially offset by prior year higher unrealized mark to market losses on public securities, as well as the monetization of royalty rights. Regarding taxes in the quarter, our effective tax rate was 19.3% versus 17.4% in the same period last year. This increase was primarily driven by the tax treatment of the NM26 bispecific antibody acquisition and OECD Pillar 2.
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year. This increase was primarily driven by the tax treatment of the NM26 bispecific antibody acquisition and OECD Pillar 2. Excluding special items, the effective tax rate was 19.3% versus 15.6% in the same period last year. I encourage you to review our upcoming third quarter 10-Q filing for additional details on specific tax-related matters. 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] (ph). Innovative Medicine margin declined from 45.4% to 37.9%, primarily driven by the $1.25 billion acquired IPR&D expense to secure the global rights for NM26 bispecific antibody, partially offset by the monetization of royalty rights. MedTech margin declined from 24.7% to 24.1%, driven by increased R&D investment and lapping of a prior year divestiture gain, partially offset by supply chain efficiencies. As a result, adjusted income before tax for the enterprise as a percentage of sales decreased from 37.6% to 32.4%, with acquired IPR&D expense impacting results by 560 basis points. Starting in 2025, aligned with recent FASB reporting disclosure requirements, we will begin providing additional P&L details by segment. This concludes the sales and earnings portion of the call. I'm now pleased to turn it over to Joe.
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Joe Wolk: Thank you, Jessica. In the third quarter, Johnson & Johnson delivered results that illustrate not only the breadth of the business, but our ability to consistently beat financial expectations. Innovative Medicine continued to build on strong first-half revenue momentum. We are advancing our pharmaceutical pipeline, achieving significant clinical and regulatory milestones across key therapeutic areas. Our MedTech business, with the addition of Shockwave, delivered operational growth of 6.4% in the quarter, but did experience headwinds in the Asia Pacific region. We continue to fortify our future advancing the OTTAVA robotic surgery system to IDE, expanding VELYS use and launching new intraocular lenses. Due to dynamics in the Asia Pacific region, specifically in China, we are taking a responsibly conservative approach by assuming no material improvement in that part of the business for the remainder of this year. And as such, we expect MedTech adjusted operational sales growth for the full year 2024 to be closer to 5% versus the 6% we referenced last quarter. The strength of a diversified business enables us to more than offset volatility in one part of our business, but yet be in a position to once again increase 2024 guidance for the enterprise. Before diving into the results, I'll take a moment to touch on some enterprise-wide updates from the quarter. We are making progress towards resolving talc litigation. Our pre-packaged bankruptcy plan received overwhelming support from the current claimants of roughly 83% as well as the future claimants representative. As announced last Thursday, the case will be heard in the Texas Bankruptcy Court. And while we remain committed to bringing this matter to a resolution, it would be premature to speculate on timing. In addition to the pipeline highlights Joaquin mentioned, there are some additional notable advancements throughout the quarter. In oncology, we received U.S. and EU regulatory approval for RYBREVANT in combination with chemotherapy as a second line
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In oncology, we received U.S. and EU regulatory approval for RYBREVANT in combination with chemotherapy as a second line treatment for adults with advanced EGFR-mutated non-small cell lung cancer. With FDA priority review underway for a subcutaneous formulation of RYBREVANT, along with data supporting a treatment regimen to reduce adverse events, we are building a best-in-class EGFR portfolio. We also presented Phase 1 data for RYBREVANT with chemotherapy in metastatic colorectal cancer patients, extending the asset's potential beyond lung cancer. In multiple myeloma, we advanced our leadership position with FDA approval and filing of two DARZALEX FASPRO quad-based regimens for newly diagnosed patients. With CARVYKTI, we announced three-year follow-up data showing significantly extended overall survival and gained approval for commercial production at our Ghent facility, further expanding supply capacity. Finally, in oncology, we added to the growing evidence base for our TARIS platform with positive Phase 2b data in patients with high-risk non-muscle invasive bladder cancer and positive interim to Phase 2 data in patients with muscle invasive bladder cancer. In neuroscience, we submitted to the U.S. and European regulatory bodies for what would be the first global approval of nipocalimab for the treatment of people living with generalized myasthenia gravis. For the remainder of the year, we expect approval of TREMFYA subcu for Crohn's disease and data readouts on JNJ-2113, our targeted oral peptide for psoriasis and ulcerative colitis, JNJ-4804, our co-antibody therapeutic for inflammatory bowel disease, aticaprant for adjunctive major depressive disorder and nipocalimab for rheumatoid arthritis. In MedTech, we completed enrollment of the Omny-IRE clinical trial to evaluate safety and effectiveness in mapping and treating symptomatic paroxysmal atrial fibrillation during standard ablation procedures. Also in Cardiovascular, we are preparing for the anticipated approval of VARIPULSE in the U.S. and the
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ablation procedures. Also in Cardiovascular, we are preparing for the anticipated approval of VARIPULSE in the U.S. and the submission of Impella ECP for regulatory approval. In Orthopaedics, we launched several exciting new products in the U.S., including our VELYS SPINE robot and VOLT Plating System. The plentiful pipeline progress across our businesses will ensure continued success. Let's now turn to cash and capital allocation. Free cash flow year-to-date was approximately $14 billion compared to $12 billion last year, which included eight months contribution from the Consumer Health business. We ended the third quarter with $20 billion of cash and marketable securities and $36 billion of debt for a net debt position of approximately $16 billion. Our capital allocation priorities remain unchanged. Our strong balance sheet enables us to strategically invest to grow our business while simultaneously returning capital to our shareholders. Innovation remains core to our strategy. During the quarter, we invested nearly $5 billion in research and development. This is an increase over 2023 levels even after excluding acquired in-process R&D expense. Thus far in 2024, Johnson & Johnson has deployed approximately $18 billion for strategic acquisitions and licensing agreements, which includes the recent acquisition of V-Wave, another innovative treatment in heart failure, which closed last week. Turning to our full-year 2024 guidance. Excluding the impact from acquisitions and divestitures, we are increasing our adjusted operational sales guidance. We now expect growth in the range of 5.7% to 6.2% with a midpoint of 6%. We are also increasing operational sales growth by $200 million to a range of 6.3% to 6.8% with a midpoint of $89.6 billion or 6.6%. As you know, we don't speculate on future currency movements. For today's call, we are utilizing a euro spot rate relative to the U.S. dollar of $1.10, slightly above last quarter's guidance. This results in an estimated incremental positive foreign currency impact of
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of $1.10, slightly above last quarter's guidance. This results in an estimated incremental positive foreign currency impact of $200 million, reducing our previous full-year negative impact to $1 billion. As such, we expect reported sales growth between 5.1% to 5.6% with a midpoint of $88.6 billion or 5.4%. Regarding the rest of the P&L, with the addition of the V-Wave transaction, we now anticipate our 2024 adjusted pre-tax operating margin to decline by approximately 200 basis points. Excluding the impact of asset acquisition accounting and related R&D investment, we would be on track to improve operating margins by 50 basis points, which is consistent with what we guided to at the beginning of the year. As we strive to advance and accelerate our pipeline, you can anticipate elevated levels of investment in the fourth quarter. Net interest income is now projected to be between $450 million and $550 million, $150 million greater than our previous guidance. Other income is anticipated to be in the range of $1.9 billion to $2.1 billion, an increase versus previous guidance, driven by the one-time monetization of royalty rights, which Jessica referenced, that will be utilized for that higher Q4 investment I referenced a moment ago. Our effective tax rate, consistent with previous guidance, is expected to be between 17.5% and 18.5% for the full year. Similar to last quarter, we have provided an EPS bridge to outline the impact from acquisition activity throughout the year. Before the impact of the V-Wave acquisition, our outlook for adjusted operational EPS performance is once again increasing. As the schedule reflects, we are expecting an incremental $0.10 per share increase on our operational performance for a total increase of $0.18 per share for the year. On this basis, when excluding acquisition activity throughout the year, EPS growth is 9.2%. To account for the completion of the V-Wave transaction, as previously disclosed, our adjusted operational EPS guidance now includes dilution of $0.24 per share in the
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transaction, as previously disclosed, our adjusted operational EPS guidance now includes dilution of $0.24 per share in the fourth quarter and $0.06 per share in 2025. Combined, this yields an updated 2024 adjusted operational EPS guidance of $9.91 at the midpoint of the range, basically flat year-on-year despite absorbing approximately $0.92 of acquisition activity. While not predicting the impact of currency movements utilizing the recent exchange rates just referenced, our reported adjusted earnings per share for the year now estimates a full year positive impact of $0.02 per share. As such, we expect reported adjusted earnings per share of $9.93 at the midpoint. We are still finalizing our plans for next year, but let me provide you some preliminary qualitative commentary to inform your modeling for 2025. For Innovative Medicine, we remain very confident in our ability to deliver growth despite a significant LOE resulting in sales above the $57 billion commitment we stated in 2021. This will be driven by our end market brands and continued progress from our recently launched products, including TREMFYA in IBD and RYBREVANT in non-small cell lung cancer. Regarding the STELARA LOE, we are planning for biosimilar entries in the U.S. in January, assuming that HUMIRA's erosion curve is a relatively good proxy for your models. We continue to expect a negative impact associated with the Part D redesign. In our pipeline, we anticipate data readouts across all our priority platforms: anticipated approvals of TREMFYA subcu in Crohn's disease, RYBREVANT subcu for lung cancer and nipocalimab in generalized myasthenia gravis, as well as potential filings for TARIS in bladder cancer and aticaprant in major depressive disorder. As a reminder, TREMFYA, RYBREVANT and TARIS continue to be the three largest underappreciated assets in terms of our revenue projections versus what analysts are estimating for the back half of this decade. For MedTech, we continue to expect to deliver on our long-term objective identified at last
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for the back half of this decade. For MedTech, we continue to expect to deliver on our long-term objective identified at last year's Enterprise Business Review of growing operational sales in the upper end of the 2022 through 2027 weighted average market growth rate of 5% to 7%. We also expect continued adoption of newer products across all MedTech businesses, such as VARIPULSE in electrophysiology, VELYS enabling technology across Orthopaedics, Odyssey and PureSee in Surgical Vision and contributions from our Abiomed and Shockwave integration. Specific to volume-based pricing in China, we expect continued impacts from the rollout of the 2024 tenders in Orthopaedics sports and intraocular lenses and anticipate VBP to continue expanding across provinces and products. Moving to the rest of the P&L. When thinking about operating margin, there are pluses and minuses. Tailwinds include an anticipated reduction of acquired IPR&D expense year-over-year, continued focus on MedTech margin improvement and continued OpEx optimization benefits post the separation. Working against us is unfavorable product mix driven by STELARA biosimilar entrants and Part D redesign. With a brief look at your models last week, the consensus margin does not appear unreasonable, and we'll provide further clarity in January once we complete our 2025 plan. We do not expect to maintain the heightened levels of interest income due to a reduction in interest rates and impact from debt experienced in 2024 related to acquisition activity. Regarding other income and expense, we expect lower net other income due to the non-recurring nature of the monetization of royalty rights experienced in Q3, a lower benefit related to employee benefit programs based on discount rate assumptions, as well as income lost on the Kenvue dividend. Lastly, based on what we know today, under current tax law, we anticipate our 2025 tax rate to be slightly lower than our anticipated 2024 tax rate. To wrap up prior to Q&A, we are pleased with our underlying 2024 performance
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slightly lower than our anticipated 2024 tax rate. To wrap up prior to Q&A, we are pleased with our underlying 2024 performance that simultaneously fortified a strong foundation for continued success heading into 2025. With that, I'll now turn it over to Kevin to open the call for your questions.
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Operator: Thank you. We'll now be conducting a question-and-answer session. [Operator Instructions] Our first question is coming from Chris Schott from JPMorgan. Your line is now live. Chris Schott: Great. Thanks so much for the question. Maybe just one on talc here. I know this is still limited comments, but it seems though the company has obviously made some advancements here into getting this behind the organization. Maybe just can you help us a little bit in terms of, from your perspective, next key steps to watch from here? And what is J&J's overall level of confidence that you have a path to resolve this in the relative near term for the story? Thanks so much. Joaquin Duato: Yeah, thank you, Chris. And as you have heard me before, our intention with respect to the talc litigation is to bring a responsible, final and comprehensive resolution to these claims. And we are making meaningful progress to do just that. We have filed our pre-packaged reorganization plan with the support of 83% of the claimants. And also, we have had a decision of the court to keep the filing in Houston. So, as I said, we are making progress in this resolution that I refer. As far as next steps, Erik? Erik Haas: Hi. Thanks, Chris. This is Erik Haas, Head of Worldwide Litigation. Judge Lopez last week on Thursday, after ruling that the case properly and appropriately should remain in Texas, ordered the parties to meet and confer and agree to a schedule for the expeditious resolution of the case. And by that, it means setting forth a schedule to get through to the confirmation procedure, addressing any ancillary motions, whether the motions to dismiss or issues relating to the votes. And the parties are in that process. We contemplate putting forth a schedule that resolves those issues through the end of the year for a confirmation hearing sometime at the beginning of next year. So that's the schedule we're on. Operator: Thank you. Next question is coming from Larry Biegelsen from Wells Fargo. Your line is now live.
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Operator: Thank you. Next question is coming from Larry Biegelsen from Wells Fargo. Your line is now live. Larry Biegelsen: Good morning. Thanks for taking the question. Tim, on MedTech, maybe help us understand the impact of the one-time items in Q3, such as the ortho SKU rationalization. How you're thinking about the impact from the hurricanes in Q4? And what gives you confidence you can deliver the high end of that 5% to 7% next year? Thanks for taking the questions.
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Tim Schmid: Larry, thank you for the question. And we're proud of the 6.4% operational growth for the quarter -- sorry, 5.7% for full year. And I think the results really talked about the success of our deliberate move into higher-growth, higher-margin categories, especially in the cardiovascular space. You'll recall, and you'll see that from our results, almost $300 million has been added from the Shockwave acquisition, which continues to perform to expectations as does Abiomed. And we've also added to the portfolio acquisition of Laminar in the fourth quarter of last year, and then more recently, the announced closure of the acquisition of V-Wave, which, once again, takes us into even more exciting high-growth, high-margin opportunities within Cardiovascular. Specifically to Orthopaedics, we believe this is going to be another solid year for Orthopaedics, 3.2% growth for the year. We did have a slightly softer third quarter, which was a result, to your point, of the restructure within Orthopaedics. And as we look to the full year, we expect a return to a significantly better performance, especially in Orthopaedics, which typically has a stronger fourth quarter. And we are seeing tremendous performance specifically within the hips and knees categories growing 6% and 7%. And I think that's really been enabled by the success of our enabling technologies in VELYS in knees, which also, by the way, we've added indication of the [Uni Knee] (ph), as well as our KINCISE and Hip Navigation systems within hips. I'd also add to the Orthopaedics performance, we are significantly addressing portfolio gaps within our trauma portfolio with the launch of TriLeap, [indiscernible] and VOLT in the back half of the year. And I think you know our spine portfolio has been challenged, and we're addressing that with the launch of TELIGEN, our new TriALTIS thoracal lumbar system and the new spine robot, which we just received approval for. As it relates the hurricanes, we did see the impact, certainly of Hurricane Helene, in the final
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we just received approval for. As it relates the hurricanes, we did see the impact, certainly of Hurricane Helene, in the final weeks of the third quarter and continue to see the impact of Milton over the last coming days especially in the areas most impacted by those storms. I do think the watch out that we all need to watch carefully is certainly the impact of the recently announced IV saline shortages, which if they do persist, could potentially impact surgical procedures across our portfolio. Thank you, Larry.
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Operator: Thank you. Next question is coming from Louise Chen from Cantor Fitzgerald. Your line is now live. Louise Chen: Hi. Thank you for taking my question here. I wanted to ask you how you see TREMFYA, JNJ-2113 and some of your other pipeline products coming together to replace sales lost to STELARA and then take share from entrenched competitors? Thank you.
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Jennifer Taubert: Hi. Louise. It's Jennifer. And good morning, everyone. And I wanted to start off by having a chance to really recognize and thank all my Innovative Medicine colleagues around the world for fabulous quarter in the third quarter. We really continue to deliver against our strategy with 11 key brands having double-digit growth and achieving a few really notable milestones, notably the TREMFYA approval and launch in ulcerative colitis, also RYBREVANT plus LAZCLUZE in first line non-small cell lung cancer, and we also completed the acquisition of NM26, which is a Phase 2-ready asset for atopic dermatitis. So, as we take a look at the immunology portfolio, we're really excited about TREMFYA, what we see as the prospects ahead. I just mentioned that we got approval during the quarter for that product in ulcerative colitis. We believe we truly have a winning proposition for that asset in IBD. And it's off to a really nice start with a good -- a really strong reception amongst the medical community. And we see that product having a lot of strength because it's the only dual act of IL-23. So, it blocks both IL-23 and the CD64 receptor cells. It really sets what we believe is a new bar in terms of efficacy with the highest rate of endoscopic normalization. And we've got rigorous head-to-head data versus STELARA showing superiority in Crohn's disease. And we think that we've got unrivaled flexibility and what will ultimately be a subcu both induction and maintenance dose for TREMFYA. So, TREMFYA was $4 billion in sales for the quarter. And that was really on psoriasis and psoriatic arthritis alone. When we take a look going forward and what we had seen with STELARA in terms of the strength in IBD and the potential, we think that TREMFYA definitely is an asset that is STELARA size or bigger and better. So, a lot of exciting opportunity for us ahead. For 2113, we're really excited about our oral asset that we're developing. And I'll let John Reed, my colleague, John Reed, actually talk about why we're so
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about our oral asset that we're developing. And I'll let John Reed, my colleague, John Reed, actually talk about why we're so excited about it and some of the data -- upcoming data there, but we do think that being able to have that advanced efficacy and known safety profile in a simple oral tablet is not only going to be great for the existing biologics' appropriate patients, but we think it gives us a great market expansion opportunity moving into earlier lines of therapy as well. John?
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John Reed: Yeah, thanks. The 2113 is really moving along nicely. As you know, this is our targeted oral peptide, a very exquisite, elegantly designed molecule that binds to and blocks the IL-23 receptor, and it is orally available with once-daily dosing. The psoriasis indication is fully enrolled now, four Phase 3 studies, which are quite broad and include head to heads against TYK2 inhibitors as well as both adult and adolescent patients as well as a study in patients that have disease affecting hard-to-treat areas, scalp and other parts of the anatomy that can be very difficult to clear typically. So, we're really looking quite comprehensively there, and the data will be rolling out in the next few months. So, we look forward to sharing those at the appropriate time. In inflammatory bowel disease, we're in a signal-seeking Phase 2 study in ulcerative colitis where we're exploring different doses before moving into more advanced studies, given that the IL-23 pathway is well validated inflammatory bowel disease. Thanks to STELARA and TREMFYA, we're quite confident that those studies will come through for us, but we'll wait for those data later this year to see how that oral medication is faring there. The other thing I'd maybe mention just in case it's not on your radar is we also have a co-antibody approach, we call it 4804, where gus and gol, TREMFYA and our TNF inhibitor are combined for patients tend to be on the more refractory side. And we're in the middle of inflammatory bowel disease studies there that will read out next year. So, really excited about that antibody combination as well. So altogether, the immunology portfolio is really quite robust and particularly in inflammatory bowel disease in the areas of dermatology where we've had traditional strengths.
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Jennifer Taubert: We really do think that we've got a winning portfolio for inflammatory bowel diseases. And maybe just one addition because I know we've had questions on this in the past on 2113, we're going to be developing that really across the spectrum, so both ulcerative colitis as well as Crohn's disease. So, we're starting off in ulcerative colitis, but absolutely have plans to develop it in Crohn's as well. Operator: Thank you. Next question today is coming from Terence Flynn from Morgan Stanley. Your line is now live. Terence Flynn: Great. Thanks so much for taking the question. Maybe just on the multiple myeloma portfolio, obviously, very nice growth in CARVYKTI this quarter. I know you spoke to some of the drivers, but just was wondering if you can elaborate on what you're seeing in the second-line setting at this point? And then, as you look at TECVAYLI through the rest of this year into next year, what's it going to take to really see an acceleration in growth in this product? Or is this -- or do we have to wait until we get to earlier lines of treatment here to see growth again in that franchise? Thank you.
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Jennifer Taubert: Hi, Terence, thanks so much for the question on multiple myeloma. And I won't go into a lot of detail on DARZALEX, but it's worth noting that we had $3 billion in sales, more than 20% growth. And DARZALEX really continues to perform quite strongly for us as we continue to grow share, particularly in frontline, in both transplant eligible and ineligible patients. I really appreciate the question on CARVYKTI. So, $286 million in sales, 88% growth year-over-year and 53% quarter-over-quarter. And we're really seeing that continued growth for a number of reasons. So first, we're seeing very strong demand based on the CARTITUDE-4 approval for that second-line-and-beyond patients. In addition, overall survival data was just presented for CARVYKTI in this line, which was very, very significant and further adds to the importance of this medicine for patients with multiple myeloma. And the other aspect is we continue to progress really nicely with our continued capacity expansion, both in terms of number of slots per day in Raritan, we gained approval for our Ghent manufacturing site in Europe for commercial production, that is now underway and able to serve patients, and our CMO in the United States as well is producing on the clinical end. And so, all the way around from performance of the product from new data as well as continued capacity expansion, we continue to see very strong performance for CARVYKTI. And as we discussed before, I don't know that we will see that as a complete exact linear growth curve quarter-to-quarter simply because the capacity expansion works in a bit more of a stair-step fashion, but as we have discussed, second quarter for us being definitely more robust than the first half, that's playing through. And I think if you think about that going forward, that makes a lot of sense. And we're over 4,200 patients now with CARVYKTI, and it is the most successful CAR-T launch for across -- throughout the industry across all CAR-Ts. Then last, you asked about TECVAYLI and talquetamab.
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CAR-T launch for across -- throughout the industry across all CAR-Ts. Then last, you asked about TECVAYLI and talquetamab. So, if we take a look at -- start off basically with TEC. So, TEC sales were $135 million and 21% growth for the quarter, but it was flat sequentially. We're seeing really nice uptake in the market in terms of new patients. There's also a dynamic where physicians are treating with longer treatment durations. So, we do think that there's a lot of continued growth and expansion for the product. It's performing very well for patients and not only in its current lines of therapy, but we're also taking a look and studying it in combinations, whether with DARZALEX, whether with TAL. And so, we do believe that there's a lot of growth potential on there. For TALVEY, we're not reporting out the sales yet. I think we'll start on that probably next year. But both TAL and TEC, we continue to expand not only with the academic, but also out into the community setting. And so, we think there's a lot of growth ahead.
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John Reed: Maybe just a couple of things to highlight as well. With TEC, that is not only the first-in-class BCMA-targeting T-cell engager, but the data really showed also is best-in-class relative to other molecules in that -- of that type. The deepest responses -- complete response rates are approaching 50%, about half of patients. Duration of response is nearly two years, and very low discontinuation rates, less than 5%, showing the weight-adjusted dosing where we can really optimize for the patients, it's really playing out there. Very excited about the early data we're seeing when we combine TEC with dara, where we're seeing really high response rates in patients who have been multiply treated and now in Phase 3 studies in patients with one to three prior lines. And then, similar story with TAL. That is a B-cell preserving target, as you know. So, there are fewer risks of severe infections with TAL. And it has shown in the late line, the highest overall response rates of any T-cell engager bispecific for myeloma. So, we think there's a lot of upside opportunity there. And again, the data in combo with dara are really impressive. So, we're marching along with that combination and where we can have the benefits of both the T cell engager together with the CD38 class. And really only J&J is positioned to do that. Operator: Thank you. Next question is coming from Danielle Antalffy with UBS. Your line is now live. Danielle Antalffy: Hey, good morning, everyone. Thanks so much for taking the question. Just a quick question on the EP business. I mean, obviously, that's very topical. You haven't really seen much of a slowdown. I appreciate Q3 was probably arguably the first quarter where we had a more -- a full quarter of PFA launching. I guess, I'm just curious about what you think the underlying market is growing and where PFA is versus RF, and also, as we look ahead to 2025 and VARIPULSE, how that changes dynamics for J&J's EP business. Thanks so much.
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Tim Schmid: Thank you, Danielle. And as you said, it is a really exciting time to be in electrophysiology. And we couldn't be more proud of the significant leadership position we've held in this category for more than 20 years. And just to put our performance in context, our EP business is a $5 billion business, which grew 11% in the third quarter and 17% year-to-date. We are actively progressing our launch of VARIPULSE in EMEA and in Japan, where we still are executing against our soft launches. We've had over 800 successful cases. We shared the data from our admIRE study at the recent HRS meeting showing 85% primary effectiveness in that portfolio and that product. And we believe we've got a product that really will hunt. As it relates to the U.S., you're right, we're seeing continued competition, especially in the ablation space, given that we don't currently have a PFA product. But having spent a lot of time in EP labs over the last couple of weeks, I can tell you that we are incredibly excited for the availability of VARIPULSE, which we expect to have approval sometime later this quarter or in Q1 of next year. We are still, by the way, mapping the majority of those cases, Danielle. That's what most people don't see is that while we may not have that product in the portfolio, we are mapping more than 50% of competitive cases. In fact, we've updated our market-leading CARTO software to actually reflect better visualization for competitive products. And what we've seen in the market, and I can't give you specific data, but a significant increase in procedures on the time it's taking EPs to perform ablation procedures with PFA. And by the way, today, we're benefiting from the volume increase from PFA even though we don't have that catheter. And so, that combination of the 5,500 installed base of CARTO system's best-in-class mapping and highly trained mappers, we believe, is a significant advantage and positions us extremely well when PFA comes to market. I will also say that similar to RF, which by the way, we
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advantage and positions us extremely well when PFA comes to market. I will also say that similar to RF, which by the way, we still believe has a play within the portfolio, we have the best-in-class RF catheter with QDOT, 86% primary effectiveness, this winning strategy in RF has been a full portfolio. And similarly, in PFA, beyond our first launch with VARIPULSE, you will see a full portfolio of focal, large focal single shot and dual energy catheters. By the way, we already applied for CE marking for our dual energy catheter. And so, we're confident in our leadership position in EP and our sources of differentiation for the future. Thank you, Danielle.
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Operator: Thank you. Next question today is coming from Shagun Singh from RBC Capital Markets. Your line is now live. Shagun Singh: Good. Thank you so much. I was hoping you could elaborate on the dynamics that you're seeing in the Asia Pacific region in MedTech, specifically China. Could you quantify the headwind? When do you expect it to normalize? And you did talk about China VBP, and that has expanded into additional provinces and products. So, could you just elaborate on the impact there, and how we should think about it in '25? Thank you.
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Tim Schmid: Thank you, Shagun. And yes, we've had a myriad of issues hitting us in the Asia Pacific region of late. And let me just highlight a couple, and I'll certainly get to your question on China. Firstly, you may know that in February of this year in Korea, the government initiated or at least a strike was initiated among the healthcare professional community. Unfortunately, we don't see any end in sight to that. And so that certainly has been a headwind. We're seeing macroeconomic pressures in Japan. And then, more importantly, to your question, the ongoing impact of volume-based procurement, which has also been exacerbated by the anti-corruption campaign. And by the way, while we believe this is absolutely the right thing to do and we support it for the long term, it is impacting procedures and the engagement by healthcare professionals with companies like ours, especially on premium products. We have a leadership position. We have the largest medtech company in China. And given the high leadership positions, we are seeing a disproportionate impact from VBP. We have five major categories impacted through tenders in 2023 in electrophysiology, trauma, spine, endocutters and energy, and more recently, IOLs and sports in our Orthopaedics business. We do believe that this will be a headwind through the remainder of '24 and into '25. That said, we are absolutely confident that China continues and will continue to be an important part of our portfolio. Even with the impact of VBP, we believe we can deliver tremendous growth and returns for our shareholders. And I think this really talks to the strength of our global portfolio across medtech, the fact that we can offset headwinds in one geography with better performance in places like Europe and the U.S. Please rest assured, we also believe that this part of the world, especially in Asia Pacific, will continue to be a growth opportunity. And let me tell you why. 60% of the world's patients live in that part of the world. And we're proud of the fact that we've
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And let me tell you why. 60% of the world's patients live in that part of the world. And we're proud of the fact that we've been in many of these markets many, many years and expect to continue to do so. The final point I'll make is, let's remember, while, this is a headwind for MedTech, this is not material to Johnson & Johnson. When we look at our global sales across Johnson & Johnson, less than 5% of our business is in China. Thank you again.
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Operator: Thank you. Next question is coming from Vamil Divan from Guggenheim Securities. Your line is now live. Vamil Divan: Great. Thanks for taking my question. I have a question on the immunology side, just on TREMFYA and STELARA. So, you mentioned the U.S. sales for both those products were a little bit lighter. And we were expecting and you mentioned this unfavorable patient mix impact in the quarter. So, I'm just curious if you can just go in a little more detail on what you're seeing for those products in the U.S. specifically. And is this patient mix issue sort of this quarter? Is it adjustments from prior quarters? And is it something specific to Johnson & Johnson, or is it maybe something broader to the immunology market? Thank you. Jessica Moore: Yeah, Vamil. If you talk about with patient mix, this would be something that is specific to some of the true-ups that we do. As you are all aware, we end up having to make an assessment on our gross to net reduction. And as we get final bills in, there always are some true-ups. Sometimes they're for the positive, sometimes it is a negative reduction. So, when we refer to patient mix, this is different patients coming through different channels as well as some of the accounting true-ups for the final payments that we make. Then, I will hand it over to Jennifer to specifically talk about the performance and the commercial perspective of TREMFYA and STELARA in the U.S.
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Jennifer Taubert: And I think -- so if we look for TREMFYA, outside the U.S., really nice growth at 27%. In the U.S., it was a little over 9% specifically for that patient mix issue that Jess just spoke about. We do think that the prospects are very strong for continued TREMFYA growth based on what I articulated before around the launches in ulcerative colitis and the upcoming launches that we're planning for in Crohn's disease as well. I think for STELARA, we did see a decline and that, again, sort of similar patient mix piece in the U.S. We've also -- and also we've noted the decline ex U.S., particularly in EMEA due to biosimilar competition. We know that STELARA is near or at its end of life and really that TREMFYA and across the rest of our portfolio, we've got a very robust stable of products with pretty significant growth. Jessica Moore: Thank you, Vamil. Kevin, we have time for one last question. Operator: Thank you. Our final question today is coming from Jayson Bedford from Raymond James. Your line is now live. Jayson Bedford: Good morning. Maybe just a question for either Tim or Joe. Appreciate the color on MedTech, but the 5% bogey for the year still implies a decent acceleration in 4Q off a tougher comp. What gets better in 4Q? And then, just a quick clarification. The IV solutions dynamic from Helene, are you seeing an impact on volumes outside of Western North Carolina and Florida? Thanks.
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Tim Schmid: Jayson, thank you for the question. And let me hit the last one first. No, we have seen the majority of the impact in the areas impacted by that storm. As I mentioned earlier, I think the watch out is any potential impact from additional shortage of IV fluid, which may impact elective procedures, and certainly, we're continuing to monitor that very carefully. As Joe mentioned, we expect now on the back of the headwinds we mentioned earlier in Asia Pacific to deliver adjusted operational growth of around 5% and north of 6% on an operational basis for the year. We believe that the momentum we're carrying into the fourth quarter, especially in our Cardiovascular businesses with our winning portfolio in electrophysiology, strong double-digit growth in Shockwave, Abiomed, I mean, those are, as you can see from the performance, absolute home runs. The other important dynamic here is that, as we signaled in the first and second quarter, we expect to see improvement within our Vision business, which typically has delivered solid single -- mid-single-digit growth. We had a tremendous third quarter, which really gives us confidence in even stronger fourth. This was delivered by much better performance, especially in our contact lens business. In fact, here in the U.S., our most important market, double-digit growth for contact lenses in the quarter. And this just really has been delivered from a stabilization of our distributor inventory in the U.S., the fact that we're able to get back to taking new wearer share now that we have unconstrained supply, especially within our astig portfolio. And so, we do believe that Vision has a very strong quarter ahead. And then finally, across the portfolio, we're benefiting from tremendous new product launches, both within Cardiovascular, the E8 peripheral catheter within Shockwave, continued performance within Abiomed with our broad portfolio of pumps. And then, within our surgery business as well as orthopaedics, as I mentioned earlier, tremendous new products to add
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of pumps. And then, within our surgery business as well as orthopaedics, as I mentioned earlier, tremendous new products to add differentiation to the portfolio. And typically, that fourth quarter also is a stronger one for us. So, once again, very confident in our performance at around 5% on an adjusted basis and north of 6% operationally. Thank you.
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Jessica Moore: Thank you, Jayson, and thanks to everyone for your questions and your continued interest in our company. We apologize to those we couldn't get to because of time, but don't hesitate to reach out to the Investor Relations team with any remaining questions that you may have. I would now turn the call over to Joaquin for some brief closing remarks. Joaquin Duato: Thank you, everyone, for joining the call today. As you have heard, we delivered strong results in the third quarter. Our high-innovation and high-growth portfolio and pipelines are advancing rapidly, and we are increasingly confident in our expectations for 2025 and beyond. Enjoy the rest of your day. Operator: Thank you. This concludes today's Johnson & Johnson's third quarter 2024 earnings conference call. You may now disconnect.
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Operator: Good morning, and welcome to Johnson & Johnson's Second Quarter 2024 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. [Operator Instructions] I would now like to turn the conference to Johnson & Johnson. Please go ahead.
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Jessica Moore: Hello, everyone. This is Jessica Moore, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of the second quarter business results and our full-year financial outlook for 2024. A few logistics before we get into the details. As a reminder you can find additional materials including today’s presentation and associated schedules 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 risk and uncertainties that may cause the company's actual results to differ materially from those projected. A description of these risks, uncertainties, and other factors can be found in our SEC filings, including our 2023 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, I will start by reviewing the second quarter sales and P&L results for the corporation, as well as highlights related to our two businesses. Joe Wolk, our CFO, will then provide additional business and financial commentary before sharing an overview of our cash position, capital allocation priorities, and guidance for 2024. Joaquin Duato, our Chairman and CEO, will then provide some closing remarks before we open it up for questions. Jennifer Taubert, John Reed, and Tim Schmid, our innovative medicine and MedTech leaders will be joining us for Q&A. To ensure we provide enough time to address your questions, we
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medicine and MedTech leaders 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. Unless otherwise stated, the financial results and guidance highlighted today reflect the continuing operations of Johnson & Johnson. Furthermore, the percentages quoted represent operational results and therefore exclude the impact of currency translation. Turning to our second quarter sales results. Worldwide sales were $22.4 billion for the second quarter of 2024. Sales increased 6.6%, with growth of 7.8% in the U.S. and 5.1% outside of the U.S. Excluding the impact of the COVID-19 vaccine, sales growth was 7.2% worldwide and growth of 6.4% outside of the U.S. Sales growth in Europe, excluding the COVID-19 vaccine was 6%. Turning now to earnings. For the quarter, net earnings were $4.7 billion and diluted earnings per share was $1.93 versus diluted earnings per share of $2.05 a year ago. Excluding after-tax intangible asset amortization expense and special items for both periods, adjusted net earnings for the quarter were $6.8 billion and adjusted diluted earnings per share was $2.82, representing increases of 1.6% and 10.2%, respectively, compared to the second quarter of 2023. I'll now comment on business sales performance in the quarter. Beginning with Innovative Medicine, worldwide Innovative Medicine sales of $14.5 billion increased 7.8%, with growth of 8.9% in the U.S. and 6.4% outside of the U.S. Excluding the impact of the COVID-19 vaccine, operational sales growth was 8.8% worldwide and 8.7% outside of the U.S. Innovative Medicine growth was driven by our key brands and continued uptake from recently launched products with 10 assets delivering double-digit growth. We continue to drive strong sales growth across our multiple myeloma portfolio. DARZALEX growth was 21.3%, primarily driven by share gains of 4.6 points across all lines of therapy and 9.4 points in the frontline setting, as well as market growth. CARVYKTI achieved
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of 4.6 points across all lines of therapy and 9.4 points in the frontline setting, as well as market growth. CARVYKTI achieved sales of $186 million, with growth of 59.9%, driven by continued capacity expansion, manufacturing efficiencies, and strong demand. TECVAYLI sales achieved $135 million in the quarter, with growth of 43.5%, reflecting a strong launch in the relapsed-refractory setting. Demand remained strong while sequential growth slowed due to adoption of recently approved longer-duration dosing intervals. ERLEADA continues to deliver strong growth of 32.5%, primarily driven by share gains and market growth in metastatic castrate-sensitive prostate cancer. Other oncology growth was driven by continued strong uptake of TALVEY, our GPRC5D bispecific, and RYBREVANT, our bispecific antibody for non-small cell lung cancer. Within immunology, we saw sales growth in TREMFYA of 30.7%, driven by market growth, share gains in PSO and PSA, and favorable patient mix. STELARA growth of 4.9% was driven by market growth, partially offset by net unfavorable patient mix. We continue to anticipate biosimilar entry in Europe later this month, while in the U.S., we expect continued volume growth largely offset by price declines as we move towards biosimilar entry in 2025. In neuroscience, SPRAVATO growth of 60.8% continues to be driven by increased physician and patient confidence. In pulmonary hypertension, OPSUMIT grew 9.1% due to share gains and market growth, partially offset by unfavorable mix. UPTRAVI growth of 8.1% was driven by market growth and share gains, partially offset by inventory dynamics. Total Innovative Medicine sales growth was partially offset by a decline in other neuroscience, unfavorable patient mix in Xarelto and competitive pressures in IMBRUVICA. I'll now turn your attention to MedTech. Worldwide MedTech sales of $8 billion increased 4.4%, with growth in the U.S. of 5.7% and 3.2% outside of the U.S. Acquisitions and divestitures had a positive impact of 40 basis points on sales growth in the
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5.7% and 3.2% outside of the U.S. Acquisitions and divestitures had a positive impact of 40 basis points on sales growth in the quarter. Growth was driven by commercial execution, strength of new product introductions, and continued strong procedure volume, partially offset by performance in China and competitive pressures in US distributor stocking dynamics and vision. In cardiovascular, electrophysiology delivered a double-digit growth of 13.4% with strong growth across all regions. The performance was driven by global procedure growth, new product uptake, and commercial execution, partially offset by the previous one-time inventory build in Asia-Pacific from the prior quarter. In addition, Abiomed delivered growth of 15.4%, driven by double-digit growth in all regions and continued strong adoption of Impella 5.5 and Impella RP technology. Results include $77 million associated with the acquisition of Shockwave, which closed on May 31. Contact lenses adjusted operational sales growth, excluding the Blink divestiture was 2.1%. Growth was driven by strong performance in the ACUVUE OASYS 1-Day family of products, partially offset by U.S. distributor stocking dynamics and competitive pressures, and Japan macroeconomic pressures. The Blink divestiture negatively impacted growth by approximately 130 basis points. Surgical vision grew 1.2%, driven by TECNIS Eyhance, our monofocal interocular lens, partially offset by China VBP and refractive softness in the U.S. Surgery adjusted operational sales growth, excluding the Acclarent divestiture was approximately flat. Performance was driven primarily by competitive pressures in energy and endocutters, China VBP, prior year China recovery, EMEA tender timing across advanced surgery and supply constraints, and wound closure. This was partially offset by strength of new products. The Acclarent divestiture negatively impacted growth by approximately 110 basis points. Orthopedics growth of 3.3% was driven by strong performance in hips and knees, due to procedure growth,
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110 basis points. Orthopedics growth of 3.3% was driven by strong performance in hips and knees, due to procedure growth, strength of new products, and EMEA tender timing in knees. This growth was partially offset by competitive pressures and impacts of China VBP in spine and sports. Now, turning to our consolidated statement of earnings for the second quarter of 2024. I'd like to highlight a few noteworthy items that have changed, compared to the same quarter of last year. Cost of product sold margin deleveraged by 60 basis points, primarily driven by product mix within innovative medicine and macroeconomic factors across both sectors. We continue to invest strategically in research and development at competitive levels, investing $3.4 billion or 15.3% of sales this quarter. We invested $2.7 billion or 18.8% of sales in innovative medicine, compared to 22.2% of sales in 2023. As a reminder, last year included an upfront payment of $245 million associated with the AbelZeta partnership. In MedTech, R&D investment was $0.7 billion or 9% of sales, an increase driven by continued investment in strategic platforms. Other income and expense was a net expense of $653 million in the second quarter of 2024, compared to income of $384 million in the second quarter of 2023. The increase in expense was primarily driven by costs related to the closing of the Shockwave acquisition, the loss on the completion of the debt for equity exchange of the retained stake in Kenvue and prior year favorable intellectual property litigation settlements in MedTech. This was partially offset by the gain on the Acclarent divestiture. Regarding taxes in the quarter, our effective tax rate was 18.5% versus 14.7% in the same period last year. This increase was primarily driven by unfavorable one-time international audit settlements and the continued impact from Pillar 2. Excluding special items, the effective tax rate was 18.6% versus 15.9% in the same period last year. I encourage you to review our upcoming second-quarter 10-Q filing for
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rate was 18.6% versus 15.9% in the same period last year. I encourage you to review our upcoming second-quarter 10-Q filing for additional details on specific tax-related matters. 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. In the second quarter of 2024, our adjusted income before tax for the enterprise as a percentage of sales increased from 37.2% to 37.4%. Innovative Medicine margin improved from 42.3% to 44.6%, primarily driven by an upfront payment of $245 million associated with the AbelZeta partnership in 2023, partially offset by product mix and cost of products sold. MedTech margin declined from 28.2% to 25.7%, driven by prior year favorable intellectual property litigation settlements worth approximately 300 basis points. This concludes the sales and earnings portion of the call. I'm now pleased to turn it over to Joe.
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Joe Wolk: Thank you, Jessica, and hello, everyone. Thank you for joining today's call. Overall, Johnson & Johnson delivered solid top and bottom-line, as well as free cash flow growth in the quarter. Our Innovative Medicine business made great progress in the second quarter. We have strong momentum with key end-market products and continue to advance our pipeline with significant clinical and regulatory milestones being attained. Our MedTech business delivered growth that fell below our expectations of growing in the upper range of our markets, which as you recall correlates to a weighted-average market growth rate of 5% to 7% from 2022 through 2027. We came into the year thinking 2024 would be in the upper end of that range. With acceleration planned in the second-half, given some of the first-half dynamics Jessica outlined, we now expect growth closer to 6% for 2024. To me, this reflects the power and breadth of our company, where we can more than offset quarterly volatility in one part with overperformance from another part of our business. Before I get into the numbers, I'd like to provide some qualitative business highlights from the quarter. Starting with innovative Medicine, in oncology, we continue to make meaningful progress across our disease areas of focus. Of note, we received FDA approval for CARVYKTI in earlier lines of therapy and reported positive top-line overall survival results from the CARTITUDE-4 study. We also submitted a filing with the FDA for our subcutaneous formulation of RYBREVANT. We presented updated results for TAR-200 and TAR-210 and we met primary endpoints for two DARZALEX studies, Cepheus and Aquila, where results will be presented at an upcoming major medical meeting. Turning to immunology, we achieved key milestones for TREMFYA in inflammatory bowel disease, including the presentation and filing of Phase III studies in ulcerative colitis and Crohn's disease, as well as the filing of our subcutaneous formulation, which would make TREMFYA the only IL-23 inhibitor with a fully
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disease, as well as the filing of our subcutaneous formulation, which would make TREMFYA the only IL-23 inhibitor with a fully subcutaneous regimen. We also expanded our immunology portfolio with the acquisitions of Proteologix and NM26. These bispecific antibodies will further strengthen our portfolio and enhance our ability to address significant unmet need in atopic dermatitis. Finally, spanning immunology and neuroscience, we presented positive results for nipocalimab in Sjogren's disease and myasthenia gravis. But it doesn't stop with the second quarter. We are excited for what awaits in the second half of this year with the anticipated approval and launch of both RYBREVANT plus Lazertinib in frontline EGFR positive lung cancer and TREMFYA in IBD. We also expect data from JNJ-2113, our targeted oral peptide in psoriasis and ulcerative colitis, JNJ 4804, our co-antibody therapeutic in IBD and nipocalimab in rheumatoid arthritis. As we continue to bring new innovations to market and execute against clinical and regulatory milestones, Innovative Medicine is well-positioned to achieve sustainable growth in both the near and long-term. Turning to MedTech, we continue to advance our pipeline, launch new commercial products and integrate strategic acquisitions that broaden and further differentiate our portfolio. In cardiovascular, we are enhancing our portfolio and shifting into higher growth markets through strategic acquisitions such as Shockwave Medical. In May, we announced the launch of our CARTO 3 Version 8 electroanatomical mapping system. This is the latest version of our 3D heart mapping system, which has machine learning capabilities that increase efficiency, reproducibility, and accuracy in maps electrophysiologists use to treat atrial fibrillation and other arrhythmias. In pulsed field ablation, we initiated the commercial launch of the VARIPULSE platform in the EU and Japan receiving early positive physician feedback in the external evaluation period. We also delivered results from the pivotal phase
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receiving early positive physician feedback in the external evaluation period. We also delivered results from the pivotal phase of the admIRE trial, where the VARIPULSE platform demonstrated 85% peak primary effectiveness with minimal adverse events, short PFA application times and low fluoroscopy exposure. In orthopedics, we received 510(k) FDA clearance for the clinical application of the VELYS Robotic-Assisted Solution in unicompartmental knee arthroplasty. This is designed for both medial and lateral procedures enabling surgeons to guide precise implant placement without a CT scan. In surgery, we launched the ECHELON 3000 in the U.S., which combines 3D stapling and gripping surface technology to enable greater staple line security. This has been shown to deliver 47% fewer leaks, reduce surgical risks and improve surgical outcomes. In surgical vision, we launched TECNIS Odyssey in the U.S., and head into a full market launch in the second-half of 2024. For the remainder of the year, we will continue to advance our electrophysiology and cardiovascular pipelines as we prepare for the anticipated U.S. approval of VARIPULSE, as well as the submission of Impella ECP for regulatory approval. Within robotic surgery, we are on track to submit an investigational device exemption to the FDA for OTTAVA in the second-half of the year. Before turning to cash flow and guidance, I wanted to provide an update on the talc litigation. As announced on May 1, the company has committed to pay ovarian claimants a present value of approximately $6.5 billion or $8 billion nominally over 25-years, resulting 99.75% of all pending talc lawsuits against the company and its affiliates in the United States. We are currently in a voting period for the plan, where for the first time, claimants are able to vote for themselves for or against the plan. The last day of voting is scheduled for July 26. It will then take a few weeks for the vote administrator to vet and tally the votes. Once that process concludes, we plan to make a public
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take a few weeks for the vote administrator to vet and tally the votes. Once that process concludes, we plan to make a public announcement on the next steps regarding a pre-packaged bankruptcy filing. Our confidence that we will reach the requisite 75% vote is bolstered by the continued support of council representing the vast majority of claimants with whom the plan was developed, as well as the announcement of support by additional prominent plaintiff law firms recently, including Ailstock, Keller Postman, and Miller. Additionally, in furtherance of our goal of achieving a comprehensive solution, we finalized the previously announced agreements reached with all states that advanced talc claims in the Imerys and Cyprus entities, owners of the mines that supplied talc to the company. In the second quarter, we continued to make progress with mesothelioma claimants with 95% of claimants now settled. Turning to cash and capital allocation. We ended the second quarter with approximately $25 billion of cash and marketable securities and approximately $41 billion of debt for a net debt position of $16 billion. Free cash flow year-to-date was approximately $7.5 billion, compared to $5.5 billion in the prior year period, which included cash flow from the Consumer Health business. During the quarter, we exited our retained stake in Kenvue, bringing the separation to a close. The net proceeds from the secondary offering were $3.6 billion. Our capital allocation priorities remain unchanged. We maintain a strong balance sheet, which continues to enable us to strategically invest in and grow our business, while returning capital to our shareholders. Innovation remains core to our strategy. In the second quarter, we invested more than $3.4 billion or 15.3% of sales in research and development. In terms of acquisitions and licensing, during the first half of 2024, Johnson & Johnson has deployed approximately $17 billion in strategic value creating inorganic growth opportunities. This includes Shockwave, Proteologix and the
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$17 billion in strategic value creating inorganic growth opportunities. This includes Shockwave, Proteologix and the NM26 bispecific antibody transaction announced last week, as well as more than 20 other smaller complementary business development transactions. While we will always explore strategic deals of any size that can create value, we foresee modest tuck-in deals as the preferred route over the near-term. Now turning to our full-year 2024 guidance. Given the moving parts associated with the acquisitions this quarter, I'll start where I usually end with earnings per share. Before the impact of recent acquisitions, our outlook for adjusted operational EPS performance is once again being increased. As this schedule reflects, we are expecting a $0.05 per share increase in our operational performance. This would result in year-over-year EPS growth of 8.2% at the midpoint. To account for the completion of Shockwave, Proteologix, and the NM26 bispecific antibody transactions, and as previously disclosed, our adjusted operational EPS guidance now includes dilution of $0.68 per share. Combined, all of this yields an updated adjusted operational EPS guidance in the range of $10 to $10.10 per share. In addition to assist with your future models, these transactions are expected to have a smaller impact of $0.33 to adjusted operational EPS in 2025. Now to address all elements of P&L guidance for 2024. As a reminder, our sales guidance continues to exclude any impact from COVID-19 vaccine sales. We are increasing our operational sales guidance for the full-year by $500 million to reflect the completion of the Shockwave acquisition. We now expect growth in the range of 6.1% to 6.6% compared to 2023 with a midpoint of $89.4 billion or 6.4% at the midpoint. Excluding the impact from acquisitions and divestitures, we are maintaining our adjusted operational sales growth to the range of 5.5% to 6.0% compared to 2023. As you know, we don't speculate on future currency movements. We are utilizing a euro spot rate relative to
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compared to 2023. As you know, we don't speculate on future currency movements. We are utilizing a euro spot rate relative to the U.S. dollar of 1.08, consistent with last quarter. However, there have been notable strengthening of the U.S. dollar versus other currencies, specifically the Japanese yen and Chinese yuan. As a result, we estimate an incremental negative foreign currency impact of $500 million, resulting in a full-year impact of $1.2 billion. As such, combined with the Shockwave acquisition, we expect reported sales growth between 4.7% to 5.2%, compared to 2023 with a midpoint of $88.2 billion or 5% growth. Turning to the rest of the P&L. Based solely on the dilution from the transactions, we now anticipate our 2024 adjusted pre-tax operating margin to decline by 120 basis points, more than offsetting the previously communicated 50 basis point improvement. We projected net interest income between $300 million and $400 million, lower than previous guidance driven by interest expense associated with financing of our recent acquisitions. Other income is anticipated to be in the range of $1.5 billion to $1.7 billion, an increase versus previous guidance driven by year-to-date performance. Our effective tax rate is now expected to be between 17.5% and 18.5% for the full-year, much higher than 2023, largely due to the impact of OECD Pillar 2, as well as the non-deductible nature of the recently announced NM26 bispecific antibody acquisition. While we do not provide guidance by segment or on a quarterly basis, I'd like to provide some qualitative considerations to support your modeling. We continue to expect Innovative Medicine sales growth to be lower in the second half of the year compared to the first half, given the anticipated entry of STELARA biosimilars in Europe beginning the last week of July. This headwind will be partially offset by continued uptake from our recently launched products. While we had COVID-19 vaccine sales in the second quarter, we do not anticipate any future sales. Finally, it is
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products. While we had COVID-19 vaccine sales in the second quarter, we do not anticipate any future sales. Finally, it is worth noting that distribution rights for REMICADE and SIMPONI in Europe will be returned in the fourth quarter. In preparation for this transfer, we expect limited third-quarter sales in Europe. Turning to MedTech, as previously stated, we expect growth to accelerate back in line with our long-term expectations in the second-half of the year. This will be driven by recovery in contact lenses, evidenced by sequential monthly improvement within Q2. Further expansion into high-growth segments, including the integration of Shockwave and continued growth of new products and commercial execution across the portfolio. As you think about our adjusted operating margin, we continue to expect it to be higher in the first-half of the year, compared to the second-half. Again, this is due to the IP R&D charge for the NM26 bispecific antibody transaction in Q3 as well as the anticipated entry of STELARA biosimilars in Europe later this month. Lastly, as a reminder on share count, we only expect a partial benefit in the third quarter resulting from the share count reduction following the Kenvue exchange offer in August of 2023 with the fourth quarter being neutral. As we move forward, we remain focused on advancing our differentiated portfolio and achieving key clinical and regulatory milestones across Innovative Medicine and MedTech. We remain confident in our ability to deliver sustained growth and long-term value for patients, customers, and shareholders. With that, I am now pleased to turn the call over to Joaquin for concluding remarks before taking your questions.
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Joaquin Duato: Thank you, Joe, and hello, everyone. With a strong second quarter, I'm excited about the rest of 2024. Our Innovative Medicine business is on track for a 13th consecutive year of above-market growth. Our success is driven by a portfolio of innovative best and first-in-class medicines, many of which have the potential to change the practice of medicine. Across the board, oncology, immunology, neuroscience, we are reinventing treatment paradigms and transforming lives. As Joe mentioned, we have made significant progress across our pipeline. In particular, I would like to highlight two major milestones on the horizon that will help drive sustained growth through 2025 and beyond. First, the approval and launch of RYBREVANT plus Lazertinib for first-line treatment of EGFR-positive non-small cell lung cancer. And second, the approval and launch of TREMFYA in Inflammatory Bowel Disease or IBD, which follows the recent presentation of data that demonstrated superiority versus STELARA. This represents a meaningful opportunity for TREMFYA as approximately 75% of STELARA sales today come from IBD. We also have regulatory and data milestones for many of the assets that we expect to generate more than $5 billion in peak year sales. As the pipeline and portfolio progress, so too does our confidence in our near and long-term growth trajectory. We are confident in our ability to grow through the upcoming STELARA biosimilar entry and see accelerating momentum through the back half of the decade. In MedTech, year-to-date adjusted operational sales growth of 5.2% reflects continued progress with the portfolio as we move into higher growth markets. As you heard from Joe, we expect MedTech growth to accelerate in the second-half of the year. Growth will accelerate through continued expansion of new products, including ACUVUE OASYS Max 1-Day Contact Lenses, TECNIS Odyssey in the U.S., and VARIPULSE in Europe and Japan. Our confidence in the business outlook remains unchanged. With meaningful outcomes from the danger
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in Europe and Japan. Our confidence in the business outlook remains unchanged. With meaningful outcomes from the danger shock trial in Abiomed and the second quarter close of the shockwave acquisition, we look forward to continue the expansion into high-growth MedTech markets. As you know, Johnson & Johnson is laser-focused on advancing the next wave of medical innovation. We are building on a strong foundation to unlock accelerated growth with a healthy balance sheet and industry-leading investments in the best science and innovation. This enables us to move into the second-half of 2024 from a position of strength. With that, let's open the line for questions.
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Operator: Thank you. [Operator Instructions] Our first question today is coming from Chris Schott from JPMorgan. Your line is now live. Chris Schott: Great. Thanks so much for taking my question. Maybe just a question on RYBREVANT. I know, Joaquin, you mentioned that as one of the key upcoming milestones for the company, but this does seem like a product where there's a disconnect between J&J's enthusiasm in the Street. So, maybe just enlighten us with some of the data we recently saw at ASCO on subcutaneous dosing, et cetera, the upcoming label expansion? Can you just talk about how you see RYBREVANT evolving overtime and your confidence that this product can take share in the frontline setting? Thank you. Jennifer Taubert: Hi, Chris, it's Jennifer and thanks so much for the question. Real quick before I get into that one, I just wanted to give a quick shout-out to all my internal Innovative Medicine colleagues around the world for a terrific quarter. Our first $14 billion-plus quarter that we hit in over 10 products with double-digit growth. So, really, really a tremendous quarter and looking-forward to a great half of the year as well. So, we are very excited about RYBREVANT plus Lazertinib and the data that we're seeing and really believe that it's going to have a significant place in frontline non-small cell lung cancer. As we've discussed before, there is a significant unmet need in frontline non-small cell lung cancer with about a quarter of patients never even making it to second-line therapy. So, a lot of patients that are there with high unmet medical need. When we take a look at the data that we've been able to generate in terms of PFS and when you add to that, the new data that we brought forward on our subcu dosing, we think together, we're going to have a really winning combination for patients in that frontline setting. So, high unmet need, really spectacular results that we're seeing and the subcu dosing we think is going to be a great combination.
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Operator: Thank you. Next question is coming from Larry Biegelsen from Wells Fargo. Your line is now live. Larry Biegelsen: Good morning. Thanks for taking the question. Tim, maybe we can do a deeper dive into MedTech. Just talk about what drove the reduction in the expected growth for MedTech in 2024? And how are you thinking about the Medtech end-markets in the second half and which J&J businesses do you see improving in the second-half and why? Thank you.
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Tim Schmid: Larry, thank you for the question. Let me be very clear, we remain absolutely committed to delivering solid growth in the full-year for 2024. And Larry, when you actually look at ‘24 Q2, it was a tougher quarter for us. And we knew this, given the fact that at this time last year around the second quarter, we saw the opening up of the China market, which as you know is an important market for us and that was expected. That was actually by the way, last year our fastest-growing quarter. Now in all transparency, as you heard initially in the comments earlier, there have been two businesses that have or two areas of our business that have performed below expectations. Number one is Vision and secondly, our performance in China, which right now is a very volatile market. Now in Vision, we initially announced in the first quarter some challenges with distributor stocking dynamics here in the U.S., some competitive pressures, as well as some macroeconomic challenges in Japan. What gives me confidence in the turnaround of that business is that we actually saw sequential improvement through the second quarter. Some of those stocking dynamic dynamics I mentioned bled into April, but month-on-month, we saw strong rebound of that business, in fact, to the end of the quarter back to historical levels. And so as we look to the back half of the year, while it's been a slower start there, we're very confident that we're going to be able to bring that business back to historical norms, driven primarily by innovation. Our ACUVUE OASYS 1-Day MAX portfolio and that global launch as well as the addition of our premium IOLs with TECNIS PureSee in Asia-Pac and EMEA as well as Odyssey here in the U.S., and so we believe we've got that under control. When I look to the back half onto answer your question more directly, the reason we are confident is firstly, not only the return to more normalized growth within Vision, but in surgery, by the way, that -- all that business also was impacted by a slower start, especially in
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growth within Vision, but in surgery, by the way, that -- all that business also was impacted by a slower start, especially in China. We see that starting to normalize. And also remember in our surgery business, the results were impacted by the divestiture of a Acclarent last year. And so normalized growth -- our adjusted operational growth was actually closer to flat. We see that continuing to grow at low-single-digit through the back half of the year. We're proud of the solid results in ortho and see that continuing to be driven by strong results within hip 6%, in knees, almost 10%, driven by tremendous innovation, especially in VELYS. And then more broadly, I'll end with our real confidence in the growth of our cardiovascular portfolio. And remember, Larry, that we've got an EP business that's $5 billion today, grew 21% last year, 19% for the first-half of the year. In fact, in the second quarter, in the face of competition, here in the U.S. we grew that business 16%. And so we're very confident in our ability to grow that leadership position. And then finally, the addition of Abiomed still continuing to grow ahead of our deal expectations, 15.4%. I think that's going to be bolstered by the landmark results, the first time in 25 years, where we have the DanGer Shock study showing survivability benefits of Impella, which will continue to open new markets for that portfolio. And then finally, I'll end with how delighted we are to inch very, very short order, welcome Shockwave to Johnson & Johnson. We closed that transaction in record timing and are really excited by the fact that we will shortly announce that they will be the 13th business with sales in excess of $1 billion annually. And so for all those reasons, Larry, while a tougher second year -- second quarter primarily due to comps, we remain very confident in a solid 2024.
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Operator: Thank you. Our next question is coming from Louise Chen from Cantor Fitzgerald. Your line is now live. Louise Chen: Hi, thank you for taking my question. Wanted to ask you about your Phase III nipocalimab data that you presented recently. And how do you compare and contrast the efficacy and durability of your product versus other FcRns and mechanisms of actions on the market? Thank you. John Reed: Yes, John Reed here. Thanks for that question. Well, we're really excited about the data in Sjogren's with nipocalimab. It's the data we delivered shows really sustained disease control, which is so important by our dosing regimen as compared to some of the intermittent dosing regimens used by others. And the consistent efficacy we've seen across all primary, secondary endpoints, et cetera, is really compelling as a guess that we may be on the first advanced therapy for Sjogren's that disease has ever seen. As you know, that's a very prevalent disorder affecting its estimated 4 million people around the world, perhaps 1 million in the United States, 90% of the people impacted are women right in the prime of life. So, we're really excited about the possibility of bringing forward the first advanced therapy for that disorder. Jessica Moore: Maybe I can add-in a couple of things on as well because we're really excited by what we're seeing from all the data that's coming out. And over the last 18 months, we've demonstrated clinical effect in actually four auto-antibody driven diseases and we are the only FcRn blocker that's in development where we've got proof-of-concept in all three segments of auto-antibody driven diseases from rare auto-antibody to prevalent room to maternal fetal. So as we take a look at all the data that's coming forward as we're bringing this to market, we are even more confident -- in terms of confidence that this is a $5 billion-plus asset for us. Operator Our next question today is coming from Rick Wise from Stifel. Your line is now live.
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Rick Wise: Good morning, everybody. If I could talk a little bit about the EP business. Obviously, this is the first full quarter where we're really seeing a broader launch of a competitive PFA system. You updated us on your system. But maybe if you could give us more color broadly on the impact you're seeing on EP growth and the outlook for the second-half, and help us better understand how this launch and the lot of CARTO 3 version 8 launch is being affected here. I’m assuming mapping growth was strong, but maybe -- I don't know, maybe the catheter business was pressured by the competitive system. Can you help give us that macro color and maybe the specific impact on Biosense Webster. Thank you.
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Tim Schmid: Of course, Rick and thank you for the question. And Rick, I'd start with firstly, recognizing that we believe that PFA is really good for electrophysiology and really good for patients. It is a tailwind for the entire market. And as I mentioned earlier, that's a $5 billion market for us today, growing 19% year-to-date. And let me be clear, we clearly see some competition, especially here in the U.S., especially between now and the time that we bring our PFA technology to market, we're confident. While we don't control the timing, we expect to have that by the end of the year or early next year. As you know, we already have and are commercializing our PFA technology in EMEA and in Japan, and we are very fortunate to actually benefit from a very global EP business. What gives us confidence in the future, Larry, is that we believe that while PFA has a role to play in the portfolio, so does RF. From everything we're hearing from EPs around the world, what they like about PFA is the relative safety of the technology, but they also like about RF, which by the way, we have 20-years of leadership in safety and clinical efficacy, is the durability of that product. In fact, even today, Rick, here in the U.S., for every five procedures where PFA is used, RF is used in conjunction. And so we believe that leisure position that we built over the last 20-years will continue, both in RF and then obviously, we're excited by the launch of our PFA technology. You'll know that at the HRS conference in May, we announced the results of our admIRE study, which showed the 86% relative effectiveness -- primary effectiveness of our PFA technology. And we are going to continue to employ the same strategy we did in RF, which is building out a broad portfolio of PFA offerings, both in dual energy, focal, large focal and single shot. Did you know that today, the number one used catheter on the market is our SPF catheter within RF. And we are -- and you'll know that in the second -- first quarter of this year, we announced a
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is our SPF catheter within RF. And we are -- and you'll know that in the second -- first quarter of this year, we announced a application for a CE mark for our dual energy catheter. This will be one catheter used, both for RF and PFA technology. And so we've got a lot of reasons to believe. And I think to touch on your point on CARTO, one of the benefit of our portfolios, not just our energy source and catheters, it really is the installed base of 5,500 CARTO systems around the world. We just version 8 of that software. It is best-in-class in the market. And that's also complemented by highly trained clinical specialists in every cath lab around the world who are supporting EPs each and every day. And so once again, PFA is a good thing for the marketplace, it's a tailwind and we expect to continue to benefit on that. Thank you.
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Operator: Thank you. The next question is coming from Terence Flynn from Morgan Stanley. Your line is now live. Terence Flynn: Great. Thanks for taking the question. Two parts for me on IRA. Was just wondering if you can offer any perspective on the impact of IRA negotiation STELARA and XARELTO as we're getting close to the disclosure of the pricing decision? And then also Part D redesign in 2025, just some high-level thoughts? And the second part of the question relates to your confidence that DARZALEX FASPRO will be looked at separately than DARZALEX just given the Hyaluronidase component there. Thank you. Jennifer Taubert: Thanks so much for the question. I'll answer the second part first. We do have very good confidence that DARZALEX FASPRO is treated separately than DARZALEX IV. And so yes, we continue forward with that perspective on that. In terms of IRA and kind of what's been going on, if we take a look at Part D redesign, while we're not externally quantifying the impact at this time, what we can say is that we do anticipate a net unfavorable impact in 2025. However, as outlined at our enterprise business review last November, we do anticipate, as a business, growing 3% plus next year and then 5% to 7% out through 2030. And these numbers are actually already included in that guidance that we provided. Same thing as it pertains to the government price setting process, we are still in that. We have received the final numbers from the government, we're not disclosing that at this time. That will be disclosed in the September time frame. And while we are not in alignment with IRA and the price setting process, those numbers have been included in the guidance that we provided last year at EBR, that still looks very good to us today. It's very consistent today.
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John Reed: Since you mentioned, DARZALEX. John Reed here, I thought maybe I would just remind you that actually, in this quarter, we delivered four additional positive Phase III studies with DARZALEX across a number of indications, including transplant ineligible frontline, including in the maintenance setting, after transplant, including smoldering condition that is as large as the entirety of diagnostically defying myeloma and in amyloidosis. So the momentum continues with DARZALEX. Jennifer Taubert: And we had 21% growth. $2.9 billion in sales and 21% growth. So yes, DARZALEX is our single largest asset now for the corporation. Operator: Thank you. Our next question is coming from Josh Jennings from TD Cowen. Your line is now live. Josh Jennings: Hi, good morning. Thanks for taking the questions. I was hoping to just touch on MedTech and outlook for procedure volume trends in the back half. There have been some concerns that there's some tough comps on the utilization side and particularly for [Technical Difficulty] half? And then maybe also, if you could just touch on the pricing environment and your outlook for device pricing and where pricing stands for the MedTech portfolio? Thanks for taking the question.
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Joe Wolk: Sure, Josh. And I think my answer to your sort of volume question will be very brief and consistent with what we've shared before. For the most part, across the portfolio, we've seen volumes normalize. We did mention that we expected to see some of the -- some tailwinds from the backlog within Orthopedics in the first-half of the year. And we've seen that, but we expect that to normalize in the back half. We remain consistent in our belief in the 5% to 7% growth for our end markets and that we will perform well within that. As it relates to pricing, inflation has not been a friend to our industry, and we have put a lot of effort into really ensuring that we can secure preferential pricing across the world. I do think we benefit from the global nature of our business. While there are pockets cost containment efforts that we're managing, like VBP in China, we see tremendous opportunity to really secure a premium pricing, especially where we have differentiated innovation. And especially now that we're entering or are entering is like cardiovascular of significant unmet need, there is tremendous opportunities for us to ensure that we secure premium pricing for truly differentiated innovations, especially in areas like electrophysiology, in heart recovery with Abiomed, and more recently with Shockwave. Thank you. Operator: Thank you. Our next question today is coming from Dave Risinger from Leerink Partners. Your line is now live. Dave Risinger: Yes, thanks very much. Could you please comment on the J&J U.S. pharma exposure to efforts by plans to extract greater rebates in 2025 than in typical years in order to offset Part D plan losses in 2025? Thanks very much.
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Jennifer Taubert: Thanks for the question on that. We're still in the process of working with all payers for the planned formularies and everything for 2025 and 2026. I think what's really most important is to go back to the guidance we provided at the EBR last year in November. And as we take a look at the corporation, we have factored in and anticipated what we think will happen. And as an organization, we feel very confident in the guidance of 3% plus growth in 2025, and really, importantly, that accelerating growth out through the end of the decade, the 5% to 7% growth. Joe Wolk: Dave, I'd also remind you too that over the last six years, and certainly a compliment to John, Jennifer and the team, that innovation really underscores the success that we've had with quarter in, quarter out performance in our Innovative Medicines business. Discounts and rebates six years ago, as compared to list price was only about 25% of that list price. Today, that number -- and this is not just the J&J number, but an industry number, gravitates towards 60%. So what we want to make sure that happens is this great innovation gets to patients and makes a difference in their lives and get them -- they have access through the discounting that we already provide. Operator: Thank you. Next question is coming from Danielle Antalffy from UBS. Your line is now live. Danielle Antalffy: Hey, good morning, everyone. Thanks so much for taking the question. Just a quick MedTech question on China. So China, it sounds like things are evolving in China. I mean this is no surprise to anyone. But just curious about how you guys are thinking about China as a contributor going forward given all the evolution in that market and some of the issues, VBP, things like that. How meaningful? I mean, it's been a big growth driver for you guys historically. How do we think about China going forward? And is the strategy for J&J, does it have to change to adapt to the evolving market there? Thanks so much.
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Joaquin Duato: Thank you, Danielle, it's Joaquin. So we were one of the first companies that started to operate in China, and we've been in China for decades. So we have a history of having constructive engagements with China, and we are looking forward for that to continue. Now we recognize the situation and we have robust business continuity planning practices in place, and we are able to mitigate any potential exposure. But we continue to see China as an important growth driver, both for our Innovative Medicine business and also for our MedTech business. Specifically, you had some questions that Tim can address on MedTech and how we see our MedTech business in China moving forward.
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Tim Schmid: Sure. And Danielle, we are fortunate to have a global business with more than 50% of our revenue already out of the U.S. And I think that gives us the flexibility to really manage a number of challenges that occur on a quarterly and yearly basis across the world. To Joaquin's point, we've been in China for 37-years. One of the reasons why we've been successful is our ongoing commitment in navigating multiple headwinds and opportunities. And when we look at our performance in China, remember, we had the end of COVID when we came out of lockdown, and so that has impacted the results in the second quarter. But when you look at on the ground, what's really happening is there's two factors. Firstly, you look at the impact of VBP, which is a government-driven cost containment effort. And given our leadership position in China, we are seeing that as a short-term tailwind. We do believe the volume opportunity will far offset over time the impact we're seeing on price, but that certainly is a short-term pain that we are enduring. That has also been exacerbated by the anticorruption campaign. You may know that in July of last year, the government initiated an anticorruption campaign, which actually has had an impact on both procedural volumes and engagement from health care professionals. Now I must reiterate that we see this as a really good thing. We believe that any effort on behalf of any government to really build integrity and compliance into the health system is a good thing for more fair competition and aligns with our credo and our commitment to compliance across all of the markets in which we participate in. So it's a short-term headwind, but long-term, really good for our industry and really good for J&J. We remain absolutely committed to China. And we will continue, as we always have, to navigate some of the challenges we have on the ground with pricing and geopolitical challenges, and we remain committed to the 1.4 billion patients who rely on us each and every day. Thank you.
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Operator: Thank you. Next question today is coming from Chris Shibutani from Goldman Sachs. Your line is now live. Chris Shibutani: Thank you. Good morning. Together with my colleague, David Roman, a genuine question that we had related to the MedTech market dynamics and outlook. Can you help us better understand comments that were made about a fair amount of inventory destocking that's been happening and juxtapose that and perhaps reconcile with your expectation that the demand outlook would strengthen. We're just trying to put together this notion of inventory stocking, destocking ahead of an anticipated acceleration versus a potential deceleration or a tougher demand environment going forward? That would be helpful. Thank you. Joe Wolk: Thank you. It's a good question and the only area across the vast businesses that we have, where we have seen a destocking is really in our contact lens business. And you'll recall in the first quarter, we mentioned that on the back of some historical supply chain challenges, the distributor inventory was reduced here in the U.S., and we've now seen that bleed into the second quarter as mentioned earlier. And so that is the only area of significant stocking that has had a short-term impact on our business. As I mentioned earlier, what gives us confidence is that as we look through the full second quarter, we saw sequential improvement across that portfolio. Remember that we actually serve the needs of 40 million patients. We have, by far and away, a market leadership position here in the U.S. and globally with contact lenses. And so we see this as a blip and by no means a longer impact on our ability to continue to be leaders in contact lens. Thank you. Jessica Moore: Thank you, Chris. Kevin, we have time for one last question. Operator: Thank you. Our final question today is coming from Joanne Wuensch from Citibank. Your line is now live.
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Operator: Thank you. Our final question today is coming from Joanne Wuensch from Citibank. Your line is now live. Joanne Wuensch: Thank you very much for taking the question. I'd like to wrap up with the orthopedics question. Hips and knees are growing faster than the historic rates, could you sort of unpack that a little bit and give us an idea of how much of that is patient volume, price, new products or maybe something else? And have a great day. Tim Schmid: You too, Joanne, thank you. We are so proud of, , frankly the resurgence of orthopedics, and I couldn't be more grateful for the incredible effort across the world to really return as to high solid growth across the two platforms that you referenced. Specifically within hips, and I mentioned this in the first quarter, for the first time ever, we were able to declare market leadership position in hips here in the U.S. And to be direct in answering your question, it is all innovation based. It's not only continuing to drive our best-in-class implants, but it's also how we've surrounded those with enabling like our VELYS Hip Navigation and Kenzie. That 6% growth you saw in the second quarter is really indicative our innovation working for patients. On knees, another shout out to the team, almost 10% growth. We haven't seen that historically and once again driven by innovation. In a short roughly 2.5-year period, we have launched our VELYS system for knees into more than 20 markets. We have more than 70,000 procedures, and that is driver of our performance. And what gives us confidence is that we're continuing to build indications. You may know in the second quarter, we received 510(k) approval for our VELYS Uniknee. And we also are looking to build out that portfolio. And in short order, you will see news about our commitment to really bringing robotics to other parts of the orthopedic portfolio, especially in spine. And so once again, it's all innovation driven, and we expect it to continue. Thank you.
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Jessica Moore: Thank you, Joanne, and thanks to everyone for your questions and your continued interest in our company. We apologize to those that we couldn't get to because of time, but don't hesitate to reach out to the Investor Relations team with any remaining questions you may have. I will now turn the call over to Joaquin for some brief closing remarks. Joaquin Duato: Thank you, everyone, for joining the call today. I'm proud of the progress we made through the first-half of the year. And I'm also energized as we look towards the remainder of 2024 and heading to 2025. As the only company dedicated to both medical technology and pharmaceuticals, we are uniquely positioned to lead the next wave of health care innovation. We are entering the second-half of the year from a position of strength, advancing our diverse portfolio and pipeline to continue bringing innovation into the patients we serve. Thank you. Operator: Thank you. This concludes today's Johnson & Johnson second quarter 2024 earnings conference call. You may now disconnect.
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Operator: Good morning, and welcome to Johnson & Johnson's First Quarter 2024 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. [Operator Instructions]. I would now like to turn the conference call over to Johnson & Johnson. You may begin.
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Jessica Moore: Hello everyone. This is Jessica Moore, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of the first quarter business results and our full year financial outlook for 2024. A few logistics before we get into the details. As a reminder you can find additional materials including today’s presentation and associated schedules 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 risk and uncertainties that may cause the company's actual results to differ materially from those projected. A description of these risks, uncertainties and other factors can be found in our SEC filings, including our 2023 Form 10-K, which is available at investor.jnj.com and on the SECs 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 I will start by reviewing the first quarter sales and P&L results for the corporation as well as highlights related to our two businesses. Joe Wolk our CFO will then provide additional business and financial commentary before sharing an overview of our cash position, capital allocation priorities, and guidance for 2024. The remaining time will be available for your questions. Joaquin Duato our Chairman and CEO as well as Jennifer Taubert, John Reed, and Tim Schmid, our Innovative Medicine and MedTech leaders will be joining us for Q&A. To ensure we provide enough time to address your questions, we anticipate the
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and MedTech leaders 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. Unless otherwise stated the financial results and guidance highlighted today reflect the continuing operations of Johnson & Johnson. Furthermore, the percentages quoted represent operational results and therefore exclude the impact of currency translation. Turning to our first quarter sales results. Worldwide sales were $21.4 billion for the first quarter of 2024. Sales increased 3.9% with growth of 7.8% in the U.S. and a decline of 0.3% outside of the U.S. Excluding the impact of the COVID-19 vaccine, operational sales growth was 7.6% worldwide and 7.4% outside of the U.S. Sales growth in Europe excluding the COVID-19 vaccine was 6%. Turning now to earnings. For the quarter net earnings were $5.4 billion and diluted earnings per share was $2.20 versus basic loss per share of $0.19 a year ago. Excluding after tax intangible asset amortization expense and special items for both periods, adjusted net earnings for the quarter were $6.6 billion, and adjusted diluted earnings per share was $2.71, representing increases of 3.8% and 12.4%, respectively compared to the first quarter of 2023. On an operational basis, adjusted diluted earnings per share increased 12.8%. I will now comment on business sales performance in the quarter. Beginning with Innovative Medicine, worldwide Innovative Medicine sales of $13.6 billion increased 2.5%, with growth of 8.4% in the U.S. and a decline of 4% outside of the U.S. Excluding the impact of the COVID-19 vaccine, operational sales growth was 8.3%, both worldwide and outside of the U.S. Innovative Medicine growth was driven by our key brands and continued uptake from recently launched products, with nine assets delivering double-digit growth. We continued to drive strong sales growth across our multiple myeloma portfolio. DARZALEX growth was 21%, primarily driven by share gains of six points across all lines of
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our multiple myeloma portfolio. DARZALEX growth was 21%, primarily driven by share gains of six points across all lines of therapy and ten points in the front line setting. As of this quarter, we are now disclosing TECVAYLI sales, which were previously reported in other oncology. Sales achieved $133 million in the quarter, compared to $63 million in the first quarter of last year, reflecting a strong launch in the relapsed refractory setting. CARVYKTI achieved sales of $157 million, compared to $72 million in the first quarter of last year, driven by continued capacity expansion, manufacturing efficiencies, and strong demand. While sequential growth was roughly flat due to phasing, we continued to anticipate quarter-over-quarter growth with acceleration in the back half of the year. Other oncology growth was driven by continuing strong uptake of TALVEY, our GPRC5D bispecific, and RYBREVANT our bispecific antibody for non-small cell lung cancer. Also in oncology, ERLEADA continues to deliver strong growth of 28.4%, primarily driven by share gains. Growth of 22.4% in pulmonary hypertension was driven by favorable patient mix, share gains, and market growth for both OPSUMIT and UPTRAVI. As a reminder, favorable patient mix was a driver in Q2 2023 through Q1 2024. Therefore, while we still anticipate growth, we expect to lap this dynamic beginning in Q2 2024. Within immunology, we saw sales growth in TREMFYA of 27.6%, driven by market growth and share gains. STELARA growth of 1.1% was driven by market growth and share gains in IBD, partially offset by unfavorable patient mix in the U.S. and as expected, share loss in PSO and PSA. We anticipate continued volume growth largely offset by price declines as we move towards biosimilar entry. In neuroscience SPRAVATO growth of 72% continues to be driven by share gains and additional market launches. Total Innovative Medicine sales growth was partially offset by unfavorable patient mix in XARELTO, which we anticipate continuing throughout the year, as well as a decrease in
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offset by unfavorable patient mix in XARELTO, which we anticipate continuing throughout the year, as well as a decrease in IMBRUVICA due to competitive pressures, partially offset by stocking dynamics in the U.S. Finally, it is worth noting distribution rights for REMICADE and SIMPONI in Europe will be returned in Q4. I'll now turn your attention to MedTech. Worldwide Med1ech sales of $7.8 billion increased 6.3%, with growth in the U.S. of 6.6% and 6.1% outside of the U.S. In the quarter, worldwide MedTech growth was negatively impacted by approximately 80 basis points due to fewer selling days, disproportionately impacting orthopedics. In cardiovascular previously referred to as Interventional Solutions, electrophysiology delivered double-digit growth of 25.9%, with strong growth in all regions. Performance was driven by global procedure growth, new product uptake, commercial execution, and a onetime inventory build in Asia-Pacific, impacting worldwide growth by approximately 370 basis points. In addition, Abiomed delivered growth of 15%, driven by continued strong adoption of Impella 5.5 and Impella RP technology. Orthopedics growth of 4.8% includes a onetime revenue recognition timing change related to certain products across all platforms in the U.S. positively impacting worldwide growth by approximately 300 basis points. As a reminder, orthopedics was over indexed by the impact of reduced selling days in the quarter. Strong performance in hips and knees was driven by procedure recovery, growth of new products, and commercial execution. While trauma and spine were negatively impacted by competitive pressures and core trauma was further impacted by weather related softness in the U.S. Growth of 1.9% in surgery was driven primarily by procedure recovery and strength of our bio surgery and wound closure portfolios, partially offset by competitive pressures in China volume based procurement and energy and endo cutters. Contact lenses declined 2.3%, driven by U.S. stocking dynamics, partially offset by strong
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and energy and endo cutters. Contact lenses declined 2.3%, driven by U.S. stocking dynamics, partially offset by strong performance in ACUVUE OASYS 1-day family of products. Worldwide growth was negatively impacted by 120 basis points due to the Blink divestiture in Q3 2023. Surgical Vision grew 1.1%, driven by CNIS EYHANCE, a monofocal intraocular lens partially offset by China's VBP. Now turning to our consolidated statement of earnings for the first quarter of 2024. I'd like to highlight a few noteworthy items that have changed compared to the same quarter of last year. Cost of product sold margin leveraged by 160 basis points, primarily driven by lower COVID-19 supply network related exit cost. Selling, marketing, and administrative margins deleveraged 110 basis points, driven primarily by timing of marketing investment in the Innovative Medicine business. We continued to invest strategically in research and development at competitive levels investing $3.5 billion, or 16.6% of sales this quarter. We invested $2.9 billion, or 21.4% of sales in Innovative Medicine, with the increase in investment being driven by continued pipeline progression. In MedTech, R&D investment was $0.6 billion, or 8.3% of sales, a slight decrease driven by phasing. Interest income was $209 million in the first quarter of 2024, as compared to $14 million of expense in the first quarter of 2023. The increase in income was driven by a lower average debt balance and higher interest rates earned on cash balances. Other income and expense was income of $322 million in the first quarter of 2024, compared to an expense of $6.9 billion in the first quarter of 2023. This change was primarily due to the $6.9 billion charge related to the talc settlement proposal recorded in the first quarter of 2023. Regarding taxes in the quarter, our effective tax rate was 16.9% versus 61.8% in the same period last year, which was primarily driven by the tax benefit on the talc settlement proposal recorded in the first quarter of 2023. Excluding special
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primarily driven by the tax benefit on the talc settlement proposal recorded in the first quarter of 2023. Excluding special items, the effective tax rate was 16.5% versus 15.9% in the same period last year. I encourage you to review our upcoming first quarter 10-Q filing for additional details on specific tax related matters. 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. In the first quarter of 2024 our adjusted income before tax for the enterprise, as a percentage of sales increased from 36.1% to 36.8%, primarily driven by an increase in non-allocated interest income with both Innovative Medicine and MedTech margins remaining relatively flat year-over-year. When comparing against the fourth quarter and full year 2023, Innovative Medicine and MedTech adjusted income before tax margins have improved. This concludes the sales and earnings portion of the call. I am now pleased to turn it over to Joe.
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Joseph J. Wolk: Thank you, Jessica. Hello, everyone. As you just heard, we are off to a solid financial start in 2024, complemented by sustained momentum within our Innovative Medicine and MedTech pipelines, marked by significant regulatory and clinical milestones. Before we delve into segment highlights from the quarter, I want to touch upon some important announcements that we made that will further enhance our competitive positioning. Earlier this month, we announced a definitive agreement to acquire Shockwave Medical. Johnson & Johnson has a long history of addressing cardiovascular disease through both our Innovative Medicine and MedTech businesses. The acquisition of Shockwave with its leading intravascular lithotripsy or IVL technology will provide us with a unique opportunity to impact coronary artery and peripheral artery disease, two of the highest growth innovation oriented segments within cardiovascular intervention. This addition is not only adjacent to our other cardiovascular businesses but also consistent with our strategy of becoming a best-in-class MedTech company. During the first quarter, we also expanded our Innovative Medicine portfolio with the completion of the Ambrx acquisition. With its promising pipeline and ADC platform, Ambrx will further strengthen our oncology portfolio and ability to deliver enhanced precision biologics that treat cancer. Now I'll move to segment highlights from the quarter. As Jessica previously shared, our growth in Innovative Medicine continues to be driven by momentum from key brands and the adoption of new products. During the quarter, we hit several regulatory and clinical targets that are key to delivering longer-term growth. Starting with oncology, in multiple myeloma, we received FDA approval and a positive CHMP opinion for CARVYKTI for patients who have received at least one prior therapy, making it the only BCMA targeting treatment available for patients in the second-line setting. We also received biweekly dosing approval from the FDA for TECVAYLI, the