Thanks, everybody. Welcome back from lunch. I'm Lee Hambright, US MedTech analyst at Bernstein, and we are thrilled to host Johnson & Johnson Chairman and CEO, Joaquin Duato. Thank you so much for being here.
Thank you.
We're scheduled here for a 50-minute fireside chat. Just a reminder that you can submit questions at any time through the Pigeonhole app, and we'll try to work in as many as possible. So Joaquin, you've been in the CEO role now for almost 2.5 years. Maybe you can kick us off with some opening remarks on how you see the state of the business at Johnson & Johnson.
Thank you. Yeah, it's been 2.5 years after 35 years in the company, so I've been around for some time. So we had a very strong Q1, so that gives me confidence on the trajectory of the company and on the health of the company overall.
Our growth in the Q1 was 8%. We grew 8.3% in our Innovative Medicine business, and we grew 6.5% in our MedTech business. So it was a good start of the year. And normally, if you want to have a good year, a good Q1 is always a good condition. In Innovative Medicine, we had some important progress in our pipeline overall.
For example, we had the approval of CARTITUDE-4, which is the indication of our BCMA CAR T in one prior line. And that's gonna expand the market for our BCMA CAR T medication that is called CARVYKTI, which is one of the medicines that we have pointed out to be more than $5 billion medicine.
We also presented important data on some of our major products. For example, we presented data from TREMFYA, our IL-23 in the Digestive Disease Week that happened several weeks ago, both in ulcerative colitis and in Crohn's disease, and those were phase III data. In that context, we have already filed in the U.S. for the indication of TREMFYA in ulcerative colitis.
We also presented important data of our frontier study with our oral IL-23 targeted peptide, and that's going to be another important asset in our portfolio. We continue presenting data, and you're gonna see some data in this upcoming ASCO next week of amivantamab, specifically on the subQ formulation.
So we had, you know, important data presentations, filings, and approvals during the Q1 that shows how well we are working in delivering in our pipeline. I don't think we have had a single misstep in our pipeline in the last 24 months, so every single aspect of our pipeline is delivering exactly where we want it to be. In MedTech, which we grew 6.5%, we also had significant progress in pulsed field ablation.
We are market leaders in ablation, and we have made a lot of progress in pulsed field ablation. We had the approval of our new PFA catheter called VARIPULSE in Japan and in Europe. We already have filed for VARIPULSE in the US, so our expectation is that we will be in PFA in the US, sometime at the end of this year or next year.
And we continue to make progress in some of the acquisitions that we just did, for example, Abiomed, which is performing ahead of our expectations. We completed the Impella ECP study, which is the Impella with a smaller French, with nine French, which is gonna be easier to be able to place the pump.
Importantly, during the Q1, we signed the agreement to acquire Shockwave, which is gonna help us entering into the fast-growing market of coronary arterial disease, which is a great complement also to our Abiomed franchise.
And it configurates what I think it's one of the best specialty cardiology franchises in the MedTech industry, with a combination of atrial fibrillations with Biosense Webster, heart failure with Abiomed, and then calcified arterial disease with Shockwave. So we are pleased of that. You know, keeping in MedTech, we also initiated the clinical studies with Laminar, our new atrial appendage, we call it, elimination device.
Mm-hmm.
That's another important innovation that we can bring into a fast-growing market. So overall, great progress from an operational perspective, with 8% growth for an $85 billion company, and also great progress in our pipeline, meeting every single milestone that we had put in front of us, showing the quality of execution of a company like Johnson & Johnson, and that makes me really confident in the future of Johnson & Johnson.
Amazing, amazing. Very exciting stuff to double-click on there. But before we jump into some of those points, across the businesses, pulling up and talking about priorities, you know, you, you, you've said that your top three priorities are to, number one, make MedTech a best-in-class performer. Two, deliver on long-term growth goals in pharma. And three, ensure the successful creation of a new consumer health company. Kenvue, of course, IPO'd successfully last year. Maybe you can give us some updated thoughts on how you're thinking about your priorities?
Yeah, so we can check one of the priorities already, right? Which was the successful creation of a new consumer champion, which is Kenvue, which is now a public company, and it was a very successful IPO. Also, in a moment in which most of the markets for IPOs were closed. So I think it was a good demonstration of the quality of Kenvue as a company. When I think about the priorities that are remaining and when I think about Johnson & Johnson, my first priority is to be able to continue to be a multi-decade successful company.
We have 138 years of history, 62, 62 consecutive years of increasing our dividend, and that's because we have a high-quality company, which is a principal company, where, you know, putting the patient at the center is paramount to everything we do. A company with high-quality people. People at Johnson & Johnson stay longer than in other companies, high level of engagement.
There's not a meeting that I don't go, that they don't tell me the high quality of the Johnson & Johnson people. And then, at the same time, an operating model, which is based on being a diversified company, not a one-trick pony company, that has enabled us to be successful during a long period of time. So that's my goal.
My goal is to bring a company that it has success over decades, not only in the next two or three years, that's already for sure. I will discuss that with you later, is that we build a company that is able to grow over decades, the way we have been able to do. That takes a special type of company, and I think that we are unique in the healthcare industry.
Mm-hmm.
We are the only company now that can bring, all the capabilities and expertise to be able to have an impact in, in major diseases like cardiovascular, oncology, trauma, neuroscience. We are the only company now that has the ability to have med tech and pharmaceutical business, and, and that, I believe, it's one of the reasons we can be more diversified, we can reach to more customers, and we can have better insights to develop unique products and solutions.
So that makes us special, and, and that's one of the reasons of success. When I think about, the projections that we have for the company in this decade, most of them were already outlined in our enterprise business review, that I hope you-
Mm.
You were there, Julie, in November last year. We spoke about the fact that we are projecting 5%-7% compounded average growth from 2025 to 2030. So that is our estimation, and that is including all the different pros and headwinds that we are going to be experiencing during that period.
So for a company our size, last year we were $85 billion company, being able to project 5%-7% growth over the next 5 years, I think it's a very significant achievement. And, oh, by the way, it's very rare for us that we have missed any projection that we have put out there.
Mm-hmm.
I mean, in pharma, we spoke about our portfolio. We commented on the fact that we have 10 assets of more than $5 billion and 15 assets of $1 billion-$5 billion peak year sales. And in med tech, we also discussed the fact that we plan to grow at the top end of our markets in the period of 2022-2027, and that we continue to make progress in moving into faster growth markets.
Now, 50% of our sales in med tech, which has had a very positive trajectory, 8% growth in 2023, being the second largest med tech company. 50% of our sales are in what you call faster growth markets, so markets that are growing more than 5%.
So I'm, I'm very optimistic about our ability to continue to drive best-in-class growth in pharma, which is one of my priorities, even in the context of the entry of the biosimilars of Stelara. And I'm very optimistic in driving our med tech group, which is a more than $30 billion group, into being a best-in-class group, and we are in the middle of that transformation.
And when I think about the growth that we delivered in the Q1 or last year, it's already there. It's a reality. It's not something that investors need to wait to see happening. It's happening already as we speak.
Great. Before we get into a lot of those exciting opportunities, one thing we just need to get out of the way is, talc. There's been a lot of recent activity related to talc litigation. How is the prepackaged bankruptcy different from your previous attempts? And how confident are you that you can get to that 75% support threshold that you need by the end of this solicitation period in July?
Let me tell you upfront, I mean, 99.9% of the people at Johnson & Johnson is working in delivering medical devices and pharmaceutical products for patients in need. So in our company, everybody's focused on that goal. Now, we have to address our talc situation, and we have clearly stated that we are unequivocally decided to be able to put talc behind us.
So rather than having to use time in these meetings discussing about talc, we can continue talking about the exciting things that the 135,000 employees of Johnson & Johnson do every day, and how we are improving the standard of care for patients globally. So I mean, what is the strategy now? What's different? What's different is that we are letting the claimants vote.
It's as simple as that. What we are doing now is that we are entering into a solicitation of votes period, and we are letting the claimants vote. We are focusing on claimants with ovarian cancer. We have essentially addressed claimants with mesothelioma that we have addressed 95% of them. We have addressed the consumer protection claims from the states, and we are focusing now in claimants with ovarian cancer.
What we want is that for these claimants that now represent more than 99% of the claimants, we let them vote and see if they want to go along with the reorganization plan that we have presented, that we think is very fair. So that's my expectation. Let the claimants vote. I mean, the vote will be what it'll be.
I am not going to comment on that myself because people may consider that I'm positively biased, but many of your colleagues have issued reports after consulting with legal experts. I'm sure you have consulted with legal experts, and some of you may have consulted with legal experts. In every single note issued by your colleagues in consulting with legal experts, the opinion that has come out is that we have a high probability of success.
Yeah.
I'm going to leave it there. I'm not a lawyer. I'm not prepared to go more. I mean, the strategy, if somebody asks you, is simple: let the claimants vote. If we let the claimant vote, we are confident that with any other interference, we will be able to move forward.
That's great. Great. Hopefully, we're not talking about this next year. It seems like a good good potential that this is gone by the end of the year. Let's hope. Okay, EPS expectations. So you're, you're guiding to organic sales growth of 5.5%-6% in 2024, and EPS growth of around 6.5-8 this year. Consensus has EPS growth dropping a bit in 2025 as Stelara LOE becomes a little bit more of a headwind. How do, how do you think about key sources of upside and downside to current investor expectations?
So, I mean, if I give you the big picture, what we have said is that we, we see 5%-7% growth in the, in the following five years, including in 2025, that we guided to 3% growth, and that's in the context of the Stelara biosimilar entry. I cannot think about any other company that in that scenario, it's able to grow. And if you give me one example, I would be very appreciative. But I can- I cannot think about any other company that in that scenario, it's able to grow.
What we have discussed as far as margins, other than the guidance we have provided for 2024, that is already public, is that given all the puts and takes that we're going to have during that period, our EPS growth is going to be, we use the expression, commensurate with our sales growth. Obviously, there's going to be ups and downs with that.
I mean, in certain periods we may be ahead, in other periods we may not be ahead. That's driven by the situations that we're going to go through every year. But we are committed to deliver earnings growth, which is commensurate with our sales growth, even in the context of the headwinds that we have in front of us.
Very good.
Sources of upside. Look, I think that if investors would believe the 5%-7% growth, there's a lot of upside, right? Because while we are very much in the same place when it comes to 2024 and 2025, as far as the projections, we have a divergence in what happens post-2025. So if we are able to deliver what I told you, the 5%-7% growth, there's a massive upside versus the consensus that the sales side have. So that in itself is an upside.
Mm-hmm.
So the upside that I see is, you know, to what extent, you know, you are able to believe the 5%-7% growth, and what upside exists with that growth versus the existing consensus. I get very frequently asked, "Where are the disconnects?" I would say there's lots of disconnects, and you may want to talk to me about that. But I mean, they are in existing products like TREMFYA-
Mm
... in which the biggest indication, which is the ulcerative colitis and Crohn's disease, has not been factored in yet. And they are adding new products that maybe are more difficult to understand, like our drug-eluting stent for non-muscle invasive bladder cancer, which, as you know, have an analog, is difficult for people to forecast, and we have said $5 billion.
The consensus is 400. So just there, you have a reason to think about. Either we don't know what we do, or there's some disconnect there. And as I told you, we have a track record of delivering in our commitments, and we plan to deliver of that. I think that if you want to look for a source of upside, it is in the disconnect that exists from 2025 onwards between our projections and the models that the analysts are putting forward.
Very good. Let's talk about M&A. So from the start of your tenure, you've talked about getting more acquisitive, particularly in med tech. Your CFO, Joe Wolk, raised some eyebrows last year when he referred to J&J's M&A appetite as voracious. You know, starting in med tech, you've done a couple of larger deals recently with Shockwave and Abiomed. Should we expect more big deals in med tech, or do you need a little bit of time to integrate those two first?
It's good that I have English as a second language, and then I cannot use such florid language as the CFO. But M&A, I mean, it's always been an important component of our capital allocation priorities. So just to be clear, our capital allocation priorities are in order, investing in our business. Last year, we invested $15 billion in research and development. I believe that that makes us the largest investor in R&D in healthcare.
The second one is to continue to grow our dividend, and we have 62 consecutive years of dividend increases. That's a pretty good proof that we plan to continue to grow our dividend. The third one is M&A, and then finally, look, we also would consider share repurchases, share repurchases as appropriate.
So M&A, how do we look at M&A, I mean, in general? I look at M&A as something that I am agnostic to the sector, and also we have the ability because the strength of our balance sheet, we are a AAA-rated company, so we can still have significant leverage if we elected to do so. We are agnostic to size. So we're open to any opportunity that we think can create value.
There's a number of criteria we use when we look at that. One is, is it close to our areas of expertise? We always have seen that if we acquire companies that are close to our area of expertise, we have a higher probability of creating value than if we acquire a company in which we don't have capabilities, and we don't have good insight and knowledge.
So we always look at our areas of expertise, and they are very wide, by the way. I mean, because we operate in oncology, in immunology, in cardiovascular, in neuroscience, in orthopedics, in vision, in surgery. So there's a lot of, you know, waterfront for us to be able to look at, in which we have experts.
The second one is that we wanna make sure that it's a true innovation, so it's a clear improvement on the standard of care. We are not about buying me-toos. When we do M&A, it's not because we see synergies from a cost perspective, it's because we see growth. And that's the reason we buy companies, is because we see growth.
We are not buying companies to create synergies by cost cutting, and that's why we don't look that much at large M&A, because that's not something that we think it's conducive to creating value over the long term. And then the third one is that we have to be disciplined in our financial metrics in order to maintain a high return on capital investment for the investors.
We have, you know, very high return on capital investment in our pharmaceutical business, without any question, the highest return on capital investment of any company at Johnson & Johnson, based on the fact that we have done relatively, you know, minor M&A. So that's the principles. Now, I have to tell you, we are doing M&A all the time, every day, but it doesn't make the headlines.
Last year we did in pharma alone, about 50 deals, and some of them are starter partnerships, some of them are alliances, some of them are acquisitions. So we don't stop doing M&A. I mean, every week or every other week, we are doing M&A. This past week, we did two acquisitions. Nobody even pays attention to it, but we did two.
We acquired a company called Proteologix for $850 million, that has bispecific antibodies, and we just announced this week that we acquired a subsidiary of a Swiss company called Numab, that has a bispecific antibody in atopic dermatitis for a total consideration of $1.5-$50 million. But nobody covers that, you know? But we don't stop doing M&A, and we go to the sweet spots.
The sweet spot for us in pharmaceuticals is early on in areas in which we have expertise and we can add more value. Yes, in med tech, we have done bigger M&A, Shockwave and Abiomed. The total consideration combined is $30 billion, because we had the stated goal of moving into faster growth markets, as I said from day one when I became CEO.
And with Abiomed and Shockwave, we are moving into faster growth markets in cardiology, which I think it's a good area. Are there good areas in orthopedics, in surgery, and in vision? Absolutely, there are good areas too, and we will continue to look at the areas, but the first two that we identified were there in, in cardiology. So that's our approach to M&A, is agnostic to sector and to size. It has to meet certain criteria.
What we have found that creates more value is to go early on, to nurture internally those opportunities, so we can utilize our scale in development, in manufacturing, in commercialization, to create more value than if we were going to buy an established large company.
Yeah, very good. So, like you said, big investment in cardiology and med tech, you know, is there potentially more focus in that area going forward that is an area of high growth overall, or would you say it's still kind of agnostic across cardiology?
I am agnostic. We also acquired Laminar, for example, too-
Yes, yes.
In the area of left atrial appendage, we call it elimination, not closure.
Yeah.
And we will continue to look up opportunities there. What I want to say, I mean, we are not only looking in cardiology. Cardiology is one aspect, and, you know, now we have integrated two companies, you know, Abiomed and Shockwave. And we are also interested in opportunities in other areas in which we operate that may be faster growth markets. Most of them are relatively small M&A.
Yeah, very good. Okay, in MedTech, you know, end markets have been pretty healthy. You've talked about parts of your MedTech business, particularly in ortho, that benefit from continued recovery of COVID-related backlogs. Some investors worry a little bit that growth could decelerate when those COVID backlog recovery tailwinds start to peter out... Can you talk to that a little bit?
Yeah, I mean, it's true that for everybody, especially in 2023, there's been some tailwind from the COVID COVID backlog. I mean, that, that COVID backlog is improving now in 2024. If I look at our existing growth that we are experiencing, it's based on our improving operational performance and an, and an improving introduction of new products into the market.
Mm-hmm.
So if I look at our growth in orthopedics, for example, especially in areas that we had high single digits, double-digit growth in the Q1, like knees, hips, or shoulders. The growth is driven by the fact that we are introducing new products.
For example, in the knees, we see increased utilization of our robot, VELYS. We have our ATTUNE platform that we think is a best-in-class platform, that combined with VELYS, is having a very positive impact. When we go to hips, we have anterior, our anterior approach with ACTIS. Some of the technologies like KINCISE, VELYS hip navigation, which is helping us. Our shoulders are doing very well.
So I think it's a combination of our improved execution and the cadence of introduction of new products that is making us very sustainably stabilize or improve share in every market that we are competing. So I don't see that as something that is only the result of the COVID backlog. I think it's an improved execution on our side, and I'm confident on the trajectory of our orthopedic business, to which we are very committed.
As you know, in our orthopedics business too, we are doing a restructuring plan in order to be able to improve our operating margins, and we are in the middle of that plan, too. So yeah, I'm optimistic about our improved execution and cadence of new products in our orthopedic business, driving growth, as you have seen in the Q1.
Very good. Let's shift to Biosense Webster. This has been such a strong business for you. Been a dominant player in AFib ablation for a very long time. Obviously, lots of excitement about pulsed field ablation right now. A couple of your competitors are working hard to ramp up new PFA systems, but your EP business continues to grow really nicely, and you've got a bunch of investments in the PFA space as well. Now, what's your outlook for J&J's EP business as competitive PFA systems ramp up?
The headline is that we plan to remain the leaders on the atrial fibrillation ablation market. First, the market, it's going to grow. It's going to grow because it's under-penetrated, and it's under-penetrated in part because of awareness issues, but also because of capacity issues. So there's not enough electrophysiologists.
There's not enough capacity to address the incoming patients. So PFA, as a new modality, it's going to make it potentially easier for more people to be able to do ablation, and it may require less time. So that's gonna increase the capacity, and as a consequence, as the patients are there, you're gonna see an increase in the market of atrial fibrillation ablation. We guided in our EBR 11%-13%. We may have come short in that estimation of market growth in ablation.
So I think that that's gonna be something good for everybody. Now, I want something good for us also, right? So we are going to remain the market leader there. We have very nice growth in the Q1. We have a suite of catheters in development. I explained them before. We have VariPulse, which is a loop PFA catheter that has been approved in Europe and in Japan. We have filed in the U.S. already, so it's possible that we have VariPulse, our first PFA catheter, at the end of this year in the U.S.
Mm-hmm.
We also have a dual energy catheter that is being already submitted for CE mark in Europe. Dual energy, meaning it will have radiofrequency and PFA in the same catheter, and it will be the catheter that electrophysiologists are more used to manage, which is our own SF. And then we have a focal catheter called OMNIPULSE, that we are filing now in the U.S. to start our clinical trials.
We're filing our IDE. So we're gonna have a suite of catheters. But most importantly, we are the ones having now the best mapping system in the market. We are just now upgrading our mapping system to version eight. So clearly, we have the best mapping system in the market, which is fundamental for the electrophysiologist in order to know where they are and what to do. Even today, 70% of the PFA cases that are done in the US are done with our own mapping system.
Mm-hmm.
So the combination of the PFA suite that we have, the strength of our radiofrequency portfolio, because radiofrequency will still have a role. Our information is that in 20% of the PFA cases, you still have to go with radiofrequency in order to get deeper lesions. So the strength of our radiofrequency portfolio with QDOT, that you know, that is a best-in-class catheter.
Plus, you know, our mapping system and our installed base of mapping systems, which is in version 8, with 5,500 mapping systems installed in the U.S., and the largest clinical support group that we have in the country, it's gonna make us remain market leaders there and be able to drive what is gonna be a significant expansion of the market driven by PFA, and it will continue to be a core driver of growth for our MedTech business.
Very good. So, also within cardiovascular, you've touched on Abiomed, Shockwave, and Laminar. Maybe can you talk a little bit about how J&J brings value to those three deals, and how they together help build on your presence in cardiovascular?
Yeah. I'll talk, I'll talk about—more about Abiomed and about, Laminar. We have not yet closed-
Yes
... Shockwave, so I have to be more economic on that. I mean, we plan to close mid-year, and every single milestone is progressing well. So Abiomed, great company. We are exceeding our model of acquisition in our growth, 15% growth in the Q1. We are also exceeding analyst consensus numbers.
Mm-hmm.
And we are excited about the possibilities that we have with the Impella CP, which is the most used pump, which with Impella 5.5, which is the surgically implanted pump, which is launching and is doing really well. And at the same time, we have just completed the clinical study for Impella ECP, which is the smaller bore 9 French pump, which is gonna make it easier to insert and to implant.
So we are very positive about the progress that we are doing because of the different pumps, and at the same time, we continue to progress with our clinical studies. PMA intended clinical studies. One is PROTECT IV, which is in our existing indication to demonstrate superiority versus standard of care. The other one is STEMI DTU, which is in myocardial infarction without shock, and we have a large trial there in STEMI DTU.
So these two trials are on one side. One is gonna reinforce the benefits of utilizing the pump versus other strategies that the interventional cardiologists may want to use, and that's gonna reinforce the use of it. The other one, it will open a large population of patients with heart attacks and no cardiogenic shock.
So I'm excited about that, and I'm excited about the possibilities that it may have. Together with that, what Johnson & Johnson can bring is not only continue to execute fully with these programs, but also the international expansion-
Mm
... of Abiomed into other markets that would utilize our global capabilities that otherwise a smaller company would not have been able to do. And if we do a proxy with atrial fibrillation of Biosense Webster, there's a lot of room for Abiomed to have the same weight of ex-US sales that Biosense Webster has today.
So there's a significant portion of the value creation, which is driven by the international or US expansion of those technologies. So very positive about Abiomed, and I mean, the proof is in the reality. We are exceeding the analyst models and not... I want to tell you, most of the deals do not exceed the analyst models when they are completed, so this is an exception in which it's exceeding the analyst model. That has given us the internal conviction to move on and sign an agreement to acquire Shockwave, that has an impressive technology for calcified arterial disease.
Mm-hmm.
Which, by the way, is very complementary with Abiomed, because in high-risk percutaneous interventions, sometimes there are calcified arteries, so, the Shockwave technology and the Abiomed technology sometimes are used in the same intervention. It's a fast-growing technology. You've seen the results of the Q1. They have been really strong.
Mm.
And, we're looking forward to onboard them into Johnson & Johnson. They will be an independent company, the same way that Abiomed is. Our goal with this company is we're playing for growth. We're not playing for cost synergies, so there's a lot of growth to be gained, both in Abiomed and in Shockwave, so we plan to run them independently.
But certainly, it's creating a very differentiated, high-growth franchise in cardiology between Biosense Webster, Abiomed, and Shockwave. And then to close with Laminar, I mean, it's an interesting market. We are already in clinical trials, so earlier than we thought.
And, and that's something that may enable us to have a differentiated offering in a growing market of left atrial appendage closure, and that's another opportunity. And that's another way of investing in cardiology. It's not only about acquiring companies that are already in the market, but also about acquiring companies that may have some runway until they get to market.
Very good. You mentioned VELYS briefly before. In Orthopedics, you've got nice momentum with your VELYS robotic platform. Within the first couple of years, you're in 18 markets. There's growing adoption in ASCs. You've done a lot of procedures, over 50,000 procedures. What's your strategy here to differentiate VELYS from the other orthopedic robots that are out there?
Yeah. So we are pleased with VELYS. There's been already 50,000 procedures utilizing VELYS. Together with some of the improvements in our ATTUNE line that we have done with the cementless knee, with our medial stabilizer, it's giving us the growth that you are seeing in our knee platform. So we are pleased with the VELYS introduction.
What we hear from orthopedic surgeons is that VELYS is a more compact robot than the competition, and it occupies a smaller footprint. So especially in the context of having crowded operating rooms or even in the context of ASCs, having a smaller footprint as VELYS has, is an advantage. I'm sure you've seen Mako and VELYS, right?
Mm-hmm.
So you realize how different they are in the footprint. So I think that's an advantage that orthopedic surgeons are seeing. And fundamentally, it remains that they like ATTUNE, they like our knee. So I often hear, and I also attend many of the orthopedic meetings, that we have the best knee platform in the market.
So I think that what we were missing was the robot. So now that we have the robot and the best knee platform in the market, you know, we have the opportunity to regain share, and to deliver growth in our, in our knee, in our knee platform. We are doing really well with our hip platform, too. I mean, our data shows that in the Q1 of 2024, for the first time ever, we are market leaders in the U.S. in numbers of procedures.
Very good.
So we are doing very well in our hip platform. That's our modality with Actis, with the anterior approach. It's our KINCISE for preparation, so we are very pleased. It's our hip navigation software, which is helping in the placement, so we are very pleased also with our hip trajectory, and we are very confident on the growth trajectory that we have in orthopedics.
Very good. MedTech analysts love talking about robots. You have lots of, lots of robots across the portfolio. Monarch is your endoscopic surgery platform. You're the only one out there that has two indications there, one for bronchoscopy and one for endourology. That's an increasingly competitive market with another competitor in that space. Can you just talk a little bit about progress on Monarch and sort of plans for the future there?
So we're progressing well in our robotic bronchoscopy area. We are improving our overall operational performance. We're improving the system, we're improving our cost of goods, and we are getting to more hospitals. I'm excited about the opportunities in endourology. For the audience, you know, it's in kidney stones, in difficult to treat kidney stones.
And it is an opportunity in which, at this point, we are the only company working on that too, and it's a significant market. I think that Monarch also, on top of that, could be a platform for us in what you would call interventional urology or interventional oncology, because with our robotic-assisted system, we could deliver drugs, energy, or other devices directly into the urogenital system or into the lungs.
Mm-hmm.
So it's not only exciting as a diagnostic treatment, as a diagnostic in bronchoscopy or as a treatment in kidney stones, but also, you know, it has the possibility of being a platform for us to deliver energy, other devices or drugs into those systems.
Yeah.
So, an exciting platform, and we just got the approval of, Monarch bronchoscopy in China, and China, as you know, has a high incidence of lung cancer. So we are looking forward to see another, opportunity for growth of Monarch today, based on the Chinese approval.
Great. Maybe rounding out the robotic trio, Ottava. You know, there's still a bit of work to do on your soft tissue robot, Ottava. You're targeting FDA IDE submission in the second half of this year. You know, Medtronic is out there and potentially will have a bit of a lead.
Maybe can you share your thoughts on how you will compete in the market for soft tissue robotic surgery? And then, how do you think about that trade-off between kind of maximizing Ottava's capabilities, really focusing on bringing something new and different to the market versus potentially waiting, you know, too long?
It's a balance. So, I feel good about the system that we have and our ability to compete with the incumbent. Why do I feel good? One, because we have a differentiated system, and I will explain the differentiation in a second.
The other element is because surgeons want to have competition, and they are going to welcome having other robotic soft tissue systems in the market, especially if they are coming from Johnson & Johnson, because they have been working with us for decades. For decades. Many of them have been trained with our instruments. All of them use our sutures, so they are gonna welcome to have another competitor there.
So the combination of the differentiation of our system, that I will go into in a second, and the fact that it's us, and they want to have other options, which I think it's logical, make me confident that we're gonna be successful. Why do I think our system is different? One is that, you know, we have a different architecture. So, we have a unified architecture in which the arms are integrated into the bed.
That makes it more seamless, occupy a smaller footprint, and in a very crowded OR, that's something that matters. The second thing is because we have a feature which we call Twin Motion, so the bed and the arms move in unison. So you don't need to move the patient, it's gonna all move together.
Mm-hmm.
In the feedback that we have gotten from surgeons that have been testing, road testing the system, that becomes really important and convenient. And then the third one is because our system will carry the Ethicon instruments that are the instruments that they prefer and the instruments that they have trained with, the instruments that they are used to.
So they will carry our energy devices, they will carry our staplers, and I think that's gonna be a significant advantage for what we hear from our surgeons or the surgeons that are testing our system. So I'm confident that we're gonna continue to progress with Ottava. As you mentioned, we're gonna start clinical trials in the second half of the year.
I'm confident that we have the differentiation elements, including our instruments. I'm confident in our established relationships globally with the surgeons, and I'm confident in our ability to deliver there, as a growth driver for us in the second half of the decade.
Very good. So a couple questions from the audience. One, about the longer term outlook. The question is, does the 5%-7% revenue and EPS guide and the EPS guide over the next five years, or this means from 2025 to 2030, does that include the two big MedTech deals?
Yeah, everything is included there. I mean, we have a cadence of M&A that I would consider business as usual. So I don't think that what we have done in the last two years is different from business as usual. It would not include things that would be outside of the business as usual. Then if we would do large M&A, I would not consider that something that plays into that equation.
But, you know, everything that we have done so far, I would consider that part of our normal cadence of M&A. It's nothing extraordinary when you look at the amount of M&A that we do annually. It's relatively small for us. Even the contribution from a sales perspective is not that material, you know? So-
Yeah
... it's more a new growth driver, a multi-decade growth driver, that we have in our toolbox.
Got it. Maybe another one, you know, you touched a little bit on the benefits of having pharma and med tech under the same roof. You know, how do you think about sort of tangible examples of benefit from that strategic combination?
I will give you one. And look, I think at the end of the day, it's all about the numbers. It's all about, can you deliver higher growth in revenues and in earnings by being a company that is unique, as I said, that can play in the entire patient journey, both in med tech and in pharma?
When we compare ourselves with the company our size, and I underline size, in 2023, we are better than them in every single line. We're better than them in revenue growth, we're better than them in margins, and we're better than them in earnings growth. There's no question about that. So the proof is there.
Mm-hmm.
When we compare ourselves with companies our size, more than $30 billion in med tech and more than $50 billion in pharma, we are better than that competitive composite. Now, do you want tangible examples of how we combine the technology? I just mentioned one. It's our drug-eluting device called TARIS. We presented data in the latest American Urological Association.
Two platforms, one that releases gemcitabine, another one that releases erdafitinib, which is an FGFR inhibitor. Both of them have breakthrough designation, and we have guided that these are gonna be more than $5 billion peak year sales. This is the result of our understanding of how to combine a drug in a device, in a product. It's gonna be a very large product, and it's only possible because of our expertise in both areas. So those are two tangible examples.
I think that this combination is unique. This is different from other combinations. I mean, we are not combining an aerospace company with a bank, with a chemical industry. No, we are talking about a company that is working in the same diseases, cardiovascular, oncology, orthopedics, that is having exactly the same customers, exactly the same hospitals, exactly the same payers, the same regulatory agency. So I think you have to take that off your mind. Those are not different. I mean, we are trying to do exactly the same thing. We're trying to cure diseases.
Mm-hmm.
We do it with a medical technology or with a drug, but it's exactly the same mission, the same purpose.
Very good. One question from the group on Stelara LOE. You know, given how PBMs have been willing to kind of break the rebate wall with drugs like Humira and appear to have kind of cracked the code on driving biosimilar adoption, should we expect a more material roll-off in Stelara than maybe you previously thought, or we've seen from other drugs?
With my information today, I think the best analog that you can find with the variability that this is introduced, it's the Humira erosion.
Mm-hmm.
I don't have any other comments there. I cannot improve upon giving better guidance than using the closest analog, which is the Humira erosion.
Very good.
Again, we are guiding that despite of the entry of biosimilar Stelara, we're gonna grow 3%.
Yeah. Great. So, maybe one more on IRA. You know, how should we be thinking about IRA effects on the pharma business, particularly the redesigned Part D benefit, in 2025?
Look, IRA overall is something that creates a negative precedent for innovation and for investment in R&D and for developing new cures. Let me put that upfront. And IRA, what it's doing is price setting. So we don't think that this is something that recognizes the value that we are creating. So, you know, what is the impact of the negotiation?
We are about to understand that. So I don't want to speculate upon that. As you guys know, it will have an impact in 2026, and we are in the process, in the middle of the negotiation process. The estimates that I gave you include IRA impact, if anybody is thinking about those. So the estimates that I give you, a 5%-7% growth from 2025 to 2030, include the IRA impact.
As far as the impact of the Part D redesign, we shall see. I cannot really speculate about that. There's one positive element there, which is the out-of-pocket cap for the patients in Medicare Part D, which I think is very welcome, because the design of Part D was very difficult for patients that were in specialty medications because of the co-pay that they had to have in the catastrophic phase.
By capping the total out-of-pocket expense, we're gonna—and smoothing the payment, we're gonna alleviate that issue, so I think that's a positive development. How much is that going to impact one way or another? I don't know. We'll see when we have it. But again, our projections include any impact from the IRA.
Very good. Maybe just one concluding thought. You know, this is the Strategic Decisions Conference, so, you know, you're two and a half years into your CEO tenure. When you look over to the next 3-5 years, you know, what are the, what are the most important, kind of, one or two strategic decisions you might face as, as a company?
I believe this is a fantastic moment for healthcare innovation. On one hand, in the medical technology side, you have the incorporation of new technologies into the medical devices, and that's gonna help surgeons, that's gonna help cardiologists, that's gonna help physicians to be much better in the way they do surgery, in the way they do procedures.
We are seeing that already. I mean, when we are launching our version 8 of Carto, it does have some smart machine learning tools that we didn't have in the past. Our medical devices, our instruments now, they are connected, and they can give you indicators that in the past was not possible.
I think we're gonna see significant progress in the medical device side by the incorporation of connectivity and technology into the medical devices, and that will transform surgery over time. I also believe that we are in a particularly exciting era on the medical side, because new technologies are going to help us process large amounts of data, giving us a better understanding of the underpinning of
the disease to identify new targets, new pathway, be much faster in screening the medicines, being faster in understanding the toxicology of them, and getting them earlier to market. I think we are gonna see significant progress in treating diseases in this decade, and I am excited about that, and I think healthcare is an area where you're gonna see significant progress.
From a J&J perspective, we have a number of things that we have to address that are strategic for us. One is the success on the new product launches that we have in front of us. In pharmaceuticals, we have a number of new product launches in front of us, TREMFYA. In IBD, we're gonna be launching amivantamab, our RYBREVANT, our bispecific antibody in non-small cell lung cancer, first line, so that's a very important one for us.
And we are going to be also launching our TARIS, our bladder cancer platform. So how successful we are with these initial launches are gonna give you confidence, you confidence, that we're gonna be able to navigate the Stelara biosimilars.
And then we need to continue in our great trajectory in MedTech. We grew 8% last year. We're in a trajectory of growth. If we are able to sustain and deliver best-in-class MedTech growth, we are going to be seeing a significant impact in our overall value creation, and I hope investors will appreciate and recognize that.
Very good. We'll have to leave it there. Thank you so much for being here, Joaquin.
Thank you.
Thank you.