Johnson & Johnson (NYSE:JNJ) Goldman Sachs Global Healthcare Conference June 16, 2022 1:00 PM ET
Company Participants
Jennifer Taubert – EVP and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson.
Conference Call Participants
Chris Shibutani – Goldman Sachs
Chris Shibutani
Welcome, everyone, to our highlight, final presentation of the Goldman Sachs Healthcare Conference. We are so honored that J&J could come join us for this, [indiscernible] in so many ways, getting in the last word as they say. My name is Chris Shibutani. I’m a member of the research team, cover pharmaceuticals and biotechnology.
Very quickly ask to do a moment from J&J and say thank you to so many folks who have pulled together this event. Just a tremendous amount of effort, a display of excellence across so many domains within our conference planners, people who are too many to shout out, but obviously, this has been a tremendous effort. Thank you also to our clients who joined together with us, took this bold step to be in person, I think, genuinely worthwhile, and we’re seeing that manifest. I think this was an event that we’ll continue to have opportunities, seeds of breathing through how we’re going to continue to think about things for the balance of this year. So thank you so much.
Really been looking forward to this conversation, and I really do think of this as a conversation. You are, in so many ways, a titular representative here at this event and with investors for J&J. But who is Jennifer Taubert?
Jennifer Taubert
Oh, boy.
Chris Shibutani
When I think about it, it’s like I did a little bit of research as we would. Certainly, many of the financial journals have talked about your presence as a leader, as a woman within the industry, and particularly, pharmaceutical industries. The iconography is there as well, some photos of you in Washington, D.C. next to some familiar names, like Albert and Ken, and there you are, right in the middle of that. So tell us about your journey. I think you first started in sales, but who are you?
Jennifer Taubert
Yes. So well, first of all, Chris, so nice to be here with you today, and hello to everybody. really, really glad to have the last word here at the conference, and congratulations on just what sounds like an extraordinary event over the last few days. So great to have everybody back together and talking about health care, which is obviously so vital, even more so now post-pandemic than before.
So boy, a little bit about me. I’m a native Californian, so born and raised and have had 35 great years in health care. I’ve really dedicated my whole career to trying to advance patient care and had the really good fortune to start my career with Allergan, here in Southern California, makes sense as a native Californian, and then was able to work for Merck for the better part of a decade and launched products all around the world and then have now been with Johnson & Johnson for 17 years and really feel like we truly are on a mission to transform patient care. And I’m so thankful to J&J and then the companies that I worked for, for really being able to do this and have a significant impact around the world. Been married. I’ve got a 27-year-old son and just really, really feel so fortunate to be able to have a career in health care, where I believe we’re really making a difference, able to have impact.
Question-and-Answer Session
Q – Chris Shibutani
Perfect. And thank you for sharing that. I think it’s the totality of the experiences that people bring to bear, even when you have a worldwide Chairman title of pharmaceuticals that, I think, helps us understand how to listen to you, how you think and how process your decisions. So it is really with that broad purview that you have that perhaps we can ask you to comment of how you feel operating a pharmaceutical business in the world today? And just starting in from macro, and I’ll go macro, maybe thinking about the industry, some common themes, and then we’ll really dig into some of the J&J pharmaceutical issues.
Jennifer Taubert
Our CEO, Joaquin Duato, has said recently, in the next 10 years, he envisions more advances than have taken place in the last 100 years. And I think that he’s really onto something there, and that the pace of innovation and the good that the pharmaceutical industry is able to do in the world is really extraordinary and is really moving at an even accelerated pace, with the technologies that we’re bringing forward, the notion of not only treating diseases, but being able to prevent and cure them and to bring a whole host of different types of options to bear, even including things like cell therapy and gene therapy and things that might have been almost more in science fiction books a long time ago. And these are actually real that are having very, very meaningful impact for patients today.
And so I think as we think about the business, it really starts and stops with the patient and what is that unmet need and how can we bring the best resources to bear to have impact there and do so in a way that also is value creating for the company and preserves that ability for us to continue to innovate for that next wave of patients. And so for us, back in November of last year, so anybody who had a chance to tune in, we made some pretty big commitments to the Street on our business. And so we really talked about continued growth this year is our 11th year of consecutive above market growth.
And as we look going forward, we think that the future is very bright. And that between now and 2025, we’ll continue with above-market growth, 5% or greater, and achieving $60 billion in sales in 2025. And so doing that based on our existing stable of products with significant additional growth potential as well as bringing our next wave of innovation forward.
So whether we’re in COVID, whether we’re coming out, regardless of the market situation, we keep that patient at the forefront and really don’t let anything deter us from our mission of really identifying the best in technology and transformational medical innovation and then doing our best to ultimately bring it to market and get it to the patients who need it.
Chris Shibutani
Yes. I think that the definitions around that mission are certainly clear, the structure of the business as well. I think at the interface that we sit here with this audience right now, obviously, thinking about from the investment purview, which inevitably then has to intertwine economics, broadly speaking, we’re in an environment where as we sit here at the midpoint of the year, our economic forecasts at the house include thinking about slowing of trends there. We’re seeing threaded through conversations of companies across every industry thinking about inflationary pressures, which impacts costs, the ability to have pricing power there. So maybe perhaps if you can discuss some of those push-pulls from the economic environment on your business, particularly the pharmaceutical side.
Jennifer Taubert
Yes. So we are really focused in on serious health matters, and I mentioned transformational medical innovation. So I really think as we continue to drive, these are our patients throughout the world that need help, and we believe that we develop really strong value propositions to support getting the access that we need for patients and also getting the important reimbursement for it as well.
I think if you look across industries, pharma is not immune to the inflation pressures, but I don’t think that we are as exposed or as vulnerable as, say, consumer products or some of the other areas.
So our teams have really done a fabulous job around the world and building very, very robust supply chains and business continuity plans and a lot of things that can help us be able to navigate through this in a very, very successful way. So for us, we’re continuing on our mission and our commitments and continuing to move forward.
Chris Shibutani
And J&J housed you on the question of whether or not we’re going to see anything on the drug pricing front.
Jennifer Taubert
Yes.
Chris Shibutani
We have some midterms coming up in a couple of months, right? Logistically, the calendar of getting legislative things to happen is looking kind of tight. What’s the J&J perspective?
Jennifer Taubert
Yes. I think we work very closely with our industry associations like pharma and bio as well as ourselves as Johnson & Johnson and continuing to advocate for pro-patient type of policies. So things that can help patient access and that can help with patient affordability and lowering types of things a out-of-pocket costs. I do think we’re getting tight time-wise before the midterms were much to be done. That’s not to say that there can’t or that there won’t, but just that, that timing is getting very, very tight and very short.
So we’re continuing to work to help make sure that if anything is done, we’re working through to make sure pro patient, pro access, pro affordability ways. So we’ll have to see, but that time windows increasingly narrowing.
Chris Shibutani
I appreciate your commentary there. Keeping it to top-of-mind themes, business development, M&A, let’s say, how should we approach this? Obviously, the innovation seems to be unrelenting, but it’s a really tough environment out there. And on a company-specific level, everyone watches pharma. They look at the revenue arcs through the back end of the decade, and everybody’s got some sort of double-edged sword. A great product like STELARA creates for you a nearer-term issue in terms of LOE. How do you manage that trajectory, obviously, internal innovation, R&D, but hooking certainly made no secret of the fact that business development is integral to the business plan.
Let’s talk about it from the standpoint of the pharmaceutical business. The usual sort of template of questions is about what, how big, et cetera. I mean let’s talk about what, with the therapeutic areas. As you map out the pharma business, as you did in the November Analyst Meeting, which was a terrific event, by the way, very 21st century. Rachel and Jess and the team put together all sorts of three-dimensional video archive, which I think which is a really nice way to shift the emphasis on Q&A. So kudos to you for that.
But as you think about the pillars within the therapeutics business, you’re not everywhere. You’re in particular areas. It’s [technical difficulty]
Jennifer Taubert
— with business development. Historically, we had in-sourced about 50% of our innovation. And so we are constantly combing the external landscape, looking for the absolute best in innovation in the areas that we’ve identified as high priority and high unmet need. And these are related. We’ve got six therapeutic areas that we’re focused in on. There are a number of disease states within those. We really look there and certain adjacencies as well as from a strategy perspective, sometimes some other areas where we want to expand.
So within those focused areas where we’ve built really, really great expertise, we try to bring we look for great opportunities on the outside and where we have got really differential insights and then look to bring those in. That continues. So historically, it’s been 50%. We are out in front now doing the exact same thing that it really doesn’t change in the environment because we know that, that is really one of the keys for our success.
Now as we take a look at where are we going, why are we so confident with that $60 billion that we put out there, and we don’t put numbers out lightly. So we don’t share those without really, really good insights on our end and very, very strong reasons to believe. So across those six therapeutic areas, our leading areas are very clearly oncology and immunology. We’ve also got a very strong neuroscience business. We’ve also got a terrific pulmonary hypertension business, which we brought in with Actelion a number of years ago as well as cardiovascular, metabolic and infectious diseases and vaccines.
As we take a look at those, the majority of our growth, though, is really coming from oncology, immunology and neuroscience. So you can envision a majority, a good deal of our business development might be there as well. As we think about why we’re so confident for the $60 billion, I think the first is when you take a look at our existing portfolio, the assets that we have, the terrific momentum and trajectory that they are on as well as the fact that products like DARZALEX, ERLEADA, TREMFYA, even our long-acting injectable therapies in neuroscience, we continue to build those assets out. They’re on a great trajectory, and we believe there’s a lot of runway, going into earlier patient populations, advancing combination therapies, et cetera.
So we believe that those assets are going to continue to grow. We think that, that business is also de-risked. These are assets that are already on the market. And we’ve got great insights for the additional indications that are going to come.
Then the second piece is our pipeline. So what we communicated back in November was as many as 14 transformational new assets coming to market across those key therapeutic areas that I mentioned, each having at least $1 billion in peak sales potential and in fact, five that we believe have $5 billion-plus potential. Those five being our BCMA CAR-T, CARVICTY that we actually already got approval for and have launched in the United States this year and just got approval for in EMEA. The next is nipocalimab that we brought in from our Momenta acquisition and where we’re currently developing 11 different indications simultaneously.
We really believe that this is a pipeline in a product and where we’re going to be able to transform autoantibody-driven diseases. And so we’re really building that out. We think that, that is going to have a significant impact.
The next one is a combination of rybrevant plus lazertinib for EGFR-positive lung cancer. And we think that this regimen has potential to be superior to TAGRISSO and EGFR-positive lung cancer, and we think that, that has very strong potential. Let me keep going through the list, Nivexian. I’m sure you heard from BMS this week. We’re very excited about the potential for Factor XIa and being able to go into new populations where there still is high unmet medical need and where a different benefit risk profile is warranted versus the current Factor Xa.
So things like secondary stroke prevention, acute coronary syndromes, some areas in atrial fibrillation, et cetera. And so we’re really excited about the portfolio and where we’re going to go. And with good line of sight, there are others as well. And we’ve got multiple assets in development for major depressive disorder. We’ve got another asset coming through for pulmonary hypertension and others. But we’re very excited and very confident in how these are progressing and our ability because of that, both the strength of the existing products portfolio as well as the pipeline, that we can hit that $60 billion by 2025.
Chris Shibutani
A facility which you ripped through the totality of everything that I would like to dig into more just really demonstrates how much you live and breadth through this. I will pull you back into this BD discussion, however, and do a little bit of Goldman Sachs’ inside baseball. We took the first bus tour to visited people, Mathai, your VP of R&D, was very gracious. And it was an in-person meeting, that opportunity to look people in the eye. And from the investor audience, there was always kind of like the give me question, which was just like, what about CNS, to which Mathai was very thoughtful and clear-eyed and said, obviously, this is kind of — it wasn’t really his worth, but the CNS is kind of this galaxy out there, right? And he chose planet retinal diseases. How would you reflect upon that comment? And how do you see that as something there fitting in with the answer to how CNS might be strategic again.
Jennifer Taubert
And I’m sorry to say, I want to make sure I understand your question in terms of retina or on CNS?
Chris Shibutani
Retinal diseases more specifically.
Jennifer Taubert
More specifically.
Chris Shibutani
But then also CNS, because CNS is risk.
Jennifer Taubert
Yes. So if we start on retina, we believe there’s a — well, Johnson & Johnson, we’ve got a long track record in the eye area. So between Vistakon and contact lenses with our Medical Optics business and surgery and other areas, we believe that there is a lot of remaining unmet need. And we think that we’ve got the ability to bring forward transformational opportunities. And so we’re actually in partnership with MeiragTX working on gene therapy right now in retina for some inherited retinal diseases. And we’ve also partnered in some assets for geographic atrophy and dry AMD, which you know that there really are no other good therapies there right now.
And so we do believe that we’ve got some keen insights that can allow us a chance to get into those markets do really good for patients and if the trials prove out, be able to ultimately win in the marketplace there as well. So it goes back to really understanding key areas of unmet need where we’ve got key insights and capabilities and going in to be able to win.
And so retina diseases is definitely one of the newer ones that we’re in, where we’ve been building out a pipeline. And I think on our website, I know in the past, Jim List actually has done an update. That’s a good primer on the areas and where we’re going there and why we believe that we’re going to win. Obviously, it does end up relating back to CNS, although we’ve got retina carved out separately in a different area in development than CNS.
Neuroscience is definitely higher risk we’ve seen historically. A lot of times, you have to do a number of trials to get a couple successful for registration, but it’s absolutely clear that the unmet need is there. You can take a look at depression today as an example, particularly coming out of the COVID pandemic and the really mental health issues that are quite prevalent to underscore and see that there’s clearly a need for additional advances in neuroscience.
As I mentioned, we’ve got both seltorexant and Aticaprant in development for major depressive disorder, where we hope to be able to bring forward-meaningful assets. I think we’ve — under Bill Martin’s leadership, is a terrific R&D leader. He’s really taking us into new areas in neuroscience where we believe we’re going to be able to make a meaningful mark. So we just announced a deal with potential, I believe, in Parkinson’s, and we’re looking at a number of neuro degeneration related areas, where we hope to be able to make our mark in sort of later this decade and beyond, in addition to the nearer term, like major depressive disorder and such.
Chris Shibutani
So some prudent recognition of risk there, but still some appetite to get involved?
Jennifer Taubert
With something we have got an extraordinary heritage as a Janssen organization in this area. And while a number of other companies have kind of been in and out, because it is hard, as you noticed, one — or as you mentioned, this really has been an area where we have been committed to and where we stand. There’s still so much unmet medical need. We believe we’ve got the right team and the right insights and that we can do a lot of good here.
Chris Shibutani
Got it. Appetite for risk question as well on the M&A front. Historically, J&J has had a great track record in terms of capturing things relatively earlier stage, talk to me about earlier stage, in particular, in this new year that we’re in currently where there’s a lot of cool biotech stuff, companies that went public, valuations that are pretty roughed up, how does that thread into your thinking?
Jennifer Taubert
So we are constantly combing the external landscape and really trying to find the best in innovation. You mentioned our sweet spot historically, has been identifying that early to mid-stage opportunity, being able to, whether partner, in-license, partnership and collaboration or acquisition, be able to bring it in and to be able to provide our capabilities to help really advance and add to the great work that the company has done. And so that’s everything from our clinical development expertise and really being able to go broad and big. Our regulatory expertise to get approval are really keen, market access and commercialization capabilities to help patients really get access to it around the world. And so historically, that really has been our sweet spot.
That being said, we also, when we found other areas where we want to go, and I’ll use Actelion as an example, we wanted to get into rare diseases. We really liked pulmonary and arterial hypertension, the potential for even broader into pulmonary hypertension and the diseases and then related pulmonary diseases.
And so we were able to, in that instance, with the resources of J&J being able to go after and bring an Actelion basically into our house and to be able to continue the fabulous work that Actelion had done at that date and also help even take it to a broader and bigger population over time. So we…
Chris Shibutani
And Actelion, it’s been a little bit quieter. Should we think about being able to hear about more going forward?
Jennifer Taubert
Yes. So great question. So the teams have progressed really nicely, with both OPSUMIT and UPTRAVI as leading agents in PAH, doing tremendous things for patients around the world. And so those assets are really growing nicely. We’ve got other products in the pipeline, a different dose, macitentan, 75 milligrams, which we think is going to offer additional potential. And we’re always looking at other opportunities in that space and related pulmonary diseases as well to basically bring into the fold to continue to build and expand.
So pulmonary arterial hypertension, that’s our seventh therapeutic area. So that is one of our key areas that both focusing on now, but also looking to continue to build out for the future.
Chris Shibutani
Okay. No, it’s a long-standing favorite of mine, oligopoly structure, rare disease patients, et cetera. So…
Jennifer Taubert
And maybe a summary answer to the question, we’re really open to innovation. So yes, we’ve got a sweet spot, but it really focuses in on what is that unmet patient need? Where do we believe we’re bringing differential insights? And how can we add value both to patients, but also to J&J and shareholders? So when we find those, we go for them regardless of the stage, and we’ve got the terrific resources of J&J that we can bring to bear.
Chris Shibutani
Yes. Okay. That sounds excellent. I’m sure that the company is out there in the ecosystem know how to find you. And so on behalf of our resilient audience and people listening on the webcast and recording later, we will continue to be optimistic about your commitment to sort of adopting risk and continuing that track record there.
Okay. Let’s get into the meat of some of the businesses, immunology in particular. Let’s talk a little bit market dynamics, stemming from comments that were made from the team during the first quarter call about how the doors, I guess, Omicron-related impacts particularly in the GI IBD treatment setting market, where are we now? How has that trended since you commented upon that recently?
Jennifer Taubert
Yes. So our first quarter results, we delivered 9% operational growth. So even in the face of Omicron as a total business, we were able to deliver quite significant growth. What I did comment on that call was really particular to the U.S. And Omicron, we had seen an impact on diseases, particularly where medical procedures were required for diagnosis. And so new starts were down. So new starts were down, for example, in PAH where you need a right heart cath procedure for diagnosis. They were also down in GI in immunology, where you need an intestinal endoscopy as an example. And so we saw new starts really depressed there.
As we look — as we’re coming out of this wave and looking at it, we’re really seeing those new diagnoses and new starts starting to tick back up. We look at it. We want to see it above the 2019 level. So kind of wash COVID behind us. We want to see it go back and judge it versus ’19 and then try to drive significant growth from there. And we’re just now really seeing those numbers and those diagnoses start to pop up.
So we believe that we’re coming out of that in those specific areas. And it really was impacted by staffing shortages as well as impact in those areas where there were medical procedures that were required for diagnosis.
Chris Shibutani
Right. Okay. Let’s talk about STELARA, a tremendous franchise product. In comparison to say [indiscernible] where I almost feel it’s constantly melting under the glare of attention, STELARA perhaps is slightly protected. I mean J&J, let’s say, for instance, the analyst community, we are 6 blind men and you are the elephant for those 6 blind men or medical device analysts. I’m not being pejorative. I cover devices for five years, but it’s just like ability to focus precisely on everything. So there is a little bit of an uncomfortable truth out there that perhaps the Street is not accurately or appropriately thinking about how STELARA may confront biosimilars, what the erosion can be like? Talk to us about what you think we should know about J&J’s thinking, about how the erosion with biosimilars entry, particularly if you could speak to price, volume, that kind of dynamic.
Jennifer Taubert
So I think, first, it’s really helpful as a reminder that we are really the leader in the market in terms of $1 billion-plus brands. So as a company, we are not dependent on any one single asset. So yes, we’ve got STELARA. Yes, it is a big powerhouse. But we’ve got a lot of other powerhouses as well. And we’ve got big brands, using DARZALEX as an example that are —
Chris Shibutani
And that certainly explains why you’re relative protection in immunology is for separation over like, oh my God, STELARA.
Jennifer Taubert
So we’ve got a very broad stable of significant assets that both have a lot of momentum right now and a lot of growth and a lot of future growth potential.
Chris Shibutani
Absolutely, well done.
Jennifer Taubert
I think that companies still…
Chris Shibutani
With STELARA and the biosimilars.
Jennifer Taubert
Good. Thank you, bring back. As you take a look at STELARA specifically, we, with REMICADE, we showed that we could continue to grow when one of our larger assets actually went off patent. And so we’ve shown in the past that we can break that boom-bust cycle. When we think about STELARA in particular, obviously, when it goes biosimilar, there will some loss in terms of volume, and we can also anticipate some increased price competition, right?
We will continue to compete for our patients. If patients are on STELARA and would like to stay on it, we think that they should be able to. So we’re going to continue to work in the marketplace and with payers to try to enable that to happen as much as possible. There’s a date in 2023 in the U.S. There’s another in 2024 in Europe. So there isn’t sort of one absolute date in timing. We’ll have to see if and when would assets get approved, the profile and all that. I think if you think about STELARA, we’ll probably learn a lot from what happens with HUMIRA before it, right? And I think it obviously won’t be something like small molecule generics. It may not be what REMICADE was.
Chris Shibutani
Sure. There’s a different time.
Jennifer Taubert
It may be some different time, something in between.
Chris Shibutani
Yes. I always feel like we’re learning, and the external environment is perpetually different.
Jennifer Taubert
Yes.
Chris Shibutani
So to ask you a question a little bit, as HUMIRA and STELARA lose exclusivity, how do you expect this to potentially impact some of the other mechanisms? And we’ve lived through this in different things. It’s like going back to optic ulcer disease and those drugs, right, or even REMICADE, different time in infusion, dynamics. How do you see the landscape in the INI win those two giants?
Jennifer Taubert
So maybe let’s — we can start with TREMFYA. So TREMFYA, that is really experiencing tremendous growth in both psoriatic arthritis as well as psoriasis, right? That’s an IL-23 competing in or part of that market space. When we develop TREMFYA, we really believe that it is a superior IL-23. We demonstrated it with data with superiority to HUMIRA and with superiority to STELARA in patients where with inadequate response to STELARA and also did data to demonstrate superiority in some dimensions to IL-17s.
And so we believe with this that we’ve got a very robust profile with TREMFYA and that we believe that these assets are going to continue to grow, and we’ll have a meaningful difference versus both, say, HUMIRA and STELARA and the biosimilars.
So if you think about it, we believe there is still extraordinary growth potential in these new mechanisms, where we believe it’s going to offer even better treatment for patients over time. There’s a still broad base of patients that have yet been diagnosed or inadequately treated. There’s also a very large base of patients that have been treated with biologics but are not satisfied right now and are looking for those next-generation therapies.
So we do believe we’re a really, really compelling offering right now with TREMFYA in PSO and PSA. And we’re very optimistic for our trials in Crohn’s disease in UC as being an even better and more competitive offering.
Chris Shibutani
Terrific. Let’s keep going. There’s a lot that I need to cover. Jess and Rachel, whilst they’re going to give me a hard time because I typically don’t make — necessarily get through some of the pipeline items. But on commercial oncology, IMBRUVICA, U.S. market trends in and around COVID in competition. Quick takes there?
Jennifer Taubert
Yes. So IMBRUVICA in the U.S. is still a bit challenged, both in terms of new starts as well as competitiveness outside the U.S., with a very, very strong picture as truly leading agent and still very, very strong growth profile. I think we really believe with our partners in IMBRUVICA. We take a look at, at the five-year overall survival data, the only asset that’s got 8 years proven safety data. We’re continuing to look at it and advance it in novel combination therapies. We’ve got frontline MCL that we’re looking at and working on. And so it still is an important contributor for us. It’s still — this year has been softer, most notably in the U.S., but we do believe that it remains an important asset for us going forward.
Chris Shibutani
Sticking with oncology and DARZALEX, an absolute locomotive powerhouse. Subcu has been a nice booster here. How much more can we go here? Talk a little bit about the sort of treatment settings, maintenance versus, et cetera, that you think could continue to pulse this kind of performance.
Jennifer Taubert
Yes. So you are absolutely right, the subcu has been an extraordinary further catalyst for DARZALEX, and it really is doing wonders for patients with multiple myeloma. So we continue to move DARZALEX earlier and earlier. Right now, there is still a lot of growth potential in the frontline setting. There is also growth potential in the maintenance setting. And so we’re actually studying it. And the goal there is really DARZALEX as a backbone of therapy in multiple myeloma, regardless of sort of stage of disease. So some of the other regimens could be — agents could be swapped in and out, but DARZALEX really could stay concurrent.
So we believe that DARZALEX really has a really big runway continuing. And pretty soon, it will be our largest asset actually and with much further growth potential. We’ve also got quite a compelling offering across multiple myeloma. And it’s really important to mention. So I mentioned DARZALEX really as that backbone. We’ve launched CARVYKTI as our first cell therapy, which is ramping and scaling in the U.S. And we look forward to doing that later, in near future, moving into Europe and other parts of the world.
We’re optimistic for teclistamab, approval later this year and are actually looking at it in combination studies with DARZALEX for later lines of therapy. Initial approval will hopefully come in relapsed/refractory and then settings. And then another bispecific, talquetamab as well that’s in development. We do believe, based on the levels of unmet need and how we’re developing these agents, that they’re actually complementary and additive. They’re not — they don’t — the intention is not that they cannibalize each other. It’s actually that we’re able to develop the best combination regimens that can hopefully lead to functional cures.
Chris Shibutani
Yes. No, and myeloma, it really has been this ability to sort of combine this mosaic of treatments that’s completely kind of bent that survival curve and redefine what we’re trying to achieve goal-wise with myeloma, right?
Jennifer Taubert
Exactly. And it really goes to — I had mentioned that deep expertise. We really have a team that is second to none in multiple myeloma that really is on a mission to help deliver functional cures there. And so they’ve got the insights to be able to figure out where we want to go and then how we want to develop these assets to truly bring really meaningful innovation to patients and also JNJ. So that’s a great example of how we really provide that expertise and really try to bring all of J&J to bear there.
Chris Shibutani
Yes. Bispecific certainly got some visibility at ASCO, the question of bispecifics in cell therapy, how do they fit together, fight, et cetera, you guys actually addressed that in-house. We are Wall Street, however, we are worrywarts. And so on the worrywart list of questions, is CARVICDI, the launch, supply, what gets said about being able to get up to speed in the second half. I think folks have talked to a bunch of the folks in the value chain here. What is the J&J response? What is it the Jen Taubert view?
Jennifer Taubert
Yes. So CARVYKTI, let’s start with the data, and the results and the results continue to be really nothing short of spectacular for CARVYKTI. So hopefully, you saw that at ASCO as well. So the 98% overall response in the really, really strong complete response out through 28 months. So CARVYKTI, from a data perspective, continues to perform absolutely in line with our very high expectations.
Now we said from the beginning, as we brought this product to market that we were going to do it in a really thoughtful staged way. We know it’s hard and it’s difficult to do so. We’ve activated the key sites and centers that were a key part of our clinical trials where they had a lot of experience. And we’re now we’re working through and treating patients. So the patient material is flowing through our manufacturing facilities and getting back out and getting into patients. We’re working through any of the sort of initial bugs that happen anytime that you start up something, but we are really, really optimistic with what we’re seeing for patients.
Now the — for you and your question on scaling, for us, lentivirus still continues to be a rate-limiting factor really for all cell therapies. So what we’ve done is we’re investing both in the United States and outside and big capacity and big facilities that will end up taking that off of the critical path for us, so that as we continue to launch CARVYKTI around the world, as we move it earlier into therapy and hopefully even into first-line settings, that lentivirus will not be any type of rate-limiting factor for us.
Additionally, we’re building out — because we’ve got such great confidence in the asset, we continue to expand upon and build out our manufacturing pods, our manufacturing facilities as well, both in the U.S. Europe, et cetera, to make sure that both of those items end up getting off of the critical path. So we’re really excited with what we’ve seen with CARVYKTI so far, obviously, in a scale and in ramp period. And we’re really optimistic for what we’re ultimately going to be able to do here.
Chris Shibutani
Yes. No, the confidence comes through the $5 billion.
Jennifer Taubert
Yes.
Chris Shibutani
And unrisk-adjusted guidance speaks to that. How important is earlier line opportunity to get there?
Jennifer Taubert
We think important. We think that there’s a lot of unmet need for patients, and we think that, that’s definitely part of what gives us confidence in going out with that $5 billion-plus commitment there. So that definitely includes going into second line plus and also some of that front-line setting.
Chris Shibutani
And the debate always on cell therapies in that indication is on durability of that data, how important?
Jennifer Taubert
Yes. And it is important. And so far, what we’ve seen looks so far, so good. So right.
Chris Shibutani
Okay. Great. This is the benefit of being here live in person. You saw her nodding as she said words and smiles. So okay, that’s very good. We’re about out of time, but I’m going to take the luxury of being a little bit over time. This is what I’ve typically done. But I had a couple of quick hits on the pipeline item, something that’s very topical as well. Your partners over at Bristol were also speaking to us, Milvexian.
Jennifer Taubert
Yes.
Chris Shibutani
Secondary stroke prevention. You touched upon this a little bit earlier. Data is in-house. We’re all trying to read body language. The comment that came out of Bristol was that we are moving into Phase 3, you concur? And help us maybe think about how you’re going to be using the information that you have to map out this Phase 3 strategy?
Jennifer Taubert
Yes. So we’re really proud to partner with Bristol on this exciting asset. And you mentioned the data is in-house. So our teams are combing through it individually and together and figuring out that best path forward. I’m really excited about the potential. The Factor Xas have done a tremendous job in the market, but there’s a lot of places where they can’t go yet because of their benefit risk profile, and that’s really where this asset comes in.
And so the opportunity to develop it for secondary stroke prevention, acute coronary syndromes and the potential in Afib and areas where the Factor Xas can’t go right now, we think, is actually pretty significant, which is why we have it on our $5 billion-plus list. So we are looking through the data right now and look forward to working with BMS on where we go from here with it. We’re absolutely very excited about the opportunity and the potential ahead with the asset.
Chris Shibutani
Okay. You’re lucky, we’re almost out of time. Otherwise, I’d steer you down with all the medical meetings and see which one makes you blink or twitch. But I’ve got two others I got to hit. Nipocalimab, so not just about Myasthenia gravis. I read between the lines there. But within MG, is it about differentiating versus the other FcRns? Or is it about thinking about how to fit in this approach to other existing therapies?
Jennifer Taubert
Yes. So really important with nipocalimab, and I put nipocalimab as one of the great things that came out of COVID because we were able to do that deal with Momenta during that period. And we do have 11 trials underway, most of which those areas, we believe, we’re going to be first-in-class and best-in-class. And some are small markets, some are much larger markets. And so we’re very, very excited about the potential. And right now, we’re working through the right dosing, the right put-ups, everything to help make sure that we’ve got the best product literally going to the patients based on their auto antibody-driven disease.
MG is one of the rare cases where we won’t be first to market, obviously. And so we — but we see that as one of the rare exceptions. We’ve got insight or reasons to believe. We’ll have to see the final data to prove it all out, but where we believe that we can actually be best-in-class there. But I look at the totality of it, and for most of the places where we want to go with it will definitely be first-in-class.
Chris Shibutani
Okay. And then I’ll close with asking you about vaccines. Very much the cool kids in this world that we live in currently, right? I mean, think back five years ago, vaccines just, okay, vaccines. RSV, we care. We love this because it’s kind of a foot race, big name players, big stocks, invested, competing, Pfizer, GSK, you guys, et cetera. Phase 3, clinictrials.gov, recently expanded enrollment. Was this to capture more cases?
Jennifer Taubert
Yes. So we did. So you guys are obviously checking all of the details. With RSV, we know this is going to be a competitive space, right, a competitive race. We got a number of companies that are going at it. As we take a look, how can we make sure that we’re both developing the best profile and data set, that we’re meeting the regulatory requirements and all of that. And so we have gone ahead and expanded our data set there and patients, but we are sticking to what we’ve committed to in terms of data this year and filing before the end of the year. So we feel good and like that is on track.
So view that expansion as being how do we make sure that we are competitive and that we’re going to both meet — have what we need for market access as well as for the right regulatory approvals and such as well.
Chris Shibutani
And the final question was that, you already answered part of it, are you expecting approval in ACIP recommendation prior to the 2023 RSV season? Do we even know when the actual season is going to be in 2023?
Jennifer Taubert
It used to be very predictable. In this post-COVID world, it’s a little bit different. So I won’t speculate on that at this point in time. But what I will speculate is the closer things and the confidence that we have in terms of completing the trials this year and living into our goals of trying to file by year-end on that. So I want to…
Chris Shibutani
Great. Thank you, Jennifer Taubert. You are a powerhouse commensurate to the J&J franchise. And if I get the opportunity, again, we look forward to addressing more of the pipeline items in future conversations going forward. Thank for having the last word.
Jennifer Taubert
Well, thank you so much. I really appreciate the time with you, Chris, today, really, really enjoyable and just a hope that you have picked up my sincere enthusiasm around not only our existing assets, but where we’re going with our pipeline, and our wonderful good that we’re going to do. For patients around the world, and also what we’re going to be doing for Johnson & Johnson as well. So, definitely with that confidence leaving into the $60 billion in 2025.
Chris Shibutani
Great. The perfect punctuation point to this discussion and to this meeting. Thank you very much.
Jennifer Taubert
Thank you very much. Thank you, everybody.
Chris Shibutani
Thank you, everybody.
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