AbbVie, Inc. (ABBV) Goldman Sachs 45th Annual Global Healthcare Conference (Transcript)

AbbVie, Inc. (NYSE:ABBV) Goldman Sachs 45th Annual Global Healthcare Conference June 12, 2024 10:00 AM ET

Company Participants

Robert Michael – President & COO
Jeffrey Stewart – EVP & Chief Commercial Officer
Roopal Thakkar – SVP & Chief Medical Officer, Global Therapeutics
Scott Reents – EVP & CFO

Conference Call Participants

Chris Shibutani – Goldman Sachs

Chris Shibutani

Welcome everybody. Glad that you can join us. My name is Chris Shibutani, member at the Goldman Sachs Healthcare Research team. We are thrilled to have such a great representation from AbbVie across the C-suite, including our incoming CEO, Chief Operating Officer currently and President, Rob Michael, who we spoke last year.

Robert Michael

Yes.

Chris Shibutani

We should — everybody should listen very carefully to what you say, because you mean what you say. So we’ll look forward to this conversation as well. Scott Reents, Chief Financial Officer; sorry, Jeff Stewart. We do have Scott, who is present here. Is he in the ecosystem? He is kind of hiding. So we’ll see how much he can escape. And then Roopal Thakkar from the Research Organization. So thank you very much for joining us.

Robert Michael

Thanks for having us, Chris.

Question-and-Answer Session

Q – Chris Shibutani

We always manage to find or maybe it’s always the case for AbbVie that there are some sentinel junctures. It’s hard to keep you guys out of the spotlight, but we’re post 2023, such a momentous year. You guys navigated extremely well through that, as we get through 2024, and with the announcement of your ascendancy. Talk to us about how you’re feeling about where the company is at? Just big picture and then we’ll dive deeper.

Robert Michael

Yeah. Look, I’m very — thanks for having us, Chris. I’m very pleased with the performance of the business. When you think about the ex-Humira platform, it makes up more than 80% of our revenue now. It’s growing in the mid-teens. It’s allowed us to return to revenue growth just one year after the U.S. Humira LOE, which no one in our industry has ever experienced. It also positions us very well for return of robust growth next year. And we would define that as being above industry average. Industry average is low-single digits.

So we expect to be above that in 2025 and then deliver a compound annual revenue growth that’s high-single digits through the end of the decade. We’re very pleased as we look across the portfolio, clearly we continually raise our guidance. We’ve seen outperformance across the growth platform. When I think about the priorities for the business, really maximizing Skyrizi and Rinvoq in its current indications. And we have another wave of indications, we’ll have UC for Skyrizi. We’ll certainly have another wave of indications for Rinvoq.

In the future, we think about elevating standard-of-care, thinking about combination therapies with new mechanisms with Skyrizi, Rinvoq as a backbone. So there’s a lot of excitement and we’ll certainly continue to be a large player, a leader in immunology for the long term. So I feel very confident about that part of our growth platform. Neuroscience, our second largest therapeutic area, a lot of excitement there. We’ve seen Vraylar with the adjunctive MDD approval over a year ago, performed very nicely, well on its way to that $5 billion peak we’ve talked about.

Our migraine portfolio is very strong. You see the uptake for Ubrelvy and Qulipta in addition to about — a little bit over 40% of Botox Therapeutic is for chronic migraines. So when you think about that combined migraine portfolio for the company, it’s very, very strong. We’re excited about the Cerevel transaction, we continue to expect to close that transaction in the middle part of the year. That gives us several legs of growth, certainly in psychiatry with Emraclidine, Tavapadon. The early data looks very promising.

It gives us, I’d say, a very fulsome portfolio in Parkinson’s, because we also have VYALEV and we have Duodopa. So again, if you think about the portfolio in migraine, now we have the portfolio in Parkinson’s very, very strong. Oncology, a lot to be excited about. We’ve talked for a long time about returning to growth in oncology. The pipeline, we certainly just came off of ASCO, a lot to be excited about there with 383 and Heme, 400 in solid tumors, obviously Elahere with the ImmunoGen acquisition, their next-generation FR alpha targeted ADC-151, a number of legs of growth in oncology.

And eye care, we’ve talked about REGENXBIO being an important part of the overall strategy, as we look at that gene therapy for wet AMD and diabetic retinopathy, clearly a growth driver for us. And then aesthetics, we expect to continue to deliver on that greater than $9 billion revenue target for 2029. Great opportunities there. That’s one that we’re market leaders. We’ve I think done a very nice job protecting share despite the entry of DAXXIFY, a lot of attention during our conversation last year on what DAXXIFY could mean for us.

So when I look at the business overall, I think about that growth platform, we’re very well-positioned. We certainly, as you think about the growth profile of the company going forward, we’ll be in the industry leadership position. And it affords us the ability then to really invest for growth in the next decade, which is ultimately how we’re thinking about BD.

Chris Shibutani

Okay. That’s terrific. I kind of struggled with how to sequence the topics of conversations. I’m going to queue up of the way you delivered that. I personally am a little bit fatigued about the Humira dialog, and yet if you see where the stock is of recently, that’s clearly sort of still front of mind. So maybe we’ll start with a little bit of that, although my personal emphasis is my endogenous excitement for all the developments that you’ve been doing, particularly building the portfolio from a business development standpoint.

So let’s talk about Humira. Masterful in my mind was the precision with which you guided to what the revenue trajectory was going to be in 2023. It wasn’t like, oh 30% to 40%. It was just like precision like 46%, etc. So it suggested that there were some very sharp pencils and math underlying that. And yet, there were some dimensions that didn’t go exactly as you expected, and in 2023 actually slightly better on the international standpoint. So what did we learn that is informing as you talk about 2024, 2025 from that 2023 experience, as precise as you were, there were some things that were naturally going to be slightly different?

Robert Michael

I think if you look at ’23, the two areas I’d say of overperformance, if you look at U.S., we saw less volume erosion than we anticipated. I mean, so we had, I think, call price very precisely. But the beat, if you will, wasn’t a significant beat, but we did beat our guidance was we saw less adoption in the marketplace than we expected. So I’d say that was the driver of the ’23 beat there. I think internationally ’23, I think it’s largely timing. I think we’ve called it fairly close. I wouldn’t — I’d say there’s not a lot of indexing I would put on the international overperformance, although we’re pleased with it, but a lot of it I think is timing.

As it’s — as we think about ’24, ’25, I mean, clearly we have good visibility to our payer contracts. We clearly when we gave the guidance for ’24, now we’ve had five quarters we’ve performed at or above our guidance in the U.S. We have good visibility to those contracts. I think we’ve clearly anticipated the CVS formulary changes of April 1 that was built into our guidance. It’s playing out in line with our expectations. Actually one part of it that’s actually when you think about the overall portfolio, what we didn’t anticipate was the switching from Humira to the biosimilars, it’s not 100%. We’re seeing about 20% go to new mechanisms, including Skyrizi and Rinvoq.

So I’d say that was something we didn’t contemplate. And that’s obviously a positive development. But I think we have got good visibility to those payer contracts. We also anticipated interchangeable coming in the market. So that was also contemplated in our guidance. And so I think as we go through each of these cycles and we’re going through a next wave of negotiations now with payers for ’25, it’s very clear to us that where we land in those and we can then therefore use that to inform our guidance. So I think that’s why we’ve had a pretty good handle on the developments for Humira.

Chris Shibutani

Yeah. I think you guys have contemplated this so deeply and it’s interesting because, so much of what we saw in the prescription trends literally starting from the first week of April was an element of surprise from the investment community. But to be absolutely clear, and you’ve been very consistent in this. This is something that you had anticipated, you were aware of and was fully contemplated in guidance, and probably Liz and her team are a little bit fatigued from rearticulating that.

You also do bring up the aspect of this ecosystem that is kind of a multivariable equation and is that notion that, oh there is sort of spillover and a dynamic that involves utilizing other indications, clearly a positive. I think investors who worry for a living are wondering about any other spillover implications in terms of sort of the dynamics and pricing pressures across the immunology portfolio to those other indications.

For instance, a year ago, we were talking about the positive of having additional label expansion, but then the pricing headwind. So to the extent that obviously, we’re seeing utilization of other mechanisms, which seems very natural in the evolution of how clinicians were thinking about your next-generation therapies, which will turn to, what are some of the things that you can reassure us about in terms of spillover from pricing dynamics into these other categories?

Jeffrey Stewart

Yeah, Chris, it’s a very good question. I’ll take that one. If you think about what we’ve said and how we’ve analyzed the market, when we had an unprecedented, let’s say, bolus of indications last year, there were seven, I mean, and they all came within a couple of quarters. We definitely made the decision to have some concessions that we highlighted. And that worked out very, very well for the brand. I mean these brands are growing volume 50%, 60%, its super impressive. And we were able to get full access, full paid access within a quarter.

So that means we don’t have to worry about giving free drugs or having long — long cycle time negotiations with the payers. And so that ROI was very, very clear. We also said that, we’re not going to see that type of bolus for a long time. We’re not going to see it really forever. And so that we would go back to maybe a normal sort of pricing dynamic in the low single digits. And that’s exactly what happened in ’24. So we can see that in the early reports. The pricing is stable.

Like this is importantly not a pricing-positive environment, okay, for I&I for immunology. But it’s very, very stable in terms of what we can deliver with that low-single digit concession as we basically continue to cascade the new indications, the promotion. And really what is happening is that you’re seeing a migration away from the first-generation of biologics like a Humira or like a Stelara to the advanced therapies. And so it’s been very, very consistent. So as we look forward, we don’t see again another — and another cycle like this bolus that we saw. And so we’re quite confident that we’ll be able to manage that.

Importantly it’s just not about negotiations or how things are working. It’s the profile of the medications themselves. And it’s also strategies that we took to make sure that both payers and providers can understand the distinctiveness versus the other choices they have. So we’ve done something that’s really unprecedented and we’ve highlighted before, where we’ve had 10 head-to-head trials against almost all mechanisms across the indications there. So it’s quite clear to the stakeholders, how good and how transformative Skyrizi and Rinvoq, for example are.

Chris Shibutani

Continuing with this theme related to how the trajectory of Humira revenues will go. One tool that I think AbbVie’s team has been very effective about communicating, engaging with the Street has been this notion of trough guidance, related to Humira, this notion of a plateauing of revenue. You’ve talked about this in the standpoint of learning progressively more and more as we get this — through this year and next. And some of the debate is about at what time and at what level that could be? What’s been informing you as we’re now at mid-2024? Any updates to your confidence in being able to provide what you think will be that sort of plateau level of Humira revenues?

Robert Michael

Sure. I mean, and to clarify, trough — when we think about trough guidance, the trough is ’24. So we clearly expect to have robust growth as we think about the years that follow. So there isn’t a concern over the trough being in different year than ’24. And I think we’re performing quite well in ’24. As we’ve talked about the way to think about the tail on Humira is at what point is it really no longer a headwind to growth for the company.

And so, you would expect it to step down. It was step down in the U.S. $6.5 billion last year. We’re guiding to $4.5 billion this year. I’d expect another step down next year. I wouldn’t expect the same level of step down in terms of absolute dollars, but another step down in ’25. And then you get into ’26, as we think about this year, you’ll have the first full year of biosimilar competition. Last year was a partial year. You have inter-changeables now in the market. We have another wave of payer negotiations.

So as we get into, I’d say, in the ’25 time-frame, we’ll be in a pretty good position to be able to articulate what we see this tail look like and think of it emerging in the ’26 timeframe. And when I say that, I mean in terms of really not a headwind to growth. It’s not to say that the absolute dollars will be the same, because the thing to keep in mind is that the molecule share has been eroding, because you have new mechanisms and we are accruing the benefit with Skyrizi and Rinvoq.

So it’s, I think the way to think about it is as a headwind to growth when you get — by the time you get to ’26 and even in ’25, even with it, we’re still going to deliver robust growth. But imagine what that growth looks like when you get into ’26 and you don’t have that same Humira erosion dynamic that you’ve had over the last few years. And so that’s the way we’re thinking about it. And those are the variables that will inform, when we communicate what the tail looks like, it will be based on that biosimilar competition, round of payer contracting, interchanges of being on the market, I think we’ll be better informed come next year.

Chris Shibutani

Great. And as far as just thinking about having a strategy for developing growth drivers, Skyrizi and Rinvoq are two of the athletes that I would definitely want on my squad here. Clearly developing strong performance, outperformance. You’ve been very specific with guidance, which has been incredibly helpful like on a quarterly basis and that guidance level has come up. How is the momentum with that progress that has gotten you off to such a strong start to the year following through now approaching the midpoint of the year? Any updates there?

Jeffrey Stewart

Yeah. We’re very happy with the momentum and you can see it in the reports, you can see it in the prescriptions from IQVIA. What I would say is how we measure at AbbVie are competitiveness, our compete level is we look at that in-play share, okay. And the in-play share is basically how many new patients plus switching patients are you capturing. That’s the dynamic market. And we have very, very high levels of dynamic capture that have a lot of headroom to where our total prescriptions are.

So you simply take your capture rate by your persistency curve and that becomes your TRx. And that’s where you get, of course, the revenue. So we have a significant amount of headroom across all of the indications. So all of the indications are moving very, very well. We’re growing nicely in the rheumatology indications. Remember, we have two products in the large psoriatic arthritis indication, both Rinvoq and Skyrizi. Atopic dermatitis continues to — we continue to gain share there both in the U.S. and around the world.

I would say that late last year, even though we had a very, very exceptional launch of our IBD indications for particularly for Crohn’s and UC for Rinvoq, was this head-to-head trial that came late in the year, and it was announced in Europe. That led to a significant acceleration of that, Chris, that capture rate. And so, we see that as a very, very dynamic situation that’s creating a lot of value around the world. So in a nutshell, I would say we’re pleased with the — all of the indications on how they’re progressing — progressing, but particularly with the IBD indications.

Chris Shibutani

Yeah. I think the utilization of head-to-head trials and the boldness of being able to commit to those is something that’s a bit of a signature with your team here. What’s the right timing to be able to unleash that data in order to have optimal commercial impact and to make sure that the payers are paying attention as well?

Jeffrey Stewart

Yeah. I think that it has been an unusual approach. And one of the philosophies that we had, we knew that immunology would be very, very competitive.

Chris Shibutani

Absolutely.

Jeffrey Stewart

And when we — when we take a look at our initial datasets, typically those are placebo-controlled trials. And you can still see very unique dynamics in terms of what happens with the placebo-controlled trials. But fundamentally, physicians and payers don’t really care about placebo. They compare about what are my discrete choices I can make.

Chris Shibutani

100%.

Jeffrey Stewart

So we have to go through a very careful process that’s actually led by Roopal’s team with the statisticians, the clinicians to say, what is the study design, how do we power it. Are we sure that we can win. What are the endpoints that we look at that are meaningful to the market. So we go through an exceptionally rigorous process at AbbVie. And just the pure performance that we saw in the placebo-controlled trials allowed us to basically play those hands very, very aggressively. And it’s paid off significantly.

So what happens is, as I mentioned with Skyrizi for Crohn’s, it accelerates the clarity over the choices that the prescriber is going to make, which is, wow, it is very clear, I’m going to move away from Stelara, because of this dataset. And it also helps us with the payer. I’ll give you a quick example where we were able to take that dataset, which was called SEQUENCE in IBD with Skyrizi versus Stelara.

And in a blinded fashion, we gave it to the German HTA, very difficult technology assessor. And they were able to look at that and ultimately said, we are going to give you what’s called a significant added benefit, which helps with the pricing, the positioning in the marketplace. And for example, in the German business. So it’s been a critical strategic component for us in terms of making those choices in those bets to help drive this momentum, that we see with Skyrizi and Rinvoq.

Chris Shibutani

No, absolutely makes sense. Immunology is such a core franchise, capital F on franchise there and your ability to continue to grow that is naturally going to be a little bit challenging. I started by saying we should always listen to you, because you were quite specific, Rob, in terms of how you were thinking about this. I think there were assets that have been in the ecosystem that most of us in the investment community would think, are they going to run into potential antitrust issues here? And yet, you were quite specific about having an appetite for next-generation mechanisms, and you’ve taken steps to act upon those.

So first to you in terms of strategic context, your ability to navigate and do these. I’d love to get your thoughts there. Then I’ll turn to Roopal, and I’ll prompt you, Roopal, and you can begin to think about this new toolkit that you have with some of the recent deals, Landos etc., and what generates excitement there. But your ability to navigate from a business development standpoint, particularly as you said, we’re open for business more so now that Allergan has been financially addressed appropriately. How are you feeling about that, particularly in a space where you’re such a strong leader?

Robert Michael

Yeah. And the strategy around immunology for us because we achieved this higher level of efficacy or raised standard of care with Skyrizi and Rinvoq. As we look across each of the disease areas, how do you then take that next step? It was clear to us that as we look at new mechanisms that potentially could combine with Skyrizi or Rinvoq, that was the longer-term opportunity, because we have quite a bit of runway. Obviously, we’re going to deliver robust growth for Skyrizi and Rinvoq through until 2033, right.

So it’s really about looking at the pipeline and how do we invest and leveraging both our internal R&D pipeline as well as external opportunities. And we have been active of bringing in new mechanisms that we think can help raise standard-of-care, and that was part of our BD strategy. And so we’ve been successful. We have a number of deals we’ve announced. And so that’s something we’ll continue to pursue. And think of these as these are early-stage opportunities. There’s different risk profiles for each of them, but we’re very optimistic about what we’re picking in terms of the various mechanisms.

In some cases, they’ve been proven. And so we’re very good in terms of if you think about our best — our best-in-class capability, we certainly demonstrated that in our past. But we are very confident that as we look at the landscape, we have a good understanding. Our R&D teams do know immunology very well, that we can pick the right opportunities, the right mechanisms to potentially combine to raise that standard-of-care and that’s fundamental to the strategy.

Chris Shibutani

So if I listened to what you say, it’s less about sort of going after potentially the same patient or indication set and maybe being advantaged when you have a unique or differentiated mechanism of action. Is that the right way to think about the probability of success component of being able to get a deal done? Is that fair?

Robert Michael

I think we view it as we look at each of the, I mean, we look at our core disease areas and if you look at what is the level of efficacy that we’ve achieved, and they vary, right. So you look at in psoriasis, very high level of efficacy. But if you look at an IBD, we’ve taken a step up, but there’s still more headroom. So we think about from a strategic standpoint, what do we need to do to take the next step in terms of raising the standard-of-care. So that would be, I think the way we’re looking at it.

I think in terms of probability of success, it’s based on, I mean, clearly with early-stage, you appropriately account for that risk in the way you invest. And so that’s something that’s naturally part of our ecosystem. But I would say we’re not — I would — clearly the way we structure deals is really dependent up on the partner. It’s not so much one versus the other, it’s not an FTC consideration there. It’s really more about, we have flexibility in terms of how we structure them. It’s really about what we need to do to acquire these assets that we think can drive the next level of innovation.

Chris Shibutani

And that was my breadcrumb to ask you a follow-up conversation with Cerevel, which is, but let’s stick with immunology briefly. Roopal, what excites you about some of the novel mechanisms that you’ve recently been able to enact and they are now in the toolkit or about to be?

Roopal Thakkar

Yeah. I think what’s most exciting is, as Rob mentioned, an opportunity to certainly study them as a monotherapy, but as a combination therapy. And that we look for a few different things, right. Is it orthogonal to the mechanisms that we are already have like a Rinvoq and Skyrizi. The second piece is what does that emerging safety profile potentially look like to allow for a combination to facilitate that? And then are there unique insights that we may have internally or perhaps in the literature that we have observed that lead to potential resistant or resistance or escape mechanisms, if you will, for Skyrizi or Rinvoq.

And then we look to these other mechanisms to potentially combine with the Landos NX-13 asset. That is a very unique mechanism that may help with the epithelial barrier along with an anti-inflammatory effect. It could perform well as a monotherapy in the Phase 1b data we saw in ulcerative colitis. But it could also be a nice combination agent with Rinvoq in ulcerative colitis and Crohn’s.

And to tick another box, this is gut-restricted, so it doesn’t have as very minimal systemic absorption. So you take a Rinvoq, which already has a well-characterized safety profile, combine it with that, I’m not going to do anything different from a systemic standpoint. And I think Jeff has mentioned this before, and so did Rob in IBD, although we have great success in efficacy with Skyrizi and Rinvoq across ulcerative colitis and Crohn’s, there’s still room to go to get to that ceiling to get — to approach a 100% of patients in remission long-term. So that is an — and the prevalence continues to increase of these disease states. To continue to invest there makes quite a bit of sense.

And what we’re also doing with Skyrizi is we are — this year we’ll generate a platform study that’s always on essentially in a proof-of-concept setting and dose-ranging. We’ll take Skyrizi as a backbone as well and add biologics to it, because of the safety profile that we have, we have Lutikizumab that has shown very strong efficacy in hidradenitis suppurativa. It binds — it’s a bispecific to IL-1 alpha and beta.

And we’ve seen beta as a resistance mechanism potentially in IBD. We’ve observed it, we’ve seen it externally in the literature. So that could be a unique combination that will happen this year. We have our own alpha-4, beta-7, that we have internally. We have a CD40. We’ll have others that we can access. So as they come, we can mix and match with Skyrizi, ultimately leading to a combination offering down the road, which would be a biologic and the Rinvoq example with Landos is also another exciting one with a potential oral offering.

Chris Shibutani

Yeah. No, an exciting time with an enriched toolkit to which contemplate all these different combinations. And it’s exactly the reason that I love IBD. The dermatologic indications were competitive. When you open that press release on the positive and the EC scores, you expect to see numbers that start with like 5, 6, 7, not 2, 3, 4, 20, 30, 40. And so, and yet the commercial validation is there, how robust these markets are approaching probably $30 billion worldwide. So a lot of headroom there for growth and opportunity to flex those combinations to really benefit and manifest commercially in the IBD indication.

Turning back to you, however, Rob, let’s pivot over to neuroscience. I think kind of a little bit of a sleeper success with the way Vraylar has executed in terms of the MDD opportunity demonstrates here again a vast commercial opportunity, a lot of unmet need, cycling of patients through therapies, but there’s a genuine presence there with that product. You’ve made continued strategic moves, moving into the muscarinic space, the announced acquisition of Cerevel here. What is your confidence in the ability to get this deal closed and completed and then I’ll turn to Scott in terms of thinking about what the setup is in terms of positioning this novel mechanism. But on the…

Robert Michael

We’re making very good progress with that piece. You continue to expect to close the transaction in the middle part of the year. When you think about, there’s really not any significant overlap here. I mean, you mentioned Vraylar, but Vraylar has a very, very low share in schizophrenia. We don’t even promote Vraylar in schizophrenia. And so there really isn’t overlap there. And then on Parkinson’s Tavapadon participates in an earlier segment of the disease, whereas you think about our offering with [indiscernible] to Duodopa, that’s later-stage of Parkinson’s. So there really isn’t overlap there either. So for those reasons, we’re confident that we’ll close the transaction. We’re making good progress with the FTC.

Chris Shibutani

Scott, muscarinics, brave new world here, a lot of need for things with better profiles from the adverse event standpoint. Talk to how you see a positioning here likely potentially not first to market. Can the market support more than one in what way will you think the Cerevel assets could be positioned?

Scott Reents

Yeah. We think this market is a chance to completely restate the schizophrenia market. There is an incredible desire for new mechanisms that don’t have the baggage of the old antipsychotics. I mean, these are very, very challenging drugs. I mean, you look at the weight gain, the movement disorders, the glucose issues, it’s a substantial problem and it’s been seen in the literature forever over that the schizophrenic patients are very fragile and they just won’t take the medication. It’s very difficult. They’re heavily drugged, so to speak.

Now that’s important, because you have to stop, you have to stop those positive symptoms. So when you look at the profile, I would say, particularly on Emraclidine, it’s just exceptional. So we’re super excited. So very, very high efficacy that we saw, which is what you need. That’s a — that’s critical, but the tolerability profile and the simplicity, once a day, no titration, you’ve got this long half-life, it is really a remarkable opportunity to restate. And we’re actually, we’re fine with multiple — multiple competitors in there. In fact, that’s the way markets work, right.

Typically having more than one help to build the market, build the understanding. So we’re perfectly comfortable being number two. We believe that the profile is — will be the superior profile and we’ll ultimately be rewarded for that. But this is a huge opportunity for patients around the world.

Chris Shibutani

And then remind us, I think we’re going to get some pretty meaningful clinical data updates on the Cerevel asset timeline and how to frame that data expectation?

Robert Michael

Yeah. A couple of things. So one, I’ve just mentioned Tavapadon in Parkinson’s with the two Phase 3’s readout, further readouts. We already have one positive one. And for Emra, we’ll start seeing data at the end of this year. If all goes successful, we’ll be planning submissions next year and launches in 2026.

Chris Shibutani

And you weren’t able to design those studies, etc., but does past year SNF test?

Robert Michael

Yeah, that’s right. Each study is over 370 patients. This is Emraclidine. These are the EMPOWER studies. Both are above 370 patients and they have two doses. They are 90-plus percent powered. They have robust statistical analysis plan that has a multiplicity adjustment. So all the criteria one would want for a robust Phase 3 are designed in these trials that we consider pivotal.

Chris Shibutani

Terrific. I want to move a little bit to aesthetics since the conversation about oncology is going to tie over to the topic afterwards, aesthetics is just one of the great resilient businesses here. It’s one thing, however, the challenge of sort of, I would maybe I’ll use the word defend, but you could argue over a longer time-period of conversation whether that’s the right word.

But across the neurotoxin space, it seems as if it’s commercially always competitive, you’ve been able to respond to changes in the economic backdrop. But the typical playbook where we think of innovation and next-generation products is not necessarily there, I will say skeptically. But what’s going to keep growth going separate? Is there some dynamic competitively separate from the notion of what’s going on with the customer’s appetite? What’s the growth driver for aesthetics?

Jeffrey Stewart

Chris, it’s a very, very good question. I think one of the things that I’m personally and certainly the company is proud of is we’re able to defend share very, very strongly. So for example, Rob mentioned it, last year with DAXXIFY, they were — they’re not able to take any share from Botox. So we’ve been, to your point, very, very resilient with the way that we’re able to connect with the customers, connect with the med spas, the derms, etc., to basically be a pretty critical part of their practice. And so the brand and the performance that Allergan can bring to the table for these are small businesses is quite strong.

I would say also that we are on the cusp of some significant — some significant innovation, because if you look at it, we feel confident that we can clearly defend our share position in the marketplace. And then it becomes about how do you continue to drive the marketplace. And we certainly have a lot of digital capabilities, consumer capabilities. I mean, we’re still working through, we’re returning to growth. But to get the more robust growth, we see certainly there’s an economic component, which will improve over time.

But importantly, there is an innovation component. And this goes back to this innovation that we’ve highlighted, which is BoNT/E. It’s our short-acting toxin. And this is a very, very special product, because it meets the needs of the market, when you think about the market growth. When we talk to consumers, we can see that they’re somewhat worried about jumping in and trying a full-blown toxin. So this is a trial toxin. So we believe that we will be able to price it right and it’s on very, very fast. So you get the full aesthetics effect and sometimes within hours, 8 hours, and it’s gone after 2.5 weeks.

So the commitment from the consumer is pretty low. So you lower the barrier, and then we know with our commercial and medical model, that benefit will start to accrue to the brand leader, which is Botox. So this is a pretty critical innovation. It will be the first-ever short-acting toxin, we’re going to file at the end of this year and by early ’26, we’ll be — we’ll have that in the marketplace to basically continue to drive to that expectation of the $9 billion we’ve highlighted.

Chris Shibutani

Great. And I think that’ll be sort of like the socially acceptable version of a gateway drug. So we’ll see what happens there. And I think Carrie is going to give you a little bit of hard time. I heard you specifically vocabulary, critically important part, I would say foundational part of most of the aestheticians practices is where Botox has been. It is the vernacular, everyone says they’re getting Botox regardless of whether they’re actually getting that product. Briefly on oncology, in particular, I’m turning back to you, Rob, with ImmunoGen ADCs, solid tumors, we love to give better multiples for solid tumors, that’s where the patients are.

A starter kit for you, more to do, particularly with the next-generation modalities here. And I bring that up in part because last year, you very specifically said, we’re back in business, we’re going to do next-generation mechanisms of actions for immunology, [indiscernible] check. Next-generation modalities for thinking about neuropsychiatric conditions, check. Thinking about ADCs, particular additional mechanisms, check. You also did say for eye disease, I’ll take a pencil and maybe put a soft check there. Yeah, we’ll see what we’re doing here. But specific to the question of ADCs, how much more can you do? You have a revenue-generating product, ambitions to go further.

Robert Michael

Look, I think we’re very excited about — we think about the ADC portfolio now with Elahere, what we got from ImmunoGen on market with significant expansion opportunities. We think about going from platinum-resistant to platinum-sensitive, that’s a doubling. Going from high express risk to medium, that’s another doubling. So there’s considerable expansion opportunity for Elahere. They also have the next-generation FR alpha targeting ADC, which can deliver deeper response and potentially expand the tumor types that we pursue. So there’s great growth potential within the Elahere — within the ImmunoGen portfolio, not to mention PVAc in blood cancers.

And so, a lot there. I think investors should pay attention to 400 and 383 in terms of our internal pipeline. I think those are significant growth drivers for the company. Clearly, as we think about the investment in multi-specifics, Insight-2 (ph) CAR-T, we did the deal with Umoja. We’re continuing to look for that type of innovation, so I think about ADCs, multi-specifics Insight-2 CAR-T, that’s where our BD teams are focused and if there’s opportunities to bring in more assets there, we certainly will do that.

Chris Shibutani

And quick hits on two areas that are very thematically hot as well, radiopharmaceuticals.

Robert Michael

I’ll let Roopal take that.

Roopal Thakkar

Yeah. It has been an active space. We’ve, I would say, observing right now, we see that there is room in this space. There’s also a need for infrastructure that one would have to have. And as Rob was touching on ADCs with Elahere with 400, we have another asset 706 in small-cell lung cancer that we just rolled out data showing ORs of 50% in small-cell lung. And then we have another topo warhead in prostate cancer that just went into the clinic. So what I would say is right now, our emphasis would be on the ADCs and on the immunologic front in oncology as we’re maybe again still observing the radiopharmaceutical space.

Chris Shibutani

Another hot innovation topic is cell therapies in immunology, what’s AU appetite interest intrigue.

Roopal Thakkar

Yeah. Well, as Rob mentioned, the Umoja partnership that creates an interesting opportunity where you could have a time where you don’t require lymphodepletion, and you don’t require the extensive manufacturing and waiting time and potentially to able to titrate and have an easier ramp for patients. So that’s one opportunity. We have some preclinical assets that may be leaning more towards B-cells, which is functionally where these CAR-Ts are going that could also be more off-the-shelf that we’re interested in. So I would say more to come there and there is a definite interest, but we would want to leapfrog and make it –improve the tolerability and onboarding.

Chris Shibutani

And then I’ll risk going into overtime. But Rob, a final question for you. As your business card switches over to have CEO, a question you’ll be hearing plenty about IRA implications. Maybe the most concrete one is to understand, what the implications are of the Part D redesign on 2025 profile, because I’ve been told that really got to look at product-by-product and think about the portfolio. And then any broader comments that you have about negotiation and the process that’s unfolding?

Robert Michael

Yeah. I mean, I think it was very clear to us. I mean we I think have done a pretty good job of assessing the impact of IRA even back to shortly after that legislation was passed, reconfirmed our expectation, deliver high single-digit compound revenue growth even with IRA. That said, it was clear that investors didn’t necessarily appreciate the timing of the impact with Part D benefit redesign in ’25. I think many were focused on ’26 negotiation being the first year you’d see the impact.

But for our portfolio, clearly, as you think about its 10% of gross sales in the initial coverage phase, 20% of gross sales in catastrophic, you do see a volume benefit for that, I’ll call one-third of the patients have a high out-of-pocket burden that are abandoning their prescriptions. We would see some volume benefit, but it won’t fully offset the cost-share impact in ’25. And so we’ve said, expect that to impact immunology, oncology in Vraylar. I’ve said think of it as being worth several points of growth.

That said, we still expect to deliver robust growth, I’ve said, above industry average, industry average is low-single digits, so above that even with that headwind. And as we move forward, because we think about that impact includes Humira, which will be declining, so that impact wanes over time, as well as in the legislation when a product is selected for negotiation, it’s no longer subject to the cost-share, so you think about Imbruvica.

So as a headwind to growth beyond ’25, it doesn’t really represent a headwind to growth. We see the impact in ’25. And despite that, we still deliver on the robust growth. So that’s the context we’re trying to provide. It was clear that there wasn’t that full understanding clearly when we were at JP Morgan having — we want to make sure that we’re transparent with investors, we provide our understanding as clearly as we can. And that was the intent with that communication. But despite all that, we still feel very confident in our growth profile.

Chris Shibutani

Terrific. Many thanks to Liz and her team. Always very helpful, and you guys travel in packs. Appreciate that. It always enriches the conversation. All the best going forward.

Robert Michael

Thank you, Chris.

Chris Shibutani

Thanks for joining us.