AbbVie Inc. (ABBV) Earnings Call Transcript
January 15, 2025
Earnings Call Speaker Segments
Good morning, everybody. I'm Chris Schott at JPMorgan, and it's my pleasure to be hosting a fireside chat today with AbbVie. From the company. We have a broad swath of the management team. We've got Rob Michael, the company's CEO; Jeff Stewart, Chief Commercial Officer; Scott Reents CFO; and Roopal Thakkar, Chief Medical Officer. So happy new year, everybody. Thanks very for joining us.
Thank you. Glad to be here.
Yes, Rob, I know you're about a year into the CEO role. So maybe just to start the conversation. I'd love to hear what you're most focused on at this point? And how we should think about the AbbVie story evolving from here?
Well, Chris, I've been very, very pleased with the performance of the company. And you look at -- if you go by the third quarter guidance, I mean, we're essentially beating our top line by $1.8 billion, well ahead on earnings. The growth platform has been tremendous. So for me, the focus is really about driving strong execution of that growth platform, which will give us essentially, a clear runway to growth for at least the next 8 years. I don't think that's always appreciated by investors that we have this clear runway to growth for the next at least 8 years. And so my focus is also on adding the pipeline, so giving us that depth of the pipeline, so we can drive growth in the period beyond that. That growth platform, again, covers immunology, oncology, neuroscience aesthetics and eye care. It makes up over 80% of our revenue base. If you go by our guidance, it will grow by 17% in 2024. That allows the company to grow by nearly 4% and despite the pullback for HUMIRA. So we returned to growth, as we said in '24. We would expect to return a robust growth in '25. If you look at the activity on the BD front, and obviously, a lot of my focus was there in '24. We've signed about 20 deals, and they're all focused on early-stage opportunities, primarily immunology, oncology and neuroscience, new mechanisms in immunology to combine with SKYRIZI and RINVOQ we think about elevating standard of care. A big really focus for us is what mechanisms can combine with SKYRIZI and RINVOQ to allow us to drive that future differentiation. That worked quite well with SKYRIZI and RINVOQ as we thought about the HUMIRA biosimilars. And clearly, you saw us grow through that. And so we think that's the right strategy as we go forward in immunology. Oncology, I think underappreciated, frankly. I think we have a lot in the pipeline. Some of it is timing. I think our ADC platform, certainly 400, our bispecific 383, I think, is very compelling in myeloma. We'll see as the data reads out, but I don't think it's getting as much credit. But as I think about our role in oncology, our BD efforts are around trispecifics, multispecifics, T-cell engagers, insight to CAR-T opportunities. So we think about next-generation platforms for oncology that we've been focused. In neuroscience, we're very committed to that area. It's our second largest therapeutic area growing very nicely. When you think about the investments we've made, we expanded our collaboration with Gedeon Richter, who discovered VRAYLAR. We're very excited about that partnership. So we have that commitment in psychiatry. We've also explored a novel approach with psychoplastogens with Gilgamesh for mood disorders. That's certainly an interesting opportunity. We also invested in a next-generation A beta antibody for Alzheimer's with Aliada. So we've been very active with these early-stage opportunities. I would expect us to continue to focus there because we have the luxury of having a clear runway to grow for the next 8 years. So the investment opportunities for us in terms of business development are really about the early stage.
Excellent. And maybe a question for Rob and Scott. Just looking out to 2025, can you just help us think about pushes and pulls as we think about the AbbVie business?
Yes. Maybe I'll start and then let Scott get from there. Again, going back to our guidance, if you look at just the ex-Humira growth platform, we'll deliver nearly $7 billion of growth in '24. A little bit over $5.5 billion of that is for SKYRIZI and RINVOQ. I mean those assets have been on the market for 5 years and are delivering 40%, 50% growth. We're seeing tremendous momentum, particularly from the IBD indication. So that momentum, I would expect to continue. And we saw a little bit over. We expect to see over $1 billion of growth from neuroscience VRAYLAR, Botox, Ubrelvy and QULIPTA. So that momentum we expect to continue, plus we'll get the annualization impact for the launches of SKYRIZI in UC as well as VYALEV Parkinson's, which right now, we're seeing tremendous ramps in the international markets. Once we get reimbursement in the U.S., we would expect the same for VYALEV. So we're very, very excited about that. And while not big revenue contributors, but important for the portfolio, we do anticipate the approval of the GCA indication for RINVOQ, as well as the accelerated approval for Teliso-V, which is our ADC targeting c-Met lung cancer, which we're very excited about. Really, that is a prelude to 400. We think that's a great opportunity. That will be partially offset by another step down in HUMIRA, as we would expect. Now I wouldn't expect that step down to be the same in terms of absolute -- expect less absolute erosion in '25 versus '24, but we will see another step down as well as the Part D benefit redesign impact, which we have been very clear about communicating a roughly 3-point impact on the top line, primarily impacting the portfolio -- across the portfolio in immunology, oncology and VRAYLAR. But despite that, we will still return to a robust mid-single-digit growth.
From a P&L perspective, when you think about that robust mid-single-digit top line growth, we do anticipate and are very confident in our ability to deliver similar in-line growth from an EPS perspective. And when you walk down the P&L and think about, we're seeing stability in the gross margin. We've talked about that at roughly 84% this year. And we're going to see that continued stability. From an R&D perspective, we have a continue to increase investment, even throughout the U.S. LOE for HUMIRA, and we'll continue to increase our R&D investment, certainly in line with sales and possibly even a little bit more, but we'll give specific guidance on R&D where it is for '25, but continued R&D investment. From an SG&A perspective, that's where we see an opportunity to drive some efficiencies, but to continue to leverage SG&A. We have a strong track record of leveraging SG&A. And that leveraging of SG&A is going to allow us to expand the operating margin. So we will have operating margin expansion. Now when you think about it from an EPS perspective, though, we do have some headwinds on the net interest line while the full year annualization for the funding costs associated with ImmunoGen Cerevel. And in addition to the roughly 20 deals that Rob mentioned. Those were all cash deals, so a little bit lower cash. So we'll have a little bit more net interest, but that operating margin expansion will go ahead and negate the impact of that net interest expense. So that will end up with EPS roughly in line and the tax rate, we'll have some stability there as well. We'll give specifics, but we've talked about that from a modeling perspective, and we feel very confident that we'll deliver that.
I think Scott makes a very important point on the R&D line. If you've seen us even through the HUMIRA LOE, increase our R&D investment. We expect to continue doing that, and we can still grow our operating margin profile because we can essentially leverage SG&A. So I would anticipate -- I think investors should anticipate that AbbVie will continue to increase R&D investment over the long term. We have the capacity to do that. Obviously, we're very focused on the role of the pipeline really being about driving growth in the next decade. So expect to see us continue increasing the R&D line.
One follow-up there. When you look at The Street modeling right now of your core growth versus HUMIRA, as you look out to 2025? I know that's been an evolving dynamic. But do you feel like the balance is right as you look at Street models?
Yes, this is something that we spoke about when we released our third quarter guidance. We raised SKYRIZI and RINVOQ by $600 million combined, and we took down HUMIRA. We are seeing a couple of things in the marketplace. We are seeing the access was in line with what we thought, but we're seeing a greater compression in the HUMIRA molecule itself. So the HUMIRA, the HUMIRA molecule was losing patients to other novel mechanisms and SKYRIZI and RINVOQ were picking up some of that. It's not what's driving the momentum for SKYRIZI and RINVOQ, but it certainly is a tailwind. And so I think that mix adjustment, which we did when we did the guidance for '24. That's something that Rob, in fact, mentioned, this is -- that's something that needs to be thought about for '25 as well. We'll give specific guidance. But when I look at consensus, I think some of that mix still needs to change. And so we're not going to have any more erosion in HUMIRA on an absolute sense relative that we had, but you'll see HUMIRA continues to erode and then the growth of SKYRIZI will be reflected.
I think the other thing that we're noticing with consensus, in total, it looks good. Sometimes at a product level, there are some differences. And I think one of the dynamics is this flow-through on HUMIRA, but then the upside on SKYRIZI and RINVOQ. So that doesn't appear to be fully adjusted, which is okay because in total, it looks reasonable. But the Part D benefit redesign, again, in total, looks okay. But when we go product by product, it doesn't appear to be reflected across the portfolio. It's hard to see for SKYRIZI and RINVOQ because they're growing so rapidly that it sort of gets lost -- it becomes noise. But for HUMIRA, for VRAYLAR, Venclexta, you start to see like I don't know that The Street's model that appropriately at a product level, but in total, it's fine.
And that's something that we've debated how we give that Part D redesign guidance. So I think that where it makes sense to inform. We'll give a little more granularity about the Part D impact where it lies. And that will give a little sense of kind of the underlying growth rates that will be...
That will be helpful, and we're all struggling with the Part D piece this year. Maybe one last bigger picture question. Longer term, as we look past '25, can you just talk about the growth algorithm at AbbVie, and how we should think about kind of top line growth as well as the margin component of the story longer term?
Sure. So we've talked about through the decade through 2029, we'll have high single-digit growth. We continue to remain very confident in our ability to deliver that. And so we feel very good about that. Now if you think about if we're talking about robust mid-single-digit growth for next year and then high single-digit growth through the decade.
This year.
That means it's going to -- yes, I'm sorry, this year, it's '25, that means that, that growth is going to be accelerating through the decade. And that's because we'll come over the first year of Part D redesign, the first full year of that. And then HUMIRA erosion will not be as large of a step down on an absolute basis. So that growth will accelerate on the top line through the decade. And then we'll continue to expand our operating margin, driving those efficiencies, primarily in the SG&A line and leveraging there. And so that's going to be operating margin expansion. We won't have that net interest headwind. So you could anticipate accelerating top line growth at a high single-digit rate through the decade, but then EPS growing a little bit faster than that without margin expansion.
Excellent. Maybe just pivoting into the core products. I mean starting with SKYRIZI, RINVOQ, IBD has obviously been a great story for the last few years. Just talk a little bit about how much more runway you see with these drugs, both in Crohn's and UC. And just maybe as part of that, how are you thinking about your longer-term targets on those products? Because it seems like the launches have gone exceptionally well.
Yes. The launches have been very, very strong. And I would say that IBD is a very important part of the growth story, but all of the indications are growing really, really well. I mean rheumatology, we continue to gain share, psoriasis and psoriatic disease. We continue to gain share and obviously, the IBD indications were sort of on the later side of it, so more recent. So let me give you some perspective on that. We've seen very, very strong capture rates in Crohn's, okay, over the last year or so. We have now with SKYRIZI in the Crohn's market, which is 2/3 of the overall IBD market, about 35% of capture rate. So that's new patients or switching patients, and it continues to grow week over week, and that gets paired with RINVOQ. So when you add the 2 together, because we have 2 brands operating in that environment, we're now capturing over 50% of that market. So when you -- when you think about that, that's very impressive. Now more recently, we launched UC for SKYRIZI. And we can now see that launch ramp, which is very impressive. So in a matter of a few months, we became the leading in-play brand in UC. And so this is now working across both indications, UC and Crohn's with both SKYRIZI and RINVOQ. And in terms of what that means, that capture rate is very important because it's the leading indicator of ultimately, where your demand will go over time. So that's your new to brand is up very, very high rates, and we still have high single-digit, low double-digit TRx rates. So we really see this as a super dynamic market and very important for the future. So it looks really good. We're pleased with the performance.
Excellent. Can you just elaborate on the competitive dynamics in that space? I know we've got TREMFYA coming to market. We've been seeing some of the data from the TL1As. How are you thinking about the landscape over time?
Yes. This market is -- has a lot of capacity for new innovation because all of these conditions are very difficult, but IBD is extremely challenging. So even with incredible products like SKYRIZI and RINVOQ, you're only getting about half the patients in some form of remission. So there's lots of space for dynamism. We're in a very good position. Maybe I'll start with TREMFYA. I ultimately think that what's going to happen is TREMFYA is going to be a pretty strong competitor. Their data is good. But we don't think it stacks up with SKYRIZI. And we've seen that dynamic play out in psoriasis. So we've competed with J&J and TREMFYA in psoriasis, and we do very well in terms of the relative capture rate. So we feel very, very strong. What's more likely to happen is that these IL-23s will continue to grow as a category. And then, of course, we have the unique dynamic in the back end of the market with RINVOQ. So we're in a very, very strong position there. In terms of the TL1As, they're going to come in the latter part of the decade, and they show them the proof of concept. We'll see really ultimately, how the Crohn's data plays out because that's the bigger market. But I don't think they're going to be very disruptive. I don't think they're going to fundamentally change the standards that basically have been met with our 2 brands. Having said that, we like that mechanism, and Rob highlighted this in his opening remarks, as a potential to combine with SKYRIZI to change the standard of care, Roopal can touch on that at some point in terms of how we're thinking about combinations because combinations are how we think that we're going to transform again above SKYRIZI and RINVOQ as we go into the next decade.
And maybe a good transition to that. Roopal, maybe talk a little bit about pipeline immunology. I know it's such an important part of the company. What should we be thinking about kind of what's next for AbbVie?
Yes. I think Jeff kicked off this conversation with this concept of combination. So as we think about TL1A as was mentioned or other novel agents and the proof-of-concept data that we're seeing. It's still not differentiated where we're at with RINVOQ and SKYRIZI today in Crohn's and UC, as an example. And where we see those playing, for example, with SKYRIZI as a foundational asset, we can combine some of these novel mechanisms, including TL1A, which is one that we have with extended duration that will go into first in human this year. This will allow us to really fundamentally shift standard of care higher than what it is today, which is where we see the proof of concept similar to SKYRIZI and RINVOQ. In addition to TL1A, we have our own bispecific Lutikizumab, IL-1 alpha beta, which is currently in Phase III for hidradenitis suppurativa. That data was very strong in Phase II. We're also going to combine that asset with SKYRIZI. And we have our own alpha 4 beta 7, which we think is a good mechanism in IBD that can also be combined. And even later, we have a TREM1. And this gives you a sense of what we're looking at internally for novel mechanisms and even externally to continue that focus. We also have an oral that will read out in ulcerative colitis from Landos later this year. That's a potential play with RINVOQ. So that's an example of where we could take elements of immunology, we would also be looking at a combo in psoriatic arthritis and potentially rheumatoid arthritis. So that's that first step. We would also be -- we are currently working on co-formulation so that would enable Phase III and potential approvals. But the next step after that is we have internal bispecific technology, lutikizumab is one of those agents. So if we're seeing in the clinic, these pairs working well, we can construct fairly rapidly bispecific antibodies that could then follow on. And then you -- we've recently talked about the deal for Nimble, which is peptide, oral peptide platform. So if you see that going well, you can also consider oral peptides. And what we like about that particular platform, which potentially differentiates from others is the potency, high potency, so meaning less drug that needs to be delivered may enable combinability of different mechanisms, even in an oral. The other thing that was desirable about that platform is long half-lives as well. So that's, I think, one way you can think about how we are approaching immunology across multiple mechanisms and multiple modalities.
Great. On the pricing side, I think you've talked about annual low single-digit pricing for the -- for SKYRIZI and RINVOQ. Can you just talk a little bit about pushes and pulls in '25 because I think IRA counts as pricing or not or how you just think about that. And then just longer term, do you think that low single-digit annual erosion pricing algorithm is a reasonable one to think about?
Yes, we do. And I think we've been very consistent with that. So as we look into 2025, I mean, we have visibility, and we're going to have very strong consistent access for SKYRIZI and RINVOQ. And in terms of the concessions or rebating that low single-digit approach is really that's been very, very consistent. And that -- we think that's not a bad assumption also moving forward in terms of how this market will develop. Now to your point, the Part D redesign is unique. And maybe I'll ask Scott to address that in terms of how we sort of structured our guide there.
Yes. So we'll give -- as I said, we'll give the right amount of specificity around that. But in totality, we've talked about that being in the 3% range for the overall business as a whole. Certainly, depending on the Part D mix, the various products, as Rob mentioned, we've got immunology, oncology and VRAYLAR will be impacted predominantly by those. But that Part D redesign is going to be incremental to in '25 the low single digit that Jeff talked about. That's really driven by rebates. So we'll see that on top. And I think generally speaking, the gating won't be exactly flat throughout the year, but you can expect that gating to one be incorporated in our guidance but also to be relatively flat throughout the year.
I think what you're seeing is just the clinical differentiation, the number of head-to-heads we've had against many competitors. As we've gone through this HUMIRA biosimilar event, we've gotten questions about the STELARA biosimilar. It's very clear that we've been able to grow through that, deliver on the expectations that we communicated about the low negative single-digit price concessions as these brands grow tremendously. As I mentioned 40%, 50% growth with low single-digit negative price. So -- and I know who was concerned about the impact of the HUMIRA biosimilar, STELARA biosimilar, hopefully, you can take some confidence from the way these brands are performing. I mean these are formularies that are open. There's many on -- so it's not a situation where there's exclusions. I mean we're openly competing. Everyone's offering rebates, but we're openly competing with each other, and you can see the level of share capture. So it just speaks to the power of these therapies and the differentiation that we've been able to demonstrate.
Great. Maybe Just a couple more on immunology. I know AbbVie is planning a number of new indications for RINVOQ. I think somebody's get maybe a bit less attention, alopecia, lupus, et cetera. Can you talk a little bit how large those indications are and when can those start contributing to growth?
So we've said that for those indications, collectively, think of them as peak sales of a couple of billion dollars. There's 5 indications. I mentioned earlier, GCA will be the first one approved this year. But I'll let Roopal because he's done a really nice job on this development program speak to the full portfolio there.
Yes. So thanks, Rob. The giant cell arteritis is the smallest one, but an important one because mostly rheumatologists would treat and they currently use RINVOQ today. That is under review by regulators this year. And then in addition, alopecia areata and vitiligo will read out this year, and then we'll start the submission process. And then next year, lupus and hidradenitis suppurativa will come, and then we'll start those submission processes. So 5 more in process.
And these are in areas that we already participate in. So you think about the efficiency of adding these indications is something that is worth noting as well that we already participate in this space. We're just essentially expanding the portfolio.
Great. And maybe just last question on this topic. I know this year -- or I guess, last year, 2024. We start to see some move away from HUMIRA and some HUMIRA biosimilars on more potent, more novel agents. How much more of a tailwind is there for RINVOQ and SKYRIZI on those? And maybe as part of that, is STELARA also come an opportunity, especially in the IBD indications as assuming payers do maybe similar things we saw with HUMIRA.
Yes. Just a reminder on that. So what we started to see, we started to see it really right before or right around when we saw the CVS exclusion, which was back in April. And as we monitor the market dynamics around that, we saw that not all of HUMIRA was moving to the preferred biosimilar. About 20% of it was moving to other mechanisms, including SKYRIZI and RINVOQ. And as we tried to understand what was happening, there clearly were segments of physicians that given that event that those patients would be switched they were bringing them back in and assessing them, maybe taking a little bit of a closer look there and deciding that, hey, the maybe they still have active disease. I'm going to move them to one of these more advanced therapies, and we saw that. Now as time goes by, what we've observed is the molecule, to Scott's point, the HUMIRA molecule continues to compress versus some prior trends. But again, SKYRIZI and RINVOQ are growing so fast. It's hard to know exactly, it's a component, but it's a smaller component. So as the brand gets smaller, we still can see it if there's like an event that takes place, but it's probably sort of built into some of the base at this point. Your point on STELARA is a very good one. Now we anticipate that STELARA will largely be sort of the hold on to their volume probably through '25. But it's not a stretch to imagine that when you when the payers may try to switch STELARA, we could see the same dynamic. And that's because these are the same physicians. They use both STELARA and HUMIRA. And I think it's important to remember that given the investments that we've made from a clinical standpoint, we have a head-to-head trial against STELARA in psoriasis. And also, I think, importantly, a very powerful one in IBD. That's where most of the STELARA business remains. So we very well could see the same dynamic take place over time.
Great. maybe switching over to the aesthetic business. We'd love just latest thoughts in terms of broad outlook for that one, both U.S. and as well as the major international markets.
Yes. We very much like the aesthetics business. It's an important business for us. And when we look at the fundamentals, I mean, this is a highly, highly underpenetrated market. So if you look at people considering aesthetics procedures or facial procedures it's in the single digits in the big markets like the U.S. and China. Having said that, we have clearly seen consumer sentiment is challenging, particularly. I would say in the filler space. So you know that we took down some of the guidance earlier in the year, and we see this primarily concentrated in the market. So the markets just haven't returned as fast as we had thought. And I would say it's, again, concentrated in the filler area. We're still seeing growth in toxins, but the fillers have been more difficult. So those are higher-priced procedures they can more easily be deferred because of the length of time between those procedures. So that's been the big challenge. I mean if we look at overall our capture rate, in China, for example, that's been a -- there's big macro pressures there, particularly on that filler space. We continue to see very stable share. In fact, our share is probably growing a little bit there. So we know that when that market comes back, we'll be well positioned. And I also think it's important to note that we've got continued innovation coming. We have new indications in Asia with masseter, which is very unique as slimming of the jaw line and face that we recently got approved. And also, we are moving forward with our short-acting toxin, which we think will be a significant stimulant to the market as time goes by.
That one I think is, frankly, a bit underappreciated that with that short-acting toxin, it can drive not only market growth in flagship, but market share inflection as well for BOTOX. And that is the #1 barrier to entry is if you're of an unnatural look, and we feel like this opportunity for fast onset, rapid offset, the short-acting could really unlock those patients that are essentially on the sidelines. And so that one could certainly drive market growth and market share inflection.
Do you feel '25 as the year we see this business start to recover? Or is it too early to call at this point?
I mean we will give guidance in a couple of weeks. I think we'll be reasonably, I think, prudent here. We would anticipate a recovery in '24, frankly. So I think it's a question. It's hard to predict when exactly it's going to recover. We do think it will recover. If you look at historically, it's a market that's grown in though, let's say, low double digits. And so given the penetration rates being very low, we think when it does recover, it will robustly recover, but it's really difficult to predict when that will occur.
Great. And maybe one last one, just talk about long-term target for aesthetics, are you still feeling comfortable with that number?
If you take our guidance from '24 to get to $9 billion, you would need a compound growth rate of about 11.5%. Now historically, the market has grown at that level. So one can say, well, if it recovers and it returns to historical levels, you should get there. And plus, we have this innovation that's coming with Bonti as well as some fillers. So that should support it as well. We'll have to see. It's really a question, I think, for us as we go through when we give the guide for '25, as we think about the timing of the market recovery, is that still an achievable number? Regardless of whether we can achieve it or not, we're -- it's a very attractive business, but our overall high single-digit compound growth expectation is not at risk. I mean the overall portfolio, just if I go back to what I said earlier, we're almost $2 billion ahead of our initial guidance based on the Q3 guide. So there's a lot of momentum in the business has been able to absorb the takedown in aesthetics. So we have to see how it plays out. I think we lean a little bit more time to assess that.
Maybe pivoting over to emraclidine. I know it's a big surprise for folks as we went through last year. Just next steps for that asset. Now you've had maybe a little bit more time to digest the data and what happened there?
Yes. So we were disappointed by the results from the data, but we've taken a deeper look at it, and the main assessment was to understand the placebo effect and the uniformity or lack thereof. And our finding was it wasn't a uniform effect. It was specific sites where we saw very deep placebo effects. And then if we look beyond those sites, we see a signal. Now albeit modest versus what we saw in the Phase Ib. However, there's still a reasonable signal there. That being said, we still feel that there's an opportunity as an adjunct with the current atypical class because it is difficult to combine their given tolerability profiles. And what we did observe in the Phase IIIs for emraclidine was very strong tolerability, very low adverse events. So there continues to be a potential there for a very tolerable asset, even with modest efficacy with strong safety once a day driving strong adherence. That continues to be a potential that we believe could be very important for patients. So that is a path that will go down. However, just before we do that, I'll point out another observation we had from the data set. And that was a good amount of variability in the PK that we saw, along with a very strong safety profile. So given that finding, we believe it's important to restudy the dose in a multiple ascending dose study. We think there's an opportunity to raise the dose, raise those variable serum concentrations higher for all patients and potentially drive higher efficacy that was more consistent with what was observed in Ib. And that higher efficacy would be needed if we would want to go back into monotherapy. So start with the dosing study, see how far we can go on dose, continue to pursue adjunct in a Phase II setting. If we see our ability to move just higher then we would kick off another Phase II in monotherapy schizophrenia. While all that is happening, we're still pursuing psychosis in neurodegeneration, Alzheimer's and Parkinson's. So that's all happening in parallel. Now given this additional work we're going to do in a very deliberate, stepwise manner, that would push out our original launch time lines. But still, if we're successful, can contribute in the first half, start contributing in the first half of the 2030s.
So the impairment that you saw us communicate last week reflects that later timing. It reflects risk adjustment. So if you think about we ascribed a large amount of value to the monotherapy indication. As Roopal mentioned, it's not a 0% chance. But we've obviously heavily risk-adjusted that and pushed out the time line, which then based on the accounting rules, you need to take an impairment. But we're still studying it. We still think emraclidine can play a role. The strategic intent of that transaction was to give us a growth driver in the next decade. We haven't talked about Tavapadon yet, but we're very encouraged by the data we're seeing for that Parkinson's asset that could certainly exceed our initial expectations from the deal model. Clearly, we were disappointed with the results from the EMPOWER trial for emraclidine, but we're still continuing to pursue emraclidine. So we get to the middle part of the next decade or the and we haven't mentioned the core antagonist as well can still play an important role, helping us drive growth. We don't see it as a 0, but certainly, we're disappointed with the results from the emraclidine trial, but we're still continuing to pursue those opportunities.
Great. And just one quick follow-up on this. On the higher dose, when would we have visibility on what that could look like?
Well, probably around midyear, we'll be able to kick off a study. So end of this year, early into next year, we'll be able to get a readout because we'll take it step-wise. You take one dosing cohort if they do well, then you go to the next one. So we'll see how far we get into that. But end of this year, early next year, we'll have an idea on that.
Maybe bigger picture business development question. Have the priorities for the company changed at all? Or were there any learnings from Cerevel that we should think about going forward?
The priorities haven't changed. As I mentioned earlier, the priorities have been before the readout and after the readout, continue to invest in early-stage assets to help drive growth in the next decade. So that hasn't changed. I think our learning from the -- that psych is we know is a challenging area. Committing that much capital for an early data, I'd say we would certainly rethink that in psych. That said, we weren't the only party that was bidding for Cerevel. I think the next highest was it would have been, I think, roughly a $7.5 billion deal. So they saw the same thing we did. Clearly, we were encouraged by the 1b results or we're disappointed by the EMPOWER results, the readout. But I'd say we would be certainly thoughtful we can commit less capital, particularly in psych, but it doesn't change our willingness to take calculated risks and I think we have a very strong M&A track record if you look at SKYRIZI, clearly, Allergan, clearly. I mean, IMBRUVICA, clearly, the role that plays strategically to really help bolster our hem/onc presence. So I think overall, we have a very strong M&A track record. We're obviously disappointed that happens in this business, unfortunately, but that's the way we're thinking about psych. I would say I'm so focused on the 5 key growth there. those, as I mentioned earlier, those are, I'd say, the primary focus of our business development efforts. That said, there's a large market with high unmet need, and we see a differentiation that we can drive. We've proven in the past we've entered markets like you think about migrine, hep C have been very successful in markets that we didn't necessarily participate in before. So if there's something that's compelling, but there have to be -- have to be convinced that there's enough differentiation that -- and of course, that we can generate a lot of incremental value.
Is there a bias in the BD of -- I guess, some of the later stage, I think we saw kind of at the end of '23, some later-stage transactions versus this year felt a little bit more kind of mid-stage. Any bias right now of kind of where how the development looking?
It's more of a strategic question, right? When I mentioned earlier, we have a platform now that can deliver growth for at least the next 8 years. So what the company needs is depth in the pipeline to deliver growth in the period beyond that, which is why we're focused. It's not a capacity issue. We have plenty of capacity, but it's more about what is the strategic need for the company, which is these early-stage assets. So I would expect that to continue.
Okay. Great. Roopal, I know we talked on the pipeline in different places. Just -- and Rob, feel free to weigh in. Just bigger picture, your comfort with the pipeline right now and the ability to kind of drive through as we look out to the -- maybe beyond that 8 years to continue kind of a healthy growth rate for the company. Like what inning of that kind of pipeline build out?
Yes. Well, I would say we're quite excited, especially as the way you framed it as we think about 2030 and beyond, and there's a tremendous amount of work that's ongoing I'll touch on a couple of topics that we didn't spend much time on, and that's oncology. We have Teliso-V in lung cancer, EGFR wild type that's under review right now that's in the ADC asset against c-Met. We already have a follow-on to that called the ABBV-400 that Rob had just mentioned. That has a very stable linker in the topoisomerase warhead. We started to read out early data, similar to the Teliso-V patient population, but that efficacy is already substantially higher than what we've observed with Teliso-V, again, which is currently under review for accelerated approval by the FDA, and we've seen almost a doubling of the patient population that we may be able to access, and that's in wild-type, EGFR wild type. This year, we'll see data readout in the mutant population. And if all of these are holding, you'll see dose optimization in Phase III plans initiating. We're also in gastroesophageal adenocarcinoma, that has kicked off with 400. And also this year, we also have a tumor-agnostic approach in MET amplified looking at a variety of tumor types that have amplification of c-MET could be a tumor-agnostic approach. This would be also reading out this year. So quite a bit of work that allows us to have greater depth. That's not dissimilar to what we're doing with ELAHERE, which is in Phase III for platinum-sensitive ovarian cancer, a doubling of the population of platinum resistance where we're approved today with very positive overall survival data that goes. And we also have another ADC that's following on that one, the ImmunoGen 151 asset, which is the next gen. That will start to read out this year, and we'll start getting an idea of dose optimizing, both of them in combination with platinum, bevacizumab and PARP inhibitors, and be able to pick the best one in that particular segment and even given different FR alpha expression levels. We have a -- part of that platform, another ADC with the same Topo warhead and linker, a stable technology in SEZ6, which is in small cell lung cancer, which we showed data, very encouraging data last year at ASCO. We're going to get more follow-up duration this year, and that will be presented and also potential to move into earlier lines, replace chemo and as a monotherapy in later lines. So quite a bit happening there on the ADC front. Moving briefly to him. PVEK has another ADC that we have in rare hematologic malignancy, that will be submitted this year. And then in multiple myeloma, our 383 molecule is in Phase III now enrolling very well. And this year, all the multiple combinations that we're going to look at that would allow us to get into earlier lines of therapies. That's all been initiated as well. And then we even have a next-gen molecule, GPRC5D with BCMA, that we just announced. So there's a tremendous amount of work. And these data will start to read out in a meaningful way with Phase IIIs in the '27, '28, '29, well ahead of 2030. And the other brief mention to neuroscience, Rob mentioned Tavapadon that's where 3 Phase IIIs from the Cerevel deal, all positive and actually, I would say, more positive than we had anticipated. The efficacy of this selective dopamine agonist that goes after D1/D5 spares, D2/D3 is approaching levo/carbidopa in the -- against placebo and can also -- has shown positive data as an add-on to levo/carbidopa where one can optimize the oral. It's a 24-hour once a day asset, and the adverse events of key interest are sedation and impulse control disorder. And so far in the 6 months of data for 3 studies, that's been fairly low. So we'll get longer-term data for that this year and then submission this year. And the final one I'll mention is in the toxin space. We think this is also very important, essential tremor. This is a very frustrating, very debilitating, very common disease state and multiple failures, very unsatisfying treatment options today, we're going to get a toxin without in Phase II, I would say, in this first quarter, and that's another set of data that we'll be working on potentially moving into later phases.
Great. Well, thanks for all the comments. Appreciate you guys for joining today. Thank you.
Thank you.
Thanks so much.
Read the full transcript via the API
You're viewing the first half of this call. Get the complete AbbVie Inc. transcript - plus 251,000+ transcripts from 12,000+ companies, speaker segments and full-text search - through the EarningsAPI REST API or hosted MCP server.
Get an API key View API docs →For developers and AI pipelines
Programmatic access to AbbVie Inc. earnings transcripts and 251,000+ others is available through the
EarningsAPI REST API and the hosted MCP server.
Quarterly plans from $105 - full transcripts, speaker segments, full-text search,
and the /api/v1/transcripts/recent polling endpoint for ETL pipelines.