AbbVie Inc. (ABBV) Earnings Call Transcript & Summary

Well, good morning, and welcome once again to TD Cowen's 45th Annual Healthcare Conference. We're absolutely delighted to have AbbVie senior management here at the Cowen conference. Representing the company is Scott Reents, who is Executive Vice President and CFO; Jeff Stewart, who is Executive Vice President and Chief Operating Officer; and Roopal Thakkar, who is Executive Vice President, R&D and Chief Scientific Officer. AbbVie is TD Cowen Pharma team's top pick in 2025. And thanks to their brilliant execution, it's been so far a very good stock. So thank you for your brilliant execution.

So let's launch right into questions, and I'm going to start with you. We're very pleased with the AbbVie story, but they would even be more pleased if there were multibillion potential seller late-stage assets in the AbbVie pipeline. Are there such assets and we don't see them? Or are you looking for those in the marketplace? Tell us what is the complexion of big selling opportunities in your pipeline?

Maybe right before I kick off, Scott, maybe mention our strategy a little bit, and then I can go into a few.

Yes. I mean I think, Steve, it's helpful. I think it's a great question, and Roopal will walk with a set of assets that we have in place, obviously, we've just navigated the HUMIRA LOE. We've returned to robust growth in 2025, consistent with how we've guided. And the assets that we have in place will deliver this high single-digit guidance through the decade that we've spoken about. So that is with the current assets we have in place. And in fact, the growth will continue beyond that with our current assets for at least stable assets that we have in place. We have a strong balance sheet. We've obviously increased our R&D expenditure over time, in fact, $2 billion since 2022 in absolute terms. So we're coming from a position of strength. And the assets that we have in place that Roopal will talk about will be providing that growth for the next decade and beyond. So Roopal?

Yes. So very quickly, RINVOQ still has 5 more indications that will deliver over the next couple of years, giant cell arteritis being the first and then alopecia areata, vitiligo and then hidradenitis suppurativa and lupus. So we still have those that will add $2 billion at peak. And then I should mention in immunology, lutikizumab, is as we speak, for hidradenitis suppurativa, delivered very high response rates in a 100% TNF failure population. And that asset is also in ulcerative colitis and Crohn's disease, particularly in Crohn's disease as a combination asset with SKYRIZI. So there's a potential suite of combinations that we're working on, not just with lutikizumab, again, which is in Phase III, but with an in-licensed TL1A and our own alpha 4 beta 7 asset. So we think those are going to be really nice opportunities. Moving to neuroscience. I should mention Parkinson's, start with VYALEV, which is very late in the sense that it's launched, but the U.S. will take some time to ramp up. But while that's happening, we also have Tavapadon from the Cerevel acquisition, which has read out 3 out of 3 positive Phase III studies and the data that we're looking at is better than what we had anticipated when we were looking at the -- during the original diligence. And what we've observed, not just high efficacy approaching levo/carbidopa, but a safety profile that may be differentiated with older generic dopamine agonists that aren't as specific as Tavapadon, where we're seeing very low rates of dyskinesia, particularly low rates of impulse control disorder in the single digits. We're going to get longer-term data, but we are hopeful that, that holds. So in Parkinson's, that is a very high area of unmet need and will serve as a very large opportunity together. In eye care, REGENXBIO partnership gene therapy for wet AMD for these patient populations that are dependent on very frequent injections that can be extremely challenging for patients. This would be one injection of the gene therapy. That is in 2 Phase III studies that should complete enrollment this year. That could also be another very sizable opportunity for us. If I think about oncology, I should mention ABBV-400 or TmAb A. This is currently in Phase III for colorectal cancer in later lines. And colorectal cancer is similar to our entry into ovarian cancer with another ADC, which is ELAHERE. Why I say they're similar is that there's been very little innovation in ovarian and colorectal cancer, and it's mostly chemo-driven. However, colorectal cancer is much, much larger than ovarian cancer. So that Phase III is ongoing as a monotherapy. We have potential for Phase IIIs in combination with bevacizumab, and we have ongoing combinations with upfront chemo to access the front and second line. That asset is also in gastroesophageal adenocarcinoma, and we've read out strong data in EGFR wild-type lung, and that's going to proceed into frontline combos with PD-1. And then this year, we'll read out EGFR mutant data, which has been trending to be superior than our Teliso-V asset that which we can talk about later that's under review by the FDA right now. And there's also a heme asset in multiple myeloma, known as 383, which could be a very large opportunity. That's also in Phase III as a monotherapy, while we are looking at combinations with other therapies to enter earlier lines. We like this asset because it delivers what patients and clinicians are looking for, once a-month dosing, a single step-up, rapid efficacy, potentially outpatient utilization and a strong safety profile that's enabling combination, again, which allows you to access earlier lines and can compete with CAR-T, especially for those patients that can't wait for CAR-T or can't access CAR-T. So there's a number of assets, I would say, that are in the later stage or almost within launch mode, which could be -- address a very large unmet need and very important commercially, in particular, for 2030 and beyond.

Great. It sounds like investors should spend more time looking at the pipeline. You did a deal on Monday. You acquired Amylin. It wasn't the most obvious target to go after if you wanted to have a footprint in obesity. So tell us why that was a good decision.

So a couple of things I'll mention. One is we've been interested in this space. We've been considering it and looking for the right entry point. And we felt that this was a very opportune time. We like the deal terms. We like our ability to influence the ongoing R&D and even commercial execution, we'll be able to influence that fully. So the deal terms are very nice. We like amylin due to the potential for improved tolerability versus GLP, GIPs, other combinations. So that was very important in our consideration because many of these patients, 20% to 30% may only last a month on these current assets, up to 70% may fall off after a year. So many patients are cycling off and they're going to need a place to go after that. Now some of this might be price related, but we feel much of this is tolerability related. And if we see the asset like this that has lower levels of nausea and vomiting, we feel that people will onboard easier and then have a longer durability of staying on the asset. What we saw initially was a single-dose study in a patient population that did not have obesity, BMI average of 26, all men. The 3 lower doses, there was no nausea or vomiting after a single dose through 6 weeks. The 3 higher doses, there was a little bit, but that was without titration. And we saw a 3% weight loss at 6 weeks after a single dose placebo corrected would have been 4%. So for those reasons, we felt there was a nice opportunity. I should mention that the formulation is a neutral pH, so it allows for combinability. I would say this is our first entry point. We are still very interested in other mechanisms and potential combinations. So -- that's why we like...

To be more active in this area over time.

Okay. And I think in the context, I mean, we're not saying -- as we know, we have 5 therapeutic areas for 5 pillars within the business. We still have 5 pillars. This is not a new pillar. We're not saying we're building on a new pillar. But this is a differentiated asset that we felt very strong and gave us a nice opportunity patent life goes into the 2040s. And as Roopal said, we certainly will continue to look in the area for opportunity.

Got it. Got it. Financial question. So AbbVie looks for high single-digit sales growth through the end of the decade. Is there any reason not to anticipate margin improvement during this time as well? I mean, usually, when you have a growing top line, you can also deliver margin improvement. Is that kind of what we should assume?

Yes, absolutely. That's something that we've talked about. We've talked about the high single digit on the top line through the decade. We've talked about EPS expanding at a rate faster than that. That will be driven by operating margin. And I think when you think through the components, gross margin, we've talked about relative stability. We're at 84% this year. R&D, we do see R&D continuing to grow in line with sales. We're around a 14% profile today. But it's also important to think R&D is going to continue to increase on an absolute basis. As I mentioned, it's increased $2 billion since 2022, and the absolute increase will continue. We'll see that same profile. But the expansion of the operating margin will come from the SG&A, leveraging that top line, as you said, and also driving efficiencies, and we've proven that we can do that. In fact, operating margin did expand this year versus last year. It's just that EPS is in line this year because there's some incremental interest expense for the full year of the ELAHERE -- I'm sorry, the Cerevel and ImmunoGen financing.

Okay. Question for Jeff. You've finished the 2025 contracting season, obviously. Just in general, how has it gone? And the company had said at one point that a HUMIRA tail would be visible this year. wouldn't be realized until next year, but would be visible this year. So is it visible?

Yes. I mean, overall, the contracting season went quite well. We've highlighted that we would still have about half of the total lives in the U.S. as parity lives. So that's been stepped down from almost 100% the first year of the LOE, about 75% this year, 50% -- 75% last year, 50% this year. So we still believe that in '26, a tail will start to appear, and we've looked at that in a couple of different ways. First is that it will probably be small enough where it's not going to significantly be a headwind to growth. At the same time, though, we probably need to go through this next cycle, so we really understand how '26 shakes out and also look to exactly how the interchangeable dynamics start to work because by May of this year, we'll start to see multiple interchangeables. So we're getting closer probably to the emergence of that tail, but exactly the shape and size, we'll have a better sense as we sort of conclude this next contracting cycle.

Got it. Okay. So for SKYRIZI and RINVOQ, what do you think will be the biggest contributors to sales growth through 2030 in terms of indications?

Yes. I think the -- it's a great question. I would say, on balance, all of the indications, so across rheum, derm and gastro are going to significantly contribute. You'll probably see a little bit more of a mix towards gastroenterology. But overall, very, very nice growth across the board. So if we look at our overall performance and we look at the visibility going forward, we continue to gain significant share in rheumatology, which is largely RA and PSA. In PSA, we have 2 assets. We have SKYRIZI and RINVOQ in that fast-growing category. If you look at dermatology, we continue to have very strong momentum in derm with psoriasis, derm, psoriatic arthritis and atopic dermatitis. Atopic dermatitis is our fastest-growing immunology market. Now we're in the second position there behind Dupixent, but a lot of runway in terms of penetration rates and potential for share capture. And in gastroenterology, as I mentioned, very nice contributions. We're seeing significant share capture for both RINVOQ and SKYRIZI across both now Crohn's and ulcerative colitis. So to give you some flavor for that, Steve, we are now capturing in Crohn's between both assets, one is positioned in early lines, one in later lines, half, 50% of all patients that are new to the market or switching are coming to AbbVie. And it's about 1/3 in ulcerative colitis. And we just recently launched over the last quarter or 2 ulcerative colitis. And we'll see that cascade through the international markets as well. So a very nice mix, a very balanced mix. We're not relying on one indication or one asset to sort of give that growth rate to 2030. And then one more point, I think, is important, and Roopal mentioned this, is we still have 5 more pending indications for RINVOQ that will start to gate in at the 2027 roughly time frame and start to gate into the 2030s. So that's sort of the relative mix, very well balanced, very nice to give us that growth.

One product that has been kind of quietly becoming a very large product is VRAYLAR. However, it seems to be kind of collecting some issues, right? So we have now IRA price negotiation and then we also have competition. So how do you see VRAYLAR progressing over the subsequent, say, 4, 5 years?

Yes. VRAYLAR is going to continue to be a nice growth asset for us. I mean if you think of that space, roughly 90% of that space is generic. And right now, we sort of step through -- typically, you step through at least one generic from -- in terms of the payer utilization management. Despite that, we see continued growth in our new prescription share, which is a good balance between bipolar I and our new -- our relatively new adjunctive major depression indication. So if we look at our share capture rate, roughly our new-to-brand is about 6.5% of a very large market. and the total prescription share is about 4.5%. So we still have that headroom that sort of allows for the TRx growth moving forward. There's still a lot of awareness that a drug like VRAYLAR that's got a very good balance between sort of the tolerability and the efficacy is a really nice add-on to major depression to sort of your baseline SSRI, for example. So we see a significant amount of room to run. And we've guided, and I think it's a good guidance to approaching $5 billion by the time this asset goes LOE, which will be sometime in 2030 with the pediatric extension. And we've contemplated. We knew we had predicted quite well that we would see the selection for the IRA. And all of that calculus is in sort of how we look at the momentum of the brand over time.

And I think with IRA, it's also important, as Jeff said, we -- this is how we've modeled it. Remember, the Part D the fee that's paid, that goes -- the contribution goes away with negotiations. So that headwind that we saw this year in our guidance for VRAYLAR, that piece will go away to offset the impact of the negotiation.

Okay. A couple for Roopal. So we know that you're doing the SKYRIZI plus versus ENTYVIO trial in UC. What is it that you hope to demonstrate in this trial? What would be a win? And would greater efficacy with inferior tolerability be, in your eyes, a win?

Maybe I'll start with the second part, a little bit of perspective there. Jeff has already mentioned the in-place share in Crohn's disease of 50% of the 2 assets. But Crohn's has been launched for some time. So physicians really like SKYRIZI in Crohn's disease, and they have a tremendous amount of experience with it. And they also believe with -- and part of the reason for this is the strength of the efficacy and a very strong, well-tolerated safety profile. The same thing is being observed in ulcerative colitis because they have the experience with Crohn's. And as Jeff stated, we're already at 1/3 in-place share, which Jeff can correct me if I'm wrong, is already exceeding vedolizumab. So the safety profile, I think, is already well known, well characterized, and I wouldn't see -- predict any safety differences. So I think we already have that covered. Second part is efficacy. What we want to test, in particular, is endoscopic endpoints, the most objective endpoints that appear to correlate best with longer-term outcomes. And clinicians more and more are now interested, obviously, how the patient is feeling, but that objective endpoint of endoscopic response is also of critical importance. So that's where we think we have an opportunity. When we looked at that bio-naive population with SKYRIZI in UC, there was a 76% endoscopic response rate, the highest we've seen in a trial, higher than the other IL-23s and what we believe higher than what ENTYVIO can deliver. We would assume going into this study, probably noninferiority from a clinical response or remission standpoint because of the subjective nature of some of these endpoints, they can bounce around. So that's the potential for that one in addition to all the work that we're doing in combination with other novel assets.

Okay. One franchise that has moved from kind of the -- has moved to the worry list from the not worry list is Botox. And we have economic concerns, we have competitive concerns. It just seems that it's a franchise which may never get back to its former kind of health in terms of opportunity. Am I way overstating that? Or how would you articulate the future of Botox?

Yes. I think it's certainly an iconic brand. And historically, that toxin market, I'm giving the U.S. numbers there, prior to COVID grew sort of in the low double digits. And over the last couple of years, it's been growing more in the low to mid-single digits, both here and around the world. I think that's been suppressed. And I think that we'll see that recover for several reasons. I think the economics will get better. And I also think we can stimulate that. And we have -- certainly, we've highlighted the short-acting toxin, which we think will basically stimulate that market. It will increase the funnel or the flow to Botox and work on 2 elements of the market model. It will work on the market itself, and it will work on Botox share, because you can imagine commercially or otherwise, once someone goes on the short-acting toxin to get that initial very fast result and understand how it will work, you can imagine their next appointment will be for full strength Botox. So I do think we should feel very good about that toxin market. If we think about share over time, in most countries around the world, most affiliates, our share is stable to up. In China, for example, it's grown a little bit. In the U.S., as I've highlighted before, we have seen a little bit of share loss in the fourth quarter based on some of our patient support program. And that basically, we think will recover. And we're already starting to see some share recovery here in the first quarter. So I think it's a fantastic market, highly underpenetrated. And when you have a brand like Botox and behind it, the short-acting BoNT/E, we're very, very excited about this market for many years to come.

And shares in Europe, are they also...

Very stable.

Okay. I should have said at the outset, should anyone in the room have questions, please just raise your hand, and we'll make sure your question gets asked. Let's move back to Roopal. So Teliso-V LUMINOSITY data, is that sufficient to get an approval both in c-Met high and c-Met intermediate populations?

So our base case for the accelerated approval potential undergoing review right now at the FDA is in the high population. That's where we saw the highest response rates. However, with high and intermediate, the median OS was quite extended, and that was similar in both. So those both populations around 25% are being addressed in the larger confirmatory study called TeliMET. So that's ongoing. But if we think about the high expression versus intermediate, it's about a 50-50 split. So I'd say 12.5%, 12.5%. The initial approval, should we get it, will be a more modest launch, but it's very important to start establishing c-MET as a biomarker that clinicians should be looking for. So when we launch, I think we'll have at least 50% of major labs that will be up and running that will be testing for c-Met, which is very important because it sets up the TmAb A or 400 asset that I mentioned earlier, which is also c-MET targeting, but with the topoisomerase warhead. So that way, the market, the clinicians are all ready for the next-gen asset that will follow.

So just to be clear, the 50% of labs are already doing c-MET?

No. As we -- when we launch Teliso-V, we should get that relatively quickly. So teams are working on that already. And then that will ramp up over time.

Okay. Questions from the audience? What is this -- this is on emraclidine. What is the quickest path to market for this product? Paint that perfect picture. What is that perfect picture?

We'd love to give you a perfect picture. I think right now, it's a horse race among which indication. I'll step back for a second. What we're going to do first is a multiple ascending dose study to see if we can raise the dose. That's the first thing we want to do. That way, we can have higher serum level concentrations, better receptor occupancy. The first thing is -- that's what we're going to do. And as long as it's safe and tolerated, we can take a higher dose forward. That would enter into Alzheimer's, Parkinson's, who are having psychosis that will enter into an adjunctive setting as an add-on. And if we are able to access a higher dose, that would also go back to monotherapy schizophrenia. So it's a bit of a horse race. We're putting them all into parallel. And depending on which one enrolls faster will be the quickest one that will enter the market. Currently, we anticipate that in the early part of the 2030s.

Okay. So you've alluded to them a number of times, but you're doing these combination trials in both UC and Crohn's. What is the -- earlier studies, what is the threshold for moving those forward to Phase III. So do you need to see a 10 percentage point improvement, 15 percentage point improvement in remission rates? Is that sufficient? Or do you need to see more or less?

Well, some of the data that we have with SKYRIZI and RINVOQ has high levels of response rates. But as we try to drive remission rates, especially on the endoscopic side, I would think we would want quite a bit higher than what we have today. That way, it's clinically meaningful enough to use a combination asset. So we are looking for something that would be a step change that would result in a new standard of care. Now we do understand it's going to be harder and harder to treat because these patients are now expanding from frontline bio-naive very rapidly into second and third and fourth line. Those patients are going to need something novel, and we think those combinations can provide that. And remember, in the Phase II that's running and we just keep adding assets to it, it's all benchmarked to SKYRIZI. So we're going to want to meaningfully beat the benchmark of SKYRIZI, and we'll be able to observe that in Phase II and derisk these combinations. And at the same time, we're working on co-formulation plans because we'd want to deliver in a convenient way to the patient.

Some investors are looking forward and envisioning a very dark scenario where we have tariffs on every country in the planet. How problematic would that be for AbbVie from the following standpoint? What percent of drugs that AbbVie produces are made in the U.S. versus outside the U.S., production comes out of a plant?

Yes. So it's a little difficult to state that way because these are all multi -- a number of plants will go along the supply chain and the manufacturing process. But that being said, maybe I answer your question. So we do have a significant U.S. manufacturing process. We have some even at our headquarters in North Chicago, we've got a large presence. So a number of our products do touch the U.S. But maybe the more important question is what does that supply chain look like? How much flexibility? We have a supply chain that always has assurance of supply. So that means we have redundancy in our supply chain. We can move things around. But the tariffs that are out there today are something that's very manageable. Our profile is very similar to everyone in our industry. Certainly, Europe, we have a manufacturing presence in Europe as to many of our peers. That would be something that would be impactful. But again, that we will look through to mitigate. It's something that we certainly, at this point in time, based on what we know, feel very comfortable with managing.

Okay. We actually are out of time. Allow me one more question, and that is, there's stuff about AbbVie, obviously, which investors don't know. What if we knew we'd have the greatest change in perception? Is it the pipeline? We just don't fully grasp the breadth and depth of the pipeline. Is it the full potential of SKYRIZI and RINVOQ and maybe Botox and maybe VRAYLAR? Or is it something else? What if investors knew they would look at AbbVie in a very different way?

Maybe I'll start and then [indiscernible] the pipeline. I think when we look at from where we see the disconnect with, say, the consensus numbers, I think we see a lot of alignment through '27. The guidance that we gave for SKYRIZI and RINVOQ in '27 was probably closer to where the Street was. I think what is not fully respected is the last part of the decade, and that's why we started to talk about growth from today for at least the next 8 years with our current assets. I think in the later periods, that is not fully -- it's something that has not been fully embraced, I would say. And I think seeing our ability to continue to execute, that is one thing I think I would like to see.

So -- but you've already given, I think, SKYRIZI and RINVOQ guidance for 2030, have you not?

No, 2027.

2027.

Whole company guidance at the top line through '29. That's right. So just the farther out you get, the more embracing of the projections and what we've talked about and the strength of the assets is one piece of it.

Yes. And I think as R&D representative, I would say I think the pipeline is underappreciated. I think we've been very successful with SKYRIZI and RINVOQ, and we continue to believe in that success. Sometimes that may overshadow the rest of the pipeline. For example, we have a very, I would say, impressive migraine franchise that is underappreciated that's growing very swiftly with wonderful assets, including QULIPTA, Ubrelvy and of course, Botox in the therapeutics migraine. So that, I think, is very important. And we continue to do development there to expand acute across the globe and even menstrual migraine, which doesn't currently have an indication. So that's one thing I think we don't really talk about very much or get questions. But in addition to that, I mentioned the rest of the pipeline, how we're coming in to backfill in immunology and also entering into solid tumor, not just with TmAb A and 383 in multiple myeloma. We also have 706 in small cell lung cancer. So we have a variety of ADCs that are performing very well, and we'll share more data this year. But I think those are a few things that maybe are still underappreciated.

And you're absolutely right on migraine. I've underestimated it. And Jeff, you've done an incredible job against a very tough competitor. We have to end. Thank you so much for making the journey to be with us, and thank you for joining us.

Thanks for having us.