AbbVie Inc. (ABBV) Earnings Call Transcript & Summary

Great. Well, thanks, everybody, for joining us. I'm Terence Flynn, the U.S. pharma analyst here at Morgan Stanley. We're very pleased to be hosting AbbVie today. First, before we get started, for important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that out of the way, today from the company, we have Rob Michael, Vice Chairman and President; Jeff Stewart, Executive Vice President and Chief Commercial Officer; and Neil Gallagher, Vice President, Development and Chief Medical Officer. Thank you so much for being here today. Really appreciate it. Great to see you in person.

Great to see you, too. Thanks for having us.

Thanks so much.

I thought maybe we'd start with a big picture question to Rob. Just you guys have, I'd say, one of the more successful track records on M&A here if we think back to the Pharmacyclics deal, the Allergan acquisition, you're going to be at a net leverage ratio of about 2x by the end of the year. And so a question we get frequently -- more frequently now, I'd say, is how to think about capital deployment here for AbbVie in that context, recognizing you have a pretty good growth trajectory with Skyrizi and Rinvoq -- Humira rolling off. But as we think to the end of the decade, Imbruvica coming off, probably more to do. So how are you thinking about capital deployment on the forward?

So you're right. We expect by the end of this year to be at 1.8x net leverage. We'll have paid down $30 billion of cumulative debt. I've got about $4 billion maturities next year that will likely pay off as well, but we will have more flexibility. That's for sure. That said, we really like the portfolio we have. We've got 5 key therapeutic areas that can drive very strong industry-leading growth. Once you get on the other side of the Humira, we will have the lowest LOE exposure in the industry through the end of the decade. So we're set up very well. So -- but you're right, we will have more financial flexibility, certainly in terms of capital allocation, we're very committed to growing the dividend. I think '23, '24, you'll see lower growth, but we'll still grow the dividend. Payout ratio is about 41% today. It will be in the low 50s in '23 and '24. And then think of it getting back to the mid-40s by -- in the second half of the decade. Buybacks, we said, we're really just limiting it to offsetting the dilutive impact of equity compensation. That's still the way to think about it because to the extent that we have additional capital, I want to put that to work to grow the business. So that's probably the best way to think about it. So we're not in a position where we feel like we need to do something, but we will have much more financial flexibility now that we've paid down the debt.

Yes. Okay. And I guess, as we think about the Inflation Reduction Act, that's the other thing we've been talking to a lot of companies about is just, does that change at all your, either internal R&D investments or how you think the lens through which you look at external opportunities as we think about the implications of that more so, I guess, in terms of small molecule versus biologics or maybe development times for cancer versus other areas? So is that shaping at all how you guys are thinking about investing in the business?

I mean we're certainly going through that assessment now as we study the new rules. And certainly, we think about things like inflation penalties, that's not going to have a significant impact on our business. We're not looking at price for growth. It's really driven by volume. So while there will be an impact, we're not in favor of price controls, it won't be significant. With Part D redesign, we're not favor of that because that does help patient out-of-pockets. We've said that's been the big issue, also helping patients with smoothing. Those costs over the course of the year. We'll have a higher cost share in Part D. So there will be a financial impact. There'll be a volume offset as well. And so I think in '25 and beyond, there will be an impact from Part D redesign, but something we can manage. As it relates to negotiation, that's a little trickier. And that's when we're trying to better understand which drugs will get selected when, what level of discounts will be expected? Is there an impact across the class if one drug in the class is subject to negotiation, do others then can get impacted as well, is this spillover into different channels? Those are all things we're studying now. Certainly, there's an impact on small molecule innovation. I mean you've -- Rick did a very nice job on the second quarter call talking about the impact that could have on oncology development, for example. And so we're studying it very carefully. It is clearly a disincentive for small molecules. And you have to look at what parts of your business are more exposed to Medicare versus others. But that's an assessment we're going through right now.

Okay. Any [ just first pass, ] the thing about impact on long-range plan? I know you guys have probably a lot of different scenarios built in there. And I think you have said in the past, you assume there would be some kind of pressure on U.S. price. But as you think about the key components of the IRA, any thoughts on how that would impact the long-range plan?

If you think about the next couple of years, there really won't be much of an impact. I've said the inflation penalties really won't impact us. In '25 and '26, you're talking -- you're looking at more Part D redesign, negotiation does then kick in. So there will likely be an impact if you think about '26 and beyond. We've said we expect to deliver industry-leading growth, that doesn't change because it will impact many players in the industry. So we still feel very good about our long-term growth prospects but we're going through the scenario planning right now to understand. There's still, I think, a lot yet to be determined of how negotiation will work. And that is of all the components, the one that we'll have potentially the largest financial impact. So we're not in a position today to be able to get more clarity other than to say, we still feel very confident we can deliver industry-leading growth.

Okay. Great. Maybe, Jeff, over to you. Obviously, Skyrizi and Rinvoq, 2 key franchises for the company in terms of thinking about that ongoing growth here. I think IBD maybe is one of the more underappreciated opportunities from an investor standpoint. But maybe just remind us how you're positioning both Skyrizi and Rinvoq, in the market? And any early color from those launches of both Rinvoq in UC and Skyrizi in Crohn's that you can provide?

Yes. Thank you. No, I would say for sure, we think it's underappreciated. I mean if you take a step back over the years, frankly, internally, we were always surprised at how fast IBD moved in the first generation of the biologics with Humira. I mean at one point, it was 40% of the revenue. And so now as you think about that movement with Rinvoq and Skyrizi, it's the later therapy areas that's launching. But we're pretty excited. I mean we've had 3, 4 months of sales for both assets and the results are very strong. So we've launched in the U.S. I'll give you a bit of color. First is that the idea that's really resonating with the gastroenterologist is from the data package. And both Rinvoq in UC and Skyrizi in Crohn's have very strong sort of bowel healing, so endoscopic healing. And that's been the way the guidelines have started to move around the world to say that's the #1 most important thing. Of course, you got to think about symptoms. That's a priority. But can you deliver endoscopic healing? And so it's really resonating with the gastroenterologist. So ulcerative colitis is moving very, very quickly in the U.S, we've launched in Germany, similar feedback. So in a matter of a month or 2, we already have about 15% in-play share in the post-TNF marketplace, that market segment, where we're approved for Rinvoq in UC, which is very encouraging. The other dynamic that we looked at, which is how many of the big gastroenterologists, that's about 3,000, okay, 3,000 heavily targeted gastroenterologists. Most of them never wrote XELJANZ, which was the only other JAK inhibitor approved. And we can see that 70% of our prescribers already never wrote XELJANZ. So in other words, the profile of Rinvoq with its high efficacy, it's speed of onset and that high endoscopic healing has really activated them. So that's very good news in terms of as we watch sort of the fundamental momentum. Unlike some of the other indications as well, gastroenterologists can pick the 30-milligram based on the profile of the patient. And we see -- because of the urgency of that disease, we see a high level of the 30-milligram being used. Similar feedback from Germany. In terms of Skyrizi, we have less data, less visibility because the way that Skyrizi in Crohn's works, and it will be the same in ulcerative colitis, you have to give 3 basically IV infusions. So it's harder to see the momentum of the market there. But when we look at our 2 market sales and the feedback from the gastroenterologists, it's actually remarkably even stronger than Rinvoq. So this is very, very good early feedback, and we'll start to see the other global approvals later in the year. Now in terms of positioning, which is an important consideration, the first set of indication we'll have to position or co-position will be Skyrizi for Crohn's, and then next year, we'll have Rinvoq for Crohn's. In the U.S. market, it is actually relatively straightforward because you have with Skyrizi frontline access, okay, with a very infrequent dosing. And then in later lines, you'll have the ability to sequence over to Rinvoq in Crohn's with a simple oral dosing. So that actually from a sales positioning and representative standpoint is a very nice offering from AbbVie. We will continue to work in other territories where they'll be on top of each other, how to think about which patient types may be better for which asset and that work is underway with the marketing team. So overall, very, very encouraged over how we're going to perform over time with IBD. Very exciting for the company.

Yes. Great. Is there any reason why Skyrizi couldn't be larger than Stelara in Crohn's? I mean that's kind of the dominant injectable right now. But given the profile, I mean, is that a realistic expectation?

I think that's a very realistic expectation. I mean again, the -- if you think about it from the Stelara perspective, they have a loading dose and then they have to sequence over to a self-injectable. When you look at very similar profile for Skyrizi in some cases, more convenient dosing and what's really resonating, as I mentioned, is just the clinical profile. We also have declared that we're doing a comparative trial against Stelara with the primary endpoint being that deep endoscopic bowel remission, which we believe we will achieve that endpoint and that will help us move towards leadership over the LRP in Crohn's.

Okay. Great. Maybe one more, given the approval over the weekend of Bristol's deucravacitinib, we've been fielding some questions on could we see an impact from this kind of differentiated oral on the injectable side of the psoriasis business broadly. And so I guess, when you're talking to Bristol, they've positioned it as we're mainly going to be focused on Otezla as kind of the primary focal point. But as you think about your view and any potential impact on psoriasis from this new oral?

Yes, we've studied this a lot over the years, first with Otezla, and then we've also studied it with the pending approval of Ducray obviously. And we actually think that Bristol is right. We looked at for years to say, would there be a delay of -- delay to biologics or would there be an interaction in certain segments. And it's remarkable that it's almost like the 2 don't interact. So we saw Otezla set up essentially like a prebiologic oral space with very little to no interaction on the high-end, high-efficacy products. And so -- what we think is that Ducray will sort of fit in there, and there'll be more of a choice and war that comes into that prebiological space. But we don't see material interaction with a drug like Skyrizi, which is right now, I mean, 1 out of every 2 patients in the biological space is going on to Skyrizi because of its profile, and we don't expect that to change.

Okay. Great. Maybe, Neil, I don't want to leave you out of this. So I'll go to a pipeline question. Now I think one focal mid-stage asset is 154 here. Obviously, you had some data couple of years ago on kind of the first-gen asset, 3373. You're going to have the RA data. Again, I think you said later this year from a Phase IIb study, primary endpoints, ACR50 at 12 weeks. So as you -- what do you want to see from that study with respect to efficacy? And then maybe just remind us of your confidence in the safety side because I know that's another key differentiated piece of what you guys are trying to accomplish here?

Sure. So thanks for the question. So 154 is an ADC, right, of adalimumab, bound to a very, very potent steroid warhead. So the whole concept, and I'll talk a little bit about the precursor molecule, which is 3373 and what gave us confidence to go ahead. So the concept here is now primarily, for instance, in RA or inflammatory bowel disease, you see, for instance, is that you get 2 mechanisms of action, right? The binding of adalimumab as well as local delivery of the steroid warhead, clearly, steroids are still widely used in these diseases. But the problem, as I think the entire room and everyone knows is that long-term exposure to systemic steroids comes with a huge price for the patients. So this is around building on our experience with ADCs and actually other disease areas, primarily oncology but also -- and then extrapolating that into the autoimmunity space. So local delivery of the steroid with also the power of delivering adalimumab. The complex is internalized. The steroid can connect locally internal to the cell. Just minimizing the systemic side effects, right? So stepping back to 3373, the precursor molecule, which is very -- is quite similar other than the linker. So we swapped at the linker for 154 because it comes with some stability improvements that -- also some manufacturing -- to deliver benefits to us from a manufacturing perspective. What we observed in the original Phase IIa was that there was a significant improvement compared to historical controls, relatively recent adalimumab historical controls and 90% chance that combining historical controls within study control, that 3373 was better. So there's no reason from an efficacy perspective to assume that we could not then extrapolate to 154, which is what we did. Based on those early data, what we did then was initiate 3 -- actually very large randomized Phase III. So the RA study, which we've communicated previously, we're expecting data from during the course of this year, it's 475 patients across a number of different arms, a number of dose range that we haven't talked about publicly. Now what do we expect to see? Well, it is reasonable to assume, based on what I just said that what we want to see is something that's clearly superior to adalimumab delivers the benefits -- the additional benefits of an incredibly potent steroid without the systemic steroid side effects. And that's going to deliver competitive activity across all of the therapeutics in that space. So it's going to be better, right? How much better? Well, we'll see. That's why we're doing the study. And as I said, it's a big study. So we should have a reasonable feel for how the molecule is behaving.

Yes.

What's -- I know in oncology, it's typically like 20% is kind of the bar for clinical meaningful difference. Do you think that kind of holds true here as you think about what you need to show versus [ Humira ] differentiation or because of the steroid-sparing effect, maybe there's room for less of a delta?

I think it's very difficult to extrapolate across from oncology, even within certain areas of oncology on what's clinically meaningful. Very, very difficult because of the differences in benefit-risk, also to extrapolate across into immunology. So I couldn't -- it would be remiss of me to kind of speculate in that way. But I think, look, it's reasonable. Anything human being would say, right, it's going to be better, right? We anticipate that it will be based on the original data that we had from 3373. So it's going to be better. Once we have the data, we can -- just also to say we'll have the 12 -- initially, we'll have the 12-week data.

Right.

There will be longer-term data that we anticipate coming late -- well, that will come later.

And should we benchmark the -- I know there's not a Humira control in this group. So should we use the prior historical Humira data that you guys use for the 337 study (sic) [ 3373 study ]. 3373 study is kind of a reference point when we think about how to benchmark?

Yes. I mean -- I mean we can help you do that when we communicate the data. Clearly, we have a lot of very recent adalimumab historical control data as well. But what we did not want to do, okay, was to -- although it's a big study, it's not -- we wanted [ it in the placebo ] control because it would have been impossible to power a Phase IIb to do a controlled study against adalimumab, right? So there's just some inherent risk from a methodological perspective. But clearly, as we did previously, bearing in mind how adalimumab performed historically will be important.

Okay. Maybe this is probably for both Rob and Jeff, just thinking about biosimilar Humira. Just wondering if you guys have had any preliminary contracting discussions on 2023 yet. And then again, as you think about competitor pricing, I know that's the one variable that Rick said on the call, you don't have a lot of visibility until probably mid next year. But I guess my question would be, why would that be different from historical precedents in other biosimilar launches, whether it's Europe or in the U.S.?

Right. So we are deep in discussions with the large payers now. So as I think I've highlighted before, so typically, for the annual negotiations on the commercial plans, you start in late spring, early summer. And typically, those progress through summers, latest through to October. So the large immunology space, sometimes you miss the initial publications for the exclusionary drug list from the big GPOs and PBMs. But we are really in the thick of it right now. And so they're deep and pretty intense negotiations. I mean it's an important decision for these payers and also for us. So we've as mentioned before, taking this principle-based approach where our go-in approach is that we will negotiate and concede price to maintain sort of continuity for the Humira patients. And that's largely where we sit with the negotiations. Obviously, the individual payers have to think about their own trade-offs over depending on where that price may be, do we have exclusive biosimilars, and do we try to switch out much like a total exclusion. That's part of the negotiation, as you might expect, Terence. But largely, they're progressing as we would have seen fit. They're difficult negotiations. It's not certainly easy. So when we look at that, we know that we're going to have more visibility over that early October, maybe mid-October time frame, where we think we'll know the outcome of the negotiations. There is a little bit more uncertainty with this biosimilar because -- year, as Rick highlighted, because of the -- basically the clustering of those second biosimilars that come in. So at least 6, maybe more by the time we get to midyear. So while we will negotiate for that full year, we have to be a little cautious over the uncertainty over that many competitors in an unprecedented situation. So it's a little less stable than, let's say, a normal year of negotiation. So we'll have to see. I mean we clearly are going to negotiate for the whole year. In some cases, we may even be discussing '24 as we've highlighted 1 or 2 years. But we don't have anything certainly for today where these things are closed. Anywhere near announcements or things like this. And so that's kind of how we see things playing out. The other comment I'd make, which is largely where we see this going again with that pricing concession. It's likely that we will coexist for '23 with one or more biosimilars if we were to close those deals. And that's just based on how the payers want to start to set up their formularies and that's reasonable. AbbVie has highlighted, we're not -- we want to make sure, within reason, there's a healthy biosimilar market. And so it's likely that there will be a coexistence where physicians can choose to continue on Humira, start people on Humira or choose a preferred biosimilars, probably how things will start to shake.

Okay.

And I appreciate that there's a lot of focus in trying to understand what's the floor for AbbVie, whether it's '23 or '24. What I can tell you is when we give that guidance for '23, that guidance range will essentially be the floor because we would expect even if there were more erosion happening in '24 or [indiscernible] you're going to have another year of all the growth brands and delivering on their promise. And so we'll be -- and I think about it in even a stronger position regardless of where Humira plays out. So I know there is a desire to understand that. But the way to think about it is really whenever we gave that guidance range, that should essentially represent the floor. We wouldn't expect that, that the '24 earnings would be less in the guidance range we've given in '23, even if '23 plays out differently.

Okay. So you're confident that, that's going to be the trough. And essentially, '24 should be flat to up versus '23 from earnings.

The guidance range would be...

The guidance...

So if we end up beating it, right? But again, if you work with that guidance range, would represent that. I think that's maybe not as clear. We understand why we've got so many questions on into '23 or '24. But I think given that context, hopefully, it's helpful.

Okay. So the guidance range will encompass the floor and that could -- whether it's '23 or '24, hard to know, but that will encompass trough EPS. Okay. Okay. That's very helpful. I guess one of the -- sorry, one follow-up, Jeff, just as you mentioned, the contracting discussions sound like you said those are progressing in line with your expectations. Is that?

That's right. Okay. We don't know until the [ pens on the ink. ] But I think on principal, the idea that we'll compete for volume. It's likely that there'll be coexistence on the major formularies, and we continue to have good formulary status for Skyrizi and Rinvoq. I think those are progressing along with what our expectations are.

One other point you guys have highlighted in the past is just the consistency of supply is so important to the PBMs. And obviously, you guys have been manufacturing Humira for decades whereas some other companies are still just getting started, and we saw a competitor had some issues on the manufacturing side, CRL. So is that entering into those discussions at all that you're having right now? Or is that -- is it still kind of TBD? But as we think about consistency of supply, I mean, how -- how is that factor playing there?

Yes, I think that's absolutely in the consideration set of a PBM or a payer because there are up to 10. Now the first one with Amgen, they've been able to consistently supply globally. And so a payer will look at Amgen perhaps differently than some of the others in that second tier of the launches. And we've been asked this morning, what does it mean with the Alvotech CRL? And what I've sort of highlighted, which is, look, when the payers set their mind to it despite the fact that there is citrate-free, non-citrate free, different doses, different concentrations, they do have to go through that set to pick which biosimilars, maybe there are 1 or 2 preferred biosimilars and supply has to be in that consideration set. So I think probably the biggest -- and I don't know for sure, Terence, but one of the biggest considerations from that notification that we saw with Alvotech is a little bit of, "ha!, okay, now." That makes me nervous, even if they can correct it which who knows. I mean I'm sure they can correct it, maybe reasonably quickly. But it sort of raises that continuity of supply with whoever I want to partner with from a biosimilar to a pretty high level.

Okay. Great. Very, very helpful. The other topic coming out of 2Q that I think there's been a fair amount of focus on is just the aesthetics business. Obviously, very strong growth coming out of COVID, it seems like we're seeing a little bit of a slowdown here now, maybe in 2Q. I know you guys talked about pressure in Russia, China and then U.S. maybe on the filler side, a little bit of softness there. So again, any more recent data points you guys have in terms of the kind of U.S. market dynamics that you're seeing now? And I guess, overall confidence in that $5.9 billion guidance number for the franchise for '22?

So obviously, we suspended the operations for aesthetics in Russia and had the China COVID lockdowns. And even with that, given the [indiscernible] performance, we felt we can still work within that range. Obviously, we started to see at the end of the second quarter, a slowdown, but it wasn't clear to us whether that was really more a seasonality impact with obviously more leisure travel, business travel appointments being booked out, potentially spending going more towards travel in that period. Is that seasonal impact happening sooner versus is it an impact from the economy, higher inflation fears of recession? As we studied it, and it really depends on which segment of the business. So what we're seeing is less of an impact in BOTOX but more for fillers and body contouring and that makes sense because those are higher price points. And so there appears to be some impact from inflation, and I'd say, defensive spending from consumers. It will be clear to us when we go into the next season, we see obviously with return to school, do we start to see a bounce back. But clearly, there is -- ad you can monitor things like Google searches, we have our own [indiscernible] treatment data we can look at, consumer confidence index is a good one, a real personal consumption, another very good metric to look at. And we are seeing all those would indicate there is some level of slowdown. We've studied this very carefully. Obviously, we acquired Allergan. We looked at the '08, '09 example. We saw that the aesthetics business, while smaller scale, but still fillers and toxins were in the portfolio. The business pulled back about 9% in 2009, then bounced back very robustly after that. So could we see an impact for several quarters if inflation persists, and we then see a recession? There could be an impact, but it will be transient. We still feel very good about the long-term outlook, high single-digit growth for this business.

Okay. And do you make any changes or tweaks on the spend side as a result of that? Or is it kind of invest through the cycle because you know you'll get the benefit on the other side?

Well, there's definitely -- we're going to keep investing, but it's -- there's differential, right? So obviously, body contouring, probably more of a pullback there. But for BOTOX, I mean it's still a market that's growing, very nice promotional response, and so we will continue to invest there.

Okay. And maybe just in the last, I think we've got about 1.5 minutes left here. Epcoritamab and other important pipeline product, Neil? So bispecific for lymphoma. Just any update on the BLA filing? And then again, as you think about competitive landscape, I mean, -- how do you see that playing out given the profile you guys have generated?

Sure. So we haven't announced a filing yet, so it hasn't happened. So -- but we remain on track. I think we said that we plan -- we and the partner have said that we plan to file this year in the U.S. So that's on track. In terms of the molecule competitively, look, I know we're running out of time, so I'll try to keep this brief. We were very purposeful about going after an asset in that class, right? We had a strategic imperative that we laid out back in 2017 to broaden the hematology pipeline into [ lymphoma, right? And CD20-CD3 ] was an asset class that was high on the list. So I think that you can infer from that, that we did a lot of diligence around the deal that we would be doing, right? And we were looking for best-in-class. We knew that one of the competitors was out ahead of us. And I don't want to -- all the caveats about cross-trial comparisons. If you look at the response rate, 63%, if you look at the safety profile of the molecule, lower rates of CRS numerically than has been observed elsewhere, mostly grade 1 and 2, only 2.5% grade 3, no grade 4. The convenience of subcu administration, the durability is good, and we anticipate that, that could improve over time because we had shorter follow-up when we reported the data initially. The other thing to bear in mind in class, I'm not naming the molecule but I think it's the main competitor. But again, you can infer what it probably is. Epcoritamab binds to a different epitope. It does not bind to rituximab epitope. So that also confers some additional options for us as we develop the molecule. So I think when you take all of that together, we think that we have a potentially best-in-class molecule. And we feel very good about what we've seen so far. Also, the other thing to bear in mind is that we observed how those data were evolving over time before we did the deal. So we were discussing in negotiations with Genmab for a long time, and we were able to observe the data as they strengthen and you -- one knows from experience that with better -- with stable data over a longer-term observation period, it gives you kind of a good feeling, and that's why we do [ a deal. ]

Great. Well, I think we're up against time. But thank you so much, guys. Really appreciate it.

Thanks, Terence.

Thank you, Terence.

Pleasure. Thank you.