AbbVie Inc. (NYSE:ABBV) Q4 2023 Earnings Call Transcript

And what you can expect when you get that announcement is that, we would make an announcement that we were going to make the transition out at some point in the future, in all likelihood four months to six months in the future. And the purpose of that is to make the final transition between myself and that person. And that’ll take four months to five months in order to be able to do that. I would say it’s also very likely at that time, based on the discussions I’ve been having with the Board, is that, I will be named the Executive Chair for a period of time, and the purpose of that will be to make the transition of the full position over a period of time. So I think it’s a very well thought out, I think very well managed process. And I think that’s what you can expect going forward.

Jeff Stewart: And Terence, this is Jeff, I’ll start-off and have Roopal will address the second part of your second question. So we established many years ago now this HS market with the approval of Humira. And we thought it was a relatively small market, and it turned out to be quite a surprise. There is a significant amount of patients around the world that suffer from HS, it’s already a multi-billion dollar category. And we think it’s going to continue to expand. And I say that, because we can see that like IBD, there’s just some new approvals just coming. So, everyone sort of holds on Humira as long as they can if they’re exposed to a biologic. And so we see the same dynamic as you start to see IL-17s come into this space, and certainly, we’re very excited about lutikizumab because of the profile that we’re seeing emerge in the clinic.

So it’s a significant commercial opportunity. And I would say that when we look back over all the Humira indications, over the last decade or more, HS was one of the most rapid indications that moved to $1 billion plus business. So it’s an exciting opportunity, both commercially and certainly for patients. And Roopal can address your comment on IBD.

Roopal Thakkar: Yes. Hi, Terence. Part of it starts, I would say, almost 15 years ago with our insights in Crohn’s disease with Humira, as Jeff was discussing, where we started to see efficacy in patients that had HS. We saw a good amount of overlap between Crohn’s and HS. So that’s part of it. Now that doesn’t really pan out for IL-17, but what we’ve observed with IL-1 beta in particular is that, our internal data and external data do show elevated expression signals with one beta. So we think we have that opportunity with luti, because it also covers 1 beta and we have two shots at this, right. One is, to go specifically and look at a biomarker-driven targeted profile where we would be able to distinguish which patients actually have that higher expression.

And the other approach, which we maybe weren’t talking about years ago because we didn’t have a product like Skyrizi which have high efficacy and very strong safety profile in Crohn’s. What we have now is the opportunity to also look at in combination. So a biomarker approach and a combo approach, our insights from Humira and preclinical or biopsy-based insights that we have externally and internally.

Liz Shea: Thanks, Terence. Operator, next question, please.

Operator: Yes, the next question comes from Andrew Baum with Citi. Your line is open.

Andrew Baum: Hi, many thanks. Couple of questions. One, given AbbVie’s strength in market access in managed market, I’d be curious the extensive future contagion from RNA IRA-mediated price cuts on the Medicare book spending over onto the commercial book of business. How much of concern do you think this is, given that has basically the same. And then second question on lutikizumab, if I remember from the canakinumab trials secondary to neutropenia, there was an increase in fatal infections. If you lay on this on top of another immunosuppressive, how are you thinking about the safety concerns in these IBD patients?

Jeff Stewart: Yes. Hi, Andrew. Thanks for your question. It’s Jeff. We think that the, particularly the negotiation aspects of the IRA will be very contained on the Medicare side. And as you can imagine with government programs over the years — when we had discussion with payers, they’ll often say things over, well we know what the FSS price is for the VA or demand mandated discounts and supplemental discounts in the Medicaid channel. But we think those are really government actions and government rules. And so, we see that the market we believe will play out largely like it has with the other government channels, that it’s a unique dynamic in terms of essentially a forced negotiation that we think will be contained largely in the Medicare space. So that’s how we view the world.

Roopal Thakkar: Hi it’s Roopal, I’ll talk about luti and your question around neutrophils. Yes, we do see impact on neutrophils, it’s dose-driven. However, I think we think about inflammatory bowel disease, probably lupus, others to have a different tolerance for benefit-risk, because today in those disease states despite the success that we’ve seen with Skyrizi and Rinvoq, there’s still substantial headroom to lead to more transformational efficacy, not every patient is getting into remission, though high levels, not every patient. So we still believe that a combo can get to that and break that efficacy threshold. The other opportunity there is what we’ll do with the combination is obviously optimize the dose to assure safety. And thus far in the HS trial, even at the highest dose we saw very little infections.

Liz Shea: Thanks, Andrew. Operator, next question, please.

Operator: Yes, the next question comes from Mohit Bansal with Wells Fargo. Your line is open.

Mohit Bansal: Great. Thank you very much for taking my questions. Congrats on all the progress. I just want to go back to the ImmunoGen acquisition and the comments you made before. Can you talk a little bit about the plans to move the drug into earlier lines of ovarian cancer. You talked about maintenance setting, but more we are reading it, I mean, in first-line maintenance, the PFS and OS tends to be really long. So could you talk a little bit about the strategy there and how do you overcome the existing OS benefit that these drugs provide? Thank you.

Roopal Thakkar: Hi, Mohit. It’s Roopal, I’ll take that. So, I think as you’ve seen in resistance we’ve seen that overall survival benefit, a very substantial one, unprecedented thus far. And to your point, the plan is to move into earlier lines of therapy. Secondly, it’s also part of the strategy to move into sensitive populations, which is around 55% of the population, resistance is around 45%. And then the third aspect is, we’ve seen encouraging data in medium expressers of FR alpha. And those are approximately 30% of the patients, high is around 35%. So those are the three strategies to go forward. Now how do we get into earlier lines of therapy? Well, a couple of things, insights that we’ve seen. One is, we’ve seen Elahere been able to combine at full dose with carbo-platinum.

So that’s encouraging, that gives you an opportunity to upfront combine. And then as you stated, maintain on Elahere or with Elahere plus BEV. So the other approaches that we would do getting to earlier line of maintenance is have that upfront therapy and then we see patients that go onto BEV, we can combine with BEV at that time point. And we’ll be looking at combinations with PARP inhibitors, which is about the other half of the patient populations, which are HRD deficient. So, taken altogether, we see there is an opportunity. Now, the PFS is going to be a little bit longer, along with OS. So that is something that we’re planning for, we’ll start these studies as soon as possible, but they will read out in the later part of the decade and into 2030.