AbbVie Inc. (NYSE:ABBV) Q1 2024 Earnings Call Transcript

Jeff Stewart : Yes, it’s a great question. So it’s early, but we believe the data is accurate. I mean, if you look at the first two weeks to give you some sense, and this is inclusive of the Cordavis Humira. There was a downdraft of about 13,000 prescriptions for Humira from baseline. And the biosimilars captured about — which was primarily the Cordavis Humira, captured about 10. So there’s 3,000 prescriptions or over 20% that we can see in our data moving to other mechanisms of action, including our Skyrizi and Rinvoq. And again, it’s very logical because this is just not a one-to-one type of switch like these physicians are interviewing and discussing with patients, their care path forward. And so we think that clearly, some are moving to other mechanisms, and we’ve seen that in other analogs as well.

So we believe the data is accurate. Again, it’s early. We’re going to continue to monitor it. Where that ultimately lands, we’ll have to see. Again, I want to reiterate the pure Humira downdraft is within line with what we assumed and we are seeing this other market behavior that’s taking place.

Robert Michael : And Carter, this is Rob. Just to clarify my earlier comments. Yes, it is ex-IP R&D. We always guide to ex-IP R&D. What I was trying to highlight is you should expect robust revenue growth in ’25 and that growth accelerating in 2016 and beyond given that Part D benefit redesign impact in ’25. And given that operating margin will expand, you typically would expect our earnings to grow faster than our revenue. And that is generally true with 1 exception in ’25 being that we will have an annualization impact from net interest expense. We’ll still deliver a very solid earnings growth. But as you model it, just keep in mind that while you expect typically earnings to outpace revenue growth given expanding operating margin, you do have that dynamic in ’25, that’s important for your modeling.

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

Operator: Our next question comes from Simon Baker with Redburn Atlantic.

Simon Baker : Two quick ones, if I may. Just going back to Humira, but in a slightly broader sense. There’s been a degree of political noise around the role of PBMs in blocking or rather than assisting biosimilar uptake. I just wondered if you expect that to come to anything in terms of structural changes within the market? And then secondly, on Rinvoq and the Level Up deal — Level Up data. I wonder how you see the competitive dynamics evolving in that space? Is this about switches? Or is this about market expectation expansion. I asked because this morning Sanofi said that they welcome competition as a way of expanding the number of people treated in an area that’s still relatively unpenetrated. So I just wonder how you see the opportunity commercially?

Jeff Stewart : It’s Jeff again. I would say that we’re not anticipating like a wholesale restructure of the PBM industry, for example. I mean, we certainly think that there’s very reasonable chance of sort of transparency reform, exactly how some of the economics are working, maybe transparencies to the government or downstream to the clients, that’s very possible. But a major wholesale change, we don’t see that happening in the near-term. Obviously, we are continuing to monitor that and would make adjustments as we might need to. Regarding your atopic dermatitis question, I think the answer is really a bit of both. I think as we’ve highlighted before, the market here is exceptional in terms of the low bio penetration or oral and bio penetration.

It’s really only about 4% or 5%. And so I think Sanofi’s comments are very well timed. I mean this marketplace is going to grow significantly as this innovation is able to be delivered to the global population with this very serious disease. But we also think this Level Up study is good for our market share penetration, and I’ll give you some perspective. Our U.S. market share is lower. It’s around 9%. So typically, where our countries have been able to highlight more direct comparisons. We couldn’t do that because of the starting dose, I highlighted. We see that most of our international affiliates have market shares in the mid-teens in some cases in the low 20s. And so the ability to bring a comparative study that’s directly linked to the U.S. label and show the physicians how you can get to higher levels of control and really patients want — they want no disease on their skin and they really don’t want itch if they can get there.

And that’s what we studied in Level Up. So we think it’s certainly going to help with both market expansion and in particular, around the world with our ability to capture some more share. So I hope that helps.

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

Operator: Next question comes from Tim Anderson with Wolfe Research.

Tim Anderson : I have questions on contracting for Skyrizi in ’25. How many lives do you already have locked up through your general multi-year contracting? And then do you continue to think that the availability of cheap versions of Humira, either brand or biosimilar won’t lead to any increase in step edits on Skyrizi under the idea that while Skyrizi is better, something like Humira or biosimilar Stelara might be just fine. That same arrangement can be made in the statin category, for example, Crestor is the best Zocor might do just fine.

Jeff Stewart : Yes. I think we’ll probably pass on the number of lives locked up. I mean we are confident, given the market position TAM of Skyrizi and Rinvoq, I think, in particular around the momentum that we have across the Skyrizi indication that we’re going to have very favorable access in 2025 and beyond. I think the other thing that we’ve highlighted is I’m very pleased with how the adoption of Skyrizi is going in IBD. I mean it’s very, very clear that we’re taking significant share from Stelara and the doctors are voting with their pen, or they’re basically electronic prescribing because the ability to get these very sensitive patients under significant control, the world’s really never seen anything like the sequence trial in terms of the ability to control the most difficult aspect of this challenging disease.

So as time goes by, we think that differentiation is going to aid us significantly as we think about the formulary positions relative to not only Humira, but also to Stelara.

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

Operator: The next question comes from Luisa Hector with Berenberg.

Luisa Hector : It’s on Elahere. I wonder whether you might be able to tell us the full quarter of sales. And then any commentary around penetration rate of Elahere and how much off-label use you think may be happening with the guideline inclusion?

Scott Reents : Sure. It’s Scott. With respect to the Elahere full quarter of sales, we closed mid-year in February. Prior to that there were — according to what we’ve seen approximately, just let me just double check here, $70 million — I’m sorry, $110 million in the full quarter, $113 million in the full quarter.

Jeff Stewart : And it’s Jeff. What we also see in the marketplace, a big catalyst that we saw in the first quarter was the movement from the accelerated approval to the full approval that Roopal highlighted with the MIRASOL data. So we were rapidly able to basically integrate that into all the material of the medical liaisons and certainly account managers and sales folks. And having that definitive table in the label and the ability to go deeper into our call plan is going to be very positive to continue the growth rates through the rest of the year. In terms of off-label, that’s difficult to say. We think that the majority of the sales thus far are in that platinum-resistant population. However, the guidelines do allow for reimbursement with different levels of FRA alpha some of the updates that I mentioned in my prepared remarks.

So we’ll continue to monitor it, but there’s certainly a significant headroom in terms of the populations that are coming in terms of the ovarian cancer marketplace.

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

Operator: The next question comes from Gary Nachman with Raymond James.

Gary Nachman : When looking at the strong performance of the neuro franchise of Vraylar and migraine in particular, talk about the competitive dynamics there in those markets. And how did the gross connects impact you in 1Q versus what you expected? And how should that trend for the rest of the year? And then with respect to Cerevel, just your confidence that it will still close by mid-year, and how FTC is viewing the schizophrenia market and how much overlap there might be between emraclidine and Vraylar? Just the latest thinking on that based on your conversations with FTC.

Jeff Stewart : It’s Jeff. I’ll take the competitiveness comment in terms of what we’re looking at. We’re very pleased with the competitive — our ability to gain market share in these segments. I’ll start off with migraine. We continue to be the new to brand share leader in Botox for chronic migraine, and we see that Qulipta is accelerating significantly. So Qulipta is now the leading preventative agent. And what’s nice is there’s very little interaction with Botox because if you’re an injector, you use Botox, if you’re not an injector, you have access to a fantastic drug with Qulipta. So Qulipta is really clearly taking over the market leadership position among the injectable and the oral CGRPs. Ubrelvy continues to have a very meaningful and substantial lead over the main competitor, Nurtec and we are seeing some increased penetration into the larger triptan segment, which is key to our long-term growth.

Vraylar continues to perform very well, ongoing market growth. And it’s really because we have — if we look at our perceptions, Gary, of our key prescribers, you’re at the very, very top of the table, the league table in terms of perceptions around the efficacy around adjunctive major depression, which is our most recent indication and we have probably the best scope of indications for bipolar 1. And so both of those are allowing us to continue to gain share. So we’re in a pretty good position. We also feel that the gross to net our vouchers, our co-pay, which sometimes can get a little funky in the first quarter. We have strong controls there and we’re seeing a lot of stability. So overall, those businesses are performing very well.