Bristol-Myers Squibb Company (NYSE:BMY) Q4 2022 Earnings Call Transcript

We’ve got the data in the Phase II setting for psoriatic arthritis as well as SLE, and we are in the Phase III clinical trials for all of these indications. So I think the profile of Sotyktu is well set now, I think, and the confidence that we have on the data and the evolution of the data is making it very promising for physicians to prescribe it, as Chris talked about earlier. So we will rely on that information and the evolution of the data for our own molecule. I cannot speak to what Pfizer will do when their data reads out. But certainly, I’m pretty sure you will all be asking the question, is a JAK inhibitor right thing to do in psoriasis when there are efficacious safe therapies available for these patients.

Operator: The next question is from the line of Olivia Brayer with Cantor Fitzgerald.

Olivia Brayer : Chris, maybe one for you. Is there any update on Revlimid sales expectations looking beyond this year? I know you’ve talked about a $2 billion plus annual decrease in the past. But any changes to your thinking with respect to the revenue run rate there? And then a quick clarifying question on Sotyktu. Where are you guys at with the high-dose program? And could we see that move into any indications beyond UC at some point?

David Elkins : Great. Hi, Olivia, it’s David Elkins here. I’ll take the Revlimid one. Nothing has really changed in our outlook for Revlimid through 2025. We provide our update for this year, that $6.5 billion, which is a $3.5 billion step-down given better performance this — last year in 2022. As we think about ’24 and ’25, on average, about a $2.5 billion step-down is how we’re thinking about it. Chris or Samit?

Samit Hirawat : Actually, thank you, David. So Olivia, certainly, so TYK2 has two studies in IBD that are ongoing, one of them using a higher dose in ulcerative colitis. If you recall, we do not have a proof-of-concept in ulcerative colitis or IBD at this time. And the — one of the hypothesis that we want to test is the higher dose of Sotyktu in IBD or specifically over here in ulcerative colitis. So we are looking forward to seeing the data in the latter part of this year. And dependent on that data dependent on outcome, then we’ll be able to formulate the strategies as to how to move forward in IBD and/or other indications at the higher dose. You recall, though, that we’ve also tested higher doses in previous trials and other indications, and our safety profile has been maintained in those clinical trials. So we are not necessarily looking forward to any major signals that could arise at the higher dose, but certainly looking for the efficacy signals.

Operator: Our next question is from the line of Andrew Baum with Citi.

Andrew Baum : A couple of questions on your LPA1 antagonist. Can you just remind us when we might see that Phase II data? And also, given the failure of Roche’s pentraxin today, how you’re thinking about the Phase III trial design? And then finally, what other fibrotic indications aside from IPF you are looking at for that drug?

Samit Hirawat : Thank you, Andrew. So LPA1 certainly, we’re looking forward to presentation of the data within this year, within the first half of this year. And certainly, as soon as we have confirmation on the conference, we will be able to share that information. We did see the news from the competitive program, as you’re referring to Roche that the Phase III trial was stopped. We do see that our data, the Phase II data that we’ve seen thus far are very strong. We’ve talked about the patient population with no background standard of care as well as in combination with the background standard of care therapies, and we are pleased with what we’ve seen. We are in discussions on the appropriateness of the clinical trial design with the regulatory authorities, and you will get to see that as we launch that and as we make that public.