Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) Q4 2022 Earnings Call Transcript

And again, I think it speaks well to that more advanced population. So look, the unmet need in NASH is high. I guess just the last point I would stress is in any chronic class, and clearly, NASH will be over time, an important chronic class of therapy, it always takes multiple drugs to address the different segments of patients that are out there, and we’re working towards defining the right introductory approach and the right segments for success for OCA and for the patients who have this high level of unmet needs.

Operator: Thank you. Our next question comes from the line of Eliana Merle with UBS. Your line is now open.

Eliana Merle: Just in terms of the NASH commercial landscape, you mentioned there’s a large number of undiagnosed patients. I guess what trends have you been seen recently on the horizon as potential initial therapies approved. And on the topic of reimbursement and diagnosis, I guess, as you do your pre-commercial conversations with payers, what feedback are you getting in terms of what they will view as a NASH diagnosis and any types of potential restrictions or step-throughs from the payer conversations, just given the potential for us to be able to this class and say, potential biopsies or any other types of sectors that might be needed or adjusted by payers?

Jerry Durso: Yes. Maybe a couple of dynamics to have in mind, Eliana thank you for the question. As I indicated earlier, obviously, we’re doing all of the in-depth work. And look, our plan would be to come back with more details on the commercial plan in a formal way when we get closer to PDUFA. Nonetheless, I think there are a couple of key themes which continue to play out. One is that we continue to see the utilization of noninvasives overall move in the right direction, right? There’s good momentum there. There is a larger utilization of the variety of different noninvasives for identifying patients. And the payers do understand this dynamic and are monitoring the progress and are looking for the right ways to identify patients consistent with what the KOLs are saying and what clinical practices, which is clearly utilizations of noninvasives.

I think with the payers, one of the themes which has been really important and productive for us is that we’re talking in the early discussions with the payers about a subset of our potential indication, right? We’re talking about the more advanced population. We’re talking about working together to find a way to find the right patients. And one of the big payer concerns is always utilization beyond your indication. So it’s a great starting point that we’re talking about the more advanced population and actually identification of a subset of our indication. And I think that gives us a good productive discussion. Of course, as I said, this will be an ongoing dialogue with the payers, and we’ll come back with more details as we get closer to finalization of the strategy.

And just the last point, of course, our final decision on price, et cetera, will be taken with approval, and we would communicate that as one of the last pieces in the equation.

Dr. Michelle Berrey: The only thing I might add to that, Eli, is at this point, unlike four or five years ago when we were talking about initial payer discussions, the idea and the acceptance of IT is also broader. So that plays into people trying to get to an easier path on the expense and the time and frankly, the pain per patient of biopsy. So I really feel like that is an advancement from where we were before and should help with different — the expansion of NITs being available and access to different ways to find appropriate advanced patients really has moved significantly from our earlier work.