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

And we know from the profile of OCA, including, importantly, the greater level of efficacy that we showed in some of the analysis that we reported out in the latter part of last year showing higher efficacy. For example, in that F3 subset goes in that same direction. We would also be focused in the initial phase on those patients that are already under care of the specialists of and GIs. And as Linda said earlier in response to the one of the questions, we’re seeing most of those physicians already today. So, I think we have a good understanding of those practices and of those individual and group prescribers. So Linda, anything you want to add on.

Linda Richardson: Yes. I think the combination of calling on these folks with the urgency that’s been noted over and over again by physicians with the fibrotic patients, advanced patients we estimate that there are probably 20 million adult patients with NASH, but only a small percentage, roughly about 3.8 million have been actually diagnosed, right? There’s nothing to use to treat them. So you see an increase in diagnosis that comes following the ability to have on-label treatment and therapies and lots of discussions. We continue to estimate that approximately 500,000 diagnosed NASH patients. These are diagnosed are currently under the care of a HEP or GI and have advanced fibrosis without cirrhosis. So from a launch mode, we feel that those patients reside in the offices that we’ll be calling on and have the most need and we have the best data in that set.

Operator: Thank you. Our next question comes from the line of Brian Skorney with Baird. Your line is now open.

Brian Skorney: I guess on the Ocaliva guidance for 2022, maybe you can just frame how to think about getting that higher end of the guidance, it’s almost 20% increase year-over-year, which is quite a bit of acceleration compared to where it’s been trending for the last two years. So can you just characterize what you’re seeing in the more that might get you there? And does that high end include anything for NASH?

Jerry Durso: Andrew, maybe you just start on that.

Andrew Saik: Yes, sure. Thanks, Brian. Look, the guidance that we gave is kind of in the 9% to 19% range growth. We tend to try to target the center of that growth as to where our focus is internally, Again, we’re continuing to put effort and energy into growing our top line and we’re really comfortable with our guidance overall. What I would say is that the guidance that we gave on Ocaliva is unimpacted by NASH. In my prepared remarks, you probably noted that I mentioned that we would reserve the right to come back and reissue guidance when and if we get approval from the FDA. And at that point, would we give more of a blended and that secondary guidance would include any impact from NASH on Ocaliva.

Jerry Durso: Yes, Brian. The only other thing that I would add just in terms of dynamics, we talked in the second half of last year about the emerging data that we were beginning to publish from the real-world data sets on outcomes. We know that some of those publications came late in the year, and look, all indications, that data, we’re getting it out there appropriately in the context of the medical affairs and/or a commercial plan. But that data is just starting to get into the hands of the prescribers. And we know from the market research that we’re doing, it can be quite important to those prescribers as they think about potentially increasing their utilization of Ocaliva for the right second line patients.