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

Andrew Saik: Yes, sure. Thanks, Brian. Yes, so look, we’re extremely happy that we were able to get such a positive settlement. Not going to litigation on the IP was a great outcome for the Company and getting 70% of the value of those 2033 patents is a real win for the Company. Look, we can’t speak to the current additional filer out there, which is Zanera Pharma. That’s a separate trial. It’s the same jurisdiction, the same judge, same fact set it would — but it’s out there in 2024. The good news for the Company is that we’re completely ready for trial, right, because we did all the work, we did all the prep. Zenara would have to start over from scratch. We’re never going to predict an outcome, but it’s the same fact set, and we’re ready to enforce our IP vigorously.

In terms of carry on to NASH, again, assuming that we get approval, that’s the same fact set. It will — presumably, if people file against it, it would be a completely different trial. But again, we’re very comfortable with the IP. We’ve been through it. It’s the same patents. So we would have the same level of comfort that we have with Ocaliva as we have with NASH. I don’t know, Jerry, if you want to add to that?

Jerry Durso: Nope.

Operator: Thank you. Our next question comes from the line of Michael Yee with Jefferies.

Unidentified Analyst: This is P.J. on for Mike. One question from us today. So some competitors have Phase 3 data coming up over the span of the next year. Could you comment to us a little bit of your view on how the competitive landscape is involved is evolving and how Ocaliva is positioned in this and.

Jerry Durso: So I assume you’re talking about competitive landscape on PBC just so that I’m clear.

Unidentified Analyst: Yes, PBC.

Jerry Durso: Yes. Maybe a couple of comments from me, and then Linda can get in a little deeper. I think importantly, we continue to position ourselves for a long-term effort in PBC. We have leadership there. Our goal is to maintain that leadership. And I think, as Andrew just indicated, the patent settlements give us more runway and certainty on Ocaliva. And then importantly, we have the opportunity with the next generation and the FTC coming to not only potentially provide a better therapeutic solution but also more runway because there’s incremental exclusivity and IP potential on the combination. So this is a long-term play for us now. And as we get ready for potentially some Phase 3 data to come and new entrants in the second-line therapy, I think we feel good about our position and the work to do ahead. Maybe Linda, you can comment on how we see that evolving.

Linda Richardson: Yes. I mean, obviously, we’re the incumbent, we are still growing. We have new data that’s changing the way prescribers think about the goals. We have probably two more publications to come this year, reinforcing our real-world evidence. And what we’re really trying to do is say it goes beyond ALP and just normalizing or lowering scores, it really is about what is the long-term impact on the patient. And we are the only people right now in the new second line, not discounting or so. But in the second-line market, we are the only ones with that data, and it is important, and we are repeating the data in multiple studies, and that gives credibility and credence to what we are able to communicate and generate.

And in that commitment to this space, we will continue to move the goalpost. Again, impacts lives, not labs. We have the ability to still call on these folks if we have a future NASH launch. We’re in there day in and day out. And we’re also strongly engaged with patient organizations with the groups that are making guidelines, et cetera, so we feel we have a lot of game and growth as is evidenced by our accelerating growth in the second half. Our plan is to carry that forward into the year.