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

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Operator: Thank you. Our next question comes from the line of Jeff Meacham with Bank of America. Your line is now open.

Unidentified Analyst: This is Susan on for Jeff. Given the Company’s stronger cash position, are there any interesting external business development opportunities? And if external business development isn’t on the books this year, which internal programs do you expect to accelerate in.

Jerry Durso: Yes. So as you can imagine, we’re always looking for externally for good opportunities, but we’re also making sure that we’re managing the cash we have on hand appropriately given the work that we’re trying to do and funding the important internal programs that we discussed some this morning, INT-787, with a lead indication ongoing. And importantly, the long-term next-generation in PBC for the fixed-dose combination will be our primary focus. We’re also looking for additional indications for both of those internal assets should it should it make sense. So, we’ll continue to evolve the pipeline in the right way while we also make sure that we’re focusing our cash and our investment on the growth drivers.

Operator: Thank you. Our next question is the follow-up from Mayank Mamtani with B. Riley Securities. Your line is now open.

Mayank Mamtani: So maybe just one more NASH NDA review question. Has there been any indication for biopsy endpoint definition changing or being mechanism specific, et cetera. Anything that to suggest that agency might be looking to go beyond the scope of their 2018 draft guidance document, Michelle?

Dr. Michelle Berrey: Well, as Linda was to, we have seen a lot of interest and some great publications now coming out on the noninvasive tests. I think it’s recognized certainly by the community and by the GI division that those patients and providers would really look for an alternative to biopsy. Really the only reason first to getting a liver biopsy is to participate in clinical trials. Having said that, we have relied on histology for decades in viral hepatitis and now in NASH, and that is our agreement with the agency that this planned interim analysis would focus on histology. We’re confident that the histology results that we’ve seen now with two independent analyses confirm our antifibrotic benefit, and we’re excited about that opportunity to discuss it with the agency at upcoming opportunities.

I think it does remain draft guidance as you point out though. So, as more data are being reviewed, we may see some modifications to that, but we are confident in our submission and our analyses that have been submitted with the NDA. Thanks for the question.

Operator: Thank you. And now, I will turn the call back over to Jerry for closing remarks. Jerry?

Jerry Durso: So thanks, everybody, for joining us today. Just to reiterate, I’m really extremely proud of the performance that the Intercept team delivered both in the fourth quarter and for the year of 2022. We clearly have a lot of work ahead of us, but I think the achievements that we’ve discussed this morning, set us up to drive continued long-term growth for Intercept, and I definitely look forward to sharing updates as we progress through what is an important and exciting year ahead. So thanks, and everybody, have a great day.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.

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