Krystal Biotech, Inc. (NASDAQ:KRYS) Q4 2023 Earnings Call Transcript

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Gavin Clark-Gartner: Okay, great. And last one, I just wanted to ask what your latest expectations for VYJUVEK pricing in Europe was, and thanks for taking all the questions.

Krish Krishnan: We don’t know. We — look, it’s a differentiated drug. The efficacy profile is very strong. We’re seeing really good demand on name patient sales from a handful of countries. Our conversations with the MA are going well. Our job is to make a case for, we know it’s going to be lower, but our job is to get to less than a 50% discount if we’re fortunate. Less as in, like, I hope I’m not confusing people there, something north of, say, $15,000 per vial would be great for us.

Gavin Clark-Gartner: That makes sense. Thank you.

Operator: Thank you. The next question is coming from Josh Schimmer from Cantor. Josh, your line is live.

Josh Schimmer: Great. Thanks for taking the questions. I have two quick ones. So, 228 reimbursement approvals out of around 428 start forms, that’s 55% conversion. For the remaining 45%, how many of those or what proportion of those do you expect to be able to capture with the new J-code and over what period of time? Second question is if you can quantify any contribution from either inventory building or named-patient access in Europe? And then last question, the annual cap of $900,000 gross, is that on a per patient basis or a per plan basis averaged across their population? Thank you.

Krish Krishnan: Look, on the first one, our internal goal is to try and get to all, you talked about the gap between the start forms and the thing. We’re trying to get to — get all the patients in 2023 on to reimbursement by the end of Q1. That’s the goal. And then, so I don’t — instead of — answering your question as 228 versus 428, our internal goal is all the patients who we know of at the end of 2023, we want them on reimbursement by the end of Q1. In terms of, was there any inventory or NPP, hardly any yet. We’re just starting to get NPP, it’ll probably get reflected more going forward. And on the annual cap, look, it is — the overall discount, I think I’ve mentioned is measured at the payer level. So it’s kind of like a blended average depending on the number of patients in the plan.

Josh Schimmer: Thank you.

Operator: Thank you. And the next question is coming from Ritu Baral from TD Cowen. Ritu, your line is live.

Unidentified Analyst: Hi, good morning, guys. This is [Technical Difficulty] for Ritu today. Congrats on the quarter. I have two questions. So as you see more reauthorizations taking place, could you just expand on how — what’s the process of that, and then what does the prescriber need to show for a successful reauthorization? And I have a follow-up after that.

Krish Krishnan: Yeah, and the reauthorization happens every six months, usually you need a, it’s called clinical notes from a physician saying that the VYJUVEK is working. Some of them certified without a patient visit and some certified wanting a patient visit and we’re talking a local patient visit for the most part and that’s what it entails. So depending on the patient, it could take a certain amount of time, but usually it’s pretty quick.

Unidentified Analyst: Got it. And then could you talk about the market research efforts in the EU ahead of the potential launch there and like in terms of how patients are currently managed there and now — and just to confirm, now you’re expecting a launch there in next year versus later this year? Thank you.

Krish Krishnan: Look, later, I want to be clear, it depends on when we get approved. And if you saw what happened to us in the US, we’re always adding three months to PDUFA date from this point on. It appears to be the norm that anything management says. Having said that, if the launch is scheduled for late in the year, like say in December, we’d probably push it out to January. In terms of launch plans, I think we’re going to have a General Manager in Germany at the beginning of March to build out the team. That will be the first country of launch. In terms of market research, our current EU General Manager, Laurent, has already been talking to physicians and centers of excellence who have really strong registries, so we feel really good about the identified patient population.

A lot of home dosing in Europe is handled by the hospital, so a lot of the logistical complications you see in the US, like getting home dosing in place, finding patients are not as big issues in Europe. What is important in EU is that we get to a good place on access. If you get to a good place with respect to access, then the EU launch becomes a bit simpler logistically than the US launch. And kind of very similar in Japan story.

Unidentified Analyst: Great, very helpful. Thank you.

Operator: Thank you. There were no other questions in queue at this time. This now concludes the call at this time. Thank you all participants for joining the Krystal Biotech fourth quarter and full year 2023 earnings call. You may now disconnect.

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