Benazir Ali: Excellent. Thank you so much.
Operator: The next question is coming from Andrea Tan from Goldman Sachs. Andrea your line is live.
Andrea Tan: Good morning. Thanks for taking our question. Krish, maybe one for you. Just as patients have been on commercial drug now for quite a bit of time. Just wondering if you could provide an update on what you’re hearing on the experience of these patients with respect to wound closure. Curious if you’re starting to hear of any patients starting to come off therapy as their wounds close? Or do you still believe the induction phase that previously you had projected at two years is still intact? Thank so much.
Krish Krishnan: Yes. So to start with your last question, I think we continue to see a very high level of compliance — it has been almost a year. Actually, August is the first time a patient got on VYJUVEK in a commercial setting. But compliance seems to be high, and we are continuing to say that the injection period, we expect induction to last maybe 15 months to 18 months, after which you should expect patients to consume less number of vials going forward as the wound heal. Now look at 91% or 93% on a high — over 90% compliance. If you think about 200 to 300 patients on drug on a weekly administration to get to 91%, we are talking a handful of patients may be missing a week here and there. So for all practical purposes, most of the patients are still on track.
Now there have been one or two instances with dominant patients where we have actually heard look, all the wounds have here to be healed, especially in really young patients and calling us to ask “hey, can we take a pause and resume if we see some kind of disruption in the wound?” Hasn’t happened a lot. It just happens with young kids predominantly on dominant DDEB, but it does have happened. Anything else, Jen you want to add to that question?
Jennifer McDonough: No. I think, again, I think real world experience, we continue to hear very, very positive feedback from patients and pictures that we are seeing from our patients showing the improvement in the skin, the durability of the skin, just the skin feeling different all over. So the patients are very excited and we are happy that they are where they’re at.
Andrea Tan: Perfect. So just to confirm, the majority of your patients you are still seeing receive about 1 vial per week.
Jennifer McDonough: Absolutely, yes.
Andrea Tan: Thank you so much.
Operator: Thank you. [Operator Instructions] The next question is coming from Gavin Clark Gartner from Evercore ISI. Gavin, your line is live.
Gavin Clark-Gartner: Hi, thanks for taking my questions. I have a few, so I’ll just go one by one. First, for the reimbursement approvals, are all these patients going on to receive paid drug? Or is there any leakage along the way?
Jennifer McDonough: Sure. So while definitely the majority are going on therapy. We continue to work with those that are — as we get through the process. But for the most part — they are all going on therapy, yes.
Gavin Clark-Gartner: Okay. And you note — I believe you noted that the Change Healthcare hack resulted in a lower number of reimbursement approvals in the quarter. Can you just help us quantify what that impact is?
Jennifer McDonough: Yes. I don’t have — quantifying it. In most part, it slowed it down a bit if you are aware of that when it came to change, some of that claim adjudication, some of the benefit verification had to pause because our partner relied on changed exclusively I think. — they definitely had a pause there. So it is back to normal, and we are back kind of expediting those approvals as fast as possible.
Krish Krishnan: Hi, Gavin, I would say look, if you do track something at reimbursement approvals on a weekly basis, the disruption can be quantified as a week to two weeks of disruption.
Gavin Clark-Gartner: Okay. That helps. Thanks. And I wanted to just clarify on the compliance metric, that 91% that you provided. I think you noted it was 91% of patients who are on once-weekly therapy is the other — are the other 9%? Are they on less frequent therapy? Or is there a different group of patients who have kind of discontinued treatment altogether?
Jennifer McDonough: No. That measurement is actually compliant to weekly therapy. How many patients receive their treatments weekly if they miss a dose, and that would negatively impact it. But in general 91% of patients receive it weekly. And then if they miss a dose again, it could take it down a bit. But does not mean that patients are getting it any alternative way. It is weekly. That’s how it’s prescribed, that’s how it’s dosed.
Gavin Clark-Gartner: Okay. Like is there a different group of patients who have discontinued.
Jennifer McDonough: No, no. It is just the balance of adverts that just missed a dose.
Gavin Clark-Gartner: Got it. Thanks so much.
Operator: Thank you. And the next question is coming from Yigal Nochomovitz from Citigroup. Yigal your line is live.
Yigal Nochomovitz: Hi, Krish and team thank you for taking my questions. I just had a question on the ophthalmic study, this small open-label study in 10 patients. Could you just explain, are these patients, ones that are existing VYJUVEK patients — or could they have been or is the use of VYJUVEK an exclusion criteria for those 10 patients? And then regarding your inhaled technology, I don’t think you’ve talked a lot about the delivery system there. Could you just explain or using a nebulizer. How long is the inhalation session per dose? Could you just explain a little bit more about the way that’s delivered? Thank you.
Suma Krishnan: Hi, this is Suma. I’ll answer the first part of your question. With regarding to the eye, yes — a good chunk of the patients that are on a Phase III study also have manifestation I mean, impact on their eye. They have severe blistering or wounding — as a result they can’t open the eye and it’s very painful. So we already have a good chunk of patients who know about the study and are actually proactively want to enroll in the study. So we feel pretty good. We should be able to enroll these patients pretty rapidly. Again as I said, as we discussed with the agency, it seven to eight patients, small number of patients that we need to show wound healing compared to their actual history at — [technical difficulty] forward study and we anticipate enrolling the study pretty rapidly because we already know patients that are lining up for the study.
With regarding to your second question with the inhalation, yes it’s a standard nebulizer that is off-the-shelf that’s available. The beauty of our product is unlike some of the mRNA deliveries because of the viscous nature of the material, you have to dilute a lot for it to go through the mesh. In our case, I mean this is — you can nebulize the product in less than 15 minutes. So it is a pretty rapid, fast nebulization time for these patients.
Yigal Nochomovitz: Okay. Thanks. And just one quick follow-up on Japan and Europe. I assume that those approvals would be for the skin application first and then the ophthalmic application later? Or is there any possibility that the data from the ophthalmic product could be included with those submissions?
Suma Krishnan: I mean, obviously at the moment, it’s all for the skin, it’s the same. But once we complete the US study, we may use the same strategy to go into these two countries. You can use the US data to seek approval in those regions.
Yigal Nochomovitz: Okay, thanks.
Operator: Thank you. And there were no other questions at this time. And this does conclude today’s conference call. At this time, thank you all participants for joining the Krystal Biotech first quarter 2024 earnings conference call. You may now disconnect.
