Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) Q4 2022 Earnings Call Transcript

Patrick Burnett: So with regard to €“ yes, all right. With regard to the read-through from INTEGUMENT-1, INTEGUMENT-2 to the INTEGUMENT-PED trial, keep in mind that 1 and 2 enrolled patients ages six and above and the INTEGUMENT-PED trial at ages two to five. I think that reading out two successful Phase III studies in atopic dermatitis, where we’re not really seeing within our data or looking across other data in atopic dermatitis, a really significant difference in how patients are responding based on their age and especially considering the fact that INTEGUMENT-1 and 2 included a lot of pediatric patients from the ages of six, all the way up and including adolescents up to the age of 17. So we’re seeing a very strong read-through from INTEGUMENT-1 and 2 over to the pediatric trial that we’re planning to readout in the second half of this year.

With regard to 234, we haven’t released any time lines with regard to that program right now. We’ll probably be in a place later this year to say a little bit more about them. But we do see based off of just the mechanism of action of CD200R, as well as some of the clinical data that’s out there, not with ours with another CD200R agonist. What we’re seeing is that we’re seeing the potential ability of this pathway to have an extended effect on the immune system, not specifically by suppressing the immune system but by adjusting the response so that it’s targeting specifically those pathways that may have been activated. And in the case of diseases like atopic dermatitis, these are pathways that would have been activated, not in response to a signal that needs to be managed, but more kind of pathologically activated is the potential to be able to have a more long-term response than what you might be seeing with IL-4 and IL-13, which needs to be dosed quite frequently as well as an ability maybe to manage this disease without creating any kind of immune suppression.

So these are some of the aspects of CD200R that made it very interesting to us, and we’re looking forward to giving you more information about that program as we progress it internally.

Louise Chen: Thank you.

Operator: Thank you. And our next question coming from the line of Rohit Bhasin with Needham & Company. Your line is open.

Rohit Bhasin: Hi. This is Rohit on for Serge. Thanks for taking our questions. Can you talk about any particular trends you’re seeing in terms of new Rxs versus refills? And then in terms of the OpEx, I know you mentioned you expect SG&A to increase, but can you provide any additional color there? Thanks.

Frank Watanabe: Sure, Rohit. So I think you probably are seeing the same trends as we are. NRx remains strong. And one of the things that’s tricky about TRx is because this is a cry condition in the topical space though, the therapy seems to be used acutely, and that’s why we see kind of overall expectations for adherence to be in the neighborhood of 3 to 4, 2. So it was a little bit tricky to see kind of patients are continuously using because they’re coming in at all different levels of severity and all different levels of body surface area. I will say, though, we are seeing positive trends with respect to some patients coming back for 2, 3 and 4 already. So certainly a good sign with respect to overall patient satisfaction and adherence.

But the ratios, if you will, that you can kind of see them in the weeklies are pretty representative of what’s happening. What I’m enthused about is that our NRx trends appear to be quite strong. And again, the TRx is — the refills that are sporadic because it’s not a 1:1, a patient might pick up a refill now for a prescription they got in August, for example. So it’s a little bit trickier there. But the NRx trends for us, I think, look good and the more awareness and confidence that the community builds additionally with the additional coverage, I would expect that to continue to grow.