Novan, Inc. (NASDAQ:NOVN) Q4 2022 Earnings Call Transcript

That’s how we can get out and build awareness, but with reference to Verrica, they will build awareness for the disease of molluscum if they are approved, so they have a PDUFA date in late July but, again, this is for a procedure, and as I said, we believe that we would be–once if approved, we would likely be the first line therapy because it is a prescription take-home gel topical treatment once a day, versus a procedure that is potentially requiring three of four doctor’s visits. But we believe because roughly 70% of patients today go untreated because there is no FDA approved treatment, we believe that there are patients that will begin to hear and be offered this–you know, it’s really not a new procedure, it’s a new way of delivering the same product, cantharidin.

But we have a novel new chemical entity that, again, is a prescription benefit as opposed to a medical benefit, so those are some of the differences.

Oren Livnat: Okay, and when you talk about preparing with your existing commercial infrastructure for that launch, can you remind us how much of that SB206 market is addressable with your current infrastructure versus how much you think you would need to scale up more and add onto your capabilities to actually launch it?

Paula Brown Stafford: Yes, it’s a good question. Thank you Oren. We will begin with the dermatologists because as I mentioned in my statement, we believe that the dermatologists will be the first to prescribe berdazimer gel if it’s approved, and we believe that in a community, the pediatricians know the dermatologists to whom they refer their patients for the treatment, because generally pediatricians don’t offer these in-office procedures. After they begin to see that the dermatologist is offering a prescription, they will look to the dermatologist as the key opinion leader in their community and then the pediatricians will follow. There are a large number of pediatricians in the U.S., it’s a very difficult market to call on with reps, and we are planning for digitally informing them once the product is approved, and that’s the way we would do that, and so it wouldn’t necessarily be increasing our number of reps at this point.

Preparing the field also means looking at the payor access and preparing for that, and then preparing ourselves to train a sales force. We are limited by our funds or lack thereof, and so this preparedness is an investment that we will make as funds are available.

Oren Livnat: Okay, and you kind of just segued on one more follow-up on payor prep. Can you just remind us, what’s your thinking on pricing? I know it’s early, but have you done any more since the data was out, since you’ve filed? Have you been doing more payor outreach and research and refining your thinking around likely net monthly pricing around the product?

Paula Brown Stafford: Yes, we did some market research in August of last year, and we continue to have some discussions. In terms of payor research, it was from August, and it was pretty much in line with the–you know, maybe a bit of an increase from what we had seen in 2019 when we went out and did that research, so we’ve updated it. We haven’t given guidance, but I know our analysts have been looking at anything between $500 and $1000 per kit, and a kit is–

Oren Livnat: Okay. Sorry, go ahead? I didn’t mean to interrupt.

Paula Brown Stafford: Yes, I was just saying, a kit is for four weeks of treatment.

Oren Livnat: All right, I appreciate the time. Thank you.

Operator: Thank you. The next question comes from Jeff Jones with Oppenheimer.

Jeff Jones: Hi guys. Congratulations on the quarter and thanks for taking the question. I guess two questions. In terms of cash needs, which you’ve spoken to in terms of where you get later–the latter part of Q2, what are you looking at to get through the year, and what does that allow you to do in terms of building up for sales and marketing prep for launch? Then, any update on discussions with Sato or others around further ex-U.S. partnering for Rhofade?