Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q4 2023 Earnings Call Transcript

Dan Barber: Thanks, Frank.

Operator: One moment for the next question. The next question comes from Jason Butler with Citizens JMP Securities. Your line is open.

Jason Butler: Hi, thanks for taking the question. Dan, you talked about the commercial prep work you’re going to be doing, getting ready for launch at the back end of ’25. Can you maybe just talk about the work you can do between data and throughout the regulatory submission? And obviously, you’re going to be gating your spend, but what’s the kind of work you can do in terms of physician targeting, building awareness, et cetera to get ready for a launch? Thanks.

Dan Barber: Yeah. And Jason, the way you asked the question actually you put in two important elements, right, which is, for us, in 2024 and even the first part of 2025, the commercial spend will not be a large onerous amount that we can’t handle. We do believe that given our cash position and the levers that we have in our business that it is a very manageable set of activities. In terms of what those activities are, as you alluded to, awareness is by far an important factor prior to launch. And one of the things that helps us in the dynamics that exist right now is not only is the market already growing, but some of our competitors in the marketplace are also focused on awareness. So, by nature, just making people aware of the alternate products that will be available to them and of the necessity of having a rescue product with them at all times helps as we look to come to the market.

In terms of the other activities that we will focus on, we will, of course, make sure we have the base infrastructure in our company. So, think of people who are dealing with payers, people who are on the medical affairs side, and we will, of course, make sure that our messaging is ready and clear as we get closer to launch.

Jason Butler: Got it. And then just briefly on 108, can you maybe just give us an idea at a high level what the target PK profile or absorption profile looks like for — when we look ahead to data later this year?

Dan Barber: Sure. So, for that one, I’ll pass it over to Carl.

Carl Kraus: Yeah. The PK profile would be consistent with what we’ve been targeting all along, which is demonstration of a PK curve that is north of a reference listed drug for the duration of observation and remains within the bracketing that has been discussed at last year’s advisory committee where we are north of at least the reference listed drug as well as staying within a reasonable bound on the bracket between ourselves and the autoinjectors.

Dan Barber: And Jason, I think Carl gave a really important point that we talk a lot about here in the way he said that, it would be north. The one place you don’t want to be, we believe, is lower — in that first 10 minutes in particular, lower than the manual IM. So that’s a spot that everyone can look for in terms of where we’re able to be above that mark.

Jason Butler: Okay. Great. Thanks for taking the questions.

Operator: One moment for the next question. The next question comes from Andreas Argyrides with Wedbush. Your line is open.

Andreas Argyrides: Good morning, and thanks for taking our questions. Just a couple from us here. So, looking ahead to the commercial opportunity for Anaphylm, how are you thinking about penetrating the various segments of the market outside of EpiPen and generics, which is currently less than $1 billion? The immediate goal to target patients who should carry and don’t, those who are given a script and don’t fill it? And what does the market look beyond that those two segments? And then lastly, how are you thinking about positioning Anaphylm against competitors on the market? Thank you.

Dan Barber: Sure. Good morning, Andreas. Nice to hear your voice. So, I think the way to think about launching our products, I think is very similar to the way other products have been launched in this space. Of all of the pieces and parts that all of us have to go through to bring a product to market, the launch is actually fairly simple. It’s obviously all of the packaging to make sure the FDA is comfortable in getting through that work that we believe is the more difficult task. In terms of penetrating, our launch process will be very straightforward. You first go after the people who are already using or carrying an EpiPen who have a script, and then you work your way into the segments where people have either gotten a script and didn’t fill it to your point, or used to carry a product and don’t anymore, or should be carrying a product and never have.