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

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Ram Selvaraju: Okay. And lastly, and I’m just asking this as a housekeeping item. I’m sure all of you are very well aware of the Change Healthcare cyberattack that occurred last month. Just wanted to ask whether your guidance for 2024 includes any potential impact that you may see, I don’t even know whether that’s really relevant in your case, from the Change Healthcare cyberattack and the disruptions to processing of prescriptions?

Dan Barber: Yeah. No that — for 2024, I don’t see any impact to Aquestive. The only comment I would give you for our IT is just even as a company, we do all of the things you would expect a public company to do to protect from cyberattacks that could affect our business.

Ram Selvaraju: Thank you.

Operator: One moment for the next question. Next question comes from James Molloy with Alliance Global Partners. Your line is open.

James Molloy: Hey, good morning, guys. Thank you for taking my questions. I had a question on the — couple of questions. The Anaphylm Human Factors program, can you walk us through what that encompasses? And then, can you talk a little bit about outreach to advocacy or allergy networking groups in advance of launch and how that sort of — how that has played out?

Dan Barber: Yes. Good morning, James. I’ll — or Jim. I’ll take the second question first and then I’ll hand it over to Carl who can talk to you about the Human Factors program. From an advocacy perspective, as you probably know, in this space, there are roughly four advocacy groups that are at a national level and all of them do great work. I mean just phenomenal work where they’re looking to make sure patients’ rights are protected and access to drug is protected and all of the things you would want. So, we do think that having a good relationship and supporting the various advocacy groups in this space is important. We have done that. We actually, if you look at even last year, we did that even more than most of our competitors.

So that shows you how seriously we take it. We met with all of them at AAAAI just a few weeks ago and we’ll continue to support them as best we can as they do the good work that they do. But with that, I’ll turn it over to Carl on the Human Factors.

Carl Kraus: Sure. Thanks, Dan, and thanks for the question, Jim. As far as our Human Factors program goes, as you’re probably aware, these programs are an iterative process and ours is no different. We are evaluating how adults, pediatrics and their caregiver patients might engage our technology in a pathway where we better understand interactions between our technology and the patients. So that’s a process that goes through a typical formative and then validated protocol, which we have gone through great lengths to support and we are in the midst of completing and progressing those efforts between ourselves and the FDA with ongoing dialogue. So, that’s an ongoing iterative process that is on schedule.

James Molloy: All right. Great. Maybe one quick follow-up. I know that certainly, Dan, you got plenty on your plate to keep you busy coming up. But looking beyond the horizon, what do you see as potential — are you seeing any potential acquisition candidates or things to bring on board to bolster the pipeline?

Dan Barber: Sure. Well, I would first look at where our pipeline is. If you look beyond Anaphylm, we are definitely excited about the opportunity with AQST-108 as a topical cream. I know we haven’t spent a lot of time with you or the public on what we see in that space, but we are actively doing work, and in the second half of the year, we’d love to talk about it more. We’re actually in the clinic right now with that program and we’re looking forward to having more to say. In terms of the acquisition world, I think we have a lot on our plate right now to focus on and we want to deliver Anaphylm on time, on schedule, with the right results and the right package. So obviously, we’ll be opportunistic like any public company, but that is not our focus right now.

James Molloy: Great. Thank you for taking the questions.

Operator: I show no further questions at this time. I would now like to turn the call back to Dan Barber for closing remarks.

Dan Barber: Thank you, Michelle. Thank you for joining us today. This is an exciting time for Aquestive and we’re looking forward to speaking with you again in the next couple of weeks. And with that, I hope all of you have a good day.

Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect.

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