So, it is a sequence process that I would be surprised if our competitors didn’t follow the same process. In terms of positioning, I think we’ve been clear, but I’ll make sure we say it the right way, when we look at our product, we think the single biggest advantage we have in the marketplace is that people — we believe people are likely to carry it with them where they are not carrying a product today. And that’s why in my remarks before I focused on this idea of not having to think about carrying our product, you just have it with you. But clearly, there are other benefits. We do believe there is the potential for people to use the product faster or earlier in the disease state, because it is an oral product. And we also believe that our scientific data, which shows a very rapid uptake of epinephrine, as you know, it has a very rapid median Tmax is an important set of data that particularly for the healthcare providers will be an advantage compared to some of the other or could be an advantage compared to some of the other products that may be in the market.
Andreas Argyrides: Okay. Great. And looking forward to the upcoming data. Congrats on all the progress.
Dan Barber: Thanks, Andreas.
Operator: One moment for the next question. Next question comes from Thomas Flaten with Lake Street Capital Markets. Your line is open.
Thomas Flaten: Hey, good morning, and congrats on all the progress as well. Dan, we talked a lot about Anaphylm commercialization, but you did leave open the possibility of you guys perhaps launching Libervant later this year. Any commentary on what you’ve done or need to do and what timeframe we might think about if you go it alone with that?
Dan Barber: Sure. Good morning, Thomas. And I’m glad you brought Libervant up. There’s a lot of excitement around Anaphylm both outside and inside of our company as there should be. But Libervant is an important product. And from a FDA perspective right now, all of the questions the FDA has asked, we’ve answered and we’re awaiting the decision date. I do have to remind people that there is an orphan drug challenge that could occur with this product. So, we obviously want to get past the next couple of months and see how that unfolds. Having said that, I do believe that there are appropriate epilepsy focused companies who not only could do a good job with launching Libervant, but would be interested in launching Libervant. If those were to not unfold or we were not able to get the fair deal that we’ve talked about, we would launch the product and I would point to the second half of 2024 as where we would look to do that.
Thomas Flaten: Great. Appreciate that. And a quick one for Ernie. Gross margins were kind of all over the place this past year. And I’m guessing fourth quarter was a little bit of an uptick for some one-time royalty payments. Anything you can help us there? Anything you can help us there with respect to gross margins, Ernie?
Ernie Toth: Hi, Thomas. Good to talk to you. Certainly, the biggest item is the recognition of the milestone payment from Zevra for Azstarys. So, that $1 million in the fourth quarter, there was no cost associated with that. So, that would have an impact on gross margin.
Thomas Flaten: Appreciate it guys. Thank you.
Operator: One moment for the next question. The next question comes from Ram Selvaraju with H.C. Wainwright. Your line is open.
Ram Selvaraju: Thanks very much for taking my questions, and congrats on all the progress. Can you hear me?
Dan Barber: Yes, Ram.
Ram Selvaraju: So, just very quickly with respect to Anaphylm. I was just wondering if you had any updated thoughts regarding the regulatory outlook for these kinds of alternative delivery epinephrine products, particularly given recent developments with Neffy. And if you see any additional perspectives there for Anaphylm as you gear up to the submission of the NDA?
Dan Barber: Yeah. Nice to hear your voice, Ram. From our perspective, in our experience with the FDA from the first time we spoke with them about products for anaphylaxis through to today, we believe the FDA has been very consistent. And we actually think the FDA is doing their job. They want to make sure if we or anyone else are creating a product that is a rescue product that has the potential to save lives that we do all the work we’re supposed to do to make sure that it works the way it’s supposed to work under all conditions of use. So, we understand that’s a big responsibility for us and our competitors, and we understand that, which is why our package is robust and we are confident that the FDA will continue to be consistent in how they look at the market and how they think about approval.
In terms of our competitor, obviously, we just see what is public just like you. And our read through is that it appears from a distance like the FDA is being consistent with them as well at least when we think about the comments given to us and then what we hear coming through the public domain from competitors.
Ram Selvaraju: Okay. Great. Just also with respect to kind of optimizing the value of Anaphylm as a franchise, do you have any sort of broader strategic thoughts regarding that, particularly if this pertains to any potential opportunities for Anaphylm as a product that may exist outside of the United States, and how you might be able to access those?
Dan Barber: Yeah. No, that’s a really good point, Ram. From — given where we are in our company evolution, and this goes back to the idea of long-term growth, right, we do not have designs at this point in time to launch on our own the product outside of the U.S. at all. So, we — like we have done with Libervant, we will be and actively are talking with potential partners in different markets around the world. For us, the nice thing about where we are right now is we don’t have to find a partner tomorrow or this quarter or anything like that. We can make sure we find the right partner to get through the regulatory process in different markets and also support the product once it has been launched. But yes, an important part of the Aquestive story for both Libervant and Anaphylm is the ex U.S. potential.
