The first phase, so the first couple of years of launch, the very straightforward, obvious place to focus are on these scripts that exist, right? So the healthcare providers who are writing scripts to patients today. So I am sure just like our competitors, that’s where our focus will be, right? Converting those existing low hanging prescriptions to Anaphylm. As time goes on, as our brand is established, yes, of course, there will be more of a digital, direct-to-patient advertising component, but that is not what you do. In our view, day one. Day one is about the existing base of the second phase is about the expansion of the market. I will let Ernie give you his thoughts on your expense question.
Ernie Toth: Good morning, Ram. So I think you are referring to our mention of our cash runway based on the recent capital raise of where that would get us and we stated that that would get us into 2026. So though we haven’t given specific guidance for 2025, both our 2024 guidance, what we expect to spend in 2025 will dozen and get us into 2026 on that cash does include some anticipated spend on pre-commercial activities this year, more around the payer perspective, and then next year of an increased spend to be prepared to launch the product.
Dan Barber: So, Ram, let me just add to what Ernie said and just put a finer point on that. We have plenty of money right now. We’re very happy with our balance sheet right now. And as Ernie said in his prepared remarks, while we have an ATM in place, we are not using it right. So we think we are well set up for what we need to execute upon, and we think that fits us not just to our approval, but past our approval and into the launch phase. And at that point, obviously, there is a lot of different parts of our business we will have to see how things go over the next two years.
Ram Selvaraju: So if I could just sneak in one more thing with respect to optimizing the value of Anaphylm as an asset, how do you see the picture changing outside of the United States, particularly given where you currently are with the product, all the clinical data that has already been generated? What are you seeing in terms of potential partnering interest or other opportunities to potentially optimize the value of Anaphylm as an asset looking at ex-U.S. territories?
Dan Barber: Ram you are absolutely right. We think Anaphylm is a global product, and we think there are a variety of places where – let me even take the word right, we think on a global basis, anyone who can have access to Anaphylm we think will benefit. When we look at the ex-U.S. markets, there is a few dynamics going on, right. So let’s take China. China right now is just not a good market for, I believe, I’ll make a macro statement of our industry in general pharmaceutical products, it’s just not only the geopolitical world, but the pricing world is not a good place. So I don’t think you’ll see us focus on China. Europe, however, is a very different story. We have done the work and we do believe Europe is a bigger opportunity than perhaps we had previously thought.
So, we do have business development activities going on in Europe. I think the timing remains to be seen. I will admit I don’t think our competitors have done us any favors in that regard because their products have struggled a little bit in Europe on the regulatory side. So I think we need to be clear with our story and make sure we’ve positioned ourselves correctly. But ultimately, I do believe Europe will be important to us.
Ram Selvaraju: Thank you.
Operator: Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is open.
Unidentified Analyst : Good morning, this is Joseph [ph] for Jason. Thanks for taking our question. Just a very quick one follow-up, clarifying question. Is a pediatric trial needed for approval, or do you plan to include the safety data from the study to FDA during the NDA review for the temperature/pH trials? We’re just wondering what you’re expecting to share. And lastly, on the topical product, do you also need to look at the potential of accidental exposure to another person, whether it’s another subject, a healthcare provider or family member? Thank you.
Stephen Wargacki: I apologize you were very soft coming through. I think I captured some of it, but not all of it. I heard you asked on the temperature/pH study when – what our thoughts are on sharing data. I heard you ask on the topical product, I think a sizing question about what the opportunity looks like. Did I miss one of the other questions?
Unidentified Analyst : For the topical product if you need to look at the potential exposure or accidental exposures to another subject or a healthcare provider.
Stephen Wargacki: You catch that? Okay, well, let me, I apologize, I am just not quite hearing it. But I will give you my thoughts on what I think you asked. So, on the temperature/pH study, yes, we will share that data. I think the timing of when we share is what we need to clarify with everyone. And that’s why we gave guidance today that definitely at the Q2 earnings call in August, if not earlier, we will share the clinical data that we have. But I think the important thing to remember around not just the temperature/pH study, but the three supportive studies is unlike the Phase 3 pivotal study this is not a pass fail series of endpoints. This is comparison work, right? So we are comparing. We are showing in the temperature/pH study, as an example, what our curves look like, single dose, after a variety of different liquids are administered.
You can actually see the liquids in the supplemental materials we gave. So while we – don’t expect any differences, even if there are differences, we think that all we’re doing is quantifying those differences so that it’s complete in our NDA. So these three supportive studies, we think, are exactly that supportive. So we’re excited to share that data in the future. In terms of the AQST-108 topical gel product, I know we haven’t shared a lot of information on this product yet. We do plan to in the second half. But I will tell you, we are very excited about being able to penetrate the skin with an epinephrine prodrug. We think that opens up a host of opportunities that is very meaningful. If your question on exposure was around absorption, I think, we will have more to share in the future.
Does that capture a reasonable amount of your questions?
Unidentified Analyst : Yes. So I am in exposure as an accidental transference to another patient, another subject, or a healthcare provider, since it…
Stephen Wargacki: Got you. Okay. Yes, so, with any topical gel, transference is always something you have to manage. Right? So we would be no different than any other topical gel that is on the market today. What we would expect to be no better, no worse than all of the other topical gels, which, as you know, is a substantial market.
Unidentified Analyst : Very helpful, thanks.
Operator: Thank you. Our next question comes from Gary Nachman at Raymond James. Your line is open.
