Aquestive Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the Request of Therapeutics second quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is pre-recorded. I would like to hand the conference over to our first speaker today, Ryan Korb. Please go ahead.

Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for the second quarter of 2025, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Carl Krause, Chief Medical Officer, and Sherry Korchinski, Chief Commercial Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, a recording of today's call will be made available on Equestria's website within the Investors section shortly following the conclusion of this call. To remind you, the Equestria team will be discussing some non-GAAP financial measures this morning as part of its review of second quarter 2025 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the investor section of Equestria's website. During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in yesterday's earnings release, as well as the risks and uncertainties affecting the company as described in the risk factors section and in other sections included in the company's quarterly report on the Form 10-Q filed with the Securities Exchange Commission on August 11, 2025. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval, and commercialization of its products and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results made differ materially from these statements. All forward-looking statements attributable to a questive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. Now, I would like to turn the call over to Dan.

Thanks, Brian, and good morning, everyone. We are now less than six months away from our FDA action date for anafilm epinephrine sublingual film, potentially the first and only oral product for the treatment of severe allergic reactions, including anaphylaxis. As a reminder, our action date is scheduled for January 31st, 2026. I'm pleased to tell you this morning that we are on track across the important elements of anafilm. We are on track in our FDA review process, our ANIFILM Advisory Committee preparations, which may or may not occur, and our pre-commercial launch activities. We are on track in responsibly securing launch financing for the company, and we are on track in our international expansion efforts for ANIFILM. Let's start with the FDA review of our ANIFILM application. We recently submitted our 120-day safety update to the FDA. I'm pleased to say that there was nothing new or of consequence to report in this safety update. We also believe the FDA is about to conclude its mid-cycle review. While we do not participate in this review, we would expect to have more clarity on whether we will have an advisory committee meeting once the FDA has fully processed its mid-cycle review meeting. In terms of advisory committee meeting preparations, we recently completed our first in-house mock or practice advisory committee meeting, including participation from our key opinion leaders. We were pleased with the results and continue to strengthen our discussion points every week. It's also worth noting that we have included our pediatric study data and the supplemental materials on our website. As we have discussed before, this data was in line with expectations and, importantly, enabled us to submit our NDA for patients down to 30 kilograms or approximately seven years of age. Now let's turn to our pre-commercial activities. As a starting point, it's important to remember that we continue to believe the rescue market for severe allergic reactions is poised for growth for years to come. Before the launch of a nasal spray last year, there had been very little innovation and very little physician detailing in this space for quite some time. When we launch, if we are approved by the FDA, there will be only a few companies detailing physicians and highlighting the need for patients to carry and use rescue medications for severe allergic reactions. I believe that this, along with the underlying market growth, should propel the market from roughly 5 million prescriptions a year to as many as 10 million prescriptions a year. Using the estimated current net prices of today's epinephrine products, this could be as much as or more than $2 billion a year in global market. A recent survey conducted by an expert research analyst in this space concluded that 90% of the market will move from injectables to non-injectable products over the years to come. And in our surveys, we found that when patients are presented with a choice between injectables, nasal sprays, and oral films, they favor the convenience, size, durability, and oral administration of anafil. We believe this market remains a compelling opportunity for Equestit and its stakeholders, especially patients and caregivers, if approved by the FDA. Let's focus on patients and caregivers for a moment. According to one of the leading allergy advocacy groups, the Allergy and Asthma Network, an estimated 225 Americans die each year from anaphylaxis. Sadly, it seems that this rate has not improved in decades. We believe the way to improve bad outcomes is to one, improve the carry rate, two, lower the barrier to use, and three, ensure broad availability and coverage. We think the inherent characteristics of anafilm will address the first two items because anafilm fits patients' lives. Unfortunately, the third item, market access, is harder. We have been disappointed to see the number of barriers that the most recently approved epinephrine product has faced when it comes to market access. Pricing and product access should not prevent patients from having access to life-saving medicines. Delayed tactics, NDC blocks, and prior authorization documentation are just a few ways that payers make it hard for patients to get the drugs that they need. And for pharmaceutical manufacturers like us, These barriers add significant costs to putting our products into the hands of patients. Simply put, Americans are not getting the coverage they expect through the healthcare insurance that they pay for. In fact, some companies have indicated that the average healthcare plan deductible for a single person has risen from roughly $900 in 2010 to $1,800 in 2024. and it is still climbing. As you can imagine, the deductibles are considerably higher for a family. That is why for Anafilm, we will be taking a patient-first approach. On day one, we will have a cash pay program available to patients and caregivers. While we are not announcing our pricing today, we will do everything we can to make sure that patients have immediate access to Anafilm even if their provider puts up barriers to access. We will share more details on this program as we get closer to approval and launch. Additionally, our market access group possesses significant enterprise-level pricing, contracting, coding and reimbursement, trade and distribution, patient services, and government affairs experience. The team is engaging with payers as you would expect at this point in the approval process of ANIFILM. Now let's turn to financing the launch. As you saw in our press release, we ended the last quarter with $60 million in cash. While this is sufficient for the initial launch, we will need more funding to appropriately support ANIFILM. Ernie will talk more about our financials, but I do want to give you my perspective on our pathways to financing the launch. We currently have multiple proposals in process, including for EU-only rights and alternate financing vehicles. We are working through the pathways available to the company and will select the best pathway when the time is right. However, as of today, we remain confident that launch financing is available to the company and that we will have secured financing prior to launch. The final update for ANIFILM is on the international front. We have secured meetings in both Canada and the EU for discussion on the filing packages necessary with each regulatory body. Our plan remains to complete these meetings by the end of the year and then begin the work to prepare and submit filings. Regarding the remainder of our business, we continue to make progress. We continue to believe AQST-108, our epinephrine topical gel, could provide a compelling improvement for patients with alopecia areata. We are on track to open our IND with the FDA before the end of the year and begin our next human studies in early 2026. Our base business grew year over year in the second quarter when adjusted for one-time revenue events. This was driven by strong growth in our international products. We continue to work towards offsetting the decline of Suboxone with new business opportunities. In conclusion, we remain on track for a launch of Anifilm in the first quarter of 2026, if approved by the FDA. Our focus remains on our interactions with the FDA, finalizing our launch financing, and pre-commercial activities. Now, I will turn the call over to Ernie.