Good morning, and welcome to Aquestive Therapeutics Fourth Quarter and Full Year 2023 Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Bennett Watson of ICR Westwicke Investor Relations. 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 fourth quarter and year-end 2023, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Carl Kraus, Chief Medical Officer, and Dr. Stephen Wargacki, Senior Vice President, Research and Development. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday. In addition, a recording of today's call will be made available on Aquestive's website within the Investors section shortly following the conclusion of this call. To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of fourth quarter and year-end 2023 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 Investors section of Aquestive'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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2024. 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 may differ materially from these statements. All forward-looking statements attributable to Aquestive 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. With that, I will now turn the line over to Dan.

Thank you, Bennett. We have once again made tremendous progress since our last earnings call. We finished 2023 on a high note with solid revenue growth, improvements in non-GAAP adjusted EBITDA, a healthy cash balance, and significant progress in the product development part of our business. While these are significant achievements, our focus is firmly on the future and on building a solid foundation for long-term growth. Our strategy for accomplishing this remains simple and straightforward. Over the next two to three years, we expect to bring not one but two oral rescue products to patients for conditions for which they are currently dependent on rescue medical devices. In the allergy space, Anaphylm (epinephrine) Sublingual Film is a transformational product for patients and for the company, if approved by the FDA. We believe annual peak sales of Anaphylm on a global basis could surpass $1 billion. In the epilepsy space, Libervant (diazepam) Buccal Film could begin launching in markets around the world, including here in the U.S. as early as this year, if approved by the FDA. We believe worldwide annual peak sales of Libervant could be between $100 million and $200 million. We continue to advance in-house technology to replenish our pipeline once Anaphylm and Libervant graduate to the commercial product phase. We are currently conducting initial human studies using our Adrenaverse technology and expect that our initial indication targets will also represent multi-hundred-million dollar peak sales opportunities. Finally, as you know, we continue to have a profitable base business with partnerships on multiple continents that grew in 2023 and we are focused on continuing this growth in 2024. These four pillars of growth position us well to expand the company in the years to come. Regarding Anaphylm, we have completed dosing in our pivotal study and we should receive data shortly. We expect to publicly announce our top line data within the next two weeks. We are more excited than ever by the opportunity to transform patient care in the treatment of severe allergic reactions including anaphylaxis. As I've talked about in the past, the number one problem in this patient population is having a rescue product with you when you need it. Patients as a whole simply don't carry the product with them. While this has many reasons, we firmly believe that Anaphylm will bend the carrying curve and potentially decrease bad outcomes associated with anaphylaxis. For the past several months, I have been testing how carriable Anaphylm truly is. I've carried Anaphylm in my pocket with my ID and credit cards and I've also carried Anaphylm inside the case on the back of my phone. For me, this means that literally 24/7 without exception, I can access Anaphylm in a matter of seconds. This also means I don't have to remember a carrying case or to bring a rescue product with me or to do anything other than live my life. In the world of psychology, this is referred to as habit stacking. I always carry my phone with me and therefore by putting the film on the back of my phone, I've aligned carrying my rescue product with my existing habits. Habit stacking is a powerful tool and one that potentially aligns well with Anaphylm. Two weeks ago, I attended the American Academy of Allergy, Asthma and Immunology Conference, or AAAAI, in Washington, DC. I was able to spend time with some of the most important leaders in the allergy space, both advocacy leaders and clinical leaders who spend their days focused on better serving patients at risk for anaphylaxis. Without exception, they agreed and resonated towards bending the carrying curve by fitting our product within the daily lives of patients. I asked one clinician, 'But how do you know that people may carry Anaphylm more than the existing medical devices?' She held up the sample film in front of her and said, 'All you need to do is look at this. It's just too obvious.' We will continue to share more of our findings from interactions such as this over the months to come. We have also begun planning for a commercial launch for as early as the second half of 2025. Given the analogs in the market, we believe the commercialization path for this indication is well understood. We are currently working on our marketing and market access approach and will continue to share our strategy as it evolves. On a separate note, we are rapidly approaching our FDA action date for Libervant. Every month, thousands of adults fill a prescription for a diazepam rectal gel with the specific intent of using it to rescue their two- to five-year-old child when seizure clusters occur. We believe there is a better way and that is Libervant. As previously disclosed, we have tested Libervant in an epilepsy monitoring unit in children within this age group and found the product to be comparable to the rectal gel. We are hopeful that on our action date of April 28, the FDA will also see the benefits of treatment for this patient population. We continue to believe that distribution of Libervant is better in the hands of a company that is focused on CNS and epilepsy. We are in active discussions with potential distribution collaborators now. As I've said in the past, we will maintain value discipline, and if a reasonable distribution arrangement is not realized, we will launch the product ourselves. Beyond Libervant in the U.S., we remain active with business development discussions. Our focus in 2024 will be on expanding our ex-U.S. licensing opportunities for our lead assets and on monetizing any of our non-core assets. Regarding our future pipeline, we continue to move forward with AQST-108, which comes out of our Adrenaverse platform. This is a topical cream formulation that we believe has potential application among dermatology indications. We are currently in the clinic with our first-in-man study, which is focused on characterizing the absorption profile of AQST-108 at different dose levels. We will have more to say on this program later in the year. In conclusion, 2023 was a phenomenal year for the company and we are now focused on building the foundation for long-term growth. Our upcoming milestones remain on track with Anaphylm data expected in the next two weeks and an FDA action date on Libervant in late April. We continue to guide towards an Anaphylm NDA filing in 2024. Our collaboration activities remain robust and ongoing. With that, I will turn the call over to Ernie.

Thank you, Dan, and good morning, everyone. By now, you will have seen our financial results in our earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the fourth quarter and full year 2023 results in the Q&A. We continue to evolve as a company with a solid base business generating revenue, a validated platform having produced over 2.6 billion strips, and two key pipeline assets, Anaphylm and Libervant. During the fourth quarter, we continued to execute on our strategy to strengthen our financial position by refinancing our outstanding debt as well as managing expenses to extend our cash runway to support the continued development of our lead product, Anaphylm, the first and only non-device-based orally delivered epinephrine product. As a reminder, during the fourth quarter, we refinanced the 12.5% senior secured notes that had a maturity date of June 30, 2025. The new financing of $45 million by a large leading institutional investor was used to repay all outstanding obligations under the prior credit facility and for general corporate purposes. The notes are senior secured obligations of Aquestive and will mature on November 1, 2028. The notes bear interest at a fixed rate of 13.5% per year payable quarterly. Principle will be repaid starting on June 30, 2026. In connection with the financing transaction, the company entered into royalty agreements granting the note holders a tiered royalty between 1% and 2% of annual worldwide net sales of Anaphylm for a period of eight years from the first sale of Anaphylm on a global basis. The note holders are also entitled to a tiered royalty between 1% and 2% of annual worldwide net sales of Libervant until the earlier of the first sale of Anaphylm and eight years from the first sale of Libervant. Importantly, the notes contain no revenue or cash covenants and no warrants for purchase of the company's stock. The structure of this non-dilutive refinancing transaction maximizes our flexibility in the short term and reduces our cash requirements by approximately $28 million through June 30, 2025, the due date of the original credit facility. Despite very difficult market conditions, the investors' willingness to invest in our future represents an important step forward in the continued growth of Aquestive. Now, let's turn to the recap of our quarterly and full year financial results. Excluding the impact of prior year proprietary sales of Sympazan, total revenues increased $10.1 million in the fourth quarter 2022 to $13.2 million in the fourth quarter 2023. This 31% increase was primarily due to a one-time milestone royalty payment of $1 million for Azstarys from Zevra Therapeutics and higher revenue from the company's five out-licensed products. Total reported revenues were $13.2 million in the fourth quarter 2023 compared to $10.7 million in the fourth quarter 2022, an increase of 24%. For the fourth quarter 2023 compared to the prior period, we saw a 104% increase in license and royalty revenue mostly due to the milestone licensing revenue for Azstarys from Zevra. A 23% increase in manufacturing and supply revenue due to increased manufacturing revenues of $3.2 million for Suboxone, offset by decreased revenues of $0.8 million for Sympazan and $0.3 million for Ondif for Hypera in Brazil, and a 33% increase in co-development and research fees revenue. For the full year 2023, excluding the impact of prior year proprietary sales at Sympazan, total revenues increased from $40 million for the year ended December 31, 2022, to $50.6 million for the year ended December 31, 2023, an increase of 26%. Total reported revenues for $50.6 million for the full year of 2023 compared to $47.7 million for the full year of 2022, an increase of 6%. The change was due to increase in manufacture and supply revenue and license and royalty revenue, offset by the discontinuance of proprietary product sales of Sympazan subsequent to the out-licensing agreement with Assertio in October 2022. Manufacture and supply revenue increased 20% or $7.4 million for the year ended December 31, 2023 compared to the same period in 2022. This change was due to increased revenues of $4.4 million for Suboxone, $2.1 million for Ondif, and $0.6 million for Sympazan. License and royalty revenue increased 129% or $3 million for the year ended December 31, 2023 compared to the same period in 2022. This change was due to $1.5 million in milestone licensing revenues for Azstarys from Zevra, increased licensing revenue of $0.6 million and royalty revenues of $0.7 million for Sympazan, and increased royalty revenue of $0.3 million for Azstarys. Co-development and research fees increased 8% or $0.1 million for the year ended December 31, 2023 compared to the same period in 2022. Proprietary product sales decreased $7.7 million for the year ended December 31, 2023 compared to the same period in 2022. This decrease was due to the discontinuation of Sympazan proprietary product sales revenue in the fourth quarter of 2022. Our net loss for the fourth quarter of 2023 was $8.1 million, or $0.12 loss per share. The net loss for the fourth quarter 2022 was $12.4 million, or $0.23 loss per share. This reduction in net loss was driven by increases in revenue described above, decreases in selling, general and administrative expense, including severance costs, lower administrative costs in our commercial organization subsequent to the out-licensing of Sympazan, a decrease in research and development costs and expenses, partially offset by a one-time loss on extinguishment of debt of $1 million and higher non-cash interest expense related to the amortization of debt discount on the refinancing of the 12.5% debt. Our net loss for the full year 2023 was $7.9 million, or $0.13 loss per share. The net loss for the full year 2022 was $54.4 million, or $1.12 loss per share. The reduction in net loss was driven by other income of $14.5 million, which consisted of $6 million from the amendment to the Indivior Commercial Exploitation Agreement, $8.5 million from the patent litigation settlement with BioDelivery Sciences International, an increase in revenue as previously described, a decrease in selling, general and administrative expense, including severance costs and significantly lower administrative costs in our commercial organization, a decrease in research and development costs and expenses, and lower non-cash interest expense related to the KYNMOBI monetization transaction, partially offset by one-time loss on extinguishment of debt of $1.4 million and higher non-cash interest expense related to the amortization of debt discount on the refinancing of the 12.5% debt. Non-GAAP adjusted EBITDA loss was $2.8 million in the fourth quarter 2023 compared to $9.6 million loss in the fourth quarter 2022. Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses was $0.1 million in the fourth quarter 2023, compared to a non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses, of $5.6 million in the fourth quarter 2022. Non-GAAP adjusted EBITDA loss was $11.6 million for the full year 2023 compared to a loss of $35.3 million in the full year 2022. The year-over-year change in non-GAAP adjusted EBITDA loss was driven by the items previously described. Non-GAAP adjusted EBITDA income, excluding adjusted R&D expenses, was $1 million for the full year 2023 compared to a non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses, of $18.7 million for the full year 2022. Cash and cash equivalents were $23.9 million as of December 31, 2023. Under the at-the-market, or ATM, facility, we accessed net proceeds of $3.7 million during the fourth quarter of 2023 and $9 million for the full year of 2023. The ATM facility has approximately $24 million available at December 31, 2023. In addition, during the year ended December 31, 2023, approximately 8.7 million common stock warrants were exercised with proceeds of approximately $8.3 million. Our focus in 2024 will continue to be reporting top line data from our pivotal trial, advancement of our Anaphylm program and following our NDA with the FDA by the end of the year. As outlined in the press release issued last night after market close, our full year 2024 financial guidance is as follows: total revenues of approximately $48 million to $51 million, and non-GAAP adjusted EBITDA loss of approximately $22 million to $26 million. Please note, revenue guidance does not include any revenue for Libervant. In addition, our guidance for 2024 includes increased R&D investments related to the continued development and planned NDA filing of Anaphylm, the first orally administered epinephrine product. I will now turn the line back to the operator to open the line for questions.

Thank you. The first question comes from François Brisebois with Oppenheimer. Your line is open.

Hi. Thank you for taking my questions and congratulations on the progress. I have a couple of questions. As we are two weeks away, can you help us set expectations around data? What should we anticipate in terms of pharmacokinetics, pharmacodynamics, single and repeat dosing?

Sure. Good morning, Frank. Well, I'll outline for you what we will be releasing from a package perspective. And then I'll turn it over to Carl who can tell you about what we from our side think success looks like. From a package perspective, as we've shared over the last few months, we'll have all of the data from our pivotal study. So, as you recall, there's a Part A, which is a repeat dose part, and a Part B, which is single dose. We'll have all of that data. And we'll also have our findings from meeting with the FDA under a Type C meeting event. But let me pass it over to Carl, who can tell you about, from our perspective, what we think success looks like.

Sure. Thanks, Dan, and thanks for the question, Frank. The data we're expecting related to successful outcomes here would be, one, demonstration of sustainability of our pharmacokinetic and pharmacodynamic curves over the period of observation, as well as bio comparability demonstrating that we are able to achieve levels that are north of our RLD, our reference listed product. So, those two items in conjunction with characterization of the safety of our product within our minds demonstrate success.

Thank you very much. Regarding the commercial potential of Anaphylm, could you clarify how successful EpiPen was? It would be helpful to see a breakdown of the peak sales, which I believe exceeded $1 billion globally. Additionally, could you provide insights into the market potential within the U.S. compared to markets outside the U.S.? Thank you.

In regard to EpiPen's peak sales, I don't have the exact figure. However, we see a couple of key factors at work. First, the market is expanding, not only in the U.S. but globally, as the incidence of severe allergic reactions and anaphylaxis increases, so does the demand for these products. Second, access to rescue medications for anaphylaxis is improving in healthcare systems around the world. Based on our analysis, we believe that achieving the $1 billion mark globally is a reasonable expectation. When it comes to the split between the U.S. and other regions, it's consistent with industry trends that indicate the U.S. typically represents the larger share of the opportunity.

When you spend time at AAAAI, we discuss the availability of the product and the willingness to use it compared to an autoinjector. Are patients delaying the use of the autoinjector until the last moment, or are many not using it at all? Essentially, could we say that the market might be larger if people used the product sooner? Those who take it earlier are likely to refill their prescriptions, unlike those who either don’t take it or wait too long. Is that a fair assessment?

Yes, Frank. This relates to your earlier question. What I didn't mention is that the global opportunity shows a significant gap between the prevalence rate and the usage rate. As we know, many people are not carrying rescue devices. We believe that as alternative delivery technologies like ours enter the market, people will be more inclined to use and carry these products. It’s interesting that you brought up AAAAI. I spent considerable time there discussing with physicians to ensure we understood both their views and those of the patients. It was encouraging to find that our beliefs align with the insights from physicians. They recognize that eliminating the needle and simplifying the product design could lead to more people carrying it and having it accessible when necessary.

Okay, great. We're clearly hearing that there's an unmet need, and it seems like many people, even those carrying the products, have them expired anyway. That's it for me. Thank you for the questions.

Thanks, Frank.

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

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.

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.

Got it. Can you provide a high-level overview of the target PK profile or absorption profile as we look ahead to data later this year?

Sure. For that one, I'll pass it over to Carl.

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.

Jason, I think Carl made a very important point that we frequently discuss here. He mentioned that ideally, we want to be above the manual IM, especially in the first 10 minutes. That's a key area for everyone to focus on in terms of our ability to exceed that benchmark.

Okay. Great. Thanks for taking the questions.

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

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.

Good morning, Andreas. It's great to hear from you. When it comes to launching our products, I believe it's quite similar to how other products have been introduced in this market. The actual launch is relatively straightforward compared to the extensive preparations needed to ensure FDA compliance, which is the more challenging aspect. For our launch strategy, we'll start by targeting individuals who already use or have an EpiPen prescription. Then we will reach out to those who have had a prescription but didn't fill it, as well as individuals who previously carried a product but no longer do, and those who should be using a product but currently aren't. I would expect our competitors to adopt a similar approach. Regarding our positioning, we believe our product's main advantage in the market is that it's likely to be carried by people who do not currently carry any product. This concept of having it readily available without added thought was a key point in my earlier comments. However, there are additional benefits as well. We anticipate that people may use our product sooner or earlier in their condition, since it’s an oral medication. Our scientific data shows a rapid uptake of epinephrine, with a quick median Tmax, which could provide an edge for healthcare providers compared to some other available products.

Okay. Great. And looking forward to the upcoming data. Congrats on all the progress.

Thanks, Andreas.

One moment for the next question. Next question comes from Thomas Flaten with Lake Street Capital Markets. Your line is open.

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?

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.

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?

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.

Appreciate it guys. Thank you.

One moment for the next question. The next question comes from Ram Selvaraju with H.C. Wainwright. Your line is open.

Thanks very much for taking my questions, and congrats on all the progress. Can you hear me?

Yes, Ram.

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?

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.

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?

That's a great point, Ram. Considering our company’s evolution, we currently have no plans to launch the product outside of the U.S. on our own. Similar to our approach with Libervant, we are actively engaging with potential partners in various global markets. The advantage is that we don’t have to rush to find a partner immediately; we can take the time to identify the right partner for navigating regulatory processes in different regions and to support the product after its launch. The potential for both Libervant and Anaphylm outside the U.S. is a significant aspect of our story.

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?

For 2024, I do not anticipate any impact on Aquestive. I would like to mention that as a public company, we take all necessary steps to safeguard against cyberattacks that could affect our operations.

Thank you.

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

Good morning, everyone. I appreciate you taking my questions. I have a couple of inquiries regarding the Anaphylm Human Factors program. Could you explain what that includes? Additionally, can you share some details about your outreach to advocacy or allergy networking groups before the launch and how that has unfolded?

Yes. Good morning, James. I will address your second question first, and then I'll pass it over to Carl to discuss the Human Factors program. From an advocacy standpoint, there are about four national advocacy groups in this field, all of which do exceptional work to ensure patients' rights and access to medications are protected. We believe that building strong relationships and supporting these advocacy groups is crucial. We have made significant efforts in this area, even more so than many of our competitors last year, which demonstrates our commitment. We met with all of them at the recent AAAAI event and will continue to support their important work. Now, I’ll turn it over to Carl to discuss the Human Factors.

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.

Great. I have a quick follow-up. Dan, I know you have a lot on your plate, but looking ahead, do you see any potential acquisition candidates or opportunities to enhance the pipeline?

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.

Great. Thank you for taking the questions.

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

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.

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