Aquestive Therapeutics - Q1 2023

Transcript

Operator (participant)

Good morning, welcome to the Aquestive Therapeutics first quarter 2023 conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star one one on your phone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. 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. You may begin.

Bennett Watson (Investor Relations Associate)

Thank you, operator. Good morning, welcome to today's call. On today's call, I am 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 first quarter 2023, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Steve Wargacki, Senior Vice President of R&D, and Ken Marshall, Chief Commercial Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday. 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 first quarter 2023 results.

A description of these measures, along with the 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 our annual report on Form 10-K filed with the Securities and Exchange Commission on March 31st, 2023, and in our quarterly reports on Form 10-Q and current reports on Form 8-K filed with the SEC.

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. The impact of the ongoing COVID-19 pandemic is highly uncertain and cannot be predicted with certainty or clarity. 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.

Dan Barber (CEO)

Thank you, Bennett. As I shared with you recently on our March 8th earnings call, this remains an exciting time for Aquestive as we continue to execute against our 2023 key initiatives. We had a successful first quarter, and the momentum continued into April.

In the first four months of the year, we reduced our debt by over $9 million, thereby reducing our interest payments by over $1 million a year, entered into an amendment with Indivior that significantly deepened our relationship and solidified our economics, settled our lawsuit with BDSI, generating $8.5 million in non-dilutive financing, expanded our relationship with Pharmanovia to support the eventual distribution of Libervant diazepam buccal film to patients around the world, won motions to dismiss on our outstanding shareholder class action and derivative lawsuits, and announced the branding of AQST-109 as Anaphylm epinephrine sublingual film after receiving conditional approval of the name from the FDA.

These successes bring our total non-dilutive financing over the last several quarters to $47 million while also reducing our debt by almost 20% and ending the quarter with approximately $27 million in cash. While we are proud of our achievements, our focus remains on maintaining our momentum and continuing to execute at a high level. In our ultimate mission to help patients, our goals remain straightforward: build a healthy balance sheet, file Anaphylm for FDA review as soon as we've completed the necessary studies, and obtain U.S. market access for Libervant earlier than 2027. Looking ahead to the coming months, there are several important moments for our Anaphylm program. First and foremost is learning from next week's FDA Advisory Committee meeting for a competing epinephrine product.

We believe this meeting will provide important insights on the FDA's thinking regarding alternate delivery of epinephrine for anaphylaxis. While some of the feedback, good or bad, may only apply to nasal sprays, the overall read-through on the scientific community and FDA's willingness to accept innovation in this area will be important. As a prominent allergy advocacy group recently wrote to the FDA, and I quote, "We are optimistic about the continued advancements in scientific research and development of treatments for anaphylaxis, which include needle-free nasal sprays and sublingual under-the-tongue administration that give people additional treatment options. These are smaller size alternatives for those who are reluctant to use or carry an auto-injector." End quote. We expect to have more to say after this public event occurs.

Secondly, equally important, we continue to work to match the pharmacokinetic bracketing approach recommended by the FDA at our end of phase two meeting in November. We have completed two pilot pharmacokinetic studies since November and believe that we have a good understanding of the differences between approved auto-injectors. We also have done work toward progressing our understanding of the appropriate administration instructions for Anaphylm prior to submitting our pivotal protocol to the FDA. This work is ongoing, and once completed, we will immediately send the FDA our pivotal protocol with the recommended dosing instructions and reference listed products. We look forward to sharing more on this in the near future. Additionally, as we announced a few weeks ago, we have received FDA clearance for the brand name Anaphylm.

While final clearance only occurs upon approval of the product candidate, and there is always the possibility of a required change, we believe it is appropriate to begin referring to the development product as Anaphylm Epinephrine Sublingual Film. I want to spend one more moment on this topic. While on the surface it may not seem important to announce the brand name, I believe it is actually very important. As we continue the development of Anaphylm, we understand that helping patients and caregivers is about the entirety of their interaction with the product. The science of any product only works if you have it with you when you need it. In the case of anaphylaxis, over 50% of patients don't carry their rescue medication with them today. This is an astounding statistic. Think about it.

A trained physician informs a patient that they are at risk for a life-threatening condition, and the physician prescribes a life-saving product. Yet over 50% of the time, patients and caregivers don't follow the doctor's orders. There are many reasons for this, and no product can address every potential shortfall. However, we believe Anaphylm could be uniquely positioned to address some of these shortfalls. The first and most basic way starts with the name of the product. The leading products on the market today include references to needles or injections in their brand name. In my view, this potentially reinforces the barrier to usage for products in a needle form. The conditionally approved names of the nasal sprays in development contain no reference to their form.

While we respect their choice, we believe that in our case, referring to the film form of the product in the name is just one step in reminding patients that a different oral form is available for use. Now let's talk about Libervant. We are continuing to pursue U.S. market access for Libervant with the goal of bringing our product to patients before 2027. Libervant is not currently available because although the FDA has tentatively approved Libervant as safe and efficacious, the agency has not yet determined that Libervant is different than the nasal spray that has been granted market access exclusivity in the U.S. Based on our review of publicly available documents, we believe that this nasal spray was never tested in humans for the impact of food on drug absorption prior to approval, or for that matter, since approval.

This is important because as a biocompatibility program to Diastat diazepam rectal gel, both the nasal spray and Libervant have to rely on absorption levels as a primary way of ensuring efficacy. As the FDA has previously written to us, a drop in absorption levels may also result in a drop in efficacy. We took this guidance seriously at the time we received it, and we continue to take this seriously now. That is why we had a third-party clinical research organization conduct a standard crossover study of the nasal spray in both a fasted and fed state. As published in Epilepsia, this study showed that drug absorption does indeed decrease with the nasal spray when administered after a high-fat meal. Our development program took this into account, and regardless of a patient's fed state, they received significant enough drug absorption to be comparable to Diastat when taking Libervant.

That is also why our tentatively approved drug label indicates that Libervant can be taken with or without food. The current drug label of the nasal spray is silent on the effect of food. We believe that patients deserve to know and understand the potential impact of food when taking any medication, especially one in a rescue situation. While we acknowledge the benefit that nasal sprays have brought to patients at risk for seizure clusters, we continue to believe the impact of food is meaningful and makes Libervant different from the nasal spray. In the months to come, we will have more to say on our FDA interactions and the actions we are taking so that patients have the ability to benefit from Libervant. For now, rest assured that we will continue to advocate for patients and for our product. Let's turn to our collaborations and potential deals.

We continue to interact with several companies on the potential acquisition of US rights to Libervant. As I've continuously guided, we will remain disciplined in this process. We expect this process to evolve as our interactions with the FDA evolve. We also continue to focus on the expansion of our ex-US collaborations for our products, including Libervant and Anaphylm. We believe these activities represent a potential source of ongoing non-dilutive capital, and we remain focused on identifying the right collaborations for the patients we serve and for the company. Refinancing our debt remains another important activity, and as I've guided before, we believe that the second half of 2023 may offer opportunities on this front as we continue to reduce our debt and improve our loan-to-value ratio.

This is, of course, based on a variety of factors, including broader market conditions, the company's outlook, and our ability to continue to strengthen our balance sheet. On a final note, I would like to recognize the efforts of our legal team. Since October, we have greatly reduced the number of outstanding legal matters in which the company is involved and the resulting litigation costs and risks faced by the company. Most recently, the team won separate motions to dismiss in each of the company's ongoing shareholder class action and derivative lawsuits. This track record is an important aspect of our company as we move forward. A strong legal team allows us to defend ourselves appropriately, creatively manage our collaborations, and even seek out opportunities to expand our company. We are thankful to have this strength within our company.

As we move forward, you can expect us to continue to focus on the advancement of Anaphylm with near-term milestones associated with the upcoming FDA Advisory Committee meeting and our outreach to the FDA on our pivotal protocol. Continue to pursue U.S. market access for Libervant. Continue to expand our collaborations and strengthen our balance sheet, and we look forward to the day we can pursue additional pipeline or acquisition opportunities. With that, I will turn the call over to Ernie.

Ernie Toth (CFO)

Thank you, Dan. Good morning, everyone. By now, you will have seen our financial results in the earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the first quarter of 2023 results in the Q&A. During the first quarter, we continued to execute our strategy to strengthen our financial position by reducing our debt, raising non-dilutive capital, and 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. We reduced our outstanding debt from $51.5 million on December 31, 2022, to $42.4 million on March 31, 2023, through a combination of principal prepayments of $5.6 million and scheduled principal amortization of $3.4 million.

During the quarter, we executed a number of transactions that brought into the company $22 million of non-dilutive capital, including $11.5 million related to the amendment to our existing Indivior commercial exploitation agreement, $8.5 million from the settlement of outstanding legal issues with BioDelivery Sciences International, or BDSI, and $2 million from the expanded license and supply agreement with Pharmanovia for Libervant. As we have previously stated, we will always pursue non-dilutive sources of capital first to extend our cash runway when possible. We continue to manage expenses prudently with savings in research and development costs and expenses related to the out-licensing of SYMPAZAN and the elimination of our commercial infrastructure.

Excluding the impact of prior year proprietary sales of SYMPAZAN, total revenues increased from $10.1 million in the first quarter of 2022 to $11.1 million in the first quarter of 2023. This 10% increase in revenue was primarily driven by higher revenue from licensed products, including SUBOXONE from Indivior, Ondif from Hypera, and SYMPAZAN from Assertio. Total reported revenues were $11.1 million in the first quarter of 2023, compared to $12.3 million in the first quarter of 2022. For the first quarter of 2023 compared to the prior year period, the company saw an 82% increase in license and royalty revenue, a 12% increase in co-development and research fees, and a 6% increase in manufacturer and supply revenue.

Net income for the first quarter of 2023 was $8.1 million, or $0.15 basic earnings per share, and $0.11 diluted earnings per share. The net loss for the first quarter of 2022 was $13.2 million, or $0.32 for both basic and diluted loss per share. The change in net income was primarily driven by $14.5 million of other income, which consisted of $6 million from the amendment to the Indivior Commercial Exploitation Agreement and $8.5 million from the patent litigation settlement with BDSI. Decreases in selling, general and administrative expenses, research and development expenses, and non-cash interest expense related to the KYNMOBI monetization transaction. These decreases in expenses were partially offset by lower revenue due to the out-licensing of SYMPAZAN.

non-GAAP adjusted EBITDA loss was $3.9 million in the first quarter of 2023, compared to a non-GAAP adjusted EBITDA loss of $8.1 million in the first quarter of 2022. Cash and cash equivalents were $26.9 million as of March 31, 2023. Under the at-the-market, or ATM facility, we accessed $915,000 during the first quarter of 2023. The ATM facility has approximately $32.4 million available at March 31, 2023. We are focused in 2023 on the continued development of our epinephrine program and commencing our pivotal PK program later in the year. SUBOXONE continues to retain a strong presence in both the U.S. commercial and CMS market and continues to provide an opportunity outside the U.S.

While SUBOXONE is a legacy product for us, it remains a significant part of our near-term revenue outlook. Our revenue guidance for 2023 considers a modest level of market share erosion. In addition, we anticipate additional revenue from our licensed products during the remainder of 2023. Moreover, we will continue to focus on capital conservation to extend our cash runway as far as possible. As outlined in the press release issued last night after market close, based on our first quarter results and positive outlook for the remainder of 2023, we raised our full year 2023 financial guidance as follows: Total revenues of approximately $42 million-$46 million, from $37 million-$41 million. non-GAAP adjusted EBITDA loss of approximately $24 million-$28 million, from $31 million-$36 million.

Please note our revenue guidance for 2023 no longer includes proprietary net sales for SYMPAZAN due to the out-licensing agreement with Assertio, but does include manufacturing and supply revenue and royalty fees. Our guidance for 2023 includes focused R&D investments related to the continued development of Anaphylm, the first and only non-device-based orally delivered epinephrine product. With that, I will now turn the line back to the operator to open the line for questions.

Operator (participant)

Thank you. As a reminder, to ask a question, please press star one one on your phone and wait for your name to be announced. To withdraw your question, please press star one one again. Stand by as we compile the Q&A roster. One moment please for our first question. Our first question will come from the line of Jason Butler of JMP. Your line is open.

Jason Butler (Managing Director)

Hi. Thanks for taking the questions, and congrats on the progress. I guess I have two on Anaphylm. First, Dan, you talked about the PK bracketing and the pilot studies you completed. Can you maybe give us an update on what you've learned about the auto-injectors, and specifically, how you're thinking about variability, inter- and intra-patient variability of the auto-injectors and how that could impact the pivotal trial design for Anaphylm? Then secondly, the AdCom next week, are there specific topics that you're paying attention to that you believe could have read-through for, you know, beyond just product-specific topics? Thanks.

Dan Barber (CEO)

Right. Good morning, Jason. Thank you for the questions. I'm actually gonna take your second question first because I believe it builds onto the first question you asked. You asked about the FDA's advisory committee meeting coming up on May 11th for the competing nasal spray. We do believe that's a really important meeting, obviously, not just for the nasal spray, but-

For our program as well, because it will allow us to have a great deal of insight into the FDA's thinking and how the FDA interacts with the advisory committee, excuse me. We are looking for several things out of that meeting. One, as we have continued to say, we believe speed is really important when it comes to treating anaphylaxis, and we're curious to see how the FDA and the advisory committee talk about speed and of absorption in the front side of the curve, which is a place we think we're very strong. We also are looking to hear more about the FDA's views on pharmacodynamic and pharmacokinetic impacts, and how they interact with each other. That goes to your first question on variability.

We know that with the auto-injector and with all products with epinephrine, there will be lower levels of PK in certain instances. PD, pharmacodynamics, appears to still be robust, so we'd like to see how the FDA deals with that issue. Then third, it is a different route of administration that will be talked about on May 11th. We'd like to understand how the FDA deals with that change in administration and what they're looking for. Those are the topics we'll be focused on hearing about on May 11th. When I go back to your first question about our learnings on the work we've done to date, yes, we continue to see the inherent variability of epinephrine, but we think that is reasonably understood and already outlined in the literature that exists today.

We did test a variety of auto-injectors. We do look forward to sharing that data with you, which we will do after the Advisory Committee meeting in the weeks to come after that. I think we at this time do have a pretty good understanding on how we will approach the auto-injector reference list of products. I'll refrain from sharing with you the exact ones we wanna use today, but I think we have a pretty good understanding at this point of how to approach it.

Jason Butler (Managing Director)

Okay, great. That's helpful. Thanks for taking the questions.

Operator (participant)

Thank you. One moment please, for our next question. Our next question is coming. The next question will come from François Brisebois of Oppenheimer. Your line is open.

François Brisebois (Managing Director)

Hi. Thanks for taking my questions, and congrats on the progress. Clearly, the outcome here will be very important and interesting. Can you just remind us maybe, like, what kind of gap is there between, you know, what was EpiPen even approved on? Just a reminder and, you know, how much of a step is it to start looking at PK/PD? On that note, you talked about PK/PD. Can you just give any color on expectations or thoughts around not just the first dose, but also the second dose and what that can do, if you think that'll be important at the outcome?

Dan Barber (CEO)

Thanks, Frank. Yes, you bring up some really interesting points. As many of you know and or may remember, there has never been an efficacy study for epinephrine in the 100 years plus that it's been used for anaphylaxis. The auto-injectors were approved way back when based on being comparable to the blood levels of the manual injection. Obviously, they moved the curve forward. No one really knows how much epinephrine you need to stop a severe allergic reaction or the progression to anaphylaxis. In terms of the interaction of PK and PD, I will hand it over to Steve Wargacki in a second, who can talk a little bit about the literature and what is known. Let me first address the first dose, second dose.

We do think that the second dose, from what we have seen in practical use and in the literature is very important. We know that there is a variety of times that the second dose is given with the EpiPen, and we think that ensuring that patients have access to not just the first dose, but the second dose and a willingness to take both is critical to how we approach our product in bringing it to the market. Let me hand it over to Steve for a second on the PK/PD questions.

Steve Wargacki (SVP of R&D)

Thank you. The PK/PD is certainly an interesting topic, and there's been very little controlled human work done with that. There is some IV-related work that has been cited in the epinephrine injection, manual injection, and published in the literature. I think both all alternative deliveries under development now are really characterizing this both for the reference products and for their products in a more thorough way than ever has been done before. I think that is, that is why it's going to be very interesting to learn where the FDA stands on this data. There certainly is the manual IM and the curves we've shown previously, you know, produce very low levels.

Again, our advisory board, and our allergists in the community

Dan Barber (CEO)

I found that it works and it elicits this, PD response. That's what they look for, right? For to ensure that the epinephrine is working. It's going to be very interesting to learn the FDA staff on it.

François Brisebois (Managing Director)

Great. Okay. My other one was more in terms of timing of, you know, submission of protocol, but it seems like this is let's get through the AdCom, let's learn what we can and we'll go from there.

Dan Barber (CEO)

Yeah, I think that's a reasonable way to think of it. It would be, I think it would be unwise of us, whatever we are, eight days before learning a lot to say anything other than we'd like to hear what the FDA and the advisory committee has to say. In terms of our work, we've completed the work we wanted to do on the RLDs. We're focused on our administration instructions as you'd expect us to be. We recognize that the pivotal protocol we send to the FDA has to have the administration instructions that we ultimately want to put into the label and then the commercial product. That's important. I think we remain focused on those things just like we shared last time we spoke back in March.

François Brisebois (Managing Director)

Great. Okay, that's it for me. Thank you.

Dan Barber (CEO)

Thanks, Frank.

Operator (participant)

Thank you. One moment please for our next question. Next question is coming up. The next question will come from Thomas Flaten of Lake Street Capital Markets. Your line is open.

Thomas Flaten (Senior Research Analyst)

Hey, good morning, guys. Appreciate you taking the questions. Dan, just back on the administration instructions. In the press release, you refer to them as administration parameters. I guess intuitively I'm trying to understand what complicating factors there might be. Could you just dig a little deeper on that for us and help us understand, you know, what challenges you're trying to address or what the stumbling points might be just to give us some more color?

Dan Barber (CEO)

Yeah, sure. Good morning, Thomas. It's always interesting when we put this information out what people hone in on. I want to assure you there's no magic between the word parameter and instruction. Our intention is the same with both words. Look, just like the nasal spray, we are doing something different than the products on the marketplace. We're asking people to take several different steps that have to be thoroughly understood, done the right way in order to ensure an outcome happens the way you want it to happen.

We just, especially with the history we have of 20 years with this technology, we know and not just this technology, but working with the FDA, we know that being thorough at this spot is really important to getting to the end of job the right way and on the timeline we want to. That's why we're focused on it. In terms of what parameters or instructions we're talking about, it's pretty straightforward. Carrying the product with you, taking the product out of the foil, placing it in the mouth, what you should do at that time. There's nothing more mystical around the process than that.

Thomas Flaten (Senior Research Analyst)

Got it. Assuming that you don't learn anything surprising from the AdCom, I just wanted to confirm that you would be on track to hit the timelines that you laid out in your fourth quarter earnings release. Protocol submission second quarter, study initiation third quarter, or do you see a risk of that slipping?

Dan Barber (CEO)

I would put it this way, the AdCom, I believe the AdCom is going to be a wealth of information for us. I look forward to hearing what the FDA has to say at that AdCom, and I think you'll hear from us after the AdCom on our thoughts. I think that's the right place at this point in time to leave how we're thinking about things. Again, I want to reiterate having said it that way, that we continue to do the things we said we're going to do, and we've continued to complete the things we said we're going to complete.

Thomas Flaten (Senior Research Analyst)

Got it. Then one quick final one. Ernie, there was a pretty nice bounce in gross profit in the first quarter. Do you think that particularly given the new Indivior agreement, is that a sustainable level of gross margins going forward, or can you help us think that through a little bit?

Dan Barber (CEO)

Hi, Thomas. Well, I think, you know, the first quarter had a number of items included that certainly that impacted our guidance for the rest of the year. You know, certainly the Indivior price increase as we go forward is helpful. In addition, we had strong demand from some of our partner products from Hypera and also from Assertio with on their milestones with SYMPAZAN now. I think as we move forward, we could see that same range. Again, subject to certainly fine-tuning as we move forward.

Thomas Flaten (Senior Research Analyst)

Excellent. Appreciate you guys taking the questions. Thank you.

Operator (participant)

Thank you. One moment please for our next question. Our next question will come from Andreas Argyrides of Wedbush Securities. Your line is open.

Andreas Argyrides (Analyst)

Good morning. This is Caroline on for Andreas, just one from us. In our discussions with some experts in heading into the AdCom, we have heard some questions around PK when compared to IM epinephrine. Just curious, what has the FDA's communications been with you in regard to using IM epinephrine as an RLD?

Dan Barber (CEO)

Good morning, Caroline. When you say I.M. epinephrine, are you referring to the manual injection?

Andreas Argyrides (Analyst)

Yes. Yeah.

Dan Barber (CEO)

Yeah, I think that's the, I mean, you hit the probably the biggest topic in this area of the world. You hit the nail on the head, really. It is unclear in my view how close to the EpiPen, so the auto-injector pharmacokinetic curves have to be compared to the space between the pharmacokinetic curves for the EpiPen and the manual injections. It's unclear how close a product needs to come to the auto-injector in order to get approved. I think that's one of the really, and if you think about the comments we said before around what we're really curious to hear about, we'd like to hear more around not only what the FDA thinks, but also what the advisory committee thinks. Let's take that to our product.

We believe one of the strongest points on our product is that we have a very fast front end of the curve and fast absorption. The front end of our curve, we believe, looks very similar, much more similar to the auto-injector than it does to the manual IM. We think it's an area of strength for us. We are interested to hear and learn what the FDA thinks and how they're viewing it.

Andreas Argyrides (Analyst)

Okay, great. Thank you.

Operator (participant)

Thank you. Again, to ask a question, please press star one one on your phone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment please for our next question. Our next question will come from Ram Selvaraju of H.C. Wainwright & Co.. Your line is open.

Ram Selvaraju (Managing Director)

Thanks very much for taking my questions. With respect to Anaphylm, can you comment on what you see as the potential size of the ex-U.S. market opportunity for the product? In particular, which territories you expect to be most significant, as well as whether you have seen any indication from ex-U.S. regulatory authorities regarding their own views, with respect to, the reference list of drugs and whether you expect the FDA to sort of lead the line with respect to, establishing the approval requirements, for Anaphylm, globally. Thank you.

Dan Barber (CEO)

Good morning, Ram. I'll answer the second part first, and then I will pass it over to Ken Marshall, our Chief Commercial Officer, who's on the line as well, to talk about the market size. We're focused on partnering in Europe and China, which Ken will talk about. In China at this point, we don't have a lot of regulatory interaction where we have a good understanding of how they will view it, so that's remains to be seen. In Europe, while we have not had interaction as of yet, one of our competitors, one of the nasal sprays did submit an application, and there are public documents that do show us some of the concerns and problems that that nasal spray in particular faced.

We have been able to learn from those issues that were brought up. We do believe at this time those issues were more about the nasal spray than they were about what our product would bring to the market. It would appear from those documents that Europe is going to be very similar to the U.S. in standard and wanting the product to look like the auto-injector. Having said that, let me pass it over to Ken, who can talk a little bit about the market opportunities in Europe and China.

Ken Marshall (Chief Commercial Officer)

Yeah. Thanks, Dan. Good morning, Ram. Yeah, those are the two markets that are of most interest. We've got good interest globally, but if you look at the ones that are most important to us, it will be the EU and China. We've got good engagement in both of those markets. If you look at the opportunities there, the EU looks very much like the US in aggregate with the major countries. The population looks about the same. The prevalence of the issue looks about the same. The standard of care, as Dan mentioned, is very similar. The difference there is price. There's a lot. It's much more challenging for our partners to price in those European markets than it is in the US, so that's where you see the separation between the two.

China, while there are a lot of people, the literature suggests the prevalence is maybe a little bit lower. I don't fully understand why that is, but the literature suggests it's a little bit lower. There's still, there are enormous number of people, so it's an enormous opportunity from a patient perspective. Their standard of care is a little bit different. They don't have a lot of field-based rescue, it appears, there. They tend to shuttle you into the hospital. That could be a function of not having good rescue tools to be used in the field, or it could just be the way their health system works. As Dan mentioned, we don't have a lot of visibility into the details there. We usually leave that to our partner. The same thing with price.

There'll be a little bit of price pressure there. The price will be different than you'll see, in the U.S.

Ram Selvaraju (Managing Director)

Thank you. Just one other quick follow-up is, with respect to SYMPAZAN in the hands of Assertio. Do you have any indication that Assertio might start to utilize additional sales techniques, new sales channels that could meaningfully boost SYMPAZAN's sales trajectory and thus positively impact the income you get from the product going forward?

Dan Barber (CEO)

Yeah. Thanks, Ram. I think you bring up some interesting points. We'll be respectful of our partner and allow them to talk about what they're going to do and how they're going to approach expanding the market. What we have been pleased to see is that the scripts have continued to move in the right direction since the collaboration started. I believe, just Ken, correct me if I'm wrong, but I believe March had the highest number of scripts to date for SYMPAZAN since launch, which was nice to see. We look forward to seeing more of that.

Ram Selvaraju (Managing Director)

Thank you.

Operator (participant)

Thank you. I'm seeing no further questions in the queue. I would now like to turn the conference back to Dan Barber for closing remarks.

Dan Barber (CEO)

Thank you, Chris. Thank you for joining us today. We always, as always, appreciate your time. We'll continue to focus on the key initiatives as we laid them out today for Q2 and the rest of the year. We look forward to speaking with you very soon, in the months to come. Have a great day.

Operator (participant)

This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.