Q1 2025 Aquestive Therapeutics Inc Earnings Call
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郭子健: The pharmacy company with product candidate 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.
郭子健: May differ materially from these statements all forward looking statements attributable to acquire or any person acting on 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 forward looking statements.
郭子健: 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.
Dan: Thanks, Brian and good morning, everyone.
Dan: We are now over a month into our FDA review for Ana film Epinephrine, Sublingual film, which if approved by the FDA will be the first and only oral medication indicated for the treatment of severe allergic reactions, including anaphylaxis.
Dan: As a reminder, we believe that in the years to come the rescue medication market for severe allergic reactions.
Dan: Row into a multi billion dollar opportunity.
Dan: We anticipate receiving our FDA acceptance letter next month with an FDA assigned action date in late January or early February of 2026.
Dan: This is truly the most exciting time in the history of requested and we have officially entered the commercial prelaunch phase for NFL.
Dan: As the review clock ticks toward approval, we are shifting more and more of the company's attention towards ensuring a successful commercial launch in the first quarter of 2026, if approved by the FDA.
Dan: The first area of focus is ensuring we have the right people who have significant experience in the allergy space and the right commercial experience to launch NFL.
Dan: I am pleased to say that we have the marketing team that built epipen to over a billion dollar brand.
Dan: And we have added colleagues with decades of market access and commercial launch experience.
Dan: I am thrilled by the team we have put in place.
Dan: Our second area of focus is awareness of anaphylaxis and our clinical data among health care professionals.
Dan: As we are in the prelaunch phase. This work is conducted by our medical team to outreach to health care providers.
Dan: We are very active and attending allergy conferences, both national and local where we present, our posters and publications.
Dan: I'm proud to share that by the end of this year. We expect to have attended 25 conferences and published 16 posters and manuscripts.
Dan: By our anticipated FDA action date, we will have published almost 30 posters and maintenance scripts over the life of the Ana film Development program.
Dan: As a comparison.
Dan: A sponsor of the recently approved nasal spray published approximately 20 posters and manuscripts before their approval.
Dan: It's work like this that have any confidence that we're well positioned to continue to increase our prelaunch awareness.
Dan: The third area of focus is payer engagement.
Dan: As I mentioned in March we now have in house market access expertise and we are actively working with payers given the FDA rules that allow us to engage with payers in advance of anticipated approval.
Dan: We will benefit from the distribution and payer contracts that were setup during our marketing of Liberty.
Dan: These contracts remain in place and we will be able to utilize them for NFL.
Dan: Critically these will say months and months of startup time.
Dan: Add to our launch efficiency.
Our positioning and advertising materials are well ahead of schedule for launch in early 2026.
Dan: We have been clear about our positioning for quite some time.
Dan: Among patients and caregivers, we will focus on the ability to easily carry and a film.
Dan: We believe <unk> is the only product that if approved by the FDA allows for not just one but two doses to easily fit on the back of your phone into a wallet for a small purse providing patients with an epinephrine product that can be with them anytime anywhere.
Dan: This clearly resonates across the stakeholder spectrum.
Dan: I'm genuinely excited about the progress our marketing team has made.
Dan: We remain very active on the advocacy front as well.
Dan: We have significant engagement with all four of the national allergy advocacy groups.
Dan: We continue to sponsor several important patient programs with these groups and more recently have become involved in shaping state level legislative actions.
Dan: <unk> towards ensuring patients have access to all pre measured forms of epinephrine.
Dan: So from a commercial preparedness perspective.
Dan: Built a team of the right people.
Dan: Developed a robust prelaunch awareness platform utilize.
Dan: Utilize our existing payer relationships to prepare for NFL.
Dan: <unk> built our product messaging and advertising and established significant relationships with the key advocacy groups.
Dan: This to me positions us incredibly well for a fast start in 2026.
Dan: Now, let's dig a little deeper into exactly how patients will experience NFL.
Dan: Think about your phone for a minute.
Dan: Think about the incredible power that you hold in your hand every single day.
Dan: From your phone you can check the security at your house.
Dan: Start your car track your heart rate search the web for any piece of information on the planet.
Dan: And now thanks to NFL and our Pharmfilm technology.
Dan: It can act as your medicine cabinet.
Dan: Now that's transformational.
Speaker Change: In fact, the mom of a teenage patient recently told us and I quote My Kid never takes this current device with them.
Speaker Change: While there are times I have no idea, where he is what he is doing what he might be eating I do know I see his epinephrine device.
Speaker Change: At home and his bedroom dresser.
Speaker Change: Which puts me into complete stress mode.
Speaker Change: The other thing I know is that without fail. He has his phone with him.
Speaker Change: How confident I would be knowing that two doses of epinephrine, we're tucked into the back of his phone.
Speaker Change: In other words, you would never leave home without it and.
Speaker Change: <unk> quote.
Speaker Change: It is realizations like this one that we believe drive caregivers and patients to show a two to one preference for NFL over the existing medical devices.
Speaker Change: And that is also why with Ana film theme.
Speaker Change: <unk> truly is believing.
Speaker Change: When we have the opportunity to show our technology physically we find excitement and growing interest in prescribing opportunities.
Speaker Change: In fact, almost 100% of health care providers, we have surveyed and we've done a lot of surveys.
Speaker Change: We'll leave their patients will be interested in NFL.
Speaker Change: We also know that direct to consumer or DTC engagement.
Speaker Change: <unk> element to awareness in this disease state.
Speaker Change: DTC efforts cost money, and we will need to strengthen our balance sheet ahead of launch to use this part of our strategy effectively.
Speaker Change: While Ernie will give you more specifics on our financials I'd like to share how I think about our cash position.
Speaker Change: First we announced last night that we will deemphasize our accuracy 100 weight studies during this launch period.
Speaker Change: While we are as committed as ever to want to wait this frees up significant capital for commercial activities.
Speaker Change: Similarly, while we were unhappy with the court outcome on Liberman, and we think that's ultimately harms patients.
Speaker Change: This also allowed us to shift cash from supporting Liberty to the launch of anthem.
Speaker Change: We will opportunistically look to strengthen our balance sheet through X U S out licensing of any film and potentially refinancing our debt.
Speaker Change: These pathways could provide adequate runway for the supportive Ana film not just through launch, but through the first year of launch and into 2027.
We also continue to engage with potential sales and marketing partners in the U S.
Speaker Change: However, as I've said before the conditions have to be just right for this to be our path forward.
Speaker Change: Now, let me turn to the FDA review of Amazon.
Speaker Change: We are pleased to say that we have already had engagement with the review division regarding our application.
Speaker Change: As of today, we believe everything is on schedule for receipt of our 74 day acceptance letter in mid June.
Speaker Change: We also believe our reviewers remain employed at the FDA, but we do know that Sally Seymour The division had for pulmonary allergy and critical care recently announced her retirement.
Speaker Change: We do not believe this has an impact on our application.
Speaker Change: We continue to prepare for an advisory committee meeting should the FDA require one.
Speaker Change: Work remains on schedule and we continue to believe we will be fully prepared for an AD com well ahead of schedule should it occur.
Speaker Change: Our regulatory team is also turning its focus to international markets.
Speaker Change: As I've mentioned before we expect to engage with Canada.
The Kingdom and the European Medicines agency or EMA prior to approval of any film in the U S.
Speaker Change: These activities are in support of strengthening our balance sheet and finding a strategic ex U S partner.
Now, let's turn to the macro environment for public life Sciences companies.
Speaker Change: For most companies the last few months have been very difficult.
Speaker Change: Long term prospect of tariffs and economic uncertainty has created volatility in many ways, including revenue streams supply chain and long term outlook.
Speaker Change: In this environment I am pleased to say, we are well positioned.
Speaker Change: We have examined our supply chain and see minimal risk the price or supply volatility.
Speaker Change: Importantly, we also house, our intellectual property here in the U S.
Speaker Change: Simply put we believe we are well positioned to weather the economic storm that has been impacting small businesses.
Speaker Change: And the life Sciences industry.
Speaker Change: Finally.
Speaker Change: I want to acknowledge and honor the previously announced <unk>.
Speaker Change: <unk> passing.
Speaker Change: Doctor Stephen work out.
Speaker Change: Our Chief Science Officer.
Speaker Change: David I worked together for over a decade.
Speaker Change: And he was not only a brilliant scientist and a colleague but also a friend through.
Speaker Change: It was a major contributor to the scientific advancement of NFL.
Speaker Change: And we will honor his memory as we seek approval of Ana film around the world.
Speaker Change: While we are fortunate to have his mentor, the former Chief Technology officer, and founding CEO Mark shovel.
Speaker Change: Over interim oversight of R&D.
Speaker Change: Steve will be profoundly missed by.
Speaker Change: By all of Us.
Speaker Change: So as we move forward our focus over the coming months will be engagement with the FDA on the review of our application.
Speaker Change: Engagement with ex U S regulatory bodies on NFL.
Speaker Change: Strengthening our balance sheet through partnerships and potentially debt refinancing.
Maintaining our strong position in relation to tariffs and economic uncertainty and more.
Speaker Change: <unk> than anything else.
Speaker Change: Having laser light focus on our commercial launch of Amazon.
Ernie: With that I will turn the call over to Ernie.
Ernie: Thank you Dan and good morning, everyone.
Ernie: By now you will have seen our financial results in our earnings release that was issued last evening.
Ernie: As we typically do we will address most of the discussion related to the first quarter results in the Q&A.
Ernie: During the first quarter, we continued to execute on our strategy to support the continued development of the recently filed NDA for NFL. Our lead product candidate that has no needle is not a device is orally administered and is easy to care.
Ernie: This included strengthening our balance sheet with additional capital through our ATM facility.
Ernie: And pre commercial launch activities for NFL to increase awareness among physicians.
Ernie: <unk> and the advocacy community.
Ernie: Our quest is manufacturing business remained steady with a gradual decline of suboxone being partially offset by growth across Newark collaborations, including further license product R&D Center, then and MLS.
Our questions manufacturing facility continues to diversify its operations to support a broader range of products and collaborations.
Ernie: In addition, being a U S based manufacturer with intellectual property domiciled in the U S.
Ernie: Our supply chain currently remains largely unaffected by both implemented and proposed tariffs providing continued revive ability and stability in production and global distribution for the near term.
Ernie: Now, let's turn to the first quarter results.
Ernie: Total revenues decreased to $8 7 million in the first quarter 2025 from $12 1 million in.
Ernie: In the first quarter 2020 for.
Ernie: This 28% decrease in revenue was primarily driven by decreases in manufacturer and supply revenue and license and royalty revenue, partially offset by increases in proprietary product revenue net.
Ernie: Manufacturer and supply revenue decreased to $7 2 million in the first quarter 2025 from $10 5 million in the first quarter 2024, primarily due to decreases in suboxone revenues, partially offset by an increase in R&D revenues.
Ernie: License and royalty revenue decreased 30% or <unk> 3 million in the first quarter 2025 compared to the same period in the prior year.
Ernie: This decrease was primarily due to lower his tars royalty revenues and lower license revenues associated with the termination of a licensing and supply agreement in the prior year.
Ernie: Co development and research fees in the first quarter of 2025 remained relatively unchanged compared to the same period in the prior year.
Ernie: Research and development expenses decreased to $5 4 million in the first quarter of 2025 from $5 9 million in the first quarter of 2020 for the.
Ernie: The decrease in research and development expenses was primarily due to lower clinical trial costs associated with the continued advancement of the NFL development program, partially offset by increases in product research and preclinical expenses higher personnel costs and higher share based compensation.
Ernie: Selling general and administrative expenses increased to $19 1 million in.
Ernie: In the first quarter of 2025% from $10 7 million.
Ernie: In the first quarter 2024, primarily due to regulatory fees of $4 8 million, including the NFL producers.
Ernie: Higher legal fees of $2 3 million.
Ernie: Higher commercial spending of approximately $2 1 million.
Ernie: Higher personnel costs of approximately <unk> 4 million.
Ernie: And higher share based compensation expense of $3 million, partially offset by decreases in severance costs of approximately $1 1 million and lower insurance expenses of <unk> $2 million.
Ernie: Request, a net loss for the first quarter of 2025 was $22 9 million.
Ernie: Our 24 <unk> for both basic and diluted loss per share compared to the net loss for the first quarter 2024 at $12 8 million or <unk> 17 for both basic and diluted loss per share.
Ernie: The increase in net loss was primarily driven by the previously discussed changes partially offset by increases in interest income and other income.
Ernie: non-GAAP adjusted EBITDA loss was $17 6 million in the first quarter of 2025 compared to non-GAAP adjusted EBITDA loss of $7 2 million.
Ernie: In the first quarter of 2024.
Ernie: Cash and cash equivalents were $68 7 million.
Ernie: As of March 31, 2025.
Ernie: A question has revised its full year 2025 financial guidance as a result of the change in regulatory status of liver bent and pausing sales and marketing activities for the product.
Ernie: The company now expects total revenue of 44 million to $50 million.
Ernie: And non-GAAP adjusted EBITDA loss of $47 million to $51 million.
Ernie: Our revenue guidance for 2025, no longer includes revenue for liver event for ages between two and five years.
Ernie: As a reminder, our 2024 revenue included one time nonrecurring recognition of deferred revenue related to the termination of certain licensing and supply agreements.
Ernie: Our non-GAAP adjusted EBITDA loss guidance for 2025 includes significant pre commercial spending for NFL costs associated with the recent submission of the NFL NBA and related filing fee completion of the NFL pediatric clinical trial and preparations.
Ernie: For a potential advisory committee meeting if required by the FDA for approval of Amazon.
Ernie: With that I will now turn the line back to the operator to open the line for questions.
Speaker Change: Thank you ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone. If your question has been answered or you wish to move yourself from the queue. Please press star one again, we will pause for a moment, while we compile our Q&A roster.
Ernie: Yes.
Ernie: Our first question comes for ROE in a recent Leerink partners. Your line is open.
Speaker Change: Hey, good morning, everyone.
Speaker Change: A couple from me I was curious if you could update us on where you are in your commercial readiness efforts, including CMC manufacturing scale up et cetera for Ana film.
Speaker Change: And this is.
Speaker Change: Also wanted to see if you refined your goals for hiring a field force for Anophthalmia, including how many physicians would they target out of the gate.
Speaker Change: Good morning.
Speaker Change: So I'll take the.
Speaker Change: Hi, This is Dan I'll take the first.
Speaker Change: Part of your question, then I'll hand, it over to Sherri.
Sherri: Talk about that.
Sherri: Salesforce, how she thinks about it.
Sherri: One of the highlights.
Sherri: Were things that were.
Sherri: Proud of and think of the strength for our company is the fact that we have the manufacturing in house. So as you know CMC manufacturing scale up that is all well within our capabilities and something we've done several times before without issues.
Sherri: We believe we're very well prepared on that side, we will have product ready to go day one.
Sherri: And.
Sherri: Those plans are in place.
And being worked on.
Sherri: Has it already sure you talked about the sales force Hi, Ron Nice to hear your voice. This morning, I have to say I'm. So excited to be chatting with everybody. This morning.
Sherri: On a on a successful launch as you know.
Sherri: The team that built epipen to over $1 billion and.
Sherri: As I reflect upon that build.
Sherri: One of the things that I have been looking very closely as the number of salespeople and so.
Sherri: We will probably start at around 50 sales representatives and focused on the top.
Sherri: For prescribers as I'm sure you can imagine that will include about four or 5000 on the top of allergists.
Sherri: Pediatrician as well as the PPA staff that that really support the physicians and the allergist and the office and so that's where that's where we are right now we're in the process.
Sherri: Yes.
Sherri: Segmentation and ensuring our marketing mix model.
Sherri: Works very smart for us.
Speaker Change: Yes, very helpful and one follow up for me I was thinking ahead to the NFL launch could you explain a bit more about your key goals and interacting with payers to set up broader favorable access for anthem and do you have any idea of the timelines it would take to set up this access.
Speaker Change: And the best cases favorable coverage ran a phone for a majority of patients.
Sherry: Right well I'll, let Sherry give you heard.
Sherry: Our thoughts in a second here, but I just wanted to reiterate as you just heard in my comments before.
Sherry: With the work we did on Liberman one of the great benefits.
Sherry: Is the contracts that we now have in place both from a distribution and a payer perspective. So it does remain open and we will definitely be able to leverage those as we go into this launch period, where you can talk more about specific thoughts on renewals sure.
Dan: As Dan mentioned, we have hired a VP of market access.
Dan: And we took our time to make sure we hire the right person and so we brought on.
Dan: Someone who has experience.
Dan: And small pharma and very large pharma so knows the payors personally and has extensive experience in launching products and so we're very excited about her and her team.
Dan: She is bringing on Dan mentioned.
Dan: We have been working with the payers both on liberman.
Dan: On messaging around Ana film given the guidance that permits us to do that and so when we think about the acts that as you know we will.
Dan: The entering a period.
Dan: No further furthering those conversation and upon approval.
Be ready to have our contracting strategy implemented now if you take a look and you can just use our competitor as an example.
Dan: There are there is timing associated the payors do require.
Dan: Rather significant amount of time several months.
Dan: Before they will consider adding to formulary.
Dan: So I would think about it as kind of this first six months of launch we will be ensuring that we have upwards of 80% coverage by the end of that six months withdraw on them.
Dan: What would take us right into the back to school season, So I feel very confident in the team I have to implement and drive that success from a market access perspective.
Dan: Okay.
Dan: Sounds good thanks a lot.
Dan: One moment for our next question.
Dan: Yeah.
David Solomon: Our next question comes from David Solomon Piper Sandler Your line is open.
David Solomon: Thanks, So a couple for me first.
Speaker Change: Can you talk to any learnings that you've gleaned from the launch of Murphy I know, it's fairly early days, but.
Speaker Change: Maybe you can talk to the extent to which that product is expanding the market.
Speaker Change: And what you think that could mean.
Speaker Change: For Anna films. So that's number one and then number two is on the potential for an AD com.
Speaker Change: Maybe give US a reminder of how youre thinking about that in other words, what do you think are sort of the key salient topics that would come up in an AD com to the extent there is one thank you.
Speaker Change: Sure David.
Speaker Change: No.
Speaker Change: I'll hand, it over to sharing our second here again.
Speaker Change: Give your thoughts on what cheese. She obviously her and her team are on a daily basis.
Speaker Change: Watching the market, but I will say to you.
Speaker Change: We do see the expansion in the market occurring that we would expect in Q1 of this year volumes were up 5% over last year and we do expect as you've heard me say many times this market too.
Speaker Change: Two.
Speaker Change: At least double over the years to come so.
Speaker Change: So I'll, let Sherry give you her thoughts and then I'll address the outcome for you as well Hi, David Great question again, I go back to my Epipen Jr. Whenever.
Speaker Change: Look over that brand, we were at about $150 million to $200 million and say.
Speaker Change: I think one of the things that we learned very quickly is the <unk>.
Speaker Change: Absolutely critical nature of market expansion, and we were able through market expansion efforts our disease state awareness.
Speaker Change: Asian engagement.
Speaker Change: And calling on the HCP.
Speaker Change: Your April this market is.
Speaker Change: Promotional insensitive and so we saw increases of 25%.
Speaker Change: Back in kind of the.
Speaker Change: Mid 2010, 11, 12, Mark and to look at the end of the day is doing the same as Dan mentioned, the more messaging that's out there the better for all of us.
Speaker Change: And so I think that Theyre doing absolutely the right thing they went out to the physicians first as theyre, gaining payer access to drive demand and now youre seeing a pick up more patient engagement.
Speaker Change: Media marketing.
Speaker Change: And.
Speaker Change: They've announced publicly that they are launching a big DTC campaign again dot is fantastic.
Speaker Change: A rising tide rises.
Speaker Change: Oh.
Speaker Change: I think it will benefit all of us.
Speaker Change: Okay. Thanks, Sherry I'll hand, it over to Karl and a second for his thoughts on the Yadkin, what I would say in terms of the topics specific topics. Obviously, we don't know, but I would just remind you we've had extensive interactions with the FDA. We've been very transparent about the discussions we've had with the FDA. So I think the issues for topics that.
Karl: We would expect that the AD com I think.
Karl: Are pretty well documented but Karl can give his thoughts on how we're preparing.
Speaker Change: Where we are at work thanks, Dan and David. Thank you for the question. It's an important question and I would just state that this is probably the most robust data set.
Speaker Change: Conducted to date for an epinephrine product we've had over 930 years. So dosing is probably 800 singles at 125 repeat dose.
Speaker Change: It's a comprehensive NDA that was submitted difficult to know what the FDA may request of us, but we are fully prepared to respond to whatever those questions maybe.
Speaker Change: In the midst of a aggressively preparing for anything that they make one further information on I would say that this is the first oral epinephrine.
Speaker Change: So depending on how they get excited by that and what kind of questions. They may have we will be happy to respond in due course.
Speaker Change: Okay.
Speaker Change: Okay I'll leave it there thank you.
Speaker Change: One moment for our next question.
Kristen: Our next question comes from Kristen <unk> with Cantor Fitzgerald. Your line is open.
Kristen: Hi, Good morning, everybody wanted to ask how you envision.
Kristen: <unk> Division head for this pulmonology allergy space could potentially influence both an ad com.
Kristen: And the review process and outside of doctors see more of the people you've been engaging even before you filed as you currently filed would you say that there are other changes as well.
Kristen: Sure.
Kristen: Kristen so.
Kristen: And our interactions.
Kristen: Not dealt with the division had we have had a deputy division as the person who oversaw the interactions and.
Kristen: As of today, and obviously, the Fda's evolving organization today's environment, but as of today. The review team and the Deputy director all remain the same.
Kristen: For our program and those were also the same people for the program that came before us so.
Kristen: From our review process standpoint, all of the interactions. We've had so far suggests that things are getting a normal state.
Kristen: Which is positive we believe in terms of the AD com.
Kristen: We've stated before the best I can tell you is we are ready we want to have an outcome. We are ready we hope it happens I do have some doubts that we will tell you on weather.
Kristen: The government is in.
Speaker Change: In a position to.
To make things happen for an outcome, but we will be ready and we hope it.
Speaker Change: It does happen.
Speaker Change: Thank you so much.
Speaker Change: One moment for our next question.
Speaker Change: Yeah.
Jason Butler: Our next question comes from Jason Butler with citizens JMP. Your line is open.
Jason Butler: Hi, Thanks for taking my questions.
Speaker Change: Two for me first of all can you just talk about where you think awareness of Ana film.
Speaker Change: Providers is today and how youre measuring are assessing how that awareness is building.
Speaker Change: Throughout the year heading into the launch and then secondly, I'm just when you think about the seasonality of the market as well as the time taken to get payer access how should we think about the adoption curve in the first few months of the launch thank you.
Speaker Change: Sure.
Speaker Change: So I will pass it over to Sherri for for both of those items.
Sherri: Good morning, Jason.
Sherri: You know as we think about Anna and knowing that we certainly have created.
Sherri: Transfer more transformational.
Sherri: And our friend for patients and their caregivers.
Sherri: As the only non white oral epinephrine.
Sherri: <unk> are very very excited about the products. So we've done upwards of a thousand.
Sherri: And interviews with patience and HCP the light.
Speaker Change: There continues to be incredible excitement as Dan mentioned, we are from a medical perspective, engaging heavily with Kols and.
Sherri: And.
Sherri: The allergy community.
Sherri: So I believe.
Sherri: Our awareness is growing significantly we did conduct a baseline HEU.
Sherri: At the end of December and so we are measuring how that awareness continues to grow but that is where all of our focus is right now and again Dan.
Sherri: And <unk> team have really been engaged.
Sherri: Being at a variety of not only the big conferences, the big allergy conferences, but also state and regional conferences.
Sherri: Sure the exciting brand that we have for patients suffering from severe allergic reactions. So I feel really good about the awareness and how it is growing to prepare us for a fantastic launch and.
Sherri: Early Q1 of 2006.
Speaker Change: As it relates to your second question, how do we think about seasonality.
Speaker Change: This market is pretty tried and true you start to see the pick up in the April may timeframe. It really peaks again August and September and that back to school timeframe and so.
Speaker Change: As we've mentioned previously we are engaging with payers now as soon as there is approval we will work to have the contract incomplete as quickly as possible.
Speaker Change: I do think that you can book to the left the curve to a certain degree to say it will probably follow the similar.
Speaker Change: Uptake the payors take their time, they somehow blocks for the first handful of months, but we will have other ways for patients to access the medication.
Speaker Change: Now with that being said I do feel super confident by that back to school season, we will have the majority of the market covered for our access and that will be the most important time. So that August September October timeframe.
Speaker Change: Does that answer your question that's great. Thank you very much.
Speaker Change: One of them for our next question.
Speaker Change: Our next question comes from Ram Silverado with H C. Wainwright Your line is open.
Ram Silverado: Thanks, very much for taking my questions. Firstly on NFL I wanted to ask if you could comment on your thoughts regarding direct to consumer advertising strategies that would most appropriate to support this product what those might look like specifically how they might be.
Ram Silverado: Similar to analogous to or different from the DTC advertising thats been used in support of Murphy. So far and also if you could give us a sense of when in the launch trajectory you consider it most appropriate to deploy stretch such strategies. Thank you.
Ram Silverado: Alright, good morning, Rob.
Speaker Change: I'll hand, it over to sharing a second to talk about when we would deploy but let me give you. Some just general thoughts on DTC awareness, I think especially in a space like this DTC.
Speaker Change: It is important for awareness right. It is.
Speaker Change: Great way to drive awareness around the disease state.
Speaker Change: And to drive people to their physician to ask about what they should be doing if you listen or watch a lot of DTC advertising often times.
Speaker Change: The product isn't as prominently.
Speaker Change: And that DTC as it is the awareness of the disease. So we actually believe.
Speaker Change: Ill borrow from Sherry's statement before which we firmly believe that a rising tide raises all boats in this particular market. This is a very large market.
Speaker Change: Spanish market and we believe that the DTC efforts of anyone this market helps the overall group so in terms of our positioning.
Speaker Change: If you take away anything from today's call. It should be that we are focused and we're focused on making sure that we are in the physician's office is where we can win where we can.
Speaker Change: Sure our scripts start to flow and that will be the number one priority DTC.
Speaker Change: Well I don't want to I don't want to steal share his thunder. So I'll, let her talk about where we would layer it yeah.
Speaker Change: Yes, it's a great question Ron.
Speaker Change: So again, when you think about a launch first.
Speaker Change: And for those physicians have to be aware of the product and so the focus is typically heavy physicians for the first several months.
Speaker Change: While you're also in parallel beginning the DTC effort, so social media digital advertising working very hard with the patient advocacy groups.
Speaker Change: That can make patients aware so if you think about.
Speaker Change: It kind of has I am thinking I should say of the launch of <unk>.
Speaker Change: I'm thinking of it in three buckets one is awareness.
Speaker Change: Second is preparedness and the third is access so awareness is critical awareness of the HCP as critical a physician has to be aware of the product how to rate the product.
Speaker Change: And so again, that's what you've seen with our competitor that's what you see really with.
Speaker Change: Most pharma brands that are very DTC okay.
Speaker Change: While that is happening.
Speaker Change: Patients are also being made aware through again social media.
Speaker Change: Digital advertising print advertising and now radio advertising has come back on the market and so patients are becoming aware. So you have an intersection where the patients are in the offices.
Speaker Change: Speaking with the physicians you have the sales reps out there.
Speaker Change: We're working to make more and more physicians aware of the product and so you have this intersection where a physician is ready to prescribe and the patient is ready to receive.
Speaker Change: So again first and foremost is that HCP promotion.
Speaker Change: Starting to layer in more and more of the DTC promotion as your coverage for market access coverage increases and so I would you would expect that and just like you are seeing with our competitor there'll be out eight months. They are starting to talk about their heavy DTC campaign, you would start to that's how.
Really a big brands think of direct to consumer and Thats based on my experience as well.
Speaker Change: Thank you and then just following on from that I was wondering if you could just describe for us the distribution infrastructure in the channel that's likely to be used in support of Ana film.
Speaker Change: As and when the product gets approved for the U S. And also if you could talk a little bit, particularly in the context of the most favored nation pricing construct how you are thinking about optimizing the opportunity for Ana film outside the United States and what you're currently considered to be the most the highest value or territories.
Speaker Change: For the product ex U S.
Speaker Change: Sure Rob.
Speaker Change: Let me go in.
Speaker Change: Almost reverse order so I'll leave.
Speaker Change: Sure the distribution infrastructure in the U S, but let me.
Speaker Change: Address.
Speaker Change: The most favorite nation.
Speaker Change: You made which I think is in reference to the executive order that we saw come out yesterday from the White house from.
Speaker Change: From our perspective for companies like US who are up and coming our agile are looking to be disruptive to different there's not.
Speaker Change: But opportunity.
Speaker Change: And some of the different ways.
Speaker Change: Things seem to be evolving as you saw on that executive order that was actually I've mentioned.
Speaker Change: Finding ways to cut out the middleman, we would love that right I don't know if its completely practical in todays world, but those are things that we as a.
Speaker Change: Smaller a flexible company love and we'd like to take advantage of as time goes on.
Speaker Change: In terms of outside the U S.
Speaker Change: And Rob as you know Thats really just.
Speaker Change: That data is public.
Speaker Change: Biggest markets to focus on our Canada, the UK and Germany. So that's why we've said that our international <unk>.
Speaker Change: Interactions this year with regulatory bodies will be Canada, the U K and EMEA.
Speaker Change: So we've line those up with where we see the value X U S.
Speaker Change: With that I'll, let sherri take on the distribution structure.
Speaker Change: And as you know NFL is absolutely transformation will be upfront approval, absolutely transformational for patients and caregivers alike.
Speaker Change: We do know is this is still predominantly a retail driven product and support at the corner of health and happiness.
Speaker Change: Distribution through the retail channel however, our mass market access lead we brought on specifically based on her experience looking at and using alternate distribution channels and models and so we are assessing the different ways in which our customer patient care.
Speaker Change: Give or can access.
Speaker Change: And so yes, you would expect it to be and your local Cvs and Walgreens, but you can also expect to see other ways in which a patient will be able to access the NFL.
Speaker Change: Thank you.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from Gary Nachman with Raymond James Your line is open.
Speaker Change: Hey, guys. Good morning. This is Dennis resonates on for Gary Thanks for taking our questions. So.
Speaker Change: So first for animal ex U S. If youre looking for partner there would you want them to do the regulatory submissions in those international markets or would that be something that you would take on your own and then as an ex U S partnerships something that you hear about this year and then when we think about the U S. Commercialization launch can you just talk a little bit more about what your ideal earlier.
Speaker Change: Adopter prescriber of NFL looks like I've got one follow up.
Speaker Change: Thanks Dennis.
Speaker Change: No.
Speaker Change: Ill, let Sheridan a minute talk about how she thinks about hcp's.
Speaker Change: Patients in the ideal adopters.
Speaker Change: Turning to the ex U S regulatory submission strategy.
Speaker Change: That is.
Speaker Change: Definitely partner dependent.
Speaker Change: But I would say this we have an excellent regulatory team that does a phenomenal job not just here in the U S. But in our interactions around the world as you know from our previous.
Speaker Change: <unk> and partnerships, we have extensive experience ex U S and so the engagement with regulatory bodies and even submitting ex U S. It's not an issue for us to support.
Speaker Change: Again that would be more partner based on what the right setup would be in terms of timing Dennis I learned long ago with us in this role that timing is a dangerous thing when it comes to partnerships. What I would tell you is that we are very active.
Speaker Change: On.
Speaker Change: Engaging on that front.
Speaker Change: As we learn more and as we understand how that will evolve will.
Speaker Change: Communicate as we can.
Speaker Change: With that I'll, let Jerry take on me Adaptors. Good morning, Dennis Thanks for the question. It's a great question as we have done more.
Speaker Change: More than a thousand interviews with HCP the patient.
Speaker Change: Even those recently, while we continue to hear.
Speaker Change: Is it there is still an enormous unmet need for a non device discrete convenient easy to carry an easy to use.
Speaker Change: So while there are more choices now there is still a tremendous unmet need as Dan mentioned in his earlier comments. It is not atypical for us to have parents teenagers and physicians come up to us at the conferences and say Oh, My Gosh I would absolutely carry this I can put.
Speaker Change: On the back of my phone, it's like an extension of myself and so it fits and the film will fit into patient lifestyle, I believe better than any product.
Speaker Change: That is currently on the market and so as we think about who are early adopters will be what we're thinking is that.
Speaker Change: First of all it's the physicians that are seeing the majority of patients or physicians that are hearing from their patients or their patients mothers that are kids still doesn't carry.
Speaker Change: I cannot know wanted to buy and and so we believe that the adoption will be in early prescribers.
Speaker Change: Our competitor as well as then those physicians who continue to hear that.
Speaker Change: Patients want an oral medication and I'll just leave you with that and some of our market research that we did with physicians.
Speaker Change: 95% of physicians believe that a film dosing option fills an unmet meet unmet need and the epinephrine market.
Speaker Change: Five out of 10 physicians, that's a lot of doctors and 85% have told us that they will prescribe a film dosing option and they expect their prescription to increase and so.
Speaker Change: Well I love to boil the ocean.
Speaker Change: Be able to impact.
Speaker Change: Thousands of physicians, we are going to have a very targeted very focused approach to.
Speaker Change: To call on.
Speaker Change: The highest decile prescription in order to drive that early adoption and that that early revenue stream does that answer your question.
Speaker Change: Yes that is a super helpful. Thanks, so much.
Speaker Change: Then just one quick follow up on the topline pediatric data that you had previously presented.
Speaker Change: When you look at the geometric mean adjusted epinephrine concentration between the pediatric and adults on can you just provide a little bit more color as to why the pediatric patients, perhaps an increase earlier than the adult and then why they didn't reach the same high concentration. Thanks for all the color guys.
Speaker Change: Yes, I'm going to pass it over to Carl but just to reiterate our.
View on the pediatric data, we think that pediatric data is exactly in line with expectations and is supportive of the.
Speaker Change: The product, having a label down to 30 kilos and up but I'll, let Carl I'll give you some more specific thoughts yes. No. Appreciate the question I would just remark that the data.
Speaker Change: That we've evaluated is completely in line with what we had expected and hoped for based on the.
Speaker Change: Characteristics of the adult dosing and statistically there is no difference that we found to be of any clinical significance. So I. Appreciate your observation, but when you look at detail.
Speaker Change: It's completely in line with our hopes or expectations.
Speaker Change: We're excited by this data.
Speaker Change: Great. Thanks, so much guys.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from Nelson <unk> with Lake Street Capital markets. Your line is open.
Speaker Change: Great. Thanks for taking the questions and Nelson on for Thomas first one just wondering maybe quickly. If you can talk about the cash you believe youll need for the launch of Dana Perlman.
Speaker Change: Just any commentary there I think it would be helpful.
Speaker Change: Sure.
Ernie: I'll pass it over to Ernie in a second.
Speaker Change: Let me just frame cash because that's a really important piece for launch right first.
Speaker Change: I would remind everyone.
Speaker Change: Especially as this company has evolved over the last few years, we have something of incredible value and we are focused on making sure that we maximize that value for our shareholders. So we're actually very excited about where we are especially from where we've come from and we think we have.
Speaker Change: A lot of Optionality that we did not have when I look back several years ago, but I'll, let Ernie give you a little bit more specifics around that sure.
Ernie: Sure Nelson So art.
Speaker Change: We have as Dan said, something very valuable add with that we have a number of paths to help finance the launch and just to reiterate we have said we are not hiring one sales rep until we have approval, we will do all the preparatory work through all that.
Ernie: Pre commercial work this year, but we will not spend.
Ernie: Spend money on sales reps until we have approval.
Ernie: And then we will ramp up.
And to be prepared to sell as soon as possible.
Ernie: Our cash provides us runway.
Ernie: Through this year and the initial stages of that launch next year, but we have a number of leavers to pull at how rapidly we spend.
Ernie: Our cash and also as previously mentioned.
Ernie: Opportunities to partner NFL outside the U S.
Ernie: Refinancing our debt all these non dilutive ways to help fund the launch so we feel we're in a good position to be prepared for next year.
Ernie: Perfect. That's helpful. Thanks, and then maybe just a two parter quick.
Ernie: Will you recognize any <unk> revenue in the second quarter I know it probably be minimal, but any commentary there and then when is the earliest you might know about advisory Committee meeting.
Ernie: The revenue for <unk> in the second quarter is minimal.
Ernie: And just to reiterate what I said in my comments our guidance for this year.
Ernie: Yes.
Ernie: The revised guidance, we've essentially taken out their prevent completely for the rest of the year.
Ernie: <unk>.
Ernie: The revenue we reported for the first quarter is not significant even though we were making great progress on ramping up.
Ernie: They're bad but it is.
Ernie: Not.
Ernie: We are now reporting.
Ernie: A significant amount of revenue for this year for government.
Ernie: But importantly, we are taking out expenses.
Ernie: Will.
Ernie: Add incrementally to our cash for the rest of the year.
Karl: Karl do you want to take.
Karl: When we were doing an outcome, but sure so.
Karl: The FDA the division in particular.
Karl: Clearly has liberty.
Karl: To alert us at any time, but we are certainly hopeful that we would do so by day 74, but obviously it's at their discretion.
Karl: Great. Thanks for taking the questions guys.
Karl: One moment for our next question.
Karl: Our next question comes from James Molloy with Alliance Global Partners. Your line is open.
Speaker Change: Hi, guys, Matt <unk> on for Jim.
Karl: Thanks for taking the questions.
Speaker Change: So about the potential partnerships ex U S for distribution and how would you characterize the partnership environment currently.
Speaker Change: And in terms of Ecu SD Wan to wait when would you anticipate potentially re prioritizing that clinical development should we look at it and sometimes 27 post launch of anthem.
Speaker Change: <unk>.
Speaker Change: Okay. Thanks, Matt Let me let me go in.
Speaker Change: Reverse quarter I, just want to reiterate and I made this comment earlier, but I want to make sure I make it clearly.
Speaker Change: I believe went away.
Speaker Change: Great product I believe it is.
Speaker Change: Big opportunity for the company there I think the science is very interesting and a science that we can deliver and can be transformative in another area.
Speaker Change: So.
Speaker Change: No way are we backing away from how much we like went away, but there's millions of dollars that we were going to spend it went away. This year that are better off in the hands of Sherry and art NFL watch so Michael.
Speaker Change: Desire is to get back to prioritizing one away as soon as possible.
Speaker Change: But we will not do that.
Speaker Change: The way our sacrifices any ability to launch NFL.
Speaker Change: Best way, we can.
Speaker Change: In terms of the partnership environment outside the U S. I would say it's active.
Speaker Change: You, obviously saw our competitor.
Speaker Change: Have a deal in Europe with another company there are other companies that are.
Speaker Change: Are interested in being in that market and we're in discussions with.
Speaker Change: The right people. So we will continue to push that along and.
Speaker Change: We'll tell you more as we know more.
Speaker Change: Great. Okay. Thank you guys for taking my questions.
Speaker Change: And I'm not showing any further question at this time I would like to turn the call back over to Dan for any closing remarks.
Dan: Thanks, Kevin and hopefully.
Speaker Change: The theme you've heard from US today came through loud and clear, which is we are focused on the launch of NFL.
Speaker Change: It's the right place to be for this company at this time with a filing in at the FDA and the launch clock ticking down.
Speaker Change: We appreciate you joining us this morning, and I look forward to updating you everyone as we progress through our NFL FDA review period, and as Sherry and her team continue to prepare for launch with that I wish all of you a great rest of your day.
Speaker Change: Thank you ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
Speaker Change: Okay.
Speaker Change: [music].