Q4 2024 Aquestive Therapeutics Inc Earnings Call
Good day and thank you for standing by. Welcome to the 4th quarter, 2024 Questive their Peter's earnings conference call.
During the call the company will make some forward looking statements. We remind you of the Companys 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 other sections included in the company's annual report on Form 10-K filed with the Securities Exchange Commission in March 2025.
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.
These statements all forward looking statements attributable to questions 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.
Dan: Wired under applicable law now I would like to turn the call over to Dan.
Dan: Thanks, Brian.
Dan: I am thrilled to announce today that we have begun the filing process with the FDA for approval of our NFL epinephrine Sublingual film application.
Dan: We will complete this application process over the next several weeks and expect the next major milestone for this program the acceptance of the NDA sometime in June.
Dan: This puts us on track to launch and a film if approved by the FDA right on schedule in the first quarter of 2026.
Dan: Today represents the achievement of a major milestone for our company colleagues and stakeholders.
Dan: This achievement was years in the making by scores of dedicated people with focus their energy on making an impact on patients' lives.
Dan: I am incredibly proud and humbled by the achievements of these individuals.
Dan: For almost three years, you've heard me talk about what we believe patients need in order to be better prepared for a severe allergic reactions, including anaphylaxis.
Dan: We believe an epinephrine product that is carried more often will save lives.
Dan: We believe epinephrine that is orally administered maybe more likely to be used and used quickly and will save lives.
Dan: We believe that speed matters, when it comes to epinephrine absorption and fast and significant absorption will save lives.
Dan: NFL was built to meet these needs and because of this we believe patients will ultimately choose and film.
Dan: As their preferred product.
Dan: Our plan is that less than a year from now <unk> will be approved and available for patient use.
Dan: This is truly an exciting time for the company.
Dan: I'm also pleased to announce today that our pediatric study for Ana film has progressed as expected.
Dan: Our NDA will include the necessary pediatric data to support a product label that if approved by the FDA would mirror the weight and age parameters of the existing 0.3 milligram Epipen auto injector.
Dan: Our pediatric data is in line with expectations and we are wrapping up the final pediatric study activities over the coming days.
Dan: We believe that this will conclude all the information that will be necessary for filing our NDA for anecdote.
Dan: In addition, we have begun preparing for a potential advisory committee meeting for anecdote.
Dan: As you May remember, our FDA pre NDA meeting notes from November indicated that the FDA may decide to hold an advisory Committee meeting.
Dan: If this were to happen we would expect it to occur in the second half of 2025.
Dan: We have hired an experienced regulatory communications firm to Adas and our preparations and we expect to be ready well in advance of the potential meeting.
Dan: Now, let's turn to our sales and marketing preparations for Amazon.
Dan: We recently conducted an awareness trial and usage or <unk> study regarding anaphylaxis and NFL.
Dan: While this work is always a critical component of preparing for launch.
Dan: We felt it was especially important since the non needle nasal spray became available to the public over five months ago.
Dan: In this study on an aided basis, 92% of the 125 physicians that were interviewed were aware of the SBA approved nasal spray product.
Dan: Roughly 65% of these physicians have already written a prescription for the nasal spray.
Dan: Yet when asked to allocate their potential future prescribing habits between auto injectors nasal sprays and sublingual film.
Dan: Film received a higher percentage in both the auto injectors and nasal spray.
Dan: While I generally view survey data as just directional I believe it is powerful that physicians, who are aware of and have prescribed the existing nasal spray with still list sublingual film as their preferred most prescribed product.
Dan: Under the theoretical price that film was FDA approved and available to patients.
This is before we have done significant awareness work and marketing efforts that occurred after approval.
Dan: Now, let's turn to commercialization.
Dan: We believe there are multiple pathways to commercializing NFL if approved by the FDA.
Dan: We continue to prepare for launching NFL on around and most recently hired in house market access expertise.
Dan: Further drive our ongoing discussions with payers.
Dan: This is in addition to the medical affairs awareness work, we have been conducting including increasing our medical publications posters and presence at regional and National medical conferences.
Dan: This work will intensify in the coming quarters as will our commercial preparation.
Dan: As a reminder, our plan remains to obtain FDA approval prior to hiring a sales force.
Dan: Another pathway for us to commercialize and film if approved by the FDA would be to augment our commercial capabilities with a larger more established sales and marketing organization.
Dan: This is something that we're actively contemplating but we'll only do if the conditions are right for our company.
Dan: These conditions at a minimum.
Dan: <unk> working with a company that has the size and scale to truly expand our engagement efforts and a true commitment to patients in this therapeutic area.
Dan: Only time will tell what the right path is for NFL.
Dan: Once we have completed our anthem submission to the FDA. We will also begin focusing on international markets and partnerships.
Dan: Our initial focus will be to submit applications in the EU UK and Canada.
Dan: We are exploring partnerships for ex U S commercialization of any film and expect these ex U S partnerships would contribute significantly.
Dan: The company.
Dan: We are also actively planning for our future.
Dan: In the next quarter, we will open our investigational new drug application or IND.
Dan: <unk> SD Wan away, our topical gel formulation of epinephrine.
Dan: As previously discussed we believe that <unk> could be extremely meaningful to the millions of patients managing alopecia, areata or AA as well other dermatological conditions, we expect to start our phase Iia trial for <unk> do you want to wait in the next quarter and have.
Dan: Some level of clinical data available to share with you before the end of this year.
Dan: This timing is dependent on patient recruitment as well as our final protocol design.
Dan: As a reminder, an estimated $6 7 million people in the U S are effected by AI.
Dan: Those affected 43% are considered severe.
Dan: The existing therapies for AA, our Janus kinase or JAK inhibitors.
Dan: These systemic treatments with known side effects come with a black box warning in our expensive for patients.
Dan: Even with these limitations the current estimated market opportunity for JAK inhibitors is over $1 billion.
Dan: As Amazon comes to market if approved by the FDA, we expect HST waterway.
Dan: Our lead pipeline opportunity.
Dan: Now, let's turn to Liberty.
Dan: We were obviously disappointed by the recent federal court ruling that held the Fda's rationale for granting liberman approval and orphan drug market exclusivity for underserved patients aged between two and five years was not acceptable and we have appealed this ruling.
Dan: Let's keep in mind that liberman currently treat young vulnerable children, who have in their case recently been diagnosed with epilepsy are on maintenance medication and are still at risk of Caesar seizure clusters.
Dan: We remain committed to doing everything you can keep liberty on the market for these young patients.
Dan: We will continue to engage the FDA and a court system to protect these patients.
Dan: We will keep you informed as we learn more.
Dan: However, it is important to remember that in less than two years, we expect to be able to provide liberman.
Dan: All age groups, regardless of any outcome in the courts.
Dan: In conclusion. This is a remarkable time for our questions.
Dan: We have more levers of growth than ever before in the history of the company.
Dan: We expect to realize the following milestones in the coming months.
Dan: FDA acceptance of our anecdote NDA submission.
Dan: Opening of our IND for <unk> and the start of our phase Iia clinical trial <unk>.
Dan: Engagement with international regulatory bodies for expanding anecdote filings to ex U S territories.
Dan: Continuing to build towards the commercial launch of <unk> if approved by the FDA.
Dan: And continuing to fight for patient access delivered.
Ernie: With that I will turn the call over to Ernie.
Ernie: Thank you Dan and good morning, everyone.
Ernie: By now you 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 fourth quarter 2024, and full year 2024 results into Q&A.
Ernie: During 2024, we made great progress in positioning our questar for success.
Ernie: We strengthened our balance sheet by raising over $78 million in capital from high quality institutional healthcare investors.
Ernie: Our continued investment in our strategic priorities.
Ernie: <unk> and advancing the development of NFL, our lead asset by completing all planned adult clinical trials.
Ernie: And receiving positive feedback in the pre NDA meeting with the FDA.
Ernie: Kevin a successful pre IMD meeting for our product candidate <unk> 108, a topical gel formulation of epinephrine.
Ernie: Now, let's turn to the recap of our quarterly and full year financial results.
Ernie: Total revenue decreased to $11 9 million.
Ernie: In the fourth quarter 2024 from $13 2 million in the fourth quarter 2023.
Ernie: This 10% decrease in revenue was primarily driven by decreases in license and royalty revenue.
Ernie: Due to $1 million of milestone royalty revenue for our stars from Zebra therapeutics recognized in the prior year.
Ernie: Manufacturer and supply revenue decreased to $10 7 million in the fourth quarter of 2024 from $11 million in the fourth quarter 2023, primarily due to a decrease in suboxone revenues, partially offset by an increase in revenue for Andy from Hi, Pierre.
Ernie: License and royalty revenue decreased to $8 million in the fourth quarter 2024 from $1 9 million in the fourth quarter 2023, primarily due to the previously mentioned royalty revenue first tourists from Zebra therapeutics recognized in the prior year.
Ernie: Co development and research fees in the fourth quarter of 2024 remained relatively unchanged compared to the same period in the prior year.
Ernie: Total revenues increased to $57 $6 million for the full year 2024 from $56 million for the full year 2023.
Ernie: This 14% increase in revenue was primarily driven by increases in license and royalty revenue due to the recognition of deferred revenue from the termination of licensing and supply agreements and increases in co development and research fees, partially offset by decreases in man.
Ernie: Facture and supply revenue.
Ernie: Excluding this onetime recognition of deferred revenue total revenues decreased by $4 5 million or 9% year over year.
Ernie: Manufacture and supply revenue decreased to $40 million for the full year 2024 from $43 $8 million for the full year 2023.
Ernie: <unk> due to decreases in suboxone and <unk> revenues, partially offset by an increase in <unk> revenues from Zamboni and an increase in R&D revenues from Hi, Pierre.
Ernie: Excluding a onetime retroactive price increase of $1 $7 million recognized in the prior year manufacturer and supplier revenue decreased to $40 million from $42 1 million.
Ernie: Research and development expenses increased to $4 9 million in the fourth quarter 2024 from $2 $9 million in the fourth quarter 2023.
Ernie: The increase in research and development expenses was primarily due to clinical trial costs associated with the continued advancement of the NFL development program.
Ernie: Research and development expenses increased to $23 million for the full year 2024 from $13 1 million for the full year 2023.
Ernie: The increase in research and development expenses was primarily due to clinical trial costs and product research expenses associated with the continued advancement of both the NFL and <unk> programs as well as increase in personnel cost and an increase in share based compensation.
Ernie: Selling general and administrative expenses increased to $16 million in the fourth quarter 2024 from $9 6 million.
Ernie: In the fourth quarter of 2023, primarily due to increased commercial spending and regulatory fees related to the approval of liver event for ages two to five <unk>.
Ernie: Pre commercial preparations for NFL.
Ernie: Severance cost of $1 $8 million and higher legal expenses of $1 5 million.
Ernie: Partially offset by a decrease in insurance fees.
Ernie: Selling general and administrative expenses increased to $52 million for the full year 2024 from $31 8 million for.
Ernie: For the full year 2023.
The increase was partially driven by severance costs of $2 9 million and higher personnel cost there.
Ernie: The remainder of the increase is largely driven by higher commercial spending and regulatory fees related to the approval of <unk> for ages, two to five and pre commercial preparations for Ana film, partially offset by a decrease in insurance fees.
Ernie: Our questions net loss for the fourth quarter 2024 was $17 1 million.
Ernie: Our 19th.
Ernie: Both basic and diluted loss per share.
Ernie: Compared to the net loss for the fourth quarter of 2023 of $8 $1 million for 12 for both basic and diluted loss per share.
Ernie: Our quest is net loss for the full year 2024 was $44 1 million.
Ernie: Our 51.
For both basic and diluted loss per share compared to the net loss for the full year 2023 of $7 9 million or 13 for both basic and diluted loss per share.
Ernie: The increase in net loss for both the fourth quarter 2024, and full year 2024 was driven by increases in selling general and administrative expenses research and development expenses noncash interest expense related to the amortization of the debt and royalty.
Ernie: Obligation discounts.
Ernie: The decreases in revenues, partially offset by increases in interest income and other income and decreases in manufacturer and supply expenses and loss on the extinguishment of debt.
Ernie: non-GAAP adjusted EBITDA loss was $11 million in the fourth quarter 2024, compared to non-GAAP adjusted EBITDA loss of $2 8 million in.
Ernie: In the fourth quarter 2023.
Ernie: non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses were $6 6 million.
Ernie: In the fourth quarter 2024, compared to a non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses of $1 million in the fourth quarter of 2023.
Ernie: non-GAAP adjusted EBITDA loss was $23 million for the full year 2024, compared to non-GAAP adjusted EBITDA loss of $11 $6 million for the full year 2023.
Ernie: non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses was $4 million for the full year 2024 compared to non-GAAP adjusted EBITDA income, excluding adjusted R&D expenses of $1 million for.
Ernie: For the full year 2023.
Ernie: As of December 31, 2024, cash and cash equivalents were $71 5 million.
Ernie: On a pro forma basis, the company's cash and cash equivalents were approximately $93 million adjusted for the $21 4 million raised through the company's ATM facility on February 14 2025.
Ernie: The recent ATM activity continued our goal of strengthening our balance sheet as we prepare for the commercial launch of <unk> if approved by the FDA.
This sale of stock under the ATM facility was a result of inbound interest from two high quality institutional healthcare investors, one being an existing investor.
Ernie: There are additional investment and requested shows confidence in our story and our goal of getting products in the hands of patients.
Ernie: Our focus in 2025 is on the advancement of our NFL and <unk> development programs and continued commercialization of liver band for patients ages between two and five years.
Ernie: As outlined in the press release issued last night after market close our outlook for 2025 is total revenues of approximately $47 million to $56 million.
Ernie: And non-GAAP adjusted EBITDA loss of approximately $46 million to.
Ernie: <unk> to $53 million.
Ernie: Our revenue guidance for 2025 includes live event for ages between two and five years and some level of erosion in the demand for suboxone.
Ernie: As a reminder, our 2024 revenue included onetime 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.
Ernie: Costs associated with submission of the NFL NBA and related filing fee.
Ernie: <unk> of the NFL pediatric clinical trial.
Ernie: Preparations for a potential advisory committee meeting if required by the FDA for approval of NFL.
Ernie: Commencing the <unk> went away phase Iia clinical trial in the second quarter 2025.
Ernie: Continued commercialization of wherever event for epilepsy patients between ages, two and five years.
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 were seeing with yourself from the queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.
Roanna Ruiz: Our first question comes from Roanna Ruiz with lyric Leerink partners. Your line is open.
Speaker Change: Hey, Good morning. This is Nick Ethicon for Rwanda, Thanks for taking the questions maybe first.
Roanna Ruiz: From us.
Could you could you remind us what are some of the key topics that the FDA might want to clarify or dig into it a potential advisory committee meeting and what gives you confidence and NFL profile I guess grow our PK PD standpoint heading into this potential meeting.
Roanna Ruiz: Sure.
Roanna Ruiz: Good morning, nice to hear your voice.
Roanna Ruiz: It's been an interesting process with the team here.
Roanna Ruiz: As we put the NDA together and starting to submit it to the FDA and one of the outcomes of that is we've just continued to grow more and more uncertain and the profile of our product and that that profile is the preferred and best profile for someone who is experiencing.
Roanna Ruiz: Reaction.
Roanna Ruiz: And when you think about it.
Roanna Ruiz: It's really just common sense.
Roanna Ruiz: All know the epinephrine stabilizes mast cells and stops mediator release.
I'll know that without epinephrine mast cell degranulation accelerates.
Roanna Ruiz: Life, threatening and what some of you may not know is that.
Roanna Ruiz: When there is a bad outcome from an allergic reaction.
Roanna Ruiz: That typically almost always happens in the first 30 minutes.
Roanna Ruiz: That's due to a drop in blood pressure or blocked airway. So when you look at our profile, we have a fast and rapid uptake of epinephrine, we have a rapid change in blood pressure, we've shown that localized epinephrine rapidly reduces mucosa with EMA.
Speaker Change: Love. This comparison to the products that are out there we think the ability of that first 15 minutes to say that we are comparable to the auto injector is really powerful and we also think going back to the common sense approach that.
Speaker Change: Individual basis, when you ask someone what would you want.
Speaker Change: The obvious answer is I want something that gives me enough epinephrine to ensure that I stopped the allergic reaction that I have so when we get to the AD comm we.
Speaker Change: We believe that we will have the opportunity to tell our story on our profile and we think that will be received really very very positively not only by.
Speaker Change: The AD com, but by the other constituents of that day. So we're looking forward to the outcome if it does occur.
Dan: Got it thanks, Dan and then maybe a second question from me I guess thinking ahead to a potential approval and launch.
Dan: Which types of patients you think would be the early adopters of <unk>.
Dan: Some of the other approved commonly used epinephrine products are out there.
Speaker Change: Right right, well look I'll hand, it over to Sherri and a second to give you her view, but I will I will fully admit my view is that anyone and everyone who.
Dan: Is at risk.
Sherri: Having anaphylaxis, one should carry a rescue product into our rescue product.
Sherri: Absolutely should fit whatever profile that individual has but I'll, let Gary give you some current thoughts.
Sherri: Nice to chat with you again as you know we spent a lot of time at.
Sherri: This past weekend.
Doug: Sure Doug.
Doug: One on one key opinion leader.
Doug: And allergists and what we continue to hear over and over again.
Doug: NFL is the easiest to carry.
Doug: So quickly and it's not a device.
Doug: It's really opened the door to all patients and so we're really excited about that.
Speaker Change: From a marketing segmentation perspective.
Speaker Change: We definitely believe anybody any starting at the age where it can start carrying the phone.
Speaker Change: It would certainly be.
Speaker Change: Our primary target and then.
Speaker Change: Yeah.
Speaker Change: But there will be lots of opportunities and options for all patients 2122.
Speaker Change: Jerry and Phil.
Speaker Change: Again, we feel very strongly that it is a.
Speaker Change: Very broad market for NFL.
Speaker Change: How easy it is to carry and to use it.
Speaker Change: And certainly there will be certain segments that again teenagers and young adults.
Speaker Change: Yes.
Speaker Change: Certainly want to be able to have it.
Speaker Change: And there are pockets in there found very very quickly.
Speaker Change: Got it that's helpful. Thanks, guys I'll hop back in the queue.
Speaker Change: One moment for our next question.
David: Our next question comes from David <unk> with Piper Sandler Your line is open.
David: Thanks, So just got a few first on commercialization.
David: Just wanted to clarify so it sounds like you are close to being ahead in terms of building your commercial infrastructure, but you are open to.
David: To some sort of.
David: Partnership arrangements. So I just wanted to get a sense of how likely.
David: Some sort of partnership is versus just going it alone.
David: Number one number two regarding the launch of Nazi any sort of early learnings that you've gleaned from that launch in terms of how you're thinking about your opportunity.
David: Particularly interested in the extent to which.
David: The availability of Nafie is expanding the market and the evidence of that.
David: So that's number two and then lastly on live events and I know I've asked this question a bunch of times, but.
David: It bears asking again is just how are you thinking about this asset just given all the other things you have going on in the organization.
David: And is that something youre looking to out license.
David: Sure.
David: Thanks, David and good to hear your voice.
David: No.
David: Let me first tackle your question on commercialization going it alone versus having a partner.
David: And then I'll pass it over to Sherry give you his thoughts on what you've seen with the competitor launch in your questions. There. So first as Ernie outlined.
David: His prepared comments.
David: Our.
David: Our financial guidance for the year is baked.
David: <unk> launching.
David: And it's all on our own so we are investing significant time resources energy money.
David: In the second half of this year to make sure that we are ready to launch as soon as that approval comes through in the first quarter of 2026, which by the way as a reminder is all for the allergy season next year, so great timing from our perspective.
David: Since the launch.
David: The likelihood of which path we take.
David: It really hard one right because our role here at the management team is to maximize the value of NFL and for all stakeholders and that value obviously.
David: Heavily includes investors and what what is good for them, but it also includes patients and making sure that we can get to the broadest scope of patients that we possibly can so.
David: We're prepared to do that on our own and we've lined up.
David: Ed.
David: Plan.
David: Pending to do that.
David: If it's the right match comes along to make us bigger bolder and be able to get the product out further.
David: Absolutely, we'll engage in that so.
David: We will see as the months go by and I'll keep you.
David: Everyone else is important as they can.
David: Now, let me pass it over to.
Sherri: Sherri to talk about what you've seen with the competitive launch.
Sherri: Good morning.
Sherri: As you know and as we saw.
Sherri: Quad AI this past weekend.
Sherri: Awareness.
Sherri: Turn it is to the needle auto injector remains key.
Sherri: It's about.
Sherri: A strong message about what else is now available.
Sherri: I would say physicians are asking the question.
Is the product to work and so that's the key we feel very strongly that we have with the data.
Sherri: Upon approval that we will be able to share with physicians that it works.
Sherri: <unk>.
Sherri: What I believe is the most robust package ever iOS.
Sherri: For epinephrine.
Sherri: This study is.
Sherri: Is very supportive and so.
Sherri: And we're seeing that.
Sherri: The IRS lines of Nafie, they're driving messaging to ADP.
Sherri: We'll be launching consumer campaigns, and so overall working to get the switches and go to market. That's a good thing as it relates to.
Sherri: And ultimately the payers are the key and so we know that it is critically important to hcp's patients to have full access to epinephrine product.
Sherri: We have heard loud and clear.
Adam Films: Adam films.
Speaker Change: Game changer for patients because time is of the essence and that's life threatening situation.
Adam Films: Yes.
Adam Films: Physicians believe that the product will be carried more often and used earlier and so it's our responsibility and why we have brought in house expertise.
Adam Films: Our most recent hire our new VP of market access.
Adam Films: 20.
Adam Films: 25 plus years.
20.
Adam Films: Big and small pharma.
Adam Films: To help us.
Adam Films: Yes.
Adam Films: It is a key area of focus we know it is for <unk> and it will be for us as well.
Adam Films: And.
David: David I think the last part of your question was on <unk>, which.
Adam Films: Okay.
Ben: Ben has unfortunately just.
Adam Films: Time after time based.
Struggles better outside of the value of the product to patients right.
Adam Films: Today I believe in the value of liberman for patients just as much if not more.
Adam Films: Eight years ago. So.
Adam Films: There will come a day, where we can provide live event to all patients and we look forward to that day, we think that will be a valuable day, not only for patients but for us as an organization.
Adam Films: In terms of where it fits in the broader strategy.
Adam Films: A question.
Adam Films: Think we're at an interesting crossroads right now as a company, where we have tremendous value in a variety of places.
Adam Films: It remains to be seen over the next 12 to 24 months, how that value regardless of the company. So.
Adam Films: <unk>.
Adam Films: It is important.
Adam Films: We'll continue to be important.
Adam Films: And its place in our organization I think will be will be clarified as time goes on.
Yeah.
Adam Films: Okay helpful. Thank you.
Adam Films: One moment for our next question.
Speaker Change: Our next question comes from Francois <unk> with Oppenheimer. Your line is open.
Francois Oppenheimer: Alright, Thanks for taking my question and congrats on the progress here with the.
Speaker Change: The submission.
Just wanted to touch on something you just mentioned on David <unk> question about the importance of the timing of the launch can you just help us understand what that means and how seasonality is important for this specific market and then I have a follow up.
Speaker Change: Sure Yeah, let.
Sherry Frank: Let me pass that over to Sherry Frank Thanks, Brian Nice to chat with you again, great seeing you.
Speaker Change: Look I think that you are.
Speaker Change: Going to launch at a perfect time, so there is seasonality the epinephrine market.
Speaker Change: Seasonality and the epinephrine market. So you see I'm sure you see from the same numbers idea.
Speaker Change: Market starts to build in that April may timeframe.
Speaker Change: Ready for Cam.
Speaker Change: True season begins in mid summer and then really peaks.
Speaker Change: August and September so as we think about launching.
Speaker Change: Early.
Speaker Change: I assume we haven't.
Speaker Change: <unk> data early February.
Speaker Change: Well Quad AI will be our coming out party and we will be ready in time for this season.
Speaker Change: And especially if you think about six months in it'll be right at that time, where patients are going in for their retail getting their new prescriptions for back to school and so we think it is a great timing.
Speaker Change: May be saying well what about payers that again. This is why we have brought in house expertise.
Speaker Change: To really ensure that we are working with the payers today.
Speaker Change: Repair as best as possible for that launch.
Speaker Change: Hopefully next February.
Speaker Change: 2026.
Speaker Change: Excellent and then you discussed the imports.
Speaker Change: GAAP at onset and being comparable to epipen and the importance of the start but another topic.
Speaker Change: That comes up sometimes when people think about the outcome and what might be important that you guys have mentioned it is on the safety front. So I was just wondering if you could share a little bit more about what makes you feel comfortable about the PK PD profile on the safety front.
Speaker Change: And especially with emphasis on kind of the C. Max.
Speaker Change: But especially on the repeat dose and just what makes you comfortable with those levels of epinephrine. Thank you.
Speaker Change: Yes, no. Thanks, Thanks Frank.
Speaker Change: No.
Speaker Change: Sure.
Speaker Change: That's something before that I think deserves a little bit more airtime. This is the most robust package ever put together for epinephrine for the SBA, we have over 900 dosing in our film we have twice as many subjects in our package as the competing nasal spray that was just approved.
Speaker Change: So we have a very very robust package that we're putting in with the FDA, which has a very clean from our perspective AE profile and no sae's. So when we look at package we've created we're very.
Speaker Change: We're very excited and you mentioned.
Onset with the first dose and you really do have to start with the first dose.
Speaker Change: When you think about you've heard people in this space talk about this idea of bracketing to get to approval.
Speaker Change: Weakness in Bracketing is it allows you to be low for the first 15 or 30 minutes. If you want to be and still get approved we think thats. The wrong profile. We think that is when mortality occurs in fact and Karl can tell even more if we had time mortality rate hasnt changed in decades.
Speaker Change: So clearly something needs to be done to make sure you get a robust enough amount of epinephrine and that first 15 or 30 minutes. So we don't.
Speaker Change: It's interesting as as.
Speaker Change: As you hear comments around around the space, we don't apologize for it the amount of epinephrine, we are giving with our first dose or a second dose that's exactly what we think people need so let's talk about that second dose.
Speaker Change: This suppose it concern about the level of <unk>.
Speaker Change: If you need a second dose of epinephrine.
Speaker Change: <unk> has gone by you're farther into the disease state.
Speaker Change: The Cascade of mast cell. The granulation is further along and now you are in real trouble.
We need.
Speaker Change: Need a significant amount of effort effort do you get out of that cycle, and we think and Carl and the team are.
Putting everything together, we think any outcome that we will have a very compelling story to tell that lines up with the science and the data that we have supporting what we're what our profile looks like and how it is the preferred one for patients.
Speaker Change: Okay, Great and just maybe to finish on that is that the level that we've seen with the curves is that still a physiological range of epinephrine in the body or are we talking about super Super physiological here.
Speaker Change: Yes.
Karl: I'll pass it over to Karl to give you his view.
Karl: No I appreciate the question and when you say physiologic range, obviously, the human body is is well designed to.
Karl: The address various states.
Karl: Ron obviously, youre epinephrine levels are going to rise and if you're resting at home. It's obviously going to go down the pharmacokinetic profile of epinephrine is such that we see linear kinetics or pharmacokinetics, but hemodynamic pharmacodynamics, it's not linear reach the threshold. So whatever epinephrine level that you have in your body.
Karl: At some point trees don't grow ever taller you don't have.
Your heart rate and your blood pressure going to ever higher. So there is a threshold that's reached but those levels that are required to make sure you address stress situations, we're built for that.
Karl: We're seeing any any concerns outside of the geologic range right now.
Speaker Change: Excellent alright, thank you very helpful and congrats again.
Speaker Change: Thanks, Greg one remember for our next question.
Speaker Change: Our next.
Christopher: Comes from Christopher <unk> with schedule for Sterling Your line is open.
Christopher: Hi, good morning, everybody. Thanks for taking my questions. The first one is can you speak a little bit more about some of the potential pre AD com, where could that youre doing I think you are in a pretty unique situation, having a list of all the unsolicited FDA comments around the pre NDA meeting have you consider.
Christopher: Hiring any of the AD com services are conducting a mock AD comm yourself ahead of this potential event.
Christopher: Yes.
Speaker Change: Thank you Kristen, yes, we have.
Christopher: So as you know.
Christopher: Gaiseric Committee process with the FDA is it's formulaic. So there is an order to how the day goes and every AD comm follows that process. So we have brought on external expertise to help us make.
Christopher: Make sure we are ready for each section of that date.
Christopher: There is already.
Christopher: A team inside of our company that meets on a weekly basis to.
Christopher: Go through the pieces and parts and.
Christopher: While we don't expect the outcome if it occurs.
Christopher: To happen until the fall.
Christopher: We are going to be ready.
Christopher: Well in advance of that so look it's a lot of work for a company to get prepared but it is if the outcome occurs is a really nice day for us to be able to showcase all the great things about our program.
Speaker Change: Okay, Thanks, and as you're doing a lot of the we're getting in front of physicians at conferences et cetera, we often talk about the current.
Speaker Change: Market. These patients obviously understand the seriousness of need to carry a form of epinephrine, but as we started thinking about the market shifting into Neil as forms how would you think in the future about penetrating into those.
Speaker Change: Markets, where patients know that they have a serious condition, but they know that they didn't want to carry a needle or they were afraid of a needle or it was too large et cetera. Do you think there could be an uptick in that cell relative to what we would you know.
Speaker Change: And actually expect is a big shift from patients also on right.
Speaker Change: Right now thank you.
Speaker Change: Yes.
I'll pass it over to Sherri and a second to give her thoughts, but I'll just give one global thought which is as we again as we've been putting the NDA together.
Speaker Change: Preparing all the pieces and parts for the FDA one thing that continues to strike me as the number.
Speaker Change: Time anaphylaxis occurs.
Speaker Change: And including.
Speaker Change: Where there is.
Speaker Change: Ultimately bad outcome.
Speaker Change: That's where the individual has never been prescribed.
Speaker Change: A rescue product can be even though they needed a rescue product. So in terms of just globally. There absolutely is a need for.
Speaker Change: Much greater awareness to protect people sure you could talk more about how that manifests itself in the marketplace, Hi, Chris Dan Nice to hear your voice.
Speaker Change: What I believe based on all the market research that we have been conducting Dan mentioned, our recent Apu as well as the meetings that we are attending.
Speaker Change: I met with dozens of physicians this past weekend one on one.
Speaker Change: And I think something that Youll see.
Speaker Change: Believe will occur.
Speaker Change: Right now the market the way people are maybe looking at it it's about a needle versus a non needle.
Speaker Change: We believe based on our.
Speaker Change: Our research and our conversation is this will the market will shift from devices <unk> and Oracle.
Speaker Change: So that's a key difference and all devices and when you think about not only it is not an oral pill. It's an oral film that fits in the back of your phones and so it's something that you want people always have with them is their phones and so again.
Do you believe this will grow because it is the Arizona the easiest to carry it is the easiest to use it's got to work quickly and that and that life threatening situation and.
Speaker Change: Obviously, I'm very bullish about it and but I do believe we're going to see over time, a shift from device carrying to the film or oral so that's how I'm thinking about it Kristen.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from Jason Butler with citizens JMP. Your line is open.
Jason Butler: Hi, Thanks for taking my questions.
Jason Butler: Just a couple for me so first on <unk>, how do you think about.
Jason Butler: Investing in the product commercially in the fall.
Jason Butler: Following the court decision last month.
Jason Butler: How could that change throughout 2025, and then just on NFL can you talk about what additional awareness work you can do this year, obviously quite AI and.
Jason Butler: An important meeting, but what additional work Youll youll do to prepare for the launch thanks.
Jason Butler: Sure Good morning, Jason.
Jason Butler: On liberman.
Jason Butler: So for me the.
Jason Butler: Biggest thing to keep in mind on liberman.
Speaker Change: Yes, it's interesting in this industry, sometimes people forget that we are our ultimate purpose is to actually improve patients' lives. So when I look at <unk>. We're very proud here that we haven't product that we think.
Speaker Change: Is meaningful to patients does save patients' lives and helps in a spot where we're talking about two to five year old children.
Speaker Change: So my focus right now is on making sure that we do everything we can to ensure.
Speaker Change: Patients in that age group, who are using our products continue to be able to use our product.
Speaker Change: Over the mid to long term.
Speaker Change: Once that sorted out.
Speaker Change: We continue to believe that liver vent.
Speaker Change: Is useful and meaningful for all age groups.
Speaker Change: And Youll see us look to make sure patients have access to that now how they have access whether it's to your question on investing in more commercial infrastructure or.
Speaker Change: Partnering or finding another way to provide access to patients where always on every product always looking at what's the best way to do that but my primary focus right. Now is how do we make sure patients continue to have access to a.
Speaker Change: Product that we think is very important to them and a film awareness and the activities that we will be focused on this year outlook I'll pass it over to Sherry again, alright. Thanks, Dan.
Sherry Frank: As we mentioned.
Sherry Frank: In Q going to conferences, but AI the college.
Sherry Frank: We're doing investing significantly and our medical presence so not only the big conferences, but dozens of regional and local conferences.
Sherry Frank: Thank you.
Sherry Frank: Sure that the messaging is out of Oxford with the Presto, then and why and film.
Sherry Frank: As a game changer and will be the best choice for patients.
Sherry Frank: When it when it is available I think some other things you want to think about is.
Sherry Frank: <unk> been conducting CME.
Sherry Frank: Additionally, non CMV disease state awareness work.
Sherry Frank: As I mentioned dozens of conferences under the poster publication medical team that is.
Sherry Frank: Talking to customers Kols regional Kols. So we're really working to get our messaging out another aspect of that as you prepare for as we prepare for launch and the deep relationships, we have with advocacy organization. So in this space. There's four main advocacy organization and based on my prior.
Sherry Frank: Her experience as well.
Sherry Frank: Here at attractive team members, we do have significant relationships with the advocacy organizations and we will continue to be present at arrowhead.
Sherry Frank: Yeah.
Great. Thank you.
Sherry Frank: One moment for our next question.
Record Silver: Our next question comes from record Silver, Russia with H C. Wainwright Your line is open.
Record Silver: Thanks, very much for taking my questions and congrats on all the recent progress.
Wanted to see if you could comment on sort of what so far has been the commercial experience with <unk>.
Record Silver: The epinephrine nasal spray what you've.
Record Silver: Been hearing with regard to whether or not that product has outperformed expectations and in particular, if you could talk about the promotional activities that have been undertaken in support of that product and what <unk>.
Record Silver: Relevance those might have to your potential future launch of Amazon as an example, there is a fair amount of DTC activity going on in support of that product just wanted to see how that fits into your thinking regarding the future marketing campaign for Ana film as and when it gets approved and if there is any granularity.
Record Silver: Can provide to us at this time regarding what you expect annualized promotional budget to be for a product like Anna film once it is approved in the United States.
Speaker Change: Yes so.
Record Silver: Let me give you Mike.
Speaker Change: Sharing his thoughts before space, let me give you some of my thoughts.
Record Silver: Sure I can round it out.
Record Silver: If need be but first on the expectations, the commercial experience and expectations from.
Record Silver: A competing product.
Record Silver: <unk>.
Record Silver: I will leave it to our competitor to tell the space, how they feel about their performance versus expectations.
<unk>.
Record Silver: Don't want to.
Record Silver: Don't want to see that one way or the other for them.
Record Silver: What I would say in terms of the commercial experience of what we're seeing as sheri laid out before.
Record Silver: Sure.
Record Silver: There is a significant need in this space to build awareness.
Record Silver: So and that awareness is that truly is a rising tide raises all boats in this case because it is about making sure that the people who were not carrying <unk>.
Record Silver: Realize there are other solutions that may bring them back into them to the market the people who.
Record Silver: Our carrying but are not satisfied with their solutions showing them that there is something out there. So we there are big dollars being spent on awareness right now.
Record Silver: Very happy about that.
Record Silver: We hope it continues and we think that helps everyone.
Speaker Change: Our hearing is sheri.
Speaker Change: Talked about before.
Record Silver: That.
Record Silver: Physicians want to know that the product works.
Record Silver: And that is a difficult thing to do in a space, where efficacy studies can't be performed and youre using a $5 5 billion to comparability package.
Record Silver: You'll hear us this year and we just did acquire AI focused a lot on our Oasis study.
Our Oasis study.
Record Silver: Deepa.
Record Silver: With resolve and I believe I am just looking at call. It make sure I get the number but I believe it's five minutes.
Record Silver:
Record Silver: We know that we have.
Record Silver: A study that no one else has in patients who are having an allergic reaction and their oral cavity, where we can show that benefit how quickly that benefit comes through so we're very excited about that in terms of the last part of your question on DTC spend.
Record Silver: The.
Record Silver: Positives about a drug like <unk> in this space that if it is.
Record Silver: It's flexible right.
Record Silver: Literally probably a mathematical equation.
Record Silver: Where you spend you get that's the lessee spend you'll get this so we think it's a large market that as.
Record Silver: As we scale and as we're able to afford bigger and bigger DTC budgets will continue to grow and grow so.
Record Silver: We won't start out with a giant DTC budget, because that's just not us.
Record Silver: It will be respectful of the balance sheet that we have but we think it still will be meaningful enough.
Record Silver: To get NFL into a growth mode, and where we can continue to build it over time.
Record Silver: That's very helpful with respect to liver event I just wanted to clarify the court decision.
Record Silver: <unk>.
Record Silver: It seems as though the court of going off of the orphan drug exclusivity for Val cocoa and is not paying attention to the demarcation between the Volte Toco label and liver Vance label is that correct.
Record Silver: Yes.
Record Silver: Okay.
Record Silver: Got it.
Record Silver: With courts, you'd never really sure, which way things are going to turn right. So it's always.
Record Silver: Kind of a coin toss of.
Record Silver: What a judge will do what the Appeals court, we will do what the Nextgen will do so look we're.
Record Silver: I think the right way to think about it is we understand.
Record Silver: That NFL.
Record Silver: Is something we have to get filed.
Record Silver: And get through the FDA and continue to build our organization, but we think that prevent is important to patients and so we will continue to do.
Record Silver: Invest in making sure that.
Record Silver: We fight in the courts.
Record Silver: And that we get.
Record Silver: The provision to a place where.
Record Silver: Patients can continue to have access to it having said that it's the court system.
Record Silver: And you don't know until its over.
Record Silver: But in any case just to clarify.
Record Silver: While the appeal process is ongoing there is no change to our.
The authorization that deliver events currently has is that correct.
Record Silver: That's up to the judge and the courts right. So.
Record Silver: It depends on how they.
Record Silver: What their decisions are as we go through the process. So.
Record Silver: There is a broad range of outcomes that could occur in.
Record Silver: Just like all of you listening today at some level, we're listening as well we have to see where the judge ultimately ends up.
Record Silver: And then just in terms of how long it could take for the appeals process to play out can you just contextualize that for us in the context of the timing with which the OE for Val <unk> is slated to expire.
Record Silver: Yes, well, let's so let's start with the <unk> expires right that is in early 2027. So we.
Record Silver: A global product basis, we'll be ready to provide liver bent to all age groups.
Record Silver: That day comes and none of this court exercise, we will change that.
Record Silver: In terms of how long an appeal process takes right now for the two to five year old space on liver bed.
Record Silver: <unk>.
Record Silver: I hate to give guidance on that.
Record Silver: I think the courts at times can move very slowly at times can move very fast and all we can do is.
Record Silver: Keep pushing to make sure patients have access and that's what we'll do.
Speaker Change: Okay. Thank you for that clarification, and then just very quickly for Ernie.
Speaker Change: As has been the case in years past you've provided a relatively wide topline guidance range. I was just wondering if a you expect as has been done previously to narrow that range. As we go further into 2025 and B. If you could maybe give us some sense of what the tailwind might be.
Speaker Change: That you are factoring in to driving the company's topline performance towards the upper end of that range in other words, what could be the factors that drive you towards that 66 million number as opposed to the 47 million number. Thank you.
Speaker Change: Rob Nice to talk to you so.
Speaker Change: One thing we got remember we do have for this year revenue from <unk>.
Speaker Change: For two to five.
Speaker Change: The guidance of course.
Speaker Change: Just discussed about the court case.
Speaker Change: That is something that could impact.
Speaker Change: The range of guidance as we move.
Speaker Change: Forward during the year in.
Speaker Change: In addition, no answer.
Speaker Change: The box one as I mentioned in my script. There is some level of erosion that we baked in as we usually do.
Speaker Change: Whether there could be increased.
Speaker Change: <unk> competition for Suboxone.
Speaker Change: Were just unsure of right now so I think as the year progresses, and we see how the market.
Speaker Change: Firms up for Suboxone, and the orders we get from heavier.
Speaker Change: That would impact our guidance as we move forward and we could we certainly would be tightening the range.
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.
Gary Nachman: Alright, Great Hey, guys good morning.
Gary Nachman: Back to the AD com as you're preparing for you specifically called out some decent spending behind that Dan. It sounds like you are now leaning much more to the likelihood that youll have the AD com. So has there been any more guidance from FDA on that as you've been preparing the filing or are you just being extra cautious on this.
Gary Nachman: And then have some follow ups.
Gary Nachman: Good morning, Gary Yes, we have no additional insight from the FDA we are.
Gary Nachman: We're doing what.
Gary Nachman: Good stewards of our company should do and preparing without sort of whether it will or will not happen.
Gary Nachman: And obviously ultimately up to the SBA weather, whether they decide to have it or not.
Gary Nachman: Okay.
Speaker Change: And then you said you saw some initial data from the pediatric study trying to film that you said was in line with expectations any more color on that and when will you have the final data just to ensure there are no issues there.
Gary Nachman: Filing.
Gary Nachman: And then on commercial if you end up commercializing NFL on your own how many reps will you need and then how quickly will you be able to get them on board after the approval to launch very quickly there.
Gary Nachman: Right, well I'll pass it over to.
Speaker Change: Karl in a second I know you've been dying to jumping on the pediatric study. So thank you for that.
Gary Nachman: Question, but I'll just give a timing.
Gary Nachman: Answer in terms of the pediatric data we have.
Gary Nachman: A big chunk of it right now we're getting more shortly.
Gary Nachman: And in terms of.
Gary Nachman: Making sure it gets in the NDA, we have that timing mapped out.
Gary Nachman: So that Theres no issue, but I'll let.
Carl: Carl will give you his thoughts and what he's seeing yes, no I appreciate the question.
Carl: As Andrew stated the intention is to provide the necessary elements of the pediatric study into the filing that is certainly a completely on schedule. The profile. We're seeing from the pediatric study are completely in accord with our expectations.
Carl: And further requirement of submitting the filing.
Carl: As stated we will have the necessary data from the pediatric setting to support it. So we're extremely pleased not only with the timing, but also the data that we're seeing coming out of that study.
Gary Nachman: And I think the next part of your question Gary was on the number of reps I'll, let Sherry give you his thoughts and how she would build up too.
Gary Nachman: The rate amount, but just as a reminder, we have.
Gary Nachman: Given clear guidance, we will not hire a single sales rep until after approval, but sure I can take it from there.
Gary Nachman: Thanks, Gerry nice to hear your voice as you think about the number of allergists.
Gary Nachman: At R.
Gary Nachman: Our practices as well as some very kind of high guess out pediatrician.
Gary Nachman: The Pvp nurse practitioner PAA, we believe in that around 100, Mark is a good number for us to start with as far as the sales force.
Gary Nachman: They go up they go down.
Gary Nachman: Hey.
Gary Nachman: But overall the cover of the most important customers I think we're at a sweet spot of about 100, So thats first and foremost as Dan mentioned, we will not.
Gary Nachman: We will not make offers until after approval. However, we will spend.
Gary Nachman: The all time and Q4 preparing to make those hires so that upon approval, we would be ready to hire their own.
Gary Nachman: Okay.
Gary Nachman: And then just last question back on the partnership discussions that Youre having.
Gary Nachman: Is it possible.
Gary Nachman: Possibly pull that you could have a full global partner for NFL or that it would more likely be split up by geography U S versus ex U S. And then Dan maybe you can just give a little bit of color of just the type of partnership that you think would make sense is probably a different iterations there.
Gary Nachman: But if you do sign somewhat in the U S.
Gary Nachman: And you decided to go down that path.
Gary Nachman: What do you think that might look like and are you really leaning towards having a cocoa where you would also have a commercial presence is that an important piece of it.
Gary Nachman: <unk>.
Gary Nachman: Yes, no for the U S. In particular, we will not compromise. So so we are we will not.
Gary Nachman: We were too.
Gary Nachman: To partner with somewhat.
Gary Nachman: We'll not partner with someone and less as I said in my prepared remarks.
Gary Nachman: They have significant muscle.
Gary Nachman: Help us and that they have a significant commitment to the therapeutic space. So those are.
Gary Nachman: Entry criteria for talking with us that we will not waver from.
Gary Nachman: In terms of weather.
Gary Nachman: Ultimately, we find a global partner or a U S partner, if we go down that path.
Gary Nachman: I think there are.
Gary Nachman: Large companies that fit both of the criteria laid.
Gary Nachman: Laid out.
Gary Nachman: That could be both global or just U S. So I think both of those are available.
Gary Nachman: I do want to just remind everyone that ex U S. We clearly in the U S.
Gary Nachman: More about what's the right path.
Gary Nachman: We're getting and film to everyone.
Gary Nachman: Outside the U S. We will be on a partnership only approach so a little bit of a nuance between those two those two positions.
Speaker Change: Okay, and I mean, just in terms of timing and how this might be a difficult question to answer but.
Speaker Change: Do you think you could have a partnership in place.
Speaker Change: But where there would be an AD com if there is an ad com.
Speaker Change: Just because you are spending a lot.
Speaker Change: Behind all of your prelaunch activities. So.
Speaker Change: You have to manage that with the possibility that you could have a partner that would share in that so.
Speaker Change: Is it reasonable to think that people would want more visibility on the path forward or do you think theres enough, there, where you could potentially execute it sooner.
Yes, Gary you and I have known each other a long time right.
Speaker Change: I learned long ago, you don't run a business based on trying to do something by a date right. So we're not focused on any particular date or any moment in time or inflection point you have to do something here or not do something where we have our patent we have our plan.
Speaker Change: <unk> fortunate to have not only sharing but people under Sherri, we're very talented we're more than happy to bring this to market ourselves and.
Speaker Change: If the right partner comes along that can augment our ability, we'll do that if they don't we won't so there's no timing.
Speaker Change: Element to that that we will.
Speaker Change: We will force ourselves or anyone else too.
Speaker Change: Okay got it thank you.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from Thomas Flaten with Lake Street Capital markets. Your line is open.
Thomas Flaten: Hey, good morning, Thanks for taking the questions just a follow up on a couple of questions have been asked already share it back to the hiring of the sales force and the very peculiar seasonality associated with this type of product when would be the optimal time, then assuming a February <unk> date like you had said in an earlier response would you want to have those reps out in the field.
Thomas Flaten: Almost immediately.
Thomas Flaten: So if you think about where an early thing you just assume early February you have plenty of ni.
Thomas Flaten: At the end of February 2026, and so and the season starts.
Thomas Flaten: To ramp up and so yes, we would look to do all the preparation work prior to the <unk> and then higher that hire the reps immediately thereafter.
Speaker Change: And then Dan just just to clarify given the pediatric data how many presentations of the product will it be how many dosage forms will you actually have available for prescribing once a product is approved.
Thomas Flaten: Yes.
Thomas Flaten: The initial approval will be for <unk>.
Thomas Flaten: Patients 30, kilos and up which is about seven years of age that will be.
Thomas Flaten: Comparable to the adult dose of the Epipen.
Thomas Flaten: The adult ANP down to $30.
Thomas Flaten: So thats just one dose.
Thomas Flaten: We will after that just like.
Speaker Change: The other companies around us.
Speaker Change: Put a junior dose through its paces with the FDA to bring that to market. So at launch next spring there'll be one dose over time as we.
Speaker Change: Take.
Speaker Change: The whole market that will ultimately be two doses.
Speaker Change: Got it I appreciate it thank you.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from James Molloy with Alliance Global Partners. Your line is open.
James Molloy: Hey, guys. Thank you very much for taking the question earlier, just a quick one on the.
James Molloy: And this may tie into the partnership question was just asked earlier looked at the $16 million.
James Molloy: G&A spend in the fourth quarter is that the level, we should be looking at going forward is that dependent upon whether or not youre going to have a partner to.
James Molloy: And the film or is that that number going to be going Dublin cutting back going back to the 12 level through 25. Thank you.
James Molloy: Well one thing in the gym in the fourth quarter, there was a severance charge in there so that inflated somewhat of the fourth quarter, but looking forward to 'twenty five as I said in my prepared remarks on our guidance we have included.
<unk> score.
James Molloy: <unk>.
James Molloy: The pre commercial work for NFL.
Sherry Frank: Some with Sherry as alluded to earlier in our comments, we are continuing to commercialize <unk>.
Sherry Frank: And so we would see some increase in our SG&A most likely in the second half of the year.
Sherry Frank: It would be more heavily weighted as we prepare for it.
Sherry Frank: As we continue to all the pre commercial work ahead of them.
Sherry Frank: Alright, great. Thank you and then last question for me then on the live event.
Sherry Frank: Any risk and marketing live event with us.
Sherry Frank: Willing out there I know it was touched upon you don't really know what's going to happen with the courts.
Sherry Frank: Any thoughts on timing and any risk you might have in store marketing live event given this recent ruling.
Sherry Frank: Yes look the risk on marketing Liberman is completely the court system. So.
Sherry Frank: Similar to my answer.
Sherry Frank: Gary on timing of if we were to partner NFL, It's similar with Liberty with the courts.
Sherry Frank: Certain things, we can control in this universe and the court system timing and a core system decisions is not one of those so we.
Sherry Frank: We will we're committed to patients in this space, we think our product is important.
Sherry Frank: We think it's important to patients will continue to fight and advocate for them and we will see we will see what happens.
Sherry Frank: Thanks for taking questions.
Speaker Change: And im not showing any further questions at this time I'd like to turn the call back over to Daniel Barbara Steele for any closing comments.
Speaker Change: Thanks, Kevin.
Speaker Change: Thank you for joining us this morning as you heard today, we're incredibly excited about the progress. The company has made and we believe we are well positioned for a successful 2025, we.
Speaker Change: We look forward to the next time, we interact with that I wish all of you a wonderful 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].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.