Q2 2025 Aquestive Therapeutics Inc Earnings Call

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

Speaker #2: Good day, and thank you for standing by. Welcome to the Aquestive Therapeutics second quarter 2025 earnings conference call. At this time, all participants are in listen-only mode.

Speaker #2: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star one-one on your telephone.

Speaker #2: You will then hear automated message advising your hand is raised. To withdraw your question, please press star one-one again. Please advise that today's conference is being recorded.

Speaker #2: I'll now hand the conference over to your first speaker today, Ryan Korb. Please go ahead.

Brian Korb: Thank you, operator. Good morning and welcome to today's call. On today's call, I am joined by Daniel Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for the second quarter of 2025, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Carl Kraus, Chief Medical Officer, and Sherry Korchinski, Chief Commercial Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, a recording of today's call will be made available on the Questive Therapeutics website within the Investors section shortly following the conclusion of this call. To remind you, the Questive Therapeutics team will be discussing some non-GAAP financial measures this morning as part of its review of second quarter 2025 results.

Speaker #3: Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer.

Speaker #3: We're going to provide an overview of recent business developments and performance for the second quarter of 2025. Followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Karl Kraus, Chief Medical Officer, and Sherry Korczynski, Chief Commercial Officer.

Speaker #3: As a reminder, the company's remark today corresponds with the earnings release that was issued after market close yesterday. In addition, a recording of today's call will be made available on Aquestive's website within the investor section shortly following the conclusion of this call.

Speaker #3: To remind you, the Aquestive team will be discussing some non-GAAP AP financial measures this morning as part of its review of second quarter 2025 results.

Brian Korb: A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the Investors section of the Questive Therapeutics website. During the call, the company will be making forward-looking statements. We remind you of the company safe harbor language as outlined in yesterday's earnings release, as well as the risks and uncertainties affecting the company as described in the Risk Factors section and in other sections included in the company's quarterly report on the Form 10-Q filed with the Securities Exchange Commission on August 11, 2025. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval, and commercialization of its products and other matters related to operations.

Speaker #3: A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the investors' section of Aquestive's website.

Speaker #3: During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in yesterday's earnings release, as well as the risks and uncertainties affecting the company as described in the risk factors section and in other sections included in the company's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 11, 2025.

Speaker #3: As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business, and the development, regulatory approval, and commercialization of its products and other matters related to operations.

Brian Korb: Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributable to Questive Therapeutics or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. Now, I would like to turn the call over to Daniel.

Speaker #3: Given these uncertainties, you should not place undue reliance on these forward-looking statements. We speak only as of the date made. Actual results may differ materially from these statements.

Speaker #3: All forward-looking statements attributable to Aquestive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement, as well as the cautionary statements contained in the earnings release issued yesterday.

Speaker #3: The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law.

Speaker #3: Now, I would like to turn the call over to Dan.

Daniel Barber: Thanks, Brian, and good morning, everyone. We are now less than six months away from our FDA action date for Anafilm Epinephrine Sublingual Film, potentially the first and only oral product for the treatment of severe allergic reactions, including anaphylaxis. As a reminder, our action date is scheduled for January 31st, 2026. I am pleased to tell you this morning that we are on track across the important elements of Anafilm. We are on track in our FDA review process, our Anafilm Advisory Committee preparations, which may or may not occur, and our pre-commercial launch activities. We are on track in responsibly securing launch financing for the company, and we are on track in our international expansion efforts for Anafilm. Let us start with the FDA review of our Anafilm application.

Speaker #4: Thanks, Brian. And good morning, everyone. We are now less than six months away from our FDA action date for antifilm epinephrine sublingual film. Potentially the first and only oral product for the treatment of severe allergic reactions including anaphylaxis.

Speaker #4: As a reminder, our action date is scheduled for January 31, 2026. I'm pleased to tell you this morning that we are on track across the important elements of antifilm.

Speaker #4: We are on track in our FDA review process, our antifilm advisory committee preparations, which may or may not occur, and our pre-commercial launch activities.

Speaker #4: We are on track in responsibly securing launch financing for the company, and we are on track in our international expansion efforts for Antifilm. Let's start with the FDA review of our Antifilm application.

Daniel Barber: We recently submitted our 120-day safety update to the FDA. I am pleased to say that there was nothing new or of consequence to report in this safety update. We also believe the FDA is about to conclude its mid-cycle review. While we do not participate in this review, we would expect to have more clarity on whether we will have an advisory committee meeting once the FDA has fully processed its mid-cycle review meeting. In terms of advisory committee meeting preparations, we recently completed our first in-house mock or practice advisory committee meeting, including participation from our key opinion leaders. We were pleased with the results and continue to strengthen our discussion points every week. It is also worth noting that we have included our pediatric study data in the supplemental materials on our website.

Speaker #4: We recently submitted our 120-day safety update to the FDA. I'm pleased to say that there was nothing new or of consequence to report in this safety update.

Speaker #4: We also believe the FDA is about to conclude its mid-cycle review. While we do not participate in this review, we would expect to have more clarity on whether we will have an advisory committee meeting once the FDA has fully processed its mid-cycle review meeting.

Speaker #4: In terms of advisory committee meeting preparations, we recently completed our first in-house mock or practice advisory committee meeting. Including participation from our key opinion leaders, we were pleased with the results and continue to strengthen our discussion points every week.

Speaker #4: It's also worth noting that we have included our pediatric study data in the supplemental materials on our website. As we have discussed before, this data was in line with expectations and, importantly, enabled us to submit our NDA for patients down to 30 kilograms, or approximately seven years of age.

Daniel Barber: As we have discussed before, this data was in line with expectations and, importantly, enabled us to submit our NDA for patients down to 30 kilograms or approximately seven years of age. Now, let us turn to our pre-commercial activities. As a starting point, it is important to remember that we continue to believe the rescue market for severe allergic reactions is poised for growth for years to come. Before the launch of a nasal spray last year, there had been very little innovation and very little physician detailing in this space for quite some time. When we launch, if we are approved by the FDA, there will be only a few companies detailing physicians and highlighting the need for patients to carry and use rescue medications for severe allergic reactions.

Speaker #4: Now, let's turn to our pre-commercial activities. As a starting point, it's important to remember that we continue to believe the rescue market for severe allergic reactions is poised for growth for years to come.

Speaker #4: Before the launch of a nasal spray last year, there had been very little innovation and very little physician detailing in this space for quite some time.

Speaker #4: When we launched, if we are approved by the FDA, there will be only a few companies detailing physicians and highlighting the need for patients to carry and use rescue medications for severe allergic reactions.

Daniel Barber: I believe that this, along with the underlying market growth, should propel the market from roughly 5 million prescriptions a year to as many as 10 million prescriptions a year. Using the estimated current net prices of today's epinephrine products, this could be as much as or more than $2 billion a year in the global market. A recent survey conducted by an expert research analyst in this space concluded that 90% of the market will move from injectables to non-injectable products over the years to come. In our surveys, we found that when patients are presented with a choice between injectables, nasal sprays, and oral films, they favor the convenience, size, durability, and oral administration of Anaphylm. We believe this market remains a compelling opportunity for Questive Therapeutics and its stakeholders, especially patients and caregivers, if approved by the FDA. Let's focus on patients and caregivers for a moment.

Speaker #4: I believe that this, along with the underlying market growth, should propel the market from roughly 5 million prescriptions a year to as many as 10 million prescriptions a year.

Speaker #4: Using the estimated current net prices of today's epinephrine products, this could be as much as or more than $2 billion a year in global market.

Speaker #4: A recent survey conducted by an expert research analyst in this space concluded that 90% of the market will move from injectables to non-injectable products over the years to come.

Speaker #4: And in our surveys, we found that when patients are presented with a choice between injectables, nasal sprays, and oral films, they favor the convenience, size, durability, and oral administration of antifilm.

Speaker #4: We believe this market remains a compelling opportunity for Aquestive, and its stakeholders, especially patients, and caregivers. If approved by the FDA, let's focus on patients and caregivers for a moment.

Daniel Barber: According to one of the leading allergy advocacy groups, the Allergy and Asthma Network, an estimated 225 Americans die each year from anaphylaxis. Sadly, it seems that this rate has not improved in decades. We believe the way to improve bad outcomes is to, one, improve the carry rate, two, lower the barrier to use, and three, ensure broad availability and coverage. We think the inherent characteristics of Anaphylm will address the first two items because Anaphylm fits patients' lives. Unfortunately, the third item, market access, is harder. We have been disappointed to see the number of barriers that the most recently approved epinephrine product has faced when it comes to market access. Pricing and product access should not prevent patients from having access to lifesaving medicines.

Speaker #4: According to one of the leading allergy advocacy groups, the Allergy and Asthma Network, an estimated 225 Americans die each year from anaphylaxis. Sadly, it seems that this rate has not improved in decades.

Speaker #4: We believe the way to improve bad outcomes is to, one, improve the carry rate; two, lower the barrier to use; and three, ensure broad availability and coverage.

Speaker #4: We think the inherent characteristics of Antifilm will address the first two items because Antifilm fits patients' lives. Unfortunately, the third item, market access, is harder.

Speaker #4: We have been disappointed to see the number of barriers that the most recently approved epinephrine product has faced when it comes to market access.

Speaker #4: Pricing and product access should not prevent patients from having access to life-saving medicines. Delay tactics and deceive blocks and prior authorization documentation are just a few ways that payers make it hard for patients to get the drugs that they need.

Daniel Barber: Delay tactics, NDC blocks, and prior authorization documentation are just a few ways that payers make it hard for patients to get the drugs that they need. For pharmaceutical manufacturers like us, these barriers add significant costs to putting our products into the hands of patients. Simply put, Americans are not getting the coverage they expect through the healthcare insurance that they pay for. In fact, some companies have indicated that the average healthcare plan deductible for a single person has risen from roughly $900 in 2010 to $1,800 in 2024. It is still climbing. As you can imagine, the deductibles are considerably higher for a family. That is why for Anaphylm, we will be taking a patient-first approach. On day one, we will have a cash-pay program available to patients and caregivers.

Speaker #4: And for pharmaceutical manufacturers like us, these barriers add significant costs to putting our products into the hands of patients. Simply put, Americans are not getting the coverage they expect through the healthcare insurance that they pay for.

Speaker #4: In fact, some companies have indicated that the average healthcare plan deductible for a single person has risen from roughly $900 in 2010 to $1,800 in 2024.

Speaker #4: And it is still climbing. As you can imagine, the deductibles are considerably higher for a family. That is why for Antifilm, we will be taking a patient-first approach.

Speaker #4: On day one, we will have a cash pay program available to patients and caregivers. While we are not announcing our pricing today, we will do everything we can to ensure that patients have immediate access to Antifilm, even if their provider puts a barrier to access.

Daniel Barber: While we are not announcing our pricing today, we will do everything we can to make sure that patients have immediate access to Anaphylm, even if their provider puts up barriers to access. We will share more details on this program as we get closer to approval and launch. Additionally, our market access group possesses significant enterprise-level pricing, contracting, coding and reimbursement, trade and distribution, patient services, and government affairs experience. The team is engaging with payers, as you would expect at this point, in the approval process of Anaphylm. Now let's turn to financing the launch. As you saw in our press release, we ended the last quarter with $60 million in cash. While this is sufficient for the initial launch, we will need more funding to appropriately support Anaphylm.

Speaker #4: We will share more details on this program as we get closer to approval and launch. Additionally, our market access group possesses significant enterprise-level pricing, contracting, coding and reimbursement, trade and distribution, patient services, and government affairs experience.

Speaker #4: The team is engaging with payers, as you would expect at this point, regarding the approval process of Antifilm. Now, let's turn to financing the launch.

Speaker #4: As you saw in our press release, we ended the last quarter with $60 million in cash. While this is sufficient for the initial launch, we will need more funding to appropriately support antifilm.

Daniel Barber: Ernie Toth will talk more about our financials, but I do want to give you my perspective on our pathways to financing the launch. We currently have multiple proposals in process, including for EU-only rights and alternate financing vehicles. We are working through the pathways available to the company and will select the best pathway when the time is right. However, as of today, we remain confident that launch financing is available to the company and that we will have secured financing prior to launch. The final update for Anaphylm is on the international front. We have secured meetings in both Canada and the EU for discussion on the filing packages necessary with each regulatory body. Our plan remains to complete these meetings by the end of the year and then begin the work to prepare and submit filings. Regarding the remainder of our business, we continue to make progress.

Speaker #4: Ernie will talk more about our financials but I do want to give you my perspective on our pathways to financing the launch. We currently have multiple proposals in process, including for EU-only rights and alternate financing vehicles.

Speaker #4: We are working through the pathways available to the company and will select the best pathway when the time is right. However, as of today, we remain confident that launch financing is available to the company and that we will have secured financing prior to launch.

Speaker #4: The final update for Antifilm is on the international front. We have secured meetings in both Canada and the EU for discussion on the filing packages necessary with each regulatory body.

Speaker #4: Our plan remains to complete these meetings by the end of the year and then begin the work to prepare and submit filings. Regarding the remainder of our business, we continue to make progress.

Daniel Barber: We continue to believe AQST-108, our investigational product, could provide a compelling improvement for patients with alopecia areata. We are on track to open our IND with the FDA before the end of the year and begin our next human studies in early 2026. Our base business grew year over year in the second quarter when adjusted for one-time revenue events. This was driven by strong growth in our international products. We continue to work towards offsetting the decline of Suboxone with new business opportunities. In conclusion, we remain on track for a launch of Anaphylm in the first quarter of 2026 if approved by the FDA. Our focus remains on our interactions with the FDA, finalizing our launch financing, and pre-commercial activities. I will turn the call over to Ernie.

Speaker #4: We continue to believe AQST 108, our epinephrine topical gel, could provide a compelling improvement for patients with alopecia areata. We are on track to open our IND with the FDA before the end of the year.

Speaker #4: And we will begin our next human studies in early 2026. Our base business grew year over year in the second quarter when adjusted for one-time revenue events.

Speaker #4: This was driven by strong growth in our international products. We continue to work towards offsetting the decline of Suboxone with new business opportunities. In conclusion, we remain on track for a launch of antifilm in the first quarter of 2026.

Speaker #4: If approved by the FDA, our focus remains on our interactions with the FDA, finalizing our launch financing, and pre-commercial activities. Now, I will turn the call over to Ernie.

Ernie Toth: Thank you, Dan, and good morning, everyone. By now, you have seen our financial results in our earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the second quarter 2025 result in the Q&A. During the second quarter, we continue to execute on our strategy to support the continued development of the recently filed NDA for Anaphylm, our lead product candidate that has no needle, is not a device, is orally administered, and is easy to carry. This includes supporting pre-approval launch activities for Anaphylm to increase awareness among physicians, payers, and the advocacy community as we approach the PDUFA action date of January 31, 2026. As Dan mentioned, we continue to evaluate all financing alternatives to support the commercial launch of Anaphylm if approved by the FDA.

Speaker #4: Thank you, Dan, and good morning, everyone. I know you have seen our financial results in our earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the second quarter of 2025 results in the Q&A.

Speaker #4: During the second quarter, we continue to execute on our strategy to support the continued development of the recently filed NDA for antifilm, our lead product candidate, that has no needle, is not a device, is orally administered, and is easy to carry.

Speaker #4: This includes supporting pre-approval launch activities for antifilm to increase awareness among physicians, payers, and the advocacy community as we approach the PADUFA action date of January 31st, 2026.

Speaker #4: As Dan mentioned, we continue to evaluate all financing alternatives to support the commercial launch of antifilm. If approved by the FDA, this includes non-dilutive alternatives such as the Xale of Global Right, EU-only rights, refinancing our existing debt, additional debt, as well as revenue interest financing.

Ernie Toth: This includes non-dilutive alternatives such as the sale of global rights, EU-only rights, refinancing our existing debt, additional debt, as well as revenue interest financing. We are evaluating all options to find the best financing structure to support the future growth of Aquestive. Aquestive's manufacturing business remains steady with the gradual decline of Suboxone being offset by growth across newer collaborations, including for the licensed products Ondif, Sympazan, and Emylif. Aquestive's manufacturing facility continues to diversify its operations to support a broader range of products and collaborations. In addition, the company being a U.S.-based manufacturer with intellectual property domiciled in the U.S. has a supply chain which currently remains unaffected by both implemented and proposed tariffs, providing continued reliability and stability in production and global distribution for the near term. Now, let's turn to the second quarter results.

Speaker #4: We are evaluating all options to find the best financing structure to support the future growth of Aquestive. Aquestive's manufacturing business remains steady, with the gradual decline of Suboxone being offset by growth across newer collaborations, including for the licensed products Andis, Tempazan, and Emilif.

Speaker #4: Aquestive's manufacturing facility continues to diversify its operations to support a broader range of products and collaborations. In addition, the company being a US-based manufacturer with intellectual property domiciled in the US has a supply chain which currently remains unaffected by both implemented and proposed tariffs.

Speaker #4: Providing continued reliability and stability in production and global distribution for the near term. Now, let's turn to the second quarter results. Excluding the impact of one-time recognition of deferred revenue in the second quarter of 2024, total revenues increased by $0.3 million, or 3%, year over year to $10 million in the second quarter of 2025.

Ernie Toth: Excluding the impact of one-time recognition of deferred revenue in the second quarter of 2024, total revenues increased by $0.3 million, or 3% year over year, to $10 million in the second quarter of 2025. As a reminder, the one-time recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreements. Including the deferred revenue recognized in the prior year, total revenues decreased to $10 million in the second quarter of 2025 from $20.1 million in the second quarter of 2024. Manufacturer and supply revenue increased to $9.6 million in the second quarter of 2025 from $8.1 million in the second quarter of 2024, primarily due to increases in Ondif revenues partially offset by decreases in Suboxone revenues.

Speaker #4: As a reminder, the one-time recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreements. Including the deferred revenue recognized in the prior year, total revenues decreased to $10 million in the second quarter of 2025 from $20.1 million in the second quarter of 2024.

Speaker #4: Manufacturer and supply revenue increased to $9.6 million in the second quarter of 2025, up from $8.1 million in the second quarter of 2024, primarily due to increases in Andis revenues, partially offset by decreases in Suboxone revenues.

Ernie Toth: Total revenues decreased to $18.7 million for the six months ended June 30, 2025, from $32.2 million for the six months ended June 30, 2024, due to one-time recognition of deferred revenue in the prior year. Excluding this one-time recognition of deferred revenue, total revenues decreased by $2.8 million, or 13% year over year. Manufacturer and supply revenue decreased to $16.8 million for the six months ended June 30, 2025, from $18.6 million for the six months ended June 30, 2024, primarily due to decreases in Suboxone revenues partially offset by increases in Ondif revenues. Research and development expenses in the second quarter of 2025 remained relatively consistent compared to the second quarter of 2024. Research and development expenses decreased to $9.5 million for the six months ended June 30, 2025, from $10.1 million for the six months ended June 30, 2024.

Speaker #4: Total revenues decreased to 18.7 million dollars for the six months ended June 30th, 2025, from 32.2 million dollars for the six months ended June 30th, 2024, due to one-time recognition of deferred revenue in the prior year.

Speaker #4: Excluding this one-time recognition of deferred revenue, total revenues decreased by $2.8 million, or 13% year over year. Manufacturer and supply revenue decreased to $16.8 million for the six months ended June 30, 2025, from $18.6 million for the six months ended June 30, 2024, primarily due to decreases in Suboxone revenues, partially offset by increases in Andis revenues.

Speaker #4: Research and development expenses in the second quarter of 2025 remain relatively consistent compared to the second quarter of 2024. Research and development expenses decreased to $9.5 million for the six months ended June 30, 2025, from $10.1 million for the six months ended June 30, 2024.

Ernie Toth: The decrease in research and development expenses was primarily due to a decrease in clinical trial costs associated with the continued advancement of the Anafilm program, partially offset by increases in personnel costs and an increase in share-based compensation. Selling, general, and administrative expenses increased to $12.7 million in the second quarter of 2025, from $11.4 million in the second quarter of 2024, primarily due to higher commercial spending for pre-launch activities of approximately $2 million, higher regulatory and licensing fees of approximately $0.8 million, higher personnel costs of approximately $0.4 million, higher share-based compensation expenses of approximately $0.2 million, and higher consulting fees of approximately $0.2 million, partially offset by lower legal fees of approximately $2.5 million and lower insurance expenses of $0.2 million.

Speaker #4: The decrease in research and development expenses was primarily due to a decrease in clinical trial costs associated with the continued advancement of the antifilm program, partially offset by increases in personnel costs and an increase in share-based compensation.

Speaker #4: Selling general and administrative expenses, increased to 12.7 million dollars in the second quarter of 2025, from 11.4 million dollars in the second quarter of 2024 primarily due to higher commercial spending for pre-launch activities of approximately 2 million dollars, higher regulatory and licensing fees of approximately 0.8 million dollars, higher personnel costs of approximately 0.4 million dollars, higher share-based compensation expenses of approximately 0.2 million dollars, and higher consulting fees of approximately 0.2 million dollars partially offset by lower legal fees of approximately 2.5 million dollars and lower insurance expenses of 0.2 million dollars.

Ernie Toth: Selling, general, and administrative expenses increased to $31.8 million for the six months ended June 30, 2025, from $22 million for the six months ended June 30, 2024.

Speaker #4: Selling, general, and administrative expenses increased to $31.8 million for the six months ended June 30, 2025, from $22 million for the six months ended June 30, 2024.

Ernie Toth: The increase primarily represents regulatory fees related to the Anafilm PDUFA fee of approximately $4.3 million, higher commercial spending on pre-launch activities for Anafilm of approximately $4.2 million, higher regulatory and licensing fees of approximately $1.5 million, higher personnel costs of approximately $0.8 million, higher share-based compensation expenses of approximately $0.5 million, and higher consulting fees of approximately $0.3 million, all partially offset by decreases in severance costs of approximately $1.1 million, lower insurance expenses of approximately $0.5 million, and lower legal fees of approximately $0.4 million. Questive Therapeutics' net loss for the second quarter 2025 was $13.5 million, or $0.14 for both basic and diluted loss per share, compared to the net loss for the second quarter of 2024 of $2.7 million, or $0.03 for both basic and diluted loss per share.

Speaker #4: The increase primarily represents regulatory fees related to the antifilm PADUFA fee of approximately 4.3 million dollars, higher commercial spending on pre-launch activities for antifilm of approximately 4.2 million dollars, higher regulatory and licensing fees of approximately 1.5 million dollars, higher personnel costs of approximately 0.8 million dollars, higher share-based compensation expenses of approximately 0.5 million dollars, and higher consulting fees of approximately 0.3 million dollars, all partially offset by decreases in severance costs of approximately 1.1 million dollars, lower insurance expenses of approximately 0.5 million dollars, and lower legal fees of approximately 0.4 million dollars.

Speaker #4: Aquestive's net loss for the second quarter of 2025 was $13.5 million, or $0.14 for both basic and diluted loss per share, compared to the net loss for the second quarter of 2024 of $2.7 million, or $0.03 for both basic and diluted loss per share.

Ernie Toth: Excluding the impact of one-time recognition of deferred revenue, the net loss in the second quarter of 2024 was $13.2 million. Questive Therapeutics' net loss for the six months ended June 30th, 2025, was $36.5 million, or $0.37 for both basic and diluted loss per share, compared to the net loss for the six months ended June 30th, 2024, of $15.6 million, or $0.19 for both basic and diluted loss per share. Excluding the impact of one-time recognition of deferred revenue, the net loss for the six months ended June 30th, 2024, was $26 million. Non-GAAP adjusted EBITDA loss was $9.3 million in the second quarter of 2025, compared to non-GAAP adjusted EBITDA income of $1.8 million in the second quarter of 2024. Excluding the impact of the one-time recognition of deferred revenue, non-GAAP adjusted EBITDA loss in the second quarter of 2024 was $8.6 million.

Speaker #4: Excluding the impact of one-time recognition of deferred revenue the net loss in the second quarter of 2024 was 13.2 million dollars. Aquestive's net loss for the six months ended June 30th, 2025, was 36.5 million dollars or 37 cents for both basic and diluted loss per share compared to the net loss for the six months ended June 30th, 2024, of 15.6 million dollars or 19 cents for both basic and diluted loss per share.

Speaker #4: Excluding the impact of one-time recognition of deferred revenue, the net loss for the six months ended June 30, 2024, was $26 million. Non-GAAP-adjusted EBITDA loss was $9.3 million in the second quarter of 2025, compared to non-GAAP-adjusted EBITDA income of $1.8 million in the second quarter of 2024.

Speaker #4: Excluding the impact of the one-time recognition of deferred revenue non-GAAP-adjusted EBITDA loss in the second quarter of 2024 was 8.6 million dollars. Non-GAAP-adjusted EBITDA loss was 27 million dollars for the six months ended June 30th, 2025, compared to non-GAAP-adjusted EBITDA loss of 5.4 million dollars for the six months ended June 30th, 2024.

Ernie Toth: Non-GAAP adjusted EBITDA loss was $27 million for the six months ended June 30th, 2025, compared to non-GAAP adjusted EBITDA loss of $5.4 million for the six months ended June 30th, 2024. Again, excluding the impact of one-time recognition of deferred revenue, non-GAAP adjusted EBITDA loss for the six months ended June 30th, 2024, was $15.8 million. Cash and cash equivalents were $60.5 million as of June 30th, 2025. Questive Therapeutics' full-year 2025 financial guidance remains unchanged. The company expects total revenue of $44 million to $50 million, and non-GAAP adjusted EBITDA loss of $47 million to $51 million. Our revenue guides for 2025 no longer include revenue for Libervant for ages between two and five. As a reminder, our 2024 revenue included one-time non-recurring recognition of deferred revenue related to the termination of certain licensing and supply agreements.

Speaker #4: Again, excluding the impact of one-time recognition of deferred revenue non-GAAP-adjusted EBITDA loss for the six months ended June 30th, 2024, was 15.8 million dollars.

Speaker #4: Cash and cash equivalents were 60.5 million dollars as of June 30th, 2025. Aquestive's full year 2025 financial guidance remains unchanged. The company expects total revenue of 44 million dollars to 50 million dollars, and non-GAAP-adjusted EBITDA loss of 47 million dollars to 51 million dollars.

Speaker #4: Our revenue guidance for 2025 no longer includes revenue for liver vent for ages between 2 and 5. As a reminder, our 2024 revenue included one-time, non-recurring recognition of deferred revenue related to the termination of certain licensing and supply agreements.

Ernie Toth: Our non-GAAP adjusted EBITDA loss guidance for 2025 includes significant pre-approval launch spending for Anaphylm, costs associated with a recent submission of the Anaphylm NDA and related filing fee, completion of the Anaphylm pediatric clinical trial, and preparations for a potential advisory committee meeting, if required by the FDA for approval of Anaphylm. With that, I will now turn the line back to the operator to open the line for questions.

Speaker #4: Our non-GAAP-adjusted EBITDA loss guidance for 2025 includes significant pre-approval launch spending for antifilm, costs associated with a recent submission of the antifilm NDA, and related filing fee.

Speaker #4: Completion of the Antifilm pediatric clinical trial and preparations for a potential advisory committee meeting, if required by the FDA for approval of Antifilm. With that, I will now turn the line back to the operator to open the line for questions.

Operator: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star one-one on your telephone and wait for your name to be announced. To withdraw your question, please press star one-one again. Please stand by. We will compile the Q&A roster. Our first question comes from the line of Rona Ruiz of LURINC. Your line is now open.

Speaker #2: Thank you. At this time, we'll conduct a question-and-answer session. As a reminder, to ask a question, you'll need to press star one-one on your telephone and wait for your name to be announced.

Speaker #2: To withdraw your question, please press star eleven again. Please stand by while I compile the Q&A roster. In our first question concerning the line of Rona Ruiz of Lyrinc, your line is now open.

Brian Korb: Hello. Yes, good morning. Just wanted to touch base. This is Mazion for Rona Ruiz, but I just wanted to touch base. We mentioned the possible FDA ADCOM meeting ahead of the PDUFA. Could you provide any more details on the likelihood of the ADCOM being required and how confident you are in your clinical data package going into this?

Speaker #5: Hello, yes, good morning. so just wanted to touch base. This is Maisie on for Rona Ruiz. But, just wanted to touch base. So we mentioned, the possible FDA ad-com meeting ahead of the PADUFA.

Speaker #5: Could you provide any more details on the likelihood of the Ad-Com being required and how confident you are in your clinical data package going into this?

Daniel Barber: Sure. And this is Mazie, right?

Speaker #4: Sure. And this is Maisie, right?

Brian Korb: Yes, it is.

Speaker #5: Yes, it is.

Daniel Barber: Nice to hear your voice.

Speaker #4: Nice to hear your voice. So, thanks. The insurance of the likelihood of an ad-com, nothing has changed on that front since our last conversation.

Brian Korb: Thanks.

Daniel Barber: In terms of the likelihood of an ADCOM, nothing has changed on that front since our last conversation. As you know, the FDA accepted our application back in June, where they reiterated that they may or may not want to have an advisory committee meeting. By our math, the FDA should be just about in the process of having its mid-cycle review. We would continue to believe that in the coming weeks, to a month, we would have an indication from them of whether they want an ADCOM or not. From our perspective, the important part is to be ready. We have focused a lot of energy and time on making sure that we are ready for any ADCOM if the FDA desires. In terms of how we feel about our clinical package, I will pass it over to Dr. Carl Kraus to give you his high-level view.

Speaker #4: As you know, the FDA obviously accepted our application back in June, where they reiterated that they may or may not want to have an advisory committee meeting.

Speaker #4: By our math, the FDA should be just about in the process of having its mid-cycle review. We would continue to believe that in the coming weeks, to a month—call it—we would have an indication from them of whether they want an ad-com or not.

Speaker #4: so again, from our perspective, the important part is to be ready and we have focused a lot of energy and time on making sure that we are ready for any ad-com, if the FDA desires.

Speaker #4: In terms of, how we feel about our clinical package, I will pass it over to Karl to give you, his, his high-level view.

Ernie Toth: I appreciate the question. I believe we may have commented on that last discussion as well, which is that the package is quite robust. We probably have one of the largest epinephrine studies conducted to date. The package consists of 10 independent studies, well over 930-plus exposures, and well over 350 subjects. So it's a robust package. It should be able to address any and all potential questions that the agency may have. We're very proud of it, and we believe it's a strong package.

Speaker #6: Yeah, no, I appreciate the question. And I, I believe we may have commented on that, last, last discussion as well, which is that the, the package is quite robust.

Speaker #6: We probably have one of the largest epinephrine studies conducted to date. The package consists of 10 independent studies, with well over 930 exposures and well over 350 subjects.

Speaker #6: So it's a robust package. It should be able to address any and all potential questions that the agency may have. So we're very proud of it.

Speaker #6: And we believe it's a strong package.

Brian Korb: Great. Thank you both for your response. We look forward to seeing it play out.

Speaker #5: Great. thank you both for your response. We look forward to, seeing the play out.

Speaker #4: Thanks, Maisie.

Operator: Thank you. One moment for our next question. Our next question comes from a line of David M. Sellom of Piper Sandler. Your line is now open.

Speaker #2: Thank you. One moment for our next question. Our next question concerns the line of David M. Salem of Piper Sandler. Your line is now open.

David M. Amsellem: Thanks. I just have a couple. I am interested in your comments regarding out-of-pocket exposure for patients and the payer landscape. My question here is, is your commentary a function not only of what you are seeing with your competitor, the nasal spray formulation, but also a function of your discussions with payers? Maybe talk to the extent of your discussion with payers, how that is going, and how you are thinking about access issues. That is number one. Number two, regarding the cash-pay initiative, my question here is, how much of the intranasal business is actually cash pay? What kind of cash-pay market do you think is going to evolve into over time? I am just trying to get a better understanding of your thought process here. Thank you.

Speaker #7: thanks. So just have, a couple, interested in your comments regarding, out-of-pocket exposure for patients and just the payer landscape. And I guess my, my question here is, is your commentary a function not only of what you're seeing with your, competitor, the, the nasal spray formulation, but also a function of your discussions with payers, maybe talk to the extent of your discussion with payers, how that's going, and, how you're thinking about, access issues?

Speaker #7: So, that's number one. And then, number two regarding the cash pay initiative: I, I guess my question here is, how much of the intranasal business is actually cash pay?

Speaker #7: And what kind of cash pay market do you think is going to, evolve into? over time. And, and just trying to get a better understanding of your thought process here.

Speaker #7: Thank you.

Daniel Barber: Sure. Thanks, David. Good morning. Let me start with what we are doing. From discussion with payers, Sherry Korchinski, who is here with me this morning, and her team have done a great job of engaging on the payer landscape. We have some really solid expertise in-house. To the extent that the pre-commercial world allows you to engage with the payers, we are obviously engaged with the payers. Those discussions do not, at this time, get to a place where we talk about coverage or what that would look like. That is not obviously allowed until approval. Right now, our focus with payers is strictly on awareness. In terms of the out-of-pocket exposure in the payer landscape, my commentary would be for our entire industry.

Speaker #4: Sure. thanks, David. Good morning. So let me start with what we're doing, right? so from discussion with payers, Sherry, Korczynski was here with me this morning and her team have done a great job of engaging, on the payer landscape.

Speaker #4: We have some really solid expertise in-house. And so, to the extent that the pre-commercial world allows you to engage with the payers, we are obviously engaged with the payers.

Speaker #4: those discussions do not, at this time, get to a place where we talk about coverage or what that would look like. That's not obviously allowed until approval.

Speaker #4: So, right now our focus with payers, is, is strictly on awareness. And in terms of the out-of-pocket exposure and the payer landscape, I, I, I my commentary would be for our entire industry.

Daniel Barber: I do not think there is a single drug that gets launched right now that does not have concerns over how their patients get the product that they need without extreme or additional issues in the chain of getting a product. I would not say that is specific to just the nasal spray. In terms of cash pay, I will leave it to our competitor to talk about what percentage of their business is cash pay or is not cash pay. When we look across the landscape, our view is that cash pay is an important part of any product that is launching in the near term. We think that given the trends of how the payer world works, that it is likely to continue.

Speaker #4: I, I don't think there's a single drug that gets launched right now that doesn't have concerns over how their patients get the product that they need without extreme or, additional issues, in, in the, in the, chain of getting a product.

Speaker #4: So I wouldn't say that is specific to just the nasal spray. In terms of cash pay, I'll leave it to, our competitor to, to talk about what percentage of their business is cash pay or isn't cash pay.

Speaker #4: When we look across the landscape, our view is that cash pay is an important part of any product that is launching. in the, in the near term.

Speaker #4: And we think that, given the trends of how the payer world works, it's likely to continue. Over time, we would expect for most drugs, other than, call it very highly priced drugs, that the cash pay portion will continue to grow and be a significant portion.

Daniel Barber: Over time, we would expect for most drugs, other than very highly priced drugs, that the cash pay portion will continue to grow and be a significant portion. In terms of what it can ultimately be for Anaphylm, I think that will really be informed by the market.

Speaker #4: In terms of what it can ultimately be, by, for antifilm, I think that will really be informed by the market.

David M. Amsellem: That's helpful. If I may just sneak in a follow-up to the extent that you're going to be buying down here and this is a product, right? This is a chronic treatment. As you think about that, where does copay buy down play into your overall strategy and how should we think about that? Thanks.

Speaker #7: that's helpful. So I may just sneak in, a follow-up to, to the extent that, you're going to be buying down, here. And, and this is a tricky product, right?

Speaker #7: This is in chronic treatment. As you think about that, where does copay buy-down play into your overall strategy, and how should we think about that?

Speaker #7: Thanks.

Daniel Barber: Look, our role right now, our job right now, beyond getting the product approved and available to patients, is to make sure that they have access in a reasonable fashion. Not just Questive Therapeutics, but every company utilizes the copay buy-down program. Obviously, the important part with the copay buy-down program is to make sure it is balanced, that you balance it with the coverage that you are either getting or have versus where you are at that stage. I do not think you will see us do anything that is out of the ordinary on copay buy-downs, but we absolutely will have it as a part of our world.

Speaker #4: Yeah, look, our, our role right now, our job right now beyond getting the product approved and available to, to patients, is to make sure that they have access in a reasonable fashion.

Speaker #4: So, not just us, but every company utilizes the copay buy-down program. Obviously, the important part with the copay buy-down program is to make sure it's balanced.

Speaker #4: That you balance it with the coverage that you are either getting or have, versus where you are at that state. So I don't think you'll see us do anything, that is out of the ordinary.

Speaker #4: On copay buy-downs, but we absolutely will have it as a part of our world.

David M. Amsellem: Okay. Thanks, guys.

Speaker #7: Okay. Thanks, guys.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Kristen Klisko of Cantor Fitzgerald. Your line is now open.

Speaker #2: Thank you. One moment for our next question. Our next question concerns the line of Kristen Kliska of Cancer Fitzgerald. Your line is now open.

Kristen Kluska: Hi. Good morning, everyone. Thanks for taking the question. Recently, former CRLs were made publicly available, including one from your peer who now has an approval. I know you are in a unique position because you are differentiated, but also you get to leverage that experience to help with your own prep. I am curious if you reviewed any of these documents and anything that you can really gain from material beyond what we already knew, including from the ADCOM experience.

Speaker #8: Hi, good morning, everyone. Thanks for taking the question. So recently former CRLs were made publicly available, including one from your peer who now has an approval.

Speaker #8: I know you're in a unique position because you're differentiated, but also you get to leverage that experience to help with your own prep. So I'm curious if you reviewed any of these documents and anything that you can really gain from material beyond what we already knew, including from the ad-com experience.

Daniel Barber: Sure. Thank you, Kristen. Yes, of course, one of the benefits of being second is you get to see what the person who was ahead of you or the company that was ahead of you went through. So both from an ADCOM and a CRL perspective, we have definitely watched and tried to learn. Our biggest learning, and I will focus on the CRL, though I think it played into the ADCOM as well, our biggest learning is kind of an age-old one for us. As a reminder, we have six FDA approvals over the years, which is listen to the FDA. Our read of the CRL is there was a study that was not completely done the way that the FDA wanted it to be done, and our competitor had to go back and do that.

Speaker #4: Sure, thank you, Kristen. And yes, of course, one of the benefits of being second is you get to see what the person who was ahead of you, or the company that was ahead of you, went through.

Speaker #4: So, both from an ad-com and a CRL perspective, we have, we have definitely watched and, and, and tried to learn. Our biggest learning, and I'll focus on the CRL, though I think it played into the ad-com as well, our biggest learning is, is kind of an age-old one for us and, and as a reminder, we have six FDA approvals over the years.

Speaker #4: which is listen to the FDA. So, our read of the CRL is there was a study that, was not completely done. the way that the FDA wanted it to be done and, our competitor had to go back and do that.

Daniel Barber: In our package, and Carl talked before about the completeness of our package, one of the things we really focused on is making sure we did everything that the FDA asked for. To be specific, in our oral allergy syndrome study, we did not just a single dose, but a repeat dose arm. That was specifically listening to what the FDA had asked for and ties to the allergic rhinitis component of the CRL that you referenced.

Speaker #4: So, in our package, Karl talked before about the completeness of our package. One of the things we really focused on is making sure we did everything that the FDA asked for.

Speaker #4: So to be specific, in our oral allergy syndrome study, we did not just a single dose, but a repeat dose arm, that was specifically listening to what the FDA had asked for and ties to the allergic rhinitis component of the CRL that you, you referenced.

Kristen Kluska: Thank you.

Speaker #8: Thank you.

Operator: Thank you. One moment for our next question. Our next question comes from a line of Andreas Agreitz of Oppenheimer. Your line is now open.

Speaker #2: Thank you. One moment for our next question. Our next question concerns the line of Andreas Eigreiz of Oppenheimer. Your line is now open.

Andreas Argyrides: Great. Good morning. Thanks for taking our questions and the update here, guys. Just a quick one on us. We see that you provided some additional details on the pediatric study, PKPD, which is great. Can you give us a little bit more color on the safety? How confident are you in the submission for PED as part of the NDA submission? Thank you.

Speaker #9: Great. Good morning, and thanks for the, for taking our questions and, and the update here, guys. just a quick one on us. We see that you provided some additional details on the pediatric study.

Speaker #9: PKPD, which is great. Can you, can you give us a little bit more color on the safety and then how, how confident are you in the, in the submission for P as part of the NDA submission?

Speaker #9: Thank you.

Daniel Barber: Sure. Well, good morning, Andreas. I will pass it over to Carl in a second here. I will just open with this. As Carl said at the top of this Q&A session, we are confident in the package we have put together. We think it is a robust package and the right one for what we are looking to accomplish. But I will let Carl talk on the pediatric studies.

Speaker #4: Sure. Well, and good morning, Andreas. I'll, I'll pass it over to Karl in a second here. I'll, I'll just open with, as, as Karl said at the top of this, the Q&A session, we're, we're, we're confident in, in the package we've put together.

Speaker #4: We think it's a robust package and, and the right one for what we're looking to accomplish. But I'll let Karl's, talk on the pediatric study specifically.

Ernie Toth: Yeah. No, thanks for the question. The pediatric study was crafted in such a way really just to provide characterization of the concentration time curve and the PK profile in that population. There was no internal competitor per se that was agreed upon with the agency, but we have done cross-study evaluations showing that it's quite comparable to the adult dose. As you saw in the supplementary slides, you can almost see overlapping concentration time curves between the pediatric and adult study. From that perspective, the powering, the addressing FDA's concerns and requests for the appropriate number of subjects, and also the subsequent PK profile that we saw at the outcome, we're extremely pleased with those data. As far as safety goes, there was no difference really in the character, frequency, or severity of outcomes that we saw in the pediatric population.

Speaker #3: Yeah, no, thanks for the question. The pediatric study was crafted in such a way really just to provide characterization of the concentration time curve in the, PK profile in that population.

Speaker #3: there was no, internal comparator per se. That was agreed upon with the agency. But we have done cross-study evaluations showing that it's quite, comparable to the adult dose.

Speaker #3: And as you saw in the supplementary slides, you can almost see overlapping concentration time curves between the pediatric and adult study. So from that perspective, the powering, the addressing FDA's, concerns and requests for the appropriate number of subjects and also the subsequent PK profile that we saw at the outcome, we're extremely pleased with those data.

Speaker #3: As far as safety goes, there was, no difference really in the character frequency or severity of outcomes that we saw in the pediatric population.

Ernie Toth: Overall, quite in line with what we were hoping for and expected.

Speaker #3: So overall, quite in line with what we were hoping for and expected.

Andreas Argyrides: Okay, great. That was my question. Thanks. Yep.

Speaker #9: Okay, great. That was my question. Thanks. Yep.

Operator: Thank you. One moment for our next question. Our next question comes from a line of Jason Butler of Citizen JNP. Your line is now open.

Speaker #2: Thank you. One moment for our next question. In our next question concerns the line of Jason Butler of Citizen J&P. Your line is now open.

David M. Amsellem: Hi. Thanks for taking the questions. Two from me. The first one, you mentioned that you had submitted the 120-day safety update. Just wondering if there have been any other substantial data analysis or information requests from FDA during the review so far. Second, on the commercial prep, you talked about the reimbursement piece. Can you also just talk about the work you have done to increase awareness of Anaphylm and where you think you have, whether or not you have moved the needle there? Thanks.

Speaker #10: Hi, thanks for taking the questions. two for me. The first one, you mentioned that you'd, you'd submitted the 120-day safety update. Just wondering if there have been any, other substantial data analysis or information requests from FDA during the review so far?

Speaker #10: And then second, on the commercial prep, you talked about the reimbursement piece. Can you also just talk about the work you've done to, to increase awareness of antifilm and where, where, where you think you've, you know, whether or not you've moved the, the needle there?

Speaker #10: Thanks.

Speaker #4: Morning, Jason. good to, good to hear your voice. So on the first one, we have, had the usual back and forth, with the FDA that you would expect to date.

Daniel Barber: Good to hear your voice. So on the first one, we have had a useful back and forth with the FDA that you would expect to date. There is nothing that I would describe as a major data set or anything to that standpoint beyond the standard 120-day safety update. In terms of our awareness activities, I will turn it over to Sherry to give you a question.

Speaker #4: there is, nothing that I would describe as a major data set or anything to that, standpoint beyond the, the standard 120-day safety update. In terms of our awareness activities, I'll turn it over to Sherry to give you her view.

Sherry Korchinski: Sure. Thanks so much for your question. As Daniel Barber mentioned in his comments, we continue to drive significant awareness of the brand. What we are hearing back is consistent. The feedback from the broader allergy community, both patients and HCPs, continues to be positive. We have been conducting CME, non-CME. We have published a number of, we have had a number of posters and have been very active in the medical side of things, being at local, regional, and national conferences. So we have really spent the entire year increasing the awareness of Anaphylm. At the end of the day, what the HCPs continue to tell us is that they love the product. They believe it will improve the carry rate and it will decrease the barriers to use.

Speaker #11: Sure. Thanks so much for your question. As Dan mentioned in his comments, we continue to drive significant awareness of the brand and what we're hearing back is consistent.

Speaker #11: The feedback from the broader allergy community, both patients and HCPs, continues to be positive. We have been conducting CME, non-CME, we have, published a number of, we have had a number of posters, and have been very active in the medical side of things, being it local regional and national conferences.

Speaker #11: So we have really spent the entire year increasing the awareness of antifilm and at the end of the day, what the HCPs continue to tell us is that they they love the product.

Speaker #11: They believe it will improve the carry rate, and it will decrease the barriers to use.

David M. Amsellem: Great. Thank you.

Speaker #10: Great. Thank you.

Operator: Thank you. One moment for our next question. Our next question comes from a line of Rahul Zaraju of HC Wainwright & Co. Your line is now open.

Speaker #2: Thank you. One moment for our next question. Our next question concerns the line of Razaraju of HC Wainwright & Co. Your line is now open.

Daniel Barber: Good morning. This is Daniel Barber. Thanks for taking our question. We were curious about the business development strategy related to Anaphylm. Is Aquestive Therapeutics planning to partner the drug ahead of regulatory applications in the XUS territory, or will they wait until those filings have been submitted? How is Aquestive Therapeutics thinking about XUS pricing in the context of most favored nations? Thank you. Morning, Dan. Thanks for the question. We have been pretty open all along, probably for the better part of a couple of years now. From our perspective, our number one job is to make sure that Anaphylm gets put into the hands of as many patients as it can be useful for. From that perspective, we are always looking at how to have the broadest coverage and the broadest capabilities.

Speaker #9: Good morning. This is Dan Altaran. Thanks for taking our questions. So we were curious kind of, in terms of business development strategy related to antifilm.

Speaker #9: is Aquestive planning to partner the drug ahead of regulatory applications and XUS territories or wait until those filings have been submitted? And how is Aquestive thinking about XUS pricing in the context of most favored nations?

Speaker #9: Thank you.

Speaker #4: morning, Dan. Thanks for the, the question. So, we, we've been pretty open all along, probably for the better part of a couple of years now.

Speaker #4: from our perspective, our number one job is to make sure that antifilm gets put into the hands of as many patients as it can be useful for.

Speaker #4: So from that perspective, we are always looking at how to have the, the broadest, the broadest coverage and the broadest capabilities. whether that is, ultimately a, a launch just by, the company or a launch in conjunction with another company, is something we continue to, to talk through as I, I, I, said in my comments at the beginning.

Daniel Barber: Whether that is ultimately a launch just by the company or a launch in conjunction with another company is something we continue to talk through, as I said in my comments at the beginning. In terms of XUS pricing and most favored nation pricing, I do not see, well, I suppose it will have an impact on all companies in the space. I think the primary impact will be on the larger companies that have very expensive drugs. I think if you look at this rescue epinephrine market, you have a rescue treatment that is usually only filled once a year, so it is not a chronic medication. The price point on the product is obviously way below some of the high-priced biologics or something like that.

Speaker #4: in terms of XUS pricing and, most favored nation, pricing, I, I don't, I don't see, well, well, I suppose that we'll have an impact on all companies in the space.

Speaker #4: I, I think the, the primary impact will be on, the larger companies that have, very expensive, drugs. I think if you look at, this rescue market, you have, a rescue treatment that is, is, is usually only filled once a year, so it's not a chronic medication.

Speaker #4: And the price point on the product is obviously way below some of the high-priced biologics or something like that. So, I don't think we're the target.

Daniel Barber: I do not think we are the target of those activities, and I would not expect them to be a major component of how things play out here.

Speaker #4: Of, of those activities and, and I wouldn't expect them to be a major, component of how things play out here.

David M. Amsellem: Thank you.

Speaker #9: Thank you.

Operator: Thank you. One moment for our next question. Our question comes from a line of Gary Nachman of Raymond James. Your line is now open.

Speaker #2: Thank you. One moment for our next question. Our next question concerns the line of Gary Nashman of Raymond James. Your line is now open.

Dennis Resnick: Hey, guys. Good morning. This is Dennis Resnick on for Gary Nockman. Thanks for taking our questions. In terms of the pre-commercial efforts, can you just detail what the ideal physician who would be a top desktop prescriber of Anafilm looks like? Are there any characteristics about them that you would highlight? Given some of the headwinds it sounds like you are seeing on the payer landscape, are you still confident that you can likely get 80% coverage within the first six months of launch? Thanks so much.

Speaker #12: Hey, guys. Good morning. This is Dennis Resnick on for Gary Nockman. Thanks for taking our questions. So, in terms of the pre-commercial efforts, do you have details on what the ideal physician who would be a top desktop prescriber of antifilm looks like?

Speaker #12: Are there any characteristics about them that you'd highlight? And then, given some of the headwinds it sounds like you're seeing on the payer landscape.

Speaker #12: Are you still confident that you can likely get 80% coverage within the first six months of launch? Thanks so much.

Daniel Barber: Morning, guys. Let me take the second one first, and then I will pass it over to Sherry for the ideal physician. Yeah, we are confident that from a payer perspective, we will have broad coverage and that that coverage will be competitive with the other products available in the space. The 80% mark, I do not know how to feel about that, but I would generally say yes, we will have broad coverage across most people. Why do not I pass it over to Sherry? She can give you her thoughts on the ideal physician.

Speaker #4: Mor-morning, Dennis. Let me take the first, the second one first, and then I'll pass it over to Sherry for the, the ideal the ideal physician.

Speaker #4: so yeah, we are confident that, from a payer perspective, we will have broad coverage and that that coverage will be competitive with the other products available in the space.

Speaker #4: the, the, the 80% mark, I, I, I don't know w how to feel about that, but I would generally say yes, we'll have broad coverage across most people.

Speaker #4: but, why don't I pass it over to Sherry? She can give you her thoughts on the ideal physician.

Sherry Korchinski: It's a good question. I always like to say that this market is an inch deep and about 10,000 miles wide. What I mean by that is you have a very, very broad range of physicians that prescribe epinephrine. Everyone from the primary care physician that on average prescribes one to two prescriptions to the allergist on average that prescribes 200-plus prescriptions annually. As we look at where our focus will be upon launch, it will certainly be in the allergist space. We know, and I've worked with allergists for the better part of 15 years, we know how excited they are about the innovation that Anafilm brings to the marketplace because they absolutely believe that patients will carry. If patients carry the product, then they are more likely to use the product at the first signs and symptoms.

Speaker #11: It's a good question. And, did I always like to say that this market is an inch deep and about 10,000 miles wide? And what I mean by that is you have a very, very broad range of physicians that prescribe epinephrine.

Speaker #11: everyone from the primary care physician that on average prescribes once two prescriptions, to the allergist on average that prescribes 200-plus prescriptions annually. And so as we look at our, our, where our focus will be upon launch, it will certainly be in the allergist space, we know and I've worked with allergists for the better part of 15 years.

Speaker #11: We know how excited they are about the innovations that Antifilm brings to the marketplace because they've absolutely believed that patients will carry. And if patients carry the product, then they're more likely to use the product.

Speaker #11: At the first signs and symptoms, and because Antifilm works so quickly, as you've seen in our data, again, the HCP allergists are very, very excited.

Sherry Korchinski: Because Anafilm works so quickly, as you've seen in our data, the allergists are very, very excited. Over time, you will look to scale. You can only look as far as what our competitors have done as you think about that. That allergist is our key target upon launch.

Speaker #11: Over time, you will look, we will look to scale and you can only look as far as what our competitors, have done. As you think about that, but again, that allergist is our, our key target, upon launch.

Dennis Resnick: Thanks so much.

Speaker #9: Thanks so much.

Operator: Thank you. One moment for our next question. As a reminder, to ask a question, you will need to press star one-one on your telephone. Our next question comes from the line of Thomas Stanton of Lake Street Capital Markets. Your line is now open.

Speaker #2: Thank you. One moment for our next question. Again, as a reminder, to ask a question, you'll need to press star one-one on your telephone.

Speaker #2: In our next question concerns the line of Thomas Flatten of Lake Street Capital Markets. Your line is now open.

Thomas Stanton: Yeah, thanks for taking the question. Perhaps kind of hanging on to the last question that was asked. I am curious, Sherry, if you guys have done any Anaphylm launch patient research just to try and better understand what is it that activates that patient? Is it a recommendation from a physician? Are they seeing ads out there? I am just trying to understand who those patients are that are coming in and actually filling that prescription for a needle-free alternative.

Speaker #9: Yeah, thanks for taking the question. just, perhaps kind of, hanging onto the last question that was asked. I'm, I'm curious, Sherry, if you guys have done any post-nephew launch patient, research, just to try and better understand, you know, what is it that activates that patient?

Speaker #9: Is it, is it a recommendation from a physician? Is it, is, are they seeing ads out there? I'm just trying to understand who those patients are that are, that are coming in and actually filling that prescription for a, for a needle-free alternative.

Sherry Korchinski: Yeah, it's a good question. I am sure we will hear more from the competition in their call. However, as we have looked at it and as we have talked to patients and physicians alike, patients want choice first and foremost. They want a choice that is easy to carry, easy to use. As we think about this, the ability to, one, convince the physician that epinephrine is epinephrine is epinephrine, and I think our competition is doing a good job that alternative forms of epinephrine work. Then, obviously, from a consumer perspective, moms who are the Chief Medical Officers of the home want a medication and epinephrine that their kids will carry.

Speaker #11: Yeah, it's a good question. And I'm, I'm sure we'll hear more from, the, the competition and our, and their call. However, a-as we've looked at it and as we've talked to patients and physicians alike, patients want choice.

Speaker #11: First and foremost. And they want a choice that is easy to carry, easy to use. And so as, as we think about this, the ability to, one, convince the physician that epinephrine is epinephrine is epinephrine.

Speaker #11: And I think our competition is doing a good job that alternative forms of epinephrine work. And then obviously, from a consumer perspective, moms who are the chief medical officers of the home want a medication, an epinephrine that their kids will carry.

Speaker #11: And so again, a-as you think about the physicians and the patients and moms, they want a product that the patients will carry and have with them.

Speaker 1: As you think about the physicians and the patients and moms, they want a product that the patients will carry and have with them. I do believe that all of the consumer education, the direct-to-consumer that our competition has started and is doing a great job of, quite frankly, is increasing that awareness. That will only help, as Daniel Barber mentioned in his opening comments, the growth of the rescue epinephrine market to ultimately prevent those deaths that occur due to anaphylaxis.

Speaker #11: And so I do believe that all of the consumer education, the direct-to-consumer, that our competition has started. And it's doing a great job of, quite frankly, is increasing that awareness.

Speaker #11: That will only help, as Dan mentioned, in his opening comments, of the growth of the rescue market to ultimately prevent those deaths that occur due to anaphylaxis.

Operator: Great. Thank you.

Speaker #9: Great. Thank you.

Brian Korb: Thank you. I am showing no further questions at this time. I would now like to turn it back to Daniel Barber for closing remarks.

Speaker #2: Thank you. I'm showing no further questions at this time. I would now like to turn it back to Dan Barber for closing remarks.

Daniel Barber: Thank you, Marvin. We appreciate everyone joining us this morning. As you heard, we're excited about where we are, and we're looking forward to continuing to update everyone on our progress in the weeks and months to come. Take care.

Brian Korb: Thank you for your participation in today's conference. This concludes the program. You may now disconnect.