Q1 2024 Aquestive Therapeutics Inc Earnings Call
Yeah.
Operator: Good morning, and welcome to the Equestive Therapeutics First Quarter 2024 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, we will conduct a question and answer session. To ask a question, you will need to press star 1 1. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Bennett Watson of ICR Westwick Investment Relations. You may begin.
Good morning, and welcome to the request of Therapeutics first quarter 2020 for a conference call. At this time all participants are in a listen only mode.
After the Speakers' presentation, we will conduct a question and answer session.
Ask a question you will need to press star one one.
As a reminder, this call will be recorded.
Bennett Watson: I'd now like to introduce your host for today's conference call minute Watson of ICR at Westwood Investor Relations you may begin.
Bennett Watson: Thank you, Operator. Good morning and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for the first quarter of 2024, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Stephen Wargacki, Chief Science Officer.
Bennett Watson: 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 <unk>, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for the first quarter 2024, followed by a Q&A session.
Speaker Change: The Q&A session. The team will be joined by Dr. Steven Workout Chief Science Officer.
Bennett Watson: As a reminder, the company's remarks today correspond with the earnings release that was issued after the market closed yesterday. In addition, a recording of today's call will be made available on Equestiv's website within the Investors section shortly following the conclusion of this call. To remind you, the Equestive team will be discussing some non-GAAP financial measures this morning as part of its review of first quarter 2024 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the Investors section of Equestria's website.
Speaker Change: As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday.
Speaker Change: In addition, a recording of today's call will be made available on request its website within the investors section. Shortly following the conclusion of this call.
Speaker Change: To remind you that you're quite 15, we'll be discussing some non-GAAP financial measures. This morning as part of its review of first quarter 2020 for adults.
Speaker Change: 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 request its web site.
Bennett Watson: During the call, the company will be making forward-looking statements, and I will 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 Exchange Commission on May 7, 2024. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business, and the development, regulatory approval, and commercialization of its products, and other matters related to operations.
Speaker Change: During the call the company will be making forward looking statements.
Speaker Change: Mind, 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 quarterly report on Form 10-Q filed with the Securities Exchange Commission on May seven 2024.
Speaker Change: 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.
Bennett Watson: Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. The actual results may differ materially from those statements. All forward-looking statements attributable to a company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. With that, I will now turn the line over to Dan.
Speaker Change: 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 a cluster of or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements and the cautionary statements contained in the earnings.
Release issued yesterday.
Speaker Change: The company assumes no obligation to update its forward looking statements. After the date of this conference call, whether as a result of new information future events or otherwise, except as required under applicable law with that I'll now turn the line over to Dan.
Daniel Barber: Thank you, Bennett, and good morning, everyone. It has been only 64 days since our last earnings call, and the company has largely transformed over those 64 days. To be specific, since our last call, we have announced positive phase 3 results and a positive FDA interaction for our lead product candidate, anafilm epinephrine stubbleable film. We have raised over $75 million in new capital from high-quality investors and received FDA approval for liver vent diazepam buccal film for the treatment of seizure clusters in patients aged 2 to 5 years. We have realized these accomplishments while also progressing the This was truly a remarkable 64 days for the company.
Daniel Barber: Thank you Bennett and good morning, everyone.
Daniel Barber: It had been only 64 days since our last earnings call.
Daniel Barber: The company has been largely transformed over those 64 days.
Daniel Barber: To be specific since our last call, we have announced positive phase III results.
Daniel Barber: And a positive FDA interaction for our lead product candidate NFL epinephrine Sublingual film.
Daniel Barber: Raised over $75 million in new capital from high quality investors Andrew.
Daniel Barber: And received FDA approval for Liberman Diazepam buccal film for the treatment of seizure clusters in patients aged two to five years.
Daniel Barber: We have realized these accomplishments while also progressing the companys long term growth initiatives.
Daniel Barber: This was truly a remarkable 64 days for the company.
Daniel Barber: For me, and for all of the members of the management team, it is gratifying to reach the other side of the transformation we have been planning for over the last two years. We continue to rapidly progress Anafilm in the clinic. As we previously shared with you, we have three supportive studies to perform before our adult application is ready for filing with the FDA. We refer to these as our temperature pH study, our self-administration study, and our allergen exposure study.
Speaker Change: For me and for all of the members of the management team. It is gratifying to reach the other side of the transformation we had been planning.
Speaker Change: Over the last two years.
Speaker Change: We continued to rapidly progress and a film in the clinic.
Speaker Change: As we previously shared with you we have three supportive studies performed before our adult application is ready for filing with the FDA.
Speaker Change: We refer to these as our temperature ph study, our self administration study and our allergen exposure study.
Daniel Barber: I am pleased to say that our temperature pH study is well underway and remains on track to complete dosing this quarter. We submitted our protocols for our self-administration and allergen exposure studies to the FDA with a request to receive responses within 45 days. We were pleased to receive positive comments back from the FDA in less than 30 days.
Speaker Change: I am pleased to say that our temperature ph study is well underway and remain on track to complete dosing this quarter.
Speaker Change: We submitted our protocol for our self administration and allergen exposure studies to the FDA with a request to receive responses within 45 days.
Speaker Change: We were pleased to receive positive comments back from the FDA and less than 30 days.
Daniel Barber: We are now in the process of commencing both studies. We currently expect to complete all three studies before the end of the third quarter. Our current guidance is that we will be able to provide clinical results from at least a portion of these studies by our second quarter earnings call in August. We have provided more details on each of these studies in our supplemental materials, which can be found on our website.
Speaker Change: We are now in the process of commencing both studies.
Speaker Change: We currently expect to complete all three studies before the end of the third quarter.
Speaker Change: Our current guidance.
Speaker Change: We will be able to provide clinical results from at least a portion of these studies.
Our second quarter earnings call in August.
Speaker Change: We have provided more details on each of these studies in our supplemental materials, which can be found on our website.
Daniel Barber: We may seek to conduct our pre-NDA meeting with the FDA upon completion of these studies and before conducting our pediatric study. This may save us valuable time in the development process. Under this scenario, our pre-MDA meeting could occur around the end of the third quarter.
Speaker Change: We may seek to conduct our pre NDA meeting with the FDA upon completion of these studies and before conducting our pediatric study.
Speaker Change: This may save us valuable time in the development process.
Speaker Change: Under this scenario, our pre NDA meeting could occur around the end of the third quarter.
Daniel Barber: As we progress towards our filing, we are also spending more time identifying the optimal distribution model for Anafil. As we all know, distributing medication in the pharmaceutical industry is a complicated process and requires significant preparation. Unfortunately, for caregivers and patients, the process is often complex to navigate and results in many unanswered questions. Will my medication be covered? How much will I owe?
Speaker Change: As we progress towards our filing we are also spending more time on identifying the optimal distribution model for NFL.
Speaker Change: As we all know distributing medication in the pharmaceutical industry is a complicated process and requires significant preparation.
Speaker Change: Unfortunately for caregivers and patients.
Speaker Change: Often complex to navigate and result in many unanswered questions.
Daniel Barber: Can I afford it? What if I lose my medication and need to replace it? These are common questions that are faced by millions of Americans every day. Over the coming months, we will spend a significant amount of time with payers and market access experts so that we understand the optimal strategy for antifilm where it belongs: in the hands of patients. This is an area of our industry that is ripe for innovation, and if practical, we will seek to help drive change.
Speaker Change: Well my medication be covered how much will io can I afford it.
Speaker Change: But if I lose my medication and need to replace it.
Speaker Change: These are common questions that are faced by millions of Americans every day.
Speaker Change: Over the coming months, we will spend a significant amount of time with payors and market access experts so that we understand optimal strategy for.
Speaker Change: NFL, where it belongs in the hands of patients.
This is an area of our industry that is ripe for innovation and if practical we will seek to help drive change.
Daniel Barber: We have also begun to work on typical launch activities, such as packaging design, marketing materials, and Salesforce planning. We have hired and engaged a variety of key commercial experts. And we will continue to build this part of our business throughout the year. Now, let me turn to LibriVent.
Speaker Change: We have also begun to work on typical launch activities, such as packaging design marketing materials and sales force planning.
Speaker Change: We have hired and engaged a variety of key commercial experts and we will continue to build as part of our business throughout the year.
Speaker Change: Now, let me turn to liberman.
Daniel Barber: As you heard me say last week, we were pleased to obtain FDA approval and market access for the two- to five-year-old patient population. We have already begun the process of obtaining commercial and government reimbursement, and we continue to fill non-Medicaid prescriptions as they are received. Similar to Anafilm, we continue to examine our distribution model for LibraVent.
Liberman: As you heard me say last week, we were.
Liberman: We're pleased to obtain FDA approval and market access for the two to five year old patient population.
Liberman: We have already begun the process of obtaining commercial and government reimbursement and we continue to fill non Medicaid prescriptions as they are received.
Liberman: Similar to Amazon, we continue to examine our distribution model for Liberty.
Daniel Barber: We have a very concentrated call point that can be managed through a small internal team. As time goes on, we expect to either expand our internal team or collaborate with other sales and marketing organizations to expand market access for these young patients. There are over 55,000 prescriptions still every year within the 2- to 5-year-old population, and this number continues to grow.
Liberman: We have a very concentrated call point that can be managed through a small internal team.
Liberman: As time goes on we expect to either expand our internal team will collaborate with other sales and marketing organizations to expand market access for <unk>.
Liberman: The young patients.
Liberman: There are over 55000 prescriptions still every year within the two to five year old population and this number continues to grow.
Daniel Barber: We are excited to finally provide the first and only FDA-approved oral medication for the rescue treatment of seizure clusters to this very important patient population. In fact, early feedback from health care providers and caregivers has been very positive. One health care provider told us that her families were going to be, quote, so happy, end quote, to no longer have to use the rectal gel. And another health care provider told us that she was extremely excited because many daycare centers were refusing to administer the rectal gel.
Liberman: We are excited to finally provide the first and only FDA approved oral medication for the rescue treatment of seizure clusters.
Liberman: Very important patient population.
Liberman: In fact.
Liberman: Early feedback from health care providers and caregivers has been very positive.
Speaker Change: One health care provider told us that her family's we're going to be quote still happy and quote and no longer have to use the rectal gel.
Speaker Change: And another health care provider told us that she was extremely excited because many daycare centers were refusing to administer a rectal gel.
Daniel Barber: We continue to progress our Adreniverse platform with our AQST-108 program, our epinephrine prodrug topical gel. We completed our first human clinical study in the first quarter, and the data remains promising. This initial study measured the amount of epinephrine that remained on the skin or was found in circulation over time after application of the gel.
Speaker Change: We continue to progress our <unk> platform with our <unk> program, our epinephrine prodrug topical gel.
Speaker Change: We completed our first human clinical study in the first quarter and the data remains promising.
Speaker Change: This initial study measured the amount of epinephrine that remained on the skin or was found in circulation overtime after application of the gel.
Daniel Barber: While we are not releasing the data for competitive reasons, we found the results compelling enough to continue our product development effort. We expect to be back in the clinic over the summer and continue to aim for providing more information on this program in the second half of the year. Our base business remains steady, and first quarter shipments were significantly higher than the first quarter of last year.
Speaker Change: While we are not releasing the data for competitive reasons, we found the results compelling enough to continue our product development efforts.
Speaker Change: We expect to be back in the clinic.
Speaker Change: This summer and continue to aim for providing more information on this program in the second half of the year.
Speaker Change: Our base business remained steady.
Speaker Change: First quarter shipments were significantly higher than the first quarter of last year.
Daniel Barber: To sum it up, I have never been more excited about the prospects of the company. We have great technology, an experienced management team, and a growing track record. These are the basic building blocks necessary to be successful in our industry. I believe we will continue to progress from our transformation phase into an emerging growth story. For the balance of the year, we expect to announce clinical data from the Anafilm-supported studies on or before our second quarter earnings call in August, expand our distribution capabilities to ensure maximum on-label patient availability for liver veins, advance the clinical development of AQSC-108 as rapidly as we can, and continue to efficiently manage our base business. With that, I will turn the call over to Ernie.
Speaker Change: To sum it up I have never been more excited about the prospects of the company.
Speaker Change: We have great technology, and experienced management team and our growing track record.
Speaker Change: These are the basic building blocks necessary to be successful in our industry.
Speaker Change: I believe we will continue to progress from our transformation phase and into an emerging growth story.
Speaker Change: For the balance of the year, we expect to announce.
Speaker Change: Announced clinical data from the anecdotes supported studies on or before our second quarter earnings call in August.
Expand our distribution capabilities to ensure maximum on label patient availability for Liberty.
Speaker Change: Advanced the clinical development of <unk>, one way as rapidly as we can.
Speaker Change: And continue to efficiently manage our base business.
Speaker Change: With that I will turn the call over to Ernie.
Ernie Toth: Thank you, Dan, and good morning, everyone. By now, you will have seen our financial results in our earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the first quarter 2024 results in the Q&A. During the first quarter, we continued to execute on our financial strategy to strengthen our financial position by raising capital that extends our cash runway and supports the continued development of our lead product, Enafil, the first and only non-device-based orally delivered epinephrine product candidate.
Ernie: Thank you Dan and good morning, everyone.
Ernie: By now you will have seen our financial results in our earnings release that was issued last evening.
Ernie: As we typically do we will address most of the discussion related to the first quarter 2024 results in the Q&A.
Ernie: During the first quarter, we continued to execute on our financial strategy to strengthen our financial position by raising capital that extends our cash runway and supports the continued development of our lead product NFL, the first and only non device based orally delivered.
Ernie: Epinephrine product candidate.
Ernie Toth: In March, we closed an underwritten public offering of 16.7 million shares of our common stock at the public offering price of $4.50 per share. The underwriters purchased approximately 600,000 shares of common stock to cover over-avotments in the offering on April 22, 2024, bringing the total gross proceeds to the company from the offering to approximately $77.5 million before deducting underwriting commissions and other offering expenses payable by the company. All of the securities were sold by the company.
Ernie: In March we closed an underwritten public offering of $16 7 million shares of our common stock at the public offering price of $4 50 per share.
Ernie: The underwriters purchased approximately 600000 shares of common stock to cover over allotments and the offering on April 22024.
Ernie: Bringing the total gross proceeds to the company from the offering for approximately 77 5 million.
Ernie: Before deducting underwriting commissions and other offering expenses payable by the company.
Ernie: All of the Securities were sold by the company.
Ernie Toth: We intend to use the net proceeds from this offering, together with our existing cash and cash equivalents, primarily to advance the development and commercialization of our product pipeline, including Anafilm for the treatment of severe, life-threatening allergic reactions, including anaphylaxis, and LibraVan for the treatment of seizure clusters in epilepsy patients aged 2 to 5, as well as for working capital, capital expenditures, and general corporate purposes. This capital will provide the company with a cash runway into 2026. We are pleased this offering included high-quality institutional health care investment.
Ernie: We intend to use the net proceeds from this offering together with our existing cash and cash equivalents, primarily to advance the development and commercialization of our product pipeline, including NFL for the treatment of severe life threatening allergic reactions, including anaphylaxis.
Ernie: And liver bed for the treatment of seizure clusters in epilepsy patients aged two to five and for working capital capital expenditures and general corporate purposes.
Ernie: This capital will provide the company cash runway into 2026.
Ernie: We are pleased this offering included high quality institutional healthcare investors.
Ernie Toth: These investors' willingness to be part of our future represents another important step forward in the continued growth of Equestria. Also, on April 3, 2024, the company filed a new prospective supplement to register the offer and sale of up to $250 million worth of shares of common stock pursuant to the amended equity distribution agreement under a shelf registration statement on Form S-3. The company also established a new ATM facility for $100 million as part of this shelf registration statement to replace the company's prior ATM facility, which expired in April of 2020.
Ernie: These investors' willingness to be part of our future represents another important step forward in the continued growth of requested.
Ernie: Also on April <unk> 2024, the company filed a new prospective supplement to register the offer and sale of up to $250 million worth of shares of common stock pursuant to the amended equity distribution agreement under a shelf registration statement on form.
Ernie: S III.
Ernie: The company also established a new ATM facility for $100 million.
Ernie: As part of this shelf registration statement to replace the Companys prior ATM facility, which expired in April 2024.
Ernie Toth: We consider both the new shelf and the ATM facility as good corporate financial planning and have no current intentions to utilize either of these facilities in the foreseeable future. Now, let's turn to the first quarter results.
Speaker Change: We consider both the new shelf and the ATM facility as good corporate financial planning and have no current intentions to utilize either of these facilities in the foreseeable future.
Ernie Toth: Total revenues increased from $11.1 million in the first quarter 2023 to $12.1 million in the first quarter 2024. This 8% increase in revenue was primarily driven by higher revenue from our outlicensed products. Excluding the one-time retroactive 2022 price increase of $1.7 million recognized in the three months ended March 31, 2023, manufacturing and supply revenue increased by 30 percent, primarily due to an increase in Suboxone and Cifazan manufacturing revenues offset by lower on-beef revenue.
Speaker Change: Now, let's turn to the first quarter results.
Ernie Toth: In addition, license and royalty revenue increased by 23%, primarily due to higher royalty revenue for Astaras from Zevra and for Simpizan from Asturias. Co-development and research fees decreased by 11% for the first quarter of 2024 versus the prior period. Research and development expenses increased from $3.5 million in the first quarter of 2023 to $5.9 million in the first quarter of 2024. The increase in research and development expenses was primarily due to the continued development of the NFLM program.
Speaker Change: Total revenues increased from $11 1 million.
Speaker Change: In the first quarter 2023 to $12 1 million.
Speaker Change: In the first quarter 2024.
Speaker Change: 8% increase in revenue was primarily driven by higher revenue from our out licensed products.
Speaker Change: Excluding the onetime retroactive 2022 price increase of $1 $7 million recognized in the three months ended March 31, 2023 manufacturing and supply revenue increased by 30% primarily due to an increase in suboxone and <unk>.
Speaker Change: Dan manufacturing revenues offset by lower <unk> revenue.
Speaker Change: In addition license and royalty revenue increased by 23% primarily due to higher royalty revenue for our stars from Zebra and for Sip of that from a <unk>.
Speaker Change: Co development and research fees decreased by 11% for the first quarter 2024 versus the prior period.
Speaker Change: Research and development expenses increased from $3 $5 million in the first quarter of 2023 to $5 9 million.
Speaker Change: In the first quarter 2020 for.
Speaker Change: The increase in research and development expenses was primarily due to the continued development of the NFL program as.
Ernie Toth: As a reminder, the first three quarters of 2024 will contain expenses from multiple clinical studies being conducted to advance the NFL program. Selling, general, and administrative expenses increased from $7.5 million in the first quarter of 2023 to $10.7 million in the first quarter of 2024. This increase was composed of $1.7 million in one-time expenses related to severance and higher share-based compensation, as well as the effects of a year-over-year change in the allocation of expenses to manufacturing and supply costs. Given this year-over-year change, we expect to continue to see a positive benefit in gross margin offset by somewhat higher SG&A expenses. Excluding these items, there was a modest increase in SG&A compared to last year.
Speaker Change: As a reminder, the first three quarters of 2024 will contain expenses from multiple clinical studies being conducted to advance the NFL program.
Speaker Change: Selling general and administrative expenses increased from $7 $5 million in the first quarter of 2023 to $10 7 million in the first quarter of 2024.
Speaker Change: This increase was composed of $1 7 million.
Speaker Change: In one time expenses related to severance and higher share based compensation.
Speaker Change: As well as the effects of a year over year change in the allocation of expenses to manufacturing and supply costs.
Speaker Change: This year over year change, we expect to continue to see a positive benefit in gross margin offset by somewhat higher SG&A expenses.
Speaker Change: Excluding these items there was a modest increase in SG&A compared to last year.
Ernie Toth: Acquesta's net loss for the first quarter of 2024 was $12.8 million, or $0.17 for both basic and diluted loss per share, compared to the net income for the first quarter of 2023 of $8.1 million, or $0.15 basic earnings per share and $0.11 for diluted earnings. The change in net loss was primarily driven by the one-time $14.5 million of other income, which was recognized in the first quarter of 2023, and increases in selling general and administrative expenses, research and development expenses, and non-cash interest expense related to amortization of the debt emeraldty obligation discount, non-GAAP-adjusted EBITDA loss was $7.2 million in the first quarter 2024 compared to a non-GAAP-adjusted EBITDA loss of $3.9 million in the first quarter 2023, non-GAAP-adjusted EBITDA loss excluding adjusted R&D expenses was $1.4 million in the first quarter 2024 compared to a non-GAAP-adjusted EBITDA loss excluding adjusted R&D expenses of $0.5 million in the first quarter 2023, cash and cash equivalents for $95.2 million as of March 31st, 2024.
Speaker Change: Our questions net loss for the first quarter of 2024 was $12 8 million.
Speaker Change: Our 17th for both basic and diluted loss per share.
Speaker Change: <unk> to the net income for the first quarter of 2023 of $8 1 million or.
Speaker Change: <unk> basic earnings per share and <unk> 11.
Speaker Change: For diluted earnings per share the change in net loss was primarily driven by the one time $14 5 million of other income which was recognized in the first quarter 2023 and increases in selling general and administrative expenses research and development expenses.
Speaker Change: And noncash interest expense related to amortization of the debt earn royalty obligation discounts.
Speaker Change: non-GAAP adjusted EBITDA loss of $7 2 million in.
Speaker Change: In the first quarter 2024, compared to a non-GAAP adjusted EBITDA loss of $3 9 million in the first quarter 2023.
Speaker Change: non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses was $1 $4 million in the first quarter of 2024 compared to a non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses of $5 million in the first quarter 2023.
Speaker Change: Cash and cash equivalents for $95 2 million as of March 31, 2024.
Ernie Toth: Under the Companies at the Market, or ATM, facility, we accessed approximately $12 million during the first quarter of 2020. We continue to be focused on the advancement of our antifilm epinephrine program with a goal of following the NDA for antifilm before the end of 2024. We are also in the process of reviewing our existing collaboration to prioritize our focus on promising products from a long-term profitability perspective. We will have more to say on this after the second quarter of 2020.
Speaker Change: Under the Companys at the market or ATM facility, we accessed approximately $12 million.
Speaker Change: During the first quarter of 2024.
Speaker Change: We continue to be focused in 2024 on the advancement of our NFL Epinephrine program with a goal of following the NDA for NFL before the end of 2024.
Speaker Change: We are also in the process of reviewing our existing collaborations.
Speaker Change: Prioritize our focus on the promising products from a long term profitability perspective.
Speaker Change: Have more to say on this after the second quarter of 2024.
Ernie Toth: As outlined in the press release issued last night after market close, our outlook for 2024 is as follows: total revenues of approximately $48 million to $51 million, and non-GAAP-adjusted EBITDA loss of approximately $22 million to $26 million. Our guidance for 2024 includes focused R&D investments related to the continued development of Anafil, the first and only non-device-based, orally-delivered epinephrine product candidate, but excludes any revenue or expenses for the liver band following the recent FDA approval for patients ages two to five. With that, I will now turn the line back to the operator to open the line for questions.
Speaker Change: As outlined in the press release issued last night after market close our outlook for 2024 is as follows.
Speaker Change: Total revenues of approximately $48 million to $51 million.
Speaker Change: And non-GAAP adjusted EBITDA loss of approximately $22 million to $26 million.
Speaker Change: Our guidance for 2024 includes focused R&D investments related to the continued development of NFL. The first and only non device based orally delivered epinephrine product candidate, but excludes any revenue or expenses for liver band following the recent FDA.
Speaker Change: Crude oil for patients ages two to five.
Speaker Change: With that I will now turn the line back to the operator to open the line for questions.
Speaker Change: Thank you.
Speaker Change: You'd like to ask a question. Please press star one one if your question has been answered and you'd like to remove yourself from the queue. Please press star one again.
Operator: Thank you. If you'd like to ask a question, please press star 1 1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1 1 again. Our first question comes from David M. Sellum with Piper Sandler. Your line is open.
Speaker Change: Our first question comes from David <unk> with Piper Sandler Your line is open.
David M. Sellum: Thanks. So I wanted to pick your brain on the competitive landscape in the epi space. So there are a number of intranasal products, as you know, that are moving through development, and I wanted to get your thoughts on how you're thinking about not just the payer landscape in the context of a more crowded landscape, but also just patient and practitioner preferences for a nasal spray modality versus an oral fill modality. So that's number one.
Speaker Change: Thanks.
Speaker Change: Two.
David: Pick your brain on the competitive landscape.
David: In the B space.
So there are a number <unk>.
David: Intranasal products.
David: As you know that are moving through development and wanted to get your thoughts on.
David: How you're thinking about.
David: Not just the payer landscape in the context of a more crowded landscape, but also just patient and practitioner preferences.
David: For our nasal spray modality versus.
David M. Sellum: And secondly, on LibriVant, any more color and how you're thinking about the future of that product, whether you're looking at more fullsome commercialization down the road or partnering it out, just help us better understand where your heads are at on that product. And then lastly, you mentioned the partnerships, and you'll have more to say. I guess that means that you're looking to sort of monetize these income streams? So I'm just trying to get a better sense of what you meant by that. Thanks.
David: And oral sel modality. So so that's number one.
David: Secondly on on Liberty rent any more color on how youre thinking about.
David: The future of that product, whether youre looking at.
David: More fulsome commercialization down the road or partnering it out just help us better understand where your heads are at on that product.
And then lastly, you mentioned the partnerships and you'll have more to say.
David: Does that mean that youre looking to sort of monetize.
David: Monetize these.
David: These income streams.
Speaker Change: I'm, just trying to get a better sense of what your what you meant by that.
Speaker Change: Thanks.
Daniel Barber: Morning, David. Good to hear your voice. So, yeah, in terms of the competitive landscape for epinephrine, I will admit I have lost count of how many intranasals are in development. But I know there are a number of them.
Speaker Change: Good morning, David Good to hear your voice so.
Speaker Change: Yes in terms of the <unk>.
Speaker Change: Landscape.
Speaker Change: Our epinephrine.
Speaker Change: I have lost count of how many intranasal <unk> are in development, so, but I know there are a number of them.
Daniel Barber: But as far as I'm aware, and what gets us excited, and where we think we are unique, is we are the only oral product, and we are what we believe is a very portable product, and we're the only product that I'm aware of that is biocomparable to the auto-injectors for the first 30 minutes following administration. This is for a rescue product designed to save someone from anaphylaxis. So, I don't know how many nasal sprays they're developing, but I do know I have a very differentiated product that we're very excited about.
Speaker Change: I'm aware in what.
Speaker Change: I was excited and where we think we are unique is we are the only oral.
Speaker Change: We are what we believe is a very portable product.
Speaker Change: All of the products that I'm aware of.
Speaker Change: <unk> comparable to the auto injectors for the first 30 minutes. Following administration. This is for a rescue product designed to save someone from anaphylaxis. So.
Speaker Change: Don't know, how many nasal sprays or development.
Speaker Change: Have a very differentiated product that we're very excited about.
Daniel Barber: So when I look at the market research and survey work that we do, which we do the same work all companies do, there absolutely is, in our view, a difference in how patients and caregivers view our product versus medical devices, right? So our portability clearly shines through, as does our... the speed of being able to access the product, the speed of being able to give the product, the speed of the epinephrine concentration in your blood, and getting to Tmax in 12 minutes. All of those things in our mind are major differentiators that are important as we go forward.
Speaker Change: So when I look at the market research and survey work that we do which we do the same work all all companies do.
Speaker Change: There absolutely is.
Speaker Change: In our view.
Speaker Change: And how patients and caregivers to our product.
Speaker Change: Medical devices right. So.
Speaker Change: Portability clearly.
Speaker Change: Shines through.
Speaker Change: Our speed speed of being able to access the product speed of being able to give the product the speed of the.
Speaker Change: And that's a great concentration in your blood.
Speaker Change: C Max and 12 minutes.
Speaker Change: All of those things in our mind are major differentiators that are important as we go forward in terms of the payer landscape we are.
Daniel Barber: In terms of the payer landscape, as I said in my prepared comments, we are clearly doing a lot of work on the payer front. Our findings to date, which match what we've said in the past, are that payers understand this is a rescue space typical of other rescue spaces. And as long as your pricing is within the envelope of existing pricing, we do not expect those dynamics to change.
Speaker Change: I said in my prepared comments, we are clearly doing a lot of work on the payer front, our findings to date, which match what we've said in the past.
That payers understand the.
Speaker Change: The rescue space typical to other rescue spaces, and as long as youre pricing headwinds within the envelope of existing pricing, we do not expect those dynamics to change. So it's other branded intranasal products coming to the market.
Daniel Barber: So as other branded intranasal products come into the market, we don't see those dynamics changing. And as I've said in the past, we would expect the market, as the waters settle over the next few years, to have a component that stays auto-injected for whatever reason, have a component that is intranasal that the intranasal products fight it out for, and then have the component for oral. And in particular, we believe the oral part of the market will be a major, if not the major part of the market.
Speaker Change: We don't see those dynamics.
Speaker Change: Angie.
Speaker Change: As said in the past, we would expect the market at the water settle over the next few years to have a component that state auto injector for whatever reason have a component that is intranasal intranasal prize fight it out for and then has a component.
Speaker Change: And in our particular view, we believe the oral part of the <unk>.
Market will be.
Speaker Change: A major if not the major part of the market.
Daniel Barber: In terms of liver veins, I have to tell you, we couldn't be more delighted with where we are right now. To have liverven finally in the hands of patients is just such a great feeling for the management team here. And quite frankly, liverven, which sometimes gets lost in the shuffle with Enfilm, is really valuable. And not only is it valuable to patients and caregivers who only have a rectal gel they can use right now, but it's valuable to us as the company who created the product. So where we stand right now, nothing's changed from my prior view.
In terms of live event.
Speaker Change: I have to tell you, we couldnt be more delighted with where we are right now.
Speaker Change: To have Liberty finally.
Speaker Change: And their patients is just such a great feeling to the management team here and quite frankly.
Speaker Change: Which sometimes it gets lost in the shuffle with Amazon listen, it's really valuable and not only that valuable to patients and caregivers only have a rectal gel.
Speaker Change: Use right now, but it's valuable to us.
Speaker Change: At the company, who has created the product so where do we stand right now nothing.
Daniel Barber: The most important thing with Liverven is to get it in the hands of patients. We are happy to work with other sales and marketing organizations if they can help us to get it in the hands of patients, but I will say one thing we will not compromise on. So if we do like Liverman to another company, we will expect them to convert the 55,000 scripts that are currently rectal gel users into film because that's what patients and caregivers need.
Speaker Change: Nothing has changed from my prior view the most important thing is to get.
Speaker Change: In the hands of patients.
Speaker Change: Happy to work with other sales and marketing organizations.
Speaker Change: If they can help us to get it.
Speaker Change: Cancer patients, but I will say the one spot we will not compromise on is performance. So if we do license levered to another company, we will expect them to convert at 55000 scripts that are currently rectal gel users into film because thats, what patients and caregivers.
Daniel Barber: If they're unable or unwilling to commit to that level of performance, we will do it ourselves. I think probably the question that comes up next is, well, what does that mean? Do we do it ourselves? Well, quite frankly, as we sit here today, we are doing it ourselves. We do have individuals who are talking with physicians and working on getting scripts for our liver pin product. Ultimately, if we were to keep it, I continue to believe this is a very concentrated small team of people. Think of it as a dozen or 10 people, not overly large, and that's not sales reps that sells, and all of the support. And we do believe that a majority of the 55,000 scripts could be converted by that small team. So, when you think of it from just a financial term, obviously, that is Nowhere near the NFL opportunity.
Speaker Change: <unk>.
Speaker Change: Unable or unwilling to commit to that level of performance, we will do it ourselves so.
Speaker Change: I think probably a question that comes up next is well what does that mean.
Speaker Change: Yourself.
Speaker Change: Quite frankly.
Speaker Change: As we sit here today, we are doing it ourselves we do have individuals who are talking with physicians and.
Speaker Change: Working on bringing scripts.
Speaker Change: Through most of our.
Speaker Change: They are buying products.
Speaker Change: Ultimately if we were to keep it and continue to believe this is a very concentrated small team of people think of it as a dozen patent people not not hopefully large and thats not sales reps sales reps and all of the support pieces and we do believe that a majority of the 75.
Speaker Change: <unk> could be converted by.
Speaker Change: Small team. So when you think of it from just a financial term obviously that is while it's nowhere near the NFL opportunity is meaningful.
Daniel Barber: So, your last question was on monetizing the income stream. In my view, I think it's a little early. We have work to do in both cases. So with Livervine, while there is a possibility we could out-license it, and I suppose you would say that comes with some dollars, that is monetizing. I view that as more of finding someone to help us have the breadth of ability to bring the product to patients. In terms of Antfilm, we are very focused on the next 90 days. We have an execution plan ahead of us. We know what we need to do, and that is where our focus will be. In terms of things like monetization, that will be.
Speaker Change: So your last question was a monotonic monetizing the income streams.
Speaker Change: In my view I think it's a little early for that we have we have work to do.
Speaker Change: Both cases, so with liver.
Speaker Change: Well there is a possibility we out licensed and I suppose you could say that comes with some dollars in added monetizing.
Speaker Change: That is more of a finding someone to help us have the breadth.
Speaker Change: To bring the product to patients in terms of Amazon.
Speaker Change: Very focused on the next 90 days, we have an execution plan ahead of US we know what we need to do and that is where our focus will be.
Speaker Change: In terms of things like monetization that will be later.
David M. Sellum: Great, that's helpful. Thank you.
Speaker Change: Great. That's helpful. Thank you.
Operator: Thank you. Our next question comes from Franois Brisebois with Oppenheimer. Your line is open.
Speaker Change: Thank you. Our next question comes from Francois <unk> with Oppenheimer. Your line is open.
Franois Daniel Brisebois: Thanks for the question. So, I was just wondering if you could comment on the allergen test now that seems to be the requirement and the cancellation of the angioedema test that you initially thought you would have to run. Is that helpful? Can you help us just contextualize what that means to the company, if it's easier or harder?
Francois: Okay. Thanks for the question.
Francois: So I was just wondering if you can comment on the allergen test now that seems to be the requirement and the cancellation of the angioedema test that you. Initially thought you would have to run is that is that helpful. Just can you help us just contextualize what that means to the company.
Franois Daniel Brisebois: And angioedema in the real world; how common do you see this with anaphylaxis here? Thank you. Good morning, Frank.
Speaker Change: As you are harder.
Speaker Change: Angioedema in the real World how come in do you see this.
Speaker Change: With with Anaphylaxis here. Thank you.
Daniel Barber: Good morning, Frank. It's good to hear your voice.
Speaker Change: Sure Mark morning, Frank Good to hear your voice.
Daniel Barber: Yeah, you know, I'm glad you brought up this topic because, in our view, there appears to be some confusion out in the world around edema and what is experienced by someone going through the process of anaphylaxis. So, edema, the onset of edema with anaphylaxis is a cascade, right? So it starts as a tingle, it starts as a change that an individual may feel, and of course, if you allow time to go by, it will progress and get worse, and that's not just in the oral cavity; that can be manifested in other parts of the body, nasal cavities, many parts of the body.
Speaker Change: I'm glad you brought up the topic because they are in our view there appears to be some confusion.
Speaker Change: Yes.
Speaker Change: In the world.
Speaker Change: A D var and <unk>.
Speaker Change: As experienced by somewhat going through.
Speaker Change: Process anaphylaxis so.
Speaker Change: Demos.
Speaker Change: The onset of a depot with anaphylaxis is a cascade right. So it starts.
Speaker Change: Single it starts out as.
Speaker Change: The change that an individual may feel and of course, if you allow time to go by it will progress and get worse and Thats not just in the oral cavity that can be manifested in other parts of the body nasal cavities.
Daniel Barber: So when we think about angioedema, we think about the need to dose quickly, right? Which is exactly what our study will allow us to show. In our allergen exposure study, we will expose individuals to whatever oral allergen syndrome they have, so cherries, mango, kiwi, whatever it may be.
Speaker Change: Parts of the body. So when we think about angioedema, we think about the need to dose quickly right, which is exactly what our study will allow us to show.
Speaker Change: Our allergen exposure study, we will expose individuals' too.
Speaker Change: Whatever oral allergy and central they have so cherries bank can be whatever it may be.
Daniel Barber: And the individual will work with the clinician to say what level of discomfort they're feeling, and we will then dose our product and, of course, track the pharmacokinetic profile of that product. So that's going to, in our minds, show what a real-world experience looks like, right? As we've talked about in the past, you're sitting there, you think you may have had something, your feeling is tingling, something's progressing, and then you take our product.
Speaker Change: And the individual will.
Speaker Change: Work with the clinician to say what level of discomfort. They are fueling and we will dose our products and of course track pharmacokinetic profile of that product, so thats going to in our minds show.
Speaker Change: Real world experience looks like right.
Speaker Change: You talked about in the past are sitting there.
Speaker Change: Do you think you may have had something youre feeling this tingling, how things progressing and then you take our product.
Daniel Barber: What we don't believe is realistic or something that happens in the real world on any regular basis is the extreme edema that I know has been shared in other settings. That's just not the experience we hear from KOLs and experts. So, we think the FDA did a very good job, and we're very pleased with the way they worked with us to say don't do an angioedema study where you're trying to create this false level of swelling.
Speaker Change: We don't believe is realistic or something that happens in the real world any regular basis.
Speaker Change: Extreme edema has.
Speaker Change: Ben shared in other settings, that's just not the experience we share from Kols experts. So we think the FDA did a very good job and we're very pleased with the way they worked with us to stay.
Speaker Change: We don't do an angioedema study or you are trying to create this level of swelling.
Daniel Barber: Instead, show people what it really looks like in the real world. So we'll have a patient-based study, right? These are patients who will be in the allergen exposure study. So, we're excited to get that going, and we'll have more to say about that over the next couple of weeks.
Speaker Change: Instead show people, what it really looks like in the real world.
Speaker Change: A patient studied right. These are patients who will be in the allergen exposure study. So we're excited to get that going.
Speaker Change: We'll have more to say about that.
Franois Daniel Brisebois: Thanks, and then if I could just squeeze in one last one here. In terms of Anafilm, obviously a gigantic market, how does it accompany your size? Can you just talk about a little bit, I know you're doing a lot of work right now on this, but what can you share about commercial prep and maybe the sales rep side, and what kind of doctors are you going after here? Thank you.
Speaker Change: Over the next few months.
Speaker Change: Thanks, and then if I could just squeeze in one last one here in terms of Ana film, obviously gigantic market how does a company. Your size can you just talk about a little bit.
Speaker Change: I know you're doing a lot of work right now on that but what can you share about commercial prep and Navy sales rep side, and what kind of docs are you going after here. Thank you.
Daniel Barber: Yeah, yeah, I think that's another thing we should learn more and especially now is that our balance sheet is appropriately sized. I think size is a misnomer, right?
Speaker Change: Yes, I think that's another as we learn more and especially now.
Speaker Change: Our balance sheet is appropriately sized.
Speaker Change: <unk>.
Speaker Change: I think I think size is a misnomer right.
Daniel Barber: We believe that a relatively modest sales force, and as I said in the past, somewhere between 80 and 100 reps, is a great place to launch this product. Not only that, while the entire market is spread across a lot of call points, because there is a general, a GP component to this, but if you target allergists and pediatricians, the top five deciles can be targeted with 80 to 100. So when I look at our nasal spray competitors and how they're approaching the market, I think everyone has a similar approach, and I don't think that you have to be a big multi-product pharmaceutical company to attack this market. This is... perfect for a company of our size.
Speaker Change: We believe that our relatively modest sales force.
Operator: Thank you. Our next question comes from Ram Selvaraju, with HC Wainwright. Your line is open.
Speaker Change: As I've said in the past somewhere between 80 to 100 reps is a great place to launch this product.
Speaker Change: Not only that.
Speaker Change: While the entire market is spread across a lot of call points because there is a general at GP component of this.
Speaker Change: You target Allergist pediatricians.
Speaker Change: The top decile can be targeted with 80 to 100 reps so.
Speaker Change: When I look at our.
Speaker Change: Nasal spray competitors and how they're approaching the market I think everyone has a similar approach.
Speaker Change: I don't think that you have to be.
Speaker Change: Big.
Speaker Change: Multi.
Speaker Change: Product pharmaceutical company to attack this market.
Speaker Change: Perfect for a company of our size.
Speaker Change: Thank you. Our next question comes from Ram <unk> with H C. Wainwright Your line is open.
Raghuram Selvaraju: Hi, thanks very much for taking the time to answer my questions. Firstly, with respect to the timeline for the submission of the Anafilm NDA, based on your current objectives with respect to the pre-NDA meeting, can you confirm whether you still expect to submit the NDA before the end of this year, or if it's possible that it could slip into next year simply because of the lag between concluding the pre-NDA meeting and completing the final pediatric study? Cue.
Ram: Hi, Thanks, very much for taking my questions Firstly with respect to the timelines for the submission of the NFL NBA based on your current objectives with respect to the pre NDA meeting.
Ram: Can you confirm whether you still expect to submit the NDA before the end of this year or if it's possible that it could slip into next year simply because of the lag between concluding the pre NDA meeting and completing final pediatric study.
Daniel Barber: Sure. Good morning, Ram.
Ram: Sure.
Speaker Change: Good morning, Rob and I'm glad you brought that up because there was.
Speaker Change: Our prepared remarks and in the supplemental materials, we've given we did show everyone something a little different than last time I want to make sure we're clear with everyone. What that difference is.
Daniel Barber: And I'm glad you brought that up because, in our paired remarks and in the supplemental materials we've given, we did show everyone something a little different than last time, and I want to make sure we're clear with everyone what that difference is. We believe, so before we had laid out a plan where we would do all of our studies and then go have our pre-NDA meetings. Looking at it now, we actually think it's much more efficient for both us and the FDA given that we're moving so rapidly through the three supportive adult studies, we think it's more efficient for everyone if once those three studies wrap up, we just have our pre-NDA meeting. And why?
Speaker Change: We believe so before we had.
Speaker Change: Laid out a plan, where we would do all of our studies and then you'll have our pre NDA meeting.
Speaker Change: Looking at it now we actually think it's much more efficient for both us and the FDA given that we're moving so rapidly through the three reported supportive adult studies, we think it's more efficient for everyone. If once those three studies wrap up.
Daniel Barber: Because we want to show that data to the FDA anyway before starting the pediatric study, so why not just turn it into your pre-NDA meeting? The pediatric study is a very straightforward meeting. We are literally giving one dose to a child between the ages of seven and 17 who is over 30 kilos, and that's it. Is it possible that things could change? Of course, that's our industry, right? Who knows? But our guidance, our goal, our focus remains exactly like we said it was before, filing by the end. And we'll do that by having a pre-NDA meeting at the end of our supportive studies and then doing the very straightforward pediatric study that we've laid out.
Speaker Change: Just have a pre NDA meeting.
Speaker Change: Why because we want to show that data to the FDA anyway.
Speaker Change: Quarter, starting the pediatric study so why not just turning into your pre NDA, especially.
Speaker Change: The pediatric study is a very straightforward study we are literally giving one dose.
Speaker Change: Two.
Speaker Change: Child between the ages of seven and 17, who has over 30 kilos and Thats it.
Speaker Change: Is it possible that.
Speaker Change: Things change of course, that's our industry right, who knows but our guidance our goal our focus remains exactly like we said it was before filing by the end of this year and we will do that by having a pre NDA meeting at the end of our support of studies and then doing very straightforward pediatric study.
Speaker Change: <unk> that we've laid out.
Raghuram Selvaraju: Okay, that's helpful. And then, secondarily, with respect to all of this discussion around the commercialization of Anafilm and the likely sales and marketing infrastructure that would be necessary, can you comment on the following two? Firstly, what kind of promotional effort do you anticipate is likely to be most applicable here? Let's say in the hypothetical scenario where a Questive launches Anafilm independently. Is it driven by digital marketing? Is there any, you know, meaningful DTC through traditional channels?
Speaker Change: Okay. That's helpful and then secondarily with respect to all this discussion around our commercialization of NFL and the likely sales and marketing infrastructure that would be necessary can you comment on the following two things firstly, what kind of promotional efforts do you.
Speaker Change: The pace is likely to be most applicable here, let's say in the hypothetical scenario where.
Speaker Change: A question lots of NFL them independently is it digital marketing driven is there any meaningful DTC through traditional channels how does.
Daniel Barber: You know, what does that look like? Just frame that for us if you can. And secondly, this may be a question for Ernie. The financial guidance that has been promulgated, particularly with respect to the length of your current cash runway post the most recent raise, does that actually factor in both pre-launch as well as launch activities related to Anafilm? Thank you.
Speaker Change: What does that look like to frame that for us as we can and secondly, this may be a question for Ernie Thus financial guidance that has been promulgated particularly with respect to the length of your current cash runway post. The most recent raise does that actually factor in both pre launch as well as launch activity.
Speaker Change: It's related to MSL.
Daniel Barber: Sure, Rob. So, also a great question and something that's really important to highlight for everyone. When you look at the launch of this product, and we have, by the way, made a considerable amount of effort over the last 90 days to start bringing in some commercial expertise, make some changes in our commercial organization to be ready for Anna Film, as well as bring experts around us, So, obviously, and I'm sure Ernie will, at some point in the discussion here, talk a little bit about expenses, but that's where we're spending our money, right, on R&D and commercials for Anna Film.
Ernie: Sure Rob.
Ernie: Also a great great question and something that's really been the highlight for everyone.
Speaker Change: When you look at the launch of this product and we have by the way.
Speaker Change: A considerable amount of effort over the last 90 days to start bringing in some commercial expertise make some changes in our commercial organization to be ready for NFL as well as bringing experts around us. So obviously that mature Ernie will at some point in the discussion here talk a little bit about expenses, but that's where we're spending our money.
Speaker Change: On R&D and commercial for NFL.
Daniel Barber: So having said that, so we spend all this money to build a commercial infrastructure, what are they going to do, right? And that is a, when you think about the 20-year span of this product being on the market, there are several phases. In the first phase, so the first couple of years of launch, the very straightforward, obvious place to focus on these scripts that exist, right? So healthcare providers are writing scripts to patients today.
Speaker Change: So having said that what so we spend all this money to build a commercial infrastructure what are they going to do it right and that is a when you think about the 'twenty. Your span of this product being on the market. There are several phases. The first phase. So the first couple of years of launch.
Speaker Change: Very straightforward obvious place to focus on these scripts that exist right. So the healthcare providers, who are writing scripts to patients today. So I am sure. It just like our competitors, that's where our focus will be converting those existing low hanging.
Daniel Barber: So I'm sure just like our competitors, that's where our focus will be, right? Converting those existing low-hanging prescriptions to Anafil. As time goes on, as our brand is established, yes, of course, there will be more of a digital, direct-to-patient advertising component. But that is not what you do, in our view, day one. Day one is about the existing base. The second phase is about
Speaker Change: Prescriptions to anecdote as time goes on and as our brand is established.
Speaker Change: Yes of course, there will be more of a digital direct to patient.
Speaker Change: Advertising component, but that is not what you do in our view day 181 is about the existing base.
Speaker Change: The second phase is about expansion of the market.
Speaker Change: I'll, let Ernie gives you his thoughts on Europe.
Ernie Toth: Good morning, Ram. So I think you're referring to our mention of our cash runway based on the recent capital raise.
Speaker Change: Your next question.
Ernie: Good morning, Rob So I think you're referring to.
Ernie: <unk> mentioned, our cash runway based on our recent capital raise of where that would get SMB stated that that would get us into 2006, So though we haven't given specific guidance for 2025.
Ernie Toth: that that would get us into 26. So they'll...
Ernie Toth: So, though we haven't given specific guidance for 2025, our 2024 guidance, what we expect to spend in 2025 and get us into 2026 on that cash, does include some anticipated spend on pre-commercial activities this year, more around the payer perspective, and then next year of an increased spend to be prepared to launch the product.
Ernie: Our 2020 for guidance, what we expect to spend 25000.
Ernie: And get us into 'twenty six on that cash does include <unk> and <unk>.
Ernie: Dissipated.
Ernie: On pre <unk> pre commercial activities this year more around the payer perspective in the next year.
Ernie: An increased spend to be prepared to launch the product.
Daniel Barber: So, Rob, let me just add to what Ernie said, just to clarify. We have plenty of money right now. We're very happy with our balance sheet right now. And as Ernie said in his prepared remarks, while we have an ATM in place, we're not using it, right?
Ernie: So Rob let me just add to what Ernie said, just put a finer point on that.
Speaker Change: Plenty of money right now, we're very happy with our balance sheet right now and as Ernie said in his prepared remarks, while we haven't.
Speaker Change: We're not using it right. So we think we're well set up for what we need to execute.
Speaker Change: And we think that it does not just through our fruitful, but past our approval and into the launch phase and at that point, obviously, there's a lot of different parts of our business. We will have to see how things go over the next two years.
Raghuram Selvaraju: So if I could just sneak in one more thing with respect to optimizing the value of Anafilm as an asset. How do you see the picture changing outside of the United States, particularly given where you currently are with the product and all the clinical data that has already been generated? You know, what are you seeing in terms of potential partnering interest or other opportunities to potentially optimize the value of Anafilm as an asset? Looking at ex-U.S. territories.
Speaker Change: So if I could just sneak in one more thing with respect to optimizing the value of NFL them as an asset how do you see the picture changing outside of the United States, particularly given where you currently are with the product all the clinical data that has already been generated.
Speaker Change: What are you seeing in terms of potential partnering interest or other opportunities to potentially optimize the value of Amazon as an assets looking at ex U S territories.
Daniel Barber: Ram, you're absolutely right. We think Anafilm is a global product, and we think there are a variety of places where – well, let me even take the word variety. We think on a global basis, anyone who can have access to Anafilm will benefit. When we look at the ex-US markets, there are a few dynamics going on, right? So let's take China. China right now is just not a good market. I believe I'll make a macro statement about our industry in general pharmaceutical products.
Daniel Barber: Yeah, no, Ram, you're absolutely right.
Speaker Change: Yes, Rob.
Speaker Change: Youre absolutely right, we think that it's only the global product and we think there are a variety of places where.
Speaker Change: I mean, you can take the word right.
Speaker Change: Global basis anyone who can have access to NFL and we think we'll benefit.
Speaker Change: When we look at the ex U S markets.
Speaker Change: There is a few dynamics going on right. So, let's take China, China right now, there's just not a good market for us.
Speaker Change: I believe I'll make a macro statement of our industry in general pharmaceutical products.
Daniel Barber: Not only the geopolitical world but the pricing world is not a good place, so I don't think you'll see us focus on China. Europe, however, is a very different story. We have done the work, and we do believe Europe is a bigger opportunity than perhaps we had previously thought. So we do have business development activities going on in Europe. I think the timing remains to be seen. I will admit I don't think our competitors have done us any favors in that regard because their products have struggled a little bit in Europe on the regulatory side. So I think we need to be clear with our story and make sure we position ourselves correctly. But ultimately, I do believe Europe will be a better place.
Speaker Change: Not only the geopolitical world, but the pricing is not a good place. So I don't think you'll see us focus on China.
Speaker Change: Europe. However, it is a very different story, we have done the work and we do believe Europe is.
Speaker Change: A bigger opportunity than perhaps we had previously thought so.
Speaker Change: So we do.
Speaker Change: We do have.
Speaker Change: Business development activities going on in Europe.
Speaker Change: The timing remains to be seen.
Speaker Change: I don't think our competitors have done us any favors in that regard because.
Speaker Change: Products have struggled a little bit in Europe on the <unk>.
Speaker Change: <unk> side so.
Speaker Change: I think we need to.
Speaker Change: Clear with our story.
Speaker Change: Make sure we positioned ourselves correctly, but ultimately I do believe Europe is important to us.
Speaker Change: Thank you.
Operator: Our next question comes from Jason Butler with J&P Securities. Your line is open.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Jason Butler with JMP Securities. Your line is open.
Jose: Good morning. This is Jose for Jason.
Speaker Change: Good morning. This is Jose for Jason Thanks for taking our question just a very quick one follow up clarifying question is.
Jose: Thanks for taking our question. Just a very quick follow-up and clarifying question. Is a pediatric trial needed for approval, or do you plan to include the safety data from the study in FDA during the NDA review? For the temperature and pH trials, we're just wondering what you're expecting to share. And lastly, on the topical product, do you also need to look at the potential of accidental exposure to another person, whether it's another subject, a healthcare provider, or a family member? Thank you.
Jose: Is it a pediatric trial needed for approval or do you plan to include the safety data from this study to FDA during the NDA review.
Speaker Change: For the temperature in ph trials.
Speaker Change: We're just wondering what are you expecting to share and lastly on the topical product deals.
Speaker Change: You also need to look at the potential of accidental exposure to another person whether it's another subject to health care provider or a family member. Thank you.
Jose: So I apologize. You were very soft coming through.
Speaker Change: So I apologize you were very soft coming through.
Speaker Change: I think I captured some of it but not all of it I heard you ask on the temperature PK study.
Daniel Barber: I think I captured some of it, but not all of it. I heard you asked about the temperature pH study when What are your thoughts on sharing data? I heard you ask about the topical product, I think, a sizing question about what the opportunity looks like. Did I miss one of the other questions? For the topical product, if you need to look at...
Speaker Change: <unk>.
Speaker Change: What are thoughts aren't sharing data I heard you ask on the topical products.
Speaker Change: Think of sizing question about what the opportunity looks like did I Miss one of the other questions.
Jose: For the topical product, if you need to look at a potential exposure or accidental exposure to another subject or a healthcare provider.
Speaker Change: For the topical product if you need to look at the potential exposure.
Speaker Change: Accidental exposures to another subject.
Speaker Change: Our health care provider.
Speaker Change: You catch that.
Daniel Barber: Okay, well, let me, I apologize; I'm just not quite hearing it, but I'll give you my thoughts on what I think you asked. So on the temperature pH study, yes, we will share that data. I think the timing of when we share it is what we need to clarify with everyone. And that's why we gave guidance today that, definitely, at the Q2 Earnings Call in August.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Let me.
Speaker Change: I apologize im just not quite hearing it but I'll give you my thoughts and what I think you asked so on the temperature ph study.
Speaker Change: We will share that data.
Speaker Change: I think the timing of when we share is what we need to clarify with everyone and that's why we gave guidance today that.
Speaker Change: Definitely.
Speaker Change: At <unk>.
Daniel Barber: If not earlier, we will share the clinical data that we have. But I think the important thing to remember about not just the temperature pH study but the three supported studies is, unlike the phase three pivotal study, this is not a simple series of endpoints. This is comparison work, right? So we are comparing, and we are showing in the temperature pH study, as an example, what our curves look like, single dose, after a variety of different liquids that are administered.
Speaker Change: Q2 earnings call in August if not earlier, we will share the clinical data that we have.
Speaker Change: The important thing to remember around not just the temperature ph study, but the three supported studies.
Speaker Change: The phase III pivotal study this is not a.
Speaker Change: Pass fail Siri.
Speaker Change: A series of endpoints. This comparison right. So we're comparing we are showing in the temperature ph D. As an example, when our curves look like single dose.
Speaker Change: After a variety of different.
Daniel Barber: You can actually see the liquids in the supplemental materials we gave. So while we don't expect any differences, even if there are differences, we think that all we're doing is quantifying those differences so that it's complete in our NDA. So these three supported studies are exactly that, supported. So we're excited to share that data in the future. In terms of the AQST-108 topical gel product, I know we haven't shared a lot of information on this product, but we do plan to in the second half, but it will tell you we are very excited about being able to penetrate the skin with an epinephrine pro-drug, and we think that opens up a host of opportunities that are very meaningful. If your question on exposure was around absorption, I think Did I capture a reasonable amount of your questions?
Liquids are administered and you can actually see the liquids and the <unk>.
Raghuram Selvaraju: Implement all materials Gabe.
Speaker Change: While we expect we don't expect any differences even if there are differences.
Raghuram Selvaraju: We think that all we're doing is quantifying those differences so that is complete and our NDA. So these three supported studies, we think are exactly that supportive so.
Daniel Barber: So we're excited to share that data in the future in terms of the.
Daniel Barber: <unk> topical gel product.
Daniel Barber: I know, we havent shared a lot of information on this.
Daniel Barber: Yes, we do plan to in the second half than we will.
Daniel Barber: I'll tell you we are very excited about.
Speaker Change: Being able to.
Daniel Barber: Penetrate the skin with the epinephrine pro drug and we think that opens up a host of opportunity.
Daniel Barber: That is very meaningful if youre question on exposure was around <unk>.
Daniel Barber: Absorption I think we'll have more to share in the future.
Daniel Barber: Then capture a reasonable amount of your questions.
Jose: Yeah, so I'm in exposure. I see an accidental transference to another patient, another substitute, or another healthcare provider. Ah, gotcha. Okay.
Daniel Barber: Yes, so I'm going to expose horizon accidental transference to another patients another subset or a health care provider.
Daniel Barber: Gotcha. Okay. Yeah.
Daniel Barber: So with any topical gel, transference is always something you have to manage, right? So we would be no different from any other topical gel that is on the market today. And we would expect it to be no better, no worse than all of the other topical gels, which, as you know, is a substantial market.
Speaker Change: Got you, okay, so with any topical gel.
Daniel Barber: Transparency is always.
Daniel Barber: Something you have to do up to manage right. So we would be no different than any other topical gel that is on the market today.
Daniel Barber: What we would expect to be.
Daniel Barber: No better no worse and all of the other topical gel, which as you know is a substantial market.
Speaker Change: Very helpful. Thanks.
Operator: Thank you. Our next question comes from Gary Nachman at Raymond James. Your line is open.
Daniel Barber: Thank you. Our next question comes from Gary Nachman had Raymond James Your line is open.
Gary Nachman: Thanks, guys. Good morning.
Operator: Yeah.
Gary Nachman: Thanks, guys. Good morning, So first on <unk>, just a follow up I think it was just asked but not answered.
Gary Nachman: On the pre NDA meeting in the pediatric study is there a scenario where you would file suggest adults.
Gary Nachman: The pediatric study.
Gary Nachman: Is it just a question of confirming the design of that pediatric study that you laid out I'm, assuming 7% to 17.
Gary Nachman: A big portion of the market that you need in the filing.
Gary Nachman: Yeah, Good morning, Gary.
Gary Nachman: I will admit to being disappointed you didn't ask deliver good question.
Gary Nachman: With us today.
Gary Nachman: Quite some time.
Gary Nachman: Well I'm not certain yet another question on that.
Gary Nachman: Alright, I will get to that but we will get there.
Gary Nachman: And I appreciate you asking that question, so that I'm clear with everyone.
Gary Nachman: So, first, on Adafoam, and just to follow up, I think it was just asked but not answered. So, on the pre-NDA meeting and the pediatric study, is there a scenario where you would file for just adults without that pediatric study? Or is it just a question of confirming the design of that pediatric study that you laid out? I'm assuming 7 to 17 is a big portion of the market that you need in the filing.
Gary Nachman: No intention I'll, even repeat we have no intention of filing our NDA without the pediatric component. So we're not signaling at any way that we are going to do adjusted adult filing. This is just in our view the most efficient way of getting to a complete filing so we would expect.
Gary Nachman: Our label at launch to be the same as the patent.
Gary Nachman: Dose label so there.
Speaker Change: <unk> looked it up.
Gary Nachman: In terms of ability to dose.
Gary Nachman: Okay and.
Speaker Change: And just again, how long would it take for you to run that study and just that when you break down the market piece versus adults can you quantify that a little bit just so we have a sense.
Speaker Change: Yes, my memory of the difference between peds and adults is somewhere around that 50 50, Mark so about half the market is about that market for the kids.
Gary Nachman: In terms of how long it will take to run the pediatric study.
Gary Nachman: We don't believe this is Tim.
Gary Nachman: <unk> study to run at all.
Gary Nachman: It is again, it's a single dose. So there is no crossover there's no having tds.
Gary Nachman: Pediatric patient come back in.
Gary Nachman: Ken so literally.
Gary Nachman: <unk>.
Gary Nachman: Child comes in I think it does.
Gary Nachman: Our NFL.
Gary Nachman: Rack, there PK for a period of time and Steve.
Gary Nachman: How long we track.
Gary Nachman: Great.
Gary Nachman: Few hours.
Gary Nachman: So we do not believe that is a long study and any.
Gary Nachman: Any fashion.
Gary Nachman: Okay.
Gary Nachman: And then on liver event, but congrats on getting that approval in two to five and I am curious on the commercial side. So what youre doing now with Liberty Bank. Currently how much are you going to be able to leverage that for NFL.
Gary Nachman: Setting up a distribution network I know the NFL, it's still a ways away, but how much of a consideration is that in terms of the investments that you're putting behind <unk>.
Gary Nachman: And then.
Gary Nachman: Did want to get a sense from you guys.
Gary Nachman: Given the whole situation with the OBE, if youre expecting a challenge from new relic at some point on this approval.
Gary Nachman: And do you think it's impossible to assign a potential partner before having better visibility on that I know.
Gary Nachman: Ideally you would like to find a partner if you can but do you think youll need better visibility on the legal front for that to happen.
Speaker Change: Yes, yes no.
Gary Nachman: Gary you know as well its like <unk> been sitting in our board room with us.
Gary Nachman:
Gary Nachman: Deliver been products.
Gary Nachman: Really I'll call it tantalizing things, whereas with liberman.
Gary Nachman: If we were to keep it we do get to build out pieces of infrastructure and not only build it but get to use it.
Gary Nachman: Well ahead of the NFL launch so think of distribution payer access all of those pieces you can almost think of it as gate.
Gary Nachman: Went out a little bit.
Gary Nachman: The system before launch.
Gary Nachman: So that that is appealing.
Speaker Change: I don't know ultimately that that will drive the decision because I think we have to stay true to our mission statement, which is we.
Gary Nachman: We want to help patients and you need to maximize getting this product into patients' hands, but.
Gary Nachman: It's definitely a factor that we are aware of.
Gary Nachman: In terms of OE.
Speaker Change: Yes, it really interesting.
Gary Nachman:
Gary Nachman: Situation on that front as you noted so first on our products.
Speaker Change: Phil in the waiting phase.
Gary Nachman: To get the determination from the FDA.
Gary Nachman: <unk>.
Gary Nachman: Our orphan drug exclusivity for the two to five year old space as I said in the prepared comments, we anticipate receiving OA E. There is no reason, we shouldnt look at analogs. They received <unk> <unk>. So we think thats, just a matter of waiting and seeing.
Gary Nachman: So once we have that obviously for our product we would have seven years out.
Gary Nachman: Two to five year old space for four just are.
Gary Nachman: Product.
Gary Nachman: And the existing products in terms of being challenged.
Gary Nachman: The approval and market access of our products.
Speaker Change: Well, obviously, we don't control.
Gary Nachman: The actions of any of our competitors.
Gary Nachman: All we can say is as of.
Gary Nachman: 850, <unk> eastern time on May eight.
Gary Nachman: We're not aware of a complaint filed against the FDA.
Gary Nachman: So it is as you know is no small undertaking to effectively sue the FDA.
Gary Nachman: You would think that if you were going to you would you would want to get that started so.
Speaker Change: I I don't have any more color for you on what others will do in this space.
Gary Nachman: Okay.
Gary Nachman: Our partnership.
Speaker Change: Yes, I'm sorry, if you did have one last parts to that question.
Speaker Change: Yes, we absolutely do think it is.
Gary Nachman: We can partner, we can license out.
Gary Nachman: Lubricant products at our discretion.
Speaker Change: Thanks Pat.
Gary Nachman: Our interactions with various.
Gary Nachman: Companies that are interesting.
Gary Nachman: Not appear to be a roadblock at this time.
Speaker Change: Okay, great. Thank you.
Speaker Change: Okay. Thank you.
Gary Nachman: Reminder, to ask a question. Please press star one one.
Gary Nachman: Our next question comes from Thomas Flaten with Lake Street Capital markets. Your line is open.
Speaker Change: Great. Thanks for taking the questions just on that last point, Dan I know you guys had backed off a little bit your engagement with FDA around the six plus liberman approval because you wanted to get to two to five year old out now that Thats been approved how are you thinking about re engaging with FDA kind of on a major contribution to patient care basis to see if you can overturn the <unk>.
Gary Nachman: That is in place in that space.
Daniel Barber: Yeah, good morning, Gary, and I will admit to being disappointed you didn't ask a liver vent question since you've been with us on liver vent for quite some time. But, I'm not sad yet. I have a question about that. All right, we'll get to that then. We'll get to that, and I appreciate you asking that question so that I'm clear with everyone. Yeah, we have no intention. I'll even repeat that.
Gary Nachman: Yes.
Thomas: Good morning Thomas.
Speaker Change: And by the way. We noted you were the first one on the line. This morning, so definitely impressed considering you're in a different time zone.
Gary Nachman: We have no intention of filing our NDA without the pediatric dose label, so we're not signaling in any way that we are going to do just an adult filing. This is just viewed as the most efficient way of getting to a complete file. So we would expect our label at launch to be the same as the EpiPen dose label, so 30 kilos and up in terms of ability to dose.
Daniel Barber: But in terms of.
Daniel Barber: Okay. And just, again, how long would it take for you to run that study? And just the, you know, when you break down the market, peds versus adults, can you quantify that a little bit, just so we have a sense? Yeah, my memory of the difference between
Gary Nachman: Okay.
Daniel Barber: My memory of the difference between teens and adults is somewhere around that 50-50 mark. So about half the market is adults, and half the market is teens.
Daniel Barber: In terms of how long it will take to run the pediatric study, we don't believe this is a difficult study to run at all. It is, again, a single dose, so there's no crossover, there's no having the pediatric patient come back and go again. So literally, the child comes in, they take a dose of our antifilm, we track their PK for a period of time, and Steve... calls how long we track for. A few hours, then they leave. So we do not believe that this is a long study in any way.
Gary Nachman: In terms of your question on that front.
Daniel Barber: Okay. And then on LibreVent, so congrats on getting that approval in two to five. And I'm curious on the commercial side. So what you're doing now with LibreVent currently, how much are you going to be able to leverage that for Anafilm, setting up a distribution network? I know that Anafilm is still a ways away, but how much of a consideration is that in terms of the investments that you're putting behind LibreVent?
Daniel Barber: <unk>.
Daniel Barber: Okay.
Daniel Barber: I think that.
Daniel Barber: The.
Daniel Barber: The engagement with the FDA will happen sorry, I was looking across the room at my colleagues here in terms of our engagement with the FDA.
Daniel Barber: We'll now that we've gotten is.
Daniel Barber: <unk> filing out of the way.
Daniel Barber: We will pursue the adult again.
Daniel Barber: As you know, while we think we have very good.
Daniel Barber: Arguments the wheels epic SBA move at a certain pace. So we will we will just continue to follow that process and see where it leads.
Daniel Barber: And then I also, you know, did want to get a sense from you guys, you know, given the whole situation with the ODE, if you're expecting a challenge from Norellis at some point on this approval, and do you think it's even possible to sign a potential partner before having better visibility on that? I know, you know, ideally, you would like to find a partner if you can, but do you think you'll need better visibility on the legal front for that to happen? Yeah. Yeah.
Daniel Barber: And then you mentioned earlier that with the Salesforce of our 80 to 100, you can hit the top five desktops was that based on specialty or was that just epipen prescribing period, regardless of whether it's specialty or primary care.
Daniel Barber: My understanding from the debt filing that we have seen is that is that is across the REIT universe. So look there are a couple of.
Daniel Barber: Non allergy non pediatric call points that would just be high prescribers that are baked in there some degree but very minor.
Daniel Barber: The decile book.
Speaker Change: Got it appreciate it thanks so much.
Daniel Barber: Okay.
Daniel Barber: Thank you I'm showing no further questions I'd like to turn the call back over to Dan for closing remarks.
Speaker Change: Thank you Michelle and thank you everyone for joining us today.
Daniel Barber: Yeah, yeah. No, it's, Gary, you know as well, it's like you've been sitting in our boardroom with us.
Daniel Barber: The liver vent product, the really tantalizing thing for us with liver vent is that if we were to keep it, we do get to build out the pieces, the structure, and not only build it but get to use it well ahead of the NFL launch. So think of distribution, payer access, all of those pieces; you can almost think of it as getting the cobwebs out a little bit of the system before the NFL launch. So that is appealing.
Daniel Barber: I don't know ultimately whether that will drive the decision because I think we have to stay true to our mission statement, which is that we want to help patients and you need to maximize getting this product into patient hands, but it is definitely a factor that we are aware of. In terms of ODE, yeah, really interesting situation on that front, as you noted. So first, on our product, we're still in the waiting phase to get the determination from the FDA on our organ drug exclusivity for the 2- to 5-year-old space. As I said in the prepared comments, we anticipate receiving ODE. There's no reason we shouldn't. When we look at analogs, they received ODE, so we think that's just a matter of waiting and seeing.
Daniel Barber: I couldnt be happier with where we are as a company right now we're in a great place and we are focused on the execution of our business plan as we shared with you we.
Daniel Barber: So once we have that, obviously, for our product, we would have 7 years of the 2- to 5-year-old space for just our product and the existing products. In terms of being challenged on the approval and market access of our product, while obviously we don't control the actions of any of our competitors, all we can say is, as of 850 Eastern Time on May 8th, we are not aware of a complaint being filed against the FDA by anyone.
Gary Nachman: Okay, great. Thank you.
Daniel Barber: So it is, as you know, it is no small undertaking to effectively sue the FDA. You would think that if you were going to, you would want to get that started. I don't have any more color for you on what others will do in this space.
Operator: Thank you. As a reminder, to ask a question, please press star 1 1. Our next question comes from Thomas Flaten with Lake Street Capital Markets. Your line is open.
Daniel Barber: Okay, and then the partnership, yeah.
Thomas Flaten: Great, thanks for taking the questions. Just on that last point, Dan, I know you guys had backed off a little bit your engagement with FDA around the six-plus liver of an approval because you wanted to get the two to five-year-old out. Now that that's been approved, how are you thinking about re-engaging with FDA kind of on a major contribution to patient care basis to see if you can overturn the OD that is in place in that space? Yes.
Daniel Barber: You did have one last part to that question. Yes, we absolutely do think so. We can partner, and license out the liver vent product at our discretion. I don't think that from our interactions with the various companies that are interested, this does not appear to be a roadblock at this point.
Daniel Barber: Yes, good morning, Thomas. And by the way, we noted you were the first one on the line. I'm definitely impressed considering you're in a different time zone.
Daniel Barber: But in terms of..., in terms of your question on that front, I think that engagement with the FDA will happen. Sorry, I was looking across the room at my colleagues here. In terms of our engagement with the FDA, now that we've gotten this particular filing out of the way, we will pursue the adult again. As you know, while we think we have very good arguments, the wheels at the FDA move at a certain pace, so we will just continue to follow that process and see where it leads.
Daniel Barber: And then you mentioned earlier that with a sales force of 80 to 100, you could hit the top five deciles. Was that based on specialty, or was that just the EpiPen prescribing period, regardless of whether it was specialty or primary care? My understanding is that
Thomas Flaten: My understanding from the dexiling that we have seen is that this is across the universe. So look, there are a couple of non-allergy, non-pediatric call points that would just be high prescribers that are baked in there to some degree, but very minor. But no, that's a dexile.
Daniel Barber: Thank you, Michelle, and thank you, everyone, for joining us today. I couldn't be happier with where we are as a company right now. We're in a great place, and we are focused on the execution of our business plan, as we've shared with you. We have a variety of what we believe are important milestones between now and our Q2 earnings call in August, and we look forward to keeping you updated for the next several weeks. With that, I will close the call.
Daniel Barber: Got it. I appreciate it. Thanks so much.
Operator: Thank you. I'm showing no further questions. I'd like to turn the call back over to Dan for closing remarks.
Thomas Flaten: Have a variety of what we believe are important milestones between now and our Q2 earnings call in August.
Dan: We look forward to keeping you updated for the next several months with that I will open up.
Operator: Thank you for your participation. This does conclude the program, and you may now disconnect. Everyone, have a great day.
Dan: Thank you for your participation. This does conclude the program and you may now disconnect everyone have a great day.
Operator: Okay.
Operator: [music].
Operator: Okay.
Operator: Good.
Operator: Yes.
Operator: [music].
Operator: Okay.
Operator: Okay.
Operator: Okay.