Q4 2021 Aquestive Therapeutics Inc Earnings Call
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Operator: David Amsellem, David Amsellem, David Amsellem, David Amsellem Good morning, and welcome to the Acquested Therapeutics fourth quarter and full year 2021 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star, then one on your chat to some
Good morning, and walk you through the quest of Therapeutics fourth quarter and full year 2021 conference call. At this time all participants are in a listen only mode.
Operator: If anyone needs assistance during the conference, please press star then zero to reach an operator. As a reminder, this call will be recorded. I will now introduce your host for today's conference call, Bennett Watson of Westwick Investments, from Best Relations. You may begin. Thank you, operator.
After the Speakers' presentation there'll be a question and answer session to ask a question. During the session you will need to press Star then one.
Had some telephone if anyone should require assistance during the conference. Please press Star then zero to reach an operator.
As a reminder, this call will be recorded I would now like to introduce your host for today's conference call.
Watson of Westlake investment Investor Relations you may begin.
Okay.
Yeah.
Bennett Watson: Good morning, and welcome to today's call. On today's call, I'm joined by Keith Kendall, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the fourth quarter and full year 2021, followed by a Q&A. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday. In addition, a recording of today's call will be made available on Questive's website within the Investors section shortly following the conclusion of this call.
Thank you operator, good morning, and welcome to today's call on today's call I'm joined by Keith Kendall, Chief Executive Officer, and Ernie Tooth Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the fourth quarter and full year 2021, followed by a QE.
The next session.
As a reminder, that accompanies our remarks today correspond with the earnings release that was issued after market closed yesterday.
In addition, a recording of today's call will be made available on <unk> website within the investors section. Shortly following the conclusion of this call.
To remind you of your questions team, we'll be discussing some non-GAAP financial measures. This morning, as part of its review of fourth quarter and full year 'twenty 'twenty. One 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 investor.
Speaker: To remind you, the Acoustic Team will be discussing some non-gap financial measures this morning as part of its review of 4th quarter and full year 2021 results [inaudible] 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 Equestiv's website. During the call, the company will be making forward-looking, We remind you of the company's Safe Harbor language as outlined in yesterday's earning as well as the risks and uncertainties affecting the company, as described in the risk factors section in an update, who did in our annual report on form 10K filed with the security [inaudible] on March 8th, 2022, and in our quarterly reports on form 10Q and current reports on form 8K files with the RCC.
Her section up a question website.
During the call the company will be making forward looking statements. We remind you of the company's safe Harbor language as outlined in yesterday's earnings release as well as the risks and uncertainties affecting the company as described in the risk factors section and other sections included in our annual report.
On Form 10-K filed with the Securities Exchange Commission on March eight 2022, and in our quarterly reports on Form 10-Q , and current reports on form 8-K filed with the SEC.
As with any pharmaceutical company with product candidates under development and products being commercialized there are significant risks and uncertainties with respect to the company's business and development regulatory approval and commercialization of its products and other matters related to operations.
Speaker: 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 development, regulatory approval, and commercialization of its products, and other matters related to operations. The impact of the ongoing COVID-19 pandemic is highly uncertain and cannot be predicted with certainty or clarity, given these uncertainties. You should not place undue reliance on these forward-looking statements, which speak only as of the date I write this letter. Actual results may differ materially from these statements.
The impact of the ongoing COVID-19 pandemic is highly uncertain and cannot be predicted with certainty or clarity. Given these uncertainties you should not place undue reliance on these forward looking statements, which speak only as the deep need.
Actual results may differ materially from these statements all forward looking statements attributable to a question or any person acting on its behalf are expressly qualified in their entirety I. This cautionary statement and the cautionary statements contained in the earnings release issued yesterday.
Speaker: 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 statement 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 David Amsellem. David Amsellem, David Amsellem, David Amsellem. Thank you, Bennett, and thank you to everyone on the call for joining us this morning.
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 Keith.
Thank you Ben and thank you to everyone on the call for joining us this morning.
Keith Kendall: In our remarks today, Ernie and I will be discussing recent developments in our business during the fourth quarter of 2021 and through early March. As always, Ernie and I will be joined by additional members of the Aquestive Leadership Team during the Q&A session afterward. We remain as a company keenly focused on the two most important value drivers for Equestria. Libervant and AQST 109.
In our remarks today, Ernie and I will be discussing recent developments in our business during the fourth quarter of 2021 and through early March.
As always Ernie and I will be joined by additional members of your question leadership team during the Q&A session afterward.
We remain as a company keenly focused on the two most important value drivers for quest at Liberum.
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Keith Kendall: We continue to engage with the FDA regarding the ongoing review of the NDA for LibraVamp. Related to our F and F program, we recently reported positive pop-line data from part one of the F of FAST crossover study for AQST109 and the commencement of part two of that study. In late February, we received clearance from the FDA for the USIND for AQST-109. Additionally, our core business outperformed our expectations in 2021. As you saw in our release last night, and as Ernie will discuss more fully in a few minutes, our full-year 2021 revenue came in above the updated guidance provided in November, and our non-gap-adjusted EBITDA loss came in better than expected.
We continue to engage with the FDA regarding the ongoing review of the NDA for <unk>.
Related to our Epinephrine program, we recently reported positive top line data from part one of the F. A fast crossover study for <unk> T. One O nine and the commencement of part two of that study.
In late February we received clearance from the FDA for the U S. I M D for <unk> 109.
Additionally, our CT business outperformed our expectations in 2021.
As you saw in our release last night and as Ernie will discuss more fully in a few minutes. Our full year 2021 revenue came in above the updated guidance provided in November and our non-GAAP adjusted EBITDA loss came in better than expected.
Let's start with liver fat.
Keith Kendall: Let's start with liver. On December 20, 2021, we received notification from the FDA that it would not be ready to act by the PDUFA date of December 23, for the company's NDA for liver vans, diazepam, and buccal film. The agency was unable to provide an estimate of the timing of an expected action.
On December 22021, we received notification from the FDA that it would not be ready to act by the <unk> date of December 23rd for the company's NDA for Liberal rent Diazepam buccal film.
The agency was unable to provide an estimate of the timing of an expected action.
We were surprised by the Fda's unexpected notice that they were unable to provide a decision by the <unk> date. The agency's review Division had finished its review and indicated that no additional information was necessary from the company.
Keith Kendall: We were surprised by the FDA's unexpected notice that they were unable to provide a decision based on the PDUFA data. The agency's review division had finished its review and indicated that no additional information was necessary from the company. We had previously completed the pre-notice requirements, such as labeling negotiations, additional information requests, and post-marketing adverse drug experience reporting, or PEDA orders. Since that notice in December, we've interacted with the agency, who in their most recent correspondence in February stated the following two points: and I quote, I quote, I quote, I quote, I quote, The agency is continuing to consider whether the orphan drug exclusivity identified for another diazepam product affects the approvability of your application.
Keith Kendall: Additionally, they went on to say, and I quote again, we're continuing to consider the information and argument. Submitted by and on behalf of the, At this time, we cannot provide a specific update regarding timelines or an anticipated action date. Close quote. The company continues to believe that LibriVant is an approvable product for safety and efficacy as evidenced by the completion of the pre-notice requirement. Cast a minute ago.
We had previously completed the pre notice requirements such as labeling negotiations official information requests and post marketing adverse drug experience reporting we're paid afforded.
Since that noticed in December we've interacted with the agency who in their most recent correspondence in February stated the following two points and I quote.
The agency is continuing to consider whether the orphan drug exclusivity identified for another diazepam product affects the approve ability of your application.
Additionally, they went on to say quote again, we're continuing to consider the information and arguments submitted by and on behalf of a question.
At this time, we cannot provide a specific update regarding timelines or an anticipated action date closed quotes.
The company continues to believe the labor ramp as an approvable product for safety and efficacy as evidenced by the completion of the pre notice requirements I discussed a minute ago.
Keith Kendall: With respect to the FDA granting market access, given the orphan drug exclusivity issue, we continue to believe we've made a compelling case that LibraVent represents a clinically superior product to their previous rectal and nasal products, based on LibraVare providing a major contribution to patient care as outlined in the agency's guidelines. LibraVant, if granted market access, has the potential to transform the lives of refractory epilepsy patients, seeking a non-invasive and innovative product for the management of seizure clusters.
With respect to the FDA granting market access given the orphan drug exclusivity issue. We continue to believe we've made a compelling case that liberal represents a clinically superior product to their previous rectal and nasal products based on liver via providing a major contribution to patient.
[noise] care as outlined in the agency's guidelines.
Liberum if go.
Granted market access has the potential to transform the lives of refractory epilepsy patients seeking a noninvasive and innovative products for the management of seizure clusters.
Keith Kendall: This patient population remains underserved, with more patients over the last 12 months across all age groups continuing to utilize the diazepam rectal gel product versus the diazepam nasal product despite good pair coverage. The vast majority of potential patients are still not accessing either of these difficult to interact with alternatives, so a preferred method of delivery, an oral product, that can be used where it's needed, when it's needed, and in a preferred form. A Potential Highly Differentiated Treatment Option for this patient population
This patient population remains underserved with more patients over the last 12 months across all age groups continuing to utilize the diazepam rectal gel product versus the diazepam nasal products. Despite good payer coverage.
The vast majority of potential patients are still not accessing either of these difficult to interact with alternatives.
Providing a preferred method of delivery on oral product that can be used where it's needed when it's needed and in the preferred form.
Tensile highly differentiated treatment option for this patient population.
Obviously, we believe lipper van utilizing our Pharmfilm technology provides a preferred or a product that will be a meaningful improvement in treatment options available for these patients.
Keith Kendall: Obviously, we believe LibraVent, utilizing our farm film technology, provides a preferred oral product that will be a meaningful improvement in treatment options available for these patients. Equestiv continues to prepare to launch this important product for epilepsy patients if granted market access by the FDA. Now, let's move on to FNF.
Quest continues to prepare to launch this important product for epilepsy patients if granted market access by the FDA.
Let's move on to epinephrine.
Keith Kendall: Our next key value driver and priority is advancing our F&F and product candidates for severe allergic reactions, including anaphylaxis. AQST 109. Our question is advancing the clinical development of AQST-109, the first and only orally delivered epinephrine product candidate to demonstrate results comparable to autoinjection and Zachary Penn, which are the current standard of care for the emergency treatment of a severe allergic reaction. As we had committed on our last call, we announced in late February that the FDA had provided clearance for Equestiv's IND, allowing clinical development in the United States.
Our next key value driver in priority is advancing our epinephrine product candidate for severe allergic reactions, including anaphylaxis <unk> T 109.
A question of us advancing the clinical development of <unk> T. One O nine the first and only orally delivered epinephrine product candidate to demonstrate results comparable to auto injectors, such as epipen and RV queue that up.
The current standard of care for the emergency treatment of severe allergic reactions.
As we had committed on our last call we announced in late February that the FDA has provided clearance requested XI AMB, allowing clinical development in the United States.
This is a necessary step to eventually moving the project to an NDA filing expected in late 'twenty early 'twenty four.
Keith Kendall: This is a necessary step to eventually moving the project toward an NDA filing expected in late 2023 or early 2024. As a reminder, the agency previously confirmed the 505-B2 regulatory approval path as appropriate for ATSC 109. Additionally, we announced in late February positive top-line results from Part 1 of our EPIFAS study evaluating AQSP-109. The product candidate continues to show rapid absorption and conversion of the prodrug to epinephrine in subjects, achieving a median time to maximum concentration, or Tmax, of 13 and a half.
As a reminder, the agency previously confirmed the five O five beat to regulatory approval path as appropriate for <unk> 109.
Additionally, we announced the late February positive topline results from part one of our epic study evaluating <unk> 109.
The product candidate continues to show rapid absorption and conversion of the prodrug to epinephrine in subjects, achieving a median time to maximum concentration or <unk> 13, and a half minutes.
Keith Kendall: We are obviously pleased with these results and have already begun part two of the study and expect to report top-line data before the end of the second quarter. We're excited that we've again shown pharmacokinetic results that demonstrate delivery of epinephrine with the absorption and conversion speed necessary for a rescue product of this kind, with a significant part of this patient population not having this medicine where they need it, when they need it, for a variety of reasons, including Needle Phobia, and Convenience.
We are obviously pleased with these results and have already begun part two of the study and expect to report top line data before the end of the second quarter.
We're excited that we have again shown pharmacokinetic results that demonstrate delivery of epinephrine with the absorption and conversion speed necessary for our rescue product at this time.
With a significant part of this patient population not having this medicine, where they need it when they need it for a variety of reasons, including needle phobia convenience delayed or incorrect administration.
Keith Kendall: The Lade, or Incorrect Administration, David Amsellem, David Amsellem, AQS-T109 represents a meaningful improvement in this group of patients and caregivers' lives. We're looking forward to the continued development of AQSP-109 and, as we've indicated previously, we expect to move forward with the manufacture of registration batches and initiate pivotal trials in the U.S. under the IND before the end of 2020. Finally, our corpus.
<unk> 109 represents a meaningful improvement in this group of patients and caregivers lives.
We're looking forward to the continued development of <unk> 109, and as we've indicated previously we expect to move forward with the manufacture of registration batches and commence pivotal trials in the U S. Under the <unk> before the end of 2022.
Finally, our core business.
Keith Kendall: Our core business continues to contribute new opportunities as well as cash in 2021. Our Suboxone business remains resilient and continues to contribute at a higher level than expected. Stemperzand continued to perform and has now grown 12 straight quarters since its approval and launch. These will all contribute revenue and cash in 2022 and beyond. And as we just announced, we've signed a new licensing agreement with a Chinese-based pharmaceutical company, Hysco, for the development, manufacture, and commercialization of Exervan in China.
Our core business continued to contribute new opportunities as well as cash in 2021.
Our suboxone business remains resilient and continues to contribute at a higher level than expected.
<unk> continued to perform and has now grown 12 straight quarters since its approval and launch.
These will all contribute revenue and cash in 2022 and beyond.
And as we just announced we signed a new licensing agreement with a China based pharmaceutical company high Scho for the development manufacture and commercialization of extra van in China.
The deal contribute $7 million of upfront cash manufacturing revenue with the quest of as the sole supplier at the high school as double digit royalties once the product was launched in China.
Keith Kendall: The deal contributes $7 million of upfront cash, manufacturing revenue with Questiv as the sole supplier at the high scope, and double-digit royalties once the product is launched and shipped. In conclusion, as we progress through the first quarter of 2022, we're focused on advancing our proprietary product. We remain in close contact with the FDA regarding the application for liver vans. The FDA is continuing to evaluate the impact of orphan drug exclusivity on our NDA. We believe that LibriVant is an acceptable product.
In conclusion as we progressed through the first quarter of 2022, we're focused on advancing our proprietary products.
We remain in close contact with the FDA regarding the application for Liberty.
The FDA is continuing to evaluate the impact of orphan drug exclusivity bought our NDA.
We believe that Liberty.
As an approvable product for safety and efficacy as evidenced by the completion of pre notice requirements that I discussed earlier.
Keith Kendall: Safety and efficacy, as evidenced by the completion of the pre-notice requirements that I discussed earlier. We're prepared to launch immediately if granted U.S. market access. AQSD has advanced into part two of the FFA study after we reported positive results from part one last month.
We're prepared to launch immediately if granted U S market access.
<unk> has advanced into part two of the <unk> study. After we reported positive results from part one last month.
Ernie Toth: And currently, the FDA has provided clearance for the IND, and we're on track to commence pivotal trials later this year. Finally, again, our ongoing business continues to perform well, and we look forward to delivering the strong results outlined in our release, which Ernie will discuss shortly. Thank you, Keith, and good morning, everyone.
Currently the FDA provided clearance for the IND and we are on track to commence pivotal trials later this year.
And finally again, our ongoing business continues to perform well and we look forward to delivering the strong results outlined in our release, which Ernie will discuss shortly.
Thank you Keith and good morning, everyone.
Ernie Toth: By now, you will have seen our financial results in our $10K and earnings release that were filed last month. As we typically do, we will address most of the discussion related to the fourth quarter 2021 results in the Q&A. Complimenting our business focus on the priorities of LIBERVANT and AQST 109 that Keith just discussed has been a strong financial focus in 2021 and admittedly some complexity that I will attempt to clarify.
By now you will have seen our financial results and our 10-K and earnings release that were filed last evening.
As we typically do we will address most of the discussion related to the fourth quarter of 2021 results into Q&A.
Complementing our business focus on the priorities of liver event and <unk> 109 to keep just discussed has been a strong financial focus in 2021 and admittedly some complexity that I will attempt to clarify.
First during the fourth quarter as we previously announced we worked closely with our lenders to provide additional optionality to the company by extending the time that we have access to an additional $30 million available within our existing debt facility from December 2021.
Ernie Toth: First, during the fourth quarter, as we previously announced, we worked closely with our lenders to provide additional optionality to the company by extending the time that we have access to an additional $30 million available within our existing debt facility from December 2021 until June 2022 if we choose to fully fund the launch of LiberBand if we are granted market access. Additionally, we reached agreement with our lenders to amend the principal amortization schedule of our debt.
Until June 2022, if we choose to fully fund the launch of Bluebird band if granted market access.
Additionally, we reached agreement with our lenders to amend the principal amortization schedule of our debt.
As a result during the fourth quarter 2021, we recognized a one time non cash loss on extinguishment of debt of $13 $8 million for fees and expenses related to the fourth supplemental indenture that was executed on October seven 2020.
Ernie Toth: As a result, during the fourth quarter of 2021, we recognized a one-time non-cash loss and extinguishment of debt of $13.8 million for fees and expenses related to the fourth supplemental indenture that was executed on October 7, 2021. This agreement with our lenders amended the principal amortization schedule to free up over $10 million of capital between the execution date and year-end 2022 for a $2.7 million fee payable in four quarterly installments beginning May 15, 2022.
One.
This agreement with our lenders amended the principal amortization schedule to free up over $10 million of capital between the execution date and year end 2022 for a $2 7 million dollar fee payable in four quarterly installments, beginning may 15th 2022.
This one time non cash loss and extinguishment of debt had an impact on EPS up 34 loss per share in the fourth quarter and up 36 cents loss per share for the full year based on the weighted average number of shares outstanding for the three and 12 months ended.
Ernie Toth: This one-time non-cash loss and extinguishment of debt had an impact on EPS of $0.34 loss per share in the fourth quarter and of $0.36 loss per share for the full year based on the weighted average number of shares outstanding for the three and 12 months ended December 31, 2021. Also, the full-year effect of the accounting for the Kenmobi royalty monetization transaction was $12.4 million in interest expenses related to the sale of future revenue resulting in an EPS impact of $0.33 loss per share. As a reminder, this accounting does not and will never represent a cash obligation or payment by the company.
December 31 2021.
Also the full year effect of the accounting for the can mobi royalty monetization transaction was $12 $4 million in interest expense related to the sale of future revenue, resulting in an EPS impact of 33 loss per share.
As a reminder, this accounting does not and will never represent a cash obligation or payment by the company.
Ernie Toth: Overall, we saw continued strong performance from our existing business, including new opportunities generated with HEISCO, as well as continued contribution from CAHPS. While Suboxone is a legacy product, it remains a significant part of our near-term revenue outlook. This product continued to perform well and exceed expectations in 2021. However, our revenue guidance for 2022 considers that some level of erosion of market share will continue in the future. As Keith mentioned previously, Ciphan Generated Sequential Quarterly Revenue Growth for the 12th Stray Course.
Overall, we saw continued strong performance from our existing business, including new opportunities generated with HEICO as well as continued contribution of cash.
While suboxone is a legacy product for us it remains a significant part of our near term revenue outlook.
This product continues to perform well and exceed expectations in 2021 are.
Our revenue guidance for 2022 considers that some level of erosion of market share will continue in the future.
As Keith mentioned previously citizen generated sequential quarterly revenue growth for the 12th straight quarter.
Ernie Toth: Our trends in wholesaler shipments of Simpazan to retail pharmacies and growth in new and repeat prescribers represent a very solid 77% increase when you compare the fourth quarter of 2021 with the same period last year. We anticipate continued growth in 2022. In addition to the Continued Strong Business Development Act, we continued our prudent expense management and diligently managed our cash position in order to not only improve results but also extend our capital horizon. As of December 31, 2021, Cash and Cash Equivalents were $28 million during the fourth quarter of 2020.
Our trends on wholesaler shipments of samples and to retail pharmacies and growth in new and repeat prescribers represent a very solid at 77% increase when you compare the fourth quarter 2021, with the same period last year.
We anticipate continued growth in 2022.
In addition to the continued strong business development activities.
We continued our prudent expense management and diligently managing our cash position in order to not only improve results, but also extend our capital horizon.
As of December 31, 2021, cash and cash equivalents were $28 million.
During the fourth quarter 2021, we received $5 $2 million in net proceeds from our at the market or ATM facility.
Ernie Toth: We received $5.2 million in net proceeds from our at-the-market or ATM facility. For the year ended December 31st, 2021, we received $29.8 million in net proceeds from our ATM facility. We expect that our existing cash and cash equivalents, as well as revenue from our ongoing manufacturing operations and commercialized products. Continuing Business Development Act and Prudent Expense Management Actions combined with ATM activity will provide adequate funds and meet expected cash requirements for the next 12 months. While we have not been accessing the ATM recently, it remains an important tool to support the capital needs of the company.
For the year ended December 31, 2021, we received $29 $8 million in net proceeds from our ATM facility.
We expect that our existing cash and cash equivalents revenue from our ongoing manufacturing operations and commercialized products continuing business development activities and prudent expense management actions combined with ATM activity will provide adequate funds and media.
Expected cash requirements for the next 12 months.
While we have not been accessing the ATM recently it remains an important tool to support the capital needs of the company.
Ernie Toth: Separately, we expect the potential launch of LiberVant, if granted U.S. market access by the FDA, to be funded by the additional $30 million of contingent funds available as part of the existing 12.5% note. Looking forward, we expect royalty streams from license agreements to contribute to our future revenue. These royalty streams include Astaris, which was launched in 2021 by Corium under license from Chemco; Suboxone in markets outside of the U.S. within W. Excervant in the U.S. with Mitsubishi Tanabe in the E.U. with Zamboni, and has recently been announced in China with high sales as well as the launch of Undancetron by Hypera in Brazil following their recent approval.
Separately, we expect the potential launch of liver band if granted U S market access by the FDA to be funded by the additional $30 million of contingent funds available as part of the existing 12, 5% notes.
Looking forward, we expect royalty streams from license agreements to contribute to our future revenue.
These royalty streams include as tourists, which was launched in 2021 by corium under license from Chem farm.
<unk> zone in market outside of the U S with <unk>.
Extra ban in the U S with Mitsubishi Tanabe in the EU with Zamboni and as recently announced in China with High school as well as the launch of Ondansetron by high PURA in Brazil. Following the recent approval.
In addition to contributing revenue in cash to the company. These assets also represent potential opportunities to monetize streams or royalties as we did for the kind of movie royalties.
Ernie Toth: In addition to contributing revenue and cash to the company, these assets also represent potential opportunities to monetize streams of royalties, as we did for the Kainmobi Royalty. As outlined in the press release issued last night after the market closed, we issued our full-year 2022 financial guide. Sipazan Growth, the continued strong performance of our manufacturing and supply operations, and our other ongoing business activities are expected to provide strong operating results during 2022.
As outlined in the press release issued last night after market close we issued our full year 2022 financial guidance.
Citizens growth the continued strong performance of our manufacturing and supply operations and our other ongoing business activities are expected to provide strong operating results during 2022.
Spending in R&D is projected to accelerate as we continue development of <unk> 109 during 2022.
Moreover, we have taken steps to continue to strengthen our capital position.
Ernie Toth: Spending on R&D is projected to accelerate as we continue the development of AQST 109 during 2022. Moreover, we have taken steps to continue to focus on our capital position. As such, we are providing our full-year financial expectations as follows: total revenues of approximately $42 million to $47 million, non-GAAP adjusted gross margin of approximately 70% to 75%, and non-GAAP-adjusted EBITDA loss of approximately $51 million to $58 million.
We are providing our full year financial expectations as follows total revenues of approximately $42 million to $47 million non.
non-GAAP adjusted gross margin of approximately 70% to 75%.
And non-GAAP adjusted EBITDA loss of approximately $51 million to $58 million.
Operator: It is worth reiterating that this 2022 financial guidance does not include any revenues from, and will not until U.S. market access is certain and the launch is underway. In summary, our 2022 guidance for full-year, non-GAAP-adjusted EBITDA loss reflects a lower-projected revenue base from suboptimal, partially offset by steady growth in Sympathan and significant additional focus R&D investments related At the same time, we will continue to prudently manage our costs across our business to be as capital efficient as possible.
It is worth reiterating that this 2022 financial guidance does not include any revenues from river Bend, and we will not until U S market access is certain and the launch is underway.
In summary, our 2022 guidance for full year non-GAAP adjusted EBITDA loss reflects a lower projected revenue base from suboxone.
Partially offset by steady growth in <unk> and significant additional focused R&D investments related to the advancement of <unk> 109.
At the same time, we will continue to prudently manage our cost across our business to be as capital efficient as possible.
Operator: With that, I will now turn the line back to the operator to open the line for questions. As a reminder, to ask a question, please press star then 1. If your question hasn't been answered and you wish to remove yourself from the queue, press the pound key.
With that I will now turn the line back to the operator to open the line for questions.
As a reminder to ask a question. Please press Star then one if your question has been answered and you wish to remove yourself from the queue press the pound key.
Gary Nachman: Our first question comes from Gary Nachman with BMO Capital Markets. Your line is open. Hi, good morning, guys. Regarding FDA's communication on LibraVan, so we know it's the ODE that's holding it up, but how much back and forth have you had with them, Keith, or did they just send you that update in February that you quoted, and did you provide them with any additional information demonstrating it's a major contribution to patient care either upon request or proactively? And if there's no update on the timing of their decision, what are you able to do in terms of launch preparations without spending too much given some of your capital constraints? Sure. Thanks, Gary. Thanks for joining us.
Our first question comes from Gary Nachman with BMO capital markets. Your line is open.
Yes.
Hi, good morning, guys.
Regarding fda's communication on Libre van So we know it's the OE that's holding it up.
How much back and forth have you had with then Keith or they just sent you that update in February that you quoted and did you provide them with any additional information demonstrating its a major contribution to patient care either upon request or proactively.
And if there is no update on timing of their decision what are you able to do in terms of launch preparation without spending too much given some of your capital constraints.
Sure. Thanks, Kerry thanks for joining and thanks for the question.
Keith Kendall: Thanks for the question. Let me take the question in pieces. We submitted a number of documents and arguments, even clinical data, to support our major contribution to patient claims throughout the process. We've touched the agency in a number of different ways since we got the original notice, including interacting with the commissioner's office, with the head of CDER, with the project team, and even the Office of General Counsel to try to understand, A, what the issue was and what the timing would be. In each case, they've assured us that they're working actively on it, but they don't have a time frame. You know, this is an important product for this patient population. You can see the data here.
Let me let me take the question in pieces.
We submitted.
A number of documents.
And arguments.
Clinical data to support our major contribution to patient.
Jim.
Throughout the process.
We've touched the agency in a number of different ways since we got the original notice.
<unk> interacting with the Commissioner's office with the head of Cedar.
With the project team and even the office of General Counsel.
To try to understand what the issue was and what the timing would be.
In each case, they have assured us that.
Working they are working actively on it but don't have a timeframe.
Keith Kendall: A good portion of the patient population is still without a product that they think is attractive to them, so we're working hard to get that. The agency has continued to take the position at this point that there's nothing more that they need from us but that they have more work to do. So we'll continue to interact with them in whatever way we can to try to move this along, but right now, it appears that they've got work to do internally, and we'll support it when asked. The last part of your question, I'm sorry, was about launch preparation.
This is an important product for this patient population.
You can see the data.
A good portion of the patient population is still without a product that they think is attractive to them.
So we're working hard to get through that the agency has continued to take the position at this point that.
Theres nothing more that they need from us.
They have more work to do so we will continue to interact with them in whatever way, we can to try to move this along but.
Right now it appears that they've got work to do internally and we will support it where it is.
The last part of your question I'm, sorry was about launch preparation, obviously, where the biggest part of our spend and the launch is going to be building out the sales force as you know we've got a sales force in place for Suzanne what we've always looked at that sales forces.
Keith Kendall: Obviously, the biggest part of our spend on a launch is going to be building out the sales force. As you know, we've got a sales force in place for Symposan. We've always looked at that sales force as the kind of advanced beachhead party for launching LiberVant.
Kind of Advair.
Advanced beachhead party.
Launching liver man, we're not going to build up the sales force until we have knowledge of an approval and access to the market, but in terms of positioning kols positioning prescribers and you recall that is.
Keith Kendall: We're not going to build up the sales force until we have knowledge of an approval and access to the market. But in terms of positioning KOLs, positioning prescribers, and you recall that there's a very, very high degree of overlap between Symposan prescribers and potential LiberVant prescribers. Helping them understand what that product could be, if it's approved and granted access, and having them positioned to be prepared to write as quickly as it's launched are all things we'll continue to do until we can build out the sales force. Okay, great. And then just a couple more on epinephrine.
Very very high degree of overlap between <unk> prescribers and potentially prevent prescribers, helping them understand what that product could be if it is approved and granted access and having them positioned.
To be prepared to write as quickly as its launched are all things. We will continue to do until we can build up the sales force.
Okay, Great and then just a couple more on epinephrine, so part two of <unk>.
Keith Kendall: So, part two of Epifast, how many patients will that include? And which dose or formulation are you evaluating for that? And at this point, what do you expect will be involved in the pivotal PK study, if you have some visibility on that? And then for RNA, just how much is left on the ATM that you can tap into? And the 30 million contingent debt, if LibraVan gets market access, any, you know, additional restrictions on that, or limitations in terms of timing?
How many patients will that include them.
Which dose formulation are you evaluating for that.
And at this point, what do you expect will be involved in the pivotal PK study. If you had some visibility on that and then for Ernie just how much is left on the ATM that you can tap into and the $30 million contingent debt.
Liberal van gets market access any.
Additional restrictions on that.
Our limitations in terms of timing and could it be possible to push that out again.
Keith Kendall: And could it be possible to push that out again if you don't hear from the FDA? Let me go backwards, and then I'll leave you with Professor Barber on the up and we, we, I think that $30 million will be available to us at whatever time we have a decision on market access for Liver Van. Our debt holders have been incredibly cooperative and collaborative up to this point.
You don't hear from the FDA.
Let me, let me go backwards and then I'll leave you with.
Professional farmer on the epinephrine questions Okay.
We certainly are.
Think that $30 million will be available to us at whatever time, we have decision for.
Market access for <unk>.
Our debt holders have been incredibly cooperative and collaborative up to this point, we see no reason why.
Keith Kendall: We see no reason why they wouldn't continue to be at this point. As you know, we've moved that date back now two or three times already based on FDA actions. There's probably just under $40 million left on the ATM at this point in time, give or take $1 or $2.
They wouldn't continue to be at this point as you know we've moved that date back two or three times already based plus.
FDA actions.
It's probably just under $40 million left on the ATM at this point in time give or take a dollar or two.
We have not been in the ATM market very much recently, so that number has been stable since around the end of the end of the year.
Keith Kendall: We have not been in the ATM market very much recently, so that number has been stable since around the end of the year. And I'll let Dan walk you through the epinephrine questions. Good morning, Gary.
And.
Dan Walk you through the epinephrine questions wondering Gary.
Daniel Barber: So, there are 24 subjects in Part 2, and just as a reminder, this is a partial replicate crossover study with the 0.3 milligram I am. In part one, we compared ourselves to the 0.5, which is a higher dose, seldom used version of the I, and what you'll see in part two is a nice comparison to the product that is used almost exclusively in the market. So we're excited to see that data because that will give us a really good data set on how we compare to what could be our reference-listed product as we go into this pivotal study. In terms of the formulation that we put in, I wouldn't focus so much on the different iterations that we have done in the first human trial and in part one.
There is 24 subjects in part two.
And just as a reminder.
This is a partial replicate crossover study with <unk> three.
Eight milligram I and so in part one we compared ourselves to the 0.5, which is a higher dose seldom used version of the iam and what Youll see in part two is a nice comparison to the product that is used almost exclusively in the marketplace. So we're excited to see that.
Is it because that will give us a really good.
Dataset on how we compare to what could be our reference listed product.
As we go into the pit.
Study.
In terms of the formulation that we put in.
I wouldn't focus so much on the different iterations that we have done in the first in human and in part one I think the way we would have you think about it and frame. It is we have a formulation. We're really excited about we think the formulation has really good potential to be the commercial formulation. It's the <unk>.
Daniel Barber: I think the way we would have you think about it and frame it is that we have a formulation we're really excited about. We think the formulation has really good potential to be the commercial formulation. It's the right size for patient use.
<unk> size for patient use it has the right components and the results. We saw in part one we used to believe that we will get the right.
Daniel Barber: It has the right components, and the results we saw in part one lead us to believe that we'll get the right comparison to the 0.3 IM out of part. So what you'll see us do is obviously complete part two. We'll go right into part three, and before the end of the second quarter, we'll have our entire fast study result available. And that'll be a spot where we can really show you where we are as a program.
Comparison to the 0.3 I am out of part two.
So what Youll see US do is obviously complete part two.
We will go right into part three and before the end of the second quarter, we will have our entire as affect study results available and that will be a spot where we can really show you where we are.
As a program out of that will go meet with the FDA as we've as we've talked about before and after that meeting with the FDA. We would start our pivotal study. So if we continue to get the results that we expect yes, the formulation and part two would be the one we see in the pivotal study, but obviously clinical development product development.
Daniel Barber: Out of that, we'll go meet with the FDA, as we've talked about before. And after that meeting with the FDA, we would start our pivotal study. So if we continue to get the results that we expect, yes, the formulation in Part 2 would be the one we see in the pivotal study. But obviously, clinical development and product development are processes, and we'll see how the results unfold as the year goes on. Okay, that's helpful.
Is the process and we'll see we'll see how the results unfolded as the year goes on.
Yes.
Okay. That's helpful. Thanks, guys.
Daniel Barber: Thanks, guys. Our next question comes from Jason Butler with J&P Securities. Your line is open. Hi, thanks for taking the questions. I had a couple on epinephrine.
Our next question comes from Jason Butler with JMP Securities. Your line is open.
Jason Butler: Can you maybe expand a little bit more on the data that you'll get from Part 2 and Part 3 and what it actually will inform in terms of the pivotal trial design, both in terms of statistical assumptions but also how those data will inform the final commercial product profile? And then, secondly, can you talk about manufacturing capabilities for AQST-109? What else needs to be done to fully integrate the product to be ready in your commercial manufacturing facility and produce those commercial batches? Thanks. Sure. So, and Jason, keep me honest.
Hi, Thanks for taking the questions had a couple on epinephrine.
Can you maybe expand a little bit more on the data that youll get from part two and part three and what actually it will inform in terms of the.
The pivotal trial design you know both in terms of statistical.
Assumptions, but also how has that this data will inform the final commercial product profile and then secondly can you just talk about manufacturing.
Capabilities for.
<unk> 109, what else needs to be done to fully integrate the product to be ready in your commercial manufacturing facility in and produce those commercial batches.
Sure.
Daniel Barber: I want to make sure I understand all of the parts of your questions. So, in part two, we will get a nice crossover look versus the 0.3 IM intramuscular injection, right? So, we'll have a really good look at a variety of measures, not just median Tmax, Cmax, AUC but all of the elements that we know are important to the agency for this particular drug, which would include the partial AUCs, you know, 10 minutes, 20 minutes, time to 100 picograms per milliliter. It seems to be a place that the agency is interested in. And there's also a variety of well-known pharmacodynamic measures, changes in valve flood pressure, and heart rate.
So.
Jason keep me honest I want to make sure I get all of the parts of your question. So in part two.
We will get.
A nice crossover look versus the 0.3.
Intramuscular.
Injection rate. So we'll have a really good look at a variety of measures not just medium T magazine, Max AUC, but all of the elements that we know are important to the agency for this particular drug which would include the partial AUC 10 minutes 20 minutes time too.
100, picogram per milliliter, it seems to be a spot that the agency is interested in and Theres also a variety of well known pharmacodynamic measures changes in systolic blood pressure heart rate those all of those measures will have a nice.
Daniel Barber: All of those measures will have a nice amount of data out of Part 2. The other thing we're doing in Part 2 is the IM is a replicate design. So you asked how we are, what we are doing to inform the pivotal studies. We'll be able to use the replicate portion of Part 2 to really define patient size or subject size, excuse me, that we will need in the pivotal study. And you can see from those who've come before us that given the variability of epinephrine, especially as we've seen in the injection form, those PK studies can be larger than usual, right? I think in the case of OB-GYN, with their pivotal study, it was over 80 subjects.
Amount of data out of part two the other thing we're doing and part two is the.
<unk> is a replicate design so.
How are we what are we doing to inform the pivotal study.
We will be able to use the replicate portion of part two to really define patient size are subject size excuse me that we will need in the pivotal study and you can see from those who've come before us that.
Given the variability of epinephrine.
Especially as we've seen in the injection form.
Dose PK studies can be larger than usual right I think.
In the case of <unk> with their pivotal study it was over 80 subjects. So we would expect part two to help inform us on that.
Daniel Barber: So we would expect Part 2 to help inform us on that. Part 3 is more about showing the agency how our product... will perform, call it that under conditions of use. So if someone has a peanut butter and jelly sandwich and then takes our film, if someone has a cold liquid and then takes our film, that's some of the data that we'll get out of part three.
<unk> three is more about showing the agency how our product.
Well performed call it under conditions of use so if someone has a.
Our peanut butter jelly Sandwich, and then Pixar film if someone has a cold liquid and that takes our film. That's some of the data that we'll get out of part three and that will allow us when we go to the FDA to show.
Daniel Barber: And that will allow us, when we go to the FDA, to show a robust package and get them comfortable with our program. I think the last part of your, question was on manufacturing capabilities, that process, the tech transfer and scale-up process is already underway, and we continue to plan on being through that process before we get too far into the fall, so one of the things you'll look for in that is when we're able to say we've made our registration batches, and put product on stability because that will be a key moment or milestone in that process. Jason, did I answer all of your questions?
Buck package and get them comfortable with our program.
I think the last part of your.
Question was on manufacturing capabilities that processes.
<unk>.
Tech transfer and scale up process is already underway.
And we continue to plan on being through that process.
Before we get to.
Too far into the fall.
One of the things Youll look forward and that is when we're able to say we've made a registration batches and put products on stability because that will be a key moment or milestone in that process. Jason did I answer all of your questions. Yeah. That's great. Thanks, Dan really appreciate it.
Our next question comes from Thomas Flaten with Lake Street Capital. Your line is open.
Daniel Barber: Yes, that's great. Thanks, Dan. Really appreciate it. Our next question comes from Thomas Flaten with Lake Street Capital. Your line is open. Good morning, guys. Without wishing to antagonize the agency, are there any other remedies available to you?
Good morning, guys.
Thomas Flaten: Are there citizen petition like activities that patient groups could undertake or anything like that that could, you know, put the pressure on the agency? You started out by saying not wanting to antagonize the agency and then picked probably one of the things that would be the most antagonistic to use as an example. We're trying the best we can, Thomas, to interact with them. We've had a good relationship with them over the years, right?
Without wishing to antagonize. The agency are there any other remedies available to you or their citizens petition like activities that patient groups could undertake anything like that that could now up to up the pressure on the agency.
You are.
You started out by saying not wanting to antagonize the agency and then take the probably one of the things that would be the most in tagging to speak to use as an example.
We are trying the best we can.
I missed to interact with them.
We've had we've had a good relationship with them through the years right. We built it on.
Thomas Flaten: We built it on a principle of being collaborative, being open with them, dealing with problems head on, not trying to kind of opaquely get around things. We've had a good relationship with this division. We'd like to keep it that way, but at the same time, we do believe they have an obligation, and we do believe it's inappropriate to miss commitment dates and then have an unlimited and undefined period of time with which to do the work that they're charged with.
We built it on a principle of being collaborative being open with them dealing with problems head on I'm not trying to kind of opaque we get around things we had a good relationship with this with this division.
To keep it that way, but at the same time, we do believe they have an obligation.
We do believe it's inappropriate to mis commitment dates and then have a unlimited.
An undefined period of time with which to do the work. They are charged with as I said earlier, we have interacted with the Commissioner's office, we have interacted with the commissioners outlets person, we have interacted with the head of Cedar.
Keith Kendall: As I said earlier, we have interacted with the Commissioner's Office, we have interacted with the Commissioner's Ombudsperson, we have interacted with the head of CDER, and with the project team. We'll continue to do that, we'll try to find ways to do it in a non-antagonistic way, but we deserve an answer, and we want to drive to one. So yeah, we may get more aggressive as time goes on, but we're going to try to do it in as constructive a way as we possibly can. I just walked a tightrope there.
And with the project team.
I'll continue to do that we'll try to find ways to do it in a non antagonistic way.
We deserve an answer and we want to drive to one so yeah. We may get more aggressive as time goes on but we're going to try to do it in as construct pupil way as we possibly can.
I just what's the tight rope there I hope you appreciate that.
Keith Kendall: I hope you appreciate that. But we're certainly not going to come out guns blazing while we're trying to work with them to get to the right outcome. Got it. And then, one for Ernie. You mentioned in your prepared comments the opportunity for future royalty monetization deals. Is that something you would consider if Fliverband continues to be delayed? Or is that part of the plan regardless of what happens with Fliverband? [inaudible] Yeah, I think in my comments, Thomas, I mentioned a variety of products that we have that are commercialized and produced. Our royalties, I think we could be opportunistic to monetize any or all of those royalties, and the preventative measures, certainly if approved, could fall into that basket. I got it.
We're certainly not going to come out with guns blazing, while we're trying to work with them to get to the right outcome.
Got it and then one for Ernie you mentioned in your prepared comments the opportunity for future royalty monetization deals is that something you would consider if <unk> continues to be delayed or is that part of the plan regardless of what happens with liberum.
I think in my comments, Tom as I mentioned, a variety of products that we have that are that are commercialized in producing royalties I think we would be we could be opportunistic to monetize.
Any or all of those royalties and prevent certainly if approved.
Quick fall into that basket.
Got it I appreciate it guys. Thank you.
Yeah.
Ernie Toth: I appreciate it, guys, thank you. Our next question comes from Ram Selvaraju with H.C. Wainwright. Your line is open.
Our next question comes from Ron Silverado with H C. Wainwright Your line is open.
Ram Selvaraju: Thanks very much for taking my questions. Firstly, I just wanted to get a quick clarification on some of the language in the press release that pertains to the timing with which you expect commercialization of Liver Vent to occur, assuming approval. Can you just clarify how quickly you expect the product would be available once you were to receive approval, if that occurs? Sure.
Thanks, very much for taking my questions. Firstly I just wanted to get a quick clarification.
On some of the language in the press release that pertains to the timing with which you expect commercialization of liver event to occur.
Sumit approval can you just clarify how quickly you expect the product would be available.
Once you were to receive an approval if that occurs.
Sure.
Keith Kendall: As we've said before, Ram, we certainly believe that the strategy that we employed of launching Symposan first into the prescriber community that will be interested in liver vans is going to help us commercialize liver vans when it is available. We are intent to get the product into distribution as quickly as we can get into prescriber offices and get LibraVant onto their prescription path for some of their patients.
As we've said before ROM, we we certainly believe that the strategy that we employed of launching Susanne first into the very prescriber community that will be interested in liver math isn't going to help us commercialize liver event when it is approved.
Keith Kendall: That's as quickly as we'll launch LibraVant with the existing Salesforce. In parallel, the minute we know we're going to be granted market access in the United States, we'll begin building out the sales team; we'll wind up with 60 plus. Prescriber-focused, facing people out in the field, trying to drive that business.
We our intent would be as quickly as we can get product into distribution as quickly as we can get into prescriber offices.
And jetblue prevent onto their prescription pads for some of their patients.
Quickly as.
We will launch live event with the existing sales force in parallel.
We know we're going to be granted market access in the United States.
We will begin building out the sales team will wind up with.
60, plus.
Prescriber focused facing people out in the field trying to drive that business.
Keith Kendall: But we won't build out the sales force until we have clear... P.A. So, we have to get visibility into that market access. But the existing sales force is trained, they're prepared, and as soon as we have product to distribute in the forward distribution centers, it's as fast as LibraVent will start to be written in February. Can you also comment on your 2022 guidance and what specifically is in it relating to liver vent, if anything, at this juncture?
We won't build out the sales force until we have clear.
Visibility into that market access, but the existing sales force is trained they're prepared and as soon as we have products to distribute in the forward distribution centers is as fast as <unk> will start to be written and filled.
Can you also comment on your 2022 guidance and.
What specifically is in there relating to Liberum if anything at this juncture.
Keith Kendall: I think we were pretty clear in the prepared remarks that we have not included any revenue in the guidance for the liver ban, and we won't until the product is approved by the U.S. FDA for market access and it is launched. So there is zero revenue in there this year in the guidance.
I think we were pretty clear in the prepared remarks that we have not included any revenue.
In the guidance for rubber band and we Wouldnt until the product is approved by the U S. FDA for market access and it is launch so there is zero revenue in there this year.
Guidance.
Okay, and then with respect to additional non U S business development activities.
Keith Kendall: Okay, and then with respect to additional non-US business development activities, you know, we saw the XRVAN China licensing deal recently. Can you comment on whether we should expect any other potential transactions in that vein? And if so, which elements of your portfolio are most likely to be the subject of such transactions, you know, to whatever extent you're able to comment on that at this point?
We saw recently the extra Pan China licensing deal can you comment on whether we should expect any other potential transactions in that vein and if so.
Which elements of your portfolio are most likely to be the subject of such transactions you know if to whatever extent, you're able to comment on that at this point also in future.
Ram Selvaraju: Also, in the future, if you have a portfolio of those non-US kind of regional deals that may ultimately wind up generating revenue, can you comment on strategically thinking about potentially monetizing those most effectively? And if you might seek to do things that are similar to what you did with the Kinmovi royalty stream going forward. Obviously, those are hypotheticals, but just wanted to get your take on that at this point.
You have a portfolio of those non U S kind of regional.
Deals that may ultimately wind up generating revenue.
Can you comment on strategically how we're thinking about potentially monetizing those most effectively and if you might seek to do things that are similar to what you did with the Kid Mobi royalty stream going forward. Obviously those are hypotheticals, but just wanted to get your take on that at this time.
Keith Kendall: No, that's a great question. Thanks, Ram. Look, we are. Our core business continues to do a pretty good job of creating cash and opportunities for us. You know, we've announced a number of deals over the last few years, and we'll continue to search for those. Our strategy currently is we'll focus on marketing in the United States, and we'll license outside the United States for the core proprietary products, like Sips Van and Liver Vans and others. You know, our strategy is to extract whatever value we can out of the assets we have in our portfolio, whether they're already approved in the United States or not. Exervan is a good example.
No. That's a great question. Thanks ROM look we are our core business continues.
To do a pretty good job of creating cash and opportunities for us.
We've announced a number of deals over the last few years and will continue to search for those are.
Our strategy currently use will focus on marketing in the United States.
And we'll license outside the United States for the for the core proprietary products like Suzanne and different vantage than others.
Our strategy used to extract whatever value we can out of the assets we have in our portfolio.
Whether theyre already approved in the United States or not.
And.
Keith Kendall: We've got three different deals relating to that. Zooplens is another good example, which announced the deal last year, and Hypera just got regulatory approval in Brazil. So we'll continue to look at those opportunities. Obviously, LIBRIVANT, once it's clarified here in the United States, is potential for deals outside the United States. We'll continue to look for ways to extract value out of our assets, as we always have, and I think we've done, frankly, a very good job. Loyalty Streams are... a great optionality to have, right?
Extra van is a good example, we've got three different deals relating to that.
<unk> is another good example.
Announced the deal last year in high parents, just getting approval in Brazil. So we'll continue to look at those opportunities obviously.
They prevent once.
Clarified here in the United States.
Potential for deals outside the United States, we'll continue to look for ways to extract value out of our assets as we always have and I think we've done frankly, a very good job of that.
Royalty streams are.
Oh, great Optionality to have right.
Keith Kendall: We will always evaluate whether or not they're more valuable as cash flow periodically to us as the royalty payments are made or whether they represent an opportunity to be monetized, much as we did with Ken Moby in one transaction that provides a slug of cash and some potential upside over time. We, you know, wanted to be clear to people who look at our cash balance and our spend and do simple math and talk about the cash horizon that there are other opportunities for cash on our balance sheet.
All of these will evaluate.
Whether or not theyre more valuable as cash flow periodically to us is the royalty payments are made or whether they represent an opportunity to monetize as much as we did with <unk>.
In one transaction that provides a slug of cash and some potential upside over time.
We wanted to be clear to people, who look at our.
Cash balance at our spend and do simple math and talk about cash horizon that there are other opportunities for cash.
On our balance sheet.
Keith Kendall: Actually, they may not even be cash on our balance sheet in the case of the $30 million available under the debt facility, but there are sources of capital, and these royalties represent that, that we have available to us as we go forward. As each of those products that are generating royalties matures and ages in their respective markets, we'll continue to monitor what the royalty monetization market is willing to pay for them, and we will make a choice about whether or not they're more valuable as cash flow or they're more valuable as a transaction. But they represent assets to us in either case.
Actually they may not even be cash on our balance sheet in the case of the $30 million available under that facility that there are sources of capital and these royalties represent that.
That we have available to us as we go forward as each of those products that are generating royalties mature and age in their respective markets will continue to monitor.
What the royalty monetization market is willing to pay for them and make a choice about whether or not they're more valuable is cash flow, where theyre more valuable as a transaction, but they represent assets to us in either case.
Thank you.
There are no further questions I'd like to turn the call back over to Keith Kendall for any closing remarks.
Operator: Thank you. There are no further questions. I'd like to turn the call back over to Keith Kendall for any closing remarks. Great, thank you, operator.
Keith Kendall: Thank you, everyone, for joining us this morning. We appreciate it, as always. We appreciate your questions and a chance to address them with you. We've got a lot of exciting things in front of us, and obviously, trying to resolve the FDA's decision around Livervant is job number one. And job number one, obviously, is taking epinephrine and AQST 109 through the rest of the FFES study, getting back to the agency, and moving toward our pivotal trials at the end of the year if all goes as planned and hoped.
Great. Thank you operator, thank you everyone for joining us. This morning, we appreciate it as always we appreciate your questions and the chance to address that with you.
We've got a lot of exciting things in front of US obviously trying to resolve the fda's.
Decision around liver Vance is job number one.
And job number one obviously is taking.
<unk> one O nine through the rest of it yet fast study getting back to a discussion with the agency and moving toward our pivotal trials at the end of the year.
<unk> works is as planned and hoped.
Keith Kendall: We look forward to keeping you updated on all of these, and I know we'll be talking to you in another 60 days or so, but at the end of our first quarter, so we look forward to that as well. And again, thank you for joining us, and we'll talk to you all soon. This concludes the program. You may now disconnect. Everyone, have a great day. [music] BF-WATCH TV 2021 BF-WATCH TV 2021 BF-WATCH TV 2021
We look forward to keeping you updated on all of those.
And I know, we'll be talking to you in.
Another 60 days or so at the end of our first quarter. So we look forward to that as well and again. Thank you for joining us and we'll talk to you all soon.
This concludes the program and you may now disconnect everyone have a great day.
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