Q2 2021 Aquestive Therapeutics Inc Earnings Call
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Okay.
Operator: Good day, and thank you for standing by. Welcome to the second quarter, 2021, a quarterly qualitative therapeutic earnings 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 this session, you'll need to press star 1 on your telephone. Please be advised that today's conference may be recorded. I would now like to hand the conference over to your speaker today, Stephanie Carrington from Investor Relations. Please go ahead.
Good day and thank you for standing by welcome to the second quarter 2021, Acquisitive Therapeutics earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star 1 on your telephone please.
Please be advised that today's conference may be recorded I would now like to hand, the conference over to your Speaker a day, Stephanie Carrington with Investor Relations. Please go ahead.
Thank you operator.
Stephanie Carrington: Thank you, operator. Good morning and welcome to today's call. On today's call, I am 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 second quarter of 2021, followed by a Q&A session. In total, we expect today's call to last approximately 60 minutes.
Good morning, and welcome to today's call on today's call I am joined by Keith Kendall, Chief Executive Officer, and Ernie talked Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the second quarter 2021 followed by a Q&A session. In total we expect today's call to last approximately.
On the 60 minutes.
Stephanie Carrington: 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 a Questus website within the investor section shortly following the conclusion of this call. To remind you, the EQUESIF team will be discussing some non-GAAP financial measures this morning as part of its review of the second quarter of 2021 results. A description of these measures, along with a reconciliation to GAAP, can be found in their earnings release issued yesterday, which is posted on the investor relations section of Equestive's website.
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 our questions website within the investors section shortly following the conclusion on this call.
To remind you request a team will be discussing some non-GAAP financial measures. This morning as part of its review of second quarter of 2021results.
A description of these measures along with a reconciliation to GAAP can be found in their earnings release issued yesterday, which is posted on the Investor Relations section other questions website. During the call the company will be making forward looking statements.
Stephanie Carrington: 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 factor section and other sections, including, in our annual report on Form 10K, filed with the Securities and Exchange Commission on March 10, 2021, and in our quarterly reports on Form 10Q and current reports on Form 8K with the SEC.
And you of the Companys Safe Harbor language as outlined in yesterday's earnings release as well on the risks and uncertainties affecting the company as described in the risk factors section and other sections, including.
In our annual report on form 10-K filed with the Securities and Exchange Commission on.
On March 10, 2021, and in our quarterly reports on form 10-Q and in current reports on form 8-K with the SEC.
As with any pharmaceutical company with product candidates under development and product candidates being commercialized.
Stephanie Carrington: As with any pharmaceutical company, with product candidates under development and product candidates 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. 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 made.
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. 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 day.
Actual results may differ materially from these statements all forward looking statements attributable to classes 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.
Stephanie Carrington: Actual results may differ materially from these 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 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.
The company assumes no obligation.
To update its forward looking statements. After the date of this conference call, whether a result of new information future events or otherwise, except as required under applicable law with that I will turn the line over to Keith.
Keith Kendall: Thank you, Stephanie, and thank you to everyone on the call for joining us this morning. In our remarks today, Ernie and I will be discussing recent developments in our business during the second quarter of 2021 and through July. As always, Ernie and I will be joined by additional members of the requested leadership team during the Q&A session. After the Q&A session, I want to welcome Ernie on his first earnings call as our new CFO after serving in an interim role for us since last December. I and all the management team look forward to continuing to have Ernie on the team and contributing his experience to the growth of the company.
Thank you Stephanie and thank you for everyone on the call for joining us this morning.
In our remarks today, Ernie and I will be discussing recent developments in our business during the second quarter 2021 through July.
There's always Ernie and I will be joined by additional members of your question leadership team during the Q&A session.
I want to welcome Ernie on his first earnings call as our new CFO.
Serving in an interim role for us since last December.
And all the management team look forward to continuing to have already on the team and contributing his experience to the gross growth question.
Through the second quarter, we were able to execute as we committed on our key priorities and delivered a number of important milestones that will talk about this morning.
Keith Kendall: Through the second quarter, we were able to execute as we committed to our key priorities and delivered a number of important milestones that we'll talk about this morning. First and foremost, we continue to focus on building our CNS franchise. In mid-July, the FDA accepted for filing the resubmission of our NDA for Livervan, a buckle film under the management of Caesar Cluss. The FDA is assigned the PDUFA target goal date of December 23, 2021.
First and foremost we continue to focus on building our CNS franchise.
In mid July the FDA accepted for filing the resubmission of our NDA for liver fat.
Buccal film for the management of seizure clusters.
The FDA has assigned to produce a target goal date of December 23rd 2021.
As you May recall, our quest of received a complete response letter from the FDA in September of 2020.
Keith Kendall: As you may recall, a quest received a complete response letter from the FDA in September of 2020, completed a type A meeting with the FDA in November of 2020, and received further guidance from the FDA in February of 2021. Based on the agency's guidance, the submission included additional statistical modeling and supporting analyses of the existing clinical data.
Completed a type a meeting with the FDA in November of 2020 and received further guidance from the FDA in February of 2021.
Based on the agency's guidance. The submission included additional statistical modeling and supporting analyses of the existing clinical data.
Keith Kendall: The company continues to believe that no additional clinical studies will be required for FDA approval of Livervan. Leibovant, if approved, represents a significant addition to the treatment options available to this patient. We're pleased with the FDA's decision to accept for review the Libravan NDA and remain committed to filling the unmet need for a non-invasive, innovative product for the manager of seizure clusters in the underserved population of We are developing Libravant as an alternative to more invasive, inconvenient, and difficult to administer device-driven products, including erectile gel, for patients with refractory epilepsy. As a result of issues these patients have with their current alternatives, a large portion of the patient population does not receive adequate treatment or foregoes treatment altogether.
Company continues to believe that no additional clinical studies will be required for FDA approval of liver fat.
<unk> if approved represents a significant addition to the treatment options available for this patient group.
We're pleased with the Fda's decision to accept for review deliver van NDA and remain committed to fill the unmet need for a non invasive innovative product for the manager of seizure clusters in the underserved population of refractory epilepsy patients.
We are developing liberman is on alternatives to more invasive inconvenient and difficult to administer device driven products, including a rectal gel for patients with refractory epilepsy.
As a result of issues. These patients have with their current alternatives a large portion of the patient population does not receive adequate treatment or for goes treatment altogether.
Keith Kendall: We continue to believe that Libervant, if approved by the FDA, will enable a larger share of these patients to receive more appropriate treatment by providing consistent, therapeutic dosing in a non-invasive, innovative, and preferred treatment form. Regarding FDA approval for U.S. market access, we believe that we've provided a strong set of facts supporting a decision by the FDA of clinical superiority to prior approved drugs for this indication, in order to overcome orphan drug exclusivity based upon a finding that Libervant represents a major contribution to patient care.
We continue to believe that liver van if approved by the FDA will enable a largest share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a noninvasive innovative and preferred treatment for them.
Regarding FDA approval for U S market access we believe that we've provided a strong set of facts supporting a decision by the FDA clinical superiority to prior approved drugs for this indication.
In order to overcome orphan drug exclusivity.
Based upon a finding that liver event represents a major contribution to patient care.
Now that the FDA has accepted for filing the NDA for live event and have signed up to do for gold day in December of 2021, we have re engaged with the agency and we will update our prior communications to demonstrate our position that liver Vance as an orally delivered product meets.
Keith Kendall: Now that the FDA has accepted for filing the NDA for Libervant and assigned a Bedoufa goal date of December of 2021, we have re-engaged with the agency and will update our prior communications to demonstrate our position that Libervant, as an orally delivered product, meets one or more of the following FDA criteria to be considered a major contribution to patient care, convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease You've completed additional analyses related to the commercial opportunity, including patient needs and preferences and Libravan's attributes relative to other available products.
1 on more of the following FDA criteria to be considered a major contribution for patient care.
Genius of treatment location duration of treatment treatment patient comfort reduced treatment burden.
Advances in ease and comfort of drug administration and longer periods between doses.
We continue to refine our plan for the commercial launch of liver man.
Completed additional analyses related to the commercial opportunity inclusive of patient needs and preferences and liberal Vance attributes relative to other available products.
We have started to prepare for commercial launch of Liberal rent if approved for U S market access as soon as possible after that approval.
Keith Kendall: We've started to prepare for a commercial launch of Libervant, if approved, for U.S. market access as soon as possible after that approval. Upon approval, we expect to launch with the existing Salesforce platform and then plan to expand further in 2022. We anticipate that capital available within our existing debt facility will be available if we choose to support the launch of this product. We continue to believe Libervant is an important new choice for epilepsy patients in a form they prefer.
Upon approval, we expect to launch with the existing sales force and then plan to expand further in 2022.
We anticipate the capital available within our existing debt facility will be available if we choose to support the launch of this product.
We continue to believe Lipper van is an important new choice for epilepsy patients in a form they prefer we remain excited about and believe <unk> continues to be a meaningful opportunity for the company and we will generate material and significant significant sales revenues at peak.
Keith Kendall: We remain excited about and believe Libravant continues to be a meaningful opportunity for the company and will generate material and significant sales revenues at peak. Our next priority is advancing our epinephrine program. As you may recall, this program encompasses two candidates, AQST108 and AQST109. Our first generation candidate, AQST108, was granted fast track designation last year and was given the go-ahead by the FDA to use the 505B2 regulatory development pathway, potentially making the clinical development trajectory faster and cheaper. Moreover, the FDA acknowledged that our sublingual film formulation of epinephrine satisfies an unmet need in the patient population relating to those patients resistant to taking intramuscular or subcutaneous injections.
Our next priority is advancing our epinephrine program as you May recall. This program encompasses 2 candidates <unk> and <unk> T..1 on 9.
Our first generation candidate <unk> do you want on weight was granted fast track designation last year and was given the go ahead by the FDA to use the 505, 2 regulatory development pathway potentially making the clinical development trajectory faster and cheaper.
Moreover, the FDA acknowledged that our sublingual film formulation of epinephrine satisfies an unmet need in that patient population relating to those patients resistant to taking intramuscular or subcutaneous injection.
As such our candidates have the potential to be transformative for this patient population as the first orally administered epinephrine based rescue medications.
Keith Kendall: As such, our candidates have the potential to be transformative to this patient population as the first orally administered epinephrine-based rescue medications. We plan to request a meeting with the FDA in the coming months to discuss the data from the two completed phase one PK trials with AQST 108. The data from the two phase one PK studies demonstrate that AQST108 can consistently deliver epinephrine sublingually, and all subjects had measurable plasma concentrations of epinephrine. Top-line data for QSD108 provides further evidence that we've developed a unique technological solution that can deliver epinephrine sublingually.
We plan to request a meeting with the FDA in the coming months to discuss the data from the 2 completed phase 1 PK trials with <unk> 1 away.
The data from the 2 phase 1 PK studies demonstrate that 8 USD, 1 on weight and consistently deliver epinephrine Sublingual, Inc. And all subjects had measurable plasma concentrations of epinephrine.
The topline data for 8 USD 1 away provides further evidence that we have developed a unique technological solution that can deliver epinephrine Sublingual, Inc.
Keith Kendall: We plan to outline to the FDA our strategy to develop AQSD108 and a separate indication beyond the treatment of allergic reactions, including anaphylaxia. The first Newman P-K study for our second generation candidate, AQST109, a potential oral alternative to injectable epinephrine such as the Epipen, is progressing well.
We plan to the outline we plan to outline to the FDA our strategy to develop 8 USD, 1 on weight and a separate indication beyond the treatment of allergic reactions, including anaphylaxis.
The first in human PK study for our second generation candidate <unk> do you want on 9 a potential oral alternative to injectable epinephrine such as the Epipen is progressing well we're on track to complete part 1 of this 2 part study and obtain.
Keith Kendall: We're on track to complete part one of this two-part study and obtain top-line data in the second half of 2021. We anticipate scheduling a meeting with the FDA shortly thereafter to discuss a path forward for regulatory approval of AQST 109 for anaphylaxis. Finally, our first proprietary commercial product, Sympazan, continues to meet key performance indicators. Throughout the second quarter of 2021, Simpazan Scripps shipped to pharmacies grew 14% quarter over quarter and 57% year over year.
Topline data in the second half of 2021, we.
We anticipate scheduling a meeting with the FDA shortly thereafter to discuss a path forward for the regulatory approval for <unk> T..1 O 9 for anaphylaxis.
Finally, our first proprietary commercial product <unk> continues to meet key performance metrics.
Throughout the second quarter of 2021, simple <unk> continued to perform and grow.
<unk> scripts shipped to pharmacies grew 14% quarter over quarter and 57% year over year.
Our continued growth in prescriptions and net revenue demonstrates our ongoing ability to continue to connect with this group of prescribers, even virtually and grow this product.
Keith Kendall: Our continued growth in prescriptions and net revenue demonstrates our ongoing ability to connect with this group of prescribers, even virtually, and grow this product. Our strategy has always been to have two complementary products available to a common set of prescribers, with Simpazan leading the way prior to a potential launch of Libravan. We feel that our commercial team, with its efforts on Sympazan, has done a good job establishing our footprint. In terms of our position with prescribers, the company's focus group of Simpizan prescribers currently also write over 70% of the rescue scripts for nasal formulations of Diazepa.
Our strategy has always been to have 2 complementary products available to a common set of prescribers with symposia on leading the way prior to a potential launch of liver fat.
We feel that our commercial team with the efforts on Suzanne has done a good job of establishing our footprint. In addition in terms of our position with prescribers. The company's focus group of synthesis and prescribers. Currently also right over 70% of the rescue scripts for nasal formulations of diazepam.
They are familiar with Pharmfilm technology, and the major contribution for patient care potentially provided by liver Vance for epilepsy patients.
Keith Kendall: They are familiar with FarmFIM technology and the major contribution to patient care potentially provided by Librevant to epilepsy patients, and they will be important as we prepare for a successful launch of Livervant once approved. Simpezan also saw continued growth in the prescriber base, with over 30% penetration into the company's focused group of prescribers, with approximately 78% of those prescribers writing multiple scripts. We anticipate that Simpizan sales will continue to expand, and this business will become a net positive cash contributor to the company in 2020.
And they will be in them they will be important as we prepare for a successful launch of Liberum once approved.
Suzanne also saw continued growth in the prescriber base with over 30% penetration into the company's focus group of prescribers with approximately 78% of those prescribers writing multiple scripts.
We anticipate that simple and sales will continue to expand and this business will become a net positive cash contributor to the company in 2022.
Keith Kendall: In conclusion, as we progress through the summer and into the fall, we're focused on advancing our proprietary product. Our team is continuing to focus on the commercial launch of Livervan if it's approved and granted market access following December 21, Purdue Day. If approved, U.S. market access will launch shortly after that approval and immediately begin expanding the sales force at that time. The first in Newman's phase one P-K study for AQST109 for anaphylaxis is progressing, and we anticipate reporting top-line data from part one of this two-part study in the second half of 21.
In.
<unk> as we progress through the summer and into the fall we're focused on advancing our proprietary products. Our team is continuing to focus on the commercial launch of liver man, if it's approved and granted market access following the December 'twenty, 1 could do per day.
If approved.
For U S market access will launch shortly after that approval and immediately begin expanding the sales force at that time.
First in human Phase 1 PK study for <unk>, 1 on 9 for Anaphylaxis is progressing and we anticipate reporting topline data from part 1 of this 2 part study in the second half of 'twenty 1.
Thereafter, we are planning for an FDA meeting to discuss the path forward for <unk>, 1 O 9 and in parallel we plan to request a meeting with the FDA to discuss data from the 2 studies completed with <unk> do you want to wait and our plan to pursue additional indications for this candidate.
Ernie Toth: Thereafter, we're planning for an FDA meeting to discuss the path forward for AQST 109, and in parallel, we plan to request a meeting with the FDA to discuss data from the two studies completed with AQST108 and our plan to pursue additional indications for this candidate. As demonstrated by our second quarter results and updated financial outlook, we continue to efficiently grow Simpizan shipments and revenue, as well as expand strategic relationships across the epilepsy market in preparation of a potential Librevant law. We look forward to continuing to update all of you as we advance all of these initiatives throughout 2021. With that, I'd like to turn the floor over to Ernie, who will provide specifics about our financial performance and outlook. Thank you, Keith, and good morning, everyone.
As demonstrated by our second quarter results and updated financial outlook, we continue to efficiently growth simply <unk> shipments and revenue as well as expanding strategic relationships across the epilepsy market in preparation of a potential that prevent launch.
We look forward to continuing to update all of you as we advance all of these initiatives throughout 2021.
With that I'd like to turn the floor over to Ernie who will provide specifics about our financial performance and outlook.
Thank you Keith and good morning, everyone.
Ernie Toth: First of all, I would like to take this opportunity to say how happy I am to be part of the Equestive team following the CFO appointment in June after serving in an in-term role over the past six months. I look forward to this exciting time and the growth of Equestive as we plan for the potential approval and launch of Liverman and continue the development of our HUST-108 and 109 product candidates. By now, you will have seen our financial results in our 10Q and earnings release that were filed last evening.
First of all I would like to take this opportunity to say how have value to be part of the question scheme. Following the CFO appointment in June after serving in an interim role over the past 6 months.
I look forward to this exciting time in the growth of requested as we plan for the potential approval and launch of liver fat and continue the development of our HFC, 1 way and 1 on on product candidates.
By now you will have seen our financial results and our 10-Q and earnings release that were filed last evening.
Ernie Toth: As we typically do, we will address most of the discussion relating to the second quarter of 2021 results in the Q&A. Overarching our 2021 strategy are some key principles that Keith outlined in his remarks, including preparing for Liverbant's potential approval and launch with the now assigned to Dufant, continuing the development of our epinephrine program, advancing our business development activities, executing prudent expense management, and diligently managing our cash position and extending our capital horizon.
As we typically do we will address most of the discussion relates to the second quarter of 2021 results in the Q&A.
Overarching, our 2021 strategy or some key principles that Keith outlined in his remarks, Inc.
Including preparing for liver bands for potential approval and launch with analysis on for <unk> day.
Continuing the development of our epinephrine program.
Advancing our business development activities.
Executing prudent expense management and diligently managing our cash position.
Ending our capital Horizon.
Our total revenues were $15.3 million in the second quarter of 2021.
Ernie Toth: Our total revenues were $15.3 million in the second quarter of 2021, compared to $21.7 million in the second quarter of 2020. As a reminder, second quarter 2020 revenues included a one-time $12 million recognition of license and royalty revenue as a result of the Kinmobi FDA approval. Comparing the second quarter of 2021 to the prior year period, the company saw a 57% increase in Sipazan net revenue despite the continued market access limitations due to COVID-19, and a 47% increase in manufacturing and supply revenue.
Paired with $21.7 million in the second quarter 2020.
As a reminder, second quarter 2020 revenues included a onetime $12 million recognition of license and royalty revenue as a result of the <unk> FDA approval.
Comparing the second quarter 2021 to the prior year period income.
<unk> saw a 57% increase in sympathy on net revenue. Despite the continued market access limitations due to COVID-19, and a 47% increase in manufacture and supply revenue.
Excluding the impact of the onetime Kip <unk> revenue for 2020 period total revenues in the second quarter of 2021 would have increased $5.7 million.
Ernie Toth: Excluding the impact of the one-time Kenmobi revenue in the 2020 period, total revenues in the second quarter of 2021 would have increased $5.7 million or 59% year on year. Our net loss for the second quarter of 2021 was $12.4 million, or 33 cents a loss per share. The net loss for the second quarter of 2020 was $2.3 million for $7.7. The year-over-year change in net loss was driven by the one-time revenue event related to the Kimmobi FDA approval, which obviously did not reoccur in 2021, and an increase in non-cash interest expense related to the Kenmobi monetization transaction, which does not represent a cash outflow or monetary obligation at any time during the life of the SG&A expenses were 5% lower in the second quarter of 2021 compared to the prior year period.
Or 59% year over year.
Our net loss for the second quarter of 2021 was $12.4 million or <unk> 33.
Loss per share.
The net loss for the second quarter, 2020 was $2.3 million for 7 cents loss per share.
The year over year change in net loss was driven by the onetime revenue event related to the can mobi.
CA approval, which obviously did not reoccur in 2021.
And an increase in non cash interest expense related to the <unk> mobile monetization transaction, which does not represent a cash outflow for monetary obligations at any time during that like for the transaction.
SG&A expenses were 5% lower in the second quarter of 2021 compared to prior year period.
Non-GAAP adjusted EBITDA loss was $4.1 million in the second quarter of 2021 compared to an income of $2.9 million in the second quarter of 2020.
Ernie Toth: Non-Gap adjusted EBIDA loss was $4.1 million in the second quarter 2021, compared to an income of $2.9 million in the second quarter 2020. The year-over-year change in non-Gap adjusted even-dop was driven by the one-time $12 million recognition of license and royalty revenue as a result of the Kinmobie FDA approval. Comparing the second quarter of 2021 to the prior year period, the company saw a 57% increase in Sipazan net revenue despite the continued market access limitations due to COVID-19 and a 47% increase in manufacturer and supply revenue.
The year over year change in non-GAAP, adjusted EBITDA was driven by the onetime $12 million for recognition of license and royalty revenue as a result, other kin mobi FDA approval.
Comparing the second quarter 2021 to the prior year period. The company saw a 57% increase in simple net revenue. Despite the continued market access limitations due to COVID-19.
On a 47% increase in manufacturer and supply revenue.
Excluding the impact on the 1 time I know the revenue into 2020 period total revenues in the second quarter of 2021 would've increased $5.7 million or.
Ernie Toth: Excluding the impact of the one-time Kainobi revenue in the 2020 period, total revenues in the second quarter of 2021 would have increased $5.7 million or 59% year every year. Our net loss for the second quarter of 2021 was $12.4 million, or 33 cents a share. The net loss for the second quarter of 2020 was $2.3 million, for seven cents of loss per share. The year-every-year change in net loss was, again, driven by the one-time revenue event related to the Kynobie FDA approval, which obviously did not reoccur in 2021, and an increase in non-cash interest expense related to the Kainobi monetization transaction, which does not represent a cash outflow or SG&A expenses were 5% lower in the second quarter of 2021 compared to the prior year period.
For 59% year over year.
Our net loss for the second quarter of 2021 on 12.
$12.4 million or.
Or <unk> 33.
Loss per share.
The net loss for the second quarter 2020 was $2.3 million for.
For 7 loss per share.
The year over year change in net loss was again driven by the onetime revenue event related to the Cardona <unk> FDA approval, which obviously did not reoccur in 2021.
And an increase in non cash interest expense related to the <unk> monetization transaction, which does not represent a cash outflow for monetary obligations.
Anytime during that like for the transaction.
SG&A expenses were 5% lower in the second quarter of 2021 compared to prior year period.
Non-GAAP adjusted EBITDA loss was $4.1 million in the second quarter 2021, compared to an income of $2.9 million in the second quarter 2020 day.
Ernie Toth: Non-Gap adjusted EBIDA's loss was $4.1 million in the second quarter 2021, compared to an income of $2.9 million in the second quarter 2020. The year-over-year change in non-gap adjusted EBADA was driven by the one-time $12 million recognition of license and royalty revenue as a result of the Kenmobi FDA approval. As of June 30th, 2021, cash and cash equivalents were $34.2 million, an increase of $6.7 million as compared to $27.5 million as of March 31st, 2021.
The year over year change in non-GAAP, adjusted EBITDA was driven by the onetime $12 million recognition of license and royalty revenue as a result of the kin Mobi FDA approval.
As of June 32021.
Cash and cash equivalents for $34.2 million.
An increase of $6.7 million.
As compared to 27.5 billion.
As of March 31, 2021.
The increase in cash during the second quarter of 2021 was due to $8.6 million in net proceeds from our aftermarket or ATM facility.
Ernie Toth: The increase in cash during the second quarter of 2021 was due to $8.6 million in net proceeds from our at-the-market or ATM facility, $2 million in milestones from Chem Farm triggered by the FDA approval of Estaris, and $2 million in milestones from Mitsubishi Tanavi for the license of U.S. rights to Exterman, all of which were partly offset by cash used in operations. We expect that our existing cash and cash equivalents, revenue from our ongoing business, including synthesis, the 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.
$2 million in milestones from Kevin Farr triggered by the FDA approval on that chart.
$2 million milestone from Mitsubishi Tanabe for the license of U S rights to Extravert, all of which were partly offset by cash used in operations.
We expect that our existing cash and cash equivalents revenue from our ongoing business, including centers in continuing business development activities.
Prudent expense management actions combined with ATM activity will provide adequate funds to meet expected cash requirements for the next 12 months.
Ernie Toth: Separately, we expect the potential launch of Liverman, if approved by the FDA for U.S. market access, to be funded by the additional $30 million of contingent funds available as part of the existing 12.5%. Looking beyond Liverman, we expect royalty streams from license agreements to contribute to our future revenue. These rodi streams include Taurus, which was recently launched by Corium under license from ChemFAR and Subopsome in markets outside of the US within Diviore.
Separately, we expect the potential launch of liver band if approved by the FDA for U S market access to be funded by the additional $30 million on contingent funds available as part of the existing 12, 5% notes.
Looking beyond Zipper ban, we expect royalty streams from license agreement to contribute to our future revenue.
These royalty streams include as tourists, which was recently launched by Corium under license from Kevin Farr.
Suboxone in markets outside of the U S within DDR.
Extra ban in the U S with Mitsubishi Tanabe and in the EU with Zen bone as well as the potential additional payments available on mobile monetization agreements.
Ernie Toth: Exervant in the U.S. with Mitsubishi Tanabi and in the EU with Dambone, as well as the potential additional payments available under the Kenmobi monetization agreement. As outlined in the press release issued last night after market close, we are increasing our full year 2021 financial guidance. Syphazan growth despite the continued limitations due to COVID-19, the performance of our manufacturing and supply operations, and our other ongoing business activities generated strong operating results during the first half of 2020.
As outlined in the press release issued last night after market close we are increasing our full year 2021 financial guidance.
<unk> growth. Despite the continued limitations due to COVID-19, the performance of our manufacturing and supply operations.
In our other ongoing business activities generated strong operating results during the first half of 2021.
Ernie Toth: As such, we have updated our full-year financial expectations as follows. Total revenues of approximately $46 million to $48 million, increased from $38 million to $42 million in the prior budget, non-gap adjusted gross margin of approximately 70% to 75%, unchanged from prior guidelines, and non-gap adjusted EBITDA loss of approximately $39 million to $42 million, improved from $42 million to $45 million in the prior guidance. It is worth reiterating that this updated 2021 financial guidance does not include any revenues from Riverman, which has a maturity date of December 23rd, 2021. With that, I will now turn the line back to the operator to open the line for questions.
As such we have updated on our full year financial expectations as follows.
Total revenues of approximately 46 million to $48 million.
Increased from 38 million to $42 million in the prior guidance.
Non-GAAP adjusted gross margin.
Proximately, 70% to 75% unchanged from prior guidance.
Non-GAAP adjusted EBITDA loss of approximately $39 million to $42 million improve.
Improved from $42 million to $45 million in the prior guidance.
It's worth reiterating this updated 2021 financial guidance does not include any revenues from <unk>, which has a producer date of December 23.2021.
With that I will now turn the line back to the operator to open the line for questions.
Okay.
Operator: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. And our first question comes from Gary Knockman with BMO Capital Markets. Your line is open.
Thank you as a reminder to ask a question you will need to press star 1 on your telephone to withdraw your question press the pound key.
And our first question comes from Gary Nachman with BMO capital markets. Your line is open.
Hey, congrats on the quarter and thanks for taking my questions.
Evan (filling in for Gary Knockman): Hey, I'm a quarter, and thanks for taking my questions. This is Evan filling in for Gary.
And then filling in for Gary.
So I had a couple.
Evan: I had a couple of questions. First, there was some solid growth from Subbosk in this quarter. How durable is that revenue, given that guidance is raised quite a bit in 2021? And how long do you expect that to continue? I have a couple of follow-ups.
Questions for.
There are some solid growth from Boston this quarter, how durable is that revenue given that guidance raise quite a bit in 2021.
How long do you expect that to continue on.
A couple of follow ups after this.
Sure. Thanks, Debbie can you hear me okay.
Keith Kendall: Sure, thanks, Evan. Can you hear me, okay? Uh, yep. Okay, great.
Yes.
Okay, great well look we.
Yeah.
Keith Kendall: Well, look, we, we're excited that Saboxone remains a strong presence in both the U.S. commercial and CMS markets, and it continues to provide opportunity for acquestive outside the U.S. We're obviously very pleased that the quality of this product built on our farm film technology continues to drive meaningful revenues. We think it's demonstrated a resilience beyond what anybody would have expected a product like that facing the kind of generic opposition that it does.
Where.
We're excited that the box still remains a strong presence in both the U S commercial and CMS markets.
It continues to provide opportunities for Westwood outside the U S.
Obviously very pleased at the quality of this product.
Pharmfilm technology.
<unk> continues to drive meaningful revenue requested we think it's demonstrated a resilience beyond what anybody would have expected a product like that facing the kind of <unk>.
Derek.
Position that it does we think that EBITDA is done.
Keith Kendall: We think that Vibier has done a really good job of continuing that product and its strength in the market. Look, we continue to say that that product is going to erode over time, but it has demonstrated that it is resilient. We don't think this is a one-time, you know, first half of 2021 event and that it will continue to show strength and resilience going forward. That said, though, of course, our focus is on the future of the question and delivering transformative products to Tractory Epilepsy patients in Liver Vance and Adaphylaxis with the Quest of 109 and potentially other products with the Quest of 108.
Really good job.
<unk> net product and its strength in the market.
Yes.
Look it's we continue to say that that product is going to erode over time, but it has demonstrated that.
It is resilient and we don't think this is a 1 time first half from 2021 event.
And that it will continue to show strength and resilience.
Going forward.
That said, though of course, our focus is on the future of the quest <unk> been delivering to the market.
Formative products.
Refractory epilepsy patients who deliver man.
I'd add a full access.
Question, 1 on 9 and potentially other products from the quest 1 of late.
Yeah.
Keith Kendall: Thanks for the color on that. And my next question is, can you provide some more color on how you've been preparing for the launch of Liberbent with potential approval in December? How much overlap is there with their strategy for Simpsin?
Hey, thanks, Thanks for the color there on that.
My next question is can you provide some more color on how you've been preparing for the launch for liver bent.
With potential approval on December how much overlap is there with their strategy for simple sense.
Keith Kendall: Well, I'll give some remarks and then Ken Marshall, our chief commercial officer, can add some additional color. Um, it is You know, Syphazan was launched first, and it was launched first for a reason. And while it continues to grow in its own right, much more important to us is the penetration that we've accomplished among the highly overlapping basis prescribers of Sympazan and Diasopan-based rescue medications. Actually, the Sympazan prescribers account for several. 70% of the nasal diasopoeia rescue prescriptions in the country.
Well I will give some remarks and then Ken Marshall.
Yes.
Our chief commercial officer can add some additional color.
It's <unk>.
<unk> was launched first and it was launched first for a reason and while it continues to grow on its own right.
What's more important for us is the penetration.
Penetration.
We have accomplished in the highly overlapping base of prescribers of Suzanne.
And based on rescue medications actually.
Suzanne prescriber.
For 70%.
Nasal diazepam rescue prescriptions in the country. So that overlap is incredibly important for us.
Keith Kendall: So that overlap is incredibly important. We think we've done a good job of penetrating the prescriber base. We think we've done a good job of demonstrating the value of farm film and the contribution it makes to the care for those prescribers' patients. So we are counting on that as a very important strategic element in helping us launch liver van quickly and successfully. Ted, is there anything you want to add to that? No, Keith, I think that's the key point.
We think we've done a good job of penetrating the prescriber base, we think reported good job of demonstrating the value for.
I'm Phil.
And the contribution it makes to the care for those prescribers patients.
So we are counting on on that.
Great.
<unk> element in helping us launch liver van quickly and successfully.
Ken is there anything you want to add to that.
No Keith I think that's the that's the key point, our core team now establishing our platform.
Kenneth W. Marshall: Our core team is now establishing our platform, uh, Farm Film with Centipan, and our core prescribers, around 4,000, are writing the vast majority of rescue medicine. So we're going to be solid in that group. Maybe a piece to add to Keith. Our medical team is also very busy putting our key data in the public domain. We've got a couple of big meetings that line up very well with our Pesdaite, CNS, and AES, and we'll have some of our important data presented there to start to put that in more of a visible position.
Foreign film with Simpson, and our core prescribers of around 4000.
Our writing the vast majority of rescue medicine, So we're going to be solid and that group, maybe a piece to add Keith is our medical team was also very busy putting our key data in the public domain. We've got a couple of big meetings that lineup very well with our pizza day.
CNS in Aes and won't have some of our important data presented there too.
To put that in more of a visible position.
Great.
Kenneth W. Marshall: And my last question is regarding AQST 109 and 108. When in the second half are you currently planning to meet with the regulators? And do you plan on discussing potential fast-track designation for ATSP 109 at this meeting?
My last question is regarding T 109, and 1 on wheat.
On when in 2 in the second half are you currently planning to meet with the regulators and do you plan on discussing potential.
Fast track designation for.
For Acs tier 1 on 9 at this meeting.
Keith Kendall: Yeah, so again, I'll start that Dan can still be in. The exact date of the meeting is yet to be determined. We've got to pull the data together and make the request, but we intend to do that this year.
This book.
Yes, so again I'll start and then Dan can.
Okay.
The exact day to day meeting.
It could be entirely we've got to pull that data together to make that request.
And to do that this year.
Keith Kendall: I think that... As we've said before, this is all about absorption and conversion in both the 108 and 109 products. We think the 108 product will likely be a product candidate for an indication distinct from anaphylaxis on its own, and that 109 or a successor product will continue to be an indication for anaphylaxis. We think that given the agency's designation for Fast Track of 108, 109 meets all the same criteria for anaphylaxis that 108 did when we applied, and we expect that we'll get the same outcome there.
I think that.
As we've said before this is all about absorption and conversion.
Both the 1 way 109 products, we think that 1 of the way.
We will likely be a product candidates for an indication distinct from asthma anaphylaxis on its own.
And that 109 or a successor product.
We will continue toward an anaphylaxis indication.
We think that given the agency's designation for fast track that want to wait 100 now.
It meets all the same criteria.
For the full access to on a linked it would leave.
When we apply that we expect it will get the same outcome there.
Great. Thanks.
Yeah.
Jason Nicholas Butler: Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is open.
Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is open.
Jason Nicholas Butler: Hi, thanks for taking the questions. First one, maybe just a quick follow-up on the FDA meeting for 108, acknowledging that it's a different indication here. Are there things that you think you can take away from the meeting that would have re-through to 109, for example, the size of the safety database or other components of the development program that might read through to both candidates? Good morning, Jason. This is Dan.
Hi, Thanks for taking the questions first 1 maybe just a quick follow up on on the meaningful on a late acknowledging that it's a different indication here are there things that you think you can take away from the meeting but would have read through for 109 for example that the size of the safety database for or other components of the development program.
Any thoughts about candidates.
Okay.
Good morning, Jason This is absolutely what we already met with the FDA do you want to wait for <unk> setting and if all of that work.
Dan (no last name provided): Absolutely, look, we already met with the FDA and AUSD-108 in a pre-I&D setting, and all of that work is related to antifalactics at the target and absolutely has a read-through. As we go forward with both meetings for 109 and 108, which would be separate meetings, because of the nature of the pro-drug platform we have and the way the FDA guidance is on safety, in particular, as you pointed out, work, there absolutely is some cross-pollination and knowledge that we'll gain as we have those meetings, so we're, as Keith said, we're very excited to meet with the FDA and we'll do And then on Libervan, you mentioned you re-engaged with FTA on the market access piece. Can you just give us a little bit more color there?
Is it related to anaphylaxis target absolutely hasn't read through as we go forward with both the meeting from 1 guide and went away which would be separate meetings.
Of.
For the nature of pro drug platform, we have and the the way the FDA guidance is on safety in particular as you pointed out work there absolutely is some cross pollination and knowledge that will gain as we have those meetings. So as Keith said, we're very excited.
To meet with the FDA and we will do that for the second half for this year.
And that should give us even more data on how to progress both targets.
Great and then on Liberman.
Mentioned, you Reengage with FCA on the market access.
Can you just give us a little bit more color there I know you're not going to go into the details but is this a 2 way conversation are you getting are you.
Keith Kendall: I know you're not going to go into details, but is this a two-way conversation? Are you getting questions from the agency? Just any color around what the dialogue is right now on market access? Yeah, it will be a two-way conversation. We're waiting for them to come back to us.
Are you getting questions from the agency.
Any color around what the dialogue is right now on market access.
Yes, it will be it will be a 2 way conversation we're waiting.
For that for Q.
Come back to us we re engaged.
Keith Kendall: We re-engaged by asking for further conversation and resubmitting a fair amount of data that we had given during the first approval cycle. We intend to supplement that with some additional data that we've developed. Since then, around the major contribution to patient care criteria. So we expect this to be the start of the process now that the application has been accepted. There was not much they were going to engage on until there was something to engage on, and it was the acceptance date on the 23rd of July that kind of kicked off that process. So it's early days, real time, but we do expect it to be. A robust two-way discussion. That's helpful; thanks, Keith.
<unk>.
Asking for further conversation resubmitting.
For a fair amount of data that we have given during the FERC approval cycle.
We intend to supplement that with some additional data that we've developed.
Since then.
The major contribution for patient care price.
<unk> area. So we expect this to be the started the process now that the application has been accepted it was not much day, we're going to going to engage on until there was something to engage on and it was the acceptance date on the 23rd on July <unk>.
Kicked off that process. So it's early days for real time, but we do expect it to be a robust 2 week discussion.
That's helpful. Thanks, Keith and just last 1 for me you mentioned, you're continuing to do market research for liver event.
Keith Kendall: Last one from me, you mentioned you're continuing to do market research for Livervan. Any updated thoughts on what you're hearing from potential prescribers on how quickly the market can expand to patients that are not using a rescue therapy now or how long it would take for this market to reach peak? Yeah, that's a great question, Jason. You know, obviously, we had a view of the ramp to peak when we thought we would be the first alternative to the rectal gel or at least hit the market simultaneously with one or both of the nasal sprays. Being delayed by the CRL probably changes the nature of that ramp, because the fact that the nasals have not.
Any updated thoughts on what youre hearing from potential prescribers on how quickly the market can expand to.
The patients that are not using a rescue therapy now or how long it would take for this market to reach peak.
Yes.
A great question Jason.
Obviously, we had a view of the ramp to peak when we book, we would be the first of alternative to the rectal gel or at least hitting the market simultaneously with 1 or both the day nasals being.
Being delayed by the CRA will probably changes the nature of that ramp.
Fact that engage will have not expanded the market very much.
Keith Kendall: Expanding the market very much since their introduction into the market continues to indicate to us that there's a great deal of opportunity here. We continue in our marketing research to see patients express a preference for an oral solution to choose from. So we're encouraged by that. And, you know, as we get closer to launch or at launch, we'll update expectations, post-launch expectations on Livervan, but we continue to see this as a very significant addition to the choices the patients have and certainly a material and significant contribution to the revenues of the company, even if it's a small, great one. Congratulations on the progress and thanks again for taking the time to answer the question.
Since their introduction into the market continues to indicate to us that there's a great deal of opportunity here, we continue in our.
Marketing research to see patients.
Expressed a preference for an oral.
Solution to choose from.
So we are encouraged by that.
As we get closer to launch or at launch we will update expectations post what's your expectations on liver event, but we continue to see this as a very significant addition to the.
For the choices for patients have and certainly a material and significant contribution to the revenue to the company once it's launched.
Great.
Congrats on the progress and thanks again for taking the questions.
Operator: Thank you. Our next question comes from Daniel Busby with RBC Capital Markets. Your line is open.
Thanks, Jason.
Thank you. Our next question comes from Daniel Buzby with RBC capital markets. Your line is open.
Daniel Barber: Hey, good morning. I've got a couple more on Libravant. Maybe to start with a follow-up to that last question, is there a particular segment of the market that you expect to be early adopters?
Hey, good morning, I've got a couple more on liver fat maybe to start with a follow up for that last question is there a particular segment of the market that you expect to be early adopters.
Daniel Barber: And second, assuming approval, can you please update us?
And second assuming approval can you update us on your expectations for payer coverage for Liberty that for both in terms of the ultimate level of access that you're targeting and also how long you think it will take to get there.
Daniel Barber: on your expectations for pay or coverage for Libravant, both in terms of the ultimate level of
Daniel Barber: level of access that you're targeting and also how long you think it will take to get there.
Daniel Barber: Sure. Ken, do you want to take this?
Sure Ken do you want to take that.
Kenneth W. Marshall: Yes, sure. If you look at the market in segments, you can probably cut it into two gross segments, the pediatric and the adult. The peds are routinely faster adopters because they're cared for by a caregiver who is usually pretty motivated to help solve that problem. So if you look for fast uptake, that's where you'll usually see it, and that's where you saw it with the nasals. If you look at the meat of the market, which is about 80%, that's the adult piece. And that's the piece right now that's really just not engaging. They never engage with the rectal gel, and they have not, in any material way, engaged with the nasal mucosa.
Yes sure.
If you look at the market in segments that you can cut it probably into 2 growth segments, the pediatric and the adult the peds are routinely faster adopters because they're cared for by a caregiver who are usually pretty motivated to help solve that problem. So if you look for fast uptake, that's where you usually see it and that's where you saw it with the nasals.
As you look at the meat of the market, which is about 80%. That's the adult piece and that's the piece right now that's really just not engaging they never engaged with the rectal gel.
And they have not in any material way engaged with nasals and that piece is usually slower to come into the market, but will usually be your biggest contributor.
Kenneth W. Marshall: And that piece is usually slower to come into the market but will usually be your biggest contributor as you go in. So does that answer the question on segments, Daniel? Yeah, that's helpful.
As you go in so.
Does that answer the question on on segments. Daniel Yeah. That's that's helpful. Yeah, and then just some some color on.
Kenneth W. Marshall: Yeah, and then just some color on payer coverage, if you could. Yeah, on the coverage front, we expect to have good access there. I mean, if you look at what we've done with Simpson, about 90% of all the scripts that go into the pharmacy come out, either through traditional coverage through the payer or one of our programs. We'll execute along those same lines. It'll take a few months. To get traditional coverage, you usually take six to eight months to get into the range of probably 60, 70% of lives covered.
Payer coverage, if you could yeah on the.
Coverage front, we expect to have.
Good access there I mean, if you look at what we've done with sympathy and about 90% of all the scripts that go into the pharmacy come out either through traditional coverage through the payer or 1 of our programs.
We will execute on those same lines it'll take a few months.
Get the traditional coverage you usually takes 6 to 8 months to get into the range of probably 60, 70% of lives covered but we've got programs that will offset those copays and help get patients access so we don't see.
Kenneth W. Marshall: But we've got programs that will offset those co-pays and help get patients access, so we don't see a big problem there. And frankly, if you look at the nasal sprays, they've managed to get pretty good access in their first year. We think we'll do the same.
A big problem, there and and frankly, if you look at the nasals, they've managed to get pretty good access in their first year, we think well we think we'll do the same.
Got it thank you.
Operator: Thank you. Our next question comes from Thomas Flatton with Lake Street Capital. Your line is open. Okay.
Thank you. Our next question comes from Thomas Flaten with Lake Street Capital. Your line is open.
Thomas Flaten: Great, thanks guys for taking the questions. Just since Ken's on, any updates on the state of the market in terms of rep access, office openings, closings, et cetera, particularly in light of the Delta-driven surge. Ken, do you want to take that? Sure, yeah, Keith.
Great. Thanks, guys for taking the questions just 2.
Since ken's on any updates on the state of the market in terms of Rep access office openings closings et cetera on particularly in light of the more recent delta driven surge.
Ken you want to take that sure yeah, Keith Yeah, we watch that very closely actually because there's definitely a correlation if you can get in front of physicians, it's much more effective than than virtual.
Kenneth W. Marshall: Yeah, we watch that very closely, actually, because there's definitely a correlation. If you can get in front of positions, it's much more effective than virtual. The market is normalized right around 75% live, and that's with physicians and their staffs and 25% virtual, and it's kind of stayed there. I am hearing some qualitative comments about the individual institutions, re-invoking masks and requiring vaccinations and putting their policies in place.
The market is normalize right around 75% lives and.
And that's with physicians and their staffs and 25 per cent virtual on it and it's kind of stayed there.
I am hearing some qualitative comments about the individual institutions re and boating masks and requiring vaccinations and putting their policies in place.
Kenneth W. Marshall: So it may change back a little bit, depending on how the Delta variant presents itself in the fall. But right now, we've got good access, and hopefully, it stays behind. Great. And then just one final question. What is your current expectation around the timing of an ODE decision? I kind of got the sense from the last call that you're thinking it's more likely that it might come simultaneously, precedent, but I was just curious if you guys had any, Sure.
It may change back a little bit depending on how the adult variant.
<unk> itself in the in the fall, but right now we've got good access.
And hopefully it stays there.
Great and then.
Just final question.
What is your current expectation around timing of an ODT decision on kind of got the sense from from the last call that youre thinking it's more likely that it might come simultaneous given precedent, but I was just curious if you guys had any updated thinking on on the O D decision timing.
Sure.
Kenneth W. Marshall: Look, we don't control the process, and we're not sure we can even influence the process, but it is our sense that it will, based on what's happened up to this point, be simultaneous with the Cedar Review Division decision. You know, that said, though, because we don't control the process and don't have visibility, and through it, it could be separated by days or as many as 30 days. But our current view is that the decisions will be issued simultaneously. Great. Congratulations on the Quarter, guys.
But we don't control the process.
We're not sure we can even influence the process.
It is our sense that it will based on.
What's happened up to this point that is likely to be simultaneous with the with the Cedar Review Division decision.
That said, though because you don't control the process and don't have visibility into it it could be separated by.
5 days or as many as 30 days, we don't know what our current view is that the decision will be issued simultaneously.
Great Congrats on the quarter guys. Thanks for taking the questions.
Thanks.
Our next question comes from Andreas <unk> with Wedbush. Your line is open.
Operator: Our next question comes from Andreas Argarize with Webbush. Your line is open. Good morning, guys. Thank you for taking my questions. This is Andre.
Good morning, guys. Thank you for taking my questions. This is andreas on for Liana.
Andreas Argyrides: Just a quick one; most of our questions
Andreas Argyrides: questions already asked. Could you just provide color, you know, looking forward to the pediatric opportunity for Libergant? Time on. Sure, Andreas, nice to hear your voice, good morning. I'll start it off from just the mechanical side of the label. So our current application is for 12 years enough. So as soon as we get past our fidufa,
Just a quick 1 most of our questions questions already asked.
Can you just provide color.
Looking forward on the.
Pediatric opportunity for Libertad.
On Monday.
Sure.
Andreas Thank you for your voice. Good morning. This is Dan I'll start it off from the just the mechanical side of.
Dan (no last name provided): the pediatric opportunity for Libergant, on my going. Sure, Andreas, nice to hear your voice. Good morning, this Stan.
Dan (no last name provided): I'll start it off with just the mechanical side of the label. So our current application is for 12 years and up. So as soon as we get past our CEDUFA date, we'll meet with the FDA to work on a pediatric filing. We'll put the pediatric filing in rapidly in 2022, and we expect to have a label down to two years of age as we get closer to the medical. at the end of 2022.
The label So our current application is for 12 years and up.
So as soon as we get past due for the date, we'll meet with the FDA to work on the pediatric filing with pediatric filing in rapidly.
22, and we expect to have a label down to 2 years of age.
As we get towards the end of 2022.
Dan (no last name provided): I'm not sure if your question was about the mechanics of getting it on the label, or if it was about how big the market size is in that area. Yeah, all of those things, just a little bit more on the opportunity as far as, and as well as the timelines and, you know, Sure. Well, I give you the time.
I'm not sure. What's your question about the mechanics of getting it in the label was your question about how big the market sizes in that area.
Yes, all of those things just a little bit more on the on the opportunity as far and as well on the timelines.
Dan (no last name provided): Sure, well, I'll give you the timeline, and I'll turn it over to Ken to talk about what slice of the market that Okay, Dan, thanks. Hi, Andreas.
You know on it.
Sure.
I gave you the timeline on I'll turn it over to Ken to talk about what slice of the market that represents.
Okay, Dan Thanks on heightened.
Yeah, that's that's about from a patient volume standpoint, it's about 20%.
Kenneth W. Marshall: Yeah, that's about, from just a patient volume standpoint, it's about 20% of the patients. As I mentioned earlier, they usually are the earlier adopters because of the caregiver support that they get. If you look at where the market parses out now, you have Tocco going down to age six, and you've got nasal LAM going down to age 12. So when we submit our data, if we're successful, Dan, correct me if I'm wrong, but I believe we're going down a little bit lower than H6.
All of the patients as I mentioned earlier, they usually are the earlier adopters because of caregiver support that they get.
If you look at where the market pushes out now you've got.
About Tokyo going down to age 6 and you've got a nasal I'm going down to age 12, so when we submit our day to if we're successful any day and correct me if I'm wrong, but I believe we're going down a little bit lower than each 6 we're going down to 2 so there'll be a segment that we would have.
Kenneth W. Marshall: We're going down to two. So there'll be a segment that we would have been able to promote two uniquely, that two to five group, and then we'd be able to compete with Val Tocco in that next segment between six and 12. So a little less crowded market there.
Be able to promote to uniquely that 2 to 5 group and then we'd be able to compete 1 day.
Against about telco and that next segment between 6 and 12, so little less crowded market.
Kenneth W. Marshall: Does that answer your question, Andreas?
Hi, there.
Does that answer your question Andre.
Again as a reminder, if you would like to ask a question press. The Star then the 1 key on your Touchtone telephone.
Andreas Argyrides: Again, as a reminder, if you would like to ask a question, press the star, then the one key on your touchtone telephone. We have a question from Rom Savarju on H.C. Wainwright. Your line is open.
We have a question from Ram <unk> with H C. Wainwright Your line is open.
Operator: Hi, thanks very much for taking my question. So I just wanted to drill down a little bit further on 108 relative to 109 and if you could give us some additional clarity regarding the additional indications beyond anaphylaxis that could be targeted with these two product candidates, as well as what the overall development strategy and commercial strategy might be for these two drugs. Sure, thanks, Rom. I'll start, and Dan could add some color.
Hi, Thanks, very much for taking my question.
Just wanted to drill down a little bit further on 1 oh wait relative to 109, and if you could give us some additional clarity regarding the additional indications beyond anaphylaxis that.
Could be targeted with these 2 product candidates as well as what the overall development strategy and commercial strategy might be.
For these 2 drugs. Thank you.
Sure. Thanks, Rob.
I'll start Dan Keith can add some color.
E.
Raghuram Selvaraju: We're very happy that we have been able to demonstrate that it can consistently deliver epinephrine sublingually into subjects. We think that there's a good deal of application for epinephrine beyond just anaphylaxis and a potential epipen alternative, and we intend to mine that technology and that capability through the program platform we've developed as best we can. It's probably premature to talk about the next indication, but we're doing the work to round that out.
We are very happy about it.
We have been able to demonstrate.
We can consistently deliver.
<unk> for the sublingual Lee into.
Interest subject.
Think that Theres, a good deal of application for epinephrine beyond just anaphylaxis.
A potential epipen alternatives.
And we intend to mine.
That technology net capability through the appropriate platform, we've developed especially we can its probably premature to talk about the next indication we are doing the work to round that out.
Keith Kendall: And if we don't have an indication to talk about, it's equally premature to talk about the marketing strategy for a product that's in the early stages of development. We're focused on getting through the current trial with 109 and then having a conversation with the agency about 109 and 108. We'll get those requests in this year so we can meet with the A's and Q's as quickly as we can. Once we have those things buttoned up, we'll talk about what the interesting information for the 208 is and our thoughts about the market for.
We don't have an indication to talk about it will be premature to talk about.
Getting strategies for product fits into early stages of development.
We're focused on getting through the current trial with 109.
And then getting to a conversation with the agency on.
On 191 other way.
We'll get those requests in this year. So we can meet with the agency as quickly as we can once we have those things buttoned up we'll talk about what the interest.
It is and what our thoughts about the market for it or.
Keith Kendall: Yeah, Ron, the only thing I would add to that is beyond, as Keith said, we're doing our homework on those indications so that we have a full and fulsome view before we speak to the world about where we are. But I think the really exciting thing about our pro-drug platform when it comes to what happens after. If you think about the different ways that epinephrine can be used, especially in the allergy space, our ability to alter the profile of how epinephrine is converted in the body is what really drives a lot of different opportunities. So we're pretty excited about the different opportunities in front of us, and we look forward to talking more about them in the future. Great, fantastic.
Rami on the only thing I would add to that is yes.
As Keith said, we're doing our homework on those indications so that we have a fulsome view.
Before we speak to the world about where we are but I think the really exciting thing about a prodrug platform when it comes to epinephrine.
If you think about the different ways that <unk> been effort can be used.
Actually in the allergy space.
Our ability to alter the profile of how epinephrine is absorbed and.
Converted in the body is what really drives a lot of different opportunities. So we're pretty excited about that.
And opportunities in front of us.
Look forward to talking more about it in the future.
Yeah.
Great Fantastic also I wanted to ask if you've heard any indication from any prescriber or any reimbursement agency that if and when liberty that makes it for the market share would be any indication of it.
Dan (no last name provided): Also, I wanted to ask if you have heard any indication from any prescriber or any reimbursement agency that if and when Libervant makes it to the market, there would be any indication of the implementation of some prior authorization requirement involving BALTOE. Ken, no, we haven't had any conversation along those lines. Can you add any color to that?
Implementation of some prior authorization requirements involving about Tokyo.
Ken.
No we haven't had any conversation.
On slide 10, you have any color to add to that.
Keith Kendall: No, it's just, It would be. There aren't a lot of precedents I can point to where payers try to leverage alternate delivery platforms, and they're not stepping anybody through the rectal gel. I mean, that's probably not a huge stretch to think about that one, but they don't usually step you through drug devices to orals. It's just, they're just too different, and there are just different characteristics and patient needs in those groups. Okay, and then lastly, I was just wondering if you could comment on the Libervant partnering or commercial strategy as this pertains to the ex-US, particularly Europe, and if you could comment on any potential relevance of the recent licensing deal that Marinus announced with Orion on a rare form of childhood epilepsy and its potential relevance to
No it does.
It would be.
There aren't a lot of precedent that could point to where where payers tried to leverage alternate delivery platforms and.
And they're not stepping anybody through the rectal gel I mean that and that's that's probably not a huge stretch to think about that 1 but they don't usually step you through drug devices to oral <unk>.
They're just too different and there's just different characteristics and patient needs in those in those groups.
Okay, and then lastly on you, but just wondering if you could comment on the liberal rent partnering or commercial strategy as this pertains to ex U S, particularly Europe and if you could comment on any potential relevance of the recent licensing deal that Marin has announced with Orion on.
On a rare form of childhood epilepsy, and its potential relevance to prevent if any thank you.
Keith Kendall: relevance to Libravant, if any. Thank you. Yeah, we will continue
Yes, we continue to.
Keith Kendall: Yeah, we continue to look at partnerships outside of the U.S. for Liberman in a variety of regions. It's interesting as you go around the world how the rescue medication space is very different in a lot of different places. So in Europe, we believe we have a very good handle on how that market is put together, and we have conversations that continue to progress. But just to be clear, our focus is absolutely on the approval and launch of Livervin here in the U.S.
Look at partnerships outside of the U S for liver across a variety of regions.
Interesting as you go around the world.
How.
The rescue medication space, it's very different in a lot of different places. So in Europe. We believe we have a very good handle on how that market.
Is is put together.
And we have cash.
Conversations that continue to progress, but just to be clear our focus is absolutely on the approval and launch of liver event here in the U S in terms of Meredith and.
Keith Kendall: In terms of fairness and... And their activities, we have noticed from afar their recent success across a variety of elements, and that's great for them. We have not put a great deal of thought into how their activities intersect with ours. We're more focused again on how we bring both Liverment and epinephrine to the market. Thank you, and congrats on the quarter.
And their activities, we have noticed from our far there. The recent success across a variety of elements and that's great for them, but we have not put a great deal of thought into how their activities intersect with ours.
We're more focused again on how we bring.
The provision and epinephrine.
To the market over the next couple of years.
Thank you and congrats on the quarter.
Keith Kendall: Thank you, and there are no further questions in the queue. I'd like to turn the call back to Keith Kendall for closing remarks.
Thanks for them.
Thank you and there are no further questions on the queue I'd like to turn the call back to Keith Kendall for closing remarks.
Keith Kendall: Well, thank you everyone for joining us again. As we discussed our second quarter and where we are, we look forward to continuing to update everyone as we go through the next phase of these activities. Obviously, we're focused on Livervance, we're focused on AQST 108 and 109, and we're focused on continuing to grow Synthesan's position in the market, and as those activities progress, we'll continue to provide updates We appreciate your time, and we look forward to speaking to you again.
Well, thank you everyone for joining us again.
As we discussed.
Our second quarter and we are we look forward to continuing to update everyone. As we go through the next phase of.
These activities.
Obviously, we're focused on liver beds, we're focused on.
You want to wait and 109, and we're focused on continuing to grow and position Suzanne and Mark and as those activities progress. We will continue to provide updates that everyone. We appreciate your time and we look forward to speaking to you again soon.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
This concludes today's conference call. Thank you for participating you may now disconnect.
[music].
Operator: I'm going to be able to be. Thank you.