Q1 2021 Aquestive Therapeutics Inc Earnings Call
Good morning, and welcome to a question of Therapeutics first quarter 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 the question. During the session you will need the press star one on your telephone is.
Operator: And welcome to Acquestive Therapeutics' first quarter 2021 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 this session, you'll need to press star one on your telephone. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Ms. Stephanie Carrington of Westwick Investor Relations. Please.
It reminds of this call will be recorded I would now like to introduce your host for today's conference call. The Stephanie Carrington of Westlake of Investor Relations. Please begin.
Operator: will be recorded. Thank you, operator.
Yeah.
Thank you operator.
Stephanie Carrington: Good morning and welcome to today's call. On today's call, I am joined by Keith Kendall, President and Chief Executive Officer, and Ernie Toth, Interim Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the first quarter of 2021, followed by a Q&A session. In total, we expect today's call to last approximately 60 minutes.
Good morning on welcome to today's call.
On today's call I am joined by Keith Kendall, President and Chief Executive Officer, and Ernie talked interim Chief Financial Officer are going to provide an overview of recent business developments and performance in the first quarter 2021 followed by a Q&A session.
In total we expect today's call to last approximately 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 Equestria's website within the Investors section shortly following the conclusion of this call. To remind you, the Equestria team will be discussing some non-GAAP financial measures this morning as part of its review of first quarter 2021 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the Investors section of Equestria's website. 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.
As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday.
In addition, a recording of today's call will be made available on a quest of website within the investors section. Shortly following the conclusion of this call.
To remind you the question the team will be discussing some non-GAAP.
Financial measures. This morning as part of its review.
The first quarter 2021 of the results.
A description of these measures along with a reconciliation to GAAP can be found in the earnings release issued yesterday, which is posted on the investors section of a question of website.
During the call the company will be making forward looking statements.
Mind, you of the company's Safe Harbor language.
Finally in yesterday's earnings release, as well as of the risks and uncertainties affecting the company described in the risk factors section included in the company's annual report on form 10-K filed with the SEC on March 10 2021.
Stephanie Carrington: This report was included in the company's annual report on Form 10-K, filed with the SEC on March 10, 2021.
Stephanie Carrington: As with any pharmaceutical company, the product candidates under development...
As with any pharmaceutical company the part of the candidates under development and products being commercialized.
Stephanie Carrington: 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...
There are significant risks and uncertainties respects of the company's business and the development regulatory approval and commercialization of its products on the other matters related to operations.
Back 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 made actual results may differ materially from.
Stephanie Carrington: These are statements that speak only as of the date made. However, actual results may differ materially from these statements. All forward-looking statements attributable to a questioner or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. With that, I'll now turn the line over to Keith.
These statements all forward looking statements attributable to quest of or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday.
The company assumes no obligation to update its forward looking statements. After the date of this conference call were the result of new information future events or otherwise, except as required under applicable law.
I'll now 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 first quarter of 2021 and through April. As always, Ernie and I will be joined by additional members of the Equestive leadership team during the Q&A session afterwards. Through this period, we were able to execute on our key priorities and deliver a number of key milestones that we'll talk about this morning.
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 first quarter of 2021 and two.
Through April as the.
Always Ernie and I will be joined by additional members of the question of leadership team during the Q&A session. Afterwards.
Through this period, we were able to execute on our key priorities and delivered a number of key milestones that will talk about this morning.
Keith Kendall: First and foremost, we continue to focus on building our CNS franchise. Our team is focused on preparing the resubmission of our new drug application for LibraVan after receiving guidance from the FDA on its expectations for information and supporting analysis. Relating to the pharmacokinetic modeling and simulations included in our prior submissions to the agency in December 2020, we're completing the necessary analysis of the existing clinical data in response to the FDA's feedback.
First and foremost we continue to focus on building our CNS franchise.
Our team is focused on preparing the resubmission of our new drug application for Liberal van.
The receiving guidance from the FDA on its expectations for information and supporting analysis relating to the pharmacokinetic modeling and simulations included in on.
The prior submissions to the agency in December 2020, we're completing the necessary analysis of the existing clinical data in response to the Fda's feedback.
Keith Kendall: We're developing LibriVant as an alternative to more invasive, inconvenient, and difficult to administer device-driven products, including a rectal gel for patients with refractory epilepsy. As a result of these issues, a large portion of the patient population does not receive adequate treatment or forgoes treatment altogether.
We are developing libera of answers on alternative to more invasive inconvenient and difficult to administer device using products, including a rectal gel for patients with refractory epilepsy.
As a result of these issues a large portion of the patient population does not receive adequate treatment of forgoes treatment altogether.
Keith Kendall: We continue to believe that LibraVant, if approved by the FDA for U.S. market access, will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form. As previously communicated, we resubmitted to the FDA a revised weight-based dosing regimen along with modeling and simulation data in December 2020 to address the issues raised by the agency in the CRL we received in September 2020.
We continue to believe the labor event, if approved by the FDA from for U S market access will enable the largest share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing and the noninvasive and innovative treatment for them.
Yes.
As we previously communicated we resubmitted to the FDA of revised weight based dosing regimen, along with modeling in simulations data in December 2020 to address the issues raised by the agency and the CRO we received in September.
2020.
Keith Kendall: The FDA confirmed that the issues identified in the CRL may be addressed by utilizing modeling and simulation based upon the information provided in our FDA meeting package submitted in October, in response to our December submission. The FDA provided written feedback in February that clarified the agency's expectations relating to the information to be presented in the Population PK model and the safety data that should be included in the NDA resubmission.
The FDA confirmed that the issues identified in the CRA may be addressed by utilizing modeling and simulations based upon the information provided in our FDA meeting package submitted in October.
In response to our December submission. The FDA provided written feedback in February the clarified the agency's expectations relating to the information to be presented in the population PK model and the safety data that should be included in the NDA resubmission.
Keith Kendall: Based on the FDA's feedback, we continue to believe that no further clinical studies will be necessary for the resubmission of the NDA for LibraVamp. We are on track to complete these analyses and resubmit the NDA as committed by the end of the second quarter of 2021. Once resubmitted, we anticipate a six-month review process.
Based on the Fda's feedback we continue to believe that no further clinical studies will be necessary for the resubmission of the NDA for liver van.
We are on track to complete these analyses and resubmit the NDA as committed by the end of the second quarter of 2021.
Once we submitted we anticipate a six month review process.
Keith Kendall: We continue to expect a PDUFA action date in 2021. However, there have been no indications to date from the FDA relating to approval for market access, and we do not expect to receive any FDA guidance regarding market access prior to the PDUFA action date. Regarding FDA approval of U.S. market access, we believe that we have provided a strong set of facts supporting a decision by the FDA of clinical superiority and prior approved drugs for the syndication, based upon a finding that LibriVant represents a major contribution to patient care.
So we expect to produce the action date in 2021.
There have been no indications to date from the FDA relating to approval from market access however, and we do not expect to receive any FDA guidance regarding market access prior to the <unk> action date.
Regarding the FDA approval of U S market access we believe that we have provided a strong set of facts supporting of decision by the FDA of <unk>.
Clinical superiority.
The prior approved drugs for the syndication.
Based on quantifying that labor event represents a major contribution to patient care.
Keith Kendall: Once we've resubmitted the NDA for LibriVant, we will re-engage with the FDA and update our prior communications to demonstrate our position that LibriVant, as an orally delivered product, meets one or more of the following 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 and comfort of drug administration, and longer periods between doses.
Once we have resubmitted the NDA for Libre event, we will reengage with the FDA and update our prior communications to demonstrate our position that liver fat as an orally delivered product meets one of more of the following criteria to be considered a major contribution to patient care.
Convenience of treatment location.
So ration of treatment.
The comfort.
Reduced treatment burden advances in ease and comfort of drug administration and longer periods between doses.
Keith Kendall: Subject to FDA approval, we're committed to launching LibriVance as soon as possible after that approval. Our next key priority is our epinephrine program. At our R&D event in March of this year, our team and two nationally recognized KOLs provided an overview of anaphylaxis, discussed the hurdles that accompany needle-based delivery standards of care, and outline the significant market opportunity that exists for a highly differentiated formulation utilizing our farm film sublingual formulation.
Subject to FDA approval, we're committed to launching libert Vance as soon as possible after that approval. Our next key priority is our epinephrine program.
At our R&D event in March of this year our team in two nationally recognized Kols provided an overview of anaphylaxis discussed the hurdles that accompany the needle based delivery standards of care and outlined the significant market opportunity that exists for our highly differentiated formulation utilizing our <unk>.
Farms films Sublingual formulation.
Keith Kendall: Our R&D team provided an extensive review of our two epinephrine project candidates, clinical results, and development strategy for the program. As you may recall, our first-generation candidate, AQST-108, was granted fast-track designation last year and was approved to use the 505B2 regulatory pathway by the FDA, 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 R&D team provided an extensive review of our two epinephrine product candidates clinical results and development strategy for the program.
As you May recall, our first generation candidate <unk> was granted fast track designation last year. It was approved the use the 505 b two regulatory pathway by the FDA.
Making the clinical development trajectory faster and cheaper.
Moreover, the FDA acknowledged that our sublingual film formulation of epinephrine satisfies the unmet need in the patient population relating to those patients resistant to taking intramuscular or subcutaneous injections.
Keith Kendall: As such, our candidates have the potential to be the first orally administered epinephrine-based rescue medications for this patient population. We anticipate that any product candidates that we bring forward for this indication would be eligible for Fast Track designation. At the March R&D event, our team reviewed the clinical data from the two completed Phase I PK studies for Equestiv-108, composed of the prodrug dipivacin. The data from the two Phase I PK studies demonstrate that Equestive-108 can consistently deliver epinephrine sublingually, and all subjects had measurable plasma concentrations of epinephrine.
As such our candidates have the potential to be the first orally administered epinephrine based rescue medications for this patient population.
We anticipate that any product candidates that we bring forward for this indication would be eligible for fast track designation.
At the March R&D event of our team reviewed the clinical data from the two completed phase one PK studies requested one of weight composed of the prodrug dip of effort.
The data from the two phase one PK studies demonstrate the request of one of the weight can consistently deliver epinephrine sublingual <unk> and all subjects had measurable plasma concentrations of epinephrine.
Keith Kendall: The top line data for a quest of 108 provides further evidence that we have developed a unique technological solution that can deliver epinephrine sublingually. We have filed multiple patent applications to protect these findings, and we're excited by the possibilities this new platform presents to us. The first in-human PK study for our second-generation candidate, AQST-109, commenced just a few weeks ago after the trial dossier received clearance from Health We are on track to complete part one of this study in the second half of 2021, and anticipate scheduling a meeting with the FDA shortly thereafter to discuss a path forward to regulatory approval for AQST-108 and AQST-109. Finally, our first proprietary commercial product, SympaVan, continues to meet key performance metrics throughout the first quarter of 2021. Sympathand continues to perform and grow despite COVID-19-related restrictions on face-to-face interactions with health care providers.
The topline data for a quest of one on weight provides further evidence that we have developed a unique technological solution that can deliver epinephrine Sublingual, Inc.
We have filed multiple patent applications to protect these findings and we're excited by the possibilities. This new platform presents two of questar.
The first in human PK study for our second generation candidate <unk> 109 commenced just a few weeks ago. After the trial dossier received clearance from health Canada.
We are on track to complete part one of the study in the second half of 2021, and we anticipate scheduling a meeting with the FDA. Shortly thereafter to discuss the path forward to the regulatory approval breaks USD one of weight and <unk> 109.
Finally, our first proprietary commercial products simple zahn continues to meet key performance metrics.
Throughout the first quarter of 2021 <unk>.
<unk> continued to perform and grow despite COVID-19 related restrictions on face to face interactions with health care providers.
It is worth noting while that debt, while total prescriptions nationally we're down 8% in the first quarter of this year simple script shifted to pharmacies grew nearly 13% quarter over quarter and 40% year over year.
Keith Kendall: It is worth noting that while total prescriptions nationally were down 8% in the first quarter of this year, symposan scripts shipped to pharmacies grew nearly 13% quarter over quarter and 40% year over year. Our continued growth in prescriptions and net revenue demonstrates our ongoing ability to continue to connect with prescribers, even virtually, and grow this product. Symposan saw continued growth in the prescriber base with over 30 percent penetration into the company's focus group of prescribers, with approximately 80 percent of those prescribers writing multiple scripts.
Our continued growth in prescriptions and net revenue demonstrates our ongoing ability to continue to connect with the prescribers, even virtually and grow this product.
Suzanne saw continued growth in the prescriber base with over 30% penetration into the company's focus group of prescribers with approximately 80% of those prescribers writing multiple scripts.
We believe our position with prescribers in the epilepsy field and payers continues to pave the way for successful launch of liver of it if approved given their familiarity with our Pharmfilm technology and the major contribution to patient care that our products provide the epilepsy pace.
Keith Kendall: We believe our position with prescribers in the epilepsy field and payers continues to pave the way for a successful launch of LibriVant, if approved, given their familiarity with our farm film technology and the major contribution to patient care that our products provide to epilepsy patients. In conclusion, as we progress through the spring, we're focused on advancing our proprietary product. Our team is continuing to perform the additional analyses outlined by the FDA and actively drafting our NDA resubmission for LibriVan.
<unk>.
In conclusion, as we progress through the spring, we're focused on advancing our proprietary products.
Our team is continuing to perform the additional analyses outlined by the FDA and actively drafting our NDA resubmission for liver of it.
We expect to resubmit at the end of the second quarter of 2021 and subject to FDA approval for U S market access we are committed to launch live event as soon as possible after approval.
We commenced the first in human Phase one PK study for request of 190 on April 2021, the pro drug candidate has demonstrated very compelling data for rapidly converting into systemic epinephrine in animal models. We look forward to completing the part one of the study later in the year.
Keith Kendall: We expect to resubmit at the end of the second quarter of 2021, and subject to FDA approval for U.S. market access, we are committed to launch LibriVant as soon as possible after approval. We commenced the first phase one PK study for Equestiv-109 in April 2021. This pro-drug candidate has demonstrated very compelling data for rapidly converting into systemic epinephrine in animal models.
Thereafter, we are planning for an FDA meeting in the second half of 2021 to discuss the path forward for <unk> and <unk> 109.
And as demonstrated by our first quarter figures, we continue to efficiently grow <unk> shipments and revenue as well as expanding strategic relationships across the epilepsy market in preparation of a potential <unk> launch.
Keith Kendall: We look forward to completing part one of this study later in the year. Thereafter, we're planning for an FDA meeting in the second half of 2021 to discuss a path forward for AQST-108 and AQST-109. And as demonstrated by our first quarter figures, we continue to efficiently grow Symposan shipments and revenue, as well as expand strategic relationships across the epilepsy market in preparation of a potential liver vant launch. We look forward to continuing to update all of you as we advance these initiatives throughout 2021. With that, I'd like to turn the floor over to Ernie, who provides specifics around financial performance and outlook.
We look forward to continuing to update all of you as we advance these initiatives throughout 2021.
With that I'd like to turn the floor over to Ernie who provide specifics of on financial performance and outlook Ernie.
Thank you Keith and good morning, everyone.
By now you will have seen our financial results and our 10-Q and earnings release that were filed last evening.
As we typically do we will address most of the discussion related to the first quarter 2021 results in the Q&A.
We have reconfirmed our full year 2021 financial guidance as previously indicated in our fourth quarter release issued during the second week of March 2021.
Overarching, our 2021 strategy or some key principles the Keith outlined in his remarks, including.
Ernie Toth: Thank you, Keith, and good morning, everyone. By now, you will have seen our financial results in our 10-Q and earnings release that were filed last evening. As we typically do, we will address most of the discussion related to the first quarter 2021 results in the Q&A. We have reconfirmed our full year 2021 financial guidance as previously indicated in our fourth quarter release issued during the second week of March 2021. Overarching our 2021 strategy are some key principles that Keith outlined in his remarks, including: We are focused in 2021 on our two most important value drivers.
We are focused in 2021 on our two most important value drivers Weber Vance Resubmission approval and launch and the continued development of our epinephrine program.
While we are targeting a great 2021, <unk> date, we have included zero revenue from Weber band and our full year 2021 guidance until we're certain of the approval and launch time.
Our epinephrine program is advancing with our second pro drug <unk> 109 currently in a phase one PK trial.
And while we do not specifically guide on simple <unk> revenue as Keith mentioned previously our trends on wholesaler shipments to retail pharmacies and growth in new and repeat prescribers are very solid quarter over quarter, and we anticipate continued growth into 2021.
Ernie Toth: Libervance resubmission, approval, and launch, and the continued development of our epinephrine program. While we are targeting a late 2021 PDUFA date, we have included zero revenue from liver band in our full year 2021 guidance until we are certain of approval and launch time. Our epinephrine program is advancing with our second prodrug, AQST-109, currently in a Phase I PK
And while Suboxone is the legacy product for us it remains a significant part of our near term revenue outlook.
Our total revenues were $11 1 million in the first quarter 2021, compared to $8 8 million in the first quarter of 2020.
This year over year increase reflects higher license and royalty revenue and growth in sympathy on revenue.
We saw net revenue growth in the first quarter 2021 compared to the prior year period of 56% for simple <unk>. The first of our proprietary products to be launched.
Ernie Toth: And while we do not specifically guide on Symposan revenue, as Keith mentioned previously, our trends on wholesaler shipments to retail pharmacies and growth in new and repeat prescribers are very solid quarter over quarter, and we anticipate continued growth into 2021. And while Suboxone is a legacy product for us, it remains a significant part of our near-term revenue outlay. Our total revenues were $11.1 million in the first quarter of 2021, compared to $8.8 million in the first quarter of 2020.
Our net loss for the first quarter of 2021 was $14 7 million or <unk> 41 loss per share.
The net loss for the first quarter 2020 was $16 $5 million or <unk> 49 loss per share.
The year over year change of net loss was driven by higher revenue and reductions in costs and expenses.
<unk> offset by increased interest expense related to the sale of future revenue.
This interest expense is due to the accounting associated with the <unk> monetization on November three 2020, and does not represent a cash output or monetary obligation at anytime during the life of the transaction.
Ernie Toth: This year-over-year increase reflects higher license and royalty revenue and growth in symposam revenue. We saw net revenue growth in the first quarter of 2021 compared to the prior year period of 56% for Symposan, the first of our proprietary products to be launched. Our net loss for the first quarter of 2021 was $14.7 million, or $0.41 loss per share. The net loss for the first quarter of 2020 was $16.5 million, or $0.49 loss per share.
Adjusted EBITDA loss was $6 3 million in first quarter 2021, compared to $11 2 million in.
In the first quarter of 2020.
The year over year change in adjusted EBITDA loss was driven by higher revenue and reduction in cost and expenses.
As of March 31, 2021, cash and cash equivalents were 27 5 million.
During the first quarter of 2021, we access capital under our at the market or ATM facility, resulting in net proceeds of $9 9 million.
Ernie Toth: The year-over-year change in net loss was driven by higher revenue and reductions in cost and expenses, partly offset by increased interest expense related to the sale of future revenue. This interest expense is due to the accounting associated with the Kenobi monetization on November 3rd, 2020 and does not represent a cash output or monetary obligation at any time during the life of the transaction. Adjusted EBITDA loss was $6.3 million in the first quarter of 2021 compared to $11.2 million in the first quarter of 2020. The year-over-year change in adjusted EBITDA loss was driven by higher revenue and a reduction in cost and expense.
The ATM facility as amended has approximately $57 $1 million available at March 31, 2021.
As outlined in the press release issued last night after market close we are reaffirming our full year 2021 financial guidance that we previously provided during the second week of March when we reported our year end results for.
For the full year 2021, we expect total revenues of approximately $38 million.
To $42 million non-GAAP adjusted gross margins of approximately 70% to 75% on total revenues.
Operator: As of March 31st, 2021, cash and cash equivalents were $27.5 million. During the first quarter of 2021, we accessed capital under our at-the-market, or ATM, facility, resulting in net proceeds of $9.9 million. The ATM facility, as amended, has approximately $57.1 million available at March 31, 2021. As outlined in the press release issued last night after market close, we are reaffirming our full-year 2021 financial guidance that we previously provided during the second week of March when we reported our year-end results.
Non-GAAP adjusted EBITDA loss of approximately $42 million to $45 million.
With that I will now turn the volume back to the operator to open the lines of questions.
Thank you as a reminder to ask a question you'll need the press star one on your cell phone.
Of all your question press the pound Keith.
Our first question comes from Gary Nachman with BMO capital markets. Your line is now from.
Hi, this is ebb and flow filling in for the Gary Nachman. Thanks for the update and thanks for taking my question.
Yes, so I have a few questions. So first.
Operator: For the full year 2021, we expect total revenues of approximately $38 million to $42 million, non-GAAP-adjusted gross margins of approximately 70% to 75% of total revenue, and non-GAAP-adjusted EBITDA losses of approximately $42 million to $45 million. With that, I will now turn the line back to the operator to open the line for questions.
For the additional work that Youre doing for liver VAT, both for the PK and safety.
52.
Could that potentially be helpful to showing a meaningful improvements of patient care and getting the orphan drug designation.
And secondly, how soon can you re engage with the FDA on liver event. After you resubmit at the end of the second quarter.
Is that immediate or would it take a while on the preferred shares.
To date.
Sure Dan do you want on sure.
Good morning, so in terms of the <unk>.
Safety and PK work, that's going into the <unk>, Inc.
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. Our first question comes from Gary Nachman with VMO Capital Markets. Your line is open.
The way I would think about the re filing or the resubmission in terms of the benefits of our product is the totality of the package.
Debt is really what drives the value. So the safety piece that we're updating which is a very simple piece of course is part of our story and the PK modeling, which relates to the dosing regimen. We're creating also in the components of the value that we will drive so theres absolutely additional VAT.
Evan Squaw: Hi, this is Evan Squaw filling in for Gary Nachman. Thanks for the update, and thanks for taking my question. I have a few questions. First, for the additional work that you're doing for LibriVent, both for the PK and safety, could that potentially be helpful in showing a meaningful improvement in patient care and getting the orphan drug designation? And secondly, how soon can you re-engage with the FDA on LibriVent after you resubmit at the end of the second quarter? Is that immediate, or would it take a while to get closer to the due date?
<unk> in the work that we're doing that will go on the resubmission debt will tie to our market access.
Of re engaging with the FDA, we will reengage immediately.
Upon Resubmission in fact, I would I would argue we've been in contact with the FDA. We received the feedback back in February we have engaged back and forth with guidance from February to now and after Resubmission.
Operator: Sure. Dan, do you want to take that? Good morning.
Right.
Dan: So, in terms of the safety and PK work that's going into the, The way I would think about the refiling or the resubmission, in terms of the benefits of our product, is the totality of the package that is really what drives the value. So, the safety piece that we're updating, which is a very simple piece, of course, is part of our story. And the PK modeling, which relates to the dosing regimen that we're creating, also is a component of the value that we will drive.
One more follow up.
Would you be able to remind us how you view of the size of the market opportunity for <unk> as well as your thoughts on the proceeds from product for the growth is.
Cocoa and how you are differentiated.
Yes, there was.
Some noise in the background, we're not sure where its coming from could you just repeat that question. Please.
So would you be able to remind us on how you view of the size of the market opportunity for liver van and as well as your thoughts on the competing product neurolysis cocoa and how you're differentiated.
Dan: So, there's absolutely additional value in the work that we're doing that will go into the resubmission, that will tie to our market action. In terms of re-engaging with the FDA, we will re-engage immediately upon resubmission. In fact, I would argue we've been in contact with the FDA. We received their feedback back in February. We have engaged back and forth with them from February to now, and after resubmission, that will continue.
Sure Ken you want if you want to take that yeah sure Keith Thanks.
Yes, the market opportunity is pretty substantial if you look at the overall epilepsy market of about $3 2 million patients about $1 2 million of them have some level of refractory disease.
And as you talk to physicians those of the types of patients that they would look to have a.
A rescue strategy in place, which will create an opportunity quite frankly for all of the rescue medicines. So it's a pretty substantial market.
Dan: Would you be able to remind us how you view the size of the market opportunity for LibraVent as well as your thoughts on the product for New Relic's soft cocoa and how you are differentiating it? Yeah, Evan. There was some noise in the background that we're not sure where it's coming from.
And if you look at.
Telco on key points of differentiation I mean, clearly one of the nasal and the other is an orally administered medicine.
The key points of differentiation.
In my mind are the preferred route of administration.
And then what will likely be our labeled population 12 and older the need to use two doses of the nasal about telco to get an effective level of therapy on those patients.
Evan Squaw: Could you just repeat that question, please? Yeah. So, would you be able to remind us of how you view the size of the market opportunity for LibraVent and your thoughts on the competing product, New Ellis' ThoughtCoco, and how you're differentiating? Sure. Ken, do you want to take that?
A pretty significant point of differentiation.
Thank you.
Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is open.
Hi, Thanks for taking the questions.
Apple on the epinephrine program.
Can you just remind us for <unk>, how predictive the preclinical data were in translating into the PK profile you saw on the initial human studies and then following on from that can you just compare and contrast, the profile of <unk> seen pre clinically to date for one of nine versus what you saw.
Keith Kendall: Yes, sure, Keith. Thanks. Yeah, the market opportunity is pretty substantial. If you look at the overall epilepsy market of about 3.2 million patients, about 1.2 million of them have some level of refractory disease. And as you talk to physicians, those are the types of patients that they would look to have a rescue strategy in place, which would create an opportunity, quite frankly, for all the rescue medicines. So it's a pretty substantial market.
For one of the Lady.
Sure Jason I'll, let Dan take that question.
Good morning, Jason Great.
Great question when you look at the preclinical data for 108, it was very predictive in our minds of what we saw in the clinic.
Keith Kendall: And if you look at Valtoko and the key points of differentiation, I mean, clearly, one's a nasal and the other's an oral medicine. The key points of differentiation, in my mind, are the preferred route of administration, and in what will likely be our labeled population 12 and older, the need to use two doses of the nasal Valtoco to get an effective level of therapy in those patients will be a pretty significant point of differentiation. Thank you. Our next question comes from Jason Butler with JNP Securities. Your line is open.
We saw solid absorption with our prodrug platform and then we saw a rapid peak of dip of deference and conversion into epinephrine and as you as you know pro drugs are simply the chemical derivative of the molecule and after absorption enzymatic cleavage turns of the pro drug back into the.
Original molecule.
With that predictive model, what we saw was and we talked about this at the R&D day. The dip of reference gave a really interesting and compelling curve.
But we think we can do better on the conversion rate. So with 109 in preclinical models, we have a much faster conversion rate.
Jason Nicholas Butler: Hi. Thanks for taking the questions. I had a couple on the epinephrine programs. Can you just remind us for AQST-108 how predictive the preclinical data were in translating into the PK profile you saw in the initial human studies? And then following on from that, can you just, you know, compare and contrast the profiles you've seen preclinically to date for 109 versus what you saw for 108? Sure. Jason, I'll let Dan take that question.
In the our second generation prodrug, so pre clinically you see.
Absorption of nice Big peak, and then you see rapid conversion into epinephrine through the end of the enzymatic cleavage. We're currently in the clinic as you know with 109.
And we're excited to see the data as we go through that study and we expect that study to readout as Keith mentioned in his remarks earlier in the second half of 2021.
Great.
And then just one point from the R&D day that the adult.
Dan: Good morning, Jason, and great question. When you look at the preclinical data for 108, it was, in our minds, very predictive of what we saw in the clinic. We saw solid absorption with our prodrug platform, and then we saw a rapid peak of dipivephrine and conversion into epinephrine. And as you know, prodrugs are simply a chemical derivative of the molecule, and after absorption, enzymatic cleavage turns the prodrug back into the original molecule.
Brought up was the what seems to be pretty meaningful risks of the incorrect use sort of delayed use of injectable epinephrine just wondering if you've gotten the market research.
To support how important these factors are.
Both of the physician into patients when thinking about.
The potential for a different delivery method of life in the world Epinephrine.
Sure. Thank you Jason Yes, we do have market research that indicates that patients do delay using the current.
Dan: With that predictive model, what we saw, and we talked about this at the R&D day, the dip in efferent gave a really interesting and compelling curve, but we think we can do better on the conversion. So with 109, in preclinical models, we have a much faster conversion rate in our second generation prodrug. So preclinically, you see rapid absorption, a nice big peak, and then you see rapid conversion into epinephrine through enzymatic cleavage.
The standards of care.
Because of a variety of issues and in fact, it's not just our market research there is a whole wealth or body of research outside of our company that indicates the patients delay using an epipen or other injection type of epinephrine product for a variety of reasons and.
And we do believe that our product lowers those barriers and will be of products that over time. We can show patients are more willing to take at the onset of any of allergic reaction. So that is absolutely a key differentiator of our oral proud of our oral sublingual product and we will.
Jason Nicholas Butler: We're currently in the clinic, as you know, with 109 patients. And we're excited to see the data as we go through that study. And we expect that study to read out, as Keith mentioned in his remarks earlier, in the second half of 2021.
We'll continue to ensure we understand how to use that differentiation as we go forward.
Great helpful. Thanks for taking the questions.
Dan: Great. And then just one point from the R&D day that the docs brought up was what seems to be a pretty meaningful risk of incorrect use or delayed use of injectable epinephrine. Just wondering if you've got any market research to support how important these factors are to both the physician and to patients when thinking about the potential for a different delivery method, like an oral epinephrine.
Thanks, Jason Thanks, Jason.
Thank you. Our next question comes from Dan Busby with RBC. Your line is open.
Great Hey, guys. This is Steve on for Dan. Thanks for taking our questions here I've got two and I'll ask the bulk of upfront.
So the first one is related to the Sip is in kind of <unk>.
Curious is as we were looking at the current COVID-19 environment, and how it's impacting patients to getting in front of doctors and now there are people are getting more vaccine restrictions across the U S are starting to line up how are you thinking about those dynamics and how it's going to impact your business here going forward and theres any of them.
Jason Nicholas Butler: Sure. Thank you, Jason. Yes, we do have market research that indicates that patients do delay using the current standards of care because of a variety of issues. But, in fact, it's not just our market research. There's a whole wealth or body of research outside of our company that indicates that patients delay using an EpiPen or other injection-type epinephrine product for a variety of reasons. And we do believe that our product lowers those barriers and will be a product that, over time, we can show patients are more willing to take at the onset of any allergic reaction.
Went up demand for that you guys are thinking about and then my second question is related to the FNF trend you guys are in the process of other first in human PK data, which looks like you're going to have some data readout later this year along with the <unk>.
Having some conversations with the FDA I guess I'm trying to get a sense is ultimately what are you looking for to help you make a decision as to which as debt you'll be more comfortable to pursuing one.
Jason Nicholas Butler: So that is absolutely a key differentiator of our oral sublingual product, and we will continue to ensure we understand how to use that differentiation as we go forward. Great. Helpful. Thanks for taking the questions. Thanks, Jason.
One of the way versus the 109, thanks for taking the questions.
Sure I'll, let Ken Marshall, our Chief commercial officer answer the first part of your question.
And then Dan will take the epinephrine part of your question Okay.
Hi, Steve This is Ken if you look back to the start of the pandemic last March leading into that about 90% of our interactions with health care practitioners were alive.
Operator: Thank you. The next question comes from Dan Busby.
Almost immediately to 10% in that April timeframe. So it was it was the very radical shift.
Operator: From Dan Busby with RBC, your line is open.
And now over time as people have figured out how to manage it and set guidelines youre seeing about.
Operator: Great. Hey guys, this is Stephen speaking for Dan.
Stephen: Thanks for taking our questions here. I've got two, and I'll ask them both up front. So the first one is related to Desipazan, and I'm kind of curious as we were looking at the current COVID environment and how it's impacting patients getting in front of doctors, and now there are people getting more vaccinated, and restrictions across the U.S. are starting to lighten up. How are you thinking about those dynamics and how they're going to impact your business here going forward, and is there any pent-up demand that you guys are thinking about?
Ah $65 to 35 ratio of <unk>.
<unk> two to virtual visits and it's ever so slightly trending back up depending on the week, we look at it can be 70%, 75% live and that's for all health care practitioners physicians in the mid levels.
We feel like we are definitely more effective and those types of settings, but we've also learned how to very effectively work and of virtual world with our speaker on peer programs and are on our interactions with physicians.
Speculating I don't know if it will go back to 90 10, and what we're doing as a company of our encouraging live visits where possible.
Stephen: And then my second question is related to FNF Friend. You guys are in the process of getting your first human PK data, and it looks like you're going to have some data readout later this year along with having some conversations with the FDA. I guess I'm trying to get a sense of ultimately what you are looking for to help you make a decision as to which asset you will be more comfortable pursuing 108 versus 109. Thanks for taking the questions. Sure.
And following the guidelines of the hospitals and clinics, if they allow folks and we go visit them. If they don't we set up virtual meetings.
And Dan I'll take the second part of your question.
And this is Dan.
From a 108 and 109 perspective, if you look at the data as we laid out for one of the way what we were really excited by on a couple of things one the rapid peak of debt. The vectoring. So of T. Max of under 20 minutes for the prodrug itself and to the really interesting PD effect that we saw the.
<unk> effects that we saw.
Operator: Sure, I'll let Ken Marshall, our Chief Commercial Officer, answer the first part of your question, and then Dan will take the epinephrine part of your question, okay? Hi, Steve. This is Ken.
Throughout the data that we collected.
So what we're doing right now with one of weight is modeling all of that PD data and how it relates to the PK work that we have to date, we will go forward and talk to the FDA about how they think about PD data and how we can use debt in our one on weight program. So that's the path from one of weight.
Kenneth W. Marshall: If you look back to the start of the pandemic last March, leading into that, about 90% of our interactions with healthcare practitioners were live. It went almost immediately to 10% in that April timeframe. So it was a very radical shift.
On 109, while we anticipate seeing.
Or we would expect to see of PD effect 109, we're looking to see what the PK. It looks like at this time price. So do we see the same rapid absorption of the prodrug.
Kenneth W. Marshall: And now, over time, as people have figured out how to manage it and set guidelines, you're seeing about a 65-35 ratio of live to virtual visits, and it's ever so slightly trending back up. Depending on the week we look at, it can be 70-75% live, and that's for all healthcare practitioners, physicians, and their mid-levels. We feel like we're definitely more effective in those types of settings, but we've also learned how to very effectively work in a virtual world through our speaker and peer programs and our interactions with physicians.
And do we see the rapid conversion that we anticipate based on our preclinical models. So we will take both 108 and 109 forward at this time and then based on our FDA interactions, we will make a decision on.
Where those two programs go whether they both go on parallel whether one goes ahead of the other or whether they are of different purposes for for the assets in different indications. So we're excited about both and we look forward to talking about them in the second half of the year.
Kenneth W. Marshall: I'm speculating, I don't know if it will go back to 9010, but what we're doing as a company is encouraging live visits where possible and following the guidelines of the hospitals and clinics. If they allow folks in, we go visit them. If they don't, we set up virtual meetings.
Great. Thanks for the color guys.
Okay.
Thank you. Our next question comes from Spud of Dine with Wedbush. Your line is open.
Hi, This is <unk> of one.
Hello, Macedo of thank you for taking our question.
For the <unk> NDA Resubmission.
Of the steps remaining to refined by the end of Q2 on the floor.
Dan: And Dan, I'll take the second part of your question, and this is Dan. Just from a 108 and 109 perspective, if you look at the data as we laid out for 108, what we were really excited about are a couple of things. One, the rapid peak of dipiveparin, so a Tmax of under 20 minutes for the prodrug itself. And two, the really interesting PD effect that we saw, or pharmacodynamic effect that we saw throughout the data that we collected.
The information the top line to add to the NDA Resubmission.
Dan sure good morning, <unk>, so the new information that will be in the.
The NDA, let me put it this way the.
The most important thing to remember is there is no new clinical data in this NDA. So this NDA is all of the information from the previous NDA, along with our population PK modeling updates.
So what we have focused on is if you look at the CRM from September of 2020, as we laid out to all of you. There are a couple of deficiencies that we needed to address one of those was making sure that we update our safety area in order to talk directly about the patient population we've done that the other.
Dan: So what we're doing right now with 108 is modeling all of that PD data and how it relates to the PK work that we have done to date. We will go forward and talk to the FDA about how they think about PD data and how we can use that in our 108 program. So that's the path from 108. On 109, while we anticipate seeing, or we would expect to see, a PD effect, 109 we're looking to see what the PK looks like at this time, right?
There was to make sure we justified our dosing regimen based on the different weight groups and the performance in our prior of wanted to 303 study we've done that.
So that's the data that will go into the Resubmission in terms of the steps between here and the <unk>.
Submission in June at this point it is an administrative task we have many of the parts of the NDA already ready to go on the safety part of particular is well on its way on the last piece to put into the NDA will be the final report from our Modeler and once we have that the step will simply be send.
Dan: So do we see the same rapid absorption of the prodrug? And do we see the rapid conversion that we anticipate based on our pre-clinical models? So we'll take both 108 and 109 forward at this time, and then, based on our FDA interactions, we'll make a decision on where those two programs go, whether they both go in parallel, whether one goes ahead of the other, or whether there are different purposes for the assets and different indications. So we're excited about both, and we look forward to talking about them in the second half.
On the NDA into the FDA for Resubmission, there's nothing else that we need to do at this point.
Thank you.
Thank you. Our next question comes from Thomas Flaten with Lake Street Capital. Your line is open.
Great. Thanks, Good morning, guys. A couple of follow ups I think mostly for Dan Dan You mentioned, you've continued interacting with the FDA with FDA on liver Vince since the since the February guidance has anything changed or has it been.
Operator: Great, thanks for the color guys.
<unk> in terms of what you're required to send and have the out of any color I'm just curious to get some color on those interactions.
Operator: Thank you. Our next question comes from Sveta Dain with Wedbush. Your line is open. Hi, this is Shweta speaking on behalf of Leanna Moussaro.
Yes.
Thank you that's good clarification the interactions are simply ensuring that we maintain the relationship specifically with the project manager of letting them know debt.
Shweta: Thank you for taking our question. For the Liberwine NDA resubmission, what are the steps remaining to refile by the end of Q2? And is there any new information that you plan to add to the resubmission? Dan? Sure. Good morning.
We'll be resubmitting letting them know that we understand the feedback they've given and making sure that everything is prepared for when that resubmission occurs so there have been no.
Interactions around the deficiencies or.
Or any of of the clarifying components that you would.
Dan: Good morning, Shveta. So the new information that will be in the NDA, let me put it this way. The most important thing to remember is that there is no new clinical data in this NDA. So this NDA is all of the information from the previous NDA, along with our population PK modeling update. So, what we have focused on is, if you look at the CRL from September of 2020, as we laid out to all of you, there are a couple of deficiencies that we needed to address. One of those was making sure that we updated our safety area in order to talk directly about the patient population. We've done that before.
That perhaps youre looking forward the at this point its administrative the substantial conversation will occur after resubmission once they have.
Seen our application.
And then just a follow up on on some clarification you guys made on this call with respect to 109 I think in the prepared comments you said the part one of the 109 study would be completed in the second half and just reflecting back on the R&D day. There was a part one ascending dose component, but then there was a part to crossover so what's the implication for timing.
On part two there is it going to be completed this year or is that something that will be initiated once you've met with FDA.
Dan: The other was to make sure we justified our dosing regimen based on the different weight groups and the performance in our prior study, our 1-8-0-3-2-3 study. So that's the data that will go into the resubmission. In terms of the steps between here and the submission in June, at this point, it is an administrative task. We have many of the parts of the NDA already ready to go. The safety part, in particular, is well on its way.
Sure.
The meeting with the FDA will occur between part one and part two but it is not of gating event.
Part two will continue onward, the preparation the dosing and the.
The other.
All of the results are on it's on track.
So I would think about it this way part one will readout we.
We will take that data, we will go talk to the FDA and while were talking to the FDA. The plans for part two will be underway.
We do anticipate at this time debt.
Part two of our program will begin dosing in 2021.
On the final date of when that completes remains to be seen.
Dan: The last piece to put into the NDA will be the final report from our modeler. And once we have that, the step will simply be sending the NDA to the FDA for resubmission. There's nothing else that we need to do at this point.
Great and then just a quick one for Ernie if I may.
On the fourth quarter call you guys mentioned that you would do the $3 million payment I think it was from Mitsubishi.
Yet in the license and royalty number it was less than 3 million could you just clarify if that payment did come in or how we should on.
Understand that.
Operator: Thank you. Our next question comes from Thomas Flaten with Lake Street Capital. Your line is open. Good, thanks.
Yes.
So there is theres two components to the Mitsui.
The Mitsubishi Tanabe amount there is an amount that the.
Thomas Flaten: Great, thanks. Good morning, guys.
Was based on signing and Theyre just the amount that is based on shipments and we did receive the cash of $3 million from Mitsubishi Tanabe.
Operator: A couple of follow-ups, I think mostly for Dan. Dan, you mentioned you've continued interacting with the FDA on LibraVan since February Guidance. Has anything changed, or has it been... I'm just curious to get some color on that.
But that was not reflected in its entirety in the first quarter number that's right. It's not all considered revenue and.
Dan: Yeah, and Thomas, thank you. That's a good clarification. The interactions are simply ensuring that we maintain the relationship specifically with the project manager, letting them know that we will be resubmitting, letting them know that we understand the feedback they've given, and making sure that everything is prepared for when that resubmission occurs. So there have been no interactions around the deficiencies or any of the clarifying components that you would, that perhaps you're looking for. At this point, it's administrative.
In the first quarter.
Got it thanks, so much thanks for taking the questions guys.
Okay.
Okay.
Thank you. Our next question comes from Rob <unk> with HC Wainwright. Your line is open.
Thanks, very much for taking my questions can you hear me.
Yes, Ron how are you doing this morning.
Pretty good pretty good.
Just to start off with.
Simple then kind of learnings as we approach the potential of <unk> commercialization.
I was wondering if you could comment specifically on what looks like an impressively high retention rate when it comes to repeat prescribers I think you quoted on 80% rate on that metric for simple then.
Dan: The substantial conversation will occur after resubmission once they have seen our application. And then, just to follow up on some clarification you guys made on this call with respect to 109, I think in the prepared comments you said that Part 1 of the 109... And just reflecting back on the R&D day, there was a part one... sending those components, but then there was a part two crossover. So what's the implication for timing on part two there? Is it going to be completed this year?
The script writers. So I was wondering if you could give us some color on whether you expect that repeat prescriber rate to be similar for liver Vance the as and when live event gets to the market.
If you can give us some perspectives on what the experience with simple event, so far might portend for the liver event, specifically with respect to repeat prescriber rates.
Ken.
Sure.
Yes, I think what drives the repeat prescriber rate for <unk> is just the clear patient type of patient profile debt.
Dan: Is that something that will be initiated once? Sure. The meeting with the FDA will occur between Part 1 and Part 2, but it is not a gating event. So Part 2 will continue onward. The preparation, the dosing, and all of the results are on their own track.
Debt benefits from getting the club exam on the strip rather than tablets or liquids.
That's a nice way to position your brands.
Dan: So I would think of it this way: part one, we'll read out. We will take that data, we will go talk to the FDA, and while we're talking to the FDA, the plans for Part 2 will be underway. We do anticipate at this time that Part 2 of our program will begin dosing in 2021, and the final date of when that completes remains to be seen. And then, just a quick one for Ernie, if I may.
The clear patient type and Thats, usually what drives multiple uses and those types of patients.
And I would expect the same type of thing with.
With the labor band.
It'll be the only orally delivered rescue medicine. So it is going to own that space, There's no doubt that oral as a preferred over other routes of administration.
Especially as they get more invasive and more challenging from a drug device standpoint.
So I would expect the physicians would adopt and I would expect that the majority of the vast majority of it right from multiple patients multiple scripts for those patients.
Great very helpful. So secondly, again on simple then.
Ernie Toth: On the fourth-quarter call, you guys mentioned that you were due a $3 million payment, I think it was from Mitsubishi, yet in the license and royalty number, it was less than $3 million. Could you just clarify if that payment did come in, or how we should understand that? Hi. So there are two components to the Mitsubishi Tanabe amount. There is an amount that was based on signing, and there is an amount that is based on shipments, and we did receive the cash of $3 million for Mitsubishi Tanabe, but that was not reflected in its entirety in the first quarter number.
I understand that youre, not giving specific simpler than product revenue guidance, but.
If you could just qualitatively comment on what you expect the kinetics of the simpler than revenue growth curve to look like over the course of 2021 are you anticipating first and foremost sequential quarter over quarter of growth going forward as we look towards the remainder of 2021 and then secondly, do you expect.
The quarter over quarter of growth, if indeed, you're expecting quarter on quarter growth to accelerate over the course of the remaining quarters of 2021 and to what extent might that be driven by quote unquote normalization of the overall market conditions relative to the COVID-19 pandemic.
Ernie Toth: That's right, it's not all considered revenue in the first quarter. Got it. Thanks much. Thanks for taking the time. Thank you. Our next question comes from Ram Selvaraju with HC Wainwright. Your line is open.
Operator: Thanks very much for taking my questions. Can you hear me? Yes, Ram. How are you doing this morning? Pretty good, pretty good. So just to start off with,
Ron can you hear me.
Yes.
Brian can you hear me.
Yes, I can hear you.
We lost the last part of your question.
Raghuram Selvaraju: Simpazan kind of learning as we approach the potential Libervant commercialization. I was wondering if you could comment specifically on what looks like an impressively high retention rate when it comes to repeat prescribers. I think you quoted an 80% rate on that metric for Simpazan script writers.
You asked whether we what we viewed or how we were feeling about the sequential growth quarter over quarter and before I, let Ernie answer that.
We lost the last part of your question, we'd like to make sure. We respond to you could you repeat it please.
Yes.
We may of loss from Ernie do you want to at least take a crack at the part of the question here.
Sure Rob.
Kenneth W. Marshall: So I was wondering if you could give us some color on whether you expect that repeat prescriber rate to be similar for Libervant as and when Libervent gets to the market. If you can give us some perspectives on what the experience with Simphevan so far might portend for Libervent, specifically with respect to repeat prescriber rates. Ken?
Tom.
Again, we don't provide any specific guidance.
On products, we don't break it out on a full year basis.
I think as we look at simple zahn.
Going through the rest of the year that we would expect quarter over quarter growth as we continue to have the.
Kenneth W. Marshall: Sure. Yeah, I think what drives the repeat prescriber rate for Symposan is just the clear patient type or patient profile that benefits from getting their Clobizam on a strip rather than tablets or lipos. That's a nice way to position your brand; it creates a clear patient type, and that's usually what drives multiple uses in those types of patients. And I would expect the same type of thing with... with LiberBand, and it'll be the only orally delivered rescue medicine that's going to own that space. There's no doubt that orals are preferred over other routes of administration, especially as they get more invasive and more challenging from a drug device standpoint.
As Ken had mentioned the in person and face to face meetings with the physicians and that also is.
As part of our strategy as we prepare for the launch of Liberty path of discipline as we've talked about previously that this dovetails with the the prevent launch because of the overlap and the prescribers. So we would.
Continue to expect to see quarter over quarter growth at this point.
Great. Thanks Ernie.
There are no other questions in the queue I'd like to turn the call back to Keith for any closing remarks.
Kenneth W. Marshall: So I would expect that physicians would adopt them, and I would expect that the majority, the vast majority, would write multiple prescriptions for those. Great, very helpful. So secondly, again on Simpazan, I understand that you're not giving specific Simpazan product revenue guidance, but if you could just qualitatively comment on what you expect the kinetics of the Simpazan revenue growth curve to look like over the course of 2021. Are you anticipating, first and foremost, sequential quarter-over-quarter growth going forward as we look towards the remainder of 2021?
Great. Thank you operator, and thank you everyone for joining us. This morning, we appreciate your time and your continued interest in our quest of.
Obviously, we're going to be focused on the things that are most important to driving the value of our company.
We're going to get.
We're going to continue to focus on delivering.
Sure.
The results out of epinephrine.
Trial on 109, as we've described and then setting up our discussion with the regulators later in the year.
We remain laser focused on finishing out the pieces of work that we need to do.
Kenneth W. Marshall: And then secondly, do you expect that quarter-over-quarter growth, if indeed you're expecting quarter-over-quarter growth, to accelerate over the course of the remaining quarters of 2021? And to what extent might that be driven by, you know, the quote-unquote normalization of the overall market conditions relative to the COVID-19 pandemic?
To prepare our re filing to the end of the second quarter.
We will continue to grow Suzanne as Ernie talked about and.
And we look forward to updating you all on the progress we make on those key items throughout the year. So thank you very much for coming this morning, and we look forward to talking to you all again soon.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
Raghuram Selvaraju: So, Ram, can you hear me? Yes. Ram, can you hear me? Yes, I can hear you.
[music].
Operator: We lost the last part of your question. You asked whether we saw any trends or how we were feeling about the sequential growth quarter over quarter. And before I let Ernie answer that, we lost the last part of your question. We'd like to make sure we respond to you. Could you repeat it, please? We may have lost prom.
Yes.
[music].
Yes.
[music].
Ernie Toth: Ernie, do you want to at least take a crack at the part of the question you can hear? Sure, Ram. So, you know, again, we don't provide any specific guidance on products. We don't break it out on a full-year basis. But I think as we look at Symposan going through the rest of the year, we would expect quarter-over-quarter growth as we continue to have, as Kenneth mentioned, in-person and face-to-face meetings with physicians.
Ernie Toth: And it also is part of our strategy as we prepare for the launch of LibraVant that this, as we've talked about previously, dovetails with the LibraVant launch because of the overlap in the prescribers. So we would continue to expect to see quarter-over-quarter growth at this point.
Operator: There are no other questions in the queue. I'd like to turn the call back to Keith for any questions.
Yes.
[music].
Operator: I'd like to turn the call back to Keith for any closing remarks. Okay.
Keith Kendall: Thank you, Operator, and thank you, everyone, for joining us this morning. We appreciate your time and your continued interest in Equestiv. Obviously, we're going to be focused on the things that are most important to driving the value of our company. We're going to get, and we're going to continue to focus on delivering the results from epinephrine and a trial on 109, as we've described, and then setting up our discussion with the regulators later in the year. We remain laser-focused on finishing out the pieces of work that we need to do to prepare our refiling for the end of the second quarter.
Okay.
Yes.
Okay.
Moving forward.
[music].
Operator: We'll continue to grow Cipazan, as Ernie talked about, and we look forward to updating you all on the progress we make on those key items throughout the year. So, thank you very much for coming this morning, and we look forward to talking to you all again soon. Thank you.
Sure.
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Moving on.
Right.
Okay.
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Yes.
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Okay.
And on that.
On.
Sure.
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During the day.
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