Q3 2020 Aquestive Therapeutics Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the Q3 2020, a question Therapeutics Inc. earnings Conference call. At this time all participant lines are in a listen only mode. After the speakers presentation. There will be a question and answer session. That's the question during the session, we'll need to press star one on your telephone.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Equestria Therapeutics, Inc. Earnings Conference Call. At this time, all participant lines are in a listen-only mode.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0.
Be advised that todays conference is being recorded if you're acquiring any further assistance. Please press star zero I would not like to have the conference over to your speaker that speaker today, Stephanie Carrington West with Investor Relations. Thank you. Please go ahead ma'am.
Operator: I would now like to hand the conference over to your speaker today, Stephanie Carrington, Westwick Investor Relations. Thank you. Please go ahead, ma'am.
Stephanie Carrington: Thank you, Operator. Good morning and welcome to today's call. I am joined by Keith Kendall, President and Chief Executive Officer, and John Maxwell, Chief Financial Officer, who will be providing an overview of recent business developments and performance of the company in the third quarter. We expect today's call to last approximately 60 minutes.
Thank you operator.
Good morning, and welcome to today's call I'm joined by keep Kindle, President and Chief Executive Officer, and John Maxwells, Chief Financial Officer, who will be providing an overview of recent business development and performance of the company in the third quarter.
We expect today's call to last approximately 60 minutes the company's remarks today correspond with the earnings release that was issued after market closed yesterday.
Stephanie Carrington: 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. This call will also include a discussion of certain non-GAAP financial measures. A reconciliation to corresponding gap measures can be found in yesterday's earnings release.
In addition, a recording of today's call will be made available on a quest as web site within the investors section.
Sure at least following the conclusion of this call.
This call will also include a discussion of certain non-GAAP financial measures.
A reconciliation to corresponding GAAP measures can be found in yesterdays earnings release.
Keith Kendall: Before we begin, let me remind you that today's call will include forward-looking statements based on the company's current expectations. These statements reflect the company's judgment as of today only and are subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. The company undertakes no obligation to revise or update these forward-looking statements in light of new information or future events, except as required by law. These risks and uncertainties are discussed in greater detail in the company's quarterly report on Form 10-Q filed today, under the caption RISK FACTS. With that, I will now turn the line over to...
Before we begin let me remind you that today's call will include forward looking statements based on the company's current expectations.
These statements reflect the company's judgment as of today, only and are subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements.
The company undertakes no obligation to revise or update these forward looking statements.
In light of new information or future events, except as required by law.
These risks and uncertainties are discussed in greater detail in the company's quarterly report on form 10-Q filed today.
In.
Greater detail under the caption risk factors.
With that I will now turn the line over to Keith.
Thank you Stephanie and thank you to everyone on the call for joining us this morning.
Keith Kendall: Thank you, Stephanie, and thank you to everyone on the call for joining us this morning. In our remarks, John and I will provide an update on our business for the third quarter. And, as always, we'll be joined by additional members of the Equestive Leadership Team during the Q&A session afterwards. During the third quarter, Equestria continued to make progress as it relates to the key drivers of value for the company.
In our remarks.
As an update on our business for the third.
Third quarter and as always we'll be joined by additional members of your question leadership team during the Q when a session afterwards.
During the third quarter as well.
We need to make progress as it relates to the key drivers of value for the company.
First symposium continues to perform against all important metrics. Despite the ongoing COVID-19 related restrictions on face to face interactions with health care providers, we're continuing to markets that does answer the same prescriber base, but our potential prescribers of all product candidate Liberty.
Keith Kendall: First, Sympathand continues to perform against all important metrics despite the ongoing COVID-19-related restrictions on face-to-face interactions with health care providers. We're continuing to market Simpozan to the same prescriber base that our potential prescribers of our product candidate, Libervan. Symposan retail shipment volume grew 18% in the third quarter over second quarter.
Yeah.
She is in retail shipment volume grew 18% third quarter over second quarter.
Next as previously announced the company is taking steps to address the issues raised in the U.S complete response letter that we received in September regarding one new drug application for Liberty.
Keith Kendall: Next, as previously announced, the company is taking steps to address the issues raised in the FDA's complete response letter that we received in September regarding our new drug application for liver veins. After submitting a meeting package to the FDA in October, we received confirmation that the FDA agreed to have a Type A meeting with us set for November 12, 2020. A Type A meeting, as you know, is granted for candidate drugs on hold to discuss impending issues and a path forward for improvement.
After submitting a meeting package to the EPS beginning in October we received confirmation that the FDA agreed to have a policy meeting with US set for November 12 2020.
A type B meeting as you know is granted candidate drugs on hold.
Discussing pending issues on a path forward for approval.
We look forward to meeting with the FDA to discuss the information we submitted it to seek feedback on the Resubmission of R&D gay for Liberty.
Keith Kendall: We look forward to meeting with the FDA to discuss the information we submitted and to seek feedback on the resubmission of our NDA for liver vaccines. We believe that we've provided a strong set of facts supporting our NDA. We will update the market once the minutes of the meeting are finalized regarding the FDA's comments, our plans for resubmitting our NDA, and the potential range of PDUFA dates for the liver ban. Additionally, in the quarter, we commenced the Phase I Pharmacokinetic Trial for Equestiv 108 in August and completed trial enrollment in October. This therapeutic candidate is a first-of-its-kind oral sublingual film formulation delivering systemic epinephrine.
We believe that we've provided a strong set of facts supporting oriented.
We will update the market once minutes of the meeting are finalized regarding the FDA comments, our plans for resubmitting R&D and the potential range is to do the dates for Liberty.
Additionally, in the quarter, we commenced the phase one pharmacokinetic trial for questions. One a week in August and completed trial will roll enrollment in October.
[noise] therapeutic candidate is a first of its time, all sublingual film formulation delivering systemic up in Africa.
Once we receive an analyzed all of the data from this trial will provide further guidance on the next stages of development as appropriate for this product.
Keith Kendall: Once we receive and analyze all of the data from this trial, we'll provide further guidance on the next stages of development, as appropriate, for this product. We believe Equestiv 108, if approved, will be the first orally administered epinephrine-based rescue medication for this patient population. Finally, the Equestive team entered into a monetization agreement with Marathon Asset Management, a leading global investment firm, for up to $125 million for the anticipated royalty associated with Sinovian's Kenmobi sublingual apomorphine product that received FDA approval in May 2020. This transaction, along with our continued expense and capital management activities, will provide a capital runway for the company through the third quarter of 2021 and potentially beyond. Now, let's discuss in more detail each of these key areas of focus for the company.
We believe the question one a week if approved will be the first orally administered after their front based rescue medication for this patient population.
Finally, you quest if team entered into a monetization agreement with marathon asset management, a leading global investment firm for up to $125 million for the anticipated royalties associated with Sunoco wins can mobi sublingual apomorphine.
Product, they're received FDA approval in May 20 Twond.
[noise] this transaction along with our continued expense and capital management activities will provide capital runway for the company through the third quarter of 2021 and potentially deal.
Now lets discuss in more detail each of these key areas of focus for the company.
First we remain focused on building our CNS franchise, we're advancing the commercialization of Suzanne whose prescribers substantially overlap with potential prescribers of Liberal game.
Keith Kendall: First, we remain focused on building our CNS grid. We're advancing the commercialization of Sympazan, whose prescribers substantially overlap with potential prescribers of Libervan. Our aim is to raise the profile of our farm film technology as a commercial precursor and complementary product in support of the LibraVent opportunity. Symposan continues to prove the build-out of our capabilities and processes in preparation for the commercial launch of LibraVent, if approved by the FDA for U.S. market access. The acceptance of Simpazan is an important building block, providing a meaningful value proposition for caregivers of patients suffering from Lennox-Gastaut syndrome, as well as positioning Liver Van for a stronger launch, despite the limitations created by the continuing COVID-19 crisis that restrict our sales team to mostly virtual interactions with health care providers. Stempizan continues to see market penetration and prescription growth. Shipment volumes sequentially quarter over quarter have grown 18% and by 130% over the same period last year.
Our aim is to raise the profile of our Pharmfilm technology as a commercial precursor complementary products in support of the Liberal van opportunity.
Super Tuesday continues to prove the build out of our capabilities and processes in preparation for the commercial launch of live event, if approved by the FDIC U.S. market access.
The acceptances SIMPAS, Dan is an important building blocks, providing a meaningful value proposition for caregivers of patients suffering from Lennox Gastaut syndrome, as well as positioning lipper bad for a stronger launch.
Despite the limitations created by the continuing COVID-19 crisis that restrict our sales team to mostly virtual interactions with healthcare providers symposium continues to see market penetration and prescription growth.
Shipment volumes sequentially quarter over quarter has grown 18% and bought 130% over the same period last year.
During that same period, we also continued to grow our prescriber base, which now approaching 700 health care providers, representing over 30% penetration into our focus group of prescribers with over 77% of those prescribers writing multiple scripts.
Keith Kendall: During that same period, we also continued to grow our prescriber base, which now approaches 700 health care providers, representing over 30% penetration into our focus group of prescribers, with over 77% of those prescribers writing multiples. Those physicians are critical to the continued success of Sympathand and will be critical to the success of LiverVant once LiverVant is launched upon FDA approval for U.S. market access. CIFIZAN revenue grew, with a 102% increase in net revenue for the three-month period ended Q3, 2020, versus Q3, 2019, and an 86% increase in net revenue for the nine-month period ending Q3, 2020 versus 2019. We continue to ramp up payer acceptance and currently have over 72% of commercialized covered and 82% coverage of state Medicaid regions. The actual third-quarter claims paid rate for commercial patients was 85%, and for Medicaid, 88%.
Those health care providers are critical to the continued success of Sudan and will be critical to the success of live event once launch upon FDA approval for U.S. market access.
Sip is AD revenue grew 100, and a 2% increase in net revenue for the three month period ended Q3 2020 versus Q3 2019.
And an 86% increase in net revenue for the nine month period, ending Q3 2020 versus 2019.
We continue to ramp up payer acceptance and currently have over 72% of commercial lives covered and 82% coverage of state Medicaid regions.
The actual third quarter claims paid rate to commercial patients was 85% and for Medicaid 88%.
We believe our position with the payers also will help us with the potential launch of liver damage.
Keith Kendall: We believe our position with the payers will also help us with the potential launch of Liverpool. During the pandemic, we have, to the best of our ability, ensured that our sales team is safe and compliant with local regulations, but we have also worked hard to maintain the sales team's connections with the prescriber and patient community that needs lymphosamines. We believe that our continued growth in prescriptions and net revenue demonstrates that we've been able to continue to connect with prescribers, even virtually, and grow this product to extraordinary heights. Next, as we previously communicated, we received a complete response letter from the FDA for the liver ban in late September. As we outlined during a previous conference call on this topic in September, we were very disappointed that our NDA was not approved and are taking immediate action to address the agency's concerns.
During the pandemic, we have to the best of our ability to ensure that our sales team is safe and compliant with local regulations, but have also worked hard to maintain the sales teams connections with the prescriber and patient community that need symposium.
We believe that our continued growth in prescriptions and net revenue demonstrates that we've been able to continue to connect with the prescribers, even virtually and grow this product to extraordinary times.
Next as we previously communicated we received a complete response letter from the FDA for Liberal back in late September.
As we outlined during the previous conference call on this topic in September we were very disappointed that our India. It was not approved and they're taking immediate action to address the agencys concerns.
As you May recall, the FDIC limited its comments the one out of the nine studies that request. We have included in R&D a submission for this product.
Keith Kendall: As you may recall, the FDA limited its comments to one out of the nine studies that it queried included in our NDA submission for this product. The study in question under the CRL was the single-dose crossover PK study in 28 patients that we refer to as study 180323. In the study, LibraVent exceeded the AUC measure when compared to Diastat, was within normal comparatability ranges for CMAX, and had a PMAX within the published diastat label. We were quite pleased with these results. However, the FDA noted in its CRL that in the study, there were two weight groups where the Cmax ratio comparing liver band to diastat was not as close to comparability as the FDA would like to see. The FDA had no further comments on the study or in any of the other ways.
The study in question under the CRL was the single dose crossover PK study in 28 patients that we referred to as study 180 323.
In the study lipper being it exceeded there you see measured when compared to die.
It was within normal comparability ranges for CMS.
And had a team that's within the publicized that label.
Well, we were quite pleased with these results.
However, the FDA noted in its CRL, but in the study there were two week groups, we have a C. Max ratio comparing liberated to divest that we're not as close to comparability as the F.B.A. I would like to see.
Yes, you had no further comments on the study or in any of the other week groups know what the safety clinical pharmacological bought biopharmaceutical CMC or other non political issues were identified in the CRL.
Keith Kendall: No other safety, clinical, pharmacological, biopharmaceutical, CMC, or other non-clinical issues were identified in the CRL. As we indicated on our September 25th conference call, we intended to submit data and information to the agency quickly to attempt to resolve their questions. After submitting the meeting packets to the FDA in October, we received confirmation that the FDA scheduled a type A meeting with us set for November 12, 2020. Again, a type A meeting is granted for candidate drugs on hold to discuss impeding issues and a path forward for approval. We included in our October submission additional data and analysis to demonstrate that we have sufficient information to update our label with an adjusted dosing regimen. We look forward to meeting with the FDA, where we will discuss the information we presented to the agency in October, attempt to confirm the pathway for approval, and propose the immediate resubmission of our NDA.
As we indicated on our September 25th Conference call, we intended to submit data and information to the agency quickly to attempt to resolve their questions.
After submitting a meeting package to the FDA in October we received confirmation that the FDA is scheduled to Taipei meeting with US set for November 12 2020.
Again, a typing meeting is granted for candidate drugs on hold to discuss impeding issues and a path forward for approval.
We included in our October submission additional data and analysis demonstrates that we have sufficient information to update our label with an adjusted dosing regimen.
We look forward to meeting with the FDA, where we will discuss the information we presented to the agency and October 10th to confirm the pathway for approval and proposed the immediate resubmission of art in India.
If the FDA agrees with our proposal than we plan on resubmitting the NDA before the end of the year.
Keith Kendall: If the FDA agrees with our proposal, then we plan on resubmitting the NDA before the end of the year. The review cycle for a resubmission of this type is typically six months. However, given the narrowness of the resubmission, we will request an expedited review cycle of two months, as is our right. This decision will be completely at the discretion of the FDA.
The review cycle for a resubmission of this type is typically six months. However, given the narrowness of the Resubmission, We will request an expedited review cycle of two months as is all right.
This decision will be completely at the discretion of yet yes.
Under a six month review cycle, our target is to do the actual date would occur in the first half of 2021.
Keith Kendall: Under a six-month review cycle, our targeted to-do for action date would occur in the first half of 2021. If the FDA does not agree with our proposal, then we will seek to understand the best path forward for resubmission and approval. We will update the market regarding the FDA's comments, our plans for resubmitting our NDA, and the potential range of PDUFA dates for LibraVant once meeting minutes are finalized. There have been no indications in our discussions with the agency relating to market access for Libervane, and we do not expect any indications until product approvability is decided.
If you gave this if the FDA does not agree with our proposal then we will seek to understand the best path forward for re submission and approval.
We will update the market regarding the FDA comments, our plans for resubmitting, our India and the potential range of could do for days for liver event once meeting minutes are finalized.
To date, there have been no indications in our discussions with the agency relating to market access for Liberty and we do not expect any indication until products Approvability is decided.
Regarding the FDA approval of U.S. market access we believe that we have provided a strong set of facts supporting a decision by the FDA clinical superiority to prior approved drugs for this indication.
Keith Kendall: 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 to prior-approved drugs for this indication, based upon a finding that liver vant represents a major contribution to patient care. We will augment and update that information to the agency prior to any new PDUFA date for Libervay. Subject to FDA approval, we are committed to quickly launching LiberVant and have the foundational commercial capabilities to do that. Next, let's turn to Requested 108. As previously reported, the FDA granted fast-track designation for Questive-108 in August 2020. FastTrack is an FDA process designed to facilitate the development and expedite the review of therapies to treat serious conditions and fulfill unmet medical needs.
Based upon a finding that liver fat represents a major contribution to patient care.
We will augment and update that information to the agency prior to any new PDUFA date for liver bad.
[noise] subject to FDA approval, we are committed to quickly launching live event and have the foundational commercial capabilities to do that.
Next let's turn to requested one away.
As previously reported the FDA granted fast track designation request of one away in August 20 Twond.
[noise] fast track is an S.J. process designed to facilitate the development and expedite the review of therapies to treat serious conditions and fulfill unmet medical needs.
In doing so the agency acknowledge that requested one really satisfies an unmet need in the patient population relating to those patients resisting taking intra muscular or subcutaneous injections.
Keith Kendall: In doing so, the agency acknowledged that Equestiv-108 satisfies an unmet need in the patient population relating to those patients resisting taking intramuscular or subcutaneous injections. In August, we also initiated the Phase I pharmacokinetic trial for this exciting product. The trial featured a four-treatment crossover design comparing the pharmacokinetics and pharmacodynamics of Equestiv-108 at two different doses of subcutaneous injection and one of intramuscular injection. The study included secondary endpoints for changes in blood pressure and heart rate.
In August we also initiated the phase one pharmacokinetic trial for this exciting product sets.
Trial featured a poor treatment crossover design, comparing the pharmacokinetics and pharmacodynamics of a quest of one away to two different doses of subcutaneous injection and one of intramuscular injection.
The study included secondary endpoints for changes in blood pressure and heart rate.
We have completed the enrollment of this study with 28 healthy volunteers dose as of October and are on track to Q see that data in the coming weeks. Once our review is completed we will update everyone as appropriate regarding the results of the study and all our clinical and regulatory path forward.
Keith Kendall: We have completed enrollment in this study with 28 healthy volunteers, dosed as of October, and are on track to QC that data in the coming week. Once our review is completed, we will update everyone as appropriate regarding the results of the study and on our clinical and regulatory path forward. If approved by the agency, Equestiv-108 will be the first orally administered epinephrine-based rescue medication for this patient population. Finally, as I mentioned a few moments ago, we've signed an agreement as expected with respect to the monetization of the royalties and other amounts due to the company under our license agreement with Stenovian Pharmaceuticals for Kinmoby, an apomorphine therapy using our farm film technology for Can Moby receive approval from the FDA on May 21, 2020?
If approved by the agency requested one or weight will be the first orally administered after their front based rescue medication for this patient population.
Finally, as I mentioned, a few moments ago, we've signed that agreement as expected with respect to the monetization of the royalties and other amounts due to company under our license agreement with Sanofi in pharmaceuticals for Tin Mobi, but apomorphine therapy, using our farms sold tick.
Policy for the treatment of off episodes in Parkinson's disease patients.
Can moby received approval from the FDA on May 21st 20 Twond.
The company ended or well monetization agreement with marathon asset management that will result in proceeds to the company of up to $125 million upon meeting certain milestones.
Keith Kendall: The company entered a royalty monetization agreement with Marathon Asset Management that will result in revenues to the company of up to $125 million upon meeting certain milestones. We believe the valuation of the royalties of Kenmobi seen in this transaction reflects the strong value farm film can bring to CNS and other disease conditions like epilepsy. Net proceeds of the transaction will fund the company's ongoing development and commercialization of its proprietary product pipeline candidates, as well as the repayment of senior notes and working capital. We expect that this transaction will close and fund later this month. As John will explain in more detail, we also were able to extend our senior credit facility reopeners to the end of 2021, giving us a longer opportunity to obtain a potential additional $30 million of capital linked to the PDUFA date and approval of LibraVan.
We believe the valuation of the royalties inmobi seen in this transaction reflects the strong value pharmfilm can bring to CNS and other disease conditions like epilepsy.
Net proceeds that a transaction will fund the company's ongoing development and commercialization of its proprietary product pipeline candidates as well as the repayment of certain senior notes and working capital for the company.
We expect that this transaction will close and fund later this month.
As John will explain in more detail. We also were able to extend our senior credit facility Reopeners to the end of 2021, giving us a longer opportunity to obtain a potential additional $30 million of capital linked to the PDUFA date and approval of liberman.
This financing along with the potential access to the Reopeners provides requested with immediate and substantial capital to reduce that support key initiatives of the company, including supporting the FDA approval of liver of it and the ongoing clinical development of a quest if one of them.
Keith Kendall: This financing, along with the potential access to the reopeners, provides Equestiv with immediate and substantial capital to reduce debt, and support key initiatives of the company, including supporting the FDA approval of LibraVent and the ongoing clinical development of Equestiv 108. We are delighted to have partnered with Marathon Asset Management and our Senior Credit Facility Lenders for this important milestone for Equestria.
We are delighted to have partnered with marathon asset management, and our senior credit facility lenders for this important milestone for a question.
Once closed the monetization transaction will provide a capital runway for the company through the third quarter of 2021 and potentially beyond.
John Maxwell: Once closed, the monetization transaction will provide a capital runway for the company through the third quarter of 2021 and potentially beyond, to 30 million senior note reopeners, assuming liver van approval and market access, which cannot be guaranteed, provide additional capital options to fund the launch of LibraVent after approval. With that, I would like to turn the floor over to John, who will provide specifics of our financial performance and outlook.
The $30 million senior note Reopeners, assuming live event approval and market access which cannot be guaranteed provide additional capital options from the launch of liberman after approval.
With that I would like to turn the floor over to John who will provide specifics of our financial performance and outlook John.
Thank you Keith good morning.
John Maxwell: Thank you, Keith. Good morning. Yesterday afternoon, we filed our 10-Q and issued our earnings release. As we typically do, we will tackle most of the discussion related to the third quarter of 2020 results in the Q&A. And in my comments, I will highlight a few points from our results that are important in order to understand our updated full year 2020 financial guidance and our progress toward. As we previously reported, we signed a monetization agreement for the royalty rights associated with Kenmore, providing a potential $125 million of capital over time, including $40 million later this month. Under the terms of the monetization agreement, we are entitled to receive up to $85 million of future non-dilutive capital at various points, beginning as early as the fourth.
We filed our 10-Q and issued earnings release yesterday afternoon, as we typically do we will tackle most of the discussion related to the third quarter of 2020 results in the Q1 day and in my comments I will highlight a few points from our results that are important in order to understand our updated full year 2020 financial guidance and our progress towards it.
As we previously reported we signed a monetization agreement for the royalty rights associated with chemo be providing a potential $125 million of capital over time, including $40 million later this month.
Under the terms of the monetization agreement, we are entitled to receive the additional up to $85 million of future Nondilutive capital.
At various points beginning as early as the fourth quarter $25 million of which could be received between now and mid 2022.
John Maxwell: $25 million of which could be received between now and mid-2020, assuming we can achieve the commercial targets associated with the monetization. Shortly after funding of the monetization transaction, we will reduce our debt from $70 million down to $51.5 million. This reduction is due to repaying $22.5 million of our senior notes and issuing $4 million of new senior notes. In lieu of paying a prepayment on the early repayment of the senior, bringing our net senior debt outstanding down and reducing our principal and interest obligations under the facility's substantial... The remaining net proceeds will be used for operations. Upon the closing of the Kenmobi monetization and the related reduction in principal and interest obligations, we will have capital visibility through Q3 of 2021 and potential. We believe this time horizon will give us the runway past the anticipated PDUFA date for LIBRIVANT in the first half. In addition, the terms of our debt agreement were modified.
Assuming we can achieve commercial targets associated with the monetization transactions.
Shortly after funding of the monetization transaction, we will reduce our debt from $70 million down to $51.5 million. This.
This reduction is due to repaying of $22.5 million of our senior notes and issuing $4 million of new senior notes in lieu of paying a prepayment premium on the early repayment of the senior notes, bringing our net senior debt outstanding down and reducing our principal and interest on it.
Patients under the facility substantially in the future.
The remaining net proceeds will be used for operations.
Upon closing of the can Moby monetization and the related reduction in principal and interest obligations. We will have capital visibility for Q3 of 2021 and potentially beyond.
We believe this time horizon will give us the runway we need to get past the anticipated due for a date for labor ramped in the first half of 2021.
In addition, the terms of our debt agreement were modified to extend the availability of $30 million of Reopeners at the company's option to December 31st of 2021.
John Maxwell: Availability of $30 million of re-openers at the company's option to December 31st, including $10 million of funds committed by our current lenders upon the FDA's product approval of LibriVant, even if there is a delay in market access under the U.S. Market Act. We have agreed to issue warrants to... [inaudible] and their potential exercises, 143,000 of which will be issued upon the closing of the inden
Polluting $10 million of funds committed by our current lenders upon the FDA.
Product approval of liver bound even if there was a delay in the market access decision.
The second $20 million of reopener.
Again at the company's option can be marketed to current or other lenders upon FDA approval of Lipper, Matt for us market access.
John Maxwell: Moving on to our operating results and our financial guidance for the rest of the day. Our third quarter 2020 revenue for April is up over 100% year-over-year and reflects stronger prescription momentum in Q3 as compared to Q2 at the height of the COVID-19 pandemic restriction. We are pleased with the performance of SempeXan, especially as a market precursor to LibreOffice.
John Maxwell: Noting that we exited Q3 on an annual revenue run of $7 to $8 million, which represents a 62% increase from the start. Despite the impact...
John Maxwell: Please continue to drive, while Suboxone remains the largest portion of our total revenue. We do expect that the U.S. component of this..., we expect it will continue to grow. We believe that ultimately, our proprietary revenue base will surpass these levels. Produced by the FDA for U.S. We have raised and tightened our range of our previously provided revenue guidance for, be in the range of $42 to $46 million. Continued erosion of sa
Yes.
We have raised and tightened our range of our previously provided revenue guidance for 2020 to be in the range of $42 million to $46 million. This guidance factors and continued erosion of suboxone.
Additional growth in samples and despite COVID-19 limitations can moby revenues are recognized in the second quarter.
John Maxwell: Additional growth in Simpazam despite COVID-19. Co-Development, our non-GAAP-adjusted gross margin in the third quarter. 2020 was 72% in line with our guidance, before considering the Kenmobe revenues recognized in the second... And as our revenue base shifts towards our proprietary products, starting with Simpazan and away from Suboxone, we expect our adjusted gross margin will exceed 70% for the full year, as we have previously guided. As outlined in the earnings release issued yesterday, our third quarter... non-GAAP-adjusted EBITDA loss was $11.6 million, in line with our expectations.
And co development fees and modest license fees and royalties.
Our non-GAAP adjusted gross margin in the third quarter of 2020 was 72% in line with our guidance before considering that can mobi revenues recognized in the second quarter and as our revenue base shifts towards our proprietary products, starting with samples and and away from Suboxone, we expect.
Our adjusted gross margin will exceed 70% for the full year as we had previously guided.
As outlined in the earnings release issued yesterday, our third quarter 2020, non-GAAP adjusted EBITDA loss was $11.6 million in line with our expectations.
We continue to tightly manage our expenses with overall expenses down sequentially before factoring in higher R&D driven by project timing.
John Maxwell: And we are down year-over-year. We will continue to tightly manage our cost base as we move forward while focusing our investments on getting LibraVamp into the market and continuing its development. Before considering the impact of Ken Moby's monetization in the fourth quarter, we are raising and tightening our guidance with respect to our anticipated EBITDA loss. This guidance reflects. Cash used for operations in the third quarter was approximately $8 million, down from $10 million in the first quarter, down from the prior year's third quarter, reflecting the capital preservation steps we have taken while still making investments in our most critical priorities, as well as the collection, and all at Kenmobe Milestone.
And we are down year over year as well.
We will continue to tightly manage our cost base as we move forward, while focusing our investments on getting liver event into the market and continuing the development of a Qs T want to wait.
Before considering the impact of can Moby monetization in the fourth quarter, we are raising and tightening our guidance with respect to our anticipated EBITDA loss to be in the range of $38 million to $42 million.
This guidance reflects continued performance on the revenue line and continued tight management of our cost base.
Cash used for operations in the third quarter was approximately $8 million down from $10 million in the second quarter and down from the prior year third quarter of nearly $15 million. This improved cash flow reflected the capital preservation steps, we have taken while still making investments in our most critical priorities as well as.
John Maxwell: Our $17 million cash position at quarter end combined with the impact, we are reconfirming our full-year cash burn guidance of $4,500. In summary, our improved guidance for 2020 reflects continued cash flow from our licensee and proprietary products revenue base, and careful focus of our investments into the most value-driven aspects of our future, LIBRIVANT and AQST 108. Continued focus on capital conservation so that cash is extended as far as possible, along with the impact of the Kenmobi monetization anticipated to close. Operator, we will now open. Thank you. As a reminder, ladies and gentlemen, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key.
Operator: Please stand by while we compile the Q&A roster. Our first question comes from the line of Gary Nachman from BMO Capital Markets. Your line is now open.
Our first question comes from the line of Gary Nachman from BMO capital markets. Your line is now open.
Hi, guys. Good morning first on liver vans described every analysis you did and the data you submitted to FDA that Youll review at the type C meeting and why you're confident you won't need additional clinical studies there.
Keith Kendall: Hi guys, good morning. First, on limbrovans, describe the reanalysis you did and the data you submitted to FDA that you'll review at the type A meeting, and why you're confident you won't need additional clinical studies there. And then, when will you get the minutes from the SBA, Keith or Dan? Is it 30 days later, just so we should have the right expectation on when we'll get an update on the next step? Sure, Gary, thanks for joining us this morning and thanks for your questions. I'll turn it over to Dan and let him walk you through the answers to both of those, okay? Morning, Gary.
And then when will you get the minutes from the FDA, Keith or Dan is it 30 days later, just so we should have the right expectation on when we'll get an update on the next steps sure Gary Thanks for joining US this morning, and thanks for your questions.
I'll I'll turn it over to Dan and let him walk you through the answer to both of those Okay morning, Gary. So we have done exactly what we said we would do back in September.
Daniel Barber: So we've done exactly what we said we would do back in September. We have updated our dosing regimen based on the FDA's CRL. We have supported that update in the dosing regimen based on the nine studies that we have completed and the linearity that we find in those nine studies. And we've provided a robust package utilizing population PK modeling to support why the existing studies are sufficient based on the totality of the data we've created to date. In terms of the minutes, the typical turnaround time for the FDA is 30 days, but we'll see how that's completely in their hands, and we'll see how long they take. Okay, and probably sticking with you Dan, the Phase 1 PK trial for 108, how many different doses did you look at for 108 and what are you looking for when you analyze the data to help determine next steps, and could you potentially go straight to a Phase 3 Yeah, I don't see, in my opinion, the need for a phase three, a true phase three for this program. We think PK is absolutely the pathway, and we have a broad depth of PK data across healthy volunteers and patients in a variety of conditions. So I don't see that as a probable outcome.
We have updated our dosing regimen based on the App Deejays CRL, we have supported that update in the dosing regimen based on the nine studies that we have completed the linearity that we find in those nine studies.
And we've provided a robust package.
Utilizing population PK modeling to support why the existing studies are sufficient based on the totality of the data we've created to date.
In terms of the minutes the typical turnaround time for the FDA is 30 minutes is 30 days.
But we'll see how that is completely in their hands and we'll see how long they take.
Okay, and probably thinking with you than the phase one PK trial for went away how many different doses did you look at for one await and what are you looking for when you analyze the data to help determine next steps and could you potentially go straight to a phase three on.
On this one.
Yes, I don't see I have in.
In my I don't see the need for a phase three a true phase three for this program. We think PK is absolutely the pathway and we have a broad depth of PK data across healthy volunteers patients in a variety of conditions. So I don't.
I see that as a as a.
Probable outcome.
Daniel Barber: The, The dosing regimen update we have done in the two weight categories, just to frame everyone, as Gary said, the study in question is study 180323, and in that study, there are two weight groups where the comparison to dyestat in only those two weight groups was not where the FDA wanted it to be. And in both of those weight groups, we have updated our dosing table by two and a half milligrams. And in doing that, because of the linearity of our product, we believe we will cure the deficiency noted by the FDA. So we think we have a very strong position.
The dose.
Dosing regimen update we have done in the two weight categories just to frame everyone is as Gary said. The study in question is study one of three to three and in that study. There are two week groups that the comparison to die stat in only those two way groups was not where the.
FDA wanted it to be and in both of those wait groups. We have updated our dosing table by two and a half milligrams and doing that because of the linearity of our product. We believe we will cure the deficiency noted by the FDA.
So that we think we have a very strong position. We're excited for the meeting next week and we'll advise out of that meeting what the conversation with the FDA.
Daniel Barber: We're excited for the meeting next week, and we'll advise from that meeting what the conversation with the FDA, what the content of the meeting with the FDA looks like. Okay, did you, um, but on 108 specifically, uh, the different doses that you're looking at there? versus the IM and the sub-Q. I'm sorry, what are you talking about? Let's talk about FNF. Okay, yeah, no, my apologies, Gary. I thought you were still in the liver bin. I apparently didn't have enough coffee this morning.
What the content of the meeting with the FDA look like.
Okay did you.
On one away that typically.
The different doses that you're looking at there.
Versus the I am in the sub Q.
I'm sorry are you talking about.
Talk about anything different.
Yes.
Okay, Yes, no my apologies Gary I thought you were still on liver Vin I, apparently didn't have enough coffee. This morning, yes.
Daniel Barber: Yeah, on AQST 108, we're really excited to see the data that comes through in the study that we are just about to complete. Could we go directly into phase three? It is possible.
Hey, QST want to wait we're really excited to see the data that.
Comes through.
In the study that we are.
Were just about to complete.
Would we go directly into a phase three it is possible.
Daniel Barber: I think we want to understand what the data looks like, and understand what the next steps would be in terms of the possibilities of this program. I think the exciting thing in this space is that we have a lot of different pathways to potential different indications, which allows for a very broad platform, almost a program initiative for us. So we'll see where the results take us. We'll also seek the FDA's feedback, and we'll keep you updated as we learn more. Okay, thanks for that. And then just last one for Keith.
I think we want to understand what the data looks like understand.
What the next steps would be in terms of the possibilities of this program I think the exciting thing in this space is that we have a lot of different pathways to potential different indications, which allows for a very broad.
Platform almost program initiative for us So, we'll see where it where were the results take US. We'll also seek the FDA feedback and we'll keep you updated as we as we know more.
Okay. Thanks for that and then just last one for Keith.
Keith Kendall: If SymptoZan is starting to accelerate, which it sounds like, it begs the question if you should put some more resources behind it, maybe before you have LibriVance approval, especially now that you'll have additional funds from Kinmobi. So just what are your thoughts on building out your commercial infrastructure before LibriVance? Thanks. That's a great question, Gary, and I think that it's a very insightful question, right? We believe at the current course and speed, we're on track for SymptoZan to be profitable next year as a stand-alone product. Obviously, as the penetration in that focused prescriber base continues to grow, the justification for additional resources is a lot easier to make, as is whether they be sales or medical affairs type of people.
Simple Dan is starting to accelerate which it sounds like it begs the question. If you could put some more resources behind it may be before you have the lipper Vance approval, especially now that you'll have additional funds from kenobi. So just what are your thoughts on building out your commercial infrastructure before a live event, thanks I talked to.
Great question, Gary and.
I think that Thats, a very insightful question right. We're.
We believe that the current course and speed we are on track for symposium to be profitable next year as a standalone product obviously.
As the penetration in that the focus prescriber base continues to grow.
Justification for additional resources is a lot easier to make.
As is whether they be sales or medical affairs type of people and obviously you all know that we believe that shippers and is a very important precursor to liver ramp. So I think you will see some increase in those resources based on its success and growth and.
Keith Kendall: And obviously, you all know that we believe that SymptoZan is a very important precursor to LibriVance. So I think you will see some increase in those resources based on its success and growth, and based on our ability, while we're trying to resolve visibility on the risk around LibriVance, you'll see us judiciously adding resources to help support that product and continue to grow. Okay, great. Thanks.
And based on our ability while were trying to resolve.
Visibility on the risk around labor van you.
We'll see us.
Judiciously, adding resources to help support that product and continue for it to grow.
Okay, great. Thanks.
Operator: Thank you. Our next question comes from the line of Randall Sanicky from RVC Capital Markets. Your line is now open. Hey guys, it's Edwin on for Randall.
Keith Kendall: Thanks for taking my questions. Just a couple from us. The first on LibriVant... I know you're going to request a two-month review. Can you just talk about what needs to happen for this to be a two-month review versus the traditional six-month review? Thanks for joining us.
Daniel Barber: Edwin, I'm going to let Dan field that question for you. Yeah, that's a really, um, my response is really basic on that one. The FDA has to agree. So the, uh, nature of their questions they had in the CRL are clinical, and our update is a clinical update because of the dosing regimen, which ties to a six-month review. So, as we said before, and as Keith pointed out in his comments, we will request a two-month review because we believe, especially if the FDA is supportive of the dosing regimen to be submitted to them, we believe the changes are narrow to the NDA that was previously submitted. We will request a two-month review, but that is completely at the discretion of the FDA. Great, thank you. And then my next one, the second one on the liver vat, just one more.
Great. Thank you and then my next one.
Second one I'll live out just one more obviously no dependents happy meeting, but how are you guys thinking about the different ways, we could play out and and how this would impact of filing tiny okay.
Daniel Barber: Obviously, it's going to depend on the type of meeting, but how are you guys thinking about the different ways this could play out and how this would impact the filing timing? Yes, so the package we submitted in our approach to curing the deficiency in the CRL is built on the conversations we had in September. So the exciting thing for us next week is this will be a continuation of our view of where we left off prior to the CRL. We think we have a very good case before us. I don't want to overly speculate about the possibilities of any feedback we may get from the FDA because we simply don't have it yet, but we're excited for the meeting. We think we have a very good case, and we're looking forward to the conversation. Thanks, and then my last one is just on the guidance for raising revenue. It implies a range of $3-7 million in 4Q.
Yeah. So the.
The package, we submitted and our approach to curing the deficiency in the <unk>.
On the conversations we were having in September so the.
The exciting thing froze next week is this will be a continuation in our view of where we left off prior to the sorrow. So we think we have a very good case before us I don't want to overly speculate about the possibilities of any feedback we may get from the SDA, because we simply don't have it yet, but we're excited for the meeting we think we have a very good case.
We're looking forward to the conversation.
Thanks, and then my last one on the guidance raising the revenue implies arrange a three to 7 million in <unk> just wanted to ask about a little bit detailed and some of the factors that drove that change and how we should be.
John Maxwell: I just wanted to ask about a little bit of detail and some of the factors that drove that change and how we should be thinking about that versus where implied 4Q is with respect to consensus. And that's all from us. Thank you. Sure, Edwin. Good morning.
Thinking about that versus where implied for queue is with respect your consent.
I think.
Sure everyone. Good morning.
So as you know we don't guide on the pieces of the components of the revenue nor do we not guide on the quarter, but if you look at the pieces of revenue. What you should see is that symposium will continue to be strong and grow.
John Maxwell: So, as you know, we don't guide on the pieces of the revenue pie, or the components of the revenue pie, nor do we guide on the quarter, but as you look at the pieces of revenue, what you should see is that Simpazan, you know, will continue to be strong and grow. We expect that, and then the revenue we would expect to follow. We'll continue to see, you know, the Suboxone product will erode over time, and we will see a little bit of that erosion, possibly because it's just the timing of manufacturing activity in the fourth quarter, and then the rest of it, you know, the smaller pieces of revenue there around license and royalty and co-development are going to be relatively small. Thanks. I appreciate it.
Certainly on the prescriber penetration front, we expect that and then the revenue we would expect to follow.
We'll continue to see.
The suboxone product will will erode over time, and we will see a little bit of that erosion, possibly because it's just timing of manufacturing activity in the fourth quarter.
And then.
The rest of it the smaller pieces of revenue there around the license and royalty codevelopment are going to be relatively small in the quarter.
Thanks, I appreciate it sure.
John Maxwell: Sure. Thank you. Our next question comes from the line of Andreas. Argyrides from Wedbush, your line is now open.
Thank you. Our next question comes through in the line of hundred.
Argue arrive from Wedbush. Your line is now open.
Alright, good morning around.
Operator: Good morning. Good morning guys, thanks for taking my question, and congratulations on the quarter. I guess I'm going to follow on some questions already. As far as liver events are concerned, how has the process with the FDA impacted the timing of the pediatric studies? Are we going to get any top-line data any time soon? Go ahead, Dan.
[laughter]. Good morning, guys. Thanks for taking my question Oh, Congrats on the quarter.
I guess I'm gonna follow on some questions already.
It's been answered, but as far as liberman concerned.
How is the the process with you have impacted the paediatric or the timing of a pediatric studies, we give me the top line data or.
At any time soon.
Daniel Barber: Thank you for the question. So we have the pediatric data now, and we're able to submit that when we feel it's appropriate. In our minds, the right time to do that is once we have adjudicated the current submission that we have.
Go ahead man.
Thank you for the question. So we have the the pediatric data now.
Where.
Able to submit that when we feel it's appropriate in our minds the right time to do that.
Is once we have adjudicated the current submission that we have so we will resubmit.
Daniel Barber: So we will resubmit the NDA that we have, and when we have approval on that NDA, we will follow on with the pediatric portion of the NDA. Okay, and in regards to, let's look at the other pipeline assets there, the opportunity to serve in ALS, how are you guys actively looking for a U.S. partner? Yeah, we continue to have conversations with potential U.S. partners. We do believe that the product will get partners in the U.S., and we'll continue to work until we get to that point.
With the NDA that we have and when we have approval on that NDA, we will follow on with pediatric portion of the of the NDA.
Okay and in regards to Uhm, let's look at the other pipeline said, Sir via the opportunity for serving and Alice how power.
<unk> you guys actively went through for you as partner.
Yeah, we continue to have conversations with potential U S partners. We do believe that product will get partnered in the U S.
And will continue to work until we get to that point.
What would what would a a potential partnership look like if you can provide any color on that.
Keith Kendall: What would a potential partnership look like, if you can provide any color on that? Well, there are several parties in the U.S. that we think would be good fits for Exerven. We're in discussions, in fairly advanced discussions in a couple of cases, and what it would look like would be fairly typical. It would be, we would expect an upfront payment, and we would expect a transfer price and royalties for access and supply of the product. Okay, that's it from me, guys. I appreciate you taking the time to answer the questions. Thank you. Our next question comes from the line of Thomas Flaten from Lake Street Capital. Your line is now open. Good morning. Thanks for taking the questions. Just kind of a strange question.
Alright.
Well there are several parties in the U S that we think would be good fits for extra then we're in discussions.
Fairly advanced discussions in a couple of cases.
And what it would look like would be fairly typical it would be that would be.
Would expect an upfront and we would expect a transfer pricing royalties for <unk>.
Access and supply of the product.
Okay.
From you guys I appreciate you taking my question Congrats man.
Thank you. Our next question comes from the line of Comics flattened Sunlight Street capital. Your line is now.
Good morning, Thanks for taking the questions.
Just just to.
Kind of a strange question you made reference to the one of eight data and need to assess the validity and quality of that data can you.
Operator: You made reference to the 108 data and the need to assess the validity and quality of that data. I've not heard that term or phrase with respect to clinical data before. What is it about the validity and quality that's up for question, or is that just the way you decided to phrase it? Thomas, I think you're going back to the moment when I thought Gary was talking about study 180323 rather than AQST 108. So on AQST 108, which is epinephrine, we are excited to see the data that comes out of our pilot study. So there's nothing we know of right now that would question the validity or quality of the data coming out of our epinephrine study. We're excited to see it.
I have not heard that turn of phrase with respect to clinical data before but what what is it about the validity and quality that.
Quick question or is that just the way you decided to Fraser.
Thomas I think you're going back to the moment, where I was I thought Gary was talking about studying one eight O 323, rather than <unk> went away. So on Aqa's do you want to wait which is epinephrine.
We are excited to see the data that comes out of our pilot study we will analyze it. So there's nothing there's nothing we know of right now that would question the validity or quality of the data coming out of our epinephrine study. We're excited to see it once we've had a chance to analyze it and absorb it we will of course come back to all of you in.
Daniel Barber: Once we've had a chance to analyze it and absorb it, we will, of course, come back to all of you and talk about it at the right level of detail. Got it. And then on SymphoVan, the, uh, the number of physicians who are writing multiple scripts, how has that trended over time? If you can just remind us what that looks like, I'm trying to get it.
And talk about it at the right level of detail.
Got it.
And then on the 10th of them the the the the.
The number of physicians, who writing multiple scripts how is that trend that over time. If you can just remind us what that looks like I'm trying to get it how entrenched the product is becoming within the larger.
Daniel Barber: How entrenched is the product becoming within a larger component of your prescriber base? I'm sorry, Thomas, can you repeat the question? I'm not sure I understood it.
And larger component of your prescriber base.
I'm sorry, Thomas can you repeat the question I don't I'm not sure I followed it.
Sure. So you made mention of I think it was 77% of your prescribers multiple prescriptions. The question is how does that trend that over time and.
Thomas Flaten: Sure, so you made mention of 77% of your prescribers writing multiple prescriptions. The question is, how has that trended over time, and is that within the quarter, or is that just over, you know, since launch? I'm trying to understand, you know, how entrenched the product is becoming within that prescriber base. How many of them are repeat prescribers versus one-and-done prescribers? Sure. Ken, are you on the phone? Yes, Keith, I am.
Within the quarter or is that just over since launch I'm trying to understand how entrenched the product is becoming within that prescriber based how many of them are repeat prescribers versus one and done prescribers.
Sure can are you on the phone.
Kenneth W. Marshall: Do you want to respond to that question? Yeah, absolutely. Thanks for the question, Thomas. This is Ken Marshall.
Kenneth W. Marshall: It's been relatively stable over time. We've been adding anywhere from seven to ten positions on a weekly basis, and so those are the ones that have written once, and you have to kind of set them aside. If you look at the bulk of the positions, it's now well over 700.
Kenneth W. Marshall: Keith quoted a number that's a couple of weeks old. If you look at our data through the 16th of this month, it's now well over 700. And as Keith stated, I think he said 77% of physicians have written more than one. And that's been a fairly consistent number as our base of prescribers has expanded. Got it. That's helpful. And then just one for John.
Kenneth W. Marshall: John, there was a pretty steep drop off in SG&A spending for the third quarter. Does that reflect kind of a new baseline, or was there something specific that happened in the third quarter with SG&A?
John Maxwell: We look, Thomas, as you know, we continue to really carefully manage our spending as part of our overall capital preservation strategy to extend our runway. And, you know, we'll continue to push that down. You will have fluctuations quarter to quarter depending upon activity levels. So I don't think there was anything unusual there other than it may have been there was nothing unusual in terms of activity, so it was a relatively low baseline.
John Maxwell: Thanks for taking the question, Ken. Thank you. Our next question comes from the line of Jason Butler from J&P Securities. Your line is now open. Jason Butler, please check your mute button.
Thanks for taking the question.
Sure.
Thank you. Our next question comes on the line of Jason Butler from J M. P. Securities. Your line is now open.
[noise], Jason Butler, Please check your me plan.
[noise], Jason Butler from JMP Security is your line is now open. Please proceed.
Operator: Jason Butler from JMP Securities, your line is now open; please proceed. As a reminder, ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Our next question goes to Raghuram. Raghuram Selvaraju from H.C. Wainwright.
[noise] as a reminder, ladies and gentlemen to ask a question you wont need to press star one on your telephone to withdraw your question.
<unk> <unk>.
Our next question goes to <unk> silver.
Silver Jew from H C. Wainwright your line is now open.
Operator: Your line is now open. Good morning, this is Muz on behalf of Raghuram. I was wondering if you're able to provide any precedent from your previous trial experience in general for dose adjustment being a successful strategy to achieve the drug exposure you're looking for? And could the variable PK profile be explained by body physiology of the weight groups in question? Sure. As you know, we have broad experience in pharmacokinetic studies. I don't have another program I would point to in the correspondence back and forth with the FDA. But I would say that in the PK world, adjusting and coming up with a dosing regimen based on your PK results as well as the linearity or lack of variability in the results you have created is a fairly normal course of business. I think I would imagine you've seen that as well.
Daniel Barber: In terms of the weight groups and the physiology creating differences in results, I would say that that would be a little speculative of us to go to that depth. I would say this on the Diastat side: in all the weight groups, no matter what dose we gave under what study, we saw high variability. So we do know that the reference product, the RLD, in this case, Diastat, is highly variable.
Daniel Barber: And when you are working with a highly variable drug as your RLD, it can create some difficulties with comparability. So we think we saw that in 108.323, and we're excited to have the conversation with the FDA about their adjusted dosing regimen. Thank you very much for the clarification.
And we're excited to have the conversation with the FDU there adjusted dosing regimen.
Thank you very much for the clarity.
Operator: Thank you. Our next question comes from the line of Jason Butler from JMP Securities. Your line is now open. Hi, it's Roy from Roy Financial Group. Can you guys hear me? Yes, Roy.
Thank you. Our next question comes from the line of Jason Butler from JMP Security. Your line is now open.
Hi, it's rained for Jason can you guys hear me.
Yeah right.
Daniel Barber: Good to talk to you. Sorry about that earlier. So yeah, we had a couple of questions on epinephrine 108. The first question is, where do you guys think there's going to be the early adopters? Is it going to be used by EMTs and other health care providers first, then expanded more broadly? Or do you think it'll be a true EpiPen alternative from the get-go? And then what are we going to see from the top line data later this year? Are we going to see CMAX, TMAX, and AUC? Are you guys going to give qualitative characterizations? Go ahead. I'll start with the study design. We've provided an outline of what the study design looks like.
Oh, sorry, sorry about that [laughter] uhm early uhm. So yeah, we had a couple of questions on epinephrine one O eight.
First question is where where do you guys think there's going to be the early adopters isn't gonna get used by Emts healthcare Provider's first then expand more broadly or do you think it'll be a true epipen alternatives from the get go and then what are we going to see from the top line data later this year, we're going to see Cemac T. Max AUC are you guys gonna give qualitative.
Characterizations.
Uh-huh.
Yeah. So we've provided the I'll start with the study design, we've provided an outline of what the study design looks like so.
Daniel Barber: So we, of course, would like the opportunity to see the data and work through it before we know exactly what we'll be providing to you. But our intent would be to provide you with as much clarity as we can on where we are, where we're going, and what it means. In terms of marketing the product, we see a variety of ways in which the product can be used. I would point more to the need in the market than exactly where we'll place the product at this stage in development. If you look at the overall allergy market, there are approximately 30 million Americans who have some level of allergy issues that could lead to anaphylaxis, while the amount who actually carry an EpiPen is a fraction of that.
So we of course would like the opportunity to see the the data and work through it.
Before we know exactly what will be providing too, but our intent would be to provide you with as much clarity as we can on where we are and where we're going and what it means.
In terms of the marketing of the products we.
Daniel Barber: So we know that there's a big gap between people who are carrying an EpiPen and people who perhaps should be carrying an EpiPen, and we think an oral product can be placed into that particular unmet need in a lot of different ways. And between Keith, myself, and Ken, as time goes on, we will be defining that for all of you. Yeah, as we've committed, once we get the data from this study and we're able to analyze it and plan a path forward and begin to interact with the FDA around it, we planned a full R&D day for discussion of the program, and we'll talk about some of the market characteristics that we see, where we think it And then on Simpazan, you know, seeing pretty good growth there, and good re-prescribing rates continue. Can you describe a little bit the feedback you're getting from the fields? How does it compare to your expectations?
And then what level of in person interaction do you guys, having and how do you see that going forward is coded researches as it seems to be thanks, sure I mean, the and I'll turn it over to Kent to give a little bit more color than I can provide I think I.
Keith Kendall: And then what level of in-person interactions are you guys having, and how do you see that going forward as COVID resurges, as it seems to be? Thanks. Sure. I mean, and I'll turn it over to Ken to give a little bit more color than I can provide.
Kenneth W. Marshall: I think a couple of things. First, obviously, a product like this in the market it's in, for the patients that it is targeted for and the caregivers who care for them and prescribe it to them, this is very promotion sensitive. So the ability to have face-to-face interactions with prescribers is important to us, as our growth rates quarter over quarter and year over year have shown. I think we've also demonstrated that even during the worst of times when there was zero face-to-face contact at the height of the COVID restrictions, we were still able to grow the product, which speaks to the level of depth and relationships that our sales group has developed with prescribers. And we think that, along with payer performance up to this point, are very important, not only contributors to the growth of Cipazan but precursors to the launch and success of LibraVent when and if it's approved, Ken? Maybe you can provide some more color on the feedback you're getting and precisely how sensitive it is to the face-to-face interaction.
I think a couple of things first.
Kenneth W. Marshall: Okay, thanks Keith. Yeah, we look at that fairly, fairly closely in a lot of detail on a weekly basis. And we seem to be flattening out right about now, about 60-40, 60% live, 40% virtual with caregivers. You're also saying, as Keith mentioned, the success rate in moving prescriptions is increasing because we've become more comfortable in a virtual world, and clearly, our healthcare practitioners have. So both sides are really starting to understand how to more effectively communicate in this manner, and we're happy with the way that's going. If you look at our ability to access their staff, which is key, their MPs and PAs are very important in any transition that's made from a tablet or a crushed tablet protocol or a liquid protocol to our strips. We've got a 70-30 ratio there, so about 70% of those discussions happen live, versus 30% virtual, so both are in a good place. It's a good question, and it would be a speculative answer on how that might change in a world where you see some level of rebound.
You mentioned the success rate and moving prescriptions is increasing because we've become more comfortable in a virtual world and clearly our health care practitioners have so both sides are really starting to understand how to more effectively communicate in this manner to manner. So we're happy with the way that's moving.
If you look at our ability to access their staff, which is key there NPS and PA is a very important.
In any transition that's made from a tablet or a crush tablet protocol or liquid protocol to our strips and we've got a 70 30 ratio there so about 70% of those discussions have been live births.
Versus 30% virtuous are both both are in a good place.
Hey.
It's a good question it would be a speculative answer on how that might change in a world, where where you see some level of rebound.
Kenneth W. Marshall: Regardless, I think we'll do better. Regardless of how people behave, if there's a rebound in COVID, we'll do better than we did back in that late Q1, early Q2 time frame when everybody was trying to figure it out. There's a much clearer path, and qualitatively, what seems to be driving the uptake in Sympyzan is just a very clear patient profile that we're now able to paint for physicians. They use Klobuzan, there's a lot of Klobuzan used, and they look for those patients where we might be a more appropriate delivery platform, and those are turning out to be, as you would expect, those that have a Those on a ketogenic diet, we have virtually zero carbs, which is a very important consideration. There are a lot of carbs in the liquid simpazan and actually quite a few carbs in the tab, and the media that you usually end up crushing it in.
Regardless I think we'll do better regardless of how people behave if theres a rebound in cove. It will do better than we did back in that late Q1 early Q2.
Timeframe, where everybody was trying to figure it out theres a much clearer path.
And qualitatively what seems to be driving the uptake in incentive and it's just a very clear patient profile that we're now able to.
To paint for physicians they they use a lot of clubs that theres a lot of clubs and used and they look for those patients where we might be a more appropriate.
Delivery platform and those are turning out to be as you would expect those that have a little bit of difficulty swallowing those on GE tubes that want to take something orally, where they can swallow in the normal course.
Just following their saliva those on a ketogenic diet, we have virtually zero carbs.
Which is a very important consideration there are a lot of carbs in the liquid simpler than actually quite a few carbs and the tablets.
And the media that usually in the crushing it and so so examples of very clear patient types that physicians can look for in their practice and simplicity.
Kenneth W. Marshall: So examples of very clear patient types that physicians can look for in their practice and use. Great. Very helpful. Thank you. Thank you. At this time, I'm showing no further questions.
Great very helpful. Thank you.
Thank you at this time I'm showing no further questions I would like to turn the call back over to Kevin Campbell for closing remarks.
Keith Kendall: I would like to turn the call back over to Keith Kendall for closing remarks. Thank you, operator. Thank you, everyone, as always, for your interest in Equestive and for joining us on the call today. We appreciate your time. We look forward to continuing to move along all of the elements we think drive value for the company and continuing to push those projects and those events forward as we expect and as we commit to all of you in these calls. And we've got some updates that we will make at the appropriate time on Libervant and epinephrine, and we look forward to those as well. So thank you all for joining us, and we look forward to talking to you all soon. Have a great day. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. BF-WATCH TV 2021