Q2 2020 Aquestive Therapeutics Inc Earnings Call
It's one moment.
Okay.
[laughter].
[noise] [laughter].
[laughter].
Oh.
[laughter].
<unk>.
<unk>.
<unk>.
[noise].
Operator: Okay, I found it. Sorry about that. May I please have your first name? David. Last name?
Okay I found the sorry about that.
[laughter].
Matt Please have your first name.
David.
Oh.
[laughter].
Last name.
Unnamed Speaker: [inaudible] Aira, A-I-E-R-A, and then I just need the email address, david at iraw.com Okay, thank you. I'm placing you now with John Maxwell, Chief Financial Officer, who is going to provide an overview of recent business developments and performance in the second quarter. Additional members of the leadership team will be available for Q&A. In total, we expect today's call to last approximately
[laughter].
[laughter].
<unk>.
Oh.
Company name.
Hi, I.
I eat all that hey.
<unk>.
[laughter].
And then just need to email address.
Yes.
David I it always does.
<unk>.
Oh.
<unk>.
Okay. Thank you place and you know.
Oh.
[noise].
The book.
Yeah.
Hi, John Maxwell Chief Financial Officer were going to provide an overview of recent business development and performance in the second quarter.
[music].
Additional members of the leadership team will be available for urinary in total we start today's call cover approximately 60 minutes.
Unnamed Speaker: 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 the Questa Therapeutics website within the investor section shortly following the conclusion of this call. To remind you, the Equestria team will be discussing some non-GAS financial measures this morning as part of its review of the second quarter. A description of these measures, along with a reconciliation to GAP, can be found in the earnings release issued yesterday, which is posted on Investor Relations.
As a reminder, the company humor to correspond with the earnings release that was issued after market close yesterday. In addition recordings of today's call will be made available in the course of therapy website within the investors section certainly bonds inclusion of this call.
To remind you eclectic team will be discussing some non-GAAP financial measures. This morning as part of its review second quarter 2020 results.
Hey description of these measures along with a reconciliation to GAAP can be found in the earnings release issued yesterday, which is posted on the investor relation.
Unnamed Speaker: Section of Equestria Therapeutics... During the call, the company will be making forward-looking statements. I remind you of the company's safe harbor language, as outlined in yesterday's earnings, as well as the risks and uncertainties affecting the company, as described in the risk factors section included in the company's annual report on Form 10-K filed with the SEC on March 11, 2020, and in the company's subsequent quarterly reports on Form 10-Q. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect The impact of the ongoing COVID-19 pandemic is highly uncertain and cannot be predicted with certainty with surgery required. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date named. However, actual results may differ materially from these statements.
One other question Therapeutics website.
During the call the company will be making forward looking statement.
I remind you of the company's safe Harbor language as outlined in Yesterdays earnings release.
Well the risks and uncertainties affecting the company as described in the risk factor section included in these companies and report on form 10-K filed with the FCC on March 11, 2020, and the company subsequent quarterly reports on form 10-Q.
As with any pharmaceutical company with product candidate under development and products being commercialized there are significant risks and uncertainty with respect to the company's business and the development and regulatory approval and commercialization of his brother and other matters related to operation.
The impact of the ongoing private 19 or there is highly uncertain.
And cannot be predicted with Turkey or clarity.
Given these uncertainties you should not place undue reliance on these forward looking statements, which speak only as of that they.
Actual results may differ materially from these statements all forward looking statements attributable to plus a therapeutic.
Keith Kendall: All forward-looking statements attributable to Cresta Therapeutics or any person acting on behalf of Cresta are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued. 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 ethical law. Thank you, Stephanie, and thank you to everyone on the call for joining us this morning. In our remarks today, John and I will provide an update on our business for the second quarter. And, as always, we will be joined by additional members of the Equestive Leadership Team during the Q&A session afterward. Our key priorities as a company always start with the safety of our colleagues, the people we do business with, and the patients and caregivers who interact with our products. During this extraordinary period, as leaders and managers of our business, we have a responsibility to ensure that, to the best of our ability, while taking all steps to keep people safe, we continue to advance the important work of the company.
Or any person asking on behalf.
Expressly qualified in their entirety by this cautionary statement.
And the cautionary statements contained in the earnings release issued yesterday.
The company's assumes no obligation to update its forward looking statements of data. This conference call, whether it was out of new information future events or otherwise, except as required under applicable law with that I'll turn over the line to Keith.
[noise]. Thank you Stephanie and thank you everyone on the pull for joining us this morning.
And our remarks today, John and I will provide an update on that business for the second quarter and as always we will be joining by additional members of the question leadership team during the Q when a session afterwards.
[noise], our key priorities as a company always set with the safety of our colleagues the people, we do business with into patients and caregivers, who interact with that products.
During this extraordinary period as leaders in managers are bought business, we have a responsibility to ensure that to the best availability.
While taking all steps to keep people safe we continued to advance the important work at the company.
We've carefully managed our business to be sure that our colleagues are safe and healthy that all key elements of our business continue including continuing to access the market for SIMPAS Dan.
Unnamed Speaker: We have carefully managed our business to be sure that our colleagues are safe and healthy, and that all key elements of our business continue, including continuing to access the market for Symposan, progressing key R&D initiatives, supporting the various FD&A review processes we are involved in, and continuing product manufacturing. The company's manufacturing facility continues to produce needed chronic use medicines for patients, including the company's proprietary product Simpazan and the company's licensee products such as Suboxone. Our sales team has continued to access prescribers, the majority of the time virtually, and where possible, face-to-face. And therefore, Simpathan has continued to be prescribed to these patients during this period.
Progressing key R&D initiatives.
Supporting the various F. DNA review processes, we are involved in and continuing product manufacturing.
The company's manufacturing facility continues to produce needed chronic use medicines for patients, including the company's proprietary products SIMPAS and.
And the company's licensee products such as Suboxone.
Our sales teams continue to access prescribers, the majority of the time, virtually and where possible face to face.
And therefore SIMPAS Dan has continued to be prescribed to these patients during this period.
We continue to make significant progress as it relates to the key areas of focus for our company.
Unnamed Speaker: We continue to make significant progress as it relates to the key areas of focus for our company. First, Equestiv is continuing to market Symposan to the same prescriber base that are potential prescribers of our product candidate, Libervant. Symposium continued to make progress in the second quarter in all the measurement areas we view as important.
First a question of is continuing to market symposium to the same prescriber base that our potential prescribers of our product candidate liver van.
Symposium continued to make progress in the second quarter in all the measurement areas. We view is important.
Unnamed Speaker: Next, in late June, we filed the investigational new drug application for Equestiv 108. This therapeutic candidate is a first-of-its-kind oral sublingual film formulation delivering systemic epinephrine using Equestiv's proprietary farm film technology. In development for the treatment of anaphylaxis. Our IND has been accepted by the FDA, and we expect to initiate the first PK clinical trials in the third quarter of this year. We believe Equestiv 108, if approved, will be the first orally administered epinephrine-based rescue medication for this patient population. Next, Equestiv continues to work with the FDA in seeking approval for liver vans. We've been providing information, responding to their information requests, and working with the agency on inspections of our manufacturing and clinical sites. In our view, there have been no surprises in their questions or during the inspections to date.
Next in late June we filed the investigational new drug application for request, if one or wait. This therapeutic candidate is a first if its kind oral sublingual film formulation delivering systemic epic nasrin using a quest is proprietary pharmfilm technology.
In development for the treatment of anaphylaxis.
Hi, Andy has been accepted by the FDA and we expect to initiate the first PK clinical trials in the third quarter of this year.
We believe a question one away if approved will be the first orally administered FNF front based rescue medication. So this patient population.
[noise] next a quest of continues to work with the FDA in seeking approval of liver van.
We have been providing information responding to their information requests and working with the agency on inspections of our manufacturing and clinical sites.
And our view there have been no surprises in their questions or during the inspections to date.
[noise] excuse me a quest is lead licensee product suboxone continues to perform as expected.
Unnamed Speaker: Equestra's lead licensee product, Suboxone, continues to perform as expected. In addition, Endivior has just received approval for Suboxone in the EU, and we understand that it will be launching Suboxone in that region in the coming months. We anticipate that the EU launch will partially offset the eroding volume of Suboxone in the United States. Finally, the Equestive team has launched a process for a potential monetization of the anticipated royalties associated with Synovion's Kinmobi sublingual apomorphine product, which received FDA approval in May. In addition to triggering the Approval Milestones payment, once launched, we will be entitled to royalties on worldwide net sales of Kenmobi. Now, let's discuss in more detail each of these key areas of focus for the company.
In addition, endeavor Youre just received approval for suboxone in the EU and we understand that it will be launching suboxone in that region in the coming months.
We anticipate that the EU launch will partially offset the eroding volume of suboxone in the United States.
Finally, the Equest if team has launched a process for a potential monetization of the anticipated royalties associated with Sanofi ons can mobi sublingual apomorphine product that received FDA approval in may.
In addition to triggering the approval milestones payments once launched we will be entitled to royalties on worldwide net sales of can mobi.
Now, let's discuss in more detail each of these key areas of focus for the company.
Unnamed Speaker: First, we remain focused on building our CNS franchise. We are advancing the commercialization of Simpozant, whose prescribers substantially overlap with potential prescribers of LibriVant. Our aim is to raise the profile of our farm film technology as a commercial precursor and complementary product in support of the LibriVant opportunity.
First we remain focused on building our CNS franchise, we are advancing the commercialization of simple than whose prescribers substantially overlap with potential prescribers of liver van our aim is to raise the profile of our foreign film technology.
As a pre commercial precursor and complementary product in support of the liver vamp opportunity.
Unnamed Speaker: Simpazan continues to prove the build-out of our capabilities and processes in preparation for the commercial launch of LiberVant, if approved by the FDA for U.S. market access. All of our commercialization efforts relating to Symposan provide an opportunity for direct conversations with healthcare practitioners, patients, caregivers, payers, advocacy groups, and others about the value of our farm film technology. The acceptance of Simpozan by those groups is an important building block providing a meaningful value proposition for caregivers of patients suffering from LGS, helping to drive Simpozan to expected profitability in 2021, as well as positioning LibraVent for a stronger launch if approved for market access. Despite the restrictions on face-to-face visits with prescribers as a result of the COVID-19 crisis, Sympozan continues to grow in all the key We continue to focus on prescription growth and further market penetration. Shipment volumes sequentially, quarter over quarter, have grown 3% and by 116% over the same period last year.
SIMPAS and continues to prove the buildout of our capabilities and processes in preparation for the commercial launch of liver event, if approved by the FDA for us market access.
All of our commercialization efforts relating to SIMPAS and provide an opportunity for direct conversations with health care practitioners patients caregivers payors advocates advocacy groups and others about the value of our Pharmfilm technology.
The excepted subsidiaries and by those groups is an important building block, providing a meaningful value proposition for caregivers of patients suffering from LG is helping to drive SIMPAS and to expected profitability in 2021 as well as positioning live prevent for a stronger launch if approved.
For market access.
Despite the restrictions on face to face visits with prescribers as a result of the covert 19 crisis.
SIMPAS and continue to grow in all the key measures we view as important at this stage.
We continue to focus on prescription growth and further market penetration.
Shipment volumes sequentially quarter over quarter have grown 3% and by 116% over the same period last year.
Unnamed Speaker: Q2 represented the highest shipment volume quarter for Symposan since its launch. The prescribing base also continues to grow by 15% since the end of Q1, with over 78% of those prescribers writing multiple scripts. We now have a penetration of 22% in our focused group of prescribers. We continue to ramp up payer acceptance and currently have over 70% of commercial lives covered and 81% coverage of state Medicaid regions. The actual Q2 claims paid rate for commercial patients was 77%, and for Medicaid, it was 85%.
Q2 represented the highest shipment volume quarter for SIMPAS and since its launch.
The prescribing base also continues to grow 15% since the end of Q1 with over 78% of those prescribers writing multiple scripts.
We now have a penetration of 22% in our focused group of prescribers.
We continue to ramp up payer acceptance and have currently have over 70% of commercial lives covered and 81% coverage of state Medicaid regions.
The actual to Q2 claims paid rate for commercial patients was 77% and for Medicaid It was 85%.
Unnamed Speaker: We believe our position with the payers also will help us on the launch of LibraVamp. The COVID-19 pandemic has created face-to-face access challenges with health care providers since mid-March for our field-based sales team. Virtually all of our target prescribers for Simpazan have eliminated live access to their clinics at some point in time.
We believe our position with the payers also will help us on a launch of liver van.
The covert 19 pandemic has created face to face access challenges with health care providers since mid March for our field based sales team.
Virtually all of our target prescribers for SIMPAS and have eliminated live access to their clinics at some point in time.
Unnamed Speaker: The CYMPATH-AN team has rapidly adopted digital tools and continues to engage with healthcare providers and their staff remotely on a frequent basis. While states are in different phases of reopening at this time, we expect to continue to have some opportunities for face-to-face visits with health care providers, but we'll also continue to have virtual interactions with them as well. During the pandemic, we have, to the best of our ability, assured that our sales team is safe and compliant with local regulations but have also worked hard to maintain the sales team's connections with the prescriber and patient community that needs Sympathand. We believe that our continued prescription growth and net revenue demonstrates that we've been able to continue to connect with prescribers, even virtually, and grow this product through a difficult time. Symposan is strategically accomplishing what was intended when we developed and launched the product last year.
The symposium team is rapidly adopted digital tools and continues to engage with healthcare providers and their staff remotely on a frequent basis.
While states are in different phases of reopening at this time, we expect to continue to have some opportunities for face to face visits with health care providers, but we'll also continue to have virtual interactions with them as well.
During the pandemic, we have to the best of our ability assured 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 needs symposium.
We believe that our continued prescriptions growth and net revenue demonstrates that we've been able to continue to connect with pride with prescribers, even virtually and grow this product with difficult time.
Since presented strategically accomplishing what was intended when we developed and launched a product last year. The work we do to continue to build the market penetration for SIMPAS and will be an important foundation for a successful launch of Libber van.
Unnamed Speaker: The work we do to continue to build market penetration for Symposan will be an important foundation for a successful launch of LibraVan. As we have said before, we anticipate that LibraVan, if approved for U.S. marketing access, would represent a potential $300 million net revenue stream for the company at its peak. We believe this base of commercial infrastructure, payer relationships, and sales teams well-positioned with key prescribers, combined with a complementary product in our sales bag would put Equestiv in a position to launch LibriVant quickly and successfully if we are granted U.S. marketing approval, even in a restricted access environment.
As we've said before we anticipate that labor van if approved for US marketing asset access would represent a potential 300 million dollar net revenue stream for the company at its peak.
We believe this base of commercial infrastructure payer relationships and sales teams well positioned with key prescribers.
Combined with a complementary product in our sales bag would put a quest IV in a position to launch Lipper van quickly and successfully if we are granted us marketing approval, even in a restricted access environment.
Now, let's turn to request of one or wait.
Unnamed Speaker: As expected, we filed the IND for a quest of 108 with the FDA in late June of this year. As confirmed by the FDA at the pre-IND meeting in February, this program will be reviewed by the FDA under the 505B2 regulatory approval pathway. Based on our interactions with the agency to date, we expect that the development program will be comprised of at least two PK clinical trials. On July 23rd of this year, we received confirmation from the FDA that it had completed its safety review of the IND and concluded that we could proceed with our planned clinical trial. We expect that the first of the PK clinical trials will commence before the end of the current quarter. This first trial will be a crossover study designed to compare the pharmacokinetics and pharmacodynamics of epinephrine administered as a sublingual film to that of epinephrine administered as an injection.
As expected we filed the I Andy for a quest of one our weight with the FDA in late June of this year.
As confirmed by the FDA at the Prebuy Andy meeting in February This program will be reviewed by the FDA under the five or five be to regulatory approval pathway.
Based on our interactions with the agency to date, we expect it to development program will be comprised of at least two PK clinical trials.
On July 23rd of this year, we received confirmation from the FDA that it completed its safety review of the R&D and concluded that we could proceed with our planned clinical trials.
We expected the first of the PK clinical trials will commence before the end of the current quarter.
The first trial will be a crossover study designed to compare the pharmacokinetics and pharmacodynamics of Apple Nasrin administered as sublingual film to that have happened efron administered as an injection.
As we do with all of our development efforts. Once we have additional information from the first trial, we will meet with the FDA and confirm our path forward, which would include a pivotal PK trial, possibly in 2021.
Unnamed Speaker: As we do with all of our development efforts, once we have additional information from the first trial, we will meet with the FDA and confirm our path forward, which would include a pivotal PK trial, possibly in 2021. We plan to provide updates on our program over the second half of 2020 as additional information develops. Next, as we previously communicated, the NDA filing for Libervant was accepted in January of this year and assigned a PDUFA goal date of September 27, 2020. We have not seen an impact from the ongoing COVID-19 pandemic in terms of our interaction with the FDA regarding the approval of Libravant and have no indication that at this point there is any reason to believe that we are not on track for a September 27, 2020 decision as scheduled. Given that the approval and the orphan exclusivity decisions will be made by different groups within the FDA, we cannot be sure that we will receive feedback for both decisions simultaneously. There is a possibility that the orphan exclusivity decision may not be received until some short period of time following the PDUFA goal date, if approved on that date.
We plan to provide updates on our program over the second half of 2020 as additional information develops.
Next as we previously communicated.
Accuse me the NDA filing for Liberal event was accepted in January of this year and assigned the PDUFA goal date of September 27 2020.
We have not seen an impact from the ongoing covert 19 pandemic in terms of our interaction with the FDA regarding the approval of liver van and have no indication that at this point. There is any reason to believe that we're not on track for September 27, 2020 decision.
As scheduled.
Given the approval in the orphan exclusivity decisions will be made by different groups within the FDA, we cannot be sure that we will receive feedback for both decisions simultaneously.
There is a possibility that the orphan exclusivity decision may not be received until some short period of time. Following the PDUFA goal date, if approved on that date.
Unnamed Speaker: We have been engaged with the agency, providing information, and responding to their information requests, as well as for their ongoing inspections of our manufacturing and clinical sites. The information requests received over the past few months are in line with our expectations, and we have been able to respond completely and in a timely manner to all information requests received to date. From our perspective, there have been no surprises in the information requests or in the inspections to date.
We have been engaged with the agency, providing information responding to their information requests as well as their ongoing inspections of our manufacturing and clinical sites.
The information requests received over the past few months are inline with our expectations and we have been able to respond completely and in a timely manner to all information requests received to date.
From our perspective, there have been no surprises in the information requests or any inspections to date.
We are seeking to demonstrate to the FDA say that liberal event will if approved for use marketing access represent a major contribution to patient care within the meaning of the FDA regulations as got end guidance as compared to currently available device driven based treatment.
Unnamed Speaker: We are seeking to demonstrate to the FDA that LibriVant will, if approved for U.S. marketing access, represent a major contribution to patient care within the meaning of the FDA regulations and guidance as compared to currently available device-driven-based treatment operations. LibriVant would also expand patient choice as the first orally delivered diazepam-based product available to manage seizure clusters. We believe we can demonstrate to the FDA why LibriVant, as an orally delivered product, has one or more of the attributes required by the FDA to be considered a major contribution to patient care. While the dialogue continues with the FDA for approval of Libravant and access to the market, we cannot assure the FDA's position on this, and we do not anticipate that we will have any clarity on the decision until at least the scheduled PDUFA goal date.
Operations.
Liberal Van will also expand patient choice as the first orally delivered diazo, Pam based product available to manage seizure clusters.
We believe we can demonstrate to the FDA why labor van as an orally delivered product has one or more of the attributes required by the FDA to be considered a major contribution for patient care.
While the dialogue continues with the FDA for approval of liver van and access to the market we cannot assure the FDA position on this and we do not end to participate that we will have any clarity on the decision until at least to scheduled PDUFA goal date.
Recognizing that the orphan drug question is an element of risk and we cannot assure that the FDA positioned what the FDA position will be we will continue to be thoughtful and prudent about our spending choices and are appropriately managing our pre launch spend on liver event and market.
Unnamed Speaker: Recognizing that the orphan drug question is an element of risk, and we cannot assure what the FDA's position will be, we will continue to be thoughtful and prudent about our spending choices and are appropriately managing our pre-launch spend on Libervant and marketing expenses for Symposan prior to having any clarity on the approval of Libervant. Subject to FDA approval, we are committed to launching LiberVant, and we have the foundational commercial capabilities to do that. Finally, as I mentioned a few moments ago, we have launched our process for the potential monetization of Ken Moby royalty.
<unk> expenses for simple than prior to having any clarity on the approval of liver Ram.
Subject to the FDA approval, we are committed for launching liver van and we have the foundational commercial capabilities to do that.
Finally, as I mentioned, a few moments ago, we have launched our process for the potential monetization of can Moby royalties.
John Maxwell: Since we are in the middle of this process, we understandably will not comment further here on any specifics. We will provide an update at such time as we may complete any transaction, and, of course, we'll provide an update at the time of our third-quarter earnings. We look forward to updating you at the time of the release of our third quarter financial results as we advance these initiatives throughout 2020. With that, I'd like to turn the floor over to my colleague, John Maxwell, who will provide specifics on our financial performance and outlook. Thank you, Keith. Good morning, everyone.
And that we are in the middle of this process, we understandably will not comment further here on any specifics we will provide an update at such time as we make complete any transaction and of course will provide an update at the time of our third quarter earnings.
We look forward to updating you at the time of the release of our third quarter financial results as we advance these initiatives throughout 2020.
With that I'd like to turn the floor over to my colleague John Maxwell Who'll provide specifics of our financial performance and outlook John.
Thank you Keith good morning, everyone.
John Maxwell: As you know, we filed our 10-Q and issued our earnings release yesterday afternoon. As we typically do, we will tackle most of the discussion related to the second quarter 2020 results in our Q&A, and in my comments, I will highlight some of the points that are important in order for you to understand our full year 2020 financial guidance and our progress towards it. In terms of our capital horizon, we have worked diligently to manage our current cash position before considering any potential non-dilutive capital from a possible Kenmobi monetization. This was done by focusing our investments and spending on our key initiatives.
As you know we filed our 10-Q and issued our earnings release yesterday afternoon. As we typically do we will tackle most of the discussion related to the second quarter 2020 results in our culinary and in my comments I will highlight some of the points that are important in order for you to understand our full year 2020 financial guidance and our progress.
Towards it.
In terms of our capital Horizon, we have worked diligently to manage our current cash position before considering any potential nondilutive capital from a possible can mobile monetization. This was done by focusing our investments and spending on our key initiatives.
John Maxwell: Our second quarter 2020 revenue included $12 million of revenue tied to the approval of Comobie in May. Breaking the Kenmobe revenue down into its pieces, $4 million of this revenue is for the approval milestone and will be collected as expected by the fourth quarter. The remaining $8 million of non-cash revenue recognizes minimum royalties under the license agreement, which will be paid in future periods. For these minimum royalties, our performance obligations have been met, and current accounting rules require that the revenue be recognized at this point. This minimum royalty revenue does not impact cash flow in the 2020 year.
Our second quarter 2020 revenue included $12 million of revenue tied to the approval of can mobi in may.
Breaking the can Moby revenue down into its pieces $4 million of this revenue is for the approval milestone and will be collected as expected by the fourth quarter.
The remaining $8 million of non cash revenue recognizes minimum royalties.
Under the license agreement, which will be paid in future periods.
For these minimum royalties are performance obligations have been Matt and current accounting rules require that the revenue be recognized at this point.
This minimum royalty revenue does not impact cash flow in the 2020 year.
Suboxone production was over 43 million doses in the second quarter of 2020 comparable to the first quarter and down year over year as a result of generic erosion.
John Maxwell: Suboxone production was over 43 million doses in the second quarter of 2020, comparable to the first quarter and down year over year as a result of generic erosion. We expect that Suboxone in the U.S. market, combined with non-U.S. markets, including the EU, which recently approved it, will continue to be a meaningful part of our revenue base, while our proprietary business continues to grow. While the non-U.S. revenue from Suboxone manufacturing is expected to rise over a period of time, our revenue in the U.S. from Suboxone manufacturing continues to decline, reflecting the erosion from generic competition, and you can see this in the year-over-year comparison. We would expect to continue to see this year-over-year decline in manufacturing at least through 2020.
We expect that suboxone in the U.S market combined with non U.S markets, including the view, which recently approved we'll continue to be a meaningful part of our revenue base, while our proprietary business continues to grow.
While the non U.S revenue from Suboxone manufacturing is expected to rise over a period of time, our revenue in the us from Suboxone manufacturing continues to decline, reflecting the erosion from generic competition.
And you can see this in the year over year comparisons we would expect to continue to see this year over year decline in manufacturing at least through 2020.
Despite the limitations that came about from the covert 19 pandemic shutdowns across the U.S symposium that reported revenue for the second quarter 2020 increased by 59% year over year to $1.2 million.
John Maxwell: Despite the limitations that came about from the COVID-19 pandemic shutdowns across the U.S., CINPAZAN net reported revenue for the second quarter of 2020 increased by 59% year over year to $1.2 million. On a sequential quarterly basis, compared to the first quarter of 2020, Symposan revenues grew by 5%. Subject to further limitations that may result from the COVID-19 pandemic, we expect that Symposan Net Revenue will continue to grow throughout 2020 as our prescription volume grows. We are reaffirming our previously provided revenue guidance of $35 to $45 million. This guidance factor in the continued erosion of suboxone.
On a sequential quarterly basis compared to the first quarter of 2020 symposium revenues grew by 5%.
Subject to further limitations that May result from the covert 19 pandemic, we expect symposium net revenue will continue to grow throughout 2020.
As our prescription volume grows.
We are affirming our previously provided revenue guidance of $35 million to $45 million.
This guidance factors them continued erosion of suboxone.
John Maxwell: Additional growth in Simpazan despite the COVID-19 limitation. A $4 million milestone payment for Kenmobi that was recognized in the second quarter of 2020 and is expected to be collected in the fourth quarter. Co-Development Fees and Modest License Fees and Royalty. We did not include the recognition of the Kenmobi minimum royalties in our guidance, given that they are non-cash, one-time revenue.
Additional growth and symposium, despite the cobot 19 limitations.
A 4 million dollar milestone payment for can mobi that was recognized in the second quarter of 2020 and is expected to be collected in the fourth quarter.
Co development fees and modest license fees and royalties.
We did not include the recognition of the can Moby minimum royalties and our guidance given that they are noncash onetime revenue.
John Maxwell: And our guidance excludes any revenue related to LibriVamp and will not be included until after the product is approved, which cannot be assured at this time. Our non-GAAP-adjusted gross margin in the second quarter of 2020 was 87%, and in excess of 70% before the Kenmobile License and Royalty Revenue. As our revenue base shifts towards our proprietary products, starting with Simpazand and away from Suboxone, and before we consider the impact of additional license fees and royalties that we recognized in the second quarter, 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 second quarter 2020 non-GAAP adjusted EBITDA was $2.9 million, due in part from the favorable revenue impact from Kim Nohee's approval described a few minutes ago.
And our guidance excludes any revenue related to Liveramp and will not be included until after the product is approved which at this time cannot be assured.
Our non-GAAP adjusted gross margin in the second quarter of 2020 was 87% and an excess of 70% before the can Moby license and royalty revenue.
As our revenue base shifts towards our proprietary products, starting with symposium and away from Suboxone.
And before we consider the impact of additional license fees and royalties that we recognized in the second quarter. We expect our adjusted gross margin will exceed 70% on the full year as we have previously guided.
As outlined in the earnings release issued yesterday, our second quarter 2020, non-GAAP adjusted EBITDA was $2.9 million due in part from the favorable rubble revenue impact from commodities approval described a few minutes ago.
John Maxwell: While this quarter's EBITDA has been impacted by Kenmobi revenue, $8 million of this is non-cash and was not included in our EBITDA guidance. Excluding this non-cash impact, we continue to expect our performance to be within our previous guidance range for the year of $45-$50 million of loss. The second quarter non-GAAP adjusted EBITDA reflects lower sequential expenses from the first quarter of 2020 to the second quarter, as well as lower year-over-year expenses.
While this quarter's EBITDA has been impacted by can Moby revenue $8 million of this is noncash and was not included in our EBITDA guidance.
Excluding this non cash impact we continue to expect our performance to be within our previous guidance range on a year of $45 million to $50 million of loss.
The second quarter non-GAAP adjusted EBITDA reflects lower sequential expenses from the first quarter of 2020 to the second quarter.
As well as lower year over year expenses.
John Maxwell: We expect to continue to prudently manage our level of spending as we progress through 2020 in order that we have the expected capital that we need for our key priorities that we have outlined in our comments. As part of our prudent cost management efforts, we are focused on being as efficient as possible across the organization. We will continue to manage our variable cost structure at the plant to match volumes of production.
We expect to continue to prudently manage our level of spending as we progress through 2020 in order that we have the expected capital that we needed for our key priorities that we have outlined in our comments.
As part of our prudent cost management efforts, we are focused on being as efficient as possible across the organization. We will continue to manage our variable cost structure at the plant to match volumes of production.
John Maxwell: We will focus on the efficiency of LibraVent investments and pre-launch marketing until we have clarity on approval. We will continue driving Simpazan towards anticipated profitability in 2021, and we will continue to manage our support costs to be in line with our focus on our key initiatives. Cash used for operations in the second quarter was approximately $10 million, down from nearly $14 million in the first quarter and down from the prior year's second quarter of $17 million.
We will focus on the efficiency of liberman investments and pre launch marketing until we have clarity on approval.
We will continue driving symposium towards anticipated profitability in 2021.
And we will continue to manage our support costs to be in line with our focus on our key initiatives.
Cash used for operations in the second quarter was approximately $10 million down from nearly $14 million in the first quarter and down from the prior year second quarter of $17 million.
John Maxwell: This improved cash flow reflected the capital management steps we have taken while still making investments in our most critical priorities. Our $25 million cash position at the end of the quarter, independent of a potential Kenmobi royalty monetization, is expected to provide the capital necessary to get into early 2021. The second quarter cash flow performance remains on track with our full year's expectations, and therefore we have reaffirmed our earlier cash burn guidance.
This improved cash flow reflected the capital management steps, we've taken while still making investments in our most critical priorities are $25 million cash position at the end of the quarter.
Independent potential can Moby royalty monetization is expected to provide the capital necessary to get into early 2021.
The second quarter cash flow performance remains on track with our four years expectations and therefore, we have reaffirmed our earlier cash burn guidance.
With our current cash resources prudent management of our spend and access to the capital markets, including any potential monetization of can Moby royalties. We believe that we are positioned to continue to extend our capital runway.
John Maxwell: With our current cash resources, prudent management of our spend, and access to the capital markets, including any potential monetization of Kenmobi royalties, we believe that we are positioned to continue to extend our capital runway. In summary, our reaffirmed guidance for 2020 reflects continued cash flow from our licensee and proprietary products revenue base. Thank you very much.
In summary, our reaffirmed guidance for 2020 reflects continued cash flow from our licensee and proprietary products revenue base.
Our full focus of our investments into the most value driven aspects of our future Liberal Vance an appetite from and continued focus on capital conservation. So the castles extended as far as possible.
Operator: We are especially pleased with our ability to continue to perform to date, given the COVID-19 pandemic and its impact on the economy at large. Operator, we will now open the line for questions. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, please press the pound key.
We are especially pleased with our ability to continue to perform to date, given the covert 19 pandemic and its impact on the economy at large.
Operator, we will now open the line for questions.
As a reminder to ask the question you need to press Star one on your telephone to tell your question. Please press the pound key.
Operator: Please stand by while we compile the Q&A. And our first question comes from the line of Gary Nachman with BMO Capital Markets. Hey, good morning, it's Raphae on for Gary. I just wanted to touch on, good morning. I just wanted to touch on Ken Moby.
Please stand by long term pelvic ULAE roster.
And our first question comes from the line of Gary Nachman with BMO capital markets. Your line is open.
Hey, good morning, it rothsay on for Gary.
I will touch on good morning, just wanted to touch on Inmobi.
Unnamed Speaker: I wanted to confirm whether your thinking around the timing of a potential transaction has changed at all since your last update. And what kind of interest are you getting from potential buyers? Are you still confident in 50 to 100 million in proceeds? Yeah, Rafael, so we are, at this time, because of the fact that we're in the middle of our process, we're really not going to provide any additional comments on the monetization. We will update you once we've concluded the process. Got it.
Wanted to confirm whether you're thinking around the timing.
So back in.
Changed at all and Carol eight.
And what kind of interest are you getting from potential buyers are you still confident and 50 to 100 million right.
[music].
Yeah, we're off base. So we are at this time because of the fact that were in the middle of our process, we're really not going to provide any additional comments on the monetization.
We will update you once where.
Concluded on the process.
Got it.
And then for lumber band have you had any labeling discussions with the FDA and I'm curious why there's no question provide you with any additional visibility on the potential to receive E.
Unnamed Speaker: And then for LibriVent, have you had any labeling discussions with the FDA? And I'm curious whether those discussions provide you with any additional visibility on the potential to receive ODE. Sure. Dan, do you want to take that question? Sure. Morning, Rafi.
Sure Dan you want to take that question, Yes sure morning. Ravi. This is Dan Barber as you know as part of the NDA submission, we did file our pie, which is the key labeling component.
Daniel Barber: This is Dan Barber. As you know, as part of the NDA submission, we filed our PI, which is the key labeling component, and we fully expect to receive comments from the FDA in the coming weeks. And as you know, labeling discussions typically happen about four weeks before a PDUFA date. So we remain on schedule, and we look forward to the comments.
And we fully expect to.
Received comments from the FDA in coming weeks and as you know.
Labeling discussions typically happened about four weeks before we do the dates we remain on schedule and we we look forward to the comments.
Got it.
Unnamed Speaker: And then for AQUEST-108, could you just remind us of the data that you've generated thus far? To what extent does that inform your level of confidence in potential success with the upcoming crossover trial? How many patients will you be enrolling in that trial? And when would you expect to see data?
And then for a quest went away could you just a reminder of the data that you've generated that are.
And that inform their level of confidence on potential success with the upcoming crossover trial.
How many patients will you be enrolling in that trial and when would you expect the data. Thank you.
Unnamed Speaker: Thank you. So, as we shared with you before, first, we remain excited about this program. As we shared with you before, we have done a previous proof of concept study in humans, and our formulation will be back in the clinic in the coming weeks. The study design is a four-period.
So we as we shared with you before so first we remain excited about this program as we shared with you before we have done a previous proof of concept study in humans.
And our formulation will be back in the clinic.
In the coming weeks. This study design is for period.
Study so.
Unnamed Speaker: It also has 24 healthy volunteers in the study, and we would expect to have data from that later in the year. In terms of confidence, our proof-of-concept study did show very good results. And so we have a high level of confidence that this upcoming study will have robust results that will help us with our interactions with the FDA. Thanks so much. Thank you, and our next question comes from the line of Randall Stanicky with RBC Capital Markets. Your line is open. Great, this is Edwin Delphinon for Randall Stanicky.
It also has 24.
Healthy volunteers in the study.
And we would expect to have data from that leader in the year.
In terms of confidence we are proof of concept concept study did show a very good results.
So we have a high level of confidence that.
The this upcoming upcoming study will will have robust results that will help us with their interactions with the FDA.
Thanks, so much.
In the next question Lima, Randall Stanicky with RBC capital markets loan.
Great and this is Alan Delta non per Randall Stanicky.
Unnamed Speaker: My first question is on liver vent. You know, given that TUDUFA is next month, can you update us on the discussions you're having with the FDA on the back and forth and anything on what they've been asking for from the information requests? That would be helpful, thanks. As Keith has shared with you over the last few calls, we have had an ongoing and proactive relationship with the FDA on this filing. They have asked the typical series of questions that any filing would receive from CMC, including safety questions. We've been able to respond to all of them with what we believe are complete and thorough answers, and we do continue to discuss with them all of the elements of our NDA, including the orphan drug component. Thank you, and my next question on LibriVant, assuming approval, how quickly do you think you can get to scale, and how will the reps be split between LibriVant and Symposan, and how much of your target subscribers can you get within your sales force? And lastly, how will virtual detailing play into this? That's a great question.
My first question is on Liberman, given the UK month month.
Update us on the discussions you're having with at EEI on the back more than anything on what they've been asking for from the information request.
Helpful. Thanks.
Dan go ahead short so we have as Keith has shared with you over the last few calls we have had a and ongoing and proactive.
Relationship with the FDA on this filing.
They have asked the typical series of questions that any filing would receive from CMC to safety questions, we've been able to respond to all of them.
With what we believe are complete and thorough answers.
And we do continue to discuss with them all of the elements of our and da including the orphan drug component.
Thank you and my next question on the Revana assuming approval how quickly do you think you can get scale and.
Well the reps is split between live event in simpler than and how much of your targets fiber can you get within your Salesforce.
Lastly, how will virtual detailing planes and.
That's a great question well look we're very happy with how we were able to adapt virtually over the last.
Unnamed Speaker: Well, look, we're very happy with how we were able to adapt virtually over the last three or four months, given the COVID travel and social distancing restrictions and the limit on face-to-face meetings at doctors' offices and clinics. We've built this commercial footprint for this very moment, and if it's approved, as expected, we'll launch LibriVant almost immediately with the group that we have, and we will then scale that group up to be probably three or four times the size of the current sales force over the last months of this year and the first couple of months of 2021. We think that the acceptance by prescribers, we think that the acceptance and excitement in the advocacy community and the patient community are going to be very helpful to us.
Three or four months.
Given the co vid travel and.
Social distancing restrictions and the limit on face to face meetings at doctors' offices in clinics.
We've built this commercial footprint for this very moments and if it's approved.
Excuse me as expected.
We'll launch Libber Vance almost immediately with the group that we have and we will then scale that group up to be.
Probably three or four times the size of the current sales force over.
The last months of this year in the first couple of months of 2021.
We think that the acceptance by prescribers, we think that the acceptance in the excitement in the advocacy community and the patient community is going to be very helpful to us. So we look forward to.
Unnamed Speaker: So we look forward to capitalizing on the work we've done so far to position ourselves in the marketplace to allow us to launch LibriVant very quickly, and we think successfully because of that. I think the fact that we've been able to do Symposan on a virtual basis since March bodes well for our ability to get prescribers to pay attention to LibriVant even if, in some cases, in some states, we still don't have face-to-face access. Thank you. And my last question is, you know, R&D was down meaningfully in the quarter, although it's not surprising. You know, how should we be thinking about normalized spend, including SG&A and the Ex Lib event, heading through the second half of the year? Evan, a good question. So the R&D timing, the R&D spend, really is a reflection of the timing of project spending. When things are occurring quarter to quarter, it will move around.
Capitalizing on the work we've done so far to position ourselves in the marketplace to allow us to launch live revamp very quickly and.
We think successfully because of that I think the fact that we've been able to do simple than on a virtual basis.
Since March.
Bodes well for our ability to get prescribers to pay attention to deliver van even if in some cases in some states, we still don't have face to face access.
Thank you and my last question is on R&D was down.
During the quarter, although not surprising how should we be thinking about.
Normalized and including at.
In the prevent heading through the second half the year. Thanks.
Yes, I have another good good question. So the R&D timing the R&D spend really as a reflection of the timing of projects bandwidth when when things are occurring quarter to quarter and when it will move around.
John Maxwell: We're going to continue to invest in our key priorities, as we've talked about. Obviously, LibraVant is coming to a conclusion from a clinical R&D perspective, but Quest of 108 is beginning to increase. So you'll see that shift, but from a dollars perspective, we don't guide quarter to quarter, but overall, I think the trend lines that you've seen are probably what we will continue to see in the future
We're going to continue to invest in our key priorities as we've talked about.
Obviously love revamp is coming to a conclusion from a clinical R&D perspective, but.
A quest of 108 is beginning to.
Increase.
So you'll see that shift but from a dollars perspective, we don't guide quarter to quarter, but overall I think the trend lines that you've seen are probably.
We will continue to see in the future otherwise across our business, whether it's on SDMA or in other categories.
John Maxwell: Otherwise, across our business, whether it's in SG&A or in other categories like the plant, we're going to make sure that we're rationalizing our spending, focusing on our top priorities, matching our volume of production, and that sort of thing throughout the business. Thanks for the questions. And our next question comes from the line of Liana Moussakos with Wedbush. Your line is open. Hi, this is Shweta for Liana.
Like the plant.
We're going to make sure that we're rationalizing our spending focusing on our top priorities.
Matching our volume of production and that sort of thing throughout the business.
Thanks for the questions.
Your next question comes in the line of Liana Moussatos with Wedbush Your line.
Hi, This is lastly, Adam.
Unnamed Speaker: Thank you for taking my question. Can you go over some of the main reasons for Symposan sales growth? Sure. Look, I think that we had...
Thank you for taking my question can you go away from of the main reason listen one sales growth.
Sure I look I think that we had.
Unnamed Speaker: Prior to COVID, I think we had done a good job of penetrating the core prescriber group that we were targeting. In the absence of face-to-face meetings, I think that those relationships played a very important part in our people being able to continue to connect with those prescribers and those clinics. I think as we continue to grow our penetration in that core prescriber group, I think we're also growing our saturation in those practices who have written for Simpazan at least once, and we're getting multiple scripts from multiple patients in those locations. I think those are the things that have played an important part. I think we took some price support action for people who were affected by COVID economically to be sure they could still have access to the product. I think that probably helped a bit for some of the families who were a bit challenged economically by the COVID crisis.
Prior to co vague I think we had done a good job of.
Penetrating the core prescriber group that we were targeting.
In the absence of face to face meetings I think that those relationships played a very important part in our folks being able to continue to connect with those prescribers and those clinics.
I think.
As you continue as we continue to grow our penetration in that core Prescriber group I think we also grow our saturation in those practices, who have written for SIMPAS and at least once and we're getting multiple scripts for multiple patients in those locations.
I think those are the things that.
Have played an important part.
I think we took some price support action for people who were affected by Cove. It.
Economically to be sure they could still have access to the product I think that probably.
Helped a bit for some of the families a bit challenged economically by the covered crisis.
Unnamed Speaker: But I think you've got a good product with a good value proposition in a very difficult, and it showed to be strong and resilient during this period of time. Our next question comes from the line of Jason Butler with J&P Securities. Your line is open.
But I think you've got a good product with a good value proposition in a very difficult market.
And the relationships that our salespeople had built.
Showed to be strong and resilient during this period of time.
Thank you.
Our next question comes from the line of Jason Butler with JMP Securities. Your line is open.
Hi, Thanks for taking the glass.
Unnamed Speaker: Hi, thanks for taking the question. Keith, you mentioned that there are two different groups, the Orphan Drug piece and the regular PDUFA review piece. I just want to clarify, are you getting questions from and interacting with both of those groups, or is it just with the PDUFA group now and then it will be the Orphan Drug group at some later point?
You mentioned that they're two different group the orphan drug.
He and the regular produce a review.
I just wanted to clarify are you getting and question from and interact with both of those group or is it would look to do for group now and then it will be the orphan drug group.
Unnamed Speaker: Sure. Thanks, Jason, for the question. Dan, you want to... Sure. Good morning, Randall. Nice to hear your voice. Jason. Jason, excuse me.
Later time point.
Sure. Thanks, Jason for the question, Dan you want to show.
Sure.
Good morning, Randall nice to hear your voice Jason.
Jason excuse me.
So.
As we progress through the.
Daniel Barber: As we progress through the discussions with the FDA, we have had a variety of conversations. As you can imagine, for a couple of reasons, we are not sharing too much about what groups those are with. I would continue to point out to you that in terms of the competitive landscape, we do believe that we have advantages over other competitive products, including the fact that nasal sprays, in general, will have issues with seasonal allergies.
Discussions with the FDA, we we have had a variety of conversations as you can imagine for a couple of reasons we are.
Not overly sharing what groups those Erwin.
I would continue to point out to you that.
In terms of the competitive landscape.
We do believe that we have advantages over the other competitive products, including including the fact that.
Nasal sprays in general will have issues with seasonal allergies.
Unnamed Speaker: We think that's a key component of an advantage for us as we go forward into the market. Okay, great. And then just a couple on the commercial side.
I think thats, a key component of advantage for us.
As we go forward into the marketplace.
Okay, Great and then just a couple on the commercial side.
Unnamed Speaker: Can you maybe talk in a little bit more detail about the, you know, any learnings that you have in terms of reimbursement access that you've secured for Symposam and how that'll lead through to your strategy for LibraVent? And then, I know you touched on this a little bit, but just in terms of, you know, assuming LibraVent approval, what kind of scale or magnitude of commercial build-out beyond what you have today would you expect? Thanks.
Can you maybe fulfilled in more detail about.
Any learnings you had in terms of reimbursement at.
Your equipment to them and how that will read through to your strategy for for LIBOR then.
Then.
I know, you're working with a little bit, but just in terms of healing, we prevent approval, what kind of gail or magnitude of commercial build out beyond what you have today.
Would you back.
Ken: Sure, Ken, do you want to respond to that? Sure, Keith, happy to, from a reimbursement learning point of view. I think we reaffirmed that when you come to market, while you're negotiating your contracts, you have to have a very... robust support system that allows you to buy down co-pays on the commercial side to facilitate movement quickly through any edits or prior authorization.
Thanks.
Sure can do you want to do you want to respond to that.
Sure keep happy too.
Yes.
From a.
Reimbursement learnings.
I think we reaffirmed that when you come to market, while you're negotiating your contracts you have to have a very.
Robust support system that allows us to buy down prepays on the commercial side.
And facilitate movement quickly through any edits or prior authorizations.
As Keith mentioned.
Ken: As Keith mentioned, and actually probably one of the most important things, how many of your prescriptions actually come out the door? If you look at our Medicaid scripts... That's over 81%, and if you look at our commercial lives, it's over 70%. Those are both very, very..., and I think we can replicate that with liver.
And actually probably one of the most important metrics.
How many of your prescriptions actually come out the door and if you look at our Medicaid scrip.
Thats over 81% and if you look at our commercial lives over 7%. Those are both very very good numbers and I think we can replicate that with Midland.
From a scale perspective.
Ken: From a scale perspective, right now, we're calling on around 4,500 key positions that manage some of the most severely effective epilepsy patients, and they are going to be the highest consumers of rescue medicines. We're doing that with StemtoXan. So we'll expand that slightly, probably in the range of 6,000 to 7,000 positions, and we'll adjust our footprint accordingly. But I think we'll be able to scale very quickly to cover those additional positions, and we're already very well entrenched in some of the most important positions that will be available later this year. Okay, great. Thanks for the color and thanks for taking the question.
Right right now we're calling on.
Usually.
Right now, we're calling on around 4500 key positions. They manage some of the most severely effective epilepsy patients than they are going to be the highest consumers of rescue medicines, we're doing that with simpler than.
So we'll expand that slightly probably in the range of six to 7000 physicians and we'll.
We will adjust our footprint accordingly, but I've been I think we'll be able to scale very quickly to cover those additional positions and we're already very well entrenched in some of the most important position.
To be writing Wonderland.
Okay, great. Thank the color and thanks for taking my question.
Our next question comes on line and Thomas flattened with Lake Street Capital markets. Your line is open.
Unnamed Speaker: Our next question comes from the line of Thomas Flaten with Lake Street Capital Markets. Your line is open. Great, thanks. Thanks guys for taking the questions. Can you describe a little bit some of the efforts you've undertaken from either an unbranded commercial perspective or from a med-ed perspective to kind of lay the groundwork for a potential liver van approval?
Great. Thanks, Thanks for taking the questions.
Can you describe a little bit some of the you've undertaken from either an unbranded commercial perspective or from a met Ed perspective to kind of laid the groundwork for a potential liberman approval.
Ken: Sure. Ken, do you want to respond to that? Sure. One of the most important things that you do leading up to the launch of a product or start to move your clinical literature into the public domain, so we've just recently had an unmet needs article published that talks about the current state of affairs in the management of breakthrough seizures and seizure emergencies. Three very prominent physicians authored that it's getting a lot of visibility, and it starts to shade the needs that you'll play into the second paper that we have in late stage review, with Epilepsia outlining our long-term safety study, which clearly focuses on the safety of the brand, but it's going to give an awful lot of insight into the efficacy in a real world situation.
Sure can do you want to respond to that.
Sure and one of the most important things that you do leading up to the launch of a product or start to move your clinical literature.
I into the public domain that we've just recently had an unmet needs article published.
That talks about whats currently the current state of affairs, and the management of breakthrough seizures in theater emergencies.
Three very prominent physician authored that it's getting a lot of visibility and it starts to say.
The needs that will play into the second paper that we have in late stage review.
With epilepsy outlines our long term safety study, which clearly focuses on safety of the brand.
But it's going up it's going to give an awful lot of insight in the efficacy in a real world situation.
Ken: The feasibility of placing, if you look at our placement rates, when you see that paper, you're going to see virtually everyone has success with placing our strip on the first attempt. And then, probably the key safety metric, 1,100 uses in that study with no negative interactions in the mouth and no biting, which I know is going to be a question, and it's something that I've been asked a few times.
The feasibility of placing if you look at our placement rates when you see that paper, you're going to see virtually everyone had success in placing our strip on first attempt.
And then probably the key safety metric 1100 uses in that study.
With no negative interactions in them out the new biting, which I know, it's going to be a question and it's it's something that I've been asked you time. So those are the two of the most important thing we're heavily engaged with advocacy right now.
Ken: So those are two of the most important things. We're heavily engaged in advocacy right now, building relationships, talking to their constituents, and that's gonna create a very nice forum to announce the introduction of a new, important medicine. And we're building out all of our materials, so we come out of the gate quick. That'll complement those and actually start to train our... Great, I appreciate that.
Add building relationships talking to their constituents and that's going to create a very nice form to announce the introduction of new important medicine.
And we're building out all of our all of our material that we come out of the gate quick that'll complement those and try and actually starting to train our sales team.
Great I I appreciate that and I just wanted to reconcile can you had mentioned you would go from something around 4500 docs to us somewhat upward of 7000, and maybe I misheard Keith in earlier response, you said the might scale three to four times the current commercial footprint gig I'm, having a little trouble right.
Unnamed Speaker: And I just wanted to clarify, Ken, you had mentioned you would go from something around 4,500 docs to, you know, somewhere upward of 7,000. And maybe I misheard it, Keith, in an earlier response, you said that you might scale three to four times the current commercial footprint. Okay, I'm having a little trouble reconciling that, but perhaps I misheard those numbers. I just want to make sure I understood, from an actual rep perspective, how much bigger do you think you'll get over the next six to nine months post-launch? Yeah, we're still working out the actual size. Keith, do you want me to take this? Yeah, go right ahead, Ken. Okay, yeah, we're working through the final size and structure. Those are the approximate numbers.
Consigned that but perhaps I Miss heard.
Mr. Those numbers I, just want to make sure I understood from a actual rep perspective, how much bigger do you think you'll get over there.
Six to nine months that post launch, yes, we're still working through the actual side that Keith you want me to take that or do you want that go right ahead Ken.
Yes, we're working through the final size and structure those are the approximate numbers.
Ken: One of the things that you'll see us do is dial up the frequency. So the current ratio that you look at, simpatizan to our current footprint, is going to be slightly different when you get to LibraVan. It's a little bit of a different cell. So we would look for a higher frequency, which will mean you'll need a few more representatives for the increased number of dots.
One of the things that you'll see us do with Dialup frequency.
So the current ratio that you look at simpler than to our current footprint is going to be slightly different when you get to LIBOR band, it's a little bit of a different Sal.
So we would look for a higher frequency, which when they will need a few more representatives for the increased number of dock.
Got it appreciate that and then just one one final one for John.
John Maxwell: Got it. I appreciate that. And then just one final one for John.
John Maxwell: John, have you made any decisions about tapping into additional debt capacity in the event that Kenmobi gets delayed or you have some challenges with getting Liboran onto the market? How should we think about that? Yes, our debt capacity, as you know, we have a $100 million facility, $30 million in re-openers. There are two re-openers, $10 million upon liver event filing, which we've completed, but we did not access, and $20 million that would be upon liver event approval. So, upon liver event approval, we'll make that decision. It is part of our tool chest of, you know, capital options, but at this time, we don't have any plans to. Take that desk down.
John that do you have you made any decisions about tapping into additional debt capacity in the event that can moby gets delayed or you have some challenges with getting live around onto the market are.
How should we think about them.
Yes, our debt capacity as you know we have a 100 million dollar facility $30 million of Reopeners. There are two reopeners $10 million upon liver event.
Filing, which we've completed but we did not access and $20 million that would be upon liver van approval.
So upon liver van approval, we'll make that decision.
It is part of our tool chest of capital options, but at this time, we don't have any plans to.
Take that that down.
John Maxwell: Excellent. Thanks for taking the questions, guys. Thank you. And as a reminder, ladies and gentlemen, if you have a question at this time, please press star and the number one. Our next question comes from the line of Ram Selvaraju. Ram, with H.C. Wainwright, your line is open.
Excellent thanks for taking the questions guys. Thank you.
And as a reminder, ladies and gentlemen question at this time, Please press star and the number one.
Our next question comes from the line of Ram now.
Selvaraju with HC Wainwright your line is open.
Unnamed Speaker: Hi, this is Blair Cohen from ROM. I just have a couple questions for you. I'm just curious about the PK trial that you have coming up for 108. Have you incorporated any elements of the trial design to accommodate for the COVID environment, you know, the difficulties you may encounter with enrollment? Dan, do you want to take that?
Hi, This is Blair Cowen on for Rob just a couple of questions for me on.
Im just curious for the PK trial that you have coming up or one only have you incorporated any element the trial designed to accommodate cobot environment.
I'll give you may encounter with enrollment.
Daniel and take that Jerry good morning, Blair yet so we have yes coven 19, obviously is not only affected us but everyone in our industry. So we have chosen a site.
Daniel Barber: Sure. Good morning, Blair. Yes, so we have, yes, COVID-19 obviously has affected not only us but everyone in our industry. So we have chosen a site for this particular study that we feel is at low risk of disruption from COVID-19. So we believe we have high confidence that our study will start on time and complete on time.
For this particular study that we feel is at low risk of disruption from covert 19, So we believe.
We have high confidence that our study will start on time and complete on time.
Great and then as far as face to face interaction. Your Salesforce can you give us an idea how much you're doing face to face were virtually and how you expect that the change in the ongoing months in with tend to launch.
Unnamed Speaker: Great. And then as far as face-to-face interaction with your sales force is concerned, can you give us an idea of how much you're doing face-to-face versus virtually and how you expect that to change in the ongoing months and with the potential launch of LibraVan? Thank you. Sure. Ken, do you want to take that? Sure, Keith. If you look at the...
Thank you.
Sure can do you want to take that.
Sure key.
Look at.
Ken: The start of this pandemic, exiting, what, March, into April, we went to about 95% virtual, as did most of the industry. And as you moved into May, you saw a slight softening in that number, but still pretty dominant in terms of virtual. As we went into June, you saw a reversion back to about 60-40, and in some of the key states, maybe even 50-50 as some of the states moved into phase two. And then as you moved into July, you're seeing it flat at around that number.
The start of its been dynamic.
Exiting wet March.
In the April we went to that 95% virtual.
As did most all of the industry.
And as you moved into May you saw a slight softening in that number but still pretty pretty dominant in terms of virtual as we went into June you saw rivers and back.
About 60 40 and in some of the key states, maybe even 50 50 and some of the state's moved into phase two.
And then as you as moved into the now July you're seeing it flat and around that number we've got the tools in place now to work very effectively.
Ken: We've got the tools in place now to work very effectively in a virtual environment, so we're, I think, managing through that pretty well. The biggest challenge in all of this is actually the offices and their ability to adapt to a virtual environment. Some have done a lot better than others, and the ones that have... www.kenhub.com our reach into those offices, and for those that look to be struggling, we'll be looking to really ramp up face-to-face as they allow it. Thank you. I appreciate it. Thank you, and I'm not showing any further questions, so now I'll turn the call back over to Keith Kendall for closing remarks. Okay, thank you everyone for joining us today. We appreciate your time. We will continue, as always, to update you as our business progresses. We look forward to providing a further update when we issue our third quarter earnings later this year.
In a virtual environments. So there were I think managing through that pretty well.
Biggest challenge and all of this or actually the offices and their ability to adapt to a virtual environment. Some have done a lot better than others in the ones that is effectively develop that scale, it's very easy to communicate with and it will remain a core piece of our.
Our reach into those offices and after those that look to be struggling we'll be looking to really ramp up face to face as they allow it.
Thank you appreciate it.
Thank you and I'm not showing entering the question now turn the call back over to keep candle for closing remarks.
Sure. Okay. Thank you everyone for joining us today, we appreciate your time.
We will continue as always too.
Update you as our business progresses, we look forward to providing a further update when we do our third quarter earnings later on this year. So thank you all for joining US this morning and have a great rest of the day.
Keith Kendall: So thank you all for joining us this morning, and have a great rest of the day. Ladies and gentlemen, this does conclude the program. You may now disconnect.
Ladies and gentlemen, this does conclude the program you may now disconnect.
[music].