Q3 2019 Earnings Call
Good morning, and welcome to the Questar Therapeutics third quarter conference call.
Operator: Good morning, and welcome to the Cuesta Therapeutics third quarter conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference, Ms. Stephanie Carrington, Westwick Investor Relations. You may begin.
Time, all participants are in listen only mode. After interest because presentation there will be a question answer session.
The question known especially you need press star one of your telephone.
As a reminder, this call will be recorded I would now like to introduce your host for today's conference Ms., Stephanie Carrington Westwicke Investor Relations you may begin.
Stephanie Carrington: Thank you, operator. Good morning, and welcome to today's call to review Acquessive Therapeutics' results for the third quarter of 2019 and business highlights. On today's call, I am joined by Keith Kendall, Chief Executive Officer, and John Maxwell, Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the third quarter. Additional members of our leadership team will be available for Q&A. In total, we expect today's call to last approximately 60 minutes.
Thank you operator, good morning, welcome todays call to review of course, if therapeutics results for the third quarter 2019 and business highlights.
On today's call I'm joined by Keith Candle, Chief Executive Officer, and John Maxwell Chief Financial Officer.
Going to provide an overview of recent business development and performance in the third quarter.
Additional members of our leadership team.
The available for culinary in total we expect today's call to last approximately 60 minutes.
Stephanie Carrington: As a reminder, our remarks today correspond to the earnings release we issued after market close yesterday. In addition, a recording of today's call will be made available on Acquesta Therapeutics' website within the investor relations section shortly following the conclusion of this call. To remind you, we will be discussing some non-GAAP financial measures this morning as part of our review of third quarter 2019 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release we issued yesterday, which is posted to the Investors section of the Questive Therapeutics website.
As a reminder, our remarks today correspond to the earnings release, we issued after market close yesterday. In addition, a recording of today's call will be made available on of course, the therapeutics website within the Investor Relations section. Shortly following the conclusion of this call.
To remind you will be discussing some non-GAAP financial measures. This morning, as part of our review of third quarter 2019 results.
A description of these measures along with a reconciliation to GAAP can be found in the earnings release, we issued yesterday, which is supposed to be investors section of of course, if therapeutics website.
Stephanie Carrington: During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in yesterday's earnings release, as well as the risks and uncertainties affecting the company as described in the risk factors section included in the company's annual report on Form 10-K filed with the SEC on March 14, 2019, and in our 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 to our business and the development, regulatory approval, and commercialization of our products and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made.
During the call the company will be making forward looking statements.
And you have the company's safe Harbor language as outlined in Yesterdays earnings release, as well as the risks and uncertainties affecting the company as described in the risk factor section included in the company's and report on Form 10-K filed with the FCC on March 14, 2019, and in our quarterly reports on Form 10-Q .
As with any pharmaceutical company with product candidates underdevelopment and products being commercialized there are significant risks and uncertainties with respect to our business and the development.
Tory approval and commercialization of our products and other matters related to operations. Given these uncertainties you should not place undue reliance on these forward looking statements, which speak only as of the date made actual results may differ materially from these statements.
Stephanie Carrington: Actual results may differ materially from these statements. All forward-looking statements attributable to Acquessive Therapeutics or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, further events, or otherwise, except as required under applicable law.
All forward looking statements attributed to cost of therapeutics or any person acting on our behalf.
Our expressly qualified in their entirety by this cautionary statements and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward looking statements. After the date of this conference call, whether result of new information further advance or otherwise, except as required under applicable law.
With that I'll now turn the line over to Keith.
Keith Kendall: Thanks, Stephanie, and thanks to everyone on the call for joining us this morning as we discuss a number of important developments in our business during the third quarter and through October. John and I are going to walk through some details of our remarks today, and we'll then be joined by additional members of the Equestive Leadership Team during the Q&A session afterwards. The third quarter was an important and successful quarter in the evolution of Equestria.
Thanks, Stephanie and thanks to everyone on the call for joining US. This morning, as we discuss a number of important developments in our business during the third quarter through October .
John I go to walk through some details in our remarks today I will then be joined by additional members of the quest of leadership team during the Q when a session afterwards.
The third quarter was an important as successful quarter in the evolution of a question do we.
Keith Kendall: We have, as previously committed... We have completed our proof-of-concept study for epinephrine, Equestive-108, for the treatment of allergic reactions including anaphylaxis and have requested a pre-IND meeting with the FDA. We've continued to grow Simpazan by more than 50% since the end of the last quarter and successfully completed the FDA-requested crossover study of LibraVan in patients against the reference- Let's discuss in more detail each of these key areas of focus for the company.
We have as previously committed.
Completed our proof of concept study for FNF from a question one or wait.
For the treatment of allergic reactions, including anaphylaxis and have requested a pre I couldn't be meeting with the FDA.
We have continued to grow SIMPAS and more than 50% since the end of the last quarter and successfully completed DFT a request the crossover study of liberated inpatients against a reference listed rectal gel.
[noise], let's discuss in more detail each of these key areas of focus for the company.
Keith Kendall: First, let's talk about Equestiv 108. In late September, as promised, we completed the Phase I proof-of-concept clinical trial for Equestiv 108, our sublingual film formulation delivering systemic epinephrine. The proof-of-concept data demonstrated our ability to deliver systemic epinephrine via our farm film formulation. Notably, we achieved similar ranges of mean values of Cmax and Tmax to that reported for injectables such as EpiPen and AviQ.
First let's talk about request if one always.
In late September as promised we completed the phase one proof of concept clinical trial for a question one away or sublingual films formulation delivering systemic up in Africa.
The proof of concept data demonstrated our ability to deliver systemic up front airframe veer off pharmfilm formulation.
Notably we achieved similar ranges of mean values of Cmax and team back to that reported for Injectables at B. Penn and RV Q.
Keith Kendall: Last week, we submitted our request to the FDA for a pre-IND meeting. We're waiting for feedback from the agency regarding potential dates for this meeting to discuss the development pathway for Questive 108. At this juncture, we anticipate this meeting will be scheduled for the early part of 2020.
Last week, we submitted our request to the S.P.A. for pre I envy meeting.
We are waiting for feedback from the agency regarding potential dates for this meeting to discuss the development pathway for questions went away.
At this juncture, we anticipate this meeting will be schedule city early part of 2020.
The central focus of our company at this time is our CNS franchise.
Keith Kendall: The central focus of our company at this time is our CNS franchise. As you all know, we launched Symposan at the very end of last year. Sempizan is a product we believe will ultimately generate $65 million in peak annual net sales.
As you all know we launched symposium at the very end of last year.
And as a product we believe will ultimately generate $65 million of peak annual net sales.
Keith Kendall: Symposan has a meaningful value proposition for caregivers of patients suffering from Lennox-Gastaut syndrome, or LGS. It also represents a significant step forward in establishing our commercial infrastructure and raising the profile for Equestiv's technology as we continue to drive toward an ultimate approval and launch of LibraVan. We launched Symposan, whose prescribers overlap greater than 90% with potential prescribers of LibraVan, late last year with the aim of raising the profile of our farm film technology. Symposan was developed and launched as a commercial precursor, an eventual complementary product in support of the LibriVant opportunity. Simpazan gave us the opportunity to build out and pressure test our commercialization capabilities and processes prior to the commercial launch of LibraVan. All of our commercialization efforts relating to Zimpazan provide an opportunity for direct conversations with healthcare practitioners, patients, caregivers, advocacy groups, and others about the value of the farm film technology that will be the basis for LibraVan. On a sequential quarterly basis, we continue to be focused on the growth and further market penetration of Symposam. The latest monthly Simpavan shipment volumes to retailers have grown over 50% since the end of the second quarter.
SIMPAS and has a meaningful value proposition for care givers of patients suffering from Lennox Gastaut syndrome or LG, yes.
SIMPAS and also represents a significant step forward in establishing our commercial infrastructure and raising the profile for quest of technology as we continue to drive toward an ultimate approval and launch of Liberal fan.
We launched symposium.
Prescribers overlap greater than 90% with potential prescribers of Liberty media.
Late last year with the aim of raising the profile of our foreign film technology.
Surface and was developed and launched as a commercial precursor and eventual complementary product in support of the live revamped opportunity.
Surface and gave us the opportunity to build out and pressure test or commercialization capabilities and processes prior to the commercial launch of liberated.
All of our commercialization efforts relating to SIMPAS and provide an opportunity for direct conversations with health care practitioners patients caregivers advocacy groups and others about the value of the farm film technology that will be the basis for Liberal van.
On a sequential quarterly basis, we continued to be focused on the growth and further market penetration is symposium.
The latest monthly SIMPAS and shipment volumes to retailers has grown over 50% since the end of the second quarter.
Keith Kendall: The prescribing base also continues to grow, over 56% since the second quarter, with over 83% of prescribers writing multiple scripts and over 70% of patients refilling their prescriptions. Additional contracts with payers and PBMs were signed since the second quarter, and we continue to expect to achieve our goal of having over 70% of lives covered by the end of the year. Sympathan is strategically accomplishing what was intended when we developed and launched the product last year.
The prescribing base also continues to grow over 56% since the second quarter.
With over 83% of prescribers, writing multiple scripts.
And over 70% of the patients refilling their scripts.
Additional contracts with payers NPV items were signed since the second quarter and we continue to expect to achieve our goal of having over 70% of lives covered by the end of year.
[noise] symposia in a strategic strategically accomplishing what was intended when we developed and launched a product last year.
Keith Kendall: The work we do to continue to build the revenue stream and market penetration for Symposan will be an important foundation for the successful launch of LibraVant, expected in 2020. Companies' efforts are most sharply focused on bringing LibraVant to market. LibriVant represents a major contribution to patient care for the treatment of seizure clusters in patients with epilepsy and we believe it will potentially contribute up to 200 to 300 million dollars in peak net revenue. Over one million patients in the U.S. have active, uncontrolled epilepsy and a need for rescue medication. Less than 10% of these patients are successfully treating their seizures with the current standard of care, a rectal gel application of diazepam. A medicine is only as good as its ability to be used by patients where they need it, when they need it, and in a form they accept.
The work, we do to continue to build the revenue stream and market penetration for SIMPAS and will be an important foundation for the successful launch of Liberty Bad expected in 2020.
The company's efforts are most sharply focused on bringing liberty aftermarket.
Lipper van represents a major contribution to patient care for the treatment of seizure clusters in patients with epilepsy.
And we believe will potentially contribute up $200 million to $300 million in peak net revenues.
Over 1 million patients in the U.S. have active uncontrolled epilepsy and the need for rescue medication.
Less than 10% of these patients are successfully treating their seizures with the current standard of care, a rectal gel application of Diageo Pam.
A medicine is only as good its its ability to be used to bite patients where they need it when they need it and then a form they except.
As we announced previously during the third quarter, we successfully completed the single dose crossover study for liver fat.
Keith Kendall: As we announced previously during the third quarter, we successfully completed the single-dose crossover study for LibraVamp. We believe that we've met the specific requirements for approval communicated to us by the FDA, and our product continues to prove that it has attributes lacking in all of the current or pending formulations of diazepam. As shown in the recently completed crossover study trial comparing Libervant with the rectal gel in patients, the peak blood concentration of diazepam following buccal film administration was comparable to that of the diazepam rectal gel. Also, the performance of the film measured by peak concentrations was more consistent across weight categories compared to the performance of the rectal gel. Importantly, the data continued to show that there were no non-responders to LibriVant. The rectal gel, however, continued to show, as it has historically, low and non-responders of 10% or more in our latest study.
We believe that we've met the specific requirements for approval communicated to us by the FDA and our product continues to prove that it has attributes lacking in all of the current or pending formulations of diazo Pam.
As shown in the recently completed crossover study trial, comparing lipper manner with the rectal gel in patients the peak blood concentration of die as a Pam following buckle film administration was comparable to that of diazo Pam rectal gel.
Also the performance of the film measured by Pete concentrations was more consistent across weight categories compared to the performance of the rectal gel.
Importantly, the data continue to show that there were no non responders to Liberty fab.
The rectal gel however continued to show as it has historically low and nonresponders of 10% or more in our latest study.
This is a critical milestone for our lead asset and puts us on a clear and straight forward path to completing the filing of our M.D.A. for liver van.
Keith Kendall: This is a critical milestone for our lead asset and puts us on a clear and straightforward path to completing the filing of our NDA for LibraVan. We filed the CMC portion of the rolling new drug application submission with the FBA in September. We expect to file the clinical data portion around the end of November, which will mark the completion of our submission. Assuming a 10-month review cycle, we are anticipating receiving a PTUFA goal date around the end of the third quarter of 2020.
We filed the CMC portion of the rolling New drug application submission with the U.S.P.A. in September .
We expect to file the clinical data portion around the end of November which will mark the completion of our submission.
Assuming a 10 month review cycle, we are anticipating receiving up to two foot goal date around the end of the third quarter of 2020.
We believe that liver fat will become the preferred rescue medication by patients and providers looking for an alternative potentially superior and clinically differentiated treatment to manage and interrupt seizure clusters. This is based on strong data that shows the product can be quickly and safely.
Keith Kendall: We believe that LibraVent will become the preferred rescue medication by patients and providers looking for an alternative, potentially superior, and clinically differentiated treatment to manage and interrupt seizure clusters. This is based on strong data that shows the product can be quickly and safely applied, results in consistent therapeutic levels, and comes in a form preferred by patients. Based on patient survey data, LibriVant is preferred by 80 percent or more of patients when compared to nasal sprays.
Applied results in consistent therapeutic levels and comes in a form preferred by patients.
Based on patient survey data Lipper event. This preferred by 80 plus percent of patients when compared to nasal sprays once approved by the FDA Liberal if it will be the only treatment option usable by and delivering a consistent predictable dose to virtually.
Keith Kendall: Once approved by the FDA, LibraVent will be the only treatment option usable by and deliver a consistent, predictable dose to virtually all patients to whom it's prescribed. We plan on having a strong presence at the American Epilepsy Society Annual Meeting in Baltimore in early December. We have multiple poster presentations, and we're planning to hold an investor and analyst R&D event on December 9th that will feature a handful of key opinion leaders in the epilepsy field. Moreover, we're sponsoring a scientific exchange meeting at AES on the morning of December 9th for clinicians and others to learn more about LIBRIVANT and the expanded clinical data set that we'll be showcasing at the meeting. We believe AES is one of the most important epilepsy conferences of the year.
All patients to whom its prescribed.
We plan on having a strong presence at the American Epilepsy Society annual meeting in Baltimore in early December .
We have multiple poster presentations and we're planning to hold in Investor and analyst R&D event on December nine that will feature a handful of key opinion leaders in the epilepsy field.
Moreover, we are sponsoring a scientific exchange meeting at eight yes. The morning of December 9th for clinicians and others to learn more about liver event and the expanded clinical dataset that will be showcasing at the meeting.
We believe Hds is one of the most important epilepsy conferences over the year.
Keith Kendall: With the imminent filing of LibriVant, we believe this is an important event for us to showcase our technology and product offerings. Finally, in line with our expectations, ExerVan, our farm film formulation of Rilazol for ALS, continues to move toward a November 30th PDUFA date. As we've said previously, we're seeking to license the product outside the United States, and we've begun the process of identifying potential commercial partners in the U.S. as well. Looking ahead for the remainder of 2019 and into 2020, we are focused on advancing our proprietary products. We will continue to grow Symposan shipments and revenue while establishing strategic relationships for us in the epilepsy market in advance of a liver vent launch. And we expect to complete the NDA filing for Libravant around the end of November, as I said before, and we will continue the regulatory process through the early part of 2020. We look forward to continuing to update you as we make progress on these key deliverables during the remainder of the year and in the early part of 2020. I'll now turn the line over to John Maxwell, who will provide specifics on our financial performance and outlook.
With the imminent filing of Lipper Van we believe this is an important event for us to showcase our technology and product offerings.
Finally in line with our expectations Exar van our Pharmfilm formulation of real is all for LSW continues to move put on November Thirtyth PDUFA date.
As we've said previously were seeking to license the product outside the United States and we've begun the process of identifying potential commercial partners in the U.S. as well.
Looking ahead for the remainder of 2019 and into 2020, we're focused on advancing our proprietary products.
We will continue to grow symposiums shipments and revenue, while establishing strategic relationships for us in the epilepsy market in advance of a liberal event launch.
We expect to complete the NDA filing for liver van around the end of November as I said before and continue the regulatory process through the early part of 2020.
We look forward to continuing to update you as we make progress on these key deliverables during the remainder of the here in the early part of 2020.
I'll now turn the line over to John Maxwell Who'll provide specifics of our financial performance and outlook.
John Maxwell: Thank you, Keith. Good morning, everyone.
Thank you Keith good morning, everyone.
John Maxwell: I will use my time this morning to address the impact of our continued strong revenue performance on our guidance ranges and provide an update on our capital planning. By now, you have seen our financial results in our 10-Q and earnings release that were filed yesterday after market close. I want to draw out a few points that are important to an understanding of our updated 2019 financial guidance published in the release. To the extent that there are questions on the Q3 results, we can address those during Q&A.
I'll use my time this morning to address the impact of our continued strong revenue performance on our guidance ranges and provide an update on our capital plan.
Now you have seen our financial results in our 10-Q and earnings release that were filed yesterday after market close.
I want to draw out a few points that are important to an understanding of our updated 2019 financial guidance published in the release.
To the extent that there are questions on the Q3 results we can take those during Q1 I.
John Maxwell: First, Suboxone performance has been strong through the third quarter, and we are changing our Suboxone revenue outlook as a result. In the third quarter of 2019, we produced 72 million doses of Suboxone in the authorized generic product compared to about 75 million doses in Q3 of 2018. Based on the franchise's market performance and our order book, we are updating our full-year guidance for suboxone manufacturing volume to a range of 260 to 270 million doses, up from previous guidance of 240 to 260 million doses. This translates into a $32-$33 million revenue outlook for manufacturing and supply revenue and is above the top end of our previous guidance range. As we have discussed previously, Suboxone is an asset that represents Equestria's past.
First suboxone performance has been strong for the third quarter and we're changing our suboxone revenue outlook as a result.
In the third quarter of 2019, we produced 72 million doses of Suboxone and the authorized generic product compared to about 75 million doses in Q3 2018.
Based on the franchises market performance and our order book, we are updating our full year guidance for suboxone manufacturing volume to a range of 260 to 270 million doses up from previous guidance of 240 to 260 million doses.
This translates into a 32 to 33 million dollar revenue outlook for manufacturing and supply revenue and is above the top end of our previous guidance range.
As we have discussed previously suboxone as an asset that represents a quest of past our future is the group of proprietary assets, we are developing and commercializing specifically sempra exam Liberal map quest of one are way up enough from.
John Maxwell: Our future is the group of proprietary assets we are developing and commercializing, specifically Symposan, LibriVant, and Equestria-108 Epinephrine. We will continue to be the sole and exclusive supplier of Suboxone to Indivior worldwide, even as the dynamics of the U.S. market continue to change. Suboxone will remain a contributor of meaningful revenue and cash flow even as overall revenue and volumes continue to decline into the future. We will continue to assess the impact of changes in the opioid market and plan to provide 2020 guidance in the first quarter. While we do not specifically guide on Symposan revenue, as Keith mentioned previously, our trends on wholesaler shipments to retail pharmacies and growth in new and repeat prescribers are very solid quarter over quarter. However, our revenue recognized is affected by wholesaler inventory levels. The major wholesalers are moving us towards an inventory level as low as 7 to 14 days.
We will continue to be the soul and exclusive supplier of suboxone to individual or worldwide, even as the dynamics of the U.S. market continued to change suboxone enrollment will remain a contributor of meaningful revenue and cash flow, even as overall revenue and volumes continued to decline into the future we will.
Continue to assess the impact of changes in the suboxone market and plan to provide 2020 guidance in the first quarter.
While we do not specifically guide on samples and revenue as Keith mentioned previously our trends on wholesale shipments to retail pharmacies and growth in new and repeat prescribers are very solid quarter over quarter.
Our revenue recognized is affected by wholesaler inventory levels. The major wholesalers are moving us towards an inventory level as low as seven to 14 days.
John Maxwell: The effect of this inventory management will continue to drive a disconnect between revenue timing and our commercial market trends into 2020. As we mentioned before, we are very pleased with the commercial performance of SimpliVan, as this most importantly prepares us for the launch of LibraVamp, expected in 2020. As a result of exceeding our Suboxone and Authorized Generic Product volume and revenue expectations for the quarter, we are raising our 2019 total revenue guidance range to $45 to $47 million, which is above the previous guidance range. While we do not provide guidance on the other components of total revenue, all components of revenue continue to perform in line with our expectations. Our adjusted gross margin continues to perform in line with the previous expectations. Our adjusted gross margin in the third quarter of 2019 was 68%. As a result, we have left Adjusted Gross Margin guidance unchanged.
The effective this inventory management will continue to drive a disconnect between the revenue timing and our commercial market trends in the 2020.
As we mentioned before we're very pleased with the commercial performance of several of them.
As this most importantly prepares us for the launch of Liberty ramp expected in 2020.
As a result of exceeding our suboxone, an authorized generic product volume and revenue expectations for the quarter. We're raising our 2019 total revenue guidance range to $45 million to $47 million, which is above the previous guidance range. While we do not provide guidance on the other components of total revenue.
All components of revenue continued to perform in line with our expectations.
Our adjusted gross margin continues to perform in line with the previous expectations.
Our adjusted gross margin in the third quarter 2000, my team was 68%.
We have left adjusted gross margin guidance unchanged as a result.
John Maxwell: Over the long term, we would expect gross margins to rise as the mix of revenue from our proprietary products rises as a component of total revenue. As with 2020 revenue, we plan to set full P&L guidance in early 2020. As outlined in the earnings release issued yesterday, our full-year non-GAAP adjusted EBITDA loss range has been improved to $49 to $50 million from our previous guidance.
Over the long term, we would expect gross margins to rise as the mix of revenue from our proprietary products rises as a component of total revenue.
As with 2020 revenue we plan to so full PML guidance in early 2012.
As outlined in the earnings release issued yesterday, our full year non-GAAP adjusted EBITDA loss range has been improved to $49 million to $50 million from our previous guidance.
John Maxwell: The new guidance reflected continued strong revenue, higher costs from continued IP litigation, acceleration of the LibriVent crossover trial, and costs related to the timing of our debt refinancing partially offset by cost management efforts. We have been very good at creating revenue opportunities to offset delays and key milestones like those from apomorphine, particularly with the opportunity to drive additional revenue from the melting ice cube and suboxone. These additional revenues carry a lower gross margin than the milestone revenues we had originally expected. This fact, combined with the pressure of the higher cost items just mentioned, along with working capital timing, has kept pressure on our year-end cash position. As a result, we're maintaining our cash burn guidance at approximately $60 to $65 million after considering the guidance ranges and timing of working capital changes.
The new guidance reflected continued strong revenue higher cost from continued IP litigation acceleration of the liberal that crossover trial and the costs related to the timing of our debt refinancing partially offset by cost management efforts.
We have been very good at creating revenue opportunity to offset delays and key milestones like those from apomorphine, particularly with the opportunity to drive additional revenue from the melting ice cube and suboxone.
These additional revenues carry a lower gross margin than the milestone revenues, we had originally expected.
So this fact combined with the pressure of the higher cost items, just mentioned along with working capital timing Cup kept pressure on our yearend cash position as a result, we're maintaining our cash burn guidance at approximately 60 to 65 million after considering the guidance ranges and timing.
Working capital changes.
John Maxwell: As you know, we plan to monetize the apomorphine royalty stream once the product is approved. We are expecting this to be in the second quarter of 2020 based on Synovian's most recent public statements. We are beginning the work now to prepare for monetization of this royalty stream and will update as this develops. We continue to expect monetization of this royalty stream could provide additional capital of up to $100 million. After considering that note holders will have the option to buy down debt with up to $40 million of proceeds from a monetizing event on apomorphine, we expect that the company will be left with a substantial new cash position and a reduced debt balance from this apomorphine monetization event.
As you know we plan to monetize the apomorphine royalty stream once the product as approved.
We are expecting this to be in the second quarter of 2020 based on Sonobi into most recent public statements.
We are beginning to work now to prepare for monetization of this royalty stream and we'll update as this develops.
We continue to expect the monetization of its royalty stream could provide an additional capital of up to $100 million.
After considering that note holders will have the option to buy down debt with up to $40 million of proceeds from a monetizing event on apomorphine.
We expect that the company will be left with a substantial new cash position and they reduce debt balance from this apomorphine.
Some of that.
John Maxwell: After completing the submission of LIBRIVANT later this month, we will evaluate accessing the first re-opener as available under the indenture, subject to majority lender approval. In summary, our spend reflects investments in our future high-value proprietary assets, including establishing an expanding position in the epilepsy market. Our capital position has been improved by our senior notes issued in July, our debt payments have been pushed out well beyond the expected liver vant launch, and our revenue continues to be strong from our proprietary and licensed products. Moreover, as discussed, we are optimistic as to the apomorphine royalty stream, which we expect to provide significant new capital as early as the first half of 2020. Operator, we will now open the line for questions.
After completing the submission of Liberal ramp later this month, we will evaluate accessing the first reopener as available under the indenture subject to a majority lender approval.
In summary, our spend reflects investments in our future high value proprietary assets, including establishing an expanding position in the epilepsy market.
Our capital position has been improved by our senior notes issued in July our debt payments have been pushed out well beyond the expected Levant launch.
And our revenue continues to be strong from our proprietary and licensed products. Moreover, as discussed we are optimistic as to the apomorphine royalty stream, which we expect to provide significant new capital as early as the first half of 2020.
Operator, we will now open the line for questions.
As a reminder to ask a question you need to press star one of your telephone to withdraw your question press the pound key.
Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key.
Operator: Please stand by while we compile the Q&A roster. Our first question comes from Gary Nachman with BMO Capital Markets. Your line is open. Hi, good morning. It's Rapha on for Gary.
Please standby only compiled acuity roster.
Our first question comes from Gary Bachman with BMO capital markets. Your line is open.
Hi, Good morning, it's rough fan for Gary.
Rapha: Morning. So starting with LibriVant, can you comment on how familiar physicians and patients are with the product currently? And outside of AES, what activities do you plan on conducting over the next year to raise awareness? And then, how should we think about the launch curve compared to what we've seen with Sympathand thus far?
Morning.
Starting with liver van can you comment on how familiar physicians and patients are with the product currently and outside of a yet what activities do you plan on conducting over the next year to raise awareness.
And then how should we think about the launch curve compared to what we've seen with the fan thus far.
Keith Kendall: Can you want to take that?
Can you want to take that yes, I'm happy to and if you. If you look at the physician base that we currently call on the 4100 samples and prescribers, they're extremely familiar with the platform and actually very familiar with the LIBOR Van program a good number of actually participated in the development plan.
Kenneth W. Marshall: Yeah, I'm happy to. And if you look at the physician base that we currently call on, the 4100 SimpsVan prescribers, they're extremely familiar with the platform and actually very familiar with the LibraVan program. A good number have actually participated in the development plan. If you look at what we'll do over the next 12 months... A big part of that is the scientific platform and publication strategy that supports LibriVant. You'll see the front end of that at AES. We've got five posters going into the show.
If you look at what we'll do over the next 12 months.
A big part of that as the scientific platform and publication strategy that supports live event you.
You will see the front end of that at eight yes, we've got five posters going into yes.
Kenneth W. Marshall: We've got a medical-scientific exchange that usually draws about 200 physicians where we'll have KOLs present that data again in a more intimate setting. We'll have two advisory boards, and then we'll have your normal booths there. Now, the booths will be limited to talking about Simpsons since that's our commercial product, but we have a big presence and allow us to talk about the platform.
We've got a.
Medical scientific exchange, which usually draws about 200 physicians will will have K allows present that data again in a more intimate setting.
We'll have to advisory boards and then we'll have your normal booth.
They're now the boost will be limited to talking about centers and since that's our commercial product, but we have big presence and allows us to talk about platform.
All right. If you look at that products uptake curve, if you'll remember with with samples and yours, you're competing in a very small market. It's algae asked there is about 55000 patients about half of them are on club exam, they're very tightly manage.
Kenneth W. Marshall: If you look at that product's update curve, if you remember with Sympathan, you're competing in a very small market. It's LGS, there are about 55,000 patients, about half of them are on Clobizam. They're very tightly managed, they're very tough to control, and they're very slow to change.
They are very tough to control and they're very slow to change. So there is a fundamentally flatter uptake curve in a market like that.
Kenneth W. Marshall: So there's a fundamentally flatter uptake curve in a market like that. When you move into a market like Rescue, you move outside of just those LGS and highly refractory patients into a population that is looking for a rescue strategy that may not be as severely affected as the LGS patients. So, first of all, it's a bigger pool.
When you move into a market like rescue you move outside of just those those LNG asked in highly refractory patients.
And those highly refractory patients into a population that is looking for a rescue strategy that may not be severely affected as the I'll just patients. So first of all at the bigger pool. When you look at that market, it's completely dissatisfied as well.
Kenneth W. Marshall: When you look at that market, it's completely dissatisfied as well. If you look at symposam, Clopazam is available, so there's some level of satisfaction. If you look at the rescue market that we'll be moving into, it's completely dissatisfied, and you can tell that by the range of ways people try to control their seizures. There's really no standard of care, so it creates a lot more interest when you come in with a preferred route of delivery for a medicine they're accustomed to, so you would expect a faster uptake. And maybe one other point on the Symposan uptake curve: that's a fully generic market. That slows down your, that flattens out your curve as well.
If you look at symptoms and Clobazam is available so theres some level of satisfaction. If you look at a rescue market it will be moving into.
Completely dissatisfied and you can tell that by the range of ways people try to control their seizures, there's really no standard of care.
So that creates a lot more interest when you come in with a preferred route of delivery for a medicine, they're accustomed with that you would expect a faster uptake.
And maybe one other point on the symptoms and uptake curve.
That's a fully generic market that slows down your that flatten veteran curve as well.
Okay.
Daniel Barber: Thanks, and for the epinephrine product, when do you think that could potentially come to market? What kind of penetration would that have, and how much of a need is there for a sublet?
Thanks for the epinephrine product when do you think that could potentially come to market, what kind of penetration would that have and how much of a need as their first sublingual form.
Hi.
Daniel Barber: Good morning. This is Dan Barber. So, we are, as Keith said, we just submitted our request to meet with the FDA and walk through the early part of our clinical program. We'll have more clarity on that early in 2020. We're very bullish on the process we'll need to go through from a clinical perspective. So, we don't see this as a long development timeline. I would say, you know, in the three to five-year range, it's a very reasonable time period to assume. What we like about this market is similar to Ken's comments on our LibraVent products. With the epinephrine anaphylaxis market, you have the same dynamics where you have devices that people don't like to use, you have a highly unsatisfied group of patients, and we think we can provide consolidation with a new standard of care that is a big step forward for all patients. In terms of penetration, I don't think we're in a position today to give you precise penetration numbers, but we see it as a disruptive force in that marketplace.
Good morning, This is Dan Barbara.
So we are we as Keith said, we just submitted our request to meet with the FDA walk through.
The early part of our clinical program will have clarity on that early in 2020.
We're very bullish on the process will need to go through from a clinical perspective.
So we don't see this as a.
A long development timeline I would say in a three to five year range is very reasonable time period to assume.
What we like about this market is similar to Ken's comments on.
Our liberman product.
The App in Africa Anaphylaxis market you have the same dynamics, where you have devices that people don't like to use you have a highly unsatisfied group of patients and we think we can.
Provide a consolidation within new standard of care that is.
A big step forward for all patients so in terms of penetration.
I don't think were in place today to give you precise penetration numbers, but we see it as a disruptive force in that marketplace.
Keith Kendall: And this is Keith again, and we intend to update everyone once we finish our meeting with the FDA and have the minutes from that meeting about what the regulatory and clinical path forward is going to be so that we can fine-tune our view on development time.
And this is Keith again, and we intend to we intend to update everyone. Once we.
Finish our meeting with the FDA and have diminished from that meeting about what the regulatory and clinical path forward is going to be so that we can fine tune.
Our view on development time.
Thank you.
Rapha: Thank you.
Thank you. Our next question comes from Liana Moussatos with Wedbush Securities. Your line is open.
Liana Moussakos: Thank you. Our next question comes from Liana Moussakos with Wetbush Securities. Your line is open. Thank you for taking my question.
Thanks for taking my question.
Liana Moussakos: Just a little more color on what you're doing right with Symposan growth and cash. What's the runway estimate?
Can you give us a little more color on what you're doing right with symptoms Andrew.
And.
Yes.
Runway.
Kenneth W. Marshall: Ken, do you want to take the Simpazan grill? Yeah.
Can you want to take the symptoms and grow yeah, I mean, as John stated, we're very pleased with.
Kenneth W. Marshall: As John stated, we're very pleased with the growth of SimpZen. It's performing in line with products that have come into this market before us that have filled niches like this, niches like Benzel and Ficompas Liquid. So we're tracking in line with those.
The growth of symptoms and is performing in line with products that have come into this market before us that have filled niche like this niches like things out and by comp as liquid so we're tracking in line with those.
Kenneth W. Marshall: You're seeing really good uptake in our target physicians. To date, we've got around 350 physicians who have written about the product, virtually all of them multiple times. We probably will close the year with around 400 physicians having written it. That's a very, very solid base of clinicians. We're seeing a strong refill rate; 70% refill rate is our calculation based on our copay card, so that's slightly above the industry standard, and as I mentioned, the vast majority of the physicians who are writing are writing more than once, which is a good sign. That number is 83%.
You are seeing really good uptake in our target physicians.
To date, we've got around 350 physicians, who have written the product virtually all of them multiple times.
We probably will close the year with around 400 physicians, having written that that's a very very solid base.
Clinicians.
We're seeing a strong refill rate, 70% refill rate is our calculation based on our co pay card. So thats slightly above the industry standard and as I mentioned, the vast majority of the physicians who are riding on writing more than once which is a good sign that numbers 83%.
In terms of.
Keith Kendall: In terms of capital, Liana... We think we have all the options available for us to provide the capital we need. The gating factors for us are the filing of Apamorphine and the filing later this month of LibraVent. Apamorphine, as you know, represents a significant non-dilutive capital opportunity for us, and once that is filed by Synovion, and their public statements continue to say that that's going to happen here shortly, once it is filed, we'll focus on creating a transaction for that royalty stream that we think creates, as John laid out in his prepared remarks, a significant non-dilutive capital stream for us going forward.
Capital Liana.
We think we have all the options available for us to provide the capital we need.
The gating factors for us to the filing of apomorphine in the filing later this month of the prevent.
Apomorphine is you know represents a significant non dilutive capital opportunity for us and once that is filed by synovial and their public statements continue to say.
That thats going to happen here shortly but once it is filed will focus on creating a transaction for that royalty stream that we think creates.
John laid out in his prepared remarks, a significant non dilutive capital stream for us going going forward.
Thank you very much.
Liana Moussakos: Thank you very much. Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is open. Hi, thanks for taking the questions. First one, can you just give us any color on how we should think about the Rylazol launch from an organizational perspective? And then secondly, on the work you're doing with 305, can you just talk a little bit more about the reformulation work, what your target profile is, and any granularity on timelines? Thanks.
Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is open.
Hi, Thanks for taking the questions them first one can can you just give us any color on how we should think about the rivals all launch.
You know from an organizational perspective, and then secondly.
On the work you're doing with Threeo five can you just talk a little bit more about three formulation work what your target profile as in any.
Any granularity on timeline thanks.
Keith Kendall: Sure. Well, I'll let Dan talk about 305 and comment on that in a second. In terms of the first part of your question, as we have been indicating to everyone, our intent is to license that product first outside the U.S. and then secondly in the U.S. We are not likely to spend very much time, other than preparing to manufacture the product for a potential partner, launching Rilazol once it's approved.
Sure well I'll, let Dan talk about.
Three or five and comment on that in a second in terms of the first part of your question as we have.
Been indicating to everyone. Our intent is to license that product.
First outside the US and then secondly in the US we are not likely to span.
Very much time other than preparing to manufacture the product for a potential partner on launching real azul once it's approved.
Thanks, Jason is that okay.
Jason Nicholas Butler: Jason, is that okay? Yep, that's great. Yep. Okay. Dan, you want to talk about... 305
That's right Yep, Okay, Dan you want to talk about.
Sure and on three of five we continue to.
Work on.
Daniel Barber: Sure. And on 305, we continue to work on the formulation and dialing in on the curve that we would like to see. We obviously had our results earlier this year from our POC, and we're using those results to continue to modify the formulation as we move forward. We'll have more to say about that, I would say, at some point in 2020.
The formulation and the end dialing in on the curve that we would like to see.
We obviously had our.
Results earlier this year from our.
We'll see.
And we are using those results to continue to modify the program for the formulation.
As we move forward.
We'll have more to say about that I would say.
At some point in.
Okay, great. Thanks for taking my questions.
Jason Nicholas Butler: Okay, great. Thanks for taking the question. Thank you. Our next question comes from Thomas Flaten with Lake Street Capital. Your line is open.
Thank you. Our next question comes from Thomas Flatten with Lake Street Capital. Your line is open.
Thomas Flaten: Good morning, guys. Thanks for taking the questions.
Good morning, guys. Thanks for taking the questions.
Keith Kendall: Just a quick question on the additional $10 million draw. Is that on submission or acceptance of the file by FDA that that would be drawable?
Just a quick question on the additional 10 million draw is that on submission or acceptance the file by FDA that that would be.
Draw.
Keith Kendall: That's on submission, and then we would need majority lender approval once it's submitted. So, as we indicated, we would expect that to be filed in late November. We'll reach out after that.
That's on a that's on submission.
And then and then we would need majority lender approval once its submitted so whereas we indicated we would expect that to be.
Filed in late November .
Rich out after that.
Keith Kendall: Got it. And then, with respect to Suboxone, I know this is looking ahead a bit, but given that Indivior has terminated the Sandoz agreement, should we be thinking about volumes just as branded, which is, you know, two-thirds of what they're selling? Or should we be thinking about the branded growing to take some of that share from the Sandoz volume as we look forward?
Got it.
And then with respect to Suboxone idols is looking forward a bit but given that.
That interviewer has terminated the sandoz agreement should we be thinking about volumes just as branded which is two thirds of what they are selling or should we be thinking about the branded growing to take some of that share from that from the Sandoz volume is as we look forward.
Keith Kendall: I think that, this is Keith again, Thomas. I think that the fact that the authorized generic represents about a third of the market is clear, exactly based on their actions. How much of that goes away, in other words, is absorbed by the other generics in the market, and how much, if any, is reclaimed by the brand remains to be seen. Our view is it is not all going to go away to the other generics, but whatever that looks like, we continue to work with Indivi or to create a forecast. Right now, we're focused on delivering what's in our order book into the early part of 2020. We'll continue to work with Indivi to understand that very new market action, and we'll provide, I think, clearer and specific guidance in the first quarter when we guide for 2020.
I think this is Keith again, Thomas I think that.
The fact that the authorized generic represents about a third of the market is clear.
Exactly based on their actions how much of that.
Goes away.
In other words is absorbed by the other generics in the market and how much if any is reclaimed the by the brand remains to be in our view is it is not it is not all going to go away to the other generics, but what that looks like.
We continue to work within DVR to create a forecast right now were focused on delivering what's in our order book into the early part of 2020, we'll continue to work within behavior to understand that very new market action and will provide I think clearer and specific guide.
Vince.
In the first quarter when we guide on 2020.
Keith Kendall: And then one final one for me, could you talk about if it's indeed true there was a citizen's petition filed with respect to Norellis' intranasal product?
And then one final one from me can you talk about if its indeed true there was a citizens petition filing.
With respect to.
Didn't relative.
Keith Kendall: Can you talk about that? If that's indeed what you did?
Nasal product is when you're talking about that.
Indeed, what you did.
Keith Kendall: There was actually a citizen's petition filed with respect to Norellis' Valcoco product. Great. Thanks, guys.
There was actually a citizens petition filed.
With respect to.
The relevance is down Togo product.
Raghuram Selvaraju: Thank you. Once again, ladies and gentlemen, if you wish to ask a question at this time, please press star then 1 on your touchtone telephone. Our next question comes from Raghuram Selvaraju with HC Wainwright. Your line is open. Hi, gentlemen.
Okay, great. Thanks, guys.
Thank you once again, ladies gentlemen, if you wish to ask a question at this time. Please press Star then one are you touched on telephone.
Our next question comes from lumps of RG with HC Wainwright. Your line is open.
Hi, gentlemen, thanks, very much for taking my questions.
Keith Kendall: Thanks very much for taking my questions. So, I just wanted to go back to the inventory management on LiberVent versus Symposan and ask if you could just give us any additional granularity and comparison between what you expect to occur with LiberVent versus what you have been seeing historically with Symposan. Is there likely to be any inventory management issues in common between those two products? And if not, why not?
So I just wanted to go back to the inventory management on liver event versus the prison and ask if you could just give us any additional granularity and.
Paris and between what you expect to occur with labor that versus what you have been seen historically with simpler than is they're likely to be any inventory management.
Issues in common between those two products.
Knock wise.
Keith Kendall: I think that remains to be seen. I think the dynamics of the two markets are very different. And, you know, 10 or 11 months out from that, I'm not sure we have done all the updating on LibraVant because it hasn't been filed. Well, the submission hasn't been completed yet.
I think that remains to be seen I think the dynamics of the two markets are very different and.
You know kind of 11 months out from that I'm not sure we have done all the updating on liver van.
Because it hasn't been filed.
Submission hasn't been completed yet I think liver van.
Keith Kendall: I think LibraVant is a very, very different market than Symposan. Symposan is highly fractured and genericized. There are multiple product alternatives in a number of different forms, and all of the mechanisms within the market like that are at play, including inventory management. LibraVant, there is no alternative. There's certainly no generic. There's certainly not going to be any generics when LibraVant comes to that market, and you have less than 8% of the patient population accessing the standard of care for a variety of reasons. So, you know, the exact dynamics of inventory management remain to be seen. But the uptake curve, regardless of how inventory is managed, we think is going to be a lot more favorable in that open market than it was and is right now for Symposan.
Is a very very different market, then SIMPAS and symposium is highly fractured and genericized, there's multiple product alternatives in a number of different forms.
And all of them mechanisms within the market.
Like that are at play, including inventory management liver fat. There is no alternative there's certainly no generic there's certainly not going to be any generics when lipper van comes to that market and you have less than 8% did a patient population accessing the standard of care for a variety of read.
So we.
Zack dynamics of inventory management remains to be seen but the uptake curves regardless of how inventories managed.
We think is going to be a lot more favorable in that open market than it was and is right now for symposium.
Keith Kendall: Okay, great. And then with respect to what you anticipate the user experience to be for LibriVent, is there anything that has emerged in your market research and your clinical assessment with this product that would lead you to believe that there might be any kind of..., near-term challenges to uptake upon approval based solely on patients getting more familiar with the product, and physicians becoming more familiar with the product, particularly from a usage and administration standpoint?
Okay, Great and then with respect to what do you anticipate the user experience to be more liberal grant.
Is there anything that has emerged youre market research.
Your clinical assessment with this product that would lead you to believes that there might be any kind of.
Near term challenges to uptake upon approval based solely on patients getting more familiar with the product position is becoming more familiar with the product, particularly from.
You said Thats ministration standpoint.
Kenneth W. Marshall: I'll let Ken add color to this, but absolutely not. All of our polling indicates that the form is vastly preferred over what the potential alternatives might be in the market. Every one of our studies indicates that the product performs better on all the key dimensions for patients and caregivers than the current alternative and any prospective alternative. So, we're very, very pleased with the outlook for this product and very pleased with the market it's going into. An underperforming standard of care with no real alternatives and no generic prospects
I'll, let Ken add color to this but absolutely not the all of our polling indicates that the form is vastly preferred over what the potential alternatives might be in the market every one of our studies indicate that the product performs better on all the key dimensions for patients.
And caregivers then the current alternative and any prospective alternative so we're very very pleased with.
The outlook for this product and very pleased with the market is going into a underperforming standard of care with no real alternatives and no generic prospects.
Kenneth W. Marshall: Yeah, and Ram, I would add a couple of places to look, and you can look at the tryptan market in order of entry and where orals ultimately shook out versus nasal injection. You can look at the allergy markets when oral decongestants or antihistamines compete with inhalation products. The orals always shake out as the preferred route of delivery.
Yeah, and ROM I would add a couple of places to look and you can look at the Triptan market in order of entry and where orals ultimately shook out versus nasal nasal and injection.
You can look at the allergy markets when oral decongestants or into his means compete with.
Insulation products and the Orals always shake out as the preferred route of delivery. We've spent some time validating that in our market. We've asked if we asked.
Kenneth W. Marshall: We've spent some time validating that in our market. We asked 60 caregivers about their preference and how they would like to administer medicines. And as Keith, I think Keith or John, one of the two referenced an 83 percent preference for an orally administered medicine. And when you scratch that a little bit to try to understand why.
60.
Our diverse.
Our preference and how they would like to administer medicines and as Keith I think keeper John one of the two referenced.
An 83% preference for an orally administered Madison and when you scratch that a little bit to try to understand why.
Kenneth W. Marshall: You come back with a lot of very interesting attributes that I think Labor Vant will be uniquely positioned to take advantage of. The first is portability. A medicine is absolutely useless if it's not where you need it, when you need it. And if you look at the various products that are in the market or coming to market, I think you would characterize all of them as not very portable.
You come back with a lot of very interesting attributes that that I think labor vanda is uniquely well be uniquely positioned to take advantage of.
The first is portability.
Medicine is absolutely useless, if it's not where you need it when you need it and if you look at the various products that are in the market or coming to market. I think you would characterize all of them as not very portable.
Kenneth W. Marshall: It's immediacy, it's how quickly you can get the drug from the package to the patient. And you've seen our strip, you saw one when we demoed it with you. I mean, it's a simple fold, tear, and stick, and you've got the drug going into the patient. You're not going to do that with drug devices or products. I think it's painfully obvious when you look at the rectal and the nasals don't seem to simplify that or improve it very much. So there are attributes like that that are going to separate out an orally delivered molecule from a rectally or nasally delivered molecule, and I think that will drive our utilization.
Hi, its immediacy, it's how quickly you can get it from the package to the patients and I think you've seen our strip you saw one when we when we demoed. It with you I mean, it's as simple fold, Terence Vic and you've got drug going into the patient you're not going to do that would drug device.
Products I think its painfully obvious when you look at the rectal and the nasals don't seem to simplify that.
Or improve that very much I said there are attributes like that that are going to separate out an oral orally delivered molecule from a rectilinear nasally delivered molecule and I think that'll that'll drive our utilization.
Great and tested and just on three or five can you comment on whether you expect the potential approval of Mike apps next year to provide advantages or disadvantages for this program firstly, it probably would establish clear record.
Daniel Barber: Great, fantastic. And just on 305, can you comment on whether you expect the potential approval of MICAPSA next year to provide advantages or disadvantages for this program? Firstly, it probably would establish a clear reference framework for regulatory authorization of products in that class, but obviously, it is potentially a competitor as well. Good morning, Ron. This is Dan.
Since framework for regulatory authorization of products in that class, but obviously it is.
Credit as well so is it just give some clarity on that.
Yes, good morning, Ron This is Dan.
Daniel Barber: From our perspective, it would be helpful. It would be the first oral product in this space, and we think there's plenty of need and plenty of room for continued improvement over the years. I don't think that takes away, though, from our focus right now on liver vent and getting liver vent into the market and making sure that we do all the things we need to do to be successful on that front. Okay, and then last question on the Sunovion product. Obviously, we've seen a lot of recent activity by Dynapon Suvitomo, particularly focused on the U.S. market, that has nothing to do with this product. And just wanted to know if you're seeing, on the corporate level from their side, any evidence whatsoever that they are not as committed to this product as they were in the past.
Yes from our perspective, it would be helpful. It would be the first oral product in this space and we think theres plenty of need and plenty of room for.
Continued improvement over the years I don't think that takes away, though from our focus right now and live event in getting liberman to the market.
And and making sure that we do all the things we need to do to be successful on that front.
Okay, and then last question on.
The Sylvia and product.
Obviously, we've seen a lot of.
Recent activity by Dynacon Sumitomo.
Particularly focused on the U.S. market that has nothing to do with this product and just wanted to know if you're seeing on corporate level from their side.
Evidence whatsoever, they are not as committed to this product as they were in the past.
Absolutely not.
Keith Kendall: Absolutely not.
Great. Thank you very much.
Raghuram Selvaraju: Great, thank you very much.
Keith Kendall: Okay.
Okay.
Keith Kendall: Thank you, and I'm currently showing no further questions at this time. I'd like to turn the call back over to Keith Kendall for closing remarks.
Thank you and I'm currently showing no further questions at this time I turn the call back over to keep Kendall for closing remarks.
Keith Kendall: Well, as usual, thank you everyone for taking the time out of your busy day to spend with us. We hope this update was useful to you and we look forward to keeping you updated on all of the events we discussed today as we move into 2020. Have a great day, and we'll talk to you all soon.
Well.
As usual. Thank you everyone for taking the time add of you're busy day for us to spend with US. We hope. This update was useful to you and we look forward to keeping you updated on all of the events. We discussed today as we move into 2020.
Great Day, and we'll talk to you also.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating.