Q3 2022 Virios Therapeutics Inc Earnings Call
Good morning, ladies and gentlemen, and thank you for your patience. This mornings conference call will begin soon please remain connected at this time and once again. Thank you for your patience.
Warnings conference call will begin shortly.
[music].
Okay.
[music].
Yes.
[music].
Okay.
[music].
Good day and welcome to the <unk> Therapeutics, Inc. Q3 earnings update at this time, all participants have been placed on a listen only mode.
The floor will be open for questions and comments after the company presentation.
It is now my pleasure to turn the proceedings over to Angela Walsh.
S VP finance and treasurer.
<unk> Therapeutics, Inc. Angela the floor is yours.
Thank you good morning, everyone and thank you for joining us on today's conference call. We are pleased to be with you today to discuss various therapeutics third quarter financial results.
As well as to provide a summary of our ongoing analysis of the results from our recently completed phase <unk> Fibromyalgia trial also known as the fortress study.
Please note that our financial results press release is now available on our website.
We'll start today's call with our CEO , Greg Duncan, providing you with a brief update on our corporate progress during the past quarter.
Then he will turn the call over to our Chief Medical Officer, Dr. Mike General, who will provide an update on our fortress study analysis.
And then I will return to review our third quarter financial results. In addition, Ralph Boswell, our senior Vice President of operations is with US for the question and answer portion of the call.
Before we begin I'd like to remind everyone that statements made during this conference call will include forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially from the.
Formation expressed or implied by the score that can statements.
For more information regarding such risks and uncertainties. Please see the risk factors outlined in the company's filings with the SEC.
Any forward looking statements are made only as of today and we disclaim any obligation to update these forward looking statements other than as required by law.
Please see the forward looking statement section in our financial results press release issued this morning for more information.
It is now my pleasure to turn the call over to our CEO Greg Duncan.
Thank you Angela and good morning to all of you joining us on today's quarter three earnings update.
Our goals for today's discussion are threefold.
<unk>.
Following our announcement of the top line results in mid September we will provide you with a summary of what we have learned so far from our detailed examination the fortress phase two b fibromyalgia study data.
Second we will outline our proposed claim.
Projected IFC one development milestones.
This year and into 2023.
And finally, we will provide a summary of our quarter three financials before opening up the call to receive participants questions.
On September 19th we reported that the fortress study demonstrated that <unk>, one was safe and.
And very well tolerated, but did not achieve statistical significance on the pre specified primary endpoint of pain reduction.
The results were confounded, particularly when viewed in the context of both mechanistic data highlighting the role of active replicating herpes infection in patients diagnosed with fibromyalgia as well as the result of our previously successful phase II fibromyalgia trial.
Recall this prior phase Iia trial clearly demonstrated.
<unk> potential as a novel approach to treat the pain fatigue and other symptoms associated with fibromyalgia diagnosis.
In mid September we discussed our preliminary top line analysis of.
The data suggested an unusual bifurcation of response based on the timing of patient enrollment in the <unk> trial.
By way of background enrollment of the first 50% of patients.
Place from June 2021 to early November 2021 for.
For context. This was one that delta variant of COVID-19 was the dominant strain here in the U S.
Pullbacks in Asian rates were far below the levels, we enjoyed today.
Probably most importantly, extensive quarantining was still in place in most geographies.
The patients enrolled and treated with IMC one in the first half of the study did not demonstrate a statistically significant reduction in pain, when compared with patients treated with placebo.
The same time period.
Conversely during the second half of the trial, which took place in November 2021 to April of this year, we enrolled the second 50% of patients into the <unk> study.
This was the time period with vaccination rates had substantially improved the less severe <unk> Barrett of COVID-19 became the dominant strain.
And quarantining restrictions were lessening or fully removed across many geographies here in the U S essentially where we're getting back to a more normal day to day lifestyle.
In Stark contrast to the first half study enrollees.
<unk> treated patients enrolled during the second half of the trial, which totaled 214 patients demonstrated a statistically significant improvement on the primary pain reduction endpoint at week 14.
As well as statistically significant improvements in fatigue and fibromyalgia symptoms.
The various management team believes that the likelihood of such a substantial differential response.
Based on the timing of patient enrollment.
Highly unlikely to be a random occurrence.
Tired of these stated we as a team believe the positive outcomes demonstrated in the patients recruited during the second half.
The fortress study our.
A sample of patients that is roughly one half the size. We believe was required to demonstrate statistically significant pain reduction over the full trial required deeper exploration.
Various management team has spent the past few weeks deeply analyzing the fortress data to better understand the factors driving the topline results.
This understanding will help the team design and AMC, one development program that targets the patients who are most likely to respond to IMC one treatment.
The team has identified several factors that had both positive and negative impacts on our final study results we.
We have vetted. These findings with multiple highly recognized fibromyalgia research thought leaders, who corroborated our view that the fortress study results were unlikely due to chance and that the positive results. We observed in the fortress trials do support the potential of IMC one.
These experts supported our proposed plan to continue the development of IFC, one as a treatment for patients diagnosed with fibromyalgia.
We will shortly be requesting a live meeting with FDA with the goal of progressing RMC one development phase III next year.
It is now my distinct pleasure to turn the discussion over to our Chief Medical Officer. Dr are Michael Jendro to share, but we have learned that underpins. Our continued belief that IFC one can improve the treatment of fibromyalgia, Mike will also share our thoughts on the broad parameters of the plan we will propose.
As to FDA to advance the development of IFC, one moving forward.
Take it away Mike.
Thank you, Greg and good morning.
Greg referenced the <unk> research team has spent the past several weeks analyzing the fortress data in detail to better understand the factors and patient demographics that led to responses that were not consistent with our prior research or with the design goals of this study, particularly with respect to the rate of placebo improvement in the trial.
However, as Greg mentioned the responses of patients enrolled in the second half of the trial from November to April 2022 were consistent with the expected efficacy profile for IMC one.
And at all time points, the safety and Tolerability of IMC, one was outstanding.
In your original post hoc first half second half analysis that Greg mentioned the subgroup of patients recruited from November to April demonstrated statistically and clinically significant improvements with half the original planned sample size R.
Our efforts over the last few weeks have been directed at achieving a better understanding of the factors that led to this different response overtime as well as identifying populations and characteristics that were more responsive overall to IFC one treatment I am now pleased to share with you a summary of what the research team has learned to date.
As you might imagine a full understanding of the factors impacting the fortress results tend to be conducted in a careful manner considering the impact of enrollment timing that we shared back in September .
Many demographic variables and subpopulations, where analyzed to understand why the fortress results differed from our original design goal. So far we have learned the following first observation is that post hoc analysis of the <unk> trial results indicate that <unk>, who were new or naive to clinical research studies, which.
We will call new patients demonstrated a clinically and statistically significant reductions in pain fatigue drive around your symptoms.
<unk> in depression symptoms improvement in this population were statistically significant for the entire study timeframe. So results in this population were far less impacted by the enrollment timing as compared to other subpopulations.
In contrast.
Enrolled patients who were prior fiber merger trial participants <unk> study site database patients, who we will call experienced patients now appear to represent a more treatment refractory or treatment resistant cohort of patients and they did not exhibit a meaningful treatment benefit in this study and either timeframe.
Historically, we've used a combination of dedicated research sites as well as sites at both recruit patients for clinical trials and provide general medical care for patients in their communities. Our data indicates that the dedicated to clinical research sites that were less likely to experience staff turnover and the pandemic delivered more consistent results.
<unk> better placebo response management as compared to the clinical practice sites. Our plan moving forward will be to execute future IMC one trials with a focus on dedicated research sites.
While we were pleased to be able to successfully recruit the fortress study in the midst of the extraordinary circumstances associated with the pandemic. It remains clear that this environment had unintended impacts on our overall fortress trial results, while we can't guarantee that future research will be conducted in a COVID-19 free environment, we're confident.
And AMC once potential when targeting new patients, who we believe represent our optimal patient target moving forward given that they demonstrated lower placebo response rates.
And the expected drug response rates irrespective of which half of the study they were recruited in.
On a related note we may now be reaching a saturation point in the United States fiber module research patient community whereby experienced trial subjects and is presently being treated for fiber module may be characterized as becoming more refractory to treatment. This trend has been observed in several other research categories such as depressed.
We're more time and energy must be expanded to recruit newer more treatment naive patients for trials. We expect this to be our plan moving forward with IFC when development.
It is important to remember that as was the case in our successful phase Iia study.
<unk> was very well tolerated by all study subjects as evidenced by a discontinuation rate due to adverse events that was lower than placebo.
This is a feature of IMC one that we believe supports progression to phase III development and if successful could be a highly differentiated feature of IFC when treatment versus other available therapies.
In summary, while there are factors impacting our trial that we will likely never fully understand such.
Such as the impact of Covid dynamics on our results over time. There are many factors. We can conclude had a material impact on the fortress results importantly, we believe with this understanding we can design future trials. They will help us better manage many of these factors we.
We will shortly be requesting a guidance meeting with FDA to review our results and present, our plans for advancing IMC one into full phase III development given the observed excellent safety profile obtained in fortress, we plan to propose a comprehensive phase III development program to FDA at that meeting.
We understand that FDA is not granting any further life meeting this year, hence we are likely to receive our FDA feedback sometime in the first half of 2023.
I would be happy to answer any further questions about our data analysis and our plans moving forward during the Q&A session. Let me welcome back our senior Vice President of Finance and Treasurer, agile Walsh to discuss our quarter three financials Angela.
Thank you Mike as discussed during our second quarter earnings update at that time, the company had cash to get through 2022.
In this context and based on the aforementioned bifurcation of response data.
The decision to raise additional capital following the reporting of our fortress topline results in September .
This additional capital provides the company with approximately 12 months of new operational runway and is allow the engagement of external consultancy resources required to review the fortress data and greater depth. The capital also provides us time to discuss both the forecast data and our proposed.
Forthcoming IMC, one development plans with the FDA, we project those discussions will most likely occur in 2023, albeit timing will be dependent upon the fda's current workload, especially related to request for life meetings, which we plan to do.
As of September 30th 2022, we had $9 $8 million in cash as compared to $14 million as of December 31, 2021.
We expect our current cash to be sufficient to fund the company's operations through the end of 2023, but note that any future IMC, one development, including phase three studies will require additional capital.
With respect to our income statement as a development stage Biotechnology company, we did not generate revenue during the three months ended September 32022 are during the three months ended September 32021.
We reported research and development expenses of one $6 million for the third quarter ended September 32022, as compared to $3 million for the year ago quarter.
The decrease in research and development expenses quarter over quarter was primarily due to a decrease in clinical trial expenses.
Our forecast steady at $9 million a decrease in expenses related to our chronic toxicology program of $4 million and a decrease in drug development and manufacturing costs of $1 million.
We reported general and administrative expenses of $9 million for the third quarter of 2022.
Compared to $1 $1 million for the year ago quarter.
Decrease quarter over quarter was primary related to a decrease in salaries and related costs.
And finally, we reported a net loss of $2 $6 million for the third quarter of 2022.
Compared to a net loss of $4 $1 million for the year ago quarter.
Lower net loss was primarily due to the lower research and development cost I just mentioned.
Let me turn the discussion back to Greg jump into wrap up and moderate the question and answer portion of the call Greg.
Thanks, once again Angela the extensive data analysis of the fortress study conducted by Mike and our research team has uncovered several key insights into which patients are most likely to respond to IFC one.
Irrespective of external factors, including Covid related dynamics.
This includes recruiting patients new to fibromyalgia research with additional emphasis on screening out fibromyalgia patients with a recent history of treatment failure or patients who have previously participated in fibromyalgia clinical trials.
This proposed approach.
Supported by data gleaned from the analysis of the fortress study.
We believe these insights will enable us to design a phase III program to be discussed with FDA over the coming months.
We hope to reach alignment with FDA in the first half of 2023 subject to FDA availability provider engagement.
And to commence the next phase of our IFC One research program in the second half of 2023.
As Angelo referenced in her remarks, we have capital to support operations and to the end of 2023.
But future research will require additional capital <unk> partnership support.
In addition to engaging with the FDA. We will also commence discussions with both current and new investors and perspective partners to determine the optimal path forward for funding and executing IMC one development.
Our ultimate goal remains the same getting IFC went to market to enhance the standard of care for hundreds of millions of fibromyalgia patients.
At least satisfied with current treatment options.
Operator, we are now ready for questions.
Thank you ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone at this time.
We ask that we're posing your question you. Please pickup your handset positioning on speaker phone to provide optimum sound quality. Please.
Please hold while we pull for questions.
Thank you.
Our first question is coming from Sean Lee with H C. Wainwright, Sir Please go ahead.
Good morning, guys and thanks for taking my questions.
I would like to get someone to understand better the rationale behind.
Analysis could you explain what.
Based on the mechanism mulatto good drug why is it that some of the.
New patients would have a better response rate than the experienced fibromyalgia patients.
Hey, Sean This is Greg Duncan, let me take that one.
As you know our whole ethos of the program.
As a fundamentally new approach to treating patients with fibromyalgia, if I'm trying to get to a potential root cause.
And that is in fact, why we recruited both treatment naive patients into the program as well as those that had been participating in other trials because of the novelty of this mechanism.
And as Mike mentioned in his earlier comments, we may be hitting a point where that second group. Those experienced trial participants may represent a more refractory patient population where may be hitting that tipping point and that was actually validated by the three key opinion leaders, we spoke to as well.
Review of the data that we're discussing today.
We don't have a clear reason as to why some patients may not have responded.
In that refractory group.
It may represent just a more refractory treatment population, which is what we've seen in depression or other areas.
There is a potential that the active replicating virus was not as consistent in that group as we saw on the newer nave patients, but that's just a guess.
We really don't have a clear view as to why that would've happened other than the fact that most of those prior trial participants were representing a group of patients that in the majority had been previously treated <unk> experienced other new therapies and not responded which is why they were candidates for our trial. So I suspect it's just a general overall.
All the refractory nature of the patients.
I see thanks for that.
In terms of the classification of patients.
Whether these newer <unk> classification had been using any other clinical studies with <unk> or whether that's a.
Spending classification for patients in this study.
So the way we defined the new patients were patients who were recruited through advertising. These were patients that had not identified as critical participants clinical trial participants.
Nor are they patients that were on physicians lists and why I referenced that second group is because.
While a patient may not have recently participated in the trial by definition, particularly in the.
Purely research centers that we used those patients will likely we're in a trial sometime in the.
In the distant past.
So the goal going forward will be to make sure that we do not use that kind of tried and true recruiting mechanism. The way you run. These trials as you go out and you say, okay, let's get all the patients. So off your list that you have been in prior clinical trials you exhaust that patient pool, then you move to the newer patient sites newer.
<unk> patients excuse me.
We know in this particular analysis, we're not prior clinical trial participants they may have been previously treated.
But they were not previously in clinical trials.
These patients are a little bit harder to find but it is relatively manageable. When you did this in depression back in the day.
Can use.
Differential screening requirements here in the U S or that you recruit only those new patients we.
You can also consider going to other geographies, which we think actually makes sense anyway as we.
Consider moving to phase III, because thats really starting to saturate other markets get them some experience with IMC one through clinical research is a precursor to launch so we do think it's manageable.
Through better screening and we think it's the wise way to go here based exactly on the data we just shared with you today.
Okay.
<unk>.
My last question is on potential.
These study so in terms of.
Hi.
And you mentioned open around the geographies what can we expect.
Well would you be proposing to the FDA.
So we're in the process of finalizing that recommendation, but are <unk>.
General approach will include the following.
Again subject to FDA feedback.
Likely do one multi factorial trial, which is an FDA regulations, so thats IMC one placebo.
It probably will include two arms, one celebrex <unk> independent components.
We can certainly argue there's probably no reason to test FEMSA could hear but FDA may have a different view on that so think of that as probably a three or four arm study.
We will make the case that we should do one head to head again, the second head to head of IMC one on placebo.
That may.
That may be a two arm trial FDA may come back and say, we would like you to do to multi factorial trials and then the third key component of the program that we would be proposing would be an open label extension to glean. The safety data that are required as part of the overall package to support.
And eventual NDA, if we continue to be successful.
So it's probably three studies.
Hopefully one multi multifactorial one head to head with the caveat that it may be too multifactorial, depending on FDA feedback and an open label extension. So three particular trials, then there'll probably be some other kind of classic trials, a food effect et cetera that are standard part of the phase III.
Thanks for the additional color that's all the questions I have and thanks again for taking my questions.
Thank you for participating Shawn I appreciate the questions.
Okay.
Once again, if there are any remaining questions or comments. Please press star one on your phone at this time.
Our next question is coming from David boats with Zacks. Please go ahead.
Actually excuse me, it's Richard Hanky, calling for David Hi, Greg Hey, Angela how are you.
Hey, Richard Good morning, Hey, Good morning, Yeah, David I'm sure is going to follow up shortly he just couldn't be on call. This morning. So you gave me a few questions to ask you guys I think you've been very clear about what happened with IMC one in.
Support this trial and things like that so I'm sure if I want to dive in and.
Dig a little bit deeper, but I think it's encouraging youre going to youre going to take it and youre going to take it into phase III with the new FM patients. So that's great.
Maybe.
And I'm sure you've given the timeline I'm sure you can't give you any more than that so as I understand it it's going to be shortly.
Getting with the FTA hopefully alive meeting the first half of next year and then hopefully approval first half of next year and then moving into phase III second half of next year. If I understood you correctly and then in the interim there's going to be additional funding required. So my question is simply what are the factors that would accelerate that will process what are the.
Factors that would delay it.
And.
Can you give a range on the kind of funding required.
Okay. Thank you Richard there is a lot in there so let me try to address that.
Number one our goal would be to go to phase III Thats, obviously subject to FDA feedback so.
I think it's important to mention that as our goal we can't guarantee that but we think.
The totality of the data the safety data the efficacy data in this in this population.
Our support progression to phase III. The timeline. We gave you is our best guess at this point. It is our understanding based on our interaction with our regulatory consultants that FDA live meetings requests.
Not being scheduled for the balance of this year. They are now targeting last.
Intelligence sometime in the middle of quarter, one to the end of quarter. One so that is our best guess at this point.
Our goal would be to have that meeting. The FDA, then has 30 days or formal feedback.
And our goal would be to clean that feedback and obviously report that out to the external community here as an entity.
The best guess, we can give you right now is if we're successful in those discussions, which we hope to be there.
We could commence recruitment in that program sometime in the second half of 2023.
Probably needless to say, but for completeness, we have good relationships with the research sites, we will continue to nurture those relationships. So that we're ready to go.
Subject to funding financing et cetera, and on FDA feedback. So that's one of the benefits of the team having some.
Such experience in this space is that we have very good relationships, Mike Graff et cetera, with the sites to.
To start as soon as possible.
The best guess on.
Capital required at this point would be a general gas youre, probably talking in the range of $65 million to $70 million for the phase III program in totality plus operations.
If we are successful in finding a partner that may be a lesser amount.
But at this point I think it's probably a little bit early to get too refined and an estimate as to what phase III would cost because it's.
It is subject to FDA feedback.
Got it okay. Thank you for that just a couple of questions I want to swing over to IMS, David wanted to swing over to IMC too we haven't talked about that have you ever considered.
Testing IMC and ethane.
And thats been considered.
So we think the data really do support IMC, one progressing to phase III IMC to as you May know so let me back up just for completeness IFC. One is a combination of FEMSA glitter and Celecoxib <unk>.
<unk> is now sick leave and Celecoxib, we selected IMC to the combination of our cyclic and Celecoxib for the loan <unk> trial.
For one reason and one reason only it's a little bit more selective based on our.
Perusal of the data on Epstein Barr, which we think is the bad actor the activation of secondary herpes viruses, including Epstein Barr, which is the bad actor leading to the fatigue brain fog et cetera, thats associated with <unk> and Thats. The test that's the valve <unk> plus celecoxib in that trial, which we hope to finish recruitment up.
By the end of this year and report out results sometime in the first half of next year. That's the program that supported through our investigational grant to the abatement harm center, who is conducting the trials. So we can't guarantee the timelines, but we do talk to them frequently and think that is the rough timeline here for the for the long Cobot program.
Famciclovir.
As very good activity against the number of herpes viruses, we have great formulation, we know how to manufacture it.
Relatively efficiently and so the goal would be to move IFC one forward for fibromyalgia, and we will explore what to do with <unk>.
IMC to pending the results of the loan corporate program.
Okay and just so unclear David had mentioned is in Ibs program that was put on the backburner or is that.
Is that something else is that what you're referring to because we're focused on local but with IMTT.
So.
We do believe this mechanism has utility across a number of different potential somatic syndrome disorders.
I Wonder vector William Pridgen was <unk>.
Gastric surgeon heat treat patients.
<unk> surgery, but also treat patients for things like functional.
GI disorders like Ibs and his original utilization of this combination.
Was in an Ibs population.
Fantastic results open label, but saw really good results.
<unk> connected with.
Virologist at the University of Alabama.
And they actually executed a very novel program, where they biopsied tick.
Tissue of patients, who had a diagnosis of fibromyalgia patients who had a diagnosis of functional Gi disorders.
And compared them to control patients. These are patients that were there for a follow up maybe for a prior Gi bleed or some other form of <unk>.
Follow up care, who were what I would describe as a control patient.
Will and he demonstrated with Dr. Carole Duffy very clearly the patients with fibromyalgia has active replicating.
Herpes infection in their gut tissue and so we believe that corroborates the activity of activated.
Herpes virus and fibromyalgia patients what was also presented as part of those data as there is a third portion of the study which were patients who had purely functional Gi disorders no fibromyalgia.
Just functional Gi disorders, including Ibs is probably the dominant category there.
Also noted active replicating infection in those patients and they have got tissue at a highly statistically significant level. The trial was so important that it was actually presented by Dr. Duffy.
Digestive disease week meeting.
Last year, sorry, this year I believe.
And those data were a late breaker analysis. The poster presentation was a late breaker. So there is certainly interest in the community and the connection between herpes virus activation.
Yes that is a program that we think we can execute as a complement to fibromyalgia, but the fibromyalgia program is priority one loan Covid right now is priority two and presuming success over time, we do think there is a potential to expand our research pipeline into Ibs.
A third potential priority, that's obviously subject to further funding community support FDA feedback et cetera.
Good news is if we did an Ibs program. We now have extensive safety data on IFC one.
As you know Mike mentioned earlier.
The Tolerability and safety of IMC, one is very good and so that safety data would be an important part of the dialogue with the FDA moving forward. If we decided to pursue that particular particular line of research with those safety data in hand.
That is our third priority right now, but we do think it is an exciting priority based on Dr. <unk> experience and the GI biopsy study.
Excellent excellent well, thank you for that Greg and.
As I mentioned I'm sure David will be in contact shortly to follow up on things like that so.
Good luck.
Can you guys move into phase III.
Patients on <unk>, one so that's great we'll be looking forward to 2020.
Alright, Thank you for your time.
Yes. Thank you Richard our goal is certainly to take AMC wanted to phase III.
We do believe in summary that the fortress data reveal that fibromyalgia patients that are new to research.
Arent excellent target for progression of IMC, one development ideally to phase III based on the demonstration of significant IMC, one benefits, including reduction in pain reduction and fatigue improvement in overall fibromyalgia patients symptoms and an improvement in overall patients global health.
We may be reaching that saturation point, where those patients that were in prior clinical trials are representing a much more refractory population. So it will take a little bit more time and attention, but it is certainly actionable.
And doable.
Those patients moving forward for IFC. Once continued development, we do beliefs very clearly that the safety data continue to impress this is the second consecutive trial.
<unk> had a lower dropout rate due to adverse events as compared with placebo.
And as you probably recall if you've heard the story before that the primary reason for dissatisfaction in the fibromyalgia patient community and amongst those doctors that treat those patients is the poor tolerability of the existing three approved medications. They are all good medications they reduce pain. The tolerability is the issue that leads to less than <unk>.
Ideal compliance.
And as I mentioned during Richard's question.
We can't get FDA will endorse going to phase III, we really do believe the totality of the data specifically the safety data support biopsy once progression to phase III and as I mentioned.
Earlier, and Mike mentioned as well, we will shortly be requesting FDA feedback to advance that progression to phase III.
Standalone Covid program continues to recruit we hope to conclude dosing by the end of this year with results in the first half of 2023.
Angela Ralph Mike myself, the whole team is committed to frequent and accurate communication moving forward as regards to operational progress full.
Full enrollment along cobot program will likely be our next key milestone and then our goal following the meeting with FDA is to immediately communicate to you all the external community. What the next steps are for IFC once development Fibromyalgia and we'll report back that at that time. Thank you for your time and attention on todays call.
This concludes our quarter.
Three earnings update thank you.
Okay.
Thank you ladies and gentlemen, this does conclude today's call you may disconnect. Your lines at this time and have a wonderful day and we thank you for your participation.