Q2 2023 DURECT Corporation Earnings Call
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Greetings and welcome to the Dara Corporation second quarter earnings Conference call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone.
Pat as a reminder, this conference is being recorded it is now my pleasure to introduce your host Tim Popp Chief Financial Officer. Thank you. Sir you may begin good.
Good afternoon, and welcome to the direct Corporation's second quarter 2023 earnings Conference call.
This is Kim Papp, Chief financial officer of Durect.
Before we begin I would like to remind you of our safe Harbor statement. During the course of this call. We may make forward looking statements regarding the development of luxury goods sterile expected product benefits market potential clinical trial results and regulatory approval and the Companys financial projections piece.
These forward looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements, including the risks that Lars because Daryl does not meet the endpoint in the trial.
Further information regarding these and other risks can be found in our SEC filings, including our 10-K and 10-Qs under the heading risk factors.
To begin I would like to review, our second quarter 2023 financial results.
Our total revenue in the second quarter were $2 1 million similar to the prior year.
R&D expenses were $7 9 million compared with $8 8 million for the prior year. The decrease was primarily due to lower employee related costs and contract research expenses, partially offset by higher costs associated with the affirmed trial and higher contract manufacturing costs.
SG&A expenses were $3 8 million compared with 4 million for the prior year.
This decrease was primarily due to lower patent expenses and recruiting costs.
As of June 32023, we had cash and investments of $34 $9 million as opposed to $43 6 million at December 31 2022.
Subsequent to the end of the quarter in July 2023, we completed a registered direct offering raising $13 8 million in net proceeds.
Our cash burn in the second quarter was approximately $10 $1 million, excluding proceeds from sales under our ATM program and we believe our cash on hand is sufficient to fund operations through mid 2024.
Now I would like to turn the call over to our CEO , Jim Brown for an update on our programs.
Thank you Tim Hello, everyone. Thank you for joining us today for our second quarter 2023 update.
We had a productive second quarter during which we achieved a significant milestone on our journey toward completing the affirm phase two b clinical trial, but like CECO sterile and alcohol associated hepatitis.
In June we announced that we had completed enrollment for our firm.
And we continue to be on track to report topline data in the fourth quarter of this year.
We are eagerly anticipating this event, which we believe has the potential to be transformative for direct and our shareholders.
Our primary focus as a company remain gaining approval for less shoe called sterile and a H and bringing these potentially life saving therapeutics to patients with no effective treatment options today.
Assuming a positive outcome from the time, we plan to review the results with the FDA in the first quarter of 2024.
If approved lifecycle sterile would be the first FDA approved treatment for a H and we look forward to the possibility of bringing this potentially life saving therapeutics to patients with no effective therapies available today.
Furthermore, during the second quarter, the American Journal of Gastroenterology published clinical data from our Phase Iia trial in a H and we held in a H focused K O all of it.
Lastly, we're excited to announce the expansion of our epigenetic modulator platform into the field of oncology.
By leveraging our expertise in epigenetic modulation, we have internally developed multiple new chemical entity that we think have attractive properties for the potential treatment of both solid and liquid tumor types.
I'll come back to our new oncology program in a few minutes.
But first I'd like to provide a quick refresher on our a H program as we get closer to the upcoming data readout.
As I mentioned, we completed enrollment in our first trial in June of this year.
We follow these patients for 90 days so our last patient last visit will be in early September which puts us on track to report topline data in the fourth quarter.
As a reminder, our firm is a placebo controlled double blind multinational study with two active dosing arms and a placebo arm of approximately 100 patients each.
In total we randomized and dose 301 patients the severe a H.
Patients with meld scores ranging from 21 to 30, and my Dream discriminant function score is greater than or equal to 32.
The primary endpoint for our firm is the difference in mortality or liver transplant at 90 days between marsico sterile treatment and placebo.
We enrolled patients in a firm to a global network of clinical sites, including many hospitals in the United States, Australia, the EU and the U K.
Our site include we know liver centers and we are working with some of the world's preeminent thought leaders in age.
The FDA has granted our last few calls sterile a H program fast track designation.
We are hopeful that a positive result, and a firm could support an NDA filing.
With this in mind like Super sterile has the potential to be the first FDA approved treatment for a H, where there is a substantial unmet need for patients.
Our confidence that the FERC trial will be successful is supported by a compelling phase Iia study data, including the recently published comparisons.
The mechanism of action of Brushy cluster I wish ties directly into the biology of a H and our multiple preclinical animal studies, where we observed profound survival benefit in multiple relevant acute organ injury models.
We designed the firm to be a potentially pivotal trial based on our phase Iia data.
In our open label Phase Iia trial, all 19 patients survived at 28 days and encourage you with yourself given that based on historical data approximately 26% of hospitalized H patients are expected to die, but 28 days.
We also observed a consistent improvement in key biochemical markers, including bilirubin level meld score and legal scores across patients and doses.
In the second quarter the data from our Phase Iia trial were published in the American Journal of Gastroenterology. This peer reviewed article includes cross study comparisons, what's well matched severe a H patients from a contemporaneous trial conducted by the defeat alcohol, Seattle hepatitis or Dash consortium.
While the sample sizes are small and these are not part of the control study. These comparisons indicate that severe a H patients treated with either 30 milligrams or 90 milligrams at Chico's Jerrell had statistically significant lower legal scores compared to patients treated with the standard of care, including steroids.
Lille scores as a reminder, our a predictor of mortality in liver disease.
In addition, liver enzymes levels decreased rapidly in the last few calls gel treated patients, including a statistically significant reduction in the liver enzyme a L T.
We believe these results provide further evidence of the potential for the CECO sterile as a treatment for a H.
In May we hosted a kols for investors to provide physician perspectives on this devastating disease.
We were pleased to be joined by Dr. Powell casually all from Columbia Presbyterian Doctor, Brett Fortunately from Montefiore edge die they.
They were able to draw from their wealth of experience treating a H patriot and share their views on the unmet need in age and the potential role of shoe cluster you all could play to transform the treatment of this highly lethal disease.
Slides and audio from this presentation are available on our website.
During our Kols, we shared additional information on the commercial opportunity for less Yoko sterile and if we obtain approval our approach to building for a successful launch.
In addition to its high mortality rate a H represents a significant cost to the U S health care system with over 150000 hospitalizations attributed to a H at a cost of between 50 to $150000 each.
As a result in addition to the potential saving patients.
Patients' lives by sequels Terra represents a potential multibillion dollar opportunity in the United States alone I could simultaneously provide overall cost savings to the health care system.
We've begun to lay the groundwork for potentially commercializing best shoe called sterile and the United States and believe we can launch the product effectively to a moderately sized hospital focused sales force.
We also continue to build awareness around the role of epigenetic regulation and acute diseases like a H.
That's one of these initiatives, we launched a new disease education website that you can find at www dot explore a H epigenetics dotcom.
Elucidate the role of the Epigenome and H H.
Hey, H, it's also a global concern, allowing us to cluster all the potential to cigarette ex U S. A H patients and their health care system.
These ex U S markets represent additional attractive commercial opportunities.
Because we enrolled patients from our global site network. We believe a positive result from our firm may support regulatory filing.
And the EMA and other regions.
We are also pleased to announce the expansion of our epigenetic modulation platform into the field of oncology.
Our mission at direct it used to be a global leader in the emerging field of epigenetic medicines and this latest development is a significant step towards achieving that goal.
Aberrant DNA methylation has been shown to play an important role in the development of tumors. As a result, we believe D. N F T inhibitors have significant potential as a draw.
Doug class for the treatment of cancer.
Building on our knowledge of epigenetic regulation and our unique understanding of D. N. S. T. We have focused on a novel approach to D. N M T inhibition.
The inhibition of D N M teeth, as a well established and highly desired target in oncology.
Working with teams of experienced chemists and biologists we have created a large complement of internally developed novel small molecule D. N N T inhibitors that exhibit broad spectrum activity against multiple liquid and solid tumor types.
We currently have multiple new chemical entities that are in preclinical development for a variety of oncology applications.
Jeez compounds display unique and desirable physical chemical properties and pharmacokinetic profile as well as favorable tolerability.
By the end of 2023 we intend to select a product candidate to advance into clinical trial in cancer patients.
Our goal for this program is to be prepared to initiate clinical trials by the end of 2024.
In summary, we completed a firm enrollment in the second quarter and are on track to report topline results in the fourth quarter of 2023.
If a firm is successful we intend to review the results with the FDA in the first quarter of 2024.
We are leveraging our knowledge of epigenetic regulation to the field of oncology and look forward to selecting our lead product candidate from our <unk> development program and advancing into the clinic.
We would now like to take any questions you may have.
Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Our first question is from Kristen <unk> with Cantor Fitzgerald. Please proceed with your question.
Hello, everyone. This is Rick on for Christian Thank you for taking our questions.
Maybe first on the oncology program you talked about today is there any color you can give us into the screening process that you've gone through with these D. These library. This library of monarch molecules in terms of you know how how large is the library was and maybe kind of where you're adding your screening process in terms of the magnitude.
Different molecules here.
We we probably won't get back that kind of detail, but just sufficient to say we screened a large number of cancers against a large number of molecules and we have actually from their paired it down into the group that the initial classes, graduating that we're taking forward. So we have a very we're very closely between now and the end of their will select.
The first cancer and first drug that we're taking forward.
Yeah.
Excellent you also mentioned ex U S opportunities for large tucows sterile. So just as you're thinking about kind of ex U S opportunities.
Was there any development kind of thinking about whether you'd be looking at ex U S. Commercial partners or how are you thinking about that process.
But it certainly wouldn't be looking to to commercialize it ourselves ex U S. We think the opportunity is.
I'm a patient number standpoint, I think western Europe , it's probably equivalent to or a bit larger than the U S patient population size and so we think it's an exciting opportunity and these patients are in desperate need as they are here in the United States. So the opportunity is absolutely there and we're looking to put a partnership in place actually and I'll, let Keith who's on the on the line as well.
A little bit more to that.
Yeah, I would just add that given the diversity of the reimbursement and pricing and various other regulatory factors in Europe and other ex U S markets are it's.
It's likely that that we would look for a formidable partnership there. So I agree with Ken's comments, there and they're certainly.
An equal if not potentially larger marketplace outside of just the U S, where we think well actually the sterile could achieve prominence air age is not regional task.
To Jesse West So it certainly is a global issue.
Okay.
Okay, and maybe one more maybe it will swing back to a D. D oncology program just to ask.
You know given the different indications with potential for D. N M. T inhibitors could you talk a little bit about the decision making process that led to undertaken in oncology, specifically and maybe also touch on you know.
Whether there could be different indications for Laura Chico sterile down the road as you've talked about in the past. Thanks.
Yeah, Firstly, just stay with our sequester all because that is the main theme here of direct and so yeah. We are obviously looking at a H, but as are we.
We've talked about in the past, we've got about a dozen different animal models, where we've shown it can protect against smoking, Oregon damage from things as broad ranging as acute pancreatitis sepsis stroke acute kidney injury things like that so there's a lot of opportunity there as well you know as you know we we did they want about city of Nashville, We showed tremendous.
Potential as both a sucrose Carol as far as the oncology program. What we're doing here as you know we often get that question from our shareholders. You know kind of what is next outside of blocks to go sterile and so it's a it's a program that our wage he has been guiding for a number of years now and has finally gotten to the point, where we're ready to bring things into development and that's why you know.
We're talking about at this point in time, certainly D N N cheese are.
Our important targets are for for various cancer.
Cancers and in the hematology.
Hematology space.
Currently we think we have a potential advantages over the age of societies and decided it didn't work because of.
Tolerability because of dosing because of a whole number of advantages that we see at least to date.
And we think we can expand the use of D. N F teeth into beyond liquid tumor spin it into the solid tumor space as well.
Excellent. Thank you.
Sure.
Our next question comes from France outfits toy with Oppenheimer. Please proceed with your question.
Hey, can you maybe remind us the differences in trial design between the phase Iia and phase two b.
That's a great question, but it's good to hear from you by the way yeah.
There really aren't many I E. The first if you look at dosing. It's the same we dose the patients on day, one and then they get another dose on day three and the first trial, we allowed steroids should be used in this trial, we I didn't want the confusion potential confusion of steroid side effects too to be later.
Upon the shoulders of luxury car sterile. So we've set up this double blind double dummy arrangement. So that if I get placebo, then I get a capsule that would have active steroids, if I get one of the two doses like Chicago sterile then I would receive a placebo.
Capstone what steps so that that is one difference. The other difference is the severity of the illness of the patients in the first study we had two components. We had the moderate patients which were melds up to 'twenty. One and then we had the severe which were 21 to 30 in this trial all 301 patients that were dosed.
We see.
Excuse me I had meld scores.
It started at 2021 and could go as high as 30.
And we saw it for 90 days versus 28 days, So 90 days, which is 28 days of severe and.
Absolutely no steroids, unless he called sterile group and if the physician why did they could get steroids to their placebo patients.
In a blinded fashion.
Can you just remind us the mortality rate at 28 days with historically known versus 90 days and has that changed in the past.
No it really hasn't changed really in the last 40 years and it's been confirmed with us they know that.
But it was at 878000 patients publication.
Yeah and to Tom Yeah, Yeah, Yeah, Yeah, Yeah, that's right.
Yeah, Yeah, Yeah 2800, okay.
And so there was a 200 to 2800 patients a large a publication that you kind of spoke to it but the mortality rate at 12.
28 days, it's been a historically, 26% and at 90 days, 30%. So you can see that you're only adding another 4% over the last two months. So it's a the majority of the AR, but the damage is done and the majority of the deaths occur early on.
Thank you.
Sure.
Our next question comes from Ed Arce with H C. Wainwright. Please proceed with your question.
Hi, Thanks for taking my questions can you hear me okay.
We can.
Great Okay.
So first of all I wanted to ask.
About your commercialization plans to focus rightly has been for several years now on the development and now that we're on the cusp of a readout potentially.
Potentially.
Enabling a filing.
Wanted to ask if you could provide a little more detail on your preparations at this stage in particular, you mentioned moderately sized hospital focused sales force are there any hum investments I know you also mentioned the the website.
And any investments now and to awareness for physicians or other things to sort of prime the market.
And then I have one yes.
Yeah, we certainly are and I'll, let keith speak to that.
Yeah. Thanks, Ken Thanks for the question Ed.
On the commercialization front, Charlie we've been doing yeah, we've had a number of efforts there we have.
Yeah personnel that have watch experience the kind of medical care side on the marketing side, even though we are a small but mighty team.
Jim mentioned in his remarks, the explore HIV genetics as a disease awareness site that we launched them late last year actually and then we certainly the past couple of years that had a light presence at the major international never conferences, we're just coming off of the presenting a poster actually.
At Eagle.
In Austria, just last month, and we have we've been at both ears O N E. S. L b.
With boots and last year really the focus was on affirm awareness.
Croutons now that that's closed we really have shifted gears into disease education.
We've certainly invested in.
Various market research and market landscaping understanding the unmet medical needs.
Where a drug with our superheroes product profile could sit and we explained some of those topline results when I presented that to K O L event in New York back in May.
But we continue those launch readiness efforts really it's about putting.
Putting plans in place internally to.
I'm sure all of our cross functional groups are singing off the same 10 sheets on timelines on budget on expectations.
And we certainly have a a fully integrated.
Integrated launch readiness plan now.
We worked with both internal and external consultants to ensure that everybody is moving at the same pace, but at the same expectation.
Because every launch is different every launch has its own challenges and obstacles and really it's going to take a village, but it's the folks at <unk> com as well as our outside consultant, but right now between now and top line results, it's really about preparation.
And you cannot over preparing if you will but preparing at the right pace and having plans in place after topline results and after our interactions with FDA to execute well it could be a very short time of launch.
If everything hits.
Great that's.
That's helpful Keith.
And maybe just a little bit further wondering if you can discuss.
How you view.
The initial the initial ramp of the launch in particular I know.
This is a very specific call point really dealing with a hospital.
Ah I see us and Theres a lot of inertia with physicians.
Physicians changing therapies in general, but in particular, and you know and high stress situations like this but on the other hand, you potentially have a therapy that is.
Life changing could save lives. So I'm just wondering in.
And the mix of that or.
How you think about.
The speed.
Ramp.
Hum in regards to not only positions, but also you.
Payors.
Yeah, but oh.
And then I'll certainly have Keith.
First of all you're right in that these are hospitalized patients.
Oftentimes in the ICU, but.
These aren't patients who.
Who are.
But typically you're going to die in the in the very very near term or their outcome is going to be determined in the next 12 hours kind of thing as you would get with stroke in sepsis and things like that that was the reason we selected a H as the first acute indication for luxury cristero because one could take the time.
And when you look at these other diseases for which we've done a lot of preclinical work.
There've been a history of more challenging clinical trials because of the variability when it gets wet with patients and here. We have the time to talk to these patients because and their families because they're on a very slow.
Unrelenting train ride that leads to death and 30% of.
And just to witness and our first enter a phase Iia trial. There was a man in his thirties at the San Diego site, who was that another hospital for a month and we sat at home on hospice to die.
Enrolled in our trial.
The steady coronary.
Commented how good he looks.
Just a week or so after dosing and.
Last time I talked to the Doctor Hassanein. He was that just a gentleman who's got a lot to two years more than two years. Later. So certainly one has the time in this circumstance to be able to evaluate the patients as far as the.
The ramp into like you know we view, obviously you know what.
If you want more information on some of this information there that keep presented during our Kols event, we have what he discussed from clear view, which was off our website, but I'll, let keith kind of give it.
Description of her thoughts with regard to that.
Yeah and.
Good question as it relates to physicians.
One of the outputs that we had from our commercial assessments earlier. This year. When we were looking at blinded target product profiles with a data that we would assume we would hit statistical significance for our firm.
We had very high willingness and a qualitative study from physicians to that product profile with a statistically significant overall survival or transplant primary endpoint, especially given a disease area like H, where there are no drug approved and the facto standard of Caribbean steroids that are only applicable on about 50.
The percent of patients.
That that is suboptimal has never shown any kind of survival benefit past 28 days. So the willingness to prescribe something that physician standpoint, particularly in the affirmed patient population that severe H now 20 to 30 range was very high and so we think that the willingness to prescribe there and the ramp there.
And it could be significant but you know we also cross check that with the reality.
The reimbursement environment, and the DRG driven reimbursement.
Hospital inpatient deliver drugs.
So we've done quite a lot of work as it relates again to the commercialization plan, particularly on the market access understanding the landscape looking at other like acute care in hospital delivered products.
And learning from what's worked in and where the challenges have been understanding those optical obstacles and internally working on developing strategies to <unk>.
Positively influence those factors understanding what what we're what we have.
Up against Us for launch.
And what we can do now to better understand that environment and what strategies, we can deploy them early and certainly after top line results.
Market access will be the initial focus for our commercialization strategic efforts.
And we can get out now given some of the changes in the commercialization regulatory environment that allows us to interact with hospitals and in certain payers prior to the launch and building out those value propositions, because those are health economics and outcomes research models that will be out of town.
On top of mind for our commercial team.
All of those and.
Start.
You start those efforts even prior to our launch.
Yes.
That's great. Thank you for all that.
I can't I'd like to squeeze one more in and that is regarding.
Your new.
Our expansion into oncology.
<unk>.
I'm just wondering given this platform.
There's you already produced several N cen and you've mentioned that they.
It could apply to both solid and liquid tumors. So I guess a couple of questions here is.
What would be your preference.
And how would you decide to sort of what criteria.
Are you looking at to help best besides sort of with which would be your first candidates that you've not wanting to.
To go into the clinic by the end of next year. Thanks, So much.
Sure I think we're gonna, let the science really drive it but if you'd like to give a brief.
Well I think they'll criteria.
L J.
Oh, what takes the time.
I'm Manny multiple oh.
Uh huh.
Compounds have January .
And then all of the indications, including I'll start with that trial design.
Population, including the so it's really not a one single SAP to one side.
Okay.
And then.
We also need to talk to them.
Yes.
P people with expertise in oncology and then get their input.
Really driven by mouth.
So I think hopefully we will be happy to talk about that.
Yeah, I think so I think we'll be taking the same filter that we use when we selected indemnification for lifecycle sterile so be looking at unmet need.
The market all the time to proof of concept in this case, obviously, but it puts oncology it's different.
So that kind of thing.
Yeah.
Right.
Thanks again, everyone.
Sure.
Our next question comes from Sean Kim with Jones trading. Please proceed with your question.
Hi, Thank you for taking my questions.
My first question is.
Is could you please remind us whether the.
Statistical plans sort of affirm Chile has been submitted.
And if you have provided any detail on the statistical powering for the trial.
Yeah. It certainly has been submitted but we.
Havent.
You haven't really provided a great bit of color to that suffice to say you know we designed it such that you know 300 patients.
Should you know the trial proceed as we'd hope and and the placebo group performed.
As history has dictated in anywhere in the range of events that would allow for that then that will have a statistically significant ah trial, but it all remains to be seen as it always does.
The data will dictate at the end.
Okay. Thank you and I thought the physician survey that you did recently.
And could you share some more color on the excitement expressed by the doctors from the survey I made a specific around their willingness and absolutely that's correct.
Love Darryl.
I'd love to but I'll, let heath do that yeah that was certainly quite nice.
Yeah. This is Keith so on that are on the market assessment that we did earlier. This year, we worked with a group called clear view who's well known in this space and with the with physicians that we recruited for the study again, they had very high willingness to.
Prescribe them. This is off of a blinded target product profile, just a one page a profile of what our drug may look like and what those statistical parameters would look like for safety and efficacy based on a presumed positive affirmed trial.
Again, it was blinded to the the company and to what the product name is so physicians had no idea of that.
But again there are their affinity for the product and pleasure with something that would have a statistical significant difference versus standard of care.
And especially how we design the trial, where it really is physician's discretion on whether or not steroids are used in that placebo arm really mimicked there a current standard of care and with that kind of an improvement.
With a what they considered as are the highest order endpoint of survival or transplant, particularly at 90 days for an acute disease like this would be very significant for them and so we did see that it was nice to see that there are preference share that they are assigned to.
This product X was quite high particularly in that severe patient population that we were testing for a firm that we're testing in a firm with knowledge between them between 20 and 30.
Yeah, I think it's a it is exactly what one would have hoped you know if you have a disease, where 30% of the patients are dying and there's no therapy that they're stable to change that.
Yeah. So it was it was both.
Receipt.
Yeah.
I just wanted to.
Maybe just one more point I mentioned that the that there was high affinity for prescribing product acts are super sterile.
In that study with a firm patient population, but given that.
We're not sure what the final label would be but there also was a willingness to.
Prescribe this product for no it's greater than 30, there are no products approved at all and there are certainly high unmet medical need for those who are extremely severe with no it's greater than a 30.
So again reassuring to hear that unbiased take from a R. Archaea pathologists that would be our target from a commercial standpoint.
That's great. Thanks Keith.
Yeah.
Sure.
Yeah, Sean just one other additional piece if you have about a 30, you've got the mortality expected.
90 days, 60% so it.
It goes up very quickly.
Okay got you and then my last question for today is as you look to most cancer programs into clinics.
And up next here.
Just curious to hear your thoughts on strategic prioritization and resource allocation between.
Is all kind of intensive programs and potential expansion into other happens to loss quantification.
For a last question.
Yeah, that's a great great question, the first and the primary focus is the age that's where our efforts are you know certainly and we've already discussed because one of the questions earlier to find partnerships. So you know if the data comes out as we hope and we and we have a successful trial with a firm we'll be looking to partner for ex U S to advance two submission as quickly as possible.
We hear a direct will be all hands on deck to move that forward and then as well we'll be looking at the next indications for the Serco sterile.
And then but that the oncology effort that way. She is running as it is not a very large budget item. It's a you know as most of you who've been involved with research no. It. It just takes time it doesn't take a lot of money it doesn't cart costing.
A reasonable amount of money at all so you get into the clinic and so as you know as the year unfolds, we'll be obviously preparing for that and that'll that'll take its own course, but the primary focus will be affirmed and meeting with the FDA deciding.
One trial will be sufficient for the submission of an NDA and commercialization partnerships in and all the rest of those kind of things.
Okay. Thank you very much.
Sure.
There are no further questions at this time I would now like to turn the floor back over to Jim Brown for closing comments.
Just wanted to thank you all for your time and as always we are here. So if you have follow up questions just reach out and look forward to talking to you. Thanks, a lot and take care.
This concludes today's conference you may disconnect your lines at this time. Thank you for parties your participation.
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