Q3 2020 Exagen Inc Earnings Call
[music].
Good afternoon, and welcome to the exhibition Inc. third quarter 2020 earnings call.
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A question and answer session will follow the formal presentation.
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As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host Mr., Mike comment on Investor Relations. Thank you you may begin.
Good afternoon, and thank you for joining us today.
Earlier today after Jenny released financial results for the quarter ended September 30 2020.
Release is currently available on the company's website at Www Dot <unk> dot.
Dot com.
Rocco President and Chief Executive Officer, Kamala data, <unk>, Chief Financial Officer, and Mark Hazeltine General manager.
Before we get started I would like to remind everyone that management will be making statements. During this call that include forward looking statements within the meaning.
Purities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1990.
Any statements contained in this call that are not statements of historical fact should be deemed to be forward.
All forward looking statements, including without limitation statements regarding our business strategy and future financial and operating performance.
The impact of the cold.
18 pandemic on our business.
Our current and future product offerings.
And reimbursement and coverage are based on current estimates and various.
These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward looking statements.
Accordingly, you should not place undue reliance on these statements.
For a list and description of the risks and uncertainties associated with our business. Please see our filings with the Securities and Exchange Commission.
During our form 10-K and subsequent filings.
The information provided in this conference call speak only to the live broadcast today November 10 2020.
Accident disclaims any intention or obligation, except as required by law to update or revise any information financial projections or other forward looking statements, whether because of new information future events or otherwise.
I will now turn the call over to Rob Walker, President and CEO of accident.
Thanks, Mike and thank you to everyone joining the call today as always we appreciate your continued support a bastion.
I'd like to take a moment to inform you that our colleague and friend Chaparral has decided to retire from the action and board of directors effective December 31st 2020.
That has been helpful in sharing his comprehensive knowledge and experience in managed markets with our entire team during our dossier development Jets guidance allowed us to avoid unnecessary activities and focus on the most meaningful actions that would resonate with the payer community visibility to share his time and insights enabled.
Action to be fully prepared for reimbursement and contracting meetings with major payors.
We are very grateful to chat for all he has done to assist us in being a driver for better care of autoimmune patients.
We're delighted with the third quarters exceptional results.
Testing franchise. Despite continued disruptions of patient visits to rheumatologist, our flagship advice P.T.D. testing volumes came in at 26201, which is greater than 90% of the levels. We have had experienced in the first quarter before COVID-19 profoundly affected our business.
We believe this is a testament to both the seriousness of autoimmune disorders as well as the value patients and health care providers received with advice suite of testing solutions.
Due to the pandemic patients must make additional efforts to visit their doctors and get their symptoms correctly diagnosed.
Further our specialized commercial team continues to support health care providers through an optimized combination of in person and virtual calls.
Along a similar vein, we achieved a record of 600 adopters in Q3 2020, 40% increase over Q2, 2020, and stickiness of 99%, which terrific given the circumstances.
Mickey This is defined as an adopter that writes again in the following quarter. This.
This further demonstrates the unique utility of the advice franchise rheumatologist challenged with clinically difficult to diagnose diseases did.
Additional value provided by our advice CGD tests. During this pandemic is the convenience and accuracy to cover multiple connective tissue disorders versus serial testing, which could take many doctor visits over numerous years as.
As we have said before life threatening diseases like lupus in chronic disorders like rheumatoid arthritis do not stop during a pandemic and testing can't either.
With the pandemic, making it more challenging for patients to see their doctors for treatment. The necessity of test that can speed up the diagnosis and prognosis of autoimmune diseases is apparent we believe our advice Brent can address the need better than anything currently on the market.
For Stephanie we reported 1.3 million of revenue in the third quarter with 100% gross margin.
If it is unique value proposition as the only once per month self injected anti TNF biologic for rheumatoid arthritis is well positioned for todays environment.
We believe our Copromotion agreement will continue to provide meaningful revenue to the top line as we leverage our de <unk> Rx model to provide differentiated value to health care providers.
Third quarter was also a productive one on the reimbursement front.
We're excited about our agreement signed in July with Humana military a managed care support contractor for Tri care East, which makes available all of our advice testing as covered in that weren't benefits to 6 million lives. We're also pleased to announce an additional agreement in September with provider network of America.
Large network of physicians hospitals, and other health care providers, which make it buys testing available as an in network benefit to approximately 8 million members served by the network.
Additional reimbursement and coverage agreements remain a major strategic effort at Exgen and we continue to negotiate with many large health care participants throughout the country. We recognized that the pandemic has redirected efforts of many payers to prioritize testing policy. We're COVID-19 delaying coverage negotiations we continue to.
Get reimbursement a top priority and on the strength of our completed dossier, we are well position to negotiate coverage.
Actually done in collaboration with leading healthcare economic experts recently announced the first ever peer review publication, demonstrating economic impact of advice lupus compared to standard diagnostic laboratory test.
The Lupus Foundation of America recently shared that the advice lupus test can diagnose lupus patients earlier and result in significant savings in health care cost.
Over a four year period advice lupus yields an estimate total direct cost savings of approximately $2 million or nearly $2000 per person.
Advice testing is known to be clinically meaningful to physicians and the challenging patients. They manage now we have peer review published data to support the economic value to Payors as well.
I'd like to say a few words on our R&D efforts. This is a key strategic focus as we continue to solidify actions position as a premier autoimmune focused company, providing an extensive range of test solutions to help rheumatologist diagnose treat and monitor auto immune diseases, which is notoriously difficult to do.
Do.
We are focused on driving multiple sources of innovation and strengthening our intellectual proprietary portfolio in August we announced a collaboration with hospital for special surgery H S. S. In New York City for a study of any buffer lip syndrome, and autoimmune clotting disorder, which most commonly increases the risk of blood clots.
And pregnancy complications as a result of any foster Olympic Anybodys. This proof of concept clinical study will investigate complement activation markers and additional biomarkers in different subgroups of patients.
In September we launched the new test advise vasculitis for the diagnosis of Anca associated Vasculitis health care providers have been asking us for this test and we were able to deliver.
We continue to advance the development of further tests to add to the advice franchise, including our test for fibromyalgia disease, which has large addressable market, while not an autoimmune disease. It is often confused with connective tissue diseases and is therefore frequently diagnosed by rheumatologist.
Having an effective rule and rule out test for fibromyalgia promises to be invaluable to health care providers, we believe that our vice test or the most effective complete and differentiated series of tests for autoimmune diseases, and we will remain focused on strategically enhancing that advantage I would now like to turn over the call to.
Kemal to discuss our financial results.
Thank you Ron and good afternoon, everyone total revenues in Q3, 2020 were 10.8 million an increase of 20% over Q2, 2020, and 3% over Q3 2019.
Revenue growth was driven primarily by a by BTD tapping volumes of 26201 compared with 18552 for Q2 2020 and 27159 for Q3 2019.
The number of order and health care providers was 1665 for Q3 2020, compared with 1442 for Q2 2020 and 1591 for Q3 2019.
By BTD has revenue was 7.4 million in the quarter and other testing revenue was 2.1 million.
Revenue for Symphony was 1.3 million with 100% gross margins.
Overall, we are pleased with the recovery of our testing business from the April Bob as Ron mentioned, our test volume in the quarter, but at greater than 90% of our pre cobot volume trends, which is a strong indicator of our commercial execution.
While the continued spread and impact of COVID-19 is highly uncertain, whether 50 big sales territory, we're fully prepared to continue to support health care providers and patients.
Cost of revenue was 4.3 million in Q3, 2020, resulting in a gross margin of 60% compared to 54% in Q3 2019.
The improvement in gross margin was driven by higher Symphony revenue, coupled with a decrease in royalty costs associated with the expiration of a royalty on a per hired Harry <unk> technology.
Operating expenses in Q3, 2020 were 14.6 million compared with 12.6 million in Q3 2019.
The increase was primarily due to employee related expenses, including stock based compensation associated with the overall increase in headcount as well as increased public company expenses.
The net loss in Q3, 2020 was 4.3 million compared with 3.1 million in Q3 2019.
Looking at our balance sheet cash and cash equivalents as of September Thirtyth were approximately 61.4 million.
We remain well capitalized endure any economic uncertainty associated with the COVID-19 pandemic, while we continue to invest in key R&D and commercial initiatives to grow the business.
Regarding the 2020 guidance, we do not believe that it is prudent to offer formal guidance at this time due to the lack of visibility caused by the resurgence in coal that 19 activity.
We will now open the call for questions.
Thank you.
I will now be conducting a question and answer session.
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One moment, please while we call for questions.
Our first question comes from Chris Flynn with Cowen. Please go ahead.
Hey, guys. Thanks for taking my questions Ron.
Ron I believe you commented that terrorists or delaying coverage negotiations as a prioritized over 19 efforts can you just elaborate on the length of this delay and when do you expect this to be resolved.
Sure Chris No problem at all we've been holding virtual meetings with a lot of the payers and obviously exchanging back and forth or E mail a normal.
Transitions of information, but they are definitely preoccupied with cove it and they have many of the bigger payers have postponed meetings. The comments are always we're gonna get to you, but we have a we have something in front of US we have to take care of right now which is how we're going to deal with all the different covert tests that are coming out and so forth. So they.
Our pre occupied.
The quick answer is we're still in queue for all these meetings.
They obviously know that our dossiers out and moving forward I anticipate that that will get in there as soon as possible, but we will be prioritized. After the cobot testing they should be coming to the end to that Chris, though I mean, they've they've had plenty of time at this point to look at all the tests. So we're hoping that within the next couple of years.
Next we start hearing that they are back on track with other things other than cobot testing.
Okay, Great and maybe forever a lot related follow up can you. Just also talk about how the new health economic study is impacting your efforts with payers and does chats retirement impact your reimbursement efforts at all going forward.
Yeah. So first we're very happy with it which that was able to do to provide us information and guidance as a former Blue Cross president.
But he has always indicated that he is looking to retire he retired from blue and he's looking to settle land. So we wish him all the best and thank them for it it doesn't really impact us going forward, because we really got the the value of his insights on how to develop the dossier to best address the issues.
For the payers the health care economic studies impacting us in this way we always knew we had the better test and in fact, most physicians and even payers has said we realize it's a better test keep in mind that.
What they were used to using the M&A Ntds names. He said that need to go back to the Fiftys in the early sixties. So they recognize that was there as far as a better quality test to get a more accurate timely diagnosis, but we didn't have the economic study so what the in Clark's. The study did was round out the information better tests saves you money.
We will be part of our dossier now and I think it's going to have great impact because how often do you get something better that actually saves you money.
Okay got it and for my last question I believe you would know the data test volume is greater than 90% of free Kobe trends has held steady even in light of the recent resurgence is thank you.
It has and I'll address that with the sticky Miss you know so you know we have achieved record levels of stickiness and and that's defined as as the Doctor that writes again in the next quarter.
That's a testimony to the value we bring the physician there's something else here, Chris It's really important before cove. It would a lot of physicians would do something called serial testing I've touched your M&A you come back in a couple of weeks of tester at your Ntds DNA Your entry Smith, and that's why it's yellow base as it took six years to get correctly diagnosed with potentially deadly.
Disorder like lupus.
Test is not only better than what's out there, but it's also more convenient when you use our advice C.T.D. because it combines not only the best lupus test, but the 11 generic markers of those those organisms that you're off often overlap with lupus. So the convenience of one test up front during cove. It is a perfect solution for.
So I like the fact that we're 90% I think the adopter shows that they're going to stick with us and there is no cure for lupus. So we feel like we're very well positioned.
During the pandemic and even after the pandemic as these bolus of patients come back.
Great. Thanks for taking my questions.
Thanks, Chris.
Our next question comes from Brian Weinstein with William Blair. Please go ahead.
Hey, guys. Good afternoon. This is Jack Griffin Entre, Brian. Thank you for taking my questions.
[noise], maybe just want to start here. So how should we be thinking about the baseline for simponi heading into 21 and is there any update on the potential for for renegotiation that deal with that with Jackson.
Yes. Good question Griffin, So we're fortunate because mark Hazeltine is here with me he's the one negotiating with Johnson and Johnson. So Mark why don't you address that absolutely Hi, Griffin nice to speak with you Yeah. We're in negotiations with Janssen for the 2021 baseline we committed in our 8-K at the end of June to have that done by the end of November and we're tracking to that date right.
Now we have a great relationship with Janssen the Symphony product is performing well in the marketplace and we're very pleased with our performance in Q3. So we're looking forward to 2021 to be another productive year for you for us what the Rx Gx model.
Great. Thank you and then just maybe a follow up there what kind of promoting are you doing for Simponi does the quarterly revenue cap impact, how you're thinking about potential promotional efforts there.
Oh, that's really good question. So we will we want all the extract all the value we can out of all of our assets.
So being that there is a cap in Q3 and Q4, we want to get all that Caf, which as you can tell from the numbers in Q3, we were right there.
What it also did was allow us to put a little bit more energy and some of our secondary products as well and we did that with the incentive comp and by that I mean, our monitoring products as well as prognostic products. So what it allowed us to do was to continue to drive forward with our entire portfolio of assets keep in mind that symphony doesn't.
Distract us from advise CGD.
We're fully leverage all these assets are assets that are core audience rheumatologists use on a daily basis.
Great. That's a that's helpful and just one more for me any updated thoughts on sales force.
A bit earlier and the pandemic so where.
Where do you want to see that go in both the near and long term. Thank you.
Yeah no problem. So we believe it's good corporate hygiene to look at balancing the territories once a year, which would which is what we do so we're in the process right now and to look at reach and frequency of our target audiences throughout 2020, and we'll adjust accordingly, and 20 2021, one of the good things about being well capitalized like we are if we need to expand.
And it's not that big of an issue what will probably happen as we look at this we'll keep an eye on cove it to see if the states are still open.
But we have no problem and expanding in areas, where we need to extract more value more reach and frequency with physicians at this point, we're doing the the alignment checks right now to make sure. The balancing is correct. So thanks for that question Griffin.
Our next question comes from.
Thank you. Our next question comes from co like some with Cantor Fitzgerald. Please go ahead.
Hi, guys. Thanks for the questions nice quarter.
You just elaborate on how my testing in the geography is that had those cobot spikes in Threeq you kind of rebounded progressed throughout the quarter. We're just trying to understand how to think about the volume recovery in areas that have these cobot charges because I generally like a four to six week cycle. I guess, you know them in other words, how long did it take the test orders to kind of normalize in one of these markets.
Yeah. That's a good question. So we actually saw a pretty interesting phenomenon still seeing it now with New York.
A lot of the New York State patience and buy a lot I don't mean, all by any stretch.
They're showing up in new Jersey, and in Florida, and South Carolina. So those patients because we have the monitoring product. We can track that so I think one of the phenomena on on your question is that they may not be seeing them in a close date, but patients that have the means youre going outside the state to see their doctors and get their refills for exam.
Bought our monitoring product.
How long does it take to get back that's a very good question. There is no cure for lupus and a lot of these autoimmune disorders that we treat so we know those patients are out there waiting for an ability to see the doctors.
As things tighten up we do get phone calls in here, saying can you directly to a physician and so forth. What's nice about some of these doctors they've gotten really good with virtual calls when your diagnosing you do need a clinical visit but the virtual calls has given them the ability to say whether or not we should send the patient directly a test kit or not.
Which we which is again a new phenomenon that came out of this.
Does that address your question.
Now.
Yeah that was perfect. Thanks, a lot mom and dad, just kind of moving on there so great to see that study you're doing the Brigham and women's some there has been some preliminary evidence that suggests that the fairly large portion of conversations actually developed the quarter end bodies. Some are those and move us already obviously, so just wanted to kind of give you the opportunity to dive a bit deeper into how you intend to use it.
As part of the study, maybe and maybe the longer term potential opportunity that you're seeing here as well I know its super early I would appreciate any color you can provide there.
Yeah, we are really happy to be partnering with Brigham women, a major milestone on Keystone institution really smart people working with are really smart scientists to do this and it's exactly what you said, we're going to use our complement testing to see if these cove it patients exhibit autoimmune disorders at a faster rate or.
More severe rate than those that Didnt have COVID-19. The results of this is we're measuring our cash we're going to measure E C and B C D as well as PC for D.. So we're going to be measuring caps on these patients. So the results of this if it's what we think it is which is the complement cascade from a virus, we'll be able to say that hope.
Fleet, our test can predict whether or not the patient will will get a autoimmune disease faster than if they didnt have co bid.
All right. That's awesome. Thank you Ron and I know what are they going out to bid or.
To the revenue line right now, but I went out some of the other testing revenue.
I just was wondering if you could speak to any specific tests that are yet you're seeing important, especially well no I won't be capillary tests like a bias touched performed during cobot, so far and on a related kind of does the televised service generally run faster or slower than the typical process of rheumatologists ordering tests.
Yeah, I don't think there's anything as fast as a rheumatologist seen you clinically and then deciding render its decision to send the test. That's just it's quick it's efficient a traditional but.
But they have gone to these virtual type of meetings and I can't tell you with assurance weathers quicker or slower, but I'm glad it's happening because these patients do need to see a doctor.
So I I can't imagine as any faster, but I don't know if it's any slower than a clinical visit.
Your first part of your question was as far as the secondary products.
While we don't disclose these in the earning call. We know we have a significant products here that are meaningful for the doctors I also want to see it come all my CFO hat wants to comment on that yeah. Thank you Ron So in Q3, our other testing revenue did approached 2.1 million, which was significantly higher than we've seen in the past two quarters.
Of 1.5 million in Q2, and 1.6 million in Q1. This was primarily driven by our prognostic testing and monitor testing, which are both been performing exceptionally well.
Okay. Thanks, a lot guys for that and I guess, just sticking with you come I wanted to ask about the kind of the spending recently, it's considered you expanded the campus in picking up the hiring but what areas are you guys looking to strengthen as you kind of grow the action now and then and then Mark can you just kind of walk through what we should be thinking about for 2021 in.
Maybe Cork operating expenses.
Sure. So our biggest area of focus on increasing the spend is going to come from the R&D Department, we have a world class R&D Department and Ron mentioned, a lot of the projects that they're working on and that's going to be our biggest.
Percentage increase quarter over quarter and year over year as Ron already mentioned with our Salesforce that is something that we look at very often and we do anticipate you add territories over the coming quarters.
And then outside of Opex in the laboratory, we do continue to make investments into automation to improve our gross margins.
All right got it that's perfect. Thanks, a lot guys I'll hop back in the queue talk to there.
Hi, Scott.
Our next question comes from Mark There'll always be T.I.G. Please go ahead.
Hi, guys. This is maybe im on for Mike.
On the portal.
Thank you.
Michelle question from given the.
How much visibility.
<unk> sales funnel relative to a year ago and approximately what percent of your sounds about right.
Yes, a good question well the sticky Miss I think is really something you've got to look at the fact it.
99% of the doctors that right or products that are doctors will write it again and we hit a record level of adopters in Q3 600 adopters as an all time high for us. So that was a really important number and I think that really shows you the value that this test brings again serial testing versus one test with the best.
Lupus markers inside is something that really appeals to rheumatologists as far as reps in the field. We do have the 56 territories. Most of them are there, but we are very clear that if your state or ZIP code shuts down that first and foremost you listen to the local laws that are in your community, but if you're not shut down.
We do recommend that you follow the office policies and they're all different throughout the country and be able to go in there and see the doctors. The reason were a little different than some other companies is we deliver a de identified test report to engage the doctor and we have to deliver the transportation kits. So we have reasons to be in.
There rather than just delivering a core message and of course, when we drop off the kits or the symphony samples or even talk about the capillary test. It was mentioned earlier that also opens up a window for our representatives to engage in a meaningful discussion of how one test that can do it all might be a perfect solution for the doctor under this current environment.
Okay. That's helpful. Thank you.
Just quickly.
Quickly follow up.
On the planning for the fiber miles Duffy.
The expectation.
Potential launch time.
Yeah, we're very excited to be working with Ohio state on the fiber miles of test it's.
Our target is to have the first rule in or rule out fiber test nobody's ever done that we've always had the rule in lupus test, which is often confused with fibrosis.
But this will be this will be the complete test we think the markets are looking for as well as the payers.
While I cant give you a timeline I can tell you I am I am pushing heavy to do whatever we need to get more sites more equipment.
Whatever we need to do to get the product up and ready for the market. It's got a big Tam.
And it's got a huge need so we're excited about the product I don't want to rush into the point, where I do anything that disrupts the scientists from building the quality test that were known for.
Okay awesome. Thank you.
Hi, Alan.
Do you anticipate.
Okay Man hour backlog beauty club.
And if you could just provide an update on the balcony and from mobile bottoming.
Okay.
I do expect to have the backup because there is no cure. So these patients you know it's happening and if you read the blogs zone for Rheumatologists, you could see there very frustrated not being able to see their doctors. They are all finding ways to do it. The one thing I'll say about these autoimmune patients are they are aggressive about making sure that they get their care taking care.
Growth, which is a good thing as as well as all patients should be so I.
I do expect that their patients sitting on the sideline. If your immuno compromised do you want to go to immunocompromised office with other meat immunocompromised patients, probably not but theyre going to come back. Eventually there are no cures for these disorders and they have to be treated my concern is by the time they come in they are very severe and I hope that doesn't occur.
Okay. So thats why we encourage them to seek help as soon as possible as far as revenue from the mobile Phlebotomist. We do have we have a lot of agreements with mobile phlebotomist.
Throughout the country.
Correct.
1200 mode.
Mobile phlebotomy locations spread out throughout the country, they're all a little different and we will probably need to add much more as time goes on.
Oh, Thank you for taking the question.
Thanks Vivian.
Our next question comes from Paul Knight with Janney Montgomery Scott. Please go ahead.
Hey, Ron could you talk to are you done with the sales build out and then adding on to the question about ordering physician can you talk about you know Weve talked at 4000 is probably the active number do you think that's still a b Phil on.
The number of sales points you now have do you think that's still the number.
Yes. Good question, Paul the sales build out we will look at our intent is to make sure we have the right and free right reach in frequency to deliver our messages throughout the country. So.
We are looking at expanding but when you first have to do the work and the work is to look at rebalancing that is that process is underway, even as we speak we worked with a very reputable company that takes a look at the number of doctors the units and so forth. So.
The Buildout will continue as needed. We're we're not going to Overstaff, we're not gonna Underspent, we want to get the right number we feel that a targeted universe of roughly 90 to 100 targets per foot per representative is is handle well with the exception of the Midwest, where you have a lot of windshield time, you might go a little.
Less in cities like.
Chicago you might go you might have bigger territories, because there's not as much windshield time, but that buildout is underway at least evaluating where to IV to build it out.
4000, Rheumatologists isn't numbers, that's always kicked out I will reiterate that even though the am may said Theres 4000 change rheumatologist, they don't always clean their list as accurately as we would like so if you're dead right.
Retired worked for academia or worked for institution, you're still considered part of that 4000, we boil that down to roughly 3000 call. It 800 that are meaningful doctors for us to target.
Now with that being said thats, the rheumatology based but autoimmune doesn't only go there there are some doctors in areas that are not rheumatologist, but act like it I'm thinking about a physician who has an internal medicine physician or why only that the next nearest office is 400 miles away, but that dr. acts like a rheumatologist, but the key here is if you think about it.
Our current structure will enable us to do what we have to with the rheumatologist and if we need to step beyond that and pick up additional accounts, we have that capability to do so.
And then regarding Simponi do you believe that the coated situation is making simponi a more attractive option to the self administration one for a month.
I, absolutely do I mean, it's it just makes sense.
Again self injecting at home once a month, how convenient could that be not having to go to an office with the other immunocompromised patients I mean, just I can see us scared patient, saying I'd rather do this the great thing about symphony. Besides its unique delivery system is that they know anti TNF doctors know at the familiar it's been now for decade.
Yes, so having them take an anti TNF at home is not as risky as it might have been a couple of decades ago. Since we're so familiar how these these work symphony is an ideal solution for the problems that we're facing today.
Okay. Thank you.
Thank you Paul.
This concludes our question and answer session I would like to turn the conference back over to Rocco for any closing remarks.
Great I want to thank everyone for joining the call today I'd like to really reiterate that our strong Q3 performance, which included a record number of adopters a 99% stickiness that's important to know they stick with is the only do that when there is a great product.
And it's a second consecutive quarter with 60% or greater gross margins were honored to be able to continue to support the care of autoimmune patients. During these challenging times. Thank you for your time and attention take care and have a wonderful day.
The conference is now concluded. Thank you for attending today's presentation you may now disconnect.