Q2 2020 Exagen Inc Earnings Call
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Greetings and welcome to the accident Inc. second quarter 2020 earnings call.
At this time all participants are in listen only mode. A question and answer session will follow the formal presentation.
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As a reminder, this conference is being recorded I.
I would now like to turn the conference over to your host Mr. Mark Hazeltine.
Senior Vice President of financing corporate development for accident, Inc. Thank you you may begin.
Good morning, and thank you for joining US today early this morning, Exigent Inc. released financial results for the quarter ended June Thirtyth 2023 leases currently available on the company's website at Www Dot exigent Dot com.
Run Rocco, President and Chief Executive Officer, Melancholy, Chief Financial Officer will host this afternoons call 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 of federal Securities laws, which are made pursuant to the safe Harbor provision.
<unk> Private Securities Litigation Reform Act of 1995 any statements contained in this call that are not statements of historical facts should be deemed to be forward looking statements.
Forward looking statements, including without limitation statements regarding our business strategy and future financial and operating performance the impact of the covert 19 pandemic on our business, our current and future product offerings and reimbursement in coverage are based upon current estimates in various assumptions. These statements involve material risk.
And uncertainties that could cause actual results to differ materially for most 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 include.
During our form 10-K, and any subsequent filings the information provided in this conference call speaks only to the life broadcast today. So I 28, 2020 exiting disclaims any intention or obligation except as required by law, the 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 run Rocca, President and CEO of accident.
Thanks, Mark and thanks to everyone joining the call today. We appreciate your continued support of action.
We all understand the 2020 has been a challenging year for every business whether public or private.
One thing however has not changed.
Autoimmune disease continues to affect millions of people throughout the U.S. and the world.
These very serious diseases do not take a break during a pandemic and neither do we.
With that backdrop, the second quarter was a good one for extra good advice testing volumes are steadily recovering from their April trough and have continued to trend higher at each successive months.
Testing revenue in the quarter was 6.8 million with 18522 of our flagship advice EGD tests performed.
Adopter sticky this was 96% for the period and a very good percentage given the circumstances.
The covert 19 pandemic highlights and increases the need to transform the care continuum for patients suffering from debilitating and chronic autoimmune disease.
By enabling timely differential diagnosis and optimizing therapeutic intervention.
Our advice test and symphony often meet that need.
Importantly, the Symphony Copromotion agreement with Janssen It was amended in June 2020.
We're very pleased to report that during the second quarter, we recognize 2.1 million in revenue from our promotional efforts.
With our amended agreement, we have the option to renew our contract for an additional year to the end up 2022.
Given these unique value proposition as the once per month self injectable anti TNF biologic for rheumatoid arthritis is well positioned for today's environment.
On the reimbursement front. We also are very excited about our agreement with Humana military a managed care support contractor for Tri care East.
Which makes available all of our advice test as a covered in that weren't benefit to 6 million lives. We continue to negotiate with many large health care plans throughout the country and hope to announce new agreements in the coming months.
Although testing bottomed in April we have experienced sequentially monthly advice TD test volume increases from April 2020 of approximately 45% in Bay and 52% in June the company saw Lumpiness and geographic irregularities entering Q3, driven by resurgence in cobot 19.
Cases in the U.S.
Lending uncertainty to the broader recovery curve for Aehr test and Symphony.
Well on the subject of our test I'd also like to say a few words around R&D a key strategic focus is expanding our product offering and we remain committed to investing in R&D. We believe this is the key to growing our leadership position within rheumatology testing space. We're excited about agreement with Ohio State innovate.
Sure Foundation for the development and marketing rights of a blood test to differentially diagnosed fibromyalgia. This promises to be the first rule in rollout test for very difficult to diagnose disease with a large total addressable market.
Proof of concept for the fiber miles a test has been completed.
We're also developing a prognostic tests to help determine the risk of thrombosis in patients with lupus for both test further clinical validation studies are ongoing and planned we believe new products like these will strengthen that testing franchise that has given us the commanding presence in rheumatology and make excellent well position to execute on our vision.
Of owning the rheumatology hilltop.
I would now like to turn over the call to come all to discuss our financial results.
Thank you Ron and good morning, everyone.
Total revenue than Q2, 2020 were 8.9 million driven primarily by inviting BTD tapping volumes of 18522 compared with 20.5 at 993, a year ago, Judy impact experience from the Coven 19 pandemic the never ordering healthcare provider was 1442.
For Q2, 2020, compared with 1450 for Q2, 2019 and 1692 in Q1 2020.
Avant CGD taps revenue was 5.4 million in Q2, 2020, and other testing revenue was 1.4 million.
Revenue from the simply Copromotion agreement was approximately 2.1 million as we benefited from an amended prescription baseline overall, we're very pleased with the trajectory of our testing business. Following the April Bob which as a reminder, saw 56% year over year decline, we experienced sequential monthly abide CGD.
He test volume increases from April 2020 of approximately 45% in May and 52% in June initial indications suggest that July maybe in line with June volumes as some areas our reinstating stay at home orders.
Cost of revenue was 3.3 million in Q2, 2020, resulting in a gross margin of 63% compared to 52% in Q2, 2019 and 53% in Q1 2020.
The improvement in gross margin was driven by higher company revenues and is a good illustration of how the DXL ARX model offers positive leveraged our financials.
Operating expenses in Q2, 2020 were 12.4 million compared with 14.8 million in Q1, 2020, due to cost cutting efforts and a reduction and business activity such as sales t. any and direct happening costs.
Q2, we continue to take steps to reduce coffee and conserve cash we eliminated 12 sales positions and three other positions, leaving us with 50 sales are up and 56 territory, which provides a reach and frequency we need at this time.
The net loss in Q2, 2020 was 3.4 million compared with 2.8 million in Q2 2019.
Looking to our balance sheet cash and cash equivalents as of June Thirtyth were approximately 53.7 million.
We believe were well capitalized to endure any economic uncertainty associated with the coven 19 pandemic.
Regarding 2020 guidance, we do not believe that it is crude into offer formal guidance at this time due to lack of visibility caused by the fluctuation in cobot 19 activity. We will now open up the call for questions.
Thank you at this time will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation turn will indicate your line is another question can you maybe press start to if you'd like to remove your question from the Q.
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Our first question comes from the line of Chrisman from Cowen. Please proceed with your question.
Hey, good morning, Thanks for taking my questions.
Based on your commentary is curious that overall volume was about 95% abnormal in June is this right and I know you talked about comparable trends in July as we'd like to the balance of Q3, whether it be reasonable to expense.
Hey returns to growth.
But it.
Yes. Good question, Chris Yeah. The volume, we saw coming back on a daily basis, and it was and it continues to be approaching the pre cobot levels on a daily basis, so we'd like to see that volume come up and it continues to do so predicting the future is really hard with this co bid as we look out and we.
See that certain states are continuing to stay closed and others that were open or closing we're evaluating that on a daily basis I think the important point here is this there is no cure for lupus, which is a very serious disease that could lead to lupus nephritis or death, those patients aren't going away, even if the city's closed so we.
Fully anticipate there's a bolus of patients as these states open up they come back into the market and we get right back to our pre cobot trajectory, which was very solid as you'll recall 2019 was a record January was terrific February is terrific. So coming back from this and looking into the future I think we'll see.
See a return to these patients simply because there is no cure, but we do have to wait until the market until the state's open up and so these local much minutes of holidays also allow patients to go back into the Doctor's office.
Got it that's actually good segue to my next question could you help us perhaps quantify the bolus of customers are really you know how much pent up demand do you think there could be once things return to normal.
Yeah, what we heard from the physicians because we are doing a lot of tele health until marketing and getting a pulse on what's going on out there is that their normal course of patient load on average for community Rheumatologist call. It anywhere from 10 to 15 patients a day, they're down in some of these areas by half.
Path or even 75% so that bolus they fully anticipate will return.
They are they're just patients right now searching for it what we're seeing is a lot of inbound calls from patients asking for doctors in local areas. When they can't find one so we know that the demand is there to quantify the exact number I would say that your we're missing roughly 50% of those patients and they're going to come back in a big way I will.
Comment this Chris when they come back the test that is a solution for them is our advice CGD test because it's not only the lupus test, but with one blood draw you're getting the 11 generic markers of those diseases that most often overlap at this early too so as you'll recall before we joined the market lupus was.
It was diagnosed basically by cereal testing they would do one test every other week or every three weeks and bring the patient back with one blood draw you can do it all with it by CTG. So we think it's the appropriate test for what's going to happen when all these patients do return.
Got it Okay, maybe from my last question I believe even if you exclude the Copromotion revenue in Q2 gross margin was about flat on a year over year basis.
Is this right and.
Seems pretty good.
Hi, impressive given that diagnostics revenue declined 3% year over year. So can you just help us understand what drove this margin result in how should we think about the sustainability of this performance going forward.
The thing scrap I'll take that question you're right. The improvement we found gross margin was driven significantly from the revenue on the 70 co promotion the 2.1 million and 70 revenue was at 100% gross margin.
So we aggressively caught the variable costs in the lab to match the decline in volume.
The only thing we couldn't Cogs cop worthy fixed costs.
Okay, and then just how should we just thinking about the sustainability of that performance in Q3.
Now all the Ontario.
Sorry go ahead.
Yeah, I'd say, it's got to say that we're going to continue to like ours bar, especially in the lab to match the volume as we continued our profit ammo third of cold in 19 endemic.
Got it thanks for taking my questions.
Thanks, Chris.
Thank you. Our next question comes on line of Brian Weinstein with William Blair. Please proceed with your question.
Hey, good morning for American early morning for you guys. So I appreciate you do in this so early.
Couple of questions first on Simponi and the co promote there that 2.1 million was that some sort of a.
Kind of a catch up payment.
What kind of getting you guys to a certain level. He ended the quarter, because obviously that there was negotiations going on throughout the quarter.
Curious what that 2.1 represented but then also on Simponi, if you could comment on.
The potential range going forward I think it's right around 1.3 to 1.69, something like that as were where covenant for future quarters based off of the new deal and then anything else on.
Negotiations with Janssen for additional co promotes there so that's the Simponi side and then we'll do some others.
Great. Thanks, Brian appreciate it and yes. It is very early here.
The 2.1 million was a performance for Q2 and strictly Q2, and that's what impressed US a lot and it also impressed there are JNJ partners as well. So that was absolutely Q2 performance because if you think about symphony the only anti TNF thats once a month and you could take at home. It does have a lot of.
Utility again Thats a good solution for today's problems with Covance. So we're happy to see that as far as the range as we disclosed we have a range and we are continuing to look at that range and we think that the.
We're going to try to achieve everything we can to get to the top end to that the agreement is for a 5% above baseline as our cap and we will have a bottom which is 300000 guaranteed which is not what we're doing as far as a bottom.
We are going to we have that extension option, which I think is spectacular and shows the commitment that JNJ hasn't us.
The relationship is really strong Brian they really appreciate their efforts we're out there really making sure that to patients are being taken care of with their anti TNS into community rheumatology offices. So relationship strong we continue to have.
Talks about other things, we can do together, but at this point, we're really focused on driving symphony to the high levels that it should be.
Got it and then.
Brendan mentioned.
Sales reps here, how does that impact your view on kind of the business outlook longer term and your ability to kind of get back to the growth rates that we've seen how critical is it to have those additional numbers of sales reps in order to do that I mean, do you expect to retire.
Those positions as things get better or is this kind of the level that we should expect going forward.
Yes, a really good question and when we talk about a lot here, Brian we flex the head count the piece, we just flat out flex them to the needs that we need today in order to optimize the performance of the company and I think we did in fact I'm confident we did the right thing to flex to the areas that we did.
Going to long term, we'll continue to monitor the reach and frequency the field to see if it's necessary to add more FC ease or not.
It's something we're going to do as we see what happens with hope it obviously it doesn't make sense to higher rep, and let's say a state that you can't the doctors can even practice because they can't get out of their houses, but it does make sense to keep your in house sales growing so we've always had a good provider relationship department internally.
These are people that answer the phone that augment what the decentralized sales representatives do weve beef that up and we're going to continue to be set up because as doctors get used to doing zoom calls we find that at least right now it's been very effective we're getting to get a lot of a time attention with office staff and so forth and its various.
Mission from a cost standpoint, because when you hear centralized you can make a lot more phone calls and so forth. So to answer your question about long term, we're going to monitor it but this tele health until a marketing maybe a staple of companies in the future regardless of what happens with cobot as we find it to be enough.
Effective way to communicate the value of your products to the doctors.
Got it in along the lines of kind of what the future may look like here have you guys talked about in heavy worked with anybody about implementing any kind of mobile bother me to work with your physician partners to be able to test people in their homes for.
For our group is there other auto immune diseases.
Yeah, we have quite a few mobile flow battery contracts now and we continue to do those we also find doing contracts with community hospitals to be an effective way to get the phlebotomy as well. So we'll look at whatever it takes we often remind doctors that they can know they know how to draw blood too.
They did go to medical school and those doctors can draw blood and if they see the value of the test. They do it themselves. So we'll continue to add more mobile full body Theres really no national company to contract with so it's almost on a state by state or even to ZIP code by ZIP code level.
But when necessary we have no problem doing that if it enables the proper.
Utility to get the blood to US. We also have to capillary test just to remind everybody and those tests or at home test. So you can test your methotrexate most widely used drug in rheumatology today, it's usually used for Ari or you can measure your HPQ your hydro actually chlorine with their touch Tesija capital.
Were tested patients can do at home, but for our big test for advice CGD, we will do whatever we can to enable the proper phlebotomy for those patients.
Great. That's one for me is on Humana and the deal that you strike.
People network can you give us some idea about where price leukemia, and obviously you won't be exact here, but relative to your average Tesla average.
Now I think it was $711 that you guys you've talked about in your dossier.
Give us some idea about kind of the range, where this style and.
I'm, assuming this would be nicely accretive to.
To your ASP.
Yeah, we're really excited about it because obviously this is how you get it started right. So we did the dossier, we got the demand and now you start to get in networking covered through each payer. So we're really excited about tri care and Humana and all the other negotiations that are ongoing because our dossier really does illustrate.
The value it has the patients and the payers to your point that healthcare economic study showed that you can actually save money by using our test upfront, we're not revealing each contracts.
Contract specific on the Asap.
But I'll, let you know what this does do it opens up our test to a lot more patients and that's the key too so.
We're excited about this Brian we think it's it's a contract is the first of many to come and we're excited to see where it leads but the rest of this year, we'll continue to drive more.
More contracts and definitely March towards that higher as a SP that is a goal with these contracts. That's why we do those going forward. When you start these like the first when we have we're also looking increasing the utility of brand beyond just a few patients, but enabling to be used for many many more patients within the system.
Thank you.
Thanks, Brian.
Thank you, ladies and gentlemen, as a reminder, if you'd like to join the question. Please press star one I knew telephone keypad at this time.
Our next question comes from the line of Kyle Mccann with Cantor Fitzgerald. Please proceed with your question.
Hey, guys insulating the question.
So now you're talking about patient flow in the backlog at your practices, but I'd have to it but can you just talked about some of the current trends at.
In those regions are markets that are experiencing surges in covenant balance right now like Texas, Arizona, Florida, I know you have us all corporate in those areas. So just curious you can provide any color there. Thanks.
Sure. Thanks, Kyle good good question, So we saw Florida do extremely well.
Early on then they went back and shut down and whats interesting here because we are a CLIA lab I know today, how many orders we got yesterday, so I know, which cities are opening close so we saw Florida come back Roaring and then slowed down same thing happened to actually in a lot of the ZIP codes in Georgia, Texas as well as Arizona.
Those are strongholds for us in that definitely affects us what's interesting, though as we've been doing a lot of tele health and tell a marketing with those doctors there.
And their unwavering so we know when those patients or turn those doctors because our adopters as you can tell over 90% stickiness.
We'll come back to using our test and again I want to remind everybody that our test advise CGD is not only the best lupus test, but it has all the other marker. So it's a very convenient test for when this bullets comes back they can't do where they can but it's going to be difficult for them to do go back to cereal testing when you have a waiting room.
The patients in a whole bunch more waiting to get in so the convenience a one blood draw that can do it all I think it's going to play in real well as this bolus of patients come back as far as the trends per state. We monitor it constantly it does appear to be in Texas. It appears to be coming back largest a little flat George is coming back.
Nicely and Arizona, partially because it's July in Arizona.
We're seeing that slowed down as the Snowbirds go now we'll say this with this northwest agreement we have in Arizona, We do have a high expectations for Arizona coming out into the fall when the snowbirds come back to Arizona.
Anything else Kyle.
No I mean, that's pretty helpful is absolutely great color, but I was curious talks about payer mix now that kind of trended throughout the quarter as well and I guess, how what kind of looking in July also and maybe what you're expecting in the second half the year as well just given elevated unemployment rates and.
Et cetera.
Yes. Good question. So we have a lot of programs if patients call in.
We have a lot of programs to enable them if they can't afford the the product and try to get them to do get on payment plan and so forth. So we have mechanisms there to help those patients as their cobra.
The ends actually but just coming up soon for a lot of patients.
The payer mix hasn't really changed we get paid by everybody because we do CP take those stack, if we're not covered and network. So we do get paid.
We as we March forward and get more the contracts. It goes back to the earlier question. That's how we're going to drive our ASP going forward, but the payer mix has been consistent and we don't see any reason why wouldn't be for the remaining part of this year.
Okay, and then I may ask the I know you touched on earlier, but I think and Tri care at kind of phase three imbursement on Medicare racist I'm. Just wondering if you think theres going to be a.
Material impact on SP distributed this new Tri care coverage and then also on the Tri care.
Agreement, yet very encouraging, but just given that.
He manages the contractor for Tri care is that kind of kind of help your relationship with Humana in terms of expanding coverage to the rest of humana's book of business as well.
Well, that's obviously the desire we do have meetings with Humana set up and were continuing scheduled more we have meetings with tri care west and their their payer as well there contractor as well. So all those are all those payers. We are driving forward to meet him. We think this is such an.
Important test in an area that has such a great unmet need.
I do want everybody to recall that this is potentially a deadly disease or could lead to lupus nephritis arup removal of the kidney and if you can treat these patients early because you diagnosed and correctly early you could actually save them a lot of pain at heartache and extend their life to a normal range. So it's really important to get there and the fact that the dossier.
Is done and it's now the demand is up to a point.
As we have these contracts and as we have these negotiations we fully expect coverage in the network in most of the payers going forward.
Getting back to your question as far as though the HP. It should increase as we get these contracts. The first few are always the most difficult, but as you get to that tipping point and you have momentum.
Actually it gives us a lot more confidence and being able to negotiate a higher hsp as it gets going you have to get started and get the momentum going so some of the early contracts may not be at the highest level that we desire look going forward as we get each one it becomes again, we get a little bit more confidence and has we negotiate these.
Okay. Thanks, that's that's interesting.
And then I, just I want to squeeze one more in here, but the pipeline. So have you begun planning for your fibromyalgia dossier, yet and then just remind us of the timelines in terms of hydro test and when we could expect revenue contribution from that as well just recognizing that there's probably three years out but just curious.
Yeah. This is really exciting for us the fibrosis as a very very difficult disorder to diagnose. It also often appears clinically like lupus, which is really important understand these patients end up in a rheumatology office and they present like a lupus patients I got rashly got a headache, I'm tired fatigue I got brain.
Doug.
And clinically the Doctor has to differentiate which is a potentially chronic disease or was potentially deadly disease and that's a big differentiation. One takes steroids lupus one does not take share, which you'd hurt the patient so understanding the difference between those two at the community Rheumatologist level is really critical.
The timelines, we're pushing as fast as possible, but science takes time and we do quality science here the highest stage collaborations terrific. They got a lot of really smart people.
We have incredible medismart people here with our CFO and CMO.
So it's going to take time, we'll try to speed it up as much as possible, but not at the risk it not doing the right studies for the dossier or an appointment as dossier here too is.
As we talk to payers they realize that these fiber patients do eat up a lot of economics in an office they hang around a lot the doctor shop, because they know something is wrong with them. They can't get a definitive diagnosis. So we think we're going to have a.
A willing participant to make sure we differentiate fibrosis from lupus going forward. So this a really really important project for us will step on the gas as much as possible as long as we don't risk of the quality of science.
Okay very helpful. Thank you so much and I'll leave the rest for a follow up congrats again, great. Thank you.
Appreciate it.
Thank you once again, if you asked a question please press star one.
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Our next question comes online Mark Massaro with BTG. Please proceed with your question.
Hey, guys. Thanks for taking my questions.
Congratulations on recognizing the revenue for Simponi.
I know historically your baseline I believe was at 29000 units per quarter of Ron I think you talked about.
Some metric about 5% above our particular baseline.
I guess was the baseline lowered in the quarter and if it wasnt can you just speak to what drove the success in Q2.
Yes, I'll take the last one first what drove the success I think was the fact that the quality of the representatives. We have is outstanding and we have the methotrexate test. So methotrexate is used along with anti TNS, it's actually in their package inserts, so being able to discuss the methotrexate level along with the anti.
TNF I think engages the doctor and a more meaningful subject matter and I think that has a lot to do with it also what can't be lost is the fact that if you're immunocompromised patient do you really want to go to infusion center with a bunch of other immunocompromised patients during this cobot period.
It seems to me to be a safer alternative it's the only once a month MP TNF that you can take at home and I think doctors are realizing that the baseline is 26000 and what we're looking at is 5% above the baseline for Q3 in Q4, we like this product from a financial standpoint, because almost 100% gross margin.
And we like it from the standpoint, it validates the DXL Rx model and also it's a relationship which we think is a very important company Johnson and Johnson.
That's super helpful. I also wanted to ask sort of a bigger picture pipeline question.
Recognizing that lupus can certainly caused damage to kidneys and other.
Vital organs.
Where are you guys as you think about.
Helping product or maybe talking to partners about.
Advancing Oregon, whether its organ transplant or kidney damage.
Yes, a really good question marks so the great thing about the complement system and CB caps itself, which is the fragment the cleaves office C. C. Four in covelli bonds to sell the great thing about that is when it comes to transplants complement has an active role.
So I can share with you that our scientists are very interested in looking at more of that.
We have had ongoing discussions to look at markers to better enable perhaps a stronger lupus nephritis product. So that is an area we're interested in.
Broader way to your point.
I can't divulge too much other than say that it's on our radar.
Understood and then maybe final question for me.
How is your conversation with commercial health plans going relative to your expectations I know that you had a lot of meetings on the schedule after having submitted the dossier.
But how should we think about commercial health plans potentially coming on.
In Q3 in Q4 here.
Yes, we have a lot of meeting set up it's a little more difficult would zoom in that you have to bring in so many people coordinated.
But we are continuing to push forward with these meetings.
There's a couple of things to keep in mind. One is there is a recognized problem with trying to diagnose systemic lupus erythematosus correctly and early and the payers no. It we know the patients now what the doctors know it is well documented to is our dossier is done and it answers the questions of clinical valid validity clinical.
Utility so we answer those questions and from the healthcare economics, we don't really burden the system. So we think we're in a really good position to have these discussions because the payers who want to help the patients we want to help the patients and right now based on the solutions that are out there. We think CB Cafs offers the best solution to help these patients correct.
We get diagnosed and treated so they can lead to more normal life and at the end of the day as healthcare companies. That's what we're about so I'm looking forward to these discussions going forward and having a lot more discussions about how we can help more of these patients.
Last question for me.
I know you guys had a pharma royalty kind of roll off I think it was in January of this year.
When should we see the benefit of that roll off benefit your gross margins.
Yes, mark that royalty expand.
Came off on January seven.
Is paid for royalty pharma and with 10% honor. The path now have done before January seven but a lot to after January seven it's still going to have an expense crop. So every quarter, we're going to the that amount the crude so slowly coming off above.
We do anticipate and to be completely off of within 12 months of the January seven days.
Understood. Thanks, guys for taking my questions.
Thanks Mark.
Thank you ladies and gentlemen, this concludes our question and answer session I'll turn the floor back to Mr. Walker for any final comments.
Right I just want to thank everybody for their time. This morning early morning do appreciate it very very happy with the way Q2 or two turned out we have a mission here to help patients and that's our drive that's what keeps us focused and we think we have products that will enable the doctors to assist us patients even better. So again. Thank you for your time, we look.
Forward to discussions in the future take care and have a wonderful day.
Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.