CareDx - Earnings Call - Q4 2016

Transcript

Speaker 0

Good day, ladies and gentlemen. Welcome to the CareDx Business Update. At this time, all participant lines are in a listen only mode to reduce background noise, but later we'll be holding a question and answer session after the prepared remarks and instructions will follow at that time. As a reminder, today's conference call is being recorded. I would now like to introduce your first speaker for today, Carolyn Corner.

You have the floor.

Speaker 1

Thank you for participating in today's call. Joining me from CareDx are Peter Maag, President and Chief Executive Officer and Charles Constanti, Chief Financial Officer. Earlier today, CareDx released preliminary financial results for the quarter and year ended December 3136. The release is on the company's website, ww.caredx.com. Before we begin, I'd like to remind you that management will make statements during this call that include forward looking statements within the meaning of federal securities laws, which are pursuant to the Safe Harbor provisions of the 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. All forward looking statements, including without limitation, our examination of historical operating trends and our future financial expectations are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to materially differ from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements. For a list and descriptions of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission.

RDX disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward looking statements, whether because of new information, future events or otherwise. This conference call contains time sensitive information and is accurate only as of the live broadcast today, March 1537. I will now turn the call over to Peter.

Speaker 2

Thanks, Caroline. Good afternoon, everyone. With so much news flow on financing and AlloSure, we thought it would be best to update you by pre announcing our results and providing a business update. Thanks for joining us on short notice. As we do on all of our calls, I would like to first recognize transplant patients.

Let me start this call by thanking the approximately 400 kidney transplant patients that provided their consent and blood samples for our landmark cell free DNA study DART. Thank you for your selfless contribution to the advancement of transplant science that promises to improve patient management. This call starts a new era here at CareDx. After becoming a public company following the IPO in 2014, we had an acquisition year in 2016 and we are now turning the page to start the AlloSure launch era. With our preliminary full year 2016 revenue of more than $40,000,000 compared to $28,000,000 in 2015, we executed on our strategy to deliver organic and inorganic growth in a specialty diagnostic therapeutic area.

As we report another quarter and look back over 2016, it is gratifying to see how our team has delivered on these growth objectives, while at the same time resolving a number of operational items, including our collections catch up and activities that are related to the acquisition. We now have a clear path ahead. We feel very well positioned for the launch of our exciting new product AlloSure. With both pre and post transplant products encompassing the continuum of care, we have become a transplant focused multi product genomic information company. We are following a clear defined strategy by focusing on a specific therapeutic area transplantation with a broadening product portfolio, we generate deep insights into a complex disease area that has been and will continue to be heavily impacted by the genomic revolution.

As transplanted organs continuously interact with a host immune system, we gather unique dynamic insights into the recipient's patient's immune response. The long term monitoring of transplant patients is essential to ensure and maintain positive outcomes for patients and is also economically attractive to us and global healthcare systems as we put personalized medicine into action. Like on prior calls, I'm going to walk you through our pre transplant efforts before moving to our post transplant activities. After that, I'll ask Charles to discuss our preliminary financials. Following the financials, we look forward to your questions.

The fourth quarter was strong for the pre transplant Olaroz business line, generating preliminary revenues in the range of 3,400,000.0 to $3,500,000 Our Olaroz product line offers best in class HLA typing solutions for transplant labs that are matching organs to recipients. You can find Olarup products in more than 50% of HLA labs around the world. Last September, we launched Olarup QType to drive further growth in our pre transplant business. Olorep QType is a real time PCR based HLA testing solution that allows for accurate and rapid turnaround typing. Reception to QType so far has been very positive.

Since launch, we have held already 23 demos in transplant centers in The U. S. And Europe. We look forward to reporting back to you with a CE marking process and the validation of additional instruments beyond the Roche Lifecycle. As we have previously outlined, olaributide addresses the $30,000,000 market opportunity and we think that a 30% market share for CareDx should be achievable within the three to five year timeframe.

Also in pre transplant, in the first quarter of twenty seventeen, we acquired SPT Resolver, HLA typing products from Illumina, maintaining and adding a source of inorganic growth. We were already selling this product line into many markets as a distributor of Illumina, but now with the acquisition completed, we have full control of the supply chain and we have a strategic foothold into the sequencing market. With the strong efforts in the pre transplant business on core and launch products, we expect revenues to grow in the mid single digit range. Moving to post transplant, our core product AlloMap is the high value diagnostic testing service that helps monitor heart transplant patients for the risk of rejection. Preliminary AlloMap revenues for the full year 2016 were in the range of 29,500,000.0 to $29,700,000 with a volume growth of 8.4% year over year.

The preliminary Q4 revenue range of 7,200,000.0 to $7,400,000 reflects continued alumab test volume growth at 5.5%. You may recall in July 2015, we made a strategic decision to bring billing and reimbursement activity in house and we are proud to be at the end of this transition. We are now close to the percentage of reimbursed AlloMap where we were before the change. Now we have the insights and infrastructure in place to further advance our collection efforts in the future. We provided approximately 3,600 AlloMap patient results in the quarter in line with our expectations.

For the full year 2016, we provided 14,100 AlloMap patient results, an accomplishment that we are proud of. In 2016, our acquisition year, we also successfully defended the rationale and basis for pricing AlloMap with CMS. We have achieved a 1% price increase for AlloMap to a reimbursement rate of 2,840. AlloMap now has a CPT code and has been published in the final clinical lab fee schedule for 2017. We have prepared the pricing of AlloMap for the implementation of the PAMA rule and will submit a weighted average median price of $3,240 for AlloMap based on the payments from private payers between January 2016 and June 2016.

If approved under the PAMA rule, this price becomes effective in January 2018. With this clarity on Alimar pricing, we can now focus on what we do best, providing the best possible care for transplant recipients, a very high need patient population and partnering with leading global medical institutions to deliver that care. Our team has made great progress on our AlloMap lifecycle management activities. AlloMap score variability, a tool that allows clinicians to identify patients at risk of poor long term outcome is now available in 59 centers. Following a successful pilot in Tampa and Newark, we are expanding our customer engagement program from 100 to 600 patients.

With our white glove approach, CareDx is supporting the establishment and adherence to center specific protocols. By directly interacting with patients, we support the scheduling for the AlloMap blood draw and ensure that the AlloMap result is available in the hands of the physician in a timely manner. With underlying growth in available heart transplant and traction with our initiatives, we believe that outgrowth in the mid single digit range is well achievable going forward. Now we had good news on Olarup, great news on AlloMap. Now we move on to the top priority for the company in 2017 AlloSure.

AlloSure is a clinical grade next generation sequencing testing service to detect transplanted organ injury. You might have seen the landmark publications for AlloSure in the Journal of the American Society of Nephrology and the Journal of Applied Laboratory Medicine, which define the value proposition of the high value molecular tests. Most kidney transplant patients that are healthy and stable have a cell free DNA from the organ circulating in the bloodstream at around 0.21%. If the next AlloSure result is elevated beyond zero point three five percent, this suggests a significant increase and is above typical biological variation in stable patients. Patients who have more than 1% donor derived cell free DNA are likely experiencing an active rejection.

The AlloSure test detects dynamic changes of the host immune system attack on the donor organ, and therefore may be used as surveillance tool, as a tool to complement or replace biopsies, as well as potentially a tool to track the success of immune suppressive therapy. We are at the exciting beginning of how to use this powerful diagnostic tool in the clinic. CareDx's dedication to high levels of evidence and support of clinical outcomes will keep CareDx in the lead in transplant patient care. We believe that AlloSure is a specialty blockbuster diagnostic opportunity with a potential to achieve more than $200,000,000 in revenue. Now how do we get there?

Let me highlight four points. Transplant centers are a highly concentrated customer group. They are our current customer base and we have established strong relationships. We will market AlloSure to roughly 200 kidney transplant centers in The U. S.

Starting with centers where CareDx has an established presence through AlloMap and a clinical trial presence through DART. Second, AlloSure reimbursement single payer with an established relationship. Eighty percent of kidney transplant patients are Medicare patients. Medicare through its MolDEX program is well advanced in understanding the value proposition of evidence based molecular diagnostic tests. We have enjoyed support from MolDEX in the past through AlloMap and we believe AlloSure provides similar clinical benefits to physicians and patients.

Thirdly, AlloSure repeat testing. Similar to AlloMap patients on AlloSure will follow a surveillance protocol providing a recurring revenue opportunity with multiple tests provided. And for the last AlloSure revolutionary technology. Targeted sequencing technology provides for fast turnaround time and competitive cost of testing. The approach of measuring cell free DNA is already a proven game changer in oncology and prenatal testing.

We look forward to update you on our launch strategy in the future. Now we are focused on working with CMS for AlloSure reimbursement. There are three important phases of the MolDX program, the technical assessment review, the local coverage decision and reimbursement pricing setting. We are currently in the technical assessment stage. After only seven days, our dossier was accepted by MolDex on November 7 and we are in an approximately ninety day review period.

After the technical review, the local coverage decision process includes an important meeting in June of the relevant MAC administrators during the coverage proposals will be considered. Subsequent to a local coverage decision, we will engage in pricing discussions. We have shared with you previously that we continue to leverage our existing resources for product launch and we'll go into full commercial launch mode once we have reimbursement. We anticipate that we will have completed the reimbursement process towards the end of twenty seventeen. Good news on Olarup, great news on AlloMap, exciting data on AlloSure.

Now on to our financing. We are very pleased that we have a new senior secured convertible note in place with JGB. As we mentioned before, the timing of access to new financing and equity was impacted by the uncertainty about the amount of AlloMap Medicare reimbursement in 2017. With the pricing resolution in November, we initiated financing efforts. We are happy to partner with JGB, which allows us to execute on our growth plan and provides optionality in support of the AlloSure launch.

Under our prior East West Bank facility, CareDx was required to make monthly principal payments through the end of the agreement in 2018. With this new agreement, the company will make interest only payments on the debt through March 2018, thereby providing liquidity in advance of the AlloSure launch. The new facility was closed and funded today. With the financing in place, we closed the acquisition year and can move into the AlloSure era, which will once again transform CareDx. We are thrilled to build a transplantation centric organization.

While our commercial focus performance metrics will continue to depend on patient results provided and test sold, we will build on our vision to build a genomic information company in transplantation. Looking ahead, we have several milestones that we are excited about and you should monitor. AlloSure reimbursement and launch updates with a focus on ATC in the April, continued growth with the ISHLT Congress coming up next month, and the olaropuputide launch updates at Effie in May and ASHI in September. I will now turn the call over to Charles to discuss our financials.

Speaker 3

Thank you, Peter. Closing the convertible debt financing today was an important step in securing financing for the launch of AlloSure. The $27,800,000 senior secured convertible note has a 9.5% coupon, can be converted into CareDx common stock at a share price of $4.56 representing 100% premium and has a thirty six month term. 1,250,000 warrants with a five point five year term exercisable at $5 per share were issued as part of the financing. The warrants become exercisable in one hundred and eighty five days.

Beginning in twelve months, the note holder can put up to $938,000 per month with puts being in stock or cash representing amortization of the loan principal. If CareDx chooses to fulfill the puts with common stock instead of cash, the common stock price will be the lower of 12% discounting or $5 Following the $11,200,000 East West Bank payoff, CareDx will have cash of approximately $21,600,000 including restricted cash of $9,400,000 Moving to our preliminary results for 2016 and the fourth quarter. Preliminary full year 2016 revenue is in the range of $40,400,000 to $40,700,000 compared with $28,100,000 in 2015. Preliminary fourth quarter twenty sixteen revenue is in the range of $10,600,000 to $10,900,000 compared with $6,600,000 in the fourth quarter of twenty fifteen. The year over year increase in revenue reflects three drivers.

First, AllRep contributed revenue in the range of $3,400,000 to $3,500,000 in Q4 and in the range of $10,600,000 to $10,700,000 in 2016 following the acquisition of the AllRep business in April 2016. Second, U. S. Test volume grew 8.4% in 2016 and five point five percent in Q4, contributing to an increase in AlloMap revenue. AlloMap revenue is in the range of $7,200,000 to $7,400,000 in Q4, up from $6,700,000 in the prior year.

For the full year 2016, AlloMap revenue is in the range of $29,500,000 to $29,700,000 This is up from last year's AlloMap revenue of $27,900,000 For the year ended December 3136, our preliminary net result is in a loss range of $41,900,000 to $39,300,000 compared to a net loss of $13,700,000 in 2015. In Q4, our preliminary net result was in a loss range of 17,900,000.0 to $15,300,000 compared to a net loss of $4,800,000 in the same period of 2015. In Q4, we incurred a preliminary impairment of goodwill recorded in the acquisition of Alonex in the range of $12,800,000 to $14,900,000 Our results in Q4 also include $700,000 of other income connected with the settlement of legal matters with Oberlin Capital and the NASDAQ Stockholm. Settlement payments for these matters totaled approximately $700,000 which was less the $1,400,000 accrued for the Oberlin matter in early twenty sixteen. Turning to guidance.

For 2017, we expect revenue to be in the range of $45,000,000 to $50,000,000 Our guidance is based on AlloMap and Alluref revenue and excludes any potential revenue from AlloSure. I'll turn the call back to Peter for closing comments. Thank you

Speaker 2

so much, Charles. Great job. Based on our core AlloMap expertise, we have built a multi product company with a focus on transplant care. Following the acquisition year and with the financing place, we can now focus our attention on AlloSure. With the ultimate vision of building CareDx into genomic information company in transplantation, we will have a series of exciting milestones coming up.

We appreciate you joining the call. We are now happy to address any questions.

Speaker 0

Ladies and gentlemen, the question and answer queue is now open. You may use star then one on your keypad to queue up for a question. We'll be taking our first question from the line of Bill Quirk from Piper Jaffray. Your line is open.

Speaker 4

Great, thanks. Good afternoon, everyone. This is Alex Nowak on for Bill today. So just on the pre transplant side, I know you didn't own the business in Q4 twenty fifteen. But just based on our math, looks like it declined about 13% or around seventeen percent year over year in Q4 twenty sixteen.

I was just curious what's going on there?

Speaker 2

Thank you so much for the question. What you see in the pre transplantation business that you have an effect of core products existing going forward and the new launch products coming in. There's also a significant FX effect in the business given that it is Stockholm based and most of the revenues are actually ex U. S. You probably appreciate that the U.

S. Dollar and monitoring that much closer.

Speaker 4

Sure. Okay. That makes sense. And then can you provide some more color on the impairment of goodwill with Alenex?

Speaker 2

Yes. I'll turn that over to Charles. But based on our acquisition case centering around the growth of the future business, we had significant accounting charge. Charles?

Speaker 3

Yes. So I mean the goodwill impairment test is something that one has to look at annually. So it is very much an accounting exercise, but it reflects impacts of our long term forecast as well as the impact of the weighted average cost of capital associated with a small cap company. The weighted average cost of capital for a small cap company is relatively large And that brings in a dynamic of significant discounting on our future cash flows associated with the business.

Speaker 4

Okay. That's helpful. And then if I remember correctly, I believe there was about 5,700,000 deferred consideration due in Q1 of twenty seventeen. Is that correct? And is that still in the forecast?

Speaker 3

That's correct. That would still be on the balance sheet.

Speaker 4

Okay, perfect. And then just last question for me. I was hoping you could clarify the timing on the AlloSure reimbursement. So it sounds like you haven't heard back from CMS on the tech assessment yet, even though we're past the ninety day review period. And then am I correct in saying that the test has been accepted for discussion at the LCD meeting in June?

Speaker 2

Then normally what happens is the technical review process is concluded prior to scheduling the local coverage decision. So I think you're on the last question, we would be waiting and finalizing technical review. You're probably, as you can imagine, there's a lot of back and forth and interaction on that in the technical review process, as we're bringing MolDEX up to speed what AlloSure can offer and provide. So there's a lot of going back and forth. But I gave you the timing of this meeting in June as an important meeting, which we focus very heavily on as a company.

Speaker 4

Okay. Thank you.

Speaker 0

Thank you. Our next question comes from the line of Bill Bonello from Craig Hallum. Your line is open.

Speaker 5

Hey, great guys. Thanks a lot. So a few questions. Just first of all, you had a couple of different publications recently and I think in terms of demonstrating the clinical value of the test, they probably got to different endpoints in terms of what they were trying to demonstrate. And I'm just wondering if you could elaborate a little bit on each of those studies, what they were trying to demonstrate and the difference between the two.

Speaker 2

Yes, absolutely happy to Bill. Jason is really the landmark publication for the product. Jason is the mainstay internal for nephrology, very, very high penetration around nephrologists in the country, or actually worldwide. What we're demonstrating in that, publication through our DART study, that AlloSure can differentiate patient populations with active rejections from those patients that have no active rejection. And keep in mind that this is done against the biopsy standard, which by definition is a very, very poor standard given on all the limitations that biopsies have.

You're And probably familiar with the limitations of biopsies because of the sample error and all the other issues that they're there. So AlloSure and Jason demonstrate that we can detect rejection. Even more important, I think, for the product into commercial validity is the JAL presentation publication where we demonstrate what are the cell free DNA levels on a healthy stable population. And there you see AlloSure measuring 0.21 as the median score, which is very exciting low, because with the second point to that is the bio variability that you see as if this increases to 0.35%, there's actually something going on in the patient. Which allows us to then monitor these patients on a closely basis to say what happens actually if the AlloSure is increasing.

So, Jason is all about what does rejection look like and JALN is all about how does it look like in a healthy stable patient population.

Speaker 5

Okay, that's very helpful. And the concept of the latter would be that presumably you'd be able to use that for surveillance purposes and trying to sort of get the greatest degree of efficiency in terms of immunosuppressants, etcetera?

Speaker 2

You hit it on the nail. Jason is about replacing biopsies. Chown is about surveillance of patients.

Speaker 5

Okay, that's really helpful. Just following up on one of the previous questions, I guess there was seem to be some implication in the question that maybe you had passed some kind of critical timeline in terms of when you would have expected to hear a response from this technical group. I don't think you were saying that, but can you just elaborate on that? Is there any concern with the dialogue that's been going on with CMS at this point?

Speaker 2

No, to the opposite. I would say that we, you know, getting to know is always easier than having a clear yes. We are in the ninety day review period. We started in the November. We are towards the end of this ninety day review period and we feel good about where we are.

This is a process which we are undergoing. And I think as previously said, I think June is very important month for AlloSure and CareDx.

Speaker 5

Okay. And maybe just for those of us who are less familiar with this, maybe what confused people was you call it a ninety day review period. You say we're in it, but it started in November. And I think that that maybe is creating some confusion because it would seem like we've gone past ninety days, But maybe just explain that.

Speaker 2

And Bill, I thank you for pointing that out. But it is the world of molecular diagnostics reimbursement, different than to the FDA world, right, where there are time clocks. This seems to be a little bit more fluid in terms of the timing. But we feel good on where we are on the product right now.

Speaker 5

Right. So just to be clear, there's no hard and fast ninety day review time period?

Speaker 2

Well, this ninety day review period I think you find on the website of MolDX, I think somebody referred to them as indicative in length.

Speaker 5

Right. Okay, perfect. That's very helpful. And do you have in terms of being positioned to be part of the LCD meeting that's coming up this summer, what degree I know you won't get scheduled on that until you finish with the review process, but what degree of confidence do you have that you can make it onto that agenda? And if you don't, sort of what's the next timeline then?

Speaker 2

I think the agenda is set a few weeks prior to the meeting. So there's still ample time since it is in June in order to get on the agenda of this meeting. I feel good on where we stand on the product. The interactions have been very constructive and positive. So I feel good where this is.

As with any technical review, there's always questions and things going back and forth. I feel good on where we stand.

Speaker 5

Okay, that's very helpful. And then just in terms of with the financing and the cash that's on the books now, what are your thoughts on cash burn over the course of the next year and particularly the next couple of quarters as you continue down this reimbursement and launch phase?

Speaker 2

As I mentioned, we're very happy with working with JGB. I mean, this facility allows us to run really hard and far with the AlloSure launch. So, I'll let Charles talk about, the financing need. But given our current cash position, I think we have increased tremendously our optionality here.

Speaker 3

I think in terms of cash usage in normal operations, we still no change to our current trajectory which is that 3,000,000 to 4,000,000 per quarter range as we continue to invest in AlloSure and move into the AlloSure launch phase. In terms of overall kind of financing needs, think this financing really gives us choices. Our key focus number one for ultimate use of cash is the AlloSure and the AlloSure launch. As you know, we have outstanding obligations to the former majority shareholders and we have flexibility as we work this out.

Speaker 5

Okay. That's very helpful. Okay, you guys. Thanks very much. It'll be exciting to see what happens as we move forward on the reimbursement and launch process.

Speaker 2

Thank you, Bill.

Speaker 0

Thank you. Our next question comes from the line of Caroline Ivan Santo from Janney Montgomery. Your line is open.

Speaker 6

Hi, good afternoon. Thank you for taking my questions. Peter, the year over year growth of arlumab was lower in the 2016 than in the first half. What is the growth rate that you bake in your 2017 guidance for this franchise?

Speaker 2

We had a mid single digit range in the script and I feel good about that guidance.

Speaker 5

Okay,

Speaker 6

thanks. And then as a follow-up question on your recent publication, out of the 107 samples studied, twenty seven came from patients presenting with rejection. Can you comment on any plans on expanding your patient population that the population of patients that present rejection? And you also mentioned that you have been going back and forth with Medicare's tech assessment. And I was wondering if there have been any concerns around the number of patients that present in projection, if it's a sufficient number really.

Speaker 2

Yeah. And thank you very much for the question. DART is really a landmark publication and the Jason is a very strong journal with a very high impact factor. So we see that as a great validation of our approach and our strategy. Now in terms of transplantation, when you look into 400 patients in 14 centers, that's actually a very substantial trial.

And if you look into rejections and the numbers that you're mentioning in the twenty seven, thirty range, is actually for a transplantation trial pretty strong. These rejecting patients actually did have antibody mediated rejection and acute cellular rejection, both rejections, which is very strong, and AlloSure demonstrated ability to detect both. So in terms of the validity of the trial, we

Speaker 0

feel very, very good.

Speaker 6

Okay, thank you.

Speaker 2

Thank you, Caroline.

Speaker 0

Our next question comes from the line of Bill Bonello from Craig Hallum. Your line is open.

Speaker 5

Hey guys, thanks for being willing to take another one. Peter, you had mentioned and I forgot to ask about this. You had mentioned when you're going through sort of the commercialization game plan that the first part would be to focus on the centers where you have overlap with AlloMap and then the centers that participated in the DIRT study. Can you just give us a sense between the two, either places where you currently have AlloMap overlap or they participated in DART, you know, many of the 200 kidney centers do you think kidney transplant centers do you think you already have some relationship with?

Speaker 2

Yeah. And there are about 200 relevant kidney transplant centers. There are about 130 heart transplant centers. There are only 30 centers that do only heart. And 100 of the 200 are doing heart and kidney.

So there's a huge overlap of these two. If you then contrast that with 50 centers in kidney transplantation do fifty percent of the number of transplants, the target group is really small for us to expand. So, overlap with our AlloMap targets. And if you were to take AlloMap targets plus 50, you are substantially covering the universe of kidney transplant centers. Huge overlap.

Speaker 5

Okay, that's great. And some of those 50 that you're talking about that do the fifty percent of the transplants, those are overlap centers, I assume, some of those 50?

Speaker 2

Absolutely. So 35 of those are heart transplant centers as well. And I'm giving you rough numbers, but that's the ratios.

Speaker 5

Okay. All right. So these are great. This is helpful. These are places you already have established clinical and sort of operational procedural relationships.

Presumably their centers sort of know what's coming down the pike as well, right? I mean, they're waiting to see what happens on reimbursement and whatnot. But it's not like you're starting from ground zero with these centers in terms of communicating the cell free DNA or kidney transplant concept?

Speaker 2

Absolutely. And when you think about the DART trial where we had 14 centers and think of those as the nucleus of the commercialization strategy. We have 14 centers already in the DART trial, which is the bridgehead into the launch. So, not surprisingly, out of the 50 centers, you would probably find the 14 DART centers being part of the 50. So strong penetration already.

Speaker 5

Okay. And then just one other commercialization question that probably leads into the cash burn question as well. Do you go through a phase where you're testing patients but not getting reimbursed? Or do you not really start doing any kind of meaningful testing until you have secured reimbursement?

Speaker 2

Being a small company and very focused and continuously driving AlloMap, we continue to focus the commercial operations on the AlloMap growth plan. We'll only switch into full commercial launch mode once we have reimbursement. So we have held back our current efforts and focused them continuously on AlloMap. This will then dramatically change once we have reimbursement of course.

Speaker 5

Right. Okay. All right, great. That's very helpful. Thank you.

Speaker 0

I'm seeing no other questioners in the queue at this time. So I'd like to take the time to thank everyone for their participation in the CareDx business update. This now concludes the program and you may now disconnect at this time. Everyone have a great