Natera Inc (NTRA) 2018 Q1 法說會逐字稿

Welcome to Natera's 2018 First Quarter Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded today, May 8, 2018.

I would now like to turn the conference call over to Michael Brophy, Chief Financial Officer. Please go ahead.

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our first quarter 2018. Also on the line is Matthew Rabinowitz, our CEO. Steve Chapman will be joining for Q&A. Today's conference call is being broadcast live via webcast. We will be referring to a slide presentation that has been posted to investors.natera.com. A replay of the call will also be available at investors.natera.com.

During the course of this conference call, we will make forward-looking statements regarding future events and our anticipated future performance, such as our operational and financial guidance for the full year 2018, our assumptions for that guidance, market size, partnerships, clinical studies, opportunities and strategies, and expectations for various current and future products, including capabilities, expected release dates and related effects on our financial and operating results.

We caution you that such statements reflect our best judgment based on factors currently known to us and that actual events or results could differ materially.

Please refer to the documents we file from time to time with the SEC, including our most recent Form 10-K and the Form 8-K filed with today's press release. These documents identify important risks and other factors that may cause our actual results to differ from those contained in the forward-looking statements.

Forward-looking statements made during the call are being made as of today. If this call is replayed or reviewed after today, the information presented during the call may not contain current or accurate information.

Natera disclaims any obligation to update or revise any forward-looking statements. We will provide guidance on today's call, but we'll not provide any further guidance or updates on our performance during the quarter unless we do so in a public forum.

We will quote a number of numeric or growth changes as we discuss our financial performance. And unless otherwise noted, each such reference represents a year-on-year comparison.

And now, I'd like to turn the call over to Matt.

Thanks, Mike. Good afternoon, everyone, and thank you for joining us. I will cover our recent highlights and progress in the business since we last spoke in March, and Mike will provide additional detail on our financial progress.

As Mike mentioned, we will be referring to slides that were just posted at investors.natera.com.

First, we are pleased and excited to see the key components of our long-term strategy coming together. We substantially expanded our leadership position in women's health genetic testing by posting unprecedented quarter-on-quarter volume growth in Q1.

Besides our superior technology and service offering, this volume growth is driven in part by the long-term decisions we made to sign in-network contracts with payers.

Based on these decisions, we expect the pricing environment going forward to be stable. Ongoing strong volume growth in Q1 and stable pricing is driving anticipated return to revenue growth for the year we described on our Q4 call and as we have predicted for some time.

In addition, we continue to improve our cost of goods sold consistent with our road map. More will be said about this later in the call, in particular, with regard to Horizon carrier testing.

Furthermore, we are seeing new DNA sequencing platforms emerge as we expected. That is contributing to our business already as we described with QIAGEN deal in March and will enable Natera to distribute our leading content broadly at high gross margins.

Lastly, we continue to release exceptional [data on oncology] that has the potential to substantially improve patient care. And as with Panorama, we are establishing a strong and differentiated position in this market that is even larger than prenatal testing. We are starting to see the beginnings of oncology's contribution to Natera's revenue.

A summary of our recent highlights on Slide 3. On volumes, we processed over 164,000 tests in the quarter, which represents 36% growth versus the same quarter last year and over 19% sequentially versus the fourth quarter of 2017.

In fact, Q1 was the largest sequential unit volume growth quarter in the history of the company by a wide margin. For Panorama, in particular, we posted the second consecutive quarter of strong sequential growth and processed 115,000 tests in Q1, which represents 18% sequential growth and 29% compared with Q1 last year.

We also saw a continued momentum in our Horizon carrier screening volumes, which grew 21% sequentially and 54% year-on-year. We generated total revenues of $62.3 million in the quarter, up 26% versus Q1 last year and 16% versus Q4 of 2017. This includes $5.5 million in revenues recognized from the QIAGEN payment we received in Q1, which was roughly in line with our expectations as discussed in our Q4 call.

Importantly, Q1 is our first quarter in which we are reporting revenues on an accrued basis, rather than booking revenues based on cash receipts. This required us to estimate what our ultimate cash collections will be for units we reported out in Q1.

Since this is our first quarter under accrual accounting, we have sought to err on the side of caution with our estimate and Mike will provide more detail later in the call.

I am very pleased to announce that we recently launched our Horizon carrier screening workflow. This has been a major initiative for our R&D team, which we expect will be a key driver of reduced cost of goods sold for the rest of 2018.

As I mentioned, our progress in oncology continues at a pace. We recently presented successful results in bladder and colon cancer studies at the American Association of Cancer Research meeting in April.

Given we've now replicated outstanding performance across lung cancer, bladder cancer and colon cancer, we believe that Signatera RUO is starting to live up to its promise as a pan-cancer platform.

On the research use only effort, we now have 14 deals for studies with leading pharmaceutical companies. We have seen strong interest from pharma for this offering and have many more deals in the pipeline.

Now I would like to summarize our commercial progress in the quarter. The next slide shows our recent volume progression for Panorama and Horizon. We spent a lot of time on our previous earnings calls talking about the activities that have driven volume growth. Our Panorama twin screening capability launched last year, innovations and user experience and new products opening doors to new accounts continues to work well in combination.

We've seen strong growth in both new accounts and in same-store sales, while maintaining very high [counter-attention] metrics. In our Panorama business, the mix of volumes has remained stable at roughly 60% average risk and 40% high-risk units. So we are seeing volume growth in both categories.

Our attachment to carrier screening has even outpaced Panorama growth, and we see strong momentum in that business continuing.

We are not yet breaking out volumes on new products like Evercord and Vistara. But these products are performing consistent with our expectations. And as we mentioned before, we expect roughly $15 million in 2018 from these newly launched products, which are early in the ramp-up period.

Historically, we have seen some seasonality driving more volumes in Q1 and that is also a factor driving results in Q1. So while we don't expect to post this level of sequential growth every quarter, the fundamentals in the business have remained positive, and we expect growth over the balance of the year.

On the oncology data, we presented 3 abstracts at the AACR conference in April. These included preliminary readouts from our previously announced studies in [muscle invasive] bladder cancer and colon cancer in collaboration with our Danish colleagues from Aarhus University. The bladder study included 50 patients and the colon study 130 patients, where blood was drawn prospectively at regular intervals of more than 2 years from initial diagnosis.

On this slide, we are showing the remarkable ability of Signatera in stratifying who would relapse and who would not, based on the presence or absence of tumor DNA as measured by Signatera in the blood after treatment. For patients who tested positive with Signatera after treatment, they all ended up relapsing clinically. This indicates the exceptionally high positive predictive value or PPV.

On average, molecular relapse was detected 4 months before clinical relapse for lung and bladder cancers and 7.4 months for colon.

In addition, relapse sensitivity was very high for all tumor types. The hazard ratio for these cohorts were between 19.8x to 34.5x, meaning an individual with a positive result is 19.8x to 34.5x more likely to relapse than an individual with a negative result.

This is an order of magnitude higher than other available biomarkers. This is especially striking when compared to the gold standard clinical staging for colon cancer, where Stage III disease has only 3 to 4x higher chance of relapse versus Stage I and II disease.

Furthermore, in multivariate analysis, Signatera is the only factor that predicts relapse with clinical stage and other traditionally high-risk features no longer being statistically significant.

From the perspective of clinical utility, the opportunity with early molecular relapse detection is to offer new treatment for patients who are Signatera-positive without waiting for clinical relapse to show up later on a scan.

In many cases, we believe this could be immunotherapy. Pharmaceutical companies are showing great interest to adopt Signatera into clinical trials to treat these patients upon molecular relapse.

In addition to the data for occurrence monitoring, our bladder and colon studies also showed great promise for treatment monitoring. Across 3 cancer types, Signatera has consistently identified which patients were responding to treatment and which were not with high accuracy. We believe that in time, Signatera can be adopted by FDA into the response evaluation criteria or resist criteria, which could make it a standard endpoint in clinical studies.

Finally, in the bladder data, we also had a unique and important finding. A single blood sample right at the time of diagnosis could predict the success or failure of treatment more accurately than any other variables.

Treatment failed for 80% of the patients who tested positive at diagnosis, while it succeeded for 100% of Signatera-negative patients. Even in a multivariate analysis, combining all other variables traditionally used for staging, including lymph nodes, tumor size, et cetera, the Signatera results became the only variable with statistical significance in predicting outcome.

Our medical team believe this alone could be enough to enter NCCN practice guidelines. This points to the urgency for clinical trials that explore new treatments for patients who are Signatera-positive at the time of diagnosis. We are currently in discussion with several pharma companies about this opportunity.

As a reminder, these studies with over 1,000 time points being analyzed across the 2 of them are hugely valuable because our collaborators, who have been collecting tumor tissue, longitudinal plasma samples, full clinical data and outcomes on all patients, were the first patients enrolled in each study over 3 years ago. We are doing the same thing with several studies in breast cancer to read out in the coming months as well as other disease types. This effectively means we are condensing many years of expensive clinical studies and analytical work into less than a year.

We often get questions on how Signatera is different from other liquid biopsy tests. Most of the other liquid biopsy tests on the market today aid in selecting appropriate targeted therapies for late-stage cancer patients. This is called genomic profiling. And it's generally something one would prefer to use a tissue biopsy for, but if tissue is not available, one can use plasma. The genomic profiling test generally consists of broad one-size-fits-all panels that scan for thousands of mutations considered clinically actionable, meaning they're associated with some targeted therapy. They produce [outer report listing specific genes] where mutation has been found.

This application requires a lot of sequencing and the cost of each panel is very high. In contrast, Signatera is the first ctDNA platform custom [bought] for monitoring and MRD assessment. Signatera produces a result focused on the presence or absence and quantity of circulating tumor DNA to be used more like a scan, where doctors want to see whether something is there or not and whether it's getting bigger or smaller in response to treatment. Each patient gets a custom assay designed and manufactured just for them based on the clonal mutations found from sequencing the tumor tissue. Clonal mutations are not necessarily associated with any targeted therapy. But by definition, they are the ones most likely to be present in every single cancer cell. So prioritizing these means we know that our test is not prone to be affected by tumor heterogeneity. We choose 16 clonal mutations to track in every patient to give ourselves 16 shots on goal to detect even a single copy of tumor DNA in a tube of blood. This means we have a highly targeted, low-cost assay that supports repeat use just like a scan. And just like scans, we expect it to be adopted for all stages of disease, both early and late. This is critical because the vast majority of new cancer diagnoses are in early stage where very few other liquid biopsy companies compete today. This is a major untapped market and a huge opportunity to help save and improve lives.

With that, let me hand over to Mike to review our financial performance. Mike?

Thanks. As Matt described, this is the first quarter in which we report revenue on an accrual basis as required by the accounting standard 606. In the past, we booked cash received in a given quarter as revenue. Now we book revenue on just the tests whose results were reported out to customers in the period based on our estimated total collections we expect to get from each test.

So going forward, we will disclose test reported in a given period as well as test processed and test [accessioned] in our CLIA lab. I think test process is still a good metric to measure volume growth overall since it includes both test [accession] in our lab and test performed via the Constellation platform. And test accession remains a good metric for assessing cost of goods sold per unit.

As we described on the Q4 call, our goal is to take a conservative approach in our collections estimates, particularly since this is our first quarter under the new accounting standard.

We presented this slide previously and predicted stable pricing for the year for the reasons Matt mentioned. We also have a number of current and future pricing tailwinds. These include payer coverage for average-risk NIPT and microdeletions that we have discussed in the past as well as broader Medicaid coverage. For example, we recently became a credentialed Medicaid provider in New York, which allows us to pursue broader reimbursement for testing we were already performing. In addition, 4 states have either priced NIPT on their fee schedule for the first time or improved their rate during Q1.

We are monitoring all these types of changes in our collections progress, and we think there is scope for our actual collections for Q1 to exceed the current estimate as we get more data.

So as we described, the context for 2018 is a return to revenue growth, driven by improvements to our core business, driving NIPT volume growth, new products contributing to revenue after making the investments in 2017, monetizing our core technology to piggyback on the emergence of new next-generation sequencing providers and stable pricing as I described previously.

The key implication here is that we can describe a path to cash flow breakeven without relying on an improvement in average-risk NIPT or microdeletions reimbursement, which we still think we can achieve. The next slide shows our COGS progression. We set a target of mid-200s COGS by the middle of this year, and we were able to drive COGS meaningfully below their Q4 level here in Q1.

This COGS performance was better than our expectations and was partially driven by our rapid volume growth temporarily outpacing our hiring plans for the lab.

So we do expect to catch up on some of that hiring in the next few months, and we are closely monitoring the recent Horizon workflow launch. As Matt mentioned, we launched the new carrier screening workflow recently, and we expect to drive COGS lower in the second half of the year with this launch.

Beyond that, we have generated concept data on the next substantial reduction in COGS based on technology improvements in NIPT, that we think will allow us to drive blended COGS much lower again over the next 18 months or so.

We've made some significant investments in R&D since the beginning of 2015, but as you can see on the right-hand side of the page, the returns have been very strong even if you only count COGS reductions we've achieved and leave aside key product improvements that have driven revenues and volumes.

Now to summarize our results from the quarter. The results for the quarter and the full year crossed the wire this afternoon. So for brevity on the call today, I'm going to focus on the key points of the Q1 results. Since we adopted the full retrospective approach to ASC 606 that I described, results from the current quarter as well as Q1 2017 are reported under this new ASC 606 standard. So it's an apples-to-apples comparison.

Our first quarter total revenues were $62.3 million compared to $49.4 million for the first quarter of 2017. As we stated in the earnings press release, we recognized $5.5 million this quarter from the QIAGEN deal we signed in March, which is slightly higher than the estimate I provided on the Q4 call. Gross margins for the first quarter 2018 was 35% compared to a 32% gross margin in the same period of the prior year.

Panorama revenues for the quarter were $33.3 million compared to $32.6 million in Q1 last year. As we described above, we believe there is scope for Q1 collections to exceed our estimate, whereas Q1 2017 collections are substantially complete at this point.

So it's possible the year-on-year growth may turn out to be higher than what we are reporting today. Horizon revenues for the quarter were $18.3 million compared to $13 million in the first quarter of 2017, an increase of 40%, which is driven by volume growth.

Total operating expenses for the first quarter increased by about $2 million compared to the first quarter of last year, an increase of about 4%. The largest component of this increase was a onetime noncash charge related to a charge on capitalized R&D.

At the close of the quarter, the company held $119.7 million in cash, cash equivalents, short-term investments and restricted cash, largely unchanged versus Q4 based on the cash we received in March from QIAGEN and the legal settlement that we paid out and disclosed previously.

As of March 31, 2018, we held a net carrying amount of $73.1 million under our 7-year term $100 million debt facility with OrbiMed Advisers and had drawn down $50.1 million, including accrued interest under the $50 million line of credit in place with UBS.

Turning to our future outlook. No changes to our guide in March, as I mentioned. We expect 2018 total revenues of $250 million to $275 million; cost of product revenues to be approximately 60% to 65% of revenues; selling, general and administrative costs to be approximately $140 million to $150 million; research and development cost to be $50 million to $55 million; and our cash burn to be $40 million to $60 million. The key assumptions in this guidance remain the same. Revenues driven by volume growth with stable underlying pricing, contributions from new products, margins driven by COGS improvements and roughly stable operating expenses, as I've described previously.

Now I would like to open the line for questions. Operator?

(Operator Instructions) Our first question comes from the line of Bill Quirk with Piper Jaffray.

First question. Just thinking about the guidance and the RevRAC on the QIAGEN payment in the quarter, will that recur here in Q's 2 through 4? And how do we kind of sort that out with no change in the guidance?

No, it's going to be -- thanks, Bill, for the question. So the upfront revenue recognition just came from the portion of the deal that we were able to book upfront. Obviously, the balance of the $40 million that we received is going to be booked as we reach certain milestones in the development process. And as we earn -- earn off the prepaid royalties that we described previously. So it's not going to be a recuring $5 million every quarter. [I think] it's going to much smaller going forward, linear from here.

Okay. Very good. And then just thinking about the significant increase in sequential growth, can you just add a little color in terms of kind of what's driving this? And obviously, we caught your comments about not being -- not necessarily maintaining the same sort of sequential pace, but was the inference that we should continue to see sequential volume performance throughout the year?

Well, you will see a great volume growth on a year-by-year basis as you've seen before. Natera has established about a 25% year-on-year growth, which is pretty phenomenal and we expect that to keep going. But as far as the quarterly dynamic is concerned, maybe Steve, you want to talk to that one?

Yes, sure. So we talked a lot, I think, in the second half of the year about improving user experience, rounding out our NIPT offering with the addition of twins. And then our 2017 launch of new products that really differentiate us and give us the opportunity to break into new customers and that is Evercord and Vistara. So continuation of our increased pace of new account closing that we saw in Q4 continued in Q1. We're now at record levels of customers. And then when you look at the volume from each customer, we're seeing increases in same-store sales. So more customers and then each customer sending more volume, largely driven by increases in same-store sales. So obviously we're very pleased with the record growth that we've just seen Q1.

And Bill, we did make that comment in the prepared remarks. There is some seasonality. We do tend to see Q1 be a high quarter, so you can't expect that kind of growth to continue in subsequent quarters. But on a yearly basis, we think our growth is going to continue strongly.

And our next question comes from the line of Steve Beuchaw with Morgan Stanley.

Actually, I want to follow-up on Bill's second question. If we take the guidance and we consider the full year guidance, we consider the first quarter results and the commentary around new product revenues, even considering the seasonality is normal and the QIAGEN cadence over the course of year, it's frankly sort of difficult to get to the guidance, meaning that it seems like the natural progression would be to drift a little higher. [So I wonder] if excluding QIAGEN, there might be anything you'd flag, that may not be so obvious that we should consider for the balance of the year on the top line?

Thanks, Steve. It's Mike. Yes, so just keep in mind, Q1 has got $5.5 million in it from QIAGEN and that's not going to recur for the balance of the year. It's going to be much, much smaller, if anything, quarter-on-quarter. And there -- as far as pricing is concerned, if you kind of assume kind of stable pricing and then the growth dynamics that the guys characterized, I mean, you're still -- that would still land you within the [250 to 275] range, but happy to elaborate from there.

But I do appreciate the positive sentiments on Q1. It was a great quarter.

I'm not very good at math, that's the real issue here. [The truth is that] I wonder if you guys, may be Steve Chapman and the group, could talk about it -- going on the environment and then I'll jump back in queue. One is, prior authorization, if you spend some time out in the field, you hear from time to time that the prior authorization is maybe actually reversing a little bit, given some of the fairly intense clinician push back on some of those policies. And then second, I wonder if you could comment on the competitive environment. It seems like [some might have been] making a push at one point or another, may not be pushing quite as hard.

Let me make an intro comment on prior authorization. So this is still an evolving dynamic that we're seeing in our markets. A lot of the plans, as a reminder, rolled out prior authorization policies in November of last year, there in that time frame. And since then, the choices they made about which parts of their books of business are subject to prior [auth] and how they actually adjudicate those prior authorization claims, just to kind of continues to evolve. Everything that we've seen so far is consistent with the expectations that we had at the beginning of the year. And we incorporated some of the inevitable challenges we have in our annual guidance. So we're continuing to monitor that. But I'd say, Steve, I appreciate that there is some -- there has been some [clinician] pushback and that's encouraging. I think that's going to continue. But for now, it's kind of steady as she goes for the rest of the year.

Yes, I'll comment on the competitive environment. Thanks, Mike. So there hasn't really been any significant changes, I think, that are notable recently in the competitive environment. So nothing necessarily to add there. I mean, it's still an extremely competitive space. We're obviously very pleased with our performance in the first quarter, and we think that we made some of the right moves as far as launching additional products and working on our user experience and so forth. But it's pretty much the same environment we've been facing now for a while.

And our next question comes from the line of Doug Schenkel with Cowen and Company.

This is Adam Wieschhaus on for Doug. On your Signatera RUO product, I might have missed it, but did you sign any new biopharma partnerships in this quarter? And is there any limit to the number of

biopharma deals that you are able to sign?

There's a limit to the amount that we can sign, but it's a large number, and the interest has been really strong. So yes, we did sign a bunch of new deals this quarter, and there's a lot more in the pipeline. So you're just going to see a steady cadence of deals being signed and results reporting out to those pharma. We're not going to be able to report most of those out to be public, because these are proprietary relationships that we have with these pharma now. But the data that we are seeing on Signatera is just consistently fantastic. The prognostic power of this test is amazing. The trials that we're doing and the studies that we're signing up are to test out the technology for a range of different applications, from residual disease detection to know whether you're done in the adjuvant setting with therapy, obviously recurrence monitoring and that's one of the most exciting things here. The specificity of the test is so high, what we see is when the cell-free DNA starts to pick up in these patients even being detected at very low levels, those patients will recur. And that specificity is such a strong, strong tailwind for this test because there's 18 million people living with cancer and remission from cancer in the United States alone and a large portion of that market is interested in catching early recurrence. And you can start to treat patients upon molecular occurrence with all sorts of different methods over the next few years if you got such a high specificity test. So that's the second big application. The third area is looking at all of the immunotherapy work, a personalized [neoantigen] tracking for the personalized cancer vaccines. And the fourth area is just as a new endpoint for clinical trials. If you look at those Kaplan-Meier curves, the data is so strong to use this as a prognostic indicator, [you use the] level of cell-free DNA, and you can substantially accelerate the trials and reduce the cost of the trials. So across all of those different indications, we're seeing a lot of interest from the pharma companies and the process of negotiating these deals and signing up new deals is ongoing. And I think that we are going to be a little bit bandwidth limited in our team. We can't just take on all the trials as fast as we want to. But obviously, that bandwidth is growing as we start gearing up for the (inaudible) launch.

Okay. I appreciate all that color. And maybe one more on Q1. I was just wondering with the size of the negative headwind due to ASC 606 shift as big as maybe you'd previously anticipated to be in Q1. I think you expected Q1 to be a little light than other quarters due to that transition [via] 26% growth through -- by the pretty solid start to the year. I'm just wondering maybe [that has less than negative impact] in Q1, which might mean it could have less of a positive impact in Q4?

So the -- is the -- the phone broke up a little bit there, but I think the summary of the question was, what was the quarterly impact of ASC 606? [And still there's] a bit more pronounced impact in Q1, but I think from modeling purposes, it's simpler to think about that as having pretty balanced through the course of the year. It's not enough to make a huge difference.

And our next question comes from the line of Mark Massaro with Canaccord Genuity.

I guess, I wanted to ask, to what extent do you think Evercord, Vistara and your recent ability to screen for twin pregnancies might be impacting competitive dynamics? And wanted to get a sense if you -- do you have a decent feel for where you stand in the marketplace in terms of market share?

Yes, I'll take it. This is Steve Chapman. So I think when you have differentiated products like Vistara, that allows us to get into customers that maybe weren't open to visiting with our sales team previously, particularly in the maternal fetal medicine sector. So as Mike outlined, we see consistent growth in the high- and low-risk space. And we are getting into maternal fetal medicine offices more regularly than we were previously. So it's nice to have something differentiated. When you look at the twins offering, again, an offering that has significantly differentiated than anything else on the market. The only company that can determine zygosity, which has very important clinical considerations. There's really 2 benefits to having that. One is you can get into customers that maybe want something unique and they want something differentiated. And the second is we can keep competitors out of our core accounts. So previously, many of our big clients had Natera and then they also have a competitor because they needed to use that competitor to offer a twins NIPT offering. So today, we've largely been able to remove those competitors from our offices. And I think that's part of the reason why we're seeing an increased account retention rate because the barriers to entry for competitors in our accounts have been [erased]. When you look at market share, we think the high-risk market is around 65-or-so percent penetrated and average risk is now between 15% and 20%, probably closer -- getting closer to 20% penetrated. And we think we have about 1/3 of the overall market as it stands today.

That's really helpful. And the ACOG annual meeting has come and gone. Wanted to get a sense for any chatter that you heard out of the meeting as it relates to greater adoption of commercial payer coverage for average risk NIPT?

Thanks for these questions. They're great. This is Matthew. So first, I want to just add some color to what Steve said. We've got about 1/3 share of the total market with so many competitors out there. I mean, that's a pretty impressive growth trajectory that Natera has been on and continuing on. And our share of the low-risk market is much higher than that. Our share of the low-risk markets are probably well above 50%, [we fall] about 55% in the past and maybe even a little bit but higher now. So this question about the payer coverage is very prescient to that issue. We are reluctant to make any strong statements about the timing of ACOG making a stronger push and a stronger policy statement that's sort of more in line with ACMG and others. And we're also reluctant to make statements about timing for the payers like Aetna and United that are holding out. But we are seeing payers. Every month or so, we see additional payers cover low risk and it is a steady ongoing process. And I can say from the ACOG and ACMG meetings that the pressure is continually mounting. So it's becoming harder and harder for these insurance companies to hold out. Obviously, they have -- some of them have held out, but now more than 50% and the growing number of covered lives are covering low risk. And so the pressure is continually mounting. And we hear from key members of these professional societies that they are concerned, that there are some payers who are holding out and that there is a certain ambiguous response from the payers. So the fact that they will cover low risk is pretty much a given, but we are reluctant to say exactly when they will fall. I can just say that at the society meetings, we see the pressure continuing to mount. And that's all I'm prepared to commit to, that it will happen and hopefully soon. But we haven't been aggressive on this on our guidance. Our guidance has assumed hardly any change in coverage of low risk.

That's really helpful. And if I can sneak one last one in. Matt, clearly, you're making strong progress building your biopharma collaborations and putting out some encouraging data on cancer liquid biopsies. Can you give us a sense -- I might have missed it, are you on track to launch clinically in oncology liquid biopsies this year? And then, can you provide a comment on how you're thinking about potentially submitting something to the FDA or maybe just going the LVT pathway?

Great questions. So look, the data on oncology, I don't think is just encouraging. The data that we're generating on oncology is phenomenal. And I would encourage you to look at the Kaplan-Meier curves of other prognostic tests that are dominant in the oncology market to just see how our data compares to those curves. The data that we're showing is really unprecedented [and I've] got to be careful when I say unprecedented because who knows where in some corner of the world data is being produced. But that data is pretty phenomenal in terms of its prognostic power and its ability to differentiate those Signatera-negative versus those that are positive. In terms of the launch timing, we are still on target and pushing to get the launch out for the clear version at the end of this year. And we will keep you guys updated. If it doesn't happen at the end of this year, it will happen very soon in next year, but right now, it looks like it's going to be Q4, and we've got a lot of the team working on all the logistics and the operations to build an infrastructure to build customized panels per patient. We've got this amazing technology that enables that capability but there is a lot of logistics and operational support that's got to go around that as well. And so we are right now on target for the end of the year. And as far as the FDA is concerned, yes, we are going to be submitting this to the FDA. And we haven't made commitments about the timing, but that is the track that we are on. And very likely, it's going to be a joint submission to CMS and the FDA as others have done and which we think would be very advantageous for the market if Signatera is going to play in. Then besides that, I'll just mention something else you didn't ask. That is a very big cash pay opportunity for Signatera because, as we've said a few times, the assay is very low cost for us, and we can go down these roughly single molecule levels of detection with a relatively small amount of sequencing. So we will -- with insurance, that in these situations that insurance doesn't cover, we will be able to bill the patients. And for patients that are in remission from a cancer, and can potentially catch the recurrence much earlier than imaging without having to subject themselves to all the radiation and the ongoing doctor visits of the imaging, this is a very attractive offering. So there's a big cash pay opportunity and Natera has become very good at managing the logistics of cash payment from very broad patient base. So I think that we will leverage our existing infrastructure of lobotomists and our existing billing infrastructure to get into this market in a significant way over the next few years.

And our final question comes from the line of Alex Nowak with Craig-Hallum.

Any update on the Illumina lawsuit? Just curious if you're looking here to settle? Or do you plan on taking this through the court process?

I'll take that. So we're not going to comment on the lawsuit beyond what we've already commented. As we said before, this was not a big surprise. We thought that Illumina may react this way to the announcement with QIAGEN. We think we're in a very good position here. We've reviewed the IP landscape very carefully. And besides that, we have this long-term supply agreement with Illumina. So it's not disrupting our business at all and we think that we're in a very good position. And it's just -- it's following the course that these litigations follow. There's nothing really surprising there.

Okay. That's helpful, Matt. And then Mike, understanding you're being cautious around estimating the cash collection with regard to ASC 606. Can you just remind us if you do receive more cash than you accrued in -- for revenue in Q1 for example, how does this flow through the P&L and show up in future results?

Yes, it would be a year from now, we would come back, and we would assess what were our total cash collections for Q1 and we would likely make an adjustment in that quarter. Although the precise mechanics would have to be worked out, Alex.

Okay. That's helpful. And then Matt, just final question from me. I would say congrats on the continued data releases for Signatera. I appreciate there's a huge opportunity here, but I think it's also a drag on the overall company's profit. So I'm just wondering, would it ever make sense to spin Signatera out into its own business, giving -- and essentially give that technology some more visibility? Because I think there is an argument to be made here that Signatera asset today is kind of being undervalued, when it's being folded into Natera.

That's a good question. Well, would there ever be an argument for spinning out Signatera into a separate company? Yes. I mean, there are arguments. At this stage, we've looked at this in various ways and we don't think that, that makes sense right now. The first thing is, it's not that much of a drag as you might think. We've made an enormous amount of progress with Signatera doing the clinical trials really cheaply. We've been piggybacking on existing trials and the performance of the technology is so strong that a lot of the top KOLs around the world, who have been collecting these banks of samples and are looking to do liquid biopsy as part of their trials, are working with us. In some cases, paying us, but in many cases, they're just working with us without the company Natera having to spend significant money on these very expensive samples. So we're getting a lot of work done. A lot of very profound data collected at a high speed and low cost. In terms of the R&D budget, I think we had a figure last year, which was around 17%, 18% of R&D budget was on the oncology. And I think now, we've got a budget for oncology which is around 25% of R&D spend. So this is not a huge drag on the company's profits. And the other thing is, speaking practically, we've got a lot of overlap in our technology. We've taken this massively multiplex PCR capability that we developed and refined in the prenatal space. And we've applied that with a bunch of tweaks to oncology, and we also expect that Constellation, which is a really beautiful software package that we built for the cloud in the prenatal space is also going to have bearing on the oncology opportunity worldwide. And so there's a lot of overlapping skills in the R&D team. And it would not be efficient for us to be dividing out the R&D team across these lines, nor would it be efficient for us to be dividing out the management of the company along these lines. So at this stage, we think that the team is working very well together. We've got a very good sort of [matrixed] organization now, where we've got a lot of very well-established protocols over the last couple of years to manage these different projects and use overlapping expertise in an efficient way. And so all these things being weighed, we don't think we would be doing the right thing to split it off right now. Could that happen in the future? Yes, it is a possibility in the future. But not something that we're looking at in the near term.

Thank you. And that does conclude today's Q&A session. Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone, have a great day.