Natera, Inc.
Q1 2021 Earnings Call Transcript

Published: 9 May 2021

[Operator:]

Welcome to Natera's 2021 First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a Q&A session. As a reminder, this conference call is being recorded today, May 06, 2021. I would now like to turn the conference call over to Michael Brophy, Chief Financial Officer. Please go ahead.

[Michael Brophy:]

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our first quarter of 2021. On the line is Steve Chapman, our CEO; Bob Schueren, Chief Operating Officer; Solomon Moshkevich, General Manager of Oncology; and Paul Billings, Chief Medical Officer. Today's conference call is being broadcast live via webcast. We will be referring to a slide presentation that has been posted to investor.natera.com. A replay of the call will also be available at investor.natera.com.

[Steve Chapman:]

Thanks, Mike. Good afternoon, everyone, and thank you for joining us. Let's get into the unit and financial highlights. As you can see from the press release, we had an exceptional quarter. We processed 348,000 tests in Q1, which is 18% growth over our record Q4 performance and 47% year-on-year growth. As our base of business has grown substantially, our growth rates have still continued to accelerate. That acceleration is being driven by continued strong growth in the women's health business, but also we are seeing some real benefit from oncology and organ health as well. Revenues were $152 million in the quarter, which included a $28 million acceleration of revenue recognition from our deal with QIAGEN, which wound down in Q1. Net revenue is a non-cash accounting benefit as we will explain later in the call, but even stripping QIAGEN out of the results revenue growth was very strong. For example, the year-on-year product revenue growth was 36%.

[Solomon Moshkevich:]

Thanks, Steve. We have had a flurry of important milestones and announcements recently. So I'm happy to provide some further detail. Genentech has followed up rapidly since the release of the IMvigor010 results incorporating Signatera as a companion diagnostic for atezolizumab in a global prospective Phase III trial called IMvigor011, natural sequel. The results from the first Phase III released last fall are on the left-hand side of the page. You can see that the 37% of bladder cancer patients identified as MRD-positive by Signatera had a clear survival benefit from treatment with atezo with a hazard ratio of 0.59, while the MRD-negative patients had no benefit. In IMvigor011, which is already underway, patients with muscle-invasive bladder cancer will be screened after surgery to 500 who are MRD positive. And those patients will be randomized to receive atezo or a placebo. If successful, Natera would seek FDA approval for Signatera as a continued diagnostic to atezolizumab for this intended use. This is the first of many registrational trials for Signatera as the IMvigor010 data has been recognized as a major proof of concept with application across cancer types.

[Michael Brophy:]

Thanks, Solomon. The slide here is just a summary set of results for the quarter. Steve covered a lot of the trends on volumes and revenues. And you can see revenues have expanded significantly even stripping out the one-time QIAGEN revenue recognition. The organic quarter significantly exceeded our internal expectations. It's worth noting that we have had a lot of new positive reimbursement decisions across the business, both with Medicare for Signatera and major commercial payers for average risk NIPT. Given we have less history with reimbursement in these areas; we were cautious in accruing revenue for the recorded volumes in Q1. At the same time, volumes obviously ramped incredibly quickly in Q1. So that caution on ASPs tempered the product gross margins in the quarter compared to what we think is achievable in the immediate term. So based on this and the good underlying recent actuals we are seeing, we are optimistic that accrued ASPs can improve over the next few quarters. Cost of goods sold per unit was excellent in the quarter, driven by continued COGS progress in the women's health products. We had about $20 million in bigger ticket nonrecurring cash outflows in the quarter. For example, we did refund $10 million of QIAGEN's initial $38 million cash payment. Despite that, we are still on track for our original cash burn guide as I'll discuss on the next slide. Okay. On to the next slide and the revised guide. Steve gave you the headline that we are resetting the guide higher as a result of our Q1 experience. The change in the guidance range well exceeds the QIAGEN contribution and the organic driver of the guidance reset is almost entirely driven by revising the volume forecast upward. The improved gross margin guide is driven by the QIAGEN revenue and reflects the same cost of goods sold per unit assumptions we've had previously. The COGS trends look good as we've discussed. In terms of quarterly revenue pacing, I do think the seasonality we've historically seen in the business is still relevant and should be taken into account. Generally, the volume trends in women's health lead to a slightly more muted sequential growth in Q2 and then expanding growth rates in Q3 and Q4. Partly in response to the increased demand across the business lines, we are marginally stepping up some investments in SG&A and R&D to support the growth. For example, we are accelerating investments for lab operations, infrastructure and staffing that we had initially planned to make next year, but the volume is exceeding our initial forecast, and so we are accelerating our expansion plans. The net impact of all of these changes to the forecast is the cash burn guide remains the same. We remain in a very strong cash position, and we'll continue to invest. We talked about the women's health business getting to cash flow breakeven this year and we feel even more confident in that goal at this point in the year. So it's an exciting time for Natera and we are very excited to have been able to share these results with you. Now, I'd like to turn the call back over to the operator for questions. Operator?

[Operator:]

Our first question comes from Tejas Savant with Morgan Stanley.

[Tejas Savant:]

Hi, guys. Good evening and congrats on the strong quarter here. Steve, let me – I'd like to start with a question on the CIRCULATE-IDEA data that you just presented, looks pretty impressive. Is there anything more you can share in terms of just the competitive positioning versus a tumor agnostic approach? Do you think the metrics that you've just shown via CIRCULATE-IDEA and I'm sure there's more to come will be enough to kind of like put enough daylight, so to speak, between you and peers where you get a commercial sort of leg up there. And then finally, in terms of the plans to accelerate liquid exome from RUO into the clinic, how does that look now that you have this data out there? Do you feel like you're pretty comfortable continuing to rely on the tissue exome? Or is that an effort you'll still pursue from a point of view of shortening the turnaround time for the assay?

[Steve Chapman:]

Yes. Thanks for the question. So I would say, at a very high level we think we stack up very, very well to the tumor naive approaches that are out there. And to the other tumor informed approaches that are out there, frankly. I mean, when you look at the breadth of data and the performance, we have a very significant lead and a great position compared to the other groups that are coming into this space. So we're doing well. We're on market. The volume is growing. The launch is successful. I feel like we're in a very strong position. As far as building personalized approaches off of liquid exome, I think that that's something that we have the capability to do and it's something that we're considering, but we don't feel like it's required at this point, just given the success that we're seeing. Solomon, would you like to add any additional points?

[Solomon Moshkevich:]

Yes, I think one other part of the question was related to the CIRCULATE-IDEA trial data. So we're very pleased with the interim results we're seeing from that trial. It is the largest perspective MRD trial of its kind. And it's enrolling very well. There's a lot of excitement on the physician and patient side to be a part of this and the data is looking even better than what we had published previously. So yes, we think this is an important validation of what we've seen before and it sets us up to only improve the adoption of the test, not only in clinical use, but also in other clinical trials because it's such a good feasibility demonstration of how this can work in a clinical trial. So we're very optimistic. And we look forward to presenting additional data at ASCO in a few weeks.

[Tejas Savant:]

Got it. And Solomon just a quick follow up there on the ASCO multiple myeloma data that you highlighted. How do you think the use case here would shape up relative to some of the immuno-sequencing assays like clonoSEQ from Adaptive, for example? Do you essentially sort of view this as being a blood-based approach and perhaps in multiple myeloma it's unclear yet whether they can be sort of bone marrow or blood based? Is that really the angle that you're taking here?

[Solomon Moshkevich:]

Yes. Thank you for your question. Without being able to present the data itself at this time, it will be shown in detail at ASCO. Yes, the general concept here is just like – it's the same Signatera product. So we start with a sample of the tumor, which in this case comes from the bone marrow biopsy for that initial analysis and personalized assay design. And once that's done, we just analyze the plasma going forward serially. And that is – presents a massive opportunity to improve the clinical utility and accessibility of MRD and monitoring for the 35,000 multiple myeloma patients per year and the 150,000, that have had a prior diagnosis because those patients today without Signatera require serial bone marrow biopsies in order to continue their monitoring, and that's a painful procedure, that's a very expensive procedure and frankly patients simply avoid it because of those hurdles in it. So with Signatera, we think if we can consistently show a similar performance that's clinically sufficient, then not only will people switch over to using Signatera in this setting, but we think the overall use of monitoring and MRD testing will just go up because of the improved accessibility.

[Operator:]

Our next question comes from Tycho Peterson with JPMorgan.

[Tycho Peterson:]

Thanks. I'll start with a couple on Signatera as we think about kind of CRC in the IO and Altera ramp, have your kind of assumptions for kind of the back half of the year ramp changed at all? And then I just want to make sure I understand your answer to the last question, because your competitors, like Adaptive are moving toward a blood draw, a blood first approach away from bone marrow. So I'm just trying to understand competitively if that changes things in your perspective on multiple myeloma.

[Steve Chapman:]

Yes, so I'll comment on the ramp. I mean, we haven't broken out our Signatera numbers or Prospera numbers specifically, but you can see our volume growth is going very well. And that includes what we believe is a very successful launch for Signatera and our other products. So, it's in line with our expectations. We're seeing good adoption. The test is working very well. And so we're pleased with the trajectory. I think on the question of multiple myeloma, so currently to run the monitoring assays that are available, you have to do repeat bone marrow biopsies in order to do that ongoing monitoring. So with the test that we're working on, you do one bone marrow biopsy for the set-up, and then all the ongoing draws are just blood draws. So there is no need for a repeat bone marrow biopsy.

[Tycho Peterson:]

And Steve, what's the latest thinking from your perspective around screening? It's probably one of the top three questions we get on you guys. Can you maybe just share your thoughts a little bit about how you're thinking about that opportunity either organically or inorganically over time?

[Steve Chapman:]

Yes, are you talking about early cancer screening?

[Tycho Peterson:]

Correct.

[Steve Chapman:]

Yes. So we've said actually recently I think on our last call that we do have a program in that space and that's an area that we're moving into. We're actually making progress. We didn't announce anything today, but the program is underway. We think we have a very efficient approach to go after that market, both technically and from a validation and commercialization standpoint. And we will be providing updates in the future, but we're not going to be providing any today.

[Operator:]

Our next question comes from Doug Schenkel with Cowen.

[Doug Schenkel:]

Hi, good afternoon everybody and thank you for taking my questions. So I just want to start on really volume trends and guidance. I think it looks like just doing some quick math that you were doing about 25,000 tests per week in Q1, which if I got that right, it's pretty remarkable keeping in mind, that's a big step up from where we've been. I'm just wondering if you could comment on how that trended over the course of the quarter? Was it pretty steady or did it continue to improve into the end of the quarter? And then kind of building off of that and just using that 25,000 tests per week in the context of full year guidance, I can get to the low end of your range with pretty nominal improvement in that figure and nominal pricing improvements. I'm not sure either of those assumptions make a ton of sense given what feels like strong momentum and various things that you called out that could drive ASP improvement, including accruals a higher mix of Prospera and Signatera, things like that. So I just want to make sure I'm not doing something wrong and assuming I'm not, it's the low end of guidance, just reflecting a scenario where you want to be conservative early in the year.

[Michael Brophy:]

Hi, Doug. This is Mike. Thanks for the question. Yes. I mean, I think your summary is basically spot on. The only caveat I'd have is something that I've mentioned in the prepared remarks was just a reminder on the seasonality of the business, particularly the women's health business, which is the majority of the volume still. And that is – historically, we've seen a strong Q1 and then the same clinic volumes are a lot lighter in Q2. And so, you see like kind of a flattish Q2 and then a kind of growth in Q3 and Q4. So we are taking into account back kind of seasonality still even though clearly, I mean, you can see from I think the first – one of the first couple of slides in the deck that something different is going on right now in terms of the trajectory and I think that's really positive. You can see that in the weekly. So the weekly volumes through this call are looking quite strong. But we do – I think the only thing I would add to your summary is the seasonality point, which I think would – I think would temper the model slightly there. But obviously when we guide, we don't – we try not to give aspirational guidance. We try to give guidance that we think is – that we think we're going to hit. So I think – I would certainly hope that the low end of any guide that we give is something that we thought we could do.

[Doug Schenkel:]

Okay, super helpful. And then just a couple on NIPT. Anything you can share on how mix is evolving and really reimbursement is evolving, obviously a lot of progress last year on the average risk guideline and reimbursement front. I'm just wondering if there's anything new in terms of how that is impacting mix and ASP? And then on microdeletions, anything new in terms of progress towards incremental reimbursement, probably pretty early for that, but any anything you could share would be of interest. Thank you.

[Steve Chapman:]

Yes. Mike, maybe I'll comment on volumes and then if you want to follow-on on ASPs…

[Doug Schenkel:]

Yes.

[Steve Chapman:]

From a volume standpoint, I think we are starting to see the long-awaited shift over towards average risk. And when we look at the growth in Q1, it's really coming from two factors. So, one is new wins from competitive takeaways. So we had our best quarter ever for growth coming from new customers and competitive takeaways. And the second thing that we're seeing is a shift towards average risk. So when we look at the mix of volume coming in this high risk versus average risk, we're starting to really see that needle move for a long time, for years it was very steady. And over the last six months, we've seen kind of a linear ramp up. And so, we think the markets moving now toward a place where it's – maybe it was 20% penetrated on average risk before, I think we're starting to get up into the 30% average risk penetration. So there is a long way to go. We're at the very early stages, but it's happening. And we're doing well both in absorbing that penetration, but also winning new customers and taking business away from others. Mike, want to comment on ASPs?

[Michael Brophy:]

Yes. The recent ASP trends were quite strong for NIPT. I mean, it's kind of happening as we've described that would. We're contracted for an NIPT code and the fraction of time we're getting paid is just steadily increasing. It takes a couple of quarters for that to flow into the revenue line, just based on the way that we do the accrual, we really need a critical mass of historical actuals to kind of get full credit for that, the way we do the accrual and that's – perhaps that's a bit cautious but we would like to be a little bit careful when we do that. So I'm cautiously optimistic as I mentioned in the prepared remarks about ASP trends for the rest of the year.

[Operator:]

Our next question comes from Puneet Souda with SVB Leerink.

[Westley Dupray:]

Hi, great. Good afternoon. This is actually on for Puneet today. I wanted to go back to MRD briefly, just for the first question, and I guess having been on the market for the better portion of the year and reimbursement since, I think, last October in CRC at least, I guess, what have you learned about the market itself? And then what feedback from potential customers who are kind of on the verge about MRD testing, in general? What are you hearing from them? What are your expectations for being able to drive penetration in stage II, III CRC still and also in some of the newer indications and potential timing on multiple myeloma?

[Steve Chapman:]

Yes, so I'll make some comments and then Solomon you can jump in. So, in general, the feedback has been very positive. I mean, if you go back four years ago, when we first started talking about this, nobody was talking about solid tumor MRD, or MRD testing in the adjuvant setting. And now if you're an oncology diagnostic company, you have to have an MRD product. Everybody is trying to move into this space. And that's really a validation of the enormous market opportunity. When you look at colorectal alone, there is a million tests that could be done per year. So these market sizes that we're talking about here are orders of magnitude bigger than anything else in the specialty diagnostics space and certainly much, much bigger than the therapy selection market alone where traditionally a lot of the energies have been focused. So we're really happy about how things are going. We're seeing the use from doctors accelerate. We're seeing lots of repeat use from patients and doctors. We're seeing use in all different stages of colorectal. We're seeing use beyond colorectal. We're getting a lot of great patient stories and great physician stories about how the test worked as advertised and how it helped your patients. So we're pleased with how things are going. Solomon, do you want to jump in on that?

[Solomon Moshkevich:]

Thanks, Steve. I agree with everything that was said. Of course, we've learned a ton about how people want to use this test and where they find it to be useful and to inform treatment. I think one of the interesting things that we've seen in addition to what Steve described is that a lot of the time we've – there are already patients who are somewhere midstream in their course of care. And many, many of our tests get ordered for patients for the first time who are six, 12, 18, 24 months out of surgery because they had some indeterminate scan. Some nodules showed up, something that was suspicious, but it's hard to assess for the physician. And more and more people are coming to us to help them triage a borderline situation, whether it's do I treat or not? Or in this case, do I perform a biopsy on this module that's indeterminate or not? How do I proceed? And once people see data come back and they start to grow comfortable with what the test can do, the adoption just increases significantly. And the other thing I'll say that Steve mentioned, but we've been very impressed to see how sticky the product is once a patient is on it, the repeat use and the frequency is frankly above our expectations. And it matches what it should be, frankly, because it's just such an informative test over time. So I'm sure there's more I could say there, but I'll stop at that point.

[Westley Dupray:]

Great. Great. Thank you. And then on the women's health side, just speaking on the average risk market specifically, Steve, you just mentioned it's about – you think it's around the 30% penetration right now. I guess what's differentiating about Panorama and, I guess, Natera's combined offering that can help drive the remaining 70% of that market? And what are you seeing that's driving the competitive wins? And then just finally, a follow-up on the last question, any update on the microdeletion timing? Thanks.

[Steve Chapman:]

Yes. So one of the reasons, if you look back at Natera's history, we were the fourth company into the NIPT space, but today, we're the market leader by far. We have the most clinical differentiation. We have the most peer-reviewed published data, and we're doing the most volume. And the reason is because our test is unique and differentiated and physicians like it. So we're the only company out of all the other companies that are out there that are looking at SNPs. And when you use SNPs, you're able to identify things that simply biologically can't be identified by the other companies, things like triploidy, for example, that are very relevant in pregnancy. But it also allows us to get higher sensitivity and specificity on things like trisomy 21 and chromosomes. When you shift over to something like 22q microdeletion disorder, and you look at the performance using SNPs there versus the shotgun sequencing method, I mean, it's really night and day, the difference in the performance. I mean we're talking about sensitivity in the 90s versus others that have published performance sensitivity in the 20s. So the technique works exceptionally well, and that's now being shown out in the volumes. On the microdeletion standpoint, we now have published – or have presented and intend to be published the largest prospective trial that has ever been done in the microdeletion space. The results look exceptional. There were two key findings on microdeletions. One is that the 22q disease is much more common than what was previously expected at approximately one in 1,500. The – and the second was that our test works really, really well. So the sensitivity was very high. And the positive predictive value was also very high. And those are two of the – I guess, combined those are the three things, disease incidence, sensitivity, specificity that societies look at when they are deciding whether or not something meets the criteria to be approved for a prenatal screening test. So we think we're in a good position to, at some point in the future, get into the guidelines and receive payer coverage. And we're doing hundreds of thousands of these tests already every year that are not reimbursed. So as soon as reimbursement comes in, this is going to be an immediate, very significant impact to Natera's revenue and the bottom line.

[Operator:]

Our next question comes from Mark Massaro with BTIG.

[Mark Massaro:]

Hey, guys. Congrats on a great quarter. I guess, it's exciting to hear that you have a program in place in early cancer detection. You guys are a women's health company. You've shown promising data in ovarian cancer initially. So when I think about the – certainly the promise of developing an ovarian cancer screening test or breast cancer screening test, the market has never seen that. So can you maybe just talk about your plans of either going indication by indication or perhaps looking at the multi-cancer screening opportunity?

[Steve Chapman:]

Yes. Thanks Mark. I think the initial area that we're looking at is colorectal, and I think similar to some of the others in the space. And then ideally, that would be expanding beyond CRC into just some of the other cancer types. But I would just say, wait until we provide a more significant update that will be coming. It's not something that we included in the call today, but there will be some solid updates coming in the future.

[Mark Massaro:]

Okay. That's helpful. And just my follow-up question. Obviously, Adaptive have done a great job in blood cancer, it's certainly interesting that you're showing data in MM. Do you think there are any limitations to – I think perhaps there's a reason why you started in solid tumors? Obviously, it's a bigger market. But are there any technical limitations of addressing blood cancers? I know Adaptive is looking primarily at lymphoid but not myeloid. So I don't know if you have any tough’s on any technical limitations of your technology in blood cancers?

[Steve Chapman:]

Yes. I'd just say the data that we have coming out at ASCO is going to speak for itself. It's early, but you'll see when you attend the conference. We think it's very positive. Of course, there's more work to be done there, but we don't think that there's technical limitations in this particular indication. Solomon, do you want to add to that?

[Solomon Moshkevich:]

Sure. I think it's hard to speak in generalities. So of course, there are going to be – yes, there's going to be technical matters we have to sort through along the way with all different types of either new indications or new specimen types or other biological variations that we're going to learn more about. But just speaking to the facts here, we're going to present great data in multiple myeloma. And I think there's a real opportunity to help a lot of patients here.

[Operator:]

Our next question comes from Rachel Vatnsdal with Piper Sandler.

[Rachel Vatnsdal:]

Great. Thanks for taking my question. We spent a lot of time on oncology today, so I'll just ask you a few on transplant and women's health. So first on transplant, can you guys just give us some color on the launch and how penetration has been with transplant centers versus community nephrologists? And then also regarding the blanket LCD for transplant testing, you mentioned heart and lung. So can you talk about your timing expectations for addressing those other organs with Prospera?

[Steve Chapman:]

Yes. Thank you. So we are pleased with how the launch is going. We have been out there now a handful of quarters, and things are in line with our expectations. We think we have a unique technology that competes very well in the areas that matter. I think that the paper that we showed here in the earnings deck, I think, highlights one important factor where we've already, in a very short period of time, completely moved the science forward. This issue of background cell-free DNA is very important. If you're looking at a metric donor-derived cell-free DNA percentage, but the background cell-free DNA is very, very high, you can mask rejection, and you can have a false negative result. And so we are now incorporating that and flagging cases where there's a very high background cell-free DNA. And that was what was covered in this paper with UCLA that looked at this COVID case study. Yes, so we are doing well. The community nephrology space, I think there's an opportunity, and that's something where we are seeing some volume come in. But certainly, I think the transplant centers are the larger opportunity in the near-term. When you look at expansion into other organs, we are – we sort of accessing what opportunities are out there for us, but there is no reason why or technology should not work very, very well and heart, lung and other indications and now there the reimbursement hurdle has been cleared, it’s certainly makes it a more attractive opportunity for us. If you look at some of our competitors and the volumes they are presenting in some of these other areas like heart, it's compelling. And we know our technology works well. We know we can get reimbursed very easily now with this new imbursement guideline, and so it's something we're assessing. And we're going to have to consider whether it makes sense for us.

[Rachel Vatnsdal:]

Great. Thanks. Next question from me. So for women's health, you guys have mentioned that you're taking share from competitors, which is great. So can you just spend a minute on your women's health sales force? Do you guys think that your sales team's rightsized to address this larger average risk market? And then what are your thoughts on keeping our business profitable versus expanding out the women's health efforts to take share, especially as average risk and then potentially microdeletions opens up that opportunity? Thanks.

[Steve Chapman:]

Yes. So we’ve been able to grow the business with some incremental increases in operating expenses that we've kind of layered in over time. So I think we're in a good position right now as far as our kind of reach and frequency on the women's health team. Of course, we're always monitoring and sort of and sort of looking at things, but I don’t think that there is any – any big changes at this point that we would anticipate. When you look at the path towards profitability and towards cash flow breakeven, I mean that path at point is very clear, the women's health side. I mean we're seeing – so with this Pano AI launch that we announced the Phase I implementation and then the remaining phases in the year, this is a big COGS savings on NIPT. We haven't talked about that in a long time, but our COGS on NIPT now are well below $200 per test. I well below because of the scale that we're operating at, because of things like Pano AI, where we're now incorporating where we are incorporating deep neural networks and machine learning from over 2 million tests that we run in our lab and we are using that to reduce the costs of the workflow and of the reagents that we put into the assay. So major COGS reductions that are hitting and I think that cap to cash flow breakeven is very clear. We're always looking out for incremental investments, but I think we're in a good position right now in women's health.

[Operator:]

Our next question comes from Alex Nowak with Craig-Hallum.

[Trenton McCarthy:]

Good afternoon, everyone. This is Trenton McCarthy jumping on for Alex. Just one quick question on NIPT and it's been six months or so since the ACOG guidelines came out. And we've heard a lot of local charters have been trending on the changes. So are you hearing in the – what are you hearing in the field? Are more clinicians embracing the guidelines and ordering more tests? If you could just give a little bit more color on that?

[Steve Chapman:]

Yes, it's definitely happening. We've seen over the past six months a linear shift in the percentage of our business that is average risk versus high risk. So that's definitely happening. It's going to continue. We think that the endpoint for this is going to be around 90% penetration, 95% penetration. And we think we can get there in three, four years something in that range. Maybe even less. Right now I think the market is 30% penetrated, so there is a long way to go. I mean NIPT growth is just really starting to ramp right down. We're just at the very beginning, and we are positioned and we are in a incredible position. We have a great sales team. They're tenured. We have the most data. We have the best performing product on the market. So we're in great position to ride the wave of expansion in average risk NIPT.

[Trenton McCarthy:]

Got it. That’s helpful. And just a pivot over to Signatera here. You obviously now breaking out Signatera's CRC which makes it kind of hard to gauge performance, but what sort of penetration do you want to see this year, next year 2023, so that you could say, yes, Natera was successful here, if that makes sense.

[Steve Chapman:]

Yes. So when you look at a lot of the historical cancer diagnostic launches, the companies that have been very successful Foundation Medicine or Genomic Health, you go back and what you see is in the first year, sort of a lower single digit penetration in the second year kind of a mid-single digit penetration into the market. And then the third year, maybe high single digit, low-double digit penetration. And that sort of what we use to kind of draft our forecast and I think its inline with other specialty diagnostics that are out there now. The data coming out, I mean we are putting so much really compelling data out, I mean it's almost every month, there is a massive announcement coming out of every conference we are now having multiple presentation. I think things could really start to accelerate, but that’s kind of what we set out as the benchmark for success just from a historical perspective, and we are pleased – very pleased with where we are right now in the launch.

[Operator:]

We are showing no further questions in queue at this time. We now conclude today's question-and-answer session. Ladies and gentlemen, thank you for participating in today's conference. This concludes the program and you may now disconnect. Everyone have a great day.