Earnings Labs

Natera, Inc. (NTRA)

Q2 2020 Earnings Call· Thu, Aug 6, 2020

$192.51

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Transcript

Operator

Operator

And welcome to the Natera, Incorporated Second Quarter 2020 Earnings Conference Call. My name is Michelle and I will be the operator for today's conference. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session. [Operator Instructions] I would now turn the call over to Mike Brophy. Mike, you may begin.

Michael Brophy

Analyst

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our second quarter 2020. Also 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. 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 outlook, our assumptions for that outlook, the impact of the COVID-19 pandemic on our business and operations, market size, partnerships, clinical studies, opportunities and strategies and expectations for various current and future products, including product capabilities, expected release dates, reimbursement coverage 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 or 10-Q and the Form 8-K filed with today’s press release. Those documents identify important risks and other factors that may cause our actual results to differ materially from those contained in or suggested by 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 will not provide any further guidance or updates on our performance during the quarter, unless we do so in a public form. We will quote a number of numeric or growth pages 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 Steve. Steve?

Steve Chapman

Analyst

Thanks, Mike. Good afternoon, everyone, and thank you for joining us. Let me get into the highlights. Q2 was another very strong quarter for Natera. We processed 234,000 tests in the quarter, which was essentially on par with our all-time record Q1 volumes, despite the obvious impacts from COVID-19. We generated $86.5 million in revenues on a 46% gross margin and grew product revenues approximately 24% year-on-year We started enrolling patients in three separate large prospective trials, BESPOKE and IDEA-CIRCULATE for Signatera in colorectal cancer and the proactive trial for Prospera in kidney transplant rejection screening. These are key trials that we believe will extend our leadership position in these areas. I'm sure many of you saw that we have now completed the process to get reimbursed for Prospera. And so far, we are being paid as expected by CMS. We were very pleased to receive the Force of Change Illuminator Award from Leading Women Entrepreneurs, which is an organization that is recognized over 500 outstanding women leaders in innovative companies over the past day. Sheetal Parmar, who leads the Clinical Services and Medical Education teams at Natera and is Cochair of Women of Natera, an employee resource group that supports workplace equality and diversity was also recognized for her individual contributions in Natera’s mission and values. So we just wanted to say thank you and congratulate Sheetal and the women of Natera for their leadership. In our oncology effort, first in IO monitoring. Just this week, we saw the publication of a groundbreaking validation study in Nature Cancer, demonstrating Signatera's ability to monitor tumor response to immunotherapy in 25 different types of solid cancer. Second in colorectal cancer, we presented data at ASCO and ESMO GI that supports the use of Signatera for metastatic colorectal cancer, with a prospective…

Solomon Moshkevich

Analyst

Thanks, Steve. The first slide here summarizes the commercial verticals we are pursuing within oncology. As a reminder, we signed a deal with Foundation Medicine last year to co-develop a test similar to Signatera, which leverages the tumor genomic data identified in a FoundationOne CDx test to design a personalized assay for each patient for serial monitoring of their ctDNA. We continue to think this is an elegant combination of industry-leading technologies from both companies. And we are excited to have the foundation oncology field force out marketing the product to both biopharma and clinical customers. We expect the new test to fit especially well for the immunotherapy response monitoring indication, which I'll discuss in greater detail in a moment. The co-development effort is going well and we remain on track for Foundation Medicine to be engaging with pharma customers this year. Another key partnership for us is with BGI, to bring Signatera technology to China. We remain on track there to get the initial launch in China by the end of this year, and we have already signed deals with leading biopharma that are just waiting for the service to launch. Within our direct commercial effort, demand in our pharma channel has been exceeding our expectations. We are generating new data together with pharma clients at a rapid pace. And the data that we presented at ASCO in collaboration with Genentech was well received. As our pharma clients plan to launch more MRD guided clinical trials, we are continuing to invest. Mike will touch on this further in his guide. We expect more news flow from the pharma channel in the second half of the year, but for today, we want to focus on new developments in our clinical channel. In the direct clinical channel, we have been extremely…

Michael Brophy

Analyst

Thanks, Solomon. The next slide here is just a summary set of results for the quarter. Steve, covered volumes, revenues and COGS, but a couple other items to note on the expensive side. When we spoke in May, we described that we were going to take a wait and see approach as it relates to investments across our businesses. Despite the uncertainty around the pandemic, the business has been resilient. So we've expanded our initial investment plans from the start of 2020. In oncology, we've made some key additions in the quarter, as the pre launch phase has given us comfort that we should pursue a full commercial launch in the second half as we had originally planned at the start of the year. We expect to be ready in time for the final reimbursement in colorectal cancer here in the second half. One other area that we think is going to require additional investment is in support of our pharma commercial and operations channel. The inbound demand for MRD guided clinical trials, including Phase 3 trials, and subsequent anticipated commercial volumes has pleasantly exceeded our expectations. We're continuing to make investments to support these larger deals. Some of that is reflected in increased R&D investments in the quarter. But also we continue to make progress with the BGI and FMI development efforts. As a reminder, we were paid cash upfront last year to support these teams. And now much of the effort is running through the R&D line. The balance of the increase in R&D is largely attributable to headcount to support several of the large clinical trials that we've launched and Solomon described. So in summary, we're glad to be ahead of schedule, in terms of making some of these client investments. And really most of this work…

Operator

Operator

Thank you, sir. [Operator Instructions] The first question comes from Mr. Doug Schenkel [Cowen and Company]. Sir, your line is open, please proceed.

Doug Schenkel

Analyst

Hey, good afternoon guys and great job in a challenging period. Mike, maybe building off of where you closed, as you noted, your revenue guidance is actually higher than where you started the year. I'm just wondering if it's possible to provide a bridge. It may not be, but I'm wondering, how much of a headwind COVID is expected to be in the context of full year guidance? And on the flip side, how much better are you now expecting, certain volume categories and ASPs to be versus original guidance, that that may be hard to do, but I figured out I’d ask just case it is possible?

Michael Brophy

Analyst

Yes, no. Thanks, Doug. I appreciate the question. I mean, I think the – we certainly would be doing better this year, if it weren't for this lockdown situation, I think we'd be doing even better as we have our strong convictions. We were able to guide above where we started the year initially, really, because I think mainly because the volume performance, I think, exceeded our expectations. And then followed by, ASPs, I think have been stable, where I could if you recall, we had guided, some conservatism around the ASP that arose in the beginning of the year. So that slightly exceeded expectations. And then third, I think the, the new businesses, you know, are performing well. So I think it's, in order of magnitude, those point 1 through 3, those are the drivers. I do see - like we said on the call, in the prepared remarks, this does - the volume assumption for the second half a year does offer some caution as it relates to like sequential volume growth. Just because there's a lot of uncertainty and we're trying to monitor the situation. So we're still on the lookout for impacts from COVID. And I wouldn't be surprised if it's still - still is a bit of a headwind for us in the second half. Steve, would you add anything to that or?

Steve Chapman

Analyst

No, thanks, Mike. I mean, I guess I'll just reiterate that we - in the guide, even though we're raising the guide, you know, we have been conservative with the second half of the year just because of the surge in COVID. And that doesn't mean that we've seen any disruption in any of the new hotspots, because frankly, we haven't. And we think that you know, a lot of the centers and our sales team will put the necessary steps in place to manage through Corona. So we're not really seeing that dip, like we saw in some of the other hotspots in March. But with that said, just with the surge and seeing the sort of peak numbers at various places we wanted to be conservative with the guide, although we did raise.

Doug Schenkel

Analyst

Yes, and that that's really helpful, I guess, I guess that's kind of a good segue to just kind of what's contemplated in guidance. Like, is it fair to say at the low end of the range you're assuming there's some resurgence in infection rates put pressure on the margin?

Steve Chapman

Analyst

Yes, that's right. I mean, I think that the lower end of the guide presumes kind of more disruption, you know, more kind of widespread lockdown kind of scenario akin to what we saw in the spring. And the upside, you know, the upper end of the guide presumes more gradual return to normal.

Doug Schenkel

Analyst

Okay. Last one, and I'll get back in the queue. Just a clean up question on gross margin guidance. Does that contemplate any benefit this year associated from the recent Illumina agreement? And if so, how should we think about quarterly pacing?

Steve Chapman

Analyst

Yes, it's not - there's not a huge benefit from the Illumina settlement. So as you recall that deal will go into effect in October. So just from a timing perspective, there's not going to be a lot of time for that. But you know, the benefit from that deal do affect full year gross margins.

Doug Schenkel

Analyst

Okay, thank you again.

Steve Chapman

Analyst

Thanks, Doug.

Operator

Operator

The next question in the queue comes from Tyco Peterson. Your line is open. Please proceed.

Unidentified Analyst

Analyst

Hey, thanks. I'll start with NIPT, it looks like Aetna extended the average risk policy through the end of the year. You know, is that factored in the guidance? And any thoughts on you know, that becoming permanent, any update from you know, United? And then, it seems like your growth on the volumes is obviously tremendous, how much of this is the market, you know, catching up versus share gains on your part for NIPT specifically? Thanks.

Michael Brophy

Analyst

I'll take the guide piece and then Steve, you want to talk to the second part?

Steve Chapman

Analyst

Yes, sure.

Michael Brophy

Analyst

Yes. So on the guide, yes. So the Aetna news, that is factored in, Tycho through the guide and then in terms of what we think about Aetna going forward, and the volumes, I hand it Steve.

Steve Chapman

Analyst

Yes. I think there is a couple of factors that we think could really move the needle. You know, one is obviously an updated ACOG guideline, I think the other is the publication of the SMART study. And then I think the third is just continued pressure from physicians, patients in the community to have updated policies. And I think across each of those fronts we're seeing, you know, very positive momentum. We've said for a while now that we've heard updated ACOG guidelines are drafted and they're coming. We really don't know when that's going to happen. But we haven't heard anything that would indicate that, you know, they're negative or that's not the case. For the SMART trial, as we said in the prepared remarks. This is the largest prospective clinical trial in NIPT that's ever been done. And it's the largest average risk NIPT trial that's ever been done. And although, we're really excited about microdeletions, I don't want to overlook the fact that there's 20,000 patients many of which were average risk where we have aneuploidy results. And we have clinical outcomes through newborn karyotypes that were done on the baby. So we're in a very good position now to have this be a very significant tipping point, if we haven't seen ACPG guidance before then. And we've seen the aneuploidy data, and we still feel strongly that this trial has the opportunity to really move the needle significantly for Natera, and, you know, for the industry on the whole. And of course, we can't comment on the data at this point. And then I think the third thing is continued momentum with physician usage from patients and from others in the industry. And we're seeing now with Aetna extending their coverage, many of their physicians are getting comfortable with ordering and many of their patients have certain expectations for what's going to be covered. So I think it's a positive sign that they've continued to extend their coverage. And we don't know if that will become permanent at some point. But certainly, the fact that they're extending their coverage is a positive sign.

Unidentified Analyst

Analyst

And then it sounded like from your comments that, you know, IVF could also drive some upside in 2H in terms of picking up and helping with ASPs. Can you just elaborate on how mature you think that could be?

Steve Chapman

Analyst

Yes, so what we saw on the IVF business was really, almost immediately of like a roughly a 80% drop in, you know, late March, early April, because the centers were basically shut down. And around mid May, we started to see centers start to open back up, but they're still in this sort of, you know, social distancing, maybe low volume, less capacity than they would have been before just for safety reasons. So we think that there's certainly a swing to the upside there, and the second half the year and we've already started to see some of that come through in recent weeks. And I guess that the trend is heading in the direction we would expect it to be.

Unidentified Analyst

Analyst

Okay. And then two quick ones, before I hop off. On guidance, I just want to make sure that you didn't factor anything in on the Signatera China launch, given that that's year end, or is that factored in as well? And then you practically brought up the mobile offering? You know, we heard from one of your peers last night about how that had been very important in the COVID environment. Can you just talk to whether you're seeing increased uptake of the mobile offering in this environment as well?

Steve Chapman

Analyst

Yes, let me talk about that first, and then maybe Mike, you can comment on any of the channel revenue. So we had built an enormous infrastructure to deal with mobile patient, blood draws, mobile phlebotomy. We've been doing that for a long time. And we have very significant tools that enhance the user experience, that allow physicians to place orders, that allow patients to interact with genetic counselors and get kits shipped directly to them or have a mobile phlebotomist come directly to their house. So this is something that we had all the groundwork for, we really just had to flip the switch and expand it across all three businesses, women's health, the transplant organization, and in our pre launch oncology phase, we've seen a significant uptick from where we were previously. And it's certainly been a driver of us getting into new customers and extending our relationships with existing customers. And we're actually seeing, you know, quite a nice uptick across all three of those businesses at this point.

Michael Brophy

Analyst

Yes, the Signatera channel in terms BGI is not in the guide, and it's again, it's more of a timing thing. It just won't be live for long enough for the year to affect a full year guide.

Unidentified Analyst

Analyst

Understood. Thank you.

Steve Chapman

Analyst

Thanks, Tycho.

Operator

Operator

Thank you. The next question in the queue comes from Catherine Sheltie. Your line is open. Please proceed.

Unidentified Analyst

Analyst

Hey, guys. Congrats on a great quarter. And thanks for the questions. I guess, first starting last quarter, you referenced that volumes declined about 15% in the last two weeks of March versus prior one 1Q levels. Can you just walk us through what the rebound looked like throughout the second quarter? Or maybe how things were trending in July when we started to see a COVID resurgence in some geographies?

Steve Chapman

Analyst

Yes, I'll take that. So yes, we did see, like we said IVF was down significantly. We saw some of the new businesses drop, you know, more significantly, initially. And then we saw some areas like New York, New Jersey, drop more significantly initially. What's happened since then is the core business has basically recovered. IVF has a very strong trajectory, heading throughout the month of July, as centers have started to open. The new businesses are actually above the levels where they were pre-COVID because of all of the tools that we put in place. And, you know, I think with the recent resurgence, although we've been cautious in our guidance, we've actually looked into the details and we haven't seen any disruption in some of the hotspot areas that you would think of now. So we're feeling good about the trajectory, but like we said, in the guidance, we just want to be cautious because of the uncertainty. I know most people actually aren’t even guiding. But, you know, we felt like we could, you know, conservatively put out what we put out now given what we're seeing in the business.

Unidentified Analyst

Analyst

Okay, very helpful. And any comments on how the initial Prospera launch has gone relative to your expectations and how much is baked into the 2020 guide for Prospero?

Steve Chapman

Analyst

Yes, I would say it's exceeding our expectations. I think, specially in this COVID environment, I mean, we look at the breadth of customers that we're reaching, I think the value being placed on the product by key centers and key physicians, and then our, you know, relatively quick enrollment and site sign up in the proactive clinical trial. We're really pleased to see the engagement that we had at the ATC conference, we had very strong presence to see presentations where we had top principal investigators lined up. So we're feeling good about things and we're seeing the volume trajectory to meet our expectations. You know, of course, certainly it would be easier for us to launch new products if we weren't in this sort of lockdown, COVID environment, but I'm really impressed with the way that our team has been nimble and been able to continue to move the ball down the court and use our mobile solutions to continue to grow the business. From a guidance standpoint, Mike, do you want to make any comments on what's in the guide?

Michael Brophy

Analyst

Yes, I mean, so echo on Steve's comment. The reality is, I mean, just compared to the very large core business for a new product like Prospero, even for it to do well on a volume basis, doesn't really have to be much more than kind of smaller tailwind in terms of impact to the guide. So if it is contemplated in the guide that we would get paid for Medicare like we're getting paid? Yes. But again, very small in terms of the overall business for the second half of the year.

Unidentified Analyst

Analyst

Okay. And maybe last one for me just on Signatera for IO response monitoring. When do you think you could see a draft LCD for that indication? I think the turnaround time for colorectal is pretty swift, maybe a month or two, Prospera closer to five or six months. I think I heard Solomon say potentially by the end of the year, but just curious what your specific timing expectations are there?

Steve Chapman

Analyst

Yes. Thanks, Catherine. I'll make a couple comments and then hand it over to Solomon. As I said, the beginning of the prepared and Solomon said, I mean, we're really excited about this opportunity because it basically is doubling what we had previously put out there for stage 2 and 3 colorectal cancer. And with this Nature paper, it again puts us in a data leadership position to be on the front foot and go out and build this clinical market. And we've already completed a significant portion of the work, which is to get the paper published and then go get the dossier submitted to Medicare. So, Solomon, you want to comment specifically on what that pathway looks like for Medicare?

Solomon Moshkevich

Analyst

Sure, I think we've mentioned in the prepared remarks that we assuming MolDx remains positive on the validity and utility, which we expect based on multiple positive pre sub meetings. We would expect something either as soon as the end of you know, late second half of this year, or something in the early part of 2021. You know, MolDx has its own timelines and priorities, and those are also affected in various ways by the current environment. So, I'm certainly not in a position to speak for Medicare or for the MolDx group. But we think there's very strong momentum here.

Unidentified Analyst

Analyst

Great, thank you.

Steve Chapman

Analyst

Thanks, Catherine.

Operator

Operator

The next question in the queue comes from Max Masucci [Canaccord Genuity] Your line is open. Please proceed.

Max Masucci

Analyst

Hi. Thanks for taking the questions and congrats on a great quarter. So, I mean, do you feel like you've been a meaningful share gainer in NIPT due to some of your larger competitors, wider testing portfolios? Maybe de- prioritizing NIPT in favor of COVID testing? And do you think that can be sticky? And then are you likely to prioritize your mobile tools beyond the pandemic, you know, as just the delivery of health care continues to evolve?

Steve Chapman

Analyst

Yes, so we definitely feel like we've been taking share but also continuing to impact the Greenfield opportunity. So if you remember NIPT, overall, we still think is only about 15% to 20% penetrated in you know, particularly in that average risk setting where there's a lot of customers that are still ordering high risk only. So we think there's a lot of room to grow. We just did a big market survey, where we, you know, in detail, you know, mapped out, high risk, low risk where the opportunity is. And it's really incredible how many physicians are still doing high risk only and how big that opportunity is. But when you look at the uniqueness of our offering where we have - we can detect things that simply other companies can't. Nobody else is doing the snip method. Everyone's doing shotgun sequencing, there's just biological limitations, things that they can detect. And you combine that with the extensive Rolodex of peer reviewed publications that we have at this point, we are by far, the leader now in published data. In fact, just recently, we had another publication in the Green Journal, with over a million patients study that confirmed are near 100% accuracy on fetal sex determination. So we just continue to push out evidence that shows are unique aspects and physicians now recognize us, as both the clinical and market leader. Now we've combined that with a strong sales force. And an extreme focus on user experience. A lot of the customer tools that are now being used in COVID are things that we've been investing in, you know, for the past four or five years. Mobile solutions, ways physicians can interact with patients, ways we can interact with physicians, and provide counseling for patients. So we certainly see that as a major part of the business going forward. I think, you know, to the extent that mobile phlebotomy itself is important, I think that really depends on you know, what happens with COVID long term, and you know, how frequently patients are returning to their offices. But absolutely, digital tools are very important. And we've always said the user expense is extremely important.

Max Masucci

Analyst

Great. And then can you just speak to how your automation initiatives are coming along? How far along are you with those projects? And when do you expect to really start gaining traction from some of those initiatives?

Steve Chapman

Analyst

Yes, I think you're referring to some of the COGS initiatives that we've described previously. So is that correct?

Max Masucci

Analyst

Yes.

Steve Chapman

Analyst

Yes. Okay. So, yes, so we had really a book of big R&D initiatives that we're working on throughout the year, this year, and then into the beginning of next year. And as we said in the prepared remarks, we stay on track to our trajectory to bring our COGS down below, $200 in the reproductive health business. And there's a couple of ways we're getting get there. One is extraction automation, where we've actually now rolled out the initial version of that in our Austin facility. And that's going to be rolled out more broadly. As this year goes on, there's a couple other projects that we've talked about that rely on our deep neural networks project and the fact that we've run more than 2 million commercial samples, we can use that to reduce some of the sequencing costs. And then there's other R&D projects that we're working on that, you know, I don't want to go into detail on right now, but would reduce costs. So we think together, you know, there's still a good chunk coming out of where we are today from - from the future R&D projects. So the stuff is all coming along. It's on track. You know, as we said, we think it will make a meaningful impact. And then, of course, I think our updated supply agreement with Illumina has put us in a strong position to continue to focus on reducing our costs, as we grow our business and that can be another benefit for us in the future. Just one last comment on that, as I said in the remarks, you know, reproductive health, it has been our goal to get down below $200. As we start to see the mix change, and some of these other products come in, we'll try to provide more color on the reproductive health business, specifically, so you can track our progress on some of these key initiatives that are moving forward.

Max Masucci

Analyst

Great. And then if I can just squeeze one more, and could you just give us a directional idea of where your different direct sales forces stand for oncology and for transplant? Just any idea about where these may shake out in the near or medium term? Thanks.

Steve Chapman

Analyst

Yes, so, you know, we've said previously on the oncology side that, you know, we had hired 25 sales reps, and that we were going to be expanding that somewhat as we go into the full commercial launch. We kind of have a sense of where some of the other teams are. And we sort of have now, kind of a schedule based on how many accounts are out there, how many calls we want people to make, and so forth. And so we, we have a good sense of what the optimized number looks like. For competitive reasons, you know, we haven't really been giving the exact number of reps that are out there. You know, on the transplant side, we've said before that, you know, we think that you can be - you can cover the market with a relatively small force, because there's only 200 transplant centers that are of meaningful size, and you just really don't need a big team. And then I think, you know, in women's health, we've sort of said the OpEx has generally been flat there, maybe slightly up as things vary a little bit. But, you know, overall, I think we really haven't been giving any exact numbers.

Max Masucci

Analyst

Great. Well, congratulations on the continued progress. Thanks.

Operator

Operator

Thank you The next question the cute comes from Steven Ma. Your line is open. Please proceed.

Unidentified Analyst

Analyst

Thank you. Congrats on the quarter, guys. Just a few follow up questions on the Signatera and wanted to follow up on Katherine's questions about the IO response monitoring application. So is the draft or is your dossier? Is it going to call out specific cancers or is it going to be a pan cancer, because I noticed on the Nature paper, you know, there was 25 solid tumors in there. So maybe just a little color on strategy there?

Steve Chapman

Analyst

Yes, Solomon, do you want to take that?

Solomon Moshkevich

Analyst

Sure. At a high level, we believe that there is ample evidence for validity and utility of using Signatera in a pan cancer fashion. So for any cancer type, any solid tumor type where the patient's indicated to either begin or continue treatment with immunotherapy, we see value being added by using Signatera in conjunction with imaging to aid decision making along the way. And, and we've discussed that specifically with the team at Medicare and I look forward to seeing what the final decision and you know, draft policies will look like.

Unidentified Analyst

Analyst

Okay, great. That's fantastic if you can do that. And then my last question is on the metastatic CRC application, it sounds like it's going to be an amendment to the existing draft LCD. So maybe a little color and how that works. Do you have to wait for the final LCD or can you amend it in parallel, while you're still getting the final LCD.

Steve Chapman

Analyst

So I think that the simple answer here is we're not 100% sure, because we haven't seen the final LCD. And, you know, based on what that final policy will look like, will dictate what approach we take. There are pathways for amendment and, you know, other paths that should be a little bit more streamlined than going out to get a brand new local coverage decision. So, you know, once we see that final will, we'll be able to share more details about the plan.

Unidentified Analyst

Analyst

Okay, great. Thanks so much for the questions.

Michael Brophy

Analyst

And Steve, I guess, I'll just add one other comment to that. I mean, if you remember I take the open comment period started in kind of roughly October of last year. So we're sort of coming up on that sort of mark where, you know, they're statutorily required to release that final LCD. So we think actually the final LCD could be coming in the near future. And so it's not really a long wait to sort of see what's in there. And then as Solomon also mentioned on CRC, we have this - although we presented great data ESMO GI, what we're actually really excited about is just prospective trial data from a Phase 2 study that's being presented at ESMO. And that will be submitted as a peer reviewed publication. So I think there's a little bit more of a lift there, but the data looks fantastic. And that's, really the biggest hurdle is, is generating this data. You know, not necessarily at this point for us, you know, getting the submissions down because it's sort of become a well oiled machine for us.

Operator

Operator

We have time for one more question. The last question will come from Alex Noack. Your line is open. Please proceed.

Unidentified Analyst

Analyst

Great. Good afternoon, everyone. Actually just following up on that last point right there. So I think statutorily, it's got to be issued by August 22 or so. So just any update on the conversations you're having with Palmetto? And am I correct that has to be issued by that date, or has to be dropped and the anything on pricing?

Steve Chapman

Analyst

No, just one correction. So it's basically 12 months from the October date, 12 months from the start of the open comment period. So we think it should be coming in before - we think it should be coming in before October. So, you know, I think it's up to a couple of months left before that comes in. But it's, you know, it's near term, certainly. And we look forward to that coming out. We've been in active engagement with them, you know, like we said, we completed multiple pre submission meetings on IO recently as recent as you know, early summer and sort of late spring, and then we submitted the dossier for IO, you know, as we said in June. So there's a lot of engagement there, and we feel like that's actually - the CRC final is on track, and we're really excited. We're sort of gearing up for that to come out in the next couple of months.

Unidentified Analyst

Analyst

Okay, got it. Thanks for the correction there as well. And then the IO monitoring application certainly seems pretty unique, pretty valuable to patients. Now Signatera CRC, that's designed for recurrence monitoring, this new indication is very much upstream for treatment monitoring. So the use cases are different. Just how do you plan to leverage the oncology sales team itself both into a recurrence and a treatment monitoring application?

Steve Chapman

Analyst

So I'll make a couple high level comments and then Solomon, or Mike feel free to jump in. I think first, there's certainly quite a bit of overlap, particularly in the community, on the ordering physicians. I think when you get into some of the academic centers, you see more specialization, but the very large community practice network that we're going to be targeting, there's going to be quite a bit of overlap in synergies within the sales force. So we're excited about that. I think the second, one of the - one for us, one of the key rationales for doing the partnership with Foundation Medicines, was because they're brilliantly set up to just dominate in this particular space. And, you know, having already run the therapy selection panel, having already, you know, performed as many tests as they perform and just have this dominant sales team, we certainly think that having them out in the field, with an indication like this is going to be very meaningful. And combined with our force, you know, our separate product, I think it's going to put us in a place to really lock this down, very, very quickly.

Solomon Moshkevich

Analyst

Yes…

Steve Chapman

Analyst

Go ahead, Solomon.

Solomon Moshkevich

Analyst

Yes, I was just going to add, I think we're excited about the opportunity to leverage the same oncology field for us to be able to educate customers about both use cases. And as Steve mentioned, you know, it's roughly 80, 20 community versus academia where patients are treated. So there, you know, there's massive overlap in the customer relationships we've already built. In academia where we, today we really focused on GI oncologist, gastrointestinal oncologist for rollout of the CRC application. I think the great news is that there's been so much excitement and engagement on the research front with other specialties, you know, from breast cancer, lung cancer, GU cancers, et cetera, that I think a lot of those relationships are already being developed and are going to set us up for success.

Unidentified Analyst

Analyst

Okay, appreciate. Thank you. That's helpful. And then just last question. I know you were billing UnitedHealthcare and appealing any denials more aggressively based on the society for field medicine decision. Can you just say if in a quarter or maybe July or, you know, first week in August, if any of those denials by UNH that you went ahead and appealed are starting to get paid?

Steve Chapman

Analyst

Mike, you want to take that?

Michael Brophy

Analyst

Yes. So I mean, I think the best way to track this is just by the coverage policies that the various payers have put out and it's basically status quo, with the exception of Aetna extending to the end of the year at this point.

Unidentified Analyst

Analyst

Okay, understood. Thank you appreciate it.

Operator

Operator

Sir, I'll turn the call back over to Mr. Brophy for any closing remarks.

Michael Brophy

Analyst

Well, thank you all for joining, fantastic questions, is a pleasure to be with you, and we're looking forward to the second half of the year.

Operator

Operator

Thank you, ladies and gentlemen, this concludes today's teleconference. Thank you for participating. You may now disconnect.