Natera Inc

NASDAQ:NTRA

Earnings Call Transcript 2019-Q4

[Operator]

Welcome to Natera's 2019 Fourth Quarter Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, February 26, 2020.

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

[Michael Brophy, CFO]

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our fourth quarter and full year 2019. Also on the line is Steve Chapman, our CEO; Bob Schueren, Chief Operating Officer and 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 guidance for the full year 2020; our assumptions for that guidance; 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-Q 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 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 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 Steve.

[Steve Chapman, CEO]

Thank you, Mike. Good afternoon everyone and thank you for joining us. I want to give a brief recap of 2019, discuss our strong annual and fourth quarter results and lay out the key goals we expect to achieve in 2020. I will then have Mike walk you through our financials in 2020 guns [ph].

The next slide is a snapshot of the most visible achievements in 2019, which was clearly a transformational year for us across all focus areas. We delivered financial results above our above the top of our previous guidance. In reproductive health we expanded our leading market share was strong volume growth, new features in new peer reviewed data. We grew average selling prices in each quarter sequentially from Q1 through Q4. We significantly reduced cost of goods sold per unit. In organ transplant we achieve each of our state of milestones. We publish compelling peer reviewed data, successfully executed clear validation and received a positive final coverage decision for Medicare all of which lays the foundation for a commercial launch in 2020.

In oncology, we publish groundbreaking clinical validity data in multiple cancer types, signed significant commercial partnerships with foundation medicine and Beijing Genomics Institute, exceeded our ambitious goal for total cumulative contracted value with former partners in security draft coverage decision for Medicare in colorectal cancer. It took us years of work to get to this point, and I know many of you have been with us for that journey. We appreciate your support and continued input.

On the next slide, you can see how our momentum coming out of 2019 forms the backdrop for our 2020 goals. In reproductive health, or 2020 goal is to drive the business towards cash flow breakeven while extending our leadership position. We intend to do that by continuing to drive volume growth while improving our unit economics. In transplant we're very excited about receiving final Medicare coverage for Prospera and our goal is to have a successful commercial launch in 2020.

In oncology, we have an opportunity to make Signatera, the standard of care for minimal residual disease and recurrence monitoring. And our goal in 2020 is to execute the first major product launch in colorectal cancer, while continuing to be the partner of choice for major clinical trials that can define the space in the coming years.

Now, let me jump into the Q4 and 2019 results. The first slide shows our long term track record of driving volume growth in our reproductive health business. We had another very strong year in 2019. Q4 in particular was a great sequential growth quarter versus Q3 of 2019. We are again seeing strong growth so far in Q1. We believe we are well positioned to have another solid growth year in 2020.

I'm very pleased to announce that we've exceeded the top end of our 2019 annual guidance with $302 million in revenues and a 42% gross margin. That was guidance that we had already raised twice during 2019. In addition, we crossed over $300 million in revenues for the first time as a company. As a reminder, we sold our Evercord business in the middle of the year, so pro forma for that sale, our revenues would have been even higher. Q4 also exceeded our expectations financially, as we posted strong revenue and gross margin growth versus last year. Revenues were up 24% year on year in the fourth quarter, from $67 million to $83 million and gross margins were up 1100 basis points from 36% to 47%. A key driver for this performance was volume growth combined with improving unit economics.

On the next slide, you can see a snapshot of our average selling price and cost of goods sold per unit on a per unit basis over time. We were pleased to see continued momentum in our ASP.

Recalled in Q4, 2018, in Q1 of 2019, we took a significant ASP hit in response to several factors including the expansion of prior authorization policies. And we described a series of efforts that we were pursuing to improve the fraction of time we are reimbursed for our tests. This was a very substantial and focused effort to identify and fix gaps, and it was a major investment by our team. So we're pleased to see our ASP improving on this slide. I'd also note that the Evercord business contributed about $10 in ASP to the previous quarters. So on an apple to apples basis, we are now in a better place on accrued revenue per test than we were before. And we have a number of initiatives underway that could further improve ASP this year.

Note that, this ASP chart does not give us the benefit of any partner revenue recognition or revenue true ups from prior periods in order to give a sustainable sense over insurance reimburse revenue pre-test.

On the right side of the slide, you can see our cost trajectory. Over time, we've significantly reduced cost of goods sold, and we're pleased to reach a new low in Q4 of about $224 per unit. That's a step down from the mid to 30 range we saw for most of 2019. Back when the cost were the 270 range, we set a target to be below $200 per unit, and we think we can achieve that goal based on funded active R&D projects we are currently pursuing it we expect those projects to complete throughout 2020. We said on a Q4 call last year that we need to generate roughly $180 million in gross profit to cover operating expenses in the reproductive health business. And one way to do that would be to get $200 margin per test with 900,000 units. A number of variables make it hard to predict precisely when we will cross that threshold or we move significantly closer in 2019 and have a path to get there in the relative near term.

Overall, reproductive health we're executing very well on volume ASP and COGS, we feel very positive about our ability to extend our leadership position and drive the business towards cash flow breakeven in the near term.

Okay, shifting gears to transplant. Just as a reminder, there are roughly 20,000 kidney transplants per year in about 180,000 patients living with a transplanted kidney. Within the first five years, about 30% of recipients will lose their kidney. And within the first 10 years, roughly 50% will lose their kidney. Our test Prospera uses our proprietary technology to detect donor derived cell free DNA in the plasma as a biomarker of organ rejection. It significantly improves on the performance of the currently available biomarkers.

We think that this market can be very significant over time, and we estimate that the market today is less than 5% penetrated. The charter the right gives you a sense of the revenue potential over time. If you assume 20,000 new transplants per year in the United States, seven tests per year, the first year and then quarterly for the next two years, you can see a range of estimated annual revenues that could be achieved at a reasonable market penetration rate. Even these conservative penetration levels, the revenue has a potential to make a meaningful impact on the tourist business.

I've had the chance to meet with several transplant centers recently. And one key takeaway from those meetings is that the vast majority of centers are in the very beginning stages of using donor derived shelf ware DNA as a tool in their patient care. We plan to grow our share by tapping into this Greenfield opportunity and by winning market share and clinics that are already using donor ad cell for DNA testing.

The next slide is just the same chart we've shown since we announced the presentation of our validation data. We've hit every milestone towards a commercial launch on time so far, we've now made the necessary preparations for our full launch and are just awaiting that are ready and local coverage decision and final pricing before we execute the full commercial launch. As a reminder, iridium follows the guidance of the MODX program where we've already received a final positive coverage decision. We expect the iridium final coverage decision to issue very soon.

We believe we're in a good position to be successful given the outstanding performance of our test versus the first generation donor derived cell for DNA test. As a reminder, or clinical validation data compete, compared favorably against the first generation tests across many aspects of performance, including the detection of T cell mediated rejection, the ability to detect subclinical rejection, where there are no other clinical signs in the overall area under the curve. Our study was approximately two times larger than the competition and has now been evaluated by independent experts at Medicare, who rated our strength of evidence more favorably than the first generation test. In our conversations we find the transplant physicians are responding positively to this data.

We previously announced our plan proactive registry study, which to our knowledge is the largest prospective donor derived cell free DNA study ever performed, led by Dr. Jonathan Bromberg from the University of Maryland. In a second study led by Dr. Phil Halloran from the University of Alberta. We're excited to be working with these key opinion leaders, and we're actively recruiting for these studies. We are really pleased with the interest thus far, and we look forward to providing updates in the future.

Okay, I will now turn it over Solomon to discuss our significant progress in oncology. Solomon?

[Solomon Moshkevich, GM, Oncology & Transplant]

Thanks, Steve. I'd like to start with the review of our firm business. Then our clinical testing businesses focused on colorectal cancer and then touch on our key commercial partnerships. We made excellent progress in 2019. With our pharma business, we outperformed our goal with over $55 million in cumulative signed contracts. We see that business accelerating now because we are able to clear a number of vigorous technical, operational and intellectual property reviews with our largest biopharma partners.

The publication of significant clinical data across multiple disease types also played a role. And finally, because of the growing consensus on the utility of our personalized MRD approach for enriching and accelerated clinical trials. Our technology is changing drug development, enabling pharma companies to bring novel treatments out of the metastatic setting straight into the Agilent and neoadjuvant settings for patients with early stage disease. Because most early stage patients are already cured by surgery alone, and therefore not derive any benefit from a novel treatment. Drug trials in this setting are historically very large, risky and expensive, as one would have to treat so many patients benefit just one. In fact, there are multiple examples of immunotherapy trials in the adjuvant setting where the trial failed and where we believe those trials may have been successful. Had they been enriched with Signatera.

With Signatera drug developers can focus the trials on the patients who have residual disease after surgery, or early signs of molecular relapse. And they can read out the trial faster by using Signatera as an early endpoint to evaluate therapy effectiveness testing for clearance of that residual disease upon treatment. This concept is gaining traction now, as we have signed that a recently announced several prospective phase two trials, in addition to multiple projects involving the analysis of specimens collected and stored from previous clinical trials. In addition to our growing pipeline of former trials, we are also focused on extending our leadership in data and clinical development in early stage colorectal cancer. One of our key wins there was our deal with AstraZeneca, which was previously described.

Another was our deal with the National Cancer Center of Japan. Running the Japanese arm of the circle idea trial in over 100 sites across Japan. This was designed to be practice changing study. His objective is to show that stage three colorectal cancer patients if they test MRD negative with Signatera after surgery, they completely for go as even chemotherapy. Today the guidelines are clear that all states three patients and colorectal should receive chemotherapy after surgery. The treatment duration has been an area of hot debate, but it requires a randomized trial like this to change those guidelines. This is the type of trial that can establish a new standard of care in Japan, which we feel very positive about.

We also launched the bespoke CRC registry study aiming to collect data on 1000 patients tested a Signatera as part of clinical practice under the criteria established by Medicare in its draft coverage policy. This study is important because we work with our principal investigators who are leading GI oncologist in the field to establish a recommended testing protocol with six tests in year one after surgery and four tests in year two.

As a reminder, Medicare draft local LCD proposes coverage for the series of Signatera in two settings. After surgery to evaluate the need for argument chemotherapy, and in the surveillance setting to be used with the same frequency as CEA three or five to detect recurrence and help resolve those positives from both CEA and CT imaging. We received the draft coverage decision last year, we expect to have the final coverage and pricing in mid-2020. And we're planning a full launch commercially later this year. Early feedback from GI oncologist has been very positive and the unmet need in stage two and three, colorectal cancer is strong. We believe this clinical indication has the opportunity to translate to about a million tests per year, which gives you a sense of the size of these oncology markets that were just beginning to unlock.

Thus far on a reimbursement pathway. We have met all of our major milestones and we're navigating the process as expected. The public commentary for this draft LCD was completed in Q4 and we think it went smoothly. So we remain on track to get the final LCD, likely in a second half of 2020 based on standard times and our experience between draft and final LCDs, which then will be followed by a pricing decision. In the meanwhile, we're also preparing additional submissions for coverage of new indications.

Finally, in addition to our direct pharma and critical businesses, we're also making significant progress on the co-development efforts with foundation medicine and BGI. We received positive feedback on the partnership with foundation medicine, as it will enable both physicians and pharmaceutical customers to access personalized monitoring technology for patients whose tissue specimens have already been analyzed by foundation one CDX, and the program is on track.

Our efforts of BGI are also moving forward with the objective to make signature available in China this year. BGI will handle all the sales and marketing effort and paying Natera a royalty on sales. And in some cases, we're also collaborating together with them to win global drug trials. In fact, the first day of this nature has already been signed. We believe China represents a large market with roughly 4.3 million new cancer cases annually. And the BGI is the ideal partner with a significant scale or regulatory experience.

Now, let me hand the call over to Mike to talk about the guidance for 2020. And the investments we're making it open up these new opportunities. Mike?

[Michael Brophy, CFO]

Thanks, Solomon. Just a few housekeeping items on the next slide that summarizes the quarter. So that you will notice that we've tightened up some of the disclosure this time so instead of breaking out horizon and panorama into financials, we are giving overall product revenues, licensing and other revenues and then something that the total revenues. We talked about making that change on the Q3 call, and we had originally planned to make that change in Q1. However, because we're the only laboratory disclosing says granular performance, data, given the competitive environment wherein we brought that change for one quarter purely for competitive reasons. I can tell you that the ASP and volume trends Steve outlined at the beginning of the call were consistent across both products and clearly very strong.

We booked about $3.8 million in development revenue from our strategic partners in Q4. Also in Q4, we've benefited from about $3.4 million in revenue true ups from cash collections from prior period accruals. The majority of which is also stripped out of that ASP slide that Steve presented and that's because the goal of at ASP slide is to give you a view of ongoing insured reimbursement DSPs for our products. Some of you will recall back in 2018, when we started to book revenues on an accrual basis that we've tried to accrue with some conservatism. And I think the revenue true ups now and in the last couple quarters demonstrate that we follow through on that approach. The rest of the P&L you see here I think is largely line with our other disclosures. SG&A line did grow up meaningfully versus Q4 2018. As we've invested in the initial commercialization steps in our new business, which we talked about on the Q3 call.

Okay, now on to the 2020 guide, we are expecting total revenues of $335 million to $350 million gross margins to be 43% to 49%. SG&A to be $240 million to $260 million. R&D to be $80 million to $90 million and cash burn to be $125 million to $150 million. Let me give you a couple assumptions embedded in our guide. First on the reproductive health business, we are seeing strong volume of minimum Q4 and Q1 as Steve mentioned, and we expect that to continue. You also saw on the slides that we have shown good sequential progress on ASP s. We have a number of initiatives underway that could drive ASPs higher. For the guide however, we are erring on the side of caution and modeling some very modest erosion in 2020.

This isn't due to its price competition or really any factors we're currently experiencing, but rather accounts for the chance that variables like prior off become more intense during the year. And we need to take a few quarters again to meet new pair requirements as we get a 2019. This approach may prove to be conservative, and we look forward to updating this in future quarters. Finally, we're not modeling any positive impact from increased average risk and ITT reimbursement or future revenue true ups. And we'll just leave that as upside.

Because we don't have a history of actual to us in the forecast, we are taking a cautious approach to guiding revenue contributions for the new clinical product launches in transplant and colorectal cancer. We've timed these launches to start really at the same time as when we get final pricing and coverage from the radiant. For transplant we expect that in Q1 or early Q2 of 2020, and for colorectal cancer, we expect that in the second half of the year. Our past experience generally indicates that it takes a sales rep time in the field to really get productive. So we factored that productivity ramp into our model. This is another variable that could prove conservative, and we look forward to giving updates through the course of the year.

Finally, on the partner channels, we booked $16.4 million in licensing and development revenues in 2019. So we do expect a modest amount of revenue recognition from that effort this year, but less than what we saw in 2019, just because a meaningful proportion of the revenue to be recognized in the development phase of these deals, was booked upfront as licensing revenue when we signed the deal.

Okay, let me go on to the next slide and walk through the plan investments for the year. On the reproductive health side, we've completed a number of projects last year that drove down our cost of goods sold protests from the $270 range, down to $224 that we see now in Q4. And now the those resources are willing over to a new set of initiatives that are designed to drive us to our cause goal of $200 per test. Because we are using the same core technology across all of our businesses, these advances generally also drive future benefits for oncology and transplant as well.

On the sales and marketing side, we are maintaining our level of investment to ensure we continue to expand our market leadership position and grow volume.

Steve summarizes the path to cash flow breakeven as a section so I won't reiterate that, but you can see we made real strides toward that target at 2019 and we remain on track. In oncology and transplant, we are making planned investments for two major product launches. The unit economics in these areas are compelling in the markets are large. We think the potential for creating shareholder value in these areas is significant. And we raise capital in October specifically to make sure the commercial launches are fully resourced. The R&D effort in these areas are focused on clinical trial spend design to establish these tests as the standard of care, and to scale the products effectively.

So to summarize, we're pleased to have had a strong Q4 and we feel like we're in a strong position to execute our 2020 goals across the business.

Now, I'd like to open the line for questions. Operator?

[Operator]

[Operator Instructions] Our first question comes from Max Masucci with Canaccord Genuity. Your line is now open.

[Max Masucci, Canaccord Genuity]

Hi, good afternoon, apologize for any airport noise in the background. So first on [indiscernible]. Can you just give us some additional color around your guidance philosophy for 2020 with the sales of Evercord and Signatera transplant wrapping up and can you comment on the key assumptions and the pacing included in the guide?

[Steve Chapman, CEO]

Yes, thanks Max. So as we note on the call, overall, we're taking a cautious approach to revenue contributions in the model from the new products in terms of the pacing of that revenue, really, you won't see revenue coming into the model until we get final pricing and final covers decisions from the radian. We gave our timing in the prepared remarks, we expect for Prospera, we expect that you know, first half Q1 or early Q2, and second half of the year for Signatera colorectal cancer. So obviously, that will drive also the pacing revenues. So the revenues are volumes for Prospera. We're modeling a cautious ramp as we kind of get actual and we start that process. Same for Signatera and then the revenues translate once we have pricing kind of Q2 for Prospera and second half the year for Signatera.

[Max Masucci, Canaccord Genuity]

Great. And then, so earlier this week one of your competitors in looking back at monitoring spoke about their intention to invest heavily in monitoring data trials, additional capabilities, can you just speak for how you're balancing the right level of investment and monitoring with your reasonable cash management?

[Steve Chapman, CEO]

So, this is Steve. Thanks for the question. I mean, if you look at some of the increases and investment we made going into 2020. A lot of it is expanding our capabilities, specifically around investments in clinical trials. Of course, for the new businesses, we have these investments in commercialization as well. But a lot of the other increase we've seen is in the space of clinical trials. So specifically, and colorectal cancer, we've now announced this Columbia 2 trial with AstraZeneca, the circulate idea trial with Japan and this very large, bespoke colorectal trial. So we feel like we're putting our focus in the right areas that can deliver significant revenue growth and guideline changes in the future.

[Max Masucci, Canaccord Genuity]

Great. And one more effect dance and gross margins beat us in Q4 2020 guide is that ahead of where we were thinking, these higher than specific factors that are helping drive gross margin expansion and then expectations for the timing and the impact of automation?

[Steve Chapman, CEO]

Yes. So I think the number one driver for the gross margin guide is really the trajectory on COGS. And so we laid that out on the slide, we're pretty pleased to have a very strong Cost of Goods Sold quarter in Q4. And we've got projects launching through the course of 2020 that we think can get us to our target. Now, whether the target actually shows up in a quarter in 2020 is really a function of just the timing of when we can get projects launched. That's the number one variable. I would just also just keep in mind partner revenue recognition and things like that that did boost margins somewhat ahead of schedule in 2019.

[Max Masucci, Canaccord Genuity]

Thanks, guys, congrats on a great 2018

[Operator]

Thank you. Our next question comes from Doug Schenkel with Colin. Your line is now open.

[Doug Schenkel, Colin]

Good afternoon, guys. And thanks for taking the questions. Maybe again to starting on Signatera. I know you mentioned this in answering the last question. Hopefully I got it right. I think he talked about a midyear, early second half LCD finalization for Signatera. Given you already have the draft LCD in hand. Is the timing of that a little longer than you might have expected originally in it and if so, why? And then how long do you expect it to take from finalization to actually getting paid and I guess the third part for this one, any thoughts on the need for a registry study there?

[Steve Chapman, CEO]

Yes, this is Steve, I'll make a couple comments. The timeline that sort of second half 2020 is absolutely within the expected timeframe. And I think that that's what we've indicated before. You know, there's a window in which Medicare has the opportunity to take the draft to final and we're still well within that window. So we feel confident about that. With respect to the registry trial, we are doing a registry study, that's the bespoke trial.

Bob, do want to make additional colors on bespoke?

[Bob Schueren, COO]

Doug, if you're asking about the bespoke CRC trial, so we outline that that's going to be a big investment for us, over 1000 patients where we're going to be tracking all the clinical data and the outcomes data for patients who are using Signatera under the criteria spelled out by Medicare in stage two and three colorectal cancer. So, I think that's going to be important for a lot of reasons. And it's going to help us establish this as a key indication for MRB testing going forward.

[Doug Schenkel, Colin]

Okay, super helpful. I guess the one other part of that, which maybe we got it just in terms of what's implied in guidance, but I guess, Mike, are you expecting shortly after the foot finalization of the LCD that you're going to get paid right away? Or are you expecting some delay?

[Bob Schueren, COO]

Steve, you want to come back?

[Steve Chapman, CEO]

I'll take that. So once the Noridian issues the final LCD, you can effectively start billing patients that are that are drawn after that date. So there's a 60 day waiting period where there is sort of an administrative process where they're loading the tests in the code, but you can backfill for all those patients. So as soon as we get the Noridian LCD, we should be able to monetize the test going forward.

[Doug Schenkel, Colin]

And presumably you're not assuming any catch up payments but it's possible that you could get those down the line.

[Steve Chapman, CEO]

No, there's only catch up payments back to the date to which Noridian issues the LCD. There's no catch up payments for periods prior to the issuance of the LCD, and the real commercialization efforts, you know start after we get that final LCD. Okay.

[Doug Schenkel, Colin]

On BGI, a modeling question, given some of the associated revenue is tied to work that's being done over at BGI and milestones and working with them given what's going on in China with COVID-19 does it make sense to assume that anything that's coming in from BGI this year, at least for now is going to be a little bit more back end loaded?

[Steve Chapman, CEO]

Well, it's going to be more muted than it was in 2019. It's got nothing to do with coronavirus. It's just has everything to do with the fraction of the of the cast that we booked as revenue by virtue of assigning license deal versus the fraction of the cast will book as revenue via doing the ongoing work. It's really it's not a coronavirus deal.

[Doug Schenkel, Colin]

Well, yes, I understood it. I heard what you said in your prepared remarks about it being lower this year than last year, because I thought the upfront but I also thought that some of the additional funding that was going to come in the revenue was tied to them actually doing work. So does that comment might mean that you're not assuming any that that right now, there's no reason to assume there's any disruption related to anything that t you're selling right now?

[Steve Chapman, CEO]

We're expecting a disruption that’s still going to work and that been great.

[Doug Schenkel, Colin]

Okay. And that last one, the obviously foundation in BGI were nice developments in 2019. Doesn't sound like you're assuming in your guidance that any more types of deals like that come in, but it is their bandwidth and potential for more of those types of deals in 2020 that that would potentially drive outside what you're targeting for revenue this year?

[Bob Schueren, COO]

So over the years if you look at -- sort of materials history, I mean, we have a very novel technology that is proprietary and can be used in many different ways. And of course, we're always involved in various business development discussions whether that be with partners or now with pharma, where we've done extremely well, in driving our total contracted value, and now we're seeing that accelerate. And some of those are sort of more unique projects.

So, there's nothing necessarily that you should bake into the guidance, but this is always an aspect of the business that we're working on and we keep a keen eye on.

[Doug Schenkel, Colin]

Okay, super helpful. Thanks, guys.

[Operator]

Thank you. Our next question comes from Will Quirk with Piper Sandler. Your line is now open.

[Rachel Vatnsdal, Piper Sandler]

Hi, good afternoon. This is Rachel on for Bill and first question. Can you give us an update on the second oncology testing your conversations that you've been having with CMS?

[Michael Brophy, CFO]

Yes, so we said previously that we had a second pre submission meeting. I mean, if you look at the total available market for Signatera, it's enormous. So colorectal cancer, we project to have a potential of over a million tests per year, which would make it one of the largest specialty diagnostic tests ever approved by Medicare on its own. And that's just colorectal cancer. So when you look at the data that we've generated in breast, lung, muscle, invasive bladder, and now recent data that was presented at ASCO and asthma last year, on therapy, effectiveness monitoring, and there's lots of different opportunities for us to expand using the same tool with very limited additional research and development work to open up a lot of new markets.

Now with respect to our pre submission meeting we had very positive discussions with Medicare. We haven't released specifically what our second indication is going to be. But there will be many indications and Signatera in the future.

[Rachel Vatnsdal, Piper Sandler]

Great. And then next question. Can you just give us the latest on ACOG and if you've had any conversations with endorsing average risk, I know we've been waiting on a while. But if you have any updates, that would be great?

[Steve Chapman, CEO]

Yes, we said previously that we have heard that there's a guideline coming. We haven't heard anything contrary to that. But we really don't control the timeline. And we don't have a lot of insight into the timeline. When we look at some of the factors that are happening in the background there's a lot of positive momentum. So a year ago, there was really no state Medicaid plans that were covering average risk and IPT. Today, there's roughly 15 or so they cover a significant portion of the breast in the United States. And we're now starting to see national payers covering average risk in IPT through their managed Medicaid programs.

So one of the two national payers, who doesn't cover the test commercially, has now issued a coverage policy for one particular managed state Medicaid. So all of these things start to add up over time and are sort of pointing in the right direction. Again, we feel positive about it. But we really just don't control the timeline. Now, the great news for Natera, because we've done such an awesome job reducing our cost of goods sold and managing some of these prior authorization policies. We do not need average risk and IPT to come in to get the women's health business profitable. And we have not included it in our guideline, or excuse me, in our guidance in 2020.

[Rachel Vatnsdal, Piper Sandler]

Great, that's it for me. Thank you.

[Operator]

Thank you. Our next question comes from Catherine Schulte with Baird. Your line is now open.

[Catherine Schulte, Baird]

Hey guys, thanks for the question. First, you talked about seeing some of your Signatera pharma discussions accelerating? Do you guys have an updated goal in terms of where total contracted value could be by the end of this year?

[Steve Chapman, CEO]

Hey Catherine, thanks for the question. So we're going to sunset, that goal discussion. We put that out there last year because the business was really nascent, and we were just responding to investor questions about just trying to frame what the opportunity can be. So we beat that goal. And we're no longer going to get a focus on that as a metric. You can see from where we landed, though, that the demand is really meaningful and can be a serious contributor to our business. What we saw over the course of 19 is that that business accelerated through the course of the year and we're seeing continued momentum here in 20.

[Catherine Schulte, Baird]

Okay, great. That's helpful. And then I guess also with some of these new products launching later in the year, and I think you've also historically seen some seasonality impacts in the first quarter. Can you just help us frame how to think about first quarter revenue?

[Michael Brophy, CFO]

Yes. So I think that there are a couple of puts and takes there. On balance though, because you got new products coming in kind of in the second half of the year. I think that is, as I think about kind of seasonality of the revenues. I think that's going to be something to keep in mind, as relates to Q1 it's just the puts and takes around revenue true ups, we've had a couple of good quarters here we've gotten some true-ups. We had some in Q4. I don't think that's not included in the guide. I wouldn't necessarily bake that in two quarters into 20. And then as I mentioned with Doug, I don't expect the partner revenue recognition to be a substantial in 20, so I think what that sets up for is a modest back in waiting to the revenue quarters of the year.

[Catherine Schulte, Baird]

Okay. And then, last one for me on foundation, any updated thoughts when we could see the clinical version of that tests come to market? And how should we think about the checkmarks along that that path to commercialization and from a reimbursement perspective?

[Steve Chapman, CEO]

Yes, Catherine. Just one last comment on the previous question as well. I mean, as Mike said in a prepared remarks, the volumes are looking very strong in Q1, as we've seen in historical years, and you can see, just looking at the quarter over quarter growth between Q3 and Q4, there's an acceleration going into the beginning of the year, like we've seen in previous years. So Solomon, you want to just comment on the foundation Partnership, which is going really well.

[Solomon Moshkevich, GM, Oncology & Transplant]

Yes, happy to so as we announced the time to deal the initial focus of the partnership is to enable personalized ctDNA monitoring in biopharmaceutical trials. And we expect that to be enabled this year, we're on track for that. I think that's where companies are staying focused as a first step. As we've got new information, we're going to share that.

[Catherine Schulte, Baird]

Great, thank you.

[Operator]

Thank you. Our next question comes from Alex Nowak with Craig-Hallum. Your line is now open.

[Alex Nowak, Craig-Hallum]

Good afternoon, everyone. Steve or Mike, your competitor here had a bit of a blow up due to prior authorizations. But can you just confirm you're not seeing any sort of change in this pair environments, so far in the February you're just being prudent here, putting some sort of conservatism into the 2020 assumption?

[Steve Chapman, CEO]

So, I'll come in just briefly on sort of some of the building operations stuff and then Mike can talk about you know what's in the assumptions. If you go back and look at our ESP is so as we turn the corner into 2019, we saw a pretty significant drop off, both some reductions in Q4 2018 and then a pretty significant reduction in Q1 of 2019. And so we dealt with a lot of these prior authorization, coding change issues at that point, and we worked super hard over the course of the year with daily stand up meetings and a lot of initiatives to try to put ourselves in a better position. And we're pleased to see the fruits of that effort now. As we showed on the slide, Mike, you want to talk about the conservativeness in the guidance?

[Michael Brophy, CFO]

Yes. Just -- Alex, you did hear that correctly. That's not a reflection of anything we're seeing currently. It's been pretty stable environment over the last few quarters, and it's just erring on the side of caution as relates to forecasting for the full year.

[Alex Nowak, Craig-Hallum]

Okay, got it. And then I get Noridian hasn't issued the final decision here for Prospera. But shouldn't there be a price out by Palmetto given the LCD is effective February 3, again, I understand that Noridian needs to have their policy out there and final for you to get paid, but I've got to imagine Palmetto must have mentioned something around pricing here?

[Steve Chapman, CEO]

Yes, the discussions are sort of in the later stages. I mean, they're very positive. We'll be announcing something in the near future. We're feeling good.

[Alex Nowak, Craig-Hallum]

Okay, understood. And then Mike, can you just say what the mix of the incremental $120 million OpEx spend is for 2020. What is the next for prenatal transplant cancer roughly?

[Michael Brophy, CFO]

So, overall, so the contribution of OpEx in women's health business is remarkably stable, and not consistent with what we said previously, we feel like we can continue to deliver volume growth for a relatively stable level of investment and then the incremental total OpEx spend is really dedicated to ecology and transplant.

[Alex Nowak, Craig-Hallum]

Okay, I understood. Well, congrats on a great end of the year.

[Operator]

Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect. Goodbye.