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Edited Transcript of NTRA earnings conference call or presentation 9-May-19 8:30pm GMT

Q1 2019 Natera Inc Earnings Call

San Carlos Jun 13, 2019 (Thomson StreetEvents) -- Edited Transcript of Natera Inc earnings conference call or presentation Thursday, May 9, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Michael Brophy

Natera, Inc. - CFO

* Paul R. Billings

Natera, Inc. - Chief Medical Officer & Senior VP of Medical Affairs

* Solomon Moshkevich

Natera, Inc. - General Manager of Oncology & Transplant

* Steve Chapman

Natera, Inc. - CEO, President & Director

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Conference Call Participants

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* Adam Joseph Wieschhaus

Cowen and Company, LLC, Research Division - Associate

* Catherine Walden Ramsey Schulte

Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst

* Daniel Henry Macek-Alwell

Piper Jaffray Companies, Research Division - Research Analyst

* Eleni Maria Apostolatos

JP Morgan Chase & Co, Research Division - Research Analyst

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Presentation

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Operator [1]

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Welcome to Natera's 2019 First Quarter Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded today, May 9, 2019.

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

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Michael Brophy, Natera, Inc. - CFO [2]

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Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our first quarter. Also on the line is Steve Chapman, our CEO; and Bob Schueren, Chief Operating 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 this 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 2019, 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 and related effects on our financial and operating results. We caution you that such statements reflect our best judgment based on factors currently known to us and that actual events or results could differ materially. Please refer to the documents we file from time-to-time with the SEC, including our most recent Form 10-K and the Form 8-K filed with today's press release. Those documents identify important risks and other factors that may cause our actual results to differ from those contained in the forward-looking statements.

Forward-looking statements made during the call are being made as of today. If this call is replayed or reviewed after today, the information presented during the call may not contain current or accurate information. Natera disclaims any obligation to update or revise any forward-looking statements. We will provide guidance on today's call but 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.

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Steve Chapman, Natera, Inc. - CEO, President & Director [3]

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Thanks, Mike. Good afternoon, everyone, and thank you for joining us. I will cover our recent highlights and progress in the business since we last spoke in March, and Mike will provide additional detail on our financial progress. As Mike mentioned, we will be referring to slides that were just posted at investor.natera.com.

In 2019, we have 3 key goals: extend our leadership position in reproductive health and drive toward cash flow breakeven in that business, deliver real commercial progress in oncology with Signatera and to pass the key tipping points in our organ transplant business by commercializing Prospera and obtaining Medicare coverage. We've been productive thus far in 2019.

Let me hit the highlights. First, we processed over 200,000 tests in the first quarter, which represents a 15% sequential increase over Q4 of last year. We were very pleased with this representing one of the fastest net unit growth quarters in our history given the evolving competitive dynamics in the market. Total revenues in the quarter were $66.8 million, at the top end of the range we had preannounced as part of our equity raise. We stripped out the nonrecurring revenue of $5.5 million from QIAGEN in Q1 of last year. We grew organic revenues at roughly 18% year-on-year. We reached a crucial milestone in our transplant business since our last earnings call. We received a very positive draft local coverage decision from Medicare, and we believe we are on track to receive a final positive local coverage decision and commercialize the tests later this year.

We are also very pleased with the progress we've made in oncology recently. Since our last call in mid-March, we have announced 3 major publications, announced a plasma-based whole exome capability, were awarded breakthrough designation from the FDA and conducted a successful presubmission meeting with Medicare as the first step toward a local coverage decision in colorectal cancer. Our past investments are paying off, and we remain on track for our target of $40 million to $50 million in Q1 of total contracted value to this year.

We haven't spent a lot of time historically talking about our IP portfolio. We had a particularly active effort in the first quarter of this year where we had 12 new patents issued or allowed. We will cover this in more detail later in the call. Finally, most of you know we successfully priced a $115 million gross proceeds equity follow-on in April after the end of the quarter. We launched a deal with $100 million on the cover, and we met that target and received the greenshooting proceeds a few weeks ago. Overall, we're making great progress towards our 3 key corporate goals.

Now let me jump into the details. On Q1 volumes, we had a very strong quarter. The net unit growth was among the best we have seen in the company's history. We continue to see benefits from the hard work we've put into the product improvements and user experience initiatives that we've described in the past. We continue to make targeted investments in our commercial effort, and we intend to stay vigilant on protecting our market share.

There have been some significant changes in the competitive landscape over the last 6 months. This space has been always been very competitive, and several new entrants are doing well. But we're pleased to see our safe technology, clinical differentiation and strong sales channel are delivering strong results. We have a long history of competing in this very large and highly competitive but still relatively underpenetrated market, and we'll continue to do so.

The next slide shows a breakdown of the growth performance in the last 5 quarters for both Panorama and Horizon. You can see Q1 represents an obvious step-up in both products beyond the strong volumes we generated last year. Over the last few years, we have seen that existing accounts tend to grow their volumes meaningfully in Q1 compared to Q4. That seasonal dynamic, coupled with continued growth in new accounts, has driven our Q1 outperformance again this year. In Q2, the seasonal effects will reverse, requiring strong new account growth to stay roughly flat sequentially. We expect to see roughly the same pattern this year, and we've been pleased with new account growth so far in Q2 and are on track to hit our overall volume trajectory for the year.

I'm sure many of you are interested in the progress we're seeing with average-risk NIPT. The average-risk market remains a largely untapped market opportunity. Today, it's only about 15% to 20% penetrated, representing an enormous volume, revenue and cash growth opportunity for Natera. In fact, on a significant portion of our NIPT business today, we collect 0 from payers due to lack of average-risk coverage. On just the volumes we perform on our lab today, with no growth on an annualized basis, we believe achieving full average-risk coverage could be worth $60 million in additional revenue and cash flow.

We are seeing some traction on expanding coverage. In addition to the previously discussed Blue Cross Blue Shield policy changes, we've seen a notable uptick in the number of Medicaid average-risk covered lives. We think this change in average-risk coverage is an important dynamic in the market because Medicaid represents roughly 50% of the births in the United States. So this trend has the potential to be very meaningful.

As we talked about extensively on the Q4 call, we saw the expected pressure on ASPs in Q1 in line with our model. This was largely due to variables that we think could be remedied in the medium term, like new prior authorization policies. Mike will go into this topic a little bit more later in the call. But we have a number of initiatives in place to drive improved reimbursement that we think could make a difference this year.

The next slide describes our blended cost of goods sold progression. As you can see on this slide, we made a significant progress in the quarter on our blended COGS metric, going from $263 in Q4 to roughly $232 per unit in Q1. Some of this is a function of volume growth over a base of fixed facilities and labor expenses that didn't need to grow as quickly as our volumes. But most of the savings are from small measures we have been implementing over the past 9 months that are now coming to fruition. These include savings from vendors, more efficient staffing and relatively minor workflow improvements. Looking forward, we think the next wave of savings will come from larger projects that we think can hit in the second half of 2019 and early 2020.

We talked a lot about driving towards cash flow breakeven in the women's health business and making real progress on the COGS per unit is obviously a key part of that effort. We think to getting below $200 per unit is achievable for us. Bob Schueren, Natera's Chief Operating Officer, is responsible for this effort, and our momentum on COGS is accelerating under his leadership.

Switching gears to oncology. We're excited about our forecast in pharma services, where we're targeting $40 million to $50 million in cumulative contracted value, as this is a leading indicator for revenue. Our trajectory is similar to that of other successful oncology diagnostic companies, and we believe we're at the very early stages of a large opportunity.

Before I jump into the details, I want to level set on the market opportunity and where we are positioned. We're not focused on asymptomatic cancers strain or early detection, seen here on the left side of the slide. On the right, typically, when you hear the liquid biopsy, it's in reference to this $6 billion therapy selection market. The goal of therapy selection is to find a gene in the patient's tumor that's actionable for a specific therapy. We've recently announced a plasma exome capability that will interrogate roughly 20,000 genes, leapfrogging anything else on the market today, allowing us to enter this $6 billion market. We'll talk about that a little bit later on the call.

We think the biggest opportunity is monitoring, seen in the middle, valued at roughly $15 billion. And that's where our Signatera test is focused. There are 3 key clinical categories within monitoring: first, prognostic testing, where circulating tumor DNA can inform the chance of recurrence; second, serial blood monitoring to detect recurrence earlier than other methods like imaging; and third, therapy effectiveness monitoring. We're making great progress in each of these areas. Combined, we believe our oncology opportunity in monitoring and therapy selection is roughly $21 billion.

We've chosen to focus Signatera on monitoring because we see a major unmet need for patient care, and we believe our technology and approach is well suited to this task. We start by running a roughly 20,000 gene exomes of a patient's tumor, and then we build a patient-specific assay using a proprietary algorithm designed to target only clonal variance. We design to 16 variants and then perform our proprietary, highly efficient extraction and library prep, followed by multiplex PCR and then ultra-deep sequencing at greater than 100,000x coverage per mutation.

We chose 16 mutations to optimize the sensitivity and specificity, and one patient's top 16 can be very different from another's. There's a common misperception that the number of genes you track determines the monitoring performance. However, mutations, not genes, are the circulating tumor DNA signature you're looking for to distinguish tumor DNA from germline DNA when monitoring. By starting with 20,000 genes from the exome, we are making sure we select the best 16 mutations to track for each patient. Cancer is sufficiently diverse such that in one-size-fits-all 73-gene panels, a typical patient will only have 2 to 3 mutations available to track.

On the right of the slide, you can see the number of mutations identified in an on-market 73-gene panel from the polished literature across lung, breast and colorectal cancer. These studies found on average 3 mutations per patient. Compare that to our approach that routinely tracks 16 mutations per patient. Tracking more mutations is a major advantage for our personalized approach, especially when you're testing very low levels of variant allele frequency. For a one-size-fits-all panel to consistently track 16 mutations in each patient, the panel would have to be very large, not ideal for a surveillance test you would like to repeat over time, especially given the extreme depth of sequencing that would be required to match our accuracy. Because we track only the relevant mutations for the patient, we're very efficient with our sequencing reads, and we can afford to sequence each mutation at greater than 100,000x coverage, a very high depth of read without generating high costs.

Our highly efficient extraction of library chemistry and massively multiplexed PCR capability allows us to pursue this personalized approach which, as you've seen from our data, generates a very high sensitivity and specificity at a relatively low cost of goods sold. We've had an incredible dataflow in the past few weeks. This is the culmination of several years of determined work by our own team and the clinical investigators. All of these trials prospectively collected blood samples and patient outcomes over many years. To start fresh now, to recreate this evidence would take 3 or more years. So these large trials and top peer-reviewed journals are now a major advantage for us.

In addition to these publications, we will read out compelling data at ASCO showing Signatera's ability to assess patient response to immunotherapy in the metastatic setting across multiple cancer types. The combined studies show the power of our technology for prognostic, recurrence and therapy monitoring indications directly mapping over to the $16 billion market opportunity for monitoring we outlined earlier in the call. We believe the emergence of MRD testing for solid tumors has the potential to make a major impact on both pharmaceutical trials and clinical care.

Let me now walk through the data. First, in April, our breast cancer validation data was published in Clinical Cancer Research. The study evaluated 208 plasma samples from 49 patients with early-stage breast cancer who had recently completed treatment with surgery and adjuvant chemotherapy. Plasma samples were collected prospectively every 6 months for up to 4 years from each patient. Signatera detected relapse with a sensitivity of 89% and specificity of 100% up to 2 years ahead of imaging as Signatera test-positive was highly prognostic of relapse. In this study, 100% of patients who were Signatera-positive with no further treatment relapsed. This is important for informing treatment decisions at various stages of patient care. For example, extended adjuvant therapy where a patient when he's positive may need additional treatment.

Additionally, in the future, serial recurrence monitoring could help the greater than 3 million women living in the United States today with breast cancer. We're seeing interest from pharma companies to run prospective trials treating patients on molecular recurrence. These trials could drive our pharma services business in the near term, and then if the trials are successful, this could change the paradigm for breast cancer monitoring and treatment in a major way.

Earlier this week, we announced a publication of a bladder cancer clinical validation study in the Journal of Clinical Oncology. Prospective study analyzed 656 blood samples from 68 patients with muscle-invasive bladder cancer. Similar to our breast cancer results, the study showed that Signatera was highly prognostic of recurrence. In fact, the Signatera result was the strongest prognostic marker of disease recurrence and long-term patient outcomes relative to all other risk factors. Our results show that circulating tumor DNA analysis predicts treatment efficacy better than other available methods. In addition, serial monitoring correctly identified all patients with metastatic disease progression up to 8 months ahead of radiographic imaging with 100% sensitivity and 98% specificity. This study is important because until now, it's been clinically difficult to evaluate which muscle-invasive bladder cancer patients have benefited most from chemotherapy. Now we have a precise tool that is much more predictive of treatment response. Also, detecting metastatic disease sooner could guide earlier medical interventions.

On the next slide. Just today, our colorectal cancer validation was published in JAMA Oncology. This is a multicenter trial of 125 patients with Stage 1 through 3 colorectal cancer. The blood was taken prospectively before and after adjuvant surgery and then serially over time. Signatera was again highly prognostic for recurrence, and serial recurrence monitoring detected relapse up to 16.5 months earlier than imaging with a sensitivity of 88% and a specificity of 99.8%. Physicians may use Signatera to better inform adjuvant treatment decisions or they may serially monitor to identify recurrence earlier than the standard of care. Based on the strength of this validation we have, we're pursuing coverage for Medicare for this colorectal cancer indications.

The next slide shows our path to obtaining a local coverage decision with Medicare to offer the Signatera test for prognostic and early recurrence detection in colorectal cancer. We've already obtained the relevant z-codes and had a very encouraging presubmission meeting with MolDX. We plan to submit a formal application for a local coverage decision this year. Many of you will recognize the format of this slide since it's the same process we laid out last summer for transplant rejection monitoring. We will keep you posted on this effort as we make progress toward a coverage decision, which we anticipate would occur in 2020. Because the reimbursement path for Signatera and colorectal cancer is now very clear, we're also launching a prospective trial to gather additional utility evidence for prognostic and recurrence monitoring indications. Site selection is underway, and there's significant interest from major academic centers and KOLs in the space. Once we receive Medicare coverage, we will ramp up our commercial efforts significantly.

Meanwhile, we're focusing our efforts mostly on pharma services, which has been ramping very quickly for us. To support our pharma services business, we have been in active discussions with the FDA regarding Signatera, and we were very pleased to receive a breakthrough device designation from the agency. The designation enables expedited development and review with the FDA. This is particularly relevant for our pharma customers that would like to use Signatera in prospective Phase III trials because it confirms that there is a clear path for personalized assay like Signatera to receive FDA approval alongside therapy. We received this designation for a specific indication for use in conjunction with a therapy being developed by a large pharma partner. We will provide more information here in the future when the clinical trial details are made public. This designation will be a significant benefit to our pharma partnering efforts, helping to achieve our goal of $40 million to $50 million in total contracted value by the end of 2019.

Finally, we're excited to announce our plans to begin offering a plasma-based whole exome screening as an RUO capability in the second half of 2019. Instead of first requiring exome be run from tumor tissue, patients and pharma customers will be able to simply send us the blood draw for Signatera. From that blood draw, we will generate a patient's mutation profile from the full 20,000 genes of the exome and then build a personalized Signatera panel from that data. This capability expands our Signatera market opportunity in pharma because it allows us to access patients and trials where tissue is not available, and also, pharma partners can access the full store of library prep from the Signatera blood draw and retrospectively analyze the patient's full mutation profile. This offering also creates a standalone therapy selection capability, which at 20,000 genes is a leapfrog ahead of anything else on the market. This product relies on the extremely high molecular conversion efficiency of our proprietary chemistry, and our early data shows strong concordance between whole exome results from plasma and tumor biopsy at the time of metastasis.

Okay. Now let me transition for a quick update on our progress in transplant. As I mentioned at the top of the call, we reached a key milestone with the draft local coverage decision that came out a few weeks ago. Medicare's assessment of our data and technology was unequivocally favorable to our test, which we had branded Prospera. The draft local coverage decision stated that Prospera is effective with better performance than the current standard of care, and the evidence we have provided is sufficient to support the use of Prospera to test for the presence of active allograft rejection. Medicare also highlighted Prospera's ability to identify both antibody-mediated and T-cell mediated rejections and that the test is validated to detect subclinical active rejection. Bottom line, we're very well positioned to achieve our goal of obtaining Medicare coverage in 2019.

The next slide is the same one we've showed consistently since we announced our transplant data last summer. And we continue to check the boxes towards a commercial launch. The public comment period opened with a public hearing which went very well, and we're now in the open comment period. Based on precedents, we would expect a final LCD in Q4. In parallel, we're building up our commercial capability and getting the assay ready for launch on the same time line.

Finally, I want to touch on our IP portfolio. Because we've been analyzing tiny quantities of DNA for greater than 10 years with our first commercial product launching in 2008, we have a large IP portfolio covering our core technologies. In addition, we have assay-specific IP covering reproductive health, oncology and transplant. We now have 70 issued or allowed patents broadly across our portfolio. As I mentioned, in Q1 alone, we had 12 new patents issued or allowed. We're very pleased with our position, and we continue to make progress on this front.

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

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Michael Brophy, Natera, Inc. - CFO [4]

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Thanks, Steve. Now to summarize our results from the quarter. The results for the quarter crossed the wire this afternoon, and for brevity on the call today, I'm going to focus on the key points of the Q1 results.

As Steve mentioned, our first quarter total revenues were $66.8 million at the top end of the range we preannounced for the deal. And if you strip out the nonrecurring $5.5 million revenue that we received from QIAGEN in Q1 of last year, that implies roughly 18% revenue growth. Gross margins were 35% in the quarter which, again, if you stripped out QIAGEN from Q1 last year, that implies a roughly 700 basis point improvement on a like-for-like basis, which has been driven primarily by the reduction on COGS per unit, as Steve described.

It's worth noting on both revenues and margins that we did not materially benefit from recognition of cash-based revenue from older appeals. In 2018, we booked approximately $10 million in revenues from these older appeals. I think there is potential to collect on more appeals in the future, but as we described on the Q4 call, we don't have any of that benefits factored into our guide for this year and we didn't see a lot of it in Q1.

Also as expected, you can see the realized pricing was marginally lower in Q1 versus prior periods. Net of onetime reserves and similar variables, we estimate the organic blended average selling price in the quarter was roughly $384 compared to about $407 in Q4 2018. This is largely due to factors that we think can resolve in the medium term, as Steve described, and are an area of future opportunity for our appeals collections, where we've had a lot of success very recently. Everything we've seen on volumes and pricing is consistent our expectations from the beginning of the year.

Panorama revenues for the quarter were $37.2 million compared to $33.3 million in the first quarter of 2018, an increase of roughly $4 million, which was driven primarily by volume growth. Horizon revenues for the quarter were $22.7 million compared to $18.3 million in the first quarter last year, an increase of roughly 24% again driven by volume.

Our total operating expenses for the quarter were $55.3 million in the first quarter 2019 compared to $52.3 million in the first quarter of 2018. We do expect to see operating expenses ramp up consistent with our guide through the year as we launch transplant and expand our commercial footprint in oncology. At the close of the quarter, the company held $128.5 million in cash, cash equivalents, short-term investments and restricted cash compared to $158.5 million as of December 31.

The capital structure remained in the same place at the end of Q1. Post the quarter, as you know, we closed an equity offering that brought a net cash of $108 million approximately. And we extended the maturity of the undrawn portion of our senior credit facility with OrbiMed. We now have the right to draw down an additional $50 million before December 31 of this year. We also anticipate receiving roughly $30 million net cash from BGI in the second quarter as part of the collaboration we announced on the Q4 call.

Turning to our future outlook. The guide remains unchanged compared to the initial guide we gave in March. The guidance assumes we will maintain our leadership position in women's health with continued volume growth. We have made an effort to be conservative on the pricing assumptions, particularly in the first half of this year. The guide does presume steady improvement in average-risk NIPT reimbursement in the second half of the year. On revenues from new businesses, we are presuming steady growth and stable pricing in our core blood business, and the goal for total value of the contracted business for Signatera remains the same.

The guidance includes the cash inflow from the BGI deal but still excludes any upfront revenue recognition from that agreement. I do think there is potential to recognize some revenue in 2019 from that deal, but we are still in the process of confirming that and finalizing next steps on the development plan with BGI. So we'll provide more details on this on our Q2 call. The gross margin guide takes into account the volumes and pricing comments above and also presumes we make steady progress in the reductions of cost of goods sold per unit that Steve described earlier in the call, and you've seen so far here in Q1.

So with that, I'd like to open the line for questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question is from Tycho Peterson with JPMorgan.

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Eleni Maria Apostolatos, JP Morgan Chase & Co, Research Division - Research Analyst [2]

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This is Eleni on for Tycho. Starting off with -- on Signatera. It sounds like the colorectal setting is what you are considering the low-hanging fruit at this point and the MRD setting given your presubmission meeting for Medicare reimbursement in that -- with that indication. I was just wondering, what is your reasoning there? And what are your plans in terms of what will follow?

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Steve Chapman, Natera, Inc. - CEO, President & Director [3]

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Thanks for joining. This is Steve Chapman. I'm going to have Solomon Moshkevich, who's just joined us as well, he's our General Manager for Oncology and Organ Transplant. I'm going to have him jump in on that, and then we'll follow up.

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Solomon Moshkevich, Natera, Inc. - General Manager of Oncology & Transplant [4]

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Great. Thank you for the question. So I'd say there's 2 key reasons that we've prioritized the colorectal indication. The first is that our data is excellent there and really validates the performance of the test in that setting. And the second is that there's a real significant unmet need in colorectal cancer for localized and regionally advanced colorectal, where, today, physicians are making decisions for who will receive adjuvant chemotherapy and who will not receive adjuvant chemotherapy or the duration of that therapy based on prognostic factors. And the guidelines today give kind of vague guidance for which patients should be treated one way or another. So physicians are faced with a relatively large amount of uncertainty. There's a lot of borderline cases. So this is an area where there is a great opportunity to help physicians make better treatment decisions and where the data, I think, really nails the opportunity.

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Eleni Maria Apostolatos, JP Morgan Chase & Co, Research Division - Research Analyst [5]

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Okay. Great. That's helpful color. And then on the exome sequencing RUO launch you're expecting later this year. Given the 20,000 plasma whole gene capability, what are you thinking in terms of pricing the whole test then? When can we expect to see some data -- some concordance data between the tissue and plasma approach?

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Steve Chapman, Natera, Inc. - CEO, President & Director [6]

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Yes. This is Steve. I'll take that. So as we said, in the second half of 2019, we are going to make our RUO plasma exome capability available. And there's really 2 areas where we think that's going to be of significant value to pharma companies. I think the first is where there's not enough tissue available to design Signatera. So in certain cancer types, sometimes you just can't get tissue. This will open up that market for us and allow us to broaden the total available market for Signatera. And then second, as a standalone capability. The plasma exome is significantly beyond what anybody else has on the market today. So we haven't announced pricing, and we'll view that as we commercialize the test.

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Solomon Moshkevich, Natera, Inc. - General Manager of Oncology & Transplant [7]

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Just to add a little bit to your question about concordance data, we were very pleased to see our concordance data in -- preliminary concordance data published in both the colorectal and the bladder cancer papers, which came out this week. The numbers are still relatively preliminary from a sample size standpoint, but the concordance looks really, really strong between tissue samples taking -- time of metastasis versus plasma samples at the same time where we ran the whole plasma exome. So very high concordance. So it makes us feel really good that as we do more and more concordance studies over the next 6 to 9 months with the launch of the product, that it's going to be a very strong offering.

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Eleni Maria Apostolatos, JP Morgan Chase & Co, Research Division - Research Analyst [8]

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Great. And one last one for me, maybe this one for Mike. I was wondering -- you mentioned that you're seeing strong traction and an uptick in Medicaid and others in terms of increasing coverage in the average-risk setting for NIPT. Was wondering if this is in line with the higher payment rates you're expecting or embedding in your guidance for later in the year.

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Michael Brophy, Natera, Inc. - CFO [9]

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Yes. Thanks, Eleni. Yes. So the -- what we're seeing in Medicaid is definitely encouraging. It is consistent with our guide and our expectations in the beginning of the year.

And then Steve, if you want to comment on that as well.

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Steve Chapman, Natera, Inc. - CEO, President & Director [10]

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Yes. I guess the key is 50% of the births in the United States roughly are Medicaid. And so I think while we talk a lot about big commercial payers like United and Aetna and the need to unlock that, I think in the background, Medicaid is still a very large opportunity both from a volume standpoint and from a reimbursement standpoint. And so 6 months ago, we were seeing really 0 payers in the Medicaid -- state Medicaid side that had a policy in place for reimbursing for average-risk NIPT. And today, that's shifted pretty dramatically. I think it was around 5 or 6 sort of the beginning of the year, and now we're seeing maybe close to 10 or 11 where the payment coming in on average-risk is similar to high-risk. So we think that's a definite trend and we see a lot of upside there in the future, and that is key to unlocking some of the additional upside from average-risk.

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Operator [11]

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And our next question is from Doug Schenkel with Cowen and Company.

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Adam Joseph Wieschhaus, Cowen and Company, LLC, Research Division - Associate [12]

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This is Adam Wieschhaus from Doug. Your reiterated guidance despite having the transplant draft LCD coming out seemingly sooner than expected. Maybe I missed it, but was there any thought to increasing the full year revenue guidance considering you were not initially including any transplant revenue?

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Michael Brophy, Natera, Inc. - CFO [13]

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Yes. Adam, it's Mike. Thanks for the question. Yes. We haven't really changed our expectations in terms of timing of that launch. It's possible it could come sooner, so that's potential upside. However, I mean, our goal with the guide is to kind of give a stable guide at the beginning of the year and really only move that when we've got really clear information that the guide doesn't capture our base case.

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Adam Joseph Wieschhaus, Cowen and Company, LLC, Research Division - Associate [14]

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Okay. And on ASPs, it looks like you expect pricing pressures to be resolved in the medium term and there can be a potential for appeals. So just to be clear, should we be expecting ASPs to step up each quarter throughout the year? And is there any potential for any sort of appeals collection revenue in 2019?

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Michael Brophy, Natera, Inc. - CFO [15]

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Thanks again. Yes. So there's potential for appeals collection revenue, certainly. I think in terms of what the pacing on the ASPs, it's same as what we've commented on this call and the last call, which is we expect there to be some pricing pressure in the first half of the year, which was just a function of things that we think are resolvable in the medium term. And in the back half of the year, we do expect some improvement driven by getting paid a higher fraction of the time on average-risk NIPT, for example.

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Adam Joseph Wieschhaus, Cowen and Company, LLC, Research Division - Associate [16]

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Okay. And maybe if I could fit one more in. Did you guys provide any update on the cumulative pharma contract value at the end of Q1? I'm just trying to get a sense for how that's tracking to plan. Does that $40 million to $50 million in expected cumulative contract value by the end of the year imply any sort of assumptions on FDA approval time lines?

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Steve Chapman, Natera, Inc. - CEO, President & Director [17]

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Yes. So we're giving an annual forecast there, and I think the $40 million to $50 million as we reiterated in the prepared remarks is intact. I mean we're feeling very positive about all the data that has just come out. I mean man, this was a super busy week with multiple peer-reviewed publications. We started off on Monday announcing the approval by the FDA, the breakthrough status. So all of those things are really important in helping us move the business forward. The $40 million to $50 million is intact. We're feeling strong about that, and that's an annual guide. We're not going to be giving an update on a sort of quarterly trajectory there.

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Operator [18]

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And our next question is from Bill Quirk with Piper Jaffray.

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Daniel Henry Macek-Alwell, Piper Jaffray Companies, Research Division - Research Analyst [19]

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This is Daniel on for Bill. So solid testing volumes. I appreciate you gave some sequential color there in terms of that as well as some ASP color. Could you just help us think about testing momentum throughout the rest of the year then?

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Michael Brophy, Natera, Inc. - CFO [20]

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Yes. Sure. So thanks for the question. As Steve mentioned, we expect to have the seasonal patterns of our volume growth to maintain consistent this year with what we've seen previously. So what we've seen in the past is that Q1 is a big sequential volume growth quarter for us because our existing accounts are sitting as 105%, 107% of the volume they sent us in Q4. And then behind that, we also have just steady new account growth really driving a strong Q1.

In Q2, that trend just based on seasonality reverses itself with the existing accounts, where we're getting something like 90% of the volumes from existing accounts in Q2 as we got from Q1. So in order to have kind of sequential flat volumes in Q2, you got to have really strong new account volume growth, and that's roughly what we expect to see happening here in Q2. That still implies like really strong growth for the full year, and it's absolutely consistent with everything that we planned for in the beginning of the year.

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Daniel Henry Macek-Alwell, Piper Jaffray Companies, Research Division - Research Analyst [21]

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That's great color. Appreciate that. One more for me. One of your competitors is having issues with lab benefit management programs in terms of carrier stream reimbursement. Could you just provide if you're seeing anything in that market there?

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Michael Brophy, Natera, Inc. - CFO [22]

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Yes. I think the verbiage can be different from company to company. I mean, I think, the prior authorization things that we're seeing may be a similar dynamic as what you've heard them -- heard tell from other quarters -- other companies.

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Operator [23]

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And our next question is from Catherine Schulte with R. W. Baird.

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Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [24]

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Great. Just curious, do you have any updated thoughts on ACOG guidance timing? And then realizing you don't have much control over that timing, are you in conversations with any payers about updating their policies even before a new guidance might come out?

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Steve Chapman, Natera, Inc. - CEO, President & Director [25]

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Catherine, yes, so we didn't expect there to be a big announcement coming out of the annual ACOG meeting. I mean they're not a public corporation that's putting announcements out at the right time. I think when their committee works through the details on what they want to put out, we do expect an updated guideline to come out. We had some really good conversations at the ACOG meeting. And those were sort of generally in line with what we said previously which is we absolutely expect an updated guideline to come out. We don't know exactly when and we don't know what it's going to say. But we do believe something is going to come out, and it's highly likely it's going to be positive.

From a standpoint of discussions with payers, we're certainly in discussions with multiple payers. As we mentioned, there's been some nice changes in state Medicaid. We recently saw 3 of the top 4 remaining Blue Cross Blue Shield plans change their guidelines. That was North Carolina, Minnesota and a handful of others. And we've been directly involved in those conversations. So our Medical Director, Paul Billings, will go meet with them. And then shortly after they've looked at the data they gave an updated policy guideline. So we feel like we're making an impact there.

Paul, do you want to make some comments?

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Paul R. Billings, Natera, Inc. - Chief Medical Officer & Senior VP of Medical Affairs [26]

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Yes. I would just say that ACOG has recently announced a change in their leadership, and we feel that, that's going to be a positive impetus to our average-risk efforts. And that we have had very high-level meetings at Aetna and United around their policy of considerations, and we're hopeful that they're understanding the importance of average-risk coverage.

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Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [27]

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Great. Very helpful. And for the colorectal cancer test you're submitting for Medicare coverage. As we think about the market opportunity there, what are you expecting in terms of testing frequency on the recurrence monitoring side?

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Solomon Moshkevich, Natera, Inc. - General Manager of Oncology & Transplant [28]

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Yes. This is Solomon. I'll take that one. So I'll just start out with saying that this is the fourth most common cancer type, third most common in men. Overall, we're seeing about 145,000 to 150,000 new diagnoses per year in colorectal cancer. Less than 1/4 of those are the distant kind of metastatic cases. So you've got a lot of localized and regionalized -- regionally advanced colorectal cancer. In terms of testing frequency per year, we are expecting episodes of care that will include multiple tests either to determine whether or not a patient has residual disease in order to help make that decision for postsurgical adjuvant chemotherapy, and also, for monitoring during treatment to see if it's working and whether a patient might need extended adjuvant treatment or escalated treatment. And then also afterwards, it is well established that early detection of recurrence in colorectal cancer specifically is useful for treating and actually curing many patients. So we expect there to be multiple opportunities for testing in that indication as well.

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Steve Chapman, Natera, Inc. - CEO, President & Director [29]

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I'll just add, Catherine, that we've now had multiple meetings with MolDX on this particular topic, and they're very engaged. I think there's a lot of good, collaborative discussion going on about exactly how this is going to play out. And with the enormous amount of data that we just put out showing consistent performance across breast cancer, bladder cancer and now colorectal cancer, I think it's clear that this personalized monitoring approach is going to be the winner in that very, very big $15 billion monitoring segment. So we feel very positive about this very large market opportunity that we have in front of us. This colorectal indication is the first of many. But again, consistent data across multiple different cancers now.

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Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [30]

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That's a good segue into my follow-up. What could the time line be for potential Medicare LCD submissions for those other cancer types?

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Steve Chapman, Natera, Inc. - CEO, President & Director [31]

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Solomon, do you want to -- let me comment on that and then you why don't you take it. I think there's really 2 ways that we're commercializing the oncology business. So I think the first is pharma services, and we've talked a lot about that. We talked about this $40 million to $50 million total contracted value projection for the year. And some of those are retrospective studies, but a lot of those also are prospective studies, where they're looking at sort of enrichment trials and using immunotherapy in the adjuvant setting. And there's things that will come out of that like maybe treatment on molecular recurrence in breast cancer, for example, where the study that we do with the pharma services or pharma company turns into a CLIA or an FDA-approved indication over time. And those can be very, very big indications. So for example, this early treatment on molecular recurrence in breast cancer, that would be an enormous, enormous indication if that were to go through with a clinical trial and then get FDA approval.

When you look at the tests that we want to take through Medicare on our own, the first one is colorectal, but there's many others. We've talked about in breast cancer, extended adjuvant treatment. I think that's an area where we could go directly to Medicare. We talked about immunotherapy setting in the metastatic context, looking at exceptional responders. That's an area where we've gotten a lot of interest. When can you take patients off immunotherapy, we think that's going to be super valuable for Medicare from a cost-saving standpoint. So we could be filing multiple LCDs in 2020. I think 2019, we will be focusing on getting the colorectal one in, and then we'll follow that very quickly with multiple additional in 2020.

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Solomon Moshkevich, Natera, Inc. - General Manager of Oncology & Transplant [32]

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That was great. Nothing to add.

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Operator [33]

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Thank you. And ladies and gentlemen, this ends our Q&A session for today and conference. Thank you for participating. You may all disconnect. Have a wonderful day.