Matthew Rabinowitz
Analyst · Morgan Stanley
Thanks, Steve. Now I would like to shift gears and provide an update on our upcoming commercial launch in oncology. Let me give you a sense of how that launch is going to happen. First, we are launching the pan-cancer research use only offering for pharma and academic research studies and we will then leverage that data to support reimbursement for the clear launch slated for next year. We view the launch into the research market as a critical first step in our oncology strategy. As we have seen with others in the space, revenues from academia and the pharmaceutical industry can initially be more meaningful contributors to the business than revenues generated from CLIA test for patients. These initial customers have access to patient samples that are crucial for clinical validation and utility studies. These are often trials that would be prohibitively expensive and risky for us to run our ourselves. We are encouraged by the discussions we have had with partners prior to the launch and look forward to updating you on our progress in future calls. The CLIA launch will be focused on recurrence monitoring for specific cancer types under the brand of Signatera. This name refers to our ability to uniquely customized the assay for a particular patient. We are in active discussions with a number of partners that can provide access to over 3,000 samples in 6 different cancer indications, where we believe there is clear value in learning about a cancer relapse as early as possible, monitoring the progress of the cancer during therapy or checking for residual disease after an intervention. In addition to the core areas like breast, ovarian and lung cancer we have discussed previously, these include examples in indication like bladder cancer, colorectal cancer and kidney cancer, where we believe many physicians would change practice based on early indication of cancer relapse or disease load monitoring. Our recent publication in Nature has been critical to getting access to these sample banks. Slide 12 recaps the market for residual disease, recurrence monitoring and treatment response monitoring, which is different from the markets that many other prominent players are chasing. We estimate that MRD and recurrence monitoring is approximately a $12 billion market in United States alone plus an additional $2 billion plus opportunity in United States with monitoring for treatment response and resistance. These numbers are based on our estimates of the number of patients currently in remission from these cancers, 2 tests on average per year and a conservative assumption of $500 price point per blood test. We believe that the worldwide market in time can be roughly 4x that of The United States. For those of you on the call who are new to Natera, let me provide a brief recap of how the test works. The advantages are shown on the left side of Slide 13. Based on the solid tissue sequencing of a patient's tumor, we build a personalized assay tailored to the specific mutation profile for each patient. Our proprietary PCR technology that we first developed for Panorama allows us to quickly and cheaply build these assays tailored for each patient to quantify and characterize any tumor DNA in the blood. This allows us to test for dozens of mutations simultaneously without splitting up the plasma sample, and our targeted approach means we can achieve very high sensitivity on the variants that matter for each patient without costly sequencing of many unnecessary genes. As a result, we can offer a recurrence monitoring panel that is roughly an order of magnitude more sensitive and substantially cheaper cost of goods sold than commercially available liquid biopsy panels. The most recent showcase for our performance was the results from the first 100 early-stage lung cancer patients analyzed with our liquid biopsy as part of the TRACERx study. The study was published in Nature and we were very pleased to be on the cover of the May 25 issue. The key findings in the Nature paper were related to our performance in detecting relapse early and predicting patient response to adjuvant therapy. We were given 0 blood samples from a subset of 24 of the patients and asked to identify on a blinded basis, which of these patients showed signs of molecular relapse, which is defined by presence of circulating tumor DNA in the blood. We accurately predicted the relapse with 93% sensitivity and 0 false positives. As the green line in the graph shows, all patients who tested positive for circulating tumor DNA at some point after treatment went on to relapse all within a year of the positive blood test. The blue line shows the superb predictive power of the test. Out of those patients who tested negative for tumor DNA after treatment, 90% of them remained relapse-free through the time of publications. Natera's test predicted outcomes with extraordinary accuracy. We believe such performance could substantially change how these patients are managed. There are many applications to this technology beyond recurrence monitoring. We plan to expand our collaboration with TRACERx to demonstrate the value of our personalized assays in predicting patient response to adjuvant therapy. Regarding patients with Phase Ib non-small cell lung cancer, after the initial surgery, physicians must decide whether to follow up with adjuvant chemotherapy. While the data suggest that less than 5% of these patients actually benefit from chemotherapy, physicians generally do not know which patients are likely to benefit. As a result, many patients are receiving unnecessary chemotherapy, incurring unnecessary health care costs and being exposed to damaging side effects. We intent to measure circulating tumor DNA after surgery to help decide whether patients should receive adjuvant chemotherapy. This is just 1 example of the cancer types and sample collection efforts we have underway. We believe there are at least 5 other indications in prevalent cancers, where using cell-free DNA can inform decision-making on adjuvant chemotherapy. We look forward to presenting additional details on the used cases of these other cancers in future calls. Now, I would like to transition to our path to cash flow breakeven and the progress we have made in the quarter. We are on track to substantially reduce our quarterly cash burn through the course of 2017. We burned roughly $29 million in Q1 and our cash burn in Q2 was roughly $16 million. There was some timing issues that held cash burn lower than expected that Mike will cover, and we expect cash burn to vary from quarter-to-quarter. But the combination of stable average selling prices, growing volumes and improving cost of goods with stable operating expenses is reducing our cash burn. We presented Slide 15 last quarter and predicted pricing would stabilize as we have now shown here in Q2. As a reminder, we have undergone 3 discrete price reducing events in the past few years. These are, transitioning from billing a procedural code for NIPT to a dedicated NIPT code in 2015; choosing to negotiate in-network agreements with essentially all of the largest payers in United States in 2016; and transitioning from a procedural code for microlesions test to a dedicated code in 2017. In each of these cases, we chose to trade price in return for long-term stability for our business. So, while it appears that there has been a steady decline of ASP, that declining line is in fact the result of these discrete events, each of which play out over roughly a year as the insurance payments are collected over time after we perform a test. We believe our results this quarter indicate we are just starting to reap the rewards of this strategy, as the blended ASPs implied by our financials improved from $408 to $452 in Q2. Now, going forward, we have steady multiyear contracts with payers representing roughly 200 million covered lives. Since these contracts have generally been in place for roughly a year or more, the effect of going in-network should no longer be a headwind for the average selling prices we report each quarter. So now we can expect, as we have predicted in the past, revenue growth to track along with volume growth through the rest of 2017 and beyond. As I will discuss on the next slide, increasing reimbursement for both average-risk NIPT and microdeletions represent 2 significant sources of upside for pricing going forward. On Slide 16, as we have described in the past, there was a huge amount of earnings power embedded in the test volumes we run today, but which are not currently reimbursed by insurance. There are 2 hurdles to clear to receive consistent insurance reimbursement for a test. Step 1 is having a negotiated rate for specific code, and the second is getting the test included in a payer's medical coverage policy. Steve described the rapid changes we have seen in NIPT reimbursement, where now insurers representing over 109 million covered lives have a medical coverage policy that reimburses for average-risk NIPT. We expect broad coverage over time. But in the meantime, we estimate that in Q2 alone we processed roughly 26,000 NIPT tests that will not be reimbursed by insurance, as you can see on Slide 16. If you assume that pricing for average-risk NIPT settled at around $450 over time and it could be above that, that would imply $12 million in quarterly revenues and cash flow from currently unreimbursed volumes. Microdeletions represent an even larger opportunity. As we described in our last earnings call, the centers for Medicare and Medicaid services has priced the new microlesions code at $802. And we have seen many payers negotiate in-network rates with us in the same range. Consistent with our guidelines and our experience earlier in the year, however, we are receiving positive coverage determinations on slightly more than 10% of our microdeletions volume today, which implies that roughly 40,000 microdeletions tests performed in Q2 will not be reimbursed by insurance. If you assume, we can increase that allowed rate over time and achieve $450 ASP, that would drive $18 million in revenues and free cash flow per quarter from our current unreimbursed volumes. A reminder on pricing. We do not need a sea change from our current reimbursed levels in these categories to reach a breakeven cash flow position, largely because of the COGS improvements we are making and the leverage we are getting out of our commercial channel. We expect to drive broader reimbursement from microdeletions by delivering more data that shows the incidence rates of these in the population and our test performance. Moving to Slide 17, we were very pleased to announce the recent publication of the results of our clinical experience with our microdeletions panel. The study of evaluated screening performance for 22q11.2, 1p36, Prader-Willi, Angelman and cri-du-chat microdeletions syndromes. For 22q, the data set included over 80,000 samples accessioned by our lab, and we demonstrated that our revised protocol resulted in a positive predictive value of 44% and a false positive rate up a 0.7%. Both of these figures are better than the performance we reported in our previous 22q clinical experience paper. Based on our commercial data, the prevalence of 22q in patients who received testing was estimated to be roughly 1 in 1,255. I would caution that our commercial cohort is likely to have a higher incidence of 22q than would be measured in the general population because some women choose to get tested after finding an ultrasound anomaly. Still, our experience supports the broad testing of both 22qs and a host of other microdeletions particularly for younger women and our test performance in microdeletions is an important driver of our market share in the average-risk NIPT market. The incidence of these microdeletions in our patients who have received test think is roughly the same as 22q. And given a strong PPVs with other microlesions, the data supports testing for the broader range of microlesions. In addition, our SMART trial remains on track to reach enrollment of 10,000 patients in the next month. SMART is a more than 10,000 patient prospective clinical trial, focusing on microdeletions. As we described previously, now that we have established this infrastructure with centers on-boarding and given the value of having born child genetic samples, coupled with prenatal examples, we may choose to extend that trial to thoroughly demonstrate the clinical utility of our broader genetic testing panels. In parallel, we are working with a principal investigator of the trial to evaluate whether we can publish an interim analysis of the data from roughly the first half of patients enrolled in the study. We will provide further updates on future calls. Slide 18 is an update on our COGS progression so far. In the left, you see a chart that shows our blended COGS at the beginning of 2015. This number is calculated by simply dividing our cost of product revenues by test accessioned in the quarter. So this includes our IVF channel products that have smaller volume yet higher COGS than the rest of our business. Our NIPT COGS are well below this blended number but this still gives you a directional sense of our progress. As you can see, we've continued to innovate with our technology to improve test performance, while substantially reducing our cost of goods. We've said previously that we think we can get the blended COGS to the mid-200s by Q1 of next year based on projects we are currently working on in the lab. There are 2 key projects that drive most of those reductions, version 3 of our Panorama test and our carrier screening automation product. We launched Version 3 in late January and we haven't yet seen the full benefits of this launch. We've been working with our suppliers during this launch phase to ensure we are realizing the expected material cost reductions and that has required rerun the samples in order to ensure conformance to our performance specifications. As a result of this process, we expect to receive some credit from suppliers later in the year for initial supplies we extend in Q2 that did not meet quality standards. This may have the effect of stretching up cost of goods sold benefit over few quarters, but the overall trajectory to our goal next year and our expected annual cash savings forecast remains unchanged. We are on track to see the initial benefits of the carrier screening automation project by Q1 of 2018, and we think we can still reduce COGS significantly beyond that point. With that, let me hand over to Mike, to review our financial performance in the quarter. Mike?