5/7/2026

speaker
Operator
Conference Operator

Ladies and gentlemen, welcome to Natera's first quarter 2026 financial results conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, please press star followed by one on your telephone keypad. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference call is being recorded today, May 7, 2026. I would now like to turn the conference over to Michael Brophy, Chief Financial Officer. Please go ahead.

speaker
Michael Brophy
Chief Financial Officer

Thanks, Operator. Good afternoon. Thank you for joining our conference call to discuss the results of our first quarter of 2026. On the line, I am joined by Steve Chapman, our CEO, Solomon Moscovich, President, Clinical Diagnostics, and Al Seleshin, General Manager of Oncology and our 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 posted to our IR website as soon as it's available. Starting on slide two, during the course of this conference call, we will make forward-looking statements regarding future events and our anticipated future performance, such as our operational and financial outlook and projections, our assumptions for that outlook, market size, partnerships, clinical studies, and expected results, opportunities and strategies, and expectations for 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 the actual events or results could differ materially. Please refer to the documents we filed from time to time with the SEC, including our most recent Form 10-K or 10-Q and the Form 8-K filed with today's press release. Those documents identify important risks and other factors that may cause our actual results to differ materially from those contained in or suggested by the forward-looking statements. Forward-looking statements made during the call are being made as of today, May 7th, 2026. If this call is replayed or reviewed after today, the information presented during the call may not contain current or accurate information. The Territory claims 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?

speaker
Steve Chapman
Chief Executive Officer

Thanks, Mike. Let's get to the highlights. We had another excellent quarter, as you can see here. We posted revenues of 697 million in Q1, 39% growth over last year. Even at our scale, Q1 shows we're still in rapid growth mode. It was just a short while ago that we celebrated a milestone by delivering 1 million units in a year. Q1 was our first to deliver 1 million units in a single quarter, headlined by excellent volume performance in women's health and another record growth quarter for oncology. We feel like we're just getting started. On women's health, the core business grew exceptionally well, and we had a very successful launch of our fetal focus product. The fetal focus launch is exceeding expectations based on the strength of our technology and data from the prospective blinded multi-site expand trial. We are winning new customers and experiencing high client retention rates. We're approaching a run rate of nearly 200,000 fetal focus orders, which is impressive given our recent launch date. In oncology, we processed 249,000 clinical oncology units in the quarter, which is 55% growth over last year, and yet another record with roughly 24,000 units over the Q4 results. This is the biggest increase we've ever achieved. In February, we got into full-year gross margins of 64% at the midpoint, and we're pleased to have exceeded that level in Q1, with gross margins coming in at just under 65%. The rapid increase in volumes in Q1 actually harmed margins by roughly two percentage points because we had more samples in process in the lab at the close of the quarter than normal, impacting our received versus reported ratio. This will resolve itself as we move forward, so we believe we are in a very good position relative to the guide. Given the fantastic start to the year, we are pleased to fully reset the revenue guide range by more than 120 million and increase our gross margin guidance to 65% at the midpoint. Enrollment in oncology clinical trials, including new interventional MRD trials and the FIND ECD study, are well ahead of schedule. So we're going to bump R&D expectations by $50 million, primarily to pull forward these trials. Of note, on the Find the ECD study, we are pleased to announce that we should be fully done enrolling in Q3 of this year, which is super exciting given the huge opportunity that provides as we look to a 2027 launch. Alex will cover this later on the call. Okay, let's unpack some of the trends on the next few slides. On volume, I want to thank our team for getting us over 1 million units in a quarter. Atara employees are very passionate about our mission to improve health and it shows in our performance. Thank you for what you do every day. We fired on all cylinders in Q1 with another strong Oregon health quarter to go alongside record units oncology and a very strong women's health quarter. While we do expect Q1 to be strong due to seasonality, this was really an incredible quarter and nearly the most unit growth we've seen since I took over as CEO. We've seen a lot of new account momentum with the launch of fetal focus, as we'll describe on the next slide. As a reminder, fetal focus is our next generation single gene NIPT. It's powered by our ultra-sensitive link SNP technology and enables direct assessment of fetal cell-free DNA across 21 genes associated with serious early onset conditions. We continue to see strong interest from clinicians, particularly given the test's ability to address a common gap in prenatal care, specifically when paternal screening is not available. That demand is now transitioning into meaningful scale. As shown on the slide, we are approaching an annualized run rate of approximately 200,000 test orders, reflecting strong adoption across OBGYNs and MFMs. For clarity, we don't count these fetal focus orders in our test process numbers when Horizon is negative for one of the 21 conditions tested. So when we say we saw an incredible growth order, we're really referring to the core of Horizon and panorama testing and not including the majority of these fetal focus orders, which would boost our numbers even higher. Importantly, this growth is supported by strong clinical foundations. The EXPAND trial has been a major success and was selected for an oral plenary presentation at the Society for Maternal-Fetal Medicine meeting, a rare distinction that underscores both the quality of the data and its clinical relevance. As a reminder, the EXPAND trial is a prospective blinded multicenter study that has definitive genetic outcomes on all participants, both positives and negatives. The goal is to enroll about 2,000 patients into the study, and this has been ongoing now for several years. The EXPAND results were recently submitted for peer-reviewed publication, and we believe we will continue to see fetal focus emerge as a meaningful contributor to growth in the women's health business. The next slide shows our clinical MRD volume progression over time. First, let's look at the total number of MRD tests. Getting nearly 250,000 tests is an incredible number, and we are now on a run rate of over 1 million MRD tests annually. We were able to grow by approximately 24,000 units in Q1, which was another record for our team. It's amazing to think we are still in the early stages of what MRD can become. In the volume, we are continuing to see strong growth in the core indications of colorectal and breast cancer, while seeing increasing contributions from other cancer types. And I'd like to cover some of those growth drivers here on the next slide. The Q1 growth was the result of some major milestones in the second half of 2025, where we had a steady cadence of important data readouts and publications across uterine, testicular, breast, colorectal, and lymphoma. A major highlight was our bladder cancer data being presented at ESMO and then being published in the New England Journal of Medicine. We are still seeing the impact of this data in our volumes in bladder cancer and beyond, as it always takes time to see new clinical data translate into real behavioral changes in the doctor's office. In addition to the new data, we launched an integration with Onco EMR across their network of 4,500 physicians, creating a much more seamless ordering experience. And you'll recall that we also expanded our commercial footprint last year, and I think we're seeing those reps start to contribute in a real way. We also differentiate our platform with the acquisition of Foresight Diagnostics. The Foresight integration is going well, and their deep research and clinical relationships have also been a tailwind for signature adoption in a clinical setting. Many hematologists are starting to order signetarian MRD for their lymphoma patients, and the biopharma interest has really been picking up in both heme and solid tumors based on the value of the phased variant technology. We are pleased to see this working well thus far. We've also listed some of the wins from the first few months of the year on this slide, and we believe that will drive future MRD growth across tumor types. Solomon will discuss a few of these later in the call, including a recent data set showing how Signatera may enable surgery avoidance, as well as the exciting new data from the Alpha 3 trial. Okay, more detail on revenue progression is here on the next slide. In addition to the strong volume growth, revenue growth is being amplified by realized average selling prices continuing to climb. We spent a lot of time detailing all this hard work and investment we put into obtaining reimbursement for covered services, and those efforts continue to bear fruit. Unit ASPs were up across the board in women's health and organ health, and signatera ASPs reached another high now at roughly $1,250. Mike will spend more time on this in his section. The second driver to realize pricing growth is worth watching as well. Even as women's health continues to grow, the rapid expansion of organ health and oncology units may contribute an increasingly large share of total revenues, This trend is a further amplifier of revenue and gross margin growth in the future. As a reminder, in Signatera, we have many histologies in submission to Medicare and are currently engaged in the standard cycle of coverage review, which represents additional ASP runway in the second half of this year. As we talked about in the past, we previously set out a long-term Signatera ASP target of $2,000 per test. We think we're still on track to hit that goal as more private payers start to pay and a broader set of indications gets covered. Just at our current annualized volumes, a $2,000 ASP would generate an additional $750 million in revenue and gross profit per year. The next slide is our standard gross margin progression, quarter by quarter, going back two years. In addition to the ASP growth this quarter, COGS per unit in the lab were clean, largely holding steady with a very strong Q4 performance. Layered on top of these unit COGS were a couple of factors that we think are transient that impacted margin in the quarter, and without these, we would have been about 2% higher. First, we took a larger than usual stock-based COG charge to COGS as part of the close of the foresight acquisition in Q4. A larger impact was just the amount of work and progress we held in the lab at the end of March. We only billed out recognized revenue on about 92% of our cases received in the quarter, while that ratio is normally 95 to 96. Since we take COGS charges as we use materials and labor to process cases in the lab, we've got a larger than usual bolus of cases hitting COGS, but not revenue in a quarter. This happened because the volume coming into the lab was so high, particularly at the end of the quarter, which is, of course, a good sign for us. I expect this factor to normalize in the subsequent quarters. Mike will spend more time on these dynamics in his section, but we are sufficiently encouraged on gross margins to meaningfully raise the four-year guide. Okay, with that, let me turn it over to Solomon to discuss more details from the quarter. Solomon?

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