NASDAQ:BLLN Billiontoone Q1 2026 Earnings Report $81.40 +1.50 (+1.88%) Closing price 04:00 PM EasternExtended Trading$87.79 +6.39 (+7.85%) As of 07:59 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast Billiontoone EPS ResultsActual EPS$0.34Consensus EPS $0.01Beat/MissBeat by +$0.33One Year Ago EPS-$0.39Billiontoone Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue Growth+83.80%Billiontoone Announcement DetailsQuarterQ1 2026Date5/6/2026TimeAfter Market ClosesConference Call DateWednesday, May 6, 2026Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Billiontoone Q1 2026 Earnings Call TranscriptProvided by QuartrMay 6, 2026 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Q1 financials were strong — revenue grew 84% YoY to $108.4M with 44% test volume growth, a 73% gross margin, 16% GAAP operating margin, and $537M cash, delivering profitability and positive cash flow. Positive Sentiment: Market access and pricing momentum — BillionToOne is now in‑network with Anthem and UnitedHealthcare, reaching ~300 million contracted lives, and ASPs rose 28% YoY to $571, prompting raised 2026 revenue guidance to $450–$465M. Positive Sentiment: Product differentiation — the launch of Unity Confirm, the company’s non‑invasive fetal cell–based confirmation assay, showed initial 100% concordance versus invasive diagnostics and is positioned to strengthen Unity as a frontline prenatal offering. Neutral Sentiment: Oncology ramp shows momentum (oncology revenue nearly 5x to $10.7M and tumor‑naive MRD on track), but longer‑term upside depends on achieving Medicare coverage for Northstar Response and scaling to improve oncology margins. Negative Sentiment: Near‑term limits and risks — BillionToOne expects Unity Confirm to address only ~0.5–1% of patients (so minimal direct revenue), its prospective concordance study may take 1–3 years, and accounts receivable rose due to new payer contracts, which could affect short‑term cash conversion. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallBilliontoone Q1 202600:00 / 00:00Speed:1x1.25x1.5x2xThere are 12 speakers on the call. Speaker 600:00:00Thank you for standing by, and welcome to the BillionToOne first quarter 2026 earnings call. Now I'd like to introduce your host for today's program, David Westenberg, Investor Relations. Please go ahead, sir. Speaker 300:00:32Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from BillionToOne we have Oguzhan Atay, Co-Founder and Chief Executive Officer, and Ross Taylor, Chief Financial Officer. Earlier today, BillionToOne released financial results for the first quarter ended March 31st, 2026. A copy of the press release is available on the company's website. Before we begin, I want to remind you that during this call we may make forward-looking statements within the meaning of federal securities laws. Such statements about future events may include statements about our financial outlook and performance, market size, our products and services, reimbursement coverage, future clinical performance, and other similar statements. We caution you that such statements reflect our current best judgment, and actual results may differ materially from those expressed or implied in any forward-looking statements. Speaker 300:01:20Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed annual report, Form 10-K, our quarterly report on Form 10-Q, to be filed following this call, and the current report on Form 8-K, filed today. Any forward-looking statement made during this call is made as of today, May 6th, 2026. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. BillionToOne disclaims any obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. With that, I'll turn the call over to Ozan. Speaker 500:02:00Good afternoon, everyone. Thank you for joining our first quarter 2026 earnings call. I'd like to start by thanking our employees who work with tremendous effort and diligence to build and deliver superior tests to our patients that improve their care and remove the fear of the unknown. Before diving into our quarterly results, I would like to remind you of our four pillars that I believe make us a different category of molecular diagnostics company. First, our revolutionary technology platform, which is enabled by our patented QCT, Quantitative Counting Template technology, achieves single molecule-level sensitivity and precision with next-generation sequencing. With this technology, we have built unique category-defining products in both prenatal and oncology. With our differentiated products, we have grown exponentially in the last six years, even as we reach scale, with a level of compounding that we believe is rare in our industry. Speaker 500:03:12There is still so much room to grow as the opportunity of prenatal and oncology cfDNA markets can exceed $100 billion in U.S. market opportunity over time. In addition to rapid growth, we have achieved a superior gross margin profile, with margins now above 70%, with still significant room for expansion through ASV growth and COGS per test reductions. Lastly, through a culture of fiscal discipline and efficient operations incorporating AI and automation, we achieved GAAP profitability and positive cash flow with less than 10% of the accumulated deficit of our public competitors. In summary, we continue to track towards our long-term goal, which has remained the same, to build a category-defining generational company and become a member of the S&P 500. Our first quarter performance was extremely strong across all four pillars. Speaker 500:04:20For the third quarter in a row, we delivered a Rule of 100+, this time, in this quarter, we paired it with a level of profitability that is extremely rare for a high-growth company. We had another quarter of high growth, expanded margins, positive operating income, and positive cash flow. Looking at our results pillar by pillar, in addition to expanded Unity Fetal Antigen NIPT and FN NIPT launches for prenatal and PGX and CH launches for oncology that were launched in February, after the end of the quarter, we launched a category-redefining prenatal test, Unity Confirm. Unity Confirm is the first non-invasive fetal cell-based confirmation assay for high-risk NIPTs. On the oncology side, our product roadmap remains on track. We responded to all MolDX comments for our response coverage submission, our tumor naive MRD launch is on track to launch by the end of this year. Speaker 500:05:37As we continue to launch new products, our business continues to grow, delivering consistent test volume growth of 44% year-over-year and total revenue growth of 84% year-over-year. In our third pillar, we have continued our progress with our in-network contracts. Most importantly, with a contract with Anthem, bringing our total contracted lives to 300 million in the U.S. As our ASPs increased 28% year-over-year to $571 per test, and as we maintained our COGS at $153 per test, despite a higher proportion of oncology tests that have a higher COGS, we expanded our gross margins to 73% in Q1, a strong 9 percentage point increase year-over-year. Speaker 500:06:41Finally, in our fourth pillar, as our growth margins expanded and as we operated with higher efficiency, we delivered a remarkable profitability profile in the first quarter with a 16% GAAP operating margin and 24% adjusted EBITDA margin, increasing our cash position to $537.5 million at the end of the quarter. Delving into each pillar one by one. For our first pillar, on May first, just five days ago, at ACOG annual meeting, we moved the field forward once again by launching what we believe is going to be seen as the innovation of the decade in prenatal genetics. Unity Confirm is the first and only non-invasive confirmation assay for high-risk pregnancies. It represents what many in our field have long considered the holy grail of non-invasive prenatal testing. Speaker 500:07:50Unity Confirm captures and sequences intact circulating fetal cells from a maternal blood sample, providing 100% fetal fraction. To put that in perspective, conventional cell-free DNA tests rely on small fractions of fetal DNA in maternal plasma. By isolating and sequencing whole fetal cells directly, Unity Confirm is in a fundamentally different category. We have launched Unity Confirm as a specialized offering, as a follow-up for high-risk pregnancies identified on our Unity Aneuploidy Screen. Today, if an NIPT returns a high-risk result, the next step is invasive diagnostic testing, which is increasingly inaccessible in maternity care deserts and also carries a small miscarriage risk. The majority of patients cannot or choose not to proceed to invasive diagnostic confirmation. Unity Confirm addresses this critical clinical gap. It gives these patients and their physicians a non-invasive option. Speaker 500:09:08Our initial results have shown 100% concordance compared to invasive diagnostics, and we are now enrolling patients in what we believe is the largest prospective circulating fetal cell-based study ever conducted with concordance to invasive diagnostics. We also built a comprehensive launch campaign around Unity Confirm. More than 500 providers attended the launch or watched on the live stream. We believe Unity Confirm will further increase the differentiation of our Unity product offerings. Turning to our second pillar, scalable rapid growth. Our leadership in product innovation and our growing commercial team continued to drive strong test volume in the quarter. In Q1, we delivered approximately 188,000 tests, representing 44% year-over-year growth and strong sequential growth across both product lines, with prenatal volumes growing approximately 10% quarter-over-quarter and oncology volumes growing approximately 25% quarter-over-quarter. Speaker 500:10:33Importantly, on the oncology side, approximately 60% of Northstar Select orders now opt in to CH, reflecting growing physician awareness of the importance of distinguishing tumor-derived from non-tumor derived variants in liquid biopsy. Our total revenues in the first quarter grew even faster, achieving 84% year-over-year growth. This was driven by 44% year-over-year growth in test volume and 28% year-over-year growth in ASP. Looking at the segment detail, both prenatal and oncology contributed meaningfully to our growth. Prenatal revenue in the first quarter was $97.7 million, up 72% year-over-year, driven by strong volume growth, commercial execution, and additional traction driven by our fetal antigen test products launched at SMFM in February. This continues to underscore the depth of Unity's differentiation and the durability of our prenatal growth. Speaker 500:11:50Oncology revenue was nearly five times over last year, reaching $10.7 million in the first quarter, an annualized revenue run rate of $43 million. The oncology ramp is being driven by increasing adoption of both Northstar Select and Northstar Response, the recent launches of PGX and CH, and strong execution of our oncology commercial team. We continue to see substantial opportunity ahead in oncology as we continue to grow our sales team, build clinical evidence, and pursue Medicare coverage for Northstar Response. Before discussing ASPs and COGS, I want to highlight a major step forward this quarter. I'm pleased to announce that BillionToOne is now in-network with Anthem, one of the largest health insurers in the U.S. This brings our total contracted lives to approximately 300 million in the U.S., representing more than 90% of patients. Speaker 500:13:02Following the in-network agreement we announced last quarter with UnitedHealthcare, the addition of Anthem further strengthens our market access position. As I have noted previously, an in-network contract removes friction for both physicians and patients, increases access, and over time, results in higher and more predictable ASPs. Turning to ASPs, we continued to see growth in the first quarter, with overall ASP increasing to $571 per test, a 28% year-over-year increase and a $10 per test sequential increase. This increase was despite the largely temporary effect of resetting of coinsurance and deductibles at the beginning of the year. We continue to expect substantial room for ASP expansion ahead, driven by additional Medicaid adoptions of our carrier panel PLA code, the continued mix shift to higher ASP oncology tests, and in time, we expect Medicare coverage of our Northstar Response test. Speaker 500:14:18In addition to driving ASP growth, we have remained committed to our operating philosophy of continuous improvement to reduce COGS per test. Our overall COGS per test was $153 in the first quarter, down 5% sequentially and only 1% higher year-over-year. This was a particularly significant achievement given two factors. First, the continued mix shift toward a higher proportion of oncology tests, which have higher COGS per test. Second, the COGS impact from recent product launches and enhancements such as CH. While we expect to continue to see COGS per test reductions, especially in oncology, over the long term, we expect overall COGS per test to increase gradually over time as our oncology business continues to grow faster. As our overall ASPs continued to increase and our overall COGS per test remained approximately stable, our gross margin profile expanded further in the first quarter. Speaker 500:15:33Gross margins were 73% in Q1, representing a 9 percentage point year-over-year increase from 64% in the first quarter of 2025, and a 2 percentage point sequential increase from 71% in Q4 2025. The increase was primarily driven by continued increases in prenatal ASP and significant COGS reductions in oncology. We are encouraged by the margin trajectory in both segments. While the faster growth of our oncology business can influence margins, as oncology currently has lower margins due to lower volume scale and prior to Medicare coverage of Response, we expect to maintain strong overall gross margins above 70%. Finally, our first quarter performance allowed us to continue making important strides toward our long-term goals. Speaker 500:16:41We delivered a 16% GAAP operating margin and a 24% adjusted EBITDA margin in Q1, while continuing to invest meaningfully in our sales force, in new product launches, and in clinical evidence generation. I'd like to note again that we have achieved this profitability at a much smaller scale than our competitors while growing faster and with less than 10% of their accumulated deficits. This combination of growth and profitability speaks to the uniqueness of our technology, the differentiation of our product portfolio, and our operational discipline. With that, I will turn the call over to Ross to review our financial results and updated 2026 guidance before I conclude. Speaker 700:17:35Thank you, Ozan. As Ozan mentioned, in Q1 of 2026, we had a strong performance that combined 84% year-over-year revenue growth with 16% operating margin and 24% adjusted EBITDA margin. Total revenue in the first quarter of 2026 was $108.4 million, compared to $59.0 million in the first quarter of 2025, representing an increase of 84%. Both our prenatal and oncology product lines demonstrated strong growth in the quarter. Prenatal revenues, consisting of clinical testing revenues and revenues from clinical trial support and other services, increased 72% to $97.7 million in Q1. Oncology revenues increased almost 400% to $10.7 million in Q1 of 2026 versus Q1 of last year. Speaker 700:18:29Our total revenue growth was driven primarily by test volume growth across both prenatal and oncology, as well as continued expansion of both our prenatal and oncology ASPs. True-up revenue was $9.2 million in the first quarter of 2026, compared to $8.4 million in the fourth quarter of 2025, and $2.9 million in the first quarter of 2025. Excluding true-up revenue, total revenue growth in Q1 was 77% compared to the same period last year. Gross profit in the first quarter of 2026 was $79.1 million compared to $38.0 million in the first quarter of 2025, resulting in a gross margin of 73% in the first quarter of 2026 versus 64% in the first quarter of 2025. Speaker 700:19:21The increase in gross margins was primarily attributable to continued increases in our overall ASP. Total operating expenses were $61.2 million in the first quarter of 2026, compared to $40.3 million in the comparable prior year quarter, representing an increase of 52%. Within total operating expenses, R&D expense was $14.7 million in the first quarter of 2026, compared to $10.4 million in the comparable prior year quarter. While SG&A expense was $46.6 million in the first quarter of 2026, compared to $29.9 million in the comparable prior year quarter. We continue to invest in our commercial team, R&D, and clinical evidence generation, yet operating expenses as a percentage of revenue declined materially. Speaker 700:20:14Operating income was $17.8 million in the first quarter of 2026, compared to an operating loss of $2.3 million in the first quarter of 2025. Our Q1 operating profit margin was 16%, representing a meaningful step-up from the 11% operating margin we delivered in the fourth quarter of 2025. Adjusted EBITDA in the quarter represented a 24% margin. Net income available to common shareholders was $18.0 million, or $0.34 per diluted share in the first quarter of 2026, compared to a net loss of $4.0 million, or $0.39 per diluted share for the same period of 2025. Cash flow from operations minus capital expenditures was $11 million in the first quarter of 2026. We are well-capitalized with a very healthy balance sheet. Speaker 700:21:08We ended the first quarter with $537 million in cash and equivalents. We believe our balance sheet positions us for strong growth moving forward, particularly given our intent to continue to manage the business for profitability and positive cash flow. I will provide an update on our full year guidance for 2026. We are raising our 2026 total revenue outlook to a range of $450 million-$465 million, representing growth of 48%-52% compared to full year 2025. Our new revenue guidance is a $20 million increase at both ends of the range over our previous guidance of $430 million-$445 million that we provided in early March. Speaker 700:21:59We are raising our guidance to reflect the strength of our business in Q1, as well as our expectation that new payer contracts will benefit our ASPs over the remainder of the year. We expect to operate the business such that we will continue to generate profitability approaching current levels, even with significant continued investments. I will now turn the call back to Ozan to conclude. Speaker 500:22:24Thank you, Ross. In summary, we are transforming healthcare one molecule at a time, one patient at a time. Looking ahead, my confidence is rooted in the durability and scalability of the foundation we have built. This is not a story dependent on one catalyst. It is a story of multiple reinforcing drivers working together over time. Each product that we launch makes our platform more powerful. Each study that we publish further validates the clinical utility of our technology. Each payer contract, including our landmark agreements with UnitedHealthcare and now Anthem, strengthens access and reinforces the value of our offerings. In Q1, we launched Unity Confirm, a first-of-its-kind offering that further differentiates our prenatal product portfolio, and we made important strides towards keeping our oncology product roadmap on track. Speaker 500:23:32We continued our strong revenue growth with 84% year-over-year growth, leading to $434 million of annualized revenue run rate. We have combined this revenue growth with impressive gross margins of 73%, a 9 percentage point year-over-year increase, even with subscale COGS and ASPs, especially in oncology. Last but not least, we have shown that rapid growth does not have to come at the expense of profitability, achieving an impressive 16% GAAP operating margin and 24% adjusted EBITDA margin. Speaker 500:24:19We are powered by a team of highly motivated, mission-driven individuals who show up every day with a shared purpose to make a meaningful difference in patients' lives. That dedication is reflected in the strength of our results and continues to drive our momentum. Looking ahead, our ambition remains clear. To build a category-defining company, earn a place in the S&P 500, transform molecular diagnostics, and help reshape healthcare. We are pleased with our progress to start the year and look forward to updating you as the year progresses. Thank you. Over to the operator. Speaker 600:25:12Ladies and gentlemen, we'd ask that you please limit yourself to one question and one follow-up. You may get back in the queue as time allows. Our first question comes from the line of Dan Arias from Stifel. Your question please. Speaker 200:25:25Yeah. Hi, guys. Thanks for the questions here. Ross, maybe just to start on the guidance raise on revenues, is there a higher volume component embedded there, or is that really just a function of ASPs? Can you maybe just talk a little bit to volume cadence over the course of the rest of the year here? Speaker 700:25:41Sure, Dan. I made some reference to this in my prepared remarks. In terms of the guidance increase, that came from the strength we had in Q1, just factoring that into the guidance as well as an ASP lift we expect to see from several additional payer contracts we entered into since the start of 2026. Not really assuming any increase in volume compared to our prior expectations other than the good results we saw in Q1. Primarily driven by lift in ASPs and again, strong performance in Q1. Speaker 700:26:19Just in terms of, you know, cadence for volumes in the year, I think, you know, the only real remark I would make there is we typically have a slower Q4 due to seasonality around the holidays and, you know, other factors. Other than that, I'd expect, you know, a little bit of sequential growth in Q2 and Q3, but, you know, Q4 is a seasonally slower quarter for us. Speaker 200:26:42Okay. Maybe on the gross margins, the step up there was pretty notable. We don't really even have a mid-70s number at all in our out year forecast. You know, how sustainable is that as new products come into the portfolio here? At the very least, it feels like the 68%-69% assumption for this year seems low unless something is about to step down in the back half. Can you just maybe help us with that? Speaker 700:27:05Sure. You may have caught during our remarks, Ozan mentioned we expect, 70% or better, you know, gross margin over the course of the year. You know, there could be a little bit of quarterly volatility, you know, in that. I would expect that, you know, a 70% or better, gross margin is something we can sustain, you know, for this calendar year. Speaker 200:27:29Okay. Thank you. Speaker 500:27:30Dan, I can add a little bit of commentary around that. You know, with these contracts, especially, you know, including Anthem and UnitedHealthcare contracts, but other contracts as well, that we are signing, roughly 5-10 contracts almost every month now. They're all incrementally helping our ASPs. Our prenatal, I think, is one of the most remarkable molecular diagnostics businesses in terms of gross margin. As you know, without response Medicare coverage, oncology has lower margins, and it is growing extremely fast, 25% quarter-over-quarter. In the short term, there is this dynamic between faster growth of oncology and remarkable gross margins of prenatal. That is going to keep further expansion, I think, in check, but we still expect it to be above 70%. Speaker 500:28:25Long term, you know, as both of these product lines mature, we expect both product portfolios to be easily above 75%. Speaker 600:28:37Thank you. Our next question comes from the line of Mark Massaro from BTIG. Your question please. Speaker 400:28:44Hey, guys. Congrats on the strong quarter. I wanted to ask about Unity Confirm. Seems like a pretty interesting novel product offering. Ozan, how do you size this market? Even starting with, I think, 3.6 million births in the U.S. roughly, how many of them do you think would be eligible to go on to confirm this? I think you're launching this later this month. Is this something that you expect to get expanded reimbursement coverage for as an add-on? Related to that, can you speak about the clinical trial that you're enrolling? How long do you think it'll take to enroll the patients in the study? Speaker 500:29:29Thank you, Mark, for the question. In terms of reimbursement or revenue additions for Unity Confirm, we expect that to be actually quite minimal, if any. The reason is that this is only going to be about 0.5% of the patients, maybe up to 1% of the patients who would test positive on a cell-free DNA test and be eligible for this. I think really the important part about Unity Confirm is that the patient is only able to get this test if they used Unity Aneuploidy. Speaker 500:30:07We believe that this is going to make our aneuploidy offering strongly differentiated and there will be an increased interest in using our Unity Aneuploidy platform over all others, so that if there is a positive high risk result, that the patient only then will be eligible to get tested with Unity Confirm. Having, you know, this exclusive offering about non-invasive confirmation for these high-risk pregnancies, we believe that this is going to be another driver of volume in terms of the Unity Confirm volume alone, but because this is only, the patients are only eligible for this if they used our aneuploidies screening as a frontline screen to begin with. Speaker 400:30:58That's great. The timing for the clinical trial readout? Speaker 500:31:02The timing, it is a very large clinical trial and, the invasive testing in the U.S., actually has significantly decreased over time. There are actually not as many patients as it used to, that are getting these invasive confirmations, which speaks to the, you know, how critical this offering is, the clinical utility that it provides. That also means that the timing of a very large clinical trial like this can easily take, you know, anywhere between 1 to 3 years. Speaker 400:31:38Right. Just to confirm the, Will these patients be measured against both amnio and CVS? Speaker 500:31:49The clinical trial, as it is designed, includes both CVS and amniocentesis, but the primary endpoint, the primary utility is against CVS because it matches with the cell type that we are measuring, as well as the timeframe of the CVS that we are measuring. Speaker 400:32:11Perfect. Last question from me. Nice to see Anthem come online. I think United started on April first, if you could confirm that. What is the go live date of Anthem? Speaker 500:32:26United, effective date was April first. Anthem is already effective. Speaker 400:32:33Fantastic. Thanks, guys. Speaker 600:32:36Thank you. Our next question comes to the line of Andrew Brackmann from William Blair. Your question please. Operator00:32:43Hi, Zan, Ross, good afternoon. Thanks for taking the questions. I also wanted to ask on Unity Confirm. Can you maybe just sort of talk about the cell capture technology, just broadly? What does this technology sort of mean to the entire prenatal genetics platform, and what are some of the future applications that does this sort of unlock for you as you think years in advance? Thanks. Speaker 500:33:04Thank you, Andrew. This has been holy grail of prenatal testing, something that people have been working on for the last 20 years. Capturing these cells is extremely difficult. You know, when we think about cell-free DNA testing, you know, about 5%, 10% of the DNA is of fetal origin. When we think about, you know, these trophoblasts, these fetal cells, it is truly 1 in a billion type of cell type. It is a more labor-intensive and more actually difficult process, and that is why, you know, this is positioned for confirmation of the high-risk cases rather than a frontline testing. Speaker 500:33:52As you can imagine, one of the really big limitations of cell-free DNA testing or even expansion of cell-free DNA testing was the concern around PPVs as you go into, you know, the rarer conditions. Having a non-invasive confirmation assay actually removes that concern. I think from a long-term perspective, I don't see cell-based methodology as a replacement of cell-free DNA methodology, both due to the cost, but also due to kind of labor-intensive purposes of Unity Confirm or any other cell-based methodology. It can really be, you know, it can really solve the fundamental problems with cell-free DNA testing, which is this gap between screening and diagnostics, which has been increasing over time. That can really enable a cell-free DNA testing to be more comprehensive and more widely adopted as well. Operator00:34:57Okay. That's very, very helpful. I just wanted to ask on capital allocation priorities. I think you called out sort of maintaining profitability while still investing pretty heavily. I assume cash should continue to grow from here. How should we sort of be thinking about you guys using cash in capital allocations from here? Thanks. Speaker 500:35:14You know, as of right now, we do not have any specific plans about how to use the cash. You know, we expect to maintain our profitability while investing in various different areas. Operator00:35:33Great. Thanks for the questions. Speaker 500:35:35Thank you, Andrew. Speaker 600:35:37Thank you. Our next question comes from the line of Subbu Nambi from Guggenheim. Your question please. Speaker 1000:35:44Hey, guys. Thank you for taking my question. You mentioned the MRD launch is on track. What is the next tangible catalyst we should look out for? If it is data, do you know the forum you would share it on, either publication or conference? Speaker 500:35:59We will launch MRD with data at the time of the launch. It's not going to be ahead of the launch, it is going to be at the time of the launch. I do not know whether it is going to be at a specific conference. It might be, a, essentially a manuscript that we release. Speaker 1000:36:26Thank you for that, Oguzhan Atay. Just remind us what is the response select ratio this quarter? Separately, ACOG guidelines were updated last week. In light of that, how has prenatal reimbursement contracting progressed so far this year, especially for expanded carrier screening and 22Q? Speaker 1000:36:45Which, depending on that, what are you expecting exiting 2026, and how might this shape your view for next year ASPs? Thank you. Speaker 500:36:56We did not see any specific changes around coverage policies. We, you know, were able to get in network with more and more payers in Q1, that is the, you know, primary contribution to our ASP growth right now. Speaker 1000:37:20Oguzhan, what was the Response versus Select ratio this quarter? Speaker 500:37:23It is similar. It is not changing. It is around 2 to 1, 2 response to 1 select is the rough ratio that we see. You know, each physician uses differently. Some physicians are repeating select and response, so it is 1-to-1 ratio. Other physicians are doing, you know, 1 select, 1 response to begin with, and then following up with, you know, 2 or 3 or 4 response tests until they see progression. At that point, they are using a select test. The blended average is staying at 2 response to 1 select test, which really speaks to the, you know, the value of a Medicare coverage of a response test for us. That is why, you know, we have been working diligently on that front. Speaker 1000:38:12Very helpful. Thank you, guys. Speaker 500:38:14Mm-hmm. Thank you, Subbu. Speaker 600:38:16Thank you. Our next question comes from the line of Casey Woodring from J.P. Morgan. Your question please. Speaker 800:38:23Hi, this is Sebastian Sandler on for Casey. Thanks for taking the question. My first question is on the sales rep ramp. Can you share the fully ramped rep count as of 1Q? Your latest expectations for fully productive reps exiting the year. If you have this by prenatal and oncology, that would be super helpful. Just any other color on how the process of getting these reps fully ramped is progressing. Is it taking more or less time compared to your initial expectations? Thank you. Speaker 500:38:52Thank you, Casey. The numbers that we shared in the March earnings call, we are approximately on track to those numbers. We are not, you know, going to share at every quarter how many exactly ramped-up reps that we have, but their productivity is staying within the expectations that we have had from the past quarters. Speaker 800:39:19Great. Thanks. On oncology ASPs, it looked like those stepped down a touch sequentially. I'm assuming this might have been on the Northstar Select slot side, maybe from true-ups rolling off. If you could give us more color on that. Just ASP progression for the rest of the year, should this be pretty stable, or do you expect it to be more back-half weighted as some of these new contracts start kicking in? Thank you. Speaker 500:39:44I believe the oncology ASPs were primarily excluding true-up where, you know, they were very similar. True-up number changes from quarter to quarter, and it can impact essentially exactly what it is being recognized at. There are no, you know, material changes in how our oncology tests are being paid. Northstar Select has, you know, broad coverage and reimbursement, and Northstar Response does not. We expect, you know, Northstar Response ASP to be significantly higher once we have Medicare coverage of Northstar Response, which will only come in around the around towards the end of the year. Speaker 800:40:39Makes sense. Thank you. Speaker 600:40:43Thank you. Our next question comes from the line of David Westenberg from Piper Sandler. Your question please. Speaker 900:40:51Hi, this is Sky on for Dave. Thanks for taking the question. Maybe just on the health system pipeline, where does that stand today? Our health system-related adoption still not embedded in the guide. Thanks. Speaker 500:41:06The health system adoption is something that, you know, we work on, but the timeline for health system adoptions can be very variable. It is not directly embedded in the guide, except for essentially any sales team members that we add are expected to grow their territory by a set amount. Those are embedded in the guide as a standard for our previous projections. Speaker 900:41:37Got it. Okay. Thanks. Next, just a little bit more color on how you see cancer monitoring adoption over the next few years and timing on that. Thank you. Speaker 500:41:50Can you repeat the question? Speaker 900:41:53Yes. How do you see cancer monitoring adoption kind of over the next few years and the timing around that? Speaker 500:42:02You mean Northstar Response, related adoption when you say cancer monitoring? Speaker 900:42:09Sure. Speaker 500:42:09referring to more surveillance with respect to MRD? Speaker 900:42:14More surveillance with respect to MRD would be great. Speaker 500:42:17Today, we do not have an MRD test, but you know, we are working on building a tumor-naive MRD test. Our belief there is that today most of the usage of MRD is in academic centers, and it is primarily in colorectal cancer. That is one area where, you know, access to tissue is much easier than other cancer types. We believe that the adoption of a tumor-naive test that is as sensitive, if not more sensitive than many of the tumor-informed tests will be much more easily adopted in, you know, by community oncologists who care for, you know, upwards of 80-plus % of oncology lives in the U.S. Speaker 500:43:11We believe that, you know, even though most of the adoption today is in colorectal and most of the adoption is in academic centers, eventually the bigger adoption of MRD is going to be in community by community oncologists, using tumor-naive tests. That is why we spend a lot of our efforts around the tumor-naive aspect of our test, even though it is so much easier to build a tumor-informed test. In fact, you know, internally, we built a tumor-informed test that is ultra-sensitive just so that we can benchmark our tumor-naive test against it. Speaker 900:43:55Very helpful. Thank you. Speaker 600:43:58Thank you. Our next question comes from the line of Brendan Kuykendall from Wells Fargo. Your question please. Speaker 100:44:05Hey, thanks. Good afternoon. Just 2 questions for you, Ross. Just wanna confirm to what extent other than the first quarter true-ups, have you embedded any additional true-ups over the balance of the year in the new guide? Then could you speak to the spike in accounts receivable in the first quarter, what's driving that? Thanks. Speaker 700:44:26Sure. With regard to the true-ups, yes. We do not include true-up revenue in the guide other than the historical, you know, kind of Q1 numbers we've already seen. You know, the out quarters, no, there's no true-up revenue embedded in that, in that guide. The change in the AR is, we entered into, you know, a number of contracts during, you know, Q1, some of which came in, you know, late Q1 as well, and we're not gonna get reimbursement for those until several months from now. Some of that new contracting drove about, you know, half of the increase in our, you know, AR this quarter or almost half of the increase in the AR. I would expect that will come down, you know, if not by the end of Q2, certainly by the end of Q3. Speaker 500:45:12It just depends on how rapidly these activities. Speaker 100:45:18Very helpful. Thank you. Speaker 600:45:21Thank you. Our next question comes from the line of Tycho Peterson from Jefferies. Your question please. Speaker 1100:45:28Hey. Love to dig into the 1Q volumes a bit. You know, you called out an increase in active ordering providers last quarter. Could you maybe just touch on, you know, how much of the volume contributions this quarter came from new providers versus repeat orders from previously integrated providers? Speaker 500:45:43Thank you, Tycho, for the question. We have seen a very similar number of newly active ordering providers that we added in this quarter compared to all the previous quarters. We haven't seen any difference. Really, the difference between test volume increases between quarters is primarily due to the number of accessioning days in the quarter and when those providers essentially become active, you know, throughout the quarter. We haven't actually seen, you know, any difference between Q4 and Q1. It is just that Q4 tends to be seasonally slow for us due to the number of accessioning days and the holidays in the quarter, which artificially decreases the test volume. Speaker 1100:46:34Okay. You know, I've had a couple on Unity Confirm. I guess I'm just wondering how you're thinking about share dynamics, you know, in the market today. There's obviously been some competitive, you know, launches as well. You know, what's your view of share dynamics today? Speaker 500:46:49You know, we are not really seeing a significant impact in the way that we are acquiring new providers, new accounts. The Unity Confirm, you know, granted it does create, you know, some noise, but just the fact that we have added a similar number of active ordering providers, newly active ordering providers in Q1 as well as Q4 as well as Q3, you know, similar to the previous quarters, really shows that, you know, our products are resonating with providers and we are executing well. Unity Confirm is another driver, another reason for providers to use our test. Speaker 500:47:32As opposed to, you know, some of our previous launches, in this particular case, you know, it is only accessible if a provider has ordered Unity Aneuploidy as a frontline screen, which we believe is going to, you know, position our test as a much more of a frontline usage in certain cases where they may be relying on our test as a second line in the past. You know, this certainly happens for instance with MFMs. Sometimes, you know, with our Unity Fetal Antigen NIPT, we would receive another Unity Aneuploidy Screen order even though frontline testing was, you know, another competitor's test or similarly, you know, we do receive tests where our Unity Aneuploidy Screen is being ordered because other tests were no calls or were incorrect results. Speaker 500:48:31In this particular case, we are only enabling Unity Confirm if our test has been used as a frontline test, which essentially means that it will be an important driver of test volume. Speaker 1100:48:45Okay. last one, understanding the timelines for MolDX on Northstar Response. You know, we hear a lot about potential delays of MolDX and, you know, longer times to turn to applicants. I guess, you know, what's the risk it gets pushed into next year? Speaker 500:49:01We are not seeing any issues with MolDX. They are responding within their stated timelines, which is 60 days. It was a very productive, you know, back and forth with MolDX. We do not anticipate any potential for delay. It might even potentially be slightly earlier than we originally anticipated. Speaker 1100:49:30Okay. Thank you. Speaker 600:49:33Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Oguzhan Atay for any further remarks. Speaker 500:49:43Thank you, operator. Thank you all for joining today's conference call. We look forward to speaking with you on our next conference call in a few months. Have a good day. Speaker 600:49:54Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.Read morePowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Billiontoone Earnings HeadlinesBillionToOne Reports First Quarter 2026 Results and Raises 2026 Revenue GuidanceMay 6 at 4:05 PM | globenewswire.comWhat Makes BillionToOne (BLLN) a Revolutionizer in Genetic Testing?May 4 at 8:51 AM | insidermonkey.comSpaceX eyes a 1.75 trillion valuation - here's what to knowElon Musk's team has quietly filed confidential paperwork with the SEC for what Bloomberg estimates could be a $1.75 trillion IPO - larger than Saudi Aramco and any tech offering in history. CNBC calls it 'the big market event of 2026.' According to former tech executive and angel investor Jeff Brown, there's a way to claim a stake before the public filing drops, starting with as little as $500.May 6 at 1:00 AM | Brownstone Research (Ad)Billiontoone, Inc.'s Lock-Up Period Set To Expire on May 5th (NASDAQ:BLLN)May 2, 2026 | americanbankingnews.comBillionToOne Launches Unity Confirm™: A category-defining test that bridges the gap between screening and invasive diagnosticsMay 1, 2026 | prnewswire.comJim Cramer Believes “BillionToOne’s a Winner”April 30, 2026 | finance.yahoo.comSee More Billiontoone Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Billiontoone? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Billiontoone and other key companies, straight to your email. Email Address About BilliontooneBilliontoone (NASDAQ:BLLN) (NASDAQ: BLLN) is a molecular diagnostics company that develops and commercializes high-precision genetic testing solutions based on single-molecule counting technology. The company’s platform is designed to detect and quantify rare genetic variants and chromosomal abnormalities from cell-free DNA, with a primary focus on applications in prenatal screening and other clinical genetic tests where sensitivity and specificity at very low allele fractions are critical. BillionToOne’s offerings center on assay development and clinical testing workflows that enable non-invasive prenatal testing (NIPT) and targeted molecular diagnostics. Its technology aims to improve accuracy in detecting fetal aneuploidies, microdeletions, and single-gene disorders from maternal blood samples by reducing measurement noise and enabling precise digital quantification. The company provides testing services and partners with clinical laboratories, healthcare providers, and research organizations to implement its assays in clinical and research settings. In support of clinical adoption, BillionToOne focuses on analytical validation, clinical studies, and building laboratory processes that integrate its single-molecule counting approach into standard diagnostic pipelines. The company positions its platform as complementary to existing sequencing and molecular methods, emphasizing improved detection of low-frequency variants and potential reductions in false positives that can drive follow-up invasive procedures. BillionToOne serves the healthcare and clinical diagnostics market, primarily through collaborations and laboratory channels. Its management and scientific teams are oriented toward translating advanced genomic measurement techniques into deployable clinical tests, with ongoing efforts to expand the clinical utility and accessibility of its assays through partnerships and regulatory and clinical validation activities.View Billiontoone ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Boarding Passes Now Being Issued for the Ultimate eVTOL ArbitrageDigitalOcean’s AI Surge: How Far Can This Rally Go?Years in the Making, AMD’s Upside Movement Has Just BegunCapital One’s Big Bet Faces Rising Credit RiskWestern Digital: The Storage Behemoth Skyrocketing on AI DemandOld Money, New Tech: Western Union's Crypto RebootHow Williams Companies Is Cashing in on the AI Power Boom Upcoming Earnings Coinbase Global (5/7/2026)Airbnb (5/7/2026)Datadog (5/7/2026)Ferrovial (5/7/2026)Gilead Sciences (5/7/2026)Microchip Technology (5/7/2026)MercadoLibre (5/7/2026)Monster Beverage (5/7/2026)Canadian Natural Resources (5/7/2026)W.W. 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There are 12 speakers on the call. Speaker 600:00:00Thank you for standing by, and welcome to the BillionToOne first quarter 2026 earnings call. Now I'd like to introduce your host for today's program, David Westenberg, Investor Relations. Please go ahead, sir. Speaker 300:00:32Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from BillionToOne we have Oguzhan Atay, Co-Founder and Chief Executive Officer, and Ross Taylor, Chief Financial Officer. Earlier today, BillionToOne released financial results for the first quarter ended March 31st, 2026. A copy of the press release is available on the company's website. Before we begin, I want to remind you that during this call we may make forward-looking statements within the meaning of federal securities laws. Such statements about future events may include statements about our financial outlook and performance, market size, our products and services, reimbursement coverage, future clinical performance, and other similar statements. We caution you that such statements reflect our current best judgment, and actual results may differ materially from those expressed or implied in any forward-looking statements. Speaker 300:01:20Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed annual report, Form 10-K, our quarterly report on Form 10-Q, to be filed following this call, and the current report on Form 8-K, filed today. Any forward-looking statement made during this call is made as of today, May 6th, 2026. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. BillionToOne disclaims any obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. With that, I'll turn the call over to Ozan. Speaker 500:02:00Good afternoon, everyone. Thank you for joining our first quarter 2026 earnings call. I'd like to start by thanking our employees who work with tremendous effort and diligence to build and deliver superior tests to our patients that improve their care and remove the fear of the unknown. Before diving into our quarterly results, I would like to remind you of our four pillars that I believe make us a different category of molecular diagnostics company. First, our revolutionary technology platform, which is enabled by our patented QCT, Quantitative Counting Template technology, achieves single molecule-level sensitivity and precision with next-generation sequencing. With this technology, we have built unique category-defining products in both prenatal and oncology. With our differentiated products, we have grown exponentially in the last six years, even as we reach scale, with a level of compounding that we believe is rare in our industry. Speaker 500:03:12There is still so much room to grow as the opportunity of prenatal and oncology cfDNA markets can exceed $100 billion in U.S. market opportunity over time. In addition to rapid growth, we have achieved a superior gross margin profile, with margins now above 70%, with still significant room for expansion through ASV growth and COGS per test reductions. Lastly, through a culture of fiscal discipline and efficient operations incorporating AI and automation, we achieved GAAP profitability and positive cash flow with less than 10% of the accumulated deficit of our public competitors. In summary, we continue to track towards our long-term goal, which has remained the same, to build a category-defining generational company and become a member of the S&P 500. Our first quarter performance was extremely strong across all four pillars. Speaker 500:04:20For the third quarter in a row, we delivered a Rule of 100+, this time, in this quarter, we paired it with a level of profitability that is extremely rare for a high-growth company. We had another quarter of high growth, expanded margins, positive operating income, and positive cash flow. Looking at our results pillar by pillar, in addition to expanded Unity Fetal Antigen NIPT and FN NIPT launches for prenatal and PGX and CH launches for oncology that were launched in February, after the end of the quarter, we launched a category-redefining prenatal test, Unity Confirm. Unity Confirm is the first non-invasive fetal cell-based confirmation assay for high-risk NIPTs. On the oncology side, our product roadmap remains on track. We responded to all MolDX comments for our response coverage submission, our tumor naive MRD launch is on track to launch by the end of this year. Speaker 500:05:37As we continue to launch new products, our business continues to grow, delivering consistent test volume growth of 44% year-over-year and total revenue growth of 84% year-over-year. In our third pillar, we have continued our progress with our in-network contracts. Most importantly, with a contract with Anthem, bringing our total contracted lives to 300 million in the U.S. As our ASPs increased 28% year-over-year to $571 per test, and as we maintained our COGS at $153 per test, despite a higher proportion of oncology tests that have a higher COGS, we expanded our gross margins to 73% in Q1, a strong 9 percentage point increase year-over-year. Speaker 500:06:41Finally, in our fourth pillar, as our growth margins expanded and as we operated with higher efficiency, we delivered a remarkable profitability profile in the first quarter with a 16% GAAP operating margin and 24% adjusted EBITDA margin, increasing our cash position to $537.5 million at the end of the quarter. Delving into each pillar one by one. For our first pillar, on May first, just five days ago, at ACOG annual meeting, we moved the field forward once again by launching what we believe is going to be seen as the innovation of the decade in prenatal genetics. Unity Confirm is the first and only non-invasive confirmation assay for high-risk pregnancies. It represents what many in our field have long considered the holy grail of non-invasive prenatal testing. Speaker 500:07:50Unity Confirm captures and sequences intact circulating fetal cells from a maternal blood sample, providing 100% fetal fraction. To put that in perspective, conventional cell-free DNA tests rely on small fractions of fetal DNA in maternal plasma. By isolating and sequencing whole fetal cells directly, Unity Confirm is in a fundamentally different category. We have launched Unity Confirm as a specialized offering, as a follow-up for high-risk pregnancies identified on our Unity Aneuploidy Screen. Today, if an NIPT returns a high-risk result, the next step is invasive diagnostic testing, which is increasingly inaccessible in maternity care deserts and also carries a small miscarriage risk. The majority of patients cannot or choose not to proceed to invasive diagnostic confirmation. Unity Confirm addresses this critical clinical gap. It gives these patients and their physicians a non-invasive option. Speaker 500:09:08Our initial results have shown 100% concordance compared to invasive diagnostics, and we are now enrolling patients in what we believe is the largest prospective circulating fetal cell-based study ever conducted with concordance to invasive diagnostics. We also built a comprehensive launch campaign around Unity Confirm. More than 500 providers attended the launch or watched on the live stream. We believe Unity Confirm will further increase the differentiation of our Unity product offerings. Turning to our second pillar, scalable rapid growth. Our leadership in product innovation and our growing commercial team continued to drive strong test volume in the quarter. In Q1, we delivered approximately 188,000 tests, representing 44% year-over-year growth and strong sequential growth across both product lines, with prenatal volumes growing approximately 10% quarter-over-quarter and oncology volumes growing approximately 25% quarter-over-quarter. Speaker 500:10:33Importantly, on the oncology side, approximately 60% of Northstar Select orders now opt in to CH, reflecting growing physician awareness of the importance of distinguishing tumor-derived from non-tumor derived variants in liquid biopsy. Our total revenues in the first quarter grew even faster, achieving 84% year-over-year growth. This was driven by 44% year-over-year growth in test volume and 28% year-over-year growth in ASP. Looking at the segment detail, both prenatal and oncology contributed meaningfully to our growth. Prenatal revenue in the first quarter was $97.7 million, up 72% year-over-year, driven by strong volume growth, commercial execution, and additional traction driven by our fetal antigen test products launched at SMFM in February. This continues to underscore the depth of Unity's differentiation and the durability of our prenatal growth. Speaker 500:11:50Oncology revenue was nearly five times over last year, reaching $10.7 million in the first quarter, an annualized revenue run rate of $43 million. The oncology ramp is being driven by increasing adoption of both Northstar Select and Northstar Response, the recent launches of PGX and CH, and strong execution of our oncology commercial team. We continue to see substantial opportunity ahead in oncology as we continue to grow our sales team, build clinical evidence, and pursue Medicare coverage for Northstar Response. Before discussing ASPs and COGS, I want to highlight a major step forward this quarter. I'm pleased to announce that BillionToOne is now in-network with Anthem, one of the largest health insurers in the U.S. This brings our total contracted lives to approximately 300 million in the U.S., representing more than 90% of patients. Speaker 500:13:02Following the in-network agreement we announced last quarter with UnitedHealthcare, the addition of Anthem further strengthens our market access position. As I have noted previously, an in-network contract removes friction for both physicians and patients, increases access, and over time, results in higher and more predictable ASPs. Turning to ASPs, we continued to see growth in the first quarter, with overall ASP increasing to $571 per test, a 28% year-over-year increase and a $10 per test sequential increase. This increase was despite the largely temporary effect of resetting of coinsurance and deductibles at the beginning of the year. We continue to expect substantial room for ASP expansion ahead, driven by additional Medicaid adoptions of our carrier panel PLA code, the continued mix shift to higher ASP oncology tests, and in time, we expect Medicare coverage of our Northstar Response test. Speaker 500:14:18In addition to driving ASP growth, we have remained committed to our operating philosophy of continuous improvement to reduce COGS per test. Our overall COGS per test was $153 in the first quarter, down 5% sequentially and only 1% higher year-over-year. This was a particularly significant achievement given two factors. First, the continued mix shift toward a higher proportion of oncology tests, which have higher COGS per test. Second, the COGS impact from recent product launches and enhancements such as CH. While we expect to continue to see COGS per test reductions, especially in oncology, over the long term, we expect overall COGS per test to increase gradually over time as our oncology business continues to grow faster. As our overall ASPs continued to increase and our overall COGS per test remained approximately stable, our gross margin profile expanded further in the first quarter. Speaker 500:15:33Gross margins were 73% in Q1, representing a 9 percentage point year-over-year increase from 64% in the first quarter of 2025, and a 2 percentage point sequential increase from 71% in Q4 2025. The increase was primarily driven by continued increases in prenatal ASP and significant COGS reductions in oncology. We are encouraged by the margin trajectory in both segments. While the faster growth of our oncology business can influence margins, as oncology currently has lower margins due to lower volume scale and prior to Medicare coverage of Response, we expect to maintain strong overall gross margins above 70%. Finally, our first quarter performance allowed us to continue making important strides toward our long-term goals. Speaker 500:16:41We delivered a 16% GAAP operating margin and a 24% adjusted EBITDA margin in Q1, while continuing to invest meaningfully in our sales force, in new product launches, and in clinical evidence generation. I'd like to note again that we have achieved this profitability at a much smaller scale than our competitors while growing faster and with less than 10% of their accumulated deficits. This combination of growth and profitability speaks to the uniqueness of our technology, the differentiation of our product portfolio, and our operational discipline. With that, I will turn the call over to Ross to review our financial results and updated 2026 guidance before I conclude. Speaker 700:17:35Thank you, Ozan. As Ozan mentioned, in Q1 of 2026, we had a strong performance that combined 84% year-over-year revenue growth with 16% operating margin and 24% adjusted EBITDA margin. Total revenue in the first quarter of 2026 was $108.4 million, compared to $59.0 million in the first quarter of 2025, representing an increase of 84%. Both our prenatal and oncology product lines demonstrated strong growth in the quarter. Prenatal revenues, consisting of clinical testing revenues and revenues from clinical trial support and other services, increased 72% to $97.7 million in Q1. Oncology revenues increased almost 400% to $10.7 million in Q1 of 2026 versus Q1 of last year. Speaker 700:18:29Our total revenue growth was driven primarily by test volume growth across both prenatal and oncology, as well as continued expansion of both our prenatal and oncology ASPs. True-up revenue was $9.2 million in the first quarter of 2026, compared to $8.4 million in the fourth quarter of 2025, and $2.9 million in the first quarter of 2025. Excluding true-up revenue, total revenue growth in Q1 was 77% compared to the same period last year. Gross profit in the first quarter of 2026 was $79.1 million compared to $38.0 million in the first quarter of 2025, resulting in a gross margin of 73% in the first quarter of 2026 versus 64% in the first quarter of 2025. Speaker 700:19:21The increase in gross margins was primarily attributable to continued increases in our overall ASP. Total operating expenses were $61.2 million in the first quarter of 2026, compared to $40.3 million in the comparable prior year quarter, representing an increase of 52%. Within total operating expenses, R&D expense was $14.7 million in the first quarter of 2026, compared to $10.4 million in the comparable prior year quarter. While SG&A expense was $46.6 million in the first quarter of 2026, compared to $29.9 million in the comparable prior year quarter. We continue to invest in our commercial team, R&D, and clinical evidence generation, yet operating expenses as a percentage of revenue declined materially. Speaker 700:20:14Operating income was $17.8 million in the first quarter of 2026, compared to an operating loss of $2.3 million in the first quarter of 2025. Our Q1 operating profit margin was 16%, representing a meaningful step-up from the 11% operating margin we delivered in the fourth quarter of 2025. Adjusted EBITDA in the quarter represented a 24% margin. Net income available to common shareholders was $18.0 million, or $0.34 per diluted share in the first quarter of 2026, compared to a net loss of $4.0 million, or $0.39 per diluted share for the same period of 2025. Cash flow from operations minus capital expenditures was $11 million in the first quarter of 2026. We are well-capitalized with a very healthy balance sheet. Speaker 700:21:08We ended the first quarter with $537 million in cash and equivalents. We believe our balance sheet positions us for strong growth moving forward, particularly given our intent to continue to manage the business for profitability and positive cash flow. I will provide an update on our full year guidance for 2026. We are raising our 2026 total revenue outlook to a range of $450 million-$465 million, representing growth of 48%-52% compared to full year 2025. Our new revenue guidance is a $20 million increase at both ends of the range over our previous guidance of $430 million-$445 million that we provided in early March. Speaker 700:21:59We are raising our guidance to reflect the strength of our business in Q1, as well as our expectation that new payer contracts will benefit our ASPs over the remainder of the year. We expect to operate the business such that we will continue to generate profitability approaching current levels, even with significant continued investments. I will now turn the call back to Ozan to conclude. Speaker 500:22:24Thank you, Ross. In summary, we are transforming healthcare one molecule at a time, one patient at a time. Looking ahead, my confidence is rooted in the durability and scalability of the foundation we have built. This is not a story dependent on one catalyst. It is a story of multiple reinforcing drivers working together over time. Each product that we launch makes our platform more powerful. Each study that we publish further validates the clinical utility of our technology. Each payer contract, including our landmark agreements with UnitedHealthcare and now Anthem, strengthens access and reinforces the value of our offerings. In Q1, we launched Unity Confirm, a first-of-its-kind offering that further differentiates our prenatal product portfolio, and we made important strides towards keeping our oncology product roadmap on track. Speaker 500:23:32We continued our strong revenue growth with 84% year-over-year growth, leading to $434 million of annualized revenue run rate. We have combined this revenue growth with impressive gross margins of 73%, a 9 percentage point year-over-year increase, even with subscale COGS and ASPs, especially in oncology. Last but not least, we have shown that rapid growth does not have to come at the expense of profitability, achieving an impressive 16% GAAP operating margin and 24% adjusted EBITDA margin. Speaker 500:24:19We are powered by a team of highly motivated, mission-driven individuals who show up every day with a shared purpose to make a meaningful difference in patients' lives. That dedication is reflected in the strength of our results and continues to drive our momentum. Looking ahead, our ambition remains clear. To build a category-defining company, earn a place in the S&P 500, transform molecular diagnostics, and help reshape healthcare. We are pleased with our progress to start the year and look forward to updating you as the year progresses. Thank you. Over to the operator. Speaker 600:25:12Ladies and gentlemen, we'd ask that you please limit yourself to one question and one follow-up. You may get back in the queue as time allows. Our first question comes from the line of Dan Arias from Stifel. Your question please. Speaker 200:25:25Yeah. Hi, guys. Thanks for the questions here. Ross, maybe just to start on the guidance raise on revenues, is there a higher volume component embedded there, or is that really just a function of ASPs? Can you maybe just talk a little bit to volume cadence over the course of the rest of the year here? Speaker 700:25:41Sure, Dan. I made some reference to this in my prepared remarks. In terms of the guidance increase, that came from the strength we had in Q1, just factoring that into the guidance as well as an ASP lift we expect to see from several additional payer contracts we entered into since the start of 2026. Not really assuming any increase in volume compared to our prior expectations other than the good results we saw in Q1. Primarily driven by lift in ASPs and again, strong performance in Q1. Speaker 700:26:19Just in terms of, you know, cadence for volumes in the year, I think, you know, the only real remark I would make there is we typically have a slower Q4 due to seasonality around the holidays and, you know, other factors. Other than that, I'd expect, you know, a little bit of sequential growth in Q2 and Q3, but, you know, Q4 is a seasonally slower quarter for us. Speaker 200:26:42Okay. Maybe on the gross margins, the step up there was pretty notable. We don't really even have a mid-70s number at all in our out year forecast. You know, how sustainable is that as new products come into the portfolio here? At the very least, it feels like the 68%-69% assumption for this year seems low unless something is about to step down in the back half. Can you just maybe help us with that? Speaker 700:27:05Sure. You may have caught during our remarks, Ozan mentioned we expect, 70% or better, you know, gross margin over the course of the year. You know, there could be a little bit of quarterly volatility, you know, in that. I would expect that, you know, a 70% or better, gross margin is something we can sustain, you know, for this calendar year. Speaker 200:27:29Okay. Thank you. Speaker 500:27:30Dan, I can add a little bit of commentary around that. You know, with these contracts, especially, you know, including Anthem and UnitedHealthcare contracts, but other contracts as well, that we are signing, roughly 5-10 contracts almost every month now. They're all incrementally helping our ASPs. Our prenatal, I think, is one of the most remarkable molecular diagnostics businesses in terms of gross margin. As you know, without response Medicare coverage, oncology has lower margins, and it is growing extremely fast, 25% quarter-over-quarter. In the short term, there is this dynamic between faster growth of oncology and remarkable gross margins of prenatal. That is going to keep further expansion, I think, in check, but we still expect it to be above 70%. Speaker 500:28:25Long term, you know, as both of these product lines mature, we expect both product portfolios to be easily above 75%. Speaker 600:28:37Thank you. Our next question comes from the line of Mark Massaro from BTIG. Your question please. Speaker 400:28:44Hey, guys. Congrats on the strong quarter. I wanted to ask about Unity Confirm. Seems like a pretty interesting novel product offering. Ozan, how do you size this market? Even starting with, I think, 3.6 million births in the U.S. roughly, how many of them do you think would be eligible to go on to confirm this? I think you're launching this later this month. Is this something that you expect to get expanded reimbursement coverage for as an add-on? Related to that, can you speak about the clinical trial that you're enrolling? How long do you think it'll take to enroll the patients in the study? Speaker 500:29:29Thank you, Mark, for the question. In terms of reimbursement or revenue additions for Unity Confirm, we expect that to be actually quite minimal, if any. The reason is that this is only going to be about 0.5% of the patients, maybe up to 1% of the patients who would test positive on a cell-free DNA test and be eligible for this. I think really the important part about Unity Confirm is that the patient is only able to get this test if they used Unity Aneuploidy. Speaker 500:30:07We believe that this is going to make our aneuploidy offering strongly differentiated and there will be an increased interest in using our Unity Aneuploidy platform over all others, so that if there is a positive high risk result, that the patient only then will be eligible to get tested with Unity Confirm. Having, you know, this exclusive offering about non-invasive confirmation for these high-risk pregnancies, we believe that this is going to be another driver of volume in terms of the Unity Confirm volume alone, but because this is only, the patients are only eligible for this if they used our aneuploidies screening as a frontline screen to begin with. Speaker 400:30:58That's great. The timing for the clinical trial readout? Speaker 500:31:02The timing, it is a very large clinical trial and, the invasive testing in the U.S., actually has significantly decreased over time. There are actually not as many patients as it used to, that are getting these invasive confirmations, which speaks to the, you know, how critical this offering is, the clinical utility that it provides. That also means that the timing of a very large clinical trial like this can easily take, you know, anywhere between 1 to 3 years. Speaker 400:31:38Right. Just to confirm the, Will these patients be measured against both amnio and CVS? Speaker 500:31:49The clinical trial, as it is designed, includes both CVS and amniocentesis, but the primary endpoint, the primary utility is against CVS because it matches with the cell type that we are measuring, as well as the timeframe of the CVS that we are measuring. Speaker 400:32:11Perfect. Last question from me. Nice to see Anthem come online. I think United started on April first, if you could confirm that. What is the go live date of Anthem? Speaker 500:32:26United, effective date was April first. Anthem is already effective. Speaker 400:32:33Fantastic. Thanks, guys. Speaker 600:32:36Thank you. Our next question comes to the line of Andrew Brackmann from William Blair. Your question please. Operator00:32:43Hi, Zan, Ross, good afternoon. Thanks for taking the questions. I also wanted to ask on Unity Confirm. Can you maybe just sort of talk about the cell capture technology, just broadly? What does this technology sort of mean to the entire prenatal genetics platform, and what are some of the future applications that does this sort of unlock for you as you think years in advance? Thanks. Speaker 500:33:04Thank you, Andrew. This has been holy grail of prenatal testing, something that people have been working on for the last 20 years. Capturing these cells is extremely difficult. You know, when we think about cell-free DNA testing, you know, about 5%, 10% of the DNA is of fetal origin. When we think about, you know, these trophoblasts, these fetal cells, it is truly 1 in a billion type of cell type. It is a more labor-intensive and more actually difficult process, and that is why, you know, this is positioned for confirmation of the high-risk cases rather than a frontline testing. Speaker 500:33:52As you can imagine, one of the really big limitations of cell-free DNA testing or even expansion of cell-free DNA testing was the concern around PPVs as you go into, you know, the rarer conditions. Having a non-invasive confirmation assay actually removes that concern. I think from a long-term perspective, I don't see cell-based methodology as a replacement of cell-free DNA methodology, both due to the cost, but also due to kind of labor-intensive purposes of Unity Confirm or any other cell-based methodology. It can really be, you know, it can really solve the fundamental problems with cell-free DNA testing, which is this gap between screening and diagnostics, which has been increasing over time. That can really enable a cell-free DNA testing to be more comprehensive and more widely adopted as well. Operator00:34:57Okay. That's very, very helpful. I just wanted to ask on capital allocation priorities. I think you called out sort of maintaining profitability while still investing pretty heavily. I assume cash should continue to grow from here. How should we sort of be thinking about you guys using cash in capital allocations from here? Thanks. Speaker 500:35:14You know, as of right now, we do not have any specific plans about how to use the cash. You know, we expect to maintain our profitability while investing in various different areas. Operator00:35:33Great. Thanks for the questions. Speaker 500:35:35Thank you, Andrew. Speaker 600:35:37Thank you. Our next question comes from the line of Subbu Nambi from Guggenheim. Your question please. Speaker 1000:35:44Hey, guys. Thank you for taking my question. You mentioned the MRD launch is on track. What is the next tangible catalyst we should look out for? If it is data, do you know the forum you would share it on, either publication or conference? Speaker 500:35:59We will launch MRD with data at the time of the launch. It's not going to be ahead of the launch, it is going to be at the time of the launch. I do not know whether it is going to be at a specific conference. It might be, a, essentially a manuscript that we release. Speaker 1000:36:26Thank you for that, Oguzhan Atay. Just remind us what is the response select ratio this quarter? Separately, ACOG guidelines were updated last week. In light of that, how has prenatal reimbursement contracting progressed so far this year, especially for expanded carrier screening and 22Q? Speaker 1000:36:45Which, depending on that, what are you expecting exiting 2026, and how might this shape your view for next year ASPs? Thank you. Speaker 500:36:56We did not see any specific changes around coverage policies. We, you know, were able to get in network with more and more payers in Q1, that is the, you know, primary contribution to our ASP growth right now. Speaker 1000:37:20Oguzhan, what was the Response versus Select ratio this quarter? Speaker 500:37:23It is similar. It is not changing. It is around 2 to 1, 2 response to 1 select is the rough ratio that we see. You know, each physician uses differently. Some physicians are repeating select and response, so it is 1-to-1 ratio. Other physicians are doing, you know, 1 select, 1 response to begin with, and then following up with, you know, 2 or 3 or 4 response tests until they see progression. At that point, they are using a select test. The blended average is staying at 2 response to 1 select test, which really speaks to the, you know, the value of a Medicare coverage of a response test for us. That is why, you know, we have been working diligently on that front. Speaker 1000:38:12Very helpful. Thank you, guys. Speaker 500:38:14Mm-hmm. Thank you, Subbu. Speaker 600:38:16Thank you. Our next question comes from the line of Casey Woodring from J.P. Morgan. Your question please. Speaker 800:38:23Hi, this is Sebastian Sandler on for Casey. Thanks for taking the question. My first question is on the sales rep ramp. Can you share the fully ramped rep count as of 1Q? Your latest expectations for fully productive reps exiting the year. If you have this by prenatal and oncology, that would be super helpful. Just any other color on how the process of getting these reps fully ramped is progressing. Is it taking more or less time compared to your initial expectations? Thank you. Speaker 500:38:52Thank you, Casey. The numbers that we shared in the March earnings call, we are approximately on track to those numbers. We are not, you know, going to share at every quarter how many exactly ramped-up reps that we have, but their productivity is staying within the expectations that we have had from the past quarters. Speaker 800:39:19Great. Thanks. On oncology ASPs, it looked like those stepped down a touch sequentially. I'm assuming this might have been on the Northstar Select slot side, maybe from true-ups rolling off. If you could give us more color on that. Just ASP progression for the rest of the year, should this be pretty stable, or do you expect it to be more back-half weighted as some of these new contracts start kicking in? Thank you. Speaker 500:39:44I believe the oncology ASPs were primarily excluding true-up where, you know, they were very similar. True-up number changes from quarter to quarter, and it can impact essentially exactly what it is being recognized at. There are no, you know, material changes in how our oncology tests are being paid. Northstar Select has, you know, broad coverage and reimbursement, and Northstar Response does not. We expect, you know, Northstar Response ASP to be significantly higher once we have Medicare coverage of Northstar Response, which will only come in around the around towards the end of the year. Speaker 800:40:39Makes sense. Thank you. Speaker 600:40:43Thank you. Our next question comes from the line of David Westenberg from Piper Sandler. Your question please. Speaker 900:40:51Hi, this is Sky on for Dave. Thanks for taking the question. Maybe just on the health system pipeline, where does that stand today? Our health system-related adoption still not embedded in the guide. Thanks. Speaker 500:41:06The health system adoption is something that, you know, we work on, but the timeline for health system adoptions can be very variable. It is not directly embedded in the guide, except for essentially any sales team members that we add are expected to grow their territory by a set amount. Those are embedded in the guide as a standard for our previous projections. Speaker 900:41:37Got it. Okay. Thanks. Next, just a little bit more color on how you see cancer monitoring adoption over the next few years and timing on that. Thank you. Speaker 500:41:50Can you repeat the question? Speaker 900:41:53Yes. How do you see cancer monitoring adoption kind of over the next few years and the timing around that? Speaker 500:42:02You mean Northstar Response, related adoption when you say cancer monitoring? Speaker 900:42:09Sure. Speaker 500:42:09referring to more surveillance with respect to MRD? Speaker 900:42:14More surveillance with respect to MRD would be great. Speaker 500:42:17Today, we do not have an MRD test, but you know, we are working on building a tumor-naive MRD test. Our belief there is that today most of the usage of MRD is in academic centers, and it is primarily in colorectal cancer. That is one area where, you know, access to tissue is much easier than other cancer types. We believe that the adoption of a tumor-naive test that is as sensitive, if not more sensitive than many of the tumor-informed tests will be much more easily adopted in, you know, by community oncologists who care for, you know, upwards of 80-plus % of oncology lives in the U.S. Speaker 500:43:11We believe that, you know, even though most of the adoption today is in colorectal and most of the adoption is in academic centers, eventually the bigger adoption of MRD is going to be in community by community oncologists, using tumor-naive tests. That is why we spend a lot of our efforts around the tumor-naive aspect of our test, even though it is so much easier to build a tumor-informed test. In fact, you know, internally, we built a tumor-informed test that is ultra-sensitive just so that we can benchmark our tumor-naive test against it. Speaker 900:43:55Very helpful. Thank you. Speaker 600:43:58Thank you. Our next question comes from the line of Brendan Kuykendall from Wells Fargo. Your question please. Speaker 100:44:05Hey, thanks. Good afternoon. Just 2 questions for you, Ross. Just wanna confirm to what extent other than the first quarter true-ups, have you embedded any additional true-ups over the balance of the year in the new guide? Then could you speak to the spike in accounts receivable in the first quarter, what's driving that? Thanks. Speaker 700:44:26Sure. With regard to the true-ups, yes. We do not include true-up revenue in the guide other than the historical, you know, kind of Q1 numbers we've already seen. You know, the out quarters, no, there's no true-up revenue embedded in that, in that guide. The change in the AR is, we entered into, you know, a number of contracts during, you know, Q1, some of which came in, you know, late Q1 as well, and we're not gonna get reimbursement for those until several months from now. Some of that new contracting drove about, you know, half of the increase in our, you know, AR this quarter or almost half of the increase in the AR. I would expect that will come down, you know, if not by the end of Q2, certainly by the end of Q3. Speaker 500:45:12It just depends on how rapidly these activities. Speaker 100:45:18Very helpful. Thank you. Speaker 600:45:21Thank you. Our next question comes from the line of Tycho Peterson from Jefferies. Your question please. Speaker 1100:45:28Hey. Love to dig into the 1Q volumes a bit. You know, you called out an increase in active ordering providers last quarter. Could you maybe just touch on, you know, how much of the volume contributions this quarter came from new providers versus repeat orders from previously integrated providers? Speaker 500:45:43Thank you, Tycho, for the question. We have seen a very similar number of newly active ordering providers that we added in this quarter compared to all the previous quarters. We haven't seen any difference. Really, the difference between test volume increases between quarters is primarily due to the number of accessioning days in the quarter and when those providers essentially become active, you know, throughout the quarter. We haven't actually seen, you know, any difference between Q4 and Q1. It is just that Q4 tends to be seasonally slow for us due to the number of accessioning days and the holidays in the quarter, which artificially decreases the test volume. Speaker 1100:46:34Okay. You know, I've had a couple on Unity Confirm. I guess I'm just wondering how you're thinking about share dynamics, you know, in the market today. There's obviously been some competitive, you know, launches as well. You know, what's your view of share dynamics today? Speaker 500:46:49You know, we are not really seeing a significant impact in the way that we are acquiring new providers, new accounts. The Unity Confirm, you know, granted it does create, you know, some noise, but just the fact that we have added a similar number of active ordering providers, newly active ordering providers in Q1 as well as Q4 as well as Q3, you know, similar to the previous quarters, really shows that, you know, our products are resonating with providers and we are executing well. Unity Confirm is another driver, another reason for providers to use our test. Speaker 500:47:32As opposed to, you know, some of our previous launches, in this particular case, you know, it is only accessible if a provider has ordered Unity Aneuploidy as a frontline screen, which we believe is going to, you know, position our test as a much more of a frontline usage in certain cases where they may be relying on our test as a second line in the past. You know, this certainly happens for instance with MFMs. Sometimes, you know, with our Unity Fetal Antigen NIPT, we would receive another Unity Aneuploidy Screen order even though frontline testing was, you know, another competitor's test or similarly, you know, we do receive tests where our Unity Aneuploidy Screen is being ordered because other tests were no calls or were incorrect results. Speaker 500:48:31In this particular case, we are only enabling Unity Confirm if our test has been used as a frontline test, which essentially means that it will be an important driver of test volume. Speaker 1100:48:45Okay. last one, understanding the timelines for MolDX on Northstar Response. You know, we hear a lot about potential delays of MolDX and, you know, longer times to turn to applicants. I guess, you know, what's the risk it gets pushed into next year? Speaker 500:49:01We are not seeing any issues with MolDX. They are responding within their stated timelines, which is 60 days. It was a very productive, you know, back and forth with MolDX. We do not anticipate any potential for delay. It might even potentially be slightly earlier than we originally anticipated. Speaker 1100:49:30Okay. Thank you. Speaker 600:49:33Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Oguzhan Atay for any further remarks. Speaker 500:49:43Thank you, operator. Thank you all for joining today's conference call. We look forward to speaking with you on our next conference call in a few months. Have a good day. Speaker 600:49:54Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.Read morePowered by