BillionToOne, Inc. Q1 FY2026 earnings call

• Four pillars of the company: revolutionary technology platform, scalable rapid growth, superior gross margin profile, fiscal discipline and efficient operations. • Launched Unity Confirm, a noninvasive confirmation assay for high-risk pregnancies. • Test volume grew 44% year over year, total revenue grew 84% year over year. • Entered into contract with Anthem, bringing total contracted lives to 300 million in the U.S. • Continued to invest in sales force, new product launches, and clinical evidence generation.

Prenatal revenue in Q1 2026 was $97.7 million, up 72% year over year. Oncology revenue was $10.7 million in Q1 2026, nearly five times over last year with an annualized revenue run rate of $43 million. Overall ASP increased to $571 per test, a 28% year-over-year increase. COGS per test was $153 in Q1, down 5% sequentially and only 1% higher year over year. Gross margins were 73% in Q1, a nine percentage point year-over-year increase from 64% in 2025.

• Raised 2026 total revenue outlook to a range of $445 million to $465 million, up from previous range of $425 million to $445 million. • Expect 70% or better gross margin over the course of 2026. • Guidance increase driven by strength in Q1 and expected ASP lift from additional payer contracts. • Q4 is seasonally slower for volume.

Q: 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? And then can you maybe just talk a little bit to volume cadence over the course of the rest of the year here?

A: Sure, Dan. As I made some reference to in my prepared remarks, the guidance increase came from the strength we had in Q1, 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. So not really assuming any increase in volume compared to our prior expectations other than the good results we saw in Q1, but primarily driven by lift in ASPs and again strong performance in Q1. Just in terms of cadence for volumes in the year, I think the only real remark I would make there is we typically have a slower Q4 due to seasonality around the holidays and other factors. Other than that, I would expect a little bit of sequential growth in Q2 and Q3, but Q4 is a seasonally slower quarter for us.

Q: And then maybe on the gross margins, the step up there was pretty notable. We do not really have a mid-70s number at all in our out-year forecast. So how sustainable is that as new products come into the portfolio? 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. So can you just maybe help us with that?

A: Sure. As mentioned during our remarks, we expect 70% or better gross margin over the course of the year. There could be a little bit of quarterly volatility in that, but I would expect 70% or better gross margin is something we can sustain for this calendar year.

Q: Congrats on the strong quarter. I wanted to ask about Unity Confirm. It seems like a pretty interesting novel product offering. Oguzhan, how do you size this market? So 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? And I think you are launching this later this month. Is this something that you expect to get expanded reimbursement coverage for as an add-on? And related to that, can you speak about the clinical trial that you are enrolling? How long do you think it will take to enroll the patients in the study?

A: Thank 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 the important part about Unity Confirm is that the patient is only able to get this test if they use Unity Aneuploidy. We 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, the patient only then will be eligible to get tested with Unity Confirm. Having this exclusive offering—noninvasive confirmation for these high-risk pregnancies—we believe that this is going to be another driver of volume, not in terms of the Unity Confirm volume alone, but because patients are only eligible for this if they used our Aneuploidy screening as a frontline screen to begin with. The timing for the clinical trial: it is a very large clinical trial, and invasive testing in the United States has significantly declined over time. There are not as many patients as there used to be getting invasive confirmation, which speaks to how critical this offering is and the clinical utility that it provides. But that also means that the timing of a very large clinical trial like this can easily take anywhere between one to three years.

Q: And just to confirm, will these patients be measured against both amnio and CVS?

A: The 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.

Q: Perfect. And then last question for me. Nice to see Anthem come online. I think United started on April 1, if you could confirm that. And what is the go-live date of Anthem?

A: United effective date was April 1. Anthem is already effective.

Q: I also wanted to ask on Unity Confirm. Can you maybe just sort of talk about the cell capture technology broadly? What does this technology mean to the entire prenatal genetics platform? And what are some of the future applications that this unlocks for you as you think years in advance?

A: Thank you, Andrew. This has been the holy grail of prenatal testing, something that people have been working on for the last 20 years. Capturing these cells is extremely difficult. When we think about cell-free DNA testing, about 5%–10% of the DNA is of fetal origin. When we think about these trophoblasts—these fetal cells—it is truly a one-in-a-billion type of cell type. It is a more labor-intensive and more difficult process, and that is why this is positioned for confirmation of high-risk cases rather than frontline testing. But as you can imagine, one of the really big limitations of cell-free DNA testing, especially as you go into rarer conditions, was the concern around PPVs. Having a noninvasive confirmation assay actually removes that concern. From a long-term perspective, I do not see cell-based methodology as a replacement of cell-free DNA methodology—both due to cost and the labor-intensive nature of Unity Confirm or any other cell-based methodology—but it can really solve the fundamental problem with cell-free DNA testing, which is this gap between screening and diagnostics that has been increasing over time. That can really enable cell-free DNA testing to be more comprehensive and more widely adopted as well.

Q: Then I just wanted to ask on capital allocation priorities. I think you called out maintaining profitability while still investing pretty heavily. So I assume cash should continue to grow from here. How should we think about you using cash and capital allocation from here?

A: As of right now, we do not have any specific plans about how to use the cash. We expect to maintain our profitability while investing in various different areas.

Q: You mentioned the MRD launch is on track. What is the next tangible catalyst we should look out for? And if it is data, do you know the forum you would share it on—either publication or conference?

A: We will launch MRD with data at the time of the launch. It is not going to be ahead of the launch; it is going to be at the time of launch. I do not know whether it is going to be at a specific conference. It might be essentially a manuscript that we release.

Q: Thank you for that. And just remind us, what is the Response versus Select ratio this quarter? And 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? Depending on that, what are you expecting exiting 2026, and how might this shape your view for next year ASPs?

A: We did not see any specific changes around coverage policies. We were able to get in network with more and more payers in Q1, and that is the primary contribution to our ASP growth right now. The Response versus Select ratio is similar; it is around two Response to one Select. Each physician uses differently. Some physicians are repeating Select and Response, so it is a one-to-one ratio. Other physicians are doing one Select and one Response to begin with, and then following up with two or three or four Response tests until they see progression, and at that point they are using a Select test. The blended average is staying at two Response to one Select, which really speaks to the value of Medicare coverage of a Response test for us. That is why we have been working diligently on that front.

Q: Hi. 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 Q1? Then your latest expectations for fully productive reps exiting the year? And if you have this by prenatal and oncology, that would be super helpful. And then just any other color on how the process of getting these reps fully ramped is progressing—taking more or less time compared to your initial expectations?

A: Thank you, Casey. The numbers that we shared in the March earnings call—we are approximately on track to those numbers. We are not going to share every quarter how many exactly ramped-up reps we have, but their productivity is staying within the expectations that we had from the past quarter.

Q: And then on oncology ASPs, it looked like those stepped down a touch sequentially. I am assuming this might have been on the NorthStar Select side, maybe from true-ups rolling off. So if you could give us more color on that. And then 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?

A: I believe the oncology ASPs, primarily excluding true-up, were very similar. True-up numbers change from quarter to quarter, and it can impact exactly what is being recognized. But there are no material changes in how our oncology tests are being paid. NorthStar Select has broad coverage and reimbursement, and NorthStar Response does not. We expect NorthStar Response ASP to be significantly higher once we have Medicare coverage of NorthStar Response, which we anticipate around the end of the year.

Q: Hi. This is Skye on for Dave. Thanks for taking the question. Maybe just on the health system pipeline, where does that stand today? Are health system-related adoptions still not embedded in the guide?

A: The health system adoption is something that we work on, but the timeline for health system adoptions can be very variable. So it is not directly embedded in the guide except for sales team territory growth expectations that are embedded as a standard in our projections.

Q: Got it. Okay. Thanks. And then next, just a little bit more color on how you see cancer monitoring over the next few years and timing on that?

A: You mean NorthStar Response–related adoption when you say cancer monitoring, or are you referring to more surveillance with respect to MRD?

Q: More surveillance with respect to MRD would be great.

A: Today, we do not have an MRD test, but we are working on building a tumor-naive MRD test. Our belief 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 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 by community oncologists who care for upwards of 80%+ of oncology lives in the United States. So, even though most of the adoption today is in colorectal and most is in academic centers, eventually the bigger adoption of MRD is going to be by community oncologists using tumor-naive tests, and that is why we spend a lot of our efforts around the tumor-naive aspect of our test, even though it is much easier to build a tumor-informed test. In fact, internally, we built a tumor-informed test that is ultra-sensitive just so that we can benchmark our tumor-naive test against it.

Q: Hey, thanks. Good afternoon. Just two questions for你, Ross. Just want to 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? And then could you speak to the spike in accounts receivable in the first quarter?

A: Sure. With regard to the true-ups, we do not include true-up revenue in the guide other than the historical Q1 numbers we have already seen. So for the out quarters, no, there is no true-up revenue embedded in that guide. The change in AR: we entered into a number of contracts in Q1, some of which came in late Q1 as well. We are not going to get reimbursement for those until several months from now, and some of that new contracting drove about half of the increase in our AR this quarter—or almost half of the increase in the AR. I would expect that will come down, if not by Q2, certainly by Q3. It just depends on how rapid these activities proceed.

Q: Hey, I would love to dig into the Q1 volumes a bit. You called out an increase in active ordering providers last quarter. Could you maybe touch on how much of the volume contribution this quarter came from new providers versus repeat orders from previously integrated providers?

A: Thank 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 previous quarters. We have not 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 become active throughout the quarter. Q4 tends to be seasonally slow for us; any difference between Q4 and Q1 is due to the number of accessioning days and the holidays in the quarter, which artificially decreases the test volume.

Q: And then, on Unity Confirm, I am just wondering how you are thinking about share dynamics in the market today. There have been competitive launches as well. What is your view of share dynamics today?

A: We are not seeing significant impact in the way that we are acquiring new providers and new accounts. Unity Confirm, granted, does create some noise, but the fact we have added a similar number of newly active ordering providers in Q1 as well as Q4—similar to previous quarters—really shows that our products are resonating with providers and we are executing well. Unity Confirm is another driver, another reason for providers to use our test. As opposed to some of our previous launches, this particular offering is only accessible if a provider has ordered Unity Aneuploidy as a frontline screen, which we believe is going to position our test much more as a frontline usage in certain cases where they may have relied on our test as a second line in the past. Sometimes, with our fetal antigen testing, we would receive another aneuploidy order even though frontline testing was another competitor's test, or we receive tests where our aneuploidy is being ordered because other tests were no-calls or were incorrect results. In this case, we are only enabling Unity Confirm if our test has been used as a frontline test, which means it will be an important driver of test volume.

Q: And then last one: understanding the timelines for MolDX on NorthStar Response. We hear a lot about potential delays with MolDX and longer times to turn new applicants. What is the risk it gets pushed into next year?

A: We are not seeing any issues with MolDX. They are responding within their stated timelines, which is 60 days, and it was a very productive back and forth with MolDX. We do not see potential for delay. It might even potentially be slightly earlier than we originally anticipated.