BLLN

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 4:30 p.m. ET Investor Relations - David Deichler Chief Executive Officer - Oguzhan Atay Chief Financial Officer - Ross Taylor Operator: Good day, and thank you for standing by. Welcome to the $1 billion 01/2026 earnings call. At this time, participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. You will then hear an automated message device and your hand is raised. To withdraw your question, please press 11 again. Please be advised that this conference is being recorded. I would now like to turn the conference over to your speaker today, David Deichler, Investor Relations. Please go ahead. Oguzhan Atay: Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from $1 billion we have Oguzhan Atay, cofounder and chief executive officer and Ross Taylor, chief financial officer. Earlier today, BilliontoOne released financial results for the second quarter ended 06/30/2026. 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 may differ materially from those expressed or implied in any forward looking statements. The risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed annual report on 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, August 5, 2026. If this call is replayed or reviewed after today, the information made during this call may no longer contain current or accurate information. Billion to 1 disclaims any obligation to publicly update any forward looking statements whether because of new information, future events or otherwise, except as required by law. And with that, I will turn the call over to Ozan. Good afternoon, everyone. Thank you for joining our second quarter 26 earnings call. I would like to start by thanking our patients and providers. Who trust us with incredibly important health care decisions and our employees, who show up every day with tremendous effort to build and deliver superior tests. That improve our patients' care and remove the fear of the unknown. Before diving into our quarterly results, I would like to remind you of the 4 pillars that I believe make us a different category of molecular diagnostics company. The first pillar is our revolutionary technology platform, enabled by our patented QCT, quantitative counting template technology. Our technology achieves single molecule level and precision with next generation sequencing. This has allowed us to build unique category defining products in both prenatal and oncology. In turn, in our second pillar, our products have allowed us to scale rapidly, from zero to $438 million in annualized revenue run rate in 6 years. But we believe we are still in the early days, perhaps at less than 1% of what is possible. As we believe prenatal and oncology cell free DNA testing can exceed an estimated $100 billion in The United States alone. Importantly, in our third pillar, with the higher signal to noise advantage that our unique technology offers us, and with our relentless focus on COGS reductions and ASP growth, have been able to couple our rapid growth with a superior gross margin profile. We now have margins above 70%, with still significant room for expansion through ASP growth, and COGS per test reductions. Finally, this superior gross margin combined with a culture of fiscal discipline and efficient operations incorporating AI, has allowed us to achieve GAAP profitability. We have done this at a much lower scale than our public competitors, with an accumulated deficit that is approximately 10% of theirs. In summary, we continue to track toward our long term goal. Which has remained the same. To build a category defining generational company transform molecular diagnostics and the standard of care for millions of patients. And become a member of the S&P 500. Our second quarter performance was strong across all pillars. As we delivered another quarter with high growth, excellent margins and positive operating income and cash flow. I will cover each pillar in more detail. But to summarize, we are launching new products both in prenatal and oncology, and we have published data that we believe will support MolDX coverage for North Star response. Our rapid growth continued with test volume up 35% year over year and revenue up 64% year over year. We maintained our superior gross margin profile which was 70.5% in the quarter, an expansion of 5 percentage points year over year. Our gross margins stayed remarkably consistent in the past few quarters, despite an increase in COGS per test, as our mix shifts toward a higher proportion of oncology tests. And lastly, even as we accelerated our investments in commercial scale and R&D, We maintained a strong level of profitability. Achieving $5.5 million of GAAP operating income, a 5% operating margin and a remarkable 15% adjusted EBITDA margin. As a result, we increased our cash position to $549 million at the end of the quarter. Let me take you through the quarter pillar by pillar. Starting with our first pillar, our platform and products, In prenatal, UnityConfirm has seen strong adoption following the launch of May 28. As a reminder, it is the first and only non invasive confirmation assay for high risk pregnancies. It captures and sequences intact circulating fetal cells to provide 100% fetal fraction. A fundamentally different category from conventional cell free DNA tests. We launched it as a specialized follow on for high risk pregnancies identified on our Unity aneuploidy screen. Unity Confirm gives patients who cannot or choose not to proceed to invasive diagnostic testing a non invasive option they did not have before. At a sensitive time when options may feel limited. The early reception of UnityConfirm has been exceptional. Providers are already ordering Unity Confirm on more than 50 percent of their eligible high risk unity aneuploidy patients. We also continue to enroll patients in what we believe is the largest prospective circulating fetal cell based study ever conducted. In the meantime, Unity Confirm is opening doors even to no see health systems that typically do not allow any sales reps. We expect its long term impact for the Unity franchise to be significant especially as future readouts from the study mature, and it is established as the next paradigm in noninvasive testing. But our prenatal product engine did not stop there. On August 17, we are expanding our UNITY Fetal Antigen Screen to 130 genes. The largest panel on the market that does not rely on partner testing, by far, leapfrogging competitive offerings. Approximately 50% of all providers prefer large panels for these inherited conditions. So we believe that this expansion will meaningfully increase our service market. The panel screens for prevalent actionable conditions selected from ACOG ACMG, and RUST guidelines and it reinforces Unity's position as the leader in cell free DNA testing for recessive conditions. Turning to oncology, we generated important new clinical evidence this quarter. On June 24, we published a peer reviewed study in the Journal of Liquid Biopsy validating North Star response, for Monitoring Immunotherapy and immuno immunocombination therapy. This study included 142 patients and more than 570 samples across 2 prospective cohorts and 12 tumor types. Molecular progression strongly predicted worse survival. Notably, a stronger predictor than imaging alone, and stronger still when the 2 are combined. The test also separated radiographically stable patients into true responders, and nonresponders further demonstrating value over standard of care imaging. This publication is designed to support our pursuit of MolDX Medicare coverage for North Star response in the IO and IO combination therapy settings. Since response accounts for almost 2-thirds of our oncology test volume, this coverage remains 1 of our most meaningful catalysts. And is still expected by the end of this year. Speaking of catalysts, we remain on track for our highly sensitive tumor naive MRD launch by the end of the year as well. It is important to note that our liquid biopsy assays have a QC failure rate below 1 percent. Compared to 15 percent to 30 percent typical of assays that require tissue sequencing. We are also updating NorthStar Select on September 1, in 2 important ways. First, we are expanding the panel to 102 genes, to cover recent and upcoming FDA therapy approvals. Including the highly sensitive detection of MTAP copy number loss. MTAP loss is present in approximately 15 percent of all cancer patients. And is the target of several promising ongoing clinical trials. As we previously discussed, copy number losses are extremely difficult to detect in liquid biopsy. A problem that our technology resolves. Second, we are launching North Star Origin, a tissue of origin add on which we believe will deliver best-in-class performance. With higher call rates than any similar offering. Roughly 3 percent of patients present with cancer of unknown primary. Which results in a lack of effective therapy options. Moreover, the percentage of patients with uncertain diagnoses can reach 10 percent in community oncology settings, especially when they do not have access to detailed pathology workups. NorthStar Origin uses QCT based molecular counting of methylation. To deliver 91% top 386% top 1 accuracy in identifying the tissue of origin. Helping these patients get to a diagnosis and effective therapy. Turning to our second pillar, scalable rapid growth. In the second quarter, total test volume grew 35% year over year to approximately 196 thousand tests. Up approximately 8 thousand sequentially. Our growth was in line with our expectations for prenatal and above expectations for oncology. Importantly, we added approximately 70 sales representatives in the first half of the year. Ahead of our plan given the strength of our hiring pipeline. While this rate of hiring did have some impact, on our short term sales productivity, we expect our hiring to translate into faster growth exiting the year and into the early part of the next year. As these representatives become fully productive, and penetrate the health systems, especially as these health systems also become EMR integrated. Speaking of EMR integrations, we launched on Epic Aura platform in under 5 months, a record speed for any laboratory. To launch on Epic Aura. And completed our first Aura health system integration in just 2 weeks. From start to first test order. Epic Aura removes a critical barrier to health system adoption. It will still take time to convert health systems. Since each health systems IT team must slot our integration into a road map that is often 2 to 4 quarters out. But we expect the impact to be meaningful as we enter next year. Given how quickly our oncology tests are scaling, we also signed the lease for a dedicated 62 thousand square foot oncology production lab. Directly across from our existing Prenatal Production Lab in Union City, California. Design and build out are underway, with production expected by the end of 27 and the facility is designed to support oncology capacity of approximately 5 thousand tests per day over time. Looking at each product line, both prenatal and oncology contributed meaningfully to our growth. Prenatal revenue in the second quarter was $95.8 million up 56% year over year. Driven by strong commercial execution and rising ASPs. Oncology was even faster. With its revenue growing 176% year over year. Nearly 3 times, to $13.7 million an annualized revenue run rate of approximately $55 million. Our total revenue performance in the quarter demonstrates the remarkable growth we have delivered in the last 6 years. Rising from approximately 0 to $438 million in annualized run rate. Total revenue was 109 million in the quarter. Representing 64% year over year growth driven by strong year over year increase in both tests delivered up 35% and ASP up 21%. I would note that while reported revenue was only slightly up sequentially, that understates our underlying momentum. Excluding true up revenue, total revenue grew 8% sequentially quarter over quarter. The sustained level of growth continues to be an important part of our pillars. Moving to our third pillar, and starting with our ASPs. Overall, ASP increased 21% year over year to $551 per test. ASP did decline about $20 sequentially, but this is simply a result of true up timing. True up was $49 per test in the first quarter, versus $14 per test in the second quarter. Importantly, excluding the true ups impact ASVs increased $15 quarter over quarter. During the quarter, through a mutual agreement, we held more than $10 million of claims while waiting for the in network implementation of our codes by national payers. This had a temporary impact on cash collections, slightly impacted the ASPs that we could realize, and potentially reduced the true up revenue for the quarter. We expect this to resolve through the second half of the year as these claims are processed and paid. The more important underlying signal is this. Excluding true up, overall ASP continued to increase sequentially. Driven by a record number of payer contracts signed in the quarter. In addition to driving ASP growth, we have remained committed to our operating philosophy of continuous improvements. To reduce COGS per test. Overall COGS per test was $101 in the second quarter up from $152 in the first quarter and $156 a year ago. With the increase driven by the shift in our volume mix towards oncology. Underneath that mix effect, the operational discipline is very much intact. 10% quarter over quarter in oncology. As oncology continues to grow, faster than prenatal, we expect overall COGS per test to rise gradually over time. As a result, our gross margin held at 70.5% in the second quarter, approximately 5 percentage points higher year over year driven by higher ASPs even as our earlier stage lower margin oncology tests grew more than 100% during this same period. Importantly, small quarter over quarter difference in gross margin over the past 4 quarters are almost entirely attributable to quarterly true up differences. Excluding true up, our gross margin has been remarkably stable at around 70% even with the significant mix shift towards oncology. By continuing to drive ASP increases across both prenatal and oncology, and by continuing to reduce COGS in oncology, we expect to maintain strong gross margins at or above 70% even as oncology becomes a much bigger part of our overall business. With that, I will turn the call over to Ross to review our financial results and guidance. Ross Taylor Jr.: Before I conclude. Thank you, Ozan. As Ozan mentioned, in Q2 of 26, we had a strong performance that combined 64% year over year revenue growth with a 5% GAAP operating margin and a 15% adjusted EBITDA margin. Total revenue in the second quarter of 26 was $109 million compared to $66.6 million in the second quarter of 25, representing an increase of 64%. 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 56% to $95.8 million in Q2 Oncology revenues increased 176% to $13.7 million in Q2 of 26 versus Q2 of last year. Our 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 year over year. True up revenue was $2.8 million in the second quarter of 26, compared to $9.2 million in the first quarter of 26. And $2.1 million in the second quarter last year. Excluding true up revenue, total revenue grew 8% sequentially versus the first quarter of 26. Gross profit in the second quarter of 26 was $77.1 million compared to $43.5 million in the second quarter of 25. Resulting in a gross margin of 70.5% in the second quarter of 26 versus 65.3% in the second quarter last year. The increase in gross margin was primarily attributable to continued increases in our overall ASP. Total operating expenses were $71.6 million in second quarter of 26, compared to $45.1 million in the comparable prior year quarter. Representing an increase of 59%. Within total operating expenses, R&D expenses were $17.3 million in the second quarter of 26 compared to $11.8 million in the comparable prior year quarter. SG&A expenses were $54.3 million in the second quarter of 26 compared to $33.3 million in the comparable prior year quarter. Operating income was $5.5 million in the second quarter of 26, compared to an operating loss of $1.6 million in the second quarter of 25. Our Q2 operating profit margin was 5%, compared to the 16% operating margin we delivered in the first quarter of 26. Slightly over half of the difference in operating profit compared to Q1 was due to the difference in true up revenue between the 2 quarters, The remaining portion was driven by continued investment in our commercial and R&D organizations, as well as faster growth in oncology. Adjusted EBITDA in Q2 represented a 15% margin. Net income available to common shareholders was $8.1 million or $0.15 per diluted share in the second quarter of 26 compared to a net loss of $200 thousand for the same period in 2025. Looking at the cash flow statement for the second quarter, The cash flow from operations was $9.1 million capital expenditures were $4 million This resulted in free cash flow of $5.1 million in the second quarter of 26. We are well capitalized with a very healthy balance sheet. We ended the second quarter with $549 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. Finally, I will provide an update on our full year guidance for 2026. We are reiterating our 2026 total revenue outlook of $450 million to $465 million representing growth of approximately 48% to 52% compared to full year 2025. We also expect to operate the business such that it will continue to generate profitability similar to current levels even with significant continued investments. I will now turn the call back to Ozan to conclude. Oguzhan Atay: Thank you, Ross. In summary, we are transforming health care 1 molecule at a time 1 patient at a time. My confidence, as always, is rooted not in any single element. But in the compounding nature of what we have built. Each product we launch makes our platform more powerful. From Unity Confirm to our expanded fetal risk screen to NorthStar Origin. And each study we publish further validates the clinical utility of our technology as our North Star Response publication did this quarter. Our financial profile remains best in class for our industry. Once again, this quarter, we demonstrated strong revenue growth to $438 million in annualized run rate. We held gross margins above 70%. And we show that rapid growth does not have to come at the expense of profitability. We 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. Our ambition remains clear. To transform molecular diagnostics build a category defining company, and earn a place in the S and P 500. We are pleased with our progress and look forward to updating you as the year progresses. Thank you, Over to the operator. Operator: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press 11 on your telephone. If your question has been answered, you wish to remove yourself from the queue. Our first question comes from Mark Massaro with BTIG. Your line is open. Mark Massaro: Hey, guys. Thank you for taking the questions. Maybe the first 1, obviously, it looks like the true up number dropped by approximately 6 million or so, In Q2 relative to Q1. I guess, Ozan and Ross, I just wanted to check if x true ups just double checking that your prenatal test revenue would have increased sequentially. Is that correct? Oguzhan Atay: That is correct, Mark. Both test volumes and ASPs for prenatal true up actually increased, so the combination increased significantly as well. Ross, do you want to comment on the actual numbers? Ross Taylor Jr.: Well, the actuals on the prenatal revenue, Yeah. Prenatal revenue. You know, honestly, Mark, you can assume that you know, virtually all of the true up is related to prenatal. We do have a chart in, I guess, slide 14 in the deck where I think you can make some pretty good estimates as to where the prenatal revenue is x true up. So I do not have the actual numbers right in front of me, and we have not given out those specifics in the past. But it is up, you know, more than a couple million dollars, you know, sequentially, you know, ex true up. Yeah. Okay. Mark Massaro: And then, I do understand you guys operate in a competitive market. There are many other players operating in the space. I know you have been taking share for years now. I guess, can you just speak to what you might be seeing in the competitive market And then related to that, my last question, you did accelerate hiring of sales reps, it sounds like, relative to your plan. Just curious if any of those stepped up hires might have something to do with the competitive environment. Oguzhan Atay: So, second quarter volumes were almost entirely as we expected in the quarter, Mark. You know, we did grow as much as we expected in prenatal, and slightly above expectations in oncology with respect to test volume. We were not doing the hiring due to the competitive environment, but all actually due to continued opportunity that we have, especially with respect to health systems. You know, we are managing the business, for more medium to long term growth. And you know, there are maybe about 4 factors that we believe that will come together in the next 2 to 4 quarters that will really drive significant growth in prenatal. You know, the hiring of sales reps is 1, but, of course, that takes time for them to be onboarded and be productive and start penetrating health systems. You know, just as we onboard these sales reps, Unity Confirm to confirm is opening up doors to no see health systems. And, you know, we believe that will be further accelerated with more data readouts that we will have, you know, in the next 2 to 3 quarters. Third, you know, we completed the onboarding to Epic Aura platform, you know, faster than any other lab. And that will, you know, take 2 to 4 quarters to see a significant impact but we are executing extremely well there. Now finally, I want to really underline the importance of the 130-gene UNITY Fetal Antigen Screen launch. You know, this is going to be a significant competitive advantage but it will make an even bigger impact in health systems where they want to portfolio of offerings, including these large panels. So we really believe, like, these 4 factors are going to come together in the next 2 to 4 quarters to create a-- really an engine of health system adoption that can drive substantial volume growth And, you know, what we are really doing in the first half of the year is to you know, with the hiring pipeline that, you know, we have been able to generate post-going public. You know, we have accelerated hiring so that all of these reps are joining and getting onboarded at the right time so that as all of these opportunities are coming together, we have a really strong, chance of, converting these test volumes from health systems. Yeah. Ross Taylor Jr.: Maybe just a quick follow-up, Mark. I did look up some of the numbers to try to answer the earlier part of your question, and I am not gonna get overly specific, but I think you know, quarter to quarter, we did see about a $4.5 million increase in prenatal revenues. If you exclude the true up, you know, it is about 5% growth sequentially. Just to get a little more specific. Mark Massaro: that is really helpful. Alright. Thanks, guys. Operator: 1 moment for our next question. Our next question comes from Daniel Arias with Stifel. Your line is open. Daniel Arias: Oguzhan, I think you alluded a little bit to the volume trend there. Can you maybe just put some additional color to the trend sequentially in oncology if you strip out the ASP dynamic To what degree was quarterly volume up as a trajectory, and then how should we think about things for the second half of the year relative to the way that maybe you were thinking about things earlier in the year? Oguzhan Atay: So ASPs for oncology actually did not change in quarter over quarter. You know, we are we are you know, we are waiting and working on the Moldex cover of response. So until that happens, ASPs are pretty stable in oncology. And if you look at the chart that Ross referred to, true up for oncology was both quarters was almost you know, very minimal as well. So all of the growth that you are seeing, see, sequentially is coming from the test volume growth in oncology. So oncology test volumes are doing really well, you know, even ahead of our expectations. And that is 1 of the you know, reasons that we have we have started to build this oncology lab to you know, I think we are we are seeing that we are winning in the market with the products that we have, and as we are adding more competitive components to our oncology products, you know, we are very confident on the trajectory. Daniel Arias: Do you think that trajectory will lead to sequentially up volumes each quarter? I mean, 4Q can be a little bit of a funky quarter. And but you do sound like you have good momentum. So not to put too fine of a point on it, but I am just curious whether 2Q to 3Q can be up and then 3Q to 4Q can be up as well for that we model this thing correctly. Thank you. Oguzhan Atay: Yeah. I think, you know, we certainly see very strong momentum. And as you mentioned, Mark to April tends to be a little bit of a-- in terms of number of providers that we add, it tends to be a strong quarter. But in terms of the number of accessioning days and how the test volumes and revenues translate, you know, it tends to be a little bit of a shorter quarter, but we are we are seeing that our oncology is progressing ahead of the plan. Okay. Thank you. Operator: 1 moment for our next question. Our next question comes from Subhalaxmi Nambi with Guggenheim. Your line is open. Analyst: Hi, this is Ricky on for Subhalaxmi. Thanks for taking our questions. So you gave some color on the Unity Confirm launch and adoption and the 50% opt in for the eligible results. While it is still early in the launch, do you think that is already starting to drive share gains in NIPT? Oguzhan Atay: I think it is certainly opening up doors, and it is reducing the tendency for at least some accounts to split. You know, I think it is rare for prenatal clinics to split their test volumes over multiple labs, but Unity Confirm does prevent that splitting, I think, more significantly. But I think it is going to be a long term driver rather than a much shorter term driver, particularly because a lot of the remaining opportunities are health systems, and they do not get onboarded within 1 or 2 months. You need to confirm launched on May 28, and it is already seeing strong adoption, and it is already getting us you know, through the door in these health systems. But these health systems require, you know, many other things like EMR, before they can switch to another lab. And is why, you know, we are really confident that all of these factors are coming in together to drive an acceleration of growth, especially, as you look to growth next year. Got it. that is helpful. And you also announced the expanded 130-gene fetal risk screen panel Just wondering if there is any change to how you are thinking about the economics per test there, either in terms of reimbursement or the COGS? Thanks. We do not expect much of a difference in the economics with respect to the 130-gene panel. it is not going to be immediately a large portion of our test volume either, but I think it is going to enable us to get into some of these health systems and other places that strongly prefer the existence of a large panel And because this is the only large panel with the cell free DNA offering, I think it is going to be a big competitive advantage for us. Thank you. Operator: 1 moment for our next question. Our next question comes from Tycho Peterson with Jefferies. Your line is open. Noah Kava: Hi. This is Noah Kava on for Tycho. Thanks for taking our questions. I want to ask on the North Star Origin announcement today. What percentage of your patient base, say, you think is, you know, relevant for potential attach here? And are you assuming that the economics pad here over the next couple of quarters? Oguzhan Atay: So NorthStar Origin will not necessarily change the economics of the product that much. But it is going to, I think, drive incremental adoption of our product. In particular, you know, this has been an increasingly important point of discussion with providers that we are seeing So it is, I think, very it is becoming very important especially in community oncology settings where the percentage of CUP cases is not 3%. So CUP cases, the truly unknown primary case is about 3 percent. And, you know, that can be an important reason for some of the oncologists to prefer 1 platform over others. But we are also seeing that in the community oncology settings, this problem is more than a 3 percent problem, especially as they do not have access to always pathology workups And there, you know, 1 in 10 patients might actually have an uncertain diagnosis. And that really makes next steps very difficult for these patients. So I do not think it will change the economics but it will be another driver of adoption, you know, similar to what we have seen so far with our, CH, chip sequencing as well as the PGX offerings that we launched in the first quarter. Noah Kava: Thanks. And for my follow-up here, 1 of your competitors noted incremental payer friction in prenatal testing, more so on the carrier screening side of things. Curious if there is, you know, anything you can comment on there, if you are seeing any friction there. Oguzhan Atay: We are not seeing any friction there, but this is also because we have been, I think, very intentional about how we went about coding in this particular field. You know, we bill almost you know, vast majority of our tests. Using the PLA codes that we have obtained. Rather than relying on some of the you know, bundled or stacked billing, that tends to be more common. And, this is something that, you know, we have observed, especially with some of the national payers, you know, requiring these panels not to be unbundled and built with separate codes, but, you know, we were able to get our PLA code effective January 2025. So we do not have the problem that I think some of the other prenatal testing companies might have with respect to friction. Operator: 1 moment for our next question. Our next question comes from David Westenberg with Piper Sandler. Your line is open. David Westenberg: So I wanted to ask, if you look year-over-year,, you actually on Slide 14, and thanks, that is a lot of data. I think Ross mentioned $4.5 million sequentially revenue. If you look over year over year, it looks like the same. I am just kind of curious. You know, I know Deterra reports seasonality in Q2. I know, traditionally, you guys said you have not seen it. But, you know, you were a lot smaller percentage of the market. So do you think you might have additional seasonality in Q2 in non-cfDNA testing and that, you know, maybe would follow the same exact trends where you would see, you know, Q3 and Q4 potentially doing better. Oguzhan Atay: So, certainly, there are fewer patients that are getting tested in the accounts that we already have. So there is, I think, certainly a small impact with respect to seasonality. We do not model that seasonality, and we were able to be ahead of our plan even with that seasonality. And we did not know, want to refer to seasonality in a quarter where we were able to be you know, at or ahead of, you know, what we had modeled without the seasonality. But it is certainly true. You know, if you look at the number of you know, pregnancies and births or even the number of tests that you get from a count that you know you are getting 100% of the test volume, there is a drop in Q2 in terms of the test volume. So there is that seasonality, I think, is real. I think the effect tends to be relatively small. But if as I think as you pointed out, as we get larger, there is certainly the seasonality can have a bigger impact. We did not want to refer to it because, you know, we did not model it that way. Got it. Okay. David Westenberg: And then I just want to talk about the disclosed claims of 10 million I think, pending in Q2 in-network by National payers that you suppressed up your true ups. Can you help us bridge once those specific claims are processed, how does that $10 million flow through? And then, you know, I just wanna make sure a clarification. I think it is you know, always been the case, but you were not modeling true ups in the back half with your guidance. Correct? I just you know, I think that is been you know, how you have always done it, but just want to confirm. Thank you. Thank you guys so much. Ross Taylor Jr.: Ross, do you want to take the true up question, and then I will take the $10 million question? Yeah. that is correct regarding the, you know, true ups and our guidance. You know, David, we really are not including any true ups in our you know, kind of forward looking guidance here beyond what we have already reported. Oguzhan Atay: And with respect to the $10 million of health claims, While a portion of it is embedded in realized revenue, as we are required under ASC 6 zero 6. You know, we have been very conservative in how we approach this. And so there is meaningful upside if all these back claims are processed and paid. You know, we want to be conservative here. We do not yet know the full timing or amount of, you know, what will ultimately be collected on the claims held. So that is why we are maintaining guidance, you know, until that is clearer. Thank you. Operator: 1 moment for our next question. Our next question comes from Casey Woodring with JPMorgan. Your line is open. Casey Woodring: Maybe just 1, you talked a lot about launching on Aura in the quarter and that you have integrated faster than any other lab Is there a scenario where you can be fully integrated by the time we enter 2027? And you know, you talked about a meaningful impact next year. Maybe, like, any way to quantify you know, what the impact would look like from full integration in your base case? Thank you, Casey. Oguzhan Atay: We are fully integrated with Epic Aura. The issue is that even after the full integration with Epic Aura, there is still work that each health system needs to do. To turn on their epic aura and make sure that, you know, everything goes back and forth correctly with respect to orders and test results. Typically, the time that the lab takes to integrate with each health system separately, like, uniquely, still tends to be you know, with many labs, 6 months or more. You know, that is what we heard in the field. We our integration have been lightning fast in comparison. You know, our first integrations have been, you know, 2 to 4 weeks, which is a record time even for, you know, these individual health system integrations. So we are using that to try to get these health systems to prioritize our integration and slot the kind of in individual integration into their road map but it can still be, you know, 2 to 4 quarters ahead. But as soon as we are green lighted, you know, we can do these integrations extremely fast. And, you know, once they are done, I think we see, you know, meaningful test volume growth. Just to give you a sense, you know, once a health system is onboarded, you know, each 1 can be anywhere between, you know, 1 thousand to 3 thousand tests per quarter. The issue tends to be you know, this tends to be a funnel. And, you know, the funnel really started you know, as of know, May or June. And, you know, as we are getting into their road maps, I think it is going to be slow initially, and it will, you know, accelerate you know, over time pretty significantly. You know, in terms of, you know, how much test volume that it is going to incrementally bring, that is very difficult to say because, again, it is not about our own teams and what they can do. It is how many health systems, you know, that we can convince to put our individual integration into their road map. Casey Woodring: I see. that is that is helpful. And then maybe just 1 on the gross margin profile. You know, you did 70 and a half. Percent here How should we think about that progression once response you know, is reimbursed? Kind of like what is the forward looking trajectory there once you are able to turn that on? Thank you. Oguzhan Atay: Thank you. that is a good question. The you know, 1 way to think about this is that we are really managing the business for balancing that growth and, you know, with gross margin and profitability. And, you know, even when response comes in, you know, with the MolDX coverage, we will be launching MRD at that time, and we are not going to be throttling the MRD test volume. So what that will mean is that as the response ASP goes up and as our oncology gross margins increase, you know, we will have dilutive gross margins that will be coming from that growth that we will see from MRD. So the way that you know, we are thinking about this is that if the business operates as planned and modeled, we expect to maintain 70% gross margin regardless of the mix or growth of oncology or lumpiness of the true up revenue, this is what we have seen in the last 4 quarters. Where the gross margin was 70% without true-up every quarter. You know, despite the really fast growth that we had in oncology. So I think, you know, we will continue to see that, and we will continue to, I think, manage the business to be above 70% gross margins by increasing ASPs in different product lines and reducing COGS, especially in oncology. That said, you know, an unexpected acceleration in oncology business, far beyond what we are modeling. Could even result in gross margins to be temporarily below 70%. I think the important thing here is that every product is designed to generate 70 to 80% gross margin in the long term, with scale and appropriate coverage. It is just that, you know, as some of our products that are more mature that get closer to 80% gross margin, we are building and launching new products that become dilutive to gross margin. The balance becomes, you know, something in the range of 70% gross margin. Understood. Thank you. Operator: And I am not showing any further questions at this time. And as such, this does conclude today's presentation. Thank you for your participation. You may now disconnect, and have a wonderful day. Before you buy stock in BillionToOne, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and BillionToOne wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $403,337!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,334,946!* Now, it’s worth noting Stock Advisor’s total average return is 958% — a market-crushing outperformance compared to 214% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 12, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends BillionToOne. The Motley Fool has a disclosure policy. BillionToOne (BLLN) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved GAAP profitability at a significantly lower scale than competitors, driven by a 70.5% gross margin profile and a culture of fiscal discipline incorporating AI. Performance was underpinned by the proprietary QCT technology platform, which enables single-molecule precision and high signal-to-noise ratios in both prenatal and oncology settings. Revenue growth of 64% year-over-year was fueled by a 35% increase in test volume and a 21% expansion in Average Selling Price (ASP). Oncology revenue grew 176% year-over-year, representing a strategic mix shift toward higher-value liquid biopsy testing despite higher initial COGS per test. Management attributed the sequential revenue stability to a lower 'true-up' revenue contribution in Q2 compared to Q1, noting that underlying core revenue grew 8% sequentially. The company intentionally held over $10 million in claims to wait for in-network implementation of codes by national payers, which temporarily impacted cash collections and realized ASPs. Reiterated full-year 2026 revenue guidance of $450 million to $465 million, assuming continued profitability and positive cash flow generation. Expects MolDX Medicare coverage for NorthStar Response by the end of 2026, which serves as a primary catalyst for oncology ASP expansion. Anticipates a highly sensitive tumor-naive MRD (Minimal Residual Disease) product launch by year-end to further expand the oncology portfolio. Projecting accelerated health system adoption in 2027 as Epic Aura integrations move through 2-4 quarter implementation roadmaps at individual institutions. Management aims to maintain gross margins at or above 70% by balancing ASP growth in mature products against the dilutive effects of scaling new oncology tests. Signed a lease for a 62,000 square foot dedicated oncology production lab to support a future capacity of 5,000 tests per day by late 2027. Accelerated sales force hiring by adding 70 representatives in the first half of the year, which impacted short-term productivity but is expected to drive growth exiting 2026. Launched UnityConfirm, the first non-invasive confirmation assay for high-risk pregnancies, which is already seeing a 50% opt-in rate among eligible patients. Expanding the UNITY Fetal Antigen Screen to 130 genes on August 17 to capture the approximately 50% of providers who prefer large-panel inherited condition screening. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that accelerated hiring was not a defensive move against competitors but a proactive strategy to capture health system opportunities. The new hires are timed to coincide with the Epic Aura integration and the launch of the 130-gene panel to maximize conversion of large institutional accounts. Oncology volumes are progressing ahead of internal plans, with sequential growth expected to continue despite typical Q4 calendar fluctuations. Management noted that oncology ASPs remain stable for now as they await the meaningful catalyst of MolDX coverage. Management stated they are not experiencing the 'payer friction' reported by competitors because they utilize specific PLA codes rather than 'stacked' or unbundled billing. This intentional coding strategy, effective since January 2025, has insulated the company from recent national payer scrutiny on panel testing. Management expects to hold the 70% margin floor even as oncology grows, though an 'unexpected acceleration' in oncology could cause a temporary dip below that level. Long-term targets for all products remain in the 70% to 80% range as they achieve scale and full reimbursement coverage.

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. BillionToOne (BLLN) is back in focus after its August 5 update, when the company reported second quarter 2026 results and reaffirmed its full-year revenue outlook in the mid US$400 million range. See our latest analysis for BillionToOne. The recent earnings beat and reiterated 2026 revenue guidance have been met with strong buying interest, with BillionToOne’s share price return of 61.4% over 90 days and 68.0% year to date signaling firm positive momentum. If BillionToOne’s move has caught your attention, this can be a good moment to see what else is gaining traction in healthcare diagnostics and AI, starting with 42 healthcare AI stocks. BillionToOne now has strong reported growth, profitability and a fast rising share price on the table. The next step is to ask whether that recent excitement already captures the value on offer or leaves room for more. At a last close of $149.97 compared with a narrative fair value of $122.14, BillionToOne is priced above the level implied by the most followed story on the stock, which leans heavily on oncology and prenatal testing growth assumptions. Read the complete narrative. Analysts behind this BillionToOne narrative are incorporating expectations of faster scaling of test volumes, rising profitability and a rich future earnings multiple. This raises the question of which specific revenue and margin paths would need to align to support that fair value story. Result: Fair Value of $122.14 (OVERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, BillionToOne’s story can change quickly if larger prenatal competitors win key accounts or if future Medicare and MolDX coverage decisions for Northstar products disappoint. Find out about the key risks to this BillionToOne narrative. The first narrative leans on earnings and analyst targets and concludes BillionToOne looks 22.8% overvalued at $149.97 versus a $122.14 fair value. Our DCF model arrives at a fair value of $198.02, which implies the current price trades at a 24.3% discount instead. Which set of assumptions feels more realistic to you? Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out BillionToOne for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 51 high quality undervalued stocks. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. With BillionToOne drawing mixed signals on value, this is a moment to look at the data directly and move quickly to shape your own view with 3 key rewards and 1 important warning sign. If BillionToOne has sharpened your appetite for opportunities, do not stop here. Use the Simply Wall St screener to uncover fresh, data driven stocks worth a closer look. Scan for quality at a discount and see which companies currently sit in the 51 high quality undervalued stocks before the crowd catches on. Strengthen your core holdings by focusing on financial resilience with the solid balance sheet and fundamentals stocks screener (50 results) while others overlook balance sheet strength. Hunt for overlooked opportunities by checking the screener containing 17 high quality undiscovered gems that combine solid fundamentals with lower profile market attention. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include BLLN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

This article first appeared on GuruFocus. Total Revenue: $109.4 million in Q2 2026, up 64% year-over-year. Prenatal Revenue: $95.8 million, up 56% year-over-year. Oncology Revenue: $13.7 million, up 176% year-over-year. Gross Margin: 70.5%, up 5 percentage points year-over-year. Operating Income: $5.5 million, with a 5% operating margin. Adjusted EBITDA Margin: 15%. Net Income: $8.1 million, or $0.15 per diluted share. Cash Flow: $9.1 million from operations; free cash flow of $5.1 million. Cash Position: $549 million in cash and equivalents at quarter end. Test Volume: Approximately 196,000 tests, up 35% year-over-year. Average Selling Price (ASP): $551 per test, up 21% year-over-year. COGS per Test: $161, up from $152 in Q1 2026. Full-Year 2026 Revenue Guidance: Reiterated at $450 million to $465 million. Warning! GuruFocus has detected 5 Warning Sign with BLLN. Is BLLN fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue grew 64% year-over-year to $109.4 million, with test volume up 35% and ASPs up 21%. Gross margin expanded to 70.5%, up 5 percentage points year-over-year, driven by higher ASPs. Achieved GAAP operating income of $5.5 million and a 15% adjusted EBITDA margin, with positive free cash flow of $5.1 million. Unity Confirm, the first non-invasive confirmation assay for high-risk pregnancies, saw strong adoption with providers ordering it on over 50% of eligible patients. Oncology revenue grew 176% year-over-year to $13.7 million, and the company is on track for MOLD-X coverage for Northstar Response and the launch of a tumor-naive MRD test by year-end. True-up revenue declined to $2.8 million in Q2 from $9.2 million in Q1, impacting reported revenue and operating margin sequentially. Overall COGS per test increased to $161 from $152 in Q1 due to a mix shift toward oncology, which has higher costs. The company held more than $10 million in claims pending in-network implementation by national payers, temporarily impacting cash collections and ASPs. Operating margin fell to 5% in Q2 from 16% in Q1, partly due to lower true-up revenue and increased investments in commercial and R&D. The accelerated hiring of 70 sales reps in the first half has had a short-term negative impact on sales productivity, with benefits expected only later in the year. Q: Can you confirm that prenatal test revenue increased sequentially when excluding true-up revenue, and can you provide more specific numbers on the growth? A: CFO Ross Taylor confirmed that virtually all true-up revenue is related to prenatal. Excluding true-ups, prenatal revenue increased by approximately $4.5 million sequentially, representing about 5% growth quarter-over-quarter. CEO Ozan Atay added that both test volumes and ASPs for prenatal increased on an ex-true-up basis. Q: Can you provide additional color on the sequential volume trend in oncology, and how should we think about the trajectory for the second half of the year? A: CEO Ozan Atay noted that oncology ASPs were flat quarter-over-quarter as the company awaits MolDX coverage for Northstar Response, meaning all sequential growth was driven by test volume, which is performing ahead of expectations. He confirmed strong momentum from Q2 to Q3, and while Q4 typically has fewer accessioning days, oncology is progressing ahead of plan. Q: Regarding the $10 million of claims held in Q2 while waiting for in-network implementation by national payers, how will this flow through once processed, and does guidance include true-ups in the back half? A: CFO Ross Taylor confirmed that guidance does not include any true-up revenue beyond what has already been reported. CEO Ozan Atay explained that while a portion of the $10 million is embedded in realized revenue under ASC 606, the company has been conservative in its approach. There is meaningful upside if these claims process and pay, but guidance is maintained until the timing and amount of collections are clearer. Q: Is there a scenario where you can be fully integrated with Epic Aura by 2027, and can you quantify the potential impact from full integration? A: CEO Ozan Atay clarified that while the company is fully integrated with Epic Aura, each health system must still slot the individual integration into their own IT roadmap, which can take two to four quarters. Once green-lighted, integrations are completed in two to four weeks, a record speed. Each onboarded health system can generate 1,000 to 3,000 tests per quarter, but quantifying the incremental volume is difficult as it depends on how many health systems prioritize the integration. Q: How should we think about the gross margin progression once Northstar Response is reimbursed under MolDX? A: CEO Ozan Atay stated that the company manages the business to maintain 70% gross margins regardless of mix or true-up lumpiness. Even with MolDX coverage for Response, the simultaneous launch of MRD will be dilutive to margins. The company expects to maintain gross margins above 70% through ASP increases and COGS reductions, though an unexpected acceleration in oncology could temporarily push margins below 70%. Q: Is Unity Confirm already starting to drive share gains in NIPT, and what is the impact of the expanded 130-gene panel on economics? A: CEO Ozan Atay noted that Unity Confirm is opening doors to no-see health systems and reducing account splitting, but it will be a longer-term driver as health systems require EMR integration before switching labs. Regarding the 130-gene panel, he stated there is no expected change in economics per test, but it will be a significant competitive advantage as it is the only large panel offering with cell-free DNA, helping penetrate health systems that prefer large panels. Q: What percentage of your patient base is relevant for Northstar Origin, and how should we think about the economics over the next couple of quarters? A: CEO Ozan Atay explained that while only about 3% of patients present with cancer of unknown primary, the percentage of patients with uncertain diagnoses can reach 10% in community oncology settings. Northstar Origin will not change the economics of the product much but will drive incremental adoption, similar to the CHIP sequencing and PGx offerings launched in Q1. Q: Have you seen any incremental payer friction in prenatal testing, particularly on the carrier screening side, as noted by a competitor? A: CEO Ozan Atay stated the company is not seeing friction because of its intentional approach to coding. BillionToOne bills the vast majority of tests using proprietary PLA codes obtained in January 2025, rather than relying on bundled or stacked billing, which has been a source of friction for other prenatal testing companies with national payers. Q: Given the seasonality that competitors report in Q2, do you expect to see similar trends with Q3 and Q4 potentially performing better? A: CEO Ozan Atay acknowledged that there is real seasonality in Q2 due to fewer pregnancies and births, which has a small impact on test volumes. While the company did not model seasonality and still met or exceeded its plan, he noted that as the company grows larger, seasonality could have a bigger impact on results. Q: You accelerated hiring of sales reps in the first half. Was this related to the competitive environment, and how should we think about the impact on growth? A: CEO Ozan Atay clarified that the accelerated hiring was not due to competition but rather to capitalize on the opportunity in health systems. He outlined four factors that will drive significant growth in the next two to four quarters: the onboarding of new sales reps, Unity Confirm opening doors to no-see health systems, Epic Aura integration, and the 130-gene fetal risk screen launch. The hiring was accelerated so reps would be productive as these opportunities converge. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

MENLO PARK, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today reported its financial results for the second quarter ended June 30, 2026 and reiterated guidance for full year 2026. Financial Highlights: Total revenue of $109.4 million in the second quarter of 2026, compared to $66.6 million in the second quarter of 2025, an increase of 64%. Prenatal clinical testing revenue was $94.2 million in the second quarter of 2026, an increase of 55% from the second quarter of 2025. Oncology clinical testing revenue was $13.7 million in the second quarter of 2026, 176% higher than the $4.9 million reported in the second quarter of 2025. Gross profit margin was 70% in the second quarter of 2026, compared to 65% in the second quarter of 2025, a 5 percentage-point increase year-over-year. 196,000 tests delivered in the second quarter of 2026, compared to 145,000 tests delivered in the second quarter of 2025, an increase of 35%. Income from operations of $5.5 million in the second quarter of 2026, compared to a $1.6 million operating loss in the second quarter of 2025. Free cash flow, defined as cash flow from operations minus capital expenditures, was $5.1 million in the second quarter of 2026. Reiterating 2026 full year revenue guidance to be in a range of $450 million to $465 million, which represents 48% to 52% growth over 2025. Expects to operate the business such that it will continue to generate profitability similar to current levels, even with significant continued investments. Recent Operating Highlights: Today, we announced the upcoming expansion of our Unity Fetal Risk Screen with the addition of a 130-gene panel, which is the largest single-gene NIPT panel available. Our expanded panel significantly broadens the addressable market for Unity and reinforces BillionToOne's position as the leader in cfDNA testing for recessive conditions. This expanded panel will be available commercially on August 17, 2026. Today, we announced the planned launch of Northstar Origin, an add-on tissue-of-origin feature for our Northstar Select test that can benefit patients with unknown or uncertain diagnoses. This feature will be available commercially on September 1, 2026. In June 2026, we announced the peer-reviewed data published in The Journal of Liquid Biopsy, in collaboration with Allegheny Health Network, demonstrating that Northstar Response was a stronger predictor of survival than standard-of-care imaging in patients with advanced solid tumors receiving immunotherapy or immunotherapy combination therapy. "Our second quarter demonstrated the durability of our model, with our differentiated technology platform, category-defining products, and disciplined execution driving continued growth and profitability," said Dr. Oguzhan Atay, Co-Founder and CEO of BillionToOne. "We grew revenue 64% year-over-year to a $438 million annualized run-rate while advancing our product roadmap with the launch of Unity Confirm and the upcoming launches of our expanded Fetal Risk Screen and Northstar Origin. We believe we are still in the earliest chapters of what our smNGS platform can achieve, and we remain relentlessly focused on transforming molecular diagnostics and healthcare.” Second Quarter 2026 Financial Results Total revenue was $109.4 million in the second quarter of 2026 compared to $66.6 million in the second quarter of 2025, an increase of 64%. The increase in total revenue was driven by a 35% increase in the number of total tests delivered and a 21% increase in Overall ASP. Both prenatal and oncology delivered strong test volume growth year-over-year. Gross profit was $77.1 million in the second quarter of 2026, compared to $43.5 million in the second quarter of 2025, representing a gross margin of 70% in the second quarter of 2026 and 65% in the second quarter of 2025. An increase in Overall ASP drove the improvement in gross profit margin compared to the second quarter of 2025. Overall cost-per-test increased slightly in the second quarter of 2026 compared to last year, as improvements in cost-per-test for both of our oncology products and for our prenatal products were offset by the faster growth of our oncology products, which have higher costs-per-test. Total operating expenses were $71.6 million in the second quarter of 2026, compared to $45.1 million in the second quarter of 2025 an increase of 59%. Income from operations was $5.5 million in the second quarter of 2026, compared to a loss from operations of $1.6 million in the second quarter of 2025. Operating margin was 5% in the second quarter of 2026. Net income in the second quarter of 2026 was $8.1 million, or $0.15 per diluted share, compared to a net loss of $0.2 million, or $(0.02) per diluted share, in the second quarter of 2025. Financial Outlook BillionToOne continues to expect full year 2026 total revenue of $450.0 million to $465.0 million, representing growth of 48% to 52% compared to full year 2025. BillionToOne also expects to operate the business such that it will continue to generate profitability similar to current levels, even with significant continued investments. Webcast and Conference Call Information BillionToOne will host a conference call today, August 5, 2026, at 1:30pm Pacific Time / 4:30pm Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event for interested listeners can be accessed at https://investors.billiontoone.com/. About BillionToOne Headquartered in Menlo Park, California, BillionToOne is a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company's patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of federal securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements in this press release include, but are not limited to, statements regarding revenue, income and other financial information for the full year of 2026. These statements are based on management’s current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, some of which are beyond BillionToOne’s control. These and additional risks and uncertainties that could affect BillionToOne’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. These risks and uncertainties include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in BillionToOne’s most recently filed quarterly report on Form 10-Q, the annual report on Form 10-K and other filings BillionToOne makes with the Securities and Exchange Commission from time to time. The forward-looking statements in this press release are based on information available to BillionToOne as of the date hereof, and BillionToOne disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing BillionToOne’s views as of any date subsequent to the date of this press release. Non-GAAP financial measures We use certain non-GAAP financial measures to supplement our unaudited financial results, which are presented in accordance with GAAP. These non-GAAP financial measures include EBITDA, adjusted EBITDA and free cash flow. By excluding the impact of certain items that we believe do not directly reflect our underlying operations, we are of the opinion that EBITDA, adjusted EBITDA and free cash flow provide meaningful supplemental information regarding our performance. Accordingly, we believe these non-GAAP financial measures are useful to investors and others because they allow for additional information with respect to financial measures used by management in its financial and operational decision-making and forecasting. These metrics also provide investors and other users of our financial information with additional tools to compare business performance across companies and periods, while eliminating the effects of items that may vary for different companies for reasons unrelated to core operating performance. However, there are a number of limitations related to the use of non-GAAP financial measures, and these non-GAAP measures should be considered in addition to, not as a substitute for or in isolation from, our financial results prepared in accordance with GAAP. Other companies, including companies in our industry, may calculate these non-GAAP financial measures differently or not at all, which reduces their usefulness as comparative measures. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables. A reconciliation of the forecasted range for adjusted EBITDA for the full year 2026 is not included in this release due to the number of variables in the projected range and because we are currently unable to quantify accurately certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation. EBITDA We define EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, and depreciation and amortization expense. Adjusted EBITDA We define Adjusted EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, depreciation and amortization expense, and certain other items which include significant non-cash items events that are highly variable, significant in size, and that we do not believe are indicative of ongoing or future business operations, which include: stock-based compensation expense; change in fair value of term loan; and change in fair value of warrant liabilities. Free Cash Flow We define Free Cash Flow as net cash provided by operating activities adjusted for purchases of property and equipment. Investor [email protected] Media [email protected]

Interested in Billiontoone, Inc.? Here are five stocks we like better. Billiontoone’s Q2 revenue surged 64% year over year to $109.4 million, driven by a 35% increase in test volume and a 21% rise in average selling price. The company achieved $5.5 million in operating income, $5.1 million in free cash flow and a 70.5% gross margin. Prenatal revenue rose 56% to $95.8 million, while oncology revenue jumped 176% to $13.7 million. More than $10 million in claims is awaiting processing by national in-network payers, creating uncertainty around the timing of collections and true-up revenue. Management reiterated its 2026 revenue forecast of $450 million to $465 million and expects profitability to continue while investing in sales and research. Product and coverage catalysts include expanded prenatal and oncology panels, a planned tumor-naive MRD launch by year-end, and an expected MolDX Medicare coverage decision for Northstar Response. Billiontoone (NASDAQ:BLLN) reported second-quarter 2026 revenue growth of 64% year over year, driven by higher testing volumes and average selling prices across its prenatal and oncology businesses. The molecular diagnostics company also posted positive operating income and free cash flow while reiterating its full-year revenue outlook. Total revenue for the quarter ended June 30 was $109.4 million, compared with $66.6 million a year earlier. Test volume increased 35% to approximately 196,000 tests, while overall average selling price rose 21% year over year to $551 per test. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Chief Executive Officer Oguzhan Atay said the company’s annualized revenue run rate reached $438 million, while its gross margin remained above 70% despite the increasing contribution of oncology testing. Gross profit rose to $77.1 million from $43.5 million in the prior-year quarter, and gross margin expanded to 70.5% from 65.3%. The company attributed the increase primarily to higher average selling prices. → 3 Drone Stocks That Should Soar After the Summer Slump Operating expenses increased 59% to $71.6 million, including research and development expense of $17.3 million and selling, general and administrative expense of $54.3 million. Still, Billiontoone generated operating income of $5.5 million, compared with an operating loss of $1.6 million a year earlier. Its GAAP operating margin was 5%. Net income available to common shareholders was $8.1 million, or $0.15 per diluted share, compared with a net loss of $0.2 million in the second quarter of 2025. Adjusted EBITDA margin was 15%, according to Chief Financial Officer Ross Taylor. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Cash flow from operations totaled $9.1 million, while capital expenditures were $4 million, resulting in free cash flow of $5.1 million. The company ended the quarter with $549 million in cash and equivalents. Prenatal revenue increased 56% year over year to $95.8 million, supported by commercial execution and rising average selling prices. Oncology revenue grew 176% to $13.7 million, representing an annualized run rate of roughly $55 million. The company said reported revenue was only slightly higher sequentially due to the timing of revenue true-ups. True-up revenue was $2.8 million in the second quarter, compared with $9.2 million in the first quarter. Excluding true-up revenue, total revenue increased 8% sequentially. Atay said the company held more than $10 million in claims during the quarter while awaiting implementation of its codes by national in-network payers. He said the move temporarily affected cash collections, realized average selling prices and potentially true-up revenue. Billiontoone expects the claims to be processed during the second half of the year, but said it was maintaining its guidance until the ultimate timing and amount of collections are clearer. Cost of goods sold per test was $161, up from $152 in the first quarter, largely because oncology testing represented a greater portion of volume. However, the company said prenatal cost of goods sold was roughly flat sequentially, while oncology cost of goods sold declined by more than 10% sequentially. Management said it expects overall cost of goods sold per test to rise gradually as oncology grows faster than prenatal, but intends to maintain gross margins at or above 70% through pricing improvements and further oncology cost reductions. Billiontoone launched Unity Confirm on May 28 as a noninvasive follow-on assay for high-risk pregnancies identified through its Unity aneuploidy screen. The test captures and sequences circulating fetal cells. Atay said providers were ordering Unity Confirm for more than 50% of eligible high-risk Unity aneuploidy patients. The company plans to expand its Unity Fetal Risk Screen to 130 genes on Aug. 17. Management said it expects the larger panel to broaden its addressable market, particularly among health systems and providers that prefer larger inherited-condition panels. In oncology, Billiontoone published a peer-reviewed study in the Journal of Liquid Biopsy evaluating Northstar Response for monitoring immunotherapy and immunotherapy-combination treatments. The study included 142 patients, more than 750 samples, two prospective cohorts and 12 tumor types. According to Atay, the study found molecular progression was a stronger predictor of worse survival than imaging alone, with the combination of molecular testing and imaging providing greater predictive value. The company said the publication is intended to support its pursuit of MolDX Medicare coverage for Northstar Response in immunotherapy settings. Management continues to expect a coverage decision by year-end. The company also said it remains on track to launch a tumor-naive minimal residual disease test by the end of 2026. On Sept. 1, it plans to expand its Northstar Select panel to 102 genes and introduce Northstar Origin, a tissue-of-origin add-on. Management said Northstar Origin demonstrated 91% top-three accuracy and 86% top-one accuracy in identifying tissue of origin. Billiontoone added approximately 70 sales representatives in the first half of 2026, ahead of its prior hiring plan. Atay said the expanded commercial team should support growth as representatives become productive and as the company pursues health-system accounts. The company also launched on Epic Aura and completed its first health-system integration in two weeks from the start of integration to the first test order. While individual health systems may take two to four quarters to place integrations on their information-technology roadmaps, management expects the impact to become more meaningful next year. Billiontoone signed a lease for a 62,000-square-foot dedicated oncology production laboratory in Union City, California. The facility is expected to begin production by the end of 2027 and is designed to support capacity of about 5,000 oncology tests per day over time. The company reiterated its 2026 revenue outlook of $450 million to $465 million, representing projected growth of approximately 48% to 52% from 2025. Taylor said Billiontoone expects to sustain profitability at levels similar to current performance while continuing to invest in commercial operations and research and development. BillionToOne (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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Billiontoone Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.