BillionToOne, Inc. (BLLN) Q4 2025 Earnings Report, Transcript and Summary

Thank you for standing by, and welcome to BillionToOne's Fourth Quarter and Full Year 2025 Earnings Conference Call. [Operator Instructions] I would now like to hand the call over to David Deuchler, Investor Relations. Please go ahead.

Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from BillionToOne, we have Oguzhan Atay, Co-Founder and Chief Executive Officer; and Ross Taylor, Chief Financial Officer. Earlier today, BillionToOne released financial results for the fourth quarter and full year ended December 31, 2025. A copy of the press release is available on the company's website. Before we begin, I want to remind you that during this call, we may make forward-looking statements within the meaning of federal securities laws. Such statements about future events may include statements about our financial outlook and performance, market size, our products and services, reimbursement coverage, future clinical performance and other similar statements. We caution you that such statements reflect our current best judgment, and actual results may differ materially from those expressed or implied in any forward-looking statements. Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed registration statement on Form S-1, our previously filed quarterly report on Form 10-Q, our annual report on Form 10-K 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, March 4, 2026. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. BillionToOne disclaims any obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise, except as required by law. And with that, I will turn the call over to Oguzhan.

Good afternoon, everyone. Thank you for joining our fourth quarter and full year 2025 earnings call. It has been a great year for BillionToOne. I want to begin by expressing how truly proud I am of what our team accomplished in 2025. This was the year we proved what disciplined and relentless execution can truly achieve. This year, we did not just march our 20 miles. We did so by going public during a government shutdown that had frozen IPO markets and delivered, in my view, one of the most remarkable annual financial results in the history of molecular diagnostics. Let's look at our metrics. Forget the Rule of 40. Our full year 2025 performance exceeded the Rule of 100. For the full year 2025, we achieved 100% year-over-year growth with an adjusted EBITDA margin of 13%, a positive GAAP operating margin and positive cash flow. Delivering an organic rule of 100 is rare for any public company. In molecular diagnostics, I believe it may be unprecedented. This revenue growth is driven by rapid increase in both test volume and ASPs. Our test volumes grew by 51% compared to full year 2024. Our ASP grew by 35%. At the same time, we continued to decrease our costs and became more efficient. Our COGS per test decreased by more than 10%, even as we built our oncology business and processed vastly more oncology tests that have higher COGS. As a result, our gross margins improved by 15 percentage points. And as we incorporated AI and automation across all our functions, we achieved an even more remarkable increase in productivity, 36 percentage point improvement in our GAAP operating margin. This was due to an incredible combination of outperformance across all our teams. Our extremely strong sales team overachieved our test volume targets. Our R&D team continued to innovate, launching multiple products, including 14-gene single-gene NIPT ahead of the competition and Response V2 with a 0.01% limit of detection. Our clinical affairs and market access teams obtained Medicare coverage for Northstar Select and signed 44 payer contracts, adding more than 25 million lives and reaching 250 million contracted lives in the United States. And last but not least, our prenatal medical affairs team changed the standard of care and medical guidelines with UNITY Fetal Antigen NIPT. Truly, the performance of every single team has been exceptional in 2025. This is just the beginning of our journey as a public company, and I am looking forward to 2026 and beyond. As you know, at BillionToOne, we have 4 pillars of differentiation that we believe set us apart as a different type of molecular diagnostics company. Everything that we do starts with our revolutionary technology platform. This platform is enabled by our patented QCT, Quantitative Counting Templates technology, which achieves single molecule level sensitivity and precision with next-generation sequencing. With our technology, we have built unique category-defining products in both prenatal and oncology. In prenatal, UNITY delivers comprehensive screening from a single blood draw, reshaping the field of noninvasive prenatal testing. In oncology, Northstar Select detects 50% more actionable variants compared to other liquid biopsies, while NorthStar Response gives oncologists a precise real-time read on how well a treatment is working. With these products, we have achieved exponential growth even as we reached $384 million in annualized revenue run rate in the fourth quarter. That said, we believe that we are just scratching the surface of what is possible. With our technology, we believe that we are uniquely positioned to address more than $100 billion in U.S. market opportunity over time. Moving on to our third pillar. BillionToOne has achieved a superior gross margin profile with margins reaching above 70% despite subscale ASPs, particularly in oncology and using only about 1/3 of our current lab capacity. Last but not least, I am perhaps most proud of our capital and operational efficiency, which enabled us to achieve GAAP profitability while growing at triple-digit rates, which I believe is an unprecedented feat in molecular diagnostics. This combination of growth and profitability speaks to the uniqueness of our technology, which enables lower COGS, differentiation of our product portfolio, which results in extremely high sales efficiency and our operational discipline. Our long-term goal remains the same: to build a category-defining business and enter the S&P 500. Our fourth quarter performance allowed us to continue making important strides towards this goal, and the results are simply stunning. In fact, our fourth quarter performance exceeded all our expectations, including the guidance we provided in December. Looking into the results pillar by pillar. First, since the end of the quarter, we have launched multiple products that further solidify our competitive advantage. In prenatal, we recently announced the dual launch of UNITY's expanded Red Blood Cell Fetal Antigen NIPT and first-and-only Platelet Fetal Antigen NIPT. In oncology, we launched Northstar PGx for pharmacogenomics and Northstar Select CH for clonal hematopoiesis. We also submitted a Northstar Response coverage dossier to MolDX, spanning 5 studies and 3 peer-reviewed publications. This is an exciting step toward gaining MolDX coverage for our Northstar Response test. With our differentiated products, we continue to see impressive rapid growth with Q4 achieving 113% year-over-year revenue growth. This remarkable growth, which accelerated even compared to the first half of the year, was driven by 47% year-over-year test volume growth and 47% year-over-year ASP growth. In our third pillar, as our ASPs increased and our COGS per test decreased, we expanded our gross margins by more than 14 percentage points year-over-year to 71.4% in the fourth quarter. Lastly, we maintained a strong profitability profile in the quarter with an impressive 11% GAAP operating margin and 19% adjusted EBITDA margin. We ended the year with a strong balance sheet of $496 million in cash and only about $50 million in term debt. Ross and I will expand on our quarterly financial results. But I'd like to first provide you with an update on our revolutionary technology platform and differentiated products. Starting with our first pillar, I am excited to announce that our current offering for Fetal Antigen NIPT is already changing the standard of care. As a reminder, our Fetal Antigen NIPT is the only test of its kind in the United States. It determines whether the fetus is positive or negative for various red blood cell antigens such as Kell when there is a risk of blood incompatibility between the mother and the fetus. This occurs when a pregnant mother produces antibodies against the red blood cell antigen that may or may not be present in the fetus. This is a hugely important and severe problem for the patients and maternal-fetal medicine specialists who manage them. These alloimmunized pregnancies are more common than aneuploidies and in the absence of our tests, MFMs typically have to do weekly monitoring and tests to manage these high-risk pregnancies. Our UNITY Fetal Antigen NIPT, by determining whether the fetus is negative for the antigen against which the pregnant mother is producing antibodies, eliminates the need for costly and time-consuming monitoring in fetal antigen negative pregnancies and removes the fear of the unknown for these patients. Importantly, in November, an expert committee of MFM key opinion leaders published a clinical practice guideline, and I believe its recommendations are stronger than any guidelines published in the cell-free DNA field for any tests in any setting. The committee wrote, and I quote, we recommend the use of cell-free fetal DNA to accurately determine the fetal red blood cell antigen status drawn after 10 weeks gestational age in pregnancies complicated by alloimmunization. And they further highlighted how reliable our results are by recommending that no further surveillance is needed for the remainder of the pregnancy after our NIPT determines that the fetus is negative. It is with this context that I am excited to announce that we recently expanded our Fetal Antigen NIPT and launched our first-and-only Platelet Fetal Antigen NIPT at the Society for Maternal-Fetal Medicine Conference in February. As I mentioned, for MFMs, this is one of the most important problems in prenatal care and the reception to our product launch was extremely positive. We had more than 100 physicians attend our dinner presentations across 3 venues during the conference, an absolute record for us for any conferences we have ever participated in, in addition to a conference presentation that was standing-room only with more than 100 additional attendees. With this dual launch, first, we expanded the antigens we detect for red blood cells, now covering 99% of antigens associated with Hemolytic Disease of the Fetus and Newborn or HDFN. In addition, we launched the first-and-only NIPT for platelet incompatibility addressing FNAIT. FNAIT is a severe condition that may lead to catastrophic fetal outcomes, including intracranial hemorrhage or fetal loss. These fetal antigen tests are available exclusively through our UNITY Aneuploidy Screen with no additional order or blood draw needed. This is a powerful demonstration of the depth of our smNGS platform. As I mentioned, these high-risk pregnancies are more common than aneuploidies, and we are excited about the clinical impact these expansions will have. We believe these tests have tremendous potential to help patients who would otherwise need weekly monitoring, testing, intervention and management by MFMs. In oncology, after the end of the quarter, we launched 2 important upgrades to Northstar Select, 2 add-on tests for pharmacogenomics and clonal hematopoiesis. The launch of these applications for Northstar Select expands our product to address 2 critical decision points in therapy selection. They also keep us aligned with evolving oncology treatment guidelines, information that is increasingly relevant to how oncologists select therapies. The PGx add-on provides pharmacogenomic insight into key variants for chemotherapy dosing. From the same blood sample and within the same 5-day average turnaround time, Northstar PGx can report a patient's predicted metabolizer status and associated clinical implications. This enables the physician to use the right dose for each patient, preventing severe toxicity, reducing hospitalizations and improving safety and quality of life. Northstar Select CH Addresses clonal hematopoiesis, the most common source of biological false positives in cell-free DNA testing. An incredible 25% of patients harbor at least 1 CH mutation in an actionable gene. These CH mutations are derived from white blood cells, not the tumor. In other words, they are biological false positives, and they can lead to the administration of ineffective therapies. Northstar Select CH combines targeted white blood cell sequencing for all guideline-recommended genes with proprietary machine learning classification for all other genes, achieving greater than 99% accuracy in distinguishing tumor-derived alterations from non-tumor findings. We believe that Northstar Select CH is highly differentiated from other offerings as it delivers more accurate, trusted liquid biopsy results. While we previously showed that Northstar Select is significantly more sensitive than other liquid biopsy competitors, we believe that this offering will also make it the liquid biopsy with the highest specificity. As awareness of the CH problem increases among physicians, we expect that white blood cell testing will be an important driver of their choice of liquid biopsy. Both PGx and CH are ordered as add-ons during Northstar Select testing, and they are integrated into the same report. These upgrades ensure that we remain at the forefront of therapy selection. Turning to our second pillar. Our leadership in product innovation and our growing commercial team continue to drive our test volume with Q4 reaching approximately 170,000 tests, a 47% year-over-year increase. We saw strong quarter-over-quarter growth across both prenatal and oncology despite Q4 being a seasonally slower quarter with fewer accessioning days. Importantly, in Q4, we added a record number of new active ordering providers, setting us up, we believe, for a strong performance in Q1 2026. This is a metric that we track closely, and we are encouraged by the momentum. Our sales team continues to operate with extremely high sales efficiency, and we continue to expand our commercial team at a systematic pace. Our total revenue performance in the fourth quarter demonstrates the exponential growth we have delivered since 2021, rising from approximately 0 to $384 million in ARR in approximately 5 years. Total revenue in the fourth quarter was $96.1 million, representing 113% year-over-year growth, driven by rapid increases in tests delivered and ASPs across both product lines. This sustained level of growth at our scale is truly differentiated in our industry. This outperformance was driven by rapid growth in both prenatal and oncology revenues. In the fourth quarter, prenatal revenue was $86.9 million, up 98% year-over-year, reaching an annualized run rate of $348 million. Our prenatal revenue is continuing to grow at a pace that underscores the depth of our UNITY differentiation. Our oncology revenue continued to grow even faster than prenatal, reaching $9.1 million in the fourth quarter, achieving $36 million annualized revenue run rate. This is up 736% year-over-year. The oncology ramp has been driven by increasing adoption of both Select and Response, execution by our oncology commercial team and the benefit of MolDX coverage for Select secured earlier in the year. In particular, excluding true-up revenue, our oncology revenue grew 29% quarter-over-quarter, driven primarily by increase in our test volume. With the addition of PGx and [ CHIP ] in Q1, we expect our 2026 test volume growth to be even stronger. We continue to see significant opportunity ahead as we grow our sales team, build clinical evidence and pursue Medicare coverage for Northstar Response. In addition to our test volume growth, our overall ASP also continues to grow rapidly. Overall ASP increased another 12% quarter-over-quarter from $501 to $561, a significant $60 per test increase in a single quarter. For the full year 2025, our overall ASP increased from $368 in 2024 to $495 in 2025, a 35% year-over-year ASP increase. The Q4 sequential step-up of $60 per test is meaningful and reflects several converging tailwinds. Additional Medicaid states adopting our Carrier PLA code, the continued build-out of our contracted payer base and a growing contribution from oncology, where Northstar Select has a much higher ASP than any of our other tests. We believe there remains substantial room for ASP expansion as we add more payer contracts and as guidelines continue to broaden the clinical indications for our tests. We are particularly excited about the prospect of the Northstar Response coverage. As Northstar Response, due to its repeat nature, accounts for almost 2/3 of our oncology test volume, any increase in Northstar Response coverage and ASPs would meaningfully expand our oncology revenue. In addition to driving ASP growth, we have remained committed to our operating philosophy of continuous improvement to reduce COGS per test. Our overall COGS per test was $161 in Q4, down 4% year-over-year. I will note that COGS per test was slightly higher compared to the last quarter. This was primarily driven by a significant continued shift toward a higher proportion of oncology tests, which have higher COGS and ASP per test. It was also impacted by higher stock-based compensation expense as a public company. To sustain our trajectory of reducing the COGS per test, we continue to deploy AI and automation across our laboratory operations. As our ASPs increased and as our COGS per test decreased year-over-year, our gross margin profile continued to expand in the fourth quarter. Gross margins were 71.4% in Q4, representing a 14.3 percentage point year-over-year increase and a modest increase quarter-over-quarter from 70% in Q3. The increase in gross margins was primarily attributable to higher overall ASPs and continued progress in reducing our COGS per test, especially in oncology. What is particularly noteworthy is that gross margins continue to increase despite a higher volume contribution from oncology, which currently has lower margins than prenatal. We are encouraged by the margin trajectory in both segments. And while the mix shift to oncology will limit substantial near-term margin expansion, we expect to maintain our gross margins near current levels. Last but not least, in our fourth pillar, we achieved GAAP profitability in both Q4 2025 and full year 2025, with year-over-year improvements of 29 percentage points in net margin and 36 percentage points in operating margin. This was due to a number of factors: increasing and high sales efficiency, increasing ASPs, reductions in COGS per test and our relentless focus on increasing productivity across all our operations through automation and AI. I'd like to note that we have achieved this profitability at a much lower scale than our competitors while growing faster and with less than 10% of their accumulated deficits. With that, I will turn the call over to Ross to review our financial results and 2026 guidance before I conclude.

Thank you, Oguzhan. As Oguzhan noted, total revenue in the fourth quarter of 2025 was $96.1 million compared to $45.1 million in the fourth quarter of 2024, representing an increase of 113%. Revenue growth for both our prenatal and oncology product lines was strong in the quarter. Prenatal revenues consisting of clinical testing revenues of $86.1 million and $800,000 in revenues from clinical trial support and other services increased 98% to $86.9 million in Q4. Oncology revenues increased 736% to $9.1 million in Q4 of 2025 versus Q4 last year. True-up revenue across both product lines was $8.4 million in the fourth quarter compared to $1.1 million in the fourth quarter of last year, reflecting higher cash collection trends related to tests delivered in prior periods. Revenues in the quarter were higher than the guidance we provided on December 9 of a range of $84 million to $90 million for Q4. About 2/3 of the higher Q4 revenues compared to this range was driven by higher test volumes than we expected and 1/3 was caused by higher true-up revenue compared to our estimate. Gross profit in the fourth quarter of 2025 was $68.6 million compared to $25.7 million in the fourth quarter of 2024, resulting in a gross margin of 71.4% in the fourth quarter of 2025 versus 57% in the fourth quarter of 2024. Importantly, ASPs and cost-per-test improved across all of our product lines year-over-year. Total operating expenses were $58.3 million in the fourth quarter of 2025 compared to $37.4 million in the comparable prior year quarter, representing an increase of 56%. Within operating expenses, R&D expense was $14.3 million in the fourth quarter of 2025 compared to $11 million in the comparable prior year quarter, while SG&A expense was $44 million in the fourth quarter of 2025 compared to $26.4 million last year. We continue to scale our operating expenses to support rapid growth with efficiency and discipline. Operating income was $10.3 million in the fourth quarter of 2025 compared to an operating loss of $11.7 million in the fourth quarter of 2024. Our Q4 operating profit margin was 11%. We expect to operate the business such that we continue to generate positive GAAP operating income in the future. Net income available to common shareholders was $4.4 million or $0.11 per diluted share in the fourth quarter of 2025 compared to a net loss of $11.5 million or $1.13 per diluted share for the same period in 2024. Turning briefly to 2025 financial highlights. Total revenue of $305.1 million was above our guidance range and 100% higher than the $152.6 million we reported in 2024. True-up revenue was $17.1 million for the full year 2025 compared to $11.2 million in 2024. The number of tests delivered in 2025 grew 51% to 610,000, and our overall ASP grew 35% to $495. Operating income for 2025 was $16.0 million versus an operating loss of $47.1 million in 2024. Our operating profit margin was 5% for the full year 2025. Adjusted EBITDA was $38.8 million, representing a 13% margin. We achieved these margins while investing meaningfully in our sales force, new product launches and clinical evidence generation. Our cash flow is strong. Cash flow from operations minus capital expenditures was $9 million in Q4 of 2025 and $16 million for all of 2025. For modeling purposes, we anticipate diluted shares outstanding to be in a range of 52 million to 54 million over the next several quarters. We are well capitalized with a very healthy balance sheet. We ended the year with approximately $496 million in cash and equivalents and just $50 million in term debt, positioning us for strong growth moving forward. Finally, I will provide an update on our full year guidance for 2026. We are raising our 2026 total revenue outlook to a range of $430 million to $445 million, representing growth of 41% to 46% compared to full year 2025. Additionally, we continue to expect positive GAAP operating income for the full year 2026. Our new revenue guidance is a $15 million increase at both ends of the range over our previous guidance provided in early January of $415 million to $430 million. I will now turn the call back to Oguzhan to elaborate on the guidance and to conclude.

Thank you, Ross. I would like to highlight that we have several additional growth drivers and catalysts in both prenatal and oncology that give us strong conviction that even our raised guidance is conservative. On the prenatal side, we see such strong continued momentum. We believe that the recently published clinical practice guideline will further position UNITY as the new standard in prenatal care and BillionToOne as the leading innovator in this field. The dual launch of our expanded Red Blood Cell Fetal Antigen NIPT and first-and-only Platelet Fetal Antigen NIPT at SMFM will further drive our growth. As awareness and practice guideline-driven adoption accelerate, we expect meaningful volume uplift in health systems where MFMs are the decision-makers. Such health system adoption is not reflected in our guidance. We also see continued ASP tailwinds from increased Medicaid coverage of our Carrier panel PLA code. 0449U has been added to 10 Medicaids in 2025, the largest of which has happened in Q4, with Florida starting to cover 0449U in Q1 2026. Each Medicaid addition can drive ASP increases and lead to further contracting with managed care organizations, MCOs, further driving our test volume in a flywheel. We also have several health systems that want to use UNITY as their prenatal screening of choice, with the only remaining blocker being the EMR integration. While the start of Epic Aura integrations is likely 6 months from now, and therefore, their contribution is not reflected in our guidance, adoption even in a single health system can be a significant upside to our projections. In oncology, the launch of Northstar Select PGx and Northstar Select CH broadened our oncology offering and deepened our value proposition for oncologists. As our test volumes grow, we are able to further drive our COGS per test down and enable additional product innovation, including a best-in-class tumor-naive MRD that we aim to launch by the end of the year. Each of these is an independent driver of growth that compounds with the others. Finally, our Northstar Response MolDX coverage submission represents a meaningful catalyst. We submitted a comprehensive coverage dossier to MolDX and an approval received even a few months before the end of the year would be a meaningful upside to our 2026 oncology revenue, given that Northstar Response accounts for nearly 2/3 of our oncology test volume. And then there is a catalyst I want to spend a moment on specifically because I believe it can be quite significant for us in 2026. In addition to the above drivers, I am extremely excited to share that we have just signed a contract to be in-network with UnitedHealthcare, the largest commercial health insurer in the United States. This is a landmark moment for BillionToOne, and I want to take a moment to convey why. When we are out of network, patients can still access our tests, but this can create significant friction with both physicians and patients. It also results in lower ASPs as patient collections can be unpredictable and challenging. An in-network contract removes all that friction at once. I believe our contracting with other payers will further accelerate in 2026, driving both additional test volume and ASPs. Our market access team has built an outstanding foundation. I'm incredibly proud of them. In summary, we are transforming health care, one molecule at a time, one patient at a time. We have changed what the industry believed was possible in cell-free DNA diagnostics, and we are just getting started. Winning from here requires continued exceptional execution, and I am confident that our team, our technology and our products position us to deliver on that. In Q4, we continued our exceptional execution in our 20-mile march. From the Northstar Response MolDX submission to multiple product launches to setting an all-time record for newly active ordering providers, our team is driving every pillar of the business forward simultaneously. Indeed, in Q4, we expanded gross margin and maintained GAAP profitability even as we absorbed onetime IPO-related costs and invested at an accelerating pace. What gives me the most confidence as I look forward is not any single catalyst. It is the compounding nature of everything we have built. Our smNGS platform gets more powerful with each new product we launch. Our clinical evidence base grows with every study we publish. Our commercial organization becomes more efficient with every new active provider we onboard and our market access position gets stronger with every payer contract we sign, including the landmark agreement we just announced. We have a team of driven purpose-built individuals who come to work every day to improve patients' lives. That commitment is what fuels everything you see in these results. Our long-term ambition is to build a category-defining company, enter the S&P 500 and continue to transform health care, one molecule at a time, one patient at a time. Every quarter, we are excited to take another step in that direction. And I believe 2026 will be our most consequential year yet. Thank you. Over to the operator.

[Operator Instructions] Our first question comes from the line of Andrew Brackmann of William Blair.

Thanks for all the remarks. Certainly a lot to dig into. Oguzhan, you mentioned the continued expansion of the prenatal portfolio as you continue to push that field forward. And certainly, I would think that this sort of increases the awareness of UNITY amongst certain providers. But if you could zoom out, can you maybe just sort of talk about where you think awareness is for all providers who order NIPT, both those who manage low-risk and high-risk pregnancies. And then how does that -- how do you sort of think about driving that higher in 2026 and beyond?

Thank you, Andrew. Very good question. And actually, this is one of the reasons why we believe we have such a long runway for our continued growth. When we -- I think this comes up in some of the surveys that analysts and others, including you have put together. But what we see in our own data that around -- depending on whether it is aided or unaided recall, at least 50% of providers do not know anything about UNITY. So that actually is a remarkable outcome that of the providers who know about UNITY, we actually have more than 50% market share or so. Around -- unaided awareness is around, I think, 30%, aided awareness is around 50%. So if you look at kind of those numbers and we look at essentially what percentage of them are actually using UNITY, we have about 50% market share if a provider knows about our tests. So from that perspective, we believe that as we continue to increase our sales team size, as we continue to cover the entirety of the United States fully, and as we continue to publish and have these clinical guideline changes and other additional products with UNITY, we believe that this awareness is going to increase, and that is going to be a really big driver of our long-term growth.

And then maybe if I could just follow up the commentary around health systems where MFMs are an important decision-maker there. Can you maybe just sort of talk about the conversations that you're having with those groups, in particular, around sort of driving uptake across these larger groups?

Certainly. MFMs are an important stakeholder, right? They are usually the ones that are taking care of the high-risk pregnancies. And when any NIPT determines a high-risk result, usually, these patients are referred to MFMs. So from that perspective, MFMs have tremendous influence over the tests that the OBs who are referring their high-risk patients to them have. So in general, this is important in health systems where those OBs and MFMs work very closely, but it is even actually important outside of the health system context where an MFM can go to the OBs who are referring their patients to them and say that, I would rather -- if they are a big advocate of UNITY, they can say that, I would rather have you use UNITY for your frontline screening in that way, when I get these high-risk patients, I have all the information that I need to be able to counsel them, to be able to manage them, to be able to treat them.

Our next question comes from the line of Dan Arias of Stifel.

Oguzhan, can you maybe talk about the new provider increased number that you mentioned for Northstar? How should we think about that as a metric? What would you consider good versus not good this year when it comes to bringing new docs on board? Just sort of would be helpful to understand how you're expanding usage in the market.

Thank you, Dan. The number that I referred to was combined across prenatal and oncology. So when we looked at the number of ordering providers, active ordering providers that we have in every quarter, what we have seen in Q4 is that number of active ordering providers actually significantly increased. That was the best quarter in terms of active ordering providers that we have been able to add. What that usually means is very strong growth for Q1. As we previously mentioned, because Q4 is fewer number of accessioning days, the true impact on the test volume growth is usually not reflected in the Q4 numbers. But if you look at the number of active ordering providers, and we actually have a high bar for calling a provider an active ordering provider. If they order just 1 or 2 tests, that doesn't count. So from that perspective, what that comment is really referring to is, compared to all the previous quarters, Q4 was actually the strongest quarters in terms of having new active providers that are not just dabbling in or using 1 or 2 tests, but that are using our products regularly within the quarter, which means usually a very strong signal for where the Q1 test numbers are going to end up with.

Okay. Okay. And then Ross, Oguzhan made a comment on gross margins. Is it right to think that the assumption is flat gross margins for the year? And then are you comfortable with that across the guidance range and across the range of mixes that you might see? I mean I know you can control that mix, but I just want to kind of make sure that that's a fully underwritable number sort of regardless of scenario.

Yes. Good question, Dan. I think we're not giving a whole lot of color around gross margins or some of the expense lines other than to say we want to operate the business with positive operating income on a GAAP basis going forward. But I would expect the gross margins to stay up in that high 60-ish range. Maybe we could continue somewhere in this 71%, low 70% range. But I think I would not get aggressive at all in terms of expectations for expansion in gross margin.

Our next question comes from the line of Mark Massaro of BTIG.

Congrats on a strong year and certainly a lot to dig into as well. I wanted to ask about the United contract going in-network. I presume this is for UNITY, although UNITY is not your only product in the market. So can you just speak to which products the United contract covers? And then historically, in diagnostics, sometimes people negotiate in-network with large health plans, and they have to take maybe a price discount. Can you just speak to how we should be thinking about that dynamic, whether or not we should expect slightly lower ASPs as a result of this going in-network?

Thank you, Mark. I think you should expect higher ASPs going forward. We have signed over the course of last 4 years, probably close to 200 contracts and not a single one decreased our ASPs. So from that perspective, when you get in-network with a payer more broadly, what happens is that you do agree to a percentage of Medicare as part of that contract. But that also means that you get reliable reimbursement for that percentage rather than the amount actually going into the coinsurance and deductible of patients. So given the patient collections are not -- are never really 100% despite best efforts, what typically happens is that you might agree to a lower percentage, let's say, 80%, 70% of Medicare, but that ends up being significantly higher than what you would otherwise get on a blended ASP basis. I can't go into the specifics of a contract due to confidentiality reasons. But what I would say is that we, again, also typically see that for every contract that we sign, it is actually for both -- all the products that you have. It is for prenatal and oncology products. That doesn't mean that a test -- every test is going to get paid, right? It is -- you need to have the coding, you need to have the coverage as well. So you need to have the contract and contract will cover what codes that you have, but that should also need to be -- there needs to be the coverage for a test to be paid. So from that perspective, [ there comes a benefit ]. And again, this is public information that can be found with UnitedHealthcare, including with many of the commercial contracts that we have.

Okay. Great. And then maybe as a follow-up, can you just speak to what you might be seeing in the field? I know Natera launched Fetal Focus, if you're seeing any impact there. And then if I can ask a cleanup, pharmacogenomics and Northstar Select CH, these are add-on products. Is this a potential source of additional ASP? In other words, will you be charging for these tests?

So taking on the oncology question first, the Northstar Select CH and PGx are add-ons to our existing tests. We do not typically expect to see significant ASP lifts coming from such add-ons, especially in the short term. In the long term, as guidelines evolve and the current guidelines with respect to ESMO, for instance, still -- they are already supportive of buffy coat sequencing with respect to CH, there can be ASP lifts as these become covered benefits. With respect to the competition, I think as you can see from the fact that we have added a record number of ordering providers in Q4, our test volume growth numbers in Q4 and the way that our prenatal revenues are increasing, I think it is relatively straightforward to conclude that we are actually not seeing any impact from the competition so far.

Our next question comes from the line of Subbu Nambi of Guggenheim.

Oguzhan, this is your second quarter reporting as a public company. As you reflect on these first 2 quarters, what has gone according to plan so far? And what has exceeded your expectations? And what could have gone better and is an area of focus for improvement in 2026?

Thank you, Subbu. I think we have been operating similar to this cadence for the last 3 years. And this is something that our pre-IPO investors would easily attest to. We have reported quarterly results and beat and raise our guidance past 3 years. In fact, our Board members will tell you that we never really missed the guidance in the time that they have been an investor. So from that perspective, everything has been going according to the plan. That doesn't mean that everything that you work on essentially ends up being -- ends up giving you better results. It is just that we work on a number of drivers, and many of those drivers are not embedded into the guidance. So if some of them turn out to be true, that still ends up having an upside to what we originally expected our results to be. In terms of what maybe did not go according to the plan, because perhaps of the timing of the IPO and the earnings calls, it has been a lot of conferences and investor meetings and earnings calls. We certainly prefer to focus on running the company and building the business to participating in the conference, no offense intended.

Oguzhan, as a complete separate follow-up, you discussed a bit about some of the upside opportunities for prenatal volumes versus the guidance. But could you discuss what the guidance assumes in terms of prenatal volume growth today and prenatal market share gains? And given the growth you have seen in prenatal volumes, you haven't been impacted by seasonality. But as you think about 2026, do you expect to see more seasonality just because of the volume, the sheer number of volumes?

We typically see Q4 always being a slower quarter for us. As we previously mentioned, we -- there are a lot of physicians who do not want to switch their test during Q4. They kind of leave the decision to the beginning of the year. There are also fewer accessioning days in Q4. So the combination of those 2 factors tend to make our Q4s slower. So it was actually a sign of particular strength in our business that we did not see a slowdown in Q4. And that, I think, really bodes extremely well for what we expect Q1 to be and the rest of the year to be. In terms of what our guidance incorporates, it really incorporates essentially our existing number of sales team members and how we expect them to grow on a quarter-over-quarter basis, essentially what they need to do to maintain and grow each of their territories. It does not include a lot of the upside that can come in from these large health system opportunities, which can be driven by either these guideline changes and the new product additions that we have had as well as the Epic Aura integrations that we mentioned. So any health system or any health system-related adoptions are not really incorporated into our guidance.

Our next question comes from the line of David Westenberg of Piper Sandler.

Congrats on the first couple of great quarters out of the IPO gate. So maybe I missed this because I can't believe no one asked this. But in the last 2 months, you raised guidance by $15 million at the endpoint. Can you give us maybe some of the details on what kind of went right over the last 2 months, what you see difference? I mean I know you have United, maybe that's a contributor. Is that purely the contributor? Anything else to think about there?

We did not incorporate any potential upside that would come from United to our revenues. United contract is effective April 1. Ross had one sentence, I think, in his prepared remarks where he mentioned that compared to the guidance that we had in December, the 2/3 of the increase came from the strength in the test volumes and 1/3 came from higher-than-expected true-up revenue. So it's essentially, we came into December with the idea that Q4s tend to be a little bit seasonally slower for us. We had October and November numbers and December ended up being extremely strong with respect to the test volumes, which ended up driving 2/3 of the beat and the 1/3 came from the fact that we had higher-than-expected true-up revenue in the quarter. For the new year guidance, we actually did not incorporate any of the developments and the upsides and drivers that we talked about. We essentially took the expectation of on a per test per sales rep growth in different territories. And then we just incorporated what our quantitative numbers are in Q4, and this is the quantitative result of that model. So we believe that, that is why it is very conservative.

Perfect. And then maybe I was just going to ask in terms of getting paid on response. I mean how are the conversations going with CMS? And there's not many response assays out there. I mean there's Guardant Response essentially. How are you anticipating this coverage policy kind of looking like? I know there's different histology types in monitoring, maybe it kind of looks more like MRD. What are kind of the pushes and pulls that CMS might look at? And I'll take it offline from there.

So MolDX under its existing policy already covers the concept of treatment monitoring. This policy was written primarily for MRD, but there is a section that actually covers how they think about treatment monitoring, and that clear line of sight to what we need to provide. We have started some of those conversations, but of course, it always takes a few back-and-forth submissions before you get to a coverage decision. So that is why we are still planning for the end of the year for the coverage decision from MolDX for Medicare lives.

Our next question comes from the line of Casey Woodring of JPMorgan.

Just curious on what you guys are seeing in the therapy selection and response monitoring competitive markets and if you're bumping into other competitors there, one of the -- your larger competitors is talking more about response monitoring. And then would be curious to hear what's embedded in the guide for oncology volume growth and how that's split across between existing providers versus share gains? And would also be curious to hear what the average test order per month is for existing customers of Northstar Select.

Can you repeat the first question? I think that was 3 questions. I want to make sure that I cover everything.

Yes. No, I'll get. Just on the therapy selection competitive market, you're bumping into competitors there and on therapy response monitoring as well, just given one of your larger competitors is talking more about that test.

Certainly. And I think it is a clear recognition of that there is a tremendous need for response monitoring. And we are seeing competition, both with therapy selection and response monitoring in the market. With respect to therapy selection, the fact that we are able to most sensitively identify 50-plus percent more actionable variants is really a game changer. So for us, it is really about getting in front of the oncologists that tends to be the bottleneck. Once we are in front of an oncologist, we have peer-reviewed publications that show a head-to-head prospective study. But even when a particular oncologist may not think that, that particular study would apply to their patient population, 50% more actionable variants is such a large number that they need to just see it for themselves for 5 or 10 patients within their context. So from that perspective, we are able to tell them, why don't we do a research trial with you where you send us 5 or 10 of your patients for research purposes where you are running them with standard of care with one of the larger competitors that we have. And we are winning those head-to-head studies and you really need one patient. If one patient's treatment journey changes because you identified an actionable variant that changed that patient's treatment journey or that your competitor didn't identify or they identified the CHIP mutation that we were able to classify as CHIP and say that this patient is not going to respond to this therapy. In both of those cases, just one patient completely changes that physician's view of your test. It only takes one patient that physician doesn't just become a user of your test, but they become an advocate for your test. This is actually where we are seeing a flywheel effect. When we initially put a sales rep in a particular region, because there is so much competition, it can take 3, 6, 9 months for them to get in front of oncologists sometimes. It is not just the diagnostics competition. It is all the pharmaceutical sales reps in oncology that are booking lunches that are taking oncologists' time. But once you have 1 or 2 or 3 physicians who are not just users, but are advocates. They are passionate about what this test does for their patients. They refer -- they advocate for your test to other physicians, which allows you to get in front of them much faster. So one thing that we are seeing is that in territories, as we kind of increase our test volume, it is actually becoming easier and easier because we are able to remove that bottleneck of being in front of oncologists, which is really the only bottleneck against our ability to win against the competition.

Got it. That's helpful. And then, yes, maybe just a quick follow-up. What's embedded in the guide for oncology volume growth? And how does that split across growth between existing providers and share gains? And would also be curious to just hear if you have an average test order per month for existing customers with Northstar Select. That's a question we'll get every now then.

I do not have a number for the average test out at Select per physician. In terms of the kind of share gains or how we are thinking about the guidance, it is exactly the same way that we think about prenatal. We know that on average, each of our sales reps is able to grow x number of tests per quarter. And that allows -- and we have seen that over the course of last 2 years with more than 40, 45 reps. So we essentially incorporate that growth into our test volume increase for oncology for 2026.

[Operator Instructions] Our next question comes from the line of Brandon Couillard of Wells Fargo.

Ross, in terms of the guide, should we be thinking about the ASP growing from the baseline of $560 in the fourth quarter? And are you assuming any true-up revenue tailwind going forward in the revenue guide?

Good question, Brandon. The revenue guide does not include any true-up revenue, so that's exclusive of true-up revenue. And I think as you think about our overall ASP, do remember that the way we compute it historically, we do include the true-up revenue. So you may want to make some adjustments or make assumptions around that.

Okay. Then, Oguzhan, can you just talk about the sales force expansion plans for '26? I mean you've been growing at a pretty ratable pace, both in oncology, call it, 8, 9, 10 reps a quarter and prenatal. Do you expect to accelerate that at all or make any adjustments in response to competition or some of the new products that you're obviously excited about?

Thank you, Brandon. As we shared in the earnings deck, we expect to maintain our growth for prenatal and oncology. Prenatal is slated to grow from 150 roughly to 185 reps by the end of the year, and oncology is expected to grow around from 45 reps to 65 reps by the end of the year. This level of growth is actually chosen not because we cannot grow faster, we certainly can. But this is the kind of maximum level of growth that we feel comfortable about in terms of maintaining the quality of our test, right? You can have the most amazing oncology test. But if your test volume is increasing more than 100% year-over-year, it becomes actually very difficult to maintain the same turnaround time, the same quality of service with those tests. So we essentially are doing this very systematic growth also because this allows us to have a level of growth that we believe is going to allow us to maintain the same level of service, right? And even if you have a great test, if your turnaround time goes from 5 days to 15 days, you are going to lose customers, especially for these very time-sensitive important tests. So from that perspective, our sales team growth numbers is set up in such a way that it will enable us to have excellent end-to-end service, all the way from client services to lab operations to everything that we do. And in that way, it also is done in such a way that prenatal growth balances some of the oncology growth with respect to the GAAP profitability.

Our next question comes from the line of Tycho Peterson of Jefferies.

This is Noah on for Tycho. I wanted to start by asking about the health systems opportunity, particularly if you could provide any context on how you're sizing it and then what the time line looks like for this to possibly show up the numbers?

Thank you. The way that we think about the health system opportunity that each health system can be really anywhere between 10,000 to 30,000 tests per year. And so these are really large health systems that take time, right, that take multiple stakeholders to be on the same page. And we do have a number of health systems where we have clinical buy-in, but we still need to get integrated with EMR before they can roll out our test as their frontline screening of choice. Given that this is not completely under our control, right? This is -- we first need to integrate with Epic and then we need to integrate with each health system, and that can take time. We haven't incorporated any of these uplifts into our test numbers for 2026. That said, given what we are seeing here, I think, especially in the second half of the year, there can be opportunities for 1, 2, 3 of these health systems to start coming in. Of course, for 2026, you are not going to see that full impact of 10,000 to 30,000 tests if they come in, in the middle of the year. But as we look at 2027, those adoptions, those wins will set us up for another extremely strong year of growth.

That's helpful color. And then for my follow-up, I just wanted to dive into the guidance a bit more. So for 1Q, should we expect any potential disruptions from weather impact? And then on the OpEx side, is there any phasing to consider throughout the year in terms of spending on MRD trials or incremental hires ahead of the launch?

In terms of weather impact, you should not expect anything because our Q1 -- with Q4 setting up Q1 very nicely, we expect to have a strong 2026, including Q1. In terms of any impact on OpEx, we are continuing to invest at a pace that would continue to make us GAAP profitable. So we do not anticipate any kind of either front-loading or end-loading of OpEx. It is a very balanced plan, not just actually for this year, but across the course of next 3 years.

Thank you. I would now like to turn the conference back to Oguzhan Atay for closing remarks. Sir?

Thank you, operator, and thank you all for joining today's conference call. We look forward to speaking with you on our next conference call in a few months. We had a really strong 2025, but we are even more looking forward to what we will achieve in 2026. Have a good day.

This concludes today's conference call. Thank you for participating. You may now disconnect.