This article first appeared on GuruFocus .
-
Total Revenue:$123.0 million in Q3 2026, up 47% YoY from $83.5 million; up 12% QoQ.
-
Prenatal Revenue:$105.9 million, up 42% YoY; annualized run rate of $424 million.
-
Oncology Revenue:$17.1 million, up 96% YoY; annualized run rate of approximately $68 million.
-
Annualized Revenue Run Rate:$492 million.
-
True-Up Revenue:$7.6 million, versus $2.8 million in Q2 2026 and $3.7 million in Q3 2025; excluding true-up, total revenue grew 8% sequentially.
-
Test Volume:Approximately 206,000 tests, up 25% YoY and more than 10,000 sequentially.
-
ASP:$589 per test, up 7% sequentially and 18% YoY; excluding true-up, $552, up 3% sequentially and 15% YoY.
-
COGS Per Test:$169, versus $161 last quarter.
-
Gross Profit:$87.1 million, versus $58.4 million in Q3 2025.
-
Gross Margin:70.9%, versus 69.9% in Q3 2025; prenatal gross margin 75%, oncology gross margin 45%.
-
Operating Expenses:$76.1 million, up 56% YoY; R&D $20.2 million and SG&A $55.9 million.
-
Operating Income:$11.0 million GAAP operating income (9% margin), versus $9.6 million in Q3 2025; fifth consecutive quarter of positive GAAP operating income.
-
Adjusted EBITDA Margin:18%.
-
Net Income:$17.4 million, or $0.32 per diluted share, versus $1.5 million, or $0.10 per diluted share, in Q3 2025.
-
Cash Flow from Operations:$12.5 million; capital expenditures $3.9 million.
-
Free Cash Flow:$8.6 million.
-
Cash and Equivalents:$562 million at quarter end.
-
Full-Year 2026 Revenue Guidance:Raised to $460 million$470 million from $450 million$465 million; implies approximately 51%54% growth versus full year 2025.
Release Date: November 04, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
-
BillionToOne Inc ( NASDAQ:BLLN ) delivered record Q3 2026 revenue of $123 million, up 47% year over year, driven by 25% test volume growth and 18% ASP growth.
-
The company achieved its fifth consecutive quarter of positive GAAP operating income, with a 9% GAAP operating margin and an 18% adjusted EBITDA margin.
-
Gross margin remained strong at 71%, with prenatal at 75% and oncology at 45%, and management expects room for further expansion.
-
BillionToOne Inc ( NASDAQ:BLLN ) published a landmark prospective study for Unity Fetal Risk Screen, showing 94.4% sensitivity and 99.5% specificity, reinforcing its position as a leading single-gene NIPT.
-
The upcoming launch of Northstar Clear, a tissue-free MRD test, on December 15, 2026, opens a $30 billion market opportunity and is expected to be a major long-term growth driver.
Negative Points
-
COGS per test rose 10% to $169 due to a mix shift toward oncology and transient costs from recent product launches, which could pressure margins if the trend continues.
-
Oncology gross margin is only 45%, significantly lower than prenatal, and as oncology grows faster, overall gross margin may face downward pressure.
-
Northstar Response and Northstar Clear lack Medicare coverage, and reimbursement timelines remain uncertain, potentially limiting ASPs and profitability in the near term.
-
Operating expenses grew 56% year over year, with SG&A up 56% and R&D up 55%, which could impact profitability if revenue growth slows.
-
Prenatal volume growth in independent clinics is slowing as the company reaches higher market share, and health system sales cycles are long (12-24 months), creating uncertainty for near-term growth acceleration.
Q & A Highlights
Q: Mark Massaro (BTIG) asked about the launch strategy for Northstar Clear, specifically whether BillionToOne would throttle MRD test volume to limit margin drag, and how reimbursement might unfold. A: CEO Oguzhan Atay explained that QCT technology gives the MRD assay a much lower cost profile than competing tests, so it should become gross margin positive even without Medicare coverage. Because of this, the company does not need to limit test volume or indications, which could drive faster adoption than peers who must constrain launches. Initial data and reimbursement submissions will focus on colorectal cancer, with studies underway in lung and breast cancer as well.
Q: Daniel Arias (Stifel) asked whether prenatal volume growth could accelerate in 2027 given rep productivity, Unity Confirm, EMR integration, and the new 130-gene panel. A: CEO Oguzhan Atay noted that prenatal is split roughly 40% independent clinics and 60% health systems. Growth in independent clinics may slow as market share there matures, but health systems remain a large untapped opportunity. Health system sales cycles run 1224 months, and several deals are nearing completion, which could add upside. Oncology is also expected to contribute a growing share of sequential volume growth in 2027.
Q: Kyle Mikson (Canaccord Genuity) asked about the health system pipeline for 2027 and the potential test volume contribution. A: CEO Oguzhan Atay said more than 20 health systems are in various stages of the pipeline, each representing 2,0005,000 tests per quarter. Not all will close within 12 months, and even after clinical decisions are made, EMR integration, legal, phlebotomy, and logistics can take six to more than 12 months. The company typically excludes these deals from guidance but expects increasing contribution in 2027 and 2028.
Q: Tycho Peterson's team (Jefferies) asked about the impact of the new CLFS proposal, including a 112% increase in carrier screening rates, a higher Northstar Response rate, and lower aneuploidy codes. A: CEO Oguzhan Atay said the overall net effect is favorable, with the single-gene NIPT increase more than offsetting the aneuploidy code decrease. A roughly 30% CLFS increase for Northstar Response would be a net positive and could make Response gross margins strongly positive even without Medicare coverage, though PAMA changes are not yet certain.
Q: Mark Massaro (BTIG) asked about the reimbursement trajectory for the pan-cancer MRD test and which cancer types would be targeted initially. A: CEO Oguzhan Atay said studies are underway across colorectal, lung, and breast cancers and their subtypes. The launch will include head-to-head and clinical data in colorectal cancer, with initial submissions likely starting there. However, tissue-free testing has significant advantages outside CRC because tissue availability is lower and tumor-informed QC failure rates are higher in other cancer types.
Q: David Westenberg (Piper Sandler) asked how BillionToOne balances investing in new products like Clear against maintaining 70% gross margins and EBITDA positivity. A: CEO Oguzhan Atay said the company intends to maintain GAAP profitability in both the short and long term, and cost-efficient assay design means oncology scaling should not hurt GAAP profitability. Overall gross margin may shift as oncology grows, but the company can simultaneously invest in sales force expansion and clinical studies, with clinical investment increasing in 2027 to drive higher ASPs through coverage.
Q: Matt Larew (William Blair) asked whether Northstar Clear could be a meaningful revenue contributor in 2027 rather than just building the funnel. A: CEO Oguzhan Atay said 2027 revenue contribution will be modest since ASPs will be limited without Medicare coverage, but Clear has the potential to be the largest revenue contributor among all product lines long term. It is positioned as the first tissue-free test with tumor-informed performance, eliminating the trade-off between convenience and sensitivity.
Q: Subbu Nambi's team (Guggenheim) asked whether Labcorp owning FirstGene, which includes fetal recessive testing, changes BillionToOne's competitive positioning in prenatal. A: CEO Oguzhan Atay said past acquisitions and consolidations have created customer disruption that became growth opportunities, and this could be another such opportunity. He believes Unity Fetal Risk Screen is highly differentiated with strong clinical data backing, so new market entrants will not significantly affect its competitive position.
Q: Tycho Peterson's team (Jefferies) asked whether the existing oncology sales force will sell the MRD test and whether there is an updated MolDX timing expectation for Northstar Response. A: CEO Oguzhan Atay said the same sales force will sell MRD, starting with providers already using Northstar Select and Response who have seen head-to-head results. On Medicare coverage for Response, he noted MolDX appears to hold tissue-free tests to a higher bar, and the head-to-head study de-risks coverage. He still believes coverage could come by year-end, though timing is uncertain.
Q: Daniel Arias (Stifel) asked whether the raised full-year revenue guidance assumes any true-up revenue in Q4. A: CFO Ross Taylor said forward-looking guidance excludes any true-up revenue. The guidance includes historical true-ups but assumes nothing for Q4.
Q: Kyle Mikson (Canaccord Genuity) asked how much of an advantage the 130-gene prenatal panel provides and whether it is a core differentiator or a commercial edge. A: CEO Oguzhan Atay said winning health systems requires products attractive to every stakeholder, including genetic counselors. The 130-gene panel may not drive most test volume, but it unlocks health system discussions by serving needs the company previously could not address with smaller panels.
Q: David Westenberg (Piper Sandler) asked whether prenatal market consolidation could lead to more contracting discipline and better ASPs. A: CEO Oguzhan Atay said BillionToOne has been disciplined, only signing contracts that are additive, so he does not expect a significant market change. Acquisitions do not tie customers to the acquirer, and the disruption they create represents a good organic growth opportunity.
Q: Matt Larew (William Blair) asked whether the October head-to-head data has been compelling enough to attract
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
