BillionToOne, Inc.

Thank you for standing by and welcome to the Billion to One First Quarter 2026 Earnings Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, David Deichler, Investor Relations. Please go ahead, sir.

Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from Billion to One, we have Ozana Tay, co-founder and chief executive officer, and Ross Taylor, chief financial officer. Earlier today, Billion to One released financial results for the first quarter ended March 31st, 2026. A copy of the press release is available on the company's website. Before we begin, I want to remind you that during this call, we may make forward-looking statements within the meaning of federal securities laws. Such statements about future events may include statements about our financial outlook and performance, market size, our products and services, reimbursement coverage, future clinical performance, and other similar statements. We caution you that such statements reflect our current best judgment and actual results may differ materially from those expressed or implied in any forward-looking statements. Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed annual report, Form 10-K, our quarterly report on Form 10-Q to be filed following this call, and the current report on Form 8-K filed today. Any forward-looking statement made during this call is made as of today, May 6, 2026. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. Billion to One 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 first quarter 2026 earnings call. I'd like to start by thanking our employees who work with tremendous effort and diligence to build and deliver superior tests to our patients that improve their care and remove the fear of the unknown. Before diving into our quarterly results, I would like to remind you of our four pillars that I believe make us a different category of molecular diagnostics company. First, our revolutionary technology platform, which is enabled by our patented QCT, quantitative counting template technology, achieves single molecule level sensitivity and precision with next generation sequencing. With this technology, we have built unique category defining products in both prenatal and oncology. With our differentiated products, we have grown exponentially in the last six years, even as we reach scale, with a level of compounding that we believe is rare in our industry. But there is still so much room to grow as the opportunity of prenatal and oncology CFDNA markets can exceed $100 billion in US market opportunity over time. In addition to rapid growth, we have achieved a superior gross margin profile, with margins now above 70%, with still significant room for expansion through ASV growth and Cox per test reductions. Lastly, through a culture of fiscal discipline and efficient operations incorporating AI and automation, We achieved GAAP profitability and positive cash flow with less than 10% of the accumulated deficit of our public competitors. In summary, we continue to track towards our long-term goal, which has remained the same, to build a category-defining generational company and become a member of the S&P 500. Our first quarter performance was extremely strong across all four pillars. For the third quarter in a row, we delivered a rule of 100 plus. And this time, in this quarter, we paired it with a level of profitability that is extremely rare for a high-growth company. We had another quarter of high growth, expanded margins, positive operating income, and positive cash flow. Looking at our results, pillar by pillar, in addition to expanded fetal antigen NIPT and FNAID NIPT launches for prenatal and PGX and CH launches for oncology that were launched in February, after the end of the quarter, we launched a category-redefining prenatal test, unity confirmed. UnityConfirm is the first non-invasive fetal cell-based confirmation assay for high-risk NIPTs. On the oncology side, our product roadmap remains on track. We responded to all Moldex comments for our response coverage submission, and our tumor-naive MRD launch is on track to launch by the end of this year. As we continue to launch new products, our business continues to grow, delivering consistent test volume growth of 44% year-over-year and total revenue growth of 84% year-over-year. In our third pillar, we have continued our progress with our in-network contracts, most importantly with a contract with Anthem. bringing our total contracted lives to 300 million in the United States. As our ASPs increased 28% year-over-year to $571 per test, and as we maintained our COGS at $153 per test, despite the higher proportion of oncology tests that have a higher COGS, we expanded our gross margins to 73% in Q1, a strong nine percentage point increase year over year. And finally, in our fourth pillar, as our gross margins expanded and as we operated with higher efficiency, we delivered a remarkable profitability profile in the first quarter with a 16% GAAP operating margin and 24% adjusted EBITDA margin, increasing our cash position to $537.5 million at the end of the quarter. Delving into each pillar one by one, for our first pillar, On May 1st, just five days ago, at ACOG annual meeting, we moved the field forward once again by launching what we believe is going to be seen as the innovation of the decade in prenatal genetics. UnityConfirm is the first and only non-invasive confirmation assay for high-risk pregnancies. It represents what many in our field have long considered the holy grail of non-invasive prenatal testing. You need to confirm captures and sequences intact circulating fetal cells from a maternal blood sample providing 100% fetal fraction. To put that in perspective, conventional cell-free DNA tests rely on small fractions of fetal DNA in maternal plasma. By isolating and sequencing whole fetal cells directly, UnityConfirm is in a fundamentally different category. We have launched UnityConfirm as a specialized offering, as a follow-up for high-risk pregnancies identified on our Unity unemployed screen. Today, if an NIPT returns a high-risk result, the next step is invasive diagnostic testing. which is increasingly inaccessible in maternity care deserts and also carries a small miscarriage risk. The majority of patients cannot or choose not to proceed to invasive diagnostic confirmation. UnityConfirm addresses this critical clinical gap. It gives these patients and their physicians a non-invasive option. Our initial results have shown 100% concordance compared to invasive diagnostics. And we are now enrolling patients in what we believe is the largest prospective circulating fetal cell-based study ever conducted with concordance to invasive diagnostics. We also built a comprehensive launch campaign around UnityConfirm. More than 500 providers attended the launch or watched on the live stream. We believe Unity Confirmed will further increase the differentiation of our Unity product offerings.