BillionToOne, Inc.

the billion to one third quarter 2025 earnings call. At this time, all participants are in listen-only mode. After the speaker's presentation, we'll open up for questions. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's call is being recorded. I would like to hand the call over to your speaker today, David Deichler, Investor Relations. Please go ahead

Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from Billion to One, we have Ozan Atay, co-founder and chief executive officer, and Ross Taylor, chief financial officer. Earlier today, Billion to One released financial results for the third quarter ended September 30th, 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, products and services, reimbursement coverage, future clinical performance, and other statements. We caution you that such statements reflect our current best judgments 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 FDC, in our previously filed registration statement on Form S-1, our quarterly report on Form 10-Q to be filed following this call, and the current report on Form 8K filed today. Any forward-looking statement made during this call is made as of today, December 9th, 2025. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. Bill 821 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'll turn the call over to Ozone.

Thank you, David. Good afternoon, everyone. Thank you for joining our third quarter earnings call. Today marks our first earnings call as a public company, and we look forward to continuing the dialogue with the investment community as our business grows in the years ahead. In November, we completed the successful initial public offering on NASDAQ, raising $314 million in gross proceeds for the company. I'd like to start this call by thanking our dedicated and hardworking employees, along with our shareholders, all of whom made this substantial milestone possible. A new chapter for BillionthOne is just beginning, and I am excited for our future as a public company. At BillionthOne, we have four pillars of differentiation that we believe makes us a different type of molecular diagnostics company. Everything that we do starts with a revolutionary single-molecule next-generation sequencing platform. This is enabled by our patented QCT quantitative counting template technology, which achieves single-molecule level sensitivity and precision. With our technology, we have built unique category-defining products, both in prenatal and oncology. In prenatal, we are redefining what it means to do non-invasive prenatal testing with our Unity products by enabling a more efficient and more sensitive test to help mothers understand health status of their developing babies. In oncology, we offer NorthStar Select to help guide therapy selection across multiple indications and NorthStar Response, which helps physicians monitor the patient's response to therapy. Both our prenatal oncology products are highly differentiated and have a direct impact on critical decision-making for patients. Our unique technology and product portfolio have led to exponential growth rates, even as we reached $304 million in annualized revenue run rate, or ARR, in the third quarter. That said, we believe that we are just scratching the surface of what is possible. With our SMNGS technology, we believe that we are uniquely positioned to address more than $100 billion in U.S. market opportunity over time. Importantly, having a unique technology and differentiated products allowed us to achieve a superior gross margin profile, achieving 70% in the Q3 2025, even with subscaled ASBs and using only about one-fourth of our current lab capacity. We believe that we have significant opportunity for further ASB growth and COGS per test reductions, both in our prenatal and oncology product lines. Last but not least, I am perhaps most proud of our capital and operational efficiency. which have allowed us to achieve emerging profitability while growing at 100 plus percent, an unprecedented feat in molecular diagnostics. As I shared with the private and public investment community over the last five or more years and throughout the IPO roadshow, our long-term goal is to build a category-defining generational company and become a member of the S&P 500. Our third quarter performance and achievements allowed us to continue to make important strides towards this goal. And the results are simply stunning. Our revolutionary SMNGS platform and products continue to be validated by publications and partnerships, including two prenatal publications, a head-to-head study on North Star Select, and an exclusive agreement with Johnson & Johnson. all of which I will cover on the next few slides. On revenue and test volume front, we continue to scale rapidly as we reported 51% test growth and 117% revenue growth year-over-year in the third quarter. Growth margins were a remarkable 70%, a 17 percentage point expansion from last year. due to robust outperformance in NASPs and continued reductions in cost per test. We were able to achieve this growth with emerging GAAP profitability, reporting 11.5% positive GAAP operating margin and bringing all year-to-date GAAP profitability metrics to be positive. Ross and I will take you through our quarter in more detail, but I'd first like to provide you with an update on a few exciting publications and business developments. We have recently had impressive prenatal oncology publications in peer-reviewed journals. Notably, the largest study of cystic fibrosis in any prenatal setting published in the Journal of Cystic Fibrosis. demonstrated 100% sensitivity for unity in identifying high-risk cystic fibrosis pregnancies. Importantly, 95% of these cases were eligible for cystic fibrosis modulator therapies, highlighting the clinical utility of our approach. Another unity publication in pregnancy validated the clinical utility of fetal antigen cell-free DNA testing and highlights the advantage in providing precision to pregnancies that are at risk for hemolytic disease of fetus and newborn, or HDFN, which Unity provides. Finally, we also finalized an exclusive agreement establishing us as the official companion diagnostic partner to Johnson & Johnson for hemolytic disease of fetus and newborn. These positions are Unity fetal antigen tests, for treatment of HDFN as the first CDX of its kind in the NIPT space, and we have successfully met all milestones to date. Turning to oncology, North Star Select demonstrated superior sensitivity in a prospective head-to-head validation study published in the Journal of Liquid Biopsy. In this study, we asked clinicians across the country to use whatever liquid biopsy that they are using for standard of care. But for the same patient, on the same day, as part of the same blood draw, send us another tube of blood as well. We did not prescribe what test that they should use. We did not create inclusion-exclusion criteria. And at the end, we reported our results, and other liquid biopsy companies reported their results. And here we show that in this head-to-head study, we detected 51% more pathogenic SMVs and 109% more copy number variants versus these comparators. These publications further validate the transformative nature of UNITY and North Star tests. With these differentiated products, we have been able to derive rapid growth. Our rapid growth is becoming even more impressive as our organization scales. In Q3 2025, total test accession in the quarter grew 51% year-over-year to 163,000 tests. Strong test volume growth was driven by expanded geographic coverage by our growing commercial team as we enter new markets and increased commercial density in existing markets while expanding in-network status with commercial payers. We also have seen acceleration even with larger health system adoptions, which was one of the drivers of our growth. We believe that the competitive product launches for fetal risk assessment validate the market need that we had identified in this market more than five years ago. Given the significant technology differentiation, more than five years of peer-reviewed publications, and significant product advantages we have, we haven't seen any impact on our business so far as it can be seen in the growth that we achieved in this quarter and until today. It's also important to note that we have achieved this phenomenal growth without having invested as significantly in EMR. That said, as we are seeing more of our growth to start to come from broad health system adoptions across the United States, we decided to invest more heavily in this area. As such, we have signed the contract with Epic for our implementation. While this may take nine months to become live. Once live, we believe this will remove one of the biggest impediments to faster immunity adoption in health systems across the United States. Total revenue in Q3 2025 was $83.5 million, which was an increase of 117% compared with $38 million in the third quarter of 2024. Our results in this quarter were driven by robust test volume growth, along with expanding average selling prices, or ASPs, across all products, drivers of which I will discuss in more detail shortly. Exceptional performance across every metric drove sequential growth of 25% from the second quarter. An error of $334 million represents an approximately $69 million increase sequentially compared to ARR in the second quarter, highlighting the demand for our test and the general momentum of our business. This odd performance was driven by rapid growth in both prenatal and oncology revenues. In the third quarter, prenatal revenue was $74 million, representing growth of 101% year-over-year. The oncology business is growing even faster than our prenatal business, delivering $8.7 million of revenue in the third quarter, growing 664% compared to the third quarter of last year. The revenue performance was driven by rapid test volume growth of both select and response tests as well as improved ASPs. We have seen tremendous growth in oncology over the last two years from when we first launched our NorthStar products and continue to expand our oncology sales team as we grow. We believe there exists a large opportunity for NorthStar in the future with expanded coverage decisions, especially for response to support meaningful revenue opportunities in the years to come. Our superior gross margin profile is driven by both expanding ASVs and a reduction in cost per test. Overall blended ASV was $501 in the third quarter, a remarkable increase of 44% year over year, and a sequential quarter over quarter growth of 10%. The primary drivers of ASV growth have been expanded payer coverage in prenatal, as we grow our commercial contracting efforts to where we now have approximately 235 million contracted lives. We have also brought reimbursement in-house last year, and our team is continuing to make strides towards getting more of our tests to be paid. Finally, we have seen more Medicates loading and covering the Unity Carrier Panel PLA code which has contributed to incremental ASB improvement. We continue to expand expanded coverage for specific parts of our test as we continue to drive ASB improvement over time. In addition to driving ASB growth, we have remained committed to our operating philosophy of continuous improvements to reduce the total cost per test. In the third quarter of 2025, our blended cost per test decreased by 10% to $151, primarily driven by our cost initiatives and increased volumes driving fixed cost per test lower. This decrease came despite an increasing shift to a higher proportion of revenues coming from oncology, which, of course, as you know, has higher COGS per test. as well as higher stock-based compensation expense as we move towards being a public company. As Billion to One's overall COGS has decreased and overall blended ASPs have increased, gross margins have rapidly expanded. Our gross margins were 70 percent in the third quarter compared to 53 percent in the third quarter of 2024. a remarkable 17 percentage point increase. Since our earliest days, we have been highly capital efficient, prioritizing spend with purpose and focus on efficiency. We expect to maintain the same disciplined approach to investment and growth to drive profitability as we continue as a public company. I will turn the call over to Ross to review our financial results and provide 2025 guidance before I conclude.