Financial Performance - For the year ended December 31, 2024, the company generated revenue of $152.6 million, representing 113% year-over-year growth, with a gross margin of 53% and a net loss of $41.6 million[141]. - During the nine months ended September 30, 2025, the company generated revenue of $209.1 million, representing 95% year-over-year revenue growth, with a gross margin of 67% and a net income of $1.5 million compared to a net loss of $30.1 million for the same period in 2024[142]. - Revenue for the three months ended September 30, 2025, increased by $45.1 million, or 117%, to $83.5 million compared to $38.4 million for the same period in 2024[180]. - Revenue for the nine months ended September 30, 2025, increased by $101.6 million, or 95%, to $209.1 million compared to $107.5 million in the same period of 2024[197]. - The net income for the three months ended September 30, 2025, was $5.7 million, a significant improvement from a net loss of $14.9 million in the same period of 2024[220]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $18.9 million, compared to a loss of $24.8 million in the same period of 2024[216]. Test Volume and Operations - The total test volume grew to approximately 162,900 tests for the three months ended September 30, 2025, compared to 107,900 tests for the same period in 2024[146]. - The company processed over 562,900 smNGS-based tests within the last 12 months ended September 30, 2025, accounting for more than 50% of the total tests processed since the initial launch[141]. - The total volume of delivered and billable tests rose by 52% to approximately 165,000 for the three months ended September 30, 2025, up from approximately 108,500 in the prior year[181]. - The total volume of delivered and billable tests rose by 52% to approximately 440,500 for the nine months ended September 30, 2025, up from approximately 289,900 in 2024[197]. Gross Profit and Margins - Gross profit increased by $38.2 million, or 189%, resulting in a gross margin of 70% for the three months ended September 30, 2025, compared to 53% in the same period of 2024[185][186]. - Gross profit increased by $84.7 million, or 153%, resulting in a gross margin improvement from 51% in 2024 to 67% in 2025[202][203]. Expenses - Research and development expenses rose by $3.4 million, or 36%, primarily due to increased personnel costs and materials expenses[188]. - Selling, general and administrative expenses increased by $12.5 million, or 54%, driven by higher salaries, commissions, and related expenditures[189]. - Operating expenses rose by $43.5 million, or 48%, totaling $134.2 million for the nine months ended September 30, 2025, driven by increases in research and development and selling, general, and administrative expenses[206][207]. - Research and development expenses increased by $9.5 million, or 37%, primarily due to a rise in personnel costs and materials[206]. - Selling, general and administrative expenses increased by $34.0 million, or 52%, largely due to higher salaries and commissions[207]. Cash and Debt Management - As of September 30, 2025, the company had cash and cash equivalents of $195.2 million and working capital of $210.9 million, following a successful IPO that raised approximately $286.4 million[221]. - The company generated $13.8 million in cash from operating activities during the nine months ended September 30, 2025, compared to cash used of $33.0 million in the same period of 2024[227]. - The company has an accumulated deficit of $280.7 million as of September 30, 2025, despite achieving positive operating income in the nine months ended September 30, 2025[222]. - The company has a debt facility with a total availability of up to $140.0 million, with the first tranche of $50.0 million advanced at an interest rate of 8.0% per annum[223]. - Interest income decreased by $0.4 million, or 21%, primarily due to lower interest rates[190]. - Interest expense decreased by $0.4 million, or 95%, due to the payoff of the Western Alliance Bank debt[192]. - Interest expense decreased by $2.2 million, or 96%, as a result of the payoff of the Western Alliance Bank debt[209]. Future Outlook and Investments - The company expects to maintain significant investment in research and development to enhance existing tests and develop new molecular diagnostic assays[157]. - The company has expanded its laboratory operations by adding a second facility in Union City, CA, and has entered a lease for a new 220,000 square feet laboratory space in Austin, Texas, expected to be operational by 2028[154]. - The company achieved revenue and gross margin thresholds triggering a $30.0 million tranche of notes to be sold by March 31, 2026, based on results from the first half of 2025[224]. Market and Risk Factors - Third-party reimbursement for the company's tests represented more than 90% of revenue for the nine months ended September 30, 2025, highlighting the importance of payor coverage and contracting[150]. - Revenue is primarily derived from third-party insurance carriers, with a new agreement with Johnson & Johnson in 2023 for clinical trial testing, although this revenue is not material to overall operations[245]. - The company is exposed to interest rate risk, but a hypothetical 10% change in interest rates would not have materially impacted financial statements for the years ended December 31, 2023 and 2024[257]. - Inflation has not materially affected the company's financial condition, but significant inflationary pressures could harm business operations and financial results[258]. - International markets contribute less than 1% of revenue, and future expansion may expose the company to foreign currency exchange rate fluctuations[260]. Accounting and Valuation - The company utilizes the Black-Scholes Model to estimate stock-based compensation, which is recognized over the requisite service period[246]. - The fair value of common stock is determined by the Board of Directors, considering various valuation methods and market conditions[248]. - The company is classified as an "emerging growth company," allowing it to delay adopting new accounting standards until they apply to private companies[255]. - The company monitors cash collections against estimated variable consideration, adjusting revenues based on actual experience[244].
BillionToOne(BLLN) - 2025 Q3 - Quarterly Report