Bionano Genomics(US:BNGO)2025-08-14 20:13PART I. FINANCIAL INFORMATION Item 1. Financial Statements This section presents unaudited condensed consolidated financial statements, detailing financial position, performance, and cash flows, with a going concern warning Condensed Consolidated Balance Sheets The balance sheet shows decreased cash, stable total assets, reduced liabilities, and increased stockholders' equity as of June 30, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,562 | $9,173 | | Total current assets | $42,662 | $39,489 | | Total assets | $76,010 | $76,670 | | Convertible debentures payable (current) | $11,762 | $20,362 | | Total current liabilities | $24,178 | $37,344 | | Total liabilities | $30,636 | $41,295 | | Accumulated deficit | $(703,184) | $(693,225) | | Total stockholders' equity | $45,374 | $35,375 | Condensed Consolidated Statements of Operations The statements show significantly lower net losses for Q2 and H1 2025 due to reduced operating expenses, despite decreased revenue Statement of Operations Summary (in thousands) | Metric | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $6,733 | $7,771 | $13,190 | $16,540 | | Loss from Operations | $(7,800) | $(17,018) | $(16,262) | $(48,139) | | Net Loss | $(6,857) | $(16,224) | $(9,958) | $(47,646) | | Net Loss Per Share | $(1.99) | $(14.41) | $(3.24) | $(47.50) | Condensed Consolidated Statements of Cash Flows Cash flow statements show significantly reduced cash used in operations, with financing activities providing capital, resulting in a net cash decrease Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,251) | $(49,109) | | Net cash (used in)/provided by investing activities | $(12,087) | $76,217 | | Net cash provided by/(used in) financing activities | $12,360 | $(23,596) | | Net (decrease)/increase in cash | $(6,011) | $3,485 | | Cash, cash equivalents and restricted cash at end of period | $3,562 | $21,833 | Notes to Condensed Consolidated Financial Statements Notes provide critical context, including a going concern warning due to recurring losses, and detail accounting policies, debt, and equity changes - The company effected a 1-for-60 reverse stock split on January 24, 2025. All share and per-share amounts have been retroactively adjusted25 - Management has substantial doubt about the company's ability to continue as a going concern within 12 months, citing recurring net losses, negative cash flows, and the need to raise additional funding2830 - As of June 30, 2025, the company had $12.1 million of principal outstanding under its Debentures and an accumulated deficit of $703.2 million29 Revenue by Source - Six Months Ended June 30 (in thousands) | Revenue Source | 2025 | 2024 | | :--- | :--- | :--- | | Instruments | $2,088 | $3,874 | | Consumables | $6,523 | $6,033 | | Software | $3,703 | $3,431 | | Total product revenue | $12,314 | $13,338 | | Service and other | $876 | $3,202 | | Total revenue | $13,190 | $16,540 | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses decreased revenue but improved net loss due to cost cuts, emphasizing a strategic shift and reiterating substantial doubt about going concern Overview and Recent Highlights The company's OGM system installed base grew, flowcell sales increased, but it faces slowdowns in the Asia Pacific region - The installed base of OGM systems grew to 378 as of June 30, 2025, up 4% from 363 a year prior124 - Flowcell sales increased by approximately 17% to 7,233 units in Q2 2025 compared to 6,165 in Q2 2024124 - The company is experiencing a slowdown in its Asia Pacific business due to regional headwinds and reliance on government funding by manufacturing partners125 Results of Operations Results show declining revenue but significantly improved profitability for Q2 and H1 2025, driven by substantial operating expense reductions Comparison of Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $6,733 | $7,771 | $(1,038) | (13)% | | Gross Profit | $3,477 | $2,585 | $892 | 35% | | Loss from Operations | $(7,800) | $(17,018) | $9,218 | (54)% | | Net Loss | $(6,857) | $(16,224) | $9,367 | (58)% | - The decrease in Q2 revenue was driven by a 38% drop in instrument sales and a 66% drop in service revenue, partially offset by a 28% increase in consumables sales138139 - Operating expenses in Q2 2025 decreased by 42% year-over-year, primarily due to headcount reductions and other cost-saving initiatives announced in 2023 and 2024137144145 Liquidity and Capital Resources The company faces critical liquidity issues and substantial doubt about its going concern, requiring additional capital in the near term - As of June 30, 2025, the company had $3.6 million in cash and cash equivalents, $12.9 million in short-term investments, and an accumulated deficit of $703.2 million164 - Management has determined there is substantial doubt about the company's ability to continue as a going concern, as available cash is not sufficient to operate for the next twelve months176 - Based on current plans, the company believes it can fund operations into the first quarter of 2026, but will require additional capital in the very near term to continue174 - In the first half of 2025, the company raised approximately $16.4 million in gross proceeds from sales of common stock and warrants through its ATM facilities and other offerings182 Item 3. Quantitative and Qualitative Disclosures about Market Risk The company is not required to provide this information as it qualifies as a smaller reporting company - As a smaller reporting company, Bionano Genomics is not required to provide the information for this item192 Item 4. Controls and Procedures Management concluded disclosure controls and procedures were effective, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report (June 30, 2025)195 - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls196 PART II. OTHER INFORMATION Item 1. Legal Proceedings The company reports no material legal proceedings - The company reports no material legal proceedings198 Item 1A. Risk Factors This section details significant risks, including financial viability, operational challenges, regulatory hurdles, intellectual property, and stock price volatility Risks related to our financial condition and need for additional capital The company faces substantial doubt about its going concern due to recurring losses, requiring immediate capital to avoid curtailing operations - The company has incurred recurring net losses since inception and expects losses to continue, with an accumulated deficit of $703.2 million as of June 30, 2025203 - There is substantial doubt about the company's ability to continue as a going concern, and without raising sufficient additional capital in the very near term, it may be required to curtail, liquidate, or cease operations entirely204 - The company's ability to raise capital may be limited by SEC rules, as its public float is less than $75.0 million, restricting the use of its Form S-3 shelf registration statement206 Risks related to our business operations Operational risks include acquisition integration, market acceptance, supply chain reliance, lengthy sales cycles, and international and data security challenges - Acquisitions could disrupt business, and the company may not achieve the expected revenues or synergies, as exemplified by the full impairment of goodwill and intangible assets from the Purigen and Lineagen acquisitions243250 - The company relies on a single contract manufacturer for its OGM systems and a limited number for its chip consumables, creating significant supply chain risk285 - The company's products are currently for Research Use Only (RUO), and any move toward clinical diagnostic use would require expensive and uncertain regulatory clearance from the FDA280 Risks related to government regulation and diagnostic product reimbursement Significant regulatory risks include FDA changes to LDTs, complex billing and reimbursement, and compliance with federal and state healthcare laws - A significant change in how the FDA regulates Laboratory Developed Tests (LDTs), which Bionano Laboratories provides, could materially harm the business338 - Billing for diagnostic testing is complex and subject to risks of non-payment, audits, and recoupment from payors, which could negatively affect revenue and cash flow343347 - The business is subject to numerous federal and state healthcare laws, including anti-kickback statutes and false claims laws, and non-compliance could result in substantial penalties368 Risks related to intellectual property Intellectual property risks include inadequate patent protection, potential challenges to existing patents, and costly infringement claims from third parties - The company relies on a global patent portfolio of over 135 issued patents, but cannot guarantee that pending applications will issue or that existing patents will not be challenged or invalidated378379 - Some of the company's intellectual property was developed with U.S. government funding and is subject to federal regulations, including "march-in" rights, which could limit exclusive rights385 - The company may be subject to costly litigation if sued for infringing on the intellectual property rights of third parties, which could result in injunctions or substantial damage awards391393 Risks related to ownership of our securities Risks for investors include high stock price volatility, potential failure of reverse stock splits, and anti-takeover provisions - The company's stock price has been and is expected to remain highly volatile, which could lead to significant investment losses421422 - The company has implemented multiple reverse stock splits to maintain its Nasdaq listing but cannot guarantee it will continue to meet the minimum bid price or other listing requirements428429433 - Anti-takeover provisions in the company's charter documents and Delaware law could delay or prevent a change of control, potentially limiting the market price of its securities446 Risks Related to Our Review of Strategic Alternatives Review of strategic alternatives offers no assurance of a transaction, potentially leading to dissolution and significant stockholder loss - The company is evaluating strategic alternatives, but there is no guarantee that any transaction will be pursued or successfully consummated453 - The process of evaluating strategic alternatives is costly and time-consuming, and may divert management's attention from the business455 - If a strategic transaction is not completed, the board may decide to pursue dissolution and liquidation, where the cash available for distribution to stockholders would be uncertain and could be minimal460 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period - None reported466 Item 3. Defaults Upon Senior Securities The company reports no defaults upon senior securities - None reported467 Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable468 Item 5. Other Information No director or officer adopted, terminated, or modified a Rule 10b5-1 trading arrangement during the quarter - No director or officer of the Company adopted, terminated or modified a Rule 10b5-1 trading arrangement during the three months ended June 30, 2025469 Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including corporate governance documents, securities forms, and certifications