Core Insights - Bionano Genomics showcased the advancements of optical genome mapping (OGM) at the AMP Annual Meeting, emphasizing its superior ability to detect structural variants compared to traditional methods [1][4] - The conference featured thirteen studies demonstrating OGM's effectiveness in identifying clinically relevant structural variants, highlighting its potential as a high-resolution technique for understanding complex diseases [2][3] Group 1: OGM Utility and Applications - OGM has been integrated into laboratory workflows, enhancing its application in clinical and translational research settings [3] - Key studies presented included applications of OGM in recurrent pregnancy loss, pediatric low-grade gliomas, and various hematological malignancies [3] Group 2: Research Highlights - Notable presentations included the use of OGM for genome-wide structural variant detection in fresh-frozen tissue and its complementarity with next-generation sequencing in multiple myeloma [3] - The studies collectively illustrate OGM's capacity to uncover genetic mechanisms driving diseases, reinforcing its role in modern genomics [2][3] Group 3: Company Commitment - Bionano Genomics is dedicated to innovating and expanding its OGM platform, aiming to make comprehensive structural variant analysis routine and accessible [4]

Core Insights - Bionano Laboratories announced a significant increase of 47% in the clinical lab fee schedule for the CPT code 81195, raising it from $1263.53 to $1853.22, effective January 1, 2026, which pertains to optical genome mapping (OGM) for hematologic malignancies [1][2][4] Summary by Sections Payment Determination - The Centers for Medicare & Medicaid Services (CMS) previously set the payment for CPT code 81195 at $1263.53, effective January 1, 2025, based on a crosswalk to an existing code. A request for reconsideration led to a unanimous vote by the clinical diagnostic laboratory test committee to re-price the code to $1853.22, effective January 1, 2026 [2] Importance of CPT Codes - CPT codes for OGM are essential for reimbursement from third-party payers for Bionano Laboratories' laboratory developed tests (LDTs). Currently, there are two codes: 81195 for hematologic malignancy analysis and 81354 for constitutional genetic disease [3] Impact on OGM Services - The increase in reimbursement for CPT code 81195 is expected to facilitate the offering of OGM-based LDTs for hematologic malignancies, as it provides a more favorable reimbursement environment. The new payment level is deemed appropriate for the additional data collection and reporting required for OGM in blood cancers [4] Company Overview - Bionano Laboratories, a subsidiary of Bionano Genomics, specializes in optical genome mapping (OGM) testing and offers a range of diagnostic services. The company aims to transform genome analysis through advanced technologies and provides OGM solutions for various research applications [5][6]

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Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $7.4 million, reflecting a 21% increase compared to Q3 2024. Adjusting for a $0.5 million write-down in 2024, core revenues increased by 12% year over year [6][7] - Non-GAAP gross margin for Q3 2025 was 46%, significantly higher than the 26% reported for Q3 2024 [7][11] - Non-GAAP operating expenses were $9.7 million in Q3 2025, a 40% reduction compared to $16.1 million in Q3 2024 [7][10] Business Line Data and Key Metrics Changes - A record 8,390 flow cells were sold in Q3 2025, reflecting a 7% increase compared to the same period last year [7] - Revenue contributions from consumables and software grew 15% year over year in Q3 2025, representing 72% of the total product mix [9] Market Data and Key Metrics Changes - In Q3 2025, there were 97 new publications demonstrating the value of optical genome mapping, a 10% growth over the same period the previous year [12] - The cumulative number of clinical research genomes published reached nearly 11,500, supporting the adoption of optical genome mapping [12] Company Strategy and Development Direction - The company is focusing on transforming pathology from analog to digital, with a strategy centered on routine users who have established sample flows [4][5] - Four strategic pillars include supporting the installed base, driving software utilization, building reimbursement support, and improving profitability and scalability [5] Management's Comments on Operating Environment and Future Outlook - The company reiterated its full-year 2025 revenue guidance of $26-30 million, expecting Q4 revenues to be in the range of $7.5-$7.9 million [17][18] - Management expressed confidence in the ongoing growth of utilization among routine users, aiming for an average of low 20s samples per week across all routine users [20] Other Important Information - The company completed a $10 million public offering of common stock, enhancing its balance sheet and extending its cash runway into Q3 2026 [8] - The establishment of a second category one CPT code for optical genome mapping is seen as a significant milestone for the community [16][17] Q&A Session Summary Question: What is the potential peak level of utilization for routine use customers? - Management indicated that labs are not sample-limited and that the average utilization is about four samples per week, with a target of reaching the low 20s on average across routine users [19][20] Question: What is the current install base in Japan and its market potential? - Currently, there is one system installed in Japan, with expectations for the market to evolve similarly to the U.S. market over time, particularly in genetic diseases and cell and gene therapy [21][22] Question: Will operating expenses remain stable going forward? - Management intends to keep operating expenses flat, with some areas identified for potential investment [23]

Financial Performance - Revenue reached $7.4 million, a 21% increase compared to Q3 2024[13] - Core revenue increased by 12% compared to Q3 2024[13] - Non-GAAP gross margin improved to 46%, significantly higher than the 26% in Q3 2024[13] - Non-GAAP operating expenses decreased by 40% compared to Q3 2024, totaling $9.7 million[13] Operational Highlights - Flowcells sold increased by 7% to 8,390 compared to Q3 2024[13] - The OGM installed base grew by 4% compared to Q3 2024, reaching 384 systems[13] - Seven new OGM installations were completed in Q3 2025, bringing the year-to-date total to 23[13] Strategic Focus and Outlook - The company completed a $10 million public offering of common stock in September 2025[13] - Cash, cash equivalents, and available-for-sale securities totaled $31.8 million as of September 30, 2025[13] - The company is reiterating its full-year 2025 revenue guidance of $26 - $30 million[30] - The company expects new OGM installations to surpass 25 systems for FY 2025, exceeding prior expectations of 20-25 systems[30]

Revenue and Sales Performance - The installed base of OGM systems grew to 384 as of September 30, 2025, representing a 4% increase from 368 as of September 30, 2024[136] - A total of 8,390 flowcells were sold in the three-month period ended September 30, 2025, a 7% increase from 7,835 flowcells sold in the same period of 2024[136] - Product revenue for the three months ended September 30, 2025, was $6,934,000, compared to $6,021,000 for the same period in 2024, reflecting a year-over-year increase[142] - Total revenue for the three months ended September 30, 2025, was $7.37 million, a 21% increase from $6.07 million in 2024[150] - Product revenue increased by $0.9 million, or 15%, to $6.9 million for the three months ended September 30, 2025, compared to $6.0 million for the same period in 2024[151] - Service and other revenue increased by $0.4 million, or 733%, to $0.4 million for the three months ended September 30, 2025, compared to the same period in 2024[152] - Product revenue decreased by $0.1 million, or 1%, to $19.2 million for the nine months ended September 30, 2025, compared to $19.4 million for the same period in 2024, driven by a 30% decrease in instrument sales[165] - Service and other revenue decreased by $1.9 million, or 60%, for the nine months ended September 30, 2025, due to the discontinuation of certain clinical service offerings, contributing no revenue in 2025 compared to $1.7 million in 2024[166] Financial Performance and Losses - The net loss for the three months ended September 30, 2025, was $8.5 million, with an accumulated deficit of $711.7 million as of the same date[147] - The company incurred net losses of $18.5 million for the nine months ended September 30, 2025, compared to $91.9 million in 2024, with cash and cash equivalents of $3.1 million as of September 30, 2025[178] - Net loss for the three months ended September 30, 2025, was $8.5 million, an improvement of $35.7 million, or 81%, from a net loss of $44.2 million in 2024[150] Operating Expenses and Cost Management - Total operating expenses decreased by $23.5 million, or 66%, to $11.9 million for the three months ended September 30, 2025, compared to $35.5 million in 2024[150] - Cost of product revenue decreased by $10.4 million, or 73%, to $3.8 million for the three months ended September 30, 2025, compared to $14.3 million in 2024[153] - Research and development expenses decreased by $1.9 million, or 40%, to $2.8 million for the three months ended September 30, 2025, compared to $4.7 million in 2024[157] - Selling, general and administrative expenses decreased by $0.4 million, or 4%, to $9.1 million for the three months ended September 30, 2025, compared to $9.5 million in 2024[158] - Research and Development (R&D) expenses decreased by $13.2 million, or 62%, to $8.1 million for the nine months ended September 30, 2025, due to headcount reductions and decreased consulting fees[172] - Selling, General and Administrative (SG&A) expenses decreased by $13.7 million, or 34%, to $26.4 million for the nine months ended September 30, 2025, driven by reductions in salaries and professional fees[173] Cash Flow and Liquidity - As of September 30, 2025, the company had $3.1 million in cash and cash equivalents, $18.5 million in short-term investments, and $10.3 million in restricted short-term investments[194] - Net cash used in operating activities was $12.2 million for the nine months ended September 30, 2025, a decrease of $50.2 million compared to $62.4 million in the same period in 2024[198] - Net cash provided by financing activities was $22.4 million during the nine months ended September 30, 2025, compared to net cash used of $17.6 million in the same period in 2024, an increase of $40.0 million[200] - The company expects to require additional capital to fund operating expenses and capital expenditures into the third quarter of 2026[192] - The company anticipates that its available cash balance will not be sufficient to operate its business for the next twelve months, indicating substantial doubt about its ability to continue as a going concern[194] Market and Operational Challenges - The company has experienced a slowdown in its Asia Pacific business, negatively impacting its manufacturing partners reliant on government funding[137] - The company is closely monitoring the potential impact of the U.S. government shutdown on its manufacturing partners and customers[141] - The company expects to continue incurring significant expenses and operating losses, raising substantial doubt about its ability to continue as a going concern within the next 12 months[147] Stock and Securities - The combined purchase price for each share of common stock and accompanying January Purchase Warrant was $15.120, with gross proceeds from the January 2025 offering approximately $10.0 million[187] - The September 2025 Offering included 4.9 million shares of common stock and generated approximately $10.0 million in gross proceeds[189] - The company sold approximately 2.0 million shares of common stock under the ATM Agreement at an average price of $3.68 per share, generating gross proceeds of approximately $7.4 million[203] - The company has a universal shelf registration statement allowing for aggregate offerings of up to $400.0 million of various securities[202] Accounting and Reporting - The management's discussion and analysis is based on unaudited condensed consolidated financial statements prepared in accordance with generally accepted accounting principles[206] - There have been no changes to critical accounting policies and estimates during the nine months ended September 30, 2025[207] - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[210]

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Financial Performance - Total revenue for Q3 2025 was $7.4 million, a 21% increase from $6.1 million in Q3 2024[5] - Total revenue for Q3 2025 was $7,367,000, a 21.3% increase from $6,073,000 in Q3 2024[20] - Product revenue increased to $6,934,000 in Q3 2025 from $6,021,000 in Q3 2024, representing a 15.2% growth[20] - Net loss for Q3 2025 was $8,503,000, compared to a net loss of $44,246,000 in Q3 2024, indicating a significant reduction in losses[20] Revenue Guidance - Full year 2025 revenue guidance is reiterated in the range of $26.0 to $30.0 million[7] - Q4 2025 revenue is expected to be between $7.5 and $7.9 million[7] Cost Management - Operating expenses were reduced by 66% to $11.9 million, with non-GAAP operating expenses down 40% to $9.7 million[5] - Research and development expenses for Q3 2025 were $2,844,000, down from $4,717,000 in Q3 2024, reflecting a 39.7% decrease[20] - Selling, general and administrative expenses were $9,064,000 in Q3 2025, slightly lower than $9,464,000 in Q3 2024[20] Profitability Metrics - Gross margin improved to 46%, up from (139)% in Q3 2024, with non-GAAP gross margin also at 46% compared to 26% in the prior year[5] - GAAP gross margin for Q3 2025 improved to 46% from a negative 139% in Q3 2024[22] - Non-GAAP gross profit for Q3 2025 was $3,401,000, compared to $1,597,000 in Q3 2024, showing a substantial improvement[22] Cash and Assets - The company ended Q3 2025 with cash and equivalents totaling $31.8 million[5] - Total current assets increased to $48,800,000 as of September 30, 2025, up from $39,489,000 as of December 31, 2024[18] - Total stockholders' equity increased to $49,799,000 as of September 30, 2025, up from $35,375,000 as of December 31, 2024[18] Product and Installation Metrics - Consumables and software revenues increased by 15% compared to the prior year[5] - The company sold 8,390 nanochannel array flowcells in Q3 2025, a 7% increase from 7,835 in Q3 2024[5] - Installed base of OGM systems reached 384, representing a 4% increase from 368 systems at the end of Q3 2024[5] - New OGM system installations are anticipated to exceed 25 for the full year 2025, up from previous expectations of 20 to 25[7] Liabilities - Total liabilities decreased to $29,263,000 as of September 30, 2025, down from $41,295,000 as of December 31, 2024[18]

Core Insights - Bionano Genomics reported a total revenue of $7.4 million for Q3 2025, marking a 21% increase from $6.1 million in Q3 2024, despite a prior year write-down of $0.5 million in clinical services revenue [5][20] - The company has shifted its business model to focus on consumables and software utilization, which has led to improved margins and reduced operating expenses [2][5] - Bionano's gross margin for Q3 2025 was 46%, a significant recovery from (139)% in Q3 2024, indicating a positive trend in financial performance [5][20] Financial Performance - Total revenue for Q3 2025 was $7.4 million, up 21% from $6.1 million in Q3 2024 [5] - Consumables and software revenues increased by 15% year-over-year [5] - Operating expenses were reduced by 66% to $11.9 million, and non-GAAP operating expenses decreased by 40% to $9.7 million [5][20] - The company ended Q3 2025 with cash and equivalents totaling $31.8 million [5] Business Highlights - Bionano sold 8,390 nanochannel array flowcells in Q3 2025, a 7% increase from 7,835 flowcells sold in Q3 2024 [5] - The installed base of optical genome mapping (OGM) systems reached 384, a 4% increase from 368 systems at the end of Q3 2024 [5] - The company completed a public offering in September 2025, raising $10 million in gross proceeds [6] Market Outlook - Bionano anticipates Q4 2025 revenue in the range of $7.5 to $7.9 million and full-year revenue between $26.0 to $30.0 million [11] - The company expects to install over 25 new OGM systems in 2025, exceeding previous expectations of 20 to 25 installations [11]

Core Insights - Bionano Genomics announced a study demonstrating that optical genome mapping (OGM) can effectively address limitations of targeted RNA-sequencing (RNA-seq) in detecting gene rearrangements in acute leukemias [1][4][5] Summary of Findings - The study published by The University of Texas MD Anderson Cancer Center indicates that OGM can identify a higher proportion of clinically significant structural variants (SVs) compared to a 108-gene targeted RNA-seq panel [4][5] - A total of 234 gene rearrangements or fusions were detected by OGM and/or RNA-seq across 206 subjects, representing 43.6% of a cohort of 467 acute leukemia research subjects [8] - OGM uniquely identified 37 events (15.8%), while RNA-seq uniquely identified 22 events (9.4%), highlighting the complementary nature of both technologies [8] - RNA-seq detected only 20.6% of the enhancer-hijacking events identified by OGM, emphasizing the importance of OGM in detecting critical gene rearrangements [8] Company Overview - Bionano Genomics provides genome analysis solutions aimed at transforming the understanding of the genome through OGM, diagnostic services, and software [6] - The company offers OGM solutions applicable across various research domains, along with a platform-agnostic genome analysis software and nucleic acid extraction solutions [6]