Summary of Bionano Genomics Conference Call (October 15, 2025) Company Overview - **Company**: Bionano Genomics (NasdaqCM: BNGO) - **Industry**: Optical Genome Mapping (OGM) technology Key Points and Arguments OGM Technology - **Definition**: OGM is a workflow that allows clinical researchers to analyze DNA for diseases such as hematologic malignancies and genetic disorders, as well as in pharmaceutical drug development [2][3] - **Differentiation**: OGM analyzes ultra high molecular weight DNA segments (hundreds of thousands of base pairs) compared to traditional sequencing methods that analyze shorter segments (hundreds of base pairs) [4][8] - **Applications**: OGM is used for detecting large structural variations in DNA, which are critical in cancer research and genetic disease analysis [10][21] Market and Customer Base - **Target Customers**: Primarily cytogenetic laboratories within pathology departments, as well as molecular pathology departments [15][16] - **Existing Customers**: Includes major cancer centers like MD Anderson and Memorial Sloan Kettering, with an estimated 2,500 labs in the U.S. and Western Europe processing around 1 million samples annually [19][20] - **Market Potential**: The total addressable market includes an additional 7,500 laboratories globally that could adopt OGM in the future [52] Instruments and Software - **Instruments**: Two main systems, Saphyr and Stratus, with Stratus designed for higher throughput (up to 10,000 samples per year) compared to Saphyr (2,500 samples per year) [28][30] - **Software**: The Via software is used for analyzing and reporting variants from OGM and other genomic data, with a significant revenue stream from software sales [35][38] Financial Performance - **Revenue Breakdown**: Instruments and consumables generated approximately $5.5 million, while services and software contributed around $1.6 million [80] - **Revenue Guidance**: Expected revenue for 2025 is between $26 million and $30 million, with a focus on increasing utilization among existing customers [86][88] Competitive Landscape - **Market Position**: Bionano is the only company providing OGM technology, with a strong intellectual property portfolio protecting against competitors [78][79] - **Software Competition**: While there are other software platforms, Via is recognized as a leading tool for analyzing structural variations [41] Challenges and Barriers - **Adoption Barriers**: Initial skepticism regarding OGM's effectiveness has been addressed through numerous publications demonstrating its utility [66][67] - **CPT Codes**: The establishment of CPT codes for hematologic malignancies and constitutional genetic disorders has removed a significant barrier to adoption [69][70] Future Outlook - **Growth Strategy**: Focus on increasing utilization in existing labs rather than aggressive new customer acquisition, aiming for double-digit growth in consumables [86][88] - **Regulatory Environment**: Positive developments regarding FDA regulations and the absence of significant regulatory hurdles for laboratory-developed tests [76][77] Stock Performance - **Recent Challenges**: The company faced stock price contraction due to industry-wide issues and a reverse stock split, but recent financing has provided a runway for future growth [90][91] Additional Important Information - **Automation Solutions**: Bionano is working on automating the DNA isolation step to increase throughput in labs [72][73] - **Guidelines and Recommendations**: Efforts are underway to have OGM included in clinical guidelines, which would further drive adoption [74]

Summary of Bionano Genomics (BNGO) FY Conference Call Company Overview - **Company**: Bionano Genomics - **Industry**: Life Sciences Instrumentation, specifically focusing on genome analysis through Optical Genome Mapping (OGM) technology [1][2] Core Points and Arguments - **Optical Genome Mapping (OGM)**: Bionano's proprietary platform is transforming workflows in cytogenetics, particularly in hematological malignancies like leukemia and lymphoma. OGM consolidates traditional methods such as karyotyping and FISH into a single digital platform, offering faster results (four days vs. four weeks) and higher accuracy (up to 85% compared to 50% for karyotyping) [5][6] - **Market Segments**: Bionano identifies three key market segments for OGM: 1. **Hematologic Malignancies**: Focus on leukemias and lymphomas. 2. **Constitutional Genetic Disorders**: Applications in developmental delays and autism spectrum disorders. 3. **Pharmaceutical R&D**: Use in cell and gene therapies to confirm genetic analysis [8][9] - **Product Development**: The introduction of the Stratus platform, which has four times the throughput of the Sapphire system, is aimed at high-volume labs. Currently, there are around 20 Stratus systems in use [12][13] - **Software Integration**: The Via software automates the OGM workflow, allowing for streamlined analysis and reporting, which enhances laboratory efficiency [14][15] Financial Performance and Strategy - **Cost Management**: Bionano has reduced operating expenses by over $100 million, improving gross margins from 22% to 46% [16][18] - **Utilization Trends**: High-volume users are generating significant consumables revenue, with some customers running close to $1 million annually in consumables [16] - **Revenue Guidance**: The company anticipates revenue between $26 million to $30 million for the year, reflecting a year-over-year decrease due to macroeconomic constraints [40] Reimbursement and Adoption - **CPT Codes**: The establishment of category one CPT codes for OGM in hematologic malignancies and constitutional genetic disorders is expected to facilitate reimbursement and drive adoption [27][30] - **Market Stability**: The company reports stable demand in oncology, particularly in the U.S. and Europe, despite uncertainties in funding and economic conditions [42][44] Growth Potential - **International Expansion**: Bionano sees growth opportunities in regions like Turkey and China, where OGM has been integrated into clinical testing registries [46][47] - **Future Outlook**: The company aims to enhance customer support and training to increase utilization rates among existing users, rather than focusing solely on new system placements [38] Key Takeaways - **Unique Value Proposition**: Bionano's OGM technology is positioned as a complementary solution to existing sequencing technologies, offering unique advantages that are currently underappreciated in the market [50][51] - **Anticipated Developments**: The company expects progress in reimbursement landscapes and potential price adjustments for CPT codes, which could positively impact revenue [52][53] This summary encapsulates the key points discussed during the Bionano Genomics FY Conference, highlighting the company's strategic focus, market opportunities, and financial outlook.

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $6.5 million, a decrease of 26% compared to Q1 2024, which included $1.4 million from discontinued clinical services [7][11] - GAAP gross margin for Q1 2025 was 46%, significantly higher than 32% in Q1 2024 [9][17] - GAAP operating expenses decreased to $11.4 million in Q1 2025 from $33.9 million in Q1 2024, primarily due to cost-saving initiatives [9][16] Business Line Data and Key Metrics Changes - The installed base of OGM systems grew to 379, a 9% year-over-year increase, with nine new installations in Q1 2025 [10] - Flow cell sales totaled 6,994 in Q1 2025, reflecting a 15% decrease year-over-year, but a 1% increase when excluding new customer sales [8][11] Market Data and Key Metrics Changes - Cash, cash equivalents, and available-for-sale securities as of March 31, 2025, were $29.2 million, with $11 million subject to restrictions [10] - The company completed a $10 million registered direct offering in January 2025 and raised net proceeds of $3.2 million through ATM sales in Q1 2025 [10] Company Strategy and Development Direction - The company has shifted its strategy to focus on existing customers who use OGM products routinely, scaling back on new instrument placements [6][7] - The strategy includes four pillars: supporting the installed base, driving utilization through software adoption, facilitating reimbursement support, and improving profitability with lower costs [7] Management's Comments on Operating Environment and Future Outlook - Management expects full-year revenues to be in the range of $26 million to $30 million, reflecting current market turbulence [17] - Q2 revenues are anticipated to be between $6.3 million and $6.8 million, with expectations to install 15 to 20 new OGM systems throughout 2025 [18] Other Important Information - The first quarter of 2025 saw 95 publications related to OGM, indicating strong engagement in research and development [13] - The company is focused on reducing cash burn and increasing gross margin, with operating expenses down 66% year-over-year [16][17] Q&A Session Summary Question: Is MD Anderson a big customer currently? - MD Anderson is an existing user and has developed a validated workflow for OGM, indicating significant adoption and impact on their operations [21][22] Question: Is the mid-40% gross margin sustainable for the remainder of the year? - Management believes the gross margin will remain stable in the mid-40% range for the rest of the year, with potential for gradual improvement [23] Question: What steps are being taken to increase SAPIRI utilization among existing routine users? - The company is focusing on training customers in using the VIA software, supporting menu expansion, and improving overall workflow proficiency [40][42]