Financial Data and Key Metrics Changes - The meeting reported that the proposal to elect Eric Holmlin, PhD, and David Barker, PhD, as class one directors was carried, indicating a positive outcome for governance [15] - The advisory vote on the compensation of the company's named executive officers was approved, reflecting shareholder support for executive pay [15] - The selection of BDO USA PC as the independent registered public accounting firm for the fiscal year ending December 31, 2025, was ratified, ensuring continuity in auditing [15] - The share issuance proposal was approved, allowing for the issuance of up to 661,374 shares of common stock [12][15] Business Line Data and Key Metrics Changes - No specific data on business lines or key metrics was provided during the meeting Market Data and Key Metrics Changes - No specific market data or key metrics were discussed during the meeting Company Strategy and Development Direction and Industry Competition - The meeting did not provide detailed insights into the company's strategic direction or competitive landscape Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments regarding the operating environment or future outlook during the meeting Other Important Information - The meeting was held virtually, with stockholders attending via a web portal, indicating a shift towards digital engagement [2][4] - A quorum was established with 47.8% of outstanding shares represented, allowing the meeting to proceed with official business [6] Q&A Session All Questions and Answers Question: Are there any questions regarding the proposals? - No questions were received from stockholders during the Q&A session, leading to the conclusion of the meeting [17]

Core Insights - Bionano Laboratories announced the establishment of a new Category I CPT code for optical genome mapping (OGM) in cytogenomic genome-wide analysis, effective January 1, 2026, which is crucial for reimbursement from third-party payers [1][2][3] Group 1: CPT Code Significance - The new CPT code is the second issued for OGM, following code 81195 established in 2024 for hematological malignancies, indicating that OGM has met rigorous Category I standards [2] - The approval of this CPT code is expected to enhance the awareness and utility of OGM in both oncology and clinical genetic testing communities [3] Group 2: Bionano Laboratories' Offerings - Bionano Laboratories provides CLIA-certified laboratory developed tests (LDTs) utilizing OGM technology to detect structural and copy number variations related to genetic disorders [1][4] - The OGM-Dx Postnatal and Prenatal Whole Genome SV tests are designed to detect all classes of structural variants traditionally tested by multiple methods, showcasing the advantages of OGM over legacy methods [3] Group 3: Company Overview - Bionano Genomics aims to transform genome analysis through OGM solutions, diagnostic services, and software, catering to applications across basic, translational, and clinical research [5]

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, while non-GAAP gross margin also stood at 46% compared to 34% in the prior year [9][17] - GAAP operating expenses decreased to $11.4 million in Q1 2025 from $33.9 million in Q1 2024, driven by cost-saving initiatives [9][16] Business Line Data and Key Metrics Changes - The installed base of OGM systems grew to 379, reflecting a 9% year-over-year increase with nine new installations in Q1 2025 [10] - Flow cell sales totaled 6,994 in Q1 2025, a 15% decrease year-over-year, but a 1% increase when excluding sales to new customers [8][12] 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 customer acquisition costs [6] - The strategy includes four pillars: support for the installed base, drive utilization through software adoption, build support for reimbursement, and improve profitability with lower costs [7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the installed base's potential for growth and profitability, despite current challenges in equity capital markets and global trade [6][16] - The company expects full-year revenues to range from $26 million to $30 million, reflecting the current market turbulence [17] Other Important Information - The first quarter of 2025 saw 95 publications related to OGM, indicating strong engagement in the research community [14] - Significant studies published by leading institutions highlight the clinical utility of optical genome mapping, which may drive further adoption [15] 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 strong adoption and potential for broader use [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 year, with potential for gradual improvement [23] Question: Can you provide more details on the global trade situation and supply chain? - The company has limited exposure to supply chain issues currently, but is monitoring the situation closely due to half of its revenues coming from outside the U.S. [24][26] Question: How is the category one CPT code impacting customer adoption? - The establishment of the CPT code is seen as a significant tailwind for reducing barriers to adoption among prospective customers [30][31] Question: What steps are being taken to increase SAPIRI utilization among existing routine users? - The company is focusing on software proficiency, menu expansion, and overall workflow proficiency to drive increased utilization [41][44]

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]

Financial Performance - Total revenue for the three months ended March 31, 2025, was $6,457,000, down from $8,769,000 in the same period of 2024, reflecting a decline of approximately 26.4%[127] - Product revenue for the three months ended March 31, 2025, was $6,004,000, compared to $6,828,000 for the same period in 2024, indicating a decrease of about 12.1%[127] - Service and other revenue dropped to $453,000 for the three months ended March 31, 2025, from $1,941,000 in the same period of 2024, a decline of approximately 76.7%[127] - Total revenue decreased by $2.3 million, or 26%, to $6.5 million for the three months ended March 31, 2025, compared to $8.8 million for the same period in 2024[136] - Product revenue decreased by $0.8 million, or 12%, to $6.0 million, driven by a 57% decrease in instrument sales and a 6% decrease in consumable sales[137] - Service and other revenue decreased by $1.5 million, or 77%, due to the discontinuation of certain clinical service offerings, contributing no revenue in 2025 compared to $1.4 million in 2024[138][139] - The net loss for the three months ended March 31, 2025, was $3.1 million, with an accumulated deficit of $696.3 million as of the same date[132] - Net loss improved by $28.3 million, or 90%, to $3.1 million for the three months ended March 31, 2025, compared to a net loss of $31.4 million for the same period in 2024[150] Revenue by Region - Revenue from the Americas was $3,058,000, accounting for 47% of total revenue, down from $4,690,000 (53%) in the same period of 2024[128] - EMEA revenue was $3,066,000, representing 47% of total revenue, compared to $3,133,000 (36%) in the same period of 2024[128] - Asia Pacific revenue fell to $333,000, making up 5% of total revenue, down from $946,000 (11%) in the same period of 2024[128] Operating Expenses - Total operating expenses decreased by $22.5 million, or 66%, to $11.4 million for the three months ended March 31, 2025, compared to $33.9 million for the same period in 2024[136] - Research and development expenses decreased by $7.4 million, or 76%, to $2.4 million, primarily due to headcount reductions and decreased professional fees[144] - Selling, general and administrative expenses decreased by $10.1 million, or 53%, to $9.0 million, driven by reductions in salaries and consulting fees[145] Cash Flow and Liquidity - As of March 31, 2025, the company had cash and cash equivalents of $3.6 million and an accumulated deficit of $696.3 million[150] - The net cash used in operating activities was $2.8 million for the three months ended March 31, 2025, a significant decrease of $25.4 million compared to $28.1 million in the same period in 2024, attributed to reduced net loss and working capital usage[167] - Net cash provided by financing activities was $10.9 million during the three months ended March 31, 2025, compared to a net cash outflow of $21.6 million in the same period in 2024, marking an increase of $32.5 million[169] - The cash flow from investing activities was a net outflow of $14.1 million for the three months ended March 31, 2025, compared to a net inflow of $47.6 million in the same period in 2024, primarily due to changes in available-for-sale securities[168] - As of March 31, 2025, the Company had $3.6 million in cash and cash equivalents, $14.6 million in short-term investments, and $11.0 million in restricted short-term investments, indicating liquidity challenges ahead[163] Future Outlook and Financing - The Company anticipates needing to raise substantial additional capital to continue operations beyond the next twelve months, with significant doubt about its ability to continue as a going concern[163] - The Company expects to incur additional costs for capital expenditures related to scaling operations and increasing manufacturing capacity throughout 2025[161] - The Company entered into a securities purchase agreement on January 3, 2025, to issue approximately 382,000 shares of common stock and warrants, with gross proceeds expected to be around $10.0 million[158] - The Company sold approximately 0.1 million shares of common stock under the Cowen ATM in January 2025, receiving gross proceeds of approximately $1.9 million[171] - The Company entered into an At The Market Offering Agreement with Wainwright on February 21, 2025, allowing for the sale of up to $75.0 million in common stock[172] - The Company has established a strategy committee to evaluate options for maximizing stakeholder value, including potential debt financing and equity investments[164] Instrument Sales and Installed Base - The installed base of OGM instruments grew to 379 as of March 31, 2025, representing a 9% increase from 347 as of March 31, 2024[121] - A total of 6,994 flowcells were sold in the three-month period ended March 31, 2025, a decrease of approximately 15% from 8,249 flowcells sold in the same quarter of 2024[121] Other Income and Interest - Interest income decreased by $0.7 million, or 72%, to $0.3 million, reflecting a reduction in investments[148] - Other income increased by $6.5 million, resulting in total other income of $5.4 million for the three months ended March 31, 2025, compared to an expense of $1.4 million in 2024[149] Classification - The company is classified as a smaller reporting company and is not required to provide the information required by Item 3[179]

Revenue Performance - Total revenue for Q1 2025 was $6.5 million, a decrease of 26% compared to $8.8 million in Q1 2024[7] - Total revenue for the three months ended March 31, 2025, was $6,457,000, a decrease of 26.3% compared to $8,769,000 for the same period in 2024[20] - Product revenue decreased to $6,004,000 from $6,828,000, representing a decline of 12.1% year-over-year[20] - Service and other revenue fell significantly to $453,000 from $1,941,000, a decrease of 76.7%[20] - Updated full year 2025 revenue guidance is projected to be between $26.0 million and $30.0 million[7] Operating Expenses - First quarter 2025 GAAP operating expense was $11.4 million, a decrease of 66% compared to $33.9 million in Q1 2024[7] - Total operating expenses for the quarter were $11,403,000, down 66.5% from $33,947,000 in the prior year[20] Gross Margin - GAAP gross margin for Q1 2025 was 46%, up from 32% in Q1 2024[7] - GAAP gross margin improved to 46% from 32% year-over-year, indicating better cost management[22] - Adjusted non-GAAP gross margin remained stable at 46%, compared to 34% in the previous year[22] Sales and Installations - Sold 6,994 nanochannel array flowcells in Q1 2025, a decrease of 15% from 8,249 flowcells sold in Q1 2024[4] - 82% of flowcells sold in Q1 2025 were to routine users of OGM[4] - Installed 9 new OGM systems, bringing the total installed base to 379, a 9% increase from 347 systems at the end of Q1 2024[4] - Anticipating installation of 15 to 20 new OGM systems in full year 2025[7] Financial Position - Cash, cash equivalents, and short-term investments as of March 31, 2025, were $29.2 million[7] - Total current assets increased to $44,929,000 from $39,489,000, reflecting a growth of 14.0%[18] - Total liabilities decreased to $30,226,000 from $41,295,000, a reduction of 26.8%[18] - Stockholders' equity rose to $48,188,000 from $35,375,000, an increase of 36.2%[18] Net Loss - The net loss for the three months ended March 31, 2025, was $3,102,000, compared to a net loss of $31,422,000 for the same period in 2024[20] Capital Raising - Completed a $10 million Registered Direct Offering in January 2025, raising net proceeds of $3.2 million through ATM sales in Q1 2025[4]

Core Viewpoint - Bionano Genomics, Inc. reported its Q1 2025 financial results, highlighting a strategic shift towards routine users of optical genome mapping (OGM) and VIA™ software, which are now primary revenue drivers. The company has achieved operational efficiencies, reduced costs, and extended its cash runway while maintaining a growing user base in the OGM community [2][4]. Recent Highlights - The company sold 6,994 nanochannel array flowcells in Q1 2025, a 15% decrease from 8,249 in Q1 2024. However, sales to existing customers increased by 1% after adjusting for new customer sales [5]. - 82% of flowcells sold in Q1 2025 were to routine OGM users [5]. - Installed 9 new OGM systems, bringing the total to 379, a 9% increase from 347 systems at the end of Q1 2024 [5]. - Significant publications in the field, including expert recommendations for OGM as a standard cytogenetic assay and studies demonstrating OGM's effectiveness in various applications [5]. Q1 2025 Financial Results - Total revenue for Q1 2025 was $6.5 million, down 26% from $8.8 million in Q1 2024. The decline was attributed to the absence of revenue from discontinued clinical services and a decrease in instrument sales [5][19]. - GAAP gross margin improved to 46% in Q1 2025 from 32% in Q1 2024. Non-GAAP gross margin also increased to 46% from 34% [5][20]. - GAAP operating expenses were $11.4 million, a 66% decrease from $33.9 million in Q1 2024, primarily due to headcount reductions and restructuring [5][19]. Cash Position and Future Guidance - As of March 31, 2025, the company had cash and equivalents of $29.2 million [5]. - For Q2 2025, the company anticipates revenue between $6.3 million and $6.8 million, with full-year revenue guidance of $26 million to $30 million [12]. - The company plans to install 15 to 20 new OGM systems throughout 2025 [12].

Core Viewpoint - Bionano Genomics, Inc. will host a conference call and live webcast on May 14, 2025, to report its financial results for the first quarter of 2025 and discuss recent corporate developments [1]. Group 1: Conference Call & Webcast Details - The conference call is scheduled for May 14, 2025, at 4:30 p.m. Eastern Time [2]. - Participants can register for the call and access a live webcast through the Bionano website [2]. - A replay of the conference call and webcast will be available on Bionano's investor relations website for at least 30 days [2]. Group 2: Company Contacts - Erik Holmlin is the CEO of Bionano Genomics, Inc., and can be contacted at +1 (858) 888-7610 or eholmlin@bionano.com [3]. - Investor relations are managed by David Holmes from Gilmartin Group, who can be reached at +1 (858) 888-7625 or IR@bionano.com [3].

Core Insights - Bionano Laboratories has announced expert recommendations for integrating Optical Genome Mapping (OGM) as a standard-of-care cytogenetic assay in various clinical settings, as published in the American Journal of Hematology [1][2] Group 1: Expert Recommendations - OGM is recommended as a first-line test for Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Myeloproliferative Neoplasms (MPN), B-cell Acute Lymphoblastic Leukemia (B-ALL), T-cell Acute Lymphoblastic Leukemia (T-ALL), pediatric leukemias, and unexplained eosinophilia [3] - OGM is suggested as an alternative to traditional methods like karyotyping, FISH, and CMA for Chronic Lymphocytic Leukemia (CLL), Plasma Cell Neoplasms/Multiple Myeloma, aplastic anemia, bone marrow failure syndromes, and germline predisposition syndromes [4] Group 2: Advantages of OGM - OGM provides higher diagnostic clarity and simplifies laboratory workflows, making it more cost-effective with faster turnaround times [5] - OGM allows for the identification of cryptic gene fusions for which targeted therapies may be available, improving risk stratification and guiding targeted therapy [7] - OGM can resolve complex or ambiguous chromosomal abnormalities and is effective for low-frequency or rare hematologic malignancies [7] Group 3: Company Overview - Bionano Laboratories offers CLIA-certified laboratory developed tests (LDTs) based on OGM, aiming to transform genome analysis in clinical diagnostics [1][9] - The company provides a comprehensive testing portfolio and support options for applications across basic, translational, and clinical research [8][9]

Core Insights - Bionano Genomics, Inc. announced a peer-reviewed publication demonstrating that optical genome mapping (OGM) is an accurate and cost-effective method for detecting and sizing large repeat expansions linked to 40 genetic disorders [1][3] - The study evaluated 85 subjects with known pathogenic expansions in three genes, providing a comprehensive assessment of OGM's capabilities [1][4] Group 1: Study Findings - OGM identified 84 out of 85 pathogenic repeat expansions, achieving a detection accuracy of 98.8% [7] - OGM measured repeat sizes accurately, even for expansions exceeding 7,000 repeat units, indicating no apparent upper size limit [7] - Evidence of somatic instability was found in 36 out of 85 samples, with variability observed in 30% of DMPK samples, 92% of CNBP samples, and 16% of RFC1 samples [7] Group 2: Methodological Advantages - OGM provides a single technique workflow that detects large repeat expansions across multiple loci, potentially reducing turnaround times and lowering costs compared to traditional methods [4][7] - The study highlights OGM's potential to address long-standing challenges in genome analysis, including structural variation and repeat expansion detection [3][4] Group 3: Company Overview - Bionano is a provider of genome analysis solutions aimed at transforming the understanding of the genome through OGM solutions, diagnostic services, and software [5] - The company offers OGM solutions for various applications in basic, translational, and clinical research, along with industry-leading genome analysis software [5]