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]

Core Insights - Bionano Genomics has announced a study that presents a new method for analyzing multiple myeloma (MM) using optical genome mapping (OGM), which addresses challenges in traditional cytogenetic analysis [1][3] - The study indicates that the new OGM method can reduce the required number of CD138-positive cells for analysis by half, making it easier to analyze limited samples [1][7] - OGM has shown a 93% concordance rate with the traditional FISH method while uncovering over 22 additional genetic variants not detected by FISH, enhancing the understanding of MM [7] Company Overview - Bionano Genomics specializes in genome analysis solutions aimed at transforming genomic research through OGM technology, diagnostic services, and software [4] - The company provides OGM solutions applicable across various research fields, including basic, translational, and clinical research [4] - Bionano also offers a platform-agnostic genome analysis software and nucleic acid extraction solutions using proprietary isotachophoresis technology [4] Industry Context - Multiple myeloma is a significant focus for researchers looking to implement OGM in routine clinical use, highlighting a substantial unmet medical need in the field of hematologic malignancies [3] - The publication of the study is seen as a pivotal advancement for OGM research in the context of blood cancers, potentially expanding the application of OGM in clinical settings [3][8]

Core Insights - Bionano Genomics has announced a study that presents a new method for analyzing multiple myeloma (MM) using optical genome mapping (OGM), which addresses challenges in traditional cytogenetic methods [1][3] - The study indicates that the new OGM method can reduce the required number of CD138-positive cells for analysis by half, making it easier to analyze limited samples [1][3] - OGM has shown a 93% concordance rate with the current standard method, FISH, while also identifying over 22 additional genetic variants not detected by FISH [6] Company Overview - Bionano Genomics specializes in genome analysis solutions aimed at transforming genomic research and diagnostics through OGM technology [4] - The company provides OGM solutions for various research applications and offers diagnostic testing services through its subsidiary, Lineagen, Inc. [4] - Bionano's mission is to enhance the understanding of the genome, which is critical for addressing complex biological and medical questions [4]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $8.2 million, a decrease of 24% compared to Q4 2023, which included $2 million from discontinued clinical services [9] - GAAP gross margin for Q4 2024 was 42%, significantly higher than the 23% reported in Q4 2023 [9] - Non-GAAP gross margin for Q4 2024 was also 42%, compared to 24% in Q4 2023 [9] - GAAP operating expense for Q4 2024 was $15.4 million, down from $27.4 million in Q4 2023 [9][10] - Cash, cash equivalents, and available-for-sale securities as of December 31, 2024, were $20.9 million, with $11.4 million subject to restrictions [11] - Full year 2024 GAAP operating expense was $104.4 million, while non-GAAP operating expense was $68.9 million [13] Business Line Data and Key Metrics Changes - Product revenues for the full year were $27 million, a 1% increase from $26.7 million in 2023, despite a nearly $2 million reduction in instrument sales [12] - Consumables sales were $12.8 million, a 14% increase from $11.2 million in 2023 [12] - Software sales for the full year were $6.2 million, an 11% increase from $5.6 million in 2023 [12] Market Data and Key Metrics Changes - Sales in the Americas region were up 9% in 2024, while sales in the Europe, Middle East, and Africa region were up 10% compared to 2023 [13] - A total of 30,307 nanochannel array flow cells were sold during 2024, including 8,058 in Q4, representing a 15% increase over the 26,444 sold in 2023 [13] Company Strategy and Development Direction - The company is focusing on a recalibration period in the life sciences and tools industry, emphasizing the importance of optical genome mapping (OGM) [15] - A shift in go-to-market strategy was implemented in September 2024, focusing on conserving cash and supporting existing customers rather than aggressively acquiring new ones [16] - The strategy includes four key pillars: supporting the installed base, driving utilization through software adoption, building reimbursement support, and improving profitability [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth of consumable sales despite a focus on existing customers, indicating that a core group of 118 customers accounts for over 80% of consumables purchases [18] - The company expects full year revenues for 2025 to be in the range of $29 to $32 million, with first quarter revenues expected to be between $6.2 million and $6.3 million [24] Other Important Information - The company has seen a 19% growth in total publications and a 39% growth in publications related to clinical research and cell and gene therapy in 2024 [21] - A Category 1 CPT code for OGM use in hematologic malignancies became effective on January 1, 2025, which is expected to drive further adoption [22][66] Q&A Session Summary Question: Guidance on core revenue growth for 2025 - Management indicated that the guidance of $29 to $32 million reflects core revenue growth [29] Question: Customer acquisition strategy - Management confirmed a focus on routine use customers and plans to add new customers in target geographies, particularly in Europe [43] Question: Feedback on Stratus Compute - Early feedback on Stratus Compute has been positive, with plans for software updates to improve performance [34] Question: Expansion of routine user group - Management believes there is substantial room for revenue growth within the routine user group, which currently averages $85,000 to $90,000 per customer [32][63] Question: Reimbursement updates - The OGM appeared on the Medicare clinical lab fee schedule as planned, with a rate around $1,300 [66] Question: Areas of strength in routine user group - Hematologic malignancies are the primary application for OGM adoption, with constitutional genetic disorders also showing strong growth [70][72]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $8.2 million, a decrease of 24% compared to Q4 2023, which included $2 million from discontinued clinical services [9] - GAAP gross margin for Q4 2024 was 42%, significantly higher than the 23% reported in Q4 2023 [9] - Non-GAAP gross margin for Q4 2024 was also 42%, compared to 24% in Q4 2023 [9] - GAAP operating expense for Q4 2024 was $15.4 million, down from $27.4 million in Q4 2023 [9][10] - Cash, cash equivalents, and available-for-sale securities as of December 31, 2024, were $20.9 million, with $11.4 million subject to restrictions [11] - Full year 2024 GAAP operating expense was $104.4 million, while non-GAAP operating expense was $68.9 million [13] Business Line Data and Key Metrics Changes - Product revenues for the full year were $27 million, a 1% increase from $26.7 million in 2023, despite a nearly $2 million reduction in instrument sales [12] - Consumables sales were $12.8 million, a 14% increase from $11.2 million in 2023 [12] - Software sales for the full year were $6.2 million, an 11% increase from $5.6 million in 2023 [12] Market Data and Key Metrics Changes - Sales in the Americas region were up 9% in 2024, while sales in the Europe, Middle East, and Africa region were up 10% compared to 2023 [13] - A total of 30,307 nanochannel array flow cells were sold during 2024, including 8,058 in Q4, representing a 15% increase over the 26,444 sold in 2023 [13] Company Strategy and Development Direction - The company is focusing on a recalibration period in the life sciences and tools industry, emphasizing the importance of optical genome mapping (OGM) [15] - A shift in go-to-market strategy was implemented in September 2024, focusing on conserving cash and supporting existing customers rather than aggressively acquiring new ones [16] - The strategy includes four key pillars: supporting the installed base, driving utilization through software adoption, building reimbursement support, and improving profitability [17] Management's Comments on Operating Environment and Future Outlook - Management expects full year revenues for 2025 to be in the range of $29 to $32 million, with Q1 2025 revenues expected to be between $6.2 million and $6.3 million [24] - The company anticipates ongoing volatility in margins but is encouraged by recent improvements [23] - The routine use customer group, which accounts for over 80% of consumables purchases, is expected to grow and drive revenue growth [18] Other Important Information - The company raised net proceeds of $3.6 million from ATM sales during Q4 2024 and completed a $10 million registered direct offering in January 2025 [11] - The American Medical Association established a Category 1 CPT code for OGM use in hematologic malignancies, effective January 1, 2025 [22] Q&A Session Summary Question: Guidance on core revenue growth for 2025 - Management indicated that the guidance for 2025 implies core revenue growth, with expectations of $29 to $32 million [29] Question: Customer acquisition strategy - Management stated that while they are not aggressively seeking new customers, they will focus on acquiring new customers that fit into the routine use group [42][43] Question: Feedback on Stratus Compute - Early feedback on Stratus Compute has been positive, with plans for software updates to improve performance [34][36] Question: Reimbursement updates - The OGM appeared on the Medicare clinical lab fee schedule as planned, with a rate around $1,300 [66] Question: Areas of strength in routine user group - Hematologic malignancies are the primary application for OGM adoption, with constitutional genetic disorders also showing strong growth [70][72]