Bionano Genomics (BNGO) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Platform innovation and clinical impact

• Introduced Stratys, a next-generation optical genome mapping system with four times the throughput of its predecessor, Saphyr, targeting high-volume labs and enabling broader adoption.

• Optical genome mapping replaces traditional cytogenetic methods, offering higher resolution, faster turnaround, and lower costs, with growing evidence of improved clinical outcomes.

• Recent publications and clinical trials show higher success rates and detection of pathogenic variants, leading to more patients receiving appropriate treatment.

• Adoption is expanding in both academic medical centers and biopharma, with 70% of Stratys placements going to new customers, many new to optical genome mapping.

• New software streamlines data visualization and reporting, enhancing workflow efficiency for labs.

Market opportunity and adoption trends

• Estimated total addressable market includes 10,000 cytogenetics labs globally, processing 10 million samples annually, representing a multibillion-dollar recurring revenue opportunity.

• Stratys is unlocking new customer segments, especially high-throughput labs and large reference centers previously unable to adopt due to volume constraints.

• Adoption in pharma for cell and gene therapy applications is accelerating, now comprising 20% of new placements, up from a small fraction in 2022.

• Clinical guidelines and reimbursement milestones, such as the new Category I CPT code for hematological malignancies, are expected to drive further adoption.

• Reimbursement progress includes a local coverage determination application for OGM-based tests, with a draft policy expected in early 2025.

Financial performance and operational adjustments

• Recent revenue guidance was lowered by $1–2 million, primarily due to delayed consumable purchases in China and temporary pauses during customer transitions from Saphyr to Stratys.

• Headcount reductions and commercial team reorganization were implemented to extend cash runway and manage expenses, contributing to near-term challenges.

• Despite short-term bumps, recurring revenue from consumables and new customer adoption are seen as strong long-term growth indicators.

• Once labs adopt optical genome mapping as a routine standard, long-term utilization is expected to remain stable, similar to the historical persistence of karyotyping.

• Product and workflow advancements, along with reimbursement progress, are anticipated to provide tailwinds for growth in the coming year.