Bionano Genomics (BNGO) H.C. Wainwright 28th Annual Global Investment Conference summary

Technology and clinical impact

• Optical genome mapping (OGM) is transforming chromosome structural analysis and replacing traditional lab standards by detecting previously undetected anomalies linked to disease.

• OGM covers a broad range of genomic analysis, from whole chromosomes down to 500 base pairs, complementing sequencing technologies.

• The VIA software integrates multiple technologies to provide comprehensive patient recommendations.

• OGM is gaining traction in hematologic oncology, constitutional genetics, and cell/gene therapy due to clinical evidence and reimbursement progress.

• Over 16,000 genomes have been analyzed globally using this technology, with thousands of clinical publications supporting its utility.

Regulatory and reimbursement progress

• CPT coding for OGM in hematologic oncology and constitutional genetic diseases became effective in January, supporting reimbursement.

• MolDX provisional LCD for OGM-based assays is under public comment, potentially covering 60% of the US population.

• New York State approved OGM for hematologic oncology at Memorial Sloan Kettering and University of Rochester, marking significant regulatory milestones.

• European market opportunities are being pursued with national authorities for reimbursement.

Business strategy and operational changes

• Strategic shift in 2023 focused on routine-use customers and de-emphasized instrument sales to drive flow cell utilization.

• Discontinued non-essential businesses, including the Lineagen reference lab, to streamline operations and offset a $7 million sales drop.

• Global restructuring led to a 71% reduction in non-GAAP OpEx and improved EBITDA loss, with a 25% gain margin.