Bionano Reports Preliminary Q4 And FY23 Results; Sees Q4 Revenue $10.4M-$10.7M Vs $10.54M Est.; FY23 Revenue $35.8M-$36.1M Vs $35.94M Est.; Achieved All Full-Year 2023 ELEVATE Milestones

Author: Benzinga Newsdesk | January 08, 2024 09:13am

• Preliminary Q4 2023 revenue expected to be between $10.4 and $10.7 million, which would represent an estimated increase of 27% to 30% over Q4 2022
  
   
• Reached installed base of 326 optical genome mapping (OGM) systems as of YE 2023; increase of 36% over the 240 installed systems as of YE 2022
• Preliminary number of nanochannel array flowcells sold in Q4 2023 expected to be 7,980, which would represent an estimated increase of 67% over the 4,781 flowcells sold in Q4 2022
• Achieved all full-year 2023 ELEVATE milestones

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (NASDAQ:BNGO) today reported certain unaudited preliminary financial and commercial highlights for the fourth quarter and fiscal year ended December 31, 2023. The Company's full results for the fourth quarter and the fiscal year ended December 31, 2023 are not yet available.

"2023 was a year in which we saw consistent progress in our business, and we ended the year with a lot of momentum across all facets of our business," commented Erik Holmlin, PhD, president and chief executive officer of Bionano. "In addition to Bionano's efforts to advance OGM, our user base has independently organized to advocate for OGM as an alternative to traditional cytogenetic methods, with user groups convening across the globe and an international consortium of researchers publishing a framework for the adoption and implementation of OGM. We believe the progress of OGM in 2023, combined with our achievement of our ELEVATE milestones and our cost savings initiatives and financing, have positioned us for success in 2024."

Q4 2023 Preliminary Unaudited Financial and Business Results

• Revenues for the fourth quarter 2023 are expected to be in the range of $10.4 million to $10.7 million, an estimated increase of 27% to 30% compared to $8.2 million in the fourth quarter of 2022.
• Full year 2023 revenue is expected to be in the range of $35.8 million and $36.1 million, an estimated increase of 29% to 30% compared to full year 2022.
• Installed base of OGM systems totaled 326 at year-end, which represented a 36% increase over the 240 installed systems reported at the end of 2022.
• Nanochannel array flowcells sold in the fourth quarter is expected to be 7,980, an estimated increase of 67% over the 4,781 flowcells sold in the fourth quarter of 2022.
• Cash, cash equivalents, and available-for-sale securities as of December 31, 2023 were approximately $102.8 million, of which $36.1 million is subject to certain restrictions. We raised net proceeds of $11.0 million from ATM sales during the period of November 14, 2023 through December 31, 2023. An additional $2.9 million has been raised in net proceeds from ATM sales in 2024 to date.
  
  
  
   

Achieved All Full-Year 2023 ELEVATE! Milestones

• Released the high throughput OGM instrument, called the Stratys™ system, as part of an early access program in the fourth quarter of 2023; the full commercial release is expected in early 2024.   The Stratys system is expected to enable a four-fold increase in raw data generation rate compared to the Saphyr®system and is designed for maximum lab flexibility by enabling up to 12 single access chips, accessible as they complete runs, without the need to batch multiple samples on a consumable.
• Released VIA™ software, which replaces NxClinical™ software with a simple and integrated workflow for visualization, interpretation, and reporting for OGM, microarray and next-generation sequencing (NGS) data types for enhanced contextualization across multiple variant types and accelerated time to results at a reduced cost. A workflow focused on hematological malignancies was released in June 2023, and in December 2023, the Company announced upgrades to its pipeline for OGM data analysis in VIA software for applications in constitutional genetic diseases.
• Pre-commercial version of the Ionic Purification System for isolation of DNA for OGM analysis running in the field with the full commercial launch planned for 2024.
• Launched an OGM laboratory developed test (LDT) for constitutional genetic disease applications through Bionano Laboratories.
• Submitted a dossier to Medicare seeking a local coverage determination (LCD) for OGM coverage.
• Conducted a pre-submission discussion with FDA in connection with the planned clearance of the Stratys system.
• Met or exceeded all previously stated 2023 milestones for prenatal, postnatal, and hematological malignancy clinical trials, including: sample enrollment and data collection for prenatal study; interim publication of the prenatal study; interim publication of the hematological malignancy study; peer-reviewed interim publication from postnatal study; and IRB approval for solid tumor study.
  
  
  
   

"In 2023, we secured additional financing and announced a series of cost savings initiatives that will continue into this year. We remain focused on financial discipline and implementing actionable processes that we believe will enable us to improve margins and further extend our cash runway. I believe in the power of OGM and that 2024 has the potential to be a tremendous year for Bionano," added Gülsen Kama, chief financial officer of Bionano.

Bionano has not completed preparation of its financial statements for the fourth quarter or full year of 2023. The financial performance measures presented in this press release for the fourth quarter of 2023 and for the year ended December 31, 2023 are preliminary and unaudited, based on management's initial review of the information presented, and are thus inherently uncertain and subject to change as Bionano completes its end-of-period reporting process and related activities for the fourth quarter of and full year 2023. Bionano is in the process of completing its customary year-end close and review procedures as of and for the year ended December 31, 2023, and the final results for this period could differ from the preliminary estimated results disclosed in this press release. During the course of the preparation of Bionano's unaudited consolidated financial statements and related notes as of and for the year ended December 31, 2023, Bionano's independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary estimates presented herein. Additional information and disclosures would be required for a more complete understanding of Bionano's financial position and results of operations as of and for the fourth quarter and year ended December 31, 2023. Accordingly, undue reliance should not be placed on this preliminary information.

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