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Bionano Genomics stock tanked more than 8% in premarket trading after Bionano Genomics Q3 net loss $20.753M, sales $4.66M beat $4.23M estimate.

Bionano Genomics, Inc. reported financial results and business achievements for the quarter ended September 30, 2021 and highlighted recent corporate updates.

– Acquisition of BioDiscovery transforms Bionano from the structural variation company into a data solutions provider with the potential to offer the most comprehensive variant analysis platform in genomics

– Total revenue of$4.7 million, a 112% year-over-year total revenue increase, driven by growth in the Saphyr® installed base

– Record number of Saphyr shipments and installations for any quarter to date

– Launched protocols for ultra-high molecular weight DNA isolation from amniocentesis and chorionic villus sampling (CVS) for prenatal applications

– Remaining 2021 milestones on track

– Strong balance sheet with$326.1 millionin cash and short term investments as ofSeptember 30, 2021

“We had the strongest quarter in Bionano’s history with a record number of Saphyr shipments and installations, including adoptions at several notable sites, including leading hospitals, cytogenetics labs and academic medical centers around the world. With the acquisition of BioDiscovery, a leading software company with best-in-class solutions for analysis, visualization, interpretation and reporting of genomics data. for microarray and next-generation sequencing (NGS), we are transitioningBionano Genomicsfrom being the structural variation company into a data solutions provider. We believe this will enable access to an expanded market opportunity by leveraging the NGS market through software. We are extremely pleased with the progress we are making and the fact that outstanding leaders are joining Bionano to join us in transforming the way the world sees the genome,” commentedErik Holmlin, PhD, Chief Executive Officer ofBionano Genomics.

Chris Stewart, Chief Financial Officer of Bionano added: “Q3 was another excellent quarter. We continued to achieve meaningful year-over-year revenue growth and maintained a strong balance sheet with$326 millionof cash and marketable securities as of the quarter-end. We also remain on track to achieve the milestones we laid out in the first quarter of 2021.”

Key Business Highlights in Q3

The Company executed on its commercialization strategy, built scientific momentum by presenting data at key scientific meetings and drove utilization of Saphyr at key institutions across the globe, with the following highlights:

– Expanded the installed base of Saphyr systems from 121 at the end of Q2 to 141 at the end of Q3. During the quarter endedSeptember 30,2021, we shipped a total of 24 Saphyr systems to the field, compared to 11 systems shipped in the same quarter in 2020.

– Sold 3,969 nanochannel array flow cells during the quarter endedSeptember 30, 2021,which is the most flow cells sold in any quarter ever and represents 122% growth over the same quarter in 2020.

– Commercial release of solutions for isolation of ultra-high molecular weight DNA for prenatal applicationssupporting the use of samples derived from amniocentesis and CVS. Bionano Prep SP Amnio and CVS Culture DNA Isolation Protocol supports both fresh cultures and cryopreserved cells, which expands the markets served for OGM.

– OGM with Saphyr was adopted at several notable cytogenetics laboratories and academic medical centersinthe United States, including Brigham & Woman’s Hospital, which is using OGM to identify structural variations in constitutional and cancer applications. Outside the US, Saphyr was adopted inAustralia,EuropeandChina.

– The largest clinical research study to date evaluating OGM was published inThe Journal of Molecular Diagnosticsfor a rare muscle disease, facioscapulohumeral muscular dystrophy, or FSHD, in about 351 patients. The results demonstrated that OGM provided data more quickly, accurately, and reproducibly than the current gold standard method of Southern blot analysis. The findings support the rationale for adopting OGM as an alternative to Southern blot analysis as OGM had a greater sizing accuracy as well as a greater than 99% concordance with Southern blot analysis.

– NuProbe Global, a global molecular diagnostics leader, adopted Saphyr to be integrated their proprietary tools,Quantitative Amplicon Sequencing (QASeq) and Blocker Displacement Amplification (BDA), for research and development efforts in reproductive health and oncology liquid biopsies.

– Saphyr customers and Bionano conducted 10 presentations at the Annual Cancer Genomics Consortium Meeting inmid-August 2021,highlighting the benefits of OGM for clinical research applications in solid tumor analysis, hematological malignancies, products of conception, prenatal and postnatal constitutional genetics. More than 500 participants from around the globe attended virtually, highlighting the strong interest in OGM for cancer genomics.

– Bionano customers presented 11 presentations on OGM at theEuropean Society of Human Genetics(ESHG) meeting in lateAugust 2021, demonstrating the clinical utility of OGM across many therapeutic application areas, along with the unique capabilities of Bionano’s Saphyr®system to detect all classes of structural variants, across the genome, at a superior resolution relative to traditional techniques.

– Added exceptional talent across commercial leadership functions,includingAmanda Lettmannas Vice President of Global Customer Experience,Alex Helmas Vice President Strategic Product Marketing,Stephanie Hoyleas Vice President Corporate Marketing,Amanda Hernandezas Vice President of Global Sales Training and Development,Justin Leightonas Vice President and General Manager,Lineagen, andBob Hertsenbergas North America Sales Director.

Financial Highlights

– Total revenue for the third quarter of 2021 was$4.7 million,up 21% from$3.9 millionin the second quarter and up 112% from$2.2 millionin the same period of 2020. The sequential increase was driven by increased demand for our Saphyr optical genome mapping solutions, including increased instrument sales and greater demand for our reagent rental program and consumables. The year-over-year increase was driven by both higher product sales and by the addition of revenue fromLineagen.

– Gross margin for the third quarter of 2021 was 24.8%,compared to 37.3% in the prior quarter and 33.4% from the third quarter of 2020. The decrease was primarily due to an increase in laboratory and warranty related expense that are expected to be non-recurring.

– Third quarter operating expense was$21.8 million,compared to$17.9 million in the prior quarter and$11.0 millionin the third quarter of 2020. The sequential increase was mainly due to a$1.8 millionincrease in headcount and related expenses and a$1.5 millionincrease in Research and Development expenses related to expanding our supply chain to produce higher volumes. Third quarter operating expense included$2.8 millionof non-cash stock-based compensation. The year-over-year increase was primarily due to increased headcount-related spending as we build out all facets of our organization to support our expected commercial progress and increased research and development costs.

– AtSeptember 30, 2021, the Company had cash, cash equivalents, and short-term investments of$326.1 millioncompared to cash and cash equivalents of$38.4 millionatDecember 31, 2020. The increase in cash is primarily due to the equity raises that were completed in the first quarter of 2021.

Remaining Anticipated Milestones for 2021 – Initiatives to Drive Global Adoption of Saphyr

– 4Q21: Interim publication of results from pediatric clinical study

– 4Q21: Validation of LDTs by 3 sites in both our prenatal clinical study and our pediatric clinical study

– 4Q21: Initial prototype of next gen high throughput Saphyr

– 4Q21: Reach installed base of 150 systems to achieve a 50% increase over year end 2020