Bionano Genomics Reports First Quarter 2022 Financial Results and Highlights Recent Business Progress
- 80% year-over-year revenue growth in Q1 2022
- Achieved all Q1 2022 ELEVATE! milestones
- Strong balance sheet with
- Conference call today,
Key Business Highlights in Q1 2022 and Recent Weeks
The Company executed on its commercialization strategy, built scientific momentum by presenting data at key scientific meetings and drove utilization of the Saphyr system at leading institutions across the globe, with the following highlights:
- Expanded the installed base of Saphyr systems to 176 as of the end of Q1 2022, up from 164 as of the end of Q4 2021 and an increase of 64% over Q1 2021.
- Sold 3,225 nanochannel array flowcells during Q1 2022, a 24% growth over Q1 2021.
- Launched the Rare Undiagnosed Genetic Disease (RUGD) initiative to elevate the focus and dedication on rare diseases in translational and clinical research. The RUGD initiative includes the Company’s suite of product offerings, support for educational awareness, work towards development of research grants, and support for professional societies with a shared mission of improving RUGD patient care and management, such as the American College of Medical Genetics and Genomics (ACMG).
- Presented the latest research on OGM for use in a variety of applications at industry conferences across the globe including the Annual ACMG meeting, the
American Association of Cancer Research(AACR) meeting and the Company’s own 2022 China Symposium.
- Launched version 6.2 of NxClinical software with an integrated genomic scar analysis for homologous recombination deficiency (HRD). This feature provides a comprehensive, consistent, and automated analysis of biomarkers from next-generation sequencing (NGS) and microarray data that can help clinical researchers stratify therapeutic response across multiple tumor types.
- Publication of the first use of OGM in combination with single-cell techniques for comprehensive evaluation of cancer genetic variation. Researchers at the University Hospitals in Leuven,
Belgium, used a combination of methods to characterize genetic variation in samples from 12 subjects with B-cell acute lymphoblastic leukemia (B-ALL) (11 pediatric, 1 adult). Multiple analysis methods, including karyotyping, fluorescent in-situ hybridization (FISH), multiplexed ligation polymorphism assay (MLPA), reverse transcription polymerase chain reaction (RT-PCR), OGM, and single-cell sequencing with a custom acute lymphoblastic leukemia (ALL) genetic panel, were used to characterize aneuploidy, structural variants (SVs), copy number variants (CNVs), gene fusions, and single nucleotide variants (SNVs). This study demonstrates that OGM can provide information on SVs across a range of sizes that could help bridge sequencing with traditional cytogenetics.
- OGM using the Saphyr system was adopted at notable cytogenetics laboratories and academic medical centers in
the United States, Switzerland, France, and Brazil.
- Publication of the first readout from the ongoing clinical study evaluating the use of OGM in the diagnosis of genetic disease for postnatal patients in support of our efforts to establish OGM as a standard of care (SOC) in this setting. The IRB-approved, multi-site, ongoing study evaluated 331 individual sample runs from 202 unique samples across 5 sites for interim measures of key endpoints:
- Concordance with SOC – 97.7% (214 out of 219 samples)
- Partially concordant with SOC – 2.3% (5 out of 219 samples)
- Concordance with SOC for pathogenic variant calls – 100% (219 out of 219 samples)
- Concordance with chromosomal microarray (CMA) – 100% (103 out of 103 samples)
- First-pass success rate for OGM – 94% (311 out of 331 samples)
- Reproducibility of analytical QC from site-to-site – 98.8% (171 out of 173 replicates)
- Reproducibility of pathogenic variant calls from site-to-site – 100% (173 out of 173 replicates)
“We believe our Q1 results, which include record revenues for any Bionano Q1, show that the momentum in our business from 2021 has carried into 2022. Bionano Symposium kicked off this year and was well-attended, which we believe showed strong support for OGM that should translate into future product uptake and revenue growth. This quarter’s expansion in the Saphyr system installed base, combined with the increasing number of publications on OGM that reported key applications within cytogenomics and genomics research, provide additional indications of the potential for further OGM adoption,” commented
Q1 2022 Financial Highlights
- Total revenue for Q1 2022 was
$5.7 million, up 80% from Q1 2021.
- Gross margin for Q1 2022 was 15%, compared to 33% from Q1 2021. The decrease was primarily due to low yields on our chip consumables produced at one of our contract manufacturers. Gross margin improved over the fourth quarter of 2021 of 4%, primarily due to lower write-off of inventory.
- Q1 2022 GAAP operating expense was
$30.8 million, compared to $12.2 millionin Q1 2021. Q1 2022 non-GAAP1 operating expense was $24.3 million, compared to $11.8 millionin Q1 2021. Q1 2022 non-GAAP operating expense excludes $5.1 millionin stock-based compensation, and $1.4 millionin amortization of intangibles. The year-over-year increase was primarily due to increased headcount-related spending, increased R&D expense, and increased marketing expenses.
March 31, 2022, the Company had cash, cash equivalents, and available-for-sale securities of $216.5 million.
|Conference Call & Webcast Details|
To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay in the Investors section of the Bionano website.
Non-GAAP Financial Measures
To supplement Bionano’s financial results reported in accordance with
Bionano believes that non-GAAP operating expense is useful to investors and analysts as a supplement to its financial information prepared in accordance with GAAP for analyzing operating performance and identifying operating trends in its business. Bionano uses non-GAAP operating expense internally to facilitate period-to-period comparisons and analysis of its operating performance in order to understand, manage and evaluate its business and to make operating decisions. Accordingly, Bionano believes this measure allows for greater transparency with respect to key financial metrics it uses in assessing its own operating performance and making operating decisions.
This non-GAAP financial measure is not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; has no standardized meaning prescribed by GAAP; and is not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measure as used by Bionano in this press release and the accompanying reconciliation table has limits in its usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
For a reconciliation of non-GAAP operating expense to operating expense reported in accordance with GAAP, please refer to the financial tables accompanying this release.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “can,” “expect,” “plan,” “anticipate,” “should,” “believe,” “would,” “could,” “potential,” “outlook,” “guidance,” "goal", and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our expectations regarding product uptake, revenue growth and increased OGM adoption, including through Bionano Symposium, publications highlighting applications of OGM, integration of OGM into the NxClinical software and development of a new high throughout imaging system; our growth prospects and future financial and operating results, including our 2022 revenue guidance, the growth of our installed Saphyr system base and the other expectations related thereto; our ability to meet our goal to drive value and penetrate into our target markets; the anticipated benefits of the NxClinical software and the timing of integration of OGM into the NxClinical software; our commercial expectations, including the potential market opportunity for structural variation analysis and OGM and the potential combination of NGS and OGM; the opportunities presented by our high-throughput prototype for the Saphyr system and the timing of its commercial release; continued research involving OGM, its utility compared to traditional cytogenetics and our technologies; our ability to drive adoption of OGM and our technology solutions; expected timing and results from our clinical studies; our ability to accelerate and broaden our position in digital cytogenetics and comprehensive genome analysis; and the execution of our strategy, including the 2022 ELEVATE! strategy and our anticipated 2022 milestones. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape, including the introduction of competitive technologies or improvements in existing technologies; changes in our strategic and commercial plans; delays in research or the receipt of supplies to advance our technologies and products, as well as delays in the anticipated timing for new product launches; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; whether medical and research institutions will adopt and/or continue to use our technologies, including as a result of their funding and the results of studies evaluating the utility and effectiveness of OGM; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the
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|Condensed Consolidated Balance Sheet (Unaudited)|
|Cash and cash equivalents||$||24,048,000||$||24,571,000|
|Accounts receivable, net||5,514,000||4,934,000|
|Prepaid expenses and other current assets||4,110,000||4,481,000|
|Total current assets||242,360,000||272,414,000|
|Property and equipment, net||12,661,000||10,318,000|
|Operating lease right-of-use asset||6,817,000||6,691,000|
|Financing lease right-of-use asset||3,897,000||3,926,000|
|Intangible assets, net||25,424,000||26,842,000|
|Other long-term assets||798,000||749,000|
|Liabilities and stockholders’ equity|
|Operating lease liability||1,730,000||1,467,000|
|Finance lease liability, related party||296,000||299,000|
|Total current liabilities||18,659,000||21,840,000|
|Operating lease liability, net of current portion||5,451,000||5,288,000|
|Finance lease liability, net of current portion||3,638,000||3,642,000|
|Long-term contract liabilities||133,000||146,000|
|Additional paid-in capital||558,864,000||553,747,000|
|Accumulated other comprehensive loss||(1,637,000||)||(539,000||)|
|Total stockholders’ equity||311,185,000||337,118,000|
|Total liabilities and stockholders’ equity||$||348,211,000||$||377,100,000|
|Condensed Consolidated Statement of Operations (Unaudited)|
|Three Months Ended
|Service and other revenue||2,580,000||1,119,000|
|Cost of revenue:|
|Cost of product revenue||3,576,000||1,513,000|
|Cost of service and other revenue||1,259,000||612,000|
|Total cost of revenue||4,835,000||2,125,000|
|Research and development||10,527,000||2,678,000|
|Selling, general and administrative||20,277,000||9,528,000|
|Total operating expenses||30,804,000||12,206,000|
|Loss from operations||(29,943,000||)||(11,163,000||)|
|Other income (expenses):|
|Gain on forgiveness of Paycheck Protection Program Loan||—||1,775,000|
|Other income (expense)||(33,000||)||(15,000||)|
|Total other income (expense)||—||1,222,000|
|Loss before income taxes||(29,943,000||)||(9,941,000||)|
|Provision for income taxes||(9,000||)||(6,000||)|
|Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (Unaudited)|
|Three Months Ended
|GAAP operating expense||$||30,804,000||$||12,206,000|
|Stock-based compensation expense||(5,102,000||)||(371,000||)|
|Intangible asset amortization||(1,419,000||)||(79,000||)|
|Adjusted non-GAAP operating expense||$||24,283,000||$||11,756,000|
Source: Bionano Genomics