Bionano Genomics, Inc. — FY 2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. This is an annual filing; it does not provide a complete standalone fourth-quarter income statement. The company develops optical genome mapping (OGM) systems and related consumables, software, and genetic testing services.
Financial performance and liquidity
| Metric | FY 2021 | FY 2020 | Change |
|---|---|---|---|
| Revenue | $18.0 million | $8.5 million | +111% |
| Product revenue | $11.7 million | $6.2 million | +88% |
| Service and other revenue | $6.3 million | $2.3 million | +177% |
| Gross profit / margin | $3.9 million / 21.5% | $2.8 million / 32.6% | Margin down 11.1 percentage points |
| Operating expenses | $81.0 million | $41.3 million | +96% |
| Operating loss | $77.1 million | $38.6 million | Loss widened |
| Net loss | $72.4 million | $41.1 million | Loss widened |
| Net loss per share, diluted | $0.26 | $0.39 | Improved per share amid share-count growth |
| Cash used in operations | $71.9 million | $38.3 million | Use increased $33.6 million |
At year-end, cash and cash equivalents were $24.6 million, available-for-sale investments were $226.0 million, and working capital was $250.6 million. The company reported no debt after repaying its term loan in 2021. Total liabilities were $40.0 million; BioDiscovery contingent consideration was $9.1 million. The company stated available cash, cash equivalents, and investments were expected to fund planned operations and capital investments for at least 12 months, based on its current plan.
Gross margin declined as cost of revenue grew faster than sales. Cost of product revenue included a $1.2 million fourth-quarter inventory write-off associated with unfavorable flowcell yields. No standalone Q4 revenue or profit figure is clearly provided in the filing text.
Business developments and comparison with prior year
- Saphyr installed base increased 69%, from 97 systems at year-end 2020 to 164 at year-end 2021. Flowcells sold increased 98%, to 12,518 for the year; 3,204 were sold in Q4, up approximately 29% year over year.
- BioDiscovery was acquired in October 2021 for estimated consideration of $74.8 million, including cash, shares, and milestone consideration. It contributed $1.1 million of revenue from acquisition through year-end; purchase accounting remained preliminary.
- Revenue growth also reflected a full year of Lineagen service revenue compared with just over one quarter in 2020, as well as increased Saphyr instrument and consumables sales.
- Operating expenses rose substantially with increased headcount, commercial expansion, research and development, acquisition-related costs, and public-company compliance spending. Research and development expense rose 119%; selling, general and administrative expense rose 88%.
- Financing activities provided $336.1 million, principally from equity offerings and ATM sales. Shares outstanding increased from 190.0 million at year-end 2020 to 289.6 million at year-end 2021, reflecting significant dilution. The company repaid $15.0 million of term-loan principal and related amounts; total payoff was approximately $17.0 million.
Outlook, commentary, and principal risks
- Management expects continued losses and higher 2022 research and development and selling, general and administrative expenses, including stock-based compensation. It provided no specific revenue or earnings guidance in the supplied filing text.
- OGM remains largely research-use-only. Clinical adoption depends on evidence generation, regulatory requirements, professional guidelines, and reimbursement; coverage and payment for OGM-based tests remain uncertain.
- COVID-19-related constraints and supply-chain disruption increased component and manufacturing costs and restricted some customer-site installation, service, and sales activity. Management said these effects negatively affected results and could continue.
- Manufacturing concentration is material: a single contract manufacturer supplies instruments and another supplies chip consumables; certain reagents also have limited or single-source suppliers. The filing cites supply constraints and flowcell yield issues.
- Commercial execution, market acceptance, long sales cycles, competition, successful integration of Lineagen and BioDiscovery, and the ability to fund ongoing losses are significant risks. Additional equity financing could further dilute shareholders.
- BioDiscovery’s $10.0 million commercial milestone payment was considered highly likely; the recorded year-end fair value was $9.1 million. The company reported no material pending legal proceedings.
- The company remediated a previously reported internal-control material weakness and management and the auditor concluded internal control over financial reporting was effective at year-end. BioDiscovery’s controls were excluded from the 2021 assessment because of acquisition timing.
Investor facts to verify
- Whether installed-base growth and consumables utilization translate into recurring revenue and improved gross margins, particularly after the flowcell yield issue and inventory write-off.
- Whether the company can achieve clinical validation, regulatory clearance where required, and durable reimbursement for OGM-based testing.
- Cash burn, investment liquidity, and the stated minimum 12-month funding runway against planned spending and any further capital needs.
- BioDiscovery purchase-price allocation, commercial milestone achievement, integration results, and the expected contribution of its software business.
- Share dilution from 2021 financing, acquisition consideration, outstanding awards, and subsequent executive option grants disclosed in the filing.
- Supply continuity, manufacturing capacity, COVID-19 effects, and progress resolving product-yield and cost pressures.