Bluejay Diagnostics, Inc. — Form 10-Q Summary
Reporting period: Quarter ended September 30, 2022; filed November 9, 2022. Bluejay develops near-patient medical diagnostic products, including its Symphony analyzer and test cartridges. Symphony’s commercial use is contingent on applicable FDA clearance, authorization, or approval.
Financial performance and position
| Metric | Q3 2022 / September 30, 2022 | Comparable period / prior year-end |
|---|---|---|
| Revenue | $0 for Q3; $249,040 for nine months | $0 for Q3 and nine months 2021 |
| Gross profit | $0 for Q3; $48,911 for nine months | $0 in comparable 2021 periods |
| Gross margin | Approximately 19.6% for nine months; not meaningful for Q3 | Not applicable |
| Net loss | $2.96 million for Q3; $6.91 million for nine months | $1.19 million for Q3; $2.03 million for nine months 2021, per financial statements |
| Cash and cash equivalents | $13.29 million | $19.05 million at December 31, 2021 |
| Operating cash used | $4.80 million for nine months | $1.84 million for nine months 2021 |
| Total assets / liabilities | $15.71 million / $1.89 million | $21.02 million / $0.64 million at December 31, 2021 |
| Stockholders’ equity | $13.81 million | $20.38 million at December 31, 2021 |
Operating expenses were $2.81 million in Q3 and $6.91 million for the nine months, up from $0.96 million and $1.86 million, respectively, in 2021. R&D and general and administrative expenses drove most of the increase. The balance sheet shows no debt; liabilities primarily include accounts payable, accruals, and lease obligations. Operating lease liabilities were approximately $529,000, with finance lease liabilities also reported.
Cash declined $5.76 million in the first nine months. Investing cash use was $961,000, mainly for laboratory and manufacturing equipment; there was no financing cash flow in the period. The filing reports a $15.2 million accumulated deficit in its liquidity discussion, while the September 30 balance sheet reports $14.61 million; these values do not reconcile clearly in the supplied filing text.
Changes, outlook, and notable items
- The $249,040 nine-month revenue came from a one-time sale of five Symphony analyzers to Toray in June; no Q3 sales occurred. Management said this sale was not an indication of market entry or expected margins, and future Toray sales were not anticipated.
- R&D expense rose as the company expanded clinical programs and scaled manufacturing for Symphony and its IL-6 test. G&A increased with infrastructure investment and public-company costs following the November 2021 IPO.
- A $210,117 impairment charge was recorded in September for ALLEREYE equipment after management changed its expectations for the equipment’s use while focusing efforts on Symphony.
- Management stated that cash should fund operations for at least 12 months from issuance of the financial statements, while also expecting near-term losses and anticipating a need to raise additional capital. There is no assurance that financing will be available.
- As of September 30, the company had approximately $1.0 million in non-cancelable purchase commitments due within one year. A separate October 12 vendor agreement committed approximately $800,000 for Symphony-related goods, with a 50% down payment due at signing.
- On October 25, Nasdaq notified the company that its share price had been below $1 for 30 consecutive business days. The notice did not immediately affect listing; the company had until April 24, 2023 to regain compliance, with a possible additional compliance period subject to conditions. Management said it would pursue compliance; a reverse split was identified as a possible measure.
- The filing cites competition, technology change, key-person dependence, inflation, and supply-chain disruption as risks. No legal proceedings were reported. Management concluded disclosure controls were effective at quarter-end and reported no material change in internal control over financial reporting during the quarter.
Data note: The financial statements report nine-month net loss of $6.91 million and operating cash used of $4.80 million. Certain MD&A text instead cites approximately $7.5 million of net losses and $5.4 million of operating cash use, and one comparative net-loss figure differs from the statements. The statement figures are used above; the filing text does not clearly reconcile these differences.
Investor facts to verify
- Whether Symphony obtains required regulatory clearances and achieves meaningful recurring analyzer and cartridge sales.
- Actual cash burn, remaining cash runway, and whether additional capital will be needed sooner than management estimates.
- Reconciliation of the MD&A loss and cash-use figures with the financial statements, and of the stated accumulated deficit with the balance sheet.
- Progress toward Nasdaq’s minimum-bid-price compliance and the potential effects of a reverse split or delisting.
- Timing and cash impact of the approximately $1.0 million purchase commitments and the additional $800,000 vendor agreement.