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Bluejay Diagnostics, Inc. (BJDX)·Q4 2022 Earnings Summary

Executive Summary

  • Q4 2022 delivered no revenue as management focused on regulatory milestones; FY 2022 revenue remained $0.249M from a single Q2 non-recurring sale, with no sales in Q3 or Q4 .
  • The de novo FDA submission timeline was pushed to H1 2024 following FDA feedback requiring expansion of the clinical study—an explicit delay from earlier H1 2023 guidance and an H2 2022 target earlier in the year .
  • FY net loss widened to $9.30M (vs. $3.49M in 2021) driven by higher R&D and public-company G&A; Q4 net loss was $2.39M (derived from FY minus 9M) .
  • Liquidity stepped down to $10.1M cash at year-end; management warned additional funding is required to reach commercialization, elevating near-term financing risk and a potential stock reaction catalyst around funding and regulatory progress .

What Went Well and What Went Wrong

What Went Well

  • FDA pre-submission feedback accepted a de novo regulatory pathway for the Symphony IL-6 Test, validating the regulatory approach .
  • Clinical study results for Symphony IL-6 were published (AACC), with management highlighting “rapid and precise testing” potential and 98% NPV to identify COVID-19 patients at risk for severe illness (per Q3 update) .
  • Strategic awareness-building via KOL event and expanded clinical program; CEO: “Significant developmental strides were made during 2022… affirming the potential of… a rapid and precise testing platform” .

What Went Wrong

  • Submission timeline delay to H1 2024 requires expanded study and implies prolonged pre-revenue period; management acknowledged the delay “will require additional funding to reach commercialization” .
  • Operating losses increased as R&D rose ~262% YoY and G&A ~166% YoY; FY net loss expanded to $9.30M vs. $3.49M in 2021 .
  • Cash declined to $10.1M by year-end from $19.0M at YE21, with Q3 commentary of a 12‑month runway superseded by Q4’s funding need disclosure .

Financial Results

Quarterly P&L (Q2 → Q3 → Q4 2022)

MetricQ2 2022Q3 2022Q4 2022
Revenue ($USD)$249,040 $0 $0
Gross Profit ($USD)$48,911 $0 $0
Research & Development ($USD)$756,283 $1,379,665 $1,321,447 (derived from FY $4,152,152 and 9M $2,830,705)
General & Administrative ($USD)$1,196,996 $1,284,411 $961,888 (derived from FY $4,763,114 and 9M $3,801,226)
Sales & Marketing ($USD)$81,357 $146,102 $170,277 (derived from FY $451,421 and 9M $281,144)
Total Operating Expenses ($USD)$2,034,636 $2,810,178 $2,453,612 (derived from FY $9,366,687 and 9M $6,913,075)
Operating Loss ($USD)$(1,985,725) $(2,810,178) $(2,453,612) (derived)
Other Income (Expense), net ($USD)$48,323 $(149,711) $67,358 (derived from FY $20,828 and 9M $(46,530))
Net Loss ($USD)$(1,937,402) $(2,959,889) $(2,386,254) (derived from FY $(9,296,948) and 9M $(6,910,694))
EPS (Basic & Diluted) ($)$(0.10) $(0.15) N/A (not disclosed; FY EPS $(0.46))

Notes: Q4 values are derived from FY 2022 minus nine months ended 9/30/2022; revenue and gross profit were zero due to no sales in Q3/Q4 .

FY Comparison

MetricFY 2021FY 2022
Revenue ($USD)$0 $249,040
Gross Profit ($USD)$0 $48,911
Research & Development ($USD)$1,147,955 $4,152,152
General & Administrative ($USD)$1,792,482 $4,763,114
Marketing & Business Development ($USD)$289,726 $451,421
Operating Loss ($USD)$(3,230,163) $(9,317,776)
Other Income (Expense), net ($USD)$(258,135) $20,828
Net Loss ($USD)$(3,488,298) $(9,296,948)
EPS (Basic & Diluted) ($)$(0.41) $(0.46)

Liquidity KPIs

KPIQ2 2022Q3 2022Q4 2022
Cash & Cash Equivalents ($USD)$15,341,862 $13,289,365 $10,114,990
Total Current Assets ($USD)$17,050,257 $13,936,259 $11,788,470
Total Current Liabilities ($USD)$979,590 $1,522,700 $1,640,254
Total Stockholders’ Equity ($USD)$16,657,736 $13,811,065 $11,541,273

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FDA de novo submission timingRegulatoryQ4 2022 (Q2 press release) H1 2024 (Q4 press release) Lowered (significant delay)
FDA de novo submission timingRegulatoryH1 2023 (Q3 press release) H1 2024 (Q4 press release) Lowered (one-year push)
Cash runway / fundingLiquidity“Sufficient to fund operations for the next 12 months” (Q3) “Delay will require additional funding to reach commercialization” (Q4) Lowered (financing need surfaced)
Commercial awareness / partnershipsGo-to-marketBuild KOL network and awareness (Q3) Timeline presents opportunity to cultivate strategic relationships and partnerships (Q4) Reframed (part