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bioAffinity Technologies, Inc. (BIAF)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 results missed Wall Street consensus: revenue $2.21M vs $2.42M estimate and EPS $-6.30 vs $-4.20 estimate; margins deteriorated meaningfully quarter over quarter due to higher operating costs, driving a larger net loss. [Values retrieved from S&P Global]*
  • Full-year 2024 revenue was a record $9.4M (+~270% YoY), propelled by consolidated pathology operations and accelerating CyPath Lung adoption; however, 2025 revenue guidance was set lower at $6–$8M as the company exits unprofitable pathology services.
  • Commercial traction improved: Medicare/private reimbursement, U.S. Federal Supply Schedule listing, expanded physician network; cash ended 2024 at $1.1M with a $2.66M financing closed in October 2024 and $1.4M raised via warrant exercises in Feb 2025.
  • Post-report, shares surged sharply on record FY revenue and improving operating narrative (multi-day reaction).

What Went Well and What Went Wrong

What Went Well

  • Medicare and private payer reimbursement with unique CPT code, plus addition to the U.S. Federal Supply Schedule expanding addressability across 1,380 VA/Military facilities; management: “Physician adoption is accelerating… positioning us for sustained growth.”
  • 2024 momentum: Record $9.4M revenue (+~270% YoY), ~1,400% growth in CyPath Lung orders vs 2023, >300% increase in signed physician offices.
  • Pipeline and pivotal trial progress: protocol submitted to IRB for ~3,500-patient FDA pivotal study; sites qualified across academic, private, military and VA centers.

What Went Wrong

  • Q4 2024 underperformed consensus: revenue and EPS both missed; EBITDA margin and EBIT margin contracted sharply QoQ, reflecting high operating expense intensity. [Values retrieved from S&P Global]*
  • 2025 revenue guide down to $6–$8M (including $1–$2M from CyPath Lung) due to discontinuation of unprofitable pathology services; though costs are expected to be reduced, top-line reset may temper near-term growth expectations.
  • Liquidity tightness: cash was $1.1M at year-end; reliance on external financing (Oct 2024 $2.66M offering, Feb 2025 warrant exercises) underscores capital needs ahead of pivotal trial ramp.

Financial Results

Quarterly comparatives vs prior periods

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$2.21*$2.40*$2.35*$2.21*
Net Income ($USD Millions)$(2.37)*$(2.11)*$(2.00)*$(2.97)*
Diluted EPS ($USD)$-7.63*$-5.56*$-4.84*$-6.30*
EBIT ($USD Millions)$(2.34)*$(2.09)*$(1.97)*$(2.95)*
EBITDA ($USD Millions)$(2.19)*$(1.84)*$(1.82)*$(2.79)*
EBITDA Margin (%)-99.11%*-76.76%*-77.54%*-126.51%*
EBIT Margin (%)-105.83%*-87.08%*-83.98%*-133.47%*
Net Income Margin (%)-107.22%*-88.01%*-85.13%*-134.40%*
Total Operating Expenses ($USD Millions)$4.56*$4.49*$4.32*$5.15*

Notes: Asterisk indicates values retrieved from S&P Global.
Cross-check: Company reported Q3 revenue “$2.4M” in the 8-K press release; net loss $2.0M ($0.16 per share).

Q4 2024 vs Estimates (S&P Global)

MetricEstimateActualSurprise
Revenue ($USD Millions)$2.42$2.21Miss: $(0.21)M (−8.8%)*
EPS ($USD)$-4.20$-6.30Miss: $-2.10*
EBITDA ($USD Millions)N/A$(2.79)N/A*
# of EPS Estimates1—*
# of Revenue Estimates1—*

Notes: Asterisk indicates values retrieved from S&P Global.

KPI snapshot

KPIQ4 2023Q1 2024Q2 2024Q3 2024Q4 2024
CyPath Lung test orders (units)12 53 168 Not disclosedNot disclosed
States ordering CyPath Lung8+ states listed 11 states FSS access to 1,380 facilities

Revenue composition (qualitative)

  • Revenue primarily generated from patient service fees (including CyPath Lung) and histology fees; 2024 increase largely driven by full-year consolidated operations of Precision Pathology (PPLS).

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenue ($USD Millions)FY 2025Not provided$6–$8Lowered vs FY 2024 actual
CyPath Lung Revenue ($USD Millions)FY 2025Not provided$1–$2First disclosure
Pathology Services (portfolio)FY 2025Not providedDiscontinue certain unprofitable servicesStrategic exit; cost offsets expected
Laboratory cost structureFY 2025Not providedLower labor/overhead expectedCost reductions to offset lower revenue
Clinical development expenseFY 2025Not providedExpected increasePivotal trial enrollment to begin

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was found via company documents or public sources. (https://ir.bioaffinitytech.com/news-events/press-releases)

TopicPrevious Mentions (Q-2)Previous Mentions (Q-1)Current Period (Q4 2024/FY release)Trend
AI/technologyFlow cytometry + AI platform highlighted; sensitivity/specificity metrics cited. Continued emphasis on AI-enabled diagnostics and pipeline expansion (COPD/asthma). Expanding
Supply chainNot discussedStable
Tariffs/macroNot discussedStable
Product performance217% QoQ sales growth; raised CyPath forecast; 168 tests in Q2. 53 tests in Q1; early traction. ~1,400% YoY order growth; expanded physician offices >300%. Improving
Regional trends8 states ordering (list provided). 11 states; FSS enables access across 1,380 facilities. Broadened footprint
Regulatory/reimbursementMedicare/private reimbursement; CPT code effective Jan 2024. Reaffirmed reimbursement; FSS listing in Oct 2024. Strengthening
R&D executionCollaboration with Brooke Army Medical Center; new product development (COPD, bronchoscopy companion). COPD/asthma diagnostic pipeline noted; pivotal trial protocol submitted to IRB; sites qualified. Advancing

Management Commentary

  • “We are proud of the tremendous strides… achieving record revenue and laying the groundwork for continued growth.” — Maria Zannes, President & CEO.
  • “Our inclusion on the U.S. Federal Supply Schedule marks a major milestone, ensuring Veterans and military personnel… have easy access to CyPath Lung.”
  • “As we look to 2025, our focus remains on expanding commercial adoption… starting our FDA pivotal study… and advancing our pipeline of diagnostics powered by artificial intelligence and flow cytometry.”
  • “With the recent streamlining of operations that will increase profitability at our laboratory…”

Q&A Highlights

  • No Q4 2024 earnings call transcript was available; guidance clarifications and analyst Q&A not published at the time of review. (https://ir.bioaffinitytech.com/news-events/press-releases)

Estimates Context

  • Q4 2024 missed both revenue and EPS consensus (one estimate each): revenue $2.21M vs $2.42M (-8.8%), EPS $-6.30 vs $-4.20 (miss $2.10). Expect near-term estimate revisions to reflect lower FY 2025 revenue guide and the discontinuation of certain pathology services. [Values retrieved from S&P Global]*

Key Takeaways for Investors

  • Near-term top-line reset: FY 2025 revenue guided to $6–$8M as unprofitable pathology services are discontinued; watch for margin improvement from cost cuts despite lower revenue.
  • Commercial tailwinds: Medicare/private reimbursement and FSS listing materially expand access; growing physician adoption bodes well for CyPath Lung test demand.
  • Clinical catalyst path: pivotal trial initiation in 2025; success could expand label and drive broader adoption; monitor trial enrollment and interim updates.
  • Liquidity and financing: tight year-end cash ($1.1M) partly mitigated by Oct 2024 financing ($2.66M) and Feb 2025 warrant exercises ($1.4M); further capital raises are possible near trial ramp.
  • Operating discipline: SG&A was $9.9M in 2024; management expects streamlining to increase lab profitability—track OpEx trajectory vs revenue mix shift.
  • Trading setup: multi-day post-earnings stock strength suggests sensitivity to commercialization milestones and clinical progress; downside risks tied to execution on guidance reset and funding cadence.
  • Estimate risk: with only one covering estimate for Q4, modeling dispersion is high; expect revisions to incorporate FY 2025 guide, margin trajectory, and trial costs. [Values retrieved from S&P Global]*

Additional references: Company FY 2024 press release and financials (Business Wire/IR site).

Footnote: * Values retrieved from S&P Global.