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bioAffinity Technologies, Inc. (BIAF)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $1.85M, down 21% year over year from $2.35M in Q3 2024 and below Street consensus; EPS was -$0.16, a penny better than market consensus, driven by cost actions that lowered direct costs 13% YoY .
  • CyPath Lung unit growth remained strong: sales up 276% YoY, with operational improvements post-quarter increasing data acquisition throughput by 50% and reducing unit cost by >25%, positioning the product for margin expansion .
  • Management executed strategic cost reductions expected to cut annual costs by ~$3.8M and discontinued lower-margin pathology services to refocus on high-margin diagnostics .
  • Liquidity was bolstered after quarter-end via a $3.25M public offering and prior $1.4M warrant exercises; cash was $0.44M at March 31, 2025, before these raises .
  • Shares rose modestly post-print despite the revenue miss; the medium-term narrative hinges on accelerating CyPath Lung adoption and an FDA pivotal trial plan submitted, with guidance for FY25 revenue of $6–$8M (including $1–$2M from CyPath) previously issued on Mar 31, 2025 .

What Went Well and What Went Wrong

What Went Well

  • 276% YoY growth in CyPath Lung sales, underpinned by Texas beta launch momentum and physician adoption; management highlighted strong commercial execution and footprint expansion across the U.S. (“We began 2025 with strong momentum…”) .
  • Operational improvements post-quarter boosted throughput by 50% and cut per-test unit cost by >25%, supporting near-term gross margin trajectory on CyPath Lung .
  • Strategic actions to streamline operations and discontinue low-margin services expected to reduce annual costs by ~$3.8M, already translating to margin improvements via lower direct costs YoY .

What Went Wrong

  • Top-line missed consensus; revenue $1.85M vs ~$2.62M market forecast, reflecting softer contributions from patient service, histology, and medical director fees relative to expectations .
  • Net loss widened in absolute terms to $(2.66)M (from $(1.96)M YoY) on higher SG&A to scale commercialization, despite improvement in per-share EPS (-$0.16 vs -$0.20 YoY) due to share count changes .
  • Cash of $0.44M at quarter-end necessitated external financing; subsequent capital raises of $1.4M (warrants) and $3.25M (offering) alleviate near-term liquidity but contribute to dilution risk .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD)$2,350,386 $2,207,593*$1,853,597
EPS ($USD)-$0.16 -$0.19*-$0.16
Total Operating Expenses ($USD)$4,324,250 $5,154,146*$4,480,736
EBITDA ($USD)$(1,822,566)*$(2,792,921)*$(2,568,794)*
EBITDA Margin (%)-77.54%*-126.51%*-138.58%*
Net Income ($USD)$(2,000,840) $(2,966,897)*$(2,660,417)
Net Income Margin (%)-85.13%*-134.40%*-143.53%*

Values marked with * retrieved from S&P Global.

Expense Detail (Q1 2025)Amount ($USD)
Direct Costs and Expenses$1,367,860
Research & Development$367,386
Clinical Development$138,353
SG&A$2,452,549
Depreciation & Amortization$154,588
Estimates vs Actuals (Q1 2025)Consensus (S&P Global)*# of Estimates (S&P)*Consensus (Market)ActualSurprise
Revenue ($USD)$2,109,000*1*$2,620,000 $1,853,597 -$766,403 vs market
EPS ($USD)-4.80*1*-0.17 -0.16 +0.01 vs market

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025$6–$8M No update provided in Q1 press release Maintained (no reiteration)
CyPath Lung RevenueFY 2025$1–$2M No update provided in Q1 press release Maintained (no reiteration)
Annual Operating Cost ReductionFY 2025N/A~$3.8M reduction from streamlining actions New action disclosed
Clinical Development ExpenseFY 2025Expected increase with FDA pivotal trial start No update beyond Q1 commentary Maintained expectation

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was located; themes below reflect press releases and prior disclosures.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024 / FY)Current Period (Q1 2025)Trend
CyPath Lung commercial rolloutOffices signed +75% QoQ; orders in 11 states; FSS listing (VA/Military) Record FY revenue; strong adoption; reimbursement by Medicare/private insurers Sales +276% YoY; Texas beta momentum; post-Q1 processing improvements (+50% throughput, -25% unit cost) Positive acceleration
Regulatory/Clinical (FDA pivotal trial)Preparation; collaboration with Brooke Army Medical Center Protocol submitted to Sterling IRB; multi-site trial expected to open Q2 2025 Clinical dev expense up on trial prep Advancing toward trial initiation
Cost structure/Focus on marginsSG&A investments to scale Discontinuation of unprofitable services anticipated to cut revenue but improve costs Strategic actions to reduce annual costs by ~$3.8M; direct costs down 13% YoY Margin-focused execution
Insurance/ReimbursementMedicare/private reimbursement confirmed; FSS access Reinforced reimbursement benefits Continued commercial focus; no new reimbursement changes disclosed Stable support
Capital & Liquidity$2.7M raise in Oct-2024 Cash $1.1M YE; $1.4M warrants in Feb-2025 $0.44M cash at Q1-end; $3.25M offering in May-2025 Liquidity bolstered post-Q1

Management Commentary

  • “We began 2025 with strong momentum, delivering 276% year-over-year growth in CyPath® Lung sales and expanding our commercial footprint across the U.S.” — Maria Zannes, President & CEO .
  • “We took decisive actions to streamline operations… These targeted actions will reduce costs approximately $3.8 million annually and accelerate the commercial growth of CyPath® Lung.” .
  • “Operational enhancements… increased our test throughput by 50% and lowered per-test cost by over 25%.” .
  • Emphasis on real-world case studies demonstrating early detection and avoidance of invasive procedures, supporting clinical and economic validation .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; no Q&A details identified after searching company IR and third-party coverage .

Estimates Context

  • Market consensus (Investing.com) for Q1 2025: Revenue $2.62M, EPS -$0.17; Actual: Revenue $1.85M, EPS -$0.16. Result: revenue miss (~$0.77M), EPS beat (+$0.01) .
  • S&P Global shows minimal coverage (1 estimate) and different EPS basis; Q1 2025 revenue estimate $2.11M*, EPS estimate -4.80*, with actuals aligned on their basis*. Use caution interpreting EPS units due to sparse coverage.*
    Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • CyPath Lung momentum is intact (276% YoY sales growth), supported by operational gains that should improve per-test economics and margins near term .
  • Near-term top-line volatility likely as legacy low-margin services are exited; watch for mix-shift toward diagnostics to tighten loss profile despite SG&A scaling .
  • Liquidity improved post-quarter via $3.25M offering and earlier $1.4M warrants; monitor cash burn vs. cost reductions as pivotal trial activities increase .
  • Estimate revisions may lower forward revenue assumptions after Q1 miss; EPS resilience suggests cost actions are bearing fruit, but SG&A investment continues .
  • Catalysts: FDA pivotal trial start, reimbursement/coverage expansion, further case study validation, and accelerating unit volumes could drive narrative and potential re-rating .
  • Risk factors: dilution from capital raises, sparse sell-side coverage leading to estimate variability, and execution on national rollout outside Texas .
  • Trading implication: near-term moves likely tied to volume updates and trial milestones; watch for confirmation of throughput/cost benefits translating to gross margin progression in Q2/Q3 .