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PI

Precipio, Inc. (PRPO)·Q1 2025 Earnings Summary

Executive Summary

  • Revenue was $4.90M, up 43% year-over-year and down 9.5% sequentially, with seasonality and onboarding delays cited as drivers of the QoQ decline .
  • Gross margin expansion continued: overall gross margin reached 43% (vs. 27% YoY), with Products at 51% (vs. 37%) and Pathology at 42% (vs. 24%) .
  • Management highlighted catalysts: MolDx approval enabling Medicare billing for NGS (estimated ~$0.25M per quarter uplift), reversal of the FDA LDT ruling unlocking paused product evaluations, and expectation of returning to positive operating cash flow in Q2 or Q3 .
  • Non-recurring ERC funds of >$0.4M were received in Q2; Change Healthcare cyber incident-related advances are being repaid over 2025 with a $130K write-off negotiated, easing liquidity near term .

What Went Well and What Went Wrong

What Went Well

  • Strong YoY growth and margin expansion: $4.9M revenue (+43% YoY) and overall gross margin of 43% vs. 27% YoY; Products gross margin rose to 51% and Pathology to 42% .
  • Regulatory and reimbursement wins: MolDx approval enables Medicare billing for NGS; management estimates ~$0.25M quarterly uplift from current case volume .
  • Product pipeline momentum post LDT reversal: distributors are generating more meetings; 1 new customer onboarded, 2 new panels launched, and validations underway for 4 panels; CEO: “We remain confident… momentum building in our Product business pipeline” .

What Went Wrong

  • Sequential revenue decline (-9.5% QoQ) attributed to seasonality (insurance deductibles reset) and temporary onboarding delays on Products .
  • Adjusted EBITDA remained negative at ($0.108M), though improved sharply from ($1.409M) YoY .
  • Customer onboarding timelines remain elongated due to regulatory updates, lab workflow issues, and staffing gaps at customer sites, delaying revenue recognition despite demand .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$5.209*$5.450*$4.929
Diluted EPS ($USD)-$0.423*-$0.245*-$0.588*
Gross Profit Margin %43.7%*48.6%*43.0%
Adjusted EBITDA ($USD Millions)N/A$0.400 -$0.108
Cash from Operations ($USD Millions)$0.041*$0.565*-$0.044

Values marked * retrieved from S&P Global.

Segment margin breakdown (YoY):

MetricQ1 2024Q1 2025
Products Gross Margin %37% 51%
Pathology Gross Margin %24% 42%
Overall Gross Margin %27% 43%

KPIs:

KPIQ1 2024Q1 2025
Pathology Revenue YoY Growth %N/A54%
Pathology Test Volume YoY Growth %N/A46%
New Ordering PhysiciansN/A11
MolDx (NGS) Approval StatusNot approvedApproved; billing enabled
Products: New Panels LaunchedN/A2
Products: New Customers OnboardedN/A1

Operating expense efficiency:

  • OpEx as % of net revenue improved from 87% to 61% YoY, driven by flat ~$3M quarterly OpEx and 43% YoY revenue growth .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating Cash FlowQ2–Q3 2025NoneExpect return to positive in Q2 or Q3 New
Pathology Gross MarginFY 2025NoneExpected to stabilize in mid-40% range New
Products Gross MarginFY 2025NoneExpected to continue to grow with scale New
Combined Gross MarginFY 2025NoneExpected to continue climbing as mix shifts to Products New
NGS Medicare Reimbursement ImpactQ2+ 2025None~$0.25M per quarter uplift from current volume New
Products Revenue RampFY 2025On track to double run-rate by end 2025 Pipeline accelerating post LDT reversal; validations in flight Maintained
Non-Recurring ERCQ2 2025$0>$0.4M received; pursuing ~$1.0M remaining New
Change Healthcare Settlement2025None$130K write-off; ~<$0.8M to be repaid over 2025 New

Earnings Call Themes & Trends

TopicQ3 2024 (Prev Mentions)Q4 2024 (Prev Mentions)Q1 2025 (Current)Trend
Seasonality & CollectionsEmphasis on approaching breakeven; lower burn Positive adjusted EBITDA and cash flow achieved Seasonal Q1 dip (deductibles reset) drove -9.5% QoQ; rebound expected Q2 Neutral to improving
Regulatory/ReimbursementAddressed conversion and regulatory challenges (LOD) MolDx approval; Medicare billing begins; FDA LDT reversal unlocks demand Positive
Products Onboarding & DistributionPipeline development; distributors to scale growth Distributor strategy refined; hiring to accelerate Products 1 new customer; 2 panels launched; 4 validations; distributors generating meetings Positive but paced
MarginsPathology above breakeven; product margins structurally higher Margin focus and distribution leverage Pathology 42%, Products 51%, Overall 43% Positive
Cash & Capital NeedsReducing burn; avoid raises Positive cash in Q4; path to profitability Expect positive op CF Q2/Q3; ERC >$0.4M; Change Healthcare write-off Positive
R&D via PathologyPathology as self-financed R&D platform Continued emphasis >12,000 samples in 2024 supporting rapid product R&D Positive

Management Commentary

  • “We remain confident in the Company’s trajectory, supported by strong year-over-year revenue growth, improved gross margins, disciplined cost control and increasing operational efficiency… We anticipate continued revenue growth and a return to positive operating cash flow by Q2 or Q3.” – CEO Ilan Danieli .
  • “In Q1… we received MolDx approval for our next-generation sequencing… Based on our internal estimates, this could equal approximately $0.25 million per quarter in increased revenue and cash from our current case volume.” .
  • “In March… the FDA ruling [on LDTs] was overturned… prospective customers reached back out saying they are now ready to proceed.” .
  • “Operating expenses as a percent of revenue dropped from 87% to 61%… achieved by keeping OpEx ~ $3M per quarter while growing revenue by 43% YoY.” .

Q&A Highlights

  • The Q1 shareholder update call was delivered as prepared remarks; a formal analyst Q&A segment was not recorded in the transcripts provided. Management proactively addressed: seasonal Q1 dynamics, MolDx approval impact, LDT reversal implications, customer onboarding timelines, and non-recurring cash items (ERC, Change Healthcare) .

Estimates Context

  • S&P Global consensus was unavailable for PRPO’s Q1 2025 EPS and revenue; no beat/miss assessment versus Street can be made based on SPGI data retrieved. Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term cash flow inflection: management expects positive operating cash flow in Q2 or Q3; monitor Q2 collections and pathology volumes as the key driver .
  • Reimbursement tailwind: MolDx approval enables Medicare billing for NGS and is estimated at ~$0.25M per quarter uplift from current volume; track claims conversion and incremental cash receipts .
  • Regulatory relief catalyzing pipeline: LDT reversal removes a key adoption barrier; watch the pace of validations converting to recurring orders, especially the multi-panel major lab onboarding cited .
  • Margin trajectory: mix-shift to Products and scale efficiencies should lift combined gross margin beyond 43% through 2025 if product revenues ramp as planned .
  • Liquidity supported by non-recurring items: ERC >$0.4M received and $130K Change Healthcare write-off ease 2025 repayments; treat ERC as one-time and adjust models accordingly .
  • Execution risk: elongated customer onboarding timelines (regulatory updates, lab workflow, staffing) can push revenue out; discount pipeline timing and look for evidence of quicker conversions via new support programs .
  • Strategic focus: Pathology remains cash engine and R&D platform (>12,000 samples in 2024), while Products aim to become the growth and margin driver through distributor leverage .