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Protalix BioTherapeutics, Inc. (PLX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $17.851M and diluted EPS was $0.03; EPS missed Wall Street consensus*, while revenue was essentially in-line, driven by partner ordering variability across Chiesi, Pfizer, and Fiocruz . EPS consensus* was $0.055, revenue consensus* was $17.866M; the EPS miss was the primary negative surprise* .
  • Year-to-date revenue reached $43.622M, up 24% YoY, supported by commercialization of Elfabrio and Elelyso; however, Q3 revenue declined 1% YoY due to timing of partner purchases .
  • Operating income was $2.131M; net income was $2.355M, reflecting higher R&D spend for PRX-115 (uncontrolled gout) as Phase 2 begins in 2025; management guided to continued elevated R&D as pipeline advances .
  • Regulatory update: EMA’s CHMP issued a negative opinion on Elfabrio’s 2 mg/kg every 4 weeks dosing regimen (E4W); Chiesi requested re-examination; the approved 1 mg/kg every 2 weeks regimen remains unaffected—a key watch item for European label expansion .
  • Stock reaction: shares fell ~13.6% premarket on the release day and previously dropped ~22.5% on the October CHMP news; EPS miss and EU dosing uncertainty were the catalysts .

What Went Well and What Went Wrong

What Went Well

  • Year-to-date revenue up 24% YoY to $43.622M and YTD sales of goods up 24% to $43.108M; company highlighted ongoing commercial traction despite quarterly variability .
  • PRX-115 IND effective; Phase 2 initiation planned later in 2025; management reiterated best-in-class potential based on Phase 1 data and long-acting profile aspirations .
  • Cash and short-term deposits of $29.370M at Q3-end, with management stating this is sufficient to fund at least 12 months from the 10-Q issuance date; supports continued R&D and operations .

What Went Wrong

  • Q3 EPS of $0.03 missed consensus* ($0.055); revenue was essentially in-line; EPS miss reflects higher R&D (up 50% YoY in Q3) and SG&A uptick .
  • EMA CHMP negative opinion on Elfabrio E4W regimen; label expansion delayed pending re-examination, increasing regulatory uncertainty in Europe .
  • Revenue down 1% YoY in Q3 (to $17.851M vs $17.959M), driven by partner ordering timing; underscores quarter-to-quarter variability and inventory management by partners .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$17.959 $10.113 $15.658 $17.851
Diluted EPS ($USD)$0.03 $(0.05) $0.00 $0.03
Operating Income ($USD Millions)$3.991 $(4.145) $1.172 $2.131
Net Income ($USD Millions)$3.236 $(3.619) $0.164 $2.355
Operating Margin %22.2% (3.991/17.959) (41.0%) (−4.145/10.113) 7.5% (1.172/15.658) 11.9% (2.131/17.851)
Net Income Margin %18.0% (3.236/17.959) (35.8%) (−3.619/10.113) 1.0% (0.164/15.658) 13.2% (2.355/17.851)
Q3 2025 vs.Revenue ($USD)EPS ($USD)
Prior Quarter (Q2 2025)+$2.193M (from $15.658M to $17.851M) +$0.03 (from $0.00 to $0.03)
Prior Year (Q3 2024)−$0.108M (from $17.959M to $17.851M) flat (from $0.03 to $0.03)
Q3 2025 vs Estimates (S&P Global)*Consensus*Actual
Revenue ($USD)$17.866M*$17.851M
Primary EPS ($USD)$0.055*$0.03
Primary EPS – # of Estimates2*N/A
Revenue – # of Estimates2*N/A

Note: Values marked with * retrieved from S&P Global.

Segment breakdown (Q3 2025):

Customer/ProductQ3 2025 Revenue ($USD Millions)
Elfabrio to Chiesi$8.8
Elelyso to Pfizer$2.8
Alfataliglicerase (Elelyso) to Fiocruz (Brazil)$6.1
License & R&D Services$0.178

KPIs and balance sheet trend:

MetricQ1 2025Q2 2025Q3 2025
Cash & Equivalents ($M)$19.458 $17.895 $13.647
Short-term Bank Deposits ($M)$15.285 $15.503 $15.723
Cash + ST Deposits ($M)$34.743 (sum) $33.398 (sum) $29.370 (sum)
Accounts Receivable ($M)$4.675 $9.443 $14.425
Inventories ($M)$19.506 $21.131 $21.255

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PRX-115 clinical timelineH2 2025Anticipated Phase 2 initiation in H2 2025 IND effective; Phase 2 to initiate later this year Maintained (timing reaffirmed)
Elfabrio EU dosing (2 mg/kg E4W)2025EMA variation submission under review CHMP negative opinion; re-examination requested; 1 mg/kg E2W remains approved Lowered (regulatory setback)
Financial guidance2025None disclosedNone disclosedMaintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
PRX-115 (uncontrolled gout)Phase 2 expected H2 2025; Phase 1 FIH completed; long-acting profile aspiration IND effective; Phase 2 initiating later this year; “best-in-class” potential reiterated Progressing to Phase 2
Elfabrio EU dosing expansionEMA evaluating E4W variation CHMP negative opinion; re-examination requested; E2W unaffected Regulatory uncertainty increased
Revenue variability by partnerPartners control inventory; quarterly fluctuations noted Reiterated; Q3 mix across Chiesi/Pfizer/Fiocruz; slight YoY decline Persistent variability
R&D spend trajectoryIncreasing with pipeline advancement Elevated R&D (+50% YoY in Q3) for PRX-115 Phase 2 prep Rising as trials advance
Corporate finance/leadershipCFO transition to Gilad Mamlok; Russell index inclusion CFO on call; reiterated funding window (~12 months); cash + ST deposits $29.370M Stable liquidity; leadership in place
Tax/Regulatory backdropHR1 restoring domestic R&D deductibility; ongoing evaluation Tax benefit in Q3; HR1 noted; GILTI-related impacts Supportive for R&D accounting

Management Commentary

  • “We are pleased to report total revenues of $43.6 million for the first nine months of 2025… Our total revenues for the third quarter were $17.9 million…” emphasizing partner-controlled inventory dynamics and ongoing commercial success .
  • “We are particularly excited about PRX-115… we believe it has the potential to be a best-in-class therapy with a long-acting profile… We are planning to initiate a phase 2 clinical trial… later this year” .
  • “In November 2025, Chiesi… requested a re-examination of the recent negative opinion… for the E4W dosing regimen for Elfabrio… The 1 mg/kg E2W regimen is unaffected” .
  • “We expect to continue to incur significant research and development expenses as we enter into a more advanced stage of… clinical trials, including the initiation of the phase 2 clinical trial of PRX-115” .

Q&A Highlights

  • EPS and revenue vs expectations: multiple outlets highlighted an EPS miss ($0.03 vs ~$0.06–$0.07) and near in-line revenue; the miss weighed on premarket trading .
  • CHMP decision Q&A: management noted Chiesi has submitted a request for re-examination of the E4W regimen; additional studies may be contemplated depending on EMA feedback .
  • Receivables and cash conversion: investors asked about receivables build and subsequent cleanup; pattern discussed with management acknowledging timing effects and subsequent collections .
  • Ordering variability: reiterated that partners manage inventories; demand trends and market expansion efforts continue, with submissions planned across multiple geographies .

Estimates Context

  • Q3 2025 actual EPS: $0.03 vs consensus* $0.055 → bold negative surprise on EPS; Q3 2025 revenue: $17.851M vs consensus* $17.866M → essentially in line*. The EPS miss largely reflects increased R&D for PRX-115 as Phase 2 preparation accelerated .
  • Adjacent quarter context: Q2 2025 beat revenue vs consensus* ($15.658M actual vs $13.486M*), while Q1 2025 significantly missed revenue vs consensus* ($10.113M actual vs $21.600M*), highlighting order timing and partner variability*.
  • Estimate breadth remains narrow (# of estimates: 2 for Q3 EPS/revenue*), increasing volatility in reported-vs-consensus outcomes*.

Note: Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Quarter was mixed: strong profitability (net income margin 13.2%) but a clear EPS miss vs consensus*; watch for normalization of R&D spend post Phase 2 ramp and partner ordering cadence .
  • Regulatory overhang: EU E4W dosing re-examination introduces timeline uncertainty; the base E2W regimen remains intact, but the upside case for label flexibility is delayed .
  • Commercial engine intact: YTD revenue +24% YoY; quarterly variability is intrinsic to a partner-led inventory model; expect continued lumpiness but expanding geographic submissions over time .
  • Liquidity adequate for near-term execution: $29.370M cash + ST deposits supports at least the next 12 months; monitor receivables build and cash conversion into Q4/Q1 .
  • Trading setup: EPS miss and EU dosing uncertainty pressured shares; a positive CHMP re-exam outcome or clean receivables conversion could be near-term catalysts, while Phase 2 first patient dosing in PRX-115 offers clinical milestones .
  • Medium-term thesis: execution on PRX-115 and broader Elfabrio market penetration drives upside; risk centers on regulatory outcomes, partner demand variability, and sustained R&D investment pace .
  • Action: reassess EPS models to reflect higher R&D run-rate and regulatory timing; maintain focus on EU label outcome and PRX-115 Phase 2 start as key inflection points .