Sign in

You're signed outSign in or to get full access.

PB

Protalix BioTherapeutics, Inc. (PLX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $10.11M, up 170% YoY, driven by higher sales to Pfizer and Fiocruz; net loss narrowed to $3.62M and EPS improved to -$0.05 versus -$0.06 last year .
  • Results missed S&P Global consensus: revenue $21.6M* and EPS $0.08*; actuals were $10.11M and -$0.05, respectively — a significant miss given limited coverage (1 estimate)*.
  • Management reiterated plans to initiate a Phase II trial for PRX‑115 (gout) in 2H 2025 and expects an EMA decision on an every‑4‑weeks dosing regimen for Elfabrio in Q4 2025, two near‑term catalysts .
  • Cash, cash equivalents and short‑term bank deposits were ~$34.7M at quarter‑end, supporting pipeline execution without near‑term financing needs .

Values retrieved from S&P Global*

What Went Well and What Went Wrong

What Went Well

  • Revenues from selling goods rose to $10.0M (+$6.3M YoY), with Pfizer +$5.9M and Fiocruz +$0.4M increments, reflecting stronger demand and partner activity .
  • PRX‑115 Phase I single‑dose data showed rapid, dose‑dependent urate reduction with potential for wide dosing intervals; program on track for Phase II initiation in 2H 2025 .
  • SG&A declined 16% YoY to $2.6M, underscoring cost discipline; operating loss narrowed to $4.1M from $4.9M .

What Went Wrong

  • Revenue and EPS missed S&P Global consensus materially: revenue $21.6M* vs $10.11M; EPS $0.08* vs -$0.05 — a clear negative surprise given low estimate count* .
  • Gross margin compressed YoY as COGS rose with higher product mix to partners (Pfizer/Brazil), pressuring profitability despite revenue growth .
  • R&D increased 21% YoY to ~$3.5M as pipeline advanced, elevating near‑term OpEx and contributing to negative operating income .

Values retrieved from S&P Global*

Financial Results

Consolidated P&L vs Prior Year and Consensus

MetricQ1 2024Q1 2025Consensus (Q1 2025)
Revenue ($USD Millions)$3.748 $10.113 $21.600*
EPS (Diluted, $USD)-$0.06 -$0.05 $0.08*
Operating Income ($USD Millions)-$4.856 -$4.145 N/A
Gross Profit Margin (%)30.6% (calc from $3.748 revenue, $2.602 COGS) 19.1% (calc from $10.113 revenue, $8.180 COGS) N/A

Values retrieved from S&P Global*

Revenue Breakdown

Revenue Category ($USD Millions)Q1 2024Q1 2025
Revenues from Selling Goods$3.677 $9.995
Revenues from License & R&D Services$0.071 $0.118
Total Revenue$3.748 $10.113

KPIs and Operating Metrics

KPI ($USD Millions unless noted)Q1 2024Q1 2025
Cost of Goods Sold$2.602 $8.180
R&D Expense$2.887 $3.475
SG&A Expense$3.115 $2.603
Financial Income, Net$0.123 $0.413
Tax Benefit$0.138 $0.113
Net Loss-$4.595 -$3.619
Weighted Avg. Shares (Basic/Diluted)73,036,569 76,611,980
Cash + Short-term Bank Deposits (End of Period)N/A$34.743

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PRX‑115 Phase II initiation2H 2025Initiate in 2H 2025 (Q4 2024 call) Initiate in 2H 2025 (Q1 2025) Maintained
Elfabrio EMA dosing regimen (2 mg/kg q4w)Decision expected Q4 2025Variation submission validated (Dec 2024) Expect EMA feedback Q4 2025 Timeline specified
Financial guidance (Revenue/EPS)FY/Q2 2025None provided None provided Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
PRX‑115 (gout)Phase I completed; dose‑dependent urate lowering; planning Phase II in 2H 2025 Reinforced Phase I outcomes; Phase II initiation timeline reiterated Consistent progress
Elfabrio commercializationChiesi investing; label variation submitted to EMA for q4w dosing Expect EMA decision Q4 2025; patient recruitment “above expectations” per Chiesi Positive momentum
Financial disciplineDebt repaid; stronger balance sheet (Q4 call) Cash + deposits ~$34.7M; SG&A down YoY Stable
Tariffs/macroNot a major focus (prior)U.S. tariffs expected to have no direct impact on PLX–Chiesi transactions (Israel–Italy), pricing decisions up to Chiesi Neutral
R&D focusPipeline prioritization; renal rare diseases strategy R&D up 21% YoY as programs advance Investment rising

Management Commentary

  • “We had another solid quarter, with an increase in revenues from selling goods compared to the prior year quarter.” — Dror Bashan, CEO .
  • “The encouraging results from [PRX‑115] suggest a long‑acting effect, and may enable us to potentially widen the dosing interval.” — CEO .
  • “We expect to hear from the EMA during the fourth quarter of this year” regarding Elfabrio q4w dosing regimen — CEO .
  • “Chiesi sales efforts and outcomes are strong... pace of recruitment of commercial patients is very good and above expectations.” — CEO .
  • “Cash, cash equivalents and short‑term bank deposits were approximately $34.7 million at March 31, 2025.” — CFO .

Q&A Highlights

  • Elfabrio milestones and commercialization: Management emphasized strong Chiesi execution and improving patient recruitment; specific figures not shared due to agreement terms .
  • EMA dosing regimen change: Application in EU ongoing; no red flags signaled; U.S. label changes would be updated when available .
  • Competitive landscape in gout (e.g., KRYSTEXXA): Management declined product‑specific comparisons; Phase II will clarify immunogenicity and safety profile .
  • Tariffs and pricing: PLX’s sales are Israel‑to‑Italy (Chiesi), so proposed U.S. tariffs should not affect PLX’s COGS; Chiesi has not indicated a price change for Elfabrio in response, but could reassess if tariffs materialize .
  • Milestone framework: Remaining regulatory milestones include potential U.S./EU q4w dosing and future superiority claims; overall global milestone potential up to ~$0.5B depending on sales thresholds under separate U.S./ex‑U.S. agreements .

Estimates Context

  • Revenue missed S&P Global consensus materially: $21.6M* vs actual $10.11M — driven by timing/mix of partner inventory sales (Pfizer/Brazil) and minimal license/R&D revenue .
  • EPS missed: $0.08* vs actual -$0.05 — operating loss and higher COGS offset YoY improvement .
  • Coverage thin: 1 estimate for both revenue and EPS*, caution on interpreting consensus.

Values retrieved from S&P Global*

Key Takeaways for Investors

  • Significant top‑line and EPS miss vs consensus amid limited coverage; watch for estimate resets and sentiment near term*.
  • Two tangible 2H catalysts: PRX‑115 Phase II initiation and EMA decision on Elfabrio q4w dosing — both can drive narrative and potential re‑rating on execution .
  • Product sales strength (Pfizer/Brazil) boosted YoY revenue; however, gross margin compression underscores sensitivity to mix and inventory timing .
  • Cost discipline persists (SG&A down YoY); liquidity (~$34.7M) supports clinical progression without immediate capital needs .
  • Chiesi commercialization trending positively per management; royalty‑driven economics over time could improve margin profile as Elfabrio uptake scales .
  • Expect ongoing R&D spend as PRX‑115 and PRX‑119 advance; monitor Phase II design, enrollment (mostly U.S.), and immunogenicity profile vs incumbents .
  • Tariff headlines unlikely to impact PLX’s COGS directly given Israel–Italy transaction flow; pricing decisions remain at Chiesi’s discretion .

Values retrieved from S&P Global*