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Protalix BioTherapeutics, Inc. (PLX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 total revenue was $15.658M, up 16.3% year over year and up 54.8% quarter over quarter; revenue beat Wall Street consensus of $13.486M by $2.172M. EPS was $0.00 versus $0.03 consensus, a miss; gross margin expanded materially on mix shift toward Chiesi’s Elfabrio .*
  • Cost of goods sold fell 38% YoY to $5.870M, driving gross margin to ~62.5% (vs. ~29.8% in Q2 2024) and EBIT margin to ~7.5% (vs. -16.9% YoY), aided by lower Pfizer/Fiocruz sales and higher Chiesi volumes .
  • Management reiterated PRX-115 timelines: randomized Phase 2 initiation in H2 2025, with first patient in Q4 2025; EMA continues reviewing Elfabrio label variation for 2 mg/kg every 4 weeks, which could support broader adoption .
  • Corporate catalysts include CFO transition to Gilad Mamlok (effective Aug 24, 2025) and Russell 3000/2000 index inclusion as of June 27, 2025, potentially enhancing visibility and liquidity .

What Went Well and What Went Wrong

What Went Well

  • Revenue beat and gross margin expansion: “We experienced a 50% increase in revenues from selling goods in the first half of 2025… driven primarily by sales of Elfabrio® to Chiesi… we are confident in the growth of our Elfabrio franchise over the long term.”
  • SG&A discipline: SG&A fell 26% YoY to $2.6M, primarily from lower salary and selling expenses, supporting operating leverage as volumes scale .
  • Balance sheet strength maintained: Cash and short-term deposits were ~$33.4M at quarter-end, providing funding runway into clinical milestones .

What Went Wrong

  • EPS missed consensus ($0.00 vs $0.03) as R&D ramped for PRX-115 Phase 2 and financial expenses rose on FX and lower deposit interest; Q2 financial expenses, net swung to $(0.5)M from +$0.2M YoY .*
  • Customer concentration/mix volatility: Q2 increase was driven by +$8.0M to Chiesi, but offset by -$4.7M Fiocruz and -$1.2M Pfizer, highlighting early-launch ordering variability and regional procurement risks .
  • Tax headwinds/uncertainty: Q2 tax expense was ~$0.5M versus a $(0.1)M benefit YoY; while U.S. tax reform restored deductibility for domestic research beginning in 2025, management is still evaluating impacts .

Financial Results

P&L and Margin Comparison

MetricQ2 2024Q1 2025Q2 2025
Total Revenue ($USD)$13.474M $10.113M $15.658M
Revenues from Selling Goods ($USD)$13.304M $9.995M $15.440M
License & R&D Services Revenue ($USD)$0.170M $0.118M $0.218M
Cost of Goods Sold ($USD)$9.456M $8.180M $5.870M
Gross Profit ($USD)$4.018M $1.933M $9.788M
Gross Margin (%)29.8% 19.1% 62.5%
R&D Expense ($USD)$2.961M $3.475M $5.992M
SG&A Expense ($USD)$3.484M $2.603M $2.624M
Operating Income (Loss) ($USD)$(2.427)M $(4.145)M $1.172M
EBIT Margin (%)-18.0% -41.0% 7.5%
Financial Income (Expenses), Net ($USD)$0.155M $0.413M $(0.511)M
Taxes on Income ($USD)$(0.069)M $0.113M $0.497M
Net Income (Loss) ($USD)$(2.203)M $(3.619)M $0.164M
EPS (Basic) ($)$(0.03) $(0.05) $0.00

Actual vs. Consensus (S&P Global)

MetricQ1 2025 ActualQ1 2025 ConsensusQ2 2025 ActualQ2 2025 Consensus
Revenue ($USD)$10.113M $21.600M*$15.658M $13.486M*
EPS ($)$(0.05) $0.08*$0.00 $0.03*

Values retrieved from S&P Global.*

Customer Contribution Changes (YoY)

CustomerQ2 2024 to Q2 2025 ChangeNotes
Chiesi+$8.0M Primary driver of growth; Elfabrio demand ramp
Fiocruz (Brazil)-$4.7M Procurement variability
Pfizer-$1.2M Lower shipments YoY

KPIs

KPIQ1 2025Q2 2025
Cash & Short-Term Deposits ($USD)$34.743M (cash $19.458M + deposits $15.285M) $33.398M (cash $17.895M + deposits $15.503M)
Accounts Receivable – Trade ($USD)$4.675M $9.443M
Inventories ($USD)$19.506M $21.131M
Weighted Avg Shares (Basic)76,611,980 78,663,884

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PRX-115 Phase 2 initiationH2 2025“Expect to commence during H2 2025” (Q1 release) “Anticipate initiation in H2 2025; first patient Q4 2025” Clarified timeline (added Q4 first-patient)
Elfabrio EMA label variation (2 mg/kg q4w)Ongoing reviewEMA validated variation submission in Dec 2024; ongoing EMA continues evaluation; accepted for review Dec 2024 Maintained (status update)
Financial guidance (Revenue, margins, OpEx, OI&E, tax rate)FY/Q2 2025None providedNone providedMaintained (no quantitative guidance)

Earnings Call Themes & Trends

Note: Q2 2025 transcript not available in our dataset; themes below leverage press releases for narrative continuity.

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Elfabrio commercialization & label expansion2024 record “selling goods” revenue; EMA validated less frequent dosing submission EMA review continues; Elfabrio driving H1 revenue growth Positive momentum; label could broaden adoption
PRX-115 (uncontrolled gout)FIH results presented; Phase 2 planned H2 2025 Phase 2 initiation H2 2025, first patient Q4 2025 Advancing to Phase 2; investment ramp
Operating leverage & expensesR&D decreased in 2024; SG&A down YoY SG&A down 26% YoY; R&D up 100% YoY for Phase 2 readiness Mix shift: growth investment offset by SG&A control
Capital structure/liquidityDebt fully repaid Sept 2024; no warrants outstanding; $34.8M cash at YE 2024 $33.4M cash & deposits at Q2; AR rose with shipments Stable liquidity supporting pipeline execution
Tax/regulatory environmentR&D capitalization under TCJA impacting taxes U.S. tax reform restores domestic deductibility from 2025; evaluating impact Potentially lower tax burden domestically

Management Commentary

  • “We experienced a 50% increase in revenues from selling goods in the first half of 2025… driven primarily by sales of Elfabrio® to Chiesi… We are confident in the growth of our Elfabrio franchise over the long term.” – Dror Bashan, President & CEO
  • “We anticipate initiation of a randomized Phase 2 trial in the second half of 2025 and enrollment of the first patient in the fourth quarter of 2025.” – Dror Bashan
  • “Eyal Rubin is stepping down as our Chief Financial Officer… [and] is to be succeeded by Gilad Mamlok… [who] will play an important role in Protalix’s management as we continue to work toward future growth.” – Dror Bashan
  • “We are very pleased to be included in the Russell 3000 and Russell 2000 Indexes… We welcome the enhanced visibility…” – Dror Bashan

Q&A Highlights

  • The company hosted a call on August 14, 2025 (8:30 a.m. EDT) with webcast/archive links provided, but a transcript for Q2 2025 is not available in our document set; therefore specific Q&A themes and clarifications cannot be summarized from the transcript .

Estimates Context

  • Q2 2025 revenue beat consensus ($15.658M vs $13.486M) while EPS missed ($0.00 vs $0.03). Q1 2025 had a significant revenue miss ($10.113M vs $21.600M) and EPS miss ($(0.05) vs $0.08), signaling estimate dispersion amid launch and customer ordering variability .*
  • Given gross margin step-up and sustained SG&A control, FY 2025 revenue consensus of $58.882M may see upward bias if Chiesi volumes persist, while EPS expectations could reflect higher R&D spend as Phase 2 initiates .*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Revenue beat with strong margin inflection suggests favorable mix and operating leverage; watch for continued Chiesi-led momentum and EMA label outcome as stock catalysts .
  • EPS miss driven by deliberate R&D investment for PRX-115 underscores near-term earnings trade-off for medium-term pipeline value creation .
  • SG&A discipline (down 26% YoY) provides cushion to fund clinical execution; financial expenses volatility (FX/lower deposit yields) is a watch item .
  • Liquidity remains solid at ~$33.4M cash/deposits; accounts receivable growth aligns with higher shipments, but working capital dynamics bear monitoring .
  • Regulatory tailwinds: EMA’s potential q4w dosing label for Elfabrio could expand addressable use and support share gains in a ~$2.3B global Fabry market .
  • U.S. tax reform restoring domestic R&D deductibility from 2025 could reduce future cash taxes; management is evaluating the impact .
  • Near-term trading implications: revenue beats and margin strength are positives; absence of formal financial guidance keeps estimate risk elevated. Medium-term thesis hinges on Elfabrio adoption breadth and PRX-115 Phase 2 execution .