Protalix BioTherapeutics, Inc. (PLX)·Q4 2024 Earnings Summary

Executive Summary

• Record year in revenues from selling goods ($52.981M, +31% YoY), with strength across Chiesi, Pfizer and Brazil; FY 2024 net income was $2.932M ($0.04 basic/diluted) .
• PRX-115 completed First-in-Human Phase I with encouraging uric acid-lowering and tolerability; management targets Phase II initiation in H2 2025 and top-line ~2 years from Mar-2025, with third-party costs “north to $20M” .
• EMA validated Elfabrio (pegunigalsidase alfa) variation to add 2 mg/kg every 4 weeks dosing in EU—an incremental label expansion catalyst .
• Balance sheet improved: 7.5% notes repaid in Sep-2024; warrants exercised and expired Mar-11-2025; cash and short-term deposits were ~$34.8M at year-end .
• No formal 2025 revenue guidance; management emphasized Chiesi uptake and royalty high-margin revenue trajectory but cited inventory shipment lumpiness and Chiesi’s private status as constraints on disclosure .

What Went Well and What Went Wrong

What Went Well

• “2024 was a record year in revenues from selling goods” driven by increases in all three revenue streams (Chiesi +$11.8M, Brazil +$0.6M, Pfizer +$0.1M) .
• PRX-115 Phase I data: single-dose reduced plasma uric acid rapidly; mean uric acid stayed <6.0 mg/dL for up to 12 weeks at the highest dose; generally well-tolerated with mostly mild/moderate transient AEs—supports Phase II in H2 2025 .
• Deleveraging and equity cleanup: convertible notes fully repaid; no warrants outstanding; “our balance sheet is stronger and we are well-positioned” .

What Went Wrong

• License and R&D revenues fell 98% YoY to $0.418M (vs. $25.076M in 2023) as the $20M Elfabrio FDA milestone rolled off; FY total revenue declined to $53.399M (from $65.494M) .
• Tax expense rose to ~$1.2M (+300% YoY) driven by GILTI and Section 174 capitalization under TCJA (R&D capitalization/amortization) .
• Safety signal noted in PRX-115 FIH: one anaphylactic reaction resolved; underscores need for robust monitoring in Phase II design .

Financial Results

Note: PLX’s FY 2024 press release focused on annual totals; standalone Q4 figures were not disclosed in the press materials or call. CFO referenced the 10-K for detailed figures .

• ND = Not disclosed in Q4 press release or call; management referenced 10-K for details .

Revenue drivers vs prior year (disclosed changes)

KPIs

FY context

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “2024 was a record year in revenues from selling goods for Protalix, as we experienced increases in all three of our revenue streams, Chiesi, Pfizer and Brazil.” — Dror Bashan, CEO .
• “We are pleased with the promising results from our first-in-human study of our gout candidate, PRX-115… [which] may enhance patient compliance and treatment flexibility.” — CEO .
• “Now that our debt is fully repaid and we no longer have outstanding warrants, our balance sheet is stronger and we are well-positioned to continue executing on our strategy through 2025 and beyond.” — CEO .
• “Net income for the year ended December 31, 2024 was approximately $2.9 million, or $0.04 per share, basic and diluted.” — CFO .
• “We cannot give guidance for 2025… we sell to [Chiesi’s] inventory… [royalty] is a higher margin revenue stream.” — CEO .

Q&A Highlights

• Revenue guidance and royalties: Management reiterated no 2025 guidance due to sell-to-inventory dynamics and Chiesi’s private status; emphasized weekly patient adds and high-margin royalty stream long-term .
• PRX-115 Phase II cost/timeline and partnering: Estimated third-party costs “north to $20M”; first patient H2 2025; top-line ~2 years; partnering likely if results are positive .
• PRX-119 vs PRX-110: PRX-119 is long-acting DNase I; PRX-110 was acute; indication selection being finalized with further preclinical work .
• Q4 Elfabrio revenue detail: Analyst requested 4Q figure; CFO pointed to 10-K filing for detail, not disclosed on call .
• Safety: One anaphylactic reaction occurred in PRX-115 FIH and resolved completely; otherwise PRX-115 generally well-tolerated .

Estimates Context

• S&P Global consensus for Q4 2024 EPS and revenue was unavailable at time of retrieval; we attempted to fetch but encountered a data limit error, so no beat/miss comparisons to Wall Street estimates can be made. As a result, estimates-based comparisons are omitted in this recap [attempted via S&P Global].

Key Takeaways for Investors

• Revenue trajectory: Selling goods drove FY 2024 strength, but quarterly lags can occur from sell-to-inventory timing; expect lumpiness until Chiesi’s cadence normalizes .
• Pipeline catalyst: PRX-115 Phase II initiation in H2 2025 with clarified timelines/costs is the next major clinical catalyst; watch for protocol details and enrollment pace .
• Regulatory upside: EMA validation to add quarterly dosing for Elfabrio could ease treatment burden and support adoption—monitor review outcome and timing .
• Margin mix shift: Royalties from Elfabrio expected to be higher-margin; as this mix grows, P&L leverage should improve over time, notwithstanding interim shipment lumpiness .
• Balance sheet de-risked: Convertible notes repaid; warrants expired; year-end liquidity ~$34.8M provides runway to fund Phase II and early-stage R&D without near-term refinancing .
• Risk checks: Section 174 capitalization raises effective tax burden; PRX-115 immunogenicity risk requires careful monitoring in patients; macro/regulatory risks flagged in FLS section .
• Near-term watch items: EMA decision on Elfabrio q4wk dosing, Phase II PRX-115 trial start, any Chiesi shipment cadence updates, and partner/market access developments in EU/Japan .

Document notes: Q4 standalone financials were not disclosed in the 8-K press release or earnings call; CFO directed analysts to the 10-K for detailed figures **[1006281_0001558370-25-003036_plx-20250317xex99d1.htm:1]** **[1006281_1973359_6]**.