Protalix BioTherapeutics (PLX) Q4 2025 earnings summary

Executive summary

• European Commission approved Elfabrio's 2 mg/kg every four weeks dosing regimen for stable adult Fabry disease patients, triggering a $25 million milestone payment and reducing patient treatment burden in the EU.

• The EU approval supports a projected cash balance of $50 million by early April 2026 and enhances treatment options.

• 2025 saw consistent operational execution, increasing patient numbers, and strong commercial performance for Elfabrio.

• Pipeline progress includes PRX-115 advancing in phase II for uncontrolled gout, PRX-119 for NETs-related diseases, and ongoing RNA-based collaborations.

• Maintained a profitable commercial business model with no outstanding debt or warrants, supporting a strong balance sheet.

Financial highlights

• 2025 revenues from selling goods totaled $51.8 million, with total revenue at $52.7 million, a modest decrease from 2024, mainly due to changes in Chiesi inventory and pricing.

• Revenues from license and R&D services increased to $0.9 million, mainly from Chiesi agreements.

• Cost of goods sold rose to $27 million, reflecting higher sales to Pfizer and increased costs.

• R&D expenses increased 51% year-over-year to $19.6 million, driven by PRX-115 clinical development.

• Net loss for 2025 was $6.6 million, or $(0.08) per share, compared to net income of $2.9 million in 2024.

Outlook and guidance

• 2026 total revenue expected to range from $78 million to $83 million, including the $25 million milestone payment.

• Revenues from Chiesi projected at $33 million-$35 million; Elelyso revenues expected at $20 million-$23 million.

• Revenue mix is expected to shift further toward high-margin Chiesi contributions, supporting improved profitability.

• Top-line results for PRX-115 Phase 2 trial anticipated in the second half of 2027.