Protalix BioTherapeutics (PLX) Q1 2026 earnings summary

Executive summary

• Achieved a $25 million milestone payment from Chiesi after EU approval of Elfabrio's four-week dosing, driving Q1 2026 net income to $18.3 million and reversing a prior net loss.

• Total Q1 2026 revenue was $33.8 million, up from $10.1 million year-over-year, mainly due to the Chiesi milestone.

• Maintained a robust balance sheet with $51.1 million in cash and equivalents at quarter-end, supporting at least 12 months of operations.

• Reaffirmed 2026 revenue guidance of $78–$83 million, including the $25 million milestone, with strong commercial momentum for Elfabrio and ongoing PRX-115 clinical progress.

• Continued advancement of the rare renal disease pipeline, notably PRX-115 Phase II RELEASE study, with top-line results expected in H2 2027.

Financial highlights

• Q1 2026 total revenue was $33.8 million, primarily from the $25 million Chiesi milestone; product sales were $7.4 million, down from $10 million in Q1 2025 due to lower Elelyso and Pfizer/Fiocruz purchases.

• Cost of revenues was $4.1 million, down 50% year-over-year, reflecting lower sales volumes.

• R&D expenses rose to $5.4 million (up 56%) due to PRX-115 Phase II preparations; SG&A expenses increased to $3.1 million, mainly from personnel costs.

• Net income for Q1 2026 was $18.3 million ($0.23 per share basic, $0.22 diluted), compared to a net loss of $3.6 million in Q1 2025.

• Operating income reached $21.1 million, compared to a $4.1 million loss in Q1 2025.

Outlook and guidance

• Reaffirmed 2026 revenue guidance of $78–$83 million, including the $25 million milestone.

• Elfabrio revenues (excluding milestones) projected at $33–$35 million and Elelyso at $20–$23 million for 2026.

• PRX-115 Phase II RELEASE trial enrollment targeted for completion by end of 2026, with top-line data in H2 2027.

• Expects Elfabrio to achieve 15–20% global Fabry market share by 2031, supported by differentiated product profile and ongoing regulatory expansion.

• Anticipates continued significant R&D expenditures as clinical programs advance.