US Exchange Filings

Protalix Reports Higher Revenue, Reaffirms Outlook, Updates Gout Trial Timeline

Protalix reported higher nine-month revenue and profit, reaffirming its $78 million–$83 million 2026 outlook. Brazil authorized more flexible dosing for its Fabry treatment, while investors await results from its mid-stage gout study, expected in the second half of 2027.

Protalix BioTherapeutics reported higher revenue and profit for the first nine months of 2026 and reaffirmed its full-year revenue outlook. The company also updated investors on its Fabry disease business and its experimental treatment for uncontrolled gout, with results from the ongoing mid-stage gout study expected in the second half of 2027.

Financial results and outlook

  • Total revenue for the first nine months of 2026 was $75.6 million, up $32.0 million from $43.6 million a year earlier.
  • Revenue from product sales was $21.8 million in the third quarter and $49.1 million for the first nine months. The comparable 2025 figures were $17.7 million and $43.1 million.
  • Net income was $4.0 million for the third quarter, compared with $2.4 million a year earlier. Net income for the first nine months was $26.1 million.
  • Protalix had $48.5 million in cash, cash equivalents and short-term bank deposits at September 30. It said it had no outstanding debt or warrants.
  • The company expects 2026 total revenue of approximately $78 million to $83 million, and said it expects to meet or exceed that range. The forecast includes a $25 million milestone payment from partner Chiesi received in the first quarter.
  • Within that outlook, Protalix expects full-year revenue from Elfabrio sales, excluding milestone payments, of $33 million to $35 million, and Elelyso sales of $20 million to $23 million.

Business and clinical update

  • Brazil authorized Elfabrio, Protalix’s treatment for Fabry disease, for both every-two-week and every-four-week dosing. Chiesi Global Rare Diseases is Protalix’s partner for the drug’s global development and commercialization.
  • Enrollment is continuing in the Phase 2 RELEASE study of PRX-115 for uncontrolled gout. Protalix expects top-line results in the second half of 2027.
  • New patient-level data from an earlier Phase 1 study are being presented at the 2026 American College of Rheumatology meeting. The analysis covers 18 mg, 24 mg and 36 mg dose groups, with six participants in each group receiving a single infusion and followed for 85 days.
  • Protalix said the new data reinforce earlier findings that higher single doses lowered uric acid for longer, and that the effect was associated with PRX-115 remaining measurable in the blood for up to 85 days. The company views the results as supportive of the drug’s potential for less frequent dosing; they are Phase 1 findings, not results from the ongoing Phase 2 trial.
  • The company is also advancing PRX-119, a long-acting DNase I program, as part of its focus on rare kidney diseases. The program remains preclinical.

What the numbers and plans indicate

The $75.6 million in year-to-date revenue includes the $25 million Chiesi milestone, so the reported total is not solely recurring product sales. Protalix’s stated priorities are to supply its commercial partners, advance PRX-115 and develop its rare-kidney-disease programs.

Original Filing

This is an automated summary of a public document. Always check the original before relying on it.