Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) reported its 2025 financial results and outlined recent regulatory, clinical and commercial developments, including a new European approval for its Fabry disease therapy and updated guidance for 2026.
"2025 was a year of meaningful progress for Protalix, marked by strong commercial execution with our partners and important advances and strategic direction across our clinical and preclinical pipeline," the company’s CEO Dror Bashan said.
"The EC approval of the E4W dosing regimen for Elfabrio in the European Union represents an advancement for patients by reducing treatment burden without compromising efficacy. This milestone strengthens the long–term value of our Fabry franchise.”
The European Commission approved a 2 mg/kg every-four-weeks dosing regimen for Elfabrio in adults with Fabry disease who are stable on enzyme replacement therapy.
The company said the less frequent dosing schedule reduces treatment burden while maintaining efficacy, supported by data from the BRIGHT study and long-term extension results. Elfabrio is now the only enzyme replacement therapy in the European Union approved for monthly dosing, according to Protalix.
The approval triggered a $25 million milestone payment from partner Chiesi, which the company said is expected to strengthen its cash position to approximately $50 million by April 2026.
Protalix expects total revenue in 2026 to range between $78 million and $83 million, including the milestone payment. Revenue from Elfabrio sales is projected at $33 million to $35 million, while Elelyso sales are expected to contribute $20 million to $23 million.
During 2025, revenue from selling goods totaled $51.8 million, down 2% from $53 million in 2024. The decline was primarily due to lower sales to Chiesi, partially offset by higher sales to Pfizer and Brazil’s Fiocruz. Revenue from license and research and development services rose to $0.9 million.
Cost of goods sold increased 11% to $27 million, reflecting higher volumes supplied to Pfizer and Fiocruz.
Research and development expenses rose 51% to $19.6 million, driven largely by preparations for a Phase 2 study of PRX-115.
The company said its Phase 2 “RELEASE” trial of PRX-115, a recombinant PEGylated uricase for uncontrolled gout, is actively enrolling patients, with initial participants already randomized. Protalix believes the therapy could offer a long-acting treatment option with flexible dosing aimed at improving adherence and outcomes. Top-line results are expected in the second half of 2027.
In addition to its gout program, Protalix said it is expanding its focus on rare renal diseases, including advancement of its PRX-119 program and a collaboration with Secarna to develop RNA-based therapeutics.
Protalix said it enters 2026 with no outstanding debt or warrants and plans to continue supporting its commercial partnerships while advancing its clinical pipeline.
“As we enter 2026, we remain committed to driving profitable growth, expanding opportunities across our portfolio, and delivering innovative therapies that meaningfully improve the lives of patients with rare diseases,” Bashan concluded.