Protalix BioTherapeutics, Inc. reported a total revenue of $52.7 million for the fiscal year ending December 31, 2025, a decrease of 1.2% compared to $53.4 million in 2024. The decline was primarily attributed to a reduction in sales to Chiesi, which was offset by increased sales to Pfizer. The company generated $18.2 million from Pfizer for Elelyso and $22.5 million from Chiesi for Elfabrio. Despite the revenue decrease, Protalix's net loss for the year was $6.6 million, a significant decline from a net income of $2.9 million in 2024, reflecting increased research and development expenses, which rose by 51% to $19.6 million, largely due to preparations for the ongoing RELEASE study of PRX-115.
In terms of operational developments, Protalix has made significant strides in its product pipeline, focusing on treatments for rare diseases. The company is advancing PRX-115, a PEGylated uricase for uncontrolled gout, which has completed Phase 1 trials and is currently in Phase 2. Additionally, PRX-119, a long-acting DNase I product candidate, is in preclinical development. The company has also successfully commercialized two enzyme replacement therapies: Elelyso and Elfabrio, with the latter receiving regulatory approvals in multiple markets, including the U.S. and EU.
Strategically, Protalix has entered into exclusive licensing agreements with Chiesi for Elfabrio, which includes potential milestone payments totaling up to $740 million, contingent on regulatory and commercial achievements. The company has also maintained its partnership with Pfizer for Elelyso, which is marketed globally, excluding Brazil, where Protalix retains distribution rights. The company’s focus on expanding its product offerings and enhancing its pipeline is evident as it seeks to address unmet medical needs in rare diseases.
As of December 31, 2025, Protalix employed 226 individuals, an increase from 213 in the previous year, reflecting its commitment to expanding its research and development capabilities. The company’s financial position remains stable, with $30.3 million in cash and cash equivalents, which it believes is sufficient to meet its operational needs for at least the next 12 months. However, Protalix acknowledges the need for additional capital to support ongoing and future clinical trials, particularly for PRX-115 and PRX-119, and plans to explore various financing options, including equity offerings and collaborations.
Looking ahead, Protalix remains optimistic about its growth prospects, particularly with the anticipated commercialization of Elfabrio and the ongoing development of its pipeline candidates. The company is focused on navigating the complexities of regulatory approvals and market acceptance while managing operational risks associated with its manufacturing processes and geopolitical conditions in Israel, where its operations are based.
About Protalix BioTherapeutics, Inc.
Protalix BioTherapeutics is a biopharmaceutical company specializing in developing, manufacturing, and commercializing recombinant therapeutic proteins using its proprietary plant cell-based ProCellEx platform. Its core products include enzyme replacement therapies for rare diseases like Fabry and Gaucher. The company focuses on innovative treatments for high unmet medical needs, leveraging unique plant-based production methods to enhance safety, efficacy, and manufacturing flexibility.
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