Protalix Biotherapeutics (NYSE American: PLX) is a biopharmaceutical company that develops and manufactures plant cell-derived recombinant proteins for the treatment of rare genetic diseases. Revenue comes from selling drug product and drug substance to commercial partners under exclusive licensing and supply agreements, plus milestone payments tied to those agreements. The company's two approved products are Elelyso (taliglucerase alfa), a treatment for Gaucher disease licensed globally outside Brazil to Pfizer under the Amended Pfizer Agreement effective until 2030, and in Brazil to Fiocruz; and Elfabrio (pegunigalsidase alfa/PRX-102), a treatment for Fabry disease partnered globally with Chiesi Farmaceutici S.p.A. under two exclusive licensing and supply agreements dated October 2017 and July 2018. Protalix manufactures drug substance at its Israeli subsidiary, Protalix Ltd., with Chiesi responsible for all global commercialization of Elfabrio. The company operates primarily out of Israel and is subject to technology-transfer restrictions and royalty obligations under Israeli research funding law administered by NATI.
Elelyso (taliglucerase alfa): plant cell-derived recombinant glucocerebrosidase, FDA-approved 2012 for type 1 Gaucher disease in adults, expanded to children four years and older in August 2014, approved in more than 40 markets as of the 10-K filed 2026-03-18. Elfabrio (pegunigalsidase alfa/PRX-102): enzyme replacement therapy for Fabry disease, commercialized globally by Chiesi Farmaceutici S.p.A.
Transactional product sales of drug substance to Pfizer and drug product to Chiesi under exclusive supply agreements, plus upfront payments, development cost reimbursements, and potential milestone payments from partners. Brazil sales of BioManguinhos alfataliglicerase are conducted directly. Partners retain downstream commercialization revenue.
Primary customers are Chiesi Farmaceutici S.p.A. (Elfabrio drug product purchaser and global commercializer), Pfizer (Elelyso drug substance purchaser under Amended Pfizer Agreement through 2030), and Fiocruz/BioManguinhos in Brazil (Elelyso commercialization rights). End patients have rare lysosomal storage disorders: Gaucher disease and Fabry disease.
Manufacturing and R&D operations based in Israel through Protalix Ltd. Products approved in more than 40 markets including the United States, Brazil, and Israel as of the 10-K filed 2026-03-18. Elelyso is not approved in the European Union. Partner Chiesi holds global commercialization rights for Elfabrio.
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