Investment Highlights - Protalix has a revenue-generating marketed drug for Gaucher disease[4] - The company's pipeline includes products in active clinical phase development, such as pegunigalsidase alfa (PRX-102) for Fabry disease, tulinercept for Inflammatory Bowel Disease, and alidornase alfa (PRX-110) for multiple indications[4] - A BLA submission for Fabry disease is anticipated by Q2 2020[4] - Protalix utilizes an advantageous proprietary ProCellEx® platform for recombinant protein expression and cGMP manufacturing, successfully inspected and audited by multiple regulatory agencies, including the US FDA and EU EMA[4] Commercial Performance & Partnerships - Sales in Brazil provide a consistent revenue stream for 5+ years, validating the company's ability to bring a treatment from concept to market and support long-term production[11] - In 2019, sales to the Brazilian Ministry of Health amounted to approximately $91 million[11] - Approximately 20% of Gaucher patients in Brazil are treated with alfataliglicerase (Elelyso®)[11] - Protalix has a global partnership with Chiesi Farmaceutici S·p·A, including a $50 million upfront payment and potential milestone payments of over $1 billion, plus tiered royalties of 15-35% (ex-US) and 15-40% (US)[22] Product Pipeline & Milestones - The Fabry disease market is estimated to be over $14 billion and growing at a CAGR of approximately 10%[15] - Final results from the BRIDGE trial are expected in Q2 2020, and final results from the BRIGHT trial are expected in Q4 2020[34] - Protalix anticipates FDA approval of pegunigalsidase alfa in Q4 2020 and a launch in Q1 2021[34]
Protalix Biotherapeutics (PLX) Investor Presentation - Slideshow