Protalix BioTherapeutics (PLX) Registration Filing summary

Company overview and business model

• Commercial-stage biopharmaceutical company specializing in recombinant therapeutic proteins using a proprietary plant cell-based expression system, ProCellEx®.

• First to gain FDA approval for a protein produced via plant cell-based expression in suspension.

• Two commercial enzyme replacement therapies: Elfabrio® for Fabry disease and Elelyso® for Gaucher disease, with global approvals and strategic partnerships for commercialization.

• Pipeline includes PRX-115 (PEGylated uricase for uncontrolled gout) and PRX-119 (long-acting DNase I for NETs-related diseases), targeting rare and orphan diseases.

• Focus on leveraging technology for new early-stage candidates addressing high unmet needs, including both genetic and non-genetic renal diseases.

Financial performance and metrics

• In 2024, generated $12.6 million from Elelyso sales to Pfizer and $11.0 million from sales to the Brazilian Ministry of Health.

• Elfabrio sales to Chiesi in 2024 totaled $29.3 million.

Use of proceeds and capital allocation

• Net proceeds will be used for R&D, clinical trials, establishing an internal sales force, acquisitions of new technologies or businesses, and general corporate and administrative purposes.

• Proceeds will be invested in short-term bank deposits or marketable securities until used.