Protalix BioTherapeutics (PLX) investor relations material

Commercial portfolio and financial outlook

• Two approved therapies: Elelyso for Gaucher disease, licensed to Pfizer outside Brazil; Elfabrio for Fabry disease, globally licensed to Chiesi. Elfabrio received EU approval for once-every-four-weeks dosing in March 2026.

• Through Q3 2026, accumulated revenue was $75.6M and cash and deposits were $48.5M. FY2026 revenue guidance was $78M-$83M, including $33M-$35M from Chiesi, 50% above the prior year.

• Chiesi batch sales track market demand but fluctuate with inventory; management cited rising patient numbers in Europe, the U.S. and other markets. The Q4W regimen is expected to support further penetration and launches.

• Elelyso generates $22M-$25M in Brazil, with ~25% market share. Elfabrio was forecast to reach 15%-25% market share, potentially driving $100M or more in revenue; management may update its forecast over the next 1-2 years.

PRX-115 gout program

• RELEASE Phase II was about two-thirds enrolled, with enrollment targeted for Q1 2027 and readout expected within about a year. The five-arm study tests Q4W, Q6W and Q8W dosing with methotrexate, Q4W without it, and placebo.

• In Phase I, the 36 mg dose brought all six active subjects below 6 mg/dL; four of six fell below 2 mg/dL. Management cited roughly 12 weeks of enzyme activity and 40-plus days below 2 mg/dL at the highest dose.

• Phase II aims to demonstrate a favorable safety and immunogenicity profile; the primary endpoint is responder proportion over the six-month protocol, with management aiming near or above Krystexxa’s cited 70%.

• Potential differentiation includes less frequent infusions and, if supported by results, Q4W dosing without methotrexate. After results, management plans to meet FDA to discuss Phase III, potentially one pivotal study.

• Management is assessing future commercialization options, including self-commercialization, licensing or co-promotion; market research with three potential third-party partners was underway, with input targeted before readout.

Pipeline and strategic priorities

• Rare renal programs are in development, with 4-6 programs targeted within two years from discovery through Phase I, using the plant-based platform and collaborations.

• Management identified commercial execution and FY2026 results, followed by FY2027 guidance, as near-term priorities; PRX-115 enrollment completion in Q1 2027 and its subsequent readout are key catalysts.