Protalix BioTherapeutics, Inc.

What they do

Protalix develops, produces, and commercializes recombinant protein therapeutics using its proprietary ProCellEx plant cell-based expression system. It has two approved enzyme replacement therapies: Elelyso for Gaucher disease (marketed by Pfizer outside Brazil, Fiocruz in Brazil) and Elfabrio for Fabry disease (partnered with Chiesi). The company also advances a pipeline including PRX-115 (PEGylated uricase for uncontrolled gout) and PRX-119 (long-acting DNase I for NETs-related diseases).

Revenue drivers

• Elfabrio — Approved for Fabry disease, marketed through Chiesi partnership; drove second quarter 2026 revenue growth (selling goods revenue up $4.4M year-over-year).
• Elelyso — Approved for Gaucher disease; sold as drug substance to Pfizer (worldwide except Brazil) and Fiocruz (Brazil) at fixed prices; orders fluctuate period-to-period.
• Milestones and licensing — Includes a $25.0 million milestone payment from Chiesi received in 2026, contributing to year-to-date total revenue.

Recent performance

In Q2 2026, revenues from selling goods increased to $19.8 million, up $4.4 million from Q2 2025, driven primarily by Elfabrio sales. Total revenue for the first half of 2026 was $53.6 million versus $25.8 million in the same period of 2025, including a $25.0 million Chiesi milestone. The company reported net income of $22.1 million year-to-date 2026. Cash, cash equivalents, and short-term bank deposits were $40.7 million as of June 30, 2026, with no outstanding debt or warrants.

Strategy

Protalix plans to grow its commercial business through manufacturing and supply to partners, advance PRX-115 through Phase 2, and expand rare renal programs. It uses its ProCellEx platform, PEGylation capabilities, and other modalities like small molecules and antibodies to address high unmet needs. The company is focused on building durable growth, limiting downside risk through partnerships, and pursuing strategic partnerships to accelerate scale.

Risks

• Dependence on two products — Revenue relies heavily on Elfabrio and Elelyso, with orders from Pfizer and Fiocruz varying and not directly reflecting patient demand.
• Elfabrio boxed warning — The FDA approval for Elfabrio includes a boxed warning, which could hinder market acceptance, reimbursement, and competitive positioning.
• Clinical and regulatory delays — Delays in PRX-115 Phase 2 enrollment or regulatory reviews could impact pipeline timeline and costs.
• Regional conflict in Israel — Operations could be disrupted by regional hostilities, affecting suppliers, partners, clinical sites, and regulatory activities.

Outlook

Management reaffirmed full-year 2026 total revenue guidance of $78.0 million to $83.0 million, including the $25.0 million Chiesi milestone. They anticipate top-line results from the PRX-115 Phase 2 RELEASE study in the second half of 2027. With $40.7 million in cash and deposits, they state sufficient capital to fund ongoing operations and the Phase 2 trial.