Protalix Hits Profitability, Fuels Pipeline with Elfabrio Milestone

CARMIEL, Israel – May 13, 2026 – Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced a significant financial turnaround for the first quarter of 2026, posting a substantial net income driven by a key regulatory achievement for its Fabry disease drug, Elfabrio. The results signal a pivotal moment for the biopharmaceutical company, as it leverages its commercial success to advance a promising pipeline targeting other rare diseases, including uncontrolled gout.

Milestone Payment Drives Profitable Quarter

Protalix reported a net income of $18.3 million for the first quarter, a stark contrast to the $3.6 million net loss recorded in the same period last year. This shift to profitability was overwhelmingly fueled by a $25 million milestone payment from its commercial partner, Chiesi Farmaceutici. The payment was triggered by the European Commission's approval of a more flexible dosing regimen for Elfabrio.

Total revenues for the quarter soared to $33.75 million, up from $10.1 million in Q1 2025. Buoyed by this performance, Protalix reaffirmed its full-year 2026 revenue guidance of $78.0 million to $83.0 million. This projection includes anticipated revenues of $33.0 to $35.0 million from Elfabrio sales and $20.0 to $23.0 million from its Gaucher disease therapy, Elelyso.

"Protalix entered 2026 with positive momentum," said Dror Bashan, President and CEO of Protalix. "With the recent regulatory progress for Elfabrio in Europe which triggered the $25 million milestone payment, the continued enrollment of our PRX–115 Phase 2 RELEASE study, and a growing focus on rare renal diseases, we believe the company is entering a pivotal period of growth and clinical advancement."

Elfabrio Gains Ground with Patient-Friendly Dosing

The catalyst for the milestone payment—the European approval for a 2 mg/kg every-4-weeks (E4W) dosing of Elfabrio—is a significant strategic win. This less frequent infusion schedule is designed to reduce the treatment burden for patients with Fabry disease, a rare genetic disorder, without compromising efficacy. This new option enhances Elfabrio's competitive standing in a crowded European market that includes established therapies like Sanofi's Fabrazyme and Takeda's Replagal.

Protalix and Chiesi aim to capture a meaningful 15% to 20% share of the global Fabry disease market, which is projected to surpass $3 billion by 2031. The E4W dosing flexibility is a key part of that strategy, potentially making it a more attractive option for both patients and physicians. In the United States, the approved dosing remains 1 mg/kg every two weeks.

The ProCellEx® Advantage: A Foundation Built on Plants

Underpinning Protalix's success is its proprietary ProCellEx® platform, a unique plant cell-based system for producing recombinant proteins. This technology circumvents the use of mammalian cells, thereby avoiding the risk of contamination from animal-borne pathogens. The company touts the system's advantages in safety, scalability, and cost-effectiveness. Protalix made history by gaining the first FDA approval for a protein produced through a plant cell-based suspension system.

This innovative platform is the engine behind both of the company's commercial products: Elfabrio for Fabry disease and Elelyso for Gaucher disease, which is licensed to Pfizer. The technology's ability to produce complex proteins serves as a competitive differentiator and the foundation of the company's entire research and development pipeline.

Targeting Gout with a Best-in-Class Contender

With a strong financial footing, Protalix is channeling significant resources into its pipeline. A key focus is PRX-115, a novel enzyme therapy for uncontrolled gout, a severe and debilitating form of the disease that affects patients who do not respond to or cannot tolerate standard oral medications.

The company is currently enrolling patients in its Phase 2 RELEASE clinical trial for PRX-115, with top-line results anticipated in the second half of 2027. Protalix is positioning PRX-115 as a potential best-in-class therapy, designed for an extended E4W dosing schedule and engineered to have a lower immunogenic risk compared to the current infused biologic, pegloticase. Success in this area could open up a substantial commercial opportunity, as an estimated 25% of gout patients managed by rheumatologists have uncontrolled disease.

Research and development expenses rose 56% to $5.4 million in the quarter, largely driven by the initiation and advancement of the PRX-115 trial, underscoring the company's commitment to this program.

Strategic Expansion into Renal Disease

Beyond gout, Protalix is strategically broadening its focus to include other rare renal indications. The company is advancing its preclinical asset PRX-119, a long-acting enzyme for treating diseases related to neutrophil extracellular traps (NETs). Furthermore, a recent collaboration with Secarna Pharmaceuticals aims to discover novel RNA-based therapies for multiple rare kidney diseases, complementing the protein-based therapies developed through its ProCellEx® platform.

This diversification demonstrates a long-term vision to build a robust portfolio targeting areas of high unmet need. The company's cash position of $51.1 million, with no outstanding debt, provides a solid runway to fund these ambitious clinical programs alongside its ongoing commercial operations. With a fortified balance sheet and a multi-pronged strategy, Protalix is positioning itself to capitalize on both its commercial successes and its deep pipeline of innovative therapies for rare diseases.