#Israel #Protalix BioTherapeutics #Carmiel #PRX-115 #Fabry disease

Protalix BioTherapeutics Reports FY 2024 Financial and Clinical Milestones

On March 17, 2025, Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical firm renowned for developing innovative treatments through its proprietary ProCellEx® plant cell-based expression system, disclosed its financial results for the fiscal year ending December 31, 2024. The year marked significant achievements for the company, both in terms of revenues and clinical advancements.

Revenue Growth

According to Dror Bashan, President and CEO of Protalix, fiscal year 2024 brought record revenue figures from product sales, totaling approximately $53.0 million. This represented a 31% increase compared to the previous year, driven in large part by increased sales to Chiesi Farmaceutici S.p.A., alongside other partnerships. Revenue escalations were particularly notable, with $11.8 million attributed to Chiesi, $0.6 million from Brazil, and $0.1 million from Pfizer. These achievements signal a robust business trajectory for Protalix amidst rising global competition in biopharmaceuticals.

Clinical Advancements

In line with its commitment to addressing unmet medical needs, Protalix announced promising results from its phase I clinical trial of PRX-115, a recombinant PEGylated uricase designed for the treatment of uncontrolled gout. This trial evaluated the safety and efficacy of PRX-115 in subjects with elevated uric acid levels, showcasing encouraging potential for effective uric acid management. The preliminary findings indicate a favorable dosing flexibility that could improve patient adherence to treatment routines. Building on this momentum, Protalix plans to kick-off a phase II clinical trial by the latter half of 2025.

These results were presented at the prestigious American College of Rheumatology Convergence 2024, highlighting Protalix's commitment to transparency and engagement with the scientific community.

Pipeline Developments

In addition to PRX-115, the company is conducting evaluations of further pipeline candidates, such as PRX-119, a novel treatment aimed at addressing NETs-related diseases. Furthermore, Protalix, in collaboration with Chiesi Global Rare Diseases, made strides regarding pegunigalsidase alfa, with the EMA validating a submission for a less frequent dosing regimen, enhancing its treatment options for Fabry disease.

Financial Position and Future Outlook

Protalix's financial health has also improved significantly with the full repayment of its convertible debt, strengthening its balance sheet and eliminating prior warrants. This positions the company favorably for sustained growth and innovation in the coming years. The reduction in selling, general, and administrative expenses, by nearly 19% from the previous year, further enhances its capacity to channel funds into R&D and product advancement.

Looking ahead, Protalix aims to expand its operational strategies, leveraging its enhanced financial standing to pursue new clinical trials and innovations in therapeutic offerings. Despite the challenges posed by global events, including regional conflicts that could threaten operations, Protalix maintains a forward-looking stance, bolstered by recent successes and a well-defined roadmap for future growth.

Concluding Thoughts

Protalix BioTherapeutics is on the verge of an exciting period of growth, with substantial financial results and an ambitious clinical development landscape. As it seeks to broaden its market reach and introduce innovative solutions for patients with chronic diseases, the global biopharmaceutical community will be watching closely. The company’s continued focus on R&D promises to yield further advancements and broaden treatment possibilities in the years ahead.