#Israel #Elfabrio #Carmiel #PRX-115 #Protalix

Protalix BioTherapeutics Reports Third Quarter 2025 Performance and Future Plans

Protalix BioTherapeutics, Inc. (NYSE American: PLX), based in Carmiel, Israel, is making strides in the biopharmaceutical industry, focusing on the development and commercialization of recombinant therapeutic proteins using their unique ProCellEx® plant cell-based expression system. As the company approaches the end of the third quarter of 2025, they have released a detailed financial report, revealing both successes and challenges in their efforts to bring innovative treatments to market.

Financial Performance Overview

On November 13, 2025, Protalix reported a total revenue of $43.6 million for the first nine months of 2025, reflecting a remarkable 24% increase from the previous year. The revenue breakdown for the third quarter alone indicated $17.9 million, which surprisingly represents a 1% decrease from Q3 of the prior year. Dror Bashan, the company’s President and CEO, attributed this variance to the purchasing behaviors of key partners like Chiesi and Pfizer, who manage their own inventory levels, leading to fluctuations in sales.

Key Revenue Contributors

The financial results highlighted the diverse revenue streams, specifically:

• - $8.8 million from sales of Elfabrio to Chiesi
• - $2.8 million from sales of Elelyso to Pfizer
• - $6.1 million from sales of alfataliglicerase (Elelyso) to Fiocruz in Brazil

These figures underline the ongoing success of Protalix’s enzyme replacement therapies, which are vital to their future research and development initiatives.

Exciting Developments in Clinical Trials

One of the standout initiatives mentioned in the report is PRX-115, a recombinant PEGylated uricase treatment currently being developed for uncontrolled gout. Dr. Bashan expressed optimism about PRX-115 following promising first-in-human data from phase 1 trials, and the company plans to begin a phase 2 clinical trial by the end of 2025. This potential best-in-class therapy aims to improve patient adherence to treatment regimens, leading to better health outcomes.

In October 2025, Protalix successfully submitted an Investigational New Drug (IND) application with the U.S. FDA for PRX-115, which was approved following a standard 30-day review period, setting the stage for its upcoming trials.

R&D Investments and Future Projections

Research and development (R&D) expenditures totaled approximately $4.5 million in Q3 2025, reflecting an increase of 50% from $3.0 million in the same quarter of 2024. These increased costs are attributed mainly to preparations for the imminent phase 2 trials of PRX-115, indicating that Protalix is heavily investing in the advancement of its clinical assets. The company anticipates incurring ongoing substantial R&D costs as they move forward with their drug development pipeline.

Conversely, Protalix’s selling, general, and administrative expenses saw a rise to $2.9 million, primarily due to higher salary costs and additional selling expenses. Despite these expenses, Protalix achieved a net income of $2.4 million in Q3 2025, down from $3.2 million in Q3 of 2024.

Challenges and Considerations

While the financial outlook appears positive, Protalix BioTherapeutics faces challenges, particularly regarding the commercialization and regulatory landscape for its products. In November 2025, Chiesi Global Rare Diseases requested a re-examination from the European Medicines Agency (EMA) for a dosing regimen of Elfabrio, highlighting the dynamic regulatory environment in which Protalix operates.

Conclusion

Protalix BioTherapeutics continues to make significant advancements in the biopharmaceutical sector, propelled by innovative treatment options and strategic partnerships. With solid revenue growth in 2025 and an exciting development pipeline, Protalix is positioned to navigate the complexities of drug development and market introduction successfully. Stakeholders and investors will be monitoring their upcoming trials and regulatory interactions closely, as these factors will be pivotal for future growth and viability in the highly competitive biopharmaceutical market.