Protalix BioTherapeutics announced its third quarter results for 2025.

Protalix BioTherapeutics Announces Third Quarter 2025 Results

CARMIEL, Israel - Protalix BioTherapeutics, Inc. (NYSE American: PLX) is a biopharmaceutical company focused on the development of recombinant therapeutic proteins. The company reported its financial results for the quarter ending September 30, 2025, and provided business updates.

Dror Bashan, President and CEO, stated, "Our total revenue for the first nine months of 2025 was $43.6 million, reflecting a 24% increase compared to the same period in 2024. Our third quarter 2025 revenue was recorded at $17.9 million, representing a 1% decline compared to the same period in 2024. Revenues are derived from our sales to Chiesi, Pfizer, and Fiocruz, and the fluctuation in these purchases from quarter to quarter is due to how these companies manage their inventory. Overall, these revenues reflect the ongoing commercial success of our enzyme replacement therapies and provide a solid foundation to support our research and development efforts," he added.

Our recombinant PEGylated uricase candidate, PRX-115, is being developed for the treatment of uncontrolled gout, and we believe it has the potential to be a differentiated therapy in this area. Additionally, based on encouraging data from phase 1 clinical trials of PRX-115, we believe it has the potential to be a best-in-class therapy. Therefore, we plan to initiate the phase 2 clinical trial of PRX-115 later this year," Bashan continued.

Corporate Developments: In October 2025, we submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) regarding our planned phase 2 clinical trial for uncontrolled gout. Our submission became effective following the standard 30-day review period by the FDA. Additionally, as of November 2025, a request for reconsideration of the negative opinion issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use in October 2025 was made by Chiesi's Global Rare Diseases unit.

Third Quarter 2025 Financial Developments

Revenue from product sales for the third quarter of 2025 was recorded at $17.7 million, which is a $0.1 million (or 1%) decrease compared to the same period in 2024. This revenue includes $8.8 million in sales to Chiesi, $2.8 million to Pfizer, and $6.1 million to Fiocruz.

Research and development expenses were approximately $4.5 million for the third quarter of 2025, compared to $3.0 million for the same period in 2024. The increase in expenses is related to preparations for the planned phase 2 clinical trial of PRX-115.

Net income was approximately $2.4 million, or $0.03 per share, as of September 30, 2025. In 2024, this figure was $3.2 million, or $0.04 per share.

Year-to-Date Results: Total revenue from product sales for 2025 was $43.1 million, representing a 24% increase. Revenue from R&D services was recorded at $0.5 million. Total research and development expenses were $13.9 million, with a significant portion being spent on the clinical development of PRX-115.

As of September 30, 2025, we have $29.4 million in cash and cash equivalents, which appears sufficient to meet our financial needs for the next year.