#Israel #Clinical Trials #Protalix BioTherapeutics #Carmiel #PRX-115

Protalix BioTherapeutics Q1 2025 Financial and Business Results

On May 9, 2025, Protalix BioTherapeutics, Inc. (NYSE American: PLX), a leading biopharmaceutical company focused on the development and commercialization of biotherapeutic proteins, reported its financial outcomes for the first quarter of 2025. The company highlighted considerable growth compared to the same quarter last year, particularly in revenue from product sales.

Revenue Growth

Protalix achieved impressive revenues of approximately $10.0 million in the first quarter of 2025, marking a 170% increase over the prior year’s $3.7 million. This surge is primarily attributed to a notable increase of $5.9 million in sales to Pfizer Inc. and an additional $0.4 million generated from sales to the Brazilian institution, Fundação Oswaldo Cruz (Fiocruz).

Dror Bashan, President and CEO of Protalix, stated, "We had another solid quarter, with an increase in revenues from selling goods compared to the prior year quarter. Our focus remains on leveraging the positive momentum from our first-in-human studies."

Advancements in Clinical Trials

The company is progressing well with its clinical trials, especially regarding its promising candidate, PRX-115, which is being developed as a treatment for uncontrolled gout. The initial phase I clinical trial for PRX-115 was successfully completed in 2024, indicating that this treatment could offer effective long-term benefits for gout patients.

Upcoming Phase II Trials

Preparations are underway for the anticipated phase II clinical trial of PRX-115, expected to initiate in the latter half of 2025. The initial results demonstrated PRX-115's potential to substantially lower uric acid levels, a crucial factor for gout management. Furthermore, these results were showcased in a late-breaking poster session at the American College of Rheumatology (ACR) Convergence 2024.

The company is also evaluating additional candidates in its pipeline, including PRX-119, aimed at addressing various early-stage clinical needs.

Financial Breakdown

Despite the revenue rise, the cost of goods sold rose dramatically to $8.2 million, a 215% increase from the $2.6 million recorded in the same quarter of 2024. This uptick aligns closely with the increased sales figures to both Pfizer and Fiocruz.

Research and development expenses have also increased, reaching approximately $3.5 million, a 21% increase compared to the previous year. This rise is part of Protalix’s commitment to advancing its clinical pipeline effectively.

Net Loss and Future Goals

For the first quarter, Protalix reported a net loss of approximately $3.6 million, or $0.05 per share, a slight improvement from the $4.6 million loss in the same period last year. The financial income saw a net increase to $0.4 million as well, demonstrating improved financial management and planning.

"As we aim towards initiating further clinical trials and developing our pipeline effectively, we continue to explore strategic partnerships and pathways for our products, enhancing our capabilities in advancing critical treatments," Bashan added.

Engaging with Stakeholders

Protalix is hosting a conference call today to further dissect these financial results and provide further business updates. The call is instrumental for stakeholders keen on understanding the company’s future directions and operational plans.

Protalix remains committed to pioneering its innovative protein expression technology via the ProCellEx® system, aiming to revolutionize biopharmaceutical manufacturing and expand its market reach in addressing unmet medical needs.

As Protalix BioTherapeutics moves forward, the company is positioned for significant developments in both its clinical endeavors and financial trajectory. Investors and interested parties are encouraged to stay informed as the company continues to make strides in biopharmaceutical innovation.