Protalix BioTherapeutics Reports Fiscal Year 2024 Financial and Business Results

Core Insights - Protalix BioTherapeutics reported a record revenue of $53.0 million for the fiscal year 2024, marking a 31% increase from $40.4 million in 2023, driven by sales growth across all revenue streams [5][9] - The company successfully completed a First-in-Human study for its gout candidate PRX-115, with plans to initiate a Phase II clinical trial in the second half of 2025 [2][6] - Protalix has strengthened its balance sheet by fully repaying its debt and eliminating outstanding warrants, positioning itself for future growth [2][7] Financial Highlights - Total revenue for 2024 was $53.4 million, a decrease from $65.5 million in 2023, primarily due to a significant drop in revenues from license and R&D services, which fell to $0.4 million from $25.1 million [9][19] - Cost of goods sold increased by 6% to $24.3 million in 2024, compared to $23.0 million in 2023, attributed mainly to higher sales to Chiesi [9] - Research and development expenses decreased by 24% to approximately $13.0 million in 2024, down from $17.1 million in 2023, due to the completion of the Fabry clinical program [9][19] Clinical Developments - The European Medicines Agency validated a variation submission for pegunigalsidase alfa, allowing for a less frequent dosing regimen for Fabry disease patients [4] - Protalix's pipeline includes PRX-115 for uncontrolled gout and PRX-119 for NETs-related diseases, with ongoing evaluations for further development [2][14] Corporate Developments - The company repaid all outstanding principal and interest on its 7.50% Senior Secured Convertible Promissory Notes in September 2024, financed entirely with available cash [7] - Protalix's cash and cash equivalents stood at approximately $34.8 million as of December 31, 2024, with a net income of approximately $2.9 million for the year [9][19]