Protalix BioTherapeutics(PLX)2025-03-17 14:22Financial Data and Key Metrics Changes - Protalix recorded revenues from selling goods of 12.6 million or 31% compared to 40.4 million for the year ended December 31, 2023 [18] - Revenues from license and R&D services decreased to 0.4 million for the year ended December 31, 2024, a decrease of 25.1 million for the year ended December 31, 2023 [18] - Net income for the year ended December 31, 2024, was approximately 0.04 per share, compared to 0.12 per share for the same period in 2023 [24] Business Line Data and Key Metrics Changes - The increase in revenues from selling goods was primarily due to an increase of 0.6 million in sales to Brazil, and 24.3 million for the year ended December 31, 2024, an increase of 23 million for the year ended December 31, 2023 [20] - Total research and development expenses decreased to approximately 4.1 million or 24% compared to 17.1 million for the year ended December 31, 2023 [21] Market Data and Key Metrics Changes - The company expects minimal revenues from license and R&D services going forward, primarily due to the completion of the Fabry clinical program and the regulatory process related to Elfabrio [19] - The company reported cash, cash equivalents, and short-term bank deposits of approximately 34.8 million at December 31, 2024 [24] Company Strategy and Development Direction - Protalix is focusing on R&D efforts on early-stage candidates such as PRX-115 and PRX-119, with plans to initiate a Phase 2 clinical trial for PRX-115 in the second half of 2025 [7][14] - The company aims to leverage its ProCellEx platform and pegylation capabilities to expand its product development pipeline, particularly in renal rare diseases [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategy and balance sheet, indicating that the three streams of revenues will support the next phase of pipeline development [26] - The management highlighted a positive outlook for the collaboration with Chiesi, expecting a steady stream of higher-margin revenues from Elfabrio in the coming years [34][37] Other Important Information - The company fully repaid all outstanding principal and interest under its 7.5% senior secured convertible promissory notes in September 2024, strengthening its balance sheet [15] - Protalix issued 908,000 shares of common stock in connection with the exercise of warrants, generating proceeds of approximately 2.1 million [15] Q&A Session Summary Question: Long-term revenue guidance based on Elfabrio royalties - Management indicated that they cannot provide specific revenue guidance for 2025 due to the nature of sales to Chiesi, a private company, but they expect a growing revenue stream from this collaboration [34][37] Question: Differences between PRX-119 and historical program PRX-110 - PRX-119 is a long-acting DNase, while PRX-110 was an acute treatment. The company is finalizing indication selection and will provide updates on market size in the coming quarters [40] Question: Cost and timeline for Phase 2 study of PRX-115 - The estimated cost for the Phase 2 study is expected to be north of 20 million, with top-line results anticipated in approximately two years, depending on patient enrollment [42]