Protalix BioTherapeutics(US:PLX)2025-03-17 14:22Financial Data and Key Metrics Changes - Protalix recorded revenues from selling goods of $53 million for the year ended December 31, 2024, an increase 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 $24.7 million or 98% compared to $25.1 million for the year ended December 31, 2023 [18] - Net income for the year ended December 31, 2024, was approximately $2.9 million or $0.04 per share, compared to $8.3 million or $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 $11.8 million in sales to Chiesi, $0.6 million in sales to Brazil, and $0.1 million in sales to Pfizer [18] - Cost of goods sold was $24.3 million for the year ended December 31, 2024, an increase of $1.3 million or 6% compared to $23 million for the year ended December 31, 2023 [20] - Total research and development expenses decreased to approximately $13 million for the year ended December 31, 2024, a decrease of $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]