Protalix BioTherapeutics(PLX) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the full year 2025, total revenues from selling goods were $51.8 million, a modest decrease compared to 2024, driven by changes in quantities sold to Chiesi's inventory and a change in average net selling price due to increased commercial patients in Europe [8] - The company recorded a net loss of $6.6 million in 2025 compared to a net income of $2.9 million in 2024, reflecting increased investment in the clinical pipeline [10] - Cash equivalents and short-term bank deposits as of December 31, 2025, were $30.3 million, with a projected cash balance of approximately $50 million by early April 2026 due to a $25 million milestone payment [10] Business Line Data and Key Metrics Changes - Revenues from Chiesi are projected to be approximately $33 million-$35 million in 2026, representing growth of more than 50% [11] - Revenues from Elelyso are expected to be approximately $20 million-$23 million in 2026 [11] - Revenues from license and R&D services increased to $0.9 million, mainly related to agreements with Chiesi [8] Market Data and Key Metrics Changes - The Fabry market is projected to reach approximately $3.4 billion by 2030, with Elfabrio's differentiated profile enhancing its competitive positioning [5] - The company anticipates that the approval of the every four weeks regimen in Europe will significantly enhance Elfabrio's market uptake [5] Company Strategy and Development Direction - The company is focused on advancing its clinical pipeline, including PRX-115 for uncontrolled gout and PRX-119 for renal conditions, with expectations of significant market opportunities [5][6] - The company aims to solidify its revenue mix towards Chiesi, which represents the majority of long-term revenue opportunities [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in entering 2026 with strong business flexibility and a growing commercial foundation through partners [12] - The projected revenue growth in 2026 of greater than 50% is attributed to the increasing number of patients on Elfabrio [12] Other Important Information - The company is expanding its renal pipeline through collaborations and expects to provide updates on specific indications by the end of Q2 [24] - The approval of the every four weeks regimen in Europe is expected to enhance the competitive edge of Elfabrio [17] Q&A Session Summary Question: Insights on marketing initiatives for Elfabrio in the U.S. - Management noted that Chiesi is implementing various promotional activities, including patient ambassador programs, to increase market uptake [16] Question: Positioning of PRX-115 in the gout market - Management highlighted that PRX-115 could offer significant differentiation in dosing frequency and potential safety advantages, targeting a market expected to exceed $2 billion [20] Question: Timeline for rollout of Elfabrio's four-week dosing in Europe - Management indicated that availability will vary by country, with expectations for some markets to see rollout in the second half of 2026 [30]