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- **Revenue Growth**: Year-to-date 2025 revenue up 24% to $43.6 million, despite Q3 2025 dip (-1% YoY).
- **Pipeline Momentum**: PRX-115 Phase II trial set to begin in Q4 2025; CHMP reexamination decision expected Q1 2026.
- **Financial Strength**: $29.4 million cash balance, 12-month runway, and 33% YoY net income growth.
- **Strategic Focus**: Balancing R&D investment (58% YoY R&D spend increase) with disciplined commercial execution.

**【CEO Summary Section】**
- **Revenue Performance**: Year-to-date 2025 total revenues reached $43.6 million (+24% YoY), driven by Elfabrio sales to Chiesi, Pfizer, and Fiocruz. Q3 2025 revenue was $17.9 million (-1% YoY) due to partner inventory management variability.
- **Pipeline Progress**: PRX-115 Phase II trial for uncontrolled gout is set to begin in Q4 2025, following FDA IND approval. The company believes PRX-115 could be a best-in-class uricase therapy with a long-acting profile.
- **Regulatory Update**: Chiesi requested reexamination of the CHMP's negative opinion on Elfabrio's 4-week dosing regimen; a decision is expected in Q1 2026. The currently approved 2-week regimen remains unaffected.
- **Financial Position**: Strong cash balance of $29.4 million as of Q3 2025, supporting R&D investments (e.g., PRX-115 Phase II) and commercial operations.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: Q3 2025 sales to Chiesi ($8.8M), Pfizer ($2.8M), and Fiocruz ($6.1M). Year-to-date R&D expenses rose 58% to $13.9 million, driven by PRX-115 preparations.
- **Profitability**: Q3 2025 net income of $2.4 million (+33% YoY), with a 12-month cash runway.
- **Cost Management**: SG&A decreased 11% YoY to $8.2 million, reflecting reduced selling expenses.

**【Q&A Key Highlights】**
- **CHMP Timeline**: Reexamination decision expected Q1 2026; no new trials planned unless needed post-reexamination.
- **PRX-115 Trial**: Phase II initiation in Q4 2025, with top-line results anticipated in Q3 2027.
- **Revenue Visibility**: Gilad Mamlok emphasized predictable royalty streams from Elfabrio, though quarterly fluctuations may occur due to partner inventory timing.
- **Pipeline Expansion**: PRX-119 in early development, with updates pending preclinical results.
- **Global Expansion**: Chiesi pursuing new Elfabrio approvals in additional markets, though no new approvals disclosed since last update.

Protalix BioTherapeutics, Inc. (PLX) Q3 2025 Earnings Call Transcript

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