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Protalix BioTherapeutics (PLX) investor relations material
Protalix BioTherapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Total revenues for the first nine months of 2025 reached $43.6 million, up 24% year-over-year, with Q3 revenues at $17.9 million, down 1% from Q3 2024.
Net loss for the nine months was $1.1 million, a significant improvement from a $3.6 million loss in the prior year; Q3 net income was $2.4 million.
Commercial success of enzyme replacement therapies continues, supporting R&D investments and pipeline advancement.
Regulatory re-examination requested for Elefabrio's every-4-weeks regimen in Europe, with a decision expected in Q1 2026; the approved every-2-weeks regimen remains unaffected.
Operating strategy focuses on commercial execution, pipeline advancement, and financial discipline.
Financial highlights
Nine-month product sales: $43.6 million (up 24%); Q3 product sales: $17.9 million (down 1%).
Cost of goods sold for nine months: $22.4 million (up 10%); Q3: $8.3 million (down 1%).
R&D expenses for nine months: $13.9 million (up 58%); Q3: $4.5 million (up 50%), mainly due to PRX-115 phase II preparations.
SG&A expenses for nine months: $8.2 million (down 11%); Q3: $2.9 million (up 12%).
Cash and equivalents at September 30, 2025: $29.4 million, sufficient for at least 12 months of operations.
Outlook and guidance
Confident in Elefabrio's long-term potential and ongoing global expansion efforts.
PRX-115 phase II trial to begin screening in late 2025, with top-line results expected in Q3 2027.
Cash runway guidance includes anticipated R&D expenses and royalty-based revenues.
No formal revenue or cash burn guidance provided, but management reiterates sufficient cash for over 12 months, including funding for PRX-115 phase II.
The company anticipates variability in period-to-period results due to the ordering patterns of commercial partners.
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