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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.
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Q3 2025 earnings summary13 Nov, 2025

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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Frequently asked questions

Protalix BioTherapeutics Inc. is a biopharmaceutical company focusing on the development, production, and commercialization of recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based protein expression system. This technology enables the company to produce proteins with clinically improved profiles and to develop a pipeline of proprietary therapeutic proteins aimed at established pharmaceutical markets. Additionally, the company is developing other products, including treatments for cystic fibrosis and Fabry Disease, utilizing its platform to manufacture complex proteins, antibodies, and vaccines. The company is headquartered in Carmiel, Israel, and its shares are listed on the NYSE.

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