Protalix BioTherapeutics (PLX) Q4 2024 earnings summary

Executive summary

• Achieved record revenues in 2024, fully repaid all outstanding debt, and advanced R&D on PRX-115, PRX-119, and early-stage candidates.

• Completed phase I clinical trial for PRX-115 and preparing for phase II trial in uncontrolled gout, with initiation targeted for the second half of 2024 or 2025.

• Commercial partner Chiesi increased investment in Elfabrio, with EMA validating a new dosing regimen submission.

• Strengthened balance sheet by repaying convertible notes, eliminating all warrants, and generating $2.1 million from warrant exercises.

Financial highlights

• Revenues from selling goods reached $53 million, up 31% year-over-year, mainly due to increased sales to Chiesi.

• Revenues from licensed and R&D services dropped 98% to $0.4 million, reflecting the absence of prior year milestone payments and completion of regulatory obligations.

• Cost of goods sold increased 6% to $24.3 million, driven by higher sales volume.

• Research and development expenses decreased 24% to $13 million, mainly due to completion of the Fabry clinical program.

• Net income was $2.9 million ($0.04 per share), down from $8.3 million in 2023.

• Cash, cash equivalents, and short-term deposits totaled $34.8 million at year-end.

Outlook and guidance

• No formal revenue guidance for 2025; expect royalty-based revenues from Chiesi to grow and become a higher-margin stream.

• Estimate north of $100 million in revenues from Chiesi by 2030, contingent on continued growth and regulatory success.

• Phase II PRX-115 trial expected to start in H2 2024 or 2025, with top-line results anticipated in about two years.

• Phase II PRX-115 study cost projected north of $20 million (third-party expenses), funded with current resources.

• Minimal future license and R&D revenue expected, except for potential milestone payments.