Protalix BioTherapeutics (PLX) Q2 2024 earnings summary

Executive summary

• Interim phase I results for PRX-115 in uncontrolled gout showed dose-dependent exposure and rapid uric acid reduction, with good tolerability; full results expected in Q4 2024 and phase II preparations underway.

• PRX-119, targeting NETs-related renal diseases, is advancing, with a strategic focus on rare renal indications and early-stage pipeline expansion.

• Maintained a strong balance sheet, supporting operations and upcoming convertible note repayment.

• Commercial partner Chiesi continues to drive Elfabrio market penetration in the US and Europe, with positive outcomes and ongoing collaboration.

• Hosted Investor Day to discuss Fabry disease and gout pipeline progress.

Financial highlights

• Q2 2024 product sales were $13.3M, down 12% year-over-year, mainly due to lower Chiesi sales post-initial launch, offset by higher sales to Brazil and Pfizer.

• License and R&D service revenue dropped to $0.2M from $20M in Q2 2023, reflecting the absence of a prior $20M milestone payment.

• Cost of goods sold rose 56% to $9.5M, driven by increased sales to Pfizer and Brazil.

• R&D expenses fell 33% to $3M, reflecting completion of the Fabry program.

• Net loss was $2.2M ($0.03/share) versus net income of $19.3M ($0.29/share) in Q2 2023.

Outlook and guidance

• Top-line phase I PRX-115 results expected in Q4 2024; phase II to start mid-2025 pending regulatory discussions.

• Revenue streams from Brazil, Pfizer, and Chiesi expected to continue and grow.

• Cash position is expected to cover capital needs for at least 12 months, including the redemption of 2024 Notes.

• No specific sales guidance for Chiesi due to batch timing and inventory dynamics.

• Management expects continued significant R&D expenditures as preclinical and clinical trials for new product candidates advance.