Protalix BioTherapeutics (PLX) Q2 2024 earnings summary

Executive summary

• PRX-115 phase I study showed dose-dependent exposure, rapid uric acid reduction, and good tolerability; dosing completed and phase II preparations underway, with topline results expected in Q3/Q4 2024.

• PRX-119 and other early-stage assets are prioritized for renal rare diseases, leveraging the ProCellEx platform and exploring new modalities.

• Commercial partner Chiesi continues to expand Elfabrio's market presence in the US and Europe, with positive uptake and ongoing collaboration.

• Net loss for Q2 2024 was $2.2M ($0.03/share), compared to net income of $19.3M ($0.29/share) in Q2 2023, which included a $20M milestone from Chiesi.

• Cash, cash equivalents, and short-term deposits totaled $45M at June 30, 2024, supporting operations and upcoming convertible note repayment.

Financial highlights

• Q2 2024 revenues from goods were $13.3M, down 12% year-over-year, mainly due to lower Chiesi sales, partially offset by higher sales to Brazil and Pfizer.

• License and R&D service revenues were $0.2M, down 99% year-over-year, 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 decreased 33% to $3M, reflecting completion of Fabry clinical and regulatory activities.

• SG&A expenses fell 13% to $3.5M, mainly due to lower salary costs.

Outlook and guidance

• Topline phase I PRX-115 results expected in Q3/Q4 2024; phase II initiation targeted for mid-2025.

• 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 $20.4M in convertible notes due September 2024.

• Management expects continued significant R&D expenditures as new product candidates advance.

• No specific sales guidance provided due to shipment timing variability; ongoing cautious approach to forecasting.