Protalix BioTherapeutics (PLX) Q3 2024 earnings summary

Executive summary

• Revenues from selling goods rose 75% year-over-year to $17.8M in Q3 2024, driven by higher sales to Chiesi and Pfizer.

• Net income for Q3 2024 was $3.2M ($0.04 per share basic), reversing a net loss of $1.9M in Q3 2023.

• Completed all eight cohorts of the phase 1 PRX-115 trial for uncontrolled gout, with promising preliminary results showing dose-dependent uric acid reduction and good tolerability.

• Fully repaid all outstanding principal and interest on 7.5% senior secured convertible promissory notes in September 2024, making the company debt-free.

• Cash and cash equivalents stood at $27.4M at September 30, 2024, expected to cover capital needs for at least 12 months.

Financial highlights

• Q3 2024 total revenue: $17.8M from goods, $0.1M from license/R&D services; cost of goods sold was $8.4M, up 71% year-over-year.

• Research and development expenses decreased 19% to $3M, mainly due to completion of Fabry/Elfabrio clinical and regulatory programs.

• Selling, general, and administrative expenses fell 30% to $2.6M, mainly from lower salary and professional fees.

• Gross margin for Q3 2024 was approximately 53%.

• Income tax expense for Q3 2024 was $0.6M, up from $0.1M in Q3 2023, primarily due to Section 174 of the TCJA.

Outlook and guidance

• Plans to initiate phase 2 trial for PRX-115 in uncontrolled gout in the second half of 2025, with top-line results anticipated by late 2026 or early 2027.

• Management expects continued significant R&D expenditures as new clinical programs advance.

• Cash and cash equivalents are projected to be sufficient for at least 12 months from September 30, 2024.

• Continued collaboration with Chiesi on Elfabrio commercialization and ongoing studies, including in Japan and pediatric populations.

• Focused R&D on rare renal diseases and early-stage pipeline development.