Apellis Pharmaceuticals (APLS) Q3 2024 earnings summary

Executive summary

• Q3 2024 revenue rose to $196.8M, up 78% year-over-year, driven by SYFOVRE and EMPAVELI sales, with SYFOVRE maintaining market leadership and over 88,500 doses delivered.

• Net loss narrowed to $57.4M from $140.2M in Q3 2023, reflecting improved operating leverage.

• EMPAVELI generated $24.6M in U.S. product revenue for PNH, with a 97% compliance rate and strong safety profile.

• Positive Phase 3 VALIANT results for Empaveli in C3G and IC-MPGN support future regulatory filings, with FDA accepting supplemental NDA and ex-U.S. submissions planned for 2025.

• Cash and cash equivalents were $397M at quarter end, expected to fund operations for at least 12 months.

Financial highlights

• Q3 2024 total revenue was $196.8M, up from $110.4M in Q3 2023; SYFOVRE net product revenue reached $152M, more than double the prior year.

• EMPAVELI U.S. net product sales were $24.6M, up slightly year-over-year.

• Net loss for the quarter was $57.4M ($0.46/share), a significant improvement from the prior year.

• SG&A expenses declined to $122M, while R&D expenses rose to $88.6M.

• Cost of sales increased 50% to $33.6M in Q3, mainly due to inventory write-downs and a $6.4M PEG purchase obligation termination expense.

Outlook and guidance

• Anticipates low single-digit percentage vial growth and flat to modest net revenue growth for SYFOVRE in Q4 2024.

• Gross-to-net expected to stabilize in the low to mid-20% range through 2025.

• Cash and expected product revenues projected to fund operations and capital expenditures to positive cash flow.

• Considering providing full-year sales guidance for 2025 as market dynamics become clearer.

• SNDA filing for C3G/IC-MPGN based on positive 6-month data expected in early 2025.