Apellis Pharmaceuticals (APLS) Q3 2024 earnings summary

Executive summary

• Total Q3 2024 revenue reached $196.8M, up 78% year-over-year, driven by SYFOVRE and EMPAVELI sales.

• SYFOVRE maintained market leadership in GA, delivering over 88,500 doses in Q3 and achieving 7% quarter-over-quarter demand growth.

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

• Net loss narrowed to $57.4M in Q3 2024 from $140.2M in Q3 2023, reflecting improved operating leverage.

• Positive Phase 3 VALIANT results for pegcetacoplan in C3G/IC-MPGN support future regulatory filings, with sNDA planned for early 2025.

Financial highlights

• Q3 2024 total revenue: $196.8M, up from $110.4M in Q3 2023.

• SYFOVRE U.S. net product revenue was $152.0M, more than double the prior year.

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

• Cost of sales rose to $33.6M, mainly due to inventory write-downs and contract termination costs.

• SG&A expenses declined to $122.0M from $145.7M year-over-year.

Outlook and guidance

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

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

• sNDA filing for pegcetacoplan in C3G/IC-MPGN planned for early 2025; Sobi to submit in EU and Japan in 2025.

• Regulatory decisions for SYFOVRE anticipated in the U.K., Switzerland, Canada, and Australia in early 2025.

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