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 generated $152M and EMPAVELI $24.6M in U.S. net product revenue.

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

• Cash and cash equivalents stood at $396.9M as of September 30, 2024, expected to fund operations for at least 12 months.

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

• Company remains on track to achieve profitability and fund core business independently.

Financial highlights

• Q3 2024 total revenue: $196.8M, up from $110.4M in Q3 2023; SYFOVRE U.S. net product revenue: $152M; EMPAVELI U.S. net product revenue: $24.6M.

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

• R&D expenses: $88.6M; SG&A expenses: $122M, down from $145.7M year-over-year.

• Net loss for Q3 2024 was $57.4M ($0.46/share).

• Cash operating expenses for Q3 were $180M.

Outlook and guidance

• Expect 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 projected revenues expected to fund operations and capital expenditures for at least the next 12 months and 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.

• Guidance for 2025 under consideration, pending further visibility on market dynamics and impact of commercial initiatives.