Apellis Pharmaceuticals (APLS) Q1 2025 earnings summary

Executive summary

• Q1 2025 revenue totaled $166.8 million, with $149.9 million from U.S. net product sales, primarily SYFOVRE ($130.2M) and EMPAVELI ($19.7M); net loss widened to $92.2 million from $66.4 million year-over-year.

• SYFOVRE maintained over 60% U.S. GA market share, achieved 4% quarter-over-quarter injection demand growth, and reached 55% share of new patient starts by late April.

• EMPAVELI posted $19.7 million in U.S. revenue with 97% compliance, and advanced toward FDA approval in C3G and IC-MPGN with a July 28, 2025 PDUFA date.

• Cash and cash equivalents stood at $358.4 million as of March 31, 2025, expected to fund operations for at least 12 months.

• Total revenue declined 3% year-over-year, impacted by inventory drawdown, copay assistance funding shortages, and increased competition.

Financial highlights

• SYFOVRE U.S. net product revenue was $130.2 million in Q1 2025 (down from $137.5 million in Q1 2024), with injection demand up 4% quarter-over-quarter.

• EMPAVELI U.S. net product revenue was $19.7 million (down from $25.6 million), with high compliance rates at 97%.

• Total operating expenses rose to $250.1 million from $234.4 million year-over-year; cost of sales increased to $34.4 million from $20.2 million.

• Licensing and other revenue grew to $16.9 million, mainly from Sobi collaboration supply and royalties.

• Net loss per share was $(0.74), compared to $(0.54) in Q1 2024.

Outlook and guidance

• EMPAVELI U.S. launch in C3G and IC-MPGN expected in Q3 2025, pending July 28 PDUFA decision.

• Cash, projected revenues, and ex-U.S. royalties expected to fund operations to profitability; additional liquidity available via $100 million undrawn credit facility.

• Phase 2 study of APL-3007 + SYFOVRE to start in Q2 2025; pivotal trials for EMPAVELI in FSGS and DGF planned for 2H 2025.

• Management expects continued significant commercialization and R&D expenses, with ongoing net operating losses for at least the remainder of 2025.

• No sales guidance planned for 2025; may consider providing guidance after achieving steady state.