Apellis Pharmaceuticals (APLS) Q2 2024 earnings summary

Executive summary

• Achieved $199.7 million in Q2 2024 revenue, up from $95 million year-over-year, driven by strong U.S. sales of SYFOVRE and EMPAVELI, with SYFOVRE maintaining GA market leadership and over 330,000 injections administered.

• EMPAVELI delivered $24.5 million in Q2 U.S. net product sales, with a 97% compliance rate and continued strong performance in PNH.

• Net loss narrowed to $37.7 million in Q2 2024 from $122 million in Q2 2023, reflecting improved operating leverage.

• Cash and cash equivalents stood at $360.1 million as of June 30, 2024, supporting operations to positive cash flow.

• Initiated re-examination of SYFOVRE’s marketing application with EMA; topline Phase 3 VALIANT data for systemic pegcetacoplan in C3G/IC-MPGN expected in August 2024.

Financial highlights

• Q2 2024 total revenue reached $199.7 million, up from $95 million in Q2 2023; SYFOVRE U.S. net product sales were $154.6 million, EMPAVELI $24.5 million.

• Licensing and other revenue totaled $20.5 million, up from $5.3 million year-over-year.

• Cost of sales increased to $23.1 million, mainly due to higher SYFOVRE volume and royalties.

• R&D expenses decreased to $77.9 million, while SG&A rose to $128.1 million in Q2 2024.

• Net loss per share improved to $(0.30) in Q2 2024 from $(1.02) in Q2 2023.

Outlook and guidance

• Management expects cash and projected revenues to fund operations to positive cash flow, with no reliance on EU approval for near-term profitability.

• Awaiting EMA decision on SYFOVRE for GA in Q4 2024 and topline Phase 3 VALIANT data for systemic pegcetacoplan in C3G/IC-MPGN in August 2024.

• Continued investment in commercial infrastructure and R&D, focusing on SYFOVRE and systemic pegcetacoplan.

• No revenue guidance for SYFOVRE for the remainder of 2024; reconsideration for 2025 is possible.