Apellis Pharmaceuticals Q4 2024: Navigating Contradictions in Market Share, Regulatory Pathways, and Seasonal Impacts

These are the key contradictions discussed in Apellis Pharmaceuticals' latest 2024Q4 earnings call, specifically including: Market Share and Patient Switch Dynamics, EMPAVELI's regulatory pathway and launch timeline, and SYFOVRE's market positioning and competition:



SYFOVRE Market Leadership and Growth:
- Apellis Pharmaceuticals reported nearly $900 million in SYFOVRE sales in less than two years, with over 510,000 injections administered through December.
- The growth was driven by SYFOVRE's status as the market-leading treatment for geographic atrophy (GA) in the U.S., with its presubsiding label offering increasing effects over time and flexible dosing.

EMPAVELI's Potential in Rare Diseases:
- EMPAVELI generated $23 million in U.S. net product revenue in Q4, maintaining compliance rates at 97%.
- The potential of EMPAVELI was highlighted by its positive Phase III results, which hit a trifecta with unprecedented reductions in proteinuria, clearance of C3 deposits, and stabilization of eGFR in rare kidney diseases.

Geographic Atrophy Treatment and Market Expansion:
- Real-world data showed that SYFOVRE reduced the annualized growth rate of GA by over 40% by month 9 of treatment.
- Apellis is focusing on expanding its GA market, with ongoing efforts to grow the overall diagnosed GA patient market share, which is currently less than 10% receiving treatment.

Pipeline and Future Initiatives:
- Apellis is advancing its early-stage pipeline, including a first-ever gene editing approach targeting the neonatal Fc gamma receptor with its partner.
- The company plans to initiate Phase II trials with OCO-07 and SYFOVRE, testing a potential next-generation treatment for GA that aims to comprehensively block complement activity in the retina and choroid.