Apellis Pharmaceuticals, Inc. Q2 FY2024 earnings call

• SYFOVRE is the market leader in GA with ~75% of the treated market, has generated over $0.5 billion in sales in first six quarters, and saw ~half of new patients choose SYFOVRE despite competitor tailwinds. Post-ASRS, SYFOVRE's efficacy profile is viewed favorably, with monthly and every other month dosing showing better efficacy vs competitor. • EMPAVELI generated $24.5M in Q2, has 97% compliance rate, and is being explored for new indications. Upcoming Phase 3 VALIANT top line readout in C3G and primary IC-MPGN expected later this month. • Pipeline includes earlier-stage programs like C3 siRNA in Phase 1. Strengthened balance sheet via non-dilutive refinancing with Sixth Street, leading to clear line of sight to positive cash flow. • SYFOVRE had $155M revenue in Q2, over 79,000 commercial doses delivered, and June was highest demand month since launch. Focus on Phase 2 of commercial and medical strategy, including educating retina community, securing payer coverage, and launching DTC campaigns. • EU GA opportunity: focused on CHMP reexamination process, encouraged by progress, with final decision expected in Q4 2024.

For the second quarter of 2024, total revenue was approximately $200 million. SYFOVRE contributed $155 million (77.75% of total revenue), and EMPAVELI US net product revenue was $24.5 million (12.25% of total revenue). SYFOVRE had revenue growth of over 12% quarter over quarter, with over 79,000 commercial doses and ~5,000 samples delivered in Q2. EMPAVELI generated $24.5 million in product sales in Q2.

• Expect SYFOVRE to continue growth with strong efficacy and flexible dosing driving new patient starts. • Upcoming Phase 3 VALIANT study results expected later this month; if positive, plan to submit supplemental NDA to FDA. • EU approval decision for SYFOVRE expected in Q4 2024, with confidence in being well-positioned heading into the appeal. • Clear line of sight to positive cash flow without relying on capital markets.

• Competitive landscape for SYFOVRE with competitor tailwinds from factors like new J-Code, though SYFOVRE maintained ~50% new patient share. • Uncertainty around EU CHMP reexamination process outcomes, though progress made. • Market dynamics and potential price degradation if discounting too aggressively.

Q: Can you confirm if volumes were up in July versus June for SYFOVRE?

A: Adam said they're thrilled with strong growth continuing into July, seeing it across multiple metrics.

Q: How are physicians responding to micropurimetry data for SYFOVRE?

A: Caroline noted physicians are excited about the micropurimetry data, which shows visual function benefit, and it's used in clinical studies and real-world cases to demonstrate benefit to patients.

Q: Thoughts on seasonality impacts on SYFOVRE revenue?

A: Cedric and Caroline mentioned no dramatic seasonality impacts noted yet, but upcoming retina conferences will drive physician learning about SYFOVRE's efficacy.