Apellis Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Apellis targets complement-driven diseases by focusing on C3, with SYFOVRE for geographic atrophy and EMPAVELI for PNH, C3 glomerulopathy, etc.
• Key milestone: FDA approval of EMPAVELI for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis, expanding its addressable market by ~5,000 patients.
• Commercial activities: EMPAVELI launch with 152 patient start forms, focusing on nephrology community; SYFOVRE maintains market leadership with 4% sequential growth in total injection demand, and initiatives like AI tools and prefilled syringe development for growth.
• Pipeline: Expanding EMPAVELI's development into FSGS and DGF, with pivotal trials to start by year-end.

SYFOVRE had net product revenue of $151 million in the third quarter, delivering approximately 101,000 doses, including 86,000 commercial doses and 15,000 free goods doses. EMPAVELI had total net product revenue across indications (including PNH, C3G, and primary IC-MPGN) of $27 million during the third quarter. SYFOVRE accounted for an estimated 52% of new patient starts in the third quarter and more than 60% of the overall market.

• SYFOVRE expected low to mid-single-digit injection growth in the fourth quarter.
• EMPAVELI launch expected to normalize into a gradual ramp.
• Long-term opportunities for SYFOVRE with AI tools and prefilled syringe development to drive growth.

• Challenges with patient access and payer policies affecting the timeline for EMPAVELI launch and patient start forms.
• Impact of co-pay assistance and patient funding on market growth for SYFOVRE, affecting physician adoption and patient treatment.

Q: About EMPAVELI launch penetration, do you expect steady growth?

A: David Acheson expects steady, consistent growth going into next year after the initial bolus of patients.

Q: About SYFOVRE sampling, should we expect it to stabilize?

A: David Acheson states they review samples in the program consistently and ensure patients have access, but programs will be available as things grow.

Q: Can you break out C3G patient breakdown and market share?

A: David Acheson mentions 152 start forms, ~50 from EAP, and sees switches from Fabhalta due to EMPAVELI's efficacy and dosing convenience.

Q: On SYFOVRE rev and growth, is this a floor?

A: Tim Sullivan says underlying demand growth is 4%, with long-term opportunities like prefilled syringe to reinvigorate growth.

Q: On EMPAVELI patient start forms trends, how did they come in?

A: Cedric Francois says it's in line with internal expectations, with high hopes for the 5,000-patient addressable market.

Q: On SYFOVRE sampling competitive dynamics?

A: David Acheson says it's about true demand from patients wanting treatment, with programs monitored regularly.

Q: About EMPAVELI launch timeline acceleration?

A: Cedric Francois says working on payer policies to reduce start to finish time from 4-6 weeks.

Q: On SYFOVRE prefilled syringe and growth trajectory?

A: Cedric Francois says prefilled syringe is being tested, improving practice flow, and expected to expand market.

Q: On GA market headwinds and shifts with physicians?

A: Timothy Sullivan and Caroline Baumal mention co-pay issues and Apellis' initiatives like AI tools and prefilled syringe to shift dynamics.

Q: On EMPAVELI patient start forms vs expectations?

A: Cedric Francois says in line with expectations, confident in addressable market.

Q: On SYFOVRE prefilled syringe availability as samples?

A: David Acheson says will launch with commercial product, samples available over time.

Q: On FSGS and DGF trial design for EMPAVELI?

A: Cedric Francois says trials just started, details on clinicaltrials.gov, excited about opportunities in these rare diseases.