• Total Revenue (Q4 2024): Approximately $213 million.
• SYFOVRE Revenue (Q4 2024): $168 million in US net product revenue.
• EMPAVELI Revenue (Q4 2024): $23 million in US net product revenue.
• Total Revenue (Full Year 2024): $781 million, nearly 100% increase compared to 2023.
• Cost of Sales (Q4 2024): $40.9 million.
• R&D Expenses (Q4 2024): $76.4 million.
• SG&A Expenses (Q4 2024): $121.5 million.
• Net Loss (Q4 2024): $36.4 million.
• Cash and Cash Equivalents (End of 2024): $411 million.
• SYFOVRE Sales (Since Launch): Nearly $900 million in less than two years.
• SYFOVRE Market Share (Q4 2024): Over 60% total market share.
• SYFOVRE Doses Delivered (Q4 2024): Approximately 94,000 doses.
• EMPAVELI Compliance Rate (Q4 2024): 97%.

• Warning! GuruFocus has detected 4 Warning Signs with APLS.

Release Date: February 28, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• SYFOVRE achieved over 120% year-over-year US net revenue growth, with nearly $900 million in sales in less than two years.
• EMPAVELI showed positive Phase III results in rare kidney diseases, with plans for a potential launch in the second half of 2025.
• Apellis Pharmaceuticals Inc (NASDAQ:APLS) has a robust development pipeline, including a next-generation treatment for geographic atrophy combining SYFOVRE and APL-3007 siRNA.
• The company has secured preferred formulary positions for SYFOVRE with major payers, providing a competitive advantage.
• Apellis Pharmaceuticals Inc (NASDAQ:APLS) maintains a strong financial position with $411 million in cash and cash equivalents, and expects to achieve profitability with existing cash and future product sales.

Negative Points

• Temporary factors such as Medicare reverifications and winter storms are expected to affect SYFOVRE orders and net revenue in the first quarter of 2025.
• There is a reported funding gap at non-profit co-pay assistance organizations, leading to increased sample usage by retina specialists.
• The overall geographic atrophy market growth is tempered, with only a small percentage of diagnosed patients receiving treatment.
• Competitive pressure from IZERVAY, despite its label limitations, poses a challenge to SYFOVRE's market share.
• Apellis Pharmaceuticals Inc (NASDAQ:APLS) faces uncertainties regarding the timing of regulatory approvals and potential delays in launching EMPAVELI in new indications.

Q & A Highlights

Q: Can you provide insights on the EMPAVELI submission and the FDA's focus on metrics? A: Cedric Francois, CEO, explained that the 24-hour results were consistent with the spot test, which was the primary endpoint. The submission highlighted consistent results across all disease phenotypes and metrics, including proteinuria reduction and histopathology improvements. The FDA's focus is on these comprehensive results, and a publication will be released soon.

Q: What are your expectations for SYFOVRE sales in Q1 compared to Q4, and how will Medicare Advantage status impact new patient share? A: David Acheson, EVP of Commercial, noted that Q1 sales are expected to be lower than Q4 due to temporary factors like Medicare reverifications and increased sample usage. However, injection demand is growing, indicating positive momentum. The Medicare Advantage status is expected to gradually impact new patient share.

Q: How do you view the competitive landscape for SYFOVRE following the IZERVAY label change? A: David Acheson emphasized that SYFOVRE's every-other-month dosing and preferred payer status provide a competitive advantage. Caroline Baumal, CMO, added that SYFOVRE's efficacy and flexible dosing are key differentiators, as IZERVAY lacks clinical trial data for every-other-month dosing.

Q: What is the strategy for the SYFOVRE and APL-3007 combination trial? A: Cedric Francois explained that the trial will synchronize intravitreal and subcutaneous injections to enhance complement blockade in the retina and choroid. The trial will explore dosing strategies and aims to establish a leading position in geographic atrophy treatment.

Q: How are you addressing the temporary funding gap affecting sample usage? A: Cedric Francois stated that the increased sample usage is due to a temporary funding gap in co-pay assistance organizations. Physicians are using samples to continue patient care, and the company expects this issue to be resolved as funding stabilizes.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.