SYFOVRE Net Product Revenue: $130 million for Q1 2025. EMPAVELI Net Product Revenue: $20 million for Q1 2025. SYFOVRE Injection Demand Growth: 4% quarter-over-quarter increase. SYFOVRE Market Share: Over 60% overall market share. SYFOVRE New Patient Starts: Exceeded 50% in Q1, reaching 55% by late April. Operating Expenses: Expected to remain in line with 2024 levels. Cash and Cash Equivalents: $358 million at the end of Q1 2025. EMPAVELI Compliance Rate: 97%.

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Release Date: May 07, 2025

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

Positive Points

Apellis Pharmaceuticals Inc (NASDAQ:APLS) reported a 4% quarter-over-quarter growth in SYFOVRE injection demand, indicating strong market interest. EMPAVELI is advancing towards its second FDA approval with a priority review designation for C3G and IC-MPGN, with a PDUFA date set for July 28. The company maintains a strong market leadership in geographic atrophy, with SYFOVRE holding over 60% market share and new patient starts exceeding 50%. Apellis Pharmaceuticals Inc (NASDAQ:APLS) has executed significant cost savings and maintained financial discipline, keeping 2025 operating expenses in line with 2024. The company has $358 million in cash and cash equivalents, providing confidence in funding its business to profitability.

Negative Points

SYFOVRE revenue fell short of expectations due to funding shortages at third-party co-pay assistance programs and a larger-than-expected inventory drawdown. The company faces ongoing challenges with co-pay assistance funding shortages, impacting commercial dose demand and increasing reliance on samples. There is uncertainty around the resolution of the co-pay assistance funding issue, which is not expected to be resolved soon. Apellis Pharmaceuticals Inc (NASDAQ:APLS) has not provided sales guidance for SYFOVRE, citing the need for a more steady state and the upcoming launch of EMPAVELI in new indications. The company experienced a decline in EMPAVELI revenue for PNH, attributed to inventory and pricing dynamics, as well as a small decrease in demand.

Q & A Highlights

Q: Can you clarify the volume dynamics for SYFOVRE from Q4 to Q1, considering the inventory and co-pay assistance issues? A: Cedric Francois, CEO, explained that there was quarter-over-quarter growth in demand, measured by injections given to patients. The inventory build at the end of Q4 led to a drawdown in Q1, impacting vials delivered. Tim Sullivan, CFO, added that the inventory at the end of Q1 returned to typical levels, and the ongoing use of samples is expected to continue due to co-pay assistance funding shortages.

Story Continues

Q: How do you calculate new patient share, and why haven't you provided sales guidance like your competitor? A: David Acheson, EVP of Commercial, stated that Apellis uses a site of care data set covering about 50% of the market, which they believe is more accurate than claims databases. Tim Sullivan, CFO, mentioned that due to recent market dynamics, including competitor issues and co-pay assistance underfunding, they need a steady state before providing guidance. They are also considering guidance for both SYFOVRE and the upcoming EMPAVELI launch.

Q: What is the status of the co-pay assistance funding issue, and are you collaborating with other companies to resolve it? A: Cedric Francois, CEO, stated that Apellis respects the independence of co-pay organizations and contributes to them without associating it with SYFOVRE's commercial activities. David Acheson, EVP of Commercial, added that they are operating under the assumption that the funding issue will not be resolved soon and are focusing on transitioning patients from samples to commercial doses.

Q: Can you discuss the payer landscape for SYFOVRE post-label update and strategies for formulary wins? A: David Acheson, EVP of Commercial, noted that SYFOVRE maintains preferred positioning on many plans, especially large Medicare Advantage plans, due to its efficacy with every other month dosing. The label update for the competitor has not significantly changed their positioning.

Q: What are your launch plans for EMPAVELI in C3G and IC-MPGN, and how do you plan to differentiate from competitors? A: David Acheson, EVP of Commercial, explained that Apellis is profiling accounts and building relationships with key physician accounts. They emphasize EMPAVELI's efficacy, which is twice that of the competitor, and believe efficacy will drive decision-making over the route of administration. The teams are preparing for a strong launch upon approval.

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

This article first appeared on GuruFocus.

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