Apellis' Syfovre Faces Challenges in Geographic Atrophy Market

Apellis Pharmaceuticals' geographic atrophy (GA) treatment Syfovre is encountering significant obstacles in the market, as revealed by the company's latest financial results. The first-quarter performance of 2025 has raised concerns among analysts and investors, signaling potential long-term challenges for the drug and the GA market as a whole.

Syfovre Sales Decline Amid Market Difficulties

Syfovre, the first FDA-approved medication specifically for geographic atrophy, reported U.S. sales of $130.2 million for the first quarter of 2025. This figure represents a 22% decrease from the previous quarter and a 3% decline compared to the same period in 2024. The sales performance fell significantly short of Mizuho Securities' forecast of $157 million, with analysts describing the miss as "worse than we could have envisioned."

Apellis CEO Cedric Francois, M.D., Ph.D., attributed the revenue shortfall to funding issues in copay assistance programs and inventory fluctuations, despite increases in patient demand. The company now expects these challenges to persist throughout the year, potentially impacting Syfovre's uptake in both the short and long term.

Copay Assistance Programs and Sampling Rates

The underfunding of copay assistance programs has emerged as a critical issue for Apellis and other pharmaceutical companies in the ophthalmology space. This funding shortfall has forced Apellis to increase its distribution of Syfovre samples significantly. The company now anticipates maintaining a sampling rate of approximately 10,000 vials per quarter, double its previous rate of 5,000 vials.

Analysts at Evercore ISI noted that while Apellis could potentially reduce this sampling rate, it remains unclear when such a reduction might occur. The increased sampling rate is likely to continue impacting Syfovre's sales performance in the coming quarters.

Market Outlook and Competitive Landscape

In light of these challenges, Mizuho Securities has revised its expectations for Syfovre, now predicting peak annual sales of $1.08 billion in 2033. This forecast represents a 16% reduction from the current consensus estimate of $1.29 billion for the same year.

The broader geographic atrophy market is also facing difficulties, with Astellas' competing drug Izervay experiencing its own growth challenges. Astellas reported in February that Izervay's sales growth had slowed to just 4% in the last quarter of 2024, despite being relatively early in its launch cycle.

Despite these setbacks, Apellis remains optimistic about the potential of the GA market. CEO Francois stated, "We are still in the early phases of growth and estimate that only half of diagnosed GA patients are seen by an eyecare professional. Of those, less than 10% are receiving treatment. Building a new market takes time."

As the geographic atrophy market continues to evolve, pharmaceutical companies and investors will be closely monitoring the performance of drugs like Syfovre and Izervay, as well as the broader trends in patient access and treatment adoption.