Apellis Pharmaceuticals’ Earnings Call Highlights Achievements and Challenges

Apellis Pharmaceuticals ((APLS)) has held its Q1 earnings call. Read on for the main highlights of the call.

The recent earnings call for Apellis Pharmaceuticals presented a mixed sentiment, highlighting both achievements and challenges. The company celebrated significant milestones, such as the FDA Priority Review for EMPAVELI and maintaining market leadership with SYFOVRE. However, concerns were raised regarding revenue challenges, particularly due to inventory dynamics and funding shortages affecting co-pay assistance programs.

EMPAVELI Priority Review and Phase 3 Success

EMPAVELI has been granted Priority Review designation by the FDA for C3G and IC-MPGN, with a PDUFA date set for July 28. The Phase 3 VALIANT study results were promising, demonstrating a 68% reduction in proteinuria, stabilization of kidney function, and a substantial clearing of C3c staining. This development marks a significant step forward in Apellis’ expansion into rare nephrology indications.

SYFOVRE Market Leadership

SYFOVRE continues to dominate the geographic atrophy market, maintaining over 60% market share. The company reported that new patient starts exceeded 50% in Q1 2025, reaching 55% by late April. This solid market position underscores SYFOVRE’s importance in Apellis’ product portfolio.

Financial Stability

Apellis reported $358 million in cash and cash equivalents, which is expected to be sufficient to fund the business to profitability. This financial stability provides a solid foundation for the company to continue its strategic initiatives and product launches.

EMPAVELI Blockbuster Potential

The U.S. launch of EMPAVELI for C3G and IC-MPGN is anticipated to be Apellis’ third new product launch in four years. This expansion into rare nephrology indications positions EMPAVELI as a potential blockbuster, further solidifying Apellis’ presence in this niche market.

SYFOVRE Revenue Decline

Despite strong market share, SYFOVRE’s net product revenue was $130 million in Q1 2025, impacted by inventory drawdowns and funding shortages at third-party co-pay assistance programs. These challenges resulted in increased sample usage, affecting revenue by approximately $10 million.

Challenges with Co-Pay Assistance

Funding shortages at third-party co-pay assistance organizations led to increased sample usage, impacting revenue significantly. This issue highlights the need for Apellis to address these funding challenges to stabilize revenue streams.

EMPAVELI Revenue Decline

EMPAVELI’s net product revenue for PNH was $20 million in Q1 2025, showing a decline due to inventory and pricing dynamics, as well as a slight decrease in demand. This decline underscores the challenges faced in maintaining revenue growth for this product.

Forward-Looking Guidance

Looking ahead, Apellis provided several key metrics and guidance. SYFOVRE injection demand grew by 4% quarter-over-quarter, with approximately 92,000 doses delivered. Despite this growth, revenue fell short of expectations due to inventory drawdown and co-pay assistance funding shortages. The company remains confident in its financial position, with $358 million in cash and cash equivalents, and expects operating expenses in 2025 to remain consistent with 2024 levels.

In summary, the earnings call for Apellis Pharmaceuticals reflected a balanced sentiment with notable achievements and challenges. While the company celebrated regulatory milestones and maintained strong market positions, revenue challenges due to inventory and funding issues were significant concerns. Moving forward, Apellis remains focused on leveraging its financial stability to achieve profitability and continue its strategic growth initiatives.