Release Date: May 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- SYFOVRE achieved robust growth with $137 million in net sales, a 20% increase from the previous quarter, highlighting strong market demand.
- Apellis Pharmaceuticals Inc (APLS, Financial) successfully launched two drugs within three years, demonstrating the company's strong scientific and operational capabilities.
- EMPAVELI has transformed the standard of care for patients with PNH, showing significant improvements in patient outcomes and generating $26 million in revenue for the quarter.
- Apellis Pharmaceuticals Inc (APLS) is exploring potential new indications for EMPAVELI, which could significantly expand its market and impact.
- The company has a strong financial position with sufficient cash to fund operations for the foreseeable future, ensuring ongoing research and development activities.
Negative Points
- The European Medicines Agency reset the review of SYFOVRE application, potentially delaying market entry in Europe.
- Increased competition in the PNH market with new entrants expected to pressure EMPAVELI sales, potentially leading to flat demand in the medium term.
- Vasculitis remains a concern with SYFOVRE, although rare, it occurs predominantly after the first injection which could affect physician and patient confidence.
- While SYFOVRE dominates the GA treatment market, the introduction of competitors and their market share claims could impact Apellis Pharmaceuticals Inc (APLS)'s dominance.
- The company reported a net loss of $66.4 million for the quarter, indicating ongoing challenges in achieving profitability despite increasing revenues.
Q & A Highlights
Q: Can you discuss the competitive dynamics in GA, particularly in light of your competitor's recent claims about market share?
A: Cedric Francois, CEO of Apellis Pharmaceuticals, responded by emphasizing the robust growth of SYFOVRE, which saw a 20% increase in Q1 compared to Q4. He clarified that Apellis calculates market share based on patients treated, which he believes is a more accurate measure than competitors' method of estimating based on vials distributed. Adam Townsend, COO, added that SYFOVRE remains the #1 chosen GA therapy and is well-positioned for continued leadership due to its strong efficacy, safety profile, and comprehensive data.
Q: What impact did the insurance resets have on the growth rate in Q1, and do you expect this to be a recurring seasonal effect?
A: Cedric Francois addressed the question by confirming that the growth rate for SYFOVRE continues to align with previous performances, excluding the specific impacts from insurance resets in Q1.
Q: Could you provide insights into the EU regulatory process for SYFOVRE and whether the recent procedural reset impacts its approval chances?
A: Cedric Francois explained that the procedural delay in the EU regulatory process for SYFOVRE does not affect the drug’s approvability. The delay was due to external legal matters unrelated to SYFOVRE, and he remains confident in the eventual outcome.
Q: How are new prescribers and patients responding to SYFOVRE in the first quarter, and what does the uptake look like for follow-up doses?
A: Adam Townsend noted that March saw the strongest performance in Q1, with a slight dip in February attributed to seasonal effects. He highlighted the continued strong growth into Q2 and the increasing number of new sites adopting SYFOVRE each week.
Q: What are the expectations for SYFOVRE's market share and growth in light of the new competitor, IZERVAY, and its recent CMS J-code implementation?
A: Adam Townsend reiterated that SYFOVRE remains the top choice for new patient starts and existing treatments, suggesting a strong market position despite new competition. He expects the CMS J-code for IZERVAY to increase prescriber access similar to SYFOVRE’s experience but remains confident in SYFOVRE’s superior drug profile and market strategy.
Q: Can you discuss the potential impact of the branded DTC campaign for SYFOVRE and your expectations for ROI and associated spending?
A: Adam Townsend shared that the branded DTC campaign is already live and expected to drive significant patient engagement and increase treatment uptake. He emphasized the strong potential ROI, which will support continued market penetration and growth for SYFOVRE.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
