Joe Thomas

Joe Thomas of Scotiabank asked for commentary on the distribution of patient start forms throughout Q2, wondering if there was any lumpiness or acceleration during the quarter and how to think about the trend going forward.

Answer

Peter Heerma, Chief Commercial Officer, stated that while there is often month-over-month variability typical for rare diseases, the company saw consistent demand throughout the second quarter, and that this consistent demand continued into July.

Joe Thomas, on for Greg Harrison at Scotiabank, asked how investors should view the time to market for axpaxly with a potential superiority label compared to competitors that might launch sooner.

Answer

Pravin Dugel, Executive Chairman, President & CEO, emphasized the significant, and currently underappreciated, value of a superiority label. He argued that such a label would place axpaxly in a 'different orbit,' immunizing it from the intense pricing competition among non-inferiority drugs. He stressed that this differentiation would be critical for physicians to ensure patients receive the best care without delay, preventing potential irreversible vision loss.

Joe Thomas, on for Greg Harrison at Scotiabank, asked about the evolving competitive landscape for Empaveli in C3G and ICMPGN, considering competitors are also studying to expand their patient populations.

Answer

CEO Dr. Cedric Francois emphasized that the VALIANT study was uniquely broad, including C3G, ICMPGN, pediatric, and post-transplant patients in a single trial, leading to a broad label. He highlighted the homogenous 'trifecta' of efficacy across all these populations as a key differentiator against competitors, who are running separate, longer trials for these subgroups.

Joe Thomas, on behalf of Greg Harrison at Scotiabank, asked about the evolving competitive landscape for Empaveli in C3G and ICMPGN, considering competitor studies aimed at expanding their patient populations.

Answer

CEO Dr. Cedric Francois highlighted Apellis's significant competitive advantage, noting that the VALIANT study's broad design led to a comprehensive label covering C3G, ICMPGN, pediatrics, and post-transplant patients. He contrasted this with the competitor needing multiple, separate trials, giving Empaveli a head start with a differentiated profile.

Joe Thomas from Scotiabank asked about the evolving competitive landscape for Empaveli in C3G and IC-MPGN, considering competitors are also working to expand their patient populations.

Answer

Co-Founder and CEO Cedric Francois emphasized that Apellis's VALIANT study was broad, including C3G, IC-MPGN, pediatric, and post-transplant patients, whereas competitors have separate, ongoing trials for these populations. He highlighted the homogenous, positive 'trifecta' of efficacy results across all studied groups, which led to the broad label and provides a strong competitive advantage.

Joe Thomas, on for Greg Harrison at Scotiabank, asked about the evolving competitive landscape for Empaveli in C3G and IC-MPGN, considering competitor studies aimed at expanding their patient populations.

Answer

CEO Dr. Cedric Francois emphasized Empaveli's significant competitive advantage stemming from its broad label, which was granted based on the VALIANT study's comprehensive design (including C3G, IC-MPGN, pediatrics, and post-transplant patients). He contrasted this with the competitor needing separate, lengthy trials for these same populations.