Tommy Smith

Tommy Smith sought details on ELEVIDYS' quarterly dynamics, how rescheduled infusions impact Q1 guidance (flat to down 15%), and the timing and magnitude of expected acceleration in the second half to reach the $1.2 billion-$1.4 billion guidance range.

Answer

President and Chief Executive Officer Doug Ingram and Executive VP and Chief Commercial Officer Patrick Moss explained that ELEVIDYS' quarter-to-quarter performance can be noisy due to its one-time nature and high cost per patient. They noted that educational efforts and the long enrollment-to-infusion cycle (4-6 months) mean revenue impact from initiatives will likely materialize significantly in H2 2026 and into 2027.

Tommy Smith asked for more details on ELEVIDYS' quarterly dynamics, how rescheduled infusions factor into the Q1 guidance of flat to down 15%, and how the $1.2 billion-$1.4 billion total net product revenue guidance (implying $300 million-$500 million for ELEVIDYS) relates to the timing and magnitude of anticipated acceleration in the second half of the year.

Answer

Doug Ingram, President and Chief Executive Officer, explained that ELEVIDYS' quarter-to-quarter performance can be noisy due to the rare disease nature and high per-patient cost, with delayed infusions not being purely additive. He clarified that the $1.2 billion guidance assumes no benefit from new educational efforts, while the $1.4 billion reflects impact from these initiatives. However, due to lead times for initiatives and the 4-6 month enrollment-to-infusion cycle, significant revenue impact is expected in H2 2026 and more substantially in 2027. Patrick Moss, Executive VP and Chief Commercial Officer, reiterated the focus on longer-term performance over quarterly variability.