Sarepta Therapeutics’ Duchenne muscular dystrophy therapy Elevidys handily beat analysts’ expectations in the fourth quarter of 2024, reflecting the biotech’s “world-class” execution, according to BMO Capital Markets analysts.
Sarepta Therapeutics on Monday provided an early peek at its fourth-quarter and full-year 2024 performances, reporting largely positive results that reflect a successful launch for its Duchenne muscular dystrophy gene therapy Elevidys.
In the fourth quarter, Elevidys brought in a net product revenue of $384.2 million, representing a more than 110% quarter-over-quarter increase. That figure easily beat the consensus earnings estimate of $334 million and the company’s own guidance, which projected product sales of approximately $320 million, according to an investor note from Jefferies.
The biotech provided this earnings preview at the 2025 J.P. Morgan Healthcare Conference in San Francisco.
BMO Capital Markets analysts were bullish about Sarepta’s results, asserting in a note that Elevidys’ Q4 growth points to the biotech’s “world-class” expertise in Duchenne muscular dystrophy (DMD).
“Importantly, despite generating $1B+ in Elevidys sales since launch, [management] estimates <5% penetration in Elevidys-eligible patients (>600 dosed to date), pointing to $20B+ Elevidys opportunity in prevalent patients,” the BMO analysts wrote.
With the strong Q4 performance of Elevidys, Sarepta leadership on Monday reiterated its 2025 guidance for product sales. The biotech expects to book $2.9 to $3.1 billion in sales this year, which is broadly in line with the consensus projection. BMO expects Elevidys to be a “key driver” of the Sarepta “story” in 2025, with a projected sales of around $2 billion this year, a potential EU approval and an upcoming readout that could “further establish efficacy/safety profile.”
As for its pipeline, Sarepta is anticipating a Phase III readout for Elevidys in the first half of 2025 as a treatment of limb-girdle muscular dystrophy (LGMD). A regulatory filing in this indication is expected by the end of the year, according to a presentation on Monday. Sarepta will also run Phase I/II studies this year for two new LGMD candidates.
Sarepta at JPM25 also touted the benefits of its recent potential $10 billion deal with Arrowhead Pharmaceuticals, which was announced in November 2024 and could yield at least seven RNA interference assets for facioscapulohumeral muscular dystrophy (FSHD), myotonic dystrophy type 1 (DM1), idiopathic pulmonary fibrosis and spinocerebellar ataxia 2. The biotech is expecting preliminary early-stage FSHD and DM1 data by the end of 2025.
“We see multiple ways to create value as well within each program,” the Jefferies analysts wrote of these Arrowhead programs, which have demonstrated best-in-class potential for DM1 and FSHD. “We see clear synergies for SRPT, who is an expert in developing rare disease drugs, finding biomarkers, and securing accelerated approvals.”
