Sarepta Therapeutics (SRPT) Q2 2024 earnings summary

Executive summary

• Achieved broad FDA approval for ELEVIDYS, expanding access to over 80% of Duchenne muscular dystrophy patients in the U.S., with traditional approval for ambulatory and accelerated approval for non-ambulatory patients ages four and older.

• ELEVIDYS launch is the largest gene therapy rollout to date, with strong demand and positive payer interactions; early launch exceeded expectations.

• Net product revenue for Q2 2024 was $360.5 million, up 51% year-over-year, with ELEVIDYS contributing $121.7 million.

• Achieved GAAP net income of $6.5 million for Q2 2024, reversing a net loss of $23.9 million in Q2 2023.

• Sarepta commercialized four FDA-approved products, including the newly expanded approval for ELEVIDYS in June 2024.

Financial highlights

• Q2 2024 total revenues reached $362.9 million, up from $261.2 million in Q2 2023.

• ELEVIDYS net product revenue was $121.7 million; PMO franchise revenue was $238.8 million.

• GAAP net income was $6.5 million ($0.07 per share) versus a net loss of $23.9 million in Q2 2023.

• Non-GAAP net income was $46.7 million ($0.44 per share), compared to a non-GAAP net loss of $89.9 million in Q2 2023.

• Cash, cash equivalents, and investments totaled $1.48 billion as of June 30, 2024.

Outlook and guidance

• 2025 net product revenue guidance for the four approved therapies is $2.9–$3.1 billion, years away from peak sales.

• Modest revenue growth expected in Q3 2024, with strong acceleration in Q4 as expanded ELEVIDYS label adoption ramps up.

• Peak year sales for ELEVIDYS anticipated in the latter half of the decade, with prevalent population treated through the 2020s and incident population addressed in the early 2030s.

• Management expects its cash, cash equivalents, and investments to fund operations for at least the next twelve months.

• Roche anticipates EMA approval for ELEVIDYS in ambulatory DMD patients ages 3–7 in 2025.