Sign in
ST

Sarepta Therapeutics, Inc. (SRPT)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 total revenues were $658.4M with GAAP diluted EPS of $1.50 and non-GAAP diluted EPS of $1.90; operating income rose to $161.7M as ELEVIDYS net product revenue surged to $384.2M and PMO net product revenue reached ~$254.0M .
  • ELEVIDYS growth was a major surprise: revenue rose 112% sequentially vs Q3 and exceeded prior quarterly guidance by >$60M; full-year net product revenue overperformed guidance by >$100M, underscoring commercial execution and demand strength .
  • Management reiterated FY2025 net product revenue guidance of $2.9–$3.1B and introduced FY2025 non-GAAP R&D+SG&A expense guidance of $1.2–$1.3B; they also secured a $600M revolving credit facility, enhancing liquidity for execution .
  • Strategic pipeline momentum continued with EMBARK Part 2 (positive crossover and 2-year durability data), EMERGENE dosing completion for SRP‑9003, and closing of the Arrowhead siRNA platform collaboration; near-term catalysts include EMERGENE data H1 2025 and a BLA filing for SRP‑9003 in 2025 .
  • Management emphasized operational cadence (3–5 months from start form to infusion), broad payer coverage (no permanent denials to date), and intent to move to suspension manufacturing to significantly improve margins over time .

What Went Well and What Went Wrong

What Went Well

  • ELEVIDYS had “the most successful launch of a gene therapy yet in history,” with Q4 sales of $384.2M and sequential growth of 112%, beating prior guidance by >$60M; PMO net product revenue remained resilient at ~$254M in Q4 .
  • Profitability inflected: Q4 GAAP net income reached $159.0M and non-GAAP net income was $206.0M; total revenues increased 66% YoY to $658.4M .
  • EMBARK Part 2 and 2-year Part 1 data reinforced durability and functional benefit (NSAA/TTR/10MWR) with supportive MRI and sustained micro-dystrophin expression, bolstering the clinical narrative for early intervention with ELEVIDYS .

Management quote: “We broadly launched ELEVIDYS in 2024 and achieved results greater than all other in vivo gene therapies combined… We became sustainably profitable and cash flow positive in 2024.”

What Went Wrong

  • Cost structure elevated: Q4 cost of sales jumped to $132.3M vs $44.2M last year, reflecting expanded ELEVIDYS label and Roche product sales; SG&A also increased by $32.2M YoY on commercialization and litigation spend .
  • Other income declined $5.7M YoY on lower interest income/accretion given rate mix, partially tempering the P&L leverage in the quarter .
  • Near-term gross margin headwinds as heavier non-ambulant dosing mix grows; management guided margins to high 70s in the medium term before improving toward ~90% with suspension manufacturing in 2027, implying interim pressure prior to process gains .

Financial Results

Summary vs Prior Quarters

MetricQ2 2024Q3 2024Q4 2024
Total Revenues ($USD Millions)$362.9 $467.2 $658.4
GAAP Diluted EPS ($)$0.07 $0.34 $1.50
Non-GAAP Diluted EPS ($)$0.44 $0.62 $1.90
GAAP Operating Income (EBIT) ($USD Millions)-$0.7 $22.2 $161.7
EBIT Margin %-0.2% (calc from )4.7% (calc from )24.6% (calc from )

Notes: EBIT Margin % is computed from reported operating income divided by total revenues using the cited figures per quarter .

Segment/Product Revenue Breakdown

MetricQ2 2024Q3 2024Q4 2024
ELEVIDYS Net Product Revenue ($USD Millions)$121.7 $181.0 $384.2
PMO Net Product Revenue ($USD Millions)$238.8 $248.8 $254.0
Roche Royalty Revenue ($USD Millions)$2.4 $9.5 $4.9

PMO Product Detail (Q4 2024)

ProductQ4 2024 Net Product Revenue ($USD Millions)
EXONDYS 51$137.6
VYONDYS 53$40.2
AMONDYS 45$76.2

KPIs and Balance Sheet

KPIQ2 2024Q3 2024Q4 2024
ELEVIDYS Patients on Therapy (cumulative)——>600
Conversion timeline (enrollment to infusion)——3–5 months
Payer permanent denials (to date)——0
Cash, cash equivalents, restricted cash & investments ($USD Millions)$1,476.1 $1,395.8 $1,503.5

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Product RevenueFY 2025$2.9–$3.1B (initiated Q2’24) $2.9–$3.1B (reiterated Q4’24) Maintained
Non-GAAP R&D + SG&AFY 2025—$1.2–$1.3B New
Gross Margin outlookFY 2025–26; 2027—High 70s near term; trending toward ~90% post suspension manufacturing (~2027) Raised long-term margin potential (process-driven)
LiquidityCurrent—$600M senior secured revolver (inaugural facility) Added flexibility

Earnings Call Themes & Trends

TopicQ2 2024 (Previous Mentions)Q3 2024 (Previous Mentions)Q4 2024 (Current Period)Trend
ELEVIDYS launch trajectoryLabel expansion & launch setup; $121.7M Q2 ELEVIDYS $181.0M ELEVIDYS; durability data at WMS and Nature Medicine publication $384.2M; 112% sequential growth; <5% on-label population treated Accelerating growth
Access & reimbursementEarly signals; prepared for broad launch Continued strong PMO performance; limited cannibalization Broad coverage; no permanent denials; 3–5 month cadence Improving payer dynamics
Manufacturing/process——Plan to bridge to suspension manufacturing; significant yield, margin uplift Structural margin expansion
Clinical durability (ELEVIDYS)Broad label; commitment to ENVISION PMR Multi-year safety/functional updates and MRI data EMBARK Part 2 crossover and 2-year durability; MRI supports muscle health Strengthening evidence
LGMD pipeline (SRP‑9003/9004/9005)Fast Track for SRP‑9003 Progress toward trials and BLA plans EMERGENE dosing complete; rolling BLA planned in 2025 Advancing to approval
siRNA platform (Arrowhead)——Collaboration closed; FSHD1/DM1 SAD readouts expected in 2H’25 Diversified pipeline

Management Commentary

  • “We broadly launched ELEVIDYS in 2024 and achieved results greater than all other in vivo gene therapies combined… We became sustainably profitable and cash flow positive in 2024.” — Doug Ingram, CEO .
  • “For the fourth quarter, ELEVIDYS revenue totaled $384.2 million, exceeding our quarterly guidance by over $60 million… we have treated approximately 5% of the on-label addressable patient population.” — Dallan Murray, Chief Customer Officer .
  • “In all prespecified measures… those on ELEVIDYS did strongly statistically, significantly better than untreated natural history would have predicted.” — Doug Ingram, CEO (EMBARK results) .
  • “We anticipate combined 2025 non-GAAP R&D and SG&A expenses to be in the range of $1.2–$1.3 billion… almost exclusively related to Arrowhead development programs.” — Ian Estepan, CFO .

Q&A Highlights

  • Revenue cadence: Management expects sequential growth throughout 2025; reiterated confidence in $3B total net product revenue with ~2/3 from ELEVIDYS and ~1/3 from PMOs .
  • Access and payer dynamics: No permanent coverage denials; robust win rates, with cadence driven by single-case contracts and operational steps across institutions (20–25 people per case) .
  • Suspension manufacturing: Bridging study planned for 2025; potential margin to >90% post-transition with materially higher yields (targeting 2027) .
  • LGMD approval bar: Emphasis on expression and safety in ultra-rare single-arm designs; agency alignment supports accelerated pathways across sarcoglycan programs .
  • Terminal value and incidence: U.S. incident DMD population ~420–430 annually; long-term outlook includes potential redosing solutions and multiple pipeline launches beyond ELEVIDYS .

Estimates Context

  • Wall Street consensus estimates (S&P Global) were not retrievable at this time due to API limits; therefore, explicit comparisons vs consensus EPS and revenue are unavailable. Management indicated comfort with Q1 consensus and PMO estimates, and reported Q4 ELEVIDYS and total net product revenue exceeded prior guidance thresholds, suggesting positive estimate revision risk on the top line .
  • Values were intended to be retrieved from S&P Global; unavailable at the time of this analysis.

Key Takeaways for Investors

  • ELEVIDYS is driving a step-change in the P&L with strong sequential growth and limited PMO cannibalization; near-term trading setup favors continued revenue beats as the conversion cadence scales and coverage broadens .
  • The margin narrative improves materially with planned suspension manufacturing; while heavier dosing mix may compress near-term margins, structural uplift toward ~90% from 2027 is an underappreciated medium-term lever .
  • Catalysts are abundant: EMERGENE (SRP‑9003) H1’25 data, a 2025 BLA filing, FSHD1/DM1 SAD readouts, and further ELEVIDYS durability publications — each with potential to extend the growth runway and diversify revenue .
  • Liquidity and capital allocation flexibility strengthened via the $600M revolver; management also has a $500M repurchase authorization over 18 months to opportunistically support the stock .
  • Risks: execution on payer approvals and site cadence (time-intensive), near-term gross margin mix, and clinical/regulatory milestones for LGMD and siRNA programs — but current data and agency alignment de-risk several pathways .

Sources: SEC 8-K earnings release and exhibits, Q4 2024 earnings call transcript, and company press releases as cited above.