Sarepta Therapeutics Reports Preliminary* Fourth Quarter and Full-Year 2024 Net Product Revenue
Sarepta Therapeutics (SRPT) reported strong preliminary Q4 and full-year 2024 financial results, with total net product revenue reaching $638.2 million for Q4 and $1.79 billion for full-year 2024, exceeding guidance by over $100 million. ELEVIDYS, their gene therapy treatment, generated $384.2 million in Q4 revenue and $820.8 million for the full year, surpassing expectations by over $60 million.
The company's RNA-based PMO products contributed $254.0 million in Q4 and $967.2 million for the full year. Year-end cash position stood at approximately $1.5 billion. Sarepta maintains its 2025 revenue guidance of $2.9 to $3.1 billion. Total net product revenue grew 75% year-over-year in Q4, with ELEVIDYS showing 112% growth over the previous quarter.
Sarepta Therapeutics (SRPT) ha riportato risultati finanziari preliminari solidi per il quarto trimestre e per l'intero anno 2024, con entrate nette totali da prodotti che hanno raggiunto 638,2 milioni di dollari per il quarto trimestre e 1,79 miliardi di dollari per l'intero anno 2024, superando le previsioni di oltre 100 milioni di dollari. ELEVIDYS, il loro trattamento con terapia genica, ha generato 384,2 milioni di dollari in fatturato nel quarto trimestre e 820,8 milioni di dollari per l'intero anno, superando le aspettative di oltre 60 milioni di dollari.
I prodotti PMO basati su RNA dell'azienda hanno contribuito con 254,0 milioni di dollari nel quarto trimestre e 967,2 milioni di dollari per l'intero anno. La posizione di cassa alla fine dell'anno si attestava a circa 1,5 miliardi di dollari. Sarepta mantiene la sua previsione di fatturato per il 2025 di 2,9 - 3,1 miliardi di dollari. Le entrate nette totali da prodotti sono cresciute del 75% su base annua nel quarto trimestre, con ELEVIDYS che ha mostrato una crescita del 112% rispetto al trimestre precedente.
Sarepta Therapeutics (SRPT) informó resultados financieros preliminares sólidos para el cuarto trimestre y el año completo 2024, con ingresos netos totales por productos alcanzando 638,2 millones de dólares para el cuarto trimestre y 1,79 mil millones de dólares para el año completo 2024, superando las expectativas en más de 100 millones de dólares. ELEVIDYS, su tratamiento de terapia génica, generó 384,2 millones de dólares en ingresos del cuarto trimestre y 820,8 millones de dólares para el año completo, superando las expectativas en más de 60 millones de dólares.
Los productos PMO basados en ARN de la compañía contribuyeron con 254,0 millones de dólares en el cuarto trimestre y 967,2 millones de dólares para el año completo. La posición de efectivo al final del año fue de aproximadamente 1,5 mil millones de dólares. Sarepta mantiene su guía de ingresos para 2025 de 2,9 a 3,1 mil millones de dólares. Los ingresos netos totales por productos crecieron un 75% interanual en el cuarto trimestre, con ELEVIDYS mostrando un crecimiento del 112% en comparación con el trimestre anterior.
사렙타 테라퓨틱스 (SRPT)는 2024년 4분기 및 전체 연도에 대한 강력한 예비 재무 결과를 보고했습니다. 4분기 동안 총 제품 순수익은 6억 3820만 달러, 2024년 전체 연도는 17억 9000만 달러에 달해 가이던스를 1억 달러 이상 초과했습니다. 그들의 유전자 요법 치료제 ELEVIDYS는 4분기에 3억 8420만 달러의 수익을 올렸고 전체 연도 동안 8억 2080만 달러를 기록하여 기대치를 6000만 달러 이상 초과했습니다.
회사의 RNA 기반 PMO 제품은 4분기에 2억 5400만 달러, 전체 연도 동안 9억 6720만 달러의 기여를 했습니다. 연말 현금 잔고는 약 15억 달러에 달했습니다. 사렙타는 2025년 수익 가이던스를 29억 - 31억 달러로 유지하고 있습니다. 총 제품 순수익은 4분기에 전년 대비 75% 증가했으며, ELEVIDYS는 이전 분기 대비 112% 성장률을 보였습니다.
Sarepta Therapeutics (SRPT) a annoncé des résultats financiers préliminaires solides pour le quatrième trimestre et l'année entière 2024, avec des revenus nets totaux provenant des produits atteignant 638,2 millions de dollars pour le quatrième trimestre et 1,79 milliard de dollars pour l'année entière 2024, dépassant les prévisions de plus de 100 millions de dollars. ELEVIDYS, leur traitement par thérapie génique, a généré 384,2 millions de dollars de revenus au quatrième trimestre et 820,8 millions de dollars pour l'année entière, dépassant les attentes de plus de 60 millions de dollars.
Les produits PMO basés sur l'ARN de l'entreprise ont contribué avec 254,0 millions de dollars au quatrième trimestre et 967,2 millions de dollars pour l'année entière. La position de trésorerie à la fin de l'année était d'environ 1,5 milliard de dollars. Sarepta maintient son orientation en matière de revenus pour 2025 de 2,9 à 3,1 milliards de dollars. Les revenus nets totaux des produits ont augmenté de 75 % d'une année sur l'autre au quatrième trimestre, avec ELEVIDYS affichant une croissance de 112 % par rapport au trimestre précédent.
Sarepta Therapeutics (SRPT) berichtete über starke vorläufige Finanzzahlen für das vierte Quartal und das gesamte Jahr 2024, mit einem Gesamtumsatz aus Produktverkäufen von 638,2 Millionen Dollar im vierten Quartal und 1,79 Milliarden Dollar für das gesamte Jahr 2024, was die Prognosen um über 100 Millionen Dollar übertraf. ELEVIDYS, ihre Gentherapiebehandlung, erzielte im vierten Quartal einen Umsatz von 384,2 Millionen Dollar und für das gesamte Jahr 820,8 Millionen Dollar, was die Erwartungen um über 60 Millionen Dollar übertraf.
Die mit RNA basierenden PMO-Produkte des Unternehmens trugen im vierten Quartal 254,0 Millionen Dollar und für das gesamte Jahr 967,2 Millionen Dollar bei. Die Bargeldposition zum Jahresende betrug etwa 1,5 Milliarden Dollar. Sarepta hält an seiner Umsatzprognose für 2025 von 2,9 bis 3,1 Milliarden Dollar fest. Der Gesamtumsatz aus Produktverkäufen wuchs im vierten Quartal um 75 % im Jahresvergleich, wobei ELEVIDYS einen Anstieg von 112 % im Vergleich zum vorherigen Quartal zeigte.
- Q4 revenue of $638.2M exceeded guidance by over $100M
- ELEVIDYS Q4 revenue of $384.2M surpassed guidance by $60M+
- 75% year-over-year growth in total net product revenue for Q4
- 112% sequential quarter growth for ELEVIDYS
- Strong cash position of $1.5B at year-end
- 56% year-over-year growth in total product revenue for 2024
- None.
Insights
The preliminary Q4 and FY2024 results showcase exceptional performance, with total net product revenue of
ELEVIDYS's performance is particularly noteworthy, with
The RNA-based PMO franchise's resilience, generating
ELEVIDYS's rapid market adoption reflects its groundbreaking position as a gene therapy for Duchenne muscular dystrophy (DMD). The therapy's expanded indication for both ambulatory and non-ambulatory patients has significantly broadened its market reach. The robust revenue growth suggests strong physician acceptance and patient uptake, despite the complex administration protocol and safety monitoring requirements.
The continued growth of PMO products alongside ELEVIDYS indicates that physicians are effectively stratifying patients for different treatment modalities, recognizing the complementary role of both therapeutic approaches in DMD management. This dual-platform strategy strengthens Sarepta's market leadership in DMD treatment.
– Preliminary total net product revenue of
– Preliminary ELEVIDYS net product revenue totaled
– Preliminary RNA-based PMO net product revenue for the fourth quarter and full-year of 2024 totaled
– Preliminary year-end 2024 cash, cash equivalents, restricted cash and investments balance of approximately
– Reiterates 2025 full-year total net product revenue guidance of
Financial Update* (preliminary and unaudited):
-
Total net product revenue of
$638.2 million $1.79 billion $100 million -
Fourth quarter and full-year 2024 net product revenue for ELEVIDYS totaled
$384.2 million $820.8 million -
Fourth quarter and full-year 2024 net product revenue for Sarepta’s RNA-based PMOs totaled
$254.0 million $967.2 million -
As of December 31, 2024, the Company had preliminary cash, cash equivalents, restricted cash and investments of approximately
$1.5 billion -
The Company reiterates 2025 full-year total net product revenue guidance of
$2.9 $3.1 billion
“2024 marked the most significant year to date for Sarepta and for the patients we serve. And consistent with our long track record of execution, we ended 2024 and enter 2025 with exceptionally strong performance,” said Doug Ingram, president and chief executive officer, Sarepta Therapeutics. “In the fourth quarter, we grew total net product revenue by
*These preliminary selected financial results are unaudited and subject to adjustment. Sarepta will report its final and complete fourth quarter and full-year 2024 financial results in late February 2025. The Company has not completed its financial closing procedures for the quarter or year-ended December 31, 2024, and its actual results could be materially different from these preliminary financial results.
About ELEVIDYS (delandistrogene moxeparvovec-rokl)
ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle.
ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age.
- For patients who are ambulatory and have a confirmed mutation in the DMD gene
- For patients who are non-ambulatory and have a confirmed mutation in the DMD gene.
The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin (noted hereafter as “micro-dystrophin”) in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene.
WARNINGS AND PRECAUTIONS:
Infusion-related Reactions:
- Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate.
- ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available.
- Discontinue infusion for anaphylaxis.
Acute Serious Liver Injury:
- Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks.
- Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled.
- Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels).
- Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended.
Immune-mediated Myositis:
- In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed.
- Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction.
- Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient’s clinical presentation and medical history if these symptoms occur.
Myocarditis:
- Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials.
- If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath.
- Advise patients to contact a physician immediately if they experience cardiac symptoms.
Preexisting Immunity against AAVrh74:
- In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies.
- Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration.
- ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400.
Adverse Reactions:
-
The most common adverse reactions (incidence ≥
5% ) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia.
Report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782).
For further information, please see the full Prescribing Information.
About Sarepta Therapeutics
Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit www.sarepta.com or follow us on LinkedIn, X, Instagram and Facebook.
Internet Posting of Information
We routinely post information that may be important to investors in the 'For Investors' section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.
Forward-Looking Statements
This press release contains “forward-looking statements.” Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to our expected financial results.
These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: the estimates and judgments we make, or the assumptions on which we rely, in preparing our consolidated financial statements could prove inaccurate; our revenues and operating results could fluctuate significantly, which may adversely affect our stock price; and those risks identified under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 as well as other SEC filings made by the Company which you are encouraged to review.
Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250113863102/en/
Investor Contact:
Ian Estepan, 617-274-4052
iestepan@sarepta.com
Media Contact:
Tracy Sorrentino, 617-301-8566
tsorrentino@sarepta.com
Source: Sarepta Therapeutics, Inc.
FAQ
What was Sarepta's (SRPT) total revenue for Q4 2024?
How much revenue did ELEVIDYS generate for Sarepta (SRPT) in 2024?
What is Sarepta's (SRPT) revenue guidance for 2025?
How much cash does Sarepta (SRPT) have as of December 2024?
What was the growth rate of ELEVIDYS sales for Sarepta (SRPT) in Q4 2024?
