Sarepta Therapeutics, Inc 8-K, filed Nov 5, 2026
Sarepta Therapeutics, Inc. (SRPT)
About this 8-K
Sarepta Therapeutics, Inc filed this 8-K on November 5, 2026.
Sarepta Therapeutics reported net product revenues of approximately $323.8 million, raised full-year product-revenue guidance to $1.25 billion to $1.3 billion, and expects SRP-1003 and SRP-1001 multiple-ascending-dose data in the fourth quarter of 2026. AI summary
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 5, 2026, Sarepta Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit |
Description |
99.1 |
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104 |
The cover page from this Current Report on Form 8-K of Sarepta Therapeutics, Inc., formatted in Inline XBRL and included as Exhibit 101 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Sarepta Therapeutics, Inc. |
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Date: |
November 5, 2026 |
By: |
/s/ Michael Severino, M.D. |
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Michael Severino, M.D. |
Exhibit 99.1
Sarepta Therapeutics Announces Third Quarter 2026 Financial Results and Recent Corporate Developments
CAMBRIDGE, Mass. -- (BUSINESS WIRE) -- Nov. 5, 2026 -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the third quarter of 2026.
“After my first 90 days at Sarepta, I believe the fundamental strengths that attracted me to the company remain firmly intact: a durable Duchenne franchise, a promising pipeline with the potential to deliver differentiated medicines, and the financial strength to invest in our highest-value opportunities,” said Michael Severino, M.D., chief executive officer, Sarepta. “This quarter, we saw continued strength in our commercial execution. Our upcoming DM1 and FSHD datasets are important opportunities to demonstrate the depth of knockdown and downstream biological effects we believe our platform can achieve. We are already preparing both programs for potential late-stage development with the intent of moving efficiently if the results support advancement. We have work to do, and I want us to be measured by execution, but I believe Sarepta has the commercial foundation, pipeline opportunities and financial strength to deliver meaningful long-term value.”
Corporate Highlights:
Conference Call
The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and following the event a replay will be archived there for one year. This event can be accessed using this link.
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Q3 2026 Financial Highlights1 |
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For the Three Months Ended |
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2026 |
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2025 |
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QTD Change |
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(in millions, except for per share amounts) |
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$ |
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% |
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Total revenues |
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$ |
381.4 |
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$ |
399.4 |
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$ |
(18.0 |
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(5 |
)% |
Operating (loss) income: |
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GAAP |
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$ |
(9.0 |
) |
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$ |
(103.4 |
) |
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$ |
94.4 |
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(91 |
)% |
Non-GAAP |
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$ |
22.9 |
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$ |
(35.7 |
) |
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$ |
58.6 |
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* |
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Net (loss) income: |
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GAAP2 |
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$ |
(28.5 |
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$ |
(50.6 |
) |
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$ |
22.1 |
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(44 |
)% |
Non-GAAP |
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$ |
15.6 |
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$ |
(12.9 |
) |
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$ |
28.5 |
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* |
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Diluted (loss) earnings per share |
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GAAP2 |
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$ |
(0.27 |
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$ |
(0.50 |
) |
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$ |
0.23 |
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(46 |
)% |
Non-GAAP |
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$ |
0.13 |
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$ |
(0.13 |
) |
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$ |
0.26 |
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* |
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For the Nine Months Ended |
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2026 |
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2025 |
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YTD Change |
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(in millions, except for per share amounts) |
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$ |
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% |
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Total revenues |
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$ |
1,513.4 |
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$ |
1,755.3 |
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$ |
(241.9 |
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(14 |
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Operating income (loss): |
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GAAP |
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$ |
362.7 |
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$ |
(288.2 |
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$ |
650.9 |
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* |
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Non-GAAP |
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$ |
507.1 |
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$ |
(122.5 |
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$ |
629.6 |
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* |
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Net income (loss): |
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GAAP2 |
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$ |
297.6 |
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$ |
(301.2 |
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$ |
598.8 |
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* |
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Non-GAAP |
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$ |
479.6 |
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$ |
(130.2 |
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$ |
609.8 |
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* |
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Diluted earnings (loss) per share |
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GAAP2 |
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$ |
2.78 |
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$ |
(3.06 |
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$ |
5.84 |
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* |
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Non-GAAP |
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$ |
3.91 |
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$ |
(1.32 |
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$ |
5.23 |
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* |
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1 For an explanation of our use of non-GAAP financial measures, please refer to the “Use of Non-GAAP Financial Measures” section later in this press release, and for a reconciliation of each non-GAAP financial measure from the most comparable GAAP measures, see the table at the end of this press release. |
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*Not meaningful |
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As of |
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As of |
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Cash, cash equivalents, restricted cash and investments |
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$ |
998.7 |
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953.8 |
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3
Revenues
Total revenues were $381.4 million for the three months ended September 30, 2026, as compared to $399.4 million for the same period of 2025, a decrease of $18.0 million. This primarily reflects a lower volume of ELEVIDYS sales due to the continued impact of our updated label that only includes the ambulatory patient population for treatment. The decrease is partially offset by an increase of $31.4 million in contract manufacturing revenues associated with increased commercial ELEVIDYS supply delivered to Roche.
Total revenues were $1,513.4 million for the nine months ended September 30, 2026, as compared to $1,755.3 million for the same period of 2025, a decrease of $241.9 million. This primarily reflects a lower volume of ELEVIDYS sales due to our updated label that only includes the ambulatory patient population for treatment. The decrease is partially offset by an increase of $189.5 million in collaboration revenues related to the $365.0 million of collaboration revenue recognized related to Roche's declined option for certain program rights and the milestone recognized under the Roche collaboration agreement for the first commercial dosing of ELEVIDYS in Japan during the nine months ended September 30, 2026, as compared to $175.5 million of collaboration revenue in 2025 related to Roche’s expiration of an option to acquire a certain program and the Japan Approval Milestone. Furthermore, contract manufacturing revenues increased $72.5 million associated with increased commercial ELEVIDYS supply delivered to Roche.
Cost of sales (excluding amortization of in-licensed rights)
Cost of sales (excluding amortization of in-license rights) were $188.5 million for the three months ended September 30, 2026, as compared to $150.8 million for the same period of 2025, an increase of $37.7 million. Cost of sales (excluding amortization of in-license rights) were $446.7 million for the nine months ended September 30, 2026, as compared to $440.9 million for the same period of 2025, an increase of $5.8 million. The increases in both periods primarily reflect a take-or-pay charge of $62.0 million related to non-cancelable manufacturing obligations with Catalent, Inc. ("Catalent") for certain inventories that we elected not to manufacture. Additionally, there was an increase in cost of sales related to products sold to Roche, primarily related to increased volume of ELEVIDYS shipments as well as write-offs of certain batches of products not meeting quality specifications under the Roche collaboration agreement. The increases in both periods were partially offset by a lower volume of ELEVIDYS sales in the United States and corresponding royalty payments.
Operating expenses and others
Research and development expenses were $82.5 million for the three months ended September 30, 2026, as compared to $218.9 million for the same period of 2025, a decrease of $136.4 million. The decrease primarily reflects a $100.0 million milestone payment made to Arrowhead Pharmaceutical, Inc. ("Arrowhead") during the three months ended September 30, 2025, triggered by Arrowhead's achievement of the first of two predetermined enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 study for the DM1 program, with no similar activity during the same period of 2026. In addition, there were decreases in manufacturing and clinical expenses primarily due to our decision to reprioritize our pipeline and developmental priorities announced in July 2025, partially offset by an increase in compensation and other personnel expenses due to the reversal of previously recognized
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expense related to certain incentive compensationour restructuring plan announced in July 2025 (the "Restructuring"). For the three months ended September 30, 2026, non-GAAP research and development expenses were $71.6 million, as compared to $206.5 million for the same period of 2025, a decrease of $134.9 million.
Research and development expenses were $327.8 million for the nine months ended September 30, 2026, as compared to $1,196.7 million for the same period of 2025, a decrease of approximately $868.9 million. The decrease primarily reflects the recognition of up-front and collaboration license fees of $583.6 million associated with the licensing, collaboration and stock purchase agreement with Arrowhead as well as the $100.0 million milestone payment made to Arrowhead during the nine months ended September 30, 2025, with no similar activity for the same period of 2026. In addition, there was a decrease in manufacturing and clinical expenses primarily due to our decision to reprioritize our pipeline and developmental priorities announced in July 2025, as well as a decrease in compensation, other personnel, and stock-based compensation expenses, all as a result of the Restructuring. This decrease was partially offset by the $50.0 million annual collaboration license fee incurred and paid to Arrowhead during the nine months ended September 30, 2026. For the nine months ended September 30, 2026, non-GAAP research and development expenses were $285.8 million, as compared to $1,137.4 million for the same period of 2025, a decrease of $851.6 million.
Selling, general and administrative expenses were $118.6 million for the three months ended September 30, 2026, as compared to $91.9 million for the same period of 2025, an increase of $26.7 million. The increase primarily reflects the reversal of previously recognized expense related to certain stock compensation awards and incentive compensation accruals in connection with the Restructuring during the three months ended September 30, 2025, with no similar activity during the same period of 2026. For the three months ended September 30, 2026, non-GAAP selling, general and administrative expenses were $97.6 million, as compared to $77.1 million for the same period of 2025, an increase of $20.5 million.
Selling, general and administrative expenses were $335.2 million for the nine months ended September 30, 2026, as compared to $363.4 million for the same period of 2025, a decrease of $28.2 million. The decrease primarily reflects a decrease in compensation, other personnel, and stock-based compensation expenses, all as a result of the Restructuring, as well as a decrease in professional services used related to ELEVIDYS commercialization efforts. For the nine months ended September 30, 2026, non-GAAP selling, general and administrative expenses were $271.7 million, as compared to $297.6 million for the same period of 2025, a decrease of $25.9 million.
Litigation settlement charge was $39.0 million for the nine months ended September 30, 2026, with no similar activity for the same period of 2025. We recorded a litigation settlement charge of $39.0 million in the second quarter of 2026 related to a settlement agreement that was executed in September 2026 between Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, REGENXBIO, INC, the Trustees of the University of Pennsylvania and Catalent regarding the resolution of certain patent infringement litigations.
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Restructuring charges were $40.5 million for the three and nine months ended September 30, 2025, with no similar activity for the same periods of 2026.
Other (expense) income, net for the three months ended September 30, 2026 and 2025 was approximately $(16.7) million and $35.0 million, respectively. Other expense, net for the nine months ended September 30, 2026 and 2025 was approximately $47.0 million and $10.1 million, respectively. The change primarily reflects a decrease in our strategic investments as a result of the sale of our investment in Arrowhead in August 2025, partially offset by an increase in interest expense due to our 2030 Notes carrying a higher interest rate than our 2027 Notes during the three and nine months ended September 30, 2026.
Gain on debt extinguishment was $3.8 million for the three and nine months ended September 30, 2025, with no similar activity for the same periods of 2026. This gain was the result of a partial refinancing of the 2027 Notes where we exchanged $700.0 million in aggregate principal amount of 2027 Notes for $602.0 million in aggregate principal amount of 2030 Notes and made cash payments of $127.3 million, including $4.0 million of accrued interest of the 2027 Notes and 5.9 million shares of our common stock with a fair market value of approximately $104.9 million, net of issuance costs of $2.4 million.
Income tax expense for the three and nine months ended September 30, 2026, was approximately $2.7 million and $18.1 million, respectively. Income tax (benefit) expense for the three and nine months ended September 30, 2025, was $(14.1) million and $6.6 million, respectively. Income tax expense for all periods presented primarily relates to state income taxes as a result of taxable profits in certain states requiring the capitalization of research and development costs and states which have suspended or limited the utilization of net operating loss carryforwards.
Use of Non-GAAP Financial Measures
In addition to the GAAP financial measures set forth in this press release, we have included the following non-GAAP measurements:
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The following components are used to adjust our GAAP financial measures into the previously defined non-GAAP measurements:
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We use these non-GAAP measures as key performance measures for the purpose of evaluating operational performance and cash requirements internally. We also believe these non-GAAP measures increase comparability of period-to-period results and are useful to investors as they provide a similar basis for evaluating our performance as is applied by management. These non-GAAP measures are not intended to be considered in isolation or to replace the presentation of our financial results in accordance with GAAP. Use of the terms non-GAAP research and development expenses, non-GAAP selling, general and administrative expenses, non-GAAP operating income (loss), non-GAAP net income (loss), and non-GAAP diluted earnings (loss) per share may differ from similar measures reported by other companies, which may limit comparability, and are not based on any comprehensive set of accounting rules or principles. All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table “Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures.”
About EXONDYS 51
EXONDYS 51 uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion, or “skipping”, of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.
EXONDYS 51 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
EXONDYS 51 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
Important Safety Information About EXONDYS 51
Hypersensitivity reactions, including bronchospasm, chest pain, cough, tachycardia, and urticaria have occurred in patients who were treated with EXONDYS 51. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion or interrupting the EXONDYS 51 therapy.
Adverse reactions in DMD patients (N=8) treated with EXONDYS 51 30 mg or 50 mg/kg/week by intravenous (IV) infusion with an incidence of at least 25% more than placebo (N=4) (Study 1, 24 weeks) were (EXONDYS 51, placebo): balance disorder (38%, 0%), vomiting (38%, 0%) and contact dermatitis (25%, 0%). The most common adverse reactions were balance disorder and vomiting. Because of the small numbers of patients, these represent crude frequencies that may not reflect the frequencies observed in practice. The 50 mg/kg once weekly dosing regimen of EXONDYS 51 is not recommended.
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The most common adverse reactions from observational clinical studies (N=163) seen in greater than 10% of patients were headache, cough, rash, and vomiting.
Other adverse events may occur.
To report SUSPECTED ADVERSE REACTIONS, contact Sarepta Therapeutics, Inc. at 1-888-SAREPTA (1-888-727-3782) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For further information, please see the full U.S. Prescribing Information for EXONDYS 51 (eteplirsen).
About VYONDYS 53
VYONDYS 53 (golodirsen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 53 of dystrophin pre-mRNA, resulting in exclusion, or “skipping,” of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 53 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.
VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
VYONDYS 53 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
Important Safety Information for VYONDYS 53
CONTRAINDICATIONS: VYONDYS 53 is contraindicated in patients with a serious hypersensitivity reaction to golodirsen or to any of the inactive ingredients in VYONDYS 53. Anaphylaxis has occurred in patients receiving VYONDYS 53.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, rash, pyrexia, pruritus, urticaria, dermatitis, and skin exfoliation have occurred in VYONDYS 53-treated patients, some requiring treatment. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion, interrupting, or discontinuing the VYONDYS 53 therapy and monitor until the condition resolves. VYONDYS 53 is contraindicated in patients with a history of a serious hypersensitivity reaction to golodirsen or to any of the inactive ingredients in VYONDYS 53.
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Kidney Toxicity: Kidney toxicity was observed in animals who received golodirsen. Although kidney toxicity was not observed in the clinical studies with VYONDYS 53, the clinical experience with VYONDYS 53 is limited, and kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Kidney function should be monitored in patients taking VYONDYS 53. Because of the effect of reduced skeletal muscle mass on creatinine measurements, creatinine may not be a reliable measure of kidney function in DMD patients. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting VYONDYS 53. Consider also measuring glomerular filtration rate using an exogenous filtration marker before starting VYONDYS 53. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein-to-creatinine ratio every three months. Only urine expected to be free of excreted VYONDYS 53 should be used for monitoring of urine protein. Urine obtained on the day of VYONDYS 53 infusion prior to the infusion, or urine obtained at least 48 hours after the most recent infusion, may be used. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, as this reagent has the potential to cross react with any VYONDYS 53 that is excreted in the urine and thus lead to a false positive result for urine protein.
If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation.
ADVERSE REACTIONS: Adverse reactions observed in at least 20% of treated patients and greater than placebo were (VYONDYS 53, placebo): headache (41%, 10%), pyrexia (41%, 14%), fall (29%, 19%), abdominal pain (27%, 10%), nasopharyngitis (27%, 14%), cough (27%, 19%), vomiting (27%, 19%), and nausea (20%, 10%).
Other adverse reactions that occurred at a frequency greater than 5% of VYONDYS 53-treated patients and at a greater frequency than placebo were: administration site pain, back pain, pain, diarrhea, dizziness, ligament sprain, contusion, influenza, oropharyngeal pain, rhinitis, skin abrasion, ear infection, seasonal allergy, tachycardia, catheter site related reaction, constipation, and fracture.
Other adverse events may occur.
To report SUSPECTED ADVERSE REACTIONS, contact Sarepta Therapeutics, Inc. at 1-888-SAREPTA (1-888-727-3782) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For further information, please see the full U.S. Prescribing Information for VYONDYS 53 (golodirsen).
About AMONDYS 45
AMONDYS 45 (casimersen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 45 of dystrophin pre-mRNA, resulting in exclusion, or “skipping,” of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 45 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.
10
AMONDYS 45 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
AMONDYS 45 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
Important Safety Information for AMONDYS 45
CONTRAINDICATION: AMONDYS 45 is contraindicated in patients with a known serious hypersensitivity to casimersen or any of the inactive ingredients in AMONDYS 45. Instances of hypersensitivity including angioedema and anaphylaxis have occurred.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients who were treated with AMONDYS 45. If a hypersensitivity reaction occurs, institute appropriate medical treatment, and consider slowing the infusion, interrupting, or discontinuing the AMONDYS 45 infusion and monitor until the condition resolves. AMONDYS 45 is contraindicated in patients with known serious hypersensitivity to casimersen or to any of the inactive ingredients in AMONDYS 45.
Kidney Toxicity: Kidney toxicity was observed in animals who received casimersen. Although kidney toxicity was not observed in the clinical studies with AMONDYS 45, kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Kidney function should be monitored in patients taking AMONDYS 45. Because of the effect of reduced skeletal muscle mass on creatinine measurements, creatinine may not be a reliable measure of kidney function in DMD patients. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting AMONDYS 45. Consider also measuring glomerular filtration rate using an exogenous filtration marker before starting AMONDYS 45. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein to-creatinine ratio (UPCR) every three months. Only urine expected to be free of excreted AMONDYS 45 should be used for monitoring of urine protein. Urine obtained on the day of AMONDYS 45 infusion prior to the infusion, or urine obtained at least 48 hours after the most recent infusion, may be used. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, as this reagent has the potential to cross react with any AMONDYS 45 that is excreted in the urine and thus lead to a false positive result for urine protein.
If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation.
Adverse Reactions: Adverse reactions occurring in at least 20% of patients treated with AMONDYS 45 and at least 5% more frequently than in the placebo group were (AMONDYS 45, placebo): upper respiratory infections (65%, 55%), cough (33%, 26%), pyrexia (33%, 23%), headache (32%, 19%), arthralgia (21%, 10%), and oropharyngeal pain (21%, 7%).
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Other adverse reactions that occurred in at least 10% of patients treated with AMONDYS 45 and at least 5% more frequently than in the placebo group were: ear pain, nausea, ear infection, post-traumatic pain, and dizziness and light-headedness.
Other adverse events may occur.
To report SUSPECTED ADVERSE REACTIONS, contact Sarepta Therapeutics, Inc. at 1-888-SAREPTA (1-888-727-3782) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For further information, please see the full U.S. Prescribing Information for AMONDYS 45 (casimersen).
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 ambulatory patients 4 years of age and older with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene.
Limitations of Use
ELEVIDYS is not recommended in patients with:
IMPORTANT SAFETY INFORMATION
BOXED WARNING: Acute Serious Liver Injury and Acute Liver Failure
Acute serious liver injury, including life-threatening and fatal acute liver failure, has occurred. Patients with preexisting liver impairment may be at higher risk.
Prior to infusion, assess liver function by clinical examination and laboratory testing. Administer systemic corticosteroids before and after ELEVIDYS infusion. Continue to monitor liver function weekly for the first 3 months after infusion and continue until results are unremarkable.
Instruct patients to maintain proximity to an appropriate healthcare facility, as determined by the healthcare provider, for at least 2 months following ELEVIDYS infusion.
Obtain prompt consultation with a specialist (e.g., gastroenterologist or hepatologist) if acute serious liver injury or impending acute liver failure is suspected.
12
CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9, including a deletion of any portion or the entirety of these exons, in the DMD gene.
WARNINGS AND PRECAUTIONS:
Acute Serious Liver Injury and Acute Liver Failure
See Boxed Warning.
Serious Infections
Myocarditis
Infusion-related Reactions
13
Immune-mediated Myositis
Preexisting Immunity against AAVrh74
ADVERSE REACTIONS
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).
Please see the full Prescribing Information for ELEVIDYS, including Boxed Warning and Medication Guide.
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 a leadership position in Duchenne muscular dystrophy (Duchenne) and are
14
building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit www.sarepta.com or follow us on LinkedIn, X, Instagram and Facebook.
Forward-Looking Statements
In order to provide Sarepta’s investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “may,” “intends,” “prepares,” “looks,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to our future operations, financial performance, projections and guidance, business plans, market opportunities and potential growth, priorities and research and development programs and technologies; the potential benefits of our technologies and scientific approaches, including our siRNA programs; the timing of our ongoing and planned clinical trials; and our expected plans and milestones, including upcoming data readouts for DM1 and FSHD by the end of 2026.
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: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, the results of future research may not be consistent with past positive results, or may fail to meet regulatory approval requirements for the safety and efficacy of our products; success in preclinical and clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; we may observe adverse reactions in our clinical trials or in patients who receive our approved products; our products may not be widely adopted by patients, payors or healthcare providers, which would adversely impact our business; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; certain programs may never advance in the clinic or may be discontinued for a number of reasons, including regulators imposing a clinical hold and us suspending or terminating clinical research or trials; if the actual number of patients suffering from the diseases we aim to treat is smaller than estimated, our revenue and ability to achieve profitability may be adversely affected; we may not be able to execute on our business plans, including meeting our expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing our product candidates to market, for various reasons, some of which may be outside of our control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.
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.
15
16
Sarepta Therapeutics, Inc. |
|
|||||||||||||||
Condensed Consolidated Statements of (Loss) Income |
|
|||||||||||||||
(unaudited, in thousands, except per share amounts) |
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Products, net |
|
$ |
323,763 |
|
|
$ |
370,043 |
|
|
$ |
982,967 |
|
|
$ |
1,494,689 |
|
Collaboration and other |
|
|
57,588 |
|
|
|
29,313 |
|
|
|
530,438 |
|
|
|
260,614 |
|
Total revenues |
|
|
381,351 |
|
|
|
399,356 |
|
|
|
1,513,405 |
|
|
|
1,755,303 |
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales (excluding amortization of in-licensed rights) |
|
|
188,512 |
|
|
|
150,775 |
|
|
|
446,665 |
|
|
|
440,897 |
|
Research and development |
|
|
82,549 |
|
|
|
218,890 |
|
|
|
327,767 |
|
|
|
1,196,730 |
|
Selling, general and administrative |
|
|
118,612 |
|
|
|
91,893 |
|
|
|
335,163 |
|
|
|
363,419 |
|
Litigation settlement charge |
|
|
— |
|
|
|
— |
|
|
|
39,000 |
|
|
|
— |
|
Restructuring charge |
|
|
— |
|
|
|
40,510 |
|
|
|
— |
|
|
|
40,510 |
|
Amortization of in-licensed rights |
|
|
718 |
|
|
|
677 |
|
|
|
2,126 |
|
|
|
1,945 |
|
Total cost and expenses |
|
|
390,391 |
|
|
|
502,745 |
|
|
|
1,150,721 |
|
|
|
2,043,501 |
|
Operating (loss) income |
|
|
(9,040 |
) |
|
|
(103,389 |
) |
|
|
362,684 |
|
|
|
(288,198 |
) |
Other (loss) income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other (expense) income, net1 |
|
|
(16,726 |
) |
|
|
34,958 |
|
|
|
(47,025 |
) |
|
|
(10,113 |
) |
Gain on debt extinguishment1 |
|
|
— |
|
|
|
3,761 |
|
|
|
— |
|
|
|
3,761 |
|
Total other (loss) income, net |
|
|
(16,726 |
) |
|
|
38,719 |
|
|
|
(47,025 |
) |
|
|
(6,352 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(Loss) income before income tax expense (benefit) |
|
|
(25,766 |
) |
|
|
(64,670 |
) |
|
|
315,659 |
|
|
|
(294,550 |
) |
Income tax expense (benefit) |
|
|
2,695 |
|
|
|
(14,102 |
) |
|
|
18,051 |
|
|
|
6,634 |
|
Net (loss) income |
|
$ |
(28,461 |
) |
|
$ |
(50,568 |
) |
|
$ |
297,608 |
|
|
$ |
(301,184 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(Loss) earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
(0.27 |
) |
|
$ |
(0.50 |
) |
|
$ |
2.82 |
|
|
$ |
(3.06 |
) |
Diluted |
|
$ |
(0.27 |
) |
|
$ |
(0.50 |
) |
|
$ |
2.78 |
|
|
$ |
(3.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of shares of common stock used in |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
|
105,930 |
|
|
|
100,237 |
|
|
|
105,453 |
|
|
|
98,545 |
|
Diluted |
|
|
105,930 |
|
|
|
100,237 |
|
|
|
107,646 |
|
|
|
98,545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
1 Other (expense) income, net and gain on debt extinguishment for the three and nine months ended September 30, 2025 have been revised to reflect the correction of an immaterial error associated with the accounting for the August 2025 Exchange, as well as the adoption of ASU 2025-07. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2025 for additional information. |
|
|||||||||||||||
17
Sarepta Therapeutics, Inc. |
|
|||||||||||||||
Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures |
|
|||||||||||||||
(unaudited, in thousands, except per share amounts) |
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP net (loss) income1 |
|
$ |
(28,461 |
) |
|
$ |
(50,568 |
) |
|
$ |
297,608 |
|
|
$ |
(301,184 |
) |
Interest expense (income), net1 |
|
|
16,093 |
|
|
|
1,078 |
|
|
|
42,386 |
|
|
|
(8,768 |
) |
Depreciation and amortization expense |
|
|
5,182 |
|
|
|
12,221 |
|
|
|
24,777 |
|
|
|
31,771 |
|
Stock-based compensation expense |
|
|
26,743 |
|
|
|
14,927 |
|
|
|
80,614 |
|
|
|
93,380 |
|
Loss (gain) on strategic investments |
|
|
523 |
|
|
|
(36,739 |
) |
|
|
2,683 |
|
|
|
17,268 |
|
Restructuring charge |
|
|
— |
|
|
|
40,510 |
|
|
|
— |
|
|
|
40,510 |
|
Impairment of strategic investment |
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
|
|
— |
|
Litigation settlement charge |
|
|
— |
|
|
|
— |
|
|
|
39,000 |
|
|
|
— |
|
Gain on debt extinguishment1 |
|
|
— |
|
|
|
(3,761 |
) |
|
|
— |
|
|
|
(3,761 |
) |
Income tax effect of adjustments |
|
|
(4,452 |
) |
|
|
9,477 |
|
|
|
(8,475 |
) |
|
|
607 |
|
Non-GAAP net income (loss) |
|
$ |
15,628 |
|
|
$ |
(12,855 |
) |
|
$ |
479,593 |
|
|
$ |
(130,177 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP (loss) earnings per share - diluted:1, 2 |
|
$ |
(0.27 |
) |
|
$ |
(0.50 |
) |
|
$ |
2.78 |
|
|
$ |
(3.06 |
) |
Add: impact of GAAP to Non-GAAP adjustments1 |
|
|
0.40 |
|
|
|
0.37 |
|
|
|
1.13 |
|
|
|
1.74 |
|
Non-GAAP earnings (loss) per share - diluted2 |
|
$ |
0.13 |
|
|
$ |
(0.13 |
) |
|
$ |
3.91 |
|
|
$ |
(1.32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of shares of common stock used in computing diluted earnings (loss) per share:3 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP |
|
|
105,930 |
|
|
|
100,237 |
|
|
|
107,646 |
|
|
|
98,545 |
|
Non-GAAP |
|
|
123,223 |
|
|
|
100,237 |
|
|
|
122,609 |
|
|
|
98,545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
1 GAAP net (loss) income, interest expense (income), net, gain on debt extinguishment, GAAP diluted loss per share and the corresponding impact of these GAAP to non-GAAP adjustments for the three and nine months ended September 30, 2025 have been revised to reflect the correction of an immaterial error associated with the accounting for the August 2025 Exchange, as well as the adoption of ASU 2025-07. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2025 for additional information. |
|
|||||||||||||||
18
Sarepta Therapeutics, Inc. |
|
|
|||||||||||||||
Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures |
|
|
|||||||||||||||
(unaudited, in thousands, except per share amounts) |
|
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|
||||
GAAP research and development expenses |
|
$ |
82,549 |
|
|
$ |
218,890 |
|
|
$ |
327,767 |
|
|
$ |
1,196,730 |
|
|
Stock-based compensation expense |
|
|
(8,509 |
) |
|
|
(4,139 |
) |
|
|
(27,295 |
) |
|
|
(36,733 |
) |
|
Depreciation and amortization expense |
|
|
(2,412 |
) |
|
|
(8,227 |
) |
|
|
(14,641 |
) |
|
|
(22,601 |
) |
|
Non-GAAP research and development expenses |
|
$ |
71,628 |
|
|
$ |
206,524 |
|
|
$ |
285,831 |
|
|
$ |
1,137,396 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|
||||
GAAP selling, general and administrative expenses |
|
$ |
118,612 |
|
|
$ |
91,893 |
|
|
$ |
335,163 |
|
|
$ |
363,419 |
|
|
Stock-based compensation expense |
|
|
(18,234 |
) |
|
|
(10,788 |
) |
|
|
(53,319 |
) |
|
|
(56,647 |
) |
|
Depreciation expense |
|
|
(2,770 |
) |
|
|
(3,994 |
) |
|
|
(10,136 |
) |
|
|
(9,170 |
) |
|
Non-GAAP selling, general and administrative expenses |
|
$ |
97,608 |
|
|
$ |
77,111 |
|
|
$ |
271,708 |
|
|
$ |
297,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|
||||
GAAP operating (loss) income |
|
$ |
(9,040 |
) |
|
$ |
(103,389 |
) |
|
$ |
362,684 |
|
|
$ |
(288,198 |
) |
|
Stock-based compensation expense |
|
|
26,743 |
|
|
|
14,927 |
|
|
|
80,614 |
|
|
|
93,380 |
|
|
Depreciation and amortization expense |
|
|
5,182 |
|
|
|
12,221 |
|
|
|
24,777 |
|
|
|
31,771 |
|
|
Restructuring charge |
|
|
— |
|
|
|
40,510 |
|
|
|
— |
|
|
|
40,510 |
|
|
Litigation settlement charge |
|
|
— |
|
|
|
— |
|
|
|
39,000 |
|
|
|
— |
|
|
Non-GAAP operating income (loss) |
|
$ |
22,885 |
|
|
$ |
(35,731 |
) |
|
$ |
507,075 |
|
|
$ |
(122,537 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|
||||
Total effective tax rate, GAAP1 |
|
|
(10.5 |
) |
% |
|
21.8 |
|
% |
|
5.7 |
|
% |
|
(2.3 |
) |
% |
Less: impact of GAAP to non-GAAP adjustments1 |
|
|
41.9 |
|
|
|
42.9 |
|
|
|
(0.5 |
) |
|
|
(2.6 |
) |
|
Total effective tax rate, Non-GAAP |
|
|
31.4 |
|
% |
|
64.7 |
|
% |
|
5.2 |
|
% |
|
(4.9 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
1 Total effective tax rate, GAAP and impact of GAAP to non-GAAP adjustments for the three and nine months ended September 30, 2025 have been revised to reflect the correction of an immaterial error associated with the accounting for the August 2025 Exchange, as well as the adoption of ASU 2025-07. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2025 for additional information. |
|
|
|||||||||||||||
19
Sarepta Therapeutics, Inc. |
|
|||||||
Condensed Consolidated Balance Sheets |
|
|||||||
(unaudited, in thousands, except share and per share amounts) |
|
|||||||
|
|
|
|
|
|
|
||
|
|
As of |
|
|
As of |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
472,760 |
|
|
$ |
801,282 |
|
Short-term investments |
|
|
406,016 |
|
|
|
138,368 |
|
Accounts receivable, net |
|
|
369,178 |
|
|
|
398,233 |
|
Inventory |
|
|
876,118 |
|
|
|
914,744 |
|
Manufacturing-related deposits and prepaids |
|
|
62,206 |
|
|
|
113,455 |
|
Other current assets |
|
|
86,611 |
|
|
|
171,856 |
|
Total current assets |
|
|
2,272,889 |
|
|
|
2,537,938 |
|
Property and equipment, net |
|
|
319,288 |
|
|
|
345,125 |
|
Right of use assets |
|
|
117,709 |
|
|
|
125,495 |
|
Non-current inventory |
|
|
200,579 |
|
|
|
184,543 |
|
Non-current investments |
|
|
108,815 |
|
|
|
1,048 |
|
Other non-current assets |
|
|
146,786 |
|
|
|
155,554 |
|
Total assets |
|
$ |
3,166,066 |
|
|
$ |
3,349,703 |
|
|
|
|
|
|
|
|
||
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
45,704 |
|
|
$ |
280,841 |
|
Accrued expenses |
|
|
321,764 |
|
|
|
359,659 |
|
Deferred revenue, current portion |
|
|
104,887 |
|
|
|
443,397 |
|
Current portion of long-term debt |
|
|
157,971 |
|
|
|
— |
|
Other current liabilities |
|
|
26,027 |
|
|
|
11,393 |
|
Total current liabilities |
|
|
656,353 |
|
|
|
1,095,290 |
|
Long-term debt |
|
|
699,393 |
|
|
|
828,974 |
|
Lease liabilities, net of current portion |
|
|
195,663 |
|
|
|
199,378 |
|
Deferred revenue, net of current portion |
|
|
83,910 |
|
|
|
83,910 |
|
Other non-current liabilities |
|
|
1,894 |
|
|
|
1,529 |
|
Total liabilities |
|
|
1,637,213 |
|
|
|
2,209,081 |
|
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock, $0.0001 par value, 3,333,333 shares authorized; none issued and |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 198,000,000 shares authorized; 107,888,367 and |
|
|
11 |
|
|
|
11 |
|
Treasury stock, at cost, 655,642 and 650,876 shares at September 30, 2026 and |
|
|
(25,013 |
) |
|
|
(25,263 |
) |
Additional paid-in capital |
|
|
6,134,817 |
|
|
|
6,042,586 |
|
Accumulated other comprehensive (loss) income, net of tax |
|
|
(1,586 |
) |
|
|
272 |
|
Accumulated deficit |
|
|
(4,579,376 |
) |
|
|
(4,876,984 |
) |
Total stockholders’ equity |
|
|
1,528,853 |
|
|
|
1,140,622 |
|
Total liabilities and stockholders’ equity |
|
$ |
3,166,066 |
|
|
$ |
3,349,703 |
|
20
Source: Sarepta Therapeutics, Inc.
Investor Contacts:
Ian Estepan, 617-274-4052, iestepan@sarepta.com
Ryan Wong, 617-800-4112, rwong@sarepta.com
Tam Thornton, 617-803-3825, tthornton@sarepta.com
Media Contacts:
Tracy Sorrentino, 617-301-8566, tsorrentino@sarepta.com
Kara Hoeger, 617-710-3898, khoeger@sarepta.com
21