Full Press Release Details
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2025.
“Following a tumultuous 2025, we entered 2026 from a position of strength, founded on: (a) solid financial footing with a robust and growing cash balance, substantial revenue, and no near-term debt overhang, (b) durable approved therapies that are bringing a better life to patients, with significant yet-tapped opportunity for ELEVIDYS gene therapy, and (c) an exciting, potentially best-in-class siRNA pipeline of advancing therapies for DM1, FSHD, Huntington’s disease, idiopathic pulmonary fibrosis, SCA1, SCA2 and SCA3,” said Doug Ingram, chief executive officer, Sarepta Therapeutics. “In 2025, we streamlined our operations, delivered strong revenue, and ended the year with nearly $1.0 billion in cash—as we anticipate remaining profitable and cash‑flow positive in 2026. ELEVIDYS has emerged from a challenging year with a clear label, traditional approval for ambulatory patients and a plan intended to put us on a potential pathway back to serving the non‑ambulatory community, and we are executing comprehensive plans designed to arm treating physicians and families with accurate and balanced information to unlock the full potential of this transformative and needed therapy. At the same time, our PMO exon-skipping therapies continue to demonstrate durable clinical value, exceptional safety, extraordinary real‑world outcomes, and unwavering support from families and physicians. Finally, with five clinical‑stage RNAi programs and multiple readouts ahead, we are poised for meaningful growth while advancing therapies that can profoundly change the lives of patients living with rare disease.”
Corporate Highlights:
Conference Call
The event will be webcast live under the investor relations section of Sarepta's website athttps://investorrelations.sarepta.com/events-presentationsand following the event a replay will be archived there for one year. This event can be accessed usingthis link.
Q4 2025 Financial Highlights1
| For the Three Months EndedDecember 31, | ||||||||||||||||
| 2025 | 2024 | QTD Change | ||||||||||||||
| (in millions, except for per share amounts) | $ | % | ||||||||||||||
| Total Revenues | $ | 442.9 | $ | 658.4 | (215.5 | ) | (33 | %) | ||||||||
| Operating (loss) income: | ||||||||||||||||
| GAAP | $ | (411.6 | ) | $ | 161.7 | (573.3 | ) | NM* | ||||||||
| Non-GAAP | $ | (369.9 | ) | $ | 221.2 | (591.2 | ) | NM* | ||||||||
| Net (loss) income2: | ||||||||||||||||
| GAAP | $ | (412.2 | ) | $ | 159.0 | (571.2 | ) | NM* | ||||||||
| Non-GAAP | $ | (375.4 | ) | $ | 207.0 | (582.4 | ) | NM* | ||||||||
| Diluted (loss) earnings per share2: | ||||||||||||||||
| GAAP | $ | (3.93 | ) | $ | 1.50 | (5.43 | ) | NM* | ||||||||
| Non-GAAP | $ | (3.58 | ) | $ | 1.91 | (5.49 | ) | NM* | ||||||||
| For the Twelve Months EndedDecember 31, | ||||||||||||||||
| 2025 | 2024 | YTD Change | ||||||||||||||
| (in millions, except for per share amounts) | $ | % | ||||||||||||||
| Total Revenues | $ | 2,198.2 | $ | 1,902.0 | 296.2 | 16 | % | |||||||||
| Operating (loss) income: | ||||||||||||||||
| GAAP | $ | (699.8 | ) | $ | 218.1 | (917.9 | ) | NM* | ||||||||
| Non-GAAP | $ | (492.5 | ) | $ | 437.7 | (930.2 | ) | NM* | ||||||||
| Net (loss) income2: | ||||||||||||||||
| GAAP | $ | (713.4 | ) | $ | 235.2 | (948.6 | ) | NM* | ||||||||
| Non-GAAP | $ | (505.6 | ) | $ | 400.7 | (906.3 | ) | NM* | ||||||||
| Diluted (loss) earnings per share2: | ||||||||||||||||
| GAAP | $ | (7.13 | ) | $ | 2.34 | (9.47 | ) | NM* | ||||||||
| Non-GAAP | $ | (5.05 | ) | $ | 3.71 | (8.76 | ) | NM* | ||||||||
| *NM: not meaningful | ||||||||||||||||
| [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 to the most comparable GAAP measures, see the tables at the end of this press release. | ||||||||||||||||
| [2]During the twelve months ended December 31, 2025, we identified and corrected an immaterial error that occurred in our unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2025, associated with the accounting for the August 2025 Exchange. During the three and nine months ended September 30, 2025, we recognized a loss on debt extinguishment of $138.6 million associated with the August 2025 Exchange. Upon further analysis during the fourth quarter of 2025, we determined that a gain on debt extinguishment of $3.8 million should have been recognized based on the fair value of the 2030 Notes at issuance. Correspondingly, the related interest expense recognized during the three and nine months ended September 30, 2025 should have been $1.9 million higher and the long-term debt balance should have been $140.5 million lower as of September 30, 2025. The correction of the errors results in a net decrease of $140.5 million to the previously reported net loss for both the three and nine months ended September 30, 2025. Accordingly, the previously reported basic and diluted net loss per share decreases by $1.40 and $1.43, respectively, for the three and nine months ended September 30, 2025. These immaterial errors have been corrected in the unaudited condensed consolidated financial statements for the twelve months ended December 31, 2025. |
| As ofDecember 31, 2025 | As ofDecember 31, 2024 | ||||||
| (in millions) | |||||||
| Cash, cash equivalents, restricted cash and investments | $ | 953.8 | $ | 1,503.5 |
RevenuesTotal revenueswere $442.9 million for the three months ended December 31, 2025, as compared to $658.4 million for the same period of 2024, a decrease of $215.5 million. The decrease primarily reflects $273.8 million less in net product revenue of ELEVIDYS as a result of lower volume following our decision to suspend shipments of ELEVIDYS to non-ambulatory patients in the U.S. in June 2025. In addition, collaboration and other revenues increased approximately $53.0 million primarily due to contract manufacturing revenues increasing $45.6 million driven by higher volume of shipments of ELEVIDYS to Roche.
Total revenues were $2,198.2 million for the twelve months ended December 31, 2025, as compared to $1,902.0 million for the same period of 2024, an increase of $296.2 million. The increase primarily reflects $77.9 million more in net product revenue of ELEVIDYS as a result of its expanded label approval in June 2024. In addition, collaboration and other revenues increased approximately $219.9 million primarily related to the $63.5 million of collaboration revenue recognized as a result of the regulatory approval in Japan and the $112.0 million of collaboration revenue recognized related to Roche's expiration of an option for a program during the twelve months ended December 31, 2025, as compared to $48.0 million of collaboration revenue recognized in the same period of 2024 related to Roche’s declined option to acquire certain ex-US rights to an external, early-stage Duchenne development program. Furthermore, contract manufacturing revenues and royalty revenues increased $75.0 million and $17.4 million, respectively, associated with an increase in commercial ELEVIDYS supply delivered to Roche as well as royalty revenue from sales of ELEVIDYS by Roche, respectively.
Cost of sales (excluding amortization of in-licensed rights)Cost of sales (excluding amortization of in-license rights)were $398.7 million for the three months ended December 31, 2025, as compared to $132.3 million for the same period of 2024, an increase of $266.4 million. The increase primarily reflects a $165.3 million increase in our inventory valuation reserve related to excess ELEVIDYS and PMO inventory on hand as of the end of 2025 as well as an increase in the write-offs of certain batches of our products not meeting our quality specifications, termination costs incurred in association with a side letter agreement entered into with a raw material manufacturer for our PMO Products in 2025 and an increase in products sold to Roche for the three months ended December 31, 2025, as compared to the same period of 2024.
Cost of sales (excluding amortization of in-license rights) were $839.6 million for the twelve months ended December 31, 2025, as compared to $319.1 million for the same period of 2024, an increase of $520.5 million. The increase primarily reflects the Q4 2025 quarter-to-date increases discussed above, as well as additional write-offs of certain batches of our products not meeting our quality specifications and an increased demand for ELEVIDYS following the expanded label approval in June 2024 for the twelve months ended December 31, 2025, as compared to the same period of 2024.
Operating expenses and othersResearch and development expenseswere $325.3 million for the three months ended December 31, 2025, as compared to $200.0 million for the same period of 2024, an increase of $125.3 million. The increase is primarily due to a $200.0 million increase in milestone expenses due to our milestone payment to Arrowhead related to the progression of the DM1 program, partially offset by a decrease in manufacturing expense related to our LGMD programs and a decrease in compensation, other personnel, and stock-based compensation expenses, all as a result of our restructuring plan announced in July 2025, with no similar activity for the three months ended December 31, 2024. For the three months ended December 31, 2025, non-GAAP research and development expenses were $308.1 million, as compared to $172.7 million for the same period of 2024, an increase of $135.4 million.
Research and development expenses were $1,522.1 million for the twelve months ended December 31, 2025, as compared to $804.5 million for the same period of 2024, an increase of approximately $717.6 million. The increase primarily reflects a $583.6 million increase in up-front expenses associated with the licensing and collaboration agreement and stock purchase agreement with Arrowhead, as well as the $300.0 million of milestone payments made to Arrowhead related to the progression of the DM1 program for the twelve months ended December 31, 2025. This increase is partially offset by a decrease in manufacturing expenses primarily due to the termination of the Thermo Agreement during the twelve months ended December 31, 2024, as well as a decrease in compensation, other personnel, and stock-based compensation expenses as a result of our restructuring plan announced during the twelve months ended December 31, 2025. For the twelve months ended December 31, 2025, non-GAAP research and development expenses were $1,445.5 million, as compared to $704.5 million for the same period of 2024, an increase of $741.0 million.
Selling, general and administrative expenseswere $128.3 million for the three months ended December 31, 2025, as compared to $163.9 million for the same period of 2024, a decrease of $35.6 million. The decreaseis primarily driven by lower compensation, other personnel, stock-based compensation, and commercial expenses as a result of our restructuring plan announced in July 2025, with no similar activity for the three months ended December 31, 2024. For the three months ended December 31, 2025, non-GAAP selling, general and administrative expenses were $105.4 million, as compared to $131.6 million for the same period of 2024, a decrease of $26.2 million.
Selling, general and administrative expenses were $491.7 million for the twelve months ended December 31, 2025, as compared to $557.9 million for the same period of 2024, a decrease of $66.2 million. The decrease is primarily driven by reduced headcount as a result of our restructuring plan announced in July 2025 for the twelve months ended December 31, 2025, and a net decrease in stock-based compensation primarily due to the reversal of previously recognized expense related to unvested awards as a result of our restructuring plan, partially offset by the fulfillment of remaining service conditions associated with certain PSUs in March 2025. For the twelve months ended December 31, 2025, non-GAAP selling, general and administrative expenses were $403.0 million, as compared to $438.3 million for the same period of 2024, a decrease of $35.3 million.
Restructuring chargeswere $1.5 million and $42.0 million for the three and twelve months ended December 31, 2025, respectively, with no similar activity for the same periods of 2024. These charges were primarily related to employee termination benefits, including severance, along with accelerated depreciation for assets impacted by our restructuring plan, announced in July 2025, that was designed to reduce operating expenses and align our cost structure with strategic priorities, aiming to enhance financial flexibility and meet our 2027 financial obligations.
Gain on debt extinguishmentwas $13.1 million and $16.9 million for the three and twelve months ended December 31, 2025, respectively, with no similar activity for the same periods of 2024. The gain on debt extinguishment is a result of two partial refinancings of the 2027 Notes through privately negotiated exchange transactions. In August 2025, we exchanged $700.0 million in aggregate principal amount of the 2027 Notes for (1) $602.0 million in aggregate principal amount of new 2030 Notes, net of issuance costs of $13.4 million, (2) cash payments of $127.3 million, including $4.0 million of accrued interests of the 2027 Notes, and (3) the issuance of 5.9 million shares of our common stock with fair market value of approximately $104.9 million, net of issuance costs of $2.4 million (collectively, the "August 2025 Exchange"). In December 2025, we exchanged $291.4 million in aggregate principal amount of 2027 Notes for (1) $291.4 million in aggregate principal amount of the 2030 Notes, net of issuance costs of $4.0 million and (2) cash payments of $31.6 million, including $1.0 million of accrued interests of the 2027 Notes.
Other (expense) income, netfor the three months ended December 31, 2025 and 2024, was $(9.2) million and $10.1 million, respectively. The change primarily reflects an increase in interest expense primarily due to a higher interest rate for the 2030 Notes as compared to the 2027 Notes that were exchanged, as well as a decrease in interest income due to lower interest rates and the investment mix of our investment portfolio during the three months ended December 31, 2025. Other (expense) income, net for the twelve months ended December 31, 2025 and 2024, was $(19.3) million and $42.7 million, respectively. The change primarily reflects the decrease in interest income due to lower interest rates and the investment mix of our investment portfolio as well as an increase in the loss on our strategic investments in publicly traded companies, including Arrowhead, during the twelve months ended December 31, 2025.
Income tax expensefor the three months ended December 31, 2025 and 2024, was $4.6 million and $12.7 million, respectively. Income tax expense for the twelve months ended December 31, 2025 and 2024, was $11.2 million and $25.5 million, respectively. Income tax expense for the three and twelve months ended December 31, 2025, and December 31, 2024, primarily relates to state, federal and foreign income taxes for which available tax losses or credits were not available to offset.
Use of Non-GAAP MeasuresIn addition to the GAAP financial measures set forth in this press release, we have included the following non-GAAP measurements:
The following components are used to adjust our GAAP financial measures into the previously defined non-GAAP measurements: