Sarepta Therapeutics(US:SRPT)2023-08-02 20:02markdown [PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This section presents Sarepta Therapeutics' unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Sarepta Therapeutics' unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, collaboration agreements, fair value measurements, and commitments [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%E2%80%94%20As%20of%20June%2030%2C%202023%20and%20December%2031%2C%202022) This section details the company's financial position, including assets, liabilities, and stockholders' equity | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Total Assets | $3,125,890 | $3,128,366 | | Total Liabilities | $2,384,479 | $2,743,416 | | Total Stockholders' Equity | $741,411 | $384,950 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20%E2%80%94%20For%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) This section presents the company's financial performance, including revenues, expenses, and net loss over specific periods | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Total Revenues | $261,238 | $233,487 | $514,738 | $444,317 | | Operating Loss | $(133,519) | $(211,132) | $(271,607) | $(298,013) | | Gain from sale of Priority Review Voucher | $102,000 | — | $102,000 | — | | Loss on debt extinguishment | — | — | $(387,329) | — | | Net Loss | $(23,940) | $(231,481) | $(540,695) | $(336,506) | | Net Loss per Share - basic and diluted | $(0.27) | $(2.65) | $(6.11) | $(3.85) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20%E2%80%94%20For%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) This section outlines changes in the company's equity, reflecting transactions with owners and comprehensive loss | Metric | December 31, 2022 (in thousands) | June 30, 2023 (in thousands) | | :------------------------------------------ | :------------------------------- | :----------------------------- | | Total Stockholders' Equity | $384,950 | $741,411 | | Issuance of common stock for exchange of 2024 Notes | — | $693,377 | | Partial settlement of capped call share options for 2024 Notes | — | $80,645 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%E2%80%94%20For%20the%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) This section details the company's cash inflows and outflows from operating, investing, and financing activities | Cash Flow Activity | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(331,630) | $(167,990) | | Net cash provided by (used in) investing activities | $109,126 | $(1,075,798) | | Net cash provided by financing activities | $107,656 | $5,329 | | Decrease in cash, cash equivalents and restricted cash | $(114,848) | $(1,238,459) | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Organization and Nature of Business](index=7&type=section&id=1.%20ORGANIZATION%20AND%20NATURE%20OF%20BUSINESS) This note describes Sarepta Therapeutics' corporate structure, business focus, and therapeutic areas of operation - **Sarepta Therapeutics** is a commercial-stage biopharmaceutical company focused on discovering and developing **RNA-targeted therapeutics**, **gene therapy**, and other genetic therapeutic modalities for rare diseases, including **Duchenne muscular dystrophy (Duchenne)**, Limb-girdle muscular dystrophies (LGMDs), and other neuromuscular and central nervous system (CNS) disorders[16](index=16&type=chunk) - The company has **four FDA-approved products** for Duchenne: **EXONDYS 51**, **VYONDYS 53**, **AMONDYS 45**, and **ELEVIDYS**, with **ELEVIDYS** receiving accelerated approval on **June 22, 2023**[17](index=17&type=chunk) | Metric | Amount (as of June 30, 2023, in millions) | | :-------------------------- | :--------------------------------------- | | Cash and cash equivalents | $851.9 | | Short-term investments | $1,008.8 | | Long-term restricted cash | $19.0 | | Total Cash, Cash Equivalents, Restricted Cash and Investments | $1,879.7 | [2. Summary of Significant Accounting Policies](index=7&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the key accounting principles and methods used in preparing the condensed consolidated financial statements - The unaudited condensed consolidated financial statements are prepared in accordance with **U.S. GAAP** and reflect Sarepta and its wholly-owned subsidiaries, operating in one segment focused on rare disease therapies[19](index=19&type=chunk) - No material changes to accounting policies occurred through **June 30, 2023**, except for the removal of stock-based compensation as a critical accounting policy as of **January 1, 2023**[25](index=25&type=chunk)[101](index=101&type=chunk) - The company's cash is concentrated at **three financial institutions**, but management does not believe there is significant credit risk[22](index=22&type=chunk)[23](index=23&type=chunk) [3. License and Collaboration Agreements](index=8&type=section&id=3.%20LICENSE%20AND%20COLLABORATION%20AGREEMENTS) This note details the financial implications and terms of the company's various licensing and collaboration agreements | Metric | Three Months Ended June 30, 2023 (in millions) | Six Months Ended June 30, 2023 (in millions) | | :------------------- | :--------------------------------------------- | :-------------------------------------------- | | Collaboration Revenue | $22.3 | $44.3 | | Costs Reimbursable by Roche | $28.2 | $48.5 | - As of **June 30, 2023**, total deferred revenue associated with the **Roche Agreement** was **$530.0 million**, with **$485.0 million** related to separate material rights for ex-U.S. Duchenne-specific programs[26](index=26&type=chunk) - Upon FDA approval of **ELEVIDYS** in **June 2023**, the company recorded a **$10.0 million** milestone payment to **Nationwide Children's Hospital** as an in-licensed right intangible asset[28](index=28&type=chunk) - The company may be obligated to make up to **$3.2 billion** in future development, regulatory, commercial, and up-front royalty payments associated with its collaboration and license agreements[30](index=30&type=chunk) [4. Gain from Sale of Priority Review Voucher](index=9&type=section&id=4.%20GAIN%20FROM%20SALE%20OF%20PRIORITY%20REVIEW%20VOUCHER) This note explains the recognition of income from the sale of a Priority Review Voucher during the reporting period - In **June 2023**, Sarepta sold the **ELEVIDYS Priority Review Voucher (PRV)** for **$102.0 million**, which was recorded as a gain from sale as it had no carrying value[31](index=31&type=chunk) [5. Fair Value Measurements](index=9&type=section&id=5.%20FAIR%20VALUE%20MEASUREMENTS) This note provides information on the fair value of financial assets and liabilities, categorized by valuation inputs | Asset/Liability | Fair Value as of June 30, 2023 (in thousands) | Fair Value as of December 31, 2022 (in thousands) | | :-------------------------- | :-------------------------------------------- | :---------------------------------------------- | | Total Assets at Fair Value | $1,494,429 | $1,686,269 | | Money market funds (Level 1) | $404,863 | $467,553 | | Commercial paper (Level 2) | $169,866 | $211,369 | | Government and agency bonds (Level 2) | $859,532 | $807,540 | | Corporate bonds (Level 2) | $21,207 | $125,741 | | Strategic investments (Level 3) | $31,000 | $31,000 | | Certificates of deposit (Level 2) | $7,961 | $42,745 | | Contingent consideration (Level 3 Liability) | $36,100 | $36,900 | - A decrease of **$0.8 million** was recorded during the **three and six months ended June 30, 2023**, for the change in fair value of contingent consideration liabilities, due to the termination of a license agreement[38](index=38&type=chunk) [6. Cash, Cash Equivalents and Marketable Securities](index=11&type=section&id=6.%20CASH%2C%20CASH%20EQUIVALENTS%20AND%20MARKETABLE%20SECURITIES) This note details the composition and management of the company's liquid assets and investment portfolio | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :------------------------------------ | :----------------------------- | :------------------------------- | | Total Cash, Cash Equivalents and Investments | $1,860,715 | $1,989,374 | | Cash and cash equivalents | $851,929 | $966,777 | | Short-term investments | $1,008,786 | $1,022,597 | - The weighted average maturity of the company's available-for-sale securities was approximately **four months** as of both **June 30, 2023**, and **December 31, 2022**[40](index=40&type=chunk) - The company's policy is to mitigate credit risk by maintaining a well-diversified portfolio that limits exposure to maturity and investment type[40](index=40&type=chunk) [7. Product Revenues, Net, Accounts Receivable and Reserves for Product Revenues](index=12&type=section&id=7.%20PRODUCT%20REVENUES%2C%20NET%2C%20ACCOUNTS%20RECEIVABLE%20AND%20RESERVES%20FOR%20PRODUCT%20REVENUES) This note breaks down product sales, related receivables, and provisions for discounts and allowances | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :---------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Products, net | $238,988 | $211,237 | $470,483 | $400,062 | | EXONDYS 51 | $134,688 | $126,377 | $267,259 | $243,510 | | AMONDYS 45 | $71,653 | $54,676 | $137,565 | $98,290 | | VYONDYS 53 | $32,647 | $30,184 | $65,659 | $58,262 | | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :------------------------------------ | :----------------------------- | :------------------------------- | | Accounts receivable | $236,808 | $214,628 | | Total reserves for discounts and allowances | $113,998 | $94,698 | - **Three individual customers** accounted for **47%**, **33%**, and **7%** of product revenues, net, for the three months ended **June 30, 2023**, and **35%**, **34%**, and **12%** of accounts receivable from product sales as of **June 30, 2023**[42](index=42&type=chunk)[43](index=43&type=chunk) [8. Inventory](index=13&type=section&id=8.%20INVENTORY) This note provides a detailed breakdown of the company's inventory components and their valuation | Inventory Component | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :------------------ | :----------------------------- | :------------------------------- | | Raw materials | $102,838 | $59,181 | | Work in progress | $243,061 | $269,185 | | Finished goods | $47,612 | $38,147 | | Total inventory | $393,511 | $366,513 | | Non-current inventory | $166,635 | $162,545 | [9. Other Assets](index=13&type=section&id=9.%20OTHER%20ASSETS) This note describes the various current and non-current assets not categorized elsewhere on the balance sheet | Other Current Assets | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Manufacturing-related deposits and prepaids | $79,007 | $66,455 | | Collaboration receivable | $28,635 | $41,758 | | Total other current assets | $148,215 | $149,891 | | Other Non-Current Assets | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :------------------------- | :----------------------------- | :------------------------------- | | Manufacturing-related deposits and prepaids | $83,479 | $97,409 | | Strategic investments | $31,000 | $31,321 | | Restricted cash | $19,024 | $19,024 | | Intangible assets, net | $18,018 | $7,578 | | Total other non-current assets | $163,039 | $162,969 | [10. Accrued Expenses](index=14&type=section&id=10.%20ACCURRED%20EXPENSES) This note details the company's short-term liabilities for expenses incurred but not yet paid | Accrued Expense Category | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :------------------------- | :----------------------------- | :------------------------------- | | Accrued contract manufacturing costs | $82,734 | $202,173 | | Product revenue related reserves | $80,424 | $68,784 | | Accrued employee compensation costs | $44,906 | $65,946 | | Total accrued expenses | $326,877 | $418,996 | [11. Indebtedness](index=14&type=section&id=11.%20INDEBTEDNESS) This note outlines the company's debt obligations, including convertible notes and their carrying and fair values | Debt Facility | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :------------------------------------ | :----------------------------- | :------------------------------- | | Principal amount of the 2024 Notes | $105,847 | $419,371 | | Principal amount of the 2027 Notes | $1,150,000 | $1,150,000 | | Total carrying value of debt facilities | $1,235,517 | $1,544,292 | | Fair value of 2024 Notes | $202,287 | $765,046 | | Fair value of 2027 Notes | $1,247,693 | $1,308,482 | - In **March 2023**, the company exchanged **$313.5 million** in aggregate principal value of **2024 Notes** for approximately **4.5 million shares** of common stock, resulting in a **$387.3 million loss on debt extinguishment**[51](index=51&type=chunk)[52](index=52&type=chunk) - The exchange also led to the termination of a portion of **2017 Capped Calls**, generating approximately **$80.6 million in cash**[53](index=53&type=chunk) [12. Stock-Based Compensation](index=15&type=section&id=12.%20STOCK-BASED%20COMPENSATION) This note explains the accounting for equity-settled compensation plans and their impact on expenses | Expense Category | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Total stock-based compensation expense | $47,377 | $102,892 | $88,627 | $132,090 | | Research and development | $21,577 | $14,467 | $37,990 | $27,535 | | Selling, general and administrative | $25,800 | $88,425 | $50,637 | $104,555 | - The decrease in **stock-based compensation expense** for both periods was primarily due to the **Chief Executive Officer grant modification agreement executed in 2022**[123](index=123&type=chunk)[124](index=124&type=chunk) - In **June 2023**, **$7.4 million** of **stock-based compensation expense** was recognized for **394,975 performance-conditioned restricted stock units (PSUs)** due to the **regulatory approval of ELEVIDYS**[58](index=58&type=chunk) [13. Other Income (Loss), Net](index=18&type=section&id=13.%20OTHER%20INCOME%20(LOSS)%2C%20NET) This note details non-operating income and expenses, including interest, investment gains, and debt extinguishment losses | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Accretion of investment discount, net | $12,786 | $1,331 | $22,825 | $1,373 | | Interest income | $8,418 | $2,409 | $17,694 | $2,582 | | Interest expense | $(5,224) | $(16,028) | $(11,547) | $(31,824) | | Gain from sale of Priority Review Voucher | $102,000 | — | $102,000 | — | | Loss on debt extinguishment | — | — | $(387,329) | — | | Total other income (loss), net | $118,934 | $(16,961) | $(255,688) | $(34,226) | [14. Leases](index=18&type=section&id=14.%20LEASES) This note describes the company's lease arrangements, including right-of-use assets and lease liabilities - The **Bedford Lease** commenced in **May 2023**, resulting in the recording of a **$76.5 million lease liability** and a **$72.0 million right-of-use asset** on the balance sheet as of **June 30, 2023**[70](index=70&type=chunk) - The initial gross ROU assets and lease liabilities for the **Bedford Lease** were based on a discount rate of **9.5%** over a remaining lease term of **15.5 years**[71](index=71&type=chunk) [15. Net Loss Per Share](index=19&type=section&id=15.%20NET%20LOSS%20PER%20SHARE) This note presents the calculation of basic and diluted net loss per share for the reporting periods | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss per share - basic and diluted | $(0.27) | $(2.65) | $(6.11) | $(3.85) | | Weighted-average common shares outstanding - basic and diluted | 88,743 | 87,511 | 88,466 | 87,383 | - **Stock options, RSUs, employee stock purchase plan, and potential conversion of 2027 and 2024 Notes** were excluded from diluted net loss per share calculation as their effect would have been anti-dilutive[73](index=73&type=chunk) [16. Commitments and Contingencies](index=19&type=section&id=16.%20COMMITMENTS%20AND%20CONTINGENCIES) This note discloses the company's contractual obligations, legal proceedings, and potential future liabilities | Commitment Type | Total as of June 30, 2023 (in thousands) | Due in July-December 2023 (in thousands) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | | Total manufacturing commitments | $1,281,753 | $489,561 | - The **Thermo Agreement** was amended in **March 2023**, removing a **$54.7 million annual minimum batch purchase commitment** and implementing a fee of up to **$60.0 million**, with the second and third installments potentially waived if purchase thresholds are met[76](index=76&type=chunk)[77](index=77&type=chunk) - The company may be obligated to make up to **$3.2 billion** in future development, regulatory, commercial, and up-front royalty payments associated with its license and collaboration agreements, which are not yet recorded as liabilities[137](index=137&type=chunk) - Sarepta is involved in several patent infringement lawsuits, including two with **REGENXBIO INC.** and the **Trustees of the University of Pennsylvania** regarding **AAV gene therapy (ELEVIDYS)**, and one with **Nippon Shinyaku Co., Ltd.** concerning **exon 53 skipping technology (VYONDYS 53)**[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Sarepta's financial performance, liquidity, and capital resources for the three and six months ended June 30, 2023, compared to the prior year. It covers revenue drivers, expense changes, and the company's outlook on funding future operations and development [Overview](index=23&type=section&id=Overview) This section provides a high-level summary of Sarepta's business, product pipeline, manufacturing strategy, and financial position - **Sarepta** is a commercial-stage biopharmaceutical company focused on **RNA-targeted therapeutics** and **gene therapy** for rare diseases, with **four FDA-approved products** for **Duchenne muscular dystrophy** and a pipeline of **over 40 programs**[89](index=89&type=chunk)[91](index=91&type=chunk)[93](index=93&type=chunk) - Key pipeline updates include anticipated top-line results from **Part B of Study 5051-201** in the **second half of 2023**, a planned meeting with the FDA in **2023** for **SRP-9003**, and top-line results from **Study 301 for ELEVIDYS label expansion in Q4 2023**[90](index=90&type=chunk)[92](index=92&type=chunk) - The company employs a hybrid manufacturing strategy, combining internal expertise with partnerships (**Thermo, Catalent, Aldevron**) to support clinical and commercial demand for gene therapy programs[94](index=94&type=chunk)[97](index=97&type=chunk) - As of **June 30, 2023**, **Sarepta** had approximately **$1,879.7 million** in cash, cash equivalents, restricted cash, and investments, which management believes is sufficient to fund its current operational plan for **at least the next twelve months**[99](index=99&type=chunk) [Results of Operations for the Three and Six Months Ended June 30, 2023 and 2022](index=26&type=section&id=Results%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) This section analyzes the company's financial performance, comparing revenues and expenses across reporting periods | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Change ($) | Change (%) | | :------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | :--------- | :--------- | | Total Revenues | $261,238 | $233,487 | $27,751 | 12 % | | Operating Loss | $(133,519) | $(211,132) | $77,613 | 37 % | | Net Loss | $(23,940) | $(231,481) | $207,541 | 90 % | | Net Loss per Share - basic and diluted | $(0.27) | $(2.65) | $2.38 | (90)% | | Metric | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | Change ($) | Change (%) | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | :--------- | :--------- | | Total Revenues | $514,738 | $444,317 | $70,421 | 16 % | | Operating Loss | $(271,607) | $(298,013) | $26,406 | 9 % | | Net Loss | $(540,695) | $(336,506) | $(204,189) | (61)% | | Net Loss per Share - basic and diluted | $(6.11) | $(3.85) | $(2.26) | (59)% | - The **three-month net loss significantly decreased** due to a **$102.0 million gain from the sale of a Priority Review Voucher** and **improved operating loss**, while the **six-month net loss increased** due to a **$387.3 million loss on debt extinguishment**[103](index=103&type=chunk) [Revenues](index=28&type=section&id=Revenues) This section details the sources and changes in the company's total revenue, including product and collaboration revenues | Product | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Change (%) | | :---------- | :---------------------------------------------- | :---------------------------------------------- | :--------- | | EXONDYS 51 | $134,688 | $126,377 | 7 % | | AMONDYS 45 | $71,653 | $54,676 | 31 % | | VYONDYS 53 | $32,647 | $30,184 | 8 % | | Products, net | $238,988 | $211,237 | 13 % | | Product | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | Change (%) | | :---------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | | EXONDYS 51 | $267,259 | $243,510 | 10 % | | AMONDYS 45 | $137,565 | $98,290 | 40 % | | VYONDYS 53 | $65,659 | $58,262 | 13 % | | Products, net | $470,483 | $400,062 | 18 % | - Collaboration revenue from the **Roche agreement** remained consistent at **$22.3 million** for the three months and **$44.3 million** for the six months ended **June 30, 2023** and **2022**[107](index=107&type=chunk) [Cost of sales (excluding amortization of in-licensed rights)](index=28&type=section&id=Cost%20of%20sales%20(excluding%20amortization%20of%20in-licensed%20rights)) This section analyzes the direct costs associated with product sales, excluding amortization of intangible assets | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Change (%) | | :------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | :--------- | | Inventory costs related to products sold | $25,541 | $23,050 | 11 % | | Royalty payments | $8,583 | $14,745 | (42)% | | Total cost of sales (excluding amortization) | $34,124 | $37,795 | (10)% | | Metric | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | Change (%) | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | :--------- | | Inventory costs related to products sold | $52,175 | $41,513 | 26 % | | Royalty payments | $16,966 | $27,725 | (39)% | | Total cost of sales (excluding amortization) | $69,141 | $69,238 | (—)% | - The **decrease in royalty payments** was primarily due to changes in **BioMarin royalty terms**[111](index=111&type=chunk)[112](index=112&type=chunk) [Research and development expenses](index=30&type=section&id=Research%20and%20development%20expenses) This section details the costs incurred for discovering, developing, and testing new product candidates | Expense Category | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Change (%) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :--------- | | Manufacturing expenses | $98,999 | $150,279 | (34)% | | Compensation and other personnel expenses | $45,132 | $34,450 | 31 % | | Clinical trial expenses | $42,508 | $28,817 | 48 % | | Stock-based compensation | $21,577 | $14,467 | 49 % | | Total research and development expenses | $241,890 | $252,329 | (4)% | | Expense Category | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | | Manufacturing expenses | $210,920 | $246,568 | (14)% | | Compensation and other personnel expenses | $91,318 | $66,646 | 37 % | | Clinical trial expenses | $83,400 | $59,255 | 41 % | | Stock-based compensation | $37,990 | $27,535 | 38 % | | Total research and development expenses | $487,569 | $446,579 | 9 % | - The **decrease in manufacturing expenses** for both periods was primarily due to **prior year shortfall payment accruals and termination charges**, partially offset by a **ramp-up of SRP-9001 manufacturing**[117](index=117&type=chunk)[120](index=120&type=chunk) [Selling, general and administrative expenses](index=32&type=section&id=Selling%2C%20general%20and%20administrative%20expenses) This section outlines the costs related to marketing, sales, and overall corporate management | Expense Category | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Change (%) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :--------- | | Stock-based compensation | $25,800 | $88,425 | (71)% | | Professional services | $37,797 | $25,772 | 47 % | | Compensation and other personnel expenses | $38,329 | $28,622 | 34 % | | Total selling, general and administrative expenses | $118,564 | $154,316 | (23)% | | Expense Category | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | | Stock-based compensation | $50,637 | $104,555 | (52)% | | Professional services | $72,888 | $43,066 | 69 % | | Compensation and other personnel expenses | $76,796 | $56,075 | 37 % | | Total selling, general and administrative expenses | $229,278 | $226,156 | 1 % | - The **significant decrease in stock-based compensation** was primarily related to the **Chief Executive Officer grant modification agreement executed in 2022**[123](index=123&type=chunk)[124](index=124&type=chunk) [Amortization of in-licensed rights](index=34&type=section&id=Amortization%20of%20in-licensed%20rights) This section details the expense recognized for the amortization of intangible assets acquired through licensing agreements - Amortization of in-licensed rights remained consistent at approximately **$0.2 million** for the three months and **$0.4 million** for the six months ended **June 30, 2023** and **2022**[125](index=125&type=chunk) [Gain from sale of Priority Review Voucher](index=34&type=section&id=Gain%20from%20sale%20of%20Priority%20Review%20Voucher) This section explains the non-operating income recognized from the sale of a Priority Review Voucher - A gain of **$102.0 million** was recognized in **June 2023** from the sale of the **ELEVIDYS Priority Review Voucher**, as it had no carrying value[126](index=126&type=chunk) [Loss on debt extinguishment](index=34&type=section&id=Loss%20on%20debt%20extinguishment) This section details the financial impact of extinguishing debt obligations during the reporting period - A loss of **$387.3 million** was incurred for the six months ended **June 30, 2023**, due to the exchange of **$313.5 million of 2024 Convertible Notes** for common stock[127](index=127&type=chunk) [Other income (expense), net](index=34&type=section&id=Other%20income%20(expense)%2C%20net) This section summarizes non-operating income and expenses, including interest and investment-related items | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :-------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Other income (expense), net | $16,934 | $(16,961) | $29,641 | $(34,226) | - The change was primarily driven by **increases in accretion of investment discount and interest income**, and a **reduction of interest expense** due to the **repayment of the December 2019 Term Loan in 2022**[129](index=129&type=chunk) [Income tax expense](index=34&type=section&id=Income%20tax%20expense) This section details the company's provision for income taxes, including federal, state, and foreign components | Metric | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :---------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Income tax expense | $9,355 | $3,388 | $13,400 | $4,267 | - **Income tax expense** for **2023** includes **state, foreign, and federal income taxes**, while **2022** only included **state and foreign income taxes**[130](index=130&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to generate and manage cash, fund operations, and meet financial obligations | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | Change ($) | Change (%) | | :------------------------------------ | :----------------------------- | :------------------------------- | :--------- | :--------- | | Total cash, cash equivalents and investments | $1,879,739 | $2,008,398 | $(128,659) | (6)% | | Total borrowings | $1,235,517 | $1,544,292 | $(308,775) | (20)% | | Total working capital | $1,973,960 | $1,938,257 | $35,703 | 2 % | - The company believes its current cash flows from operating activities and cash on hand are adequate to fund short-term financing needs and working capital requirements for **at least twelve months**[132](index=132&type=chunk) - Future cash requirements will depend on the advancement of R&D and commercialization of product candidates, with potential needs for additional financing through equity, debt, licensing, or collaborations[133](index=133&type=chunk) | Obligation Type | Total Obligations as of June 30, 2023 (in millions) | Due in less than one year (in millions) | Due in greater than one year (in millions) | | :---------------------- | :------------------------------------------ | :-------------------------------------- | :--------------------------------------- | | Debt | $1,300.0 | $15.9 | $1,307.0 | | Lease | $363.3 | $20.0 | $343.3 | | Manufacturing | $1,300.0 | $824.0 | $457.8 | [Operating Activities](index=36&type=section&id=Operating%20Activities) This section details cash flows generated from or used in the company's primary business operations | Metric | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | Change ($) | Change (%) | | :-------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | :--------- | | Cash used in operating activities | $(331,630) | $(167,990) | $(163,640) | 97 % | - **Cash used in operating activities** for the six months ended **June 30, 2023**, was primarily driven by a **net loss of $540.7 million**, adjusted for non-cash items like a **$387.3 million loss on debt extinguishment** and **$88.6 million in stock-based compensation**, partially offset by a **$102.0 million gain from the sale of the ELEVIDYS PRV**[139](index=139&type=chunk) - Net cash outflow from changes in operating assets and liabilities was driven by a **$93.7 million decrease in accounts payable/accrued expenses**, a **$44.3 million decrease in deferred revenue**, a **$27.0 million increase in inventory**, and a **$22.2 million increase in accounts receivable**[140](index=140&type=chunk) [Investing Activities](index=37&type=section&id=Investing%20Activities) This section outlines cash flows related to the purchase and sale of long-term assets and investments | Metric | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | Change ($) | Change (%) | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | :--------- | :--------- | | Cash provided by (used in) investing activities | $109,126 | $(1,075,798) | $1,184,924 | (110)% | - **Cash provided by investing activities** in **2023** primarily consisted of **$102.0 million from the sale of the ELEVIDYS PRV** and **$864.5 million from the maturity and sale of available-for-sale securities**, partially offset by **$829.8 million in purchases of available-for-sale securities**[142](index=142&type=chunk) [Financing Activities](index=37&type=section&id=Financing%20Activities) This section describes cash flows from debt, equity, and other financing transactions | Metric | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | Change ($) | Change (%) | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | :--------- | :--------- | | Cash provided by financing activities | $107,656 | $5,329 | $102,327 | NM* | - **Cash provided by financing activities** in **2023** was driven by **$80.6 million from the partial settlement of capped call share options for 2024 Notes** and **$33.9 million from stock option exercises and the Employee Stock Purchase Program**[144](index=144&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Sarepta's investment strategy focuses on a diversified portfolio of short-term, high-grade financial instruments to mitigate credit risk. The company assesses its exposure to interest rate fluctuations, estimating a minimal impact from hypothetical market movements - The company maintains a diversified investment portfolio consisting of money market investments, commercial paper, certificates of deposit, government and government agency bonds, and high-grade corporate bonds with maturities of **36 months or less**[146](index=146&type=chunk) | Metric | Amount (as of June 30, 2023, in millions) | | :------------------------------------------ | :--------------------------------------- | | Cash, cash equivalents, restricted cash and investments | $1,879.7 | - A hypothetical **10 basis point adverse movement** across all maturities would result in an estimated hypothetical loss in fair value of approximately **$0.3 million** to the company's interest rate sensitive instruments[146](index=146&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that Sarepta's disclosure controls and procedures were effective as of June 30, 2023. No material changes in internal control over financial reporting occurred during the quarter - Management, including the **principal executive officer and principal financial officer**, concluded that the company's disclosure controls and procedures were effective as of **June 30, 2023**[147](index=147&type=chunk) - There were no changes in internal control over financial reporting during the quarterly period ended **June 30, 2023**, that materially affected or are reasonably likely to materially affect internal control over financial reporting[148](index=148&type=chunk) [PART II — OTHER INFORMATION](index=39&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 16, Commitments and Contingencies, for details on material legal proceedings affecting Sarepta Therapeutics - Material legal proceedings are discussed in **Note 16, Commitments and Contingencies**, to the unaudited condensed consolidated financial statements[151](index=151&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section details various risks and uncertainties that could materially impact Sarepta's business, financial condition, and results of operations. These risks span commercial success, product development, reliance on third parties, manufacturing, intellectual property, business operations, financial health, common stock performance, and convertible senior notes [Risks Related to Our Business](index=39&type=section&id=Risks%20Related%20to%20Our%20Business) This section outlines risks associated with commercial success, regulatory approvals, market adoption, and intellectual property for existing products - **Sarepta** is highly dependent on the commercial success of its **FDA-approved products** (**EXONDYS 51, VYONDYS 53, AMONDYS 45, and ELEVIDYS**) in the U.S., facing risks from sales, marketing, and reimbursement challenges[153](index=153&type=chunk)[154](index=154&type=chunk) - Continued approval of products under the **accelerated pathway** is contingent upon verification of clinical benefit in confirmatory trials, and failure to meet post-approval commitments could lead to regulatory action or withdrawal[157](index=157&type=chunk) - Uncertainty regarding reimbursement policies from governmental authorities and private health insurers could hinder or prevent commercial success, potentially requiring discounts or rebates[159](index=159&type=chunk) - The commercial success of products depends on market adoption by patients, payors, and healthcare providers, which can be influenced by efficacy, safety, reimbursement, and distribution networks[171](index=171&type=chunk) - **Orphan drug exclusivity** is crucial for eligible products, but it may be challenged, invalidated, or rescinded under certain conditions, potentially impacting competitive position[185](index=185&type=chunk)[186](index=186&type=chunk) [Risks Related to the Development of our Product Candidates](index=46&type=section&id=Risks%20Related%20to%20the%20Development%20of%20our%20Product%20Candidates) This section details risks inherent in clinical trials, regulatory approvals, and potential side effects of pipeline products - Difficulties in identifying, recruiting, and enrolling sufficient eligible patients for clinical trials could delay or prevent the advancement of product candidates, increasing costs and impacting development timelines[204](index=204&type=chunk)[205](index=205&type=chunk) - Clinical development is lengthy, expensive, and uncertain, especially for novel gene therapy candidates, with early-stage results not always predictive of success in later, larger trials[213](index=213&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) - Product candidates may cause undesirable side effects, which could lead to clinical holds (e.g., **hypomagnesemia** in **Study 5051-201**), delays, or termination of development programs[217](index=217&type=chunk) - Obtaining and maintaining regulatory approvals is a lengthy, expensive, and uncertain process, particularly for orphan diseases and new technologies, with risks of delays, rejections, or limited indications[218](index=218&type=chunk)[219](index=219&type=chunk) - **Fast track, breakthrough therapy, RMAT, or PRIME designations** do not guarantee faster development, review, or approval, nor do they increase the likelihood of marketing approval[231](index=231&type=chunk)[233](index=233&type=chunk) [Risks Related to Third Parties](index=56&type=section&id=Risks%20Related%20to%20Third%20Parties) This section covers risks arising from reliance on external partners for distribution, research, and clinical development - **Sarepta** relies on third parties for commercial distribution of its products in the U.S. and through **Early Access Programs (EAPs)** outside the U.S., and inadequate performance or loss of these partners could adversely affect sales and operations[235](index=235&type=chunk)[236](index=236&type=chunk)[239](index=239&type=chunk) - The company also depends on third-party collaborators and **Contract Research Organizations (CROs)** for early-stage research and clinical development, and their inadequate performance or failure to commit sufficient resources could delay or terminate programs[241](index=241&type=chunk)[242](index=242&type=chunk) - Reliance on third parties necessitates sharing proprietary information, increasing the risk of discovery by competitors or misappropriation, which could jeopardize intellectual property rights[244](index=244&type=chunk)[245](index=245&type=chunk) [Risks Related to Manufacturing](index=58&type=section&id=Risks%20Related%20to%20Manufacturing) This section addresses risks associated with the production of products, including supply chain, quality control, and regulatory compliance - **Sarepta** relies on a limited number of third-party manufacturers for materials, APIs, and drug products, creating risks of supply interruptions, quality control issues, and delays in commercialization or development[247](index=247&type=chunk)[248](index=248&type=chunk) - Manufacturing gene therapies is novel and complex, posing risks of production problems, facility contamination, raw material shortages, and lot failures, which could delay clinical trials or product launches[254](index=254&type=chunk)[255](index=255&type=chunk) - Contract manufacturers must comply with **cGMP regulations**, and any failure to adhere to these standards could result in product recalls, clinical holds, delayed approvals, and significant negative consequences[261](index=261&type=chunk)[263](index=263&type=chunk)[264](index=264&type=chunk) - Challenges in optimizing manufacturing capacity and processes, including validating methods and demonstrating comparability, could negatively impact commercial availability and product development[265](index=265&type=chunk)[266](index=266&type=chunk) [Risks Related to our Intellectual Property](index=61&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) This section outlines risks concerning patent protection, infringement claims, and the defense of proprietary rights - **Sarepta's** success depends on obtaining, maintaining, and defending patent protection for its products, product candidates, and platform technologies, which is subject to numerous risks and uncertainties in the evolving patent landscape[268](index=268&type=chunk)[269](index=269&type=chunk) - The company faces significant litigation risks, including challenges to patent validity, scope, and enforceability, as well as claims of infringement by third parties, which can be costly and unpredictable[275](index=275&type=chunk) - Successful assertions by third parties that **Sarepta's** products or technologies infringe their proprietary rights could lead to substantial costs, the need for licenses (which may be unavailable or unfavorable), or the abandonment of product development[277](index=277&type=chunk)[280](index=280&type=chunk) - The **Leahy-Smith America Invents Act** and the **Hatch-Waxman Act** introduce complexities and potential challenges to patent prosecution and enforcement, including the risk of generic competition[272](index=272&type=chunk)[276](index=276&type=chunk) [Risks Related to our Business Operations](index=63&type=section&id=Risks%20Related%20to%20our%20Business%20Operations) This section details operational risks including regulatory compliance, tax implications, and dependence on key personnel - Failure to comply with complex federal and state healthcare laws and regulations (e.g., **anti-kickback, false claims, privacy laws**) could result in substantial penalties, fines, and operational disruptions[281](index=281&type=chunk)[282](index=282&type=chunk)[284](index=284&type=chunk) - Environmental, health, and safety laws and regulations, particularly concerning hazardous materials, pose compliance risks that could lead to fines, remediation costs, or cessation of operations[286](index=286&type=chunk) - Tax reforms in the U.S. (**TCJA, CARES Act, Inflation Reduction Act**) and international jurisdictions could materially impact the company's tax provision, cash tax liability, and effective tax rate[288](index=288&type=chunk)[295](index=295&type=chunk)[296](index=296&type=chunk) - The **COVID-19 pandemic** has caused and may continue to cause disruptions to commercialization, clinical trials, manufacturing, and other business operations, negatively impacting revenues and cash flows[291](index=291&type=chunk) - The ability to use **net operating loss carryforwards** and other tax attributes to offset future taxable income may be limited by Internal Revenue Code provisions (e.g., **Section 382**), potentially accelerating tax payments[293](index=293&type=chunk)[294](index=294&type=chunk) - The company is highly dependent on **key personnel**, and the inability to retain or attract qualified employees could adversely affect business objectives and future growth[299](index=299&type=chunk)[302](index=302&type=chunk) [Risks Related to our Financial Condition and Capital Requirements](index=67&type=section&id=Risks%20Related%20to%20our%20Financial%20Condition%20and%20Capital%20Requirements) This section covers risks related to historical losses, future funding needs, and potential dilution from capital raising - **Sarepta** has incurred substantial operating losses since inception, with an accumulated deficit of **$4.5 billion** as of **June 30, 2023**, and expects to continue incurring significant losses, making profitability uncertain[303](index=303&type=chunk)[304](index=304&type=chunk) - The company may require additional funding to meet post-marketing approval requirements, develop product candidates, and expand operations, but there is no assurance that financing will be available on acceptable terms[305](index=305&type=chunk)[306](index=306&type=chunk) - Raising additional capital through equity or debt financings could dilute existing stockholders, increase fixed payment obligations, or require relinquishing valuable rights to technologies or product candidates[307](index=307&type=chunk)[309](index=309&type=chunk) - Inaccurate estimates and judgments in financial statements could lead to restatements, securities class action litigation, and significant financial and management resource diversion[310](index=310&type=chunk)[311](index=311&type=chunk) [Risks Related to Our Common Stock](index=69&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) This section addresses risks concerning stock price volatility, anti-takeover provisions, and potential dilution from equity issuances - The market price of **Sarepta's common stock** is volatile and can fluctuate significantly due to factors such as commercial performance, regulatory decisions, clinical trial results, competition, and general market conditions[312](index=312&type=chunk)[313](index=313&type=chunk) - Provisions in the company's certificate of incorporation, bylaws, and Delaware law (**Section 203**) could deter acquisition bids or make it difficult for stockholders to effect changes in the board or management[315](index=315&type=chunk)[318](index=318&type=chunk) - The issuance of additional shares of common stock or warrants, including those from outstanding stock awards, could dilute the ownership interests of existing stockholders and depress the stock price[319](index=319&type=chunk)[321](index=321&type=chunk) [Risks Related to Our Convertible Senior Notes](index=71&type=section&id=Risks%20Related%20to%20Our%20Convertible%20Senior%20Notes) This section outlines risks associated with debt servicing, repurchase obligations, and hedging activities impacting stock value - Servicing the **2024 and 2027 Convertible Notes** requires significant cash, and the company may not generate sufficient cash flow from operations to meet these obligations, potentially leading to default or the need for dilutive financing[324](index=324&type=chunk) - **Sarepta** may not have the financial resources to repurchase the Notes upon a fundamental change, which could trigger a default under other indebtedness[325](index=325&type=chunk) - **Capped call transactions** entered into in connection with the Notes may impact the value of the common stock due to hedging activities by financial institutions[326](index=326&type=chunk)[327](index=327&type=chunk) [General Risks](index=72&type=section&id=General%20Risks) This section covers broad risks such as economic conditions, product liability, data security, and business interruptions - Unfavorable global economic conditions, including inflation and increased interest rates, could harm demand for products, capital raising efforts, and manufacturing operations[328](index=328&type=chunk) - The company is exposed to product liability claims from clinical trials and commercial sales, and its insurance coverage may not be adequate to cover potential damages[330](index=330&type=chunk) - Violations of data protection regulations like **GDPR, CCPA, and CPRA** could subject the company to significant fines, litigation, and reputational harm[331](index=331&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk) - Reliance on **information technology** makes the company vulnerable to failures, security lapses, and **cyberattacks**, potentially leading to data breaches, operational disruptions, and legal claims[335](index=335&type=chunk) - **Natural disasters, terrorism attacks**, and other business interruptions could severely disrupt operations, and existing business continuity plans may be inadequate[340](index=340&type=chunk)[341](index=341&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=75&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds were reported for the period[342](index=342&type=chunk) [Item 3. Defaults Upon Senior Securities](index=75&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there were no defaults upon senior securities to report for the period - No defaults upon senior securities were reported for the period[343](index=343&type=chunk) [Item 4. Mine Safety Disclosures](index=75&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section confirms that there were no mine safety disclosures to report for the period - No mine safety disclosures were reported for the period[344](index=344&type=chunk) [Item 5. Other Information](index=75&type=section&id=Item%205.%20Other%20Information) This section reports that no director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2023 - No director or officer adopted or terminated a "**Rule 10b5-1 trading arrangement**" or "**non-Rule 10b5-1 trading arrangement**" during the three months ended **June 30, 2023**[345](index=345&type=chunk) [Item 6. Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed or furnished as part of the Quarterly Report on Form 10-Q, including corporate governance documents, key agreements, and certifications - The exhibit index includes corporate documents (e.g., Amended and Restated Certificate of Incorporation, Bylaws), key agreements (e.g., Manufacturing and Supply Agreements, Exclusive License Agreements), and certifications (e.g., Section 302 and 906 certifications)[348](index=348&type=chunk) [Signatures](index=78&type=section&id=Signatures) This section contains the official signatures of Sarepta Therapeutics, Inc.'s principal executive officer and principal financial and accounting officer, certifying the report - The report is signed by **Douglas S. Ingram, President and Chief Executive Officer**, and **Ian M. Estepan, Executive Vice President, Chief Financial Officer**, on **August 2, 2023**[354](index=354&type=chunk)