UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol |
Name of exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
Common Stock with $0.0001 par value |
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(Class) |
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(Outstanding as of November 1, 2024) |
SAREPTA THERAPEUTICS, INC.
FORM 10-Q
INDEX
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Page |
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Item 1. |
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3 |
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Condensed Consolidated Balance Sheets — As of September 30, 2024 and December 31, 2023 |
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3 |
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4 |
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Condensed Consolidated Statements of Stockholders’ Equity — For the Three and Nine Months Ended September 30, 2024 and 2023 |
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7 |
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8 |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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24 |
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Item 3. |
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39 |
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Item 4. |
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40 |
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Item 1. |
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41 |
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Item 1A. |
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41 |
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Item 2. |
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78 |
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Item 3. |
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78 |
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Item 4. |
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78 |
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Item 5. |
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78 |
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Item 6. |
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78 |
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79 |
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80 |
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2
PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
SAREPTA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands, except share and per share amounts)
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As of |
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As of |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term investments |
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Accounts receivable, net |
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Inventory |
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Manufacturing-related deposits and prepaids |
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Other current assets |
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Total current assets |
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Property and equipment, net |
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Right of use assets |
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Non-current inventory |
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Non-current investments |
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Other non-current assets |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Deferred revenue, current portion |
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Current portion of long-term debt |
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Other current liabilities |
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Total current liabilities |
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Long-term debt |
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Lease liabilities, net of current portion |
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Deferred revenue, net of current portion |
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Contingent consideration |
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Other non-current liabilities |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive income, net of tax |
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Accumulated deficit |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
SAREPTA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(unaudited, in thousands, except per share amounts)
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For the Three Months Ended |
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For the Nine Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenues: |
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$ |
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$ |
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$ |
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$ |
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Collaboration and other |
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Total revenues |
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Cost and expenses: |
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Cost of sales (excluding amortization of in-licensed rights) |
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Research and development |
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Selling, general and administrative |
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Amortization of in-licensed rights |
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Total cost and expenses |
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Operating income (loss) |
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( |
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Other income (loss), net: |
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Other income (expense), net |
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( |
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Gain from sale of Priority Review Voucher |
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Loss on debt extinguishment |
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Total other income (loss), net |
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( |
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Income (loss) before income tax expense |
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( |
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Income tax expense |
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Net income (loss) |
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$ |
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$ |
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$ |
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$ |
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Other comprehensive income: |
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Unrealized gains on investments, net of tax |
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Total other comprehensive income |
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Comprehensive income (loss) |
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$ |
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$ |
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$ |
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$ |
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Earnings (loss) per share: |
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Basic |
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$ |
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$ |
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$ |
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$ |
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Diluted |
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$ |
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$ |
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$ |
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$ |
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Weighted average number of shares of common stock used in computing earnings (loss) per share: |
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Basic |
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Diluted |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
SAREPTA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited, in thousands)
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Accumulated |
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Additional |
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Other |
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Total |
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Common Stock |
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Paid-In |
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Comprehensive |
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Accumulated |
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Stockholders' |
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Shares |
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Amount |
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Capital |
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Income (Loss) |
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Deficit |
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Equity |
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BALANCE AT DECEMBER 31, 2023 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Exercise of options for common stock |
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— |
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— |
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— |
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Vest of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock under employee |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized losses from available-for-sale |
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— |
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— |
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— |
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( |
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— |
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( |
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Net income |
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— |
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— |
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— |
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— |
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BALANCE AT MARCH 31, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Exercise of options for common stock |
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Vest of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Issuance of common stock for conversion of |
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— |
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— |
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— |
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Unrealized losses from available-for-sale |
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— |
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— |
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— |
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( |
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— |
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( |
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Net income |
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— |
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— |
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— |
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— |
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BALANCE AT JUNE 30, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Exercise of options for common stock |
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— |
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Vest of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock under employee |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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Issuance of common stock for conversion of |
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— |
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— |
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— |
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— |
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Modification of 2017 Capped Calls (defined |
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— |
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— |
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— |
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— |
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Unrealized gains from available-for-sale |
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— |
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— |
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— |
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— |
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Net income |
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— |
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— |
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— |
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— |
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BALANCE AT SEPTEMBER 30, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
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5
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Accumulated |
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Additional |
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Other |
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Total |
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Common Stock |
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Paid-In |
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Comprehensive |
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Accumulated |
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Stockholders' |
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Shares |
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Amount |
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Capital |
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(Loss) Income |
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Deficit |
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Equity |
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BALANCE AT DECEMBER 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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Exercise of options for common stock |
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— |
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— |
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— |
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Vest of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock for |
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— |
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— |
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— |
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Partial settlement of capped call share |
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— |
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— |
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— |
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— |
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Issuance of common stock under employee |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized gains from available-for-sale |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
BALANCE AT MARCH 31, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Exercise of options for common stock |
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— |
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— |
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— |
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Vest of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized losses from available-for-sale |
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— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
BALANCE AT JUNE 30, 2023 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Exercise of options for common stock |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Vest of restricted stock units |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock under employee |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock-based compensation |
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized gains from available-for-sale |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
BALANCE AT SEPTEMBER 30, 2023 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
See accompanying notes to unaudited condensed consolidated financial statements.
6
SAREPTA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited, in thousands)
|
|
For the Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net income (loss) |
|
$ |
|
|
$ |
( |
) |
|
Depreciation and amortization |
|
|
|
|
|
|
||
Reduction in the carrying amounts of the right of use assets |
|
|
|
|
|
|
||
Non-cash interest expense |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Accretion of investment discount, net |
|
|
( |
) |
|
|
( |
) |
Non-cash termination charges |
|
|
|
|
|
|
||
Non-cash change in the fair value of derivatives |
|
|
|
|
|
|
||
Impairment of strategic investments |
|
|
|
|
|
|
||
Loss on debt extinguishment |
|
|
|
|
|
|
||
Gain from sale of Priority Review Voucher |
|
|
|
|
|
( |
) |
|
Other |
|
|
|
|
|
|
||
Changes in operating assets and liabilities, net: |
|
|
|
|
|
|
||
Increase in accounts receivable |
|
|
( |
) |
|
|
( |
) |
(Increase) decrease in manufacturing-related deposits and prepaids |
|
|
( |
) |
|
|
|
|
Increase in inventory |
|
|
( |
) |
|
|
( |
) |
Increase in other assets |
|
|
( |
) |
|
|
( |
) |
Decrease in deferred revenue |
|
|
( |
) |
|
|
( |
) |
Decrease in accounts payable, accrued expenses, lease liabilities and other liabilities |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchase of property and equipment |
|
|
( |
) |
|
|
( |
) |
Purchase of available-for-sale securities |
|
|
( |
) |
|
|
( |
) |
Maturity and sale of available-for-sale securities |
|
|
|
|
|
|
||
Purchase of intangible assets |
|
|
( |
) |
|
|
( |
) |
Proceeds from sale of Priority Review Voucher |
|
|
|
|
|
|
||
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
|
||
Proceeds from exercise of stock options and purchase of stock under the Employee Stock |
|
|
|
|
|
|
||
Partial settlement of capped call share options for 2024 Notes |
|
|
|
|
|
|
||
Debt conversion costs for 2024 Notes |
|
|
|
|
|
( |
) |
|
Net cash provided by financing activities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Decrease in cash, cash equivalents and restricted cash |
|
|
||||||