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 October 27, 2023) |
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, 2023 and December 31, 2022 |
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4 |
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Condensed Consolidated Statements of Stockholders’ Equity — For the Three and Nine Months Ended September 30, 2023 and 2022 |
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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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39 |
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Item 1. |
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40 |
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Item 1A. |
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40 |
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Item 2. |
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76 |
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Item 3. |
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76 |
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Item 4. |
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76 |
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Item 5. |
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76 |
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Item 6. |
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76 |
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77 |
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78 |
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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 |
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Inventory |
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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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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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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 loss, net of tax |
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( |
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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 OPERATIONS AND COMPREHENSIVE 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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2023 |
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2022 |
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2023 |
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2022 |
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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 |
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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 loss |
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Other loss, net: |
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Gain from sale of Priority Review Voucher |
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Loss on debt extinguishment |
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( |
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Other (expense) income, net |
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( |
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Total other loss, net |
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Loss before income tax expense |
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( |
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( |
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( |
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Income tax expense |
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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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Other comprehensive income (loss): |
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Unrealized gains (losses) on investments, net of tax |
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$ |
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$ |
( |
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$ |
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$ |
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Total other comprehensive income (loss) |
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( |
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Comprehensive loss |
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$ |
( |
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$ |
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$ |
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$ |
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Net loss per share - basic and 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 |
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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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(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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( |
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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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— |
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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 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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( |
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BALANCE AT JUNE 30, 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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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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( |
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BALANCE AT SEPTEMBER 30, 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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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 |
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Deficit |
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Equity |
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BALANCE AT DECEMBER 31, 2021 |
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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 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, 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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Stock-based compensation |
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— |
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— |
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— |
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— |
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