UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
OR
For the transition period from to
Commission file number
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices, including zip code)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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(The Nasdaq Capital Market) |
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, a 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.
Large accelerated filer |
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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
As of May 9, 2025, there were
INDEX
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Item 1. |
5 |
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Condensed Unaudited Balance Sheets as of March 31, 2025 and December 31, 2024 |
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Condensed Unaudited Statements of Cash Flows for the three months ended March 31, 2025 and 2024 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II. OTHER INFORMATION |
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Item 1. |
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Item 1A. |
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Item 5. |
28 |
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Item 6. |
29 |
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30 |
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2
Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. When used in this Quarterly Report on Form 10-Q or elsewhere by management from time to time, the words “believe,” “anticipate,” “intend,” “plan,” “estimate,” “expect,” “may,” “will,” “could,” “potentially,” “possibility,” and similar expressions are forward-looking statements. Such forward-looking statements contained herein are based on current expectations and beliefs. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differ materially from those discussed in the forward-looking statements as a result of various factors. Forward-looking statements made in this report include, but are not limited to, statements about:
3
We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report on Form 10-Q. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differ materially from those discussed in the forward-looking statements as a result of various factors. For a more detailed discussion of such forward looking statements and the potential risks and uncertainties that may impact upon their accuracy, see the “Overview” section of the Management’s Discussion and Analysis of Financial Condition and Results of Operations herein and Part I, Item 1A., “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025 and any additional risk factors that may be described in the “Risk Factors” section herein or in our subsequent reports filed with the SEC. These forward-looking statements reflect our view only as of the date of this report. We undertake no obligations to update any forward-looking statements. You should also carefully consider the factors set forth in other reports or documents that we file from time to time with the Securities and Exchange Commission.
4
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
DURECT CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
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March 31, |
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December 31, |
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A S S E T S |
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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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Inventories, net |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Goodwill |
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Long-term restricted investments |
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Other long-term assets |
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Total assets |
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$ |
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$ |
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L I A B I L I T I E S A N D S T O C K H O L D E R S’ E Q U I T Y |
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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 liabilities |
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Operating lease liabilities, current portion |
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Warrant liabilities |
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Total current liabilities |
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Operating lease liabilities, non-current portion |
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Other long-term liabilities |
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Stockholders’ equity: |
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Common stock |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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Accumulated deficit |
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Stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed financial statements.
5
DURECT CORPORATION
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share amounts)
(unaudited)
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Three months ended |
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2025 |
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2024 |
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Collaborative research and development and other revenue |
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$ |
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$ |
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Total revenues |
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Operating expenses: |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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Loss from operations |
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Other income (expense): |
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Interest and other income |
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Change in fair value of warrant liabilities |
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( |
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( |
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Other expense, net |
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( |
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( |
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Loss from continuing operations |
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( |
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( |
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Income (loss) from discontinued operations |
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( |
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Net loss |
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Net change in unrealized loss on available-for-sale securities, net of reclassification adjustments and taxes |
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Total comprehensive loss |
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$ |
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$ |
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Net loss per share, basic |
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Loss from continuing operations |
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$ |
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$ |
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Income (loss) from discontinued operations |
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$ |
— |
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$ |
— |
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Net loss per common share |
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$ |
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$ |
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Net loss per share, diluted |
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Loss from continuing operations |
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$ |
( |
) |
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$ |
( |
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Income (loss) from discontinued operations |
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$ |
— |
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$ |
— |
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Net loss per common share |
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$ |
( |
) |
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$ |
( |
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Weighted-average shares used in computing net loss per share |
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Basic |
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Diluted |
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The accompanying notes are an integral part of these condensed financial statements.
6
DURECT CORPORATION
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except per share amounts)
(unaudited)
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Common Stock |
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Additional |
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Accumulated |
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Accumulated |
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Total |
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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, 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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Stock-based compensation expense from stock options and ESPP shares |
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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, 2025 |
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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 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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Issuance of common stock pursuant to the 2021 Sales Agreement, net of issuance costs of $ |
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— |
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— |
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— |
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Stock-based compensation expense from stock options and ESPP shares |
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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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Change in unrealized loss on available-for-sale securities, net of tax |
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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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The accompanying notes are an integral part of these condensed financial statements
7
DURECT CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Three months ended |
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2025 |
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2024 |
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Cash flows from operating activities |
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Net loss |
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$ |
( |
) |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and accretion |
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Stock-based compensation |
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Change in fair value of warrant liabilities |
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Other |
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( |
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Changes in assets and liabilities: |
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Accounts receivable |
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Inventories |
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( |
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Prepaid expenses and other assets |
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Accounts payable |
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( |
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Accrued liabilities |
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( |
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( |
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Total adjustments |
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Net cash used in operating activities |
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( |
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Cash flows from investing activities |
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Purchases of property and equipment |
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( |
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— |
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Purchases of available-for-sale securities |
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( |
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( |
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Proceeds from maturities of short-term investments |
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— |
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Net cash provided by (used in) investing activities |
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( |
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Cash flows from financing activities |
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Payments on term loan principal |
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— |
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( |
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Net proceeds from issuances of common stock pursuant to the 2021 Sales Agreement |
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— |
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Net cash used in financing activities |
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— |
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( |
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Net decrease in cash, cash equivalents, and restricted cash |
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( |
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( |
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Cash, cash equivalents, and restricted cash, beginning of the period (1) |
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Cash, cash equivalents, and restricted cash, end of the period (1) |
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$ |
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$ |
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(1)
The accompanying notes are an integral part of these condensed financial statements.
8
DURECT CORPORATION
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Note 1. Summary of Significant Accounting Policies
Nature of Operations
DURECT Corporation (the “Company”) was incorporated in the state of Delaware on February 6, 1998. The Company is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. Larsucosterol, the Company's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases ("DNMTs"), epigenetic enzymes which are elevated and associated with hypermethylation found in alcohol-associated hepatitis ("AH") patients. Larsucosterol is in clinical development for the potential treatment of AH, for which FDA has granted a Fast Track Designation and Breakthrough Therapy Designation; metabolic dysfunction-associated steatohepatitis (“MASH”), also known as non-alcoholic steatohepatitis or NASH is also being explored. The Company also manufactures and sells certain excipients for certain clients for use as raw materials in their products.
Basis of Presentation
These condensed financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”), and therefore do not include all the information and footnotes necessary for a complete presentation of the Company’s results of operations, financial position and cash flows in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). The unaudited condensed financial statements reflect all adjustments (consisting only of normal recurring adjustments) which are, in the opinion of management, necessary for a fair presentation of the financial position at March 31, 2025, the operating results and comprehensive loss, and stockholders’ equity for the three months ended March 31, 2025 and 2024, and cash flows for the three months ended March 31, 2025 and 2024. The balance sheet as of December 31, 2024 has been derived from audited financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These financial statements and notes should be read in conjunction with the Company’s audited financial statements and notes thereto, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the SEC.
The results of operations for the interim periods presented are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year.
Liquidity and Need to Raise Additional Capital
As of March 31, 2025, the Company had an accumulated deficit of $
There are no assurances that such additional funding will be obtained and that the Company will succeed in its future operations. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and the Company may have to cease operations.
In November 2024, the Company completed the sale of its ALZET product line to Lafayette Instrument Co. ("LIC"), a portfolio company of Branford Castle Partners II, L.P., a North-American focused private equity firm. Under the terms of the agreement, LIC paid the Company $
These financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary in the event the Company can no longer continue as a going concern.
Inventories, net
Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company may be required to expense previously capitalized inventory costs upon a change in management’s judgment due to new information that suggests that the inventory will not be saleable.
9
The Company’s inventories consisted of the following (in thousands):
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March 31, |
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December 31, |
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Raw materials |
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$ |
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$ |
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Finished goods |
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Total inventories |
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$ |
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$ |
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Leases
ASC 842 requires the Company to recognize an operating lease right-of-use asset and corresponding operating lease liability for the Company’s leased properties. The Company’s operating lease right-of-use assets and liabilities are recognized under ASC 842 based on the present value of lease payments over the remaining lease term at the lease commencement date. In determining the net present value of lease payments, we estimate the incremental borrowing rate based on the information available, including remaining lease term. As of March 31, 2025, the weighted-average remaining lease term was
Revenue Recognition
Product Revenue, Net
The Company manufactures and sells certain excipients used by pharmaceutical companies as raw materials in certain of their products, including Methydur and a marketed animal health product. Prior to the sale of the ALZET product line in November 2024, the Company also manufactured and sold ALZET miniature osmotic pumps used in laboratory research.
Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon shipment to the customer. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less.
Trade Discounts and Allowances: The Company provides certain customers with discounts that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized.
Product Returns: The Company generally offers customers a limited right of return for products that have been purchased. The Company estimates the amount of its product sales that are probable of being returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities primarily using its historical sales information. The Company expects product returns to be minimal.
Collaborative Research and Development and Other Revenue
Royalties and Earn-outs: For the Company's arrangements that include sales-based royalties or earn-outs, including milestone payments based on first commercial sale or the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty or earn-out has been allocated has been satisfied (or partially satisfied).
Research and Development Services: Revenue from research and development services that are determined to represent a distinct performance obligation related to services performed under the collaborative arrangements with the Company’s third-party collaborators is recognized over time as the related research and development services are performed. The Company evaluates the measure of progress each reporting period and recognizes revenue on a cumulative catch-up basis, as collaborative research and development revenue. The Company performs analytical services for counterparties and recognizes revenue upon completion of these services. Research and development expenses under the collaborative research and development agreements generally approximate or exceed the revenue recognized under such agreements over the term of the respective agreements. Deferred revenue may result when the Company does not expend the required level of effort during a specific period in comparison to funds received under the respective agreement.
The Company receives payments from its customers based on development cost schedules established in each contract. Up-front payments are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
10
Total revenue by geographic region based on customers’ locations for the three months ended March 31, 2025 and 2024 are as follows (in thousands):
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Three months ended |
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2025 |
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2024 |
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Europe |
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$ |
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$ |
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United States |
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Other |
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Total |
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$ |
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$ |
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Revenue by geography is determined by the location of the customer.
Prepaid and Accrued Clinical Costs
The Company incurs significant costs associated with third party consultants and organizations for pre-clinical studies, clinical trials, contract research, regulatory advice and other research and development-related services. The Company is required to estimate periodically the cost of services rendered but unbilled based on management’s estimates. Estimates are determined each reporting period by reviewing the terms and conditions of the underlying contracts, reviewing open purchase orders and by having detailed discussions with internal clinical personnel and third-party service providers as to the nature and status of the services performed in relation to amounts billed. The costs for unbilled services are estimated by applying the rates and fees applicable in the underlying contracts. If these good faith estimates are inaccurate, actual expenses incurred could materially differ from these estimates.
Prepaid and Accrued Manufacturing Costs
The Company incurs significant costs associated with third party consultants and organizations for manufacturing, validation, testing and other research and development-related services. The Company is required to estimate periodically the cost of services rendered but unbilled based on management’s estimates. Estimates are determined each reporting period by reviewing the terms and conditions of the underlying contracts, reviewing open purchase orders and by having detailed discussions with internal personnel and third-party service providers as to the nature and status of the services performed in relation to amounts billed. The costs for unbilled services are estimated by applying the rates and fees applicable in the underlying contracts. If these good faith estimates are inaccurate, actual expenses incurred could materially differ from these estimates.
Research and Development Expenses
Research and development expenses are primarily comprised of salaries and benefits associated with research and development personnel, overhead and facility costs, preclinical and non-clinical development costs, clinical trial and related clinical manufacturing costs, contract services, and other outside costs. Research and development costs are expensed as incurred. Research and development costs paid to third parties under sponsored research agreements are recognized as the related services are performed. In addition, research and development expenses incurred that are reimbursed by the Company’s partners are recorded as collaborative research and development revenue.
Comprehensive Loss
Components of other comprehensive loss are comprised entirely of unrealized gains and losses on the Company’s available-for-sale securities for all periods presented. Total comprehensive loss has been disclosed in the Company’s statements of operations and comprehensive loss.
Segment Reporting
The Company operates in
Common Stock Warrants
The Company accounts for its common stock warrants in accordance with ASC 480, Distinguishing Liabilities from Equity ("ASC 480") and ASC 815, Derivatives and Hedging (“ASC 815”). Based upon the provisions of ASC 480 and ASC 815, the Company accounts for common stock warrants as current liabilities if the warrant fails the equity classification criteria. Common stock warrants classified as liabilities are initially recorded at fair value on the grant date and remeasured at each balance sheet date with the offsetting adjustments recorded in change in fair value of warrant liabilities within the statements of operations.
The Company values its common stock warrants classified as liabilities using the Black-Scholes option pricing model or other acceptable valuation models, including the Monte-Carlo simulation model.
11
Net Loss Per Share
The Company calculates basic and diluted net loss per share attributable to common stockholders in conformity with the two-class method required for participating securities. Certain warrants participate in distributions of the Company. The net loss attributable to common stockholders is not allocated to the warrant holders as the holders of warrants do not have a contractual obligation to share in losses. Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding and common stock equivalents (i.e., options and warrants to purchase common stock) outstanding during the period, if dilutive, using the treasury stock method for options.
The numerators and denominators in the calculation of basic and diluted net loss per share were as follows (in thousands, except per share amounts):
|
|
Three months ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Basic and diluted loss per share computation: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted average number of shares outstanding - basic and diluted |
|
|
|
|
|
|
||
Net loss per share - basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
||
Options to purchase approximately
The common warrants to purchase shares of common stock entitle the holders thereof to participate in dividends and other distributions of assets by the Company to its holders of common shares, but are not required to absorb losses incurred. As a result, the common warrants were excluded from basic net loss per share calculations for the three months ended March 31, 2025 and 2024, respectively. For diluted net loss per share purposes, the common warrants are included in the number of shares outstanding if the effect is dilutive. Additional common warrants to purchase
Discontinued Operations
In accordance with ASC 205-20 Presentation of Financial Statements: Discontinued Operations, a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results when the component/s of an entity meets the criteria in paragraph 205-20-45-10. At the same time, the results of all discontinued operations, less applicable income taxes, shall be reported as components of net loss separate from the net loss of continuing operations.
The Company disposed of its ALZET product line, a component of its business, in November 2024 and met the definition of a discontinued operation as of December 31, 2024. Accordingly, the Company has classified the results of the ALZET product line as discontinued operations in its statements of operations and comprehensive loss for all periods presented. All assets and liabilities associated with the ALZET product line were classified as assets and liabilities of discontinued operations in the balance sheets for the periods presented. All amounts included in the notes to the financial statements relate to continuing operations unless otherwise noted. For additional information, see Note 11, “Discontinued Operations” to the financial statements in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Recent Accounting Pronouncements
Note 2. Strategic Agreements
The collaborative research and development and other revenue associated with the Company’s major collaborators or counterparties were $
12
with respect to PERSERIS net sales, (b) research and development activities funded by our collaborators or counterparties and (c) royalty revenue from Orient Pharma Co., Ltd. (“Orient Pharma”) with respect to Methydur net sales.
Agreement with Innocoll
On December 21, 2021, the Company entered into a license agreement (as amended, the “Innocoll Agreement”) with Innocoll Pharmaceuticals Limited (“Innocoll”). Pursuant to the Innocoll Agreement, the Company granted Innocoll an exclusive, royalty-bearing, sublicensable right and license to develop, manufacture and commercialize in the United States, POSIMIR®, the Company’s FDA-approved post-surgical pain product, with respect to all uses and applications in humans. None of the additional milestones under the agreement have been met. On May 6, 2025, Innocoll terminated the Innocoll Agreement and transferred all data and know-how related to POSIMIR to the Company. The Company is evaluating next steps with respect to finding a new partner to commercialize POSIMIR. The Company does not expect that this termination will have a material impact on its financial statements.
Patent Purchase Agreement with Indivior
In September 2017, the Company entered into an agreement with Indivior (the “Indivior Agreement”), under which the Company assigned to Indivior certain patents that may provide further intellectual property protection for PERSERIS, Indivior’s extended-release injectable suspension for the treatment of schizophrenia in adults. In consideration for such assignment, Indivior made non-refundable upfront and milestone payments to DURECT totaling $
Note 3. Financial Instruments
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company’s valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company follows a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value. These levels of inputs are the following:
The Company’s financial instruments are valued using quoted prices in active markets or based upon other observable inputs. Money market funds are classified as Level 1 financial assets. Certificates of deposit and commercial paper are classified as Level 2 financial assets. The fair value of the Level 2 assets is estimated using pricing models using current observable market information for similar securities. The Company’s Level 2 investments may include U.S. government-backed securities and corporate securities that are valued based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including market research publications. The fair value of commercial paper is based upon the time to maturity and discounted using the three-month treasury bill rate. The average remaining maturity of the Company’s Level 2 investments as of March 31, 2025 is less than twelve months and these investments are rated by S&P and Moody’s at AAA or AA- for securities and A1, A2, P1 or P2 for commercial paper.
The following is a summary of available-for-sale securities as of March 31, 2025 and December 31, 2024 (in thousands):
13
|
|
March 31, |
|
|||||||||||||
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
Money market funds |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Certificates of deposit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Commercial paper |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
|
|
$ |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
||
Reported as: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
||
Short-term investments |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Long-term restricted investments |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
December 31, 2024 |
|
|||||||||||||
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
Money market funds |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Certificates of deposit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Commercial paper |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
|
|
$ |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
||
Reported as: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
||
Short-term investments |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Long-term restricted investments |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
||
The following is a summary of the cost and estimated fair value of available-for-sale securities at March 31, 2025, by contractual maturity (in thousands):
|
|
March 31, |
|
|||||
|
|
Amortized |
|
|
Estimated |
|
||
Mature in one year or less |
|
$ |
|
|
$ |
|
||
Mature after one year through five years |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
There were
As of March 31, 2025, unrealized losses on available-for-sale investments are not attributed to credit risk and are considered to be temporary. The Company believes that it is more-likely-than-not that investments in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value.
Warrant Liabilities
The following table summarizes the activity of the Company’s Level 3 warrant liabilities during the three months ended March 31, 2025 and 2024 (in thousands):
14
|
|
Three months ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Fair value at beginning of period - February 2023 issuance (Common warrants) |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|||
Fair value at end of period - February 2023 issuance (Common warrants) |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Fair value at beginning of period - July 2023 issuance (Common warrants) |
|
$ |
|
|
$ |
|
||
Change in fair value during the period |
|
|
|
|
|
|
||
Fair value at end of period - July 2023 issuance |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Total fair value at end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Common Warrants
February 2023 Warrants
In February 2023, the Company issued common warrants to purchase an aggregate of
The common warrants are accounted for as current liabilities on the balance sheets and are adjusted to estimated fair value at period end through “other income (expense)” on the statements of operations. The estimated fair value of the outstanding common warrants was $
The exercise price for the outstanding common warrants was adjusted down from $
|
|
February 8, 2023 (issuance) |
|
|
December 31, 2024 |
|
|
March 31, 2025 |
|
|||
Common stock price |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Exercise price per share |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Expected volatility |
|
|
% |
|
|
% |
|
|
% |
|||
Risk-free interest rate |
|
|
% |
|
|
% |
|
|
% |
|||
Contractual term (in years) |
|
|
|
|
|
|
|
|
|
|||
Expected dividend yield |
|
|
— |
% |
|
|
— |
% |
|
|
— |
% |
July 2023 warrants
In July 2023, the Company issued common warrants to purchase an aggregate of
15
The common warrants are accounted for as current liabilities on the balance sheets and are adjusted to estimated fair value at period end through “other income (expense)” on the statements of operations. The estimated fair value of the outstanding common warrants was $
|
|
|
|
|
|
|
|
|
|
|||
|
|
July 21, 2023 (issuance) |
|
|
December 31, 2024 |
|
|
March 31, 2025 |
|
|||
Common stock price |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Exercise price per share |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Expected volatility |
|
|
% |
|
|
% |
|
|
% |
|||
Risk-free interest rate |
|
|
% |
|
|
% |
|
|
% |
|||
Contractual term (in years) |
|
|
|
|
|
|
|
|
|
|||
Expected dividend yield |
|
|
— |
% |
|
|
— |
% |
|
|
— |
% |
There were no exercises of the common warrants issued in the July 2023 registered direct offering.
Note 4. Accrued Liabilities
Accrued liabilities as of March 31, 2025 and December 31, 2024 were comprised as follows (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
|
|
|
|
|
||
Accrued contract research and manufacturing costs |
|
$ |
|
|
$ |
|
||
Accrued compensation and benefits |
|
|
|
|
|
|
||
Accrued clinical costs |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
Note 5. Stock-Based Compensation
As of March 31, 2025, the Company has two stock-based compensation plans.
|
|
Three months ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Research and development |
|
$ |
|
|
$ |
|
||
Selling, general and administrative |
|
|
|
|
|
|
||
Total stock-based compensation |
|
$ |
|
|
$ |
|
||
The Company uses the Black-Scholes option pricing model to value its stock options. The expected life computation is based on historical exercise patterns and post-vesting termination behavior. The Company considered its historical volatility in developing its estimate of expected volatility.
The Company used the following assumptions to estimate the fair value of shares purchased under its employee stock purchase plan for the three months ended March 31, 2025 and 2024. There were
|
|
Three months ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Employee Stock Purchase Plan |
|
|
|
|
|
|
||
Risk-free rate |
|
|
% |
|
|
% |
||
Expected dividend yield |
|
|
— |
|
|
|
— |
|
Expected life (in years) |
|
|
|
|
||||
Volatility |
|
|
% |
|
|
% |
||
16
Note 6. Term Loan
In July 2016, the Company entered into a Loan and Security Agreement (as amended, the "Loan Agreement") with Oxford Finance LLC. In November 2024, the Company paid off all remaining obligations under the Loan Agreement with Oxford Finance LLC.
Note 7. Commitments
Operating Leases
The Company has lease arrangements for its facilities in California as follows.
Location |
|
Approximate Square Feet |
|
Operation |
|
Expiration |
Cupertino, CA |
|
|
Office, Laboratory and Manufacturing |
|
Under its lease, the Company is required to pay certain maintenance expenses in addition to monthly rent. Rent expense is recognized on a straight-line basis over the lease term for leases that have scheduled rental payment increases. Rent expense under all operating leases was $
Future minimum payments under this noncancelable lease is as follows (in thousands):
|
|
Operating |
|
|
Nine months ending December 31, 2025 |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
|
|
$ |
|
|
Note 8. Stockholders’ Equity
On August 14, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC (the “2024 Registration Statement”) (File No. 333-281550), which upon being declared effective on August 23, 2024, allowed the Company to offer up to $
Due to the SEC’s “baby shelf” rules, which prohibit companies with a public float of less than $
February 2023 Registered Direct Offering
The Company accounts for the common warrants as current liabilities based upon the guidance of ASC 480 and ASC 815. Estimating fair values of liability-classified financial instruments requires the development of estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the trading market price of the Company’s common stock. Because liability-classified financial instruments are initially and subsequently carried at fair value, the Company’s financial results will reflect the volatility in these estimate and assumption changes. Changes in estimated fair value are recognized as a component of other income (expense) in the statements of operations.
17
At the date of issuance, the Company valued the common warrants at an estimated fair value of $
The loss of $
The common warrant liability will be adjusted to estimated fair value at each balance sheet date until the warrants are settled. Changes in the estimated fair value of the warrant liabilities are recognized as a component of other income (expense), net in the statements of operations and comprehensive loss.
July 2023 Registered Direct Offering
The common warrants were immediately exercisable and have a
The Company accounts for the common warrants issued in the July Offering as current liabilities based upon the guidance of ASC 815. Estimating fair values of liability-classified financial instruments requires the development of estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the trading market price of the Company’s common stock. Because liability-classified financial instruments are initially and subsequently carried at fair value, the Company’s financial results will reflect the volatility in these estimate and assumption changes. Changes in estimated fair value are recognized as a component of other income (expense) in the statements of operations.
The Company valued the common warrants issued in the July Offering using the Black-Scholes option valuation model. As of the issuance date of December 31, 2024 and as of March 31, 2025, the common warrants were valued at $
The common warrant liability will be adjusted to estimated fair value at each balance sheet date until the warrants are settled. Changes in the estimated fair value of the warrant liabilities are recognized as a component of other income (expense), net in the statements of operations and comprehensive loss.
As of March 31, 2025,
ATM Financings
During the three months ended March 31, 2025, there were
As of May 9, 2025, the Company had up to $
Note 9. Discontinued Operations
On November 22, 2024 (the “Closing Date”), the Company entered into an Asset Purchase Agreement (the “APA”) with ALZET, LLC, a subsidiary of Lafayette Instrument Co. (the “Purchaser”). Under the terms of the APA, the Company agreed to sell to the Purchaser substantially all the assets, and certain specified liabilities, related to the ALZET product line (the “Sale”). The APA provided for, subject to certain terms and conditions, the entry into a Transition Services Agreement, pursuant to which the Company
18
agrees to perform certain transition services related to the purchased assets for up to six months after the Closing Date, subject to potential extensions.
On the Closing Date, the Company completed the transaction contemplated by the APA. Pursuant to the terms of the APA, the Purchaser paid the Company $
As a result of the sale of the ALZET product line, the operating results from the Company's ALZET product line have been excluded from continuing operations and presented as discontinued operations in the accompanying Statements of Operations and Comprehensive Loss for all periods presented. The results of operations and gain from discontinued operations presented below include certain allocations that management believes fairly reflect the utilization of services provided to the ALZET product line. The allocations do include interest expense of the Oxford term loan as the loan was required to pay off at the close of sale of ALZET product line for all periods presented. The allocations do not include amounts related to general corporate administrative expenses. Therefore, these results of operations do not necessarily reflect what the results of operations would have been had the ALZET product line operated as a stand-alone entity.
The components of income from discontinued operations as reported in the Company’s statements of operations were as follows (in thousands):
|
|
Three months ended March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Total revenues |
|
$ |
— |
|
|
$ |
|
|
Operating expenses: |
|
|
|
|
|
|
||
Cost of product revenues |
|
|
— |
|
|
|
|
|
Selling, general and administrative |
|
|
— |
|
|
|
|
|
Total operating expenses |
|
|
— |
|
|
|
|
|
Other expense: |
|
|
|
|
|
|
||
Interest and other expenses |
|
|
|
|
|
|
||
Total costs and expenses |
|
|
|
|
|
|
||
Income (loss) from discontinued operations |
|
|
( |
) |
|
|
|
|
Net income (loss) per share |
|
|
|
|
|
|
||
Basic |
|
$ |
— |
|
|
$ |
— |
|
Diluted |
|
$ |
— |
|
|
$ |
— |
|
Weighted-average shares used in computing net (loss) income per share |
|
|
|
|
|
|
||
Basic |
|
|
|
|
|
|
||
Diluted |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
The following table presents certain non-cash items related to discontinued operations, which are included in the Company’s statements of cash flows (in thousands):
|
Three months ended March 31, |
|
|
|
2024 |
|
|
Depreciation |
$ |
|
|
Stock-based compensation expense |
|
|
|
Non-cash items, net |
$ |
|
|
Note
The Company is committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. Larsucosterol, the Company's lead drug candidate, binds to and inhibits the activity of DNMTs, epigenetic enzymes which are elevated and associated with hypermethylation found in alcohol-AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which FDA has granted a Fast Track Designation; MASH, also known as non-alcoholic steatohepatitis or NASH is also being explored. The Company also manufactures and sells certain excipients for certain clients for use as raw materials in their products.
The Company’s long-lived assets recognized on the Balance Sheets primarily consisted of property and equipment, net and operating lease right-of-use assets, which are located within the U.S.
The Company manages the business activities on a consolidated basis and operates in
19
Significant expenses within loss from continuing operations, as well as within net loss, include research and development, and selling, general and administrative expenses, which are each separately presented on the Company’s Statement of Operations and Comprehensive Loss.
20
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This Management’s Discussion and Analysis of Financial Condition and Results of Operations for the three months ended March 31, 2025 should be read in conjunction with (i) our unaudited condensed financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on March 27, 2025 as well as Part I, Item 1A., “Risk Factors” section included therein and any additional risk factors that may be described in the “Risk Factors” section herein or in our subsequent reports filed with the SEC. References to the “Company,” “DURECT,” “we,” “us” and “our” refer to DURECT Corporation.
Overview
We are a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, a new chemical entity in clinical development, is the lead candidate in our Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, larsucosterol has been shown in both in vitro and in vivo studies to play an important regulatory role in lipid metabolism, stress and inflammatory responses, and cell death and survival. We are developing larsucosterol for alcohol-associated hepatitis (“AH”), a life-threatening acute liver condition with no approved therapeutics and 28-Day and 90-Day historical mortality rates of 20%-26% and 29%-31%, respectively. After completing a Phase 2a trial in which 100% of AH patients treated with larsucosterol survived the 28-Day study period, we conducted a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM (trial in AH to evaluate saFety and effIcacy of laRsucosterol treatMent). Through our AHFIRM trial, we evaluated larsucosterol’s potential to reduce mortality or liver transplantation compared to a placebo with or without steroids at the investigators’ discretion. In total, we enrolled 307 patients at leading hospitals in the U.S., Australia, E.U. and U.K. In November 2023, we announced topline data from the AHFIRM trial that showed a compelling efficacy signal in favor of larsucosterol in the key secondary endpoint of mortality at 90 days. Both the 30 mg and 90 mg larsucosterol doses demonstrated clinically meaningful trends in reduction of mortality at 90 days with mortality reductions of 41% (p=0.068) in the 30 mg arm and 35% (p=0.124) in the 90 mg arm compared with placebo. The numerical improvement in the primary endpoint of mortality or liver transplant at 90 days did not achieve statistical significance for either dose of larsucosterol. Both doses of larsucosterol in AHFIRM showed a more pronounced reduction in mortality in patients enrolled in the U.S., representing 76% of patients enrolled in the trial. The reductions in mortality at 90 days were 57% (p=0.014) in the 30 mg arm and 58% (p=0.008) in the 90 mg arm compared with placebo in the U.S. Larsucosterol was safe and well tolerated. There were fewer treatment-emergent adverse events (“TEAEs”) in the larsucosterol arms compared with placebo. In May 2024, we announced that the FDA granted Breakthrough Therapy Designation ("BTD") to larsucosterol for the treatment of AH. In July 2024, we held a Type B meeting with the FDA to discuss the design of our planned Phase 3 clinical trial of larsucosterol in AH that, if successful, could support a potential New Drug Application filing. Following this meeting and additional interactions with the FDA under the BTD, we have designed a randomized, double-blind, placebo-controlled, multi-center U.S. Phase 3 study to evaluate the safety and efficacy of larsucosterol in patients with severe AH. The primary outcome measure will be a 90-day survival endpoint. The Phase 3 trial is planned to enroll approximately 200 patients randomized in a 1:1 ratio across two arms: (1) larsucosterol (30 mg) or (2) placebo, which will be added to the current standard of care, with or without methylprednisolone capsules in the placebo patients at the investigators’ discretion. Patients enrolled in the trial will be monitored for an additional 90 days to collect additional safety and outcomes data. Our goal is to initiate a Phase 3 clinical trial of larsucosterol in AH in 2025, subject to obtaining sufficient funding, and present topline results within two years of initiation. We have also investigated larsucosterol in patients with metabolic dysfunction-associated steatohepatitis (“MASH”), previously known as non-alcoholic steatohepatitis or NASH with encouraging results in a Phase 1b clinical trial and may consider further development of larsucosterol for this and other indications.
NOTE: POSIMIR®, SABER® , and ORADUR™ are trademarks of DURECT Corporation. Other trademarks referred to belong to their respective owners. Full prescribing information for PERSERIS, including BOXED WARNING and Medication Guide can be found at www.perseris.com.
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In addition to our Epigenetic Regulator Program, we developed a novel and proprietary post-surgical pain product called POSIMIR® that utilizes our innovative SABER® platform technology to enable continuous sustained delivery of bupivacaine, a non-opioid local analgesic, over three days in adults. In February 2021, POSIMIR received FDA approval for post-surgical pain reduction for up to 72 hours following arthroscopic subacromial decompression. In December 2021, we entered into a license agreement (as amended, the “Innocoll Agreement”) with Innocoll Pharmaceuticals Limited (“Innocoll”), pursuant to which we granted to Innocoll an exclusive, royalty-bearing, sublicensable right and license to develop, manufacture and commercialize POSIMIR in the United States.
As a result of the assignment of certain patent rights, we have in the past received single digit sales-based earn-out payments from U.S. net sales of Indivior UK Limited (“Indivior”)’s PERSERIS® (risperidone) drug for schizophrenia and single-digit royalties from net sales of Orient Pharma Co., Ltd. (“Orient Pharma”)’s Methydur Sustained Release Capsules (“Methydur”) for the treatment of attention deficit hyperactivity disorder (“ADHD”) in Taiwan. In July 2024, Indivior announced discontinuation of sales and marketing for PERSERIS due to the highly competitive market and impending changes that are expected to intensify payor management in the treatment category in which PERSERIS participates. We do not expect that this discontinuation will have a material impact on our financial statements.
Collaborative Research and Development and Other Revenue
Collaborative research and development and other revenue consists of four broad categories: (a) the recognition of upfront license payments over the period of our continuing involvement with third parties, (b) the reimbursement of qualified research expenses by third parties, (c) milestone payments in connection with our collaborative agreements and (d) royalties and earn-out payments from our agreements with third parties.
Our collaborative research and development and other revenue primarily included (a) amounts related to earn-out revenue from Indivior with respect to PERSERIS net sales, (b) research and development activities funded by our collaborators or counterparties and (c) royalty revenue from Orient Pharma with respect to Methydur net sales.
Product Revenue
We currently generate product revenue from the sale of certain key excipients used by pharmaceutical companies as raw materials in certain of their products, including Methydur and a marketed animal health product.
Because we consider our core business to be developing and commercializing pharmaceuticals, we do not intend to significantly increase our investments in or efforts to sell or market any of our existing product lines. However, we expect that we will continue to make efforts to increase our revenues related to collaborative research and development by entering into new collaborations.
Operating Results
Since our inception in 1998, we have generally had a history of operating losses. At March 31, 2025, we had an accumulated deficit of $601.6 million. Our net losses were $4.2 million for the three months ended March 31, 2025 compared with $7.6 million for the corresponding period in 2024. These losses have resulted primarily from costs incurred to research and develop our product candidates and from selling, general and administrative costs associated with our operations and product sales. We expect our research and development expenses and our selling, general and administrative expenses in the near future to decrease compared to the first quarter of 2025. We expect to incur continuing losses and negative cash flows from operations for the foreseeable future. As disclosed in the “Liquidity and Capital Resources” section, we have concluded that substantial doubt exists about our ability to continue as a going concern for a period of at least 12 months from the date of issuance of these financial statements.
Recent Developments
On May 6, 2025, Innocoll terminated the Innocoll Agreement, and transferred all data and know-how related to POSIMIR to us. We are evaluating next steps with respect to finding a new partner to commercialize POSIMIR. We do not expect that this termination will have a material impact on our financial statements.
Critical Accounting Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. We believe that the most significant accounting estimates and assumptions relate to revenue recognition, prepaid and accrued clinical costs, prepaid and accrued manufacturing costs and valuation of warrant liabilities. Actual amounts could differ significantly from these estimates. There have been no material changes to our other critical accounting estimates as compared to the disclosures in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
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Results of Operations
Comparison of three months ended March 31, 2025 and 2024
Revenue
Collaborative research and development and other revenue
We recognize revenue from collaborative research and development activities and service contracts. We expect our collaborative research and development and other revenue to fluctuate in future periods pending our efforts to enter into potential new collaborations and any royalty or earn-out revenue recognized from collaborators or counterparties.
The collaborative research and development and other revenue associated with our major collaborators or counterparties were $321,000 for the three months ended March 31, 2025, compared with $496,000 for the corresponding period in 2024. The collaborative research and development and other revenue included (a) amounts related to earn-out revenue from Indivior with respect to PERSERIS net sales, (b) research and development activities funded by our collaborators or counterparties and (c) royalty revenue from Orient Pharma with respect to Methydur net sales.
The decrease in collaborative research and development and other revenue in the three months ended March 31, 2025 compared with the corresponding period in 2024 was primarily due to lower earn-out revenue recognized from Indivior.
Product revenue, net
As previously announced, in November 2024, we completed the sale of our ALZET product line to Lafayette Instruments Co. Revenue recognized from the ALZET product line, related cost of product revenues, associated selling, general and administrative expenses have been reclassified to discontinued operations for the three months ended March 31, 2024.
Operating Expenses
Research and development
Research and development expenses are primarily comprised of salaries, benefits, stock-based compensation and other compensation costs associated with research and development personnel, overhead and facility costs, preclinical and non-clinical development costs, clinical trial and related clinical manufacturing costs, contract services, and other outside costs.
Research and development expenses were $1.9 million for the three months ended March 31, 2025 compared to $4.1 million for the corresponding period in 2024. We incurred lower research and development costs associated with larsucosterol, partially offset by higher costs in other research programs in the three months ended March 31, 2025 compared to the corresponding period in 2024, as more fully discussed below. Stock-based compensation expense recognized related to research and development personnel was $133,000 for the three months ended March 31, 2025 compared to $212,000 for the corresponding period in 2024. As of March 31, 2025, we had 9 research and development employees compared with 26 as of March 31, 2024. We expect research and development expenses in the near future to decrease compared to the first quarter of 2025 as we have reduced our research and development staff to 4 research and development employees as of May 9, 2025.
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|
Three months ended |
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|||||
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|
2025 |
|
|
2024 |
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||
Larsucosterol |
|
$ |
1,803 |
|
|
$ |
4,045 |
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Others |
|
|
80 |
|
|
|
74 |
|
Total research and development expenses |
|
$ |
1,883 |
|
|
$ |
4,119 |
|
Larsucosterol
Our research and development expenses for larsucosterol were $1.8 million in the three months ended March 31, 2025 compared to $4.0 million for the corresponding period in 2024. The decrease in the three months ended March 31, 2025 was primarily due to lower contract manufacturing expenses and lower employee-related costs for this drug candidate compared with the corresponding period in 2024.
Other DURECT programs
Our research and development expenses for all other programs were $80,000 in the three months ended March 31, 2025 compared to $74,000 for the corresponding period in 2024. The slight increase in the three months ended March 31, 2025 was primarily due to higher employee-related costs associated with these programs compared with the corresponding period in 2024. We do not expect to increase research and development for other programs at the present time.
Selling, general and administrative
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Selling, general and administrative expenses are primarily comprised of salaries, benefits, stock-based compensation and other costs associated with finance, accounting, legal, business development, sales and marketing and other administrative personnel, overhead and facility costs, and other general and administrative costs.
Selling, general and administrative expenses were $2.6 million in the three months ended March 31, 2025 compared to $2.7 million for the corresponding period in 2024. The decrease in the three months ended March 31, 2025 was primarily due to lower employee costs compared to the corresponding period in 2024. Stock-based compensation expense recognized related to selling, general and administrative personnel was $319,000 for the three months ended March 31, 2025 compared to $285,000 for the corresponding period in 2024.
We had 11 selling, general and administrative employees as of March 31, 2025 compared with 17 as of March 31, 2024. We expect selling, general and administrative expenses in the near future to decrease compared to the first quarter of 2025 as we further reduced our headcount to 10 selling, general and administrative employees as of May 9, 2025.
Other income (expense). Other expense was $24,000 in the three months ended March 31, 2025 compared to $1.4 million for the corresponding period in 2024.
Interest and other income
Interest income was $95,000 in the three months ended March 31, 2025 compared to $321,000 for the corresponding period in 2024. The decrease in the three months ended March 31, 2025 was primarily due to lower balances in our cash, cash equivalents and investments compared with the corresponding period in 2024.
Change in fair value of warrant liabilities
The change in fair value of warrant liabilities during the three months ended March 31, 2025 was comprised of a non-cash loss of $24,000 for the common warrants issued in February 2023 and a non-cash loss of $95,000 for the common warrants issued in July 2023. The change in fair value of warrant liabilities during the three months ended March 31, 2024 was comprised of a non-cash loss of $360,000 for the common warrants issued in February 2023 and a non-cash loss of $1.4 million for the common warrants issued in July 2023.
Liquidity and Capital Resources
We had cash, cash equivalents and investments totaling $8.4 million at March 31, 2025 compared to cash, cash equivalents, and investments of $12.0 million at December 31, 2024. These balances include $150,000 of interest-bearing marketable securities classified as restricted investments on our balance sheets as of March 31, 2025 and December 31, 2024. The decrease in cash, cash equivalents and investments was primarily due to cash used in ongoing operating activities, partially offset by payments received from collaboration partners and customers.
Our cash and investments policy emphasizes liquidity and preservation of principal over other portfolio considerations. We select investments that maximize interest income to the extent possible given these two constraints. We satisfy liquidity requirements by investing excess cash in securities with different maturities to match projected cash needs and limit concentration of credit risk by diversifying our investments among a variety of high credit-quality issuers.
As discussed below, we do not have sufficient cash resources to fund our planned operations and existing contractual commitments for the next 12 months. Our auditors have issued a going concern opinion as of, and for the fiscal year ended, December 31, 2024. Unless we secure funding from collaborations, additional equity or debt financing, of which there can be no assurance, we may not be able to continue operations.
Cash Flows
We used $3.5 million of cash in operating activities for the three months ended March 31, 2025 compared to $6.8 million for the corresponding period in 2024. The cash used in operations was primarily to fund operations as well as our working capital requirements. We anticipate that cash used in operating activities in the near future will decrease compared to the first quarter of 2025 due to expected decreases in operating expenses.
We received $496,000 of cash provided by investing activities for the three months ended March 31, 2025 compared to $887,000 of cash used in investing activities for the corresponding period in 2024. The increase in cash provided by investing activities was primarily due to an increase in net proceeds from maturities of available-for-sale securities for the three months ended March 31, 2025 compared with the corresponding period in 2024.
We had no financing activities for the three months ended March 31, 2025 compared to $1.5 million of cash used in financing activities for the three months ended March 31, 2024. The decrease in cash used in financing activities was primarily due to no principal payments on the term loan with Oxford Finance LLC ("Oxford Finance") during the three months ended March 31, 2025 as we paid off the term loan in full in November 2024; the $1.5 million used in financing activities for the three months ended March 31, 2024 was a result of our making principal payments on the term loan with Oxford Finance partially offset by the sale of our common
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stock in the open market pursuant to a sales agreement dated July 30, 2021 with Cantor Fitzgerald & Co. (the “2021 Sales Agreement”) for the three months ended March 31, 2024.
Shelf Registration Statement
In the first quarter of 2024, we raised net proceeds (net of commissions) of approximately $648,000 from the sale of our common stock in the open market under the 2021 Sales Agreement.
On August 14, 2024, we filed a shelf registration statement on Form S-3 with the SEC (the “2024 Registration Statement”) (File No. 333-281550), which upon being declared effective on August 23, 2024, allowed us to offer up to $250.0 million of securities from time to time in one or more public offerings. Due to the SEC’s “baby shelf” rules, which prohibit companies with a public float of less than $75 million from issuing securities under a shelf registration statement in excess of one-third of such company’s public float in a 12-month period, we are currently only able to issue a limited number of shares under our 2024 Registration Statement, which aggregate to no more than one-third of our public float.
As of May 9, 2025, we had up to $250.0 million of our securities available for sale under the 2024 Registration Statement. However, due to the SEC’s “baby shelf” rules discussed above, only up to approximately $8.8 million of our securities are currently available for sale under the 2024 Registration Statement.
Any material sales in the public market of our common stock, under the 2024 Registration Statement, could adversely affect prevailing market prices for our common stock.
Going Concern
As of March 31, 2025, we had cash, cash equivalents and investments totaling $8.4 million compared to cash, cash equivalents, and investments of $12.0 million at December 31, 2024.
In accordance with ASU No. 2014-15 Presentation of Financial Statements – Going Concern (subtopic 205-40), our management evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued. Based on our evaluation, substantial doubt exists regarding our ability to continue as a going concern for a period of one year from the issuance of our financial statements. As a result, our independent registered public accounting firm included an explanatory paragraph regarding our ability to continue as a going concern in its report on our financial statements as of, and for the year ended, December 31, 2024.
Presently, we do not have sufficient cash resources to fund our planned operations, existing debt and contractual commitments and planned capital expenditures through at least the next 12 months from issuance of these financial statements. We may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding. We expect to incur continuing losses and negative cash flows from operations for the foreseeable future.
We may decide to raise additional capital through a variety of sources in the short-term and in the long-term, including but not limited to:
There can be no assurance that we will enter into additional collaborative agreements or maintain existing collaborative agreements, will earn collaborative revenues or that additional capital will be available on favorable terms to the Company, if at all. If adequate funds are not available, we may be required to significantly reduce or re-focus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain of our products, technologies or potential markets, either of which could have a material adverse effect on our business, financial condition and results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities would result in ownership dilution to our existing stockholders (assuming convertible debt securities were converted into shares). These factors raise substantial doubt regarding our ability to continue as a going concern. Our inability to obtain required funding in the near future or our inability to obtain funding on favorable terms will have a material adverse effect on our operations and strategic development plan for future growth. If we cannot successfully raise additional capital and implement our strategic development plan, our liquidity, financial condition and business prospects will be materially and adversely affected, and we may have to cease operations.
During the three months ended March 31, 2025, there were no significant changes in our commercial commitments and contractual obligations as compared with the information presented in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025.
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Human Capital
As of May 9, 2025, we had 14 employees, including 4 in research and development and 10 in selling, general and administrative.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
As of March 31, 2025, our exposure to market risk has not changed materially since December 31, 2024. For more information on financial market risks related to changes in interest rates, reference is made to Part II, Item 7A., “Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures: The Company’s principal executive and principal financial officers reviewed and evaluated the Company’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, the Company’s principal executive and principal financial officers concluded that as of the end of the period covered by this Quarterly Report on Form 10-Q the Company’s disclosure controls and procedures are effective at ensuring that information required to be disclosed by the Company in reports that the Company files or submits under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and is accumulated and communicated to management, including the Company’s principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting: There were no significant changes in the Company’s internal control over financial reporting (as defined in Exchange Act Rule 13a-15(f)) during the Company’s most recently completed fiscal quarter that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
We are not a party to any material legal proceedings.
Item 1A. Risk Factors.
You should carefully consider the factors discussed in Part I, Item 1A., “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025, which could materially affect our business, financial position, or future results of operations. The risks described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial position, or future results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC. The risk factor set forth below supplements and updates the risk factors previously disclosed and should be read together with the risk factors described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and with any risk factors we may include in subsequent periodic filings with the SEC.
Disruptions at the FDA caused by funding shortages and uncertainty regarding the second Trump administration’s initiatives and how these might impact the FDA, its implementation of laws, regulations, policies and guidance, and its personnel, could hinder government agencies’ ability to hire and retain key leadership and other personnel or otherwise prevent the FDA from performing normal business functions on which our business operations rely, including timely reviews, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes that may otherwise affect the FDA’s ability to perform routine functions. Disruptions at the FDA, including substantial leadership, personnel, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved, which would harm our business. Changes in FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. Similar consequences would also result in the event of another significant shutdown of the federal government. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If a prolonged government shutdown occurs, or if geopolitical or global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could materially adversely affect our business, financial condition, results of operations and prospects.
With the second Trump administration, there is substantial uncertainty as to whether and how the Trump administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates. This uncertainty could present new challenges and/or opportunities as we navigate development of our product candidates. Some of these efforts have manifested to date in the form of personnel measures that could impact the FDA’s ability to hire and/or retain key personnel, which could result in delays or limitations on our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite regulatory approvals in the future. Moreover, the Trump administration has proposed action to freeze or reduce the budget of the National Institutes of Health (“NIH”), as related to its funding for medical research, which could decrease the ability of facilities that rely on NIH funding to enroll and conduct clinical trials or increase the costs to us of conducting clinical trials. There remains general uncertainty regarding future activities. The Trump administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic products. Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to our operations. If we become negatively impacted by future governmental orders, regulations, policies or guidance as a result of the Trump administration, there could be a material adverse effect on us and our business.
Item 5. Other Information
Insider Adoption or Termination of Trading Arrangements
During the fiscal quarter ended March 31, 2025, none of our directors or officers informed us of the
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Item 6. Exhibits
Exhibit Number |
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Exhibit Name |
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31.1* |
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31.2* |
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32.1** |
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32.2** |
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101 |
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The following financial statements from the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, formatted in Inline XBRL: (i) Condensed Balance Sheets, (ii) Condensed Statements of Operations, (iii) Condensed Statements of Comprehensive Income, (iv) Condensed Statements of Changes in Stockholders' Equity, (v) Condensed Statements of Cash Flows and (vi) Notes to Condensed Financial Statements, tagged as blocks of text and including detailed tags. |
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104 |
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The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, formatted in Inline XBRL (included as Exhibit 101). |
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* Filed herewith.
** Furnished, not filed.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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DURECT CORPORATION |
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By: |
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/S/ JAMES E. BROWN |
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James E. Brown Chief Executive Officer |
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Date: May 14, 2025 |
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By: |
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/S/ TIMOTHY M. PAPP |
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Timothy M. Papp Chief Financial Officer (Principal Accounting Officer) |
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Date: May 14, 2025 |
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30