DURECT Corporation Reports $8.3 Million Net Loss for Fiscal Year 2024

DURECT Corporation (DURECT), a biopharmaceutical company, reported a net loss of $8.3 million for the fiscal year ended December 31, 2024, compared to a net loss of $27.6 million in 2023. Revenue totaled $2.0 million in 2024, a decrease from $2.6 million in 2023. This decrease was primarily due to lower earn-out revenue from Indivior, reduced revenue from feasibility agreements, and lower product revenue related to excipients for Methydur. Research and development expenses decreased significantly to $10.4 million in 2024 from $29.4 million in 2023, primarily due to the completion of the AHFIRM trial and lower costs associated with larsucosterol.

The company's lead product candidate, larsucosterol, completed a Phase 2b clinical trial (AHFIRM) in 2023, showing a compelling efficacy signal in reducing 90-day mortality in patients with alcohol-associated hepatitis (AH), although the primary endpoint was not met. Larsucosterol received Breakthrough Therapy Designation (BTD) from the FDA in May 2024. A Type B meeting with the FDA in July 2024 discussed the design of a planned Phase 3 clinical trial for larsucosterol in AH, which is expected to begin soon, pending sufficient funding, with topline results anticipated within two years of initiation. The company also completed a Phase 1b trial of larsucosterol in patients with MASH, showing encouraging results.

In November 2024, DURECT sold its ALZET product line to Lafayette Instrument Co. for $17.5 million. This sale resulted in a gain of $11.5 million, which was reported as income from discontinued operations. The company also noted the termination of its license agreement with Innocoll for POSIMIR, effective May 6, 2025, with Innocoll transferring all related data and know-how to DURECT. Indivior's discontinuation of sales and marketing for PERSERIS in July 2024 is not expected to materially impact DURECT's financial statements. As of March 25, 2025, DURECT employed 21 people, with 9 in research and development and 12 in selling, general, and administrative roles.

The company's financial statements included an explanatory paragraph from the independent registered public accounting firm, WithumSmith+Brown, PC, expressing substantial doubt about DURECT's ability to continue as a going concern due to recurring operating losses and negative cash flows. DURECT's cash, cash equivalents, and investments totaled $12.0 million at December 31, 2024, down from $29.8 million at December 31, 2023. The company plans to seek additional funding through collaborations, equity or debt financing, or asset sales to address its liquidity concerns. The company's common stock is traded on the Nasdaq Capital Market under the symbol "DRRX," and received a deficiency letter from Nasdaq in January 2025 for failing to meet the minimum bid price requirement.

DURECT's outlook is contingent upon the successful development and commercialization of larsucosterol, securing additional funding, and navigating the challenges associated with regulatory approvals and market competition. The company's future financial performance will depend on these factors, as well as its ability to manage its operating expenses and achieve profitability. The company's financial statements and disclosures are subject to various accounting estimates and assumptions, which could materially affect its reported results.