DURECT Corporation

Total revenues were $2 million in 2024, down from $2.6 million in 2023; Q4 2024 revenue was $0.5 million versus $0.9 million in Q4 2023. R&D expense was $10.4 million in 2024 versus $29.4 million in 2023, and $1.9 million in Q4 versus $5.6 million a year ago. SG&A was $10 million in 2024 versus $12.7 million in 2023, and $2 million in Q4 versus $2.2 million a year ago. Cash and investments were $12 million at year-end 2024, down from $29.8 million at December 31, 2023, and management said that cash is sufficient to fund operations through the third quarter of 2025. No EPS or gross margin figures were stated. Forward-looking guidance was limited to the company’s plan to secure funding for Phase 3 larsucosterol, with management estimating the study cost at about $20 million and saying top-line data could be available in approximately two years once the trial starts.

Jim Brown framed larsucosterol as DURECT’s sole strategic focus and called it a rare opportunity to address a disease with no approved therapy. He highlighted the Phase 2b mortality signal, FDA breakthrough therapy designation, and publication/presentation milestones as validation. His tone was confident and mission-driven, and he said the company is ready to start Phase 3 as soon as financing or a business-development solution is in place.

Tim Papp said the year’s lower revenue was driven by reduced earn-out revenue from Indivior, lower revenue from feasibility agreements, and lower excipient sales. He noted R&D and SG&A both declined materially, largely because clinical trial spending fell after the Affirm trial ended and because of lower employee, consulting, patent, and audit costs. He also said year-end cash and investments were $12 million, that the company is now debt-free after using Allset sale proceeds to repay its term loan, and that the existing cash should fund operations through Q3 2025 while management explores partnerships and capital markets financing.

Analysts focused on how DURECT would finance Phase 3 and whether the company might pursue a smaller confirmatory study first. Management estimated the Phase 3 trial would cost about $20 million and said another Phase 2b study would likely be slower and less cost-effective than moving directly to Phase 3. Questions about the U.S. versus ex-U.S. data split led management to emphasize early dosing, site-level randomization, and a U.S.-only, more uniform trial design with patients dosed within nine or ten days or earlier. Management also said an ex-U.S. regional partnership or study could be considered, but the company is currently focused entirely on alcohol-associated hepatitis.