Financial Data and Key Metrics Changes - Total revenues in 2024 were 2.6 million in 2023, and 0.9 million for the prior year [5] - R&D expenses were 29.4 million in the prior year, with fourth quarter expenses at 5.6 million in 2023 [6] - SG&A expenses were 12.7 million in the prior year, and 2.2 million for the prior year [7] - Cash and investments at the end of 2024 were 29.8 million at the end of 2023, with sufficient funds to support operations through the third quarter of 2025 [8] Business Line Data and Key Metrics Changes - The decrease in revenues was attributed to lower earn-out revenue from Indivior, reduced revenue from feasibility agreements, and lower sales of excipients [6] Company Strategy and Development Direction - The company completed the sale of the Allset product line in the fourth quarter of 2024, using proceeds to repay its term loan, resulting in a debt-free status [9] - The focus is on developing larsucosterol for alcohol-associated hepatitis, with plans to explore funding options through strategic partnerships and capital markets [10] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant mortality associated with alcohol-associated hepatitis, with larsucosterol showing nearly 60% reductions in mortality in Phase 2b trials [11][13] - The FDA granted breakthrough therapy designation for larsucosterol, and the company is committed to advancing its Phase 3 trial, expecting to report top-line data in approximately two years [14][15] Other Important Information - The company is actively exploring strategic partnerships and business development opportunities to support the Phase 3 study [38] Q&A Session Summary Question: Estimated cost of the Phase 3 trial - The estimated cost for the Phase 3 trial is approximately $20 million [18] Question: Clarification on hospitalization to first dose variations - Management explained the importance of timely intervention, noting that in the US, patients are typically treated within four days, while in poorer performing regions, it can take up to two weeks [30] Question: Updates on potential strategic partnerships - The company is actively exploring various possibilities for partnerships to advance the product, though specifics could not be disclosed [38] Question: Possibility of a smaller Phase 2b study - Management indicated that conducting a Phase 3 trial is more efficient than a smaller Phase 2b study, given the need for a larger patient cohort [46] Question: Opportunities for non-funded studies in ex-US countries - There is potential for conducting regional studies with ex-US partners, although the current focus remains solely on alcohol-associated hepatitis [50]
DURECT (DRRX) - 2024 Q4 - Earnings Call Transcript