DURECT (US:DRRX)2022-11-03 00:32Financial Data and Key Metrics Changes - Total revenues in Q3 2022 were $12 million, a significant increase from $2.2 million in Q3 2021, driven by $10 million in milestone payments from the POSIMIR agreement with Innocoll [4] - R&D expenses rose to $9.9 million from $8 million year-over-year, primarily due to higher clinical trial costs and employee benefits [5] - SG&A expenses increased to $3.9 million from $3.2 million, attributed to higher employee benefits, patent expenses, and consulting costs [5] - Cash and investments as of September 30, 2022, were $52 million, down from $70 million at the end of 2021, with a cash burn of $2.3 million during Q3 [6] Business Line Data and Key Metrics Changes - The company reported milestone payments of $10 million from Innocoll related to the POSIMIR product launch in the U.S. [11][25] - The AHFIRM trial for larsucosterol is progressing well, with over 200 patients dosed out of a target of 300, and enrollment expected to complete in Q2 2023 [10][12] Market Data and Key Metrics Changes - Alcoholic Hepatitis (AH) represents a significant healthcare burden, with approximately 158,000 hospitalizations annually in the U.S. and a 90-day mortality rate of about 30% [15] - The average cost of treating a hospitalized AH patient ranges from $53,000 to $147,000, while liver transplant costs can reach approximately $875,000 [16] Company Strategy and Development Direction - The primary focus remains on completing enrollment in the Phase IIb AHFIRM trial for larsucosterol, which has the potential to be the first FDA-approved treatment for AH [10][14] - The company is exploring international market opportunities for larsucosterol, particularly in Europe, where similar trends in AH cases are observed [30][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the AHFIRM trial's success, citing compelling Phase IIA study data and the drug's mechanism of action [27] - The company is actively working with European data vendors to understand AH diagnoses and educate physicians about the trial [33] Other Important Information - A shareholder meeting is scheduled for November 22 to discuss a potential reverse stock split to maintain NASDAQ listing [7][8] - The FDA has granted fast track designation for the larsucosterol AH program, which could support an NDA filing if the AHFIRM trial is successful [14] Q&A Session Summary Question: How is the company maximizing the opportunity for AH globally? - Management acknowledged the global nature of AH and is working with thought leaders in Europe to address the unmet need and potentially establish partnerships for commercialization [30][31] Question: What is the strategy behind the selection of clinical trial sites? - The company focused on high-volume sites with experienced clinicians to ensure quality data, with plans to expand to broader bases post-approval [36][41] Question: What are the expectations for POSIMIR sales? - Management refrained from projecting sales figures, but noted positive initial feedback from surgeons regarding the product's effectiveness [70] Question: Can you clarify the changes to the mortality or liver transplant endpoint? - The endpoint was adjusted to include liver transplant as a potential outcome, recognizing its significance in patient survival rates [45][48] Question: What is the timeline for data processing after enrollment completion? - Following the completion of enrollment in Q2 2023, data processing is expected to take several months, with a focus on analysis before unblinding [61]