DURECT (US:DRRX)2021-03-05 03:10Financial Data and Key Metrics Changes - Total revenue in Q4 2020 was $2.2 million, down from $9 million in Q4 2019, primarily due to the recognition of $6.1 million in deferred revenue in the previous year [7] - Product revenue from ALZET pumps was $1.9 million in Q4 2020, compared to $1.7 million in Q4 2019, with a gross margin of 78% [7] - R&D expenses decreased to $6.7 million in Q4 2020 from $9.3 million in Q4 2019, while SG&A expenses were $3.4 million, down from $3.7 million [8] - Cash, cash in escrow, and investments totaled $56.9 million as of December 31, 2020, compared to $64.8 million a year earlier [9] Business Line Data and Key Metrics Changes - The sale of the LACTEL product line to Evonik for $15 million resulted in a gain of approximately $12.8 million, reflected in net income for Q4 2020 [5][6] - Product revenue continues to be strong and cash flow positive, indicating a stable performance in the ALZET pumps segment [7] Market Data and Key Metrics Changes - The FDA granted fast track designation for DUR-928 for the treatment of alcohol-associated hepatitis (AH), indicating a favorable regulatory environment for the product [11][28] - The incidence of AH has reportedly increased during the pandemic, with a noted rise in younger patients [18][76] Company Strategy and Development Direction - The company is focusing on the AHFIRM trial for DUR-928, a Phase 2b study aimed at demonstrating survival benefits in severe AH patients, with a potential NDA filing if successful [54][56] - POSIMIR, a non-opioid analgesic, received FDA approval for post-surgical analgesia, and the company is exploring commercial partnerships to maximize its market potential [39][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the AHFIRM trial, citing the lack of approved therapies for AH and the potential for DUR-928 to fill this gap [15][54] - There is a growing awareness of alcohol-related liver disease, which may lead to increased hospitalizations and a larger patient population for DUR-928 [76][81] Other Important Information - The company appointed two experienced biopharmaceutical executives to its board, enhancing its leadership team [53] - The discontinuation of the COVID-19 trial allows the company to redirect resources to the AHFIRM trial, which is expected to have a more significant impact [29][90] Q&A Session Summary Question: Update on DUR-928 manuscript publication and mechanism of action - Management is close to finalizing the manuscript, which will clarify the mechanism of action of DUR-928, involving multiple signaling pathways [60][61] Question: Comparison of AHFIRM trial timeline with Gilead's trial - The current environment is expected to facilitate faster enrollment compared to Gilead's trial, which faced more stringent patient eligibility criteria [63][67] Question: Market size for subacromial decompression surgeries - There are over 600,000 subacromial decompression surgeries performed annually in the U.S., presenting a significant market opportunity for POSIMIR [68][69] Question: Long-term outlook for alcohol-related hospitalizations post-pandemic - There is uncertainty, but increased awareness and prior trends suggest that the need for treatment may persist beyond the pandemic [76][81] Question: Opportunities for DUR-928 beyond AH - The company is exploring other indications for DUR-928, including acute organ injury, while currently prioritizing AH due to its significant societal impact [88][90] Question: Enrollment mix for AHFIRM trial - The company anticipates approximately 30 sites in the U.S. and 20 in Europe and Australia for the AHFIRM trial, aiming for a balanced enrollment strategy [92]