DURECT (US:DRRX)2019-05-09 17:46Financial Data and Key Metrics Changes - Total revenues increased to $4.1 million in Q1 2019 from $3.5 million in Q1 2018, representing a growth of approximately 17% [6] - Product revenue from ALZET pumps and LACTEL Polymers rose to $2.6 million in Q1 2019 compared to $2.4 million in Q1 2018, showing a 8.3% increase [6] - Gross margin for ALZET and LACTEL product lines was 57% in Q1 2019 [6] - R&D expenses decreased to $6.3 million in Q1 2019 from $7.0 million in Q1 2018, primarily due to lower costs associated with POSIMIR [7] - SG&A expenses increased to $3.5 million in Q1 2019 from $3.2 million in Q1 2018 [7] - Cash and investments at March 31, 2019, were $28.8 million, down from $34.5 million at December 31, 2018 [7] Business Line Data and Key Metrics Changes - DUR-928 is being developed for three indications: alcoholic hepatitis (AH), non-alcoholic steatohepatitis (NASH), and psoriasis [9] - The company initiated dosing in NASH and psoriasis trials of DUR-928 during Q1 2019 [8] - Preliminary data from the ongoing Phase IIa clinical trial of DUR-928 in AH showed that all patients dosed survived through the trial period of 4 weeks [40] Market Data and Key Metrics Changes - Alcoholic hepatitis is a significant health issue, with over 320,000 hospitalizations annually in the U.S. and a short-term mortality rate of 30% to 50% for severe cases [42][43] - Alcohol-related liver disease is now the leading indication for liver transplantation in the U.S. [36][43] Company Strategy and Development Direction - The company plans to submit a response to the Complete Response Letter for POSIMIR and anticipates a 6-month FDA review period [14] - The focus is on developing DUR-928 as a potential treatment for alcoholic hepatitis, with hopes of starting a pivotal trial in 2020 [57] - The company aims to address the significant unmet medical need in alcoholic hepatitis, where current treatment options are limited [73] Management's Comments on Operating Environment and Future Outlook - Management highlighted the encouraging preliminary data from the DUR-928 trial, indicating potential efficacy in treating alcoholic hepatitis [40][57] - The management expressed optimism about the potential for DUR-928 to reduce mortality in patients with alcoholic hepatitis [57] - The company recognizes the high mortality rates associated with alcoholic hepatitis and the need for novel therapies [36][57] Other Important Information - The company has completed 16 clinical trials in the POSIMIR program involving over 1,400 patients [15] - The company receives quarterly earnout payments based on a single-digit percentage of U.S. net sales of Indivior's PERSERIS product, which is projected to generate $200 million to $300 million in peak-year net revenue [17] Q&A Session Summary Question: What is the current status of the DUR-928 trial? - The trial has completed dosing in all 10 patients, with no drug-related safety issues reported [46] Question: What are the expected outcomes for the DUR-928 trial? - The company anticipates presenting data from the completed trial at the American Association of the Study of Liver Disease meeting this fall [41] Question: How does the company view the competitive landscape for alcoholic hepatitis treatments? - There are currently no approved treatments for alcoholic hepatitis, highlighting a significant unmet medical need [73]