Enanta Pharmaceuticals(ENTA) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q2 2021, total revenue was $20.1 million, a decrease from $27.6 million in the same period of 2020, primarily due to lower royalty revenue from AbbVie's MAVYRET product sales [31][32] - Royalty revenue was based on 50% of MAVYRET sales at a royalty rate of 10%, with AbbVie's global MAVYRET product sales reported at $415 million [31][32] - Net loss for the quarter was $22 million, or a loss of $1.09 per diluted common share, compared to a net loss of $6 million, or a loss of $0.30 per diluted common share, for the same period in 2020 [36] Business Line Data and Key Metrics Changes - The company has three active clinical programs in virology and liver diseases, conducting seven clinical trials, including studies for hepatitis B, respiratory syncytial virus (RSV), and non-alcoholic steatohepatitis (NASH) [6][7][27] - Preliminary data from the Phase 1b study of EDP-514 in chronic HBV patients showed it was safe and well-tolerated, with a mean reduction of 1 log in HBV RNA compared to 0.3 log reduction in placebo [10][13] Market Data and Key Metrics Changes - The ongoing studies for EDP-938 in RSV are crucial as RSV is expected to reemerge globally after COVID-19 mitigation measures subside, with trial sites established in multiple regions [22][23] - The company is preparing for the initiation of clinical trials for EDP-721, an oral HBV RNA destabilizer, expected to start in mid-2021 [19][29] Company Strategy and Development Direction - The company aims to develop an all-oral functional cure for chronic HBV infection by combining EDP-514 and EDP-721, targeting multiple mechanisms to enhance treatment efficacy [16][18][66] - The strategy includes exploring combination therapies with external agents, such as siRNA or immunotherapy, to enhance the chances of achieving a functional cure for HBV [62][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming catalysts across the pipeline, including preliminary results from the Phase 1b study of EDP-514 in viremic HBV patients and the initiation of EDP-721 trials [5][29] - The impact of COVID-19 on clinical trial recruitment and timelines was acknowledged, particularly for the NASH program, with expectations for interim analysis data to be reported in Q3 2021 [27][51] Other Important Information - The company ended the quarter with approximately $400 million in cash and marketable securities, providing a strong financial position to support ongoing and future clinical trials [36] - The company is also advancing its discovery initiatives for SARS-CoV-2, focusing on developing oral protease and polymerase inhibitors [26][71] Q&A Session Summary Question: Can you provide more granularity on RNA declines and the 800 mg dose optimization for EDP-514? - Management noted high trough levels at both 200 mg and 400 mg doses, with a focus on safety and tolerability rather than virology in the current study [38][40][41] Question: What are the latest views on the NASH program and potential paths forward? - Management highlighted the ongoing studies for EDP-297 and EDP-305, with expectations for data in mid-2021 and a focus on identifying effective doses for combination therapies [47][52] Question: Were any serological tests done at week 2 for EDP-514? - Management clarified that the study was not designed to assess viral loads at that time, but the data will be compiled for future analysis [54][57] Question: Can you discuss the safety profile of EDP-514 and the onset of adverse events? - Management indicated that adverse events were mild and scattered throughout the study, with no concerning patterns observed [63] Question: How does the company view the potential for protease inhibitors versus polymerase inhibitors for COVID-19? - Management expressed confidence in both targets, emphasizing the importance of targeting conserved regions to minimize resistance [78][79] Question: What are the regulatory considerations for the RSV program? - Management stated that discussions with the FDA regarding pivotal trial designs and endpoints will occur after finalizing the Phase 2b program [89]