Enanta Pharmaceuticals(ENTA) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q3 2022, total revenue was $19.5 million, a decrease from $21.6 million in the same period of 2021, primarily due to lower royalty revenue from AbbVie's MAVYRET sales [32] - Research and development expenses decreased to $39.1 million from $47 million year-over-year, attributed to the timing of clinical trials [33] - General and administrative expenses increased to $12.9 million from $8.4 million, driven by higher headcount and compensation expenses [33] - Net loss for the quarter was $31.7 million, or a loss of $1.53 per diluted share, compared to a net loss of $24 million, or a loss of $1.19 per diluted share in Q3 2021 [34] - The company ended the quarter with approximately $292.7 million in cash and marketable securities, expected to be sufficient for the next two years [34] Business Line Data and Key Metrics Changes - The company is advancing its COVID-19 treatment candidate EDP-235, which has shown promising Phase I trial results, indicating potential for a best-in-class antiviral treatment [6][12] - EDP-938, part of the RSV program, did not meet primary endpoints in a Phase IIb trial but showed a statistically significant antiviral effect in a low-risk population [17] - EDP-514, a core inhibitor for hepatitis B, is being developed as part of a combination regimen for chronic HBV patients, with promising Phase Ib study results [24] Market Data and Key Metrics Changes - The COVID-19 landscape remains dynamic, with ongoing infections due to new variants, highlighting the need for effective antiviral treatments [14] - The RSV program targets high-risk populations, including children and the elderly, where there is a significant unmet medical need [16] Company Strategy and Development Direction - The company aims to leverage its expertise in virology and liver disease to develop groundbreaking medicines, focusing on antiviral treatments for COVID-19 and RSV [5] - EDP-235 is designed to be a once-daily oral treatment without the need for ritonavir boosting, facilitating rapid treatment of COVID infections [15] - The company is also pursuing a broad clinical development plan for EDP-938, focusing on high-risk populations for RSV [19] Management's Comments on Operating Environment and Future Outlook - Management highlighted the urgent need for convenient antiviral treatments for COVID-19, especially with the emergence of new variants [14] - The company plans to finalize the Phase II protocol for EDP-235 and initiate the study in Q4 2022, with expectations to advance to Phase III next year [13][39] - Management expressed confidence in the potential of EDP-514 as a best-in-class core inhibitor for HBV, emphasizing the importance of combination therapy [25] Other Important Information - The company is involved in ongoing patent litigation regarding Pfizer's infringement of its patent related to COVID-19 antiviral treatments [26] - A new Chief Medical Officer, Dr. Scott Rottinghaus, has joined the company, bringing extensive experience in infectious diseases [28] Q&A Session Summary Question: Potential for accelerated approval of COVID antivirals - Management indicated that antiviral development differs from vaccines and antibodies, and an accelerated path for antivirals is not expected [37][38] Question: Design considerations for Phase II trials - Management is currently designing the Phase II trial, considering the changing vaccination status and variant landscape [39] Question: Lung-to-plasma ratio and EC90 data - The 4:1 lung-to-plasma ratio refers to total drug measurements, and the EC90 data was not adjusted for plasma [41][43] Question: Concerns about paxlovid rebound - Management hypothesized that paxlovid's short half-life may contribute to rebound issues, while EDP-235 has a longer half-life and better tissue targeting [45][47] Question: Potential for combination therapies - Currently, there is no need for combination therapies with EDP-235, but the company is exploring other mechanisms for future variants [64][66] Question: Cost and patient response in trials - The cost of trials for EDP-235 will depend on trial design, and low variability was observed in the Phase I study, with expectations for high patient response rates [68][71]