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Sep 30, 2021
Enanta Pharmaceuticals Q4 2021 Earnings Report
Reported financial results for the fiscal fourth quarter and year ended September 30, 2021.
Key Takeaways
Enanta Pharmaceuticals reported a total revenue of $23.6 million for the quarter, consisting of royalty revenue from AbbVie's hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET®. Research and development expenses were $48.9 million, and general and administrative expenses totaled $8.4 million. The company recorded a net loss of $24.6 million, or a loss of $1.22 per diluted common share. Enanta's cash, cash equivalents, and marketable securities totaled $352.4 million at September 30, 2021.
Presented first preclinical data for EDP-235, an oral protease inhibitor designed for COVID-19 treatment, with a first-in-human study planned for early 2022.
Reported positive clinical data from two Phase 1b studies of EDP-514, a Hepatitis B Virus (HBV) core inhibitor, in viremic and NUC-Suppressed chronic HBV patients; Terminated Clinical Development of EDP-721, an Oral HBV RNA Destabilizer
Announced decision to pursue combination approaches with Farnesoid X Receptor (FXR) Agonists for Non-Alcoholic Steatohepatitis (NASH) Through an Out-Licensing Strategy
Royalty revenue for the quarter was $23.6 Million
Enanta Pharmaceuticals
Enanta Pharmaceuticals
Forward Guidance
Enanta provided financial guidance for fiscal year 2022, including research and development expenses between $150 million and $170 million, and general and administrative expenses between $35 million and $41 million.
Positive Outlook
- Evaluating EDP-938, an N-protein inhibitor, in a broad clinical development program, consisting of three ongoing Phase 2 trials: RSVP, RSVTx and RSVPEDs.
- Enanta expects that enrollment in the RSVP study will be complete during the Northern Hemisphere winter season, if there is no further significant increase in COVID-19 or mitigation measures in those regions.
- Assuming this enrollment occurs, the company expects data in the first half of 2022.
- Enanta plans to move EDP-235 into the clinic in early 2022.
- On schedule to select a clinical candidate with potent nanomolar activity against both RSV-A and RSV-B by year-end.
Challenges Ahead
- For RSVTx and RSVPEDs, which were initiated more recently, enrollment is expected to require more than one global RSV season, subject to the uncertainties of the continuing pandemic.
- Terminated development of EDP-721, an oral HBV RNA destabilizer due to adverse safety signals in a Phase 1 healthy volunteer study.
- Announced a strategic decision to discontinue internal development of FXR agonists EDP-305 and EDP-297, to prioritize combination approaches for NASH through out-licensing.
- The dependence of Enanta’s revenues in the short-term upon the continued success of AbbVie’s sales of its MAVYRET/MAVIRET HCV regimen
- Enanta’s lack of clinical development experience