Workflow
Enanta Pharmaceuticals(ENTA) - 2021 Q4 - Earnings Call Transcript
ENTAEnanta Pharmaceuticals(ENTA)2021-11-23 02:47
Filings

Financial Data and Key Metrics Changes - For Q4 2021, total revenue was 23.6million,consistentwiththesameperiodin2020,primarilyfromroyaltyrevenueonAbbVie′sHCVproductsales[19][20]−Researchanddevelopmentexpensesincreasedto23.6 million, consistent with the same period in 2020, primarily from royalty revenue on AbbVie's HCV product sales [19][20] - Research and development expenses increased to 48.9 million from 36.7millionyear−over−year,attributedtotheexpansionofclinicaltrials[20]−NetlossforQ42021was36.7 million year-over-year, attributed to the expansion of clinical trials [20] - Net loss for Q4 2021 was 24.6 million, or a loss of 1.22perdilutedshare,comparedtoanetlossof1.22 per diluted share, compared to a net loss of 29.3 million, or a loss of 1.46perdilutedshareinQ42020[23]BusinessLineDataandKeyMetricsChanges−ThecompanyisadvancingitsclinicalprogramsinhepatitisB,withEDP−514showingsignificantantiviralactivityinPhase1studies[5][7]−TherespiratoryvirologyportfolioincludesEDP−938,whichisinmultiplePhase2studies,demonstratingrobustclinicaldata[10][11]−DevelopmentofEDP−721wasdiscontinuedduetosafetyobservations,whilethefocusremainsonEDP−514forchronicHBVtreatment[9]MarketDataandKeyMetricsChanges−AbbVieexpectstotalHCVsalesofapproximately1.46 per diluted share in Q4 2020 [23] Business Line Data and Key Metrics Changes - The company is advancing its clinical programs in hepatitis B, with EDP-514 showing significant antiviral activity in Phase 1 studies [5][7] - The respiratory virology portfolio includes EDP-938, which is in multiple Phase 2 studies, demonstrating robust clinical data [10][11] - Development of EDP-721 was discontinued due to safety observations, while the focus remains on EDP-514 for chronic HBV treatment [9] Market Data and Key Metrics Changes - AbbVie expects total HCV sales of approximately 1.7 billion for 2021, with treated patient volumes remaining suppressed compared to pre-COVID levels [19] - The company anticipates that the reemergence of RSV will facilitate enrollment in clinical studies during the Northern Hemisphere winter season [12] Company Strategy and Development Direction - The company aims to develop a functional cure for chronic hepatitis B patients, focusing on combination regimens involving EDP-514 [9][17] - A strategic decision was made to prioritize combination approaches for NASH FXR agonists through out-licensing, rather than continuing internal development [17] - The company is exploring external opportunities for additional mechanisms to enhance its HBV treatment strategy [61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of EDP-235 as a best-in-class oral therapy for COVID-19, with plans to advance it into clinical trials in early 2022 [16][17] - The ongoing pandemic is expected to transition towards an endemic phase, where effective therapeutics will remain crucial [17] - Management acknowledged the challenges posed by the pandemic on patient recruitment and clinical trial designs, emphasizing the need for adaptive strategies [51] Other Important Information - The company ended the quarter with approximately 352.4millionincashandmarketablesecurities,sufficienttomeetanticipatedcashrequirementsforatleastthenexttwoyears[24]−Fiscal2022guidanceincludesresearchanddevelopmentexpensesprojectedbetween352.4 million in cash and marketable securities, sufficient to meet anticipated cash requirements for at least the next two years [24] - Fiscal 2022 guidance includes research and development expenses projected between 150 million to $170 million [24] Q&A Session Summary Question: Can you discuss the IND-enabling tox work for EDP-235? - Management confirmed completion of multi-week GLP tox studies, indicating a comfortable safety margin for predicted clinical doses [27] Question: Will you explore testing EDP-235 in combination with other classes? - Management noted that combinations could be considered based on the evolving nature of the pandemic and viral variants [29] Question: What is the potential for achieving a functional cure in hepatitis B with EDP-514? - Management believes that a core inhibitor plus a NUC would benefit from additional agents to enhance treatment efficacy [31] Question: How will you stratify patients in the RSV studies? - Management confirmed that viral load will be monitored, and analyses will include thresholds based on viral load at the time of dosing [38] Question: What are the plans for partnering EDP-235? - Management indicated that partnerships are likely but will depend on the progress of clinical trials and data generation [45] Question: How will you approach clinical development for EDP-235 given competition? - Management acknowledged the need for adaptive trial designs, potentially favoring non-inferiority studies depending on the patient population targeted [51]