Enanta Pharmaceuticals(ENTA)

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Enanta Pharmaceuticals(ENTA) - 2022 Q1 - Quarterly Report
2022-02-10 00:46
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35839 ENANTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 2834 04-3205099 (State or other jurisdiction of incorporation or organi ...
Enanta Pharmaceuticals(ENTA) - 2022 Q1 - Earnings Call Transcript
2022-02-09 02:08
Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $27.6 million, down from $31.7 million in the same period of 2021, entirely consisting of royalty revenue from AbbVie's HCV product sales of $427 million [27][28]. - Net loss for the quarter was $30.1 million, or a loss of $1.48 per diluted share, compared to a net loss of $8.3 million, or a loss of $0.41 per diluted share in Q1 2021 [33]. Business Line Data and Key Metrics Changes - Research and development expenses increased to $48.5 million from $36.7 million in the same period last year, primarily due to the timing of manufacturing for clinical studies [30]. - General and administrative expenses rose to $9.5 million from $7.4 million, attributed to increased headcount and compensation [31]. Market Data and Key Metrics Changes - AbbVie reported global HCV sales of $1.7 billion for calendar 2021 and guided to the same amount for 2022, indicating a flat year due to COVID-19 impacts [30][72]. Company Strategy and Development Direction - The company is focused on developing antiviral treatments for respiratory syncytial virus (RSV), COVID-19, and hepatitis B, with multiple clinical programs underway [5][22]. - Enanta aims to establish itself as a leader in the development of treatments for respiratory viruses, with a strong emphasis on high-risk patient populations for RSV and COVID-19 [16][20]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their antiviral candidates, particularly EDP-938 for RSV and EDP-235 for COVID-19, highlighting their robust clinical data and safety profiles [11][19]. - The company expects to report top-line data from the RSVP study of EDP-938 in the next quarter and plans to initiate a Phase 1 study for EDP-323, an RSV L-inhibitor, in the second half of the year [25][16]. Other Important Information - Enanta ended the quarter with $347.7 million in cash and marketable securities, which is expected to be sufficient for at least the next two years [33]. - The company is committed to evaluating internal and external opportunities for additional compounds to enhance its hepatitis B treatment regimen [24]. Q&A Session Summary Question: What are the competitive opportunities for EDP-235? - Management indicated that the Phase 1 study is about to begin and they plan to share safety and pharmacokinetic data in the first half of the year. They believe EDP-235 has advantages in terms of pharmacokinetics and tissue targeting [35][36]. Question: How severe are RSV symptoms this season compared to previous seasons? - Management noted that they have not observed any worsening of symptoms in current studies, and the median age of participants is expected to be around 50 [39][41]. Question: What is the strategy for the L-protein inhibitor? - The company plans to target high-risk populations for the L-protein inhibitor and is exploring various ways to position the drug in combination with other agents [46][48]. Question: How will the RSVP study inform future trials? - Management stated that the RSVP study will help de-risk future studies in high-risk populations, and they are focused on targeting pediatric and transplant patients [53][80]. Question: What is the outlook for Mavyret revenues? - The company expects AbbVie's guidance of $1.7 billion in 2022 to support ongoing royalty revenues, which will help sustain operations for at least the next two years [72][76].
Enanta Pharmaceuticals(ENTA) - 2021 Q4 - Annual Report
2021-11-24 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35839 | --- | --- | --- | |-----------------------------------------|------------------------------------------------------------|----------------------------------------------- ...
Enanta Pharmaceuticals(ENTA) - 2021 Q4 - Earnings Call Transcript
2021-11-23 02:47
Financial Data and Key Metrics Changes - For Q4 2021, total revenue was $23.6 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 $36.7 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 $1.22 per diluted share, compared to a net loss of $29.3 million, or a loss of $1.46 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 $352.4 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]
Enanta Pharmaceuticals (ENTA) Investor Presentation - Slideshow
2021-09-17 20:17
E N A N T A Pharmaceuticals CREATING SMALL MOLECULE DRUGS FOR VIRAL INFECTIONS AND LIVER DISEASES Corporate Presentation September 13, 2021 Forward Looking Statements Disclaimer This presentation contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our research and development programs, our business and the industry in which we operate. Any statements contained herein that are not statements of ...
Enanta Pharmaceuticals(ENTA) - 2021 Q3 - Quarterly Report
2021-08-09 20:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35839 ENANTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 2834 04-3205099 (State or other jurisdiction of incorporation or organizati ...
Enanta Pharmaceuticals(ENTA) - 2021 Q3 - Earnings Call Transcript
2021-08-08 16:37
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q3 2021 Earnings Conference Call August 5, 2021 4:30 PM ET Company Participants Jennifer Viera - Investor Relations Dr. Jay Luly - President and CEO Paul Mellett - Chief Financial Officer Nathalie Adda - Chief Medical Officer Conference Call Participants Brian Skorney - Baird Swapnil Malekar - Piper Sandler Brian Abrahams - RBC Capital Markets Roy Buchanan - JMP Securities Zegbeh Jallah - ROTH Capital Markets Operator Good afternoon. And welcome to Enanta Pharmaceu ...
Enanta Pharma (ENTA) Investor Presentation - Slideshow
2021-06-25 17:36
E N A N T A Pharmaceuticals CREATING SMALL MOLECULE DRUGS FOR VIRAL INFECTIONS AND LIVER DISEASES Corporate Presentation June 22, 2021 Forward Looking Statements Disclaimer This presentation contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our research and development programs, our business and the industry in which we operate. Any statements contained herein that are not statements of histo ...
Enanta Pharmaceuticals(ENTA) - 2021 Q2 - Quarterly Report
2021-05-10 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35839 ENANTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 2834 04-3205099 (State or other jurisdiction of incorporation or organizat ...
Enanta Pharmaceuticals(ENTA) - 2021 Q2 - Earnings Call Transcript
2021-05-10 05:39
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q2 2021 Earnings Conference Call May 6, 2021 4:30 PM ET Company Participants Jennifer Viera - Investor Relations Jay Luly - President and Chief Executive Officer Paul Mellett - Chief Financial Officer Nathalie Adda - Chief Medical Officer Conference Call Participants Brian Abrahams - RBC Capital Markets Yasmeen Rahimi - Piper Sandler Eric Joseph - J.P. Morgan Roy Buchanan - JMP Securities LLC Brian Skorney - Robert W. Baird & Co. William Lee - Wolfe Research, LLC Z ...