Enanta Pharmaceuticals(ENTA)

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Enanta Pharmaceuticals(ENTA) - 2023 Q3 - Quarterly Report
2023-08-07 16:00
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, 2023 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 04-3205099 (State or other jurisdiction of incorporation or organization) 5 ...
Enanta Pharmaceuticals(ENTA) - 2023 Q1 - Earnings Call Presentation
2023-05-11 15:08
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19 • Low frequency of adverse events; most were mild in severity – 1.3%, 6.4%, and 2.6% in the EDP-235 200mg, 400mg and placebo arms Clinical Symptoms – Additional analysis of patients with baseline viral load >5 log showed decline of 0.4 log at day 3 with EDP-235 compared to placebo • Rapid decline in nasal viral RNA observed in all study ar ...
Enanta Pharmaceuticals(ENTA) - 2023 Q2 - Quarterly Report
2023-05-08 16:00
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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ENANTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 04-3205099 (State or other jurisdiction of incorporation or organization) 500 Arsenal Street Watertown, Mas ...
Enanta Pharmaceuticals(ENTA) - 2023 Q1 - Earnings Call Transcript
2023-02-08 03:12
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q1 2023 Earnings Conference Call February 7, 2023 4:30 PM ET Company Participants Jennifer Viera – Investor Relations Jay Luly – President and Chief Executive Officer Paul Mellett – Chief Financial Officer Tara Kieffer – Senior Vice President-New Product Strategy Development Conference Call Participants Joe Kim – RBC Luke Herrmann – Baird Roanna Ruiz – SVB Securities Matthew Hershenhorn – Oppenheimer Ed Arce – H.C. Wainwright & Co Eric Joseph – JPMorgan Roy Buchana ...
Enanta Pharmaceuticals(ENTA) - 2023 Q1 - Quarterly Report
2023-02-07 16:00
[PART I. UNAUDITED FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20UNAUDITED%20FINANCIAL%20INFORMATION) This section presents the company's unaudited consolidated financial statements, management's discussion of financial condition, market risk disclosures, and controls and procedures [Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) The company's financial statements for Q4 2022 show decreased assets, a net loss of $29.0 million, and $35.6 million cash used in operations [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $347.5 million by December 31, 2022, driven by reduced cash, while liabilities and equity also declined Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2022 | Sep 30, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $42,223 | $43,994 | | Total current assets | $283,704 | $311,713 | | **Total assets** | **$347,534** | **$375,410** | | Total current liabilities | $23,001 | $29,827 | | **Total liabilities** | **$46,697** | **$54,076** | | **Total stockholders' equity** | **$300,837** | **$321,334** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Total revenue for Q4 2022 was $23.6 million, with a net loss of $29.0 million, an improvement from the prior year due to lower R&D expenses Quarterly Operating Results (in thousands, except per share data) | Metric | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | | :--- | :--- | :--- | | Royalty revenue | $22,585 | $27,648 | | Total revenue | $23,585 | $27,648 | | Research and development | $40,902 | $48,549 | | General and administrative | $12,696 | $9,508 | | Loss from operations | ($30,013) | ($30,409) | | **Net loss** | **($28,986)** | **($30,115)** | | **Net loss per share, basic and diluted** | **($1.39)** | **($1.48)** | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $35.6 million in Q4 2022, resulting in a net decrease in cash of $1.8 million Summary of Cash Flows (in thousands) | Activity | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($35,641) | ($13,271) | | Net cash provided by investing activities | $33,569 | $45,501 | | Net cash provided by financing activities | $301 | $9,632 | | **Net (decrease) increase in cash** | **($1,771)** | **$41,862** | [Notes to Consolidated Financial Statements (unaudited)](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements%20(unaudited)) Notes detail the company's drug development business, funding from AbbVie royalties, ongoing net losses, and a patent infringement lawsuit against Pfizer - The company's primary business is the discovery and development of small molecule drugs for viral infections, with R&D programs focused on RSV, SARS-CoV-2, HBV, and hMPV. Operations are funded by royalties from its collaboration with AbbVie on the HCV drug MAVYRET/MAVIRET[24](index=24&type=chunk) - The company has a collaboration agreement with AbbVie for HCV protease inhibitors, receiving tiered royalties on net sales of MAVYRET/MAVIRET. Total proceeds from the collaboration have reached approximately **$1.228 billion** through December 31, 2022[45](index=45&type=chunk) - In June 2022, Enanta filed a patent infringement lawsuit against Pfizer, Inc., seeking damages for the manufacture, use, and sale of Paxlovid™, alleging it infringes on Enanta's U.S. Patent No. 11,358,953[55](index=55&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses decreased royalty revenue, reduced R&D expenses, and the company's cash position, expected to fund operations into Q4 fiscal 2024, alongside pipeline progress [Overview](index=16&type=section&id=Overview) Enanta, a biotechnology company, focuses on antiviral drug development, funded by HCV royalties, and expects continued net losses while holding **$241.4 million** in cash - The company's primary R&D focus is on treatments for respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19), hepatitis B virus (HBV), and human metapneumovirus (hMPV)[62](index=62&type=chunk)[65](index=65&type=chunk) - The company reported a net loss of **$29.0 million** for the quarter ended December 31, 2022, and expects to continue incurring net losses for the foreseeable future[63](index=63&type=chunk) - As of December 31, 2022, cash, cash equivalents, and marketable securities totaled **$241.4 million**, which is expected to fund operations into approximately the fourth quarter of fiscal 2024[65](index=65&type=chunk) [Our Wholly-Owned Programs](index=17&type=section&id=Our%20Wholly-Owned%20Programs) Enanta is advancing antiviral candidates, including EDP-938 in Phase 2 for RSV, EDP-235 in Phase 2 for COVID-19, and EDP-514 for HBV, with new programs for hMPV/RSV - **RSV Program:** EDP-938 is in three ongoing Phase 2 studies (RSVPEDs, RSVTx, RSVHR) in high-risk populations. A Phase 1 study of a second compound, EDP-323, was initiated with data expected in Q2 2023[67](index=67&type=chunk) - **COVID-19 Program:** Lead candidate EDP-235 is in a Phase 2 study (SPRINT) with data expected in Q2 2023. A Phase 3 study could initiate in the second half of 2023. A new program targeting the PLpro enzyme was also announced[68](index=68&type=chunk)[69](index=69&type=chunk) - **HBV and hMPV Programs:** The lead HBV candidate, EDP-514, is a core inhibitor with potential to be best-in-class. A new research program is targeting a dual inhibitor for hMPV and RSV, with a clinical candidate selection expected in Q4 2023[69](index=69&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Q4 FY2023 total revenue was $23.6 million, down from $27.6 million, primarily due to lower MAVYRET/MAVIRET sales, while R&D expenses decreased and G&A expenses increased Comparison of Operating Results (in thousands) | Item | Q1 FY2023 (ended Dec 31, 2022) | Q1 FY2022 (ended Dec 31, 2021) | | :--- | :--- | :--- | | Royalty revenue | $22,585 | $27,648 | | License revenue | $1,000 | $— | | Research and development | $40,902 | $48,549 | | General and administrative | $12,696 | $9,508 | | **Net loss** | **($28,986)** | **($30,115)** | - Royalty revenue decreased by **$5.0 million** due to lower HCV sales by AbbVie, as patient volumes remain below pre-COVID-19 levels[90](index=90&type=chunk) - R&D expenses decreased by **$7.6 million**, primarily due to a **$4.7 million** reduction in the non-viral liver disease (NASH) program and a **$3.8 million** decrease in virology program costs related to clinical trial timing[93](index=93&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$241.4 million** in cash and equivalents as of December 31, 2022, with **$35.6 million** cash used in operations, sufficient to fund operations into Q4 fiscal 2024 Summary of Cash Flows (in thousands) | Activity | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | | :--- | :--- | :--- | | Cash used in operating activities | ($35,641) | ($13,271) | | Cash provided by investing activities | $33,569 | $45,501 | | Cash provided by financing activities | $301 | $9,632 | - Cash used in operating activities increased by **$22.4 million** year-over-year, driven by the timing of R&D payments and a federal tax refund of **$8.5 million** received in the prior-year period[98](index=98&type=chunk) - The company believes its existing cash, equivalents, marketable securities, and future royalties will be sufficient to meet cash requirements into approximately Q4 of fiscal 2024[102](index=102&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk is primarily from interest rate sensitivity on its cash portfolio and foreign exchange risk, both currently considered immaterial - The company's portfolio of cash, cash equivalents, and marketable securities (**$241.4 million** at Dec 31, 2022) is sensitive to interest rate changes, but a 1% change is not expected to have a material impact[108](index=108&type=chunk) - Foreign currency exchange risk, primarily from the British Pound and Euro, was immaterial during the quarter but may increase with the expansion of clinical trials and manufacturing outside the U.S[109](index=109&type=chunk) [Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of December 31, 2022, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[110](index=110&type=chunk) - No changes occurred in the company's internal control over financial reporting during the quarter ended December 31, 2022, that have materially affected, or are reasonably likely to materially affect, these controls[111](index=111&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section addresses risk factors and lists exhibits filed with the Form 10-Q [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended September 30, 2022, were reported - There have been no material changes to the risk factors discussed in the 2022 Form 10-K during the quarter ended December 31, 2022[112](index=112&type=chunk) [Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and financial statements in Inline XBRL format - The exhibits filed with the report include certifications from the CEO and CFO (Exhibits 31.1, 31.2, 32.1) and the financial data in Inline XBRL format (Exhibits 101, 104)[114](index=114&type=chunk)
Enanta Pharmaceuticals(ENTA) - 2022 Q4 - Annual Report
2022-11-23 21:12
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, 2022 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 organization) ...
Enanta Pharmaceuticals(ENTA) - 2022 Q4 - Earnings Call Transcript
2022-11-21 23:10
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q4 2022 Earnings Conference Call November 21, 2022 4:30 PM ET Company Participants Jennifer Viera - Senior Director, Investor Relations & Corporate Communications Jay Luly - President & Chief Executive Officer Paul Mellett - Chief Financial Officer Tara Kieffer - Senior Vice President, New Product Strategy & Development Conference Call Participants Brian Abrahams - RBC Capital Markets Yasmeen Rahimi - Piper Sandler Brian Skorney - Baird Liisa Bayko - Evercore ISI E ...
Enanta Pharmaceuticals(ENTA) - 2022 Q3 - Earnings Call Transcript
2022-08-09 01:07
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q3 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Jennifer Viera - Senior Director, IR & Corporate Communications Jay Luly - President, CEO & Director Paul Mellett - SVP, Finance & Administration & CFO Tara Kieffer - SVP, New Product Strategy & Development Conference Call Participants Douglas Buchanan - JMP Securities Brian Skorney - Robert W. Baird & Co. Hannah Adeoye - JPMorgan Chase & Co. Roanna Ruiz - SVB Securities Operator Good a ...
Enanta Pharmaceuticals(ENTA) - 2022 Q2 - Quarterly Report
2022-05-09 20:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.01 per share ENTA NASDAQ 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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commissi ...
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 | --- | --- | --- | |-----------------------------------------|------------------------------------------------------------|----------------------------------------------- ...