Financial Data and Key Metrics Changes - For Q2 2021, total revenue was $20.1 million, a decrease from $27.6 million in the same period of 2020, primarily due to lower royalty revenue from AbbVie's MAVYRET product sales [31][32] - Royalty revenue was based on 50% of MAVYRET sales at a royalty rate of 10%, with AbbVie's global MAVYRET product sales reported at $415 million [31][32] - Net loss for the quarter was $22 million, or a loss of $1.09 per diluted common share, compared to a net loss of $6 million, or a loss of $0.30 per diluted common share, for the same period in 2020 [36] Business Line Data and Key Metrics Changes - The company has three active clinical programs in virology and liver diseases, conducting seven clinical trials, including studies for hepatitis B, respiratory syncytial virus (RSV), and non-alcoholic steatohepatitis (NASH) [6][7][27] - Preliminary data from the Phase 1b study of EDP-514 in chronic HBV patients showed it was safe and well-tolerated, with a mean reduction of 1 log in HBV RNA compared to 0.3 log reduction in placebo [10][13] Market Data and Key Metrics Changes - The ongoing studies for EDP-938 in RSV are crucial as RSV is expected to reemerge globally after COVID-19 mitigation measures subside, with trial sites established in multiple regions [22][23] - The company is preparing for the initiation of clinical trials for EDP-721, an oral HBV RNA destabilizer, expected to start in mid-2021 [19][29] Company Strategy and Development Direction - The company aims to develop an all-oral functional cure for chronic HBV infection by combining EDP-514 and EDP-721, targeting multiple mechanisms to enhance treatment efficacy [16][18][66] - The strategy includes exploring combination therapies with external agents, such as siRNA or immunotherapy, to enhance the chances of achieving a functional cure for HBV [62][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming catalysts across the pipeline, including preliminary results from the Phase 1b study of EDP-514 in viremic HBV patients and the initiation of EDP-721 trials [5][29] - The impact of COVID-19 on clinical trial recruitment and timelines was acknowledged, particularly for the NASH program, with expectations for interim analysis data to be reported in Q3 2021 [27][51] Other Important Information - The company ended the quarter with approximately $400 million in cash and marketable securities, providing a strong financial position to support ongoing and future clinical trials [36] - The company is also advancing its discovery initiatives for SARS-CoV-2, focusing on developing oral protease and polymerase inhibitors [26][71] Q&A Session Summary Question: Can you provide more granularity on RNA declines and the 800 mg dose optimization for EDP-514? - Management noted high trough levels at both 200 mg and 400 mg doses, with a focus on safety and tolerability rather than virology in the current study [38][40][41] Question: What are the latest views on the NASH program and potential paths forward? - Management highlighted the ongoing studies for EDP-297 and EDP-305, with expectations for data in mid-2021 and a focus on identifying effective doses for combination therapies [47][52] Question: Were any serological tests done at week 2 for EDP-514? - Management clarified that the study was not designed to assess viral loads at that time, but the data will be compiled for future analysis [54][57] Question: Can you discuss the safety profile of EDP-514 and the onset of adverse events? - Management indicated that adverse events were mild and scattered throughout the study, with no concerning patterns observed [63] Question: How does the company view the potential for protease inhibitors versus polymerase inhibitors for COVID-19? - Management expressed confidence in both targets, emphasizing the importance of targeting conserved regions to minimize resistance [78][79] Question: What are the regulatory considerations for the RSV program? - Management stated that discussions with the FDA regarding pivotal trial designs and endpoints will occur after finalizing the Phase 2b program [89]

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, 2020 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 ...

Part I [Business Overview](index=6&type=section&id=Item%201.%20Business) Enanta Pharmaceuticals develops small molecule drugs for viral infections and liver diseases, funding its R&D pipeline primarily through royalties from AbbVie's HCV treatment - The company's primary focus is on discovering and developing **small molecule drugs** for **viral infections** (RSV, HBV, SARS-CoV-2, hMPV) and **liver diseases** (NASH)[20](index=20&type=chunk) - Funding for wholly-owned R&D programs is supported by **royalties** from the collaboration with AbbVie on the HCV treatment MAVYRET/MAVIRET[20](index=20&type=chunk) Financial Metrics (as of FY 2020) | Financial Metric | Value (as of FY 2020) | | :--- | :--- | | Cash, Cash Equivalents & Marketable Securities | $419 million | | Fiscal 2020 Royalty Revenue | $122.5 million | Enanta's Research and Development Pipeline (as of September 30, 2020) | Disease Area | Product Candidate / Class | Discovery/Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed | Status | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **HCV** | glecaprevir (Protease Inhibitor) | | | | | ✓ | Marketed by AbbVie in MAVYRET/MAVIRET | | **RSV** | EDP-938 (N-Protein Inhibitor) | | | ✓ | | | Phase 2b RSVP study ongoing | | **NASH** | EDP-305 (FXR Agonist) | | | ✓ | | | Phase 2b ARGON-2 study ongoing | | **HBV** | EDP-514 (Core Inhibitor) | | ✓ | | | | Two Phase 1b studies ongoing | | **NASH** | EDP-297 (FXR Agonist Follow-on) | | ✓ | | | | Phase 1 study ongoing | | **hMPV** | Non-Fusion Inhibitor | ✓ | | | | | Discovery | | **COVID-19** | SARS-CoV-2 Inhibitor | ✓ | | | | | Discovery | [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including heavy reliance on AbbVie's HCV drug sales, clinical development uncertainties, intense competition, and potential impacts from the COVID-19 pandemic - Financial prospects are **heavily dependent on AbbVie's success** in selling MAVYRET/MAVIRET for HCV, with sales potentially impacted by reduced diagnoses and treatment rates due to the COVID-19 pandemic[101](index=101&type=chunk) - The company faces **substantial competition** in all its target disease areas (HCV, RSV, HBV, NASH, hMPV, SARS-CoV-2), with many competitors having more advanced product candidates and greater resources[104](index=104&type=chunk)[107](index=107&type=chunk) - Clinical drug development is a **lengthy, expensive, and uncertain process**, and the company's pipeline candidates have not yet advanced beyond Phase 2 trials, with potential for delays or failures[121](index=121&type=chunk) - The ongoing COVID-19 pandemic has **impacted business operations and clinical trials**, causing delays in recruitment for studies like the ARGON-2 (NASH) and RSVP (RSV) trials[108](index=108&type=chunk)[110](index=110&type=chunk) - The company **relies on third-party manufacturers**, including some in China, for clinical drug supplies, with potential disruptions from trade wars, political unrest, or pandemics adversely affecting operations[145](index=145&type=chunk)[148](index=148&type=chunk) [Properties](index=54&type=section&id=Item%202.%20Properties) Enanta leases approximately 67,000 square feet of office and laboratory space for its corporate headquarters in Watertown, Massachusetts - The company leases a total of approximately **67,000 square feet** of office and laboratory space in Watertown, Massachusetts, across two separate lease agreements[191](index=191&type=chunk) [Legal Proceedings](index=54&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings as of the report date - The company is **not currently involved in any material legal proceedings**[192](index=192&type=chunk) Part II [Market for Common Equity and Related Matters](index=55&type=section&id=Item%205.%20Market%20for%20the%20Company%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Enanta's common stock trades on NASDAQ under "ENTA", and the company has never paid cash dividends nor anticipates doing so - Common stock is traded on **The NASDAQ Global Select Market** under the symbol "**ENTA**"[198](index=198&type=chunk) Quarterly Stock Price (Fiscal Years 2020 & 2019) | Fiscal Year | Quarter | High ($) | Low ($) | | :--- | :--- | :--- | :--- | | **2020** | First | 67.88 | 57.15 | | | Second | 62.12 | 38.40 | | | Third | 58.59 | 44.90 | | | Fourth | 54.57 | 42.07 | | **2019** | First | 86.42 | 64.09 | | | Second | 106.80 | 68.67 | | | Third | 101.27 | 80.52 | | | Fourth | 89.25 | 58.02 | - The company has **never declared or paid cash dividends** and does not expect to in the foreseeable future[199](index=199&type=chunk) [Selected Consolidated Financial Data](index=57&type=section&id=Item%206.%20Selected%20Consolidated%20Financial%20Data) This section provides selected financial data for the past five fiscal years, highlighting a shift to a net loss in FY2020 despite stable total assets Selected Historical Financial Data (in thousands, except per share data) | Metric | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | **Revenue** | $122,473 | $205,197 | $206,625 | | **Research and development** | $136,756 | $142,213 | $94,856 | | **Total operating expenses** | $164,112 | $168,459 | $118,297 | | **Income (loss) from operations** | $(41,639) | $36,738 | $88,328 | | **Net income (loss)** | $(36,168) | $46,383 | $71,956 | | **Diluted net income (loss) per share** | $(1.81) | $2.21 | $3.48 | | **Total assets (at year end)** | $486,132 | $489,829 | $414,227 | | **Cash, cash equivalents and marketable securities** | $419,283 | $400,249 | $325,119 | [Management's Discussion and Analysis (MD&A)](index=58&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, noting a significant revenue decrease and net loss in FY2020, while maintaining strong liquidity [Results of Operations](index=63&type=section&id=Results%20of%20Operations) FY2020 revenue decreased significantly to $122.5 million due to lower AbbVie royalties, resulting in a net loss of $36.2 million despite slightly reduced R&D expenses Revenue Comparison (in thousands) | Year Ended September 30, | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | Royalties | $122,473 | $205,197 | $191,625 | | Milestones | — | — | $15,000 | | **Total revenue** | **$122,473** | **$205,197** | **$206,625** | - The **$82.7 million decrease** in revenue in FY2020 was due to lower numbers of treated HCV patients as a result of the worldwide COVID-19 pandemic and competitive pricing pressures[233](index=233&type=chunk) R&D Expense by Program (in thousands) | R&D Program | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | Virology | $85,856 | $75,087 | $40,047 | | Liver disease | $45,001 | $66,892 | $54,691 | | Other | $5,899 | $234 | $118 | | **Total R&D expenses** | **$136,756** | **$142,213** | **$94,856** | - R&D expense decreased by **$5.5 million** in FY2020 compared to FY2019, primarily due to the timing of clinical studies and the impact of the COVID-19 pandemic, which paused or delayed enrollment in several trials[237](index=237&type=chunk) [Liquidity and Capital Resources](index=65&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2020, Enanta maintained strong liquidity with $419 million in cash and securities, despite a significant decrease in operating cash flow in FY2020 - The company's principal sources of liquidity are cash, cash equivalents, and marketable securities, totaling **$419 million** as of September 30, 2020[241](index=241&type=chunk) Summary of Cash Flows (in thousands) | Activity | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | Net cash from Operating | $7,088 | $71,418 | $29,220 | | Net cash from Investing | $19,830 | $(86,664) | $(35,402) | | Net cash from Financing | $8,983 | $2,574 | $4,409 | - The **decrease in cash from operations** in FY2020 was primarily driven by a decrease in royalty payments received from AbbVie and an increase in R&D costs[241](index=241&type=chunk) [Consolidated Financial Statements and Supplementary Data](index=68&type=section&id=Item%208.%20Consolidated%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements and the independent auditor's unqualified opinion, highlighting critical audit matters related to R&D accruals - The independent auditor, PricewaterhouseCoopers LLP, issued an **unqualified opinion** on the consolidated financial statements and the effectiveness of internal control over financial reporting as of September 30, 2020[293](index=293&type=chunk) - A **critical audit matter** identified was the significant management judgment required in **estimating research and development and pharmaceutical drug manufacturing accruals**, which are based on contract terms, timelines, and progress of activities[303](index=303&type=chunk)[304](index=304&type=chunk) - The company **adopted the new lease accounting standard (Topic 842)** on October 1, 2019, resulting in the recognition of right-of-use assets of $7.2 million and lease liabilities of $8.6 million[350](index=350&type=chunk) [Controls and Procedures](index=68&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that both disclosure controls and internal control over financial reporting were effective as of September 30, 2020, with no material changes - Management concluded that the company's disclosure controls and procedures were **effective** at a reasonable assurance level as of September 30, 2020[258](index=258&type=chunk) - Based on the COSO 2013 framework, management concluded that the company's internal control over financial reporting was **effective** as of September 30, 2020[260](index=260&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=70&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the company's 2021 Proxy Statement - Detailed information on directors, executive officers, and corporate governance is **incorporated by reference** from the 2021 Proxy Statement[265](index=265&type=chunk) [Executive Compensation](index=70&type=section&id=Item%2011.%20Executive%20Compensation) Details regarding executive compensation are incorporated by reference from the company's 2021 Proxy Statement - Information on executive compensation is **incorporated by reference** from the 2021 Proxy Statement[266](index=266&type=chunk) [Security Ownership and Equity Compensation Plans](index=70&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details securities authorized under equity compensation plans as of September 30, 2020, with further ownership details incorporated by reference Equity Compensation Plan Information (as of September 30, 2020) | Plan Category | Securities to be issued upon exercise (a) | Weighted-average exercise price ($) (b) | Securities remaining for future issuance (c) | | :--- | :--- | :--- | :--- | | **Equity plans approved by security holders** | 3,399,000 | $47.81 | 1,407,000 | | **Equity plans not approved by security holders** | — | — | — | | **Total** | **3,399,000** | **$47.81** | **1,407,000** | Part IV [Exhibits and Financial Statement Schedules](index=72&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all financial statements, schedules, and exhibits filed as part of the Form 10-K, including governance documents and material contracts - The financial statements are included under **Part II, Item 8** of the report[274](index=274&type=chunk) - A **list of all exhibits** filed with the report is provided, including governance documents, material contracts like the AbbVie agreement, and compensatory plans[277](index=277&type=chunk)

From Chemistry to Cures ENANTA Pharmaceuticals 1 A Phase 2 dose ranging, randomized, double-blind and placebo-controlled study of EDP-305 in subjects with primary biliary cholangitis (PBC) with or without an inadequate response to ursodeoxycholic acid (UDCA) Topline Results 06MAY2020 Forward Looking Statements Disclaimer This presentation contains forward-looking statements concerning our plans, objectives and expectations for EDP-305 and its development for NASH. Any statements contained herein that are no ...

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, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35839 | --- | --- | --- | |-----------------------------------------|-----------------------------------------------------------------|------------------------------------------ ...