Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Mar. 31, 2023 | Apr. 28, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ENTA | |
Entity Registrant Name | ENANTA PHARMACEUTICALS, INC | |
Entity Central Index Key | 0001177648 | |
Current Fiscal Year End Date | --09-30 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity File Number | 001-35839 | |
Security Exchange Name | NASDAQ | |
Entity Tax Identification Number | 04-3205099 | |
Entity Address, Address Line One | 500 Arsenal Street | |
Entity Address, City or Town | Watertown | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02472 | |
City Area Code | 617 | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Local Phone Number | 607-0800 | |
Entity Incorporation, State or Country Code | DE | |
Document Transition Report | false | |
Document Quarterly Report | true | |
Entity Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes | |
Entity Common Stock, Shares Outstanding | 21,055,392 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Sep. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 73,178 | $ 43,994 |
Short-term marketable securities | 136,906 | 205,238 |
Accounts receivable | 17,795 | 20,318 |
Prepaid expenses and other current assets | 14,484 | 13,445 |
Income tax receivable | 28,774 | 28,718 |
Total current assets | 271,137 | 311,713 |
Long-term marketable securities | 15,040 | 29,285 |
Property and equipment, net | 11,050 | 6,173 |
Operating lease, right-of-use assets | 24,554 | 23,575 |
Restricted cash | 3,968 | 3,968 |
Other long-term assets | 696 | 696 |
Total assets | 326,445 | 375,410 |
Current liabilities: | ||
Accounts payable | 11,761 | 6,000 |
Accrued expenses and other current liabilities | 15,482 | 20,936 |
Operating lease liabilities | 4,923 | 2,891 |
Total current liabilities | 32,166 | 29,827 |
Operating lease liabilities, net of current portion | 23,073 | 22,372 |
Series 1 nonconvertible preferred stock | 1,423 | 1,423 |
Other long-term liabilities | 408 | 454 |
Total liabilities | 57,070 | 54,076 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity: | ||
Common stock; $0.01 par value per share, 100,000 shares authorized; 21,049 and 20,791 shares issued and outstanding at March 31, 2023 and September 30, 2022, respectively | 210 | 208 |
Additional paid-in capital | 410,803 | 398,029 |
Accumulated other comprehensive loss | (1,815) | (3,724) |
Accumulated deficit | (139,823) | (73,179) |
Total stockholders' equity | 269,375 | 321,334 |
Total liabilities and stockholders' equity | $ 326,445 | $ 375,410 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands | Mar. 31, 2023 | Sep. 30, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 21,049 | 20,791 |
Common stock, shares outstanding | 21,049 | 20,791 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Total revenue | $ 17,795 | $ 18,716 | $ 41,380 | $ 46,364 |
Operating expenses: | ||||
Research and development | 43,468 | 42,087 | 84,370 | 90,636 |
General and administrative | 13,778 | 10,476 | 26,474 | 19,984 |
Total operating expenses | 57,246 | 52,563 | 110,844 | 110,620 |
Loss from operations | (39,451) | (33,847) | (69,464) | (64,256) |
Other income (expense): | ||||
Interest and investment income, net | 1,837 | 255 | 2,830 | 549 |
Total other income, net | 1,837 | 255 | 2,830 | 549 |
Loss before income taxes | (37,614) | (33,592) | (66,634) | (63,707) |
Income tax expense | (44) | 0 | (10) | 0 |
Net loss | $ (37,658) | $ (33,592) | $ (66,644) | $ (63,707) |
Net loss per share: | ||||
Basic | $ (1.79) | $ (1.63) | $ (3.19) | $ (3.11) |
Diluted | $ (1.79) | $ (1.63) | $ (3.19) | $ (3.11) |
Weighted average shares outstanding: | ||||
Basic | 21,035 | 20,551 | 20,882 | 20,473 |
Diluted | 21,035 | 20,551 | 20,882 | 20,473 |
Royalty [Member] | ||||
Total revenue | $ 17,795 | $ 18,716 | $ 40,380 | $ 46,364 |
License [Member] | ||||
Total revenue | $ 0 | $ 0 | $ 1,000 | $ 0 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (37,658) | $ (33,592) | $ (66,644) | $ (63,707) |
Other comprehensive income (loss): | ||||
Net unrealized gains (losses) on marketable securities | 860 | (2,031) | 1,909 | (2,655) |
Total other comprehensive income (loss) | 860 | (2,031) | 1,909 | (2,655) |
Comprehensive loss | $ (36,798) | $ (35,623) | $ (64,735) | $ (66,362) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | (Accumulated Deficit) Retained Earnings [Member] |
Beginning Balance at Sep. 30, 2021 | $ 399,429 | $ 202 | $ 351,033 | $ (382) | $ 48,576 |
Beginning Balance, Shares at Sep. 30, 2021 | 20,238,000 | ||||
Exercise of stock options | 10,409 | $ 2 | 10,407 | ||
Exercise of stock options, Shares | 248,000 | ||||
Vesting of restricted stock units, net of withholding | (777) | $ 1 | (778) | ||
Vesting of restricted stock units, net of withholding, Shares | 20,000 | ||||
Stock-based compensation expense | 6,062 | 6,062 | |||
Other comprehensive (loss) income | (624) | (624) | |||
Net loss | (30,115) | (30,115) | |||
Ending Balance at Dec. 31, 2021 | 384,384 | $ 205 | 366,724 | (1,006) | 18,461 |
Ending Balance, Shares at Dec. 31, 2021 | 20,506,000 | ||||
Beginning Balance at Sep. 30, 2021 | 399,429 | $ 202 | 351,033 | (382) | 48,576 |
Beginning Balance, Shares at Sep. 30, 2021 | 20,238,000 | ||||
Other comprehensive (loss) income | (2,655) | ||||
Net loss | (63,707) | ||||
Ending Balance at Mar. 31, 2022 | 358,583 | $ 206 | 376,545 | (3,037) | (15,131) |
Ending Balance, Shares at Mar. 31, 2022 | 20,618,000 | ||||
Beginning Balance at Sep. 30, 2021 | 399,429 | $ 202 | 351,033 | (382) | 48,576 |
Beginning Balance, Shares at Sep. 30, 2021 | 20,238,000 | ||||
Net loss | (121,755) | ||||
Ending Balance at Sep. 30, 2022 | 321,334 | $ 208 | 398,029 | (3,724) | (73,179) |
Ending Balance, Shares at Sep. 30, 2022 | 20,791,000 | ||||
Beginning Balance at Dec. 31, 2021 | 384,384 | $ 205 | 366,724 | (1,006) | 18,461 |
Beginning Balance, Shares at Dec. 31, 2021 | 20,506,000 | ||||
Exercise of stock options | 3,802 | $ 1 | 3,801 | ||
Exercise of stock options, Shares | 97,000 | ||||
Vesting of restricted stock units, net of withholding | (451) | (451) | |||
Vesting of restricted stock units, net of withholding, Shares | 15,000 | ||||
Stock-based compensation expense | 6,471 | 6,471 | |||
Other comprehensive (loss) income | (2,031) | (2,031) | |||
Net loss | (33,592) | (33,592) | |||
Ending Balance at Mar. 31, 2022 | 358,583 | $ 206 | 376,545 | (3,037) | (15,131) |
Ending Balance, Shares at Mar. 31, 2022 | 20,618,000 | ||||
Beginning Balance at Sep. 30, 2022 | 321,334 | $ 208 | 398,029 | (3,724) | (73,179) |
Beginning Balance, Shares at Sep. 30, 2022 | 20,791,000 | ||||
Exercise of stock options | 1,126 | $ 1 | 1,125 | ||
Exercise of stock options, Shares | 56,000 | ||||
Vesting of restricted stock units, net of withholding | (825) | (825) | |||
Vesting of restricted stock units, net of withholding, Shares | 37,000 | ||||
Stock-based compensation expense | 7,139 | 7,139 | |||
Other comprehensive (loss) income | 1,049 | 1,049 | |||
Net loss | (28,986) | (28,986) | |||
Ending Balance at Dec. 31, 2022 | 300,837 | $ 209 | 405,468 | (2,675) | (102,165) |
Ending Balance, Shares at Dec. 31, 2022 | 20,884,000 | ||||
Beginning Balance at Sep. 30, 2022 | $ 321,334 | $ 208 | 398,029 | (3,724) | (73,179) |
Beginning Balance, Shares at Sep. 30, 2022 | 20,791,000 | ||||
Exercise of stock options, Shares | 117,000 | ||||
Other comprehensive (loss) income | $ 1,909 | ||||
Net loss | (66,644) | ||||
Ending Balance at Mar. 31, 2023 | 269,375 | $ 210 | 410,803 | (1,815) | (139,823) |
Ending Balance, Shares at Mar. 31, 2023 | 21,049,000 | ||||
Beginning Balance at Dec. 31, 2022 | 300,837 | $ 209 | 405,468 | (2,675) | (102,165) |
Beginning Balance, Shares at Dec. 31, 2022 | 20,884,000 | ||||
Exercise of stock options | 882 | $ 1 | 881 | ||
Exercise of stock options, Shares | 61,000 | ||||
Vesting of restricted stock units, net of withholding | (2,909) | (2,909) | |||
Vesting of restricted stock units, net of withholding, Shares | 104,000 | ||||
Stock-based compensation expense | 7,363 | 7,363 | |||
Other comprehensive (loss) income | 860 | 860 | |||
Net loss | (37,658) | (37,658) | |||
Ending Balance at Mar. 31, 2023 | $ 269,375 | $ 210 | $ 410,803 | $ (1,815) | $ (139,823) |
Ending Balance, Shares at Mar. 31, 2023 | 21,049,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (66,644) | $ (63,707) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 14,502 | 12,533 |
Depreciation and amortization expense | 1,051 | 1,602 |
Premium paid on marketable securities | (42) | (802) |
Amortization (accretion) of premiums (discounts) on marketable securities | (1,345) | 928 |
Loss on disposal of property and equipment | 7 | 0 |
Change in operating assets and liabilities: | ||
Accounts receivable | 2,523 | 4,860 |
Prepaid expenses and other current assets | (1,039) | 110 |
Income tax receivable | (56) | 8,507 |
Operating lease, right-of-use assets | 1,891 | 2,784 |
Accounts payable | 5,963 | (3,473) |
Accrued expenses | (6,052) | (808) |
Operating lease liabilities | (137) | (2,498) |
Other long-term liabilities | (46) | 318 |
Net cash used in operating activities | (49,424) | (39,646) |
Cash flows from investing activities | ||
Purchase of marketable securities | (90,627) | (124,631) |
Proceeds from maturities and sales of marketable securities | 176,500 | 135,514 |
Purchase of property and equipment | (5,539) | (437) |
Net cash provided by investing activities | 80,334 | 10,446 |
Cash flows from financing activities | ||
Proceeds from exercise of stock options | 2,008 | 14,211 |
Payments for settlement of share-based awards | (3,734) | (1,228) |
Net cash provided by (used in) financing activities | (1,726) | 12,983 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 29,184 | (16,217) |
Cash, cash equivalents and restricted cash at beginning of period | 47,962 | 57,814 |
Cash, cash equivalents and restricted cash at end of period | 77,146 | 41,597 |
Supplemental disclosure of noncash information: | ||
Purchases of fixed assets included in accounts payable and accrued expenses | 1,611 | 174 |
Operating lease liabilities arising from obtaining right-of-use assets | $ 2,870 | $ 15,559 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 6 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Enanta Pharmaceuticals, Inc. (the “Company”), incorporated in Delaware in 1995 , is a biotechnology company that uses its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs, with an emphasis on treatments for viral infections. The Company discovered glecaprevir, the second of two protease inhibitors discovered and developed through its collaboration with AbbVie for the treatment of chronic infection with hepatitis C virus (“HCV”). Glecaprevir is co-formulated as part of AbbVie’s leading direct-acting antiviral (“DAA”) combination treatment for HCV, which is marketed under the tradenames MAVYRET® (U.S.) and MAVIRET®(ex-U.S.) (glecaprevir/pibrentasvir). Royalties from the Company’s AbbVie collaboration and its existing financial resources provide funding to support the Company’s wholly-owned research and development programs, which are primarily focused on the following disease targets: respiratory syncytial virus (“RSV”), SARS-CoV-2, human metapneumovirus (“hMPV”) and hepatitis B virus (“HBV”). The Company is subject to many of the risks common to companies in the biotechnology industry, including but not limited to, the uncertainties of research and development, competition from technological innovations of others, dependence on collaborative arrangements, protection of proprietary technology, dependence on key personnel and compliance with government regulation. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approvals, prior to commercialization. These efforts require significant amounts of capital, adequate personnel and infrastructure, and extensive compliance reporting capabilities. COVID-19 In March 2020, the World Health Organization declared COVID-19 a global pandemic and countries worldwide implemented various measures to contain the spread of the SARS-CoV-2 virus. National, state and local governments in affected regions implemented varying safety precautions, including quarantines, border closures, increased border controls, travel restrictions, shelter-in-place orders and shutdowns, business closures, cancellations of public gatherings and other measures. The extent and severity of any continuing impact on the Company’s business and clinical trials will be determined largely by the extent to which there are disruptions in the supply chains for its research and product candidates, delays in the conduct of ongoing and future clinical trials, or reductions in the number of patients accessing AbbVie’s HCV regimens, or any combination of those events. In addition, AbbVie experienced a decline in HCV sales compared to periods prior to March 2020 as a result of reduced numbers of patients accessing AbbVie’s HCV regimens due to the COVID-19 pandemic. The extent to which the COVID-19 pandemic will continue to impact, directly or indirectly, the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new variants and public health actions taken to contain their impact, as well as the cumulative economic impact of both of those factors and the public health impact of the announced ending of emergency public health measures. Unaudited Interim Financial Information The consolidated balance sheet at September 30, 2022 was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). The accompanying unaudited consolidated financial statements as of March 31, 2023 and for the three and six months ended March 31, 2023 and 2022 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2022. In the opinion of management, all adjustments, consisting of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of March 31, 2023 and results of operations for the three and six months ended March 31, 2023 and 2022 and cash flows for the six months ended March 31, 2023 and 2022 have been made. The results of operations for the three and six months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for subsequent quarters or the year ending September 30, 2023. The accompanying consolidated financial statements have been prepared in conformity with GAAP. All amounts in the consolidated financial statements and in the notes to the consolidated financial statements, except per share amounts, are in thousands unless otherwise indicated. The accompanying consolidated financial statements have been prepared based on continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company began reporting a net loss in fiscal 2020 and reported a net loss of $ 66,644 for the six months ended March 31, 2023 and $ 121,755 for the year ended September 30, 2022. As of March 31, 2023, the Company had an accumulated deficit of $ 139,823 . The Company expects to continue to generate operating losses for the foreseeable future as the Company continues to advance its wholly-owned programs. As of March 31, 2023, the Company had $ 225,124 in cash, cash equivalents and short-term and long-term marketable securities. The Company expects that its cash, cash equivalents, short-term and long-term marketable securities, as well as the $ 200,000 payment received in April 2023 from the sale of a portion of the MAVYRET/MAVIRET royalties and cash flows from the continuing portion of HCV royalties will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the interim consolidated financial statements. The Company may seek additional funding through equity offerings, non-dilutive financings, collaborations, strategic alliances or licensing agreements. The Company may not be able to obtain sufficient financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies For the Company’s Significant Accounting Policies, please refer to its Annual Report on Form 10-K for the fiscal year ended September 30, 2022. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, management’s judgments with respect to its revenue arrangements; valuation of stock-based awards and the accrual of research and development expenses. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. The future developments of the COVID-19 pandemic also may directly or indirectly impact the Company’s business. The Company has made estimates of the impact of COVID-19 in the Company’s consolidated financial statements as of March 31, 2023 . Actual results could differ from the Company’s estimates. Net Income (Loss) per Share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options and unvested restricted stock units. For periods presented, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported net losses for each of the three and six months ended March 31, 2023 and 2022 . The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: As of March 31, 2023 2022 (in thousands) Options to purchase common stock 4,522 4,124 Unvested rTSRUs 81 112 Unvested PSUs 81 112 Unvested restricted stock units 430 217 Recently Issued Accounting Pronouncements Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s consolidated financial statements upon adoption. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 6 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | 3. Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s financial assets and liabilities that were subject to fair value measurement on a recurring basis as of March 31, 2023 and September 30, 2022, and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value: Fair Value Measurements at March 31, 2023 Using: Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 70,562 $ — $ — $ 70,562 Marketable securities: U.S. Treasury notes 22,003 — — 22,003 Corporate bonds — 46,124 — 46,124 Commercial paper — 83,819 — 83,819 $ 92,565 $ 129,943 $ — $ 222,508 Liabilities: Series 1 nonconvertible preferred stock $ — $ — $ 1,423 $ 1,423 $ — $ — $ 1,423 $ 1,423 Fair Value Measurements at September 30, 2022 Using: Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 13,905 $ — $ — $ 13,905 Marketable securities: U.S. Treasury notes 91,328 — — 91,328 Corporate bonds — 76,411 — 76,411 Commercial paper — 66,784 — 66,784 $ 105,233 $ 143,195 $ — $ 248,428 Liabilities: Series 1 nonconvertible preferred stock $ — $ — $ 1,423 $ 1,423 $ — $ — $ 1,423 $ 1,423 During the three and six months ended March 31, 2023 and 2022 , there were no transfers between Level 1, Level 2 and Level 3. The outstanding shares of Series 1 nonconvertible preferred stock as of March 31, 2023 and September 30, 2022 are measured at fair value. These outstanding shares are financial instruments that might require a transfer of assets because of the liquidation features in the contract and are therefore recorded as liabilities and measured at fair value. The fair value of the outstanding shares is based on significant inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The Company utilizes a probability-weighted valuation model which takes into consideration various outcomes that may require the Company to transfer assets upon liquidation. Changes in the fair values of the Series 1 nonconvertible preferred stock are recognized in other income (expense) in the consolidated statements of operations. The recurring Level 3 fair value measurements of the Company’s outstanding Series 1 nonconvertible preferred stock using probability-weighted discounted cash flow include the following significant unobservable inputs: Range March 31, September 30, Unobservable Input 2023 2022 Probabilities of payout 0 %- 65 % 0 %- 65 % Discount rate 7.25 % 7.25 % There were no changes in the fair value of nonconvertible preferred stock during the three and six months ended March 31, 2023 or 2022 . |
Marketable Securities
Marketable Securities | 6 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities As of March 31, 2023 and September 30, 2022, the fair value of available-for-sale marketable securities, by type of security, was as follows: March 31, 2023 Amortized Gross Gross Credit Losses Fair Value (in thousands) Corporate bonds $ 47,329 $ 4 $ ( 1,209 ) $ — $ 46,124 Commercial paper 83,819 — — — 83,819 U.S. Treasury notes 22,229 14 ( 240 ) — 22,003 $ 153,377 $ 18 $ ( 1,449 ) $ — $ 151,946 September 30, 2022 Amortized Gross Gross Credit Losses Fair Value (in thousands) Corporate bonds $ 78,663 $ — $ ( 2,252 ) $ — $ 76,411 Commercial paper 66,784 — — — 66,784 U.S. Treasury notes 92,416 — ( 1,088 ) — 91,328 $ 237,863 $ — $ ( 3,340 ) $ — $ 234,523 As of March 31, 2023 and September 30, 2022 , marketable securities consisted of investments that mature within one year , with the exception of certain corporate bonds and U.S. Treasury notes, which have maturities between one and two years and an aggregate fair value of $ 15,040 and $ 29,285 , respectively. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses and other current liabilities consisted of the following as of March 31, 2023 and September 30, 2022: March 31, September 30, 2023 2022 (in thousands) Accrued pharmaceutical drug manufacturing $ 4,521 $ 6,932 Accrued research and development expenses 5,380 5,532 Accrued payroll and related expenses 3,075 6,439 Accrued professional fees 1,639 1,273 Accrued other 867 760 $ 15,482 $ 20,936 |
AbbVie Collaboration
AbbVie Collaboration | 6 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
AbbVie Collaboration | 6. AbbVie Collaboration The Company has a Collaborative Development and License Agreement (as amended, the “AbbVie Agreement”), with AbbVie to identify, develop and commercialize HCV NS3 and NS3/4A protease inhibitor compounds, including paritaprevir and glecaprevir, under which the Company has received license payments, proceeds from a sale of preferred stock, research funding payments, milestone payments and royalties totaling approximately $ 1,250,000 through March 31, 2023. The Company is receiving annually tiered royalties per Company protease product ranging from ten percent up to twenty percent, or on a blended basis from ten percent up to the high teens, on the portion of AbbVie’s calendar year net sales of each HCV regimen that is allocated to the protease inhibitor in the regimen. Beginning with each January 1, the cumulative net sales of a given royalty-bearing protease inhibitor product start at zero for purposes of calculating the tiered royalties on a product-by-product basis. |
Series 1 Nonconvertible Preferr
Series 1 Nonconvertible Preferred Stock | 6 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Series 1 Nonconvertible Preferred Stock | 7. Series 1 Nonconvertible Preferred Stock As of March 31, 2023 , 1,930 shares of Series 1 nonconvertible preferred stock were issued and outstanding. Since these shares qualify as a derivative, the outstanding shares are carried at fair value as a liability on the Company’s consolidated balance sheets. |
Stock-Based Awards
Stock-Based Awards | 6 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Awards | 8. Stock-Based Awards The Company grants stock-based awards, including stock options, restricted stock units and other unit awards under its 2019 Equity Incentive Plan (the “2019 Plan”), which was approved by its stockholders on February 28, 2019 and amended in March 2021, March 2022 and March 2023. The Company also has outstanding stock option awards under its 2012 Equity Incentive Plan (the “2012 Plan”) and its amended and restated 1995 Equity Incentive Plan (the “1995 Plan”), but is no longer granting awards under these plans. The following table summarizes stock option activity, including performance-based options, for the year-to-date period ending March 31, 2023: Shares Weighted Weighted Aggregate (in thousands) (in years) (in thousands) Outstanding as of September 30, 2022 3,993 $ 53.57 6.2 $ 28,778 Granted 728 45.44 Exercised ( 117 ) 17.14 Forfeited ( 82 ) 65.95 Outstanding as of March 31, 2023 4,522 $ 52.98 6.5 $ 7,572 Options vested and expected to vest as of 4,522 $ 52.98 6.5 $ 7,572 Options exercisable as of March 31, 2023 2,801 $ 51.94 5.0 $ 7,554 Market and Performance-Based Stock Unit Awards The Company awards both performance share units, or PSUs, and relative total stockholder return units, or rTSRUs, to its executive officers. The number of units granted represents the target number of shares of common stock that may be earned; however, the actual number of shares that may be earned ranges from 0 % to 150 % of the target number. The number of shares cancelled represents the target number of shares, less any shares that vested. The following table summarizes PSU and rTSRU activity for the year-to-date period ending March 31, 2023: PSUs rTSRUs Shares Weighted Shares Weighted (in thousands, except per share data) Unvested at September 30, 2022 101 $ 54.50 101 $ 36.14 Granted 50 47.24 50 36.91 Vested ( 70 ) 44.58 ( 70 ) 23.89 Cancelled — — — — Unvested at March 31, 2023 81 $ 58.58 81 $ 45.82 During the six months ended March 31, 2023, a total of 100 % of the target PSUs and 127 % of the target rTSRUs granted in December 2020 vested, resulting in the issuance of an aggregate of 104 common shares, net of share withholding. Restricted Stock Units The following table summarizes the restricted stock unit activity for the year-to-date period ending March 31, 2023: Restricted Stock Weighted (in thousands, except per share data) Unvested at September 30, 2022 219 $ 64.03 Granted 277 45.00 Vested ( 56 ) 61.10 Cancelled ( 10 ) 54.51 Unvested at March 31, 2023 430 $ 52.37 Stock-Based Compensation Expense During the three and six months ended March 31, 2023 and 2022 the Company recognized the following stock-based compensation expense: Three Months Ended March 31, Six Months Ended March 31, 2023 2022 2023 2022 (in thousands) Research and development $ 2,520 $ 2,710 $ 5,052 $ 5,294 General and administrative 4,843 3,761 9,450 7,239 $ 7,363 $ 6,471 $ 14,502 $ 12,533 Three Months Ended March 31, Six Months Ended March 31, 2023 2022 2023 2022 (in thousands) Stock options $ 5,011 $ 4,962 $ 10,057 $ 9,710 rTSRUs 546 531 1,007 823 Performance stock units 175 79 542 512 Restricted stock units 1,631 899 2,896 1,488 $ 7,363 $ 6,471 $ 14,502 $ 12,533 During the three and six months ended March 31, 2023 and 2022, the Company recognized stock-based compensation expense for performance-based stock units for which vesting became probable upon achievement of performance-based targets that occurred during the performance period. As of March 31, 2023, the Company had an aggregate of $ 70,253 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.6 years. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Litigation and Contingencies Related to Use of Intellectual Property From time to time, the Company may become subject to legal proceedings, claims and litigation arising in the ordinary course of business. For example, third parties might allege that the Company or its collaborators are infringing their patent rights or that the Company is otherwise violating their intellectual property rights. Such third parties may resort to litigation against the Company or its collaborators, which the Company has agreed to indemnify. With respect to some of these patents, the Company expects that it will be required to obtain licenses and could be required to pay license fees or royalties, or both. These licenses may not be available on acceptable terms, or at all. A costly license, or inability to obtain a necessary license, would have a material adverse effect on the Company’s financial condition, results of operations or cash flows. The Company accrues contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. On June 21, 2022, the Company filed suit in the United States District Court for the District of Massachusetts, against Pfizer, Inc. seeking damages for infringement of U.S. Patent No. 11,358,953 (the ’953 Patent) in the manufacture, use and sale of Pfizer’s COVID-19 antiviral, Paxlovid (nirmatrelvir tablets; ritonavir tablets). The United States Patent and Trademark Office awarded the '953 Patent to the Company in June 2022 based on the Company's July 2020 patent application describing coronavirus protease inhibitors invented by the Company. The Company is seeking fair compensation for Pfizer’s use of a coronavirus protease inhibitor claimed in the ‘953 patent. The Company records all legal expenses associated with the patent infringement suit as incurred in the consolidated statements of operations. The Company currently is not a party to any other litigation. Indemnification Agreements In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to customers, vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from services to be provided to the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. In addition, the Company maintains directors’ and officers’ insurance coverage. The Company does not believe that the outcome of any claims under indemnification arrangements will have a material effect on its financial position, results of operations or cash flows, and has not accrued any liabilities related to such obligations in its consolidated financial statements as of March 31, 2023. Leases The Company leases office space under various non-cancelable operating leases. There have been no material changes to the Company’s leases during the three and six months ended March 31, 2023. For additional information, please read Note 11, Leases, to the consolidated financial statements in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2022 . |
Subsequent Events
Subsequent Events | 6 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events In April 2023, the Company entered into a royalty sale agreement with an affiliate of OMERS, pursuant to which the Company was paid a $ 200,000 cash purchase price in exchange for 54.5 % of the Company’s future quarterly royalty payments on net sales of MAVYRET/MAVIRET, beginning with the payment for the quarter ending September 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, management’s judgments with respect to its revenue arrangements; valuation of stock-based awards and the accrual of research and development expenses. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. The future developments of the COVID-19 pandemic also may directly or indirectly impact the Company’s business. The Company has made estimates of the impact of COVID-19 in the Company’s consolidated financial statements as of March 31, 2023 . Actual results could differ from the Company’s estimates. |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options and unvested restricted stock units. For periods presented, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported net losses for each of the three and six months ended March 31, 2023 and 2022 . The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: As of March 31, 2023 2022 (in thousands) Options to purchase common stock 4,522 4,124 Unvested rTSRUs 81 112 Unvested PSUs 81 112 Unvested restricted stock units 430 217 |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s consolidated financial statements upon adoption. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Diluted Net Loss Per Share With Anti-dilutive effect | The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: As of March 31, 2023 2022 (in thousands) Options to purchase common stock 4,522 4,124 Unvested rTSRUs 81 112 Unvested PSUs 81 112 Unvested restricted stock units 430 217 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 6 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities that were Subject to Fair Value Measurement on Recurring Basis | The following tables present information about the Company’s financial assets and liabilities that were subject to fair value measurement on a recurring basis as of March 31, 2023 and September 30, 2022, and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value: Fair Value Measurements at March 31, 2023 Using: Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 70,562 $ — $ — $ 70,562 Marketable securities: U.S. Treasury notes 22,003 — — 22,003 Corporate bonds — 46,124 — 46,124 Commercial paper — 83,819 — 83,819 $ 92,565 $ 129,943 $ — $ 222,508 Liabilities: Series 1 nonconvertible preferred stock $ — $ — $ 1,423 $ 1,423 $ — $ — $ 1,423 $ 1,423 Fair Value Measurements at September 30, 2022 Using: Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 13,905 $ — $ — $ 13,905 Marketable securities: U.S. Treasury notes 91,328 — — 91,328 Corporate bonds — 76,411 — 76,411 Commercial paper — 66,784 — 66,784 $ 105,233 $ 143,195 $ — $ 248,428 Liabilities: Series 1 nonconvertible preferred stock $ — $ — $ 1,423 $ 1,423 $ — $ — $ 1,423 $ 1,423 |
Fair Value Measurements of the Company's Outstanding Series 1 Nonconvertible Preferred Stock | The recurring Level 3 fair value measurements of the Company’s outstanding Series 1 nonconvertible preferred stock using probability-weighted discounted cash flow include the following significant unobservable inputs: Range March 31, September 30, Unobservable Input 2023 2022 Probabilities of payout 0 %- 65 % 0 %- 65 % Discount rate 7.25 % 7.25 % |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Fair Value of Available-for-Sale Marketable Securities by Type of Security | As of March 31, 2023 and September 30, 2022, the fair value of available-for-sale marketable securities, by type of security, was as follows: March 31, 2023 Amortized Gross Gross Credit Losses Fair Value (in thousands) Corporate bonds $ 47,329 $ 4 $ ( 1,209 ) $ — $ 46,124 Commercial paper 83,819 — — — 83,819 U.S. Treasury notes 22,229 14 ( 240 ) — 22,003 $ 153,377 $ 18 $ ( 1,449 ) $ — $ 151,946 September 30, 2022 Amortized Gross Gross Credit Losses Fair Value (in thousands) Corporate bonds $ 78,663 $ — $ ( 2,252 ) $ — $ 76,411 Commercial paper 66,784 — — — 66,784 U.S. Treasury notes 92,416 — ( 1,088 ) — 91,328 $ 237,863 $ — $ ( 3,340 ) $ — $ 234,523 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following as of March 31, 2023 and September 30, 2022: March 31, September 30, 2023 2022 (in thousands) Accrued pharmaceutical drug manufacturing $ 4,521 $ 6,932 Accrued research and development expenses 5,380 5,532 Accrued payroll and related expenses 3,075 6,439 Accrued professional fees 1,639 1,273 Accrued other 867 760 $ 15,482 $ 20,936 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 6 Months Ended |
Mar. 31, 2023 | |
Summary of Stock Option Activity Including Performance Based Options | The following table summarizes stock option activity, including performance-based options, for the year-to-date period ending March 31, 2023: Shares Weighted Weighted Aggregate (in thousands) (in years) (in thousands) Outstanding as of September 30, 2022 3,993 $ 53.57 6.2 $ 28,778 Granted 728 45.44 Exercised ( 117 ) 17.14 Forfeited ( 82 ) 65.95 Outstanding as of March 31, 2023 4,522 $ 52.98 6.5 $ 7,572 Options vested and expected to vest as of 4,522 $ 52.98 6.5 $ 7,572 Options exercisable as of March 31, 2023 2,801 $ 51.94 5.0 $ 7,554 |
Summary of Restricted Stock Unit Activity | The following table summarizes the restricted stock unit activity for the year-to-date period ending March 31, 2023: Restricted Stock Weighted (in thousands, except per share data) Unvested at September 30, 2022 219 $ 64.03 Granted 277 45.00 Vested ( 56 ) 61.10 Cancelled ( 10 ) 54.51 Unvested at March 31, 2023 430 $ 52.37 |
Stock-Based Compensation Expense | During the three and six months ended March 31, 2023 and 2022 the Company recognized the following stock-based compensation expense: Three Months Ended March 31, Six Months Ended March 31, 2023 2022 2023 2022 (in thousands) Research and development $ 2,520 $ 2,710 $ 5,052 $ 5,294 General and administrative 4,843 3,761 9,450 7,239 $ 7,363 $ 6,471 $ 14,502 $ 12,533 Three Months Ended March 31, Six Months Ended March 31, 2023 2022 2023 2022 (in thousands) Stock options $ 5,011 $ 4,962 $ 10,057 $ 9,710 rTSRUs 546 531 1,007 823 Performance stock units 175 79 542 512 Restricted stock units 1,631 899 2,896 1,488 $ 7,363 $ 6,471 $ 14,502 $ 12,533 |
Performance Share Units and Relative Total Stockholder Return Units [Member] | |
Summary of PSUs and rTSRUs Activity | The following table summarizes PSU and rTSRU activity for the year-to-date period ending March 31, 2023: PSUs rTSRUs Shares Weighted Shares Weighted (in thousands, except per share data) Unvested at September 30, 2022 101 $ 54.50 101 $ 36.14 Granted 50 47.24 50 36.91 Vested ( 70 ) 44.58 ( 70 ) 23.89 Cancelled — — — — Unvested at March 31, 2023 81 $ 58.58 81 $ 45.82 During the six months ended March 31, 2023, a total of 100 % of the target PSUs and 127 % of the target rTSRUs granted in December 2020 vested, resulting in the issuance of an aggregate of 104 common shares, net of share withholding. |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Apr. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Sep. 30, 2022 | |
Entity incorporated, in year | 1995 | |||||||
Net loss | $ 37,658 | $ 28,986 | $ 33,592 | $ 30,115 | $ 66,644 | $ 63,707 | $ 121,755 | |
Accumulated deficit | 139,823 | 139,823 | $ 73,179 | |||||
Cash, cash equivalents and short-term and long-term marketable securities | $ 225,124 | $ 225,124 | ||||||
Subsequent Event [Member] | ||||||||
Payment received royalty purchase agreement | $ 200,000 | |||||||
OCM Life Sciences Portfolio LP [Member] | Subsequent Event [Member] | ||||||||
Payment received royalty purchase agreement | $ 200,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Diluted Net Loss Per Share Attributable to Common Stockholders With Anti-dilutive effect (Detail) - shares shares in Thousands | 6 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 4,522 | 4,124 |
Unvested rTSRUs [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 81 | 112 |
Unvested PSUs [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 81 | 112 |
Unvested Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 430 | 217 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities - Financial Assets and Liabilities that were Subject to Fair Value Measurement on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Sep. 30, 2022 |
Assets: | ||
Marketable securities | $ 151,946 | $ 234,523 |
Assets, Fair Value Disclosure, Total | 222,508 | 248,428 |
Liabilities: | ||
Liabilities, Fair Value Disclosure, Total | 1,423 | 1,423 |
Series 1 Nonconvertible Preferred Stock [Member] | ||
Liabilities: | ||
Liabilities | 1,423 | 1,423 |
Level 1 [Member] | ||
Assets: | ||
Assets, Fair Value Disclosure, Total | 92,565 | 105,233 |
Liabilities: | ||
Liabilities, Fair Value Disclosure, Total | 0 | 0 |
Level 1 [Member] | Series 1 Nonconvertible Preferred Stock [Member] | ||
Liabilities: | ||
Liabilities | 0 | 0 |
Level 2 [Member] | ||
Assets: | ||
Assets, Fair Value Disclosure, Total | 129,943 | 143,195 |
Liabilities: | ||
Liabilities, Fair Value Disclosure, Total | 0 | 0 |
Level 2 [Member] | Series 1 Nonconvertible Preferred Stock [Member] | ||
Liabilities: | ||
Liabilities | 0 | 0 |
Level 3 [Member] | ||
Assets: | ||
Assets, Fair Value Disclosure, Total | 0 | 0 |
Liabilities: | ||
Liabilities, Fair Value Disclosure, Total | 1,423 | 1,423 |
Level 3 [Member] | Series 1 Nonconvertible Preferred Stock [Member] | ||
Liabilities: | ||
Liabilities | 1,423 | 1,423 |
U.S. Treasury Notes [Member] | ||
Assets: | ||
Marketable securities | 22,003 | 91,328 |
U.S. Treasury Notes [Member] | Level 1 [Member] | ||
Assets: | ||
Marketable securities | 22,003 | 91,328 |
U.S. Treasury Notes [Member] | Level 2 [Member] | ||
Assets: | ||
Marketable securities | 0 | 0 |
U.S. Treasury Notes [Member] | Level 3 [Member] | ||
Assets: | ||
Marketable securities | 0 | 0 |
Corporate Bonds [Member] | ||
Assets: | ||
Marketable securities | 46,124 | 76,411 |
Corporate Bonds [Member] | Level 1 [Member] | ||
Assets: | ||
Marketable securities | 0 | 0 |
Corporate Bonds [Member] | Level 2 [Member] | ||
Assets: | ||
Marketable securities | 46,124 | 76,411 |
Corporate Bonds [Member] | Level 3 [Member] | ||
Assets: | ||
Marketable securities | 0 | 0 |
Commercial Paper [Member] | ||
Assets: | ||
Marketable securities | 83,819 | 66,784 |
Commercial Paper [Member] | Level 1 [Member] | ||
Assets: | ||
Marketable securities | 0 | 0 |
Commercial Paper [Member] | Level 2 [Member] | ||
Assets: | ||
Marketable securities | 83,819 | 66,784 |
Commercial Paper [Member] | Level 3 [Member] | ||
Assets: | ||
Marketable securities | 0 | 0 |
Money Market Funds [Member] | ||
Assets: | ||
Cash equivalents | 70,562 | 13,905 |
Money Market Funds [Member] | Level 1 [Member] | ||
Assets: | ||
Cash equivalents | 70,562 | 13,905 |
Money Market Funds [Member] | Level 2 [Member] | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Money Market Funds [Member] | Level 3 [Member] | ||
Assets: | ||
Cash equivalents | $ 0 | $ 0 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||||
Transfers between Level 1, Level 2 and Level 3 | $ 0 | $ 0 | $ 0 | $ 0 |
Series 1 Nonconvertible Preferred Stock [Member] | ||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||||
Change in fair value of nonconvertible preferred stock | $ 0 | $ 0 | $ 0 | $ 0 |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities - Fair Value Measurements of the Company's Outstanding Series 1 Nonconvertible Preferred Stock (Detail) - Level 3 [Member] - Series 1 Nonconvertible Preferred Stock [Member] | Mar. 31, 2023 | Sep. 30, 2022 |
Probabilities of Payout [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range | 0 | 0 |
Probabilities of Payout [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range | 65 | 65 |
Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range | 7.25 | 7.25 |
Marketable Securities - Fair Va
Marketable Securities - Fair Value of Available-for-Sale Marketable Securities by Type of Security (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Sep. 30, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 153,377 | $ 237,863 |
Gross Unrealized Gains | 18 | 0 |
Gross Unrealized Losses | (1,449) | (3,340) |
Fair Value | 151,946 | 234,523 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 47,329 | 78,663 |
Gross Unrealized Gains | 4 | 0 |
Gross Unrealized Losses | (1,209) | (2,252) |
Fair Value | 46,124 | 76,411 |
U.S. Treasury Notes [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 22,229 | 92,416 |
Gross Unrealized Gains | 14 | 0 |
Gross Unrealized Losses | (240) | (1,088) |
Fair Value | 22,003 | 91,328 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 83,819 | 66,784 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 83,819 | $ 66,784 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Mar. 31, 2023 | Sep. 30, 2022 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Long-term marketable securities | $ 15,040 | $ 29,285 |
Maximum [Member] | Short Term Marketable Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | 1 year | |
Long Term Marketable Securities [Member] | Maximum [Member] | Corporate Bonds and U.S. Treasury Notes [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | 2 years | |
Long Term Marketable Securities [Member] | Minimum [Member] | Corporate Bonds and U.S. Treasury Notes [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | 1 year |
Accrued Expenses - Accrued Expe
Accrued Expenses - Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Sep. 30, 2022 |
Accrued expenses: | ||
Accrued pharmaceutical drug manufacturing | $ 4,521 | $ 6,932 |
Accrued research and development expenses | 5,380 | 5,532 |
Accrued payroll and related expenses | 3,075 | 6,439 |
Accrued professional fees | 1,639 | 1,273 |
Accrued other | 867 | 760 |
Accrued expenses | $ 15,482 | $ 20,936 |
AbbVie Collaboration - Addition
AbbVie Collaboration - Additional Information (Detail) - AbbVie [Member] | 6 Months Ended |
Mar. 31, 2023 USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Cash consideration received under collaboration from milestone payments and royalties | $ 1,250,000 |
Collaboration agreement tiered royalty description | from ten percent up to twenty percent, or on a blended basis from ten percent up to the high teens, on the portion of AbbVie’s calendar year net sales |
Series 1 Nonconvertible Prefe_2
Series 1 Nonconvertible Preferred Stock - Additional Information (Detail) - Series 1 Nonconvertible Preferred Stock [Member] | Mar. 31, 2023 shares |
Class Of Stock [Line Items] | |
Preferred stock, shares issued | 1,930,000 |
Preferred stock, shares outstanding | 1,930,000 |
Stock-Based Awards - Summary of
Stock-Based Awards - Summary of Stock Option Activity Including Performance Based Options (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 6 Months Ended | 12 Months Ended |
Mar. 31, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | |
Options | ||
Outstanding as of beginning of period | shares | 3,993 | |
Granted | shares | 728 | |
Exercised | shares | (117) | |
Forfeited | shares | (82) | |
Outstanding as of end of period | shares | 4,522 | 3,993 |
Options vested and expected to vest as of end of period | shares | 4,522 | |
Options exercisable as of end of period | shares | 2,801 | |
Weighted Average Exercise Price | ||
Outstanding | $ / shares | $ 53.57 | |
Granted | $ / shares | 45.44 | |
Exercised | $ / shares | 17.14 | |
Forfeited | $ / shares | 65.95 | |
Outstanding | $ / shares | 52.98 | $ 53.57 |
Options vested and expected to vest as of end of period | $ / shares | 52.98 | |
Options exercisable as of end of period | $ / shares | $ 51.94 | |
Weighted Average Remaining Contractual Term | ||
Outstanding as of end of period | 6 years 6 months | 6 years 2 months 12 days |
Options vested and expected to vest as of end period | 6 years 6 months | |
Options exercisable as of end of period | 5 years | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value | $ | $ 7,572 | $ 28,778 |
Options vested and expected to vest as of December 31, 2021 | $ | 7,572 | |
Options exercisable as of end of period | $ | $ 7,554 |
Stock-Based Awards - Additional
Stock-Based Awards - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | 6 Months Ended | |
Mar. 31, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vested period | 2020-12 | |
Common Stock, Shares, Issued | 21,049 | 20,791 |
Aggregate of unrecognized stock-based compensation cost | $ 70,253 | |
Weighted average recognition period | 2 years 7 months 6 days | |
Relative Total Stockholder Return Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting percentage | 127% | |
Performance Shares [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting percentage | 100% | |
Executive Officers [Member] | Relative Total Stockholder Return Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares range percentage | 0% | |
Number of shares range percentage | 150% |
Stock-Based Awards - Summary _2
Stock-Based Awards - Summary of PSUs and rTSRUs Activity (Detail) shares in Thousands | 6 Months Ended |
Mar. 31, 2023 $ / shares shares | |
PSUs [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unvested, beginning balance | shares | 101 |
Granted | shares | 50 |
Vested | shares | (70) |
Unvested, ending balance | shares | 81 |
Weighted Average Grant Date Fair Value, Unvested beginning balance | $ / shares | $ 54.50 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 47.24 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 44.58 |
Weighted Average Grant Date Fair Value, Unvested ending balance | $ / shares | $ 58.58 |
rTSRUs [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unvested, beginning balance | shares | 101 |
Granted | shares | 50 |
Vested | shares | (70) |
Unvested, ending balance | shares | 81 |
Weighted Average Grant Date Fair Value, Unvested beginning balance | $ / shares | $ 36.14 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 36.91 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 23.89 |
Weighted Average Grant Date Fair Value, Unvested ending balance | $ / shares | $ 45.82 |
Stock-Based Awards - Summary _3
Stock-Based Awards - Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock Units [Member] shares in Thousands | 6 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unvested, beginning balance | shares | 219 |
Granted | shares | 277 |
Vested | shares | (56) |
Cancelled | shares | (10) |
Unvested, ending balance | shares | 430 |
Weighted Average Grant Date Fair Value, Unvested beginning balance | $ / shares | $ 64.03 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 45 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 61.10 |
Weighted Average Grant Date Fair Value, Cancelled | $ / shares | 54.51 |
Weighted Average Grant Date Fair Value, Unvested ending balance | $ / shares | $ 52.37 |
Stock-Based Awards - Stock-Base
Stock-Based Awards - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 7,363 | $ 6,471 | $ 14,502 | $ 12,533 |
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 5,011 | 4,962 | 10,057 | 9,710 |
rTSRUs [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 546 | 531 | 1,007 | 823 |
Performance Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 175 | 79 | 542 | 512 |
Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 1,631 | 899 | 2,896 | 1,488 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 2,520 | 2,710 | 5,052 | 5,294 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 4,843 | $ 3,761 | $ 9,450 | $ 7,239 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] $ in Thousands | 1 Months Ended |
Apr. 30, 2023 USD ($) | |
Subsequent Event [Line Items] | |
Future quarterly royalty payments, cash received | $ 200,000 |
OCM Life Sciences Portfolio LP [Member] | |
Subsequent Event [Line Items] | |
Future quarterly royalty payments, cash received | $ 200,000 |
Future quarterly royalty payments, description | beginning with the payment for the quarter ending September 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. |
Percentage of future quarterly royalty payments on net sales received in cash | 54.50% |