Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Sep. 30, 2023 | Nov. 01, 2023 | Mar. 31, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Sep. 30, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ENTA | ||
Entity Registrant Name | ENANTA PHARMACEUTICALS, INC | ||
Entity Central Index Key | 0001177648 | ||
Current Fiscal Year End Date | --09-30 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Common Stock, Shares Outstanding | 21,058,925 | ||
Entity Public Float | $ 799,700,757 | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-35839 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 04-3205099 | ||
Entity Address, Address Line One | 500 Arsenal Street | ||
Entity Address, City or Town | Watertown | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02472 | ||
City Area Code | 617 | ||
Local Phone Number | 607-0800 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the registrant’s Definitive Proxy Statement for its 2024 Annual Meeting of Stockholders scheduled to be held on March 6, 2024, which Definitive Proxy will be filed with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year end of September 30, 2023 are incorporated by reference into Part III of this Form 10-K. | ||
Auditor Name | PricewaterhouseCoopers LLP | ||
Auditor Location | Boston, Massachusetts | ||
Auditor Firm ID | 238 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 85,388 | $ 43,994 |
Short-term marketable securities | 284,522 | 205,238 |
Accounts receivable | 8,614 | 20,318 |
Prepaid expenses and other current assets | 13,263 | 13,445 |
Income tax receivable | 31,004 | 28,718 |
Total current assets | 422,791 | 311,713 |
Long-term marketable securities | 0 | 29,285 |
Property and equipment, net | 11,919 | 6,173 |
Operating lease, right-of-use assets | 22,794 | 23,575 |
Restricted cash | 3,968 | 3,968 |
Other long-term assets | 803 | 696 |
Total assets | 462,275 | 375,410 |
Current liabilities: | ||
Accounts payable | 4,097 | 6,000 |
Accrued expenses and other current liabilities | 18,339 | 20,936 |
Liability related to the sale of future royalties | 35,076 | 0 |
Operating lease liabilities | 5,275 | 2,891 |
Total current liabilities | 62,787 | 29,827 |
Liability related to the sale of future royalties, net of current portion | 159,429 | 0 |
Operating lease liabilities, net of current portion | 21,238 | 22,372 |
Series 1 nonconvertible preferred stock | 1,423 | 1,423 |
Other long-term liabilities | 663 | 454 |
Total liabilities | 245,540 | 54,076 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Common stock; $0.01 par value per share, 100,000 shares authorized; 21,059 and 20,791 shares issued and outstanding at September 30, 2023 and September 30, 2022, respectively | 211 | 208 |
Additional paid-in capital | 424,693 | 398,029 |
Accumulated other comprehensive loss | (1,174) | (3,724) |
Accumulated deficit | (206,995) | (73,179) |
Total stockholders' equity | 216,735 | 321,334 |
Total liabilities and stockholders' equity | $ 462,275 | $ 375,410 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands | Sep. 30, 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 | 21,059 | 20,791 |
Common stock, shares outstanding | 21,059 | 20,791 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue | |||
Total revenue | $ 79,204 | $ 86,160 | $ 97,074 |
Operating expenses: | |||
Research and development | 163,524 | 164,522 | 174,111 |
General and administrative | 52,887 | 45,482 | 32,536 |
Total operating expenses | 216,411 | 210,004 | 206,647 |
Loss from operations | (137,207) | (123,844) | (109,573) |
Other income (expense): | |||
Interest expense | (5,148) | 0 | 0 |
Interest and investment income, net | 11,360 | 1,573 | 2,021 |
Change in fair value of Series 1 nonconvertible preferred stock | 0 | 83 | (27) |
Total other income , net | 6,212 | 1,656 | 1,994 |
Loss before income taxes | (130,995) | (122,188) | (107,579) |
Income tax (expense) benefit | (2,821) | 433 | 28,583 |
Net loss | $ (133,816) | $ (121,755) | $ (78,996) |
Net loss per share: | |||
Basic | $ (6.38) | $ (5.91) | $ (3.92) |
Diluted | $ (6.38) | $ (5.91) | $ (3.92) |
Weighted average shares outstanding: | |||
Basic | 20,969 | 20,603 | 20,171 |
Diluted | 20,969 | 20,603 | 20,171 |
Royalty [Member] | |||
Revenue | |||
Total revenue | $ 78,204 | $ 86,160 | $ 97,074 |
License [Member] | |||
Revenue | |||
Total revenue | $ 1,000 | $ 0 | $ 0 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (133,816) | $ (121,755) | $ (78,996) |
Other comprehensive income (loss): | |||
Net unrealized gains (losses) on marketable securities | 2,550 | (3,342) | (1,226) |
Total other comprehensive income (loss) | 2,550 | (3,342) | (1,226) |
Comprehensive loss | $ (131,266) | $ (125,097) | $ (80,222) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Retained Earnings (Accumulated Deficit) [Member] |
Beginning Balance at Sep. 30, 2020 | $ 455,580 | $ 201 | $ 326,963 | $ 844 | $ 127,572 |
Beginning Balance, Shares at Sep. 30, 2020 | 20,077 | ||||
Exercise of stock options | 3,614 | $ 1 | 3,613 | ||
Exercise of stock options, Shares | 129 | ||||
Vesting of restricted stock units, net of withholding | (534) | (534) | |||
Vesting of restricted stock units, net of withholding, Shares | 32 | ||||
Stock-based compensation expense | 20,991 | 20,991 | |||
Other comprehensive income, net of tax | (1,226) | (1,226) | |||
Net loss | (78,996) | (78,996) | |||
Ending Balance at Sep. 30, 2021 | 399,429 | $ 202 | 351,033 | (382) | 48,576 |
Ending Balance, Shares at Sep. 30, 2021 | 20,238 | ||||
Exercise of stock options | 21,262 | $ 6 | 21,256 | ||
Exercise of stock options, Shares | 517 | ||||
Vesting of restricted stock units, net of withholding | (1,229) | (1,229) | |||
Vesting of restricted stock units, net of withholding, Shares | 36 | ||||
Stock-based compensation expense | 26,969 | 26,969 | |||
Other comprehensive income, net of tax | (3,342) | (3,342) | |||
Net loss | (121,755) | (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 | ||||
Exercise of stock options | $ 2,208 | $ 1 | 2,207 | ||
Exercise of stock options, Shares | 124 | 124 | |||
Vesting of restricted stock units, net of withholding | $ (3,757) | $ 2 | (3,759) | ||
Vesting of restricted stock units, net of withholding, Shares | 144 | ||||
Stock-based compensation expense | 28,216 | 28,216 | |||
Other comprehensive income, net of tax | 2,550 | 2,550 | |||
Net loss | (133,816) | (133,816) | |||
Ending Balance at Sep. 30, 2023 | $ 216,735 | $ 211 | $ 424,693 | $ (1,174) | $ (206,995) |
Ending Balance, Shares at Sep. 30, 2023 | 21,059 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities | |||
Net loss | $ (133,816) | $ (121,755) | $ (78,996) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 28,216 | 26,969 | 20,991 |
Depreciation and amortization expense | 2,371 | 2,973 | 3,334 |
Non-cash interest expense associated with the sale of future royalties | 5,148 | 0 | 0 |
Non-cash royalty revenue | (10,318) | 0 | 0 |
Deferred income taxes | 0 | 0 | 345 |
Premium paid on marketable securities | (73) | (846) | (4,028) |
Amortization (accretion) of premiums (discounts) on marketable securities | (2,856) | 1,171 | 2,116 |
Loss on disposal of property and equipment | 150 | 0 | 0 |
Change in fair value of Series 1 nonconvertible preferred stock | 0 | (83) | 27 |
Other non-cash items | 0 | 0 | (97) |
Change in operating assets and liabilities: | |||
Accounts receivable | 11,704 | 3,258 | (84) |
Prepaid expenses and other current assets | 182 | 743 | (533) |
Income tax receivable | (2,286) | 8,537 | (24,214) |
Operating lease, right-of-use assets | 4,598 | 4,776 | 5,418 |
Other long-term assets | (107) | (604) | 0 |
Accounts payable | (1,151) | (4,634) | 3,774 |
Accrued expenses | (2,558) | (1,477) | 8,350 |
Operating lease liabilities | (2,567) | (3,706) | (5,879) |
Other long-term liabilities | 209 | (104) | (520) |
Net cash used in operating activities | (103,154) | (84,782) | (69,996) |
Cash flows from investing activities | |||
Purchase of marketable securities | (373,391) | (171,446) | (307,348) |
Proceeds from maturities and sale of marketable securities | 328,871 | 228,468 | 345,089 |
Purchase of property and equipment | (9,058) | (2,125) | (750) |
Net cash provided by (used in) investing activities | (53,578) | 54,897 | 36,991 |
Cash flows from financing activities | |||
Proceeds from exercise of stock options | 2,208 | 21,262 | 3,614 |
Proceeds from the sale of future royalties | 200,000 | 0 | 0 |
Payments for debt issuance costs | (325) | 0 | 0 |
Payments for settlement of share-based awards | (3,757) | (1,229) | (534) |
Net cash provided by financing activities | 198,126 | 20,033 | 3,080 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 41,394 | (9,852) | (29,925) |
Cash, cash equivalents and restricted cash at beginning of period | 47,962 | 57,814 | 87,739 |
Cash, cash equivalents and restricted cash at end of period | 89,356 | 47,962 | 57,814 |
Supplemental cash flow information: | |||
Cash paid for taxes | 4,899 | 0 | 32 |
Supplemental disclosure of noncash information: | |||
Purchases of fixed assets included in accounts payable and accrued expenses | 424 | 1,215 | 137 |
Operating lease liabilities arising from obtaining right-of-use assets | $ 3,817 | $ 23,910 | $ 3,320 |
Nature of the Business
Nature of the Business | 12 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business | 1. Nature of the Business Enanta Pharmaceuticals, Inc. (collectively with its subsidiary, 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 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements include those of the Company and its subsidiary, Enanta Pharmaceuticals Security Corporation, after elimination of all intercompany accounts and transactions. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). 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; liability related to the sale of future royalties; 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. Cash Equivalents and Marketable Securities The Company considers all short-term, highly liquid investments with original maturities of ninety days or less at acquisition date to be cash equivalents. Marketable securities with original maturities of greater than ninety days and remaining maturities of less than one year from the balance sheet date are classified as short-term marketable securities. Marketable securities with remaining maturities of greater than one year from the balance sheet date are classified as long-term marketable securities. The Company classifies all of its marketable securities as available-for-sale. The Company continually evaluates the credit ratings of its investment portfolio and underlying securities. The Company invests in accordance with its investment policy and invests at the date of purchase in securities with a rating of A3/A- or higher according to Moody’s or S&P or A- by Fitch. The Company reports available-for-sale investments at fair value as of each balance sheet date and records any unrealized gains or losses as a component of stockholders’ equity. The cost of securities sold is determined on a specific identification basis and realized gains and losses are included in other income (expense) within the consolidated statements of operations. When the fair value is below the amortized cost of a marketable security, an estimate of expected credit losses is made. The credit-related impairment amount is recognized in the consolidated statements of operations. Credit losses are recognized through the use of an allowance for credit losses account in the consolidated balance sheet and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations. There were no credit losses recorded during the years ended September 30, 2023, 2022, and 2021. Restricted Cash As of September 30, 2023 and 2022 , the Company had outstanding letters of credit collateralized by a money market account of $ 3,968 , to the benefit of the landlord of the Company’s building leases. This amount was classified as long-term restricted cash as of September 30, 2023 and 2022 . Concentration of Credit Risk and of Significant Customers and Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, short-term and long-term marketable securities and accounts receivable. The Company has all cash and investment balances at one accredited financial institution, including cash in amounts that exceed federally insured limits. The Company does not believe it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company has historically generated the majority of its revenue from its collaborative research and license agreements. As of September 30, 2023 and 2022, accounts receivable consisted of amounts due from the Company’s principal collaborator (see Note 7). The Company is completely dependent on third-party manufacturers for product supply for preclinical and clinical research activities. The Company relies and expects to continue to rely exclusively on several manufacturers to supply the Company with its drug supply requirements related to these activities. These research programs would be adversely affected by a significant interruption in the supply from these third-party manufacturers. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. A fair value hierarchy is based on three levels of inputs that are used to measure fair value, of which the first two levels are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s instruments that are carried at fair value are cash equivalents, short-term and long-term marketable securities and the Series 1 nonconvertible preferred stock. The carrying values of accounts receivable, prepaid and other assets, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these assets and liabilities. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the following estimated useful lives: Laboratory and office equipment 5 years Leasehold improvements Shorter of life of lease or estimated useful life Purchased software 3 years Computer equipment 3 years Furniture 7 years Expenditures for repairs and maintenance of assets are charged to expense as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their useful lives. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed are removed from the accounts and any resulting gain or loss is included in income from operations in the consolidated statements of operations. Leases The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines if an arrangement is a lease or contains an embedded lease at inception. For arrangements that meet the definition of a lease, the Company determines the initial classification and measurement of its right-of-use asset and lease liability at the lease commencement date and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. The Company’s policy is to not record leases with an original term of 12 months or less on its consolidated balance sheets and recognizes those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. In addition to rent, the leases may require the Company to pay additional costs, such as utilities, maintenance and other operating costs, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and lease liability. Rent expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the consolidated statements of operations. Impairment of Long-Lived Assets The Company reviews long-lived assets, primarily property and equipment and right-of-use assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. To date, the Company has no t recorded any impairment losses on long-lived assets. Liability Related to the Sale of Future Royalties 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. The Company recognized the $ 200,000 received from OMERS as a liability on its consolidated balance sheets because the $200,000 will be paid back to OMERS up to a 1.42 capped amount and the Company has significant continuing involvement under the AbbVie Agreement. Interest expense for the liability related to the sale of future royalties is recognized using the effective interest rate method over the term of the royalty sale agreement. The liability related to the sale of future royalties and related interest expense are based on current estimates of future royalties, which the Company determines by using third-party forecasts of MAVYRET/MAVIRET sales. The Company periodically assesses the forecasted sales and to the extent the amount or timing of future estimated royalty payments is materially different than previous estimates, the Company will account for any such change by adjusting the liability related to the sale of future royalties and prospectively recognizing the related non-cash interest expense. Revenue Recognition The Company’s revenue has been generated primarily through collaborative research and license agreements. The terms of these agreements contain multiple deliverables, which may include (i) licenses, (ii) research and development activities, and (iii) participation in joint research and development steering committees. The terms of these agreements may include nonrefundable upfront license fees, payments for research and development activities, payments based upon the achievement of certain milestones, and royalty payments based on product sales derived from the collaboration. The Company recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company receives sales-based royalties for which the license is deemed to be the predominant item to which the royalties relate and thus the Company recognizes sales-based royalties as the underlying sales are earned. Research and Development Costs Included in research and development costs are wages, stock-based compensation and benefits of employees performing research and development, third-party license fees and other operational costs related to the Company’s research and development activities, including facility-related expenses and external costs of outside contractors engaged to conduct both preclinical and clinical studies and manufacture quantities of product for preclinical and clinical studies. The Company expenses the cost of each contract as the work is performed. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. Research and Development and Pharmaceutical Drug Manufacturing Accruals The Company has entered into various contracts with third parties to perform research and development and pharmaceutical drug manufacturing. This includes contracts with contract research organizations (“CROs”), clinical manufacturing organizations (“CMOs”), testing laboratories, research hospitals and not for profit organizations and other entities to support our research and development activities. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations to those third parties as of period end. The accrual estimates are based on a number of factors, including the Company’s knowledge of the research and development programs and pharmaceutical drug manufacturing activities and associated timelines, invoicing to date, and the provisions in the contract. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from our estimates. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are recorded as general and administrative expenses as incurred. Stock-Based Compensation The Company measures all stock options and other stock-based awards granted to employees at fair value on the date of grant. The Company uses the Black-Scholes option-pricing model in the valuation of its stock options. The fair value of restricted stock units with service-based and performance-based vesting is based on the fair value of the stock on the date of grant. The Company uses the Monte-Carlo model to calculate the fair value on the date of grant of market-based awards. The fair value of service-based awards is recognized as stock-based compensation expense over the requisite service period, which is generally the vesting period of the respective award. For awards with graded vesting, the straight-line method of expense recognition is applied to all awards with service-only based conditions. The Company uses the graded-vesting method to record the expense of awards with both service-based and performance-based vesting conditions, commencing once achievement of the performance condition becomes probable. The Company classifies stock-based compensation expense in the consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified. The Company accounts for stock-based compensation expense related to forfeitures as the forfeitures occur. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial reporting and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in income tax expense. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes based upon the weight of available evidence, that it is more likely than not that all or a portion of deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. The realization of deferred tax assets is dependent upon the Company’s ability to generate future taxable income during the periods in which those temporary differences become deductible. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. Uncertain tax positions represent tax positions for which reserves have been established. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more likely than not to be sustained, the tax position is then assessed to determine the amount of benefit to be recognized in the financial statements. The amount that may be recognized is the largest amount that has a greater than 50 % likelihood of being realized upon ultimate settlement. Income tax expense includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. 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 in which the Company reported a net loss, 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 years ended September 30, 2023, 2022, and 2021 . 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: Years Ended September 30, 2023 2022 2021 (in thousands) Options to purchase common stock 4,365 3,993 3,852 Unvested rTSRUs 81 101 111 Unvested PSUs 81 101 111 Unvested restricted stock units 411 219 117 Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is a biotechnology company focused on discovering and developing small molecule drugs, with an emphasis on treatments for viral infections. Revenue is generated exclusively from transactions occurring with partners located in the United States, and all assets are held in the United States. Comprehensive Income (Loss) Comprehensive income (loss) includes net income (loss) as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The Company’s only element of other comprehensive income (loss) is unrealized gains and losses on available-for-sale marketable securities. Going Concern In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40) (“ASU 2014-15”). The Company adopted this standard as of September 30, 2017. The standard requires the Company to assess its ability to continue as a going concern one year beyond the date of filing and, in certain circumstances, provide additional footnote disclosures. Based on a detailed cash forecast incorporating current research and development activities and related spending plans, the Company believes that its current cash, cash equivalents and short-term marketable securities on hand at September 30, 2023 is sufficient to fund operations for at least the next twelve months beyond the date of issuance of these consolidated financial statements. The amount of capital available will depend on the Company’s management of its existing cash, cash equivalents and short-term marketable securities, as well as the level of future royalties the Company earns under its agreement with AbbVie. If the Company should require financing beyond these resources to fund its research and development efforts, it may not be able to obtain financing on acceptable terms, or at all . Recently Issued Accounting Pronouncements 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 | 12 Months Ended |
Sep. 30, 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 September 30, 2023 and 2022 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value: Fair Value Measurements at September 30, 2023 Using: Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 55,357 $ — $ — $ 55,357 U.S. Treasury notes 29,755 — — 29,755 Marketable securities: U.S. Treasury notes 236,782 — — 236,782 Corporate bonds — 26,435 — 26,435 Commercial paper — 21,305 — 21,305 321,894 47,740 — 369,634 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 Cash equivalents at September 30, 2023 and 2022 consist of money market funds and U.S. Treasury notes that are readily convertible to cash and with less than 90 days until maturity. During the years ended September 30, 2023, 2022, and 2021 , there were no transfers between Level 1, Level 2 and Level 3. The fair value of Level 2 instruments classified as marketable securities were determined through third-party pricing services. The pricing services use many observable market inputs to determine value, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, and current spot rates. The outstanding shares of Series 1 nonconvertible preferred stock as of September 30, 2023 and 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: Series 1 nonconvertible preferred stock Range September 30, Unobservable Input 2023 2022 Probabilities of payout 0 %- 65 % 0 %- 65 % Discount rate 7.25 % 7.25 % The following table provides a rollforward of the aggregate fair value of the Company’s outstanding Series 1 nonconvertible preferred stock for which fair value is determined by Level 3 inputs: Series 1 (in thousands) Balance, September 30, 2020 $ 1,479 Change in fair value 27 Balance, September 30, 2021 1,506 Change in fair value ( 83 ) Balance, September 30, 2022 1,423 Change in fair value — Balance, September 30, 2023 $ 1,423 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 future quarterly royalty payments on net sales of MAVYRET/MAVIRET, after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. The Company accounted for the upfront payment as a liability related to the sale of future royalties. The carrying value of the liability related to the sale of future royalties approximates fair value as of September 30, 2023 and is based on current estimates of future royalties expected to be paid to OMERS over the next 10 years, which are considered Level 3 inputs. See Note 8 for a rollforward of the liability. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities As of September 30, 2023 and 2022, the fair value of available-for-sale marketable securities, by type of security, was as follows: September 30, 2023 Amortized Gross Gross Credit Losses Fair Value (in thousands) Corporate bonds $ 27,127 $ — $ ( 692 ) $ — $ 26,435 Commercial paper 21,305 — — — 21,305 U.S. Treasury notes 236,880 12 ( 110 ) — 236,782 $ 285,312 $ 12 $ ( 802 ) $ — $ 284,522 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 September 30, 2023, marketable securities consisted of investments that mature within one year . As of 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 three years and an aggregate fair value of $ 29,285 . |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net consisted of the following as of September 30, 2023 and 2022: September 30, 2023 2022 (in thousands) Laboratory and office equipment $ 15,891 $ 14,780 Leasehold improvements 13,804 7,276 Purchased software 1,444 1,412 Furniture 2,290 1,354 Computer equipment 962 653 Construction in progress 1,273 2,556 35,664 28,031 Less: Accumulated depreciation and amortization ( 23,745 ) ( 21,858 ) $ 11,919 $ 6,173 As of September 30, 2023, construction in progress related primarily to leasehold improvements. Depreciation and amortization expense for property and equipment, was $ 2,371 , $ 2,973 and $ 3,334 for the years ended September 30, 2023, 2022, and 2021 , respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following as of September 30, 2023 and 2022: September 30, 2023 2022 (in thousands) Accrued pharmaceutical drug manufacturing $ 3,083 $ 6,932 Accrued research and development expenses 6,120 5,532 Accrued payroll and related expenses 7,037 6,439 Accrued other 2,099 2,033 $ 18,339 $ 20,936 |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreements | 7. Collaboration Agreements 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 $ 1,287,000 through September 30, 2023. Since the Company satisfied all of its performance obligations under the AbbVie Agreement by the end of fiscal 2011, all milestone payments received since then have been recognized as revenue when the milestones were achieved by AbbVie. 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. The following table details the royalty tiers associated with cumulative calendar year net sales allocated to each royalty-bearing product as provided in the AbbVie Agreement: Calendar Year Net Sales Royalty Tier (in thousands) (%) up to $ 500,000 10 % from $ 500,000 up to $ 750,000 12 % from $ 750,000 up to $ 1,000,000 14 % from $ 1,000,000 up to $ 2,500,000 17 % greater than or equal to $ 2,500,000 20 % Royalties owed to the Company under the agreement can be reduced by AbbVie in certain circumstances, including (i) if AbbVie exercises its right to license or otherwise acquire rights to intellectual property controlled by a third party where a product could not be legally developed or commercialized in a country without the third-party intellectual property right, (ii) where a product developed under the collaboration agreement is sold in a country and not covered by a valid patent claim in such country, and (iii) where sales of a generic product are equal to at least a specified percentage of AbbVie’s market share of its product in a country. AbbVie’s obligation to pay royalties on a product developed under the agreement expires on a country-by-country basis upon the later of (i) the date of expiration of the last of the licensed patents with a valid claim covering the product in the applicable country, or (ii) ten years after the first commercial sale of the product in the applicable country. Subject to certain exceptions, a party’s rights and obligations under the agreement continue until (i) such time as AbbVie is no longer developing a product candidate or (ii) if, as of the time AbbVie is no longer developing any product candidates, AbbVie is commercializing any other protease inhibitor product, such time as all royalty terms for all covered products have ended. Accordingly, the final expiration date of the agreement is currently indeterminable. Either party may terminate the agreement for cause in the event of a material breach, subject to prior notice and the opportunity to cure, or in the event of the other party’s bankruptcy. Additionally, AbbVie may terminate the agreement for any reason upon specified prior notice. If the Company terminates the agreement for cause or AbbVie terminates without cause, any licenses and other rights granted to AbbVie will terminate and AbbVie will be deemed to have granted the Company (i) a non-exclusive, perpetual, fully-paid, worldwide, royalty-free license, with the right to sublicense, under AbbVie’s intellectual property used in any product candidate, and (ii) an exclusive (even as to AbbVie), perpetual, fully-paid, worldwide, royalty-free license, with the right to sublicense, under AbbVie’s interest in any joint intellectual property rights to develop product candidates resulting from covered compounds and to commercialize any products derived from such compounds. Upon the Company’s request, AbbVie will also transfer to the Company all right, title and interest in any related product trademarks, regulatory filings and clinical trials. If AbbVie terminates the agreement for the Company’s uncured breach, the milestone and royalty payments payable by AbbVie may be reduced, the licenses granted to AbbVie will remain in place, the Company will be deemed to have granted AbbVie an exclusive license under the Company’s interest in joint intellectual property, AbbVie will continue to have the right to commercialize any covered products, and all rights and licenses granted to the Company by AbbVie will terminate. |
Liability Related to the Sale o
Liability Related to the Sale of Future Royalties | 12 Months Ended |
Sep. 30, 2023 | |
Nonmonetary Transactions [Abstract] | |
Liability Related to the Sale of Future Royalties | 8. Liability Related to the Sale of Future Royalties 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 future quarterly royalty payments on net sales of MAVYRET/MAVIRET, after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. Because the royalty sale agreement will be paid back to OMERS up to a capped amount as well as the Company’s significant continuing involvement in the generation of future cash flows under its AbbVie Agreement, the Company recorded the proceeds from the transaction as a liability on its consolidated balance sheets which will be amortized as interest expense in the consolidated statements of operations under the effective interest rate method over the life of the royalty sale agreement. The Company will continue to record the full amount of royalties earned on MAVYRET/MAVIRET sales as royalty revenue in the consolidated statements of operations. The Company’s liability related to the sale of future royalties is estimated based on forecasted worldwide MAVYRET/MAVYRET royalties to be paid to OMERS over the course of the royalty sale agreement. This estimate requires significant judgment, including the amount and timing of royalty payments up until the end of the royalty sale agreement, which is estimated to be the stated term of June 30, 2032. As royalties are earned by OMERS, the liability is reduced on the Company’s consolidated balance sheets. At September 30, 2023 , the estimated future cash flows resulted in an effective annual imputed interest rate of approximately 6.18 %. The following table summarizes the activity of the liability related to the sale of future royalties: Liability related to the sale of future royalties (in thousands) Balance - September 30, 2022 $ — Proceeds from sale of future royalties 200,000 Debt issuance cost ( 325 ) Royalty payable to royalty purchaser ( 10,318 ) Non-cash interest expense 5,148 Balance - September 30, 2023 $ 194,505 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity The Company is authorized to issue 100,000 shares of common stock at a par value of $ 0.01 per share. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders . Common stockholders are entitled to receive such dividends as may be declared by the board of directors, if any. The Company also is authorized to issue 5,000 shares of preferred stock at a par value of $ 0.01 per share, of which 2,000 shares are designated as Series 1 Nonconvertible preferred stock and 3,000 shares are undesignated and unissued. |
Series 1 Nonconvertible Preferr
Series 1 Nonconvertible Preferred Stock | 12 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Series 1 Nonconvertible Preferred Stock | 10. Series 1 Nonconvertible Preferred Stock The Company’s Certificate of Incorporation authorizes the issuance of up to 2,000 shares of Series 1 nonconvertible preferred stock at a par value of $ 0.01 per share. Holders of Series 1 nonconvertible preferred stock are not entitled to receive dividends. In the event of any liquidation, deemed liquidation, dissolution or winding up of the Company, the Series 1 nonconvertible preferred stockholders are entitled to receive in preference to all other stockholders, an amount equal to $ 1.00 per share, adjusted for any stock dividends, stock splits or reclassifications. Series 1 nonconvertible preferred stockholders will not be entitled to vote unless required by the Company pursuant to the laws of the State of Delaware. The Company may redeem the Series 1 nonconvertible preferred stock with the approval of the holders of a majority of the outstanding shares of Series 1 nonconvertible preferred stock at a redemption price of $ 1.00 per share. The Company must redeem the stock within 60 days of such election. Shares that are redeemed will be retired or canceled and not reissued by the Company. As these shares qualify as a derivative, they are classified as a liability on the Company’s consolidated balance sheet. As of September 30, 2023 and 2022 , 1,930 shares of Series 1 nonconvertible preferred stock were issued and outstanding. For the years ended September 30, 2023, 2022, and 2021 , the remeasurement of the Series 1 nonconvertible preferred stock resulted in income (expense) of $ 0 , $ 83 , and $( 27 ), respectively, which was recorded in other income (expense) in the consolidated statements of operations. The total fair value of the Series 1 nonconvertible preferred stock was $ 1,423 as of September 30, 2023 and 2022 . |
Stock-Based Awards
Stock-Based Awards | 12 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Awards | 11. 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”), but is no longer granting awards under this plan. The Company’s 2019 Plan permits the Company to sell or issue awards of common stock or restricted common stock or to grant awards of incentive stock options or nonqualified stock options for the purchase of common stock, restricted stock units, performance units, stock appreciation rights or other cash incentive awards, to employees, members of the board of directors and consultants of the Company. The number of shares of common stock that may be issued under the 2019 Plan is subject to increase by the number of shares forfeited under any options forfeited and not exercised under the 2019 Plan or any predecessor plans such as the 2012 Plan. As of September 30, 2023, 1,535 shares remained available for future awards under the 2019 Plan. Under the Company’s Employee Stock Purchase Plan (“ESPP”) a total of 186 shares of common stock are reserved for issuance. As of September 30, 2023 , the Company had not commenced any offering under the ESPP and no ESPP shares have been issued. Options granted under the 2019 Plan to employees generally vest over four years and to non-employee directors over one year , and expire after ten years . As required under the equity plans, the exercise price for awards granted is not to be less than the fair value of common shares on the date of grant. Restricted stock units with service-based vesting conditions generally vest over four years . Stock Option Valuation The fair value of each stock option award is determined on the date of grant using the Black-Scholes option-pricing model. The volatility has been determined using the Company’s traded stock price to estimate expected volatility. The expected term of the Company’s options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield is zero due to the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The relevant data used to determine the value of the stock option awards are as follows, presented on a weighted average basis: Years Ended September 30, 2023 2022 2021 Risk-free interest rate 3.88 % 1.72 % 0.61 % Expected term (in years) 6.04 6.04 6.05 Expected volatility 48 % 47 % 52 % Expected dividends 0 % 0 % 0 % Weighted average grant date fair value $ 22.71 $ 33.22 $ 21.76 The following table summarizes stock option activity, including aggregate intrinsic value for the year ended September 30, 2023: Shares Weighted Weighted Aggregate (in thousands) (in thousands) Outstanding as of September 30, 2022 3,993 $ 53.57 6.2 $ 28,778 Granted 765 44.47 Exercised ( 124 ) 17.83 Forfeited ( 269 ) 58.64 Outstanding as of September 30, 2023 4,365 $ 52.68 5.9 $ — Options vested and expected to vest as of 4,365 $ 52.68 5.9 $ — Options exercisable as of September 30, 2023 3,086 $ 52.20 4.9 $ — The aggregate intrinsic value of options is calculated as the difference between the exercise price of the options and the fair value of the Company’s common stock. The following tables summarize additional exercise and grant date information: Years Ended September 30, 2023 2022 2021 (in thousands) Aggregate intrinsic value of stock options exercised $ 3,295 $ 17,650 $ 2,704 Proceeds to Company from stock options exercised $ 2,208 $ 21,262 $ 3,614 Market and Performance-Based Stock Unit Awards The Company awards both performance share units (“PSUs”) and relative total stockholder return units (“rTSRUs”) to its executive officers. The PSUs vest and result in issuance, or settlement, of common shares for each recipient, based upon the recipient’s continued employment with the Company through the settlement date of the award and the Company’s achievement of specified research and development milestones. The requisite service period of the PSUs is generally two years. The fair value of PSUs is based on the fair value of the stock on the date of grant, which is determined to be the closing price of the Company's common stock. Stock-based compensation expense for PSUs is recorded in the statements of operations over the service period, commencing when it is probable that the specified research and development milestone is achieved. The rTSRUs vest and result in the issuance of common stock based upon the recipient’s continuing employment with the Company through the settlement date of the award and the relative ranking of the total stockholder return, or TSR, of the Company’s common stock in relation to the TSR of the component companies in the NASDAQ Biotech Index over two specified periods that are two years apart, based on a comparison of average closing stock prices in specified periods noted in the award agreement. The number of market-based rTSRUs awarded 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, depending on the award agreement and the year of the award. The Company used a Monte Carlo model to estimate the grant-date fair value of the rTSRUs. Stock-based compensation expense for rTSRUs is recorded in the statements of operations over the service period regardless of whether the market condition is achieved. Assumptions and estimates utilized in the calculation of the fair value of the rTSRUs include the risk-free interest rate, dividend yield, expected volatility based on the historical volatility of publicly traded peer companies and the remaining performance period of the award. The table below sets forth the weighted average grant date fair value assumptions used to value the rTSRUs: Years Ended September 30, 2023 2022 2021 Risk-free interest rate 4.19 % 0.94 % 0.13 % Dividend yield 0 % 0 % 0 % Expected volatility 77 % 80 % 74 % Performance period (years) 2.03 1.97 1.97 The following table summarizes PSU and rTSRU activity (at target) for the year ended September 30, 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 40.32 Vested ( 70 ) 44.58 ( 70 ) 27.88 Cancelled — — — — Unvested at September 30, 2023 81 $ 58.58 81 $ 45.82 The total fair value of PSUs and rTSRUs vested during the years ended September 30, 2023, 2022, and 2021 were $ 8,103 , $ 1,414 and $ 0 , respectively. Restricted Stock Units The following table summarizes the restricted stock unit activity for the year ending September 30, 2023: Restricted Weighted (in thousands, except per share data) Unvested at September 30, 2022 219 $ 64.03 Granted 280 44.63 Vested ( 61 ) 61.94 Cancelled ( 27 ) 53.98 Unvested at September 30, 2023 411 $ 51.78 The total fair value of restricted stock units vested during the years ended September 30, 2023, 2022, and 2021 were $ 2,590 , $ 2,427 and $ 1,897 , respectively. Stock-Based Compensation Expense The Company recorded the following stock-based compensation expense for the years ended September 30, 2023, 2022, and 2021: Years Ended September 30, 2023 2022 2021 (in thousands) Research and development $ 9,551 $ 9,728 $ 10,075 General and administrative 18,665 17,241 10,916 $ 28,216 $ 26,969 $ 20,991 Years Ended September 30, 2023 2022 2021 (in thousands) Stock options $ 19,784 $ 19,615 $ 18,004 rTSRUs 1,893 1,597 1,537 PSUs 542 2,628 235 Restricted stock units 5,997 3,129 1,215 $ 28,216 $ 26,969 $ 20,991 As of September 30, 2023, the Company had an aggregate of $ 61,333 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.2 years. |
Leases
Leases | 12 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 12. Leases The Company has two real estate leases for properties located in Watertown, Massachusetts. The first lease, for office and laboratory space at 500 Arsenal Street and expires in September 2027 . The second lease, for office space located at 400 Talcott Avenue and expires in June 2034 . Lease payments for the Company's real estate leases include fixed lease payments that escalate over the terms of the leases and require the Company to pay certain operating expenses based on actual costs incurred. Operating expenses that are not fixed in nature are expensed in the period incurred and included in variable lease costs. The leases do not include any restrictions or covenants that had to be accounted for under the lease guidance. In May 2022, the Company entered into a new ten-year lease agreement with its existing landlord for laboratory and office space in Watertown, Massachusetts, adjacent to its 400 Talcott Avenue premises to accommodate its growing headcount. The new lab and office space will be located at Arsenal on the Charles in Watertown, Massachusetts, at a to-be-constructed facility. The Company expects to gain access to the space to perform tenant improvements beginning in December 2023. The estimated minimum lease payments as a result of the new lease total $ 76,470 over the ten-year term. The lease also contains a tenant improvement allowance of $ 15,194 . The Company will account for the lease as a right-of-use asset and lease liability upon the lease commencement date. In conjunction with the new lease agreement at Arsenal on the Charles, the Company amended its 500 Arsenal Street lease to shorten the term of the lease from September 2027 to the date when the Arsenal on the Charles facility is completed and ready for the Company's occupancy. The construction of the Arsenal on the Charles facility is being conducted by the landlord and it is expected that the facility will be ready for the Company's tenant improvement buildout in December 2023. As the construction of the facility and the timing of completion is not in the control of the Company, the Company will remeasure the term for the 500 Arsenal Street lease for financial accounting purposes at the time the contingency regarding occupancy lapses. The Company leases units of equipment over eighteen-month lease periods commencing upon shipment of each unit. The lease agreements contain options to terminate the leases early or to extend the leases for successive six-month periods , however these options were not included in the right-of-use assets and lease liability as they were not reasonably certain of being exercised. The equipment leases require the Company to pay for certain consumable and peripheral equipment supplies based on actual costs incurred. As these costs are not fixed in nature, they are expensed in the period incurred and included in variable lease costs. The components of lease expense for the Company’s real estate and equipment leases were as follows: Years Ended September 30, 2023 2022 2021 (in thousands) Operating lease cost $ 6,230 $ 6,294 $ 5,861 Variable lease cost 5,352 2,375 4,057 $ 11,582 $ 8,669 $ 9,918 Supplemental disclosure of cash flow information related to the Company's operating leases included in cash flows used in operating activities in the consolidated statements of cash flows were as follows: Years Ended September 30, 2023 2022 2021 (in thousands) Cash paid for amounts included in the measurement of operating lease liabilities $ 4,592 $ 4,966 $ 6,364 Operating lease liabilities arising from obtaining right-of-use assets $ 3,817 $ 23,910 $ 3,320 The weighted-average remaining lease term and discount rate were as follows: September 30, 2023 2022 Weighted-average remaining lease term - operating leases (in years) 6.51 7.42 Weighted-average discount rate - operating leases 7.18 % 6.96 % As the Company’s leases do not provide an implicit rate, the Company utilized its incremental borrowing rate based on information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Future annual minimum lease payments relating to the Company's lease liabilities as of September 30, 2023 were as follows: Years ended September 30, (in thousands) 2024 6,734 2025 5,314 2026 5,373 2027 5,196 2028 1,640 Thereafter 10,273 Total future minimum lease payments 34,530 Less: imputed interest ( 8,017 ) Total operating lease liabilities $ 26,513 September 30, Included in the balance sheet: 2023 2022 (in thousands) Current operating lease liabilities $ 5,275 $ 2,891 Operating lease liabilities, net of current portion 21,238 22,372 Total operating lease liabilities $ 26,513 $ 25,263 The tables above do not include lease payments related to the Company’s Arsenal on the Charles facility because as of September 30, 2023, the lease commencement date had not occurred. Additionally, the tables above do not include the impact of shortening the term for the 500 Arsenal Street Lease as the term date is contingent upon events not in the Company's control. The Company is required to maintain security deposits of $ 652 in connection with various of its real estate leases, which amounts are included in other long-term assets on the Company's consolidated balance sheets. In addition, the Company is required to maintain letters of credit for certain of its leases, collateralized by money market accounts of $ 3,968 , which amounts are classified as long-term restricted cash on the consolidated balance sheets. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. 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. Except as described below, the Company currently is not a party to any threatened or pending litigation. However, 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. In June 2022, the Company announced that it filed suit in the United States District Court for the District of Massachusetts on June 21, 2022, 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. 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 September 30, 2023 and 2022 . |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes Income before income taxes for all periods presented is from domestic operations, which are the Company’s only operations. During the years ended September 30, 2023, 2022, and 2021, the Company recorded income tax (expense) benefit as follows: Years Ended September 30, 2023 2022 2021 (in thousands) Current income tax (expense) benefit: Federal $ ( 2,522 ) $ — $ 28,721 State ( 299 ) 449 205 Deferred income tax (expense) benefit: Federal — ( 16 ) ( 343 ) State — — — Income tax (expense) benefit $ ( 2,821 ) $ 433 $ 28,583 A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective tax rate is as follows: Years Ended September 30, 2023 2022 2021 Federal statutory income tax rate ( 21.0 ) % ( 21.0 ) % ( 21.0 ) % State taxes, net of federal benefit ( 2.7 ) ( 2.9 ) ( 2.3 ) Change in valuation allowance 36.6 30.8 9.9 Federal research and development tax credit ( 4.6 ) ( 4.6 ) ( 5.3 ) Share-based compensation 2.2 ( 0.8 ) 2.4 State research and development tax credit ( 0.9 ) ( 1.5 ) ( 0.8 ) Foreign derived intangible income ( 7.0 ) — — Change in deferred tax rate ( 0.1 ) ( 0.1 ) ( 9.5 ) Other ( 0.3 ) ( 0.3 ) — Effective income tax rate 2.2 % ( 0.4 ) % ( 26.6 ) % The effective tax rates during the years ended September 30, 2023 and 2022 differ from the U.S. federal statutory rate primarily due to the full valuation allowance maintained on the Company’s net deferred tax assets. Changes in the valuation allowance for deferred tax assets during the years ended September 30, 2023, 2022, and 2021 are as follows: Years Ended September 30, 2023 2022 2021 (in thousands) Valuation allowance, beginning of year $ ( 67,726 ) $ ( 29,298 ) $ ( 18,259 ) Increase recorded to valuation allowance ( 47,394 ) ( 38,428 ) ( 11,039 ) Valuation allowance, end of year $ ( 115,120 ) $ ( 67,726 ) $ ( 29,298 ) Net deferred tax assets as of September 30, 2023 and 2022 consisted of the following: September 30, 2023 2022 (in thousands) Deferred tax assets: Share-based compensation $ 16,974 $ 14,983 Tax credit carryforwards 15,549 20,663 Capitalized research and development 34,855 — Liability related to the sale of future royalties 46,560 — Operating lease liability 6,485 6,007 Accrued compensation 1,318 1,362 Net operating loss carryforward 43 29,105 Unrealized loss 189 794 Accrued expenses 495 541 Other temporary differences 214 245 Total deferred tax assets 122,682 73,700 Valuation allowance ( 115,120 ) ( 67,726 ) Net deferred tax assets 7,562 5,974 Deferred tax liabilities: Operating lease, right-of-use assets ( 1,525 ) ( 5,606 ) Depreciation ( 5,456 ) ( 88 ) Prepaid expenses ( 581 ) ( 280 ) Total deferred tax liabilities ( 7,562 ) ( 5,974 ) Net deferred income tax assets (liabilities) $ — $ — As of September 30, 2023 , the Company did no t have federal net operating loss carryforwards. As of September 30, 2023 , the Company had state net operating loss carryforwards of $ 702 , which may be available to offset future taxable income and expires in 2032 . As of September 30, 2023 , the Company also had federal and state research and development tax credit carryforwards of $ 11,377 and $ 6,035 , respectively, which may be available to reduce future tax liabilities and expire at various dates beginning in 2042 and 2035 , respectively. Utilization of the federal and state net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code ("IRC") of 1986, and corresponding provisions of state law, due to ownership changes that may have occurred pre viously or that could occur in the future. These ownership changes may limit the amount of net operating loss and research and development tax credit carryforwards that can be utilized annually to offset future tax liabilities. In general, an ownership change, as defined by Section 382, results from transactions that increase the ownership of 5 % stockholders in the stock of a corporation by more than 50 % in the aggregate over a three-year period. The Company completed a review of the changes in ownership through September 30, 2022 and determined that the transactions have not resulted in an ownership change during the year ended September 30, 2022, as defined by Section 382. The impact of the historical ownership changes have been reflected within our deferred tax assets shown in the table above. Although the Company believes that these ownership changes have not resulted in material limitations on its ability to use these net operating losses and credit carryforwards , its ability to utilize these and future net operating losses and credit carryforwards may be limited due to future ownership changes or for other reasons. As a result, the Company may not be able to take full advantage of its carryforwards for U.S. federal and state tax purposes. The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets, which are comprised primarily of net operating loss carryforwards, research and development tax credit carryforwards and stock compensation expense. The Company considers it more likely that it will not have sufficient taxable income in the future that will allow it to realize all of its existing deferred tax assets. This is due to the fact the Company continues to progress its wholly-owned research and development programs and its declining royalty revenues from its Collaboration Agreement with AbbVie. As a result, the Company continued to record a valuation allowance as of September 30, 2023 against its deferred tax assets to reduce a portion of the Company’s deferred tax assets for which the Company does not believe it is more likely than not these will be realized. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The Company’s tax years in the U.S. are still open under statute from 2020 to the present. Earlier years may be examined to the extent that tax credit or net operating loss carryforwards are used in future periods. The Company has not received notice of examination by any jurisdiction for any tax year open under statute. Beginning in October 1, 2022, the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) eliminated the Company’s option to deduct research and development expenditures currently and requires taxpayers to amortize them over five years for domestic research expenditures and over fifteen years for foreign research expenditures, pursuant to IRC 174. The most significant impact of this provision is an increase to the current taxable income for the year ended September 30, 2023, the tax year in which the provision took effect for the Company. In response to the COVID-19 pandemic, the CARES Act was signed into law in March 2020. The CARES Act lifted certain deduction limitations originally imposed by the Tax Act. Under the CARES Act, the Company was permitted to carryback net operating losses for up to five years for losses generated in fiscal 2018 through fiscal 2021. Net operating loss carrybacks were previously prohibited under the Tax Act. The CARES Act also eliminated the 80% of taxable income limitations by allowing corporate entities to fully utilize net operating loss carryforwards to offset taxable income in fiscal years 2018, 2019 or 2020. In addition, the CARES Act made qualified improvement property eligible for 15-year cost-recovery and 100% bonus depreciation. The enactment of the CARES Act resulted in a $ 28,721 income tax benefit related to a federal net operating loss carryback at the previously enacted 35 % rate in the Company’s consolidated financial statements during the year ended September 30, 2021. As of September 30, 2023 and 2022, the Company had an income tax receivable of $ 31,004 and $ 28,718 , respectively, which includes interest receivable of $ 1,390 as of September 30, 2023. Uncertain tax positions represent tax positions for which reserves have been established. The Company’s policy is to record interest and penalties related to uncertain tax positions as part of income tax expense. Total interest related to uncertain tax positions recorded as a liability on the Company’s consolidated balance sheets were $ 3 and $ 44 as of September 30, 2023 and 2022 , respectively. A reconciliation of the beginning and ending amount of uncertain tax positions is summarized as follows: September 30, 2023 2022 (in thousands) Beginning Balance $ 226 $ 622 Additions based on tax positions for the current period 882 10 Reductions for tax positions due to lapse of statute of limitations ( 156 ) ( 367 ) Additions (reductions) for tax positions of prior periods 104 ( 39 ) Ending Balance $ 1,056 $ 226 The Company does not expect that its uncertain tax position will materially change within the next twelve months. |
401(k) Plan
401(k) Plan | 12 Months Ended |
Sep. 30, 2023 | |
Postemployment Benefits [Abstract] | |
401(k) Plan | 15. 401(k) Plan The Company has a 401(k) plan. This plan covers substantially all employees who meet minimum age and service requirements. During the years ended September 30, 2023, 2022, and 2021, the Company recognized $ 1,784 , $ 1,596 , and $ 1,353 , respectively, of expense related to its contributions to this plan. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include those of the Company and its subsidiary, Enanta Pharmaceuticals Security Corporation, after elimination of all intercompany accounts and transactions. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). 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 | 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; liability related to the sale of future royalties; 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. |
Cash Equivalents | Cash Equivalents and Marketable Securities The Company considers all short-term, highly liquid investments with original maturities of ninety days or less at acquisition date to be cash equivalents. |
Marketable Securities | Marketable securities with original maturities of greater than ninety days and remaining maturities of less than one year from the balance sheet date are classified as short-term marketable securities. Marketable securities with remaining maturities of greater than one year from the balance sheet date are classified as long-term marketable securities. |
Restricted Cash | Restricted Cash As of September 30, 2023 and 2022 , the Company had outstanding letters of credit collateralized by a money market account of $ 3,968 , to the benefit of the landlord of the Company’s building leases. This amount was classified as long-term restricted cash as of September 30, 2023 and 2022 . |
Concentration of Credit Risk and of Significant Customers and Suppliers | Concentration of Credit Risk and of Significant Customers and Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, short-term and long-term marketable securities and accounts receivable. The Company has all cash and investment balances at one accredited financial institution, including cash in amounts that exceed federally insured limits. The Company does not believe it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company has historically generated the majority of its revenue from its collaborative research and license agreements. As of September 30, 2023 and 2022, accounts receivable consisted of amounts due from the Company’s principal collaborator (see Note 7). The Company is completely dependent on third-party manufacturers for product supply for preclinical and clinical research activities. The Company relies and expects to continue to rely exclusively on several manufacturers to supply the Company with its drug supply requirements related to these activities. These research programs would be adversely affected by a significant interruption in the supply from these third-party manufacturers. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. A fair value hierarchy is based on three levels of inputs that are used to measure fair value, of which the first two levels are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s instruments that are carried at fair value are cash equivalents, short-term and long-term marketable securities and the Series 1 nonconvertible preferred stock. The carrying values of accounts receivable, prepaid and other assets, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these assets and liabilities. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the following estimated useful lives: Laboratory and office equipment 5 years Leasehold improvements Shorter of life of lease or estimated useful life Purchased software 3 years Computer equipment 3 years Furniture 7 years Expenditures for repairs and maintenance of assets are charged to expense as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their useful lives. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed are removed from the accounts and any resulting gain or loss is included in income from operations in the consolidated statements of operations. |
Leases | Leases The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines if an arrangement is a lease or contains an embedded lease at inception. For arrangements that meet the definition of a lease, the Company determines the initial classification and measurement of its right-of-use asset and lease liability at the lease commencement date and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. The Company’s policy is to not record leases with an original term of 12 months or less on its consolidated balance sheets and recognizes those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. In addition to rent, the leases may require the Company to pay additional costs, such as utilities, maintenance and other operating costs, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and lease liability. Rent expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the consolidated statements of operations. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets, primarily property and equipment and right-of-use assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. To date, the Company has no t recorded any impairment losses on long-lived assets. |
Liability Related to the Sale of Future Royalties | Liability Related to the Sale of Future Royalties 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. The Company recognized the $ 200,000 received from OMERS as a liability on its consolidated balance sheets because the $200,000 will be paid back to OMERS up to a 1.42 capped amount and the Company has significant continuing involvement under the AbbVie Agreement. Interest expense for the liability related to the sale of future royalties is recognized using the effective interest rate method over the term of the royalty sale agreement. The liability related to the sale of future royalties and related interest expense are based on current estimates of future royalties, which the Company determines by using third-party forecasts of MAVYRET/MAVIRET sales. The Company periodically assesses the forecasted sales and to the extent the amount or timing of future estimated royalty payments is materially different than previous estimates, the Company will account for any such change by adjusting the liability related to the sale of future royalties and prospectively recognizing the related non-cash interest expense. |
Revenue Recognition | Revenue Recognition The Company’s revenue has been generated primarily through collaborative research and license agreements. The terms of these agreements contain multiple deliverables, which may include (i) licenses, (ii) research and development activities, and (iii) participation in joint research and development steering committees. The terms of these agreements may include nonrefundable upfront license fees, payments for research and development activities, payments based upon the achievement of certain milestones, and royalty payments based on product sales derived from the collaboration. The Company recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company receives sales-based royalties for which the license is deemed to be the predominant item to which the royalties relate and thus the Company recognizes sales-based royalties as the underlying sales are earned. |
Research and Development Costs | Research and Development Costs Included in research and development costs are wages, stock-based compensation and benefits of employees performing research and development, third-party license fees and other operational costs related to the Company’s research and development activities, including facility-related expenses and external costs of outside contractors engaged to conduct both preclinical and clinical studies and manufacture quantities of product for preclinical and clinical studies. The Company expenses the cost of each contract as the work is performed. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. |
Research and Development and Clinical Manufacturing Accruals | Research and Development and Pharmaceutical Drug Manufacturing Accruals The Company has entered into various contracts with third parties to perform research and development and pharmaceutical drug manufacturing. This includes contracts with contract research organizations (“CROs”), clinical manufacturing organizations (“CMOs”), testing laboratories, research hospitals and not for profit organizations and other entities to support our research and development activities. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations to those third parties as of period end. The accrual estimates are based on a number of factors, including the Company’s knowledge of the research and development programs and pharmaceutical drug manufacturing activities and associated timelines, invoicing to date, and the provisions in the contract. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from our estimates. |
Patent Costs | Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are recorded as general and administrative expenses as incurred. |
Stock-Based Compensation | Stock-Based Compensation The Company measures all stock options and other stock-based awards granted to employees at fair value on the date of grant. The Company uses the Black-Scholes option-pricing model in the valuation of its stock options. The fair value of restricted stock units with service-based and performance-based vesting is based on the fair value of the stock on the date of grant. The Company uses the Monte-Carlo model to calculate the fair value on the date of grant of market-based awards. The fair value of service-based awards is recognized as stock-based compensation expense over the requisite service period, which is generally the vesting period of the respective award. For awards with graded vesting, the straight-line method of expense recognition is applied to all awards with service-only based conditions. The Company uses the graded-vesting method to record the expense of awards with both service-based and performance-based vesting conditions, commencing once achievement of the performance condition becomes probable. The Company classifies stock-based compensation expense in the consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified. The Company accounts for stock-based compensation expense related to forfeitures as the forfeitures occur. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial reporting and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in income tax expense. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes based upon the weight of available evidence, that it is more likely than not that all or a portion of deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. The realization of deferred tax assets is dependent upon the Company’s ability to generate future taxable income during the periods in which those temporary differences become deductible. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. Uncertain tax positions represent tax positions for which reserves have been established. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more likely than not to be sustained, the tax position is then assessed to determine the amount of benefit to be recognized in the financial statements. The amount that may be recognized is the largest amount that has a greater than 50 % likelihood of being realized upon ultimate settlement. Income tax expense includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. |
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 in which the Company reported a net loss, 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 years ended September 30, 2023, 2022, and 2021 . 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: Years Ended September 30, 2023 2022 2021 (in thousands) Options to purchase common stock 4,365 3,993 3,852 Unvested rTSRUs 81 101 111 Unvested PSUs 81 101 111 Unvested restricted stock units 411 219 117 |
Segment Data | Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is a biotechnology company focused on discovering and developing small molecule drugs, with an emphasis on treatments for viral infections. Revenue is generated exclusively from transactions occurring with partners located in the United States, and all assets are held in the United States. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) includes net income (loss) as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The Company’s only element of other comprehensive income (loss) is unrealized gains and losses on available-for-sale marketable securities. |
Going Concern | Going Concern In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40) (“ASU 2014-15”). The Company adopted this standard as of September 30, 2017. The standard requires the Company to assess its ability to continue as a going concern one year beyond the date of filing and, in certain circumstances, provide additional footnote disclosures. Based on a detailed cash forecast incorporating current research and development activities and related spending plans, the Company believes that its current cash, cash equivalents and short-term marketable securities on hand at September 30, 2023 is sufficient to fund operations for at least the next twelve months beyond the date of issuance of these consolidated financial statements. The amount of capital available will depend on the Company’s management of its existing cash, cash equivalents and short-term marketable securities, as well as the level of future royalties the Company earns under its agreement with AbbVie. If the Company should require financing beyond these resources to fund its research and development efforts, it may not be able to obtain financing on acceptable terms, or at all |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements 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) | 12 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Property and Equipment Estimated Useful Lives | Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the following estimated useful lives: Laboratory and office equipment 5 years Leasehold improvements Shorter of life of lease or estimated useful life Purchased software 3 years Computer equipment 3 years Furniture 7 years |
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: Years Ended September 30, 2023 2022 2021 (in thousands) Options to purchase common stock 4,365 3,993 3,852 Unvested rTSRUs 81 101 111 Unvested PSUs 81 101 111 Unvested restricted stock units 411 219 117 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Sep. 30, 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 September 30, 2023 and 2022 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value: Fair Value Measurements at September 30, 2023 Using: Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 55,357 $ — $ — $ 55,357 U.S. Treasury notes 29,755 — — 29,755 Marketable securities: U.S. Treasury notes 236,782 — — 236,782 Corporate bonds — 26,435 — 26,435 Commercial paper — 21,305 — 21,305 321,894 47,740 — 369,634 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 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: Series 1 nonconvertible preferred stock Range September 30, Unobservable Input 2023 2022 Probabilities of payout 0 %- 65 % 0 %- 65 % Discount rate 7.25 % 7.25 % |
Rollforward of Aggregate Fair Value of Company's Outstanding Series 1 Nonconvertible Preferred Stock | The following table provides a rollforward of the aggregate fair value of the Company’s outstanding Series 1 nonconvertible preferred stock for which fair value is determined by Level 3 inputs: Series 1 (in thousands) Balance, September 30, 2020 $ 1,479 Change in fair value 27 Balance, September 30, 2021 1,506 Change in fair value ( 83 ) Balance, September 30, 2022 1,423 Change in fair value — Balance, September 30, 2023 $ 1,423 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 future quarterly royalty payments on net sales of MAVYRET/MAVIRET, after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. The Company accounted for the upfront payment as a liability related to the sale of future royalties. The carrying value of the liability related to the sale of future royalties approximates fair value as of September 30, 2023 and is based on current estimates of future royalties expected to be paid to OMERS over the next 10 years, which are considered Level 3 inputs. See Note 8 for a rollforward of the liability. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Fair Value of Available-for-Sale Marketable Securities by Type of Security | As of September 30, 2023 and 2022, the fair value of available-for-sale marketable securities, by type of security, was as follows: September 30, 2023 Amortized Gross Gross Credit Losses Fair Value (in thousands) Corporate bonds $ 27,127 $ — $ ( 692 ) $ — $ 26,435 Commercial paper 21,305 — — — 21,305 U.S. Treasury notes 236,880 12 ( 110 ) — 236,782 $ 285,312 $ 12 $ ( 802 ) $ — $ 284,522 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 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following as of September 30, 2023 and 2022: September 30, 2023 2022 (in thousands) Laboratory and office equipment $ 15,891 $ 14,780 Leasehold improvements 13,804 7,276 Purchased software 1,444 1,412 Furniture 2,290 1,354 Computer equipment 962 653 Construction in progress 1,273 2,556 35,664 28,031 Less: Accumulated depreciation and amortization ( 23,745 ) ( 21,858 ) $ 11,919 $ 6,173 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following as of September 30, 2023 and 2022: September 30, 2023 2022 (in thousands) Accrued pharmaceutical drug manufacturing $ 3,083 $ 6,932 Accrued research and development expenses 6,120 5,532 Accrued payroll and related expenses 7,037 6,439 Accrued other 2,099 2,033 $ 18,339 $ 20,936 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Royalty Tiers Associated with Cumulative Calendar Year Net Sales Allocated to Each Royalty-bearing Product | The following table details the royalty tiers associated with cumulative calendar year net sales allocated to each royalty-bearing product as provided in the AbbVie Agreement: Calendar Year Net Sales Royalty Tier (in thousands) (%) up to $ 500,000 10 % from $ 500,000 up to $ 750,000 12 % from $ 750,000 up to $ 1,000,000 14 % from $ 1,000,000 up to $ 2,500,000 17 % greater than or equal to $ 2,500,000 20 % |
Liability Related to the Sale_2
Liability Related to the Sale of Future Royalties (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Nonmonetary Transactions [Abstract] | |
Summary of the Liability Related to the Sale of Future Royalties | The following table summarizes the activity of the liability related to the sale of future royalties: Liability related to the sale of future royalties (in thousands) Balance - September 30, 2022 $ — Proceeds from sale of future royalties 200,000 Debt issuance cost ( 325 ) Royalty payable to royalty purchaser ( 10,318 ) Non-cash interest expense 5,148 Balance - September 30, 2023 $ 194,505 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Data Used to Determine Value of Stock Option Grants, Presented on Weighted Average Basis | The relevant data used to determine the value of the stock option awards are as follows, presented on a weighted average basis: Years Ended September 30, 2023 2022 2021 Risk-free interest rate 3.88 % 1.72 % 0.61 % Expected term (in years) 6.04 6.04 6.05 Expected volatility 48 % 47 % 52 % Expected dividends 0 % 0 % 0 % Weighted average grant date fair value $ 22.71 $ 33.22 $ 21.76 |
Summary of Stock Option Activity Including Performance Based Options | The following table summarizes stock option activity, including aggregate intrinsic value for the year ended September 30, 2023: Shares Weighted Weighted Aggregate (in thousands) (in thousands) Outstanding as of September 30, 2022 3,993 $ 53.57 6.2 $ 28,778 Granted 765 44.47 Exercised ( 124 ) 17.83 Forfeited ( 269 ) 58.64 Outstanding as of September 30, 2023 4,365 $ 52.68 5.9 $ — Options vested and expected to vest as of 4,365 $ 52.68 5.9 $ — Options exercisable as of September 30, 2023 3,086 $ 52.20 4.9 $ — |
Summary of Additional Exercise and Grant Date Information | The aggregate intrinsic value of options is calculated as the difference between the exercise price of the options and the fair value of the Company’s common stock. The following tables summarize additional exercise and grant date information: Years Ended September 30, 2023 2022 2021 (in thousands) Aggregate intrinsic value of stock options exercised $ 3,295 $ 17,650 $ 2,704 Proceeds to Company from stock options exercised $ 2,208 $ 21,262 $ 3,614 |
Summary of Restricted Stock Unit Activity | The following table summarizes the restricted stock unit activity for the year ending September 30, 2023: Restricted Weighted (in thousands, except per share data) Unvested at September 30, 2022 219 $ 64.03 Granted 280 44.63 Vested ( 61 ) 61.94 Cancelled ( 27 ) 53.98 Unvested at September 30, 2023 411 $ 51.78 |
Stock-Based Compensation Expense | The Company recorded the following stock-based compensation expense for the years ended September 30, 2023, 2022, and 2021: Years Ended September 30, 2023 2022 2021 (in thousands) Research and development $ 9,551 $ 9,728 $ 10,075 General and administrative 18,665 17,241 10,916 $ 28,216 $ 26,969 $ 20,991 Years Ended September 30, 2023 2022 2021 (in thousands) Stock options $ 19,784 $ 19,615 $ 18,004 rTSRUs 1,893 1,597 1,537 PSUs 542 2,628 235 Restricted stock units 5,997 3,129 1,215 $ 28,216 $ 26,969 $ 20,991 |
Relative Total Stockholder Return Units [Member] | |
Data Used to Determine Value of Stock Option Grants, Presented on Weighted Average Basis | The table below sets forth the weighted average grant date fair value assumptions used to value the rTSRUs: Years Ended September 30, 2023 2022 2021 Risk-free interest rate 4.19 % 0.94 % 0.13 % Dividend yield 0 % 0 % 0 % Expected volatility 77 % 80 % 74 % Performance period (years) 2.03 1.97 1.97 |
Performance Share Units and Relative Total Stockholder Return Units [Member] | |
Summary of PSUs and rTSRUs Activity | The following table summarizes PSU and rTSRU activity (at target) for the year ended September 30, 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 40.32 Vested ( 70 ) 44.58 ( 70 ) 27.88 Cancelled — — — — Unvested at September 30, 2023 81 $ 58.58 81 $ 45.82 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Components of Lease Expense for Real Estate and Equipment Leases | The components of lease expense for the Company’s real estate and equipment leases were as follows: Years Ended September 30, 2023 2022 2021 (in thousands) Operating lease cost $ 6,230 $ 6,294 $ 5,861 Variable lease cost 5,352 2,375 4,057 $ 11,582 $ 8,669 $ 9,918 |
Schedule of Supplemental Disclosure of Cash Flow Information Related to the Company's Operating Leases | Supplemental disclosure of cash flow information related to the Company's operating leases included in cash flows used in operating activities in the consolidated statements of cash flows were as follows: Years Ended September 30, 2023 2022 2021 (in thousands) Cash paid for amounts included in the measurement of operating lease liabilities $ 4,592 $ 4,966 $ 6,364 Operating lease liabilities arising from obtaining right-of-use assets $ 3,817 $ 23,910 $ 3,320 |
Summary of Weighted Average Remaining Lease Term and Discount Rate | The weighted-average remaining lease term and discount rate were as follows: September 30, 2023 2022 Weighted-average remaining lease term - operating leases (in years) 6.51 7.42 Weighted-average discount rate - operating leases 7.18 % 6.96 % |
Schedule of Future Annual Minimum Lease Payments | Future annual minimum lease payments relating to the Company's lease liabilities as of September 30, 2023 were as follows: Years ended September 30, (in thousands) 2024 6,734 2025 5,314 2026 5,373 2027 5,196 2028 1,640 Thereafter 10,273 Total future minimum lease payments 34,530 Less: imputed interest ( 8,017 ) Total operating lease liabilities $ 26,513 |
Schedule of Lease Included in Balance Sheet | September 30, Included in the balance sheet: 2023 2022 (in thousands) Current operating lease liabilities $ 5,275 $ 2,891 Operating lease liabilities, net of current portion 21,238 22,372 Total operating lease liabilities $ 26,513 $ 25,263 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Summary of Income Tax Benefit (Expense) | During the years ended September 30, 2023, 2022, and 2021, the Company recorded income tax (expense) benefit as follows: Years Ended September 30, 2023 2022 2021 (in thousands) Current income tax (expense) benefit: Federal $ ( 2,522 ) $ — $ 28,721 State ( 299 ) 449 205 Deferred income tax (expense) benefit: Federal — ( 16 ) ( 343 ) State — — — Income tax (expense) benefit $ ( 2,821 ) $ 433 $ 28,583 |
Reconciliation of Income Tax Provision at Federal Statutory Income Tax Rate and Effective Tax Rate | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective tax rate is as follows: Years Ended September 30, 2023 2022 2021 Federal statutory income tax rate ( 21.0 ) % ( 21.0 ) % ( 21.0 ) % State taxes, net of federal benefit ( 2.7 ) ( 2.9 ) ( 2.3 ) Change in valuation allowance 36.6 30.8 9.9 Federal research and development tax credit ( 4.6 ) ( 4.6 ) ( 5.3 ) Share-based compensation 2.2 ( 0.8 ) 2.4 State research and development tax credit ( 0.9 ) ( 1.5 ) ( 0.8 ) Foreign derived intangible income ( 7.0 ) — — Change in deferred tax rate ( 0.1 ) ( 0.1 ) ( 9.5 ) Other ( 0.3 ) ( 0.3 ) — Effective income tax rate 2.2 % ( 0.4 ) % ( 26.6 ) % |
Changes in the Valuation Allowance for Deferred Tax Assets | Changes in the valuation allowance for deferred tax assets during the years ended September 30, 2023, 2022, and 2021 are as follows: Years Ended September 30, 2023 2022 2021 (in thousands) Valuation allowance, beginning of year $ ( 67,726 ) $ ( 29,298 ) $ ( 18,259 ) Increase recorded to valuation allowance ( 47,394 ) ( 38,428 ) ( 11,039 ) Valuation allowance, end of year $ ( 115,120 ) $ ( 67,726 ) $ ( 29,298 ) |
Net Deferred Tax Assets and Liabilities | Net deferred tax assets as of September 30, 2023 and 2022 consisted of the following: September 30, 2023 2022 (in thousands) Deferred tax assets: Share-based compensation $ 16,974 $ 14,983 Tax credit carryforwards 15,549 20,663 Capitalized research and development 34,855 — Liability related to the sale of future royalties 46,560 — Operating lease liability 6,485 6,007 Accrued compensation 1,318 1,362 Net operating loss carryforward 43 29,105 Unrealized loss 189 794 Accrued expenses 495 541 Other temporary differences 214 245 Total deferred tax assets 122,682 73,700 Valuation allowance ( 115,120 ) ( 67,726 ) Net deferred tax assets 7,562 5,974 Deferred tax liabilities: Operating lease, right-of-use assets ( 1,525 ) ( 5,606 ) Depreciation ( 5,456 ) ( 88 ) Prepaid expenses ( 581 ) ( 280 ) Total deferred tax liabilities ( 7,562 ) ( 5,974 ) Net deferred income tax assets (liabilities) $ — $ — |
Schedule of Reconciliation of Uncertain Tax Positions | A reconciliation of the beginning and ending amount of uncertain tax positions is summarized as follows: September 30, 2023 2022 (in thousands) Beginning Balance $ 226 $ 622 Additions based on tax positions for the current period 882 10 Reductions for tax positions due to lapse of statute of limitations ( 156 ) ( 367 ) Additions (reductions) for tax positions of prior periods 104 ( 39 ) Ending Balance $ 1,056 $ 226 |
Nature of the Business - Additi
Nature of the Business - Additional Information (Detail) | 12 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Entity incorporated, in year | 1995 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Summary of Accounting and Financial Policies [Line Items] | ||||
Adjustment to fair value | $ 0 | $ 0 | $ 0 | |
Cash and investment restricted as a collateral for outstanding letter of credit | 3,968,000 | 3,968,000 | ||
Impairment losses on long-lived assets | 0 | |||
Omers Royalty Sale Agreement [Member] | ||||
Summary of Accounting and Financial Policies [Line Items] | ||||
Proceeds from sale of future royalties | $ 200,000,000 | |||
Percentage of future quarterly royalty payments on net sales received in cash | 54.50% | |||
Letter of Credit [Member] | ||||
Summary of Accounting and Financial Policies [Line Items] | ||||
Cash and investment restricted as a collateral for outstanding letter of credit | $ 3,968,000 | $ 3,968,000 | ||
Maximum [Member] | ||||
Summary of Accounting and Financial Policies [Line Items] | ||||
Short-term investments maturity period | 90 days | |||
Short-term marketable securities maturity period | 1 year | |||
Minimum [Member] | ||||
Summary of Accounting and Financial Policies [Line Items] | ||||
Short-term marketable securities maturity period | 90 days | |||
Long-term marketable securities maturity period | 1 year | |||
Income tax benefit recognition, percentage of likelihood of being realized upon settlement | 50% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment Estimated Useful Lives (Detail) | 12 Months Ended |
Sep. 30, 2023 | |
Laboratory and Office Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property plant and equipment useful life | 5 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Leasehold improvements useful life | Shorter of life of lease or estimated useful life |
Purchased Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Property plant and equipment useful life | 3 years |
Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property plant and equipment useful life | 3 years |
Furniture [Member] | |
Property, Plant and Equipment [Line Items] | |
Property plant and equipment useful life | 7 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Diluted Net Loss Per Share Attributable to Common Stockholders With Anti-dilutive effect (Detail) - shares shares in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
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 | 101 | 111 |
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 | 101 | 111 |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share, amount | 4,365 | 3,993 | 3,852 |
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 | 411 | 219 | 117 |
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 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2019 |
Assets: | ||||
Marketable securities | $ 284,522 | $ 234,523 | ||
Assets, Fair Value Disclosure, Total | 369,634 | 248,428 | ||
Liabilities: | ||||
Liabilities, Fair Value Disclosure, Total | 1,423 | 1,423 | ||
Series 1 Nonconvertible Preferred Stock [Member] | ||||
Liabilities: | ||||
Liabilities | 1,423 | 1,423 | $ 1,506 | $ 1,479 |
Level 1 [Member] | ||||
Assets: | ||||
Assets, Fair Value Disclosure, Total | 321,894 | 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 | 47,740 | 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: | ||||
Cash equivalents | 29,755 | |||
Marketable securities | 236,782 | 91,328 | ||
U.S. Treasury Notes [Member] | Level 1 [Member] | ||||
Assets: | ||||
Cash equivalents | 29,755 | |||
Marketable securities | 236,782 | 91,328 | ||
U.S. Treasury Notes [Member] | Level 2 [Member] | ||||
Assets: | ||||
Cash equivalents | 0 | |||
Marketable securities | 0 | 0 | ||
U.S. Treasury Notes [Member] | Level 3 [Member] | ||||
Assets: | ||||
Marketable securities | 0 | 0 | ||
Money Market Funds [Member] | ||||
Assets: | ||||
Cash equivalents | 55,357 | 13,905 | ||
Money Market Funds [Member] | Level 1 [Member] | ||||
Assets: | ||||
Cash equivalents | 55,357 | 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 | ||
Commercial Paper [Member] | ||||
Assets: | ||||
Marketable securities | 21,305 | 66,784 | ||
Commercial Paper [Member] | Level 1 [Member] | ||||
Assets: | ||||
Marketable securities | 0 | 0 | ||
Commercial Paper [Member] | Level 2 [Member] | ||||
Assets: | ||||
Marketable securities | 21,305 | 66,784 | ||
Commercial Paper [Member] | Level 3 [Member] | ||||
Assets: | ||||
Marketable securities | 0 | 0 | ||
Corporate Bonds [Member] | ||||
Assets: | ||||
Marketable securities | 26,435 | 76,411 | ||
Corporate Bonds [Member] | Level 1 [Member] | ||||
Assets: | ||||
Marketable securities | 0 | 0 | ||
Corporate Bonds [Member] | Level 2 [Member] | ||||
Assets: | ||||
Marketable securities | 26,435 | 76,411 | ||
Corporate Bonds [Member] | Level 3 [Member] | ||||
Assets: | ||||
Marketable securities | $ 0 | $ 0 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||||
Transfers between Level 1, Level 2 and Level 3 | $ 0 | $ 0 | $ 0 | |
Omers Royalty Sale Agreement [Member] | ||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||||
Proceeds from sale of future royalties | $ 200,000,000 | |||
Percentage of future quarterly royalty payments on net sales received in cash | 54.50% | |||
Future royalty payment description | after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities - Fair Value Measurements of the Company's Series 1 Nonconvertible Preferred Stock (Detail) - Level 3 [Member] - Series 1 Nonconvertible Preferred Stock [Member] | Sep. 30, 2023 | Sep. 30, 2022 |
Probabilities of Payout [Member] | Minimum [Member] | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||
Range | 0 | 0 |
Probabilities of Payout [Member] | Maximum [Member] | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||
Range | 65 | 65 |
Discount Rate [Member] | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||
Range | 7.25 | 7.25 |
Fair Value of Financial Asset_6
Fair Value of Financial Assets and Liabilities - Rollforward of Aggregate Fair Value of Company's Outstanding Series 1 Nonconvertible Preferred Stock (Detail) - Series 1 Nonconvertible Preferred Stock [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning Balance | $ 1,423 | $ 1,506 | |
Change in fair value | 0 | 83 | $ 27 |
Ending Balance | $ 1,423 | $ 1,423 | $ 1,506 |
Marketable Securities - Fair Va
Marketable Securities - Fair Value of Available-for-Sale Marketable Securities by Type of Security (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 285,312 | $ 237,863 |
Gross Unrealized Gains | 12 | 0 |
Gross Unrealized Losses | (802) | (3,340) |
Fair value | 284,522 | 234,523 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 27,127 | 78,663 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (692) | (2,252) |
Fair value | 26,435 | 76,411 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 21,305 | 66,784 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair value | 21,305 | 66,784 |
U.S. Treasury Notes [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 236,880 | 92,416 |
Gross Unrealized Gains | 12 | 0 |
Gross Unrealized Losses | (110) | (1,088) |
Fair value | $ 236,782 | $ 91,328 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Long-term marketable securities | $ 0 | $ 29,285 |
Short Term Marketable Securities [Member] | Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | 1 year | 1 year |
Corporate Bonds and U.S. Treasury Notes [Member] | Long Term Marketable Securities [Member] | Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | 3 years | |
Corporate Bonds and U.S. Treasury Notes [Member] | Long Term Marketable Securities [Member] | Minimum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | 1 year |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 35,664 | $ 28,031 |
Less: Accumulated depreciation and amortization | (23,745) | (21,858) |
Property and equipment, net | 11,919 | 6,173 |
Laboratory and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 15,891 | 14,780 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 13,804 | 7,276 |
Purchased Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 1,444 | 1,412 |
Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 2,290 | 1,354 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 962 | 653 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,273 | $ 2,556 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation and amortization expense | $ 2,371 | $ 2,973 | $ 3,334 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 |
Accrued expenses and other current liabilities: | ||
Accrued pharmaceutical drug manufacturing | $ 3,083 | $ 6,932 |
Accrued research and development expenses | 6,120 | 5,532 |
Accrued payroll and related expenses | 7,037 | 6,439 |
Accrued other | 2,099 | 2,033 |
Accrued expenses | $ 18,339 | $ 20,936 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Milestone revenue payments received | $ 79,204 | $ 86,160 | $ 97,074 |
AbbVie [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
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 | ||
Agreement continuation period | 10 years | ||
Cash consideration received under collaboration from milestone payments and royalties | $ 1,287,000 |
Collaboration Agreements - Summ
Collaboration Agreements - Summary of Royalty Tiers Associated with Cumulative Calendar Year Net Sales Allocated to Each Royalty-bearing Product (Detail) - AbbVie [Member] $ in Thousands | 12 Months Ended |
Sep. 30, 2023 USD ($) | |
Scenario One [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Royalty Tier | 10% |
Scenario One [Member] | Maximum [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Calendar Year Net Sales | $ 500,000 |
Scenario Two [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Royalty Tier | 12% |
Scenario Two [Member] | Minimum [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Calendar Year Net Sales | $ 500,000 |
Scenario Two [Member] | Maximum [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Calendar Year Net Sales | $ 750,000 |
Scenario Three [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Royalty Tier | 14% |
Scenario Three [Member] | Minimum [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Calendar Year Net Sales | $ 750,000 |
Scenario Three [Member] | Maximum [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Calendar Year Net Sales | $ 1,000,000 |
Scenario Four [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Royalty Tier | 17% |
Scenario Four [Member] | Minimum [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Calendar Year Net Sales | $ 1,000,000 |
Scenario Four [Member] | Maximum [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Calendar Year Net Sales | $ 2,500,000 |
Scenario Five [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Royalty Tier | 20% |
Scenario Five [Member] | Minimum [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Calendar Year Net Sales | $ 2,500,000 |
Liability Related to the Sale_3
Liability Related to the Sale of Future Royalties - Additional Information (Detail) - Omers Royalty Sale Agreement [Member] $ in Thousands | 1 Months Ended | |
Apr. 30, 2023 USD ($) | Sep. 30, 2023 | |
Nonmonetary Transaction [Line Items] | ||
Proceeds from Royalties Received | $ 200,000 | |
Percentage Of Future Quarterly Royalty Payments On Net Sales Received In Cash | 54.50% | |
Future Royalty Payment Description | after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. | |
Royalty Purchase Agreement Interest Rate | 6.18 |
Liability Related to the Sale_4
Liability Related to the Sale of Future Royalties - Summary of the Liability Related to the Sale of Future Royalties (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Nonmonetary Transaction [Line Items] | ||||
Debt issuance cost | $ 325 | $ 0 | $ 0 | |
Omers Royalty Sale Agreement [Member] | ||||
Nonmonetary Transaction [Line Items] | ||||
Proceeds from sale of future royalties | $ 200,000 | |||
Sale Of Future Royalties [Member] | Omers Royalty Sale Agreement [Member] | ||||
Nonmonetary Transaction [Line Items] | ||||
Royalty liability - beginning balance | 0 | |||
Proceeds from sale of future royalties | 200,000 | |||
Debt issuance cost | 325 | |||
Royalty payable to royalty purchaser | (10,318) | |||
Non-cash interest expense | 5,148 | |||
Royalty liability - ending balance | $ 194,505 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - $ / shares shares in Thousands | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Class Of Stock [Line Items] | ||
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000 | |
Preferred stock, par value per share | $ 0.01 | |
Shares are undesignated and unissued | 3,000 | |
Common stock voting rights, description | Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders | |
Series 1 Nonconvertible Preferred Stock [Member] | ||
Class Of Stock [Line Items] | ||
Preferred stock, shares authorized | 2,000 | |
Preferred stock, par value per share | $ 0.01 |
Series 1 Nonconvertible Prefe_2
Series 1 Nonconvertible Preferred Stock - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Class Of Stock [Line Items] | |||
Preferred stock, shares authorized | 5,000 | ||
Preferred stock, par value per share | $ 0.01 | ||
Change in fair value of Series 1 nonconvertible preferred stock | $ 0 | $ 83 | $ (27) |
Fair value of the Series 1 nonconvertible preferred stock | $ 1,423 | $ 1,423 | |
Series 1 Nonconvertible Preferred Stock [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares authorized | 2,000 | ||
Preferred stock, par value per share | $ 0.01 | ||
Per share value adjusted for stock dividend | 1 | ||
Preferred stock redemption price per share | $ 1 | ||
Redemption period | 60 days | ||
Preferred stock, shares issued | 1,930 | 1,930 | |
Preferred stock, shares outstanding | 1,930 | 1,930 | |
Change in fair value of Series 1 nonconvertible preferred stock | $ 0 | $ 83 | $ 27 |
Fair value of the Series 1 nonconvertible preferred stock | $ 1,423 | $ 1,423 |
Stock-Based Awards - Additional
Stock-Based Awards - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected dividend yield | 0% | 0% | 0% |
Aggregate of unrecognized stock-based compensation cost | $ 61,333 | ||
Weighted average recognition period | 2 years 2 months 12 days | ||
PSUs and rTSRUs [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total fair value, vested during period | $ 8,103 | $ 1,414 | $ 0 |
Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total fair value, vested during period | $ 2,590 | $ 2,427 | $ 1,897 |
Restricted Stock Units [Member] | Service Based [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 4 years | ||
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% | ||
Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares of common stock reserved for issuance | 186 | ||
Shares issued | 0 | ||
2019 Equity Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares available for future grant | 1,535 | ||
Options granted, expiration period | 10 years | ||
2019 Equity Incentive Plan [Member] | Employees [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 4 years | ||
2019 Equity Incentive Plan [Member] | Non-Employee Directors [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 1 year |
Stock-Based Awards - Data Used
Stock-Based Awards - Data Used to Determine Value of Stock Option Grants, Presented on Weighted Average Basis (Detail) - $ / shares | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | |||
Risk-free interest rate | 3.88% | 1.72% | 0.61% |
Expected term (in years) | 6 years 14 days | 6 years 14 days | 6 years 18 days |
Expected volatility | 48% | 47% | 52% |
Expected dividends | 0% | 0% | 0% |
Weighted average grant date fair value | $ 22.71 | $ 33.22 | $ 21.76 |
Executive Officer [Member] | Relative Total Stockholder Return Units [Member] | |||
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | |||
Expected term (in years) | 2 years 10 days | 1 year 11 months 19 days | 1 year 11 months 19 days |
Expected volatility | 77% | 80% | 74% |
Risk-free interest rate | 4.19% | 0.94% | 0.13% |
Dividend yield | 0% | 0% | 0% |
Stock-Based Awards - Summary of
Stock-Based Awards - Summary of Stock Option Activity Including Performance Based Options (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Options | |||
Outstanding as of beginning of period | 3,993 | ||
Granted | 765 | ||
Exercised | (124) | ||
Forfeited | (269) | ||
Outstanding as of end of period | 4,365 | 3,993 | |
Options vested and expected to vest as of end of period | 4,365 | ||
Options exercisable as of end of period | 3,086 | ||
Weighted Average Exercise Price | |||
Outstanding | $ 53.57 | ||
Granted | 44.47 | ||
Exercised | 17.83 | ||
Forfeited | 58.64 | ||
Outstanding | 52.68 | $ 53.57 | |
Options vested and expected to vest as of end of period | 52.68 | ||
Options exercisable as of end of period | $ 52.2 | ||
Weighted Average Remaining Contractual Term | |||
Outstanding as of end of period | 5 years 10 months 24 days | 6 years 2 months 12 days | |
Options vested and expected to vest as of end period | 5 years 10 months 24 days | ||
Options exercisable as of end of period | 4 years 10 months 24 days | ||
Aggregate Intrinsic Value | |||
Aggregate Intrinsic Value | $ 0 | $ 28,778 | |
Options vested and expected to vest as of end of period | 0 | ||
Options exercisable as of end of period | 0 | ||
Aggregate intrinsic value of stock options exercised | 3,295 | 17,650 | $ 2,704 |
Proceeds to Company from stock options exercised | $ 2,208 | $ 21,262 | $ 3,614 |
Stock-Based Awards - Summary _2
Stock-Based Awards - Summary of PSUs and rTSRUs Activity (Detail) shares in Thousands | 12 Months Ended |
Sep. 30, 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 Per Share, Unvested beginning balance | $ / shares | $ 54.5 |
Weighted Average Grant Date Fair Value Per Share, Granted | $ / shares | 47.24 |
Weighted Average Grant Date Fair Value Per Share, Vested | $ / shares | 44.58 |
Weighted Average Grant Date Fair Value Per Share, 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 Per Share, Unvested beginning balance | $ / shares | $ 36.14 |
Weighted Average Grant Date Fair Value Per Share, Granted | $ / shares | 40.32 |
Weighted Average Grant Date Fair Value Per Share, Vested | $ / shares | 27.88 |
Weighted Average Grant Date Fair Value Per Share, 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 | 12 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unvested, beginning balance | shares | 219 |
Granted | shares | 280 |
Vested | shares | (61) |
Cancelled | shares | (27) |
Unvested, ending balance | shares | 411 |
Weighted Average Grant Date Fair Value Per Share, Unvested beginning balance | $ / shares | $ 64.03 |
Weighted Average Grant Date Fair Value Per Share, Granted | $ / shares | 44.63 |
Weighted Average Grant Date Fair Value Per Share, Vested | $ / shares | 61.94 |
Weighted Average Grant Date Fair Value Per Share, Cancelled | $ / shares | 53.98 |
Weighted Average Grant Date Fair Value Per Share, Unvested ending balance | $ / shares | $ 51.78 |
Stock-Based Awards - Stock-Base
Stock-Based Awards - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 28,216 | $ 26,969 | $ 20,991 |
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 19,784 | 19,615 | 18,004 |
PSUs [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 542 | 2,628 | 235 |
rTSRUs [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 1,893 | 1,597 | 1,537 |
Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 5,997 | 3,129 | 1,215 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 9,551 | 9,728 | 10,075 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 18,665 | $ 17,241 | $ 10,916 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 12 Months Ended | |||
Sep. 30, 2023 USD ($) Lease | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | May 31, 2022 USD ($) | |
Lessee Lease Description [Line Items] | ||||
Number of Leases | Lease | 2 | |||
Increase in operating lease, right-of-use assets | $ (4,598) | $ (4,776) | $ (5,418) | |
Increase in operating lease liabilities | (2,567) | (3,706) | (5,879) | |
Lease Payment | 4,592 | 4,966 | $ 6,364 | |
Lease Payment | 34,530 | |||
Security deposit of real estate lease | 652 | |||
Cash and investment restricted as a collateral for outstanding letter of credit | 3,968 | 3,968 | ||
Letter of Credit [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Cash and investment restricted as a collateral for outstanding letter of credit | $ 3,968 | $ 3,968 | ||
Equipment [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease, description | The Company leases units of equipment over eighteen-month lease periods commencing upon shipment of each unit. The lease agreements contain options to terminate the leases early or to extend the leases for successive six-month periods | |||
500 Arsenal Street, Watertown, Massachusetts [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Office lease expiration period | 2027-09 | |||
400 Talcott Avenue, Watertown, Massachusetts [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Office lease expiration period | 2034-06 | |||
Adjacent to 400 Talcott Avenue, Watertown, Massachusetts [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Lease periods commencing upon shipment | 10 years | |||
Tenant improvement allowance | $ 15,194 | |||
Lease Payment | $ 76,470 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense for Real Estate and Equipment Leases and Other Information Related to Leases (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Leases [Abstract] | |||
Operating lease cost | $ 6,230 | $ 6,294 | $ 5,861 |
Variable lease cost | 5,352 | 2,375 | 4,057 |
Lease, cost | 11,582 | 8,669 | 9,918 |
Cash paid for amounts included in the measurement of operating lease liabilities | 4,592 | 4,966 | 6,364 |
Operating lease liabilities arising from obtaining right-of-use assets | $ 3,817 | $ 23,910 | $ 3,320 |
Weighted-average remaining lease term - operating leases (in years) | 6 years 6 months 3 days | 7 years 5 months 1 day | |
Weighted-average discount rate - operating leases | 7.18% | 6.96% |
Leases - Schedule of Future Ann
Leases - Schedule of Future Annual Minimum Lease Payments (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 |
Leases [Abstract] | ||
2024 | $ 6,734 | |
2025 | 5,314 | |
2026 | 5,373 | |
2027 | 5,196 | |
2028 | 1,640 | |
Thereafter | 10,273 | |
Total future minimum lease payments | 34,530 | |
Less: Imputed interest | (8,017) | |
Total operating lease liabilities | $ 26,513 | $ 25,263 |
Leases - Schedule of Lease Incl
Leases - Schedule of Lease Included in Balance Sheet (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 |
Leases [Abstract] | ||
Operating lease liabilities | $ 5,275 | $ 2,891 |
Operating lease liabilities, net of current portion | 21,238 | 22,372 |
Total operating lease liabilities | $ 26,513 | $ 25,263 |
Income Taxes - Summary of Incom
Income Taxes - Summary of Income Tax Benefit (Expense) (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Current income tax (expense) benefit: | |||
Federal | $ (2,522) | $ 0 | $ 28,721 |
State | (299) | 449 | 205 |
Deferred income tax (expense) benefit: | |||
Federal | 0 | (16) | (343) |
State | 0 | 0 | 0 |
Income tax (expense) benefit | $ (2,821) | $ 433 | $ 28,583 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax Provision at Federal Statutory Income Tax Rate and Effective Tax Rate (Detail) | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory income tax rate | (21.00%) | (21.00%) | (21.00%) |
State taxes, net of federal benefit | (2.70%) | (2.90%) | (2.30%) |
Change in valuation allowance | 36.60% | 30.80% | 9.90% |
Federal research and development tax credit | (4.60%) | (4.60%) | (5.30%) |
Share-based compensation | 2.20% | (0.80%) | 2.40% |
State research and development tax credit | (0.90%) | (1.50%) | (0.80%) |
Foreign derived intangible income | (7.00%) | 0% | 0% |
Change in deferred tax rate | (0.10%) | (0.10%) | (9.50%) |
Other | 0.30% | (0.30%) | 0% |
Effective income tax rate | 2.20% | (0.40%) | (26.60%) |
Income Taxes - Changes in the V
Income Taxes - Changes in the Valuation Allowance for Deferred Tax Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |||
Valuation allowance, beginning of year | $ (67,726) | $ (29,298) | $ (18,259) |
Increase recorded to valuation allowance | (47,394) | (38,428) | (11,039) |
Valuation allowance, end of year | $ (115,120) | $ (67,726) | $ (29,298) |
Income Taxes - Net Deferred Tax
Income Taxes - Net Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 |
Deferred tax assets: | ||||
Share-based compensation | $ 16,974 | $ 14,983 | ||
Tax credit carryforwards | 15,549 | 20,663 | ||
Capitalized research and development | 34,855 | 0 | ||
Liability related to the sale of future royalties | 46,560 | 0 | ||
Operating lease liability | 6,485 | 6,007 | ||
Accrued compensation | 1,318 | 1,362 | ||
Net operating loss carryforward | 43 | 29,105 | ||
Unrealized loss | 189 | 794 | ||
Accrued expenses | 495 | 541 | ||
Other temporary differences | 214 | 245 | ||
Total deferred tax assets | 122,682 | 73,700 | ||
Valuation allowance | (115,120) | (67,726) | $ (29,298) | $ (18,259) |
Net deferred tax assets | 7,562 | 5,974 | ||
Deferred tax liabilities: | ||||
Operating lease, right-of-use assets | (1,525) | (5,606) | ||
Depreciation | (5,456) | (88) | ||
Prepaid expenses | (581) | (280) | ||
Total deferred tax liabilities | (7,562) | (5,974) | ||
Net deferred income tax assets (liabilities) | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Tax [Line Items] | ||||
Valuation allowance | $ 115,120 | $ 67,726 | $ 29,298 | $ 18,259 |
Description of effects of COVID-19 | In response to the COVID-19 pandemic, the CARES Act was signed into law in March 2020. The CARES Act lifted certain deduction limitations originally imposed by the Tax Act. Under the CARES Act, the Company was permitted to carryback net operating losses for up to five years for losses generated in fiscal 2018 through fiscal 2021. Net operating loss carrybacks were previously prohibited under the Tax Act. The CARES Act also eliminated the 80% of taxable income limitations by allowing corporate entities to fully utilize net operating loss carryforwards to offset taxable income in fiscal years 2018, 2019 or 2020. In addition, the CARES Act made qualified improvement property eligible for 15-year cost-recovery and 100% bonus depreciation. The enactment of the CARES Act resulted in a $28,721 income tax benefit related to a federal net operating loss carryback at the previously enacted 35% rate in the Company’s consolidated financial statements during the year ended September 30, 2021. | |||
Federal income tax expense (benefit), continuing operations | $ 2,821 | $ (433) | $ (28,583) | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21% | 21% | 21% | |
Liability for uncertainty in income taxes, current | $ 3 | $ 44 | ||
Income tax receivable | 31,004 | 28,718 | ||
Interest receivable | 1,390 | |||
Net operating loss carryforward | $ 43 | $ 29,105 | ||
Ownership of stockholders in stock | 5% | |||
Stockholders stock percentage | 50% | |||
Earliest Tax Year [Member] | ||||
Income Tax [Line Items] | ||||
Open tax year | 2020 | |||
Federal [Member] | ||||
Income Tax [Line Items] | ||||
Research and development tax credit carryforward | $ 11,377 | |||
Operating Loss Carryforwards | $ 0 | |||
Tax credit carry forward expiration year | 2042 | |||
State [Member] | ||||
Income Tax [Line Items] | ||||
Research and development tax credit carryforward | $ 6,035 | |||
Operating Loss Carryforwards | $ 702 | |||
Net operating loss carryforward, state, expiration year | 2032 | |||
Tax credit carry forward expiration year | 2035 | |||
CARES Act [Member] | ||||
Income Tax [Line Items] | ||||
Federal income tax expense (benefit), continuing operations | $ 28,721 | |||
Prior to CARES Act [Member] | ||||
Income Tax [Line Items] | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35% |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Uncertain Tax Positions (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||
Beginning Balance | $ 226 | $ 622 |
Additions based on tax positions for the current period | 882 | 10 |
Reductions for tax positions due to lapse of statute of limitations | (156) | (367) |
Additions (reductions) for tax positions of prior periods | 104 | (39) |
Ending Balance | $ 1,056 | $ 226 |
401(k) Plan - Additional Inform
401(k) Plan - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Compensation Related Costs [Abstract] | |||
Benefits charged to operating expenses | $ 1,784 | $ 1,596 | $ 1,353 |