Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 05, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | OTIC | ||
Entity Registrant Name | Otonomy, Inc. | ||
Entity Central Index Key | 0001493566 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 48,318,970 | ||
Entity Public Float | $ 103.3 | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-36591 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-2590070 | ||
Entity Address, Address Line One | 4796 Executive Drive | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | 619 | ||
Local Phone Number | 323-2200 | ||
ICFR Auditor Attestation Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE As noted herein, the information called for by Part III is incorporated by reference to specified portions of the registrant’s definitive proxy statement to be filed in conjunction with the registrant’s 2021 Annual Meeting of Stockholders, which is expected to be filed not later than 120 days after the registrant’s fiscal year ended December 31, 2020. |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 30,767 | $ 25,194 |
Short-term investments | 55,576 | 35,476 |
Prepaid and other current assets | 2,372 | 2,480 |
Total current assets | 88,715 | 63,150 |
Restricted cash | 702 | 701 |
Property and equipment, net | 2,766 | 3,702 |
Right-of-use assets | 14,082 | 15,465 |
Total assets | 106,265 | 83,018 |
Current liabilities: | ||
Accounts payable | 849 | 1,161 |
Accrued expenses | 2,953 | 5,442 |
Accrued compensation | 3,927 | 2,593 |
Leases, current | 3,265 | 3,302 |
Total current liabilities | 10,994 | 12,498 |
Long-term debt, net | 15,158 | 14,967 |
Leases, net of current | 13,847 | 15,320 |
Total liabilities | 39,999 | 42,785 |
Commitments and Contingencies | 0 | 0 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2020 and 2019; no shares issued or outstanding at December 31, 2020 and 2019 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2020 and 2019; 48,318,970 and 30,814,211 shares issued and outstanding at December 31, 2020 and 2019, respectively | 48 | 31 |
Additional paid-in capital | 570,841 | 500,084 |
Accumulated other comprehensive income | 1 | 11 |
Accumulated deficit | (504,624) | (459,893) |
Total stockholders’ equity | 66,266 | 40,233 |
Total liabilities and stockholders’ equity | $ 106,265 | $ 83,018 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares Issued | 48,318,970 | 30,814,211 |
Common stock, Shares outstanding | 48,318,970 | 30,814,211 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | |||
Product sales, net | $ 273 | $ 600 | $ 745 |
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Costs and operating expenses: | |||
Cost of product sales | $ 1,188 | $ 912 | $ 946 |
Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 27,997 | $ 32,805 | $ 31,844 |
Selling, general and administrative | 14,575 | 11,690 | 20,008 |
Total costs and operating expenses | 43,760 | 45,407 | 52,798 |
Loss from operations | (43,487) | (44,807) | (52,053) |
Other income (expense): | |||
Interest income | 326 | 1,723 | 1,689 |
Interest expense | (1,570) | (1,591) | (4) |
Total other (expense) income, net | (1,244) | 132 | 1,685 |
Net loss | $ (44,731) | $ (44,675) | $ (50,368) |
Net loss per share, basic and diluted | $ (1.10) | $ (1.45) | $ (1.65) |
Weighted-average shares used to compute net loss per share, basic and diluted | 40,845,844 | 30,726,786 | 30,610,244 |
Statements of Comprehensive Los
Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (44,731) | $ (44,675) | $ (50,368) |
Other comprehensive loss: | |||
Unrealized (loss) gain on available-for-sale securities | (10) | 34 | 77 |
Comprehensive loss | $ (44,741) | $ (44,641) | $ (50,291) |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2017 | $ 117,279 | $ 31 | $ 482,198 | $ (100) | $ (364,850) |
Beginning balance, shares at Dec. 31, 2017 | 30,558,726 | ||||
Issuance of common stock upon exercise of stock options | 32 | 32 | |||
Issuance of common stock upon exercise of stock options, shares | 18,800 | ||||
Issuance of common stock under employee stock purchase plan | 303 | 303 | |||
Issuance of common stock under employee stock purchase plan, shares | 107,886 | ||||
Stock-based compensation expense | 12,414 | 12,414 | |||
Net loss | (50,368) | (50,368) | |||
Unrealized (loss) gain on available-for-sale securities | 77 | 77 | |||
Ending balance at Dec. 31, 2018 | 79,737 | $ 31 | 494,947 | (23) | (415,218) |
Ending balance, shares at Dec. 31, 2018 | 30,685,412 | ||||
Issuance of common stock upon exercise of stock options | 5 | 5 | |||
Issuance of common stock upon exercise of stock options, shares | 2,912 | ||||
Issuance of common stock under employee stock purchase plan | 242 | 242 | |||
Issuance of common stock under employee stock purchase plan, shares | 125,887 | ||||
Stock-based compensation expense | 4,890 | 4,890 | |||
Net loss | (44,675) | (44,675) | |||
Unrealized (loss) gain on available-for-sale securities | 34 | 34 | |||
Ending balance at Dec. 31, 2019 | 40,233 | $ 31 | 500,084 | 11 | (459,893) |
Ending balance, shares at Dec. 31, 2019 | 30,814,211 | ||||
Issuance of common stock and pre-funded warrants, net of issuancecosts | 64,187 | $ 17 | 64,170 | ||
Issuance of common stock and prefunded warrants, net of issuance costs (unaudited), shares | 17,275,000 | ||||
Issuance of common stock upon exercise of stock options | $ 206 | 206 | |||
Issuance of common stock upon exercise of stock options, shares | 92,000 | 92,035 | |||
Issuance of common stock under employee stock purchase plan | $ 270 | 270 | |||
Issuance of common stock under employee stock purchase plan, shares | 137,724 | ||||
Stock-based compensation expense | 6,111 | 6,111 | |||
Net loss | (44,731) | (44,731) | |||
Unrealized (loss) gain on available-for-sale securities | (10) | (10) | |||
Ending balance at Dec. 31, 2020 | $ 66,266 | $ 48 | $ 570,841 | $ 1 | $ (504,624) |
Ending balance, shares at Dec. 31, 2020 | 48,318,970 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | |||
Net loss | $ (44,731) | $ (44,675) | $ (50,368) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 1,062 | 1,149 | 1,186 |
Stock-based compensation | 6,111 | 4,890 | 12,414 |
Accretion of discounts on short-term investments | (29) | (787) | (506) |
Amortization of debt discount | 191 | 189 | 0 |
Deferred rent | 0 | 0 | 103 |
Changes in operating assets and liabilities: | |||
Prepaid and other assets | 108 | 536 | (493) |
Accounts payable | (374) | 127 | 68 |
Accrued expenses | (2,419) | 1,656 | (166) |
Accrued compensation | 1,334 | (42) | (672) |
Right-of-use assets and lease liabilities, net | (127) | 32 | 0 |
Net cash used in operating activities | (38,874) | (36,925) | (38,434) |
Cash flows from investing activities: | |||
Purchases of short-term investments | (68,581) | (85,004) | (104,270) |
Maturities of short-term investments | 48,500 | 114,000 | 142,750 |
Purchases of property and equipment | (134) | (700) | (496) |
Net cash (used in) provided by investing activities | (20,215) | 28,296 | 37,984 |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs | 64,187 | 0 | 0 |
Proceeds from issuance of long-term debt, net of cash issuance costs | 0 | 0 | 14,830 |
Proceeds from short-term debt | 1,126 | 0 | 0 |
Principal payments on short-term debt | (1,126) | 0 | 0 |
Proceeds from issuance of common stock under employee stock purchase plan | 270 | 242 | 303 |
Proceeds from exercise of stock options | 206 | 5 | 32 |
Payments of debt issuance costs | 0 | (52) | 0 |
Net cash provided by financing activities | 64,663 | 195 | 15,165 |
Net change in cash, cash equivalents and restricted cash | 5,574 | (8,434) | 14,715 |
Cash, cash equivalents and restricted cash at beginning of period | 25,895 | 34,329 | 19,614 |
Cash, cash equivalents and restricted cash at end of period | 31,469 | 25,895 | 34,329 |
Cash and cash equivalents at end of period | 30,767 | 25,194 | 33,633 |
Restricted cash at end of period | 702 | 701 | 696 |
Supplemental cash flow information: | |||
Cash paid for interest | 1,373 | 1,394 | 4 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Purchase of property and equipment in accounts payable and accrued expenses | 67 | 76 | 7 |
Debt issuance costs in accounts payable and accrued expenses | 0 | 0 | 66 |
Debt issuance costs | $ 0 | $ 0 | $ 771 |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Description of Business Otonomy, Inc. (Otonomy or the Company) was incorporated in the state of Delaware on May 6, 2008. Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The Company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss and tinnitus. OTIVIDEX is a sustained-exposure formulation of the steroid dexamethasone that has completed two Phase 3 trials for the treatment of Ménière’s disease, with a third Phase 3 trial that has completed enrollment of patients with top-line results expected by the end of February 2021. OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine that has completed a Phase 1/2 clinical trial in tinnitus patients with positive top-line results, and the Company expects to initiate a Phase 2 clinical trial in the first quarter of 2021. OTO-413 is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) for hearing loss, with positive top-line results announced for a Phase 1/2 clinical trial that the Company intends to continue with an expansion of the trial expected to start in the second quarter of 2021. Otonomy also has multiple preclinical stage programs addressing additional hearing loss pathologies including a gene therapy for treatment of congenital hearing loss (OTO-825), an otoprotectant for prevention of cisplatin-induced hearing loss (OTO-510), and a hair cell repair and regeneration program for severe hearing loss (OTO-6XX). In October 2019, the Company entered into a strategic collaboration with Applied Genetic Technologies Corporation (AGTC), to co-develop and co-commercialize a gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction beta-2 (GJB2) gene. In July 2020, the Company entered into an exclusive license agreement with Kyorin Pharmaceutical Co., Ltd. (Kyorin) that provides Otonomy with exclusive worldwide rights to develop, manufacture and commercialize a novel compound from Kyorin for the OTO-6XX program. In addition, the Company developed, received United States Food and Drug Administration (FDA) approval and commercially launched OTIPRIO for use during tympanostomy tube placement (TTP) surgery in pediatric patients. OTIPRIO was also approved by the FDA for the treatment of acute otitis externa (AOE). In June 2020, the Company entered into a co-promotion agreement with ALK-Abelló, Inc. (ALK) to support the promotion of OTIPRIO for the treatment of AOE in physician offices in the United States, which was amended in October 2020 to include promotion of OTIPRIO for use during TTP surgery in pediatric patients. Basis of Presentation The Company follows Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements—Going Concern The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operating activities since inception. In July 2020, the Company sold in a public offering 17,275,000 shares of its common stock, which includes the underwriters’ full exercise of their option to purchase additional shares, and the Company sold pre-funded warrants to purchase 4,000,000 shares of its common stock for $64.2 million in net proceeds after deducting underwriting discounts and commissions and offering expenses. As of December 31, 2020, the Company had cash, cash equivalents and short-term investments of $86.3 million, outstanding debt of $15.2 million and an accumulated deficit of $504.6 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it: (i) develops and seeks regulatory approvals for OTIVIDEX, OTO-313, OTO-413 and its other product candidates; and (ii) works to develop additional product candidates through research and development programs. When additional financing is required, the Company anticipates that it will seek additional funding through future debt and/or equity financings or other sources, such as potential collaboration agreements. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. If the Company is not able to secure adequate additional funding, if or when necessary, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects. The Company believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations for a period of at least twelve months from the date of this report . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of product sales and expense during the reporting period. Although these estimates are based on the Company’s knowledge of current events and anticipated actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institution in which those deposits are held. Additionally, the Company established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less at the date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments. Cash and cash equivalents include cash in readily available checking, savings and money market accounts. The Company’s restricted cash consists of cash maintained in separate deposit accounts to secure a letter of credit issued by a bank to the landlord under a lease agreement for the Company’s corporate headquarters. Short-term Investments The Company carries short-term investments classified as available-for-sale debt securities at fair value as determined by prices for identical or similar securities at the balance sheet date. Short-term investments consist of Level 1 financial instruments in the fair value hierarchy (see Note 8 – Fair Value Realized gains or losses of available-for-sale securities are determined using the specific identification method and net realized gains and losses are included in interest income. The Company periodically reviews available-for-sale securities for other-than-temporary declines in fair value below the cost basis, and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company records unrealized gains and losses on available-for-sale debt securities as a component of other comprehensive loss within the statements of comprehensive loss and as a separate component of stockholders’ equity on the balance sheet s . The Company does not hold equity securities in its investment portfolio. Fair Value of Financial Instruments The Company’s financial instruments include cash, cash equivalents, short-term investments, prepaid expenses and other assets, accounts payable, accrued expenses, accrued compensation and long-term debt. The carrying value of the Company’s cash and cash equivalents, short-term investments, prepaid expenses and other current assets, other long-term assets, accounts payable, accrued expenses, and accrued compensation approximate fair value due to the short-term nature of these items. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, the Company believes the fair value of long-term debt approximates its carrying value. Inventory Inventory is recorded at the lower of cost or net realizable value. Cost is determined on a first-in, first-out method. Inventories consist of OTIPRIO finished goods and work in-process, as well as raw materials used in the manufacture of OTIPRIO. If inventory costs exceed expected market value due to obsolescence, expiry or quantities in excess of expected demand, write downs are recorded for the difference between cost and market value, less cost to sell. During the year ended December 31, 2020, the Company recorded an inventory write down of $0.3 million to cost of product sales. During the years ended December 31, 2019 and 2018, no such write downs were recorded. Property and Equipment, Net Property and equipment generally consist of manufacturing equipment, office furniture and equipment, computers, and scientific equipment and are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally two to ten years). Leasehold improvements are recorded at cost and are depreciated on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. Repairs and maintenance costs are charged to expense as incurred. Impairment of Long-Lived Assets The Company assesses the value of its long-lived assets for impairment on an annual basis and whenever events indicate that the carrying amount of such assets may not be recoverable. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, the Company believes that future cash flows to be received support the carrying value of its long-lived assets. No impairment of long-lived assets was recorded during the years ended December 31, 2020, 2019 and 2018. Right-of-Use Assets and Lease Liabilities The Company has operating leases for its facility and certain equipment and finance leases for certain computer equipment. The Company determines if an arrangement is or contains a lease at each commencement date. Leases establishes a right-of-use (ROU) model that requires a lessee to recognize an ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Accounting Standards Update (ASU) No. 2016-02, Leases (ASU 2016-02) provides a number of optional practical expedients and accounting policy elections. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. Operating leases are included in ROU assets, Leases, current, and Leases, net of current on the balance sheets. Finance leases are included in Property and equipment, Leases, current, and Leases, net of current on the balance sheets. The Company has elected a policy not to recognize short-term leases (one year or less) on the balance sheets. ROU assets and operating lease liabilities are recognized based on the present value of future minimum lease payments over the lease term at the commencement date. When the implicit rate of the lease is not provided or cannot be determined, the Company uses a collateralized incremental borrowing rate based on the information available at the commencement date, including lease term, in determining the present value of future payments. The Company considers payments for common area maintenance, real estate taxes and management fees to be variable non-lease components, which are expensed as incurred. Lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term . Clinical Trial Expense Accruals The Company estimates expenses resulting from its obligations under contracts with vendors, contract research organizations (CROs) and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided. The Company records clinical trial expenses in the period in which services are performed and efforts are expended. The Company accrues for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company estimates accruals through financial models taking into account discussion with applicable personnel and outside service providers as to the progress of trials. During the course of a clinical trial, the Company may adjust its clinical accruals if actual results differ from its estimates. Revenue Recognition The Company recognizes revenue by performing the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract with a customer under ASC Topic 606, Revenue from Contracts with Customers (ASC 606) when it is probable the Company will collect the consideration exchanged for the goods or services transferred to the customer. OTIPRIO is sold to a limited number of specialty wholesale distributors. The Company recognizes revenue when its customers obtain control of OTIPRIO, typically upon delivery by the Company to these distributors. The Company has determined the delivery of OTIPRIO to its customers constitutes a single performance obligation and no other performance obligations are present. Hospitals, ambulatory surgery centers and physician offices order OTIPRIO from the Company’s distributors and are the end users of OTIPRIO. The Company permits product returns from the distributors only if the product is damaged or is shipped or ordered in error. Product returns based on expiry are not permitted. To date, product returns have been immaterial. Sales commissions and other incremental costs of obtaining customer contracts are expensed as incurred as the amortization periods would be less than one year or the amount is immaterial . Concentration of Major Customers The Company sells OTIPRIO to specialty wholesale distributor customers. The following table summarizes the Company’s sales to its largest customers for each of the periods presented: 2020 2019 2018 First largest 41 % 38 % 44 % Second largest 29 % 33 % 33 % Third largest 24 % 24 % 21 % Collaborative Arrangements The Company has entered into co-promotion agreements and research agreements that fall under the scope of ASC Topic 808, Collaborative Arrangements Co-promotion agreements can include payments and reimbursements for a proportion of product support expenses to the Company and profit sharing payments by the Company. Payments to or by the Company are recognized in selling, general and administrative expenses in the statements of operations. Research agreements can include reimbursements to or by the Company, which are recognized in research and development expenses in the statements of operations. Research and Development Research and development expenses include the costs associated with the Company’s research and development activities, including salaries, benefits, stock-based compensation expense and occupancy costs. Also included in research and development expenses are third-party costs incurred in conjunction with contract manufacturing for the Company’s research and development programs and clinical trials, including the cost of clinical trial drug supply, costs incurred by CROs and regulatory expenses. Research and development costs are expensed as incurred. Selling, General and Administrative Selling, general and administrative expenses include the costs associated with the Company’s executive, administrative, finance and human resource functions including salaries, benefits, stock-based compensation expense and occupancy costs. Other selling, general and administrative expenses include costs associated with prosecuting and maintaining the Company’s patent portfolio, corporate legal expenses, costs required for public company activities and infrastructure necessary for the general conduct of the Company’s business. The Company’s selling, general and administrative expenses also include OTIPRIO product support expenses, and profit-sharing fees payable to the Company’s partners, which are reduced by payments received from the Company’s partners under its co-promotion agreements. Stock-Based Compensation The Company accounts for stock-based compensation expense related to stock options and employee stock purchase plan (ESPP) rights by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model. Forfeitures are recognized as incurred. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized using the straight-line method. For performance-based awards to employees, (i) the fair value of the award is determined on the grant date, (ii) the Company assesses the probability of the individual performance milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. Income Taxes The accounting guidance for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities based on the technical merits of the position. The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. As of December 31, 2020, 2019 and 2018, potentially dilutive securities excluded from the calculation of diluted net loss per share consist of outstanding options to purchase 9,842,744, 7,495,129 and 5,019,964 shares of the Company’s common stock, respectively. Risks and Uncertainties Related to COVID-19 In March 2020, the World Health Organization declared COVID-19 a global pandemic. The COVID-19 pandemic could pose significant risks to the Company’s business; however, the ultimate impact of the pandemic is highly uncertain. The Company has clinical trial sites in the United States and Europe, which may be affected by travel or quarantine restrictions imposed by federal, state or local governments due to the COVID-19 pandemic. In light of the significant uncertainty regarding the impact of the COVID-19 pandemic, the Company had suspended and subsequently updated its guidance regarding timing of trial results. The Company may in the future need to further update or suspend such guidance as a result of the impact of the COVID-19 pandemic. In addition, the Company has made and it (and its contract research organizations (CROs)) may need to make certain adjustments to the operation of clinical trials in an effort to ensure the monitoring and safety of patients and minimize risks to trial data integrity during the pandemic in accordance with the guidance issued by the FDA in 2020, among other activity. Third-party manufacturers which the Company uses for the supply of materials for its product candidates or other materials necessary to conduct preclinical studies and clinical trials are located in countries affected by COVID-19. Although the Company expects no material impact on the clinical supply of its product candidates for its current clinical trials, should its third-party manufacturers experience extended disruptions, the Company could experience delays in future trials. Furthermore, the spread of the virus may affect the operations of key governmental agencies, such as the FDA and similar organizations outside the United States, as well as local regulatory agencies and health officials, which may delay the development of the Company’s product candidates. The Company continues to evaluate the impact COVID-19 may have on its ability to effectively conduct its business operations as planned, and work with healthcare providers supporting its clinical studies to mitigate risk to patients while taking into account regulatory, institutional, and government guidance and policies and may take further actions as may be required by federal, state or local authorities or that the Company determines are in the best interests of public health and safety and that of patients, employees, partners, and stockholders. Nonetheless, the Company does not yet know and cannot predict the full extent of potential delays or impacts on its business, its preclinical programs and clinical trials, healthcare systems or the global economy as a whole. As such, it is uncertain as to the full magnitude that the COVID-19 pandemic will have on the Company’s business, strategy, collaborations, financial condition, liquidity and future results of operations. Recent Accounting Pronouncements Not Yet Adopted I n June 2016, ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13) was issued, as amended. ASU 2016-13 introduces the current expected credit loss model, which will require an entity to measure credit losses for certain financial instruments and financial assets. ASU 2016-13 will also apply to receivables arising from revenue transactions such as accounts receivable. ASU 2016-13 is effective for the Company beginning January 1, 2023. The Company does not expect the adoption of ASU 2016-13 to have a material effect on its financial position, results of operations or cash flows. Recently Adopted Effective January 1, 2020, the Company early adopted ASU No. 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes ASU 2019-12 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2020. Early adoption is permitted, including adoption in an interim period. The Company elected to early adopt ASU 2019-12. By early adopting, ASU 2019-12 is effective for the Company beginning January 1, 2020. There was no cumulative effect to be recognized in connection with the early adoption of ASU 2019-12 and the adoption did not have a material impact on the Company’s financial statements or disclosure s. |
Available-for-Sale Securities
Available-for-Sale Securities | 12 Months Ended |
Dec. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Available-for-Sale Securities | 3. Available-for-Sale Securities The Company invests in available-for-sale debt securities consisting of money market funds, certificates of deposit, U.S. Treasury securities and U.S. government sponsored enterprise securities. Available-for-sale debt securities are classified as part of either cash and cash equivalents or short-term investments in the balance sheets. Available-for-sale debt securities with maturities of three months or less from the date of purchase have been classified as cash equivalents, and were $23.3 million and $22.1 million as of December 31, 2020 and 2019, respectively. Available-for-sale debt securities with maturities of more than three months from the date of purchase have been classified as short-term investments, and were as follows (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Market Value December 31, 2020: U.S. Treasury securities $ 55,085 $ 2 $ (1 ) $ 55,086 Certificates of deposit 490 — — 490 $ 55,575 $ 2 $ (1 ) $ 55,576 December 31, 2019: U.S. Treasury securities $ 35,465 $ 16 $ (5 ) $ 35,476 $ 35,465 $ 16 $ (5 ) $ 35,476 As of December 31, 2020, the Company had four securities in a gross unrealized loss position, all of which have been in such position for less than twelve months At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are other-than-temporary. Factors considered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, and the Company’s intent and ability to hold the investment until recovery of its amortized cost basis. The Company intends, and has the ability, to hold any investments in unrealized loss positions until their amortized cost basis has been recovered. The Company determined there were no other-than-temporary declines in the value of any available-for-sale securities as of December 31, 2020 . All the Company’s available-for-sale debt securities mature within one year . The Company obtains the fair value of its available-for-sale debt securities from a professional pricing service. The fair values of available-for-sale debt securities are validated by comparing the fair values reported by the professional pricing service to quoted market prices or to fair values obtained from the custodian bank. |
Balance Sheet Details
Balance Sheet Details | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Details | 4. Balance Sheet Details Prepaid and Other Current Assets Prepaid and other current assets are comprised of the following (in thousands): December 31, 2020 2019 Inventory $ 227 $ 478 Other 2,145 2,002 Total $ 2,372 $ 2,480 Property and Equipment, Net Property and equipment, net consists of the following (in thousands): December 31, 2020 2019 Laboratory equipment $ 4,265 $ 4,179 Manufacturing equipment 1,075 1,111 Computer equipment and software 989 943 Leasehold improvements 768 768 Office furniture 1,548 1,548 8,645 8,549 Less: accumulated depreciation and amortization (5,879 ) (4,847 ) Total $ 2,766 $ 3,702 Depreciation expense was $1.1 million, $1.1 million and $1.2 million for the years ended December 31, 2020, 2019 and 2018, respectively. Accrued Expenses Accrued expenses consist of the following (in thousands): December 31, 2020 2019 Accrued clinical trial costs $ 1,477 $ 3,443 Accrued other 1,476 1,999 Total $ 2,953 $ 5,442 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Operating Leases In December 2016, the Company moved into its current headquarters location in San Diego, California. The lease commenced in December 2016 and has an initial term of 130 months, with an option by the Company to extend the lease term for an additional five years . The Company has the right to terminate the lease at the end of the 94 th month of the lease term if it is acquired by a third party and pays an early termination fee. The Company is responsible for payment of taxes and operating expenses for the building, in addition to monthly base rent in the initial amount of approximately $ 232,000 , with 3 % annual increases, which monthly base rent wa s abated for the first ten months of the lease term. The total estimated base rent payments over the life of the lease are estimated to be approximately $ 32.7 million. Upon execution of the lease in May 2015, the Company provided a security deposit in the form of a letter of credit in the amount of approximately $ million . Cash collateralizing the letter of credit is classified as noncurrent restricted cash on the balance sheets. The Company has determined that the lease is an operating lease for accounting purposes. Intellectual Property Licenses The Company has acquired exclusive rights to develop patented rights, information rights and related know-how for OTIPRIO, OTIVIDEX, OTO-311, OTO-313 and OTO-413 and potential future product candidates under licensing agreements with third parties. The licensing rights obligate the Company to make payments to the licensors for license fees, milestones and royalties. The Company is also responsible for patent prosecution costs, in the event such costs are incurred. The Company may be obligated to make additional milestone payments under the Company’s intellectual property license agreements covering OTIPRIO, OTIVIDEX, OTO-313 and OTO-413 as follows (in thousands): Development $ 1,250 Regulatory 10,275 Commercialization 1,000 Total $ 12,525 Under one of these agreements, the Company has achieved eight development milestones and one regulatory milestone, totaling $3.2 million, related to its clinical trials for OTIPRIO, OTIVIDEX, OTO-311 and OTO-413. If the Company receives positive results from the OTIVIDEX Phase 3 trial and submits an NDA to the FDA in 2021, the Company may be obligated to make a regulatory milestone payment of $1.0 million under one of the Company’s license agreements. This potential payment is included in the table above. In addition, the Company is obligated to pay royalties of less than five percent on net sales of OTIPRIO and on sales of any other commercial products developed using these licensed technologies. Such royalty expense for OTIPRIO is recorded to cost of product sales. The Company may also be obligated to pay to the licensors a percentage of fees received if and when the Company sublicenses the technology. As of December 31, 2020, the Company has not entered into any sublicense agreements for the licensed technologies. In July 2020, the Company entered into an exclusive license agreement to develop, manufacture and commercialize a novel compound as a potential treatment, OTO-6XX, for severe hearing loss. Under the terms of the agreement, the Company acquired worldwide rights to the compound for an upfront payment of $0.5 million with an additional $0.5 million due upon demonstration of preclinical efficacy. If the Company advances a product containing the compound into full development, the Company may be obligated to make payments for development and commercial milestones and pay a royalty on worldwide net sales. The license agreement was accounted for as an asset acquisition and the upfront cash payment of $0.5 million was expensed to research and development during the year ended December 31, 2020 as there is no future alternative use for the assets. The following table summarizes costs recognized, in research and development, under the Company’s license agreements and other non-cancellable royalty and milestone obligations (in thousands): Years Ended December 31, 2020 2019 2018 License and other fees $ 500 $ — $ — Milestone fees 250 100 — Total license and related fees $ 750 $ 100 $ — Other Royalty Arrangements The Company entered into an agreement related to OTIPRIO under which the Company is obligated to pay royalties of less than one percent on net product sales of OTIPRIO. The royalties are recorded as selling, general and administrative expense. The royalties are payable until the later of: (i) the expiration of the last to expire patent owned by the Company in such country covering OTIPRIO; or (ii) 10 years after the first commercial sale of OTIPRIO after receipt of regulatory approval for OTIPRIO in such country. In October 2014, the Company entered into an exclusive license agreement with Ipsen that enables the Company to use clinical and nonclinical gacyclidine data generated by Ipsen to support worldwide development and regulatory filings for OTO-313. Under this license agreement, the Company is obligated to pay Ipsen low single-digit royalties on annual net sales of OTO-313 by the Company or its affiliates or sublicensees, up to a maximum cumulative royalty totaling $10.0 million. Litigation From time to time, the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course of business. Management believes there are no claims or actions pending against the Company as of December 31, 2020 which will have, individually or in the aggregate, a material adverse effect on its business, liquidity, financial position, or results of operations. Litigation, however, is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm the Company’s business. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2020 | |
Long Term Debt [Abstract] | |
Debt | 6. Debt Term Loan On December 31, 2018 (the Closing Date), the Company entered into a Loan and Security Agreement (the Loan Agreement), among the Company, Oxford Finance LLC, as collateral agent, and the lenders party thereto from time to time. The Loan Agreement provides for a $15.0 million secured term loan credit facility (the Term Loan). The proceeds of the Term Loan may be used for working capital and general corporate purposes. The Company has the right to prepay the Term Loan in whole or in part at any time, subject to a prepayment fee of 1.00%. Amounts prepaid or repaid under the Term Loan may not be reborrowed. The Term Loan was fully funded on the Closing Date and matures on December 1, 2023 (the Maturity Date). The Company paid a facility fee of 0.75% and customary closing fees on the Closing Date. The Term Loan bears interest at a floating rate equal to the greater of 5.25% and the prime rate as reported in the Wall Street Journal from time to time, plus 3.75% (9.0% as of December 31, 2020, the minimum interest rate). Interest on the Term Loan is payable monthly in arrears. During the year ended December 31, 2020, the terms of the Term Loan were amended to extend the interest-only period from 24 months to 36 months following the Closing Date, followed by consecutive equal monthly payments of principal and interest in arrears through the Maturity Date. The extension was accounted for as a modification, with no material effect on the Company’s financial statements or financial position. The outstanding principal amount of the Term Loan, together with accrued and unpaid interest, is due on December 1, 2023. Upon repayment or acceleration of the Term Loan, a final payment fee equal to 4.00% of the aggregate original principal amount of the Term Loan is payable (the Final Payment). The Final Payment of $0.6 million, as well as the initial facility fee and all other direct fees and costs associated with the Loan Agreement, was recognized as a debt discount. The debt discount will be amortized to interest expense over the term of the Loan Agreement using the effective interest method. The Company’s obligations under the Loan Agreement are secured by substantially all its assets, excluding intellectual property and subject to certain other exceptions and limitations. The Loan Agreement contains customary affirmative covenants, including covenants regarding compliance with applicable laws and regulations, reporting requirements, payment of taxes and other obligations, and maintenance of insurance. Further, subject to certain exceptions, the Loan Agreement contains customary negative covenants limiting the ability of the Company to, among other things, sell assets, allow a change of control to occur (if the Term Loan is not repaid), make acquisitions, incur debt, grant liens, make investments, pay dividends or repurchase stock. The Company has maintained compliance with all such covenants to date. Upon the occurrence and during the continuance of an event of default, the lenders may declare all outstanding principal and accrued and unpaid interest under the Loan Agreement immediately due and payable, increase the applicable rate of interest by 5.00%, and exercise the other rights and remedies provided for under the Loan Agreement and related loan documents. The events of default under the Loan Agreement include payment defaults, breaches of covenants or representations and warranties, material adverse changes, certain bankruptcy events, cross defaults with certain other indebtedness, and judgment defaults. Interest expense, including amortization of the debt discount, related to the Loan Agreement totaled $1.6 million for the year ended December 31, 2020. Accrued interest, included in accounts payable, was $0.1 million as of December 31, 2020. The outstanding Term Loan balance was $15.2 million as of December 31, 2020, inclusive of accretion of the final payment and net unamortized debt discount. The estimated aggregate amounts and timing of payments on the Company’s long-term debt obligations as of December 31, 2020 for the next three fiscal years were as follows: 2021 $ — 2022 7,826 2023 7,774 Subtotal 15,600 Unamortized discount (442 ) Total long-term debt, net $ 15,158 PPP Loan On April 10, 2020 the Company obtained an unsecured $1.1 million loan through JPMorgan Chase Bank, N.A. under the Paycheck Protection Program (the PPP Loan) pursuant to the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). The PPP Loan bore an interest rate of 0.98% and notionally matured two years from the date of issuance. Following the issuance of new, retroactive guidance on the program from the Small Business Administration on April 23, 2020, the Company repaid the PPP Loan principal and accrued interest in full. Interest expense related to the PPP Loan was de minimis for the year ended December 31, 2020. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | 7. Leases Operating Leases The Company has existing operating leases for certain office equipment and its facility with initial terms ranging from 48 months to 130 months . The facility lease has an option for the Company to extend the lease term for an additional five years ; however, it is not reasonably certain the Company will exercise the option to renew when the lease term ends in 2027 , and thus, the incremental term was excluded from the calculation of the lease liability. The Company has the right to terminate the lease at the end of the 94th month of the lease term if it is acquired by a third party and pays an early termination fee. On March 31, 2019, the Company entered into a lease for certain equipment with an initial term of 24 months, which includes a purchase option at the end of the lease term based upon the then fair market value of the equipment. The lease payment includes customary principal and interest as well as costs related to the installation and setup of the equipment. The Company evaluated the lease in accordance with ASC 842 and recorded this lease as an operating lease in the balance sheets. The ROU assets associated with all the Company’s operating leases are recognized in the balance sheets. Rent expense was $3.1 million during the years ended December 31, 2020, 2019 and 2018. Finance Leases On March 31, 2019, the Company entered into a lease for certain computer equipment with an initial term of 24 months, which includes an option to purchase the equipment at the end of the lease term that is expected to be exercised. The lease payment includes customary principal and interest as well as costs related to the installation and setup of the equipment. The associated ROU asset is recognized within property and equipment, net in the balance sheets and is being amortized over three years in accordance with the Company’s standard depreciation and amortization policies. Years Ended December 31, Lease expenses: 2020 2019 Operating lease expenses $ 3,137 $ 3,137 Variable lease expenses 793 942 Total lease expenses $ 3,930 $ 4,079 Lease Maturities: Operating Leases Finance Leases Total 2021 $ 3,247 $ 18 $ 3,265 2022 3,333 — 3,333 2023 3,433 — 3,433 2024 3,536 — 3,536 2025 3,642 — 3,642 Thereafter 6,642 — 6,642 Total minimum lease payments 23,833 18 23,851 Imputed interest (6,739 ) — (6,739 ) Total 17,094 18 17,112 Less: leases, current (3,247 ) (18 ) (3,265 ) Leases, net of current $ 13,847 $ — $ 13,847 |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 8. Fair Value The accounting guidance defines fair value, establishes a consistency framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring basis or nonrecurring basis. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a three-tier fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. These tiers are based on the source of the inputs and are as follows: Level 1: Observable inputs such as quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. As of December 31, 2020 and 2019, the Company held no assets or liabilities measured at fair value on a nonrecurring basis and no liabilities measured at fair value on a recurring basis. The following fair value hierarchy table presents the Company’s assets measured at fair value on a recurring basis (in thousands): Fair Value Measurement at Reporting Date Using Total Level 1 Level 2 Level 3 December 31, 2020: Assets Money market funds $ 23,278 $ 23,278 $ — $ — U.S. Treasury securities 55,086 55,086 — — Certificates of deposit 490 — 490 — $ 78,854 $ 78,364 $ 490 $ — December 31, 2019: Assets Money market funds $ 22,121 $ 22,121 $ — $ — U.S. Treasury securities 35,476 35,476 — — $ 57,597 $ 57,597 $ — $ — |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity Common Stock Reserved for Future Issuance Shares of common stock reserved for future issuance are as follows: December 31, 2020 2019 Common stock options issued and outstanding 9,842,744 7,495,129 Pre-funded warrants to purchase common stock 4,000,000 — Common stock options available for future grant 2,553,854 3,548,214 Common stock reserved for issuance under ESPP 2,301,704 1,977,215 Total common stock reserved for future issuance 18,698,302 13,020,558 Sale of Common Stock and Pre-funded Warrants In July 2020, the Company sold 17,275,000 shares of its common stock at a public offering price of $3.25 per share and sold pre-funded warrants to purchase 4,000,000 shares of its common stock at a public offering price of $3.249 per pre-funded warrant. After deducting underwriting discounts and commissions and offering expenses, the Company received net proceeds from the offering of $64.2 million. The public offering price for the pre-funded warrants was equal to the public offering price of the common stock, less the $0.001 per share exercise price of each pre-funded warrant. Per their terms, the outstanding pre-funded warrants to purchase shares of common stock may not be exercised if certain holders’ ownership of the Company’s common stock would exceed 4.99% following such exercise. The pre-funded warrants are exercisable immediately and do not contain an expiration date. The pre-funded warrants include a cashless exercise provision in the event registered shares are not available, and do not include any mandatory redemption provisions. The pre-funded warrants are recorded as a component of stockholders’ equity within additional paid-in capital. The pre-funded warrants are included in the computation of basic net loss per share as the exercise price is negligible and may be exercised at any time until the pre-funded warrants are exercised in full. During the year ended December 31, 2020, none of the pre-funded warrants were exercised; accordingly, as of December 31, 2020, all of the pre-funded warrants remained issued and outstanding. |
Stock-Based Compensation and Eq
Stock-Based Compensation and Equity Plans | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation and Equity Plans | 10. Stock-Based Compensation and Equity Plans 2014 Equity Incentive Plan The Company granted awards under its 2010 Equity Incentive Plan (the 2010 Plan) until June 2014. In July 2014, the Company’s board of directors adopted and the Company’s stockholders approved its 2014 Equity Incentive Plan (the 2014 Plan), which became effective in August 2014. In connection with the adoption of the 2014 Plan, the Company terminated the 2010 Plan for future use and provided that no further equity awards we re to be granted under the 2010 Plan. All outstanding awards under the 2010 Plan continue to be governed by their existing terms. The 2014 Plan permits the grant of incentive stock options to the Company’s employees and the grant of nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to the Company’s employees, directors and consultants. Options granted under the 2014 Plan are generally scheduled to vest over four years, subject to continued service, and subject to certain acceleration of vesting provisions, expire no later than 10 years from the date of grant. Options granted under the 2014 Plan must have a per share exercise price equal to at least 100% of the fair market value of a share of the common stock as of the date of grant. Under the evergreen provision of the 2014 Plan, the number of shares available for issuance under the 2014 Plan includes an annual increase on the first day of each fiscal year equal to the lesser of (i) 2,500,000 shares; (ii) 5% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. Effective January 1, 2021, the number of shares available for future issuance was increased by 2,415,948 shares so that the total available for future issuance as of January 1, 2021 was 4,969,802 shares. As of December 31, 2020, 2,553,854 options were available for grant under the 2014 Plan. The following table summarizes stock option activity for the year ended December 31, 2020 (in thousands except per share amounts and years): Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (In Years) Aggregate Intrinsic Value Outstanding as of December 31, 2019 7,495 $ 4.43 Granted 3,099 $ 3.46 Exercised (92 ) $ 2.23 Forfeited (659 ) $ 4.93 Outstanding as of December 31, 2020 9,843 $ 4.11 7.1 $ 25,706 Options vested and expected to vest as of December 31, 2020 9,843 $ 4.11 7.1 $ 25,706 Options exercisable as of December 31, 2020 5,160 $ 4.84 5.7 $ 10,890 The following table summarizes certain information regarding stock options (in thousands, except per share data): Years Ended December 31, 2020 2019 2018 Weighted-average grant date fair value per share of options granted during the period $ 2.68 $ 1.64 $ 4.36 Cash received from options exercised during the period 206 5 32 Intrinsic value of options exercised during the period 59 2 76 Performance-based Awards In February 2018, the Company granted its chief executive officer a stock option for the purchase of 250,000 shares of the Company’s common stock which is subject to time-based vesting and certain performance-based conditions. Specifically, subject to continued service the option was scheduled to vest upon achievement of a clinical development milestone. On the grant date, the Company determined the fair value of the award and determined achievement of the milestone was probable of occurrence and recognized stock-based compensation expense, based upon the grant date fair value, over the implicit service period. The milestone was achieved , and the option grant vested and was fully expensed as of December 31, 2018. Option Exchange On December 20, 2017, the Company commenced an option exchange program (Option Exchange) which allowed eligible employees to exchange certain outstanding stock options (Eligible Options), whether vested or unvested, with an exercise price greater than $12.00 per share, for new stock options. Non-employee members of the Company’s board of directors were not eligible to participate in the Option Exchange. The Option Exchange expired on January 19, 2018. The closing price of the Company’s common stock on that date was $5.675 per share. Pursuant to the terms and conditions of the Option Exchange, the Company accepted for exchange Eligible Options to purchase a total of 1,992,000 shares of the Company’s common stock, representing approximately 81.51% of the total shares of common stock underlying the Eligible Options. All surrendered options were canceled effective as of the expiration of the Option Exchange and in exchange on January 19, 2018, the Company granted new options to purchase an aggregate of 1,570,328 shares of the Company’s common stock with an exercise price of $5.675 per share pursuant to the terms of the Option Exchange and the 2014 Plan. These new options vest over one to three years, and expire eight years from the date of grant. The Company determined this option exchange was an option modification. The exchange of these stock options was treated as a modification for accounting purposes. The difference in the fair value of the canceled options immediately prior to the cancelation and the fair value of the modified options resulted in incremental value, of approximately $0.6 million, which was calculated using the Black-Scholes-Merton option pricing model. T remaining unrecognized expense for the exchanged option, as of the exchange date, 2014 Employee Stock Purchase Plan In July 2014, the Company’s board of directors adopted and the stockholders approved the Company’s 2014 Employee Stock Purchase Plan (the ESPP), which became effective upon adoption by the Company’s board of directors. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The offering periods generally start on the first trading day on or after June 1 and December 1 of each year and end on the first trading day on or before June 1 and December 1 approximately twenty-four months later, and include six-month purchase periods. The number of shares available for issuance under the ESPP includes an annual increase on the first day of each fiscal year, equal to the lesser of (i) 800,000 shares; (ii) 1.5% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. Effective January 1, 2021, the number of shares available for future issuance was increased by 724,784 shares so that the total available for future issuance as of January 1, 2021 was 3,026,488 shares. As of December 31, 2020, the Company had issued 595,555 Stock-Based Compensation Expense The following are the weighted-average underlying assumptions used to determine the fair value of stock options and ESPP rights using the Black-Scholes-Merton option pricing model: Years Ended December 31, 2020 2019 2018 Stock Options: Risk-free interest rate 1.5 % 2.5 % 2.6 % Expected dividend yield 0.0 % 0.0 % 0.0 % Expected volatility 96.7 % 98.1 % 100.6 % Expected term (in years) 6.1 6.1 5.4 Employee Stock Purchase Plan: Risk-free interest rate 0.1 % 2.0 % 2.6 % Expected dividend yield 0.0 % 0.0 % 0.0 % Expected volatility 69.8 % 69.5 % 116.0 % Expected term (in years) 1.3 1.3 1.3 Risk-Free Interest Rate. The Company bases the risk-free interest rate assumption on observed interest rates appropriate for the expected term of the option grants. Expected Dividend Yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends. Expected Volatility. The expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biopharmaceutical industry. Expected Term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determines the expected life assumption using the simplified method, which is an average of the contractual term of the option and its ordinary vesting period. Total non-cash stock-based compensation expense recognized in the statements of operations is as follows (in thousands): Years Ended December 31, 2020 2019 2018 Cost of product sales $ 13 $ 12 $ 12 Research and development 2,456 2,085 4,447 Selling, general and administrative 3,642 2,793 7,955 Total stock-based compensation $ 6,111 $ 4,890 $ 12,414 As of December 31, 2020, unrecognized compensation cost related to stock options was $9.8 million which is expected to be recognized over a remaining weighted-average vesting period of 2.5 years. As of December 31, 2020, unrecognized compensation cost related to ESPP rights was $0.4 million which is expected to be recognized over a remaining weighted-average vesting period of 1.2 years. |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Collaborative Arrangement Disclosure [Abstract] | |
Collaboration Agreements | 11. Collaboration Agreements AGTC collaboration In October 2019, the Company announced a strategic collaboration with AGTC to co-develop and co-commercialize an adeno-associated virus (AAV)-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the gap junction beta-2 (GJB2) gene. Under the collaboration agreement, the Company and AGTC equally share the program costs and any revenue or other proceeds related to the program. As of December 31, 2020, the Company recognized a net receivable of $0.1 million from AGTC. Co-Promotion Agreements The Company entered into a co-promotion agreement with ALK in June 2020, with Mission Pharmacal Company (Mission) in August 2018 and with Glenmark Therapeutics Inc., USA (Glenmark) in April 2019 (each, a Co-Promotion Agreement) to support the promotion of OTIPRIO for the treatment of AOE in physician offices. In July 2019, Glenmark informed the Company of its early discontinuation of OTIPRIO promotional support activities due to the delay in FDA approval of its Ryaltris allergy product, and the impact of such delay on its business operations. In September 2019, the Company reached a settlement with Glenmark regarding the financial and contractual terms impacted by this decision that included committed payments by Glenmark totaling $1.0 million. In August 2019, Mission informed the Company of its non-renewal of the co-promotion agreement. ALK, Mission and Glenmark (each, a Partner) each agreed to reimburse the Company for certain expenses, including a proportion of product support expenses. All such payments are accounted for as reductions to selling, general and administrative expense. Each Partner has been entitled to a share of gross profits totaling more than 50% from the sale of OTIPRIO to each Partner’s accounts. The Company’s payments to each Partner for its portion of the gross profit is recognized as selling, general and administrative expense. The Company is the principal in the product sale of OTIPRIO and recognizes all revenue and related cost of product sales. For the years ended December 31, 2020 and 2019, the Company recognized reductions in selling, general and administrative expenses related to the Co-Promotion Agreements of $0.3 million and $2.6 million, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event that a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has completed a preliminary IRC Section 382/383 analysis, regarding the limitation of net operating loss and research and development credit carryforwards as of December 31, 2020 and does not believe there to have been an ownership change during the year then ended. The Company will continue to consider changes in ownership that may cause losses of tax attributes in the future. Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 88,013 $ 78,768 Research and development credits 9,985 8,920 Depreciation and amortization 10,212 12,608 Accrued expenses 850 381 Lease liabilities 3,816 4,349 Stock compensation 3,856 4,395 Other, net 234 181 Total deferred tax assets 116,966 109,602 Less: valuation allowance (113,826 ) (105,990 ) Total deferred tax assets, net of valuation allowance 3,140 3,612 Deferred tax liability: Right-of-use assets (3,140 ) (3,612 ) Total deferred tax liability (3,140 ) (3,612 ) Total $ — $ — Due to the Company’s history of losses and uncertainty regarding future earnings, a full valuation allowance has been recorded against the Company’s net deferred tax assets, as it is more likely than not that such net assets will not be realized. A valuation allowance of approximately $113.8 million and $106.0 million has been established as of December 31, 2020 and 2019, respectively. At December 31, 2020, the Company had federal and state net operating loss carryforwards of approximately $382.8 million net of IRC Section 382 limitations and $124.8 million, respectively. Of the federal net operating loss carryforwards, approximately $142.2 million were generated after January 1, 2018, and therefore do not expire. Federal net operating losses that occur after January 1, 2018 are subject to a taxable income limitation of 80% in accordance with the Tax Cuts and Jobs Act of 2017 (the TCJA). The remaining federal and state net operating loss carryforwards will begin to expire in 2030, unless previously utilized. As of December 31, 2020, the Company also had federal and California research and development credit carryforwards of approximately $12.0 million net of IRC Section 383 limitations and $5.8 million, respectively. The federal research and development credit carryforwards will begin expiring in 2030, unless previously utilized. The California research credit will carry forward indefinitely. The following is a reconciliation of the expected recovery of income taxes between those that are based on enacted tax rates and laws, to those currently reported for the years ended December 31 (in thousands): 2020 2019 2018 Federal statutory rate $ (9,393 ) $ (9,382 ) $ (10,578 ) State tax (net of federal benefit) 334 299 (4,383 ) Permanent items, other 9 189 (2,092 ) Stock compensation 1,595 2,470 2,570 Other adjustments 687 523 — Research and development credits (1,774 ) (1,595 ) (2,308 ) Uncertain tax positions 710 638 907 Change in valuation allowance 7,832 6,858 15,884 Provision for income taxes $ 0 $ 0 $ 0 The following table summarizes the activity related to the Company’s gross unrecognized tax benefits (in thousands): December 31, 2020 2019 2018 Balance at the beginning of the year $ 10,739 $ 10,052 $ 9,098 Adjustments related to prior year tax positions (21 ) (80 ) 242 Increases related to current year tax positions 796 767 712 $ 11,514 $ 10,739 $ 10,052 The Company’s policy is to include interest and penalties related to unrecognized income tax benefits as a component of income tax expense. The Company has no accruals for interest or penalties in the balance sheets as of December 31, 2020 and 2019 and has not recognized interest or penalties in the statements of operations for the years ended December 31, 2020, 2019 and 2018. Due to the valuation allowance recorded against the Company’s net deferred tax assets, future changes in unrecognized tax benefits will not impact the Company’s effective tax rate. The Company does not expect its unrecognized tax benefits to change significantly in the next 12 months. The Company is subject to taxation in the United States for federal and state purposes. Due to the net operating loss carryforwards, the U.S. federal and state returns are open to examination by the IRS and state tax authorities for all years since inception. The Company is not currently under examination by the federal or any state tax authority. |
Description of Business and B_2
Description of Business and Basis of Presentation (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company follows Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements—Going Concern The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operating activities since inception. In July 2020, the Company sold in a public offering 17,275,000 shares of its common stock, which includes the underwriters’ full exercise of their option to purchase additional shares, and the Company sold pre-funded warrants to purchase 4,000,000 shares of its common stock for $64.2 million in net proceeds after deducting underwriting discounts and commissions and offering expenses. As of December 31, 2020, the Company had cash, cash equivalents and short-term investments of $86.3 million, outstanding debt of $15.2 million and an accumulated deficit of $504.6 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it: (i) develops and seeks regulatory approvals for OTIVIDEX, OTO-313, OTO-413 and its other product candidates; and (ii) works to develop additional product candidates through research and development programs. When additional financing is required, the Company anticipates that it will seek additional funding through future debt and/or equity financings or other sources, such as potential collaboration agreements. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. If the Company is not able to secure adequate additional funding, if or when necessary, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects. The Company believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations for a period of at least twelve months from the date of this report . |
Use of Estimates | Use of Estimates The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of product sales and expense during the reporting period. Although these estimates are based on the Company’s knowledge of current events and anticipated actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institution in which those deposits are held. Additionally, the Company established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less at the date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments. Cash and cash equivalents include cash in readily available checking, savings and money market accounts. The Company’s restricted cash consists of cash maintained in separate deposit accounts to secure a letter of credit issued by a bank to the landlord under a lease agreement for the Company’s corporate headquarters. |
Short-Term Investments | Short-term Investments The Company carries short-term investments classified as available-for-sale debt securities at fair value as determined by prices for identical or similar securities at the balance sheet date. Short-term investments consist of Level 1 financial instruments in the fair value hierarchy (see Note 8 – Fair Value Realized gains or losses of available-for-sale securities are determined using the specific identification method and net realized gains and losses are included in interest income. The Company periodically reviews available-for-sale securities for other-than-temporary declines in fair value below the cost basis, and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company records unrealized gains and losses on available-for-sale debt securities as a component of other comprehensive loss within the statements of comprehensive loss and as a separate component of stockholders’ equity on the balance sheet s . The Company does not hold equity securities in its investment portfolio. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments include cash, cash equivalents, short-term investments, prepaid expenses and other assets, accounts payable, accrued expenses, accrued compensation and long-term debt. The carrying value of the Company’s cash and cash equivalents, short-term investments, prepaid expenses and other current assets, other long-term assets, accounts payable, accrued expenses, and accrued compensation approximate fair value due to the short-term nature of these items. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, the Company believes the fair value of long-term debt approximates its carrying value. |
Inventory | Inventory Inventory is recorded at the lower of cost or net realizable value. Cost is determined on a first-in, first-out method. Inventories consist of OTIPRIO finished goods and work in-process, as well as raw materials used in the manufacture of OTIPRIO. If inventory costs exceed expected market value due to obsolescence, expiry or quantities in excess of expected demand, write downs are recorded for the difference between cost and market value, less cost to sell. During the year ended December 31, 2020, the Company recorded an inventory write down of $0.3 million to cost of product sales. During the years ended December 31, 2019 and 2018, no such write downs were recorded. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment generally consist of manufacturing equipment, office furniture and equipment, computers, and scientific equipment and are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally two to ten years). Leasehold improvements are recorded at cost and are depreciated on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. Repairs and maintenance costs are charged to expense as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company assesses the value of its long-lived assets for impairment on an annual basis and whenever events indicate that the carrying amount of such assets may not be recoverable. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, the Company believes that future cash flows to be received support the carrying value of its long-lived assets. No impairment of long-lived assets was recorded during the years ended December 31, 2020, 2019 and 2018. |
Right-of-Use Assets and Lease Liabilities | Right-of-Use Assets and Lease Liabilities The Company has operating leases for its facility and certain equipment and finance leases for certain computer equipment. The Company determines if an arrangement is or contains a lease at each commencement date. Leases establishes a right-of-use (ROU) model that requires a lessee to recognize an ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Accounting Standards Update (ASU) No. 2016-02, Leases (ASU 2016-02) provides a number of optional practical expedients and accounting policy elections. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. Operating leases are included in ROU assets, Leases, current, and Leases, net of current on the balance sheets. Finance leases are included in Property and equipment, Leases, current, and Leases, net of current on the balance sheets. The Company has elected a policy not to recognize short-term leases (one year or less) on the balance sheets. ROU assets and operating lease liabilities are recognized based on the present value of future minimum lease payments over the lease term at the commencement date. When the implicit rate of the lease is not provided or cannot be determined, the Company uses a collateralized incremental borrowing rate based on the information available at the commencement date, including lease term, in determining the present value of future payments. The Company considers payments for common area maintenance, real estate taxes and management fees to be variable non-lease components, which are expensed as incurred. Lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term . |
Clinical Trial Expense Accruals | Clinical Trial Expense Accruals The Company estimates expenses resulting from its obligations under contracts with vendors, contract research organizations (CROs) and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided. The Company records clinical trial expenses in the period in which services are performed and efforts are expended. The Company accrues for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company estimates accruals through financial models taking into account discussion with applicable personnel and outside service providers as to the progress of trials. During the course of a clinical trial, the Company may adjust its clinical accruals if actual results differ from its estimates. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue by performing the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract with a customer under ASC Topic 606, Revenue from Contracts with Customers (ASC 606) when it is probable the Company will collect the consideration exchanged for the goods or services transferred to the customer. OTIPRIO is sold to a limited number of specialty wholesale distributors. The Company recognizes revenue when its customers obtain control of OTIPRIO, typically upon delivery by the Company to these distributors. The Company has determined the delivery of OTIPRIO to its customers constitutes a single performance obligation and no other performance obligations are present. Hospitals, ambulatory surgery centers and physician offices order OTIPRIO from the Company’s distributors and are the end users of OTIPRIO. The Company permits product returns from the distributors only if the product is damaged or is shipped or ordered in error. Product returns based on expiry are not permitted. To date, product returns have been immaterial. Sales commissions and other incremental costs of obtaining customer contracts are expensed as incurred as the amortization periods would be less than one year or the amount is immaterial . |
Concentration of Major Customers | Concentration of Major Customers The Company sells OTIPRIO to specialty wholesale distributor customers. The following table summarizes the Company’s sales to its largest customers for each of the periods presented: 2020 2019 2018 First largest 41 % 38 % 44 % Second largest 29 % 33 % 33 % Third largest 24 % 24 % 21 % |
Collaborative Arrangements | Collaborative Arrangements The Company has entered into co-promotion agreements and research agreements that fall under the scope of ASC Topic 808, Collaborative Arrangements Co-promotion agreements can include payments and reimbursements for a proportion of product support expenses to the Company and profit sharing payments by the Company. Payments to or by the Company are recognized in selling, general and administrative expenses in the statements of operations. Research agreements can include reimbursements to or by the Company, which are recognized in research and development expenses in the statements of operations. |
Research and Development | Research and Development Research and development expenses include the costs associated with the Company’s research and development activities, including salaries, benefits, stock-based compensation expense and occupancy costs. Also included in research and development expenses are third-party costs incurred in conjunction with contract manufacturing for the Company’s research and development programs and clinical trials, including the cost of clinical trial drug supply, costs incurred by CROs and regulatory expenses. Research and development costs are expensed as incurred. |
Selling, General and Administrative | Selling, General and Administrative Selling, general and administrative expenses include the costs associated with the Company’s executive, administrative, finance and human resource functions including salaries, benefits, stock-based compensation expense and occupancy costs. Other selling, general and administrative expenses include costs associated with prosecuting and maintaining the Company’s patent portfolio, corporate legal expenses, costs required for public company activities and infrastructure necessary for the general conduct of the Company’s business. The Company’s selling, general and administrative expenses also include OTIPRIO product support expenses, and profit-sharing fees payable to the Company’s partners, which are reduced by payments received from the Company’s partners under its co-promotion agreements. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation expense related to stock options and employee stock purchase plan (ESPP) rights by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model. Forfeitures are recognized as incurred. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized using the straight-line method. For performance-based awards to employees, (i) the fair value of the award is determined on the grant date, (ii) the Company assesses the probability of the individual performance milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. |
Income Taxes | Income Taxes The accounting guidance for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities based on the technical merits of the position. The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. |
Net Loss Per Share | Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. As of December 31, 2020, 2019 and 2018, potentially dilutive securities excluded from the calculation of diluted net loss per share consist of outstanding options to purchase 9,842,744, 7,495,129 and 5,019,964 shares of the Company’s common stock, respectively. |
Risks and Uncertainties Related to COVID-19 | Risks and Uncertainties Related to COVID-19 In March 2020, the World Health Organization declared COVID-19 a global pandemic. The COVID-19 pandemic could pose significant risks to the Company’s business; however, the ultimate impact of the pandemic is highly uncertain. The Company has clinical trial sites in the United States and Europe, which may be affected by travel or quarantine restrictions imposed by federal, state or local governments due to the COVID-19 pandemic. In light of the significant uncertainty regarding the impact of the COVID-19 pandemic, the Company had suspended and subsequently updated its guidance regarding timing of trial results. The Company may in the future need to further update or suspend such guidance as a result of the impact of the COVID-19 pandemic. In addition, the Company has made and it (and its contract research organizations (CROs)) may need to make certain adjustments to the operation of clinical trials in an effort to ensure the monitoring and safety of patients and minimize risks to trial data integrity during the pandemic in accordance with the guidance issued by the FDA in 2020, among other activity. Third-party manufacturers which the Company uses for the supply of materials for its product candidates or other materials necessary to conduct preclinical studies and clinical trials are located in countries affected by COVID-19. Although the Company expects no material impact on the clinical supply of its product candidates for its current clinical trials, should its third-party manufacturers experience extended disruptions, the Company could experience delays in future trials. Furthermore, the spread of the virus may affect the operations of key governmental agencies, such as the FDA and similar organizations outside the United States, as well as local regulatory agencies and health officials, which may delay the development of the Company’s product candidates. The Company continues to evaluate the impact COVID-19 may have on its ability to effectively conduct its business operations as planned, and work with healthcare providers supporting its clinical studies to mitigate risk to patients while taking into account regulatory, institutional, and government guidance and policies and may take further actions as may be required by federal, state or local authorities or that the Company determines are in the best interests of public health and safety and that of patients, employees, partners, and stockholders. Nonetheless, the Company does not yet know and cannot predict the full extent of potential delays or impacts on its business, its preclinical programs and clinical trials, healthcare systems or the global economy as a whole. As such, it is uncertain as to the full magnitude that the COVID-19 pandemic will have on the Company’s business, strategy, collaborations, financial condition, liquidity and future results of operations. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Not Yet Adopted I n June 2016, ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13) was issued, as amended. ASU 2016-13 introduces the current expected credit loss model, which will require an entity to measure credit losses for certain financial instruments and financial assets. ASU 2016-13 will also apply to receivables arising from revenue transactions such as accounts receivable. ASU 2016-13 is effective for the Company beginning January 1, 2023. The Company does not expect the adoption of ASU 2016-13 to have a material effect on its financial position, results of operations or cash flows. Recently Adopted Effective January 1, 2020, the Company early adopted ASU No. 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes ASU 2019-12 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2020. Early adoption is permitted, including adoption in an interim period. The Company elected to early adopt ASU 2019-12. By early adopting, ASU 2019-12 is effective for the Company beginning January 1, 2020. There was no cumulative effect to be recognized in connection with the early adoption of ASU 2019-12 and the adoption did not have a material impact on the Company’s financial statements or disclosure s. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Sales to Largest Customers | The following table summarizes the Company’s sales to its largest customers for each of the periods presented: 2020 2019 2018 First largest 41 % 38 % 44 % Second largest 29 % 33 % 33 % Third largest 24 % 24 % 21 % |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Available-for-Sale Debt Securities | Available-for-sale debt securities with maturities of more than three months from the date of purchase have been classified as short-term investments, and were as follows (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Market Value December 31, 2020: U.S. Treasury securities $ 55,085 $ 2 $ (1 ) $ 55,086 Certificates of deposit 490 — — 490 $ 55,575 $ 2 $ (1 ) $ 55,576 December 31, 2019: U.S. Treasury securities $ 35,465 $ 16 $ (5 ) $ 35,476 $ 35,465 $ 16 $ (5 ) $ 35,476 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Prepaid and Other Current Assets | Prepaid and other current assets are comprised of the following (in thousands): December 31, 2020 2019 Inventory $ 227 $ 478 Other 2,145 2,002 Total $ 2,372 $ 2,480 |
Property and Equipment, Net | Property and equipment, net consists of the following (in thousands): December 31, 2020 2019 Laboratory equipment $ 4,265 $ 4,179 Manufacturing equipment 1,075 1,111 Computer equipment and software 989 943 Leasehold improvements 768 768 Office furniture 1,548 1,548 8,645 8,549 Less: accumulated depreciation and amortization (5,879 ) (4,847 ) Total $ 2,766 $ 3,702 |
Accrued Expenses | Accrued expenses consist of the following (in thousands): December 31, 2020 2019 Accrued clinical trial costs $ 1,477 $ 3,443 Accrued other 1,476 1,999 Total $ 2,953 $ 5,442 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Additional Milestone Payments under Intellectual Property License Agreements | The Company may be obligated to make additional milestone payments under the Company’s intellectual property license agreements covering OTIPRIO, OTIVIDEX, OTO-313 and OTO-413 as follows (in thousands): Development $ 1,250 Regulatory 10,275 Commercialization 1,000 Total $ 12,525 |
Summary of Costs Recognized under License Agreements and Other Non-Cancellable Royalty and Milestone Obligations | The following table summarizes costs recognized, in research and development, under the Company’s license agreements and other non-cancellable royalty and milestone obligations (in thousands): Years Ended December 31, 2020 2019 2018 License and other fees $ 500 $ — $ — Milestone fees 250 100 — Total license and related fees $ 750 $ 100 $ — |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Long Term Debt [Abstract] | |
Summary of Estimated Aggregate Amounts and Timing of Payments on Long-term Debt Obligations | The estimated aggregate amounts and timing of payments on the Company’s long-term debt obligations as of December 31, 2020 for the next three fiscal years were as follows: 2021 $ — 2022 7,826 2023 7,774 Subtotal 15,600 Unamortized discount (442 ) Total long-term debt, net $ 15,158 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Summary of Lease Expenses | Years Ended December 31, Lease expenses: 2020 2019 Operating lease expenses $ 3,137 $ 3,137 Variable lease expenses 793 942 Total lease expenses $ 3,930 $ 4,079 |
Future Minimum Annual Obligations under Finance and Operating Lease Commitments | Lease Maturities: Operating Leases Finance Leases Total 2021 $ 3,247 $ 18 $ 3,265 2022 3,333 — 3,333 2023 3,433 — 3,433 2024 3,536 — 3,536 2025 3,642 — 3,642 Thereafter 6,642 — 6,642 Total minimum lease payments 23,833 18 23,851 Imputed interest (6,739 ) — (6,739 ) Total 17,094 18 17,112 Less: leases, current (3,247 ) (18 ) (3,265 ) Leases, net of current $ 13,847 $ — $ 13,847 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Assets Measured on a Recurring Basis | The following fair value hierarchy table presents the Company’s assets measured at fair value on a recurring basis (in thousands): Fair Value Measurement at Reporting Date Using Total Level 1 Level 2 Level 3 December 31, 2020: Assets Money market funds $ 23,278 $ 23,278 $ — $ — U.S. Treasury securities 55,086 55,086 — — Certificates of deposit 490 — 490 — $ 78,854 $ 78,364 $ 490 $ — December 31, 2019: Assets Money market funds $ 22,121 $ 22,121 $ — $ — U.S. Treasury securities 35,476 35,476 — — $ 57,597 $ 57,597 $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Schedule of Shares of Common Stock Reserved for Future Issuance | Shares of common stock reserved for future issuance are as follows: December 31, 2020 2019 Common stock options issued and outstanding 9,842,744 7,495,129 Pre-funded warrants to purchase common stock 4,000,000 — Common stock options available for future grant 2,553,854 3,548,214 Common stock reserved for issuance under ESPP 2,301,704 1,977,215 Total common stock reserved for future issuance 18,698,302 13,020,558 |
Stock-Based Compensation and _2
Stock-Based Compensation and Equity Plans (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity for the year ended December 31, 2020 (in thousands except per share amounts and years): Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (In Years) Aggregate Intrinsic Value Outstanding as of December 31, 2019 7,495 $ 4.43 Granted 3,099 $ 3.46 Exercised (92 ) $ 2.23 Forfeited (659 ) $ 4.93 Outstanding as of December 31, 2020 9,843 $ 4.11 7.1 $ 25,706 Options vested and expected to vest as of December 31, 2020 9,843 $ 4.11 7.1 $ 25,706 Options exercisable as of December 31, 2020 5,160 $ 4.84 5.7 $ 10,890 |
Summary of Certain Information Regarding Stock Options | The following table summarizes certain information regarding stock options (in thousands, except per share data): Years Ended December 31, 2020 2019 2018 Weighted-average grant date fair value per share of options granted during the period $ 2.68 $ 1.64 $ 4.36 Cash received from options exercised during the period 206 5 32 Intrinsic value of options exercised during the period 59 2 76 |
Weighted-Average Underlying Assumptions Used to Determine Fair Value of Stock Options and ESPP Rights | The following are the weighted-average underlying assumptions used to determine the fair value of stock options and ESPP rights using the Black-Scholes-Merton option pricing model: Years Ended December 31, 2020 2019 2018 Stock Options: Risk-free interest rate 1.5 % 2.5 % 2.6 % Expected dividend yield 0.0 % 0.0 % 0.0 % Expected volatility 96.7 % 98.1 % 100.6 % Expected term (in years) 6.1 6.1 5.4 Employee Stock Purchase Plan: Risk-free interest rate 0.1 % 2.0 % 2.6 % Expected dividend yield 0.0 % 0.0 % 0.0 % Expected volatility 69.8 % 69.5 % 116.0 % Expected term (in years) 1.3 1.3 1.3 |
Summary of Non-cash Stock Based Compensation Expense | Total non-cash stock-based compensation expense recognized in the statements of operations is as follows (in thousands): Years Ended December 31, 2020 2019 2018 Cost of product sales $ 13 $ 12 $ 12 Research and development 2,456 2,085 4,447 Selling, general and administrative 3,642 2,793 7,955 Total stock-based compensation $ 6,111 $ 4,890 $ 12,414 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 88,013 $ 78,768 Research and development credits 9,985 8,920 Depreciation and amortization 10,212 12,608 Accrued expenses 850 381 Lease liabilities 3,816 4,349 Stock compensation 3,856 4,395 Other, net 234 181 Total deferred tax assets 116,966 109,602 Less: valuation allowance (113,826 ) (105,990 ) Total deferred tax assets, net of valuation allowance 3,140 3,612 Deferred tax liability: Right-of-use assets (3,140 ) (3,612 ) Total deferred tax liability (3,140 ) (3,612 ) Total $ — $ — |
Reconciliation of Expected Recovery of Income Taxes | The following is a reconciliation of the expected recovery of income taxes between those that are based on enacted tax rates and laws, to those currently reported for the years ended December 31 (in thousands): 2020 2019 2018 Federal statutory rate $ (9,393 ) $ (9,382 ) $ (10,578 ) State tax (net of federal benefit) 334 299 (4,383 ) Permanent items, other 9 189 (2,092 ) Stock compensation 1,595 2,470 2,570 Other adjustments 687 523 — Research and development credits (1,774 ) (1,595 ) (2,308 ) Uncertain tax positions 710 638 907 Change in valuation allowance 7,832 6,858 15,884 Provision for income taxes $ 0 $ 0 $ 0 |
Unrecognized Tax Benefit | The following table summarizes the activity related to the Company’s gross unrecognized tax benefits (in thousands): December 31, 2020 2019 2018 Balance at the beginning of the year $ 10,739 $ 10,052 $ 9,098 Adjustments related to prior year tax positions (21 ) (80 ) 242 Increases related to current year tax positions 796 767 712 $ 11,514 $ 10,739 $ 10,052 |
Description of Business and B_3
Description of Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | ||
Jul. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Description Of Business And Basis Of Presentation [Line Items] | |||
Cash, cash equivalents and short-term investments | $ 86,300 | ||
Accumulated deficit | $ (504,624) | $ (459,893) | |
Common stock sold in public offering | 17,275,000 | ||
Debt outstanding | $ 15,200 | ||
Warrants to purchase common stock | 4,000,000 | ||
Net proceeds after deducting underwriters commission | $ 64,200 | ||
IPO [Member] | |||
Description Of Business And Basis Of Presentation [Line Items] | |||
Common stock sold in public offering | 17,275,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2020USD ($)Segmentshares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Inventory write-down | $ 300,000 | $ 0 | $ 0 |
Impairment of long-lived assets | $ 0 | $ 0 | $ 0 |
Options to Purchase Common Stock [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Potentially dilutive securities excluded from the calculation of diluted net loss per share | shares | 9,842,744 | 7,495,129 | 5,019,964 |
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment useful lives | 2 years | ||
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment useful lives | 10 years |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of Sales to Largest Customers (Detail) - Customer Concentration Risk [Member] - Sales Revenue, Net [Member] | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Customer One [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk percentage | 41.00% | 38.00% | 44.00% |
Customer Two [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk percentage | 29.00% | 33.00% | 33.00% |
Customer Three [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk percentage | 24.00% | 24.00% | 21.00% |
Available-for-Sale Securities -
Available-for-Sale Securities - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2020USD ($)Security | Dec. 31, 2019USD ($) | |
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale securities in unrealized loss positions for less than twelve months | Security | 4 | |
Other-than-temporary declines in the value of any available-for-sale securities | $ 0 | |
Maximum maturity of available-for-sale debt securities | 1 year | |
Available-for-sale Securities [Member] | Money Market Funds and Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cash equivalents | $ 23,300,000 | $ 22,100,000 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Schedule of Available-for-Sale Debt Securities (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 55,575 | $ 35,465 |
Unrealized Gains | 2 | 16 |
Unrealized Losses | (1) | (5) |
Market Value | 55,576 | 35,476 |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 55,085 | 35,465 |
Unrealized Gains | 2 | 16 |
Unrealized Losses | (1) | (5) |
Market Value | 55,086 | $ 35,476 |
Certificates Of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 490 | |
Unrealized Gains | 0 | |
Unrealized Losses | 0 | |
Market Value | $ 490 |
Balance Sheet Details - Prepaid
Balance Sheet Details - Prepaid and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Inventory | $ 227 | $ 478 |
Other | 2,145 | 2,002 |
Total | $ 2,372 | $ 2,480 |
Balance Sheet Details - Propert
Balance Sheet Details - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 8,645 | $ 8,549 |
Less: accumulated depreciation and amortization | (5,879) | (4,847) |
Total | 2,766 | 3,702 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,265 | 4,179 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,075 | 1,111 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 989 | 943 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 768 | 768 |
Office Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,548 | $ 1,548 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |||
Depreciation expense | $ 1,062 | $ 1,149 | $ 1,186 |
Balance Sheet Details - Accrued
Balance Sheet Details - Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued clinical trial costs | $ 1,477 | $ 3,443 |
Accrued other | 1,476 | 1,999 |
Total | $ 2,953 | $ 5,442 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||
Jul. 31, 2020USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2020USD ($)Milestone | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | May 31, 2015USD ($) | |
Other Commitments [Line Items] | ||||||
Operating lease term | 130 months | |||||
Additional operating lease term | 5 years | 5 years | ||||
Period after which company has the right to terminate lease if it is acquired by a third party and pays early termination fee | 94 months | 94 months | ||||
Monthly base rent for first year | $ 232,000 | |||||
Lease rate increase, percentage | 3.00% | |||||
Abatement period of monthly base rent | 10 months | |||||
Estimated base rent payments over the life of lease | $ 32,700,000 | |||||
Milestone fees | $ 250,000 | $ 100,000 | $ 0 | |||
Research and development | 27,997,000 | $ 32,805,000 | $ 31,844,000 | |||
License Agreement [Member] | ||||||
Other Commitments [Line Items] | ||||||
Additional payments due upon demonstration | $ 500,000 | |||||
Upfront Payment [Member] | License Agreement [Member] | ||||||
Other Commitments [Line Items] | ||||||
Payment to acquire worldwide rights | 500,000 | |||||
Research and development | $ 500,000 | |||||
Intellectual Property [Member] | ||||||
Other Commitments [Line Items] | ||||||
Milestone fees | $ 3,200,000 | |||||
Maximum percentage of royalties on sales | 5.00% | |||||
Intellectual Property [Member] | Regulatory [Member] | ||||||
Other Commitments [Line Items] | ||||||
Number of milestones achieved | Milestone | 1 | |||||
Milestones potential cash payment | $ 1,000,000 | |||||
Intellectual Property [Member] | Development [Member] | ||||||
Other Commitments [Line Items] | ||||||
Number of milestones achieved | Milestone | 8 | |||||
Royalty Agreements [Member] | ||||||
Other Commitments [Line Items] | ||||||
Maximum percentage of royalties on sales | 1.00% | |||||
Royalty period | 10 years | |||||
Data License Agreement [Member] | ||||||
Other Commitments [Line Items] | ||||||
Description of royalties payable | The Company is obligated to pay Ipsen low single-digit royalties on annual net sales of OTO-313 by the Company or its affiliates or sublicensees | |||||
Maximum cumulative royalties paid under license agreement | $ 10,000,000 | |||||
Building [Member] | ||||||
Other Commitments [Line Items] | ||||||
Construction commencement period | 2016-12 | |||||
Restricted Cash [Member] | ||||||
Other Commitments [Line Items] | ||||||
Security deposit in the form of letter of credit | $ 700,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Additional Milestone Payments under Intellectual Property License Agreements (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Other Commitments [Line Items] | |
Cash Payments | $ 12,525 |
Development [Member] | |
Other Commitments [Line Items] | |
Cash Payments | 1,250 |
Regulatory [Member] | |
Other Commitments [Line Items] | |
Cash Payments | 10,275 |
Commercialization [Member] | |
Other Commitments [Line Items] | |
Cash Payments | $ 1,000 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Costs Recognized under License Agreements and Other Non-Cancellable Royalty and Milestone Obligations (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |||
License and other fees | $ 500 | $ 0 | $ 0 |
Milestone fees | 250 | 100 | 0 |
Total license and related fees | $ 750 | $ 100 | $ 0 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Apr. 10, 2020 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | |||
Debt discount, amount | $ 442 | ||
Term Loan outstanding | 15,158 | $ 14,967 | |
Accounts Payable [Member] | |||
Debt Instrument [Line Items] | |||
Accrued interest | 100 | ||
Secured Term Loan Credit Facility [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, face amount | $ 15,000 | ||
Facility fee percentage | 0.75% | ||
Debt instrument, maturity date | Dec. 1, 2023 | ||
Interest rate description | The Term Loan bears interest at a floating rate equal to the greater of 5.25% and the prime rate as reported in the Wall Street Journal from time to time, plus 3.75% (9.0% as of December 31, 2020, the minimum interest rate). | ||
Debt instrument, interest rate at period end | 9.00% | ||
Debt instrument, minimum interest rate | 9.00% | ||
Interest frequency payments | monthly | ||
Interest only payment term | 24 months | ||
Interest only payment extension term | 36 months | ||
Repayment fee percentage | 4.00% | ||
Debt discount, amount | $ 600 | ||
Debt instrument, covenant description | The Loan Agreement contains customary affirmative covenants, including covenants regarding compliance with applicable laws and regulations, reporting requirements, payment of taxes and other obligations, and maintenance of insurance. Further, subject to certain exceptions, the Loan Agreement contains customary negative covenants limiting the ability of the Company to, among other things, sell assets, allow a change of control to occur (if the Term Loan is not repaid), make acquisitions, incur debt, grant liens, make investments, pay dividends or repurchase stock. The Company has maintained compliance with all such covenants to date. | ||
Interest expense, including amortization of the debt discount | $ 1,600 | ||
Term Loan outstanding | $ 15,200 | ||
Secured Term Loan Credit Facility [Member] | Minimum [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, reference rate | 5.25% | ||
Debt instrument, basis spread on variable rate | 3.75% | ||
Secured Term Loan Credit Facility [Member] | Thereafter Second Anniversary of Closing Date [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of debt prepayment fee | 1.00% | ||
Secured Term Loan Credit Facility [Member] | Occurrence and During Continuance of Event of Default [Member] | |||
Debt Instrument [Line Items] | |||
Increase in applicable rate of interest | 5.00% | ||
Unsecured Loan [Member] | PPP Loan [Member] | JPMorgan Chase Bank, N.A. [Member] | CARES Act Of 2020 [Member] | |||
Debt Instrument [Line Items] | |||
Loans amount | $ 1,100 | ||
Interest rate | 0.98% | ||
Loan term | 2 years | ||
Date of early repayment of loan in full | Apr. 23, 2020 |
Debt - Summary of Estimated Agg
Debt - Summary of Estimated Aggregate Amounts and Timing of Payments on Long-term Debt Obligations (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Long Term Debt [Abstract] | |
2021 | $ 0 |
2022 | 7,826 |
2023 | 7,774 |
Subtotal | 15,600 |
Unamortized discount | (442) |
Total long-term debt, net | $ 15,158 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Lessee Lease Description [Line Items] | ||||
Operating lease, description | The Company has existing operating leases for certain office equipment and its facility with initial terms ranging from 48 months to 130 months. | |||
Operating lease term | 130 months | |||
Operating lease, option to extend | true | |||
Operating lease, option to extend description | The facility lease has an option for the Company to extend the lease term for an additional five years; however, it is not reasonably certain the Company will exercise the option to renew when the lease term ends in 2027, and thus, the incremental term was excluded from the calculation of the lease liability. | |||
Additional operating lease term | 5 years | 5 years | ||
Operating lease term ending year | 2027 | |||
Operating lease, option to terminate | true | |||
Operating lease, option to terminate description | The Company has the right to terminate the lease at the end of the 94th month of the lease term if it is acquired by a third party and pays an early termination fee. | |||
Period after which company has the right to terminate lease if it is acquired by a third party and pays early termination fee | 94 months | 94 months | ||
Rent expense | $ 3.1 | $ 3.1 | $ 3.1 | |
Computer Equipment [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease, description | On March 31, 2019, the Company entered into a lease for certain equipment with an initial term of 24 months, which includes a purchase option at the end of the lease term based upon the then fair market value of the equipment. | |||
Operating lease term | 24 months | |||
Finance lease, description | On March 31, 2019, the Company entered into a lease for certain computer equipment with an initial term of 24 months, which includes an option to purchase the equipment at the end of the lease term that is expected to be exercised. | |||
Finance lease initial term | 24 months | |||
Finance lease right-of-use asset amortization term | 3 years | |||
Minimum [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease term | 48 months | |||
Maximum [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease term | 130 months |
Leases - Summary of Lease Expen
Leases - Summary of Lease Expenses (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Lease expenses: | ||
Operating lease expenses | $ 3,137 | $ 3,137 |
Variable lease expenses | 793 | 942 |
Total lease expenses | $ 3,930 | $ 4,079 |
Leases - Future Minimum Annual
Leases - Future Minimum Annual Obligations under Finance and Operating Lease Commitments (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Operating Leases, 2021 | $ 3,247 | |
Operating Leases, 2022 | 3,333 | |
Operating Leases, 2023 | 3,433 | |
Operating Leases, 2024 | 3,536 | |
Operating Leases, 2025 | 3,642 | |
Operating Leases, Thereafter | 6,642 | |
Operating Leases, Total minimum lease payments | 23,833 | |
Operating Leases, Imputed interest | (6,739) | |
Operating Leases, Total | 17,094 | |
Operating Leases, Less: leases, current | $ (3,247) | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherCurrentLiabilitiesMember | |
Operating Leases, Leases, net of current | $ 13,847 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherNoncurrentLiabilitiesMember | |
Finance Leases, 2021 | $ 18 | |
Finance Leases, 2022 | 0 | |
Finance Leases, 2023 | 0 | |
Finance Leases, 2024 | 0 | |
Finance Leases, 2025 | 0 | |
Finance Leases, Thereafter | 0 | |
Finance Leases, Total minimum lease payments | 18 | |
Finance Leases, Imputed interest | 0 | |
Finance Leases, Total | 18 | |
Finance Leases, Less: leases, current | (18) | |
Finance Leases, Leases, net of current | 0 | |
2021 | 3,265 | |
2022 | 3,333 | |
2023 | 3,433 | |
2024 | 3,536 | |
2025 | 3,642 | |
Thereafter | 6,642 | |
Total minimum lease payments | 23,851 | |
Imputed interest | (6,739) | |
Total | 17,112 | |
Less: leases, current | (3,265) | $ (3,302) |
Leases, net of current | $ 13,847 | $ 15,320 |
Fair Value - Additional informa
Fair Value - Additional information (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Measurements Nonrecurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 0 | $ 0 |
Liabilities measured at fair value | 0 | 0 |
Fair Value Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 78,854,000 | 57,597,000 |
Liabilities measured at fair value | $ 0 | $ 0 |
Fair Value - Fair Value Assets
Fair Value - Fair Value Assets Measured on a Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets | ||
Short-term investments | $ 55,576 | $ 35,476 |
U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 55,086 | 35,476 |
Certificates Of Deposit [Member] | ||
Assets | ||
Short-term investments | 490 | |
Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Assets measured at fair value | 78,854 | 57,597 |
Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 23,278 | 22,121 |
Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 55,086 | 35,476 |
Fair Value Measurements, Recurring [Member] | Certificates Of Deposit [Member] | ||
Assets | ||
Certificates of deposit | 490 | |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Assets measured at fair value | 78,364 | 57,597 |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 23,278 | 22,121 |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 55,086 | 35,476 |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | Certificates Of Deposit [Member] | ||
Assets | ||
Certificates of deposit | 0 | |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Assets measured at fair value | 490 | 0 |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 0 | 0 |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 0 | 0 |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | Certificates Of Deposit [Member] | ||
Assets | ||
Certificates of deposit | 490 | |
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Assets measured at fair value | 0 | 0 |
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 0 | 0 |
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 0 | $ 0 |
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | Certificates Of Deposit [Member] | ||
Assets | ||
Certificates of deposit | $ 0 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Shares of Common Stock Reserved for Future Issuance (Detail) - shares | Dec. 31, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 18,698,302 | 13,020,558 |
Options to Purchase Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 9,842,744 | 7,495,129 |
Pre-funded Warrants [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 4,000,000 | 0 |
Available Future Grant Year [Member] | Options to Purchase Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 2,553,854 | 3,548,214 |
2014 Employee Stock Purchase Plan [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 2,301,704 | 1,977,215 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended |
Jul. 31, 2020 | Dec. 31, 2020 | |
Class of Stock [Line Items] | ||
Common stock sold in public offering | 17,275,000 | |
Shares issued, price per Share | $ 3.25 | |
Net proceeds after deducting underwriters commission | $ 64.2 | |
Ownership percentage of common stock | 4.99% | |
Prefunded warrants exercised | 0 | |
Pre-funded Warrants [Member] | ||
Class of Stock [Line Items] | ||
Shares issued, price per Share | $ 3.249 | |
Warrants to purchase common stock | 4,000,000 | |
Difference in offering price of warrants to offering price of common stock | $ 0.001 |
Stock-Based Compensation and _3
Stock-Based Compensation and Equity Plans - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Jan. 01, 2021 | Dec. 20, 2017 | Feb. 28, 2018 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common shares reserved for issuance | 18,698,302 | 13,020,558 | |||
Stock option granted | 3,099,000 | ||||
Exchange of outstanding stock options, exercise price | $ 4.11 | $ 4.43 | |||
Common stock exercise price | $ 3.46 | ||||
Number of common stock issued pursuant to ESPP purchases | 595,555 | ||||
Unrecognized compensation costs related to stock options | $ 9.8 | ||||
Remaining weighted-average vesting period | 2 years 6 months | ||||
Unrecognized compensation cost related to stock options | $ 0.4 | ||||
Remaining weighted-average vesting period | 1 year 2 months 12 days | ||||
Option Exchange [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Contractual term of options | 8 years | ||||
Incremental fair value options | $ 0.6 | ||||
Performance-based Awards [Member] | Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option granted | 250,000 | ||||
Options to Purchase Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common shares reserved for issuance | 9,842,744 | 7,495,129 | |||
Options to Purchase Common Stock [Member] | Option Exchange [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option exchange program, expiration date | Jan. 19, 2018 | ||||
Exchange of outstanding stock options under option exchange program, closing price per share | $ 5.675 | ||||
Options to Purchase Common Stock [Member] | Common Stock [Member] | Option Exchange [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares purchased | 1,992,000 | ||||
Percentage of number of common stock purchased | 81.51% | ||||
Minimum [Member] | Option Exchange [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share based compensation vesting period | 1 year | ||||
Minimum [Member] | Options to Purchase Common Stock [Member] | Option Exchange [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exchange of outstanding stock options, exercise price | $ 12 | ||||
Maximum [Member] | Option Exchange [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share based compensation vesting period | 3 years | ||||
Equity Incentive Plan 2014 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share based compensation vesting period | 4 years | ||||
Contractual term of options | 10 years | ||||
Annual increase in common shares reserved for issuance, percentage of total shares of common stock | 5.00% | ||||
Changes in share issuance, description | Under the evergreen provision of the 2014 Plan, the number of shares available for issuance under the 2014 Plan includes an annual increase on the first day of each fiscal year equal to the lesser of (i) 2,500,000 shares; (ii) 5% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. | ||||
Options available for grant | 2,553,854 | ||||
Equity Incentive Plan 2014 [Member] | Options to Purchase Common Stock [Member] | Common Stock [Member] | Option Exchange [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option granted | 1,570,328 | ||||
Common stock exercise price | $ 5.675 | ||||
Equity Incentive Plan 2014 [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Annual increase in common shares reserved for issuance | 2,415,948 | ||||
Common shares reserved for issuance | 4,969,802 | ||||
Equity Incentive Plan 2014 [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price, percentage of fair market value | 100.00% | ||||
Equity Incentive Plan 2014 [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Annual increase in common shares reserved for issuance | 2,500,000 | ||||
2014 Employee Stock Purchase Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Annual increase in common shares reserved for issuance, percentage of total shares of common stock | 1.50% | ||||
Changes in share issuance, description | issuance under the ESPP includes an annual increase on the first day of each fiscal year, equal to the lesser of (i) 800,000 shares; (ii) 1.5% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. | ||||
Common shares reserved for issuance | 2,301,704 | 1,977,215 | |||
Eligible compensation contribution | 15.00% | ||||
Offering periods under plan | 24 months | ||||
Offering period description | The offering periods generally start on the first trading day on or after June 1 and December 1 of each year and end on the first trading day on or before June 1 and December 1 approximately twenty-four months later, and include six-month purchase periods. | ||||
2014 Employee Stock Purchase Plan [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common shares reserved for issuance | 3,026,488 | ||||
2014 Employee Stock Purchase Plan [Member] | Minimum [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Annual increase in common shares reserved for issuance | 724,784 | ||||
2014 Employee Stock Purchase Plan [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Annual increase in common shares reserved for issuance | 800,000 |
Stock-Based Compensation and _4
Stock-Based Compensation and Equity Plans - Stock Option Activity (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Options | |
Outstanding as of beginning of period | shares | 7,495 |
Granted | shares | 3,099 |
Exercised | shares | (92) |
Forfeited | shares | (659) |
Outstanding as of end of period | shares | 9,843 |
Options vested and expected to vest | shares | 9,843 |
Options exercisable | shares | 5,160 |
Weighted- Average Exercise Price | |
Outstanding as of beginning of period | $ / shares | $ 4.43 |
Granted | $ / shares | 3.46 |
Exercised | $ / shares | 2.23 |
Forfeited | $ / shares | 4.93 |
Outstanding as of end of period | $ / shares | 4.11 |
Options vested and expected to vest | $ / shares | 4.11 |
Options exercisable | $ / shares | $ 4.84 |
Weighted-Average Remaining Contractual Term (In Years) | |
Outstanding | 7 years 1 month 6 days |
Options vested and expected to vest | 7 years 1 month 6 days |
Options exercisable | 5 years 8 months 12 days |
Aggregate Intrinsic Value | |
Outstanding | $ | $ 25,706 |
Options vested and expected to vest | $ | 25,706 |
Options exercisable | $ | $ 10,890 |
Stock-Based Compensation and _5
Stock-Based Compensation and Equity Plans - Summary of Certain Information Regarding Stock Options (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Weighted-average grant date fair value per share of options granted during the period | $ 2.68 | $ 1.64 | $ 4.36 |
Cash received from options exercised during the period | $ 206 | $ 5 | $ 32 |
Intrinsic value of options exercised during the period | $ 59 | $ 2 | $ 76 |
Stock-Based Compensation and _6
Stock-Based Compensation and Equity Plans - Weighted-Average Underlying Assumptions Used to Determine Fair Value of Stock Options and ESPP Rights (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 1.50% | 2.50% | 2.60% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility | 96.70% | 98.10% | 100.60% |
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 5 years 4 months 24 days |
Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 0.10% | 2.00% | 2.60% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility | 69.80% | 69.50% | 116.00% |
Expected term (in years) | 1 year 3 months 18 days | 1 year 3 months 18 days | 1 year 3 months 18 days |
Stock-Based Compensation and _7
Stock-Based Compensation and Equity Plans - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation | $ 6,111 | $ 4,890 | $ 12,414 |
Cost of Product Sales [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation | 13 | 12 | 12 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation | 2,456 | 2,085 | 4,447 |
Selling, General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation | $ 3,642 | $ 2,793 | $ 7,955 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | |
AGTC Collaboration [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Net receivable | $ 0.1 | ||
Glenmark Co-Promotion Agreement [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Payment of committed amount in settlement | $ 1 | ||
Mission Co-Promotion Agreement [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Decrease in selling general and administrative expenses | $ 0.3 | $ 2.6 | |
Mission Co-Promotion Agreement [Member] | Minimum [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Share of gross profits, percentage | 50.00% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 88,013 | $ 78,768 |
Research and development credits | 9,985 | 8,920 |
Depreciation and amortization | 10,212 | 12,608 |
Accrued expenses | 850 | 381 |
Lease liabilities | 3,816 | 4,349 |
Stock compensation | 3,856 | 4,395 |
Other, net | 234 | 181 |
Total deferred tax assets | 116,966 | 109,602 |
Less: valuation allowance | (113,826) | (105,990) |
Total deferred tax assets, net of valuation allowance | 3,140 | 3,612 |
Deferred tax liability: | ||
Right-of-use assets | (3,140) | (3,612) |
Total deferred tax liability | (3,140) | (3,612) |
Total | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | |
Income Taxes [Line Items] | |||||
Valuation allowance | $ 113,826,000 | $ 105,990,000 | |||
Net operating loss carryforwards | $ 142,200,000 | ||||
Percentage of taxable income limitation | 80.00% | ||||
Unrecognized tax benefit, income tax penalties and interest accrued | 0 | $ 0 | |||
Unrecognized tax benefits, income tax penalties and interest expense | 0 | $ 0 | $ 0 | ||
State and Local Jurisdiction [Member] | |||||
Income Taxes [Line Items] | |||||
Net operating loss carryforwards | $ 124,800,000 | ||||
Net operating loss carryforwards, expiration | will begin to expire in 2030 | ||||
Internal Revenue Service (IRS) [Member] | |||||
Income Taxes [Line Items] | |||||
Net operating loss carryforwards | $ 382,800,000 | ||||
Net operating loss carryforwards, expiration | will begin to expire in 2030 | ||||
Tax credit carryforwards | $ 12,000,000 | ||||
Tax credit carryforwards, expiration | will begin expiring in 2030 | ||||
California Franchise Tax Board [Member] | |||||
Income Taxes [Line Items] | |||||
Tax credit carryforwards | $ 5,800,000 | ||||
Tax credit carryforwards, expiration | indefinitely |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Expected Recovery of Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory rate | $ (9,393) | $ (9,382) | $ (10,578) |
State tax (net of federal benefit) | 334 | 299 | (4,383) |
Permanent items, other | 9 | 189 | (2,092) |
Stock compensation | 1,595 | 2,470 | 2,570 |
Other adjustments | 687 | 523 | 0 |
Research and development credits | (1,774) | (1,595) | (2,308) |
Uncertain tax positions | 710 | 638 | 907 |
Change in valuation allowance | 7,832 | 6,858 | 15,884 |
Provision for income taxes | $ 0 | $ 0 | $ 0 |
Income Taxes - Activity Related
Income Taxes - Activity Related to Gross Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Balance at the beginning of the year | $ 10,739 | $ 10,052 | $ 9,098 |
Adjustments related to prior year tax positions | (21) | (80) | 242 |
Increases related to current year tax positions | 796 | 767 | 712 |
Unrecognized Tax Benefits | $ 11,514 | $ 10,739 | $ 10,052 |