Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 03, 2021 | Jun. 30, 2020 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Transition Report | false | ||
Entity File Number | 001-36485 | ||
Entity Registrant Name | ARDELYX, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-1303944 | ||
Entity Address, Address Line One | 34175 ARDENWOOD BLVD. | ||
Entity Address, City or Town | FREMONT | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94555 | ||
City Area Code | 510 | ||
Local Phone Number | 745-1700 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | ARDX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 611,732,242 | ||
Entity Common Stock, Shares Outstanding | 98,680,264 | ||
Entity Central Index Key | 0001437402 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Co-Headquarter | |||
Document Information [Line Items] | |||
Entity Address, Address Line One | 400 FIFTH AVE. | ||
Entity Address, Address Line Two | SUITE 210 | ||
Entity Address, City or Town | WALTHAM | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02451 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 91,032 | $ 181,133 |
Short-term investments | 95,452 | 66,379 |
Unbilled revenue | 750 | |
Prepaid expenses and other current assets | 8,202 | 3,800 |
Total current assets | 194,686 | 252,062 |
Property and equipment, net | 1,936 | 3,436 |
Long-term investments | 2,114 | |
Right-of-use assets | 2,274 | 3,970 |
Other assets | 552 | 314 |
Total assets | 201,562 | 259,782 |
Current liabilities: | ||
Accounts payable | 5,626 | 2,187 |
Accrued compensation and benefits | 5,672 | 4,453 |
Current portion of operating lease liability | 2,117 | 2,608 |
Loan payable, current portion | 4,167 | 1,183 |
Deferred revenue | 4,177 | 4,541 |
Accrued expenses and other current liabilities | 6,657 | 7,248 |
Total current liabilities | 28,416 | 22,220 |
Operating lease liability, net of current portion | 413 | 2,076 |
Loan payable, net of current portion | 46,621 | 48,831 |
Total liabilities | 75,450 | 73,127 |
Commitments and contingencies (Note 16) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively. | ||
Common stock, $0.0001 par value; 300,000,000 shares authorized; 93,599,975 and 88,817,741 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively. | 9 | 9 |
Additional paid-in capital | 680,872 | 647,078 |
Accumulated deficit | (554,765) | (460,452) |
Accumulated other comprehensive income | (4) | 20 |
Total stockholders' equity | 126,112 | 186,655 |
Total liabilities and stockholders' equity | $ 201,562 | $ 259,782 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
BALANCE SHEETS | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 93,599,975 | 88,817,741 |
Common stock, shares outstanding | 93,599,975 | 88,817,741 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | |||
Total revenues | $ 7,571 | $ 5,281 | $ 2,607 |
Operating expenses: | |||
Cost of revenue | 145 | 600 | 466 |
Research and development | 65,053 | 71,677 | 69,373 |
General and administrative | 33,153 | 24,267 | 23,715 |
Total operating expenses | 98,351 | 96,544 | 93,554 |
Loss from operations | (90,780) | (91,263) | (90,947) |
Interest expense | (5,099) | (5,726) | (3,534) |
Other income, net | 1,568 | 2,352 | 3,187 |
Loss before provision for income taxes | (94,311) | (94,637) | (91,294) |
Provision for income taxes | 2 | 303 | 4 |
Net loss | $ (94,313) | $ (94,940) | $ (91,298) |
Net loss per common share, basic and diluted | $ (1.05) | $ (1.47) | $ (1.62) |
Shares used in computing net loss per share - basic and diluted | 89,582,138 | 64,478,066 | 56,219,919 |
Comprehensive loss: | |||
Net loss | $ (94,313) | $ (94,940) | $ (91,298) |
Unrealized (losses) gains on available-for-sale securities | (24) | 58 | 9 |
Comprehensive loss | (94,337) | (94,882) | (91,289) |
Collaborative development | |||
Revenues: | |||
Total revenues | 5,364 | 459 | |
Product supply | |||
Revenues: | |||
Total revenues | 1,501 | 322 | 287 |
Licensing | |||
Revenues: | |||
Total revenues | $ 706 | $ 4,500 | $ 2,320 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common StockPrivate Placement | Common StockUnderwriters' Option | Common StockAt-the-Market offering | Common Stock | Additional Paid-In CapitalPrivate Placement | Additional Paid-In CapitalUnderwriters' Option | Additional Paid-In CapitalAt-the-Market offering | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income | Private Placement | Underwriters' Option | At-the-Market offering | Total |
Balance, amount at Dec. 31, 2017 | $ 5 | $ 417,568 | $ (278,214) | $ (47) | $ 139,312 | |||||||||
Balance, shares at Dec. 31, 2017 | 47,534,979 | |||||||||||||
Issuance of common stock under employee stock purchase plan, amount | 491 | 491 | ||||||||||||
Issuance of common stock under employee stock purchase plan, shares | 120,959 | |||||||||||||
Issuance of common stock for services, amount | 303 | $ 303 | ||||||||||||
Issuance of common stock for services, shares | 75,183 | 75,000 | ||||||||||||
Issuance of common stock upon exercise of options, amount | $ 1 | 53,769 | $ 53,770 | |||||||||||
Issuance of common stock upon exercise of options, shares | 14,375,000 | |||||||||||||
Issuance of common stock upon vesting of restricted stock units, shares | 410,506 | |||||||||||||
Stock-based compensation | 9,226 | 9,226 | ||||||||||||
Unrealized (losses) gains on available-for-sale securities | 9 | 9 | ||||||||||||
Net loss | (91,298) | (91,298) | ||||||||||||
Balance, amount at Dec. 31, 2018 | $ 6 | 481,357 | (365,512) | (38) | 115,813 | |||||||||
Balance, shares at Dec. 31, 2018 | 62,516,627 | |||||||||||||
Adoption of ASU No. 2014-09 on January 1, 2018 | 4,000 | 4,000 | ||||||||||||
Issuance of common stock under employee stock purchase plan, amount | 396 | 396 | ||||||||||||
Issuance of common stock under employee stock purchase plan, shares | 160,744 | |||||||||||||
Issuance of common stock for services, amount | 312 | $ 312 | ||||||||||||
Issuance of common stock for services, shares | 113,136 | 113,000 | ||||||||||||
Issuance of common stock upon exercise of options, amount | 178 | $ 178 | ||||||||||||
Issuance of common stock upon exercise of options, shares | 68,062 | |||||||||||||
Stock-based compensation | 9,936 | 9,936 | ||||||||||||
Unrealized (losses) gains on available-for-sale securities | 58 | 58 | ||||||||||||
Net loss | (94,940) | (94,940) | ||||||||||||
Issuance of common stock, value | $ 3 | $ 19,975 | $ 134,924 | $ 19,975 | $ 134,927 | |||||||||
Issuance of common stock, shares | 2,873,563 | 23,000,000 | ||||||||||||
Balance, amount at Dec. 31, 2019 | $ 9 | 647,078 | (460,452) | 20 | 186,655 | |||||||||
Balance, shares at Dec. 31, 2019 | 88,817,741 | |||||||||||||
Issuance of common stock under employee stock purchase plan, amount | 834 | 834 | ||||||||||||
Issuance of common stock under employee stock purchase plan, shares | 169,931 | |||||||||||||
Issuance of common stock for services, amount | 310 | $ 310 | ||||||||||||
Issuance of common stock for services, shares | 42,403 | 42,403 | ||||||||||||
Issuance of common stock upon exercise of options, amount | 1,020 | $ 1,020 | ||||||||||||
Issuance of common stock upon exercise of options, shares | 445,942 | 445,942 | ||||||||||||
Issuance of common stock upon vesting of restricted stock units, shares | 866,528 | |||||||||||||
Stock-based compensation | 10,583 | $ 10,583 | ||||||||||||
Unrealized (losses) gains on available-for-sale securities | (24) | (24) | ||||||||||||
Net loss | (94,313) | (94,313) | ||||||||||||
Issuance of common stock, value | $ 21,047 | $ 21,047 | ||||||||||||
Issuance of common stock, shares | 3,257,430 | |||||||||||||
Balance, amount at Dec. 31, 2020 | $ 9 | $ 680,872 | $ (554,765) | $ (4) | $ 126,112 | |||||||||
Balance, shares at Dec. 31, 2020 | 93,599,975 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities | |||
Net loss | $ (94,313) | $ (94,940) | $ (91,298) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 1,824 | 2,501 | 2,678 |
Amortization of deferred financing costs | 496 | 670 | 236 |
Amortization of deferred compensation for services | 313 | 309 | 253 |
Amortization of premium on investment securities | (92) | (698) | (1,136) |
Non-cash lease expense | 2,147 | 1,839 | |
Stock-based compensation | 10,583 | 9,936 | 9,226 |
Change in derivative liabilities | 407 | 436 | 111 |
Non-cash interest associated with debt discount accretion | 413 | 478 | 303 |
Changes in operating assets and liabilities: | |||
Unbilled revenue | 750 | 4,250 | |
Accounts receivable | 85 | 10,711 | |
Prepaid expenses and other assets | (4,653) | 93 | 525 |
Accounts payable | 3,439 | 39 | (2,730) |
Accrued compensation and benefits | 1,219 | 1,730 | (506) |
Lease liabilities | (2,604) | (1,892) | |
Accrued and other liabilities | (1,000) | (5,861) | 1,353 |
Deferred revenue | (364) | 4,541 | |
Net cash used in operating activities | (81,435) | (76,484) | (70,274) |
Investing activities | |||
Proceeds from maturities and redemptions of investments | 119,734 | 126,369 | 139,450 |
Purchases of investments | (150,852) | (102,671) | (169,033) |
Purchases of property and equipment | (324) | (325) | (311) |
Net cash (used in) provided by investing activities | (31,442) | 23,373 | (29,894) |
Financing activities | |||
Proceeds from underwritten public offering, net of issuance costs | 134,927 | 53,770 | |
Proceeds from issuance of common stock upon private placement, net of issuance costs | 19,975 | ||
Proceeds from issuance of common stock under equity incentive and stock purchase plans | 1,854 | 574 | 491 |
Payments for loan payable, net of issuance costs | (125) | ||
Proceeds from loan payable, net of issuance costs | 49,292 | ||
Net cash provided by financing activities | 22,776 | 155,476 | 103,553 |
Net (decrease) increase in cash and cash equivalents | (90,101) | 102,365 | 3,385 |
Cash and cash equivalents at beginning of period | 181,133 | 78,768 | 75,383 |
Cash and cash equivalents at end of period | 91,032 | 181,133 | 78,768 |
Supplementary disclosure of cash flow information: | |||
Cash paid for interest | 4,200 | 4,920 | 3,071 |
Cash paid for income taxes | 1 | 2 | 4 |
Supplementary disclosure of non-cash activities: | |||
Right-of-use assets obtained in exchange for lease obligations | 450 | 5,810 | |
Issuance of common stock for services | 310 | $ 312 | 303 |
Issuance of derivative in connection with issuance of loan payable | $ 546 | ||
At-the-Market offering | |||
Financing activities | |||
Proceeds from issuance of common stock in At-the-market offering, net of issuance costs | $ 21,047 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
Organization and Basis of Presentation | |
Organization and Basis of Presentation | 1. ORGANIZATION AND BASIS OF PRESENTATION Ardelyx, Inc. (the “Company,” “we,” “us” or “our”) is a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with kidney and cardiorenal diseases. The Company operates in one business segment, which is the research and development of biopharmaceutical products. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Prior Period Errors In connection with our review of our financial statements as of and for the six months ended June 30, 2019, we corrected errors related to the accounting for clinical trial accruals that had resulted in an overstatement of research and development expenses during the year ended December 31, 2018. Specifically, management concluded that the Company’s research and development expenses recorded during the year ended December 31, 2018 had been overstated by $3.6 million and that the Company’s accrued expenses and other current liabilities as of December 31, 2018 2019 Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to recognition of revenue, clinical trial accruals, contract manufacturing accruals, fair value of assets and liabilities, income taxes and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could materially differ from those estimates. Liquidity As of December 31, 2020, the Company had cash and investments of approximately $188.6 million, which include net proceeds of approximately $21.0 million from the 2020 At-the-Market Offerings, $134.9 million from the 2019 Offering, and $20.0 million received in connection with the 2019 Private Placement, respectively, as defined and discussed in Note 7. We believe our current available cash and investments will be sufficient to fund our planned expenditures and meet the Company’s obligations for at least 12 months following March 8, 2021, which is the date that the financial statements are being issued. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity date of 90 days or less on the date of purchase to be cash equivalents. Short-Term Investments Short-term investments consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than one year, from the date of acquisition. Short-term investments are carried at fair value based upon quoted market prices. Unrealized gains and losses on available-for-sale securities are excluded from earnings and are reported as a component of accumulated other comprehensive loss. The cost of available-for-sale securities sold is based on the specific-identification method. Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company is exposed to credit risks in the event of default by the counterparties to the extent of the amount recorded in its balance sheet. Cash, cash equivalents and short-term investments are invested through banks and other financial institutions in the U.S. Foreign Currency and Forward Contracts The Company manages its foreign currency exposures with the use of foreign currency purchases as well as currency spot and forward contracts. The Company primarily conducts its business in U.S. dollars; however, a portion of the Company’s expense and capital activities are transacted in foreign currencies which are subject to exchange rate fluctuations that can affect cash or earnings. The Company has been in a loss position and therefore its primary objective is to conserve and manage cash. There are generally two methods by which the Company manages the cash flow risk of foreign exchange fluctuations when a contract is signed (i) it can purchase the foreign funds, in full or in part, upon the execution of the contract, or (ii) it can obtain the right to purchase such funds, in full or in part, at the execution of the contract, i.e., obtain a forward contract from an appropriate bank, that can be exercised to obtain the currency of interest at a particular point in time. The derivative instruments that the Company uses to hedge the exposure shall generally not be designated as cash flow hedges, and as a result, changes in their fair value will be recorded in other income (expense), net, in the Company's statements of operations and comprehensive loss. The fair values of forward foreign currency exchange contracts are estimated using current exchange rates and interest rates and the current creditworthiness of the counterparties is taken into consideration. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, with ranges generally from three Impairment of Long-Lived Assets The carrying value of long-lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than the asset’s carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. For the years ending December 31, 2020, 2019 and 2018 there have been no impairment losses. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Revenue Recognition On January 1, 2018 the Company adopted the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) and related amendments The Company generates revenue primarily from research and collaboration and license agreements with customers. Goods and services in the agreements may include the grant of licenses for the use of the Company’s technology, the provision of services associated with the research and development of product candidates, manufacturing services, and participation in joint steering committees. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; research, development, regulatory and commercial milestone payments; reimbursement of research and development services; option payments; reimbursement of certain costs; payments for manufacturing supply services; and future royalties on net sales of licensed products. When two or more contracts are entered into with the same customer at or near the same time, the Company evaluates the contracts to determine whether the contracts should be accounted for as a single arrangement. Contracts are combined and accounted for as a single arrangement if one or more of the following criteria are met: (i) the contracts are negotiated as a package with a single commercial objective; (ii) the amount of consideration to be paid in one contract depends on the price or performance of the other contract; or (iii) the goods or services promised in the contracts (or some goods or services promised in each of the contracts) are a single performance obligation. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, management performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraints on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for contracts with customers, the Company develops assumptions that require judgment to determine whether promised goods and services represent distinct performance obligations and the standalone selling price for each performance obligation identified in the contract. This evaluation is subjective and requires the Company to make judgments about the promised goods and services and whether those goods and services are separable from other aspects of the contract. Further, determining the standalone selling price for performance obligations requires significant judgment, and when an observable price of a promised good or service is not readily available, the Company considers relevant assumptions to estimate the standalone selling price, including, as applicable, market conditions, development timelines, probabilities of technical and regulatory success, reimbursement rates for personnel costs, forecasted revenues, potential limitations to the selling price of the product and discount rates. The Company applies judgment in determining whether a combined performance obligation is satisfied at a point in time or over time, and, if over time, concluding upon the appropriate method of measuring progress to be applied for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, as estimates related to the measure of progress change, related revenue recognition is adjusted accordingly. Changes in the Company’s estimated measure of progress are accounted for prospectively as a change in accounting estimate. The Company recognizes collaboration revenue by measuring the progress toward complete satisfaction of the performance obligation using an input measure. In order to recognize revenue over the research and development period, the Company measures actual costs incurred to date compared to the overall total expected costs to satisfy the performance obligation. Revenues are recognized as the program costs are incurred. The Company will re-evaluate the estimate of expected costs to satisfy the performance obligation each reporting period and make adjustments for any significant changes. Amounts received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to receipt are recorded as contract assets in the Company's balance sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer. Milestone Payments: Manufacturing supply services: Royalties: Licenses of intellectual property: Options: a material right (i.e., an optional good or service offered for free or at a discount) to the customer. If the customer options represent a material right, the material right is treated as a separate performance obligation at the outset of the arrangement. The Company allocates the transaction price to material rights based on the standalone selling price, and revenue is recognized when or as the future goods or services are transferred or when the option expires. Customer options that are not material rights do not give rise to a separate performance obligation, and as such, the additional consideration that would result from a customer exercising an option in the future is not included in the transaction price for the current contract. Instead, the option is deemed a marketing offer, and additional option fee payments are recognized or being recognized as revenue when the licensee exercises the option. The exercise of an option that does not represent a material right is treated as a separate contract for accounting purposes. Contract modifications: The Company receives payments from its licensees as established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Where applicable, amounts are recorded as unbilled revenue when the Company’s right to consideration is unconditional. The Company does not assess whether a contract with a customer has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, costs associated with clinical trials, costs related to pre-commercialization manufacturing activities such as manufacturing process validation activities and the manufacturing of clinical drug supply, nonclinical research and development activities, regulatory activities, research-related overhead expenses and fees paid to external service providers and contract research and manufacturing organizations that conduct certain research and development activities on behalf of the Company. Accrued Research and Development Expenses The Company is required to estimate its accrued expenses at the end of each reporting period. This process involves reviewing open contracts and purchase orders, communicating with Company personnel to identify services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs. The majority of the Company’s service providers submit invoices in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to: ● contract research organizations, or CROs, in connection with clinical studies; ● investigative sites in connection with clinical studies; ● vendors related to product manufacturing, development and distribution of clinical supplies; and ● vendors in connection with preclinical development activities. The Company records expenses related to clinical studies and manufacturing development activities based on its estimates of the services received and efforts expended pursuant to contracts with multiple CROs and manufacturing vendors that conduct and manage these activities on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed, enrollment of subjects, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the Company’s estimate, the Company will adjust the accrued or prepaid expense balance accordingly. Stock-Based Compensation The Company recognizes compensation expense for all stock-based payment awards made to employees, nonemployees and directors based on estimated fair values. For employee and nonemployee stock options, the Company determines the grant date fair value of the awards using the Black-Scholes option-pricing model and generally recognizes the fair value as stock-based compensation expense on a straight-line basis over the vesting period of the respective awards. For restricted stock and performance-based restricted stock, to the extent they are probable, the compensation cost for these awards is based on the closing price of the Company’s common stock on the date of grant and recognized as compensation expense on a straight-line basis over the requisite service period. Stock-based compensation expense is based on the value of the portion of stock-based payment awards that is ultimately expected to vest. As such, the Company’s stock-based compensation is reduced for the estimated forfeitures at the date of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Derivatives and Hedging Activities The Company accounts for its derivative instruments as either assets or liabilities on the balance sheet and measures them at fair value. Derivatives are adjusted to fair value through other income (expense), net in the statements of operations and comprehensive loss. Leases The Company determines if an arrangement is a lease at the inception of the arrangement. Operating leases are included in right-of-use assets, current portion of operating lease liability, and operating lease liability, net of current portion in our balance sheets. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected not to separate lease and non-lease components, such as common area maintenance charges, and instead it accounts for these as a single lease component. Comprehensive Loss Comprehensive loss is composed of two components: net loss and other comprehensive income (loss). Other comprehensive income (loss) refers to gains and losses that are recorded as an element of stockholders’ equity but are excluded from net loss. Net Loss per Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potential common shares. Diluted net loss per common share in the periods presented is the same as basic net loss per common share, since the effects of potentially dilutive securities are antidilutive due to the net loss for all periods presented. Recent Accounting Pronouncements New Accounting Pronouncements - Recently Adopted In December 2019, as part of its initiative to reduce complexity in the accounting standards, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 Revenue from Contracts with Customers In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework— Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU No. 2018-15, Intangibles (Topic 350): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Cash and Investments
Cash and Investments | 12 Months Ended |
Dec. 31, 2020 | |
Cash and Investments | |
Cash and Investments | 3. CASH AND INVESTMENTS Securities classified as cash and investments as of December 31, 2020 and December 31, 2019 are summarized below (in thousands). Estimated fair value is based on quoted market prices for these investments. December 31, 2020 Gross Unrealized Amortized Cost Gains Losses Fair Value Cash and cash equivalents: Money market funds $ 88,151 $ — $ — $ 88,151 Commercial paper 2,100 — — 2,100 Cash 781 — — 781 Total cash and cash equivalents 91,032 — — 91,032 Short-term investments: Commercial paper $ 60,631 $ 2 $ (4) $ 60,629 Corporate bonds 24,547 3 (6) 24,544 U.S. government-sponsored agency bonds 9,277 2 — 9,279 U.S. treasury notes 1,000 — — 1,000 Total short-term investments 95,455 7 (10) 95,452 Long-term investments: Corporate bonds $ 2,115 $ — $ (1) $ 2,114 Total cash equivalents and investments $ 188,602 $ 7 $ (11) $ 188,598 December 31, 2019 Gross Unrealized Amortized Cost Gains Losses Fair Value Cash and cash equivalents: Money market funds $ 147,208 $ — $ — $ 147,208 Commercial paper 19,357 3 — 19,360 Corporate bonds 11,441 — — 11,441 Cash 3,124 — — 3,124 Total cash and cash equivalents 181,130 3 — 181,133 Short-term investments Commercial paper $ 36,667 $ 14 $ — $ 36,681 Corporate bonds 21,690 6 (3) 21,693 Asset-backed securities 8,005 — — 8,005 Total short-term investments 66,362 20 (3) 66,379 Total cash equivalents and short-term investments $ 247,492 $ 23 $ (3) $ 247,512 Cash equivalents consist of money market funds and other debt securities with original maturities of three months or less at the time of purchase, and the carrying amount is a reasonable approximation of fair value. The Company invests its cash in high quality securities of financial and commercial institutions. These securities are carried at fair value, which is based on readily available market information, with unrealized gains and losses included in accumulated other comprehensive income (loss) within stockholders’ equity on the Company’s balance sheets. The Company uses the specific identification method to determine the amount of realized gains or losses on sales of marketable securities. Realized gains or losses have been insignificant and are included in other income (expense), net, in the statement of operations. As of December 31, 2020, the Company held both short- and long-term investments. All short-term available-for-sale securities held as of December 31, 2020 and 2019, had contractual maturities of less than one year. The long-term securities held as of December 31, 2020 had contractual maturities greater than one year. The Company’s available-for-sale securities are subject to a periodic impairment review. The Company considers a debt security to be impaired when its fair value is less than its carrying cost, in which case the Company would further review the investment to determine whether it is other-than-temporarily impaired. When the Company evaluates an investment for other-than-temporary impairment, the Company reviews factors such as the length of time and extent to which fair value has been below cost basis, the financial condition of the issuer and any changes thereto, intent to sell, and whether it is more likely than not the Company will be required to sell the investment before the recovery of its cost basis. If an investment is other-than-temporarily impaired, the Company writes it down through the statement of operations to its fair value and establishes that value as a new cost basis for the investment. The Company did not identify any of its available-for-sale securities as other-than-temporarily impaired in any of the periods presented. As of December 31, 2020 and 2019, no investment was in a continuous unrealized loss position for more than one year and the Company believes that it is more likely than not that the investments will be held until maturity or a forecasted recovery of fair value. As of December 31, 2020, the amortized cost and estimated fair value of available-for-sale debt securities by contractual maturity were as follows (in thousands): Amortized Cost Fair Value Due in one year or less $ 95,455 $ 95,452 Due in one to two years 2,115 2,114 Total $ 97,570 $ 97,566 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 4. FAIR VALUE MEASUREMENTS Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows: Level 1 – Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by the Company at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. treasuries and trading securities with quoted prices on active markets. Level 2 – Valuations based on inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Examples of assets and liabilities utilizing Level 2 inputs are corporate bonds, commercial paper, certificates of deposit and over-the-counter derivatives. Level 3 – Valuations based on unobservable inputs in which there is little or no market data, which require the Company to develop its own assumptions. The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy (in thousands): December 31, 2020 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 88,151 $ 88,151 $ — $ — Commercial paper 62,729 — 62,729 — Corporate bonds 26,658 — 26,658 — U.S. government-sponsored agency bonds 9,279 — 9,279 U.S. treasury notes 1,000 — 1,000 — Total $ 187,817 $ 88,151 $ 99,666 $ — Liabilities: Derivative liability for Exit Fee $ 1,376 $ — $ — $ 1,376 Total $ 1,376 $ — $ — $ 1,376 December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 147,208 $ 147,208 $ — $ — Commercial paper 56,041 — 56,041 — Corporate bonds 33,134 — 33,134 — Asset-backed securities 8,005 — 8,005 — Total $ 244,388 $ 147,208 $ 97,180 $ — Liabilities: Derivative liability for Exit Fee $ 969 $ — $ — $ 969 Total $ 969 $ — $ — $ 969 Where quoted prices are available in an active market, securities are classified as Level 1. The Company classifies money market funds, U.S. treasury securities and U.S. treasury notes as Level 1. When quoted market prices are not available for the specific security, the Company estimates fair value by using benchmark yields, reported trades, broker/dealer quotes and issuer spreads. The Company classifies corporate bonds, commercial paper, asset-backed securities and foreign currency derivative contracts as Level 2. In certain cases, where there is limited activity or less transparency around inputs to valuation, securities or derivative liabilities such as the Exit Fee, as defined and discussed in Note 6, are classified as Level 3. The carrying amounts reflected in the balance sheets for cash equivalents, short-term investments, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values at both December 31, 2020 and December 31, 2019, due to their short-term nature. Fair Value of Debt The interest rate of the Company’s term loan facility approximates the rate at which the Company could obtain alternative financing. Therefore, the carrying amount of the term loan facility approximated its fair value at December 31, 2020 and 2019. |
Derivative Liability
Derivative Liability | 12 Months Ended |
Dec. 31, 2020 | |
Derivative Liability | |
Derivative Liability | 5. DERIVATIVE LIABILITY Exit Fee In May 2018, in connection with entering into the Loan Agreement, as defined and discussed in Note 6, the Company entered into an agreement pursuant to which the Company agreed to pay $1.5 million in cash, or the Exit Fee, upon any change of control transaction in respect of the Company or if the Company obtains both (i) FDA approval of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis and (ii) FDA approval of tenapanor for the treatment of patients with irritable bowel syndrome with constipation, or IBS-C, which was obtained on September 12, 2019 when the FDA approved IBSRELA® (tenapanor), a 50 mg, twice daily oral pill for the treatment of IBS-C, in adults (the “Exit Fee Agreement”). Notwithstanding the prepayment or termination of the Term Loan, the Company’s obligation to pay the Exit Fee will expire on May 16, 2028. The Company concluded that the Exit Fee is a freestanding derivative which should be accounted for at fair value on a recurring basis. The estimated fair value of the Exit Fee is recorded as a derivative liability and included in accrued expense and other current liabilities on the accompanying balance sheets. The fair value of the derivative liability was determined using a discounted cash flow analysis and is classified as a Level 3 measurement within the fair value hierarchy since the Company’s valuation utilized significant unobservable inputs. Specifically, the key assumptions included in the calculation of the estimated fair value of the derivative instrument include: i) the Company’s estimates of both the probability and timing of a potential $1.5 million payment to Solar Capital Ltd. and Western Alliance Bank as a result of the FDA approvals, and ii) a discount rate which was derived from the Company's estimated cost of debt, adjusted with current LIBOR. Generally, increases or decreases in the probability of occurrence would result in a directionally similar impact in the fair value measurement of the derivative instrument and it is estimated that a 10% increase ( decrease no more than Changes in the fair value of recurring measurements included in Level 3 of the fair value hierarchy are presented as other income (expense), net in the Company's statements of operations and were as follows for the years ended December 31, 2020, 2019 and 2018 (in thousands): 2020 2019 2018 Fair value of Exit Fee derivative liability at January 1 $ 969 $ 533 — Change in estimated fair value of derivative liability 407 436 533 Fair value of Exit Fee derivative liability at December 31 $ 1,376 $ 969 $ 533 |
Borrowings
Borrowings | 12 Months Ended |
Dec. 31, 2020 | |
Borrowings | |
Borrowings | 6. BORROWINGS Solar Capital and Western Alliance Bank Loan Agreement On May 16, 2018, the Company entered into a loan and security agreement, or the Loan Agreement, with Solar Capital Ltd. and Western Alliance Bank (“the Lenders”). The Loan Agreement provides for a $50.0 million term loan facility with a maturity date of November 1, 2022 (”the Term Loan”). The full amount of the Tern Loan was funded on May 16, 2018. The Company received net proceeds from the loan of approximately $49.3 million, after deducting the closing fee, legal expenses and issuance costs. On October 9, 2020, the Company and the Lenders entered into an amendment to the Loan Agreement (“the 2020 Amendment”) to extend the date through which the Company is permitted to make interest-only payments on the Term Loan by twelve months to December 1, 2021 subject to the repayment terms noted below. Borrowings under the Term Loan bear interest at a floating per annum rate equal to 7.45% plus the one-month The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including restrictions on payment of dividends for our common stock. As of December 31, 2020, the Company was in compliance with all of the covenants set forth in the Loan Agreement. In addition, the Loan Agreement contains customary events of default that entitle the Lender to cause the Company’s indebtedness under the Loan Agreement to become immediately due and payable, and to exercise remedies against the Company and the collateral securing the Term Loan, including its cash. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 4.0% per annum will apply to all obligations owed under the Loan Agreement. As of December 31, 2020, to the Company’s knowledge, there were no facts or circumstances in existence that would give rise to an event of default. As of December 31, 2020, the Company’s future debt payment obligations towards the Term Loan principal and final fee, excluding interest payments and the Exit Fee are as follows (in thousands): 2021 $ 4,167 2022 48,308 Total repayment obligations $ 52,475 Less: Unamortized discount and debt issuance costs (518) Less: Unaccreted value of final fee (1,169) Loan payable 50,788 Less: Loan payable, current portion (4,167) Loan payable, net of current portion $ 46,621 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity | |
Stockholders' Equity | 7. STOCKHOLDERS’ EQUITY In July 2020, the Company filed a Form S-3 registration statement, which became effective in August 2020, containing (i) a base prospectus for the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $250.0 million of the Company’s common stock, preferred stock, debt securities, warrants and/or units, from time to time in one or more offerings; and (ii) a prospectus supplement for the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $100.0 million of its common stock that may be issued and sold, from time to time, under an Open Market Sales Agreement with Jefferies LLC, as sales agent, deemed to be “at the market offerings.” As of December 31, 2020, we had sold 3.3 million shares of our common stock for aggregate gross proceeds of $21.7 million at a weighted average price of $6.65 per share under the Open Market Sales Agreement. shares of our common stock for aggregate gross proceeds of $56.7 million at a weighted average sales price of approximately $6.91 per share Pursuant to the Open Market Sales Agreement, Jefferies, as sales agent, receives a commission of up to 3.0% of the gross sales price for shares of common stock sold under the Open Market Sales Agreement. On December 9, 2019, the Company completed an underwritten public offering of 20.0 million shares of common stock at a price of $6.25 per share before underwriting discounts and commissions, or the 2019 Offering. In connection with the 2019 Offering, the Company entered into an underwriting agreement, or the 2019 Underwriting Agreement, with Citigroup Global Markets Inc., Cowen and Company LLC, SVB Leerink LLC and Piper Jaffray & Co., or collectively the 2019 Underwriters, pursuant to which the Company granted to the 2019 Underwriters a 30-day option to purchase up to an additional 3.0 million shares of the Company’s common stock, or the 2019 Overallotment. The Company completed the sale of 23.0 million shares, inclusive of the 2019 Overallotment, to the 2019 Underwriters and that sale resulted in the receipt by the Company of aggregate gross proceeds of approximately $143.8 million, less underwriting discounts, commissions and offering expenses totaling approximately $8.9 million, which resulted in net proceeds of approximately $134.9 million. On November 22, 2019, the Company and KKC entered into a stock purchase agreement, pursuant to which the Company sold an aggregate of approximately 2.9 million shares of its common stock at $6.96 per share for net proceeds of approximately $20.0 million, or the Private Placement. The Private Placement closed on November 25, 2019. On May 25, 2018, the Company completed an underwritten public offering of 12.5 million shares of common stock at a price of $4.00 per share before underwriting discounts and commissions, or the 2018 Offering. In connection with the 2018 Offering, the Company entered into an underwriting agreement, or the 2018 Underwriting Agreement, with Jefferies LLC and SVB Leerink (formerly known as Leerink Partners LLC) (together the “2018 Underwriters”) pursuant to which the Company granted to the 2018 Underwriters a 30-day option to purchase up to an additional 1.9 million shares of the Company’s common stock, or the 2018 Overallotment. The Company completed the sale of 14.4 million shares, inclusive of the 2018 Overallotment, to the 2018 Underwriters, and that sale resulted in the receipt by the Company of aggregate gross proceeds of approximately $57.5 million, less underwriting discounts, commissions and offering expenses totaling approximately $3.7 million, which resulted in net proceeds of approximately $53.8 million. In June 2015, the Company sold and issued warrants to purchase 2.2 million shares of common stock. The purchase price for the warrants was $0.125 per warrant. The warrants were exercisable for an exercise price of $13.91 per share at any time prior to the earlier of (i) 5 years from the date of issuance or (ii) certain changes in control of the Company. In June 2020, the warrants expired with none of the warrants exercised. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2020 | |
Equity Incentive Plans | |
Equity Incentive Plans | 8. EQUITY INCENTIVE PLANS 2008 Plan The Company granted options under its 2008 Stock Incentive Plan (the “2008 Plan”) until June 2014 when it was terminated as to future awards, although it continues to govern the terms of options that remain outstanding under the 2008 Plan. The 2008 Plan provided for the granting of incentive and non-qualified stock options, and stock purchase rights to employees, directors and consultants at the discretion of the Board of Directors. Stock options granted generally vest over a period of four years from the date of grant. In connection with the Board of Directors and stockholders’ approval of the 2014 Plan, all remaining shares available for future award under the 2008 Plan were transferred to 2014 Plan, and the 2008 Plan was terminated. 2014 Plan The 2014 Equity Incentive Award Plan (the “2014 Plan”) became effective on June 18, 2014. Under the 2014 Plan, 1,419,328 shares of common stock were initially reserved for issuance pursuant to a variety of stock-based compensation awards, including stock options, stock appreciation rights, or SARs, restricted stock awards, service-based restricted stock unit (“RSU”) awards, performance-based restricted stock unit (“PRSU”) awards, deferred stock awards, deferred stock unit awards, dividend equivalent awards, stock payment awards and performance awards. In addition, 35 thousand shares that had been available for future awards under the 2008 Plan as of June 18, 2014, were added to the initial reserve available under the 2014 Plan, bringing the total reserve upon the effective date of the 2014 Plan to 1.5 million shares. The number of shares initially reserved for issuance or transfer pursuant to awards under the 2014 Plan will be increased by (i) the number of shares represented by awards outstanding under 2008 Plan on June 18, 2014, that are either forfeited or lapse unexercised or that are repurchased for the original purchase price thereof, up to a maximum of 1.2 million shares, and (ii) if approved by the Administrator of the 2014 Plan, an annual increase on the first day of each fiscal year ending in 2024 equal to the lesser of (A) four percent (4.0%) of the shares of stock outstanding (on an as converted basis) on the last day of the immediately preceding fiscal year and (B) such smaller number of shares of stock as determined by our board of directors; provided, however, that no more than 10.7 million shares of stock may be issued upon the exercise of incentive stock options. 2016 Plan In November 2016, the Company’s board of directors approved the 2016 Employment Commencement Incentive Plan (the “Inducement Plan”) under which 1.0 million shares were reserved. As of December 31, 2020, 0.4 million shares of the Company’s common stock were subject to inducement grants that were issued pursuant to the Inducement Plan. Stock Plan Activity The following table summarizes activity under the 2008 Plan and the 2014 Plan, including grants issued to nonemployees, in the year ended December 31, 2020: Options Issued and Outstanding Weighted Weighted-Average Average Shares Available Exercise Price per Remaining Aggregate for Grant Number of Shares Share Contractual Term Intrinsic Value (in Years) (in thousands) Balance at December 31, 2019 1,196,746 7,272,768 $ 6.55 Options authorized 3,552,709 — $ — Options granted (3,727,947) 3,727,947 $ 6.89 Options exercised — (445,942) $ 2.29 Options canceled 764,724 (764,724) $ 8.03 Issuance of common stock for services (42,403) — — Forfeitures of PRSUs granted in prior years 13,229 — — Balance at December 31, 2020 1,757,058 9,790,049 $ 6.76 7.44 $ 12,797 Vested and expected to vest at December 31, 2020 9,790,049 $ 6.76 7.44 $ 12,797 Exercisable at December 31, 2020 5,230,640 $ 7.53 6.23 $ 7,765 The aggregate intrinsic value represents the difference between the total pre-tax value (i.e., the difference between the Company’s stock price and the exercise price) of stock options outstanding as of December 31, 2020, based on the Company’s common stock closing price of $6.47 per share, which would have been received by the option holders had all their in-the-money options been exercised as of that date. The intrinsic value of options exercised during the years ended December 31, 2020, 2019 and 2018, was $2.7 million, $0.4 million, and zero, respectively. The weighted-average grant-date estimated fair value of options granted during the years ended December 31, 2020, 2019 and 2018 was $4.82, $1.79 and $4.29 per share, respectively. The estimated grant date fair value of employee stock options was calculated using the Black-Scholes option-pricing model, based on the following weighted-average assumptions: Year Ended December 31, 2020 Expected term (years) 6.00 Expected volatility 83 % Risk-free interest rate 1.07 % Dividend yield — % Expected Term Expected Volatility used the historic volatility of its own stock over the retrospective period corresponding to the expected remaining term of the options, or the period since its shares were first quoted on The Nasdaq Global Market, if that is shorter, to compute its . Risk-Free Interest Rate Dividend Yield Restricted Stock Units The following table summarizes restricted stock unit activity under the 2014 Plan in the year ended December 31, 2020, and includes restricted stock units with time or service-based vesting and those restricted stock units with performance-based vesting: Weighted- Weighted-Average Average Grant Number of Grant Date Fair Number of Date Fair Value RSUs Value Per Share PRSUs Per Share Non-vested restricted stock units at December 31, 2019 — $ — 849,757 $ 4.30 Granted 158,626 $ 5.64 30,000 $ 7.58 Vested — $ — (866,528) $ 4.41 Forfeited — $ — (13,229) $ 4.30 Non-vested restricted stock units at December 31, 2020 158,626 $ 5.64 — $ — In July 2018, the Company granted 0.9 million PRSUs to its employees that vest upon the achievement of certain performance conditions, subject to the employees’ continued service relationship with the Company through the achievement date. During 2020, the Company granted an additional 30 thousand PRSUs subject to the same performance conditions. All 0.9 million of these PRSUs vested in September 2020. None of these PRSUs vested during the years ended December 31, 2019 or 2018. The Company recognized $1.2 million and zero of related expense during the year ended December 31, 2020 and 2019, respectively. The Company recognized $30 thousand, $0.3 million and $0.9 million of RSU related expense during the year ended December 31, 2020, 2019 and 2018, respectively. The total estimated fair value of RSUs vested during the years ended December 31, 2020, 2019 and 2018 was zero, $0.2 million and $0.6 million, respectively. Issuance of Common Stock for Services During the years ended December 31, 2020, 2019 and 2018, the Company issued approximately 42 thousand, 113 thousand and 75 thousand shares, respectively, of common stock to members of the board of directors who elected to receive stock in lieu of their cash fees under the Company’s Non-Employee Director Compensation Program. The shares issued during the years ended December 31, 2020, 2019 and 2018 were valued at $0.3 million for each year, respectively, based on the fair value of the common stock on the date of grant. Employee Stock Purchase Plan The Company adopted the 2014 Employee Stock Purchase Plan (“ESPP”) and initially reserved approximately 0.2 million shares of common stock as of its effective date of June 18, 2014. If approved by the Administrator of the ESPP, on the first day of each calendar year, ending in 2024, the number of shares in the reserve will increase by an amount equal to the lesser of (i) one percent (1.0%) of the shares of common stock outstanding on the last day of the immediately preceding fiscal year and (ii) such number of shares of common stock as determined by the board of directors; provided, however, no more than 2,230,374 shares of our common stock may be issued under the ESPP. The following table summarizes ESPP activity in the year ended December 31, 2020: Shares Available Number of Shares Purchase Price for Grant Purchased per Share Gross Proceeds (in thousands) Balance at December 31, 2019 519,578 491,680 Shares purchased (169,931) 169,931 $ 4.91 $ 834 Balance at December 31, 2020 349,647 661,611 The following table illustrates the weighted-average assumptions for the Black-Scholes option-pricing model used in determining the fair value of ESPP purchase rights granted to employees: Year Ended December 31, 2020 Expected term (years) 0.5 Expected volatility 79.4 % Risk-free interest rate 0.48 % Dividend yield — % Stock-based Compensation Total stock-based compensation recognized was as follows (in thousands): Year Ended December 31, 2020 2019 2018 Research and development $ 4,061 $ 4,104 $ 3,666 General and administrative 6,522 5,832 5,560 Total $ 10,583 $ 9,936 $ 9,226 At December 31, 2020, the Company had total unrecognized stock-based compensation expense, net of estimated forfeitures, of the following (dollars in thousands): At December 31, 2020 Unrecognized Compensation Expense Average Remaining Vesting Period (Years) Stock options grant $ 17,662 2.8 RSU grants $ 860 3.9 ESPP $ 108 0.1 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
Property and Equipment | 9. PROPERTY AND EQUIPMENT Property and equipment consist of the following (in thousands): December 31, 2020 2019 Laboratory equipment $ 7,268 $ 7,243 Office equipment and furniture 1,133 870 Leasehold improvements 7,985 7,949 Property and equipment, gross 16,386 16,062 Less: accumulated depreciation (14,450) (12,626) Total property and equipment, net $ 1,936 $ 3,436 Depreciation expense totaled $1.8 million, $2.5 million, and $2.7 million for the years ended December 31, 2020, 2019 and 2018, respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 10. Accrued expenses and other current liabilities consist of the following (in thousands): December 31, 2020 2019 Accrued clinical expenses $ 2,197 $ 3,451 Accrued contract manufacturing expenses 1,840 1,414 Derivative liability for exit fee 1,376 969 Accrued sales and marketing expenses 593 122 Accrued professional and consulting services 243 201 Accrued regulatory services 123 342 Other 285 749 $ 6,657 $ 7,248 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Leases | 11 . LEASES The Company has recorded right-of-use operating lease assets under three lease agreements. The Company has evaluated its facility leases and determined that, effective upon the adoption of Topic 842, the leases evaluated are all operating leases. The Company has performed an evaluation of its other contracts with suppliers and collaborators in accordance with Topic 842 and has determined that, except for the facility leases described below, none of the Company’s contracts contain a lease. The Company has recorded a right-of-use operating lease asset located in Fremont, California under a lease agreement entered into in September 2008 that was amended in December 2012 to extend the lease agreement to September 2016. In September 2014, the Company signed the second amendment to its facility lease agreement to add space and to extend the lease term through September 2019. In May 2016, the Company signed a third amendment to its facility lease agreement in Fremont, California to add space and to extend the lease term through September 2021 (the “Third Amendment”). The office space consists of 72,500 square feet, that includes an additional 10,716 square feet added in September 2019, with the entire lease terminating in September 2021. The Company will not exercise its option to renew the lease at our current Fremont location and expect to enter into a new facility lease in Fremont, California during the first quarter of 2021. The Company has recorded a right-of-use operating lease asset located in Waltham, Massachusetts under a lease agreement entered into in October 2018. The office space consists of 3,520 square feet with the lease terminating in September 2021. We have not renewed the lease at our current Waltham, Massachusetts facility. During December 2020, we entered into a new lease agreement for a different location in Waltham, Massachusetts which has an expected lease commencement date in April 2021. The Company has recorded a right-of-use operating lease asset located in Milwaukee, Wisconsin under a lease agreement entered into in October 2020 with a lease commencement date in November 2020. The office space consists of 4,768 square feet with the lease terminating in February 2026. The Company has an option to extend the lease term by one five-year period. This option to extend the lease term has not been included in the calculation since currently the exercise of the option is uncertain and therefore deemed not probable. The Company recorded a $0.4 million right-of use asset and lease liability All of the Company’s leases are operating leases and each contain customary rent escalation clauses. Certain of the leases have both lease and non-lease components. The Company has elected to account for each separate lease component and the non-lease components associated with that lease component as a single lease component for all classes of underlying assets. As of December 31, 2020, the weighted average discount rate used for the calculations was 11.7% and the weighted average remaining lease term was 1.5 years. The following table provides additional details of the leases presented in the balance sheets (dollars in thousands): Facilities Right-of-use assets $ 2,274 Current portion of lease liabilities 2,117 Operating lease liability, net of current portion 413 Total $ 2,530 Weighted-average remaining life (years) 1.50 Weighted-average discount rate 11.7 % The lease costs, which are included in operating expenses in our statements of operations, were as follows (in thousands): Year Ended December 31, 2020 2019 Operating lease expense $ 2,608 $ 2,592 Cash paid for operating lease $ 3,065 $ 2,645 The following table summarizes the Company’s undiscounted cash payment obligations for its operating lease liabilities as of December 31, 2020 (in thousands): Ending December 31, 2021 $ 2,280 2022 104 2023 111 2024 115 2025 119 Thereafter 20 Total undiscounted operating lease payments 2,749 Imputed interest expenses (219) Total operating lease liabilities 2,530 Less: Current portion of operating lease liability 2,117 Operating lease liability, net of current portion $ 413 Rent expense under operating leases was $2.6 million, $2.6 million and $1.8 million for the years ended December 31, 2020, 2019 and 2018, respectively. |
Collaboration and Licensing Agr
Collaboration and Licensing Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Collaboration and Licensing Agreements | |
Collaboration and Licensing Agreements | 12. COLLABORATION AND LICENSING AGREEMENTS Kyowa Kirin Co., Ltd. (2019 KKC Agreement) In November 2019, the Company entered into a research collaboration and option agreement with KKC (“the 2019 KKC Agreement”), to undergo research to identify two pre-clinical study-ready compounds for designation as development compounds, with one compound inhibiting the first undisclosed target (“Program 1”) and a second inhibiting the second undisclosed target (“Program 2”). Pursuant to the 2019 KKC Agreement, upon completion of the research and designation by the research steering committee of one or more development candidates (“DCs”), KKC has the right to execute one or more separate collaborative agreements relating to the development and commercialization of one or both DCs in certain specified territories. Under the terms of the 2019 KKC Agreement, KKC agreed to pay the Company a non-refundable, non-creditable upfront fee of $10.0 million, which was payable as follows: the first installment of $5.0 million within 30 days of the Effective Date, and the second installment of $5.0 million on the first anniversary of the Effective Date, unless the 2019 KKC Agreement was earlier terminated by KKC due to material breach by the Company. The term of the 2019 KKC Agreement commenced on November 11, 2019 (“the Effective Date”) and ends on the earliest of: (a) two years following the Effective Date, or (b) the nomination of a program DC for both programs, (c) or the nomination of one program DC and the decision by the parties to cease research for the other program, (d) or the decision by the parties to cease research for both programs. The Company assessed the 2019 KKC Agreement in accordance with ASC 606 and concluded that the contract’s counterparty, KKC, is a customer. Management also considered the modification guidance prescribed in ASC 606 and concluded that the 2019 KKC Agreement should be accounted for as a separate contract from the 2017 KKC Agreement, as defined and discussed below. The Company identified various promises in the 2019 KKC Agreement, including the grant of an initial research license, the Program 1 research, the Program 2 research, the right to obtain certain development and commercialization rights with Program 1 in certain territories and the right to obtain development and commercialization rights with Program 2 in certain territories, and participation in a joint steering committee (“the JSC”) and determined that KKC could not benefit from either of the research programs without the research license and participation in the JSC. As such, the combined license, research programs and participation in the JSC were deemed to be the highest level of goods and services that can be deemed distinct for each of the Program 1 research and Program 2 research. The Company concluded that the options to obtain additional development and commercialization rights that are exercisable by KKC under certain circumstances are not performance obligations of the contract at inception because the option fees reflect the standalone selling price of the options, and therefore, the options are not considered to be material rights. At the outset of the 2019 KKC Agreement, the Company determined that the initial transaction price is $10.0 million and that revenue associated with the combined performance obligations will be recognized as services are provided using the input method. Since transfer of control occurs over time, in management’s judgment this input method is the best measure of progress towards satisfying the performance obligations and reflects a faithful depiction of the transfer of goods and services. Revenue will be recognized over the Program 1 and Program 2 research periods. Management will re-evaluate the estimates related to the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur and adjust the timing of revenue recognition as necessary. During the years ended December 31, 2020 and 2019, the Company recognized $5.4 million and $0.5 million, respectively, as revenue under the 2019 KKC Agreement in the statement of operations and comprehensive loss. The aggregate amount of the transaction price allocated to the Company’s partially unsatisfied performance obligations as of December 31, 2019 was $9.5 million, of which $4.5 million was presented in the balance sheet as deferred revenue for the respective period. As of December 31, 2020, the Company expects to recognize the remaining transaction price allocated to the Company’s partially unsatisfied performance obligations over the remaining research terms, which are currently expected to extend through the end of 2021. Xuanzhu (HK) Biopharmaceutical Limited, or XuanZhu In November 2019, the Company entered into a license agreement with XuanZhu (“the XuanZhu Agreement for a license to certain specific patent and patent applications. The Company assessed these arrangements in accordance with ASC 606 and concluded that the contract counterparty, XuanZhu, is a customer. Under the terms of the XuanZhu Agreement, the Company recognized $1.5 million in license fees when the agreement was executed, of which, $0.8 million was received upfront in November 2019 and achievement for the second $0.8 million payment was determined to be not materially at risk and probable of achievement and it was included in the transaction price and the amount was not probable of revenue reversal. Based on the Company’s assessment, it identified that it has one combined performance obligation, which is the license and the specific patent grant. In addition to the license fee of $1.5 million, the Company may be entitled to receive milestone payments. The variable consideration related to the remaining milestone payments has not been included in the transaction price as these were fully constrained at December 31, 2019. For the years ended December 31, 2020 and 2019, zero and $1.5 million, respectively, of license revenue was recorded with no cost of revenue related to the XuanZhu Agreement. 2017 KKC Agreement In November 2017, the Company entered into an exclusive license agreement with KKC, or the 2017 KKC Agreement, for the development, commercialization and distribution of tenapanor in Japan for cardiorenal indications. The Company granted KKC an exclusive license to develop and commercialize certain NHE3 inhibitors including tenapanor in Japan for the treatment of cardiorenal diseases and conditions, excluding cancer. The Company retained the rights to tenapanor outside of Japan, and also retained the rights to tenapanor in Japan for indications other than those stated above. Pursuant to the License Agreement, KKC is responsible for all of the development and commercialization costs for tenapanor in treatment of cardiorenal diseases and conditions, excluding cancer in Japan. Under the 2017 KKC Agreement, the Company is responsible for supplying the tenapanor drug product for KKC’s use in development and during commercialization until KKC has assumed such responsibility. Additionally, the Company is responsible for supplying the tenapanor drug substance for KKC’s use in development and commercialization throughout the term of the 2017 KKC Agreement, provided that KKC may exercise an option to manufacture the tenapanor drug substance under certain conditions The Company assessed these arrangements in accordance with ASC 606 and concluded that the contract counterparty, KKC, is a customer. Under the terms of the 2017 KKC Agreement, the Company received $30.0 million in up-front license fees which was recognized as revenue when the agreement was executed. Based on the Company’s assessment, it identified that the license and the manufacturing supply services were its material performance obligations at the inception of the agreement, and as such each of the performance obligations are distinct. Additionally, on January 1, 2018, the Company recorded unbilled revenue under current assets of $5.0 million and an increase in uncharged license fees under current liabilities of $1.0 million related to the first milestone under the 2017 KKC Agreement that KKC achieved in February 2019, reflecting revenues and cost of revenue, respectively, that would have been recognized in the fourth quarter 2017 if the Company had adopted ASC 606 prior to January 1, 2018. On KKC’s achievement of the milestone in February 2019, the balance related to unbilled revenue was adjusted to zero. Correspondingly, the $1.0 million balance related to uncharged license fees that the Company owed to AstraZeneca was reclassified to accounts payable during the first quarter of 2019, and subsequently paid to AstraZeneca during the second quarter of 2019. In addition to the up-front license fee received of $30.0 million, the Company may be entitled to receive up to $55.0 million in total development milestones, of which $5.0 million has been received to date, 8.5 billion Japanese yen for commercialization milestones, or approximately $82.4 million at the currency exchange rate on December 31, 2020, as well as reimbursement of cost, plus a reasonable overhead for the supply of product and high-teen royalties on net sales throughout the term of the agreement. The variable consideration related to the remaining development milestone payments has not been included in the transaction price as these were fully constrained at December 31, 2020 and 2019. For the years ended December 31, 2020, 2019 and 2018, $1.4 million, $0.3 million, and $0.3 million, respectively, of product supply revenue was recorded for manufacturing supply of tenapanor and other materials to KKC for its product development and clinical trials in Japan, in accordance with the Company’s agreement with KKC, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. , or Fosun Pharma In December 2017, the Company entered into an exclusive license agreement with Fosun Pharma, or the Fosun Agreement, for the development, commercialization and distribution of tenapanor in China for both hyperphosphatemia and irritable bowel syndrome with constipation, or IBS-C. The Company assessed these arrangements in accordance with ASC 606 and concluded that the contract counterparty, Fosun Pharma, is a customer. Under the terms of the Fosun Agreement, the Company received $12.0 million in up-front license fees which was recognized as revenue when the agreement was executed. Based on the Company’s assessment, it identified that the license and the manufacturing supply services were its material performance obligations at the inception of the agreement, and as such each of the performance obligations are distinct. In addition, the Company may be entitled to additional development and commercialization milestones of up to $110.0 million, as well as reimbursement of cost plus a reasonable overhead for the supply of product and tiered royalties on net sales ranging from the mid-teens to 20%. The variable consideration related to the remaining development milestone payments has not been included in the transaction price as these were fully constrained at December 31, 2019. For the year ended December 31, 2019, $3.0 million revenue was recorded towards achievement of a milestone related to the Fosun Agreement, and for the years ended December 31, 2020 and 2018, no revenue was recorded. Knight Therapeutics, Inc. , or Knight In March 2018, the Company entered into an exclusive license agreement with Knight Therapeutics, Inc., or the Knight Agreement, for the development, commercialization and distribution of tenapanor in Canada for hyperphosphatemia and IBS-C. The Company assessed these arrangements in accordance with ASC 606 and concluded that the contract counterparty, Knight, is a customer. Based on the Company’s assessment, it identified that the license and the manufacturing supply services were its material performance obligations at the inception of the agreement, and as such each of the performance obligations are distinct. Under the terms of the agreement, the Company is eligible to receive up to CAD 25.0 million in total payments, or $19.6 million at the currency exchange rate on December 31, 2020, including an up-front payment and development and sales milestones, reimbursement of supply costs on a schedule specifying cost per tablet, with a reasonable mark up for overhead, as well as tiered royalty rates on net sales ranging from the mid-single digits to the low twenties. The variable consideration related to the remaining development milestone payments has not been included in the transaction price as these were fully constrained at December 31, 2020. For the years ended December 31, 2020, 2019 and 2018, $0.7 million, zero and $2.3 million of revenue was recorded, respectively, related to the Knight Agreement. For the year ended December 31, 2020, $0.1 million product supply revenue was recorded related to the Knight Agreement. There was no product revenue related to the Knight Agreement in 2019 or 2018. Pursuant to the AstraZeneca Termination Agreement, $0.1 million, zero and $0.5 million of cost of revenue was recorded during 2020, 2019 and 2018, respectively. AstraZeneca In June 2015, the Company entered into a termination agreement with AstraZeneca, or the AstraZeneca Termination Agreement, pursuant to which the Company remains liable to pay AstraZeneca license fees for (i) future royalties at a royalty rate of 10% of net sales of tenapanor or other NHE3 products by the Company or its licensees, and (ii) 20% of non-royalty revenue received from a new collaboration partner should the Company elect to license, or otherwise provide rights to develop and commercialize tenapanor or certain other NHE3 inhibitors, up to a maximum of $75.0 million in aggregate for (i) and (ii). To date in aggregate, the Company has recognized $10.6 million of the $75.0 million, recorded as cost of revenue, as follows (in thousands): Cost of Revenue Recognized Amount Paid Year 2017 $ 9,400 * $ 6,000 Year 2018 466 2,864 Year 2019 600 1,002 Year 2020 145 742 Total $ 10,611 $ 10,608 Maximum payment per termination agreement 75,000 Remaining potential commitment $ 64,392 _______________________ * |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Income Taxes | 13. INCOME TAXES The components of the provision for income taxes for the year ended December 31, 2020, 2019 and 2018, are as follows (in thousands): Year Ended December 31, 2020 2019 2018 Current: State $ 2 $ 2 $ 4 Foreign — 301 — Total current 2 303 4 Deferred: Federal — — — Total deferred — — — Provision for income taxes $ 2 $ 303 $ 4 The following is a reconciliation of the statutory federal income tax rate to the Company’s effective tax rate: Year Ended December 31, 2020 2019 2018 Change in valuation allowance (22.3) % (21.9) % (22.5) % Income tax at the federal statutory rate 21.0 21.0 21.0 Tax credits 1.3 1.6 1.4 State taxes, net of federal benefit 0.7 0.3 0.6 Stock based compensation (0.1) (0.9) (1.2) Other (0.6) (0.4) 0.7 Income tax provision — % (0.3) % — % Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Deferred tax assets: Amortization and depreciation $ 51,370 $ 45,555 Net operating loss carryforwards 53,436 40,896 Tax credits 11,777 10,136 Stock-based compensation 5,524 4,853 Lease obligation 1,804 984 Other — 940 Gross deferred tax assets 123,911 103,364 Valuation allowance (123,402) (102,344) Deferred tax assets net of valuation allowance 509 1,020 Deferred tax liabilities Right-of-use asset (479) (834) Revenue recognition — (158) Other (30) (28) Net deferred tax assets $ — $ — Realization of deferred tax assets is dependent on future taxable income, if any, the timing and the amount of which are uncertain. The Company assesses the available positive and negative evidence to estimate whether sufficient future taxable income will be generated to permit use of the existing deferred tax assets. A significant component of objective negative evidence evaluated was the Company’s cumulative loss incurred over the three-year period ended December 31, 2020. Such objective evidence limits the ability to consider other subjective evidence, such as our projections for future growth. On the basis of this evaluation, as of December 31, 2020, December 31, 2019 and December 31, 2018, a full valuation allowance has been recorded against Company’s net deferred tax asset. The amount of the deferred tax asset considered realizable, however, could be adjusted if estimates of future taxable income during the carryforward period are reduced or increased or if objective negative evidence in the form of cumulative losses is no longer present and additional weight is given to subjective evidence such as our projections for growth. As of December 31, 2020, the Company had net operating loss carryforwards for federal income tax purposes of approximately $287.9 million, of which approximately $151.0 million can be carried forward indefinitely and the remaining net operating losses expire beginning in 2030, if not utilized. Federal research and development tax credit carryforwards of approximately $13.5 million that expire beginning in 2027, if not utilized, and foreign tax credit carryforwards of approximately $1.2 million that expire in 2027, if not utilized. In addition, the Company had net operating loss carryforwards for California income tax purposes of approximately $88.3 million that expire beginning of 2030, if not utilized, and state research and development tax credit carryforwards of approximately $7.4 million which can be carried forward indefinitely. The Company had approximately $0.1 million of minimum tax credit carryovers for California income tax purposes. The minimum tax credits have no expiration date. The Company had other state net operating losses of approximately $1.9 million that begin to expire in 2035. The future utilization of net operating loss and tax credit carryforwards and credits may be subject to an annual limitation, pursuant to Internal Revenue Code Sections 382 and 383, as a result of ownership changes that may have occurred previously or that could occur in the future. Due to the existence of the valuation allowance, limitations under Section 382 and 383 will not impact the Company’s effective tax rate. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was enacted and signed into law in response to coronavirus disease 2019 (“COVID-19”). The CARES Act, among other things, included several significant provisions that impacted corporate taxpayers’ accounting for income taxes. Prior to the enactment of the CARES Act, the 2017 Tax Cuts and Jobs Act generally eliminated the ability to carryback net operating losses (“NOLs”), and permitted the NOLs arising in tax years beginning after December 31, 2017 to be carried forward indefinitely, limited to 80% of the taxpayer’s income. The CARES Act amended the NOL rules, suspending the 80% limitation on the utilization of NOLs generated after December 31, 2017 and before January 1, 2021. Additionally, the CARES Act allows corporate NOLs arising in taxable years beginning after December 31, 2017 and before January 1, 2021, to be carried back to each of the five taxable years preceding the taxable year of the loss. Also, the CARES Act allows companies to defer making certain payroll tax payments until future years. With the enactment of the CARES Act, the company does not expect a financial statement impact from income taxes. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): December 31, 2020 2019 2018 Balance at beginning of year $ 24,538 $ 23,052 $ 20,734 Additions (subtractions) based on tax positions related to prior year (1,388) 755 1,634 Additions based on tax positions related to current year 474 731 684 Balance at end of year $ 23,624 $ 24,538 $ 23,052 The Company recognizes a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits. Income tax positions must meet a more likely than not recognition at the effective date to be recognized. The unrecognized tax benefits, if recognized and in absence of full valuation allowance, would impact the income tax provision by $13.3 million, $13.2 million, and $9.8 million as of December 31, 2020, 2019 and 2018, respectively. The Company has elected to include interest and penalties as a component of tax expense. During the years ended December 31, 2020, 2019 and 2018, the Company did not recognize accrued interest and penalties related to unrecognized tax benefits. Although the timing and outcome of an income tax audit is highly uncertain, the Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change during the next 12 months. The Company files income tax returns in the U.S. federal, Arizona, California, Colorado, DC, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, New York, New York MTA, Oregon, Tennessee, Texas and Wisconsin tax jurisdictions. Due to the Company’s net operating loss and tax credit carryforwards, the income tax returns remain open to U.S. federal and state tax examinations. The Company is not currently under examination in any tax jurisdiction. |
Geographic Information and Conc
Geographic Information and Concentrations | 12 Months Ended |
Dec. 31, 2020 | |
Geographic Information and Concentrations | |
Geographic Information and Concentrations | 14. GEOGRAPHIC INFORMATION AND CONCENTRATIONS Revenue by geographic areas for the years ended December 31, 2020, 2019 and 2018, are as follows (in thousands): Year Ended December 31, 2020 2019 2018 United States $ — $ — $ — International: North America (1) 806 — 2,320 Asia Pacific (2) (3) (4) 6,765 5,281 287 Total revenue $ 7,571 $ 5,281 $ 2,607 (1) Revenues from North America are comprised of amounts earned from Canada in accordance with the Knight Agreement. (2) Revenues from Asia Pacific in 2020 are comprised of amounts earned from Japan in accordance with the 2017 KKC Agreement and 2019 KKC Agreement. (3) Revenues from Asia Pacific in 2019 were comprised of $0.8 million from Japan in accordance with the 2017 KKC Agreement and 2019 KKC Agreement, $1.5 million from Hong Kong in accordance with the XuanZhu Agreement and $3.0 million from China in accordance with the Fosun Agreement. (4) Revenues from Asia Pacific in 2018 were comprised of amounts earned from Japan in accordance with the 2017 KKC Agreement. Revenues are attributed to geographical areas based on the domicile of the Company’s collaboration partners. Revenues recorded in the years ended December 31, 2020, 2019 and 2018, were wholly from collaboration partnerships. Collaboration partnerships accounting for more than 10% of total revenues during the years ended December 31, 2020, 2019 and 2018 are as follows: Year Ended December 31, 2020 2019 2018 KKC 89 % 15 % 11 % Knight 11 % — % 89 % Fosun Pharma - % 57 % — % XuanZhu - % 28 % — % |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2020 | |
Net Loss Per Share | |
Net Loss Per Share | 15. NET LOSS PER SHARE Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, less shares subject to repurchase, and excludes any dilutive effects of stock-based awards and warrants. Diluted net loss per common share is computed giving effect to all potential dilutive common shares, including common stock issuable upon exercise of stock options, and unvested restricted common stock and stock units. As the Company had net losses for the years ended December 31, 2020, 2019 and 2018, all potential common shares were determined to be anti-dilutive. The following table sets forth the computation of net loss per common share (in thousands, except per share amounts): Year Ended December 31, 2020 2019 2018 Numerator: Net loss $ (94,313) $ (94,940) $ (91,298) Denominator: Weighted average common shares outstanding - basic and diluted 89,582,138 64,478,066 56,219,919 Net loss per share - basic and diluted $ (1.05) $ (1.47) $ (1.62) For the years ended December 31, 2020, 2019 and 2018, the total numbers of securities that could potentially dilute net income per share in the future that were not considered in the diluted net loss per share calculations because the effect would have been anti-dilutive were as follows: Year Ended December 31, 2020 2019 2018 Options to purchase common stock 9,246,047 7,128,247 5,378,008 Warrants to purchase common stock 932,091 2,172,899 2,172,899 Restricted stock units 26,121 — 199,135 Performance-based restricted stock units — 867,506 395,791 ESPP shares issuable 94,466 78,761 63,413 Total 10,298,725 10,247,413 8,209,246 The number of potential common shares that would have been included in diluted income per share had it not been for the anti-dilutive effect caused by the net loss, computed by converting these securities using the treasury stock method during the years ended December 31, 2020, 2019 and 2018, was approximately 2.1 million, 1.1 million and 1.0 million, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | 16. COMMITMENTS AND CONTINGENCIES Guarantees and Indemnifications The Company indemnifies each of its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at our request in such capacity, as permitted under Delaware law and in accordance with our certificate of incorporation and bylaws. The term of the indemnification period lasts as long as an officer or director may be subject to any proceeding arising out of acts or omissions of such officer or director in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer liability insurance, which allows the transfer of risk associated with our exposure and may enable the Company to recover a portion of any future amounts paid. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations for any period presented. Legal Proceedings and Claims From time to time the Company may be involved in claims arising in connection with its business. Based on information currently available, management believes that the amount, or range, of reasonably possible losses in connection with any pending actions against the Company will not be material to the Company’s financial condition or cash flows, and no contingent liabilities were accrued as of December 31, 2020 or 2019. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Selected Quarterly Financial Data (Unaudited) | |
Selected Quarterly Financial Data (Unaudited) | 17. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) Selected quarterly financial results from operations for the years ended December 31, 2020 and 2019 are as follows (in thousands, except per share amounts): 2020 Quarter Ended March 31 June 30 September 30 December 31 Total revenue $ 1,213 $ 1,836 $ 2,713 $ 1,809 Operating expenses $ 22,982 $ 26,043 $ 19,874 $ 29,452 Net loss $ (22,373) $ (24,956) $ (18,108) $ (28,876) Net loss per share - basic and diluted $ (0.25) $ (0.28) $ (0.20) $ (0.32) 2019 Quarter Ended March 31 June 30 September 30 December 31 Total revenue $ — $ 18 $ 3,013 $ 2,250 Operating expenses $ 25,498 $ 24,846 $ 25,102 $ 21,098 Net loss $ (26,144) $ (25,467) $ (23,539) $ (19,790) Net loss per share - basic and diluted $ (0.42) $ (0.41) $ (0.37) $ (0.27) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Prior Period Errors | Prior Period Errors In connection with our review of our financial statements as of and for the six months ended June 30, 2019, we corrected errors related to the accounting for clinical trial accruals that had resulted in an overstatement of research and development expenses during the year ended December 31, 2018. Specifically, management concluded that the Company’s research and development expenses recorded during the year ended December 31, 2018 had been overstated by $3.6 million and that the Company’s accrued expenses and other current liabilities as of December 31, 2018 2019 |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to recognition of revenue, clinical trial accruals, contract manufacturing accruals, fair value of assets and liabilities, income taxes and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could materially differ from those estimates. |
Liquidity | Liquidity As of December 31, 2020, the Company had cash and investments of approximately $188.6 million, which include net proceeds of approximately $21.0 million from the 2020 At-the-Market Offerings, $134.9 million from the 2019 Offering, and $20.0 million received in connection with the 2019 Private Placement, respectively, as defined and discussed in Note 7. We believe our current available cash and investments will be sufficient to fund our planned expenditures and meet the Company’s obligations for at least 12 months following March 8, 2021, which is the date that the financial statements are being issued. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity date of 90 days or less on the date of purchase to be cash equivalents. |
Short-Term Investments | Short-Term Investments Short-term investments consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than one year, from the date of acquisition. Short-term investments are carried at fair value based upon quoted market prices. Unrealized gains and losses on available-for-sale securities are excluded from earnings and are reported as a component of accumulated other comprehensive loss. The cost of available-for-sale securities sold is based on the specific-identification method. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company is exposed to credit risks in the event of default by the counterparties to the extent of the amount recorded in its balance sheet. Cash, cash equivalents and short-term investments are invested through banks and other financial institutions in the U.S. |
Foreign Currency and Forward Contracts | Foreign Currency and Forward Contracts The Company manages its foreign currency exposures with the use of foreign currency purchases as well as currency spot and forward contracts. The Company primarily conducts its business in U.S. dollars; however, a portion of the Company’s expense and capital activities are transacted in foreign currencies which are subject to exchange rate fluctuations that can affect cash or earnings. The Company has been in a loss position and therefore its primary objective is to conserve and manage cash. There are generally two methods by which the Company manages the cash flow risk of foreign exchange fluctuations when a contract is signed (i) it can purchase the foreign funds, in full or in part, upon the execution of the contract, or (ii) it can obtain the right to purchase such funds, in full or in part, at the execution of the contract, i.e., obtain a forward contract from an appropriate bank, that can be exercised to obtain the currency of interest at a particular point in time. The derivative instruments that the Company uses to hedge the exposure shall generally not be designated as cash flow hedges, and as a result, changes in their fair value will be recorded in other income (expense), net, in the Company's statements of operations and comprehensive loss. The fair values of forward foreign currency exchange contracts are estimated using current exchange rates and interest rates and the current creditworthiness of the counterparties is taken into consideration. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, with ranges generally from three |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The carrying value of long-lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than the asset’s carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. For the years ending December 31, 2020, 2019 and 2018 there have been no impairment losses. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. |
Revenue Recognition | Revenue Recognition On January 1, 2018 the Company adopted the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) and related amendments The Company generates revenue primarily from research and collaboration and license agreements with customers. Goods and services in the agreements may include the grant of licenses for the use of the Company’s technology, the provision of services associated with the research and development of product candidates, manufacturing services, and participation in joint steering committees. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; research, development, regulatory and commercial milestone payments; reimbursement of research and development services; option payments; reimbursement of certain costs; payments for manufacturing supply services; and future royalties on net sales of licensed products. When two or more contracts are entered into with the same customer at or near the same time, the Company evaluates the contracts to determine whether the contracts should be accounted for as a single arrangement. Contracts are combined and accounted for as a single arrangement if one or more of the following criteria are met: (i) the contracts are negotiated as a package with a single commercial objective; (ii) the amount of consideration to be paid in one contract depends on the price or performance of the other contract; or (iii) the goods or services promised in the contracts (or some goods or services promised in each of the contracts) are a single performance obligation. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, management performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraints on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for contracts with customers, the Company develops assumptions that require judgment to determine whether promised goods and services represent distinct performance obligations and the standalone selling price for each performance obligation identified in the contract. This evaluation is subjective and requires the Company to make judgments about the promised goods and services and whether those goods and services are separable from other aspects of the contract. Further, determining the standalone selling price for performance obligations requires significant judgment, and when an observable price of a promised good or service is not readily available, the Company considers relevant assumptions to estimate the standalone selling price, including, as applicable, market conditions, development timelines, probabilities of technical and regulatory success, reimbursement rates for personnel costs, forecasted revenues, potential limitations to the selling price of the product and discount rates. The Company applies judgment in determining whether a combined performance obligation is satisfied at a point in time or over time, and, if over time, concluding upon the appropriate method of measuring progress to be applied for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, as estimates related to the measure of progress change, related revenue recognition is adjusted accordingly. Changes in the Company’s estimated measure of progress are accounted for prospectively as a change in accounting estimate. The Company recognizes collaboration revenue by measuring the progress toward complete satisfaction of the performance obligation using an input measure. In order to recognize revenue over the research and development period, the Company measures actual costs incurred to date compared to the overall total expected costs to satisfy the performance obligation. Revenues are recognized as the program costs are incurred. The Company will re-evaluate the estimate of expected costs to satisfy the performance obligation each reporting period and make adjustments for any significant changes. Amounts received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to receipt are recorded as contract assets in the Company's balance sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer. Milestone Payments: Manufacturing supply services: Royalties: Licenses of intellectual property: Options: a material right (i.e., an optional good or service offered for free or at a discount) to the customer. If the customer options represent a material right, the material right is treated as a separate performance obligation at the outset of the arrangement. The Company allocates the transaction price to material rights based on the standalone selling price, and revenue is recognized when or as the future goods or services are transferred or when the option expires. Customer options that are not material rights do not give rise to a separate performance obligation, and as such, the additional consideration that would result from a customer exercising an option in the future is not included in the transaction price for the current contract. Instead, the option is deemed a marketing offer, and additional option fee payments are recognized or being recognized as revenue when the licensee exercises the option. The exercise of an option that does not represent a material right is treated as a separate contract for accounting purposes. Contract modifications: The Company receives payments from its licensees as established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Where applicable, amounts are recorded as unbilled revenue when the Company’s right to consideration is unconditional. The Company does not assess whether a contract with a customer has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, costs associated with clinical trials, costs related to pre-commercialization manufacturing activities such as manufacturing process validation activities and the manufacturing of clinical drug supply, nonclinical research and development activities, regulatory activities, research-related overhead expenses and fees paid to external service providers and contract research and manufacturing organizations that conduct certain research and development activities on behalf of the Company. |
Accrued Research and Development Expenses | Accrued Research and Development Expenses The Company is required to estimate its accrued expenses at the end of each reporting period. This process involves reviewing open contracts and purchase orders, communicating with Company personnel to identify services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs. The majority of the Company’s service providers submit invoices in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to: ● contract research organizations, or CROs, in connection with clinical studies; ● investigative sites in connection with clinical studies; ● vendors related to product manufacturing, development and distribution of clinical supplies; and ● vendors in connection with preclinical development activities. The Company records expenses related to clinical studies and manufacturing development activities based on its estimates of the services received and efforts expended pursuant to contracts with multiple CROs and manufacturing vendors that conduct and manage these activities on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed, enrollment of subjects, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the Company’s estimate, the Company will adjust the accrued or prepaid expense balance accordingly. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes compensation expense for all stock-based payment awards made to employees, nonemployees and directors based on estimated fair values. For employee and nonemployee stock options, the Company determines the grant date fair value of the awards using the Black-Scholes option-pricing model and generally recognizes the fair value as stock-based compensation expense on a straight-line basis over the vesting period of the respective awards. For restricted stock and performance-based restricted stock, to the extent they are probable, the compensation cost for these awards is based on the closing price of the Company’s common stock on the date of grant and recognized as compensation expense on a straight-line basis over the requisite service period. Stock-based compensation expense is based on the value of the portion of stock-based payment awards that is ultimately expected to vest. As such, the Company’s stock-based compensation is reduced for the estimated forfeitures at the date of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. |
Derivatives and Hedging Activities | Derivatives and Hedging Activities The Company accounts for its derivative instruments as either assets or liabilities on the balance sheet and measures them at fair value. Derivatives are adjusted to fair value through other income (expense), net in the statements of operations and comprehensive loss. |
Leases | Leases The Company determines if an arrangement is a lease at the inception of the arrangement. Operating leases are included in right-of-use assets, current portion of operating lease liability, and operating lease liability, net of current portion in our balance sheets. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected not to separate lease and non-lease components, such as common area maintenance charges, and instead it accounts for these as a single lease component. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is composed of two components: net loss and other comprehensive income (loss). Other comprehensive income (loss) refers to gains and losses that are recorded as an element of stockholders’ equity but are excluded from net loss. |
Net Loss per Share | Net Loss per Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potential common shares. Diluted net loss per common share in the periods presented is the same as basic net loss per common share, since the effects of potentially dilutive securities are antidilutive due to the net loss for all periods presented. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements New Accounting Pronouncements - Recently Adopted In December 2019, as part of its initiative to reduce complexity in the accounting standards, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 Revenue from Contracts with Customers In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework— Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU No. 2018-15, Intangibles (Topic 350): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Cash and Investments (Tables)
Cash and Investments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Cash and Investments | |
Schedule of Securities Classified as Cash and Investments | Securities classified as cash and investments as of December 31, 2020 and December 31, 2019 are summarized below (in thousands). Estimated fair value is based on quoted market prices for these investments. December 31, 2020 Gross Unrealized Amortized Cost Gains Losses Fair Value Cash and cash equivalents: Money market funds $ 88,151 $ — $ — $ 88,151 Commercial paper 2,100 — — 2,100 Cash 781 — — 781 Total cash and cash equivalents 91,032 — — 91,032 Short-term investments: Commercial paper $ 60,631 $ 2 $ (4) $ 60,629 Corporate bonds 24,547 3 (6) 24,544 U.S. government-sponsored agency bonds 9,277 2 — 9,279 U.S. treasury notes 1,000 — — 1,000 Total short-term investments 95,455 7 (10) 95,452 Long-term investments: Corporate bonds $ 2,115 $ — $ (1) $ 2,114 Total cash equivalents and investments $ 188,602 $ 7 $ (11) $ 188,598 December 31, 2019 Gross Unrealized Amortized Cost Gains Losses Fair Value Cash and cash equivalents: Money market funds $ 147,208 $ — $ — $ 147,208 Commercial paper 19,357 3 — 19,360 Corporate bonds 11,441 — — 11,441 Cash 3,124 — — 3,124 Total cash and cash equivalents 181,130 3 — 181,133 Short-term investments Commercial paper $ 36,667 $ 14 $ — $ 36,681 Corporate bonds 21,690 6 (3) 21,693 Asset-backed securities 8,005 — — 8,005 Total short-term investments 66,362 20 (3) 66,379 Total cash equivalents and short-term investments $ 247,492 $ 23 $ (3) $ 247,512 |
Schedule of the amortized cost and estimated fair value of available-for-sale debt securities by contractual maturity | As of December 31, 2020, the amortized cost and estimated fair value of available-for-sale debt securities by contractual maturity were as follows (in thousands): Amortized Cost Fair Value Due in one year or less $ 95,455 $ 95,452 Due in one to two years 2,115 2,114 Total $ 97,570 $ 97,566 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Measurements | |
Summary of Fair Value Measurements of Company's Financial Assets and Liabilities | The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy (in thousands): December 31, 2020 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 88,151 $ 88,151 $ — $ — Commercial paper 62,729 — 62,729 — Corporate bonds 26,658 — 26,658 — U.S. government-sponsored agency bonds 9,279 — 9,279 U.S. treasury notes 1,000 — 1,000 — Total $ 187,817 $ 88,151 $ 99,666 $ — Liabilities: Derivative liability for Exit Fee $ 1,376 $ — $ — $ 1,376 Total $ 1,376 $ — $ — $ 1,376 December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 147,208 $ 147,208 $ — $ — Commercial paper 56,041 — 56,041 — Corporate bonds 33,134 — 33,134 — Asset-backed securities 8,005 — 8,005 — Total $ 244,388 $ 147,208 $ 97,180 $ — Liabilities: Derivative liability for Exit Fee $ 969 $ — $ — $ 969 Total $ 969 $ — $ — $ 969 |
Derivative Liability (Tables)
Derivative Liability (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Derivative Liability | |
Schedule of Changes in Fair Value | Changes in the fair value of recurring measurements included in Level 3 of the fair value hierarchy are presented as other income (expense), net in the Company's statements of operations and were as follows for the years ended December 31, 2020, 2019 and 2018 (in thousands): 2020 2019 2018 Fair value of Exit Fee derivative liability at January 1 $ 969 $ 533 — Change in estimated fair value of derivative liability 407 436 533 Fair value of Exit Fee derivative liability at December 31 $ 1,376 $ 969 $ 533 |
Borrowings (Tables)
Borrowings (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Borrowings | |
Schedule of Future Debt Payment Obligations | As of December 31, 2020, the Company’s future debt payment obligations towards the Term Loan principal and final fee, excluding interest payments and the Exit Fee are as follows (in thousands): 2021 $ 4,167 2022 48,308 Total repayment obligations $ 52,475 Less: Unamortized discount and debt issuance costs (518) Less: Unaccreted value of final fee (1,169) Loan payable 50,788 Less: Loan payable, current portion (4,167) Loan payable, net of current portion $ 46,621 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Activity Under 2008 Plan, 2014 Plan and Inducement Plan Including Grants to Nonemployees Issued | Options Issued and Outstanding Weighted Weighted-Average Average Shares Available Exercise Price per Remaining Aggregate for Grant Number of Shares Share Contractual Term Intrinsic Value (in Years) (in thousands) Balance at December 31, 2019 1,196,746 7,272,768 $ 6.55 Options authorized 3,552,709 — $ — Options granted (3,727,947) 3,727,947 $ 6.89 Options exercised — (445,942) $ 2.29 Options canceled 764,724 (764,724) $ 8.03 Issuance of common stock for services (42,403) — — Forfeitures of PRSUs granted in prior years 13,229 — — Balance at December 31, 2020 1,757,058 9,790,049 $ 6.76 7.44 $ 12,797 Vested and expected to vest at December 31, 2020 9,790,049 $ 6.76 7.44 $ 12,797 Exercisable at December 31, 2020 5,230,640 $ 7.53 6.23 $ 7,765 |
Summary of Weighted-Average Assumptions to Estimate Fair Value of Employee Stock Options | Year Ended December 31, 2020 Expected term (years) 6.00 Expected volatility 83 % Risk-free interest rate 1.07 % Dividend yield — % |
Summary of Non-Vested RSU Activity | Weighted- Weighted-Average Average Grant Number of Grant Date Fair Number of Date Fair Value RSUs Value Per Share PRSUs Per Share Non-vested restricted stock units at December 31, 2019 — $ — 849,757 $ 4.30 Granted 158,626 $ 5.64 30,000 $ 7.58 Vested — $ — (866,528) $ 4.41 Forfeited — $ — (13,229) $ 4.30 Non-vested restricted stock units at December 31, 2020 158,626 $ 5.64 — $ — |
Summary of Stock-Based Compensation Expense Recognized | Total stock-based compensation recognized was as follows (in thousands): Year Ended December 31, 2020 2019 2018 Research and development $ 4,061 $ 4,104 $ 3,666 General and administrative 6,522 5,832 5,560 Total $ 10,583 $ 9,936 $ 9,226 |
Summary of Stock-Based Compensation Expense Not Yet Recognized | At December 31, 2020, the Company had total unrecognized stock-based compensation expense, net of estimated forfeitures, of the following (dollars in thousands): At December 31, 2020 Unrecognized Compensation Expense Average Remaining Vesting Period (Years) Stock options grant $ 17,662 2.8 RSU grants $ 860 3.9 ESPP $ 108 0.1 |
2014 Employee Stock Purchase Plan [Member] | |
Summary of Activity Under 2008 Plan, 2014 Plan and Inducement Plan Including Grants to Nonemployees Issued | Shares Available Number of Shares Purchase Price for Grant Purchased per Share Gross Proceeds (in thousands) Balance at December 31, 2019 519,578 491,680 Shares purchased (169,931) 169,931 $ 4.91 $ 834 Balance at December 31, 2020 349,647 661,611 |
Summary of Weighted-Average Assumptions to Estimate Fair Value of Employee Stock Options | Year Ended December 31, 2020 Expected term (years) 0.5 Expected volatility 79.4 % Risk-free interest rate 0.48 % Dividend yield — % |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
Summary of Property and Equipment | Property and equipment consist of the following (in thousands): December 31, 2020 2019 Laboratory equipment $ 7,268 $ 7,243 Office equipment and furniture 1,133 870 Leasehold improvements 7,985 7,949 Property and equipment, gross 16,386 16,062 Less: accumulated depreciation (14,450) (12,626) Total property and equipment, net $ 1,936 $ 3,436 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands): December 31, 2020 2019 Accrued clinical expenses $ 2,197 $ 3,451 Accrued contract manufacturing expenses 1,840 1,414 Derivative liability for exit fee 1,376 969 Accrued sales and marketing expenses 593 122 Accrued professional and consulting services 243 201 Accrued regulatory services 123 342 Other 285 749 $ 6,657 $ 7,248 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Summary of Additional Details of the Leases | The following table provides additional details of the leases presented in the balance sheets (dollars in thousands): Facilities Right-of-use assets $ 2,274 Current portion of lease liabilities 2,117 Operating lease liability, net of current portion 413 Total $ 2,530 Weighted-average remaining life (years) 1.50 Weighted-average discount rate 11.7 % |
Summary of Lease Costs | The lease costs, which are included in operating expenses in our statements of operations, were as follows (in thousands): Year Ended December 31, 2020 2019 Operating lease expense $ 2,608 $ 2,592 Cash paid for operating lease $ 3,065 $ 2,645 |
Summary of Undiscounted Cash Payment Obligations for Operating Lease Liabilities | The following table summarizes the Company’s undiscounted cash payment obligations for its operating lease liabilities as of December 31, 2020 (in thousands): Ending December 31, 2021 $ 2,280 2022 104 2023 111 2024 115 2025 119 Thereafter 20 Total undiscounted operating lease payments 2,749 Imputed interest expenses (219) Total operating lease liabilities 2,530 Less: Current portion of operating lease liability 2,117 Operating lease liability, net of current portion $ 413 |
Collaboration and Licensing A_2
Collaboration and Licensing Agreements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Collaboration and Licensing Agreements | |
Schedule of Cost of Revenue Recognized and Paid | To date in aggregate, the Company has recognized $10.6 million of the $75.0 million, recorded as cost of revenue, as follows (in thousands): Cost of Revenue Recognized Amount Paid Year 2017 $ 9,400 * $ 6,000 Year 2018 466 2,864 Year 2019 600 1,002 Year 2020 145 742 Total $ 10,611 $ 10,608 Maximum payment per termination agreement 75,000 Remaining potential commitment $ 64,392 _______________________ * |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Summary of Components of the Provision for Income Taxes | The components of the provision for income taxes for the year ended December 31, 2020, 2019 and 2018, are as follows (in thousands): Year Ended December 31, 2020 2019 2018 Current: State $ 2 $ 2 $ 4 Foreign — 301 — Total current 2 303 4 Deferred: Federal — — — Total deferred — — — Provision for income taxes $ 2 $ 303 $ 4 |
Reconciliation of Statutory Federal Income Tax Rate to the Company's Effective Tax Rate | Year Ended December 31, 2020 2019 2018 Change in valuation allowance (22.3) % (21.9) % (22.5) % Income tax at the federal statutory rate 21.0 21.0 21.0 Tax credits 1.3 1.6 1.4 State taxes, net of federal benefit 0.7 0.3 0.6 Stock based compensation (0.1) (0.9) (1.2) Other (0.6) (0.4) 0.7 Income tax provision — % (0.3) % — % |
Significant Components of the Company's Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Deferred tax assets: Amortization and depreciation $ 51,370 $ 45,555 Net operating loss carryforwards 53,436 40,896 Tax credits 11,777 10,136 Stock-based compensation 5,524 4,853 Lease obligation 1,804 984 Other — 940 Gross deferred tax assets 123,911 103,364 Valuation allowance (123,402) (102,344) Deferred tax assets net of valuation allowance 509 1,020 Deferred tax liabilities Right-of-use asset (479) (834) Revenue recognition — (158) Other (30) (28) Net deferred tax assets $ — $ — |
Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): December 31, 2020 2019 2018 Balance at beginning of year $ 24,538 $ 23,052 $ 20,734 Additions (subtractions) based on tax positions related to prior year (1,388) 755 1,634 Additions based on tax positions related to current year 474 731 684 Balance at end of year $ 23,624 $ 24,538 $ 23,052 |
Geographic Information and Co_2
Geographic Information and Concentrations (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Geographic Information and Concentrations | |
Summary of Revenue by Geographic Areas | Revenue by geographic areas for the years ended December 31, 2020, 2019 and 2018, are as follows (in thousands): Year Ended December 31, 2020 2019 2018 United States $ — $ — $ — International: North America (1) 806 — 2,320 Asia Pacific (2) (3) (4) 6,765 5,281 287 Total revenue $ 7,571 $ 5,281 $ 2,607 (1) Revenues from North America are comprised of amounts earned from Canada in accordance with the Knight Agreement. (2) Revenues from Asia Pacific in 2020 are comprised of amounts earned from Japan in accordance with the 2017 KKC Agreement and 2019 KKC Agreement. (3) Revenues from Asia Pacific in 2019 were comprised of $0.8 million from Japan in accordance with the 2017 KKC Agreement and 2019 KKC Agreement, $1.5 million from Hong Kong in accordance with the XuanZhu Agreement and $3.0 million from China in accordance with the Fosun Agreement. (4) Revenues from Asia Pacific in 2018 were comprised of amounts earned from Japan in accordance with the 2017 KKC Agreement. |
Schedule of Collaboration Partnerships | Year Ended December 31, 2020 2019 2018 KKC 89 % 15 % 11 % Knight 11 % — % 89 % Fosun Pharma - % 57 % — % XuanZhu - % 28 % — % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Net Loss Per Share | |
Computation of Basic and Diluted Loss Per Share Attributable to Common Stockholders | The following table sets forth the computation of net loss per common share (in thousands, except per share amounts): Year Ended December 31, 2020 2019 2018 Numerator: Net loss $ (94,313) $ (94,940) $ (91,298) Denominator: Weighted average common shares outstanding - basic and diluted 89,582,138 64,478,066 56,219,919 Net loss per share - basic and diluted $ (1.05) $ (1.47) $ (1.62) |
Calculation of Anti-Dilutive Potentially Dilutive Securities Not Included in Diluted Per Share | Year Ended December 31, 2020 2019 2018 Options to purchase common stock 9,246,047 7,128,247 5,378,008 Warrants to purchase common stock 932,091 2,172,899 2,172,899 Restricted stock units 26,121 — 199,135 Performance-based restricted stock units — 867,506 395,791 ESPP shares issuable 94,466 78,761 63,413 Total 10,298,725 10,247,413 8,209,246 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies | |
Summary of Undiscounted Cash Payment Obligations for Operating Lease Liabilities | The following table summarizes the Company’s undiscounted cash payment obligations for its operating lease liabilities as of December 31, 2020 (in thousands): Ending December 31, 2021 $ 2,280 2022 104 2023 111 2024 115 2025 119 Thereafter 20 Total undiscounted operating lease payments 2,749 Imputed interest expenses (219) Total operating lease liabilities 2,530 Less: Current portion of operating lease liability 2,117 Operating lease liability, net of current portion $ 413 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Selected Quarterly Financial Data (Unaudited) | |
Schedule of Selected Quarterly Financial Results from Operations | Selected quarterly financial results from operations for the years ended December 31, 2020 and 2019 are as follows (in thousands, except per share amounts): 2020 Quarter Ended March 31 June 30 September 30 December 31 Total revenue $ 1,213 $ 1,836 $ 2,713 $ 1,809 Operating expenses $ 22,982 $ 26,043 $ 19,874 $ 29,452 Net loss $ (22,373) $ (24,956) $ (18,108) $ (28,876) Net loss per share - basic and diluted $ (0.25) $ (0.28) $ (0.20) $ (0.32) 2019 Quarter Ended March 31 June 30 September 30 December 31 Total revenue $ — $ 18 $ 3,013 $ 2,250 Operating expenses $ 25,498 $ 24,846 $ 25,102 $ 21,098 Net loss $ (26,144) $ (25,467) $ (23,539) $ (19,790) Net loss per share - basic and diluted $ (0.42) $ (0.41) $ (0.37) $ (0.27) |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2020segment | |
Organization and Basis of Presentation | |
Number of operating segments | 1 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Prior Period Errors (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Research and development | $ 65,053 | $ 71,677 | $ 69,373 |
Accrued expenses and other current liabilities | $ 6,657 | 7,248 | |
Overstatement due to clinical trial accrual errors | Effect of Change | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Research and development | 3,600 | ||
Accrued expenses and other current liabilities | $ 3,600 | $ 3,600 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Cumulative Adjustments (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Reduction in accrued and other liabilities | |
Quantifying Misstatement in Current Year Financial Statements [Line Items] | |
Correction of cumulative errors | $ 3.6 |
Reduction in research and development expenses | |
Quantifying Misstatement in Current Year Financial Statements [Line Items] | |
Correction of cumulative errors | $ 3.6 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Liquidity (Details) - USD ($) $ in Thousands | Nov. 22, 2019 | Dec. 31, 2019 | Dec. 31, 2020 | Feb. 28, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Subsidiary, Sale of Stock [Line Items] | ||||||
Cash and investments | $ 188,602 | $ 188,602 | ||||
Proceeds from issuance of common stock | $ 134,900 | $ 21,700 | $ 56,700 | |||
Proceeds from issuance of common stock upon private placement, net of issuance costs | $ 19,975 | |||||
At-the-Market offering | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Proceeds from issuance of common stock | 21,047 | |||||
2019 offering | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Proceeds from issuance of common stock | 134,900 | |||||
Private Placement | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Proceeds from issuance of common stock | $ 20,000 | |||||
Proceeds from issuance of common stock upon private placement, net of issuance costs | $ 20,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2019 | Jan. 01, 2018 | |
Summary of significant accounting policies | |||||
Cash and cash equivalents original maturity dates | 90 days | ||||
Short-term investments maturity period description | Short-term investments consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than one year, from the date of acquisition. | ||||
Impairment loss of long-lived assets | $ 0 | $ 0 | $ 0 | ||
Accumulated deficit | $ (554,765) | (460,452) | |||
Unbilled revenue | 750 | ||||
Minimum | |||||
Summary of significant accounting policies | |||||
Estimated useful lives | 3 years | ||||
Maximum | |||||
Summary of significant accounting policies | |||||
Estimated useful lives | 5 years | ||||
Astra Zeneca | |||||
Summary of significant accounting policies | |||||
Uncharged license fee | $ 1,000 | ||||
ASU 2014-09 | Adjustments | Kyowa Hakko Kirin | |||||
Summary of significant accounting policies | |||||
Accumulated deficit | $ 4,000 | ||||
Unbilled revenue | $ 0 | 5,000 | |||
Uncharged license fee | $ 1,000 |
Cash and Investments - Schedule
Cash and Investments - Schedule of Securities Classified as Cash and Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Cash and cash equivalents, Amortized Cost | $ 91,032 | $ 181,133 | $ 78,768 | $ 75,383 |
Cash and cash equivalents, Amortized Cost | 181,130 | |||
Cash and cash equivalents, Gross Unrealized Gains | 3 | |||
Cash and cash equivalents, Fair Value | 91,032 | 181,133 | ||
Short-term investments, Amortized Cost | 95,455 | 66,362 | ||
Short-term investments, Gross Unrealized Gains | 7 | 20 | ||
Short-term investments, Gross Unrealized Losses | (10) | (3) | ||
Short-term investments, Fair Value | 95,452 | 66,379 | ||
Cash equivalents and short-term investments, Amortized Cost | 247,492 | |||
Cash equivalents and investments, Amortized Cost | 188,602 | |||
Cash equivalents and short-term investments, Gross Unrealized Gains | 23 | |||
Cash equivalents and short-term investments, Gross Unrealized Losses | (3) | |||
Cash equivalents and short-term investments, Fair Value | 247,512 | |||
Cash equivalents and investments, Gross Unrealized Gains | 7 | |||
Cash equivalents and investments, Gross Unrealized Losses | (11) | |||
Cash equivalents and investments, Fair Value | 188,598 | |||
Money Market Funds [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Cash and cash equivalents, Amortized Cost | 88,151 | 147,208 | ||
Cash and cash equivalents, Fair Value | 88,151 | 147,208 | ||
Commercial Paper (Cash Equivalents) [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Cash and cash equivalents, Fair Value | 19,360 | |||
Short-term investments, Amortized Cost | 2,100 | 19,357 | ||
Short-term investments, Gross Unrealized Gains | 3 | |||
Short-term investments, Fair Value | 2,100 | |||
Corporate Bonds (Investments) [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Cash and cash equivalents, Fair Value | 11,441 | |||
Short-term investments, Amortized Cost | 11,441 | |||
Cash [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Cash and cash equivalents, Amortized Cost | 781 | 3,124 | ||
Cash and cash equivalents, Fair Value | 781 | 3,124 | ||
Commercial Paper (Investments) [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Short-term investments, Amortized Cost | 60,631 | 21,690 | ||
Short-term investments, Gross Unrealized Gains | 2 | 6 | ||
Short-term investments, Gross Unrealized Losses | (4) | (3) | ||
Short-term investments, Fair Value | 60,629 | 21,693 | ||
Corporate Bonds (Investments) [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Short-term investments, Amortized Cost | 24,547 | 36,667 | ||
Short-term investments, Gross Unrealized Gains | 3 | 14 | ||
Short-term investments, Gross Unrealized Losses | (6) | |||
Short-term investments, Fair Value | 24,544 | 36,681 | ||
Long-term investments, Amortized Cost | 2,115 | |||
Long-term investments, Gross Unrealized Losses | (1) | |||
Long-term Investments, Fair Value | 2,114 | |||
U.S. Government-Sponsored Agency Bonds [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Short-term investments, Amortized Cost | 9,277 | |||
Short-term investments, Gross Unrealized Gains | 2 | |||
Short-term investments, Fair Value | 9,279 | |||
Asset-Backed Securities [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Short-term investments, Amortized Cost | 8,005 | |||
Short-term investments, Fair Value | $ 8,005 | |||
U.S. Treasury Notes [Member] | ||||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||||
Short-term investments, Amortized Cost | 1,000 | |||
Short-term investments, Fair Value | $ 1,000 |
Cash and Investments - Addition
Cash and Investments - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||
Investment in continuous unrealized loss position for more than one year | $ 0 | $ 0 |
Maximum | ||
Cash Cash Equivalents, Short Term Investments And Long-Term Investments [Line Items] | ||
Available for sale securities contractual maturity period | 1 year | 1 year |
Cash and Investments - Amortize
Cash and Investments - Amortized Cost and Estimated Fair Value of Available-for-sale Debt Securities (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Amortized Cost | |
Due in one year or less | $ 95,455 |
Due in one to two years | 2,115 |
Total | 97,570 |
Fair Value | |
Due in one year or less | 95,452 |
Due in one to two years | 2,114 |
Total | $ 97,566 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value Measurements of Company's Financial Assets and Liabilities (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Assets at fair value | $ 187,817 | $ 244,388 |
Liabilities: | ||
Derivative liability | 1,376 | 969 |
Level 1 [Member] | ||
Assets: | ||
Assets at fair value | 88,151 | 147,208 |
Level 2 [Member] | ||
Assets: | ||
Assets at fair value | 99,666 | 97,180 |
Level 3 [Member] | ||
Liabilities: | ||
Derivative liability | 1,376 | 969 |
Derivative Liability Exit Fee [Member] | ||
Liabilities: | ||
Derivative liability | 1,376 | 969 |
Derivative Liability Exit Fee [Member] | Level 3 [Member] | ||
Liabilities: | ||
Derivative liability | 1,376 | 969 |
Money Market Funds [Member] | ||
Assets: | ||
Assets at fair value | 88,151 | 147,208 |
Money Market Funds [Member] | Level 1 [Member] | ||
Assets: | ||
Assets at fair value | 88,151 | 147,208 |
Commercial Paper [Member] | ||
Assets: | ||
Assets at fair value | 62,729 | 56,041 |
Commercial Paper [Member] | Level 2 [Member] | ||
Assets: | ||
Assets at fair value | 62,729 | 56,041 |
Corporate Bonds [Member] | ||
Assets: | ||
Assets at fair value | 26,658 | 33,134 |
Corporate Bonds [Member] | Level 2 [Member] | ||
Assets: | ||
Assets at fair value | 26,658 | 33,134 |
U.S. Government-Sponsored Agency Bonds [Member] | ||
Assets: | ||
Assets at fair value | 9,279 | |
U.S. Government-Sponsored Agency Bonds [Member] | Level 2 [Member] | ||
Assets: | ||
Assets at fair value | 9,279 | |
Asset-Backed Securities [Member] | ||
Assets: | ||
Assets at fair value | 8,005 | |
Asset-Backed Securities [Member] | Level 2 [Member] | ||
Assets: | ||
Assets at fair value | $ 8,005 | |
U.S. Treasury Notes [Member] | ||
Assets: | ||
Assets at fair value | 1,000 | |
U.S. Treasury Notes [Member] | Level 2 [Member] | ||
Assets: | ||
Assets at fair value | $ 1,000 |
Derivative Liability - Addition
Derivative Liability - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
May 31, 2018 | Dec. 31, 2020 | |
Derivative [Line Items] | ||
Exit Fee | $ 1.5 | |
Solar Capital and Western Alliance Bank Loan Agreement [Member] | Level 3 [Member] | ||
Derivative [Line Items] | ||
Potential payment to Solar Capital Ltd. and Western Alliance Bank | $ 1.5 | |
Percentage increase in risk component | 10.00% | |
Percentage decrease in risk component | 10.00% | |
Fair value fluctuation due to decrease in risk component | $ 0.1 | |
Solar Capital and Western Alliance Bank Loan Agreement [Member] | Level 3 [Member] | Maximum | ||
Derivative [Line Items] | ||
Percentage increase in risk component | 100.00% | |
Fair value fluctuation due to increase in risk component | $ 0.1 |
Derivative Liability - Schedule
Derivative Liability - Schedule of Changes in Fair Value (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Derivative Liability | |||
Fair value of Exit Fee derivative liability at beginning | $ 969 | $ 533 | |
Change in estimated fair value of derivative liability | 407 | 436 | $ 533 |
Fair value of Exit Fee derivative liability at ending | $ 1,376 | $ 969 | $ 533 |
Borrowings (Details)
Borrowings (Details) - USD ($) $ in Thousands | Oct. 09, 2020 | May 16, 2018 | Dec. 31, 2018 | Dec. 31, 2020 | Dec. 31, 2019 |
Term Loans | |||||
Term loan amount | $ 50,000 | ||||
Net proceeds from the loan | $ 49,300 | $ 49,292 | |||
Interest-only payment extension term (in years) | 12 months | 6 months | |||
Amount of fee payable upon closing of the term loan | $ 100 | $ 500 | |||
Additional default interest rate | 4.00% | ||||
Future debt payment obligations | |||||
2021 | $ 4,167 | ||||
2022 | 48,308 | ||||
Total repayment obligations | 52,475 | ||||
Less: Unamortized discount and debt issuance costs | (518) | ||||
Less: Unaccreted value of final fee | (1,169) | ||||
Loan payable | 50,788 | ||||
Less: Loan payable, current portion | (4,167) | $ (1,183) | |||
Loan payable, net of current portion | $ 46,621 | $ 48,831 | |||
At Maturity | |||||
Term Loans | |||||
Final payment fee (as a percent) | 4.95% | 3.95% | |||
Prior to first anniversary of closing date | |||||
Term Loans | |||||
Prepayment fee (as a percent) | 3.00% | ||||
After first anniversary of closing date | |||||
Term Loans | |||||
Prepayment fee (as a percent) | 2.00% | ||||
After second anniversary to maturity date | |||||
Term Loans | |||||
Prepayment fee (as a percent) | 1.00% | ||||
LIBOR | |||||
Term Loans | |||||
Base interest rate | 7.45% | ||||
Floating interest rate | one-month LIBOR |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 09, 2019 | Nov. 22, 2019 | Jun. 25, 2018 | May 25, 2018 | Dec. 31, 2019 | Jun. 30, 2015 | Feb. 28, 2021 | Dec. 31, 2020 | Feb. 28, 2021 | Dec. 31, 2020 | Jul. 31, 2020 |
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Warrants sold and issued to purchase common stock | 2,200,000 | ||||||||||
Purchase price of common shares | $ 0.125 | ||||||||||
Exercise price for warrants | $ 13.91 | ||||||||||
Warrant exercise period | 5 years | ||||||||||
Warrants exercised | 0 | ||||||||||
Common stock sold and issued | 3,300,000 | 8,200,000 | |||||||||
Common stock issued | 14.4 | 88,817,741 | 93,599,975 | 93,599,975 | |||||||
Public offering price | $ 6.25 | ||||||||||
Maximum aggregate offering price | $ 250,000 | ||||||||||
Weighted average share price | $ 6.65 | $ 6.91 | |||||||||
Percentage of commission | 3.00% | ||||||||||
Underwriting discounts and commissions | $ 8,900 | ||||||||||
Gross proceeds | 143,800 | ||||||||||
Proceeds from issuance of common stock | $ 134,900 | $ 21,700 | $ 56,700 | ||||||||
Subsequent Event | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock sold and issued | 4,900,000 | ||||||||||
Weighted average share price | $ 7.09 | ||||||||||
Proceeds from issuance of common stock | $ 35,000 | ||||||||||
Offering | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock issued | 12.5 | ||||||||||
Public offering price | $ 4 | ||||||||||
2019 offering | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock issued | 20 | ||||||||||
Proceeds from issuance of common stock | $ 134,900 | ||||||||||
At-the-Market offering | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock | $ 21,047 | ||||||||||
Underwriters' Option | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock issued | 1.9 | 3 | |||||||||
Underwriting discounts and commissions | $ 3,700 | ||||||||||
Number of days to underwriters to sell additional common shares | 30 days | 30 days | |||||||||
Gross proceeds | 57,500 | ||||||||||
Proceeds from issuance of common stock | $ 53,800 | ||||||||||
Private Placement | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock issued | 2.9 | ||||||||||
Public offering price | $ 6.96 | ||||||||||
Proceeds from issuance of common stock | $ 20,000 | ||||||||||
2019 Offering and Over-Allotment Option | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock issued | 23 | ||||||||||
Common Stock | At-the-Market offering | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Maximum aggregate offering price | $ 100,000 |
Equity Incentive Plans - Additi
Equity Incentive Plans - Additional Information (Details) $ in Thousands | Jun. 18, 2014shares | Sep. 30, 2020shares | Jul. 31, 2018shares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Nov. 30, 2016shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Weighted-average grant-date estimated fair value of options granted | $ / shares | $ 4.82 | $ 1.79 | $ 4.29 | ||||
Number of options exercised | 445,942 | ||||||
Vesting period | 4 years | ||||||
Common stock reserved | 1,500,000 | ||||||
Number of options granted during the period | 3,727,947 | ||||||
Maximum shares to be issued up on exercise of incentive stock options | 1,200,000 | ||||||
Fair Value of exercise price | $ / shares | 6.47 | ||||||
Estimated fair value of options exercised during period | $ | $ 2,700 | $ 400 | $ 0 | ||||
Estimated fair value of restricted stock vested during period | $ | 0 | 200 | 600 | ||||
Stock-based compensation expenses | $ | 10,583 | 9,936 | 9,226 | ||||
Proceeds | $ | 834 | 396 | $ 491 | ||||
Recognized stock-based compensation related expense in connection with vesting of award granted | $ | $ 1,200 | $ 0 | |||||
Issuance of common stock for services, shares | 42,403 | 113,000 | 75,000 | ||||
Issuance of common stock for services, amount | $ | $ 310 | $ 312 | $ 303 | ||||
2014 Equity Incentive Award Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common stock reserved | 1,419,328 | ||||||
Maximum shares to be issued up on exercise of incentive stock options | 10,700,000 | ||||||
Possible increase in shares reserved for issuance as percentage of outstanding stock | 4.00% | ||||||
2008 Stock Incentive Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Increase in shares reserved for issuance | 35,000 | ||||||
2016 Employment Commencement Incentive Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options granted during the period | 400,000 | ||||||
2016 Employment Commencement Incentive Plan [Member] | Board of Directors [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common stock reserved | 1,000,000 | ||||||
Restricted Stock Units (RSUs) [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation expenses | $ | $ 30 | $ 300 | $ 900 | ||||
Performance-Based Restricted Stock Units (PRSUs) [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of shares, granted | 900,000 | 30,000 | |||||
Number of shares, outstanding | 0 | 849,757 | |||||
Number of vested shares | 900,000 | 866,528 | 0 | 0 |
Equity Incentive Plans - Summar
Equity Incentive Plans - Summary of Activity Under 2008 Plan, 2014 Plan and Inducement Plan Including Grants to Nonemployees Issued (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Equity Incentive Plans | |||
Shares Available for Grant, Beginning balance | 1,196,746 | ||
Shares Available for Grant, Options authorized | 3,552,709 | ||
Shares Available for Grant, Options granted | (3,727,947) | ||
Shares Available for Grant, Options exercised | 0 | ||
Shares Available for Grant, Options canceled | 764,724 | ||
Issuance of common stock for services and restricted stock units, net of forfeitures | (13,229) | ||
Shares Available for Grant, Issuance of common stock for services | (42,403) | (113,000) | (75,000) |
Shares Available for Grant, Ending balance | 1,757,058 | 1,196,746 | |
Options Issued and Outstanding Number of Shares, Beginning balance | 7,272,768 | ||
Options Issued and Outstanding Number of Shares, Options authorized | 0 | ||
Options Issued and Outstanding Number of Shares, Options granted | 3,727,947 | ||
Options Issued and Outstanding Number of Shares, Options exercised | (445,942) | ||
Options Issued and Outstanding Number, Options canceled | (764,724) | ||
Options Issued and Outstanding Number of Shares, Issuance of common stock for services | 0 | ||
Options Issued and Outstanding Number of Shares, Ending balance | 9,790,049 | 7,272,768 | |
Options Issued and Outstanding Number of Shares, Expected to vest | 9,790,049 | ||
Options Issued and Outstanding Number of Shares, Exercisable | 5,230,640 | ||
Options Issued and Outstanding Average Exercise Price per Share, Beginning balance | $ 6.55 | ||
Options Issued and Outstanding Average Exercise Price per Share, Options granted | 6.89 | ||
Options Issued and Outstanding Average Exercise Price per Share, Options exercised | 2.29 | ||
Options Issued and Outstanding Average Exercise Price per Share, Options canceled | 8.03 | ||
Options Issued and Outstanding Average Exercise Price per Share, Issuance of common stock for services | 0 | ||
Options Issued and Outstanding Average Exercise Price per Share, Ending balance | 6.76 | $ 6.55 | |
Options Issued and Outstanding Average Exercise Price per Share, Expected to vest | 6.76 | ||
Options Issued and Outstanding Average Exercise Price per Share, Exercisable | $ 7.53 | ||
Weighted Average Remaining Contractual Term, Ending Balance | 7 years 5 months 8 days | ||
Weighted Average Remaining Contractual Term, Vested and Expected to Vest | 7 years 5 months 8 days | ||
Weighted Average Remaining Contractual Term, Exercisable | 6 years 2 months 23 days | ||
Aggregate Intrinsic Value, Ending balance | $ 12,797 | ||
Aggregate Intrinsic Value, Expected to Vest | 12,797 | ||
Aggregate Intrinsic Value, Exercisable | $ 7,765 |
Equity Incentive Plans - Summ_2
Equity Incentive Plans - Summary of Non-Vested RSU Activity (Details) - $ / shares | 1 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Jul. 31, 2018 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Service Based Restricted Stock Units [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of Shares, Granted | 158,626 | ||||
Number of Shares, Ending balance | 158,626 | ||||
Weighted-Average Grant Date Fair Value Per Share, Granted | $ 5.64 | ||||
Weighted-Average Grant Date Fair Value Per Share, Ending balance | $ 5.64 | ||||
Performance-Based Restricted Stock Units (PRSUs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of Shares, Beginning balance | 849,757 | ||||
Number of Shares, Granted | 900,000 | 30,000 | |||
Number of Shares, Vested | (900,000) | (866,528) | 0 | 0 | |
Number of Shares, Forfeited | (13,229) | ||||
Number of Shares, Ending balance | 0 | 849,757 | |||
Weighted-Average Grant Date Fair Value Per Share, Beginning balance | $ 4.30 | ||||
Weighted-Average Grant Date Fair Value Per Share, Granted | 7.58 | ||||
Weighted-Average Grant Date Fair Value Per Share, Vested | 4.41 | ||||
Weighted-Average Grant Date Fair Value Per Share, Forfeited | 4.30 | ||||
Weighted-Average Grant Date Fair Value Per Share, Ending balance | $ 0 | $ 4.30 |
Equity Incentive Plans - Summ_3
Equity Incentive Plans - Summary of Weighted-Average Assumptions to Estimate Fair Value of Employee Stock Options (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected term (years) | 6 years |
Expected volatility | 83.00% |
Risk-free interest rate | 1.07% |
Dividend yield | 0.00% |
2014 Employee Stock Purchase Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected term (years) | 6 months |
Expected volatility | 79.40% |
Risk-free interest rate | 0.48% |
Dividend yield | 0.00% |
Equity Incentive Plans - Employ
Equity Incentive Plans - Employee Stock Purchase Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 18, 2014 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares Available for Grant, Beginning balance | 1,196,746 | |
Shares Available for Grant, Shares authorized | 3,552,709 | |
Shares Available for Grant, Ending balance | 1,757,058 | |
Options Issued and Outstanding Number of Shares, Beginning balance | 7,272,768 | |
Options Issued and Outstanding Number of Shares, Ending balance | 9,790,049 | |
Common stock reserved | 1,500,000 | |
Maximum shares to be issued up on exercise of incentive stock options | 1,200,000 | |
2014 Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares Available for Grant, Beginning balance | 519,578 | |
Shares Available of Grant, Shares purchased | 169,931 | |
Shares Available for Grant, Ending balance | 349,647 | |
Options Issued and Outstanding Number of Shares, Beginning balance | 491,680 | |
Number of shares issued under ESPP | (169,931) | |
Options Issued and Outstanding Number of Shares, Ending balance | 661,611 | |
Purchase Price per Share | $ 4.91 | |
Gross Proceeds | $ 834 | |
Common stock reserved | 200,000 | |
Possible increase in shares reserved for issuance as percentage of outstanding stock | 1.00% | |
Maximum shares to be issued up on exercise of incentive stock options | 2,230,374 |
Equity Incentive Plans - Summ_4
Equity Incentive Plans - Summary of Stock-Based Compensation Expense Recognized (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expenses | $ 10,583 | $ 9,936 | $ 9,226 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expenses | 4,061 | 4,104 | 3,666 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expenses | $ 6,522 | $ 5,832 | $ 5,560 |
Equity Incentive Plans - Unreco
Equity Incentive Plans - Unrecognized Stock-Based Compensation (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Options to Purchase Common Stock [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized Compensation Expense | $ 17,662 |
Average Vesting Period | 2 years 9 months 18 days |
Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized Compensation Expense | $ 860 |
Average Vesting Period | 3 years 10 months 24 days |
Employee Stock Purchase Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized Compensation Expense | $ 108 |
Average Vesting Period | 1 month 6 days |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 16,386 | $ 16,062 |
Less: accumulated depreciation | (14,450) | (12,626) |
Total property and equipment, net | 1,936 | 3,436 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 7,268 | 7,243 |
Office Equipment And Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,133 | 870 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 7,985 | $ 7,949 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property and Equipment | |||
Depreciation and amortization expense | $ 1.8 | $ 2.5 | $ 2.7 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Liabilities and Other Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued Expenses and Other Current Liabilities | ||
Accrued clinical expenses | $ 2,197 | $ 3,451 |
Accrued contract manufacturing expenses | 1,840 | 1,414 |
Derivative liability for exit fee | 1,376 | 969 |
Accrued sales and marketing expenses | 593 | 122 |
Accrued professional and consulting services | 243 | 201 |
Accrued regulatory services | 123 | 342 |
Other | 285 | 749 |
Accrued liabilities and other liabilities | $ 6,657 | $ 7,248 |
Leases (Details)
Leases (Details) | 12 Months Ended | |||
Dec. 31, 2020ft²lease | Oct. 31, 2020ft² | Oct. 31, 2018ft² | Apr. 30, 2016ft² | |
Lessee, Lease, Description [Line Items] | ||||
Number of operating lease arrangements | lease | 3 | |||
Area of office space | ft² | 10,716 | 4,768 | 3,520 | 72,500 |
Option to extend | true | |||
Weighted-average discount rate | 11.70% | |||
Weighted-average remaining life | 1 year 6 months | |||
Maximum | ||||
Lessee, Lease, Description [Line Items] | ||||
Renewal term | 5 years |
Leases - Balance Sheet and Stat
Leases - Balance Sheet and Statement of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2020 | |
Additional details of the leases | ||||
Right-of-use assets | $ 2,274 | $ 3,970 | $ 400 | |
Current portion of lease liabilities | 2,117 | 2,608 | ||
Operating lease liability, net of current portion | 413 | 2,076 | ||
Total operating lease liabilities | $ 2,530 | $ 400 | ||
Weighted-average remaining life | 1 year 6 months | |||
Weighted-average discount rate | 11.70% | |||
Facilities | ||||
Operating lease expense | $ 2,608 | 2,592 | $ 1,800 | |
Cash paid for operating lease | $ 3,065 | $ 2,645 |
Leases - Undiscounted Cash Paym
Leases - Undiscounted Cash Payment Obligations (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Nov. 30, 2020 | Dec. 31, 2019 |
Undiscounted cash payment obligations for its operating lease liabilities | |||
2021 | $ 2,280 | ||
2022 | 104 | ||
2023 | 111 | ||
2024 | 115 | ||
2025 | 119 | ||
Thereafter | 20 | ||
Total undiscounted operating lease payments | 2,749 | ||
Imputed interest expenses | (219) | ||
Total operating lease liabilities | 2,530 | $ 400 | |
Current portion of operating lease liability | 2,117 | $ 2,608 | |
Operating lease liability, net of current portion | $ 413 | $ 2,076 |
Collaboration and Licensing A_3
Collaboration and Licensing Agreements - Additional Information (Details) $ in Thousands, $ in Millions, ¥ in Billions | Nov. 02, 2018USD ($) | Nov. 30, 2019USD ($)item | Feb. 28, 2019USD ($) | Dec. 31, 2017USD ($) | Nov. 30, 2017USD ($) | Jun. 30, 2015USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020JPY (¥) | Dec. 31, 2020CAD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Mar. 31, 2019USD ($) | Jan. 01, 2018USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | $ 1,809 | $ 2,713 | $ 1,836 | $ 1,213 | $ 2,250 | $ 3,013 | $ 18 | $ 7,571 | $ 5,281 | $ 2,607 | |||||||||||
Unbilled revenue | 750 | 750 | |||||||||||||||||||
Total payments, including an up-front payment and development and sales milestones to be received | 19,600 | ||||||||||||||||||||
Cost of revenue | 145 | 600 | 466 | ||||||||||||||||||
Licensing | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 706 | 4,500 | 2,320 | ||||||||||||||||||
Kyowa Kirin Co. Ltd | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Number of pre-clinical study-ready compounds | item | 2 | ||||||||||||||||||||
Number of compounds inhibiting the first undisclosed target | item | 1 | ||||||||||||||||||||
Upfront payment recognized | $ 10,000 | ||||||||||||||||||||
License fee receivable, first installment | $ 5,000 | ||||||||||||||||||||
Term of payment of license fee, first installment | 30 days | ||||||||||||||||||||
License fee receivable, Second instalment | $ 5,000 | ||||||||||||||||||||
Term of agreement | 2 years | ||||||||||||||||||||
Initial transaction price | $ 10,000 | ||||||||||||||||||||
Revenue | 5,400 | 500 | |||||||||||||||||||
Transaction price allocated to partially unsatisfied performance obligations | 9,500 | 9,500 | |||||||||||||||||||
Contract with customer, liability | 4,500 | 4,500 | |||||||||||||||||||
Kyowa Kirin Co. Ltd | Minimum | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Number of development candidates | item | 1 | ||||||||||||||||||||
Number of separate collaborative agreements | item | 1 | ||||||||||||||||||||
Kyowa Hakko Kirin | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Upfront payment received | $ 30,000 | ||||||||||||||||||||
Kyowa Hakko Kirin | Product | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 1,400 | 300 | 300 | ||||||||||||||||||
Xuanzhu Hk Biopharmaceutical Limited Or Xuanzhu [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | $ 1,500 | ||||||||||||||||||||
Upfront payment received | 800 | ||||||||||||||||||||
License fee recognized | 1,500 | ||||||||||||||||||||
Second milestone payment | $ 800 | ||||||||||||||||||||
Cost of revenue | 0 | ||||||||||||||||||||
Fosun Pharma | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 0 | 3,000 | 0 | ||||||||||||||||||
Upfront payment received | $ 12,000 | ||||||||||||||||||||
Future development milestones | $ 110,000 | ||||||||||||||||||||
Threshold percentage of net sales for tiered royalties | 20.00% | ||||||||||||||||||||
Fosun Pharma | Adjustments | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | $ 0 | ||||||||||||||||||||
XuanZhu | Licensing | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 0 | ||||||||||||||||||||
Astra Zeneca | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Uncharged license fee | $ 1,000 | ||||||||||||||||||||
Cost of revenue | 145 | 600 | 466 | $ 9,400 | |||||||||||||||||
Cost of revenue, aggregate amount recognized | 10,611 | 10,611 | |||||||||||||||||||
Cost of revenue, Amount Paid | 742 | 1,002 | 2,864 | $ 6,000 | |||||||||||||||||
Payments of uncharged license fees, aggregate amount paid | 10,608 | 10,608 | |||||||||||||||||||
Remaining balance | $ 64,392 | 64,392 | |||||||||||||||||||
Astra Zeneca | Maximum | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Payment per termination agreement | $ 75,000 | ||||||||||||||||||||
Astra Zeneca | Adjustments | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Cost of revenue | $ 1,000 | ||||||||||||||||||||
License Agreement [Member] | XuanZhu | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 1,500 | ||||||||||||||||||||
Development and Commercialization | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 700 | 0 | 2,300 | ||||||||||||||||||
Cost of revenue | 100 | 0 | 500 | ||||||||||||||||||
Development and Commercialization | Product | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 100 | 0 | $ 0 | ||||||||||||||||||
Development and Commercialization | Kyowa Hakko Kirin | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Development milestones | 55,000 | ||||||||||||||||||||
Development milestones received | 5,000 | ||||||||||||||||||||
Commercialization milestones | $ 82,400 | ¥ 8.5 | |||||||||||||||||||
Development and Commercialization | Astra Zeneca | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Percentage of royalty revenue (as a percent) | 10.00% | ||||||||||||||||||||
Percentage of non royalty revenue (as a percent) | 20.00% | ||||||||||||||||||||
Development and Commercialization | Knight | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Total payments, including an up-front payment and development and sales milestones to be received | $ 25 | ||||||||||||||||||||
ASU 2014-09 | Kyowa Hakko Kirin | Adjustments | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Unbilled revenue | $ 0 | $ 0 | $ 5,000 | ||||||||||||||||||
Uncharged license fee | $ 1,000 |
Income Taxes - (Details)
Income Taxes - (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Current: | |||
State | $ 2 | $ 2 | $ 4 |
Foreign | 301 | ||
Total current | 2 | 303 | 4 |
Provision for (benefit from) income taxes | $ 2 | $ 303 | $ 4 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory Federal Income Tax Rate to the Company's Effective Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes | |||
Change in valuation allowance | (22.30%) | (21.90%) | (22.50%) |
Income tax at the federal statutory rate | 21.00% | 21.00% | 21.00% |
Tax credits | 1.30% | 1.60% | 1.40% |
State taxes, net of federal benefit | 0.70% | 0.30% | 0.60% |
Stock based compensation | (0.10%) | (0.90%) | (1.20%) |
Other | (0.60%) | (0.40%) | 0.70% |
Income tax provision | 0.00% | (0.30%) |
Income Taxes - Significant Comp
Income Taxes - Significant Components of the Company's Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred Tax Assets, Net [Abstract] | ||
Amortization and depreciation | $ 51,370 | $ 45,555 |
Net operating loss carryforwards | 53,436 | 40,896 |
Tax credits | 11,777 | 10,136 |
Stock-based compensation | 5,524 | 4,853 |
Lease obligation | 1,804 | 984 |
Other | 0 | 940 |
Gross deferred tax assets | 123,911 | 103,364 |
Valuation allowance | (123,402) | (102,344) |
Deferred tax assets net of valuation allowance | 509 | 1,020 |
Deferred Tax Liabilities, Net [Abstract] | ||
Right of use asset | (479) | (834) |
Revenue recognition | 0 | (158) |
Other | (30) | (28) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Line Items] | |||
Income tax, federal statutory rate | 21.00% | 21.00% | 21.00% |
California | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 88.3 | ||
Minimum Tax Credit Carryforward [Member] | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforwards | 0.1 | ||
Federal Tax Authority [Member] | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | 287.9 | ||
Net operating loss carryforwards, Without Expiration | 151 | ||
Federal Tax Authority [Member] | Research and Development Tax Credit [Member] | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforwards | 13.5 | ||
State Tax Authority [Member] | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | 1.9 | ||
State Tax Authority [Member] | Research and Development Tax Credit [Member] | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | 7.4 | ||
Foreign Tax Authority [Member] | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforwards | $ 1.2 |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes | |||
Balance at beginning of year | $ 24,538 | $ 23,052 | $ 20,734 |
Additions (subtractions) based on tax positions related to prior year | (1,388) | 755 | 1,634 |
Additions based on tax positions related to current year | 474 | 731 | 684 |
Balance at end of year | 23,624 | 24,538 | 23,052 |
Unrecognized tax benefits that would affect the effective tax rate if recognized | $ 13,300 | $ 13,200 | $ 9,800 |
Geographic Information and Co_3
Geographic Information and Concentrations (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||
Total revenues | $ 1,809 | $ 2,713 | $ 1,836 | $ 1,213 | $ 2,250 | $ 3,013 | $ 18 | $ 7,571 | $ 5,281 | $ 2,607 |
North America | ||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||
Total revenues | 806 | 2,320 | ||||||||
Asia Pacific | ||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||
Total revenues | $ 6,765 | 5,281 | $ 287 | |||||||
HONG KONG | ||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||
Total revenues | 1,500 | |||||||||
China | ||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||
Total revenues | 3,000 | |||||||||
KKC | Japan | 2019 KKC Agreement and 2017 KKC agreement | ||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||
Total revenues | $ 800 |
Geographic Information and Co_4
Geographic Information and Concentrations - Concentration Risk (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
KKC | |||
Concentration Risk [Line Items] | |||
Percentage of revenue | 89.00% | 15.00% | 11.00% |
Knight | |||
Concentration Risk [Line Items] | |||
Percentage of revenue | 11.00% | 89.00% | |
Fosun Pharma | |||
Concentration Risk [Line Items] | |||
Percentage of revenue | 57.00% | ||
XuanZhu | |||
Concentration Risk [Line Items] | |||
Percentage of revenue | 28.00% |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Basic and Diluted Loss Per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Numerator: | |||||||||||
Net loss | $ (28,876) | $ (18,108) | $ (24,956) | $ (22,373) | $ (19,790) | $ (23,539) | $ (25,467) | $ (26,144) | $ (94,313) | $ (94,940) | $ (91,298) |
Denominator: | |||||||||||
Weighted average common shares outstanding - basic and diluted | 89,582,138 | 64,478,066 | 56,219,919 | ||||||||
Net loss per share - basic and diluted | $ (0.32) | $ (0.20) | $ (0.28) | $ (0.25) | $ (0.27) | $ (0.37) | $ (0.41) | $ (0.42) | $ (1.05) | $ (1.47) | $ (1.62) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Details) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities not included in computation of diluted net loss per share attributable to common stockholders | 10,298,725 | 10,247,413 | 8,209,246 |
Potential common shares that would have been included in diluted income per share were not anti-dilutive effect caused by the net loss, computed by converting these securities using the treasury stock method | 2,100,000 | 1,100,000 | 1,000,000 |
Options to Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities not included in computation of diluted net loss per share attributable to common stockholders | 9,246,047 | 7,128,247 | 5,378,008 |
Warrants to Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities not included in computation of diluted net loss per share attributable to common stockholders | 932,091 | 2,172,899 | 2,172,899 |
Restricted Stock Units (RSUs) [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities not included in computation of diluted net loss per share attributable to common stockholders | 26,121 | 199,135 | |
Performance-Based Restricted Stock Units (PRSUs) [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities not included in computation of diluted net loss per share attributable to common stockholders | 867,506 | 395,791 | |
Employee Stock Purchase Plan [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities not included in computation of diluted net loss per share attributable to common stockholders | 94,466 | 78,761 | 63,413 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies | ||
Contingent liabilities | $ 0 | $ 0 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) - Schedule of Selected Quarterly Financial Results from Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Selected Quarterly Financial Data (Unaudited) | |||||||||||
Total revenues | $ 1,809 | $ 2,713 | $ 1,836 | $ 1,213 | $ 2,250 | $ 3,013 | $ 18 | $ 7,571 | $ 5,281 | $ 2,607 | |
Operating expenses | 29,452 | 19,874 | 26,043 | 22,982 | 21,098 | 25,102 | 24,846 | $ 25,498 | 98,351 | 96,544 | 93,554 |
Net loss | $ (28,876) | $ (18,108) | $ (24,956) | $ (22,373) | $ (19,790) | $ (23,539) | $ (25,467) | $ (26,144) | $ (94,313) | $ (94,940) | $ (91,298) |
Net loss per share: | |||||||||||
Net loss per share - basic and diluted | $ (0.32) | $ (0.20) | $ (0.28) | $ (0.25) | $ (0.27) | $ (0.37) | $ (0.41) | $ (0.42) | $ (1.05) | $ (1.47) | $ (1.62) |