Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 03, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Title of 12(b) Security | Common Stock $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes | |
Trading Symbol | DRRX | |
Entity Registrant Name | DURECT CORP | |
Entity Central Index Key | 0001082038 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 227,406,182 | |
Entity Shell Company | false | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 000-31615 | |
Entity Tax Identification Number | 94-3297098 | |
Entity Address, Address Line One | 10260 Bubb Road | |
Entity Address, City or Town | Cupertino | |
Entity Address, State or Province | CA | |
Entity Current Reporting Status | Yes | |
Entity Address, Postal Zip Code | 95014 | |
City Area Code | 408 | |
Local Phone Number | 777-1417 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 57,545 | $ 21,312 |
Cash held in escrow | 14,979 | |
Short-term investments | 39,538 | 19,421 |
Accounts receivable (net of allowances of $30 at March 31, 2021 and $72 at December 31, 2020) | 993 | 940 |
Inventories, net | 1,955 | 1,864 |
Prepaid expenses and other current assets | 4,780 | 4,545 |
Total current assets | 104,811 | 63,061 |
Property and equipment, net | 224 | 251 |
Operating lease right-of-use assets | 4,440 | 4,749 |
Goodwill | 6,169 | 6,169 |
Long-term investments | 1,000 | |
Long-term restricted investments | 150 | 150 |
Other long-term assets | 261 | 261 |
Total assets | 116,055 | 75,641 |
Current liabilities: | ||
Accounts payable | 2,150 | 1,678 |
Accrued liabilities | 4,094 | 5,801 |
Contract research liabilities | 384 | 545 |
Deferred revenue, current portion | 373 | |
Term loan, current portion, net | 2,895 | 884 |
Operating lease liabilities, current portion | 1,808 | 1,795 |
Total current liabilities | 11,704 | 10,703 |
Deferred revenue, non-current portion | 812 | 812 |
Operating lease liabilities, non-current portion | 2,881 | 3,202 |
Term loan, non-current portion, net | 18,062 | 19,936 |
Other long-term liabilities | 873 | 873 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock | 23 | 20 |
Additional paid-in capital | 581,632 | 529,884 |
Accumulated other comprehensive loss | (14) | (5) |
Accumulated deficit | (499,918) | (489,784) |
Stockholders’ equity | 81,723 | 40,115 |
Total liabilities and stockholders’ equity | $ 116,055 | $ 75,641 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Allowances for accounts receivable | $ 30 | $ 72 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Total revenues | $ 2,212 | $ 1,595 |
Operating expenses: | ||
Cost of product revenues | $ 352 | $ 396 |
Type of cost, good or service [extensible list] | Product Revenue, Net [Member] | Product Revenue, Net [Member] |
Research and development | $ 7,975 | $ 7,587 |
Selling, general and administrative | 3,531 | 3,431 |
Total operating expenses | 11,858 | 11,414 |
Loss from operations | (9,646) | (9,819) |
Other income (expense): | ||
Interest and other income | 37 | 258 |
Interest expense | (525) | (592) |
Net other expense | (488) | (334) |
Loss from continuing operations | (10,134) | (10,153) |
Income from discontinued operations | 205 | |
Net loss | (10,134) | (9,948) |
Net change in unrealized gain on available-for-sale securities, net of reclassification adjustments and taxes | (9) | (15) |
Total comprehensive loss | $ (10,143) | $ (9,963) |
Basic and diluted | ||
Loss from continuing operations | $ (0.05) | $ (0.05) |
Income from discontinued operations | 0 | |
Net loss per common share, basic and diluted | $ (0.05) | $ (0.05) |
Weighted-average shares used in computing net income (loss) per share, basic and diluted | 217,537 | 195,745 |
Collaborative Research and Development and Other Revenue [Member] | ||
Total revenues | $ 574 | $ (30) |
Product Revenue, Net [Member] | ||
Total revenues | $ 1,638 | $ 1,625 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional paid-in capital [Member] | Accumulated other comprehensive income (loss) [Member] | Accumulated deficit [Member] |
Beginning balance at Dec. 31, 2019 | $ 22,860 | $ 19 | $ 512,046 | $ (3) | $ (489,202) |
Beginning balance, shares at Dec. 31, 2019 | 195,257,000 | ||||
Stock-based compensation expense from stock options and ESPP shares | 761 | 761 | |||
Fully vested options issued to settle accrued liabilities | 416 | 416 | |||
Net loss | (9,948) | (9,948) | |||
Unrealized loss on available-for-sale securities, net of tax | (15) | (15) | |||
Ending balance at Mar. 31, 2020 | 14,074 | $ 19 | 513,223 | (18) | (499,150) |
Ending balance, shares at Mar. 31, 2020 | 195,834,000 | ||||
Stock-based compensation expense from stock options and ESPP shares, shares | 577,000 | ||||
Beginning balance at Dec. 31, 2020 | 40,115 | $ 20 | 529,884 | (5) | (489,784) |
Beginning balance, shares at Dec. 31, 2020 | 203,533,000 | ||||
Issuance of common stock upon exercise of stock options | 3,263 | $ 1 | 3,262 | ||
Issuance of common stock upon exercise of stock options, Shares | 2,502,000 | ||||
Issuance of common stock upon equity financings, net of issuance costs of $269 | 47,786 | $ 2 | 47,784 | ||
Issuance of common stock upon equity financings, net of issuance cost, shares | 21,315,000 | ||||
Stock-based compensation expense from stock options and ESPP shares | 702 | 702 | |||
Net loss | (10,134) | (10,134) | |||
Unrealized loss on available-for-sale securities, net of tax | (9) | (9) | |||
Ending balance at Mar. 31, 2021 | $ 81,723 | $ 23 | $ 581,632 | $ (14) | $ (499,918) |
Ending balance, shares at Mar. 31, 2021 | 227,350,000 |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Statement Of Stockholders Equity [Abstract] | |
Stock issuance costs | $ 269 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | ||
Cash flows from operating activities | |||
Net loss | $ (10,134) | $ (9,948) | |
Adjustments to reconcile net loss to net cash used in by operating activities: | |||
Depreciation and amortization | 30 | 62 | |
Stock-based compensation | 702 | 414 | |
Amortization of debt issuance cost | 111 | 112 | |
Net amortization on investments | (44) | 42 | |
Changes in operating lease liabilities | 1 | 21 | |
Changes in assets and liabilities: | |||
Accounts receivable | (53) | 606 | |
Inventories | (91) | 75 | |
Prepaid expenses and other assets | (235) | (1,343) | |
Accounts payable | 472 | (29) | |
Accrued and other liabilities | (1,680) | (2,800) | |
Contract research liabilities | (161) | (537) | |
Deferred revenue | 373 | 465 | |
Total adjustments | (575) | (2,912) | |
Net cash used in by operating activities | (10,709) | (12,860) | |
Cash flows from investing activities | |||
Purchases of property and equipment | (3) | (137) | |
Purchases of available-for-sale securities | (29,698) | (4,545) | |
Proceeds from maturities of available-for-sale securities | 10,616 | 14,435 | |
Net proceeds from sale of LACTEL product line | 14,979 | ||
Net cash (used in) provided by investing activities | (4,106) | 9,753 | |
Cash flows from financing activities | |||
Payments on equipment financing obligations | (1) | (1) | |
Net proceeds from issuances of common stock | 51,049 | 761 | |
Net cash provided by financing activities | 51,048 | 760 | |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 36,233 | (2,347) | |
Cash, cash equivalents, and restricted cash, beginning of the period | [1] | 21,462 | 35,074 |
Cash, cash equivalents, and restricted cash, end of the period | [1] | $ 57,695 | $ 32,727 |
[1] | Includes restricted cash of $150,000 (in long term restricted investments) included in the condensed balance sheets at March 31, 2021 and December 31, 2020. |
Condensed Statement of Cash Flo
Condensed Statement of Cash Flows (Parenthetical) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Long Term Restricted Investments [Member] | ||
Restricted cash | $ 150,000 | $ 150,000 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 1. Summary of Significant Accounting Policies Nature of Operations DURECT Corporation (the Company) was incorporated in the state of Delaware on February 6, 1998. The Company is a biopharmaceutical company with research and development programs broadly falling into two categories: (i) new chemical entities derived from our Epigenetics Regulator Program, in which the Company attempts to discover and develop molecules which have not previously been approved and marketed as therapeutics, and (ii) Proprietary Pharmaceutical Programs, in which the Company applies its formulation expertise and technologies largely to active pharmaceutical ingredients whose safety and efficacy have previously been established but which the Company aims to improve in some manner through a new formulation. The Company has several products under development by itself and with third party collaborators. The Company also manufactures and sells osmotic pumps used in laboratory research, and manufactures certain excipients for certain clients for use as raw materials in their products. In addition, the Company conducts research and development of pharmaceutical products in collaboration with third party pharmaceutical and biotechnology companies. Basis of Presentation These financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC), and therefore do not include all the information and footnotes necessary for a complete presentation of the Company’s results of operations, financial position and cash flows in conformity with U.S. generally accepted accounting principles (U.S. GAAP). The unaudited financial statements reflect all adjustments (consisting only of normal recurring adjustments) which are, in the opinion of management, necessary for a fair presentation of the financial position at March 31, 2021, the operating results and comprehensive loss, and stockholders’ equity for the three months ended March 31, 2021, and cash flows for the three months ended March 31, 2021 and 2020. The balance sheet as of December 31, 2020 has been derived from audited financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These financial statements and notes should be read in conjunction with the Company’s audited financial statements and notes thereto, included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC. The results of operations for the interim periods presented are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. Discontinued Operations In December 2020, the Company announced its decision to sell its LACTEL Absorbable Polymer (LACTEL) product line to Evonik, which was completed on December 31, 2020 and therefore the accompanying statement of operations for the three months ended March 31, 2020 has been recast to reflect the revenue and expenses related to the Company’s LACTEL product line as discontinued operations (see Note 8). The Company believes this format provides comparability with its previously filed financial statements. Risks and Uncertainties The pandemic caused by an outbreak of a new strain of coronavirus, COVID-19, has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect our business. COVID-19 initially also had a negative impact on orders for our ALZET product line as many ALZET customers reduced their activities during the pandemic. ALZET orders have recovered significantly in 2021, a trend that may or may Liquidity and Need to Raise Additional Capital As of March 31, 2021, the Company had an accumulated deficit of $499.9 million as well as negative cash flows from operating activities for the three months ended March 31, 2021, condensed financial statements are filed, may include seeking additional collaborative agreements for certain of the Company’s programs and achieving revenue from its collaboration and licensing agreements , as well as financing activities such as public offerings and private placements of its common stock, preferred stock offerings, issuances of debt and convertible debt instruments . There are no assurances that such additional funding will be obtained or that the Company will succeed in its future operations. If the Company cannot successfully raise additional capital when needed and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected. Inventories Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company may be required to expense previously capitalized inventory costs upon a change in management’s judgment due to new information that suggests that the inventory will not be saleable. If the Company is able to subsequently sell products made with raw materials that were previously written down, the Company will report an unusually high gross profit as there will be no associated cost of goods for these materials. The Company’s inventories consist of the following (in thousands): March 31, 2021 December 31, 2020 (unaudited) Raw materials $ 145 $ 136 Work in process 888 796 Finished goods 922 932 Total inventories $ 1,955 $ 1,864 Revenue Recognition The Company enters into license and collaboration agreements under which the Company may receive upfront license fees, research funding and contingent milestone payments and royalties. Product Revenue, Net The Company sells osmotic pumps used in laboratory research, and manufactures certain excipients for pharmaceutical clients for use as raw materials in their products. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon shipment to the customer. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less. Trade Discounts and Allowances: The Company provides certain customers with discounts that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. Product Returns: Consistent with industry practice, the Company generally offers customers a limited right of return for products that have been purchased from the Company. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using its historical sales information. Consistent with historical experience, the Company continues to expect product returns to be minimal. Collaborative Research and Development and Other Revenue The Company enters into license agreements, under which it licenses certain rights to its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; reimbursement of development costs incurred by the Company under approved work plans; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments results in collaborative research and development revenues, except for revenues from royalties on net sales of licensed products, which are classified as other revenues. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company 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 constraint 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 these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the standalone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company expects to recognize revenue for the variable consideration currently being constrained when it is probable that a significant revenue reversal will not occur. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up - front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up - front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaborative research and development revenues and net income (loss) in the period of adjustment. Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaborative research and development revenues and net income (loss) in the period of adjustment. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide a material right to the customer and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in collaborative research and development revenue when the customer obtains control of the goods, which is upon delivery. Royalties and Earn-outs: For arrangements that include sales-based royalties or earn-outs, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized material royalty revenue resulting from the Company’s collaborative arrangements or material earn-out revenue from the Company’s patent purchase agreement with Indivior. The Company receives payments from its customers based on development cost schedules established in each contract. Up-front payments 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. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Total revenue by geographic region (based on the location of the customer) for the three months ended March 31, 2021 and 2020 are as follows (in thousands): Three months ended March 31, 2021 2020 United States $ 1,248 $ 841 Japan 480 274 Europe 301 310 Other 183 170 Total $ 2,212 $ 1,595 Prepaid and Accrued Contract Research Expenses The Company incurs significant costs associated with third party consultants and organizations for pre-clinical studies, clinical trials, contract research and manufacturing, validation, testing, regulatory advice and other research and development-related services. The Company is required to estimate periodically the cost of services rendered but unbilled based on management’s estimates of project status. If these good faith estimates are inaccurate, actual expenses incurred could materially differ from these estimates. Research and development expenses are primarily comprised of salaries and benefits associated with research and development personnel, overhead and facility costs, preclinical and non-clinical development costs, clinical trial and related clinical manufacturing costs, contract services, and other outside costs. Research and development costs are expensed as incurred. Research and development costs paid to third parties under sponsored research agreements are recognized as the related services are performed. In addition, reimbursements of research and development expenses incurred by the Company’s partners are recorded as collaborative research and development revenue . Comprehensive Loss Components of other comprehensive loss are comprised entirely of unrealized gains and losses on the Company’s available-for-sale securities for all periods presented. Total comprehensive loss has been disclosed in the Company’s Statements of Comprehensive Loss. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding. Diluted net loss per share is computed using the weighted-average number of common shares outstanding and common stock equivalents (i.e., options to purchase common stock) outstanding during the period, if dilutive, using the treasury stock method for options. The numerators and denominators in the calculation of basic and diluted net loss per share were as follows (in thousands except per share amounts): Three months ended March 31, 2021 2020 Numerators: Net loss $ (10,134 ) $ (9,948 ) Denominator: Weighted average shares used to compute basic net loss per share 217,537 195,745 Dilutive common shares from stock options and ESPP — — Weighted average shares used to compute diluted net loss per share 217,537 195,745 Net loss per share: Basic $ (0.05 ) $ (0.05 ) Diluted $ (0.05 ) $ (0.05 ) Options to purchase approximately 4.8 million and 7.3 million shares of common stock were excluded from the denominator in the calculation of diluted net loss per share for the three months ended March 31, 2021 and March 31, 2020, respectively, as the effect would be anti-dilutive. Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update No. 2016-13 (ASU 2016-13) “Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments.” ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. This standard is effective for fiscal years beginning after December 15, 2022 for small reporting companies, including interim reporting periods within those years and must be adopted using a modified retrospective approach, with certain exceptions. Early adoption is permitted. The Company does not expect the adoption of this standard to have a material effect on its financial statements. |
Strategic Agreements
Strategic Agreements | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Strategic Agreements | Note 2. Strategic Agreements The collaborative research and development and other revenues associated with the Company’s collaborators or counterparties are as follows (in thousands): Three months ended March 31, 2021 2020 Collaborator/Counterparty Gilead (1) $ — $ (268 ) Others (2) 574 238 Total collaborative research and development and other revenue $ 574 $ (30 ) (1) Amounts related to recognition of a license upfront fee and milestone payment were zero and $(465,000) for the three months ended March 31, 2021 and 2020, respectively. The Company signed a license agreement with Gilead on July 19, 2019 and received a nonrefundable upfront license fee and a milestone payment totaling $35.0 million in 2019 which was being recognized as revenue as its obligation was being satisfied using the cost-to-cost input method. The Company recorded a net revenue reversal of $465,000 related to the upfront license fee and milestone payment in the three months ended March 31, 2020 due to a change in the Company’s estimated costs to complete its obligations under the license agreement, which was partially offset by $197,000 of reimbursable collaborative research and development services with Gilead earned during the quarter. In June 2020, the Company received notice that Gilead was terminating the License Agreement and a related R&D agreement between Gilead and the Company and as a result, the Company recognized all its remaining deferred revenue as there were no remaining substantive performance obligations to be provided to Gilead by the Company as of the date when the termination notice was received. (2) Includes: (a) amounts related to earn-out revenue from Indivior UK Limited (Indivior) with respect to PERSERIS net sales; (b) feasibility programs; (c) research and development activities funded by Santen Pharmaceutical Co. Ltd. (Santen); and (d) royalty revenue from OP Pharma with respect to Methydur net sales. Note that in January 2018, the Company was notified by Santen that due to a shift in priorities, Santen had elected to reallocate research and development resources and put the Company’s program on pause until further notice. While the main program is on pause, the parties are working together on a limited set of research and development activities funded by Santen. Patent Purchase Agreement with Indivior On September 26, 2017, the Company entered into a Patent Purchase Agreement (the “Indivior Agreement”) with Indivior. Pursuant to the Indivior Agreement, the Company assigned to Indivior certain patent rights including granted patents extending through at least 2026. The Indivior Agreement contains customary representations, warranties and indemnities of the parties. Amounts recognized in the three months ended March 31, 2021 and 2020 related to earn-out revenues from PERSERIS have been immaterial and are included in collaborative research and development and other revenue. Agreement with Santen Pharmaceutical Co., Ltd. On December 11, 2014, the Company and Santen Pharmaceutical Co., Ltd. (Santen) entered into a definitive agreement (the Santen Agreement). Pursuant to the Santen Agreement, the Company granted Santen an exclusive worldwide license to the Company’s proprietary SABER formulation platform and other intellectual property to develop and commercialize a sustained release product utilizing the Company’s SABER technology to deliver an ophthalmology drug. Santen controls and funds the development and commercialization program, and the parties established a joint management committee to oversee, review and coordinate the development activities of the parties under the Santen Agreement. In connection with the Santen agreement, Santen agreed to pay the Company an upfront fee of $2.0 million in cash and to make contingent cash payments to the Company of up to $76.0 million upon the achievement of certain milestones, of which $13.0 million are development-based milestones and $63.0 million are commercialization-based milestones including milestones requiring the achievement of certain product sales targets (none of which has been achieved as of March 31, 2021). Santen will also pay for certain Company costs incurred in the development of the licensed product. If the product is commercialized, the Company would also receive a tiered royalty on annual net product sales ranging from single-digit to the low double digits, determined on a country-by-country basis. In January 2018, the Company was notified by Santen that due to a shift in near term priorities, Santen elected to reallocate research and development resources and put the Company’s program on pause until further notice. While the main program is on pause, the parties are working together on a limited set of research and development activities funded by Santen. As of March 31, 2021, the cumulative aggregate payments received by the Company under this agreement were $3.3 million. |
Financial Instruments
Financial Instruments | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments | Note 3. Financial Instruments 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. The Company’s valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company follows a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value. These levels of inputs are the following: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—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. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s financial instruments are valued using quoted prices in active markets or based upon other observable inputs. Money market funds are classified as Level 1 financial assets. Certificates of deposit, commercial paper, municipal bonds, corporate debt securities, and U.S. Government agency securities are classified as Level 2 financial assets. The fair value of the Level 2 assets is estimated using pricing models using current observable market information for similar securities. The Company’s Level 2 investments include U.S. government-backed securities and corporate securities that are valued based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including market research publications. The fair value of commercial paper is based upon the time to maturity and discounted using the three-month treasury bill rate. The average remaining maturity of the Company’s Level 2 investments as of March 31, 2021 is less than twelve months and these investments are rated by S&P and Moody’s at AAA or AA- for securities and A1 , A2, P1 or P2 for commercial paper. The following is a summary of available-for-sale securities as of March 31, 2021 and December 31, 2020 (in thousands): March 31, 2021 Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Money market funds $ 1,152 $ — $ — $ 1,152 Certificates of deposit 150 — — 150 Commercial paper 86,094 — (10 ) 86,084 Municipal bonds 4,259 — (3 ) 4,256 Corporate debt 1,317 — (1 ) 1,316 $ 92,972 $ — $ (14 ) $ 92,958 Reported as: Cash and cash equivalents $ 53,272 $ — $ (2 ) $ 53,270 Short-term investments 39,550 — (12 ) 39,538 Long-term restricted investments 150 — — 150 $ 92,972 $ — $ (14 ) $ 92,958 December 31, 2020 Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Money market funds $ 522 $ — $ — $ 522 Certificates of deposit 150 — — 150 Commercial paper 32,213 2 (2 ) 32,213 Municipal bonds 6,310 — (5 ) 6,305 U.S. Government agencies 1,000 — — 1,000 $ 40,195 $ 2 $ (7 ) $ 40,190 Reported as: Cash and cash equivalents $ 19,619 $ 1 $ (1 ) $ 19,619 Short-term investments 19,426 1 (6 ) 19,421 Long-term investments $ 1,000 $ — $ — 1,000 Long-term restricted investments 150 — — 150 $ 40,195 $ 2 $ (7 ) $ 40,190 The following is a summary of the cost and estimated fair value of available-for-sale securities at March 31, 2021, by contractual maturity (in thousands): March 31, 2021 Amortized Cost Estimated Fair Value Mature in one year or less 91,670 91,656 Mature after one year through five years 150 150 $ 91,820 $ 91,806 There were no securities that have had an unrealized loss for more than 12 months as of March 31, 2021. As of March 31, 2021, unrealized losses on available-for-sale investments are not attributed to credit risk and are considered to be temporary. The Company believes that it is more-likely-than-not that investments in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | Note 4. Stock-Based Compensation As of March 31, 2021, the Company has two stock-based compensation plans. The stock-based compensation cost that has been included in the statements of comprehensive loss is shown as below (in thousands): Three months ended March 31, 2021 2020 Cost of product revenues $ 5 $ 2 Research and development 315 207 Selling, general and administrative 382 178 Total stock-based compensation $ 702 $ 387 As of March 31, 2021 and 2020, $16,000 and $12,000 of stock-based compensation cost was capitalized in inventory on the Company’s balance sheets, respectively. The Company uses the Black-Scholes option pricing model to value its stock options. The expected life computation is based on historical exercise patterns and post-vesting termination behavior. The Company considered its historical volatility in developing its estimate of expected volatility. The Company used the following assumptions to estimate the fair value of stock options granted and shares purchased under its employee stock purchase plan for the three months ended March 31, 2021 and 2020: Three months ended March 31, 2021 2020 Stock Options Risk-free rate 0.8-1.2% 0.6-1.4% Expected dividend yield — — Expected life of option (in years) 7.3 7.3 Volatility 74-86% 84-86% Three months ended March 31, 2021 2020 Employee Stock Purchase Plan Risk-free rate 0.1% 1.6% Expected dividend yield — — Expected life of option (in years) 0.5 0.5 Volatility 78% 103% |
Term Loan
Term Loan | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Term Loan | Note 5. Term Loan In July 2016, the Company entered into a $20.0 million secured single-draw term loan with Oxford Finance LLC (Oxford Finance). The Company and Oxford Finance entered into three subsequent amendments to the Loan Agreement in February 2018, November of 2018 and December 2019, for which the Company paid Oxford Finance loan modification fees of $100,000, $900,000 and $825,000 respectively. As amended, the Loan Agreement provides for interest only payments for the first 18 months, followed by consecutive monthly payments of principal and interest in arrears starting on December 1, 2021 and continuing through the maturity date of the term loan of May 1, 2024. The Loan Agreement provides for a floating interest rate (7.95% initially and 7.95% as of March 31, 2021) based on an index rate plus a spread. In addition, a payment equal to 10% of the principal amount of the term loan is due when the term loan becomes due or upon the prepayment of the facility. If the Company elects to prepay the loan, there is also a prepayment fee of between 0.75% and 2.5% of the principal amount of the term loan depending on the timing of prepayment. The $150,000 facility fee that was paid at the original closing, the loan modification fees and other debt offering/issuance costs have been recorded as debt discount on the Company’s balance sheet and together with the final $2.0 million payment are being amortized to interest expense using the effective interest method over the revised term of the loan. The term loan is secured by substantially all of the assets of the Company, except that the collateral does not include any intellectual property (including licensing, collaboration and similar agreements relating thereto), and certain other excluded assets. The 2016 Loan Agreement contains customary representations, warranties and covenants by the Company, which covenants limit the Company’s ability to convey, sell, lease, transfer, assign or otherwise dispose of certain assets of the Company; engage in any business other than the businesses currently engaged in by the Company or reasonably related thereto; liquidate or dissolve; make certain management changes; undergo certain change of control events; create, incur, assume, or be liable with respect to certain indebtedness; grant certain liens; pay dividends and make certain other restricted payments; make certain investments; and make payments on any subordinated debt . The Loan Agreement also contains customary indemnification obligations and customary events of default, including, among other things, the Company’s failure to fulfill certain obligations of the Company under the Loan Agreement and the occurrence of a material adverse change which is defined as a material adverse change in the Company’s business, operations, or condition (financial or otherwise), a material impairment of the prospect of repayment of any portion of the loan, or a material impairment in the perfection or priority of lender’s lien in the collateral or in the value of such collateral. In the event of default by the Company under the Loan Agreement, the lender would be entitled to exercise its remedies thereunder, including the right to accelerate the debt, upon which the Company may be required to repay all amounts then outstanding under the Loan Agreement, which could harm the Company’s financial condition. The conditionally exercisable call option related to the event of default is considered to be an embedded derivative which is required to be bifurcated and accounted for as a separate financial instrument. In the periods presented, the value of the embedded derivative is not material, but could become material in future periods if an event of default became more probable than is currently estimated. The fair value of the term loan approximates the carrying value. Future maturities and interest payments due under the term loan as of March 31, 2021, are as follows (in thousands): Nine months ended December 31, 2021 $ 2,543 2022 9,208 2023 8,563 2024 4,711 Total minimum payments 25,025 Less amount representing interest (3,222 ) Gross balance of term loan 21,803 Less unamortized debt discount (846 ) Carrying value of term loan, net 20,957 Less term loan, current portion, net (2,895 ) Term loan, non-current portion, net $ 18,062 As of March 31, 2021, the Company was in compliance with all material covenants under the Loan Agreement and there had been no material adverse change. |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | Note 6. Commitments Operating Leases The Company has lease arrangements for its facilities in California and Alabama as follows. Location Approximate Square Feet Operation Expiration Cupertino, CA 30,149 sq. ft. Office, Laboratory and Manufacturing Lease expires 2024 (with an option to renew for an additional five years) Cupertino, CA 20,100 sq. ft. Office and Laboratory Lease expires 2024 (with an option to renew for an additional five years) Vacaville, CA 24,634 sq. ft. Manufacturing Lease expires 2023 Under these leases, the Company is required to pay certain maintenance expenses in addition to monthly rent. Rent expense is recognized on a straight-line basis over the lease term for leases that have scheduled rental payment increases. The lease expense includes the amortization of the right-of-assets with the associated interest component estimated by applying the effective interest method. Rent expense under all operating leases was $479,000 and $484,000 for the three months ended March 31, 2021 and 2020, respectively. Future minimum payments under these noncancelable leases are as follows (in thousands): Operating Leases Nine months ended December 31, 2021 $ 1,418 2022 1,991 2023 1,970 2024 275 $ 5,654 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Note 7. Stockholders’ Equity In August 2018, the Company filed a shelf registration statement on Form S-3 with the SEC (the “2018 Registration Statement”) (File No. 333-226518), which upon being declared effective in October 2018, terminated the Company’s registration statement filed in November 2015 (File No. 333-207776) and allowed the Company to offer up to $175.0 million of securities from time to time in one or more public offerings, inclusive of up to $75.0 million of shares of the Company’s common stock which the Company may sell, subject to certain limitations, pursuant to a sales agreement dated November 3, 2015 with Cantor Fitzgerald & Co. (the “2015 Sales Agreement”). In February 2021, the Company completed an underwritten public offering of 20,364,582 shares of its common stock at a price of $2.2386 per share pursuant to an underwriting agreement with Cantor Fitzgerald & Co., raising total gross proceeds to the Company of approximately $45.6 million before deducting estimated offering expenses payable by the Company. Total stock issuance costs related to this financing were approximately $195,000. After deducting estimated offering expenses payable by the Company, the net proceeds to the Company were approximately $45.4 million. During the three months ended March 31, 2021, the Company also raised net proceeds (net of commissions) of approximately $2.4 million from the sale of 950,009 shares of the Company’s common stock in the open market at a weighted average price of $2.60 per share pursuant to the October 2018 registration statement and the 2015 Sales Agreement. During the three months ended March 31, 2020, the Company did not issue any shares through its the 2015 Sales Agreement. |
Discontinued Operations
Discontinued Operations | 3 Months Ended |
Mar. 31, 2021 | |
Disposal Group Not Discontinued Operation Income Statement Disclosures [Abstract] | |
Disposal Groups, Including Discontinued Operations, Disclosure | Note 8. On December 31, 2020, the Company completed the sale of its LACTEL Absorbable Polymers product line to Evonik. Under the terms of the Asset Purchase Agreement, Evonik paid DURECT approximately $15 million subject to certain adjustments, and also agreed to assume certain liabilities with respect to the transferred assets. As a result of the sale of the LACTEL product line, the operating results from the Company’s LACTEL product line have been excluded from continuing operations and presented as discontinued operations in the accompanying Statement of Operations and Comprehensive Loss for the three months ended March 31, 2020. During the twelve months ended December 31, 2020, the Company recorded a gain on sale of the LACTEL product line of $12.8 million, upon the completion of sale to Evonik. The results of operations below include certain allocations that management believes fairly reflect the utilization of services provided to the LACTEL product line. The allocations do not include amounts related to general corporate administrative expenses or interest expense. Therefore, these results of operations do not necessarily reflect what the results of operations would have been had the LACTEL product line operated as a stand-alone entity. The components of income from discontinued operations as reported in the Company’s statement of operations were as follows (in thousands): Three months ended March 31, 2020 Product revenue, net $ 1,180 Total revenues 1,180 Operating expenses: Cost of product revenues 836 Research and development 130 Selling, general and administrative 9 Total costs and expenses 975 Net income from discontinued operations $ 205 Net income per share Basic and diluted $ 0.00 Weighted-average shares used in computing net income per share basic and diluted Basic and diluted 195,745 The following table presents certain non-cash items related to discontinued operations, which are included in the Company’s statement of cash flows (in thousands): Three months ended March 31, 2020 Depreciation $ 50 Stock-based compensation expense 27 $ 77 Gain on sale of the LACTEL product line $ — Non-cash items, net $ 77 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Nature of Operations | Nature of Operations DURECT Corporation (the Company) was incorporated in the state of Delaware on February 6, 1998. The Company is a biopharmaceutical company with research and development programs broadly falling into two categories: (i) new chemical entities derived from our Epigenetics Regulator Program, in which the Company attempts to discover and develop molecules which have not previously been approved and marketed as therapeutics, and (ii) Proprietary Pharmaceutical Programs, in which the Company applies its formulation expertise and technologies largely to active pharmaceutical ingredients whose safety and efficacy have previously been established but which the Company aims to improve in some manner through a new formulation. The Company has several products under development by itself and with third party collaborators. The Company also manufactures and sells osmotic pumps used in laboratory research, and manufactures certain excipients for certain clients for use as raw materials in their products. In addition, the Company conducts research and development of pharmaceutical products in collaboration with third party pharmaceutical and biotechnology companies. |
Basis of Presentation | Basis of Presentation These financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC), and therefore do not include all the information and footnotes necessary for a complete presentation of the Company’s results of operations, financial position and cash flows in conformity with U.S. generally accepted accounting principles (U.S. GAAP). The unaudited financial statements reflect all adjustments (consisting only of normal recurring adjustments) which are, in the opinion of management, necessary for a fair presentation of the financial position at March 31, 2021, the operating results and comprehensive loss, and stockholders’ equity for the three months ended March 31, 2021, and cash flows for the three months ended March 31, 2021 and 2020. The balance sheet as of December 31, 2020 has been derived from audited financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These financial statements and notes should be read in conjunction with the Company’s audited financial statements and notes thereto, included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC. The results of operations for the interim periods presented are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. |
Discontinued Operations | Discontinued Operations In December 2020, the Company announced its decision to sell its LACTEL Absorbable Polymer (LACTEL) product line to Evonik, which was completed on December 31, 2020 and therefore the accompanying statement of operations for the three months ended March 31, 2020 has been recast to reflect the revenue and expenses related to the Company’s LACTEL product line as discontinued operations (see Note 8). The Company believes this format provides comparability with its previously filed financial statements. |
Risks And Uncertainties | Risks and Uncertainties The pandemic caused by an outbreak of a new strain of coronavirus, COVID-19, has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect our business. COVID-19 initially also had a negative impact on orders for our ALZET product line as many ALZET customers reduced their activities during the pandemic. ALZET orders have recovered significantly in 2021, a trend that may or may |
Liquidity and Need to Raise Additional Capital | Liquidity and Need to Raise Additional Capital As of March 31, 2021, the Company had an accumulated deficit of $499.9 million as well as negative cash flows from operating activities for the three months ended March 31, 2021, condensed financial statements are filed, may include seeking additional collaborative agreements for certain of the Company’s programs and achieving revenue from its collaboration and licensing agreements , as well as financing activities such as public offerings and private placements of its common stock, preferred stock offerings, issuances of debt and convertible debt instruments . There are no assurances that such additional funding will be obtained or that the Company will succeed in its future operations. If the Company cannot successfully raise additional capital when needed and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected. |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company may be required to expense previously capitalized inventory costs upon a change in management’s judgment due to new information that suggests that the inventory will not be saleable. If the Company is able to subsequently sell products made with raw materials that were previously written down, the Company will report an unusually high gross profit as there will be no associated cost of goods for these materials. The Company’s inventories consist of the following (in thousands): March 31, 2021 December 31, 2020 (unaudited) Raw materials $ 145 $ 136 Work in process 888 796 Finished goods 922 932 Total inventories $ 1,955 $ 1,864 |
Revenue Recognition | Revenue Recognition The Company enters into license and collaboration agreements under which the Company may receive upfront license fees, research funding and contingent milestone payments and royalties. Product Revenue, Net The Company sells osmotic pumps used in laboratory research, and manufactures certain excipients for pharmaceutical clients for use as raw materials in their products. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon shipment to the customer. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less. Trade Discounts and Allowances: The Company provides certain customers with discounts that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. Product Returns: Consistent with industry practice, the Company generally offers customers a limited right of return for products that have been purchased from the Company. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using its historical sales information. Consistent with historical experience, the Company continues to expect product returns to be minimal. Collaborative Research and Development and Other Revenue The Company enters into license agreements, under which it licenses certain rights to its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; reimbursement of development costs incurred by the Company under approved work plans; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments results in collaborative research and development revenues, except for revenues from royalties on net sales of licensed products, which are classified as other revenues. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company 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 constraint 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 these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the standalone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company expects to recognize revenue for the variable consideration currently being constrained when it is probable that a significant revenue reversal will not occur. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up - front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up - front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaborative research and development revenues and net income (loss) in the period of adjustment. Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaborative research and development revenues and net income (loss) in the period of adjustment. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide a material right to the customer and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in collaborative research and development revenue when the customer obtains control of the goods, which is upon delivery. Royalties and Earn-outs: For arrangements that include sales-based royalties or earn-outs, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized material royalty revenue resulting from the Company’s collaborative arrangements or material earn-out revenue from the Company’s patent purchase agreement with Indivior. The Company receives payments from its customers based on development cost schedules established in each contract. Up-front payments 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. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Total revenue by geographic region (based on the location of the customer) for the three months ended March 31, 2021 and 2020 are as follows (in thousands): Three months ended March 31, 2021 2020 United States $ 1,248 $ 841 Japan 480 274 Europe 301 310 Other 183 170 Total $ 2,212 $ 1,595 |
Prepaid and Accrued Contract Research Expenses | Prepaid and Accrued Contract Research Expenses The Company incurs significant costs associated with third party consultants and organizations for pre-clinical studies, clinical trials, contract research and manufacturing, validation, testing, regulatory advice and other research and development-related services. The Company is required to estimate periodically the cost of services rendered but unbilled based on management’s estimates of project status. If these good faith estimates are inaccurate, actual expenses incurred could materially differ from these estimates. Research and development expenses are primarily comprised of salaries and benefits associated with research and development personnel, overhead and facility costs, preclinical and non-clinical development costs, clinical trial and related clinical manufacturing costs, contract services, and other outside costs. Research and development costs are expensed as incurred. Research and development costs paid to third parties under sponsored research agreements are recognized as the related services are performed. In addition, reimbursements of research and development expenses incurred by the Company’s partners are recorded as collaborative research and development revenue . |
Comprehensive Loss | Comprehensive Loss Components of other comprehensive loss are comprised entirely of unrealized gains and losses on the Company’s available-for-sale securities for all periods presented. Total comprehensive loss has been disclosed in the Company’s Statements of Comprehensive Loss. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding. Diluted net loss per share is computed using the weighted-average number of common shares outstanding and common stock equivalents (i.e., options to purchase common stock) outstanding during the period, if dilutive, using the treasury stock method for options. The numerators and denominators in the calculation of basic and diluted net loss per share were as follows (in thousands except per share amounts): Three months ended March 31, 2021 2020 Numerators: Net loss $ (10,134 ) $ (9,948 ) Denominator: Weighted average shares used to compute basic net loss per share 217,537 195,745 Dilutive common shares from stock options and ESPP — — Weighted average shares used to compute diluted net loss per share 217,537 195,745 Net loss per share: Basic $ (0.05 ) $ (0.05 ) Diluted $ (0.05 ) $ (0.05 ) Options to purchase approximately 4.8 million and 7.3 million shares of common stock were excluded from the denominator in the calculation of diluted net loss per share for the three months ended March 31, 2021 and March 31, 2020, respectively, as the effect would be anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update No. 2016-13 (ASU 2016-13) “Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments.” ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. This standard is effective for fiscal years beginning after December 15, 2022 for small reporting companies, including interim reporting periods within those years and must be adopted using a modified retrospective approach, with certain exceptions. Early adoption is permitted. The Company does not expect the adoption of this standard to have a material effect on its financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Components of Inventories | The Company’s inventories consist of the following (in thousands): March 31, 2021 December 31, 2020 (unaudited) Raw materials $ 145 $ 136 Work in process 888 796 Finished goods 922 932 Total inventories $ 1,955 $ 1,864 |
Summary of Total Revenue by Geographic Region | Total revenue by geographic region (based on the location of the customer) for the three months ended March 31, 2021 and 2020 are as follows (in thousands): Three months ended March 31, 2021 2020 United States $ 1,248 $ 841 Japan 480 274 Europe 301 310 Other 183 170 Total $ 2,212 $ 1,595 |
Summary of Numerators and Denominators in Calculation of Basic and Diluted Net Income (Loss) per Share | The numerators and denominators in the calculation of basic and diluted net loss per share were as follows (in thousands except per share amounts): Three months ended March 31, 2021 2020 Numerators: Net loss $ (10,134 ) $ (9,948 ) Denominator: Weighted average shares used to compute basic net loss per share 217,537 195,745 Dilutive common shares from stock options and ESPP — — Weighted average shares used to compute diluted net loss per share 217,537 195,745 Net loss per share: Basic $ (0.05 ) $ (0.05 ) Diluted $ (0.05 ) $ (0.05 ) |
Strategic Agreements (Tables)
Strategic Agreements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Collaborative Research and Development and Other Revenues Associated with Company's Collaborators or Counterparties | The collaborative research and development and other revenues associated with the Company’s collaborators or counterparties are as follows (in thousands): Three months ended March 31, 2021 2020 Collaborator/Counterparty Gilead (1) $ — $ (268 ) Others (2) 574 238 Total collaborative research and development and other revenue $ 574 $ (30 ) (1) Amounts related to recognition of a license upfront fee and milestone payment were zero and $(465,000) for the three months ended March 31, 2021 and 2020, respectively. The Company signed a license agreement with Gilead on July 19, 2019 and received a nonrefundable upfront license fee and a milestone payment totaling $35.0 million in 2019 which was being recognized as revenue as its obligation was being satisfied using the cost-to-cost input method. The Company recorded a net revenue reversal of $465,000 related to the upfront license fee and milestone payment in the three months ended March 31, 2020 due to a change in the Company’s estimated costs to complete its obligations under the license agreement, which was partially offset by $197,000 of reimbursable collaborative research and development services with Gilead earned during the quarter. In June 2020, the Company received notice that Gilead was terminating the License Agreement and a related R&D agreement between Gilead and the Company and as a result, the Company recognized all its remaining deferred revenue as there were no remaining substantive performance obligations to be provided to Gilead by the Company as of the date when the termination notice was received. (2) Includes: (a) amounts related to earn-out revenue from Indivior UK Limited (Indivior) with respect to PERSERIS net sales; (b) feasibility programs; (c) research and development activities funded by Santen Pharmaceutical Co. Ltd. (Santen); and (d) royalty revenue from OP Pharma with respect to Methydur net sales. Note that in January 2018, the Company was notified by Santen that due to a shift in priorities, Santen had elected to reallocate research and development resources and put the Company’s program on pause until further notice. While the main program is on pause, the parties are working together on a limited set of research and development activities funded by Santen. |
Financial Instruments (Tables)
Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Money Market Funds and Available-for-Sale Securities | The following is a summary of available-for-sale securities as of March 31, 2021 and December 31, 2020 (in thousands): March 31, 2021 Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Money market funds $ 1,152 $ — $ — $ 1,152 Certificates of deposit 150 — — 150 Commercial paper 86,094 — (10 ) 86,084 Municipal bonds 4,259 — (3 ) 4,256 Corporate debt 1,317 — (1 ) 1,316 $ 92,972 $ — $ (14 ) $ 92,958 Reported as: Cash and cash equivalents $ 53,272 $ — $ (2 ) $ 53,270 Short-term investments 39,550 — (12 ) 39,538 Long-term restricted investments 150 — — 150 $ 92,972 $ — $ (14 ) $ 92,958 December 31, 2020 Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Money market funds $ 522 $ — $ — $ 522 Certificates of deposit 150 — — 150 Commercial paper 32,213 2 (2 ) 32,213 Municipal bonds 6,310 — (5 ) 6,305 U.S. Government agencies 1,000 — — 1,000 $ 40,195 $ 2 $ (7 ) $ 40,190 Reported as: Cash and cash equivalents $ 19,619 $ 1 $ (1 ) $ 19,619 Short-term investments 19,426 1 (6 ) 19,421 Long-term investments $ 1,000 $ — $ — 1,000 Long-term restricted investments 150 — — 150 $ 40,195 $ 2 $ (7 ) $ 40,190 |
Summary of Cost and Estimated Fair Value of Available-for-Sale Securities by Contractual Maturity | The following is a summary of the cost and estimated fair value of available-for-sale securities at March 31, 2021, by contractual maturity (in thousands): March 31, 2021 Amortized Cost Estimated Fair Value Mature in one year or less 91,670 91,656 Mature after one year through five years 150 150 $ 91,820 $ 91,806 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock-Based Compensation Cost that has been Included in Statements of Comprehensive Loss | The stock-based compensation cost that has been included in the statements of comprehensive loss is shown as below (in thousands): Three months ended March 31, 2021 2020 Cost of product revenues $ 5 $ 2 Research and development 315 207 Selling, general and administrative 382 178 Total stock-based compensation $ 702 $ 387 |
Summary of Assumptions Used to Estimate Fair Value of Options Granted and Shares Purchased | The Company used the following assumptions to estimate the fair value of stock options granted and shares purchased under its employee stock purchase plan for the three months ended March 31, 2021 and 2020: Three months ended March 31, 2021 2020 Stock Options Risk-free rate 0.8-1.2% 0.6-1.4% Expected dividend yield — — Expected life of option (in years) 7.3 7.3 Volatility 74-86% 84-86% Three months ended March 31, 2021 2020 Employee Stock Purchase Plan Risk-free rate 0.1% 1.6% Expected dividend yield — — Expected life of option (in years) 0.5 0.5 Volatility 78% 103% |
Term Loan (Tables)
Term Loan (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Future Maturities and Interest Payments due under Term Loan | The fair value of the term loan approximates the carrying value. Future maturities and interest payments due under the term loan as of March 31, 2021, are as follows (in thousands): Nine months ended December 31, 2021 $ 2,543 2022 9,208 2023 8,563 2024 4,711 Total minimum payments 25,025 Less amount representing interest (3,222 ) Gross balance of term loan 21,803 Less unamortized debt discount (846 ) Carrying value of term loan, net 20,957 Less term loan, current portion, net (2,895 ) Term loan, non-current portion, net $ 18,062 |
Commitments (Tables)
Commitments (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Lease Arrangements of Company Facilities | The Company has lease arrangements for its facilities in California and Alabama as follows. Location Approximate Square Feet Operation Expiration Cupertino, CA 30,149 sq. ft. Office, Laboratory and Manufacturing Lease expires 2024 (with an option to renew for an additional five years) Cupertino, CA 20,100 sq. ft. Office and Laboratory Lease expires 2024 (with an option to renew for an additional five years) Vacaville, CA 24,634 sq. ft. Manufacturing Lease expires 2023 |
Schedule of Future Operating Lease Minimum Payments | Future minimum payments under these noncancelable leases are as follows (in thousands): Operating Leases Nine months ended December 31, 2021 $ 1,418 2022 1,991 2023 1,970 2024 275 $ 5,654 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Disposal Group Not Discontinued Operation Income Statement Disclosures [Abstract] | |
Summary of Discontinued Operations Reported in Statement of Operations | The components of income from discontinued operations as reported in the Company’s statement of operations were as follows (in thousands): Three months ended March 31, 2020 Product revenue, net $ 1,180 Total revenues 1,180 Operating expenses: Cost of product revenues 836 Research and development 130 Selling, general and administrative 9 Total costs and expenses 975 Net income from discontinued operations $ 205 Net income per share Basic and diluted $ 0.00 Weighted-average shares used in computing net income per share basic and diluted Basic and diluted 195,745 |
Summary of Non-cash Items Related to Discontinued Operations Included in Statement of Cash Flows | The following table presents certain non-cash items related to discontinued operations, which are included in the Company’s statement of cash flows (in thousands): Three months ended March 31, 2020 Depreciation $ 50 Stock-based compensation expense 27 $ 77 Gain on sale of the LACTEL product line $ — Non-cash items, net $ 77 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | |||
Date of incorporation | Feb. 6, 1998 | ||
Accumulated deficit | $ 499,918 | $ 489,784 | |
Options to purchase common stock excluded from computation of diluted net loss per share | 4.8 | 7.3 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Components of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Inventory Net [Abstract] | ||
Raw materials | $ 145 | $ 136 |
Work in process | 888 | 796 |
Finished goods | 922 | 932 |
Total inventories | $ 1,955 | $ 1,864 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Total Revenue by Geographic Region (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 2,212 | $ 1,595 |
United States [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 1,248 | 841 |
Europe [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 301 | 310 |
Japan [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 480 | 274 |
Other [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 183 | $ 170 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Numerators and Denominators in Calculation of Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Numerators: | ||
Net loss | $ (10,134) | $ (9,948) |
Denominator: | ||
Weighted average shares used to compute basic net loss per share | 217,537 | 195,745 |
Dilutive common shares from stock options and ESPP | 0 | 0 |
Weighted average shares used to compute diluted net loss per share | 217,537 | 195,745 |
Net Income (loss) per share | ||
Basic | $ (0.05) | $ (0.05) |
Diluted | $ (0.05) | $ (0.05) |
Strategic Agreements - Summary
Strategic Agreements - Summary of Collaborative Research and Development and Other Revenues Associated with Company's Collaborators or Counterparties (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total collaborative research and development and other revenue | $ 2,212,000 | $ 1,595,000 | |
Collaborative Research and Development and Other Revenue [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total collaborative research and development and other revenue | 574,000 | (30,000) | |
Agreement with Gilead [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total collaborative research and development and other revenue | 0 | (465,000) | |
Agreement with Gilead [Member] | Collaborative Research and Development and Other Revenue [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total collaborative research and development and other revenue | [1] | (268,000) | |
Agreements With Other Collaborators or Counterparties [Member] | Collaborative Research and Development and Other Revenue [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total collaborative research and development and other revenue | [2] | $ 574,000 | $ 238,000 |
[1] | Amounts related to recognition of a license upfront fee and milestone payment were zero and $(465,000) for the three months ended March 31, 2021 and 2020, respectively. The Company signed a license agreement with Gilead on July 19, 2019 and received a nonrefundable upfront license fee and a milestone payment totaling $35.0 million in 2019 which was being recognized as revenue as its obligation was being satisfied using the cost-to-cost input method. The Company recorded a net revenue reversal of $465,000 related to the upfront license fee and milestone payment in the three months ended March 31, 2020 due to a change in the Company’s estimated costs to complete its obligations under the license agreement, which was partially offset by $197,000 of reimbursable collaborative research and development services with Gilead earned during the quarter. In June 2020, the Company received notice that Gilead was terminating the License Agreement and a related R&D agreement between Gilead and the Company and as a result, the Company recognized all its remaining deferred revenue as there were no remaining substantive performance obligations to be provided to Gilead by the Company as of the date when the termination notice was received. | ||
[2] | Includes: (a) amounts related to earn-out revenue from Indivior UK Limited (Indivior) with respect to PERSERIS net sales; (b) feasibility programs; (c) research and development activities funded by Santen Pharmaceutical Co. Ltd. (Santen); and (d) royalty revenue from OP Pharma with respect to Methydur net sales. Note that in January 2018, the Company was notified by Santen that due to a shift in priorities, Santen had elected to reallocate research and development resources and put the Company’s program on pause until further notice. While the main program is on pause, the parties are working together on a limited set of research and development activities funded by Santen. |
Strategic Agreements - Summar_2
Strategic Agreements - Summary of Collaborative Research and Development and Other Revenues Associated with Company's Collaborators or Counterparties (Parenthetical) (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | $ 2,212,000 | $ 1,595,000 | |
Agreement with Gilead [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 0 | $ (465,000) | |
Net revenue reversal related to upfront license fee and milestone payment | 465,000 | ||
Research and development expenses reimbursable | $ 197,000 | ||
Agreement with Gilead [Member] | License Fees [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Amount related to the milestone payment earned | $ 35,000,000 |
Strategic Agreements - Patent P
Strategic Agreements - Patent Purchase Agreement with Indivior - Additional Information (Detail) | Sep. 26, 2017 |
Patent Purchase Agreement with Indivior [Member] | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Granted patents extending year, minimum | 2026 |
Strategic Agreements - Agreemen
Strategic Agreements - Agreement with Santen Pharmaceutical Co., Ltd. - Additional Information (Detail) - USD ($) | Dec. 11, 2014 | Mar. 31, 2021 | Mar. 31, 2020 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | $ 2,212,000 | $ 1,595,000 | |
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Cumulative aggregate payments received by the Company | 3,300,000 | ||
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | License Fees [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | $ 2,000,000 | ||
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | Maximum [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Performance milestone payments based on successful development | 76,000,000 | ||
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | Development-Based Milestones [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Performance milestone payments based on successful development | 13,000,000 | ||
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | Commercialization-Based Milestones [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Performance milestone payments based on successful development | $ 63,000,000 | ||
Amount related to the milestone payment earned | $ 0 |
Financial Instruments - Summary
Financial Instruments - Summary of Money Market Funds and Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 92,972 | $ 40,195 |
Unrealized Gain | 2 | |
Unrealized Loss | (14) | (7) |
Estimated Fair Value | 92,958 | 40,190 |
Money market funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,152 | 522 |
Estimated Fair Value | 1,152 | 522 |
Certificates of deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 150 | 150 |
Estimated Fair Value | 150 | 150 |
Commercial paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 86,094 | 32,213 |
Unrealized Gain | 2 | |
Unrealized Loss | (10) | (2) |
Estimated Fair Value | 86,084 | 32,213 |
Municipal bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 4,259 | 6,310 |
Unrealized Loss | (3) | (5) |
Estimated Fair Value | 4,256 | 6,305 |
U.S. Government agencies [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,000 | |
Estimated Fair Value | 1,000 | |
Corporate debt [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,317 | |
Unrealized Loss | (1) | |
Estimated Fair Value | 1,316 | |
Cash and cash equivalents [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 53,272 | 19,619 |
Unrealized Gain | 1 | |
Unrealized Loss | (2) | (1) |
Estimated Fair Value | 53,270 | 19,619 |
Short-term investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 39,550 | 19,426 |
Unrealized Gain | 1 | |
Unrealized Loss | (12) | (6) |
Estimated Fair Value | 39,538 | 19,421 |
Long Term Restricted Investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 150 | 150 |
Estimated Fair Value | $ 150 | 150 |
Long-term investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,000 | |
Estimated Fair Value | $ 1,000 |
Financial Instruments - Summa_2
Financial Instruments - Summary of Cost and Estimated Fair Value of Available-for-Sale Securities by Contractual Maturity (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Investments Debt And Equity Securities [Abstract] | |
Mature in one year or less, Amortized Cost | $ 91,670 |
Mature after one year through five years, Amortized Cost | 150 |
Amortized Cost | 91,820 |
Mature in one year or less, Estimated Fair Value | 91,656 |
Mature after one year through five years, Estimated Fair Value | 150 |
Estimated Fair Value | $ 91,806 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) | Mar. 31, 2021USD ($) |
Investments Debt And Equity Securities [Abstract] | |
Unrealized loss of securities | $ 0 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Cost that has been Included in Statements of Comprehensive Loss (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 702 | $ 387 |
Cost of product revenues [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 5 | 2 |
Research and development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 315 | 207 |
Selling, general and administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 382 | $ 178 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Stock-based compensation cost capitalized in inventory | $ 16,000 | $ 12,000 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Assumptions Used to Estimate Fair Value of Options Granted and Shares Purchased (Detail) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Employees Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free rate, minimum | 0.10% | 1.60% |
Expected dividend yield | 0.00% | 0.00% |
Expected life of option (in years) | 6 months | 6 months |
Volatility | 78.00% | 103.00% |
Stock Option Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free rate, minimum | 0.80% | 0.60% |
Risk-free rate, maximum | 1.20% | 1.40% |
Expected dividend yield | 0.00% | 0.00% |
Expected life of option (in years) | 7 years 3 months 18 days | 7 years 3 months 18 days |
Volatility, minimum | 74.00% | 84.00% |
Volatility, maximum | 86.00% | 86.00% |
Term Loan - Additional Informat
Term Loan - Additional Information (Detail) - USD ($) | 1 Months Ended | ||||
Dec. 31, 2019 | Nov. 30, 2018 | Feb. 28, 2018 | Jul. 31, 2016 | Mar. 31, 2021 | |
Debt Instrument [Line Items] | |||||
Loan modification fee | $ 825,000,000 | ||||
Oxford Finance LLC Term Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Secured term loan | $ 20,000,000 | ||||
Term loan repayment description | As amended, the Loan Agreement provides for interest only payments for the first 18 months, followed by consecutive monthly payments of principal and interest in arrears starting on December 1, 2021 and continuing through the maturity date of the term loan of May 1, 2024 | ||||
First principal payment date | Dec. 1, 2021 | ||||
Term loan, maturity date | May 1, 2024 | ||||
Interest rate on term loan | 7.95% | 7.95% | |||
Term loan, floating interest rate basis | an index rate plus a spread | ||||
Facility fee paid at final payment | $ 150,000 | ||||
Percentage of an additional payment equal to principal amount | 10.00% | ||||
Debt offering/issuance costs | $ 2,000,000 | ||||
Loan modification fee | $ 900,000 | $ 100,000 | |||
Oxford Finance LLC Term Loan [Member] | Minimum [Member] | |||||
Debt Instrument [Line Items] | |||||
Percentage of prepayment fee | 0.75% | ||||
Oxford Finance LLC Term Loan [Member] | Maximum [Member] | |||||
Debt Instrument [Line Items] | |||||
Percentage of prepayment fee | 2.50% |
Term Loan - Schedule of Future
Term Loan - Schedule of Future Maturities and Interest Payments due under Term Loan (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Future maturities and interest payments under the term loan: | ||
Nine months ended December 31, 2021 | $ 2,543 | |
2022 | 9,208 | |
2023 | 8,563 | |
2024 | 4,711 | |
Total minimum payments | 25,025 | |
Less amount representing interest | (3,222) | |
Gross balance of term loan | 21,803 | |
Less unamortized debt discount | (846) | |
Carrying value of term loan, net | 20,957 | |
Less term loan, current portion, net | (2,895) | $ (884) |
Term loan, non-current portion, net | $ 18,062 | $ 19,936 |
Commitments - Summary of Lease
Commitments - Summary of Lease Arrangements of Company Facilities (Detail) | 3 Months Ended |
Mar. 31, 2021ft² | |
Vacaville, CA [Member] | Manufacturing [Member] | |
Property Subject To Or Available For Operating Lease [Line Items] | |
Approximate Square Feet | 24,634 |
Expiration | Lease expires 2023 |
Lease expiration year | 2023 |
Cupertino, CA [Member] | Office, Laboratory and Manufacturing [Member] | |
Property Subject To Or Available For Operating Lease [Line Items] | |
Lease expiration year | 2024 |
Lease renewal term | 5 years |
Cupertino, CA [Member] | Office, Laboratory and Manufacturing [Member] | Lease Amendment [Member] | |
Property Subject To Or Available For Operating Lease [Line Items] | |
Approximate Square Feet | 30,149 |
Expiration | Lease expires 2024 (with an option to renew for an additional five years) |
Cupertino, CA [Member] | Office and Laboratory [Member] | |
Property Subject To Or Available For Operating Lease [Line Items] | |
Lease expiration year | 2024 |
Lease renewal term | 5 years |
Cupertino, CA [Member] | Office and Laboratory [Member] | Lease Amendment [Member] | |
Property Subject To Or Available For Operating Lease [Line Items] | |
Approximate Square Feet | 20,100 |
Expiration | Lease expires 2024 (with an option to renew for an additional five years) |
Commitments - Additional Inform
Commitments - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | ||
Rent expenses of operating leases | $ 479,000 | $ 484,000 |
Commitments - Schedule of Futur
Commitments - Schedule of Future Operating Lease Minimum Payments (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Leases [Abstract] | |
Nine months ended December 31, 2021 | $ 1,418 |
2022 | 1,991 |
2023 | 1,970 |
2024 | 275 |
Total operating leases future minimum payments | $ 5,654 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | |||
Feb. 28, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | May 03, 2021 | Oct. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Proceeds from sale of common stock, net of commission | $ 51,049,000 | $ 761,000 | |||
Net proceeds from issuances of common stock | 51,049,000 | $ 761,000 | |||
Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Securities offered | $ 175,000,000 | ||||
Cantor Fitzgerald Co [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Proceeds from sale of common stock, net of commission | $ 45,600 | ||||
Sale of stock number of shares issued in transaction | 20,364,582 | ||||
Sale of stock price per share | $ 2.2386 | ||||
Net proceeds from issuances of common stock | $ 45,600 | ||||
Common stock issuance costs | 195,000,000,000 | ||||
Gross proceeds from sale of common stock | $ 45,400,000 | ||||
2015 Sales Agreement [Member] | IPO [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock available for sale | $ 56,200,000 | ||||
2015 Sales Agreement [Member] | Cantor Fitzgerald Co [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Proceeds from sale of common stock, net of commission | $ 2,400,000 | ||||
Sale of common stock during period | 950,009,000 | 0 | |||
Common stock weighted average price | $ 2.60 | ||||
Net proceeds from issuances of common stock | $ 2,400,000 | ||||
2015 Sales Agreement [Member] | Cantor Fitzgerald Co [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Securities offered | $ 75,000,000 | ||||
2018 Registration Statement [Member] | Maximum [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock available for sale | $ 95,600,000 |
Discontinued Operations - Addit
Discontinued Operations - Additional Information (Detail) - Evonik [Member] $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Income Statement Balance Sheet And Additional Disclosures By Disposal Groups Including Discontinued Operations [Line Items] | |
Asset purchase agreement subject to certain adjustments paid | $ 15 |
Gain from discontinued operations | $ 12.8 |
Discontinued Operations - Summa
Discontinued Operations - Summary of Discontinued Operations Reported in Statement of Operations (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Income Statement Balance Sheet And Additional Disclosures By Disposal Groups Including Discontinued Operations [Line Items] | ||
Total revenues | $ 1,180 | |
Operating expenses: | ||
Cost of product revenues | 836 | |
Research and development | 130 | |
Selling, general and administrative | 9 | |
Total costs and expenses | 975 | |
Net income from discontinued operations | $ 205 | |
Net income per share | ||
Basic and diluted | $ 0 | |
Weighted-average shares used in computing net income per share basic and diluted | ||
Basic and diluted | 217,537 | 195,745 |
Product Revenue, Net [Member] | ||
Income Statement Balance Sheet And Additional Disclosures By Disposal Groups Including Discontinued Operations [Line Items] | ||
Total revenues | $ 1,180 |
Discontinued Operations - Sum_2
Discontinued Operations - Summary of Non-cash Items Related to Discontinued Operations Included in Statement of Cash Flows (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Disposal Group Not Discontinued Operation Income Statement Disclosures [Abstract] | |
Depreciation | $ 50 |
Stock-based compensation expense | 27 |
Non-cash items, gross | 77 |
Non-cash items, net | $ 77 |