Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 28, 2020 | Jun. 30, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | DRRX | ||
Entity Registrant Name | DURECT CORP | ||
Entity Central Index Key | 0001082038 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 195,818,780 | ||
Entity Public Float | $ 105,942,850 | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common Stock $0.0001 par value per share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 000-31615 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 94-3297098 | ||
Entity Address, Address Line One | 10260 Bubb Road | ||
Entity Address, City or Town | Cupertino | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 95014 | ||
City Area Code | 408 | ||
Local Phone Number | 777-1417 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Part III incorporates information by reference from the definitive Proxy Statement for the 2020 annual meeting of stockholders, which is expected to be filed not later than 120 days after the Registrant’s fiscal year ended December 31, 2019. |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 34,924 | $ 31,644 |
Short-term investments | 29,750 | 2,671 |
Accounts receivable (net of allowances of $34 at December 31, 2019 and $102 at December 31, 2018) | 2,313 | 1,757 |
Inventories, net | 3,383 | 3,421 |
Prepaid expenses and other current assets | 1,459 | 2,247 |
Total current assets | 71,829 | 41,740 |
Property and equipment, net | 469 | 605 |
Operating lease right-of-use assets | 6,066 | |
Goodwill | 6,399 | 6,399 |
Long-term restricted investments | 150 | 150 |
Other long-term assets | 1,107 | 1,105 |
Total assets | 86,020 | 49,999 |
Current liabilities: | ||
Accounts payable | 2,109 | 1,589 |
Accrued liabilities | 6,284 | 4,668 |
Contract research liabilities | 3,653 | 1,405 |
Deferred revenue, current portion | 22,679 | |
Operating lease liabilities, current portion | 2,043 | |
Total current liabilities | 36,768 | 7,662 |
Deferred revenue, non-current portion | 812 | 812 |
Operating lease liabilities, non-current portion | 4,517 | |
Term loan, non-current portion, net | 20,262 | 20,533 |
Other long-term liabilities | 801 | 992 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value: 10,000 shares authorized; none issued and outstanding | ||
Common stock, $0.0001 par value: 350,000 shares authorized; 195,257 and 162,060 shares issued and outstanding at December 31, 2019 and 2018, respectively | 19 | 16 |
Additional paid-in capital | 512,046 | 488,608 |
Accumulated other comprehensive loss | (3) | |
Accumulated deficit | (489,202) | (468,624) |
Stockholders’ equity | 22,860 | 20,000 |
Total liabilities and stockholders’ equity | $ 86,020 | $ 49,999 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Allowances for accounts receivable | $ 34 | $ 102 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 350,000,000 | 350,000,000 |
Common stock, shares issued | 195,257,000 | 162,060,000 |
Common stock, shares outstanding | 195,257,000 | 162,060,000 |
Statements of Operations And Co
Statements of Operations And Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Total revenues | $ 29,564 | $ 18,564 | $ 49,170 |
Operating expenses: | |||
Cost of product revenues | $ 4,143 | $ 4,263 | $ 6,633 |
Type of cost, good or service [extensible list] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 30,209 | $ 25,501 | $ 31,609 |
Selling, general and administrative | 14,363 | 12,419 | 13,165 |
Total operating expenses | 48,715 | 42,183 | 51,407 |
Loss from operations | (19,151) | (23,619) | (2,237) |
Other income (expense): | |||
Interest and other income | 1,074 | 870 | 967 |
Interest expense | (2,501) | (2,573) | (2,425) |
Net other expense | (1,427) | (1,703) | (1,458) |
Net loss | (20,578) | (25,322) | (3,695) |
Net change in unrealized gain on available-for-sale securities, net of tax | (3) | 1 | 2 |
Total comprehensive loss | $ (20,581) | $ (25,321) | $ (3,693) |
Net loss per share | |||
Basic | $ (0.12) | $ (0.16) | $ (0.03) |
Diluted | $ (0.12) | $ (0.16) | $ (0.03) |
Weighted-average shares used in computing net loss per share | |||
Basic | 178,042 | 159,834 | 145,273 |
Diluted | 178,042 | 159,834 | 145,273 |
Collaborative Research and Development and Other Revenue [Member] | |||
Total revenues | $ 18,129 | $ 8,207 | $ 23,577 |
Product Revenue, Net [Member] | |||
Total revenues | $ 11,435 | $ 10,357 | 13,093 |
Revenue From Sale of Intellectual Property Rights [Member] | |||
Total revenues | $ 12,500 |
Statement of Stockholders' Equi
Statement of Stockholders' Equity - USD ($) shares in Thousands, $ 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, 2016 | $ 8,338 | $ 14 | $ 448,404 | $ (3) | $ (440,077) |
Beginning balance, shares at Dec. 31, 2016 | 141,297 | ||||
Issuance of common stock upon exercise of stock options and purchases of ESPP shares | 649 | 649 | |||
Issuance of common stock upon exercise of stock options and purchases of ESPP shares, shares | 667 | ||||
Issuance of common stock upon equity financings, net of issuance costs | 11,989 | $ 1 | 11,988 | ||
Issuance of common stock upon equity financings, net of issuance cost, shares | 8,873 | ||||
Issuance of fully vested options to settle accrued liabilities | 1,600 | 1,600 | |||
Stock-based compensation expense from stock options and ESPP shares | 2,605 | 2,605 | |||
Net loss | (3,695) | (3,695) | |||
Change in unrealized gain on available-for-sale securities, net of tax | 2 | 2 | |||
Ending balance at Dec. 31, 2017 | 21,488 | $ 15 | 465,246 | (1) | (443,772) |
Ending balance, shares at Dec. 31, 2017 | 150,837 | ||||
Issuance of common stock upon exercise of stock options and purchases of ESPP shares | 1,725 | 1,725 | |||
Issuance of common stock upon exercise of stock options and purchases of ESPP shares, shares | 1,594 | ||||
Issuance of common stock upon equity financings, net of issuance costs | 16,780 | $ 1 | 16,779 | ||
Issuance of common stock upon equity financings, net of issuance cost, shares | 9,629 | ||||
Issuance of fully vested options to settle accrued liabilities | 1,860 | 1,860 | |||
Stock-based compensation expense from stock options and ESPP shares | 2,998 | 2,998 | |||
Net loss | (25,322) | (25,322) | |||
Change in unrealized gain on available-for-sale securities, net of tax | 1 | 1 | |||
Adjustment due to changes in accounting policies | 470 | 470 | |||
Ending balance at Dec. 31, 2018 | 20,000 | $ 16 | 488,608 | (468,624) | |
Ending balance, shares at Dec. 31, 2018 | 162,060 | ||||
Issuance of common stock upon exercise of stock options and purchases of ESPP shares | 1,979 | 1,979 | |||
Issuance of common stock upon exercise of stock options and purchases of ESPP shares, shares | 1,847 | ||||
Issuance of common stock upon equity financings, net of issuance costs | 18,360 | $ 3 | 18,357 | ||
Issuance of common stock upon equity financings, net of issuance cost, shares | 31,350 | ||||
Issuance of fully vested options to settle accrued liabilities | 994 | 994 | |||
Stock-based compensation expense from stock options and ESPP shares | 2,108 | 2,108 | |||
Net loss | (20,578) | (20,578) | |||
Change in unrealized gain on available-for-sale securities, net of tax | (3) | (3) | |||
Ending balance at Dec. 31, 2019 | $ 22,860 | $ 19 | $ 512,046 | $ (3) | $ (489,202) |
Ending balance, shares at Dec. 31, 2019 | 195,257 |
Statement of Stockholders' Eq_2
Statement of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement Of Stockholders Equity [Abstract] | |||
Stock issuance costs | $ 356 | $ 566 | $ 374 |
Statement of Cash Flows
Statement of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | ||
Cash flows from operating activities | ||||
Net loss | $ (20,578) | $ (25,322) | $ (3,695) | |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Sale of intellectual property rights for non-operating purposes | (500) | |||
Depreciation and amortization | 291 | 254 | 437 | |
Stock-based compensation | 2,108 | 2,998 | 2,605 | |
Inventory write-down | 255 | 291 | 2,259 | |
Amortization of debt issuance cost | 369 | 149 | 62 | |
Net accretion/amortization on investments | 87 | 84 | (41) | |
Changes in operating lease liabilities | 215 | |||
Changes in assets and liabilities: | ||||
Accounts receivable | (556) | 619 | (1,222) | |
Inventories | (217) | (549) | (140) | |
Prepaid expenses and other assets | 786 | (15) | (1,115) | |
Accounts payable | 520 | 69 | (566) | |
Accrued liabilities | 2,894 | 1,594 | 1,594 | |
Contract research liability | 2,248 | 571 | 51 | |
Deferred revenue | 22,679 | (493) | (1,072) | |
Total adjustments | 31,679 | 5,572 | 2,352 | |
Net cash provided by (used in) operating activities | 11,101 | (19,750) | (1,343) | |
Cash flows from investing activities | ||||
Sale of intellectual property rights for non-operating purposes | 500 | |||
Purchases of property and equipment | (155) | (93) | (69) | |
Purchases of available-for-sale securities | (31,866) | (9,588) | (8,373) | |
Proceeds from maturities of available-for-sale securities | 4,697 | 14,218 | 20,632 | |
Net cash (used in) provided by investing activities | (27,324) | 4,537 | 12,690 | |
Cash flows from financing activities | ||||
Payments on equipment financing obligations | (7) | (9) | (14) | |
Net proceeds from issuances of common stock upon exercise of stock options, and purchases of ESPP shares | 1,979 | 1,725 | 649 | |
Net proceeds from issuances of common stock in connection with equity financings | 18,360 | 16,780 | 11,989 | |
Term loan amendment cost | (829) | (1,014) | ||
Net cash provided by financing activities | 19,503 | 17,482 | 12,624 | |
Net increase in cash and cash equivalents | 3,280 | 2,269 | 23,971 | |
Cash, cash equivalents, and restricted cash, beginning of the period | [1] | 31,794 | 29,525 | 5,554 |
Cash, cash equivalents, and restricted cash, end of the period | [1] | 35,074 | 31,794 | 29,525 |
Supplemental disclosure of cash flow information | ||||
Cash paid for interest | 1,942 | 1,886 | 1,703 | |
Supplementary disclosure of non-cash financing information | ||||
Fully vested options issued to settle accrued liabilities | 994 | $ 1,860 | $ 1,600 | |
Operating lease right-of-use assets obtained in exchange for operating lease obligations | [2] | $ 7,329 | ||
[1] | Includes restricted cash of $150,000 (presented as long-term restricted investments) on the balance sheets at each of December 31, 2019, 2018 and 2017. | |||
[2] | Amounts for the twelve months ended December 31, 2019 include the transition adjustment for the adoption of Accounting Standards Update ("ASU" No. 2016-02, Leases ("Topic 842"). |
Statement of Cash Flows (Parent
Statement of Cash Flows (Parenthetical) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Long Term Restricted Investments [Member] | |||
Restricted cash | $ 150,000 | $ 150,000 | $ 150,000 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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 designs, develops and manufactures a wide range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device 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 and Use of Estimates The Company’s financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). The preparation of the accompanying Financial Statements conforms to accounting principles generally accepted in the U.S. which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to revenue recognition, the period of performance, identification of deliverables and evaluation of milestones with respect to our collaborations, the amounts of revenues, recoverability of inventory, certain accrued liabilities including accrued clinical trial liability, and stock-based compensation. The Company bases its estimates on historical experience and on various other market-specific and other relevant assumptions that the Company believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. Liquidity and Need to Raise Additional Capital As of December 31, 2019, the Company has an accumulated deficit of $489.2 million as well as negative cash flows from operating activities. The Company generally has had negative cash flows from operating activities and expects its negative cash flows to continue. The Company will continue to require substantial funds to continue research and development, including clinical trials of its product candidates. Management’s plans in order to meet its operating cash flow requirements beyond the next 12 months from the date the financial statements are filed, include seeking additional collaborative agreements for certain of its programs and achieving milestone and other payments under 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 and that the Company will succeed in its future operations. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected. Cash, Cash Equivalents and Investments The Company considers all highly liquid investments with maturities of 90 days or less from the date of purchase to be cash equivalents. Investments with original maturities of greater than 90 days from the date of purchase but less than one year from the balance sheet date are classified as short-term investments, while investments with maturities in one year or beyond one year from the balance sheet date are classified as long-term investments. Management determines the appropriate classification of its cash equivalents and investment securities at the time of purchase and re-evaluates such determination as of each balance sheet date. Management has classified the Company’s cash equivalents and investments as available-for-sale securities in the accompanying financial statements. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported as a component of accumulated other comprehensive loss. Realized gains and losses are included in interest income. There were no material realized gains or losses in the periods presented. The cost of securities sold is based on the specific identification method. The Company invests in debt instruments of government agencies, corporations, and money market funds with high credit ratings. The Company has established guidelines regarding diversification of its investments and their maturities with the objectives of maintaining safety and liquidity, while maximizing yield. Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk consist principally of interest-bearing investments and trade receivables. The Company maintains cash, cash equivalents and investments with various major financial institutions. The Company performs periodic evaluations of the relative credit standing of these financial institutions. In addition, the Company performs periodic evaluations of the relative credit quality of its investments. Pharmaceutical companies and academic institutions account for a substantial portion of the Company’s trade receivables. The Company provides credit in the normal course of business to its customers and collateral for these receivables is generally not required. The risk associated with this concentration is limited to a certain extent due to the large number of accounts and their geographic dispersion. The Company monitors the creditworthiness of its customers to which it grants credit terms in the normal course of business. The Company maintains reserves for estimated credit losses and, to date, such losses have been immaterial in all periods presented. Customer and Product Line Concentrations A portion of the Company’s revenue is derived from its ALZET mini pump product line, LACTEL biodegradable polymer product line and the sale of certain excipients for Methydur Sustained Release Capsules and one excipient that is included in a currently marketed animal health product. In 2019, revenue from the sale of products from the ALZET product line and the LACTEL product line accounted for 23% and 15% of total revenue, respectively. In 2018, revenue from the ALZET product line and the LACTEL product line accounted for 38% and 18% of total revenue, respectively. In 2017, revenue from the ALZET product line and the LACTEL product line accounted for 14% and 12% of total revenue, respectively. In 2019, Gilead accounted for 58% of the Company’s total revenue. In 2018, Indivior and Gilead accounted for 27% and 14% of the Company’s total revenues, respectively. In 2017, Sandoz and Indivior accounted for 41% and 25% of the Company’s total revenues, respectively. Total revenue by geographic region for the years 2019, 2018 and 2017 are as follows (in thousands): Year ended December 31, 2019 2018 2017 United States $ 22,825 $ 7,990 $ 11,323 Europe 3,132 8,118 34,261 Japan 1,476 978 1,395 Others 2,131 1,478 2,191 Total $ 29,564 $ 18,564 $ 49,170 Revenue by geography is determined by the location of the customer. 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, among other potential factors, a denial or delay of approval of a customer’s product by the necessary regulatory bodies, or 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. In October 2017, the Company announced that PERSIST, the Phase 3 clinical trial for POSIMIR, did not meet its primary efficacy endpoint. As a result, the Company determined that certain lots of inventory were no longer considered to be probable for use prior to expiration. The Company recorded charges to cost of goods sold of approximately $2.0 million, of which approximately $503,000 related to the write-down of the cost basis of inventory on hand, $500,000 related to the prepaid inventory for the minimum purchase commitment for this excipient, and $1.0 million related to the accrual of a liability for the remaining minimum purchase commitment for the same excipient. 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 consisted of the following (in thousands): December 31, 2019 2018 Raw materials $ 282 $ 223 Work in-process 1,537 1,486 Finished goods 1,564 1,712 Total inventories $ 3,383 $ 3,421 Property and Equipment Property and equipment are stated at cost less accumulated depreciation, which is computed using the straight-line method over the estimated useful lives of the assets, which range from three to five years. Leasehold improvements are amortized using the straight-line method over the estimated useful lives of the assets, or the terms of the related leases, whichever are shorter. Goodwill Goodwill is periodically assessed and evaluated for impairment at the reporting unit level. The Company operates in one operating segment and also has only one reporting unit, which is the research, development and manufacturing of pharmaceutical products. The Company assesses the impairment of goodwill at least annually and whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors the Company considers important which could trigger an impairment review include the following: • significant decline in our stock price for a prolonged period; • our market capitalization relative to net book value; • new information affecting the commercial value of the asset; • significant underperformance relative to historical or projected future operating results; • significant changes in the manner of our use of the acquired assets or the strategy for the Company’s overall business; and • significant negative industry or economic trends. As of December 31, 2019, the carrying value of goodwill was approximately $6.4 million and no impairment of goodwill has been recorded for any of the periods presented. The Company evaluates goodwill for impairment at least annually. In 2019, 2018 and 2017, goodwill was evaluated and no indicators of impairment were identified. To date, the Company has not recorded any impairment charge related to goodwill. Impairment of Long-Lived Assets The Company reviews long-lived assets, including property and equipment, intangible assets, and other long-term assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount. Impairment, if any, is calculated as the amount by which an asset’s carrying value exceeds its fair value, typically using discounted cash flows to determine fair value. Through December 31, 2019, there have been no material impairment losses. Leases The Company leases administrative, manufacturing and laboratory facilities under operating leases. Lease agreements may include rent holidays, rent escalation clauses and tenant improvement allowances. Prior to the adoption of Accounting Standards Update ("ASU" No. 2016-02, Leases, and the related amendments ("Topic 842") Effective January 1, 2019, the Company adopted Topic 842 using the modified retrospective transition method approach with a cumulative-effect adjustment as of January 1, 2019. Other prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under previous lease guidance, ASC Topic 840: Leases (Topic 840). The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carry forward the historical lease classification of those leases in place as of January 1, 2019. The adjustments due to the adoption of Topic 842 primarily related to the recognition of an operating lease right-of-use asset and corresponding operating lease liability for the Company’s leased properties. The Company’s operating lease right-of-use asset and liability were recognized at the adoption date of ASC 842 based on the present value of lease payments over the remaining lease term at the adoption date. In determining the net present value of lease payments, we used our incremental borrowing rate of 13.8% based on the information available, including remaining lease term, at the adoption date of ASC 842. As of December 31, 2019, the weighted-average remaining lease term was 3.4 years . The impact of the adoption of Topic 842 on the accompanying Balance Sheet as of January 1, 2019 was as follows (in thousands): As of January 1, 2019 December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Balance Sheet Operating lease right-of-use assets $ — $ 7,329 $ 7,329 Operating lease liabilities: Accrued liabilities (1) $ (92 ) $ 92 $ — Other long-term liabilities (1) (270 ) 270 — Lease liabilities, current portion — (1,972 ) (1,972 ) Lease liabilities, non-current portion — (5,719 ) (5,719 ) $ (362 ) $ (7,329 ) $ (7,691 ) Includes deferred rent, current and long-term portions of operating lease liabilities which were recorded against the operating lease right-of-use asset upon adoption of Topic 842 There was no effect from the adoption of Topic 842 on the Company’s Statement of cash flows. Stock-Based Compensation The Company accounts for share-based payments using a fair-value based method for costs related to all share-based payments, including stock options and stock issued under the Company’s employee stock purchase plan (ESPP). The Company estimates the fair value of share-based payment awards on the date of grant using an option-pricing model. See Note 8 for further information regarding stock-based compensation. 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. Effective January 1, 2018, the Company adopted FASB ASC Topic 606, Revenue from Contracts with Customers, or ASC 606. In accordance with ASC 606, the Company changed certain characteristics of its revenue recognition accounting policy as described below. ASC 606 was applied using the modified retrospective method, where the cumulative effect of the initial application was recognized as an adjustment to opening retained earnings at January 1, 2018. The Company recorded a net decrease to opening accumulated deficit of $470,000 with an offset entry to reduce deferred revenue as of January 1, 2018 due to the cumulative impact of adopting Topic 606, with the impact relating to the Company’s deferred collaborative research and development revenues. Product Revenue, Net The Company sells osmotic pumps used in laboratory research, and designs, develops and manufactures a wide range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device 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. The Company expects product returns to be minimal. Collaborative Research and Development and Other Revenue The Company enters into license agreements which are within the scope of Topic 606, 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 royalty 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. 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 any 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. Research and Development Expenses 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. Segment Reporting The Company operates in one operating segment, which is the research, development and manufacturing of pharmaceutical products. 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): Year Ended December 31, 2019 2018 2017 Numerators: Net loss $ (20,578 ) $ (25,322 ) $ (3,695 ) Denominators: Weighted average shares used to compute basic net loss per share 178,042 159,834 145,273 Effect of dilutive securities: Dilution from stock options — — — Dilution from ESPP — — — Dilutive common shares — — — Weighted average shares used to compute diluted net loss per share 178,042 159,834 145,273 Net loss per share: Basic $ (0.12 ) $ (0.16 ) $ (0.03 ) Diluted $ (0.12 ) $ (0.16 ) $ (0.03 ) The computation of diluted net loss per share for the years ended 2019, 2018 and 2017 excludes the impact of options to purchase 21.4 million, 16.6 million and 20.1 million shares of common stock outstanding, respectively, at December 31, 2019, 2018 and 2017, as such impact would be antidilutive. Shipping and Handling Costs related to shipping and handling are included in cost of revenues for all periods presented. Recent Accounting Pronouncements In November 2018, the Financial Accounting Standards Board (the FASB) issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (ASU 2018-18) In August 2018, the FASB issued Accounting Standards Update (“ASU”) No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, including interim reporting periods within those years, with early adoption permitted. The Company does not expect the adoption of this standard to have a material effect on its financial statements. In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, (ASU 2017-04) 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, 2019, 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 | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Strategic Agreements | 2. Strategic Agreements The collaborative research and development and other revenues associated with the Company’s major third-party collaborators are as follows (in thousands): Year ended December 31, 2019 2018 2017 Collaborator/Counterparty Gilead (1) $ 17,133 $ 2,542 $ 1,687 Sandoz AG (Sandoz) (2) — — 20,000 Other (3) 996 5,665 1,890 Total collaborative research and development and other revenue $ 18,129 $ 8,207 $ 23,577 (1) The Company signed a license agreement with Gilead on July 19, 2019 and received nonrefundable upfront license fee and milestone payment of $35.0 million in 2019. Amounts include partial recognition ($12.3 million) of the upfront license fee and milestone payment in 2019, compared to zero for the corresponding periods in 2018 and 2017. ( 2 ) Amounts related to recognition of upfront fees were zero in 2019 and 2018, and $20.0 million in 2017; the Company and Sandoz signed a license agreement effective June 2017. As of December 31, 2017, all of the $20.0 million upfront fee had been recognized as revenue as the Company’s contractual performance obligations had been fulfilled. In January 2019, the license agreement was terminated. (3) Includes: (a) amounts related to earn-out revenue from Indivior UK Limited (Indivior) with respect to PERSERIS net sales as well as a $5.0 million milestone payment earned from Indivior in 2018; (b) feasibility program(s); (c) research and development activities funded by Santen pharmaceutical Co. Ltd. (Santen). Note that in January 2018, the Company was notified by Santen that due to a shift in near term priorities, Santen has elected to reallocate research and development resources and put our 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; and (d) research and development activities funded by Zogenix. Note that the Company and Zogenix signed a license agreement effective July 2011. In August 2017, the Company and Zogenix terminated the license agreement. As of February 28, 2020, the Company had potential milestones of up to $221.0 million that the Company may receive in the future under its collaborative arrangements, of which $88.0 million are development-based milestones and $133.0 million are sales-based milestones. Within the category of development-based milestones, $2.0 million are related to early stage clinical testing (defined as Phase 1 or 2 activities), $33.0 million are related to late stage clinical testing (defined as Phase 3 activities), $3.0 million are related to regulatory filings, and $50.0 million are related to regulatory approvals. No payments were received between December 31, 2019 and February 28, 2020. Agreement with Gilead Sciences, Inc. On July 19, 2019, the Company entered into a license agreement (the “Gilead Agreement”) with Gilead Sciences, Inc. (“Gilead”). Pursuant to the Gilead Agreement, the Company has granted Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable HIV product utilizing DURECT’s SABER ® Under the terms of the Gilead Agreement, Gilead made an upfront payment to DURECT of $25 million, with the potential for up to an additional $75 million in development and regulatory milestones, up to an additional $70 million in sales-based milestones, as well as tiered single-digit royalties on product sales for a defined period. In September 2019, the Company also earned the right to receive a $10 million milestone payment from Gilead for further development of the product candidate which was received in October 2019. Gilead has the exclusive option to license additional SABER-based products directed to HIV and HBV for up to an additional $150 million per product in upfront, development, regulatory and sales-based milestones as well as tiered single-digit royalties on sales. The Company will perform specified development activities with Gilead funding certain portions of the development programs. The lead formulation is currently being re-formulated and will undergo additional pre-clinical development work. The Gilead Agreement contains customary representations, warranties and indemnification provision. The term of the Gilead Agreement is for the duration of Gilead’s obligation to pay royalties for product sales under the Gilead Agreement. The Gilead Agreement provides each party with specified termination rights, including the right of Gilead to terminate at will with advance notice to DURECT and each party to terminate the Gilead Agreement upon material breach of the Gilead Agreement by the other party. The Company assessed the Gilead Agreement and concluded that Gilead is a customer. The Company evaluated the promised goods and services in the contract and concluded that it had two performance obligations. The first performance obligation, expected to be completed and delivered by December 31, 2020, consists of a bundle of the exclusive licenses to the HIV product candidate and exclusive access to the SABER platform for use in the fields of HIV and HBV, the research, development and manufacturing services through completion of technology transfer (“the Primary Services”), participation in the joint development committee and initial supply of the related materials. The Company obtains additional consideration related to the ongoing research, development and manufacturing services associated with the Primary Services, which approximates the estimated fair value of these services, based upon an estimated workplan between the two parties, which can be subject to change depending on a variety of factors. None of these goods and services were distinct as they are highly interdependent and each represents an input into the process through which Gilead will be able to derive the full benefits from the licensed intellectual property. The additional research and development services after technology transfer will be accounted for as the second performance obligation as these services are distinct, as these services are not essential for Gilead. The Company will also obtain additional consideration related to these research and development services, if and when they are performed, which will approximate the estimated fair value of these services. The Company also evaluated Gilead’s rights to license additional SABER-based products and concluded that these are option rights, are at market rates, and do not constitute a material right performance obligation. As such, these options have been excluded from the initial allocation of transaction price and the Company will account for them as separate contracts when and if Gilead elects to exercise each option right. During the twelve months ended December 31, 2019, the upfront and milestone consideration of $35 million received in 2019 associated with the Primary Services is being recognized as revenue when the first performance obligation is being satisfied using the cost-to-cost input method, which the Company believes best depicts the transfer of control to the customer. Under the cost-to-cost input method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs. Revenue is recorded as a percentage of the transaction price based on the extent of progress towards completion. The estimate of the Company’s measure of progress, which can include additional Primary Services, if any, and the estimate of any additional consideration for those additional Primary Services, are included in the transaction price which is updated at each reporting date, and revenue is recognized on a cumulative catchup basis. As such, management applies a certain amount of judgment in estimating both the Primary Services and the corresponding timeline to through completion of the first performance obligation, which are key inputs when using the cost-to-cost input method. During the twelve months ended December 31, 2019, the Company recognized $12.3 million of the deferred revenue within collaborative research and development and other revenues. The Company also recognized $4.8 million from Gilead during the twelve months ended December 31, 2019 from feasibility related collaborative research and development services. As of December 31, 2019, the Company intends to recognize the remaining $22.7 million in deferred revenue associated with the upfront and milestone consideration within the next 12 months, which is when the Primary Services are estimated to be completed by. Given the estimate of the Company’s measure of progress are updated at each reporting date, and revenue is recognized on a cumulative catchup basis, a significant change in the remaining estimated costs to complete the Primary Services could have a material impact on revenues recognized (including reversal of previously recognized revenue) at each reporting date, as well as the classification between the current and non-current portions of the associated deferred revenue should the development timeline for technology transfer also be significantly extended out. The following table presents changes in the Company’s contract assets and liabilities for the twelve months ended December 31, 2019 (in thousands): Balance at January 1, 2019 Additions Deletions Balance at December 31, 2019 Balance Sheet Assets Accounts receivable $ — $ 39,812 $ (39,318 ) $ 494 Total contract asset $ — $ 39,812 $ (39,318 ) $ 494 Liabilities Deferred revenue, current portion $ — $ 35,000 $ (12,321 ) $ 22,679 Deferred revenue, non-current portion — — — — Total contract liabilities $ — $ 35,000 $ (12,321 ) $ 22,679 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 patents that may provide further intellectual property protection for PERSERIS™ (risperidone), Indivior’s extended-release injectable suspension for the treatment of schizophrenia in adults. In consideration for such assignment, Indivior made an upfront non-refundable payment to the Company of $12.5 million. Indivior also agreed to make an additional $5.0 million payment to the Company contingent upon NDA approval of PERSERIS, as well as quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the assigned patent rights, including PERSERIS. The assigned patent rights include granted patents extending through at least 2026. The Company also receives a non-exclusive right under the assigned patents to develop and commercialize certain risperidone-containing products and products that do not contain risperidone or buprenorphine. The Indivior Agreement contains customary representations, warranties and indemnities of the parties. The Company received the payment of $12.5 million from Indivior in September 2017 and recognized the $12.5 million as revenue from sale of intellectual property rights in 2017 as the Company did not have any continuing obligations under the purchase agreement. In July 2018, Indivior announced that the FDA had approved the NDA for PERSERIS thereby triggering the $5.0 million payment to the Company; this payment was received by the Company in August 2018. The Company recognized the $5.0 million as milestone revenue during the twelve months ended December 31, 2018 as there is no further performance obligation associated with this milestone payment. Amounts recognized to date related to earn-out revenues from PERSERIS have been immaterial. 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 December 31, 2019). 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 December 31, 2019, the cumulative aggregate payments received by the Company under this agreement were $3.3 million. Agreement with Sandoz AG. In May 2017, the Company and Sandoz AG (“Sandoz”) entered into a license agreement to develop and market POSIMIR (bupivacaine extended release solution) in the United States. Following expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR), the agreement became effective in June 2017. On January 2, 2019, the Company received written notice from Sandoz that Sandoz terminated this agreement effective January 27, 2019. As a result of this termination, Sandoz returned its exclusive commercialization rights to develop and market POSIMIR in the United States. The parties are in dispute with regard to Sandoz’s obligation to pay a termination fee to the Company. The Company has initiated a formal dispute resolution process related to the termination fee. The cumulative aggregate payments received by the Company from Sandoz as of December 31, 2019 were $20.0 million under this agreement. |
Financial Instruments
Financial Instruments | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments | 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. The following table sets forth the fair value of the Company’s financial assets that were measured at fair value on a recurring basis as of December 31, 2019 (in thousands): Level 1 Level 2 Level 3 Total Money market funds $ 524 $ — $ — $ 524 Certificates of deposit — 150 — 150 Commercial paper — 47,218 — 47,218 U.S. Government agencies — 4,501 — 4,501 Corporate debt — 9,868 — 9,868 Total $ 524 $ 61,737 $ — $ 62,261 The following table sets forth the fair value of our financial assets that were measured at fair value on a recurring basis as of December 31, 2018 (in thousands): Level 1 Level 2 Level 3 Total Money market funds $ 502 $ — $ — $ 502 Certificates of deposit — 150 — 150 Commercial paper — 32,224 — 32,224 Total $ 502 $ 32,374 $ — $ 32,876 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, 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 December 31, 2019 is less than twelve months and these investments are rated by S&P and Moody’s at AAA or AA- for securities and A1 or P1 for commercial paper. The following is a summary of available-for-sale securities as of December 31, 2019 and 2018 (in thousands): December 31, 2019 Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Money market funds $ 524 $ — $ — $ 524 Certificates of deposit 150 — — 150 Commercial paper 47,221 1 (4 ) 47,218 U.S. Government agencies 4,500 1 4,501 Corporate debt 9,869 1 (2 ) 9,868 $ 62,264 $ 3 $ (6 ) $ 62,261 Reported as: Cash and cash equivalents $ 32,364 $ — $ (3 ) $ 32,361 Short-term investments 29,750 3 (3 ) 29,750 Long-term restricted investments 150 — — 150 $ 62,264 $ 3 $ (6 ) $ 62,261 December 31, 2018 Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Money market funds $ 502 $ — $ — $ 502 Certificates of deposit 150 — — 150 Commercial paper 32,224 — — 32,224 $ 32,876 $ — $ — $ 32,876 Reported as: Cash and cash equivalents $ 30,055 $ — $ — $ 30,055 Short-term investments 2,671 — — 2,671 Long-term restricted investments 150 — — 150 $ 32,876 $ — $ — $ 32,876 The following is a summary of the cost and estimated fair value of available-for-sale securities at December 31, 2019, by contractual maturity (in thousands): December 31, 2019 Amortized Cost Estimated Fair Value Mature in one year or less $ 61,740 $ 61,737 $ 61,740 $ 61,737 There were no securities that have had an unrealized loss for more than 12 months as of December 31, 2019. As of December 31, 2019, 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. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment Property and equipment consist of the following (in thousands): December 31, 2019 2018 Equipment $ 12,862 $ 12,785 Leasehold improvements 9,849 9,828 Construction-in-progress 90 33 22,801 22,646 Less accumulated depreciation and amortization (22,332 ) (22,041 ) Property and equipment, net $ 469 $ 605 Depreciation expense was $291,000, $254,000 and $437,000 in 2019, 2018 and 2017, respectively. Amortization expense was zero in 2019, 2018 and 2017 for assets held under capital leases. As of December 31, 2019, the Company has recorded $553,000 as a liability which was included in other long-term liabilities on its balance sheet for asset retirement obligations associated with the estimated restoration cost for its leased buildings. |
Restricted Investments
Restricted Investments | 12 Months Ended |
Dec. 31, 2019 | |
Text Block [Abstract] | |
Restricted Investments | 5. Restricted Investments As of December 31, 2019 and 2018, the Company had $150,000 recorded as restricted investments, which primarily served as collateral for letters of credit securing a leased facility in California. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 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 (with an option to renew for an additional five years) Birmingham, AL 21,540 sq. ft. Office, Laboratory and Manufacturing Lease expires 2021 (with two options to renew the lease term for an additional five years each after the current lease expires) 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. Rent expense under all operating leases was $2.3 million, $1.9 million and $1.9 million for the years ended December 31, 2019, 2018 and 2017, respectively. Future minimum payments under these noncancelable leases are as follows (in thousands): Year ending December 31, Operating Leases 2020 $ 2,200 2021 2,126 2022 1,991 2023 1,970 2024 275 $ 8,562 Other Purchase Commitments In 2005, the Company entered into a supply agreement with a vendor. The remaining minimum purchase commitment under this agreement was $500,000 in 2018, which had been recorded as an accrued liability on the Company’s Balance Sheet at December 31, 2018, and which was charged to cost of goods sold in the Company’s Statements of Operations and Comprehensive Loss in 2017. In 2019, the Company recorded a one-time settlement credit of $500,000 as a reduction to cost of goods sold upon signing a settlement and release agreement with this vendor, and forgave the contractual right to receive inventory for the same amount that was previously reserved for. |
Term Loan
Term Loan | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Term Loan | 7. 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 9.07% as of December 31, 2019) 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 under the term loan as of December 31, 2019, are as follows (in thousands): 2020 $ 1,848 2021 3,172 2022 9,381 2023 and after 13,361 Total minimum payments 27,762 Less amount representing interest (6,090 ) Gross balance of term loan 21,672 Less unamortized debt discount (1,410 ) Carrying value of term loan 20,262 Less term loan, current portion, net — Term loan, non-current portion, net $ 20,262 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity Common Stock In November 2015, the Company filed a shelf registration statement on Form S-3 with the SEC, which allowed the Company to offer up to $125.0 million of securities from time to time in one or more public offerings of its common stock. In addition, the Company entered into a Controlled Equity Offering sales agreement with Cantor Fitzgerald, under which the Company may sell, subject to certain limitations, up to $40 million of common stock through Cantor Fitzgerald, acting as agent. In August 2018, the Company filed a new shelf registration statement on Form S-3 with the SEC, which upon being declared effective in October 2018, terminated the November 2015 registration statement 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 additional shares of common stock which the Company may sell, subject to certain limitations, under the 2015 Sales Agreement through Cantor Fitzgerald, acting as agent. In 2017, the Company raised net proceeds of approximately $12.0 million from the sale of approximately 8.9 million shares of common stock in the open market through the Controlled Equity Offering program with Cantor Fitzgerald at a weighted average price of $1.39 per share. In 2018, the Company raised net proceeds of approximately $16.8 million from the sale of approximately 9.6 million shares of common stock in the open market through the Controlled Equity Offering program with Cantor Fitzgerald at a weighted average price of $1.80 per share. In 2019, the Company raised net proceeds of approximately $3.5 million from the sale of 2,349,820 shares of the Company’s common stock in the open market at a weighted average price of $1.55 per share pursuant to the October 2018 registration statement. On June 20, 2019, the Company entered into a privately negotiated transaction to sell 29,000,000 shares of our common stock to certain investors in a registered offering at a price of $0.52 per share, raising total gross proceeds to the Company of approximately $15.1 million. Description of Stock-Based Compensation Plans 2000 Stock Plan (Incentive Stock Plan) In January 2000, the Company’s Board of Directors and stockholders adopted the DURECT Corporation 2000 Stock Plan, under which incentive stock options and non-statutory stock options and stock purchase rights may be granted to employees, consultants and non-employee directors. The 2000 Stock Plan was amended by written consent of the Board of Directors in March 2000 and written consent of the stockholders in August 2000. In April 2005, the Board of Directors approved certain amendments to the 2000 Stock Plan. At the Company’s annual stockholders meeting in June 2005, the stockholders approved the amendments of the 2000 Stock Plan to: (i) expand the types of awards that the Company may grant to eligible service providers under the Stock Plan to include restricted stock units, stock appreciation rights and other similar types of awards (including other awards under which recipients are not required to pay any purchase or exercise price) as well as cash awards; and (ii) include certain performance criteria that may be applied to awards granted under the Stock Plan. At the Company’s annual stockholders meeting in June 2010, the stockholders approved amendments of the 2000 Stock Plan to: (i) provide that the number of shares that remain available for issuance will be reduced by two shares for each share issued pursuant to an award (other than an option or stock appreciation right) granted on or after the date of the 2010 Annual Meeting; (ii) expand the types of transactions that might be considered repricings and option exchanges for which stockholder approval is required; (iii) provide that shares tendered or withheld in payment of the exercise price of an option or withheld to satisfy a withholding obligation, and all shares with respect to which a stock appreciation right is exercised, will not again be available for issuance under the Stock Plan; (iv) require that options and stock appreciation rights have an exercise price or base appreciation amount that is at least fair market value on the grant date, except in connection with certain corporate transactions, and that stock appreciation rights may not have longer than a 10-year term; (v) add new performance goals that may be used to provide “performance-based compensation” under the 2000 Stock Plan; (vi) extend the term of the 2000 Stock Plan to the date that is ten (10) years following the stockholders meeting; and (vii) expand the treatment of outstanding awards in connection with certain changes of control of the Company to cover mergers in which the consideration payable to stockholders is not solely securities of the successor corporation. At the Company’s annual stockholders meeting in June 2011, June 2014, June 2016 and June 2018, the stockholders approved amendments of the 2000 Stock Plan to increase the number of shares of the Company’s common stock available for issuance by 5,500,000 shares, 4,000,000 shares, 5,000,000 shares and 7,500,000 shares, respectively, each of which had previously been approved by the Board of Directors. At the Company’s annual stockholders meeting in June 2019, the stockholders approved amendments of the 2000 Stock Plan to extend the term of the 2000 Stock Plan to the date that is ten (10) years following the stockholders meeting. A total of 33,449,989 shares of common stock have been reserved for issuance under this plan. The plan expires in June 2029. In April 2013, the Board of Directors approved certain amendments to the 2000 Stock Plan to: (i) increase the number of stock options granted to a non-employee director on the date which such person first becomes a director from 30,000 to 70,000 shares of common stock; each option shall have a ten-year term, become exercisable in installments of one-third of the total number of options granted on each anniversary of the grant and have a two-year period following termination of Director status in which the former director can exercise the option; (ii) modify the exercise period for future option grants to a non-employee director in which a former director can exercise the option following termination of Director status from a one year period to a two-year period. Options granted under the 2000 Stock Plan expire no later than ten years from the date of grant. Options may be granted with different vesting terms from time to time not to exceed five years from the date of grant. The option price of an incentive stock option granted to an employee or of a nonstatutory stock option granted to any person who owns stock representing more than 10% of the total combined voting power of all classes of stock of the Company (or any parent or subsidiary) shall be no less than 110% of the fair market value per share on the date of grant. The option price of an incentive stock option granted to any other employee shall be no less than 100% of the fair market value per share on the date of grant. As of December 31, 2019, 7,936,039 shares of common stock were available for future grant and options to purchase 29,803,766 shares of common stock were outstanding under the 2000 Stock Plan. 2000 Employee Stock Purchase Plan In August 2000, the Company adopted the 2000 Employee Stock Purchase Plan. This purchase plan is implemented by a series of overlapping offering periods of 24 months’ duration, with new offering periods, other than the first offering period, beginning on May 1 and November 1 of each year and ending April 30 and October 31, respectively, two years later. The purchase plan allows eligible employees to purchase common stock through payroll deductions at a price equal to the lower of 85% of the fair market value of the Company’s common stock at the beginning of each offering period or at the end of each purchase period. The initial offering period commenced on the effectiveness of the Company’s initial public offering. In April 2010, the Board of Directors approved certain amendments to the 2000 Employee Stock Purchase Plan. At the Company’s annual stockholders meeting in June 2010, the stockholders approved the amendments of the 2000 Employee Stock Purchase Plan to: (i) increase the number of shares of our common stock authorized for issuance under the ESPP by 250,000 shares; (ii) extend the term of the ESPP to the date that is ten (10) years following the stockholders meeting; (iii) provide for six-month consecutive offering periods beginning on November 1, 2010; (iv) revise certain provisions to reflect the final regulations issued under Section 423 of the Code by the Internal Revenue Service; and (v) provide for the cash-out of options outstanding under an offering period in effect prior to the consummation of certain corporate transactions as an alternative to providing for a final purchase under such offering period. In March 2015, the Board of Directors approved certain amendments to the 2000 Employee Stock Purchase Plan. At the Company’s annual stockholders meeting in June 2015, the stockholders approved the amendments of the 2000 Employee Stock Purchase Plan to: (i) increase the number of shares of our common stock authorized for issuance under the ESPP by 350,000 shares; and (ii) extend the term of the ESPP to the date that is ten (10) years following the stockholders meeting. At the Company’s annual stockholders meeting in June 2017, the stockholders approved amendments of the 2000 Employee Stock Purchase Plan to increase the number of shares our common stock authorized for issuance under the ESPP by 350,000 shares and to re-approve its material terms The plan expires in June 2025. A total of 2,900,000 shares of common stock have been reserved for issuance under this plan. As of December 31, 2019, 249,276 shares of common stock were available for future grant and 2,650,724 shares of common stock have been issued under the 2000 Employee Stock Purchase Plan. As of December 31, 2019, shares of common stock reserved for future issuance consisted of the following: December 31, 2019 Stock options outstanding 29,803,766 Stock options available for grant 7,936,039 Employee Stock Purchase Plan 249,276 37,989,081 A summary of stock option activity under all stock-based compensation plans is as follows: Number of Options Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in millions) Outstanding at December 31, 2018 30,317,615 $ 1.63 5.02 $ — Options granted 4,484,650 $ 0.61 Options exercised (1,735,743 ) $ 1.11 Options forfeited (116,472 ) $ 1.16 Options expired (3,146,284 ) $ 2.61 Outstanding at December 31, 2019 29,803,766 $ 1.41 5.17 $ 71.3 Exercisable at December 31, 2019 26,457,850 $ 1.47 4.78 $ 61.7 Vested and expected to vest at December 31, 2019 29,803,766 $ 1.41 5.17 $ 71.3 The aggregate intrinsic value in the table above represents the total intrinsic value (i.e., the difference between the Company’s closing stock price on the last trading day of 2019 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their in-the-money options on December 31, 2019. This amount changes based on the fair market value of the Company’s common stock. The total intrinsic value of options exercised was $1.7 million, $1.6 million and $328,000 for the years ended December 31, 2019, 2018 and 2017, respectively. In lieu of providing cash bonuses to certain employees, in January 2019, 2018 and 2017, the Company granted its employees stock options to purchase 2.3 million, 1.9 million and 1.7 million shares, respectively, of the Company’s common stock, which vested immediately on the grant date. The weighted-average grant-date fair value of all options granted with exercise prices equal to fair market value was $0.43 in 2019, $0.94 in 2018 and $0.92 in 2017 determined by the Black-Scholes option valuation method. There were no options granted with exercise prices lower than fair market value in 2019, 2018 and 2017. Expenses for non-employee stock options are recorded over the vesting period of the options, which closely approximates the non-employee’s performance period, with the value determined by the Black-Scholes option valuation method and remeasured over the vesting term. As of December 31, 2019, the Company had three stock-based equity compensation plans, which are described above. The employee stock-based compensation cost that has been included in the statements of operations and comprehensive loss is shown as below (in thousands): Year ended December 31, 2019 2018 2017 Cost of product revenues $ 85 $ 94 $ 109 Research and development 755 1,549 1,415 Selling, general and administrative 1,268 1,355 1,081 $ 2,108 $ 2,998 $ 2,605 Because the Company had a net operating loss carryforward as of December 31, 2019, no excess tax benefits for the tax deductions related to stock-based compensation expense were recognized in the statement of operations. Additionally, no incremental tax benefits were recognized from stock options exercised during 2019, which would have resulted in a reclassification to reduce net cash provided by operating activities with an offsetting increase in net cash provided by financing activities. Determining Fair Value Valuation and Expense Recognition. The Company estimates the fair value of stock options granted using the Black-Scholes option valuation model. The Company recognizes the expense on a straight-line basis. The expense for options is recognized over the requisite service periods of the awards, which is generally the vesting period. Expected Term. The expected term of options granted represents the period of time that the options are expected to be outstanding. The Company determines the expected life using historical options experience. This develops the expected life by taking the weighted average of the actual life of options exercised and cancelled and assumes that outstanding options are exercised uniformly from the current holding period through the end of the contractual life. Expected Volatility. The Company estimates the volatility of its common stock at the date of grant based on the historical volatility of the Company’s common stock. Risk-Free Rate. The Company bases the risk-free rate that it uses in the Black-Scholes option valuation model on the implied yield in effect at the time of option grant on U.S. Treasury zero-coupon issues with substantially equivalent remaining terms. Dividends. The Company has never paid any cash dividends on its common stock and the Company does not anticipate paying any cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield of zero in the Black-Scholes option valuation model. The Company used the following assumptions to estimate the fair value of options granted (including fully vested options issued in January 2019, 2018 and 2017) and shares purchased under its stock plans and employee stock purchase plan for the years ended December 31, 2019, 2018 and 2017: Year ended December 31, 2019 2018 2017 Stock Options Risk-free rate 1.5-2.7% 2.7-3.1% 2.0-2.5% Expected dividend yield — — — Expected term (in years) 7.5-10.0 7.0-10.0 6.8-10.0 Volatility 79-83% 78-86% 75-86% Forfeiture rate (1) 0.0 % 0.0 % 0.0 % (1) Effective January 1, 2017, the Company elected to account for forfeitures as they occur. Year ended December 31, 2019 2018 2017 Employee Stock Purchase Plan Risk-free rate 1.6-2.5% 1.3-2.5% 0.6-1.3% Expected dividend yield — — — Expected term (in years) 0.5 0.5 0.5 Volatility 60-103% 60-146% 44-146% There were 111,909, 119,097 and 122,033 shares purchased under the Company’s employee stock purchase plan during the years ended December 31, 2019, 2018 and 2017, respectively. Included in the statement of operations and comprehensive loss for the year ended December 31, 2019, 2018 and 2017 was $27,000, $24,000 and $34,000, respectively, in stock-based compensation expense related to the recognition of expenses related to shares purchased under the Company’s employee stock purchase plan. As of December 31, 2019, $1.9 million of total unrecognized compensation costs related to nonvested stock options is expected to be recognized over the respective vesting terms of each award through 2022. The weighted average term of the unrecognized stock-based compensation expense is 2.2 years. The following table summarizes information about stock options outstanding at December 31, 2019: Options Outstanding Options Exercisable Range of Exercise Price Number of Options Outstanding Weighted- Average Remaining Contractual Life (In years) Weighted- Average Exercise Price Number of Options Exercisable Weighted- Average Exercise Price $0.51 - $0.57 150,000 9.32 $ 0.56 1,250 $ 0.51 $0.58 - $0.58 3,286,445 8.90 $ 0.58 2,118,141 $ 0.58 $0.58 - $0.88 4,534,657 4.30 $ 0.82 4,200,824 $ 0.84 $0.93 - $1.19 3,006,451 5.92 $ 1.15 2,869,131 $ 1.15 $1.20 - $1.20 114,293 4.55 $ 1.20 114,293 $ 1.20 $1.21 - $1.21 3,004,999 3.09 $ 1.21 2,998,249 $ 1.21 $1.24 - $1.24 3,131,872 7.94 $ 1.24 2,293,016 $ 1.24 $1.26 - $1.26 140,000 3.16 $ 1.26 140,000 $ 1.26 $1.31 - $1.31 3,070,156 6.68 $ 1.31 2,478,491 $ 1.31 $1.33 - $3.61 9,364,893 3.26 $ 2.24 9,244,455 $ 2.25 $0.51 - $3.61 29,803,766 5.17 $ 1.41 26,457,850 $ 1.47 The Company received $1.9 million, $1.6 million and $562,000 in cash from option exercises under all stock-based compensation plans for the years ended December 31, 2019, 2018 and 2017, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. Income Taxes The Company accounts for income taxes using the liability method under ASC 740, Income Taxes The reconciliation of income tax expenses (benefit) at the statutory federal income tax rate of 21% for 2019 and 2018, and 34% for 2017, to net income tax benefit included in the statements of operations and comprehensive loss for the years ended December 31, 2019, 2018 and 2017 is as follows (in thousands): Year Ended December 31, 2019 2018 2017 U.S. federal taxes benefit at statutory rate $ (4,321 ) $ (5,318 ) $ (1,307 ) State taxes — — 3 Change in valuation allowance 4,394 5,143 (41,865 ) Stock-based compensation 879 999 1,832 Research and development tax credits (1,004 ) (999 ) (1,353 ) Tax Reform change in tax rate and other — — 42,528 Other 52 175 12 Total income tax (benefit) provision $ — $ — $ (150 ) In 2019, 2018 and 2017, total income tax provision (benefit) expense was zero, zero and $(150,000), respectively. The Company has presented these amounts within interest and other income, net in the Statements of Operations and Comprehensive Loss. Deferred tax assets and liabilities reflect the net tax effects of net operating loss and research and other credit carryforwards and the temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 90,102 $ 87,275 Research and other credits 18,860 17,524 Deferred revenue 248 277 Stock-based compensation 4,376 4,755 Other 5,288 2,823 Total deferred tax assets 118,874 112,654 Valuation allowance for deferred tax assets (117,245 ) (112,654 ) Deferred tax liabilities—Intangibles (1,873 ) (244 ) Net deferred tax assets and liabilities $ (244 ) $ (244 ) The Company recognizes deferred tax assets to the extent that the Company believes that these assets are more likely than not to be realized. In making such a determination, all available positive and negative evidence is considered, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If it is determined that the Company would be able to realize deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of tax benefit might change as new information becomes available. Given the Company’s history of operating losses, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $4.6 million during 2019, and $6.3 million in 2018, and decreased $43.1 million during 2017, respectively. As of December 31, 2019, the Company had net operating loss carryforwards for federal income tax purposes of approximately $358.6 million, of which $320.4 million will expire in the years 2020 through 2037, and $38.2 million which do not expire, and federal research and development tax credits of approximately $14.5 million, which expire at various dates beginning in 2020 through 2039, if not utilized. As of December 31, 2019, the Company had net operating loss carryforwards for state income tax purposes of approximately $219.2 million, which expire in the years 2020 through 2039, if not utilized, and state research and development tax credits of approximately $15.8 million, which do not expire. Utilization of the net operating losses may be subject to a substantial annual limitation due to federal and state ownership change limitations. The annual limitation may result in the expiration of net operating losses before utilization. At December 31, 2019 and December 31, 2018, the Company had unrecognized tax benefits of approximately $9.1 million and $8.4 million, respectively (none of which, if recognized, would affect the Company’s effective tax rate). The Company does not believe there will be any material changes in its unrecognized tax positions over the next twelve months. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): December 31, 2019 2018 Balance at beginning of the year $ 8,432 $ 7,849 Decreased related to prior year tax positions (73 ) (7 ) Increased related to current year tax positions 719 590 Balance at end of the year $ 9,078 $ 8,432 Interest and penalty costs related to unrecognized tax benefits, if any, are classified as a component of interest and other income, net in the Statements of Operations and Comprehensive Loss. The Company did not recognize any interest and penalties expenses related to unrecognized tax benefits for the years ended December 31, 2019, 2018 and 2017. The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The Company is subject to U.S. federal and state income tax examination for calendar tax years ending 1998 through 2018 due to unutilized net operating losses and research credits. |
Unaudited Selected Quarterly Fi
Unaudited Selected Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Selected Quarterly Financial Data | 10. Unaudited Selected Quarterly Financial Data (in thousands, except per share amounts) First Quarter Second Quarter Third Quarter Fourth Quarter 2019 2018 2019 2018 2019 2018 2019 2018 Revenue (1) $ 4,131 $ 3,488 $ 3,985 $ 3,413 $ 10,763 $ 8,036 $ 10,685 $ 3,627 Net loss $ (7,130 ) $ (8,297 ) $ (7,227 ) $ (7,011 ) $ (1,990 ) $ (2,715 ) $ (4,231 ) $ (7,299 ) Basic net loss per share $ (0.04 ) $ (0.05 ) $ (0.04 ) $ (0.04 ) $ (0.01 ) $ (0.02 ) $ (0.02 ) $ (0.05 ) Diluted net loss per share $ (0.04 ) $ (0.05 ) $ (0.04 ) $ (0.04 ) $ (0.01 ) $ (0.02 ) $ (0.02 ) $ (0.05 ) (1) The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Schedule II-Valuation and Quali
Schedule II-Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2019 | |
Valuation And Qualifying Accounts [Abstract] | |
Schedule II-Valuation and Qualifying Accounts | SCHEDULE II—VALUATION AND QUALIFYING ACCOUNTS Year Ended December 31, 2019, 2018 and 2017 (in thousands) Balance at beginning of the year Additions (Reductions) to allowances Deductions Balance at end of the year Allowance for doubtful accounts Year ended December 31, 2019 $ 102 $ (51 ) $ (17 ) $ 34 Year ended December 31, 2018 $ 155 $ (52 ) $ (1 ) $ 102 Year ended December 31, 2017 $ 73 $ 165 $ (83 ) $ 155 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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 designs, develops and manufactures a wide range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device 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 and Use of Estimates | Basis of Presentation and Use of Estimates The Company’s financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). The preparation of the accompanying Financial Statements conforms to accounting principles generally accepted in the U.S. which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to, those related to revenue recognition, the period of performance, identification of deliverables and evaluation of milestones with respect to our collaborations, the amounts of revenues, recoverability of inventory, certain accrued liabilities including accrued clinical trial liability, and stock-based compensation. The Company bases its estimates on historical experience and on various other market-specific and other relevant assumptions that the Company believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. |
Liquidity and Need to Raise Additional Capital | Liquidity and Need to Raise Additional Capital As of December 31, 2019, the Company has an accumulated deficit of $489.2 million as well as negative cash flows from operating activities. The Company generally has had negative cash flows from operating activities and expects its negative cash flows to continue. The Company will continue to require substantial funds to continue research and development, including clinical trials of its product candidates. Management’s plans in order to meet its operating cash flow requirements beyond the next 12 months from the date the financial statements are filed, include seeking additional collaborative agreements for certain of its programs and achieving milestone and other payments under 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 and that the Company will succeed in its future operations. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected. |
Cash, Cash Equivalents and Investments | Cash, Cash Equivalents and Investments The Company considers all highly liquid investments with maturities of 90 days or less from the date of purchase to be cash equivalents. Investments with original maturities of greater than 90 days from the date of purchase but less than one year from the balance sheet date are classified as short-term investments, while investments with maturities in one year or beyond one year from the balance sheet date are classified as long-term investments. Management determines the appropriate classification of its cash equivalents and investment securities at the time of purchase and re-evaluates such determination as of each balance sheet date. Management has classified the Company’s cash equivalents and investments as available-for-sale securities in the accompanying financial statements. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported as a component of accumulated other comprehensive loss. Realized gains and losses are included in interest income. There were no material realized gains or losses in the periods presented. The cost of securities sold is based on the specific identification method. The Company invests in debt instruments of government agencies, corporations, and money market funds with high credit ratings. The Company has established guidelines regarding diversification of its investments and their maturities with the objectives of maintaining safety and liquidity, while maximizing yield. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk consist principally of interest-bearing investments and trade receivables. The Company maintains cash, cash equivalents and investments with various major financial institutions. The Company performs periodic evaluations of the relative credit standing of these financial institutions. In addition, the Company performs periodic evaluations of the relative credit quality of its investments. Pharmaceutical companies and academic institutions account for a substantial portion of the Company’s trade receivables. The Company provides credit in the normal course of business to its customers and collateral for these receivables is generally not required. The risk associated with this concentration is limited to a certain extent due to the large number of accounts and their geographic dispersion. The Company monitors the creditworthiness of its customers to which it grants credit terms in the normal course of business. The Company maintains reserves for estimated credit losses and, to date, such losses have been immaterial in all periods presented. |
Customer and Product Line Concentrations | Customer and Product Line Concentrations A portion of the Company’s revenue is derived from its ALZET mini pump product line, LACTEL biodegradable polymer product line and the sale of certain excipients for Methydur Sustained Release Capsules and one excipient that is included in a currently marketed animal health product. In 2019, revenue from the sale of products from the ALZET product line and the LACTEL product line accounted for 23% and 15% of total revenue, respectively. In 2018, revenue from the ALZET product line and the LACTEL product line accounted for 38% and 18% of total revenue, respectively. In 2017, revenue from the ALZET product line and the LACTEL product line accounted for 14% and 12% of total revenue, respectively. In 2019, Gilead accounted for 58% of the Company’s total revenue. In 2018, Indivior and Gilead accounted for 27% and 14% of the Company’s total revenues, respectively. In 2017, Sandoz and Indivior accounted for 41% and 25% of the Company’s total revenues, respectively. Total revenue by geographic region for the years 2019, 2018 and 2017 are as follows (in thousands): Year ended December 31, 2019 2018 2017 United States $ 22,825 $ 7,990 $ 11,323 Europe 3,132 8,118 34,261 Japan 1,476 978 1,395 Others 2,131 1,478 2,191 Total $ 29,564 $ 18,564 $ 49,170 Revenue by geography is determined by the location of the customer. |
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, among other potential factors, a denial or delay of approval of a customer’s product by the necessary regulatory bodies, or 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. In October 2017, the Company announced that PERSIST, the Phase 3 clinical trial for POSIMIR, did not meet its primary efficacy endpoint. As a result, the Company determined that certain lots of inventory were no longer considered to be probable for use prior to expiration. The Company recorded charges to cost of goods sold of approximately $2.0 million, of which approximately $503,000 related to the write-down of the cost basis of inventory on hand, $500,000 related to the prepaid inventory for the minimum purchase commitment for this excipient, and $1.0 million related to the accrual of a liability for the remaining minimum purchase commitment for the same excipient. 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 consisted of the following (in thousands): December 31, 2019 2018 Raw materials $ 282 $ 223 Work in-process 1,537 1,486 Finished goods 1,564 1,712 Total inventories $ 3,383 $ 3,421 |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation, which is computed using the straight-line method over the estimated useful lives of the assets, which range from three to five years. Leasehold improvements are amortized using the straight-line method over the estimated useful lives of the assets, or the terms of the related leases, whichever are shorter. |
Goodwill | Goodwill Goodwill is periodically assessed and evaluated for impairment at the reporting unit level. The Company operates in one operating segment and also has only one reporting unit, which is the research, development and manufacturing of pharmaceutical products. The Company assesses the impairment of goodwill at least annually and whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors the Company considers important which could trigger an impairment review include the following: • significant decline in our stock price for a prolonged period; • our market capitalization relative to net book value; • new information affecting the commercial value of the asset; • significant underperformance relative to historical or projected future operating results; • significant changes in the manner of our use of the acquired assets or the strategy for the Company’s overall business; and • significant negative industry or economic trends. As of December 31, 2019, the carrying value of goodwill was approximately $6.4 million and no impairment of goodwill has been recorded for any of the periods presented. The Company evaluates goodwill for impairment at least annually. In 2019, 2018 and 2017, goodwill was evaluated and no indicators of impairment were identified. To date, the Company has not recorded any impairment charge related to goodwill. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets, including property and equipment, intangible assets, and other long-term assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount. Impairment, if any, is calculated as the amount by which an asset’s carrying value exceeds its fair value, typically using discounted cash flows to determine fair value. Through December 31, 2019, there have been no material impairment losses. |
Leases | Leases The Company leases administrative, manufacturing and laboratory facilities under operating leases. Lease agreements may include rent holidays, rent escalation clauses and tenant improvement allowances. Prior to the adoption of Accounting Standards Update ("ASU" No. 2016-02, Leases, and the related amendments ("Topic 842") Effective January 1, 2019, the Company adopted Topic 842 using the modified retrospective transition method approach with a cumulative-effect adjustment as of January 1, 2019. Other prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under previous lease guidance, ASC Topic 840: Leases (Topic 840). The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carry forward the historical lease classification of those leases in place as of January 1, 2019. The adjustments due to the adoption of Topic 842 primarily related to the recognition of an operating lease right-of-use asset and corresponding operating lease liability for the Company’s leased properties. The Company’s operating lease right-of-use asset and liability were recognized at the adoption date of ASC 842 based on the present value of lease payments over the remaining lease term at the adoption date. In determining the net present value of lease payments, we used our incremental borrowing rate of 13.8% based on the information available, including remaining lease term, at the adoption date of ASC 842. As of December 31, 2019, the weighted-average remaining lease term was 3.4 years . The impact of the adoption of Topic 842 on the accompanying Balance Sheet as of January 1, 2019 was as follows (in thousands): As of January 1, 2019 December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Balance Sheet Operating lease right-of-use assets $ — $ 7,329 $ 7,329 Operating lease liabilities: Accrued liabilities (1) $ (92 ) $ 92 $ — Other long-term liabilities (1) (270 ) 270 — Lease liabilities, current portion — (1,972 ) (1,972 ) Lease liabilities, non-current portion — (5,719 ) (5,719 ) $ (362 ) $ (7,329 ) $ (7,691 ) Includes deferred rent, current and long-term portions of operating lease liabilities which were recorded against the operating lease right-of-use asset upon adoption of Topic 842 There was no effect from the adoption of Topic 842 on the Company’s Statement of cash flows. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for share-based payments using a fair-value based method for costs related to all share-based payments, including stock options and stock issued under the Company’s employee stock purchase plan (ESPP). The Company estimates the fair value of share-based payment awards on the date of grant using an option-pricing model. See Note 8 for further information regarding stock-based compensation. |
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. Effective January 1, 2018, the Company adopted FASB ASC Topic 606, Revenue from Contracts with Customers, or ASC 606. In accordance with ASC 606, the Company changed certain characteristics of its revenue recognition accounting policy as described below. ASC 606 was applied using the modified retrospective method, where the cumulative effect of the initial application was recognized as an adjustment to opening retained earnings at January 1, 2018. The Company recorded a net decrease to opening accumulated deficit of $470,000 with an offset entry to reduce deferred revenue as of January 1, 2018 due to the cumulative impact of adopting Topic 606, with the impact relating to the Company’s deferred collaborative research and development revenues. Product Revenue, Net The Company sells osmotic pumps used in laboratory research, and designs, develops and manufactures a wide range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device 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. The Company expects product returns to be minimal. Collaborative Research and Development and Other Revenue The Company enters into license agreements which are within the scope of Topic 606, 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 royalty 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. 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 any 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. |
Research and Development Expenses | Research and Development Expenses 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. |
Segment Reporting | Segment Reporting The Company operates in one operating segment, which is the research, development and manufacturing of pharmaceutical products. |
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): Year Ended December 31, 2019 2018 2017 Numerators: Net loss $ (20,578 ) $ (25,322 ) $ (3,695 ) Denominators: Weighted average shares used to compute basic net loss per share 178,042 159,834 145,273 Effect of dilutive securities: Dilution from stock options — — — Dilution from ESPP — — — Dilutive common shares — — — Weighted average shares used to compute diluted net loss per share 178,042 159,834 145,273 Net loss per share: Basic $ (0.12 ) $ (0.16 ) $ (0.03 ) Diluted $ (0.12 ) $ (0.16 ) $ (0.03 ) The computation of diluted net loss per share for the years ended 2019, 2018 and 2017 excludes the impact of options to purchase 21.4 million, 16.6 million and 20.1 million shares of common stock outstanding, respectively, at December 31, 2019, 2018 and 2017, as such impact would be antidilutive. |
Shipping and Handling | Shipping and Handling Costs related to shipping and handling are included in cost of revenues for all periods presented. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2018, the Financial Accounting Standards Board (the FASB) issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (ASU 2018-18) In August 2018, the FASB issued Accounting Standards Update (“ASU”) No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, including interim reporting periods within those years, with early adoption permitted. The Company does not expect the adoption of this standard to have a material effect on its financial statements. In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, (ASU 2017-04) 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, 2019, 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) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Total Revenue by Geographic Region | Total revenue by geographic region for the years 2019, 2018 and 2017 are as follows (in thousands): Year ended December 31, 2019 2018 2017 United States $ 22,825 $ 7,990 $ 11,323 Europe 3,132 8,118 34,261 Japan 1,476 978 1,395 Others 2,131 1,478 2,191 Total $ 29,564 $ 18,564 $ 49,170 |
Summary of Components of Inventories | The Company’s inventories consisted of the following (in thousands): December 31, 2019 2018 Raw materials $ 282 $ 223 Work in-process 1,537 1,486 Finished goods 1,564 1,712 Total inventories $ 3,383 $ 3,421 |
Summary of Impact of Adoption Topic 842 on Accompanying Condensed Balance Sheet | The impact of the adoption of Topic 842 on the accompanying Balance Sheet as of January 1, 2019 was as follows (in thousands): As of January 1, 2019 December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Balance Sheet Operating lease right-of-use assets $ — $ 7,329 $ 7,329 Operating lease liabilities: Accrued liabilities (1) $ (92 ) $ 92 $ — Other long-term liabilities (1) (270 ) 270 — Lease liabilities, current portion — (1,972 ) (1,972 ) Lease liabilities, non-current portion — (5,719 ) (5,719 ) $ (362 ) $ (7,329 ) $ (7,691 ) Includes deferred rent, current and long-term portions of operating lease liabilities which were recorded against the operating lease right-of-use asset upon adoption of Topic 842 |
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): Year Ended December 31, 2019 2018 2017 Numerators: Net loss $ (20,578 ) $ (25,322 ) $ (3,695 ) Denominators: Weighted average shares used to compute basic net loss per share 178,042 159,834 145,273 Effect of dilutive securities: Dilution from stock options — — — Dilution from ESPP — — — Dilutive common shares — — — Weighted average shares used to compute diluted net loss per share 178,042 159,834 145,273 Net loss per share: Basic $ (0.12 ) $ (0.16 ) $ (0.03 ) Diluted $ (0.12 ) $ (0.16 ) $ (0.03 ) |
Strategic Agreements (Tables)
Strategic Agreements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Collaborative Research and Development and Other Revenues Associated with Company's Major Third-Party Collaborators | The collaborative research and development and other revenues associated with the Company’s major third-party collaborators are as follows (in thousands): Year ended December 31, 2019 2018 2017 Collaborator/Counterparty Gilead (1) $ 17,133 $ 2,542 $ 1,687 Sandoz AG (Sandoz) (2) — — 20,000 Other (3) 996 5,665 1,890 Total collaborative research and development and other revenue $ 18,129 $ 8,207 $ 23,577 (1) The Company signed a license agreement with Gilead on July 19, 2019 and received nonrefundable upfront license fee and milestone payment of $35.0 million in 2019. Amounts include partial recognition ($12.3 million) of the upfront license fee and milestone payment in 2019, compared to zero for the corresponding periods in 2018 and 2017. ( 2 ) Amounts related to recognition of upfront fees were zero in 2019 and 2018, and $20.0 million in 2017; the Company and Sandoz signed a license agreement effective June 2017. As of December 31, 2017, all of the $20.0 million upfront fee had been recognized as revenue as the Company’s contractual performance obligations had been fulfilled. In January 2019, the license agreement was terminated. (3) Includes: (a) amounts related to earn-out revenue from Indivior UK Limited (Indivior) with respect to PERSERIS net sales as well as a $5.0 million milestone payment earned from Indivior in 2018; (b) feasibility program(s); (c) research and development activities funded by Santen pharmaceutical Co. Ltd. (Santen). Note that in January 2018, the Company was notified by Santen that due to a shift in near term priorities, Santen has elected to reallocate research and development resources and put our 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; and (d) research and development activities funded by Zogenix. Note that the Company and Zogenix signed a license agreement effective July 2011. In August 2017, the Company and Zogenix terminated the license agreement. |
Summary of Changes in the Company's Contract Asset and Liabilities | The following table presents changes in the Company’s contract assets and liabilities for the twelve months ended December 31, 2019 (in thousands): Balance at January 1, 2019 Additions Deletions Balance at December 31, 2019 Balance Sheet Assets Accounts receivable $ — $ 39,812 $ (39,318 ) $ 494 Total contract asset $ — $ 39,812 $ (39,318 ) $ 494 Liabilities Deferred revenue, current portion $ — $ 35,000 $ (12,321 ) $ 22,679 Deferred revenue, non-current portion — — — — Total contract liabilities $ — $ 35,000 $ (12,321 ) $ 22,679 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements of Assets and Liabilities | The following table sets forth the fair value of the Company’s financial assets that were measured at fair value on a recurring basis as of December 31, 2019 (in thousands): Level 1 Level 2 Level 3 Total Money market funds $ 524 $ — $ — $ 524 Certificates of deposit — 150 — 150 Commercial paper — 47,218 — 47,218 U.S. Government agencies — 4,501 — 4,501 Corporate debt — 9,868 — 9,868 Total $ 524 $ 61,737 $ — $ 62,261 The following table sets forth the fair value of our financial assets that were measured at fair value on a recurring basis as of December 31, 2018 (in thousands): Level 1 Level 2 Level 3 Total Money market funds $ 502 $ — $ — $ 502 Certificates of deposit — 150 — 150 Commercial paper — 32,224 — 32,224 Total $ 502 $ 32,374 $ — $ 32,876 |
Summary of Money Market Funds and Available-for-Sale Securities | The following is a summary of available-for-sale securities as of December 31, 2019 and 2018 (in thousands): December 31, 2019 Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Money market funds $ 524 $ — $ — $ 524 Certificates of deposit 150 — — 150 Commercial paper 47,221 1 (4 ) 47,218 U.S. Government agencies 4,500 1 4,501 Corporate debt 9,869 1 (2 ) 9,868 $ 62,264 $ 3 $ (6 ) $ 62,261 Reported as: Cash and cash equivalents $ 32,364 $ — $ (3 ) $ 32,361 Short-term investments 29,750 3 (3 ) 29,750 Long-term restricted investments 150 — — 150 $ 62,264 $ 3 $ (6 ) $ 62,261 December 31, 2018 Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Money market funds $ 502 $ — $ — $ 502 Certificates of deposit 150 — — 150 Commercial paper 32,224 — — 32,224 $ 32,876 $ — $ — $ 32,876 Reported as: Cash and cash equivalents $ 30,055 $ — $ — $ 30,055 Short-term investments 2,671 — — 2,671 Long-term restricted investments 150 — — 150 $ 32,876 $ — $ — $ 32,876 |
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 December 31, 2019, by contractual maturity (in thousands): December 31, 2019 Amortized Cost Estimated Fair Value Mature in one year or less $ 61,740 $ 61,737 $ 61,740 $ 61,737 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following (in thousands): December 31, 2019 2018 Equipment $ 12,862 $ 12,785 Leasehold improvements 9,849 9,828 Construction-in-progress 90 33 22,801 22,646 Less accumulated depreciation and amortization (22,332 ) (22,041 ) Property and equipment, net $ 469 $ 605 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Lease Arrangements of Company Facilities | 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 (with an option to renew for an additional five years) Birmingham, AL 21,540 sq. ft. Office, Laboratory and Manufacturing Lease expires 2021 (with two options to renew the lease term for an additional five years each after the current lease expires) |
Schedule of Future Operating Lease Minimum Payments | Future minimum payments under these noncancelable leases are as follows (in thousands): Year ending December 31, Operating Leases 2020 $ 2,200 2021 2,126 2022 1,991 2023 1,970 2024 275 $ 8,562 |
Term Loan (Tables)
Term Loan (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Future Maturities and Interest Payments under Term Loan | Future maturities and interest payments under the term loan as of December 31, 2019, are as follows (in thousands): 2020 $ 1,848 2021 3,172 2022 9,381 2023 and after 13,361 Total minimum payments 27,762 Less amount representing interest (6,090 ) Gross balance of term loan 21,672 Less unamortized debt discount (1,410 ) Carrying value of term loan 20,262 Less term loan, current portion, net — Term loan, non-current portion, net $ 20,262 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Summary of Shares of Common Stock Reserved for Future Issuance | As of December 31, 2019, shares of common stock reserved for future issuance consisted of the following: December 31, 2019 Stock options outstanding 29,803,766 Stock options available for grant 7,936,039 Employee Stock Purchase Plan 249,276 37,989,081 |
Summary of Stock Option Activity under all Stock-Based Compensation Plans | A summary of stock option activity under all stock-based compensation plans is as follows: Number of Options Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in millions) Outstanding at December 31, 2018 30,317,615 $ 1.63 5.02 $ — Options granted 4,484,650 $ 0.61 Options exercised (1,735,743 ) $ 1.11 Options forfeited (116,472 ) $ 1.16 Options expired (3,146,284 ) $ 2.61 Outstanding at December 31, 2019 29,803,766 $ 1.41 5.17 $ 71.3 Exercisable at December 31, 2019 26,457,850 $ 1.47 4.78 $ 61.7 Vested and expected to vest at December 31, 2019 29,803,766 $ 1.41 5.17 $ 71.3 |
Summary of Employee Stock-Based Compensation Cost that has been Included in Statements of Operations and Comprehensive Loss | The employee stock-based compensation cost that has been included in the statements of operations and comprehensive loss is shown as below (in thousands): Year ended December 31, 2019 2018 2017 Cost of product revenues $ 85 $ 94 $ 109 Research and development 755 1,549 1,415 Selling, general and administrative 1,268 1,355 1,081 $ 2,108 $ 2,998 $ 2,605 |
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 options granted (including fully vested options issued in January 2019, 2018 and 2017) and shares purchased under its stock plans and employee stock purchase plan for the years ended December 31, 2019, 2018 and 2017: Year ended December 31, 2019 2018 2017 Stock Options Risk-free rate 1.5-2.7% 2.7-3.1% 2.0-2.5% Expected dividend yield — — — Expected term (in years) 7.5-10.0 7.0-10.0 6.8-10.0 Volatility 79-83% 78-86% 75-86% Forfeiture rate (1) 0.0 % 0.0 % 0.0 % (1) Effective January 1, 2017, the Company elected to account for forfeitures as they occur. Year ended December 31, 2019 2018 2017 Employee Stock Purchase Plan Risk-free rate 1.6-2.5% 1.3-2.5% 0.6-1.3% Expected dividend yield — — — Expected term (in years) 0.5 0.5 0.5 Volatility 60-103% 60-146% 44-146% |
Summary of Stock Options Outstanding | The following table summarizes information about stock options outstanding at December 31, 2019: Options Outstanding Options Exercisable Range of Exercise Price Number of Options Outstanding Weighted- Average Remaining Contractual Life (In years) Weighted- Average Exercise Price Number of Options Exercisable Weighted- Average Exercise Price $0.51 - $0.57 150,000 9.32 $ 0.56 1,250 $ 0.51 $0.58 - $0.58 3,286,445 8.90 $ 0.58 2,118,141 $ 0.58 $0.58 - $0.88 4,534,657 4.30 $ 0.82 4,200,824 $ 0.84 $0.93 - $1.19 3,006,451 5.92 $ 1.15 2,869,131 $ 1.15 $1.20 - $1.20 114,293 4.55 $ 1.20 114,293 $ 1.20 $1.21 - $1.21 3,004,999 3.09 $ 1.21 2,998,249 $ 1.21 $1.24 - $1.24 3,131,872 7.94 $ 1.24 2,293,016 $ 1.24 $1.26 - $1.26 140,000 3.16 $ 1.26 140,000 $ 1.26 $1.31 - $1.31 3,070,156 6.68 $ 1.31 2,478,491 $ 1.31 $1.33 - $3.61 9,364,893 3.26 $ 2.24 9,244,455 $ 2.25 $0.51 - $3.61 29,803,766 5.17 $ 1.41 26,457,850 $ 1.47 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Income Tax Expenses (Benefit) | The reconciliation of income tax expenses (benefit) at the statutory federal income tax rate of 21% for 2019 and 2018, and 34% for 2017, to net income tax benefit included in the statements of operations and comprehensive loss for the years ended December 31, 2019, 2018 and 2017 is as follows (in thousands): Year Ended December 31, 2019 2018 2017 U.S. federal taxes benefit at statutory rate $ (4,321 ) $ (5,318 ) $ (1,307 ) State taxes — — 3 Change in valuation allowance 4,394 5,143 (41,865 ) Stock-based compensation 879 999 1,832 Research and development tax credits (1,004 ) (999 ) (1,353 ) Tax Reform change in tax rate and other — — 42,528 Other 52 175 12 Total income tax (benefit) provision $ — $ — $ (150 ) |
Summary of Components of Company's Deferred Tax Assets | Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 90,102 $ 87,275 Research and other credits 18,860 17,524 Deferred revenue 248 277 Stock-based compensation 4,376 4,755 Other 5,288 2,823 Total deferred tax assets 118,874 112,654 Valuation allowance for deferred tax assets (117,245 ) (112,654 ) Deferred tax liabilities—Intangibles (1,873 ) (244 ) Net deferred tax assets and liabilities $ (244 ) $ (244 ) |
Reconciliation of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): December 31, 2019 2018 Balance at beginning of the year $ 8,432 $ 7,849 Decreased related to prior year tax positions (73 ) (7 ) Increased related to current year tax positions 719 590 Balance at end of the year $ 9,078 $ 8,432 |
Unaudited Selected Quarterly _2
Unaudited Selected Quarterly Financial Data (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data | First Quarter Second Quarter Third Quarter Fourth Quarter 2019 2018 2019 2018 2019 2018 2019 2018 Revenue (1) $ 4,131 $ 3,488 $ 3,985 $ 3,413 $ 10,763 $ 8,036 $ 10,685 $ 3,627 Net loss $ (7,130 ) $ (8,297 ) $ (7,227 ) $ (7,011 ) $ (1,990 ) $ (2,715 ) $ (4,231 ) $ (7,299 ) Basic net loss per share $ (0.04 ) $ (0.05 ) $ (0.04 ) $ (0.04 ) $ (0.01 ) $ (0.02 ) $ (0.02 ) $ (0.05 ) Diluted net loss per share $ (0.04 ) $ (0.05 ) $ (0.04 ) $ (0.04 ) $ (0.01 ) $ (0.02 ) $ (0.02 ) $ (0.05 ) (1) The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) shares in Millions | 12 Months Ended | |||
Dec. 31, 2019USD ($)Segmentshares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Jan. 01, 2018USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Date of incorporation | Feb. 6, 1998 | |||
Accumulated deficit | $ 489,202,000 | $ 468,624,000 | ||
Highly liquid investments maturity period | 90 days or less | |||
Long-term investments maturity period | One year or beyond | |||
Realized gains or losses on cash, cash equivalents and investments | $ 0 | 0 | ||
Cost of goods sold | 4,143,000 | 4,263,000 | $ 6,633,000 | |
Write-down of the cost basis of inventory on hand | $ 255,000 | 291,000 | 2,259,000 | |
Minimum purchase commitment | 500,000 | |||
Number of operating segment | Segment | 1 | |||
Number of reporting segment | Segment | 1 | |||
Goodwill | $ 6,399,000 | 6,399,000 | ||
Goodwill impairment | 0 | $ 0 | $ 0 | |
Long-lived assets, impairment losses | $ 0 | |||
Options to purchase common stock excluded from computation of diluted net loss per share | shares | 21.4 | 16.6 | 20.1 | |
Accounting Standards Update 2014-09 [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Incremental borrowing rate | 13.80% | |||
Weighted average remaining lease term | 3 years 4 months 24 days | |||
Decrease in retained earnings due to cumulative impact of adopting Topic 606 | $ (470,000) | |||
Agreement with Pain Therapeutics, Inc. [Member] | PERSIST, Phase 3 Clinical Trial for POSIMIR [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Cost of goods sold | $ 2,000,000 | |||
Write-down of the cost basis of inventory on hand | 503,000 | |||
Minimum purchase commitment | 1,000,000 | |||
Agreement with Pain Therapeutics, Inc. [Member] | PERSIST, Phase 3 Clinical Trial for POSIMIR [Member] | Prepaid Inventory [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Minimum purchase commitment | $ 500,000 | |||
Sales Revenue Net [Member] | Customer Concentration Risk [Member] | Sandoz [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Percentage of revenue accounted in Company's total revenue | 41.00% | |||
Sales Revenue Net [Member] | Customer Concentration Risk [Member] | Indivior [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Percentage of revenue accounted in Company's total revenue | 27.00% | 25.00% | ||
Sales Revenue Net [Member] | Customer Concentration Risk [Member] | Gilead [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Percentage of revenue accounted in Company's total revenue | 58.00% | 14.00% | ||
Sales Revenue Net [Member] | ALZET Product Line [Member] | Product Concentration Risk [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Percentage of revenue accounted in Company's total revenue | 23.00% | 38.00% | 14.00% | |
Sales Revenue Net [Member] | LACTEL Product Line [Member] | Product Concentration Risk [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Percentage of revenue accounted in Company's total revenue | 15.00% | 18.00% | 12.00% | |
Minimum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Short-term investments maturity period | 90 days | |||
Property and equipment, estimated useful life | 3 years | |||
Maximum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Short-term investments maturity period | 1 year | |||
Property and equipment, estimated useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Total Revenue by Geographic Region (Detail) - USD ($) $ in Thousands | Jul. 19, 2019 | Dec. 31, 2019 | [1] | Sep. 30, 2019 | [1] | Jun. 30, 2019 | [1] | Mar. 31, 2019 | [1] | Dec. 31, 2018 | [1] | Sep. 30, 2018 | [1] | Jun. 30, 2018 | [1] | Mar. 31, 2018 | [1] | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||||||||||||
Revenue | $ 25,000 | $ 10,685 | $ 10,763 | $ 3,985 | $ 4,131 | $ 3,627 | $ 8,036 | $ 3,413 | $ 3,488 | $ 29,564 | $ 18,564 | $ 49,170 | ||||||||
United States [Member] | ||||||||||||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||||||||||||
Revenue | 22,825 | 7,990 | 11,323 | |||||||||||||||||
Europe [Member] | ||||||||||||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||||||||||||
Revenue | 3,132 | 8,118 | 34,261 | |||||||||||||||||
Japan [Member] | ||||||||||||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||||||||||||
Revenue | 1,476 | 978 | 1,395 | |||||||||||||||||
Others [Member] | ||||||||||||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||||||||||||||||||
Revenue | $ 2,131 | $ 1,478 | $ 2,191 | |||||||||||||||||
[1] | The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Components of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Net [Abstract] | ||
Raw materials | $ 282 | $ 223 |
Work in-process | 1,537 | 1,486 |
Finished goods | 1,564 | 1,712 |
Total inventories | $ 3,383 | $ 3,421 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Impact of Adoption Topic 842 on Accompanying Condensed Balance Sheet (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | |
Operating lease right-of-use assets | $ 6,066 | |||
Lease liabilities, current portion | (2,043) | |||
Lease liabilities, non-current portion | $ (4,517) | |||
Operating lease, liability | $ (362) | |||
Accrued liabilities [Member] | ||||
Lease liabilities, current portion | [1] | (92) | ||
Other long-term liabilities [Member] | ||||
Lease liabilities, non-current portion | [1] | $ (270) | ||
Accounting Standards Update 2016-02 [Member] | ||||
Operating lease right-of-use assets | $ 7,329 | |||
Lease liabilities, current portion | (1,972) | |||
Lease liabilities, non-current portion | (5,719) | |||
Operating lease, liability | (7,691) | |||
Accounting Standards Update 2016-02 [Member] | Adjustments Due to the Adoption of Topic 842 [Member] | ||||
Operating lease right-of-use assets | 7,329 | |||
Lease liabilities, current portion | (1,972) | |||
Lease liabilities, non-current portion | (5,719) | |||
Operating lease, liability | (7,329) | |||
Accounting Standards Update 2016-02 [Member] | Accrued liabilities [Member] | Adjustments Due to the Adoption of Topic 842 [Member] | ||||
Lease liabilities, current portion | [1] | 92 | ||
Accounting Standards Update 2016-02 [Member] | Other long-term liabilities [Member] | Adjustments Due to the Adoption of Topic 842 [Member] | ||||
Lease liabilities, non-current portion | [1] | $ 270 | ||
[1] | Includes deferred rent, current and long-term portions of operating lease liabilities which were recorded against the operating lease right-of-use asset upon adoption of Topic 842 |
Summary of Significant Accoun_8
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 | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Numerators: | |||||||||||
Net loss | $ (4,231) | $ (1,990) | $ (7,227) | $ (7,130) | $ (7,299) | $ (2,715) | $ (7,011) | $ (8,297) | $ (20,578) | $ (25,322) | $ (3,695) |
Denominators: | |||||||||||
Weighted average shares used to compute basic net loss per share | 178,042 | 159,834 | 145,273 | ||||||||
Effect of dilutive securities: | |||||||||||
Dilution from stock options | 0 | 0 | 0 | ||||||||
Dilution from ESPP | 0 | 0 | 0 | ||||||||
Dilutive common shares | 0 | 0 | 0 | ||||||||
Weighted average shares used to compute diluted net loss per share | 178,042 | 159,834 | 145,273 | ||||||||
Net loss per share: | |||||||||||
Basic | $ (0.02) | $ (0.01) | $ (0.04) | $ (0.04) | $ (0.05) | $ (0.02) | $ (0.04) | $ (0.05) | $ (0.12) | $ (0.16) | $ (0.03) |
Diluted | $ (0.02) | $ (0.01) | $ (0.04) | $ (0.04) | $ (0.05) | $ (0.02) | $ (0.04) | $ (0.05) | $ (0.12) | $ (0.16) | $ (0.03) |
Strategic Agreements - Summary
Strategic Agreements - Summary of Collaborative Research and Development and Other Revenues Associated with Company's Major Third-Party Collaborators (Detail) - USD ($) $ in Thousands | Jul. 19, 2019 | Dec. 31, 2019 | [1] | Sep. 30, 2019 | [1] | Jun. 30, 2019 | [1] | Mar. 31, 2019 | [1] | Dec. 31, 2018 | [1] | Sep. 30, 2018 | [1] | Jun. 30, 2018 | [1] | Mar. 31, 2018 | [1] | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Revenue | $ 25,000 | $ 10,685 | $ 10,763 | $ 3,985 | $ 4,131 | $ 3,627 | $ 8,036 | $ 3,413 | $ 3,488 | $ 29,564 | $ 18,564 | $ 49,170 | ||||||||
Agreement with Gilead [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Revenue | 35,000 | |||||||||||||||||||
Collaborative Research and Development and Other Revenue [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Revenue | 18,129 | 8,207 | 23,577 | |||||||||||||||||
Collaborative Research and Development and Other Revenue [Member] | Agreement with Gilead [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Revenue | 17,133 | 2,542 | 1,687 | |||||||||||||||||
Collaborative Research and Development and Other Revenue [Member] | Agreement with Sandoz AG [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Revenue | 20,000 | |||||||||||||||||||
Collaborative Research and Development and Other Revenue [Member] | Agreements With Other Collaborators or Counterparties [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Revenue | $ 996 | $ 5,665 | $ 1,890 | |||||||||||||||||
[1] | The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Strategic Agreements - Summar_2
Strategic Agreements - Summary of Collaborative Research and Development and Other Revenues Associated with Company's Major Third-Party Collaborators (Parenthetical) (Detail) - USD ($) $ in Thousands | Jul. 19, 2019 | Aug. 31, 2017 | Dec. 31, 2019 | [1] | Sep. 30, 2019 | [1] | Jun. 30, 2019 | [1] | Mar. 31, 2019 | [1] | Dec. 31, 2018 | [1] | Sep. 30, 2018 | Jun. 30, 2018 | [1] | Mar. 31, 2018 | [1] | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | $ 25,000 | $ 10,685 | $ 10,763 | $ 3,985 | $ 4,131 | $ 3,627 | $ 8,036 | [1] | $ 3,413 | $ 3,488 | $ 29,564 | $ 18,564 | $ 49,170 | ||||||||
Total revenues | 25,000 | $ 10,685 | $ 10,763 | $ 3,985 | $ 4,131 | $ 3,627 | 8,036 | [1] | $ 3,413 | $ 3,488 | 29,564 | 18,564 | 49,170 | ||||||||
Amount related to the milestone payment earned | $ 10,000 | ||||||||||||||||||||
Agreement with Gilead [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 35,000 | ||||||||||||||||||||
Amount related to the milestone payment earned | 12,300 | 0 | 0 | ||||||||||||||||||
Total revenues | 35,000 | ||||||||||||||||||||
Agreement with Gilead [Member] | License Fees [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 12,300 | 0 | 0 | ||||||||||||||||||
Total revenues | 12,300 | 0 | 0 | ||||||||||||||||||
Agreement with Sandoz AG [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Amount related to the milestone payment earned | $ 0 | 0 | 20,000 | ||||||||||||||||||
Agreement termination month and year | 2019-01 | ||||||||||||||||||||
Agreement with Sandoz AG [Member] | License Fees [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Revenue | 20,000 | ||||||||||||||||||||
Total revenues | $ 20,000 | ||||||||||||||||||||
Patent Purchase Agreement with Indivior [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Amount related to the milestone payment earned | $ 5,000 | $ 5,000 | |||||||||||||||||||
Agreement With Zogenix Inc | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Agreement termination month and year | 2017-08 | ||||||||||||||||||||
[1] | The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Strategic Agreements - Addition
Strategic Agreements - Additional Information (Detail) - Subsequent Event [Member] | Feb. 28, 2020USD ($) | Feb. 28, 2020USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Milestone payments received | $ 0 | $ 0 |
Maximum [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Future milestone payments | 221,000,000 | |
Early stage clinical testing [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Development-based milestones | 2,000,000 | 2,000,000 |
Late stage clinical testing [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Development-based milestones | 33,000,000 | 33,000,000 |
Regulatory filings [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Development-based milestones | 3,000,000 | 3,000,000 |
Regulatory approvals [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Development-based milestones | 50,000,000 | $ 50,000,000 |
Development-Based Milestones [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Future milestone payments | 88,000,000 | |
Sales-Based Milestones [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Future milestone payments | $ 133,000,000 |
Strategic Agreements - Agreemen
Strategic Agreements - Agreement with Gilead Sciences, Inc - Additional Information (Detail) - USD ($) $ in Thousands | Jul. 19, 2019 | Dec. 31, 2019 | Sep. 30, 2019 | [1] | Jun. 30, 2019 | [1] | Mar. 31, 2019 | [1] | Dec. 31, 2018 | [1] | Sep. 30, 2018 | [1] | Jun. 30, 2018 | [1] | Mar. 31, 2018 | [1] | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Total revenues | $ 25,000 | $ 10,685 | [1] | $ 10,763 | $ 3,985 | $ 4,131 | $ 3,627 | $ 8,036 | $ 3,413 | $ 3,488 | $ 29,564 | $ 18,564 | $ 49,170 | |||||||
Amount related to the milestone payment earned | 10,000 | |||||||||||||||||||
Deferred revenue recognized | 12,300 | |||||||||||||||||||
Deferred Revenue | 22,700 | 22,700 | ||||||||||||||||||
Maximum [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Performance milestone payments based on successful development | 75,000 | |||||||||||||||||||
Sales-Based Milestones [Member] | Maximum [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Performance milestone payments based on successful development | 70,000 | |||||||||||||||||||
Upfront, Development, Regulatory and Sales-Based Milestones [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Performance milestone payments based on successful development | $ 35,000 | 35,000 | ||||||||||||||||||
Upfront, Development, Regulatory and Sales-Based Milestones [Member] | Maximum [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Performance milestone payments based on successful development | $ 150,000 | |||||||||||||||||||
Collaborative Research and Development and Other Revenue [Member] | ||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||
Deferred revenue recognized | $ 4,800 | |||||||||||||||||||
[1] | The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Strategic Agreements - Changes
Strategic Agreements - Changes in Company's of Contract Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Liabilities | ||
Deferred revenue, current portion | $ 22,679 | |
Deferred revenue, non-current portion | 812 | $ 812 |
Agreement with Gilead [Member] | ||
Assets | ||
Accounts receivable | 494 | |
Total contract asset | 494 | |
Liabilities | ||
Deferred revenue, current portion | 22,679 | |
Total contract liabilities | 22,679 | |
Agreement with Gilead [Member] | Additions [Member] | ||
Assets | ||
Accounts receivable | 39,812 | |
Total contract asset | 39,812 | |
Liabilities | ||
Deferred revenue, current portion | 35,000 | |
Total contract liabilities | 35,000 | |
Agreement with Gilead [Member] | Deletions [Member] | ||
Assets | ||
Accounts receivable | 39,318 | |
Total contract asset | 39,318 | |
Liabilities | ||
Deferred revenue, current portion | 12,321 | |
Total contract liabilities | $ 12,321 |
Strategic Agreements - Patent P
Strategic Agreements - Patent Purchase Agreement with Indivior - Additional Information (Detail) - USD ($) $ in Thousands | Jul. 19, 2019 | Sep. 26, 2017 | Sep. 30, 2017 | Dec. 31, 2019 | [1] | Sep. 30, 2019 | [1] | Jun. 30, 2019 | [1] | Mar. 31, 2019 | [1] | Dec. 31, 2018 | [1] | Sep. 30, 2018 | [1] | Jun. 30, 2018 | [1] | Mar. 31, 2018 | [1] | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 27, 2018 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Total revenues | $ 25,000 | $ 10,685 | $ 10,763 | $ 3,985 | $ 4,131 | $ 3,627 | $ 8,036 | $ 3,413 | $ 3,488 | $ 29,564 | $ 18,564 | $ 49,170 | |||||||||||
Intellectual Property Rights [Member] | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Total revenues | 12,500 | ||||||||||||||||||||||
Patent Purchase Agreement with Indivior [Member] | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Upfront non-refundable payment received | $ 12,500 | ||||||||||||||||||||||
Granted patents extending year, minimum | 2026 | ||||||||||||||||||||||
Patent Purchase Agreement with Indivior [Member] | Intellectual Property Rights [Member] | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Total revenues | $ 12,500 | $ 12,500 | |||||||||||||||||||||
Patent Purchase Agreement with Indivior [Member] | Regulatory Based Milestone [Member] | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Performance milestone payments based on successful development | $ 5,000 | $ 5,000 | |||||||||||||||||||||
Revenue recognition milestone achieved | $ 5,000 | ||||||||||||||||||||||
[1] | The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Strategic Agreements - Agreem_2
Strategic Agreements - Agreement with Santen Pharmaceutical Co., Ltd. - Additional Information (Detail) - USD ($) | Jul. 19, 2019 | Dec. 11, 2014 | Dec. 31, 2019 | [1] | Sep. 30, 2019 | [1] | Jun. 30, 2019 | [1] | Mar. 31, 2019 | [1] | Dec. 31, 2018 | [1] | Sep. 30, 2018 | [1] | Jun. 30, 2018 | [1] | Mar. 31, 2018 | [1] | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Total revenues | $ 25,000,000 | $ 10,685,000 | $ 10,763,000 | $ 3,985,000 | $ 4,131,000 | $ 3,627,000 | $ 8,036,000 | $ 3,413,000 | $ 3,488,000 | $ 29,564,000 | $ 18,564,000 | $ 49,170,000 | |||||||||
Maximum [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Future milestone payments | $ 75,000,000 | ||||||||||||||||||||
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative 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 Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Total revenues | $ 2,000,000 | ||||||||||||||||||||
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | Maximum [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Future milestone payments | 76,000,000 | ||||||||||||||||||||
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | Development-Based Milestones [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Future milestone payments | 13,000,000 | ||||||||||||||||||||
Agreement with Santen Pharmaceutical Co., Ltd. [Member] | Commercialization-Based Milestones [Member] | |||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
Future milestone payments | $ 63,000,000 | ||||||||||||||||||||
Revenue recognition milestone achieved | $ 0 | ||||||||||||||||||||
[1] | The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Strategic Agreements - Agreem_3
Strategic Agreements - Agreement with Sandoz AG - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Agreement with Sandoz AG [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Cumulative aggregate payments received by the Company | $ 20 |
Financial Instruments - Fair Va
Financial Instruments - Fair Value Measurements of Assets (Detail) - Fair Value on Recurring Basis [Member] - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | $ 62,261 | $ 32,876 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 524 | 502 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 61,737 | 32,374 |
Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 524 | 502 |
Money market funds [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 524 | 502 |
Certificates of deposit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 150 | 150 |
Certificates of deposit [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 150 | 150 |
Commercial paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 47,218 | 32,224 |
Commercial paper [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 47,218 | $ 32,224 |
U.S. Government agencies [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 4,501 | |
U.S. Government agencies [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 4,501 | |
Corporate debt [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 9,868 | |
Corporate debt [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | $ 9,868 |
Financial Instruments - Summary
Financial Instruments - Summary of Money Market Funds and Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 62,264 | $ 32,876 |
Unrealized Gain | 3 | |
Unrealized Loss | (6) | |
Estimated Fair Value | 62,261 | 32,876 |
Money market funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 524 | 502 |
Estimated Fair Value | 524 | 502 |
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 | 47,221 | 32,224 |
Unrealized Gain | 1 | |
Unrealized Loss | (4) | |
Estimated Fair Value | 47,218 | 32,224 |
U.S. Government agencies [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 4,500 | |
Unrealized Gain | 1 | |
Estimated Fair Value | 4,501 | |
Corporate debt [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 9,869 | |
Unrealized Gain | 1 | |
Unrealized Loss | (2) | |
Estimated Fair Value | 9,868 | |
Cash and cash equivalents [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 32,364 | 30,055 |
Unrealized Loss | (3) | |
Estimated Fair Value | 32,361 | 30,055 |
Short-term investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 29,750 | 2,671 |
Unrealized Gain | 3 | |
Unrealized Loss | (3) | |
Estimated Fair Value | 29,750 | 2,671 |
Long-term restricted investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 150 | 150 |
Estimated Fair Value | $ 150 | $ 150 |
Financial Instruments - Summa_2
Financial Instruments - Summary of Cost and Estimated Fair Value of Available-for-Sale Securities by Contractual Maturity (Detail) $ in Thousands | Dec. 31, 2019USD ($) |
Investments Debt And Equity Securities [Abstract] | |
Mature in one year or less, Amortized Cost | $ 61,740 |
Amortized Cost | 61,740 |
Mature in one year or less, Estimated Fair Value | 61,737 |
Estimated Fair Value | $ 61,737 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) | Dec. 31, 2019USD ($) |
Investments Debt And Equity Securities [Abstract] | |
Unrealized loss of securities | $ 0 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 22,801 | $ 22,646 |
Less accumulated depreciation and amortization | (22,332) | (22,041) |
Property and equipment, net | 469 | 605 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 12,862 | 12,785 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 9,849 | 9,828 |
Construction-in-progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 90 | $ 33 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | |||
Depreciation expense | $ 291,000 | $ 254,000 | $ 437,000 |
Amortization expense | 0 | $ 0 | $ 0 |
Restoration cost | $ 553,000 |
Restricted Investments - Additi
Restricted Investments - Additional Information (Detail) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Restricted Investments [Line Items] | ||
Restricted investments in connection with deposits on letters of credit | $ 150,000 | $ 150,000 |
California [Member] | ||
Restricted Investments [Line Items] | ||
Restricted investments in connection with deposits on letters of credit | $ 150,000 | $ 150,000 |
Commitments - Summary of Lease
Commitments - Summary of Lease Arrangements of Company Facilities (Detail) | 12 Months Ended |
Dec. 31, 2019ft²Option | |
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) |
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) |
Lease expiration year | 2024 |
Lease renewal term | 5 years |
Vacaville, CA [Member] | Manufacturing [Member] | Lease Amendment [Member] | |
Property Subject To Or Available For Operating Lease [Line Items] | |
Approximate Square Feet | 24,634 |
Expiration | Lease expires 2023 (with an option to renew for an additional five years) |
Lease expiration year | 2023 |
Lease renewal term | 5 years |
Birmingham,AL [Member] | Office, Laboratory and Manufacturing [Member] | |
Property Subject To Or Available For Operating Lease [Line Items] | |
Approximate Square Feet | 21,540 |
Expiration | Lease expires 2021 (with two options to renew the lease term for an additional five years each after the current lease expires) |
Lease expiration year | 2021 |
Lease renewal term | 5 years |
Number of renewal option for lease | Option | 2 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Commitment And Contingencies [Line Items] | |||
Rent expenses of operating leases | $ 2,300,000 | $ 1,900,000 | $ 1,900,000 |
Lessee, Operating lease, option to extend | true | ||
Remaining minimum purchase commitment | 500,000 | ||
Cost of goods sold | $ 4,143,000 | $ 4,263,000 | $ 6,633,000 |
Product Revenue, Net [Member] | Other Purchase Commitments [Member] | |||
Commitment And Contingencies [Line Items] | |||
Cost of goods sold | $ 500,000 |
Commitments - Schedule of Futur
Commitments - Schedule of Future Operating Lease Minimum Payments (Detail) $ in Thousands | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 2,200 |
2021 | 2,126 |
2022 | 1,991 |
2023 | 1,970 |
2024 | 275 |
Total operating leases future minimum payments | $ 8,562 |
Term Loan - Additional Informat
Term Loan - Additional Information (Detail) - Oxford Finance LLC Term Loan [Member] - USD ($) | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2018 | Feb. 28, 2018 | Jul. 31, 2016 | Dec. 31, 2019 | |
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% | 9.07% | ||
Term loan, floating interest rate basis | 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 | $ 825,000 | |
Minimum [Member] | ||||
Debt Instrument [Line Items] | ||||
Percentage of prepayment fee | 0.75% | |||
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 under Term Loan (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Future maturities and interest payments under the term loan: | ||
2020 | $ 1,848 | |
2021 | 3,172 | |
2022 | 9,381 | |
2023 and after | 13,361 | |
Total minimum payments | 27,762 | |
Less amount representing interest | (6,090) | |
Gross balance of term loan | 21,672 | |
Less unamortized debt discount | (1,410) | |
Carrying value of term loan | 20,262 | |
Term loan, non-current portion, net | $ 20,262 | $ 20,533 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock - Additional Information (Detail) - USD ($) | Jun. 20, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Oct. 31, 2018 | Nov. 30, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Proceeds from sale of common stock, net of commission | $ 18,360,000 | $ 16,780,000 | $ 11,989,000 | |||
Sale of stock number of shares issued in transaction | 29,000,000 | |||||
Sale of stock price per share | $ 0.52 | |||||
Gross proceeds from sale of common stock | $ 15,100,000 | |||||
October 2018 registration statement [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Proceeds from sale of common stock, net of commission | $ 3,500,000 | |||||
Sale of common stock during period | 2,349,820 | |||||
Common stock weighted average price | $ 1.55 | |||||
Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Securities offered | $ 175,000,000 | $ 125,000,000 | ||||
Cantor Fitzgerald Co [Member] | Controlled Equity Offering Program [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Proceeds from sale of common stock, net of commission | $ 16,800,000 | $ 12,000,000 | ||||
Sale of common stock during period | 9,600,000 | 8,900,000 | ||||
Common stock weighted average price | $ 1.80 | $ 1.39 | ||||
Cantor Fitzgerald Co [Member] | Maximum [Member] | Controlled Equity Offering Program [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Securities offered | $ 75,000,000 | $ 40,000,000 |
Stockholders' Equity - 2000 Sto
Stockholders' Equity - 2000 Stock Plan (Incentive Stock Plan) - Additional Information (Detail) - shares | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2016 | Jun. 30, 2014 | Apr. 30, 2013 | Jun. 30, 2011 | Mar. 31, 2000 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Reserved common stock for issuance | 37,989,081 | ||||||||
Options exercised, shares | 4,484,650 | ||||||||
Shares available for future grant | 7,936,039 | ||||||||
Common stock outstanding | 29,803,766 | 30,317,615 | |||||||
2000 Stock Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Maximum expiration term of stock appreciation rights | 10 years | ||||||||
Extended term of stock plan to the date | 10 years | 10 years | |||||||
Issuance of common stock upon equity financing, net of issuance cost | 7,500,000 | 5,000,000 | 4,000,000 | 5,500,000 | |||||
Reserved common stock for issuance | 33,449,989 | ||||||||
Plan expiry date | Jun. 30, 2029 | ||||||||
Options exercised, shares | 70,000 | ||||||||
Option plan vesting period | 10 years | ||||||||
Options granted with different vesting terms | 5 years | ||||||||
Minimum percentage of total combined voting power of stock | 10.00% | ||||||||
Minimum exercise price as percentage of fair market value to holder of more than 10% voting power | 110.00% | ||||||||
Minimum exercise price as percentage of fair market value to holder of 10% or less voting power | 100.00% | ||||||||
Shares available for future grant | 7,936,039 | ||||||||
Common stock outstanding | 29,803,766 | ||||||||
2000 Stock Plan [Member] | Minimum [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock option exercisable period | 1 year | ||||||||
2000 Stock Plan [Member] | Maximum [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock option exercisable period | 2 years | ||||||||
2000 Stock Plan [Member] | Non-employee director [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Options exercised, shares | 30,000 |
Stockholders' Equity - 2000 Emp
Stockholders' Equity - 2000 Employee Stock Purchase Plan - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Jun. 30, 2017 | Mar. 31, 2015 | Apr. 30, 2010 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 31, 2019 | Jan. 31, 2018 | Jan. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share available for future grant | 7,936,039 | ||||||||
Common stock, shares issued | 195,257,000 | 162,060,000 | |||||||
Options granted with exercise prices lower than fair market | $ 0 | $ 0 | $ 0 | ||||||
Excess tax benefits recognized for tax deductions on stock based compensation | 0 | ||||||||
Incremental tax benefits recognized from stock options exercised | $ 0 | ||||||||
2000 Employee Stock Purchase Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Employee stock purchase plan | 24 months | ||||||||
Exercise price as percentage of fair market value minimum | 85.00% | ||||||||
Stock option increase | 350,000 | 350,000 | 250,000 | ||||||
Extended term of stock plan to the date | 10 years | 10 years | |||||||
Plan expiry date | Jun. 30, 2025 | ||||||||
Options shares reserved for issuance | 2,900,000 | ||||||||
Share available for future grant | 249,276 | 2,300,000 | 1,900,000 | 1,700,000 | |||||
Common stock, shares issued | 2,650,724 | ||||||||
Intrinsic value of options exercised | $ 1,700,000 | $ 1,600,000 | $ 328,000 | ||||||
Weighted-average grant-date fair value of all options granted with exercise prices | $ 0.43 | $ 0.94 | $ 0.92 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Shares of Common Stock Reserved for Future Issuance (Detail) - shares | Dec. 31, 2019 | Jan. 31, 2019 | Dec. 31, 2018 | Jan. 31, 2018 | Jan. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options outstanding | 29,803,766 | 30,317,615 | |||
Stock options available for grant | 7,936,039 | ||||
Shares of common stock reserved for future issuance | 37,989,081 | ||||
2000 Employee Stock Purchase Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options available for grant | 249,276 | 2,300,000 | 1,900,000 | 1,700,000 | |
Shares of common stock reserved for future issuance | 249,276 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Option Activity under all Stock-Based Compensation Plans (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Outstanding, Number of Options, beginning balance | 30,317,615 | |
Options granted, Number of Options | 4,484,650 | |
Options exercised, Number of Options | (1,735,743) | |
Options forfeited, Number of Options | (116,472) | |
Options expired, Number of Options | (3,146,284) | |
Outstanding, Number of Options, ending balance | 29,803,766 | 30,317,615 |
Exercisable, Number of Options | 26,457,850 | |
Vested and expected to vest, Number of Options | 29,803,766 | |
Outstanding, Number of Options, Weighted Average Exercise Price Per Share, beginning balance | $ 1.63 | |
Options granted, Weighted Average Exercise Price Per Share | 0.61 | |
Options exercised, Weighted Average Exercise Price Per Share | 1.11 | |
Options forfeited, Weighted Average Exercise Price Per Share | 1.16 | |
Options expired, Weighted Average Exercise Price Per Share | 2.61 | |
Outstanding, Number of Options, Weighted Average Exercise Price Per Share, ending balance | 1.41 | $ 1.63 |
Exercisable, Number of Options, Weighted Average Exercise Price Per Share | 1.47 | |
Vested and expected to vest, Number of Options, Weighted Average Exercise Price Per Share | $ 1.41 | |
Outstanding, Number of Options, Weighted Average Remaining Contractual Term | 5 years 2 months 1 day | 5 years 7 days |
Exercisable, Number of Options, Weighted Average Remaining Contractual Term | 4 years 9 months 10 days | |
Vested and expected to vest, Number of Options, Weighted Average Remaining Contractual Term | 5 years 2 months 1 day | |
Outstanding, Number of Options, Aggregate Intrinsic Value | $ 71.3 | |
Exercisable, Number of Options, Aggregate Intrinsic Value | 61.7 | |
Vested and expected to vest, Number of Options, Aggregate Intrinsic Value | $ 71.3 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Employee Stock-Based Compensation Cost that has been Included in Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation cost | $ 2,108 | $ 2,998 | $ 2,605 |
Cost of product revenues [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation cost | 85 | 94 | 109 |
Research and development [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation cost | 755 | 1,549 | 1,415 |
Selling, general and administrative [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation cost | $ 1,268 | $ 1,355 | $ 1,081 |
Stockholders' Equity - Determin
Stockholders' Equity - Determining Fair Value - Additional Information (Detail) - 2000 Employee Stock Purchase Plan [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected dividend yield in Black-Scholes option valuation model | $ 0 | ||
Shares purchased under Company's employee stock purchase plan | 111,909 | 119,097 | 122,033 |
Recognition of expenses on shares purchased under employee stock purchase plan | $ 27,000 | $ 24,000 | $ 34,000 |
Expected total unrecognized compensation costs related to nonvested stock options | $ 1,900,000 | ||
Weighted average term of unrecognized stock-based compensation expense | 2 years 2 months 12 days | ||
Cash received from option exercises under stock-based compensation plans | $ 1,900,000 | $ 1,600,000 | $ 562,000 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Assumptions Used to Estimate Fair Value of Options Granted and Shares Purchased (Detail) | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | ||
Employees Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free rate, minimum | 1.60% | 1.30% | 0.60% | |
Risk-free rate, maximum | 2.50% | 2.50% | 1.30% | |
Expected term (in years) | 6 months | 6 months | 6 months | |
Volatility, minimum | 60.00% | 60.00% | 44.00% | |
Volatility, maximum | 103.00% | 146.00% | 146.00% | |
Stock Option Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free rate, minimum | 1.50% | 2.70% | 2.00% | |
Risk-free rate, maximum | 2.70% | 3.10% | 2.50% | |
Volatility, minimum | 79.00% | 78.00% | 75.00% | |
Volatility, maximum | 83.00% | 86.00% | 86.00% | |
Forfeiture rate | [1] | 0.00% | 0.00% | 0.00% |
Stock Option Plan [Member] | Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 7 years 6 months | 7 years | 6 years 9 months 18 days | |
Stock Option Plan [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 10 years | 10 years | 10 years | |
[1] | Effective January 1, 2017, the Company elected to account for forfeitures as they occur. |
Stockholders' Equity - Summar_5
Stockholders' Equity - Summary of Stock Options Outstanding (Detail) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Range of Exercise Price, $0.51 - $0.57 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | $ 0.51 |
Options Outstanding, Range of Exercise Price, maximum | $ 0.57 |
Number of Options Outstanding | shares | 150,000 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 9 years 3 months 25 days |
Options Outstanding, Weighted-Average Exercise Price | $ 0.56 |
Number of Options Exercisable | shares | 1,250 |
Options Exercisable, Weighted-Average Exercise Price | $ 0.51 |
Range of Exercise Price, $0.58 - $0.58 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 0.58 |
Options Outstanding, Range of Exercise Price, maximum | $ 0.58 |
Number of Options Outstanding | shares | 3,286,445 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 8 years 10 months 24 days |
Options Outstanding, Weighted-Average Exercise Price | $ 0.58 |
Number of Options Exercisable | shares | 2,118,141 |
Options Exercisable, Weighted-Average Exercise Price | $ 0.58 |
Range of Exercise Price, $0.58 - $0.88 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 0.58 |
Options Outstanding, Range of Exercise Price, maximum | $ 0.88 |
Number of Options Outstanding | shares | 4,534,657 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 4 years 3 months 18 days |
Options Outstanding, Weighted-Average Exercise Price | $ 0.82 |
Number of Options Exercisable | shares | 4,200,824 |
Options Exercisable, Weighted-Average Exercise Price | $ 0.84 |
Range of Exercise Price, $0.93 - $1.19 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 0.93 |
Options Outstanding, Range of Exercise Price, maximum | $ 1.19 |
Number of Options Outstanding | shares | 3,006,451 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 5 years 11 months 1 day |
Options Outstanding, Weighted-Average Exercise Price | $ 1.15 |
Number of Options Exercisable | shares | 2,869,131 |
Options Exercisable, Weighted-Average Exercise Price | $ 1.15 |
Range of Exercise Price, $1.20 - $1.20 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 1.20 |
Options Outstanding, Range of Exercise Price, maximum | $ 1.20 |
Number of Options Outstanding | shares | 114,293 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 4 years 6 months 18 days |
Options Outstanding, Weighted-Average Exercise Price | $ 1.20 |
Number of Options Exercisable | shares | 114,293 |
Options Exercisable, Weighted-Average Exercise Price | $ 1.20 |
Range of Exercise Price, $1.21 - $1.21 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 1.21 |
Options Outstanding, Range of Exercise Price, maximum | $ 1.21 |
Number of Options Outstanding | shares | 3,004,999 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 3 years 1 month 2 days |
Options Outstanding, Weighted-Average Exercise Price | $ 1.21 |
Number of Options Exercisable | shares | 2,998,249 |
Options Exercisable, Weighted-Average Exercise Price | $ 1.21 |
Range of Exercise Price, $1.24 - $1.24 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 1.24 |
Options Outstanding, Range of Exercise Price, maximum | $ 1.24 |
Number of Options Outstanding | shares | 3,131,872 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 7 years 11 months 8 days |
Options Outstanding, Weighted-Average Exercise Price | $ 1.24 |
Number of Options Exercisable | shares | 2,293,016 |
Options Exercisable, Weighted-Average Exercise Price | $ 1.24 |
Range of Exercise Price, $1.26 - $1.26 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 1.26 |
Options Outstanding, Range of Exercise Price, maximum | $ 1.26 |
Number of Options Outstanding | shares | 140,000 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 3 years 1 month 28 days |
Options Outstanding, Weighted-Average Exercise Price | $ 1.26 |
Number of Options Exercisable | shares | 140,000 |
Options Exercisable, Weighted-Average Exercise Price | $ 1.26 |
Range of Exercise Price, $1.31 - $1.31 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 1.31 |
Options Outstanding, Range of Exercise Price, maximum | $ 1.31 |
Number of Options Outstanding | shares | 3,070,156 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 6 years 8 months 4 days |
Options Outstanding, Weighted-Average Exercise Price | $ 1.31 |
Number of Options Exercisable | shares | 2,478,491 |
Options Exercisable, Weighted-Average Exercise Price | $ 1.31 |
Range of Exercise Price, $1.33 - $3.61 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 1.33 |
Options Outstanding, Range of Exercise Price, maximum | $ 3.61 |
Number of Options Outstanding | shares | 9,364,893 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 3 years 3 months 3 days |
Options Outstanding, Weighted-Average Exercise Price | $ 2.24 |
Number of Options Exercisable | shares | 9,244,455 |
Options Exercisable, Weighted-Average Exercise Price | $ 2.25 |
Range of Exercise Price, $0.51 - $3.61 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price, minimum | 0.51 |
Options Outstanding, Range of Exercise Price, maximum | $ 3.61 |
Number of Options Outstanding | shares | 29,803,766 |
Options Outstanding, Weighted-Average Remaining Contractual Life(In years) | 5 years 2 months 1 day |
Options Outstanding, Weighted-Average Exercise Price | $ 1.41 |
Number of Options Exercisable | shares | 26,457,850 |
Options Exercisable, Weighted-Average Exercise Price | $ 1.47 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Contingency [Line Items] | |||
Deferred tax liability | $ 244,000 | $ 244,000 | |
Deferred tax assets | 244,000 | ||
Deferred income tax provision | $ 0 | $ 0 | $ (153,000) |
Total income tax provision (benefit) expense | $ (150,000) | ||
Statutory federal income tax rate | 21.00% | 21.00% | 34.00% |
Increase (decrease) in valuation allowance of net deferred tax assets | $ 4,600,000 | $ 6,300,000 | $ (43,100,000) |
Unrecognized tax benefits | 9,078,000 | 8,432,000 | 7,849,000 |
Interest and penalty expense related to unrecognized tax benefits | 0 | 0 | 0 |
Federal [Member] | |||
Income Tax Contingency [Line Items] | |||
Net operating loss carryforwards for income tax purposes | 358,600,000 | ||
Net operating loss carryforwards expiration amount | 320,400,000 | ||
Net operating loss carryforwards non-expiration amount | $ 38,200,000 | ||
Tax carryforwards expire date | 2020 through 2037 | ||
Research [Member] | Federal [Member] | |||
Income Tax Contingency [Line Items] | |||
Tax carryforwards expire date | 2020 through 2039 | ||
Research and development tax credits | $ 14,500,000 | ||
Interest and other income, net [Member] | |||
Income Tax Contingency [Line Items] | |||
Total income tax provision (benefit) expense | 0 | 0 | $ (150,000) |
State [Member] | |||
Income Tax Contingency [Line Items] | |||
Total income tax provision (benefit) expense | 0 | $ 0 | |
Net operating loss carryforwards for income tax purposes | $ 219,200,000 | ||
Tax carryforwards expire date | 2020 through 2039 | ||
State [Member] | Research [Member] | |||
Income Tax Contingency [Line Items] | |||
Research and development tax credits | $ 15,800,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax Expenses (Benefit) (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | |||
U.S. federal taxes benefit at statutory rate | $ (4,321) | $ (5,318) | $ (1,307) |
State taxes | 0 | 0 | 3 |
Change in valuation allowance | 4,394 | 5,143 | (41,865) |
Stock-based compensation | 879 | 999 | 1,832 |
Research and development tax credits | (1,004) | (999) | (1,353) |
Tax Reform change in tax rate and other | 0 | 0 | 42,528 |
Other | $ 52 | $ 175 | 12 |
Total income tax (benefit) provision | $ (150) |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Company's Deferred Tax Assets (Detail) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 90,102,000 | $ 87,275,000 |
Research and other credits | 18,860,000 | 17,524,000 |
Deferred revenue | 248,000 | 277,000 |
Stock-based compensation | 4,376,000 | 4,755,000 |
Other | 5,288,000 | 2,823,000 |
Total deferred tax assets | 118,874,000 | 112,654,000 |
Valuation allowance for deferred tax assets | (117,245,000) | (112,654,000) |
Deferred tax liabilities—Intangibles | (1,873,000) | (244,000) |
Net deferred tax liabilities | $ (244,000) | $ (244,000) |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of the year | $ 8,432 | $ 7,849 |
Decreased related to prior year tax positions | (73) | (7) |
Increased related to current year tax positions | 719 | 590 |
Balance at end of the year | $ 9,078 | $ 8,432 |
Unaudited Selected Quarterly _3
Unaudited Selected Quarterly Financial Data - Selected Quarterly Financial Data (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jul. 19, 2019 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | ||||||||
Quarterly Financial Data [Abstract] | ||||||||||||||||||||
Revenue | $ 25,000 | $ 10,685 | [1] | $ 10,763 | [1] | $ 3,985 | [1] | $ 4,131 | [1] | $ 3,627 | [1] | $ 8,036 | [1] | $ 3,413 | [1] | $ 3,488 | [1] | $ 29,564 | $ 18,564 | $ 49,170 |
Net loss | $ (4,231) | $ (1,990) | $ (7,227) | $ (7,130) | $ (7,299) | $ (2,715) | $ (7,011) | $ (8,297) | $ (20,578) | $ (25,322) | $ (3,695) | |||||||||
Basic net loss per share | $ (0.02) | $ (0.01) | $ (0.04) | $ (0.04) | $ (0.05) | $ (0.02) | $ (0.04) | $ (0.05) | $ (0.12) | $ (0.16) | $ (0.03) | |||||||||
Diluted net loss per share | $ (0.02) | $ (0.01) | $ (0.04) | $ (0.04) | $ (0.05) | $ (0.02) | $ (0.04) | $ (0.05) | $ (0.12) | $ (0.16) | $ (0.03) | |||||||||
[1] | The figures for the third and fourth quarters of 2019 include $6.2 million, and $6.1 million respectively, of revenue recognized under the July 2019 license agreement with Gilead (see note 2). The third quarter of 2018 figure includes the recognition of $5.0 million in revenue associated with a nonrefundable milestone payment that the Company received in August 2018 under its agreement with Indivior (see note 2). |
Unaudited Selected Quarterly _4
Unaudited Selected Quarterly Financial Data - Selected Quarterly Financial Data (Parenthetical) (Detail) - USD ($) $ in Millions | Jul. 19, 2019 | Sep. 26, 2017 | Dec. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 |
Quarterly Financial Data [Line Items] | ||||||
Amount related to the milestone payment earned | $ 10 | |||||
Agreement with Gilead [Member] | ||||||
Quarterly Financial Data [Line Items] | ||||||
Upfront non-refundable payment received | $ 6.1 | $ 6.2 | ||||
Patent Purchase Agreement with Indivior [Member] | ||||||
Quarterly Financial Data [Line Items] | ||||||
Upfront non-refundable payment received | $ 12.5 | |||||
Amount related to the milestone payment earned | $ 5 | $ 5 |
Schedule II-Valuation and Qua_2
Schedule II-Valuation and Qualifying Accounts (Detail) - Allowance for doubtful accounts [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of the year | $ 102 | $ 155 | $ 73 |
Additions (Reductions) to allowances | (51) | (52) | 165 |
Deductions | (17) | (1) | (83) |
Balance at end of the year | $ 34 | $ 102 | $ 155 |