Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 31, 2020 | |
Cover [Abstract] | ||
Document type | 10-Q | |
Document quarterly report | true | |
Document period end date | Jun. 30, 2020 | |
Document transition report | false | |
Entity file number | 001-34962 | |
Entity registrant name | ZOGENIX, INC. | |
Entity incorporation, state or country code | DE | |
Entity tax identification number | 20-5300780 | |
Entity address, address line one | 5959 Horton Street | |
Entity address, address line two | Suite 500 | |
Entity address, city or town | Emeryville | |
Entity address, state or province | CA | |
Entity address, postal zip code | 94608 | |
City area code | 510 | |
Local phone number | 550-8300 | |
Title of 12(b) security | Common Stock, par value $0.001 per share | |
Trading symbol | ZGNX | |
Security exchange name | NASDAQ | |
Entity current reporting status | Yes | |
Entity interactive data current | Yes | |
Entity filer category | Large Accelerated Filer | |
Entity small business | false | |
Entity emerging growth company | false | |
Entity shell company | false | |
Entity common stock, shares outstanding | 55,447,840 | |
Entity central index key | 0001375151 | |
Amendment flag | false | |
Document fiscal year focus | 2020 | |
Document fiscal period focus | Q2 | |
Current fiscal year end date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 136,871 | $ 62,070 |
Marketable securities | 253,378 | 189,085 |
Inventory, net | 475 | 0 |
Prepaid expenses and other current assets | 10,833 | 11,084 |
Acquisition holdback placed in escrow | 25,000 | 25,000 |
Total current assets | 426,557 | 287,239 |
Property and equipment, net | 9,300 | 9,424 |
Operating lease right-of-use assets | 8,266 | 7,774 |
Intangible assets | 102,500 | 102,500 |
Goodwill | 6,234 | 6,234 |
Other noncurrent assets | 2,250 | 1,079 |
Total assets | 555,107 | 414,250 |
Current liabilities: | ||
Accounts payable | 8,518 | 7,979 |
Accrued and other current liabilities | 40,176 | 30,117 |
Acquisition holdback liability | 24,444 | 24,444 |
Deferred revenue, current | 5,303 | 5,927 |
Current portion of operating lease liabilities | 1,633 | 1,322 |
Current portion of contingent consideration | 13,000 | 25,600 |
Total current liabilities | 93,074 | 95,389 |
Deferred revenue, noncurrent | 5,768 | 7,425 |
Operating lease liabilities, net of current portion | 11,022 | 10,752 |
Contingent consideration, net of current portion | 40,100 | 38,200 |
Deferred tax liability | 0 | 17,425 |
Total liabilities | 149,964 | 169,191 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000 shares authorized; none issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; 100,000 shares authorized; and 55,445 and 45,272 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 55 | 45 |
Additional paid-in capital | 1,599,047 | 1,360,092 |
Accumulated deficit | (1,194,581) | (1,115,457) |
Accumulated other comprehensive income | 622 | 379 |
Total stockholders’ equity | 405,143 | 245,059 |
Total liabilities and stockholders’ equity | $ 555,107 | $ 414,250 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock par value (usd per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (shares) | 10,000,000 | 10,000,000 |
Preferred stock issued (shares) | 0 | 0 |
Preferred stock outstanding (shares) | 0 | 0 |
Common stock par value (usd per share) | $ 0.001 | $ 0.001 |
Common stock authorized (shares) | 100,000,000 | 100,000,000 |
Common stock issued (shares) | 55,445,000 | 45,272,000 |
Common stock outstanding (shares) | 55,445,000 | 45,272,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 1,032 | $ 1,069 | $ 2,281 | $ 1,069 |
Operating expenses: | ||||
Research and development | 34,373 | 27,096 | 67,613 | 51,448 |
Selling, general and administrative | 24,431 | 15,459 | 45,749 | 26,377 |
Acquired in-process research and development expense | 1,500 | 0 | 3,000 | 0 |
Change in fair value of contingent consideration | 12,200 | (700) | 4,300 | 2,300 |
Total operating expenses | 72,504 | 41,855 | 120,662 | 80,125 |
Loss from operations | (71,472) | (40,786) | (118,381) | (79,056) |
Other (expense) income, net | (157) | 40 | 19,864 | (48) |
Interest income | 880 | 2,983 | 1,968 | 6,139 |
Loss before income taxes | (70,749) | (37,763) | (96,549) | (72,965) |
Income tax benefit | (17,425) | 0 | (17,425) | 0 |
Net loss | $ (53,324) | $ (37,763) | $ (79,124) | $ (72,965) |
Net loss per share, basic and diluted | ||||
Net loss per share, basic and diluted (in dollars per share) | $ (0.96) | $ (0.89) | $ (1.53) | $ (1.72) |
Weighted average number of shares used in the calculation of basic and diluted net loss per common share (in shares) | 55,355 | 42,458 | 51,770 | 42,348 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (53,324) | $ (37,763) | $ (79,124) | $ (72,965) |
Other comprehensive (loss) income, net of tax: | ||||
Change in unrealized gains related to marketable securities | 444 | 353 | 272 | 723 |
Foreign currency translation adjustments | (34) | 0 | (29) | 0 |
Total other comprehensive income | 410 | 353 | 243 | 723 |
Comprehensive loss | $ (52,914) | $ (37,410) | $ (78,881) | $ (72,242) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit |
Stockholders' Equity Beginning Balance at Dec. 31, 2018 | $ 522,801 | $ 42 | $ 1,218,710 | $ 3 | $ (695,954) |
Stockholders' Equity - Beginning Balance (in shares) at Dec. 31, 2018 | 42,078 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (35,202) | (35,202) | |||
Other comprehensive income (loss) | 370 | 370 | |||
Issuance of common stock under employee equity plans | 5,293 | 5,293 | |||
Issuance of common stock under employee equity plans (in shares) | 380 | ||||
Shares repurchased for tax withholdings related to net share settlement of employee equity awards | (606) | (606) | |||
Shares repurchased for tax withholdings related to net share settlement of employee equity awards (in shares) | (12) | ||||
Stock-based compensation | 4,223 | 4,223 | |||
Stockholders' Equity Ending Balance at Mar. 31, 2019 | 496,879 | $ 42 | 1,227,620 | 373 | (731,156) |
Stockholders' Equity - Ending Balance (in shares) at Mar. 31, 2019 | 42,446 | ||||
Stockholders' Equity Beginning Balance at Dec. 31, 2018 | 522,801 | $ 42 | 1,218,710 | 3 | (695,954) |
Stockholders' Equity - Beginning Balance (in shares) at Dec. 31, 2018 | 42,078 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (72,965) | ||||
Stockholders' Equity Ending Balance at Jun. 30, 2019 | 465,715 | $ 42 | 1,233,866 | 726 | (768,919) |
Stockholders' Equity - Ending Balance (in shares) at Jun. 30, 2019 | 42,498 | ||||
Stockholders' Equity Beginning Balance at Mar. 31, 2019 | 496,879 | $ 42 | 1,227,620 | 373 | (731,156) |
Stockholders' Equity - Beginning Balance (in shares) at Mar. 31, 2019 | 42,446 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (37,763) | (37,763) | |||
Other comprehensive income (loss) | 353 | 353 | |||
Issuance of common stock under employee equity plans | 888 | 888 | |||
Issuance of common stock under employee equity plans (in shares) | 52 | ||||
Stock-based compensation | 5,358 | 5,358 | |||
Stockholders' Equity Ending Balance at Jun. 30, 2019 | 465,715 | $ 42 | 1,233,866 | 726 | (768,919) |
Stockholders' Equity - Ending Balance (in shares) at Jun. 30, 2019 | 42,498 | ||||
Stockholders' Equity Beginning Balance at Dec. 31, 2019 | 245,059 | $ 45 | 1,360,092 | 379 | (1,115,457) |
Stockholders' Equity - Beginning Balance (in shares) at Dec. 31, 2019 | 45,272 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (25,800) | (25,800) | |||
Other comprehensive income (loss) | (167) | (167) | |||
Issuance of common stock, net of offering costs | 221,708 | $ 10 | 221,698 | ||
Issuance of common stock, net of offering costs (in shares) | 9,798 | ||||
Issuance of common stock under employee equity plans | 3,882 | 3,882 | |||
Issuance of common stock under employee equity plans (in shares) | 297 | ||||
Shares repurchased for tax withholdings related to net share settlement of employee equity awards | (569) | (569) | |||
Shares repurchased for tax withholdings related to net share settlement of employee equity awards (in shares) | (26) | ||||
Stock-based compensation | 6,394 | 6,394 | |||
Stockholders' Equity Ending Balance at Mar. 31, 2020 | 450,507 | $ 55 | 1,591,497 | 212 | (1,141,257) |
Stockholders' Equity - Ending Balance (in shares) at Mar. 31, 2020 | 55,341 | ||||
Stockholders' Equity Beginning Balance at Dec. 31, 2019 | 245,059 | $ 45 | 1,360,092 | 379 | (1,115,457) |
Stockholders' Equity - Beginning Balance (in shares) at Dec. 31, 2019 | 45,272 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (79,124) | ||||
Stockholders' Equity Ending Balance at Jun. 30, 2020 | 405,143 | $ 55 | 1,599,047 | 622 | (1,194,581) |
Stockholders' Equity - Ending Balance (in shares) at Jun. 30, 2020 | 55,445 | ||||
Stockholders' Equity Beginning Balance at Mar. 31, 2020 | 450,507 | $ 55 | 1,591,497 | 212 | (1,141,257) |
Stockholders' Equity - Beginning Balance (in shares) at Mar. 31, 2020 | 55,341 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (53,324) | (53,324) | |||
Other comprehensive income (loss) | 410 | 410 | |||
Issuance of common stock under employee equity plans | 616 | 616 | |||
Issuance of common stock under employee equity plans (in shares) | 153 | ||||
Shares repurchased for tax withholdings related to net share settlement of employee equity awards | (1,369) | (1,369) | |||
Shares repurchased for tax withholdings related to net share settlement of employee equity awards (in shares) | (49) | ||||
Stock-based compensation | 8,303 | 8,303 | |||
Stockholders' Equity Ending Balance at Jun. 30, 2020 | $ 405,143 | $ 55 | $ 1,599,047 | $ 622 | $ (1,194,581) |
Stockholders' Equity - Ending Balance (in shares) at Jun. 30, 2020 | 55,445 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flow from operating activities: | ||
Net loss | $ (79,124) | $ (72,965) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation | 14,697 | 9,581 |
Depreciation and amortization | 740 | 552 |
Deferred income taxes | (17,425) | 0 |
Noncash lease expense | 619 | 0 |
Net accretion and amortization of investments in marketable securities | (380) | (3,299) |
Change in fair value of warrant liabilities | (162) | 158 |
Acquired in-process research and development expense | 3,000 | 0 |
Change in fair value of contingent consideration | 4,300 | 2,300 |
Changes in operating assets and liabilities: | ||
Inventory, net | (475) | 0 |
Prepaid expenses and other current assets | 251 | 6,071 |
Other assets | (1,171) | (5,963) |
Accounts payable, accrued and other liabilities | (5,737) | (5,193) |
Operating lease liability | (634) | 12,588 |
Deferred revenue | (2,281) | 14,431 |
Net cash used in operating activities | (83,782) | (41,739) |
Cash flow from investing activities: | ||
Cash paid for in-process research and development asset | (3,000) | 0 |
Purchases of marketable securities | (180,832) | (251,782) |
Proceeds from maturities of marketable securities | 114,205 | 289,357 |
Proceeds from sales of marketable securities | 2,988 | 0 |
Purchases of property and equipment | (415) | (8,922) |
Net cash (used in) provided by investing activities | (67,054) | 28,653 |
Cash flow from financing activities: | ||
Payment of contingent consideration | 0 | (10,000) |
Proceeds from issuance of common stock under equity incentive plans | 4,498 | 6,026 |
Taxes paid related to net share settlement of equity awards | (569) | (606) |
Proceeds from issuance of common stock, net of issuance costs | 221,708 | 0 |
Net cash provided by (used in) financing activities | 225,637 | (4,580) |
Net increase (decrease) in cash and cash equivalents | 74,801 | (17,666) |
Cash and cash equivalents, beginning of the period | 62,070 | 68,454 |
Cash and cash equivalents, end of the period | $ 136,871 | $ 50,788 |
Organization, Basis of Presenta
Organization, Basis of Presentation and Liquidity | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Basis of Presentation and Liquidity | Organization, Basis of Presentation and Liquidity Zogenix, Inc. and subsidiaries (the Company, we, us or our) is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. Our first rare disease therapy, Fintepla (fenfluramine) oral solution, C-IV has been approved by the U.S. Food and Drug Administration (FDA) and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for Fintepla for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. We operate in one business segment—the research, development and commercialization of pharmaceutical products and our headquarters are located in Emeryville, California. Basis of Presentation The accompanying condensed consolidated financial statements include the accounts of Zogenix, Inc. and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting. In the opinion of management, the condensed consolidated financial statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation. The results of operations for any interim period are not necessarily indicative of results of operations for any future period. Certain information and footnote disclosures normally included in annual consolidated financial statements prepared in accordance with generally accepted accounting principles in the United States (GAAP) have been condensed or omitted. Accordingly, these unaudited interim condensed consolidated financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and related notes included in our 2019 Annual Report on Form 10-K (2019 Form 10-K), which was filed with the SEC on March 2, 2020. Future Funding Requirements As of June 30, 2020, our cash, cash equivalents and marketable securities totaled $390.2 million. Excluding gains from two discrete business divestitures, we have incurred significant net losses and negative cash flows from operating activities since inception resulting in an accumulated deficit of $1.2 billion as of June 30, 2020. We expect to continue to incur significant operating losses and negative cash flows from operations to support the marketing and commercialization of Fintepla for Dravet syndrome as well as continuing to advance our clinical programs. Additionally, we are obligated to make future milestone payments that are contingent upon the successful achievement of certain development, regulatory and sales-based milestone events related to Fintepla and MT1621. Historically, we have relied primarily on the proceeds from equity offerings to finance our operations. Until such time, if ever, we can generate a sufficient amount of revenue to finance our cash requirements, we may need to continue to rely on additional financing to achieve our business objectives. On June 12, 2020, we filed a universal shelf registration statement on Form S-3 with the SEC, which became effective upon filing. The shelf registration statement permits us to offer and sell, from time to time over the next three years, in one or more offerings, an unlimited amount of any combination of our common stock, preferred stock, debt securities, warrants or units consisting of any of the foregoing. The specific terms of any offering, if any, under the shelf registration statement would be established at the time of such offering. The shelf registration statement also includes a sales agreement prospectus covering the offering, issuance and sale of up to $200.0 million of our common stock, through Cantor Fitzgerald & Co. (Cantor), acting as our sales agent, pursuant to a sales agreement with Cantor dated May 10, 2016 for our “at-the-market” equity program. During the quarter ended June 30, 2020, we did not issue any shares of our common stock through this program. We believe maintaining an active shelf registration provides additional financial flexibility to access the capital markets and allow us to act opportunistically in support of our growth objectives. However, there is no assurance that such financings could be consummated on acceptable terms or at all. Failure to raise sufficient capital when needed could require us to significantly delay, scale back or discontinue one or more of our product development programs or commercialization efforts or other aspects of our business plans, and our operating results and financial condition would be adversely affected. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of our condensed consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. Actual results may differ from those estimates. Significant Accounting Policies The significant accounting policies and estimates used in the preparation of the accompanying condensed consolidated financial statements are described in Note 2, Summary of Significant Accounting Policies to the consolidated financial statements in our 2019 Form 10-K. There have been no material changes in our significant accounting policies during the six months ended June 30, 2020 other than as set forth below. Inventory Inventory is recorded at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. We periodically review our inventories to identify obsolete, slow moving, excess or otherwise unsaleable items. If obsolete, slow moving, excess or unsaleable items are observed and there are no alternate uses for the inventory, we record a write-down to net realizable value. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. Prior to regulatory approval, we expense costs associated with the manufacture of our product candidates to research and development expense unless we are reasonably certain such costs have future commercial use and net realizable value. Since we consider attaining regulatory approval of a product candidate to be highly uncertain and difficult to predict, we expect only in rare instances will pre-launch inventory be capitalized, if at all. As of June 30, 2020, our inventory of $0.5 million consisted of raw materials received subsequent to regulatory approval and was purchased for use in commercial production. Finite-Lived Intangible Assets Purchased finite-lived intangible assets are initially recognized at fair value and subject to amortization over its estimated useful life. Our finite-lived intangible assets are amortized using a method that reflects the pattern in which the economic benefits of the intangible assets are consumed or otherwise used. If that pattern cannot be reliably determined, the intangible assets are amortized using the straight-line method over their estimated useful lives and are tested for impairment along with other long-lived assets. At June 30, 2020, our finite-lived intangible assets consisted of Fintepla product rights (see Note 7). Long-Lived Assets Long-lived assets, including right-of-use operating lease assets and our finite-lived intangible asset, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets (group) may not be recoverable. Recoverability of assets is determined by comparing the estimated undiscounted net cash flows of the operations related to the assets (asset group) to their carrying amount. If the carrying value of the assets (asset group) exceeds its undiscounted cash flows, we then compare the fair value of the assets (asset group) to their carrying value to determine the impairment loss. The impairment loss will be allocated to the carrying values of the long-lived assets (asset group), but not below their individual fair values. If we determine that events and circumstances warrant a revision to the remaining period of amortization, a long-lived asset’s remaining useful life shall be changed, and the remaining carrying amount of the long-lived asset shall be depreciated or amortized prospectively over that revised remaining useful life. Impact of COVID-19 Pandemic In March 2020, the World Health Organization declared the global novel coronavirus disease (COVID-19) outbreak a pandemic. To date, our operations have not been significantly impacted by the COVID-19 pandemic. However, we cannot predict the specific extent, duration, or full impact that the COVID-19 pandemic will have on our financial condition and operations, including ongoing and planned clinical trials, the timelines for receiving feedback or approvals from regulatory authorities, and product launch in the midst of a pandemic. Management is monitoring the potential impact of the COVID-19 pandemic, if any, on the carrying value of our finite-lived intangible asset, goodwill, long-lived assets and right-of-use assets. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international markets. If the financial markets and/or the overall economy are impacted for an extended period, our business, results of operations and financial condition may be adversely affected. Income Taxes On March 18, 2020, the Families First Coronavirus Response Act (FFCR Act) and On March 27, 2020, The Coronavirus Aid, Relief and Economic Security Act (CARES Act) were signed into law in response to the COVID-10 pandemic. The FFCR Act and CARES Act, includes provisions related to refundable payroll tax credits, deferment of employer side social security payments, retroactively and temporarily (for taxable years beginning before January 1, 2021) suspending the application of the 80%-of-income limitation on the use of net operating losses, which was enacted as part of the Tax Cuts and Jobs Act of 2017. The CARES Act also provides that net operating losses arising in any taxable year beginning after December 31, 2017, and before January 1, 2021 are generally eligible to be carried back up to five years. On June 29, 2020, Assembly Bill 85 (A.B. 85) was signed into California law. A.B. 85 provides for a three-year suspension of the use of net operating losses for medium and large businesses and a three-year cap on the use of business incentive tax credits to offset no more than $5.0 million of tax per year. A.B. 85 suspends the use of net operating losses for taxable years 2020, 2021 and 2022 for certain taxpayers with taxable income of $1.0 million or more. The carryover period for any net operating losses that are suspended under this provision will be extended. A.B. 85 also requires that business incentive tax credits including carryovers may not reduce the applicable tax by more than $5.0 million for taxable years 2020, 2021 and 2022. The enactment of the FFCR Act, CARES Act and A.B. 85 did not result in any material adjustments to our income tax provision for the three and six months ended June 30, 2020 or to our net deferred tax assets as of June 30, 2020. Given our history of losses, we do not expect the provisions of the FFCR Act, CARES Act and A.B. 85 to have a material impact on our annual effective tax rate or condensed consolidated financial statements in 2020; however, we will continue to evaluate the impact of tax legislation and will update our disclosures as additional information and interpretive guidance becomes available. Recently Adopted Accounting Pronouncements Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments revises the measurement of credit losses for most financial instruments measured at amortized cost, including trade receivables, from an incurred loss methodology to an expected loss methodology which results in earlier recognition of credit losses. Under the incurred loss model, a loss is not recognized until it is probable that the loss-causing event has already occurred. The standard introduces a forward-looking expected credit loss model that requires an estimate of the expected credit losses over the life of the instrument by considering all relevant information including historical experience, current conditions, and reasonable and supportable forecasts that affect collectability. In addition, the standard also modifies the impairment model for available-for-sale debt securities, which are measured at fair value, by eliminating the consideration for the length of time fair value has been less than amortized cost when assessing credit loss for a debt security and provides for reversals of credit losses through income upon credit improvement. The standard became effective for us beginning January 1, 2020. Based on the composition of our investment portfolio, which reflects our primary investment objective of capital preservation, the adoption of this standard did not have a material impact on our condensed consolidated financial statements or related disclosures. ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. The implied fair value for a reporting unit is determined in the same manner as the amount of goodwill recognized in a business acquisition of the reporting unit. Under the standard, an entity shall recognize an impairment charge for the amount by which the carrying amount of a reporting unit exceeds its fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. The standard became effective for us beginning January 1, 2020. The adoption of this standard did not have a material impact on our condensed consolidated financial statements or related disclosures; however, any prospective goodwill impairment losses recognized will be measured in accordance with the updated guidance. ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement modifies the disclosure requirements in Topic 820 by removing certain disclosure requirements related to the fair value hierarchy, modifying existing disclosure requirements related to measurement uncertainty and adding new disclosure requirements, such as disclosing the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. This standard became effective for us beginning January 1, 2020 and the adoption of this standard did not have a material impact on our condensed consolidated financial statements. For the new disclosures regarding our Level 3 fair value measurements, see Note 5, Fair Value Measurements to these condensed consolidated financial statements. ASU 2019-12, Simplifying the Accounting for Income Taxes (Topic 740 ) removes certain exceptions to the general principles in Topic 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. This ASU is effective for us for all interim and annual periods beginning January 1, 2021, with early adoption permitted. We early adopted ASU 2019-12 beginning January 1, 2020 on a prospective basis. The adoption of this standard did not have a material impact on our condensed consolidated financial statements and related disclosures. The only aspect of ASU 2019-12 that is currently applicable to us is the removal of the exception related to intraperiod tax allocation. Beginning January 1, 2020, we have applied the general methodology regarding the intraperiod allocation of tax expense for reporting periods where we have a loss from continuing operations by determining the amount of taxes attributable to continuing operations without regard to the tax effect of other items, including changes in unrealized gains related to marketable securities. Recent Accounting Pronouncements We have reviewed recently issued accounting pronouncements and concluded they are either not applicable to our business or no material effect is expected on our condensed consolidated financial statements as a result of future adoption. |
Collaborative Arrangement
Collaborative Arrangement | 6 Months Ended |
Jun. 30, 2020 | |
Disaggregation of Revenue [Abstract] | |
Collaborative Arrangement | Collaborative Arrangement In March 2019, we entered into an agreement (Shinyaku Agreement) with Nippon Shinyaku Co., Ltd. (Shinyaku) for the exclusive distribution of Fintepla in Japan for the treatment of Dravet syndrome and LGS. As part of the Shinyaku Agreement, we are responsible for completing the global clinical development and all regulatory approval activities for Fintepla to support the submission of new drug applications in Japan for Dravet syndrome and LGS. Upon regulatory approval of Fintepla in Japan, Shinyaku will act as our exclusive distributor for Fintepla and will be responsible for the commercialization activities including the promotion, marketing, sale and distribution of Fintepla in Japan. Upon regulatory approval of Fintepla in Japan, Shinyaku will also act as our exclusive distributor for commercial shipment and distribution of Fintepla in Japan. If we pursue global development of Fintepla for indications other than Dravet syndrome or LGS, Shinyaku has the option to participate in the development for such indications in Japan, subject to cost sharing requirements pursuant to the agreement. Activities under the Shinyaku Agreement will be governed by a joint steering committee (JSC) consisting of three representatives from each party to the agreement. All decisions of the JSC are to be made by a unanimous vote with tie-breaking rights provided to each party for certain matters related to development, regulatory approval and commercialization select distribution activities of Fintepla in that territory. Shinyaku has agreed to support development and regulatory approval of Fintepla in Japan by actively participating in the design of non-clinical, clinical and manufacturing requirements needed for regulatory submission, actively planning and participating in product labeling decisions and discussions with the Japanese Ministry of Health, Labor and Welfare (MHLW) and obtained distribution exclusivity through the payment of an initial fixed consideration. Pursuant to the terms of the agreement, Shinyaku agreed to make aggregate fixed payments of $20.0 million to us in scheduled installments. As of June 30, 2020, we have received $17.0 million with the remaining balance due within the next year. We will be actively running the clinical trials, performing manufacturing validation activities, preparing regulatory filings and holding discussions with MHLW, and negotiating pricing. We and Shinyaku have agreed to proportionally share the Japan specific development costs that may arise outside of the initial development plan and any post-approval clinical study costs in Japan. In addition, we can earn up to $66.0 million from Shinyaku for the achievement of certain regulatory milestones for the treatment of Dravet syndrome and LGS. If regulatory approval of Fintepla is received in Japan, we have agreed to supply Shinyaku with Fintepla upon receipt of purchase orders at our actual manufacturing cost plus a fixed transfer price mark-up, a fixed percentage of Shinyaku's net sales of Fintepla in Japan for such fiscal year, and a net price mark-up based on a percent of the applicable aggregate sales of Fintepla by Shinyaku for such fiscal year. The net price mark-up percentage increases with Shinyaku’s sales of Fintepla annual net sales in Japan and ranges between mid-twenties and is capped at a low thirties of the aggregate annual net sales for an applicable fiscal year. In addition, we can earn up to an additional $42.5 million tied to the achievement of certain net sales milestones by Shinyaku through the term of the agreement, which generally expires in 2045. The collaborative activities under the Shinyaku Agreement prior to regulatory approval are within the scope of the accounting guidance related to collaborative arrangements as both parties are active participants and are exposed to significant risks and rewards dependent on the success of commercializing Fintepla in Japan. Since Shinyaku is not a customer as it does not obtain an output of our development and regulatory approval activities for Fintepla as they were not provided a license to our intellectual property or the ability to manufacture the product, and we do not consider performing development and regulatory approval services to be a part of our ongoing activities. Shinyaku will only become a customer and subject to revenue from contracts from customers accounting guidance after regulatory approval of Fintepla in Japan occurs and Shinyaku places purchase orders with us. To date, Shinyaku has not provided us with any purchase orders and thus no revenue has been recognized for the supply of Fintepla. We considered the revenue from contracts with customers guidance by analogy in determining the unit of account, and the recognition and measurement of such unit of account for collaborative activities under the Shinyaku Agreement and concluded that there are two development programs akin to performance obligations related to collaborative activities for development and regulatory approval efforts for Dravet and LGS. We are the principal as it relates to the collaborative development and regulatory approval activities primarily because we are responsible for the acceptability of the results of the work of the third-party vendors that are used to assist us in performing such activities. Therefore, such collaboration revenue is presented on a gross basis in our condensed consolidated statements of operations apart from research and development expenses incurred . Since Shinyaku was not provided a license to our intellectual property or the ability to manufacture Fintepla, Shinyaku will only become a customer, and payments made under the Shinyaku Agreement will only be subject to the accounting guidance related to revenue from contracts from customers, after regulatory approval of Fintepla in Japan occurs and Shinyaku places purchase orders with us. The initial collaboration consideration consisted solely of the fixed consideration payments of $20.0 million and was allocated on a relative standalone selling price basis to the two identified development programs akin to performance obligations related to collaborative activities for development and regulatory approval efforts for Dravet syndrome and LGS. Analogizing to the revenue from contracts with customers variable consideration guidance, all potential regulatory milestone payment consideration will be included in the collaboration consideration if and when it is probable that a significant reversal in the amount of cumulative collaboration consideration recognized will not occur when the uncertainty associated with the variable collaboration consideration is subsequently resolved. At contract inception and through June 30, 2020, this consideration was fully constrained as the achievement of the events tied to these regulatory milestone payments was highly dependent on factors outside our control. Collaboration revenue is being recognized over time as the collaborative activities related to each development program are rendered. We determined an input method is a reasonable representative depiction of the performance of the collaborative activities under the Shinyaku Agreement. The method of measuring progress towards completion incorporates actual internal and external costs incurred, relative to total internal and external costs expected to be incurred over an estimated period to satisfy the collaborative activities. The period over which total costs are estimated reflects our estimate of the period over which it will perform the collaborative activities for each development program. Changes in estimates of total internal and external costs expected to be incurred are recognized in the period of change as a cumulative catch-up adjustment to collaboration revenue. For the three and six months ended June 30, 2020, we recognized collaboration revenue of $1.0 million and $2.3 million, respectively. As of June 30, 2020, the deferred revenue balance of $11.1 million related to this agreement was recorded as deferred revenue, which is classified as either current or net of current portion in the accompanying condensed consolidated balance sheets based on the period over which the collaboration revenue is expected to be recognized. We expect to recognize collaboration revenue related to these collaborative activities through the end of 2023. |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 6 Months Ended |
Jun. 30, 2020 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents, and Marketable Securities | Cash, Cash Equivalents and Marketable SecuritiesThe following tables summarize the amortized cost and the estimated fair value of our cash, cash equivalents and marketable securities as of June 30, 2020 and December 31, 2019 (in thousands): June 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Current assets: Cash $ 23,688 $ — $ — $ 23,688 Cash equivalents: U.S. Treasuries 11,300 — — 11,300 Money market funds 61,840 — — 61,840 Certificate of deposits 10,900 — — 10,900 Commercial paper 29,143 — — 29,143 Total cash and cash equivalents 136,871 — — 136,871 Marketable securities: U.S. Treasuries 55,677 3 — 55,680 Commercial paper 94,567 — — 94,567 U.S. Government-sponsored enterprises debt securities 6,200 13 — 6,213 Corporate debt securities 53,537 637 — 54,174 Certificate of deposits 42,744 — — 42,744 Total marketable securities 252,725 653 — 253,378 Total cash, cash equivalents and marketable securities $ 389,596 $ 653 $ — $ 390,249 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Current assets: Cash $ 43,058 $ — $ — $ 43,058 Cash equivalents: Money market funds 11,527 — — 11,527 Commercial paper 7,485 — — 7,485 Total cash and cash equivalents 62,070 — — 62,070 Marketable securities: Commercial paper 73,366 — — 73,366 Corporate debt securities 74,038 381 (2) 74,417 Certificate of deposits 41,302 — — 41,302 Total marketable securities 188,706 381 (2) 189,085 Total cash, cash equivalents and marketable securities $ 250,776 $ 381 $ (2) $ 251,155 The following table summarizes the cost and fair value of marketable securities based on stated effective maturities as of June 30, 2020 (in thousands): Amortized Cost Fair Value Due within one year $ 245,025 $ 245,635 Due between one and two years 7,700 7,743 Total $ 252,725 $ 253,378 We regularly review our available-for-sale marketable securities in an unrealized loss position and evaluate the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. As of June 30, 2020, no assessment of expected credit losses was necessary as we did not have any individual security in an unrealized loss position. Accrued interest receivable on available-for-sale marketable securities are recorded within “Prepaid expenses and other current assets” on our condensed consolidated balance sheets and was $0.4 million and $0.6 million at June 30, 2020 and December 31, 2019, respectively. See Note 5 for further information regarding the fair value of our financial instruments. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the price that would be received to sell 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. A three-level valuation hierarchy has been established under GAAP for disclosure of fair value measurements. The valuation hierarchy is based on the transparency of inputs to the valuation of an asset or liability as of the measurement date. The three levels are defined as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Our financial instruments consist primarily of cash and cash equivalents, marketable securities, other current assets, accounts payable and accrued liabilities, contingent consideration liabilities and our outstanding common stock warrant liabilities. Certain cash equivalents, marketable securities, contingent consideration liabilities and common stock warrant liabilities are reported at their respective fair values on our condensed consolidated balance sheets. The remaining financial instruments are carried at cost which approximates their respective fair values because of the short-term nature of these financial instruments. See Note 4 for further information regarding the amortized cost of our financial assets. The following tables summarize assets and liabilities recognized or disclosed at fair value on a recurring basis as of June 30, 2020 and December 31, 2019 (in thousands): June 30, 2020 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S. Treasuries $ — $ 11,300 $ — $ 11,300 Money market funds 61,840 — — 61,840 Certificate of deposits — 10,900 — 10,900 Commercial paper — 29,143 — 29,143 Marketable securities: U.S. Treasuries — 55,680 — 55,680 Commercial paper — 94,567 — 94,567 U.S. Government-sponsored enterprises debt securities — 6,213 — 6,213 Corporate debt securities — 54,174 — 54,174 Certificate of deposits — 42,744 — 42,744 Total assets (1) $ 61,840 $ 304,721 $ — $ 366,561 Liabilities: Common stock warrant liabilities $ — $ — $ 36 $ 36 Contingent consideration liabilities — — 53,100 53,100 Total liabilities $ — $ — $ 53,136 $ 53,136 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 11,527 $ — $ — $ 11,527 Commercial paper — 7,485 — $ 7,485 Marketable securities: Commercial paper — 73,366 — 73,366 Corporate debt securities — 74,417 — 74,417 Certificate of deposits — 41,302 — 41,302 Total assets (1) $ 11,527 $ 196,570 $ — $ 208,097 Liabilities: Common stock warrant liabilities $ — $ — $ 198 $ 198 Contingent consideration liabilities — — 63,800 63,800 Total liabilities $ — $ — $ 63,998 $ 63,998 ———————————— (1) Fair value is determined by taking into consideration valuations obtained from third-party pricing services. The third-party pricing services utilize industry standard valuation models, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; and other observable inputs. Contingent Consideration Liability Pursuant to the terms of the Brabant purchase agreement in 2014 in which we acquired worldwide development and commercialization rights to Fintepla, we are obligated to make future milestone payments that are contingent upon the successful achievement of certain regulatory and sales-based milestone events related to Fintepla. As of June 30, 2020, the potential amount of future payments that we may be required to make is between zero, if none of the remaining milestones are achieved, to a maximum of $60.0 million. The following table provides a reconciliation of our contingent consideration liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three and six months ended June 30, 2020 and 2019 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Balance at beginning of period $ 55,900 $ 71,200 $ 63,800 $ 78,200 Change in fair value 12,200 (700) 4,300 2,300 Transfers out of Level 3 fair value hierarchy (1) (15,000) — (15,000) — Settlements — — — (10,000) Balance at end of period $ 53,100 $ 70,500 $ 53,100 $ 70,500 ———————————— (1) For the three and six months ended June 30, 2020, a $15.0 million regulatory milestone payment associated with the FDA’s approval of Fintepla was achieved and such consideration payable was no longer contingent. As of June 30, 2020, the amount has been reclassified from contingent consideration liability to accrued and other current liabilities which was subsequently paid in July 2020. For the three months ended June 30, 2020, the $12.2 million increase to the estimated fair value of our contingent consideration liability consisted of updated assumptions used regarding the probability of success for achieving certain regulatory and sales-based milestone events in light of FDA approval of Fintepla in June 2020, which accounted for approximately $10.0 million of the increase, with the remaining increase attributed to a market-driven decrease in discount rates. The change in fair value for the three and six months ended June 30, 2019 and the six months ended June 30, 2020 was attributable to immaterial adjustments to certain assumptions and estimates used in the remeasurement to fair value. The following table summarizes the significant unobservable inputs used in the fair value measurement of our contingent consideration liabilities as of June 30, 2020. Fair Value Valuation Technique Unobservable Input Range Weighted Average (1) $53,100 Discounted cash flow Discount rate 4.5% — 12.7% 6.8% Probability of payment 0% — 94.3% 94.3% Projected year of payment 2021 — 2030 2022 ———————————— (1) Unobservable inputs were weighted by the relative fair value of the contingent consideration liability. For projected year of payment, the amount represents the median of the inputs and is not a weighted average. The weighted average discount rate was calculated based on the relative fair value of our contingent consideration obligations. Significant increases or decreases in projected revenues, probabilities of payment, discount rates or the time until payment is made would have resulted in a significantly lower or higher fair value measurement as of June 30, 2020. |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Accrued and Other Current Liabilities | Accrued and Other Current Liabilities The following table provides details of accrued and other current liabilities (in thousands): June 30, 2020 December 31, 2019 Accrued clinical trial expenses $ 11,335 $ 18,666 Accrued compensation 7,229 7,179 Accrued milestone payment 15,000 — Other accrued liabilities 6,576 4,074 Common stock warrant liabilities 36 198 Total accrued and other current liabilities $ 40,176 $ 30,117 |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets The following table provides details of the carrying amount of our intangible assets (in thousands): June 30, 2020 December 31, 2019 Finite-lived intangible assets $ 102,500 $ — Indefinite-lived in-process research and development (IPR&D) intangible assets — 102,500 Total intangible assets $ 102,500 $ 102,500 Our intangible assets consist of worldwide development, commercialization and related intellectual property rights including patents and licenses for our product, Fintepla (fenfluramine; formerly referred to as ZX008), which at the time of our acquisition in October 2014 and as of December 31, 2019, was classified as an indefinite-lived IPR&D asset. Upon FDA approval of Fintepla in June 2020, this indefinite-lived asset was reclassified to a finite-lived intangible asset subject to amortization. In July 2020, we commercially launched Fintepla and commenced amortization of this asset on a straight-line basis over its estimated useful life. Due to the inherent subjectivity of forecasting the timing in which the cash flows may be generated from this intangible asset over a long-term time horizon, we concluded the pattern of economic benefit cannot be reliably determined. As such, we elected to use the straight-line method of amortization for this intangible asset. In estimating the useful life of the finite-lived Fintepla intangible asset, we considered the estimated period over which the asset will contribute directly or indirectly to our future cash flows, the strength of issued or licensed patents and related period of intellectual property protection, the availability of competitor products treating similar indications and the impact of patent expiry on the sustainability of future operating cash flows of the asset. Based on these factors, we estimated the useful life of the finite-lived intangible asset to be 13 years. As of June 30, 2020, the estimated intangible asset amortization expense for the next five years and thereafter is as follows (in thousands): Estimated Amortization Expense 2020 (remaining 6 months) $ 3,942 2021 7,885 2022 7,885 2023 7,885 2024 7,885 Thereafter 67,018 Total $ 102,500 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2020 | |
Leases [Abstract] | |
Leases | Leases We have operating leases consisting of office space for our Emeryville, California headquarters and for our various subsidiaries. In March 2020, our operating lease for our former headquarters in San Diego, California and the co-terminus sublease arrangement with our sublessee expired in accordance with the terms of the leases. In February 2020, we entered into a lease for office space in Maidenhead, United Kingdom, for a five-year term with aggregate lease payments of approximately $1.5 million. Operating lease assets represent our right to use an underlying asset for the lease term. Operating lease liabilities represent the present value of lease payments over the lease term, discounted using an estimate of our secured incremental borrowing rate. The components of lease cost included in our condensed consolidated statements of operations were as follows (in thousands): Six Months Ended June 30, 2020 2019 Lease costs Operating lease cost $ 1,045 $ 995 Short-term lease cost 259 548 Sublease income (115) (290) Total $ 1,189 $ 1,253 Cash paid for amounts included in the measurement of lease liabilities for the six months ended June 30, 2020 and 2019 was $1.0 million and $0.6 million, respectively. The amounts were included in net cash used in operating activities in our condensed consolidated statements of cash flows. Right-of-use assets obtained in exchange for new operating lease liabilities were $1.2 million for the six months ended June 30, 2020. Maturities of operating lease liabilities as of June 30, 2020 and December 31, 2019 were as follows (in thousands): June 30, 2020 December 31, 2019 2020 (remaining 6 months and 12 months, respectively) $ 1,152 $ 1,986 2021 2,292 1,957 2022 2,230 1,894 2023 2,287 1,951 2024 2,300 2,010 Thereafter 5,103 5,101 Total lease payments 15,364 14,899 Less imputed interest (2,709) (2,825) Total operating lease liabilities $ 12,655 $ 12,074 June 30, 2020 December 31, 2019 Current portion of operating lease liabilities $ 1,633 $ 1,322 Operating lease liabilities, net of current portion 11,022 10,752 Total lease liabilities $ 12,655 $ 12,074 As of June 30, 2020, the weighted-average remaining lease term was 6.5 years and the weighted-average discount rate, weighted based on the remaining balance of lease payments, was 6.2%. |
Stockholders' Equity and Stock-
Stockholders' Equity and Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stockholders' Equity and Stock-Based Compensation | Stockholders’ Equity and Stock-Based Compensation Sale of Common Stock In March 2020, we completed an underwritten public offering of 9,798,000 shares of our common stock at an offering price of $23.50 per share, including 1,278,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares. Net proceeds realized from the offering amounted to approximately $221.7 million, after deducting commissions and other offering expenses. Equity Incentive Plans We have issued stock-based awards from various equity incentive and stock purchase plans, as more fully described in Note 12, Stock-Based Compensation to the consolidated financial statements in our 2019 Form 10-K. In June 2020, our shareholders approved an amendment and restatement of our 2010 Employee Stock Purchase Plan (the “Restated ESPP”). Effective May 29, 2020, the plan was amended to increase the aggregate number of shares authorized for issuance from 375,000 to 875,000 shares and to eliminate the annual evergreen feature, which automatically added 31,250 shares to the aggregate shares authorized for issuance on each January 1st. In addition, the expiration date of the Restated ESPP was modified from October 2020 to the date that all shares authorized have been issued. As of June 30, 2020, there were 524,962 shares of common stock available for future purchases under the Restated ESPP. Stock Options The following is a summary of stock option activity for the six months ended June 30, 2020 (in thousands, except per share data): Shares Weighted- Average Exercise Price per Share Outstanding at December 31, 2019 4,253 $ 29.59 Granted 1,185 29.36 Exercised (231) 16.85 Canceled (145) 39.56 Outstanding at June 30, 2020 5,062 $ 29.83 Restricted Stock Units The following is a summary of restricted stock unit activity for the six months ended June 30, 2020 (in thousands, except per share data): Shares Weighted- Average Fair Value per Share at Grant Date Outstanding at December 31, 2019 439 $ 36.97 Granted 218 27.34 Vested (194) 23.95 Canceled (28) 38.74 Outstanding at June 30, 2020 435 $ 38.09 In June 2020, approximately 128,000 shares of performance-based restricted stock units (PSU’s) granted in March 2017 vested upon satisfaction of both a service-period condition and a performance condition, the latter of which was satisfied following the FDA’s approval of Fintepla in June 2020. As of June 30, 2020, all outstanding restricted stock units were subject to time-based vesting. Stock-Based Compensation Expense Allocation The following table summarizes the components of total stock-based compensation expense included in the condensed consolidated statements of operations (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Research and development $ 3,488 $ 2,074 $ 6,217 $ 3,509 Selling, general and administrative 4,815 3,284 8,480 6,072 Total $ 8,303 $ 5,358 $ 14,697 $ 9,581 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of shares outstanding for the period. Diluted net loss per share is calculated by dividing net loss by the weighted average number of shares of common stock and potential dilutive common stock equivalents outstanding during the period if the effect is dilutive. Our potentially dilutive shares of common stock include outstanding stock options, restricted stock units and warrants to purchase common stock. A reconciliation of the numerators and denominators used in computing net loss per share is as follows (in thousands, except per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Numerator: Net loss $ (53,324) $ (37,763) $ (79,124) $ (72,965) Denominator: Shares used in per share calculation 55,355 42,458 51,770 42,348 Net loss per share, basic and diluted $ (0.96) $ (0.89) $ (1.53) $ (1.72) The following table presents the potential shares of common stock outstanding that were excluded from the calculation of diluted net loss per share for the periods presented because including them would have been anti-dilutive (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Shares subject to outstanding stock options 4,942 4,227 4,696 3,973 Shares subject to outstanding restricted stock units 555 415 520 355 Shares subject to outstanding warrants to purchase common stock 28 28 28 28 Total 5,525 4,670 5,244 4,356 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesIncome tax benefit during interim periods is based on applying an estimated annual effective income tax rate to year-to-date income, plus any significant unusual or infrequently occurring items, which are recorded in the interim period. The income tax benefit for the three and six months ended June 30, 2020 differs from the U.S. federal statutory rate of 21.0% primarily due to effect of change in the valuation allowance against our deferred tax assets, which resulted in an income tax benefit.As of December 31, 2019, our net deferred tax liability was related to book and tax basis differences for our indefinite-lived Fintepla IPR&D intangible asset that was acquired through the October 2014 acquisition of Brabant Pharma Limited. Previously, this deferred tax liability was not considered to be a source of income for purposes of establishing our deferred tax asset valuation allowance due to the uncertainty associated with the timing of the reversal of this temporary tax difference. Upon FDA approval of Fintepla in June 2020, the indefinite-lived asset was reclassified to a finite-lived intangible asset and was subject to amortization over its estimated useful life. Because the detail scheduling of the timing of reversal of this temporary tax difference became available, the deferred tax liability associated with this finite-lived intangible asset was considered to be a source of income when assessing the realizability of our deferred tax assets as of June 30, 2020. We therefore recorded a $17.4 million income tax benefit for the three and six months ended June 30, 2020 with a corresponding reduction to our valuation allowance on deferred tax assets. The income tax benefit recognized for the three and six months ended June 30, 2020 included the effects of foreign exchange differences on remeasurement of the deferred tax liability. An immaterial portion of the adjustment for foreign exchange differences was related to prior periods. As of June 30, 2020, given our recurring net operating losses, we maintained a full valuation allowance against our net deferred tax assets. |
United Kingdom (U.K.) Research
United Kingdom (U.K.) Research and Development (R&D) Tax Relief Scheme | 6 Months Ended |
Jun. 30, 2020 | |
Other Income and Expenses [Abstract] | |
United Kingdom (U.K.) Research and Development (R&D) Tax Relief Scheme | United Kingdom (U.K.) Research and Development (R&D) Tax Relief Scheme We conduct extensive research and development activities that benefit from U.K.’s small and medium-sized enterprises (SMEs) R&D tax relief scheme. Under this tax relief scheme, a SME can make an election (i) to receive an enhanced U.K. tax deduction on its eligible R&D activities or, when an SME entity is in a net operating loss position, or (ii) to surrender net operating losses that arise from its eligible R&D activities in exchange for a cash payment from the U.K. tax authorities. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not subject to accounting for income taxes. Amounts recognized by us for cash payment claims under the SME R&D tax relief scheme are recorded as a component of other income after an election for tax relief has been made by submitting a claim for a discrete tax year and collectability is deemed probable and reasonably assured. In December 2019, we elected to surrender net operating losses by submitting claims to receive cash payments of $9.9 million and $9.8 million related to our 2017 and 2018 tax years, respectively. Upon approval of our submitted claims by the U.K. tax authorities in the first quarter of 2020, we recorded income of $19.7 million as a component of other income on the condensed consolidated statement of operations. In May 2020, we received the cash payment for our submitted claims. For our 2019 tax year, we have not yet decided whether to seek tax relief by surrendering some of our losses for a tax credit cash rebate claim or electing to receive enhanced U.K. tax deductions on our eligible research and development activities. Under the U.K.’s tax legislation, there is a two-year window after the end of a tax year to seek relief under this tax relief scheme. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of EstimatesThe preparation of our condensed consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. Actual results may differ from those estimates. |
Inventory | Inventory Inventory is recorded at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. We periodically review our inventories to identify obsolete, slow moving, excess or otherwise unsaleable items. If obsolete, slow moving, excess or unsaleable items are observed and there are no alternate uses for the inventory, we record a write-down to net realizable value. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. |
Finite-Lived Intangible Assets | Finite-Lived Intangible AssetsPurchased finite-lived intangible assets are initially recognized at fair value and subject to amortization over its estimated useful life. Our finite-lived intangible assets are amortized using a method that reflects the pattern in which the economic benefits of the intangible assets are consumed or otherwise used. If that pattern cannot be reliably determined, the intangible assets are amortized using the straight-line method over their estimated useful lives and are tested for impairment along with other long-lived assets. At June 30, 2020, our finite-lived intangible assets consisted of Fintepla product rights |
Long-Lived Assets | Long-Lived Assets Long-lived assets, including right-of-use operating lease assets and our finite-lived intangible asset, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets (group) may not be recoverable. Recoverability of assets is determined by comparing the estimated undiscounted net cash flows of the operations related to the assets (asset group) to their carrying amount. If the carrying value of the assets (asset group) exceeds its undiscounted cash flows, we then compare the fair value of the assets (asset group) to their carrying value to determine the impairment loss. The impairment loss will be allocated to the carrying values of the long-lived assets (asset group), but not below their individual fair values. If we determine that events and circumstances warrant a revision to the remaining period of amortization, a long-lived asset’s remaining useful life shall be changed, and the remaining carrying amount of the long-lived asset shall be depreciated or amortized prospectively over that revised remaining useful life. |
Impact of COVID-19 Pandemic | Impact of COVID-19 Pandemic In March 2020, the World Health Organization declared the global novel coronavirus disease (COVID-19) outbreak a pandemic. To date, our operations have not been significantly impacted by the COVID-19 pandemic. However, we cannot predict the specific extent, duration, or full impact that the COVID-19 pandemic will have on our financial condition and operations, including ongoing and planned clinical trials, the timelines for receiving feedback or approvals from regulatory authorities, and product launch in the midst of a pandemic. Management is monitoring the potential impact of the COVID-19 pandemic, if any, on the carrying value of our finite-lived intangible asset, goodwill, long-lived assets and right-of-use assets. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international markets. If the financial markets and/or the overall economy are impacted for an extended period, our business, results of operations and financial condition may be adversely affected. |
Income Taxes | Income Taxes On March 18, 2020, the Families First Coronavirus Response Act (FFCR Act) and On March 27, 2020, The Coronavirus Aid, Relief and Economic Security Act (CARES Act) were signed into law in response to the COVID-10 pandemic. The FFCR Act and CARES Act, includes provisions related to refundable payroll tax credits, deferment of employer side social security payments, retroactively and temporarily (for taxable years beginning before January 1, 2021) suspending the application of the 80%-of-income limitation on the use of net operating losses, which was enacted as part of the Tax Cuts and Jobs Act of 2017. The CARES Act also provides that net operating losses arising in any taxable year beginning after December 31, 2017, and before January 1, 2021 are generally eligible to be carried back up to five years. On June 29, 2020, Assembly Bill 85 (A.B. 85) was signed into California law. A.B. 85 provides for a three-year suspension of the use of net operating losses for medium and large businesses and a three-year cap on the use of business incentive tax credits to offset no more than $5.0 million of tax per year. A.B. 85 suspends the use of net operating losses for taxable years 2020, 2021 and 2022 for certain taxpayers with taxable income of $1.0 million or more. The carryover period for any net operating losses that are suspended under this provision will be extended. A.B. 85 also requires that business incentive tax credits including carryovers may not reduce the applicable tax by more than $5.0 million for taxable years 2020, 2021 and 2022. The enactment of the FFCR Act, CARES Act and A.B. 85 did not result in any material adjustments to our income tax provision for the three and six months ended June 30, 2020 or to our net deferred tax assets as of June 30, 2020. Given our history of losses, we do not expect the provisions of the FFCR Act, CARES Act and A.B. 85 to have a material impact on our annual effective tax rate or condensed consolidated financial statements in 2020; however, we will continue to evaluate the impact of tax legislation and will update our disclosures as additional information and interpretive guidance becomes available. |
Recently Adopted Accounting Pronouncements and Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments revises the measurement of credit losses for most financial instruments measured at amortized cost, including trade receivables, from an incurred loss methodology to an expected loss methodology which results in earlier recognition of credit losses. Under the incurred loss model, a loss is not recognized until it is probable that the loss-causing event has already occurred. The standard introduces a forward-looking expected credit loss model that requires an estimate of the expected credit losses over the life of the instrument by considering all relevant information including historical experience, current conditions, and reasonable and supportable forecasts that affect collectability. In addition, the standard also modifies the impairment model for available-for-sale debt securities, which are measured at fair value, by eliminating the consideration for the length of time fair value has been less than amortized cost when assessing credit loss for a debt security and provides for reversals of credit losses through income upon credit improvement. The standard became effective for us beginning January 1, 2020. Based on the composition of our investment portfolio, which reflects our primary investment objective of capital preservation, the adoption of this standard did not have a material impact on our condensed consolidated financial statements or related disclosures. ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. The implied fair value for a reporting unit is determined in the same manner as the amount of goodwill recognized in a business acquisition of the reporting unit. Under the standard, an entity shall recognize an impairment charge for the amount by which the carrying amount of a reporting unit exceeds its fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. The standard became effective for us beginning January 1, 2020. The adoption of this standard did not have a material impact on our condensed consolidated financial statements or related disclosures; however, any prospective goodwill impairment losses recognized will be measured in accordance with the updated guidance. ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement modifies the disclosure requirements in Topic 820 by removing certain disclosure requirements related to the fair value hierarchy, modifying existing disclosure requirements related to measurement uncertainty and adding new disclosure requirements, such as disclosing the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. This standard became effective for us beginning January 1, 2020 and the adoption of this standard did not have a material impact on our condensed consolidated financial statements. For the new disclosures regarding our Level 3 fair value measurements, see Note 5, Fair Value Measurements to these condensed consolidated financial statements. ASU 2019-12, Simplifying the Accounting for Income Taxes (Topic 740 ) removes certain exceptions to the general principles in Topic 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. This ASU is effective for us for all interim and annual periods beginning January 1, 2021, with early adoption permitted. We early adopted ASU 2019-12 beginning January 1, 2020 on a prospective basis. The adoption of this standard did not have a material impact on our condensed consolidated financial statements and related disclosures. The only aspect of ASU 2019-12 that is currently applicable to us is the removal of the exception related to intraperiod tax allocation. Beginning January 1, 2020, we have applied the general methodology regarding the intraperiod allocation of tax expense for reporting periods where we have a loss from continuing operations by determining the amount of taxes attributable to continuing operations without regard to the tax effect of other items, including changes in unrealized gains related to marketable securities. Recent Accounting Pronouncements We have reviewed recently issued accounting pronouncements and concluded they are either not applicable to our business or no material effect is expected on our condensed consolidated financial statements as a result of future adoption. |
Fair Value Measurements | Fair value is defined as the price that would be received to sell 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. A three-level valuation hierarchy has been established under GAAP for disclosure of fair value measurements. The valuation hierarchy is based on the transparency of inputs to the valuation of an asset or liability as of the measurement date. The three levels are defined as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
Stock-Based Compensation | We have issued stock-based awards from various equity incentive and stock purchase plans, as more fully described in Note 12, Stock-Based Compensation to the consolidated financial statements in our 2019 Form 10-K. In June 2020, our shareholders approved an amendment and restatement of our 2010 Employee Stock Purchase Plan (the “Restated ESPP”). Effective May 29, 2020, the plan was amended to increase the aggregate number of shares authorized for issuance from 375,000 to 875,000 shares and to eliminate the annual evergreen feature, which automatically added 31,250 shares to the aggregate shares authorized for issuance on each January 1st. In addition, the expiration date of the Restated ESPP was modified from October 2020 to the date that all shares authorized have been issued. As of June 30, 2020, there were 524,962 shares of common stock available for future purchases under the Restated ESPP. |
Net Loss Per Share | Basic net loss per share is calculated by dividing net loss by the weighted average number of shares outstanding for the period. Diluted net loss per share is calculated by dividing net loss by the weighted average number of shares of common stock and potential dilutive common stock equivalents outstanding during the period if the effect is dilutive. Our potentially dilutive shares of common stock include outstanding stock options, restricted stock units and warrants to purchase common stock. |
Cash, Cash Equivalents and Ma_2
Cash, Cash Equivalents and Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Cash and Cash Equivalents [Abstract] | |
Amortized cost and fair value of cash, cash equivalents and marketable securities | The following tables summarize the amortized cost and the estimated fair value of our cash, cash equivalents and marketable securities as of June 30, 2020 and December 31, 2019 (in thousands): June 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Current assets: Cash $ 23,688 $ — $ — $ 23,688 Cash equivalents: U.S. Treasuries 11,300 — — 11,300 Money market funds 61,840 — — 61,840 Certificate of deposits 10,900 — — 10,900 Commercial paper 29,143 — — 29,143 Total cash and cash equivalents 136,871 — — 136,871 Marketable securities: U.S. Treasuries 55,677 3 — 55,680 Commercial paper 94,567 — — 94,567 U.S. Government-sponsored enterprises debt securities 6,200 13 — 6,213 Corporate debt securities 53,537 637 — 54,174 Certificate of deposits 42,744 — — 42,744 Total marketable securities 252,725 653 — 253,378 Total cash, cash equivalents and marketable securities $ 389,596 $ 653 $ — $ 390,249 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Current assets: Cash $ 43,058 $ — $ — $ 43,058 Cash equivalents: Money market funds 11,527 — — 11,527 Commercial paper 7,485 — — 7,485 Total cash and cash equivalents 62,070 — — 62,070 Marketable securities: Commercial paper 73,366 — — 73,366 Corporate debt securities 74,038 381 (2) 74,417 Certificate of deposits 41,302 — — 41,302 Total marketable securities 188,706 381 (2) 189,085 Total cash, cash equivalents and marketable securities $ 250,776 $ 381 $ (2) $ 251,155 |
Cost and fair value of marketable securities | The following table summarizes the cost and fair value of marketable securities based on stated effective maturities as of June 30, 2020 (in thousands): Amortized Cost Fair Value Due within one year $ 245,025 $ 245,635 Due between one and two years 7,700 7,743 Total $ 252,725 $ 253,378 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Assets measured at fair value on recurring basis | The following tables summarize assets and liabilities recognized or disclosed at fair value on a recurring basis as of June 30, 2020 and December 31, 2019 (in thousands): June 30, 2020 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S. Treasuries $ — $ 11,300 $ — $ 11,300 Money market funds 61,840 — — 61,840 Certificate of deposits — 10,900 — 10,900 Commercial paper — 29,143 — 29,143 Marketable securities: U.S. Treasuries — 55,680 — 55,680 Commercial paper — 94,567 — 94,567 U.S. Government-sponsored enterprises debt securities — 6,213 — 6,213 Corporate debt securities — 54,174 — 54,174 Certificate of deposits — 42,744 — 42,744 Total assets (1) $ 61,840 $ 304,721 $ — $ 366,561 Liabilities: Common stock warrant liabilities $ — $ — $ 36 $ 36 Contingent consideration liabilities — — 53,100 53,100 Total liabilities $ — $ — $ 53,136 $ 53,136 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 11,527 $ — $ — $ 11,527 Commercial paper — 7,485 — $ 7,485 Marketable securities: Commercial paper — 73,366 — 73,366 Corporate debt securities — 74,417 — 74,417 Certificate of deposits — 41,302 — 41,302 Total assets (1) $ 11,527 $ 196,570 $ — $ 208,097 Liabilities: Common stock warrant liabilities $ — $ — $ 198 $ 198 Contingent consideration liabilities — — 63,800 63,800 Total liabilities $ — $ — $ 63,998 $ 63,998 ———————————— |
Liabilities measured at fair value on recurring basis | The following tables summarize assets and liabilities recognized or disclosed at fair value on a recurring basis as of June 30, 2020 and December 31, 2019 (in thousands): June 30, 2020 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S. Treasuries $ — $ 11,300 $ — $ 11,300 Money market funds 61,840 — — 61,840 Certificate of deposits — 10,900 — 10,900 Commercial paper — 29,143 — 29,143 Marketable securities: U.S. Treasuries — 55,680 — 55,680 Commercial paper — 94,567 — 94,567 U.S. Government-sponsored enterprises debt securities — 6,213 — 6,213 Corporate debt securities — 54,174 — 54,174 Certificate of deposits — 42,744 — 42,744 Total assets (1) $ 61,840 $ 304,721 $ — $ 366,561 Liabilities: Common stock warrant liabilities $ — $ — $ 36 $ 36 Contingent consideration liabilities — — 53,100 53,100 Total liabilities $ — $ — $ 53,136 $ 53,136 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 11,527 $ — $ — $ 11,527 Commercial paper — 7,485 — $ 7,485 Marketable securities: Commercial paper — 73,366 — 73,366 Corporate debt securities — 74,417 — 74,417 Certificate of deposits — 41,302 — 41,302 Total assets (1) $ 11,527 $ 196,570 $ — $ 208,097 Liabilities: Common stock warrant liabilities $ — $ — $ 198 $ 198 Contingent consideration liabilities — — 63,800 63,800 Total liabilities $ — $ — $ 63,998 $ 63,998 ———————————— |
Reconciliation of liabilities measured at fair value using significant unobservable inputs (Level 3) | The following table provides a reconciliation of our contingent consideration liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three and six months ended June 30, 2020 and 2019 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Balance at beginning of period $ 55,900 $ 71,200 $ 63,800 $ 78,200 Change in fair value 12,200 (700) 4,300 2,300 Transfers out of Level 3 fair value hierarchy (1) (15,000) — (15,000) — Settlements — — — (10,000) Balance at end of period $ 53,100 $ 70,500 $ 53,100 $ 70,500 ———————————— (1) For the three and six months ended June 30, 2020, a $15.0 million regulatory milestone payment associated with the FDA’s approval of Fintepla was achieved and such consideration payable was no longer contingent. As of June 30, 2020, the amount has been reclassified from contingent consideration liability to accrued and other current liabilities which was subsequently paid in July 2020. |
Significant inputs used in fair value measurement | The following table summarizes the significant unobservable inputs used in the fair value measurement of our contingent consideration liabilities as of June 30, 2020. Fair Value Valuation Technique Unobservable Input Range Weighted Average (1) $53,100 Discounted cash flow Discount rate 4.5% — 12.7% 6.8% Probability of payment 0% — 94.3% 94.3% Projected year of payment 2021 — 2030 2022 ———————————— (1) Unobservable inputs were weighted by the relative fair value of the contingent consideration liability. For projected year of payment, the amount represents the median of the inputs and is not a weighted average. |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Details of accrued and other current liabilities | The following table provides details of accrued and other current liabilities (in thousands): June 30, 2020 December 31, 2019 Accrued clinical trial expenses $ 11,335 $ 18,666 Accrued compensation 7,229 7,179 Accrued milestone payment 15,000 — Other accrued liabilities 6,576 4,074 Common stock warrant liabilities 36 198 Total accrued and other current liabilities $ 40,176 $ 30,117 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | The following table provides details of the carrying amount of our intangible assets (in thousands): June 30, 2020 December 31, 2019 Finite-lived intangible assets $ 102,500 $ — Indefinite-lived in-process research and development (IPR&D) intangible assets — 102,500 Total intangible assets $ 102,500 $ 102,500 |
Schedule of Intangible Assets | The following table provides details of the carrying amount of our intangible assets (in thousands): June 30, 2020 December 31, 2019 Finite-lived intangible assets $ 102,500 $ — Indefinite-lived in-process research and development (IPR&D) intangible assets — 102,500 Total intangible assets $ 102,500 $ 102,500 |
Schedule of estimated future asset amortization expense | As of June 30, 2020, the estimated intangible asset amortization expense for the next five years and thereafter is as follows (in thousands): Estimated Amortization Expense 2020 (remaining 6 months) $ 3,942 2021 7,885 2022 7,885 2023 7,885 2024 7,885 Thereafter 67,018 Total $ 102,500 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Leases [Abstract] | |
Components of lease costs | The components of lease cost included in our condensed consolidated statements of operations were as follows (in thousands): Six Months Ended June 30, 2020 2019 Lease costs Operating lease cost $ 1,045 $ 995 Short-term lease cost 259 548 Sublease income (115) (290) Total $ 1,189 $ 1,253 |
Maturities of operating lease liabilities | Maturities of operating lease liabilities as of June 30, 2020 and December 31, 2019 were as follows (in thousands): June 30, 2020 December 31, 2019 2020 (remaining 6 months and 12 months, respectively) $ 1,152 $ 1,986 2021 2,292 1,957 2022 2,230 1,894 2023 2,287 1,951 2024 2,300 2,010 Thereafter 5,103 5,101 Total lease payments 15,364 14,899 Less imputed interest (2,709) (2,825) Total operating lease liabilities $ 12,655 $ 12,074 June 30, 2020 December 31, 2019 Current portion of operating lease liabilities $ 1,633 $ 1,322 Operating lease liabilities, net of current portion 11,022 10,752 Total lease liabilities $ 12,655 $ 12,074 |
Stockholders' Equity and Stoc_2
Stockholders' Equity and Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of stock option activity | The following is a summary of stock option activity for the six months ended June 30, 2020 (in thousands, except per share data): Shares Weighted- Average Exercise Price per Share Outstanding at December 31, 2019 4,253 $ 29.59 Granted 1,185 29.36 Exercised (231) 16.85 Canceled (145) 39.56 Outstanding at June 30, 2020 5,062 $ 29.83 |
Schedule of restricted stock unit activity | The following is a summary of restricted stock unit activity for the six months ended June 30, 2020 (in thousands, except per share data): Shares Weighted- Average Fair Value per Share at Grant Date Outstanding at December 31, 2019 439 $ 36.97 Granted 218 27.34 Vested (194) 23.95 Canceled (28) 38.74 Outstanding at June 30, 2020 435 $ 38.09 |
Stock-based compensation expense | The following table summarizes the components of total stock-based compensation expense included in the condensed consolidated statements of operations (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Research and development $ 3,488 $ 2,074 $ 6,217 $ 3,509 Selling, general and administrative 4,815 3,284 8,480 6,072 Total $ 8,303 $ 5,358 $ 14,697 $ 9,581 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
Basic and diluted net loss per share | A reconciliation of the numerators and denominators used in computing net loss per share is as follows (in thousands, except per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Numerator: Net loss $ (53,324) $ (37,763) $ (79,124) $ (72,965) Denominator: Shares used in per share calculation 55,355 42,458 51,770 42,348 Net loss per share, basic and diluted $ (0.96) $ (0.89) $ (1.53) $ (1.72) |
Schedule of antidilutive securities excluded from computation of diluted net loss per share | The following table presents the potential shares of common stock outstanding that were excluded from the calculation of diluted net loss per share for the periods presented because including them would have been anti-dilutive (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Shares subject to outstanding stock options 4,942 4,227 4,696 3,973 Shares subject to outstanding restricted stock units 555 415 520 355 Shares subject to outstanding warrants to purchase common stock 28 28 28 28 Total 5,525 4,670 5,244 4,356 |
Organization, Basis of Presen_2
Organization, Basis of Presentation and Liquidity - Narrative (Details) | Jun. 12, 2020USD ($) | Jun. 30, 2020USD ($)segmentnumberOfDivestituresnumberOfPrograms | Dec. 31, 2019USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number of late-stage development programs | numberOfPrograms | 2 | ||
Number of operating segments | segment | 1 | ||
Total cash, cash equivalents and short-term investments, estimated fair value | $ 390,249,000 | $ 251,155,000 | |
Number of discrete business divestitures | numberOfDivestitures | 2 | ||
Accumulated deficit | $ 1,194,581,000 | $ 1,115,457,000 | |
Period permitted for offering | 3 years | ||
Common stock authorized for issuance and sale under Shelf Registration | $ 200,000,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | |||||
Inventory | $ 475 | $ 475 | $ 0 | ||
Income tax benefit | $ (17,425) | $ 0 | $ (17,425) | $ 0 |
Collaborative Arrangement (Deta
Collaborative Arrangement (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 16 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Mar. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||||||
Collaboration revenue | $ 1,032 | $ 1,069 | $ 2,281 | $ 1,069 | ||
Deferred revenue | 11,100 | 11,100 | $ 11,100 | |||
Fixed consideration | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Performance obligation at inception of arrangement | 20,000 | 20,000 | 20,000 | $ 20,000 | ||
Portion of fixed consideration received | 17,000 | |||||
Variable consideration | Achievement of regulatory milestones | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Amount that can be earned upon achievement of milestone | 66,000 | 66,000 | 66,000 | |||
Variable consideration | Achievement of net sales milestones | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Amount that can be earned upon achievement of net sales milestone | $ 42,500 | $ 42,500 | $ 42,500 |
Cash, Cash Equivalents and Ma_3
Cash, Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Cash and Cash Equivalents [Line Items] | ||
Cash | $ 23,688 | $ 43,058 |
Total cash and cash equivalents | 136,871 | 62,070 |
Marketable securities, amortized cost | 252,725 | 188,706 |
Marketable securities, gross unrealized gains | 653 | 381 |
Marketable securities, gross unrealized losses | 0 | (2) |
Marketable securities, estimated fair value | 253,378 | 189,085 |
Total cash, cash equivalents and marketable securities, amortized cost | 389,596 | 250,776 |
Total cash, cash equivalents and marketable securities | 390,249 | 251,155 |
Amortized Cost | ||
Due within one year, amortized cost | 245,025 | |
Due between one and two years, amortized cost | 7,700 | |
Marketable securities, amortized cost | 252,725 | |
Fair Value | ||
Due within one year, estimated fair value | 245,635 | |
Due between one and two years, estimated fair value | 7,743 | |
Marketable securities, estimated fair value | 253,378 | |
Prepaid expenses and other current assets | ||
Fair Value | ||
Accrued interest receivable | 400 | 600 |
U.S. Treasuries | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents: | 11,300 | |
Marketable securities, amortized cost | 55,677 | |
Marketable securities, gross unrealized gains | 3 | |
Marketable securities, gross unrealized losses | 0 | |
Marketable securities, estimated fair value | 55,680 | |
Money market funds | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents: | 61,840 | 11,527 |
Certificate of deposits | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents: | 10,900 | |
Marketable securities, amortized cost | 42,744 | 41,302 |
Marketable securities, gross unrealized gains | 0 | 0 |
Marketable securities, gross unrealized losses | 0 | 0 |
Marketable securities, estimated fair value | 42,744 | 41,302 |
Commercial paper | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents: | 29,143 | 7,485 |
Marketable securities, amortized cost | 94,567 | 73,366 |
Marketable securities, gross unrealized gains | 0 | 0 |
Marketable securities, gross unrealized losses | 0 | 0 |
Marketable securities, estimated fair value | 94,567 | 73,366 |
U.S. Government-sponsored enterprises debt securities | ||
Cash and Cash Equivalents [Line Items] | ||
Marketable securities, amortized cost | 6,200 | |
Marketable securities, gross unrealized gains | 13 | |
Marketable securities, gross unrealized losses | 0 | |
Marketable securities, estimated fair value | 6,213 | |
Corporate debt securities | ||
Cash and Cash Equivalents [Line Items] | ||
Marketable securities, amortized cost | 53,537 | 74,038 |
Marketable securities, gross unrealized gains | 637 | 381 |
Marketable securities, gross unrealized losses | 0 | (2) |
Marketable securities, estimated fair value | $ 54,174 | $ 74,417 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | $ 253,378,000 | $ 189,085,000 |
Total assets | 366,561,000 | 208,097,000 |
Common stock warrant liabilities | 36,000 | 198,000 |
Total liabilities | 53,136,000 | 63,998,000 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 61,840,000 | 11,527,000 |
Total liabilities | 0 | 0 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 304,721,000 | 196,570,000 |
Total liabilities | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 0 |
Contingent consideration liabilities | 53,100,000 | |
Total liabilities | 53,136,000 | 63,998,000 |
Common stock warrant liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Common stock warrant liabilities | 36,000 | 198,000 |
Common stock warrant liabilities | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Common stock warrant liabilities | 0 | 0 |
Common stock warrant liabilities | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Common stock warrant liabilities | 0 | 0 |
Common stock warrant liabilities | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Common stock warrant liabilities | 36,000 | 198,000 |
Contingent consideration liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration liabilities | 53,100,000 | 63,800,000 |
Contingent consideration liabilities | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration liabilities | 0 | 0 |
Contingent consideration liabilities | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration liabilities | 0 | 0 |
Contingent consideration liabilities | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration liabilities | 53,100,000 | 63,800,000 |
U.S. Treasuries | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 11,300,000 | |
Marketable securities: | 55,680,000 | |
U.S. Treasuries | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 0 | |
Marketable securities: | 0 | |
U.S. Treasuries | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 11,300,000 | |
Marketable securities: | 55,680,000 | |
U.S. Treasuries | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 0 | |
Marketable securities: | 0 | |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 61,840,000 | 11,527,000 |
Money market funds | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 61,840,000 | 11,527,000 |
Money market funds | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 0 | 0 |
Money market funds | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 0 | 0 |
Certificate of deposits | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 10,900,000 | |
Marketable securities: | 42,744,000 | 41,302,000 |
Certificate of deposits | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 0 | |
Marketable securities: | 0 | 0 |
Certificate of deposits | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 10,900,000 | |
Marketable securities: | 42,744,000 | 41,302,000 |
Certificate of deposits | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 0 | |
Marketable securities: | 0 | 0 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 29,143,000 | 7,485,000 |
Marketable securities: | 94,567,000 | 73,366,000 |
Commercial paper | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 0 | 0 |
Marketable securities: | 0 | 0 |
Commercial paper | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 29,143,000 | 7,485,000 |
Marketable securities: | 94,567,000 | 73,366,000 |
Commercial paper | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents: | 0 | 0 |
Marketable securities: | 0 | 0 |
U.S. Government-sponsored enterprises debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | 6,213,000 | |
U.S. Government-sponsored enterprises debt securities | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | 0 | |
U.S. Government-sponsored enterprises debt securities | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | 6,213,000 | |
U.S. Government-sponsored enterprises debt securities | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | 0 | |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | 54,174,000 | 74,417,000 |
Corporate debt securities | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | 0 | 0 |
Corporate debt securities | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | 54,174,000 | 74,417,000 |
Corporate debt securities | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities: | 0 | $ 0 |
ZX008 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Potential contingent consideration payment, minimum | 0 | |
Potential contingent consideration payment, maximum | $ 60,000,000 |
Fair Value Measurements - Recon
Fair Value Measurements - Reconciliation of Liabilities Measured at Fair Value Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Change in fair value of contingent consideration | $ 12,200 | $ (700) | $ 4,300 | $ 2,300 |
Contingent consideration liabilities | ||||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Balance at beginning of period | 55,900 | 71,200 | 63,800 | 78,200 |
Change in fair value | 12,200 | (700) | 4,300 | 2,300 |
Transfers out of Level 3 fair value hierarchy | (15,000) | 0 | (15,000) | 0 |
Settlements | 0 | 0 | 0 | (10,000) |
Balance at end of period | 53,100 | $ 70,500 | $ 53,100 | $ 70,500 |
Change in fair value of contingent consideration | $ 10,000 |
Fair Value Measurements - Signi
Fair Value Measurements - Significant Inputs Used in Fair Value Measurement (Details) $ in Thousands | Jun. 30, 2020USD ($) |
Level 3 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value | $ 53,100 |
Discount rate | Discounted cash flow | Minimum | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input (percent) | 0.045 |
Discount rate | Discounted cash flow | Maximum | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input (percent) | 0.127 |
Discount rate | Discounted cash flow | Weighted average | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input (percent) | 0.068 |
Probability of payment | Discounted cash flow | Minimum | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input (percent) | 0 |
Probability of payment | Discounted cash flow | Maximum | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input (percent) | 0.943 |
Probability of payment | Discounted cash flow | Weighted average | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input (percent) | 0.943 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities - Details of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued clinical trial expenses | $ 11,335 | $ 18,666 |
Accrued compensation | 7,229 | 7,179 |
Accrued milestone payment | 15,000 | 0 |
Other accrued liabilities | 6,576 | 4,074 |
Common stock warrant liabilities | 36 | 198 |
Total accrued and other current liabilities | $ 40,176 | $ 30,117 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Finite-lived intangible assets | $ 102,500 | $ 0 |
Indefinite-lived in-process research and development (IPR&D) intangible assets | 0 | 102,500 |
Total intangible assets | $ 102,500 | $ 102,500 |
Intangible Assets - Estimated A
Intangible Assets - Estimated Amortization Expense (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Jul. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | |
Estimated Amortization Expense | |||
2020 (remaining 6 months) | $ 3,942 | ||
2021 | 7,885 | ||
2022 | 7,885 | ||
2023 | 7,885 | ||
2024 | 7,885 | ||
Thereafter | 67,018 | ||
Total | $ 102,500 | $ 0 | |
Subsequent event | |||
Finite-Lived Intangible Assets [Line Items] | |||
Estimated useful life of intangible asset | 13 years |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Feb. 29, 2020 | Dec. 31, 2019 | |
Lessee, Lease, Description [Line Items] | ||||
Aggregate lease payments | $ 15,364 | $ 14,899 | ||
Cash paid for amounts included in measurement of lease liabilities | 1,000 | $ 600 | ||
Right-of-use asset obtained in exchange for new operating lease liabilities | $ 1,200 | |||
Weighted average remaining lease term | 6 years 6 months | |||
Weighted-average discount rate (percent) | 6.20% | |||
Maidenhead, United Kingdom lease | ||||
Lessee, Lease, Description [Line Items] | ||||
Term of new lease | 5 years | |||
Aggregate lease payments | $ 1,500 |
Leases - Information Related to
Leases - Information Related to Operating Leases (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Lease, Cost [Abstract] | ||
Operating lease cost | $ 1,045 | $ 995 |
Short-term lease cost | 259 | 548 |
Sublease income | (115) | (290) |
Total | $ 1,189 | $ 1,253 |
Leases - Maturities of Lease Li
Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Operating Lease Liabilities, Payments Due [Abstract] | ||
2020 (remaining 6 months) | $ 1,152 | |
Maturing in first year | 2,292 | $ 1,986 |
Maturing in second year | 2,230 | 1,957 |
Maturing in third year | 2,287 | 1,894 |
Maturing in fourth year | 2,300 | 1,951 |
Maturing in fifth year | 2,010 | |
Thereafter | 5,103 | |
Thereafter | 5,101 | |
Total lease payments | 15,364 | 14,899 |
Less imputed interest | (2,709) | (2,825) |
Total operating lease liabilities | 12,655 | 12,074 |
Assets and Liabilities, Lessee [Abstract] | ||
Current portion of operating lease liabilities | 1,633 | 1,322 |
Operating lease liabilities, net of current portion | 11,022 | 10,752 |
Total operating lease liabilities | $ 12,655 | $ 12,074 |
Stockholders' Equity and Stoc_3
Stockholders' Equity and Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 13 Months Ended | |||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Mar. 31, 2020 | May 29, 2020 | May 28, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock-based compensation expense | $ 8,303 | $ 5,358 | $ 14,697 | $ 9,581 | |||||
ESPP | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Maximum number of common stock that may be issued (shares) | 875,000 | 375,000 | |||||||
Eliminated increase to the number of shares authorized for issuance that was previously automatically added annually | 31,250 | ||||||||
ESPP | Common Stock | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares available for grant (shares) | 524,962 | 524,962 | 524,962 | ||||||
Restricted stock units | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Vested (shares) | 194,000 | ||||||||
PSU's | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Vested (shares) | 128,000 | ||||||||
Stock-based compensation expense | $ 1,400 | $ 1,400 | |||||||
Underwritten public offering | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares issued in public offering (in shares) | 9,798,000 | ||||||||
Price per share (in usd per share) | $ 23.50 | $ 23.50 | |||||||
Proceeds realized from offering | $ 221,700 | ||||||||
Option to purchase additional shares | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares issued in public offering (in shares) | 1,278,000 |
Stockholders' Equity and Stoc_4
Stockholders' Equity and Stock-Based Compensation - Options Activity (Details) shares in Thousands | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Shares (in thousands) | |
Options outstanding, beginning of period (in shares) | shares | 4,253 |
Granted (in shares) | shares | 1,185 |
Exercised (in shares) | shares | (231) |
Canceled (in shares) | shares | (145) |
Options outstanding, end of period (in shares) | shares | 5,062 |
Weighted- Average Exercise Price per Share | |
Outstanding weighted average exercise price, beginning balance (in usd per share) | $ / shares | $ 29.59 |
Granted weighted average exercise price (in usd per share) | $ / shares | 29.36 |
Exercised weighted average exercise price (in usd per share) | $ / shares | 16.85 |
Canceled weighted average exercise price (in usd per share) | $ / shares | 39.56 |
Outstanding weighted average exercise price, ending balance (in usd per share) | $ / shares | $ 29.83 |
Stockholders' Equity and Stoc_5
Stockholders' Equity and Stock-Based Compensation - Restricted Stock Unit Activity (Details) - Restricted stock units shares in Thousands | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Outstanding at beginning of period (in shares) | shares | 439 |
Granted (in shares) | shares | 218 |
Vested (in shares) | shares | (194) |
Canceled (in shares) | shares | (28) |
Outstanding at end of period (in shares) | shares | 435 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Nonvested at beginning of period - Weighted average fair value per share at grant date (in usd per share) | $ / shares | $ 36.97 |
Granted - Weighted average fair value per share at grant date (in usd per share) | $ / shares | 27.34 |
Vested - Weighted average fair value per share at grant date (in usd per share) | $ / shares | 23.95 |
Canceled - Weighted average fair value per share at grant date (in usd per share) | $ / shares | 38.74 |
Nonvested at end of period - Weighted average fair value per share at grant date (in usd per share) | $ / shares | $ 38.09 |
Stockholders' Equity and Stoc_6
Stockholders' Equity and Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 8,303 | $ 5,358 | $ 14,697 | $ 9,581 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 3,488 | 2,074 | 6,217 | 3,509 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 4,815 | $ 3,284 | $ 8,480 | $ 6,072 |
Net Loss Per Share - Reconcilia
Net Loss Per Share - Reconciliation of Numerator and Denominators in Computing Net Loss per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Numerator: | ||||||
Net loss | $ (53,324) | $ (25,800) | $ (37,763) | $ (35,202) | $ (79,124) | $ (72,965) |
Denominator: | ||||||
Shares used in per share calculation (in shares) | 55,355 | 42,458 | 51,770 | 42,348 | ||
Net loss per share, basic and diluted (in dollars per share) | $ (0.96) | $ (0.89) | $ (1.53) | $ (1.72) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of earnings per share amount | 5,525 | 4,670 | 5,244 | 4,356 |
Shares subject to outstanding stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of earnings per share amount | 4,942 | 4,227 | 4,696 | 3,973 |
Shares subject to outstanding restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of earnings per share amount | 555 | 415 | 520 | 355 |
Shares subject to outstanding warrants to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of earnings per share amount | 28 | 28 | 28 | 28 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Tax Disclosure [Abstract] | ||||
Income tax benefit | $ 17,425 | $ 0 | $ 17,425 | $ 0 |
Decrease to valuation allowance | $ 17,400 | $ 17,400 |
United Kingdom (U.K.) Researc_2
United Kingdom (U.K.) Research and Development (R&D) Tax Relief Scheme (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
May 31, 2020 | Mar. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | |
U.K. tax legislation | U.K. tax legislation | ||||
Operating Loss Carryforwards [Line Items] | ||||
Window to seek relief under U.K. tax legislature | 2 years | |||
Tax year 2017 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Claim for refundable cash credit | $ 9.9 | |||
Proceeds from claims | $ 9.9 | |||
Tax year 2018 | ||||
Operating Loss Carryforwards [Line Items] | ||||
Claim for refundable cash credit | $ 9.8 | |||
Proceeds from claims | $ 9.8 | |||
2017 and 2018 tax year claims | ||||
Operating Loss Carryforwards [Line Items] | ||||
Other income | $ 19.7 |