Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-38219 | |
Entity Registrant Name | DECIPHERA PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 30-1003521 | |
Entity Address, Address Line One | 200 Smith Street | |
Entity Address, City or Town | Waltham | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 781 | |
Local Phone Number | 209-6400 | |
Title of 12(b) Security | Common Stock, $0.01 Par Value Per Share | |
Trading Symbol | DCPH | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 58,041,410 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001654151 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 90,947 | $ 135,897 |
Short-term marketable securities | 304,405 | 416,033 |
Accounts receivable, net | 18,608 | 13,896 |
Inventory | 8,206 | 5,716 |
Prepaid expenses and other current assets | 14,977 | 12,489 |
Total current assets | 437,143 | 584,031 |
Long-term marketable securities | 55,605 | 9,375 |
Long-term investments—restricted | 3,102 | 3,102 |
Property and equipment, net | 9,588 | 9,583 |
Operating lease assets | 35,128 | 36,341 |
Total assets | 540,566 | 642,432 |
Current liabilities: | ||
Accounts payable | 14,022 | 12,308 |
Accrued expenses and other current liabilities | 49,428 | 55,227 |
Operating lease liabilities | 2,604 | 2,457 |
Total current liabilities | 66,054 | 69,992 |
Operating lease liabilities, net of current portion | 27,856 | 28,764 |
Total liabilities | 93,910 | 98,756 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Common stock, $0.01 par value per share; 125,000,000 shares authorized; 58,033,984 shares and 57,596,144 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 580 | 576 |
Additional paid-in capital | 1,332,249 | 1,297,557 |
Accumulated other comprehensive income (loss) | 26 | 11 |
Accumulated deficit | (886,199) | (754,468) |
Total stockholders' equity | 446,656 | 543,676 |
Total liabilities and stockholders' equity | $ 540,566 | $ 642,432 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 |
Common stock, shares issued (in shares) | 58,033,984 | 57,596,144 |
Common stock, shares outstanding (in shares) | 58,033,984 | 57,596,144 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Total revenues | $ 23,573 | $ 7,090 | $ 48,729 | $ 7,152 |
Cost and operating expenses: | ||||
Cost of sales | 1,275 | 8 | 1,497 | 8 |
Research and development | 59,984 | 46,081 | 115,665 | 97,469 |
Selling, general, and administrative | 32,828 | 29,933 | 63,575 | 53,869 |
Total cost and operating expenses | 94,087 | 76,022 | 180,737 | 151,346 |
Loss from operations | (70,514) | (68,932) | (132,008) | (144,194) |
Other income (expense): | ||||
Interest and other income, net | 81 | 1,691 | 277 | 4,146 |
Total other income (expense), net | 81 | 1,691 | 277 | 4,146 |
Net loss | $ (70,433) | $ (67,241) | $ (131,731) | $ (140,048) |
Net loss per share—diluted (in dollars per share) | $ (1.21) | $ (1.20) | $ (2.28) | $ (2.56) |
Net loss per share—basic (in dollars per share) | $ (1.21) | $ (1.20) | $ (2.28) | $ (2.56) |
Weighted average common shares outstanding—diluted (in shares) | 57,987,095 | 55,920,122 | 57,867,795 | 54,743,778 |
Weighted average common shares outstanding—basic (in shares) | 57,987,095 | 55,920,122 | 57,867,795 | 54,743,778 |
Comprehensive loss: | ||||
Net loss | $ (70,433) | $ (67,241) | $ (131,731) | $ (140,048) |
Other comprehensive income (loss): | ||||
Unrealized losses on marketable securities | (53) | (771) | (23) | (119) |
Currency translation adjustment | 36 | 0 | 38 | 0 |
Total other comprehensive income (loss) | (17) | (771) | 15 | (119) |
Total comprehensive loss | (70,450) | (68,012) | (131,716) | (140,167) |
Share-based compensation expense | 12,371 | 10,609 | 23,490 | 17,603 |
Product revenues, net | ||||
Total revenues | 22,048 | 4,825 | 42,010 | 4,825 |
Collaboration revenues | ||||
Total revenues | $ 1,525 | $ 2,265 | $ 6,719 | $ 2,327 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 51,617,639 | ||||
Beginning balance at Dec. 31, 2019 | $ 546,467 | $ 516 | $ 1,033,819 | $ 111 | $ (487,979) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock under stock option and incentive and employee stock purchase plans (in shares) | 805,264 | ||||
Issuance of common stock under stock option and incentive and employee stock purchase plans | 7,396 | $ 8 | 7,388 | ||
Issuance of common stock sold in public offering, net of underwriting discounts, commissions and offering costs (in shares) | 3,659,090 | ||||
Issuance of common stock sold in public offering, net of underwriting discounts, commissions and offering costs | 188,385 | $ 37 | 188,348 | ||
Stock-based compensation expense | 17,603 | 17,603 | |||
Other comprehensive income (loss) | (119) | (119) | |||
Net loss | (140,048) | (140,048) | |||
Ending balance (in shares) at Jun. 30, 2020 | 56,081,993 | ||||
Ending balance at Jun. 30, 2020 | 619,684 | $ 561 | 1,247,158 | (8) | (628,027) |
Beginning balance (in shares) at Dec. 31, 2019 | 51,617,639 | ||||
Beginning balance at Dec. 31, 2019 | 546,467 | $ 516 | 1,033,819 | 111 | (487,979) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (266,500) | ||||
Ending balance (in shares) at Dec. 31, 2020 | 57,596,144 | ||||
Ending balance at Dec. 31, 2020 | 543,676 | $ 576 | 1,297,557 | 11 | (754,468) |
Beginning balance (in shares) at Mar. 31, 2020 | 55,681,027 | ||||
Beginning balance at Mar. 31, 2020 | 672,260 | $ 557 | 1,231,726 | 763 | (560,786) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock under stock option and incentive and employee stock purchase plans (in shares) | 400,966 | ||||
Issuance of common stock under stock option and incentive and employee stock purchase plans | 4,827 | $ 4 | 4,823 | ||
Stock-based compensation expense | 10,609 | 10,609 | |||
Other comprehensive income (loss) | (771) | (771) | |||
Net loss | (67,241) | (67,241) | |||
Ending balance (in shares) at Jun. 30, 2020 | 56,081,993 | ||||
Ending balance at Jun. 30, 2020 | 619,684 | $ 561 | 1,247,158 | (8) | (628,027) |
Beginning balance (in shares) at Dec. 31, 2020 | 57,596,144 | ||||
Beginning balance at Dec. 31, 2020 | 543,676 | $ 576 | 1,297,557 | 11 | (754,468) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock under stock option and incentive and employee stock purchase plans (in shares) | 265,746 | ||||
Issuance of common stock under stock option and incentive and employee stock purchase plans | 2,658 | $ 2 | 2,656 | ||
Issuance of common stock sold in public offering, net of underwriting discounts, commissions and offering costs (in shares) | 172,094 | ||||
Issuance of common stock sold in public offering, net of underwriting discounts, commissions and offering costs | 8,548 | $ 2 | 8,546 | ||
Stock-based compensation expense | 23,490 | 23,490 | |||
Other comprehensive income (loss) | 15 | 15 | |||
Net loss | (131,731) | (131,731) | |||
Ending balance (in shares) at Jun. 30, 2021 | 58,033,984 | ||||
Ending balance at Jun. 30, 2021 | 446,656 | $ 580 | 1,332,249 | 26 | (886,199) |
Beginning balance (in shares) at Mar. 31, 2021 | 57,901,020 | ||||
Beginning balance at Mar. 31, 2021 | 503,013 | $ 579 | 1,318,157 | 43 | (815,766) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock under stock option and incentive and employee stock purchase plans (in shares) | 132,964 | ||||
Issuance of common stock under stock option and incentive and employee stock purchase plans | 1,722 | $ 1 | 1,721 | ||
Stock-based compensation expense | 12,371 | 12,371 | |||
Other comprehensive income (loss) | (17) | (17) | |||
Net loss | (70,433) | (70,433) | |||
Ending balance (in shares) at Jun. 30, 2021 | 58,033,984 | ||||
Ending balance at Jun. 30, 2021 | $ 446,656 | $ 580 | $ 1,332,249 | $ 26 | $ (886,199) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||||
Net loss | $ (70,433) | $ (67,241) | $ (131,731) | $ (140,048) | $ (266,500) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | |||||
Stock-based compensation expense | 23,490 | 17,603 | |||
Depreciation expense | 1,475 | 944 | |||
Noncash lease expense | 1,675 | 1,062 | |||
Net amortization (accretion) of premium (discounts) on marketable securities | 847 | (2,010) | |||
Changes in operating assets and liabilities: | |||||
Accounts receivable | (4,712) | (7,384) | |||
Inventory | (4,156) | (798) | |||
Prepaid expenses and other current assets | (2,489) | (146) | |||
Accounts payable | 1,711 | (7,056) | |||
Accrued expenses and other current liabilities | (4,536) | (2,436) | |||
Operating lease liabilities | (1,223) | (945) | |||
Net cash flows used in operating activities | (119,649) | (141,214) | |||
Cash flows from investing activities: | |||||
Purchases of marketable securities | (212,121) | (818,182) | |||
Maturities of marketable securities | 260,612 | 323,263 | |||
Sales of marketable securities | 16,033 | 479,746 | |||
Purchases of property and equipment | (1,069) | (3,653) | |||
Increase in restricted investments | 0 | (615) | |||
Net cash flows provided by (used in) investing activities | 63,455 | (19,441) | |||
Cash flows from financing activities: | |||||
Proceeds from offerings of common stock, net of underwriting discounts and commissions | 8,588 | 189,037 | |||
Payments of offering costs | (40) | (652) | |||
Proceeds from stock option exercises and employee stock purchase plan | 2,658 | 7,396 | |||
Net cash flows provided by financing activities | 11,206 | 195,781 | |||
Net increase (decrease) in cash and cash equivalents | (44,988) | 35,126 | |||
Effect of exchange rate changes on cash and cash equivalents | 38 | 0 | |||
Cash and cash equivalents at beginning of period | 135,897 | 120,320 | 120,320 | ||
Cash and cash equivalents at end of period | $ 90,947 | $ 155,446 | $ 90,947 | $ 155,446 | $ 135,897 |
Nature of the Business and Summ
Nature of the Business and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Summary of Significant Accounting Policies | Nature of the Business and Summary of Significant Accounting Policies Nature of the Business Deciphera Pharmaceuticals, Inc. (the Company) is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. The Company is leveraging its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. The Company has one approved drug, QINLOCK® (ripretinib), referred to as QINLOCK, which was developed through its proprietary platform. Beyond QINLOCK, the Company is developing three clinical stage drug candidates and advancing its research-stage programs. The Company wholly owns QINLOCK and all of its drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in the People's Republic of China (the PRC), Hong Kong, Macau, and Taiwan, referred to as Greater China. The Company is preparing for a potential launch of QINLOCK in Europe and the Company has entered, and intends in the future to enter, into select distributor arrangements to offer QINLOCK in geographies where the Company does not intend to distribute QINLOCK on its own, such as Australia and Canada. On May 15, 2020, QINLOCK was approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. Following the FDA approval of QINLOCK, in May 2020, the Company commenced commercial sales of QINLOCK in the U.S. In June 2020, QINLOCK was authorized for sale in Canada by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. In July 2020, the Australian Therapeutic Goods Administration approved QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. In March 2021, the China National Medical Products Administration (NMPA) approved QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. In March 2021, the Hong Kong Department of Health approved QINLOCK in Hong Kong for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, market acceptance and the successful commercialization of QINLOCK or any of the Company's current or future drug candidates for which it receives marketing approval, competition for QINLOCK or any of the Company's current or future drug candidates for which it receives marketing approval, protection of proprietary technology, ability to complete late-stage clinical trials, ability to obtain and maintain regulatory approvals, compliance with government regulations, the impact of the novel coronavirus (COVID-19) pandemic on its operations, and the ability to secure additional capital to fund operations. QINLOCK and the Company's drug candidates currently under development will require significant additional research and development efforts, including extensive preclinical and/or clinical testing and regulatory approval. In addition to supporting its research and development efforts, the Company will be required to invest in the Company's commercial capabilities and infrastructure, to support its commercialization of QINLOCK, the Company's first approved drug, and any current or future drug candidate for which the Company obtains marketing approval. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company's drug development and commercialization efforts are successful, it is uncertain when, if ever, the Company will realize sufficient revenue to result in a profit from product sales of QINLOCK or any current or future drug candidates for which it receives marketing approval. The full extent to which the COVID-19 pandemic, or the future outbreak of any other highly infectious or contagious diseases, may impact the Company's business, including its preclinical studies, clinical trial operations, or commercialization efforts will depend on continuously changing circumstances, which are highly uncertain and cannot be predicted at this time, such as the duration of such pandemic including future waves of infection, new strains of the virus that causes COVID-19, or the impact of the increasing availability of effective vaccines, the actions taken to contain the pandemic or mitigate its impact, and the direct and indirect economic effects of the pandemic and containment measures, among others. The Company is continuing to monitor the long-term impact of COVID-19, if any, on its financial condition and results of operations. The ongoing fluidity of this situation precludes any prediction as to the full impact of the COVID-19 pandemic but it could have a material adverse effect on the Company's business, financial condition, and results of operations. The COVID-19 pandemic may also have the effect of heightening the risks to which the Company is subject, including various aspects of the Company's preclinical studies and ongoing clinical trials, the reliance on third parties in the Company's supply chain for materials and manufacturing of the Company's drug and drug candidates, disruptions in health regulatory agencies' operations globally, the volatility of the Company's common stock, and its ability to access capital markets, and the Company's ability to successfully commercialize and generate revenue from sales of QINLOCK. In February 2020, the Company issued and sold 3,659,090 shares of its common stock in a follow-on public offering at a public offering price of $55.00 per share, resulting in net proceeds of $188.4 million after deducting underwriting discounts and commissions and other offering expenses. In August 2020, the Company entered into an Open Market Sale Agreement℠ (the Sales Agreement) with Jefferies LLC (Jefferies), pursuant to which the Company may issue and sell shares of its common stock having aggregate offering proceeds of up to $200.0 million (the Shares) from time to time through Jefferies as its sales agent. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Jefferies may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company may sell the Shares in amounts and at times to be determined by the Company from time to time subject to the terms and conditions of the Sales Agreement, but it has no obligation to sell any Shares under the Sales Agreement. The Company or Jefferies may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. During the six months ended June 30, 2021, the Company issued 172,094 shares resulting in net proceeds of $8.5 million after deducting underwriting discounts and commissions and other offering expenses under the Sales Agreement. As of June 30, 2021, there was up to $172.5 million available for future issuance under the Sales Agreement. Basis of Presentation The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in the ordinary course of business. Since inception, the Company has incurred recurring losses including net losses of $131.7 million and $266.5 million for the six months ended June 30, 2021 and the year ended December 31, 2020, respectively. As of June 30, 2021, the Company had an accumulated deficit of $886.2 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company expects that its cash, cash equivalents, and marketable securities of $451.0 million as of June 30, 2021 will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance date of these consolidated financial statements. The future viability of the Company is dependent on its ability to raise additional capital to fund its operations. The Company will need to obtain substantial additional funding in connection with continuing operations. If the Company is unable to raise capital when needed, or on attractive terms, it could be forced to delay, reduce, or eliminate its research or drug development programs or certain commercialization efforts. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated. Unaudited Interim Financial Information These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). The consolidated balance sheet as of December 31, 2020 was derived from audited financial statements, but does not include all disclosures required by GAAP. The accompanying unaudited consolidated financial statements as of June 30, 2021 and for the three and six months ended June 30, 2021 and 2020 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company's audited financial statements and the notes thereto for the year ended December 31, 2020 included in the Company's Annual Report on Form 10-K (Form 10-K) on file with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company's consolidated financial position as of June 30, 2021 and consolidated results of operations and comprehensive loss for the three and six months ended June 30, 2021 and 2020 and consolidated cash flows for the six months ended June 30, 2021 and 2020 have been made. The consolidated results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2021. The significant accounting policies used in preparation of these consolidated financial statements for the three and six months ended June 30, 2021 are consistent with those discussed in Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements in the Company's Form 10-K for the year ended December 31, 2020. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, product revenue reserves, the accrual for research and development expenses, and the valuation of stock-based option awards. Estimates are periodically reviewed in light of changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. Net Loss per Share Basic net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of common shares outstanding for the period. Diluted net income (loss) per share is computed by dividing the diluted net income (loss) by the weighted average number of common shares, including potential dilutive common shares assuming the dilutive effect as determined using the treasury stock method. For periods in which the Company has reported net losses, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss for the three and six months ended June 30, 2021 and 2020. The following potential dilutive securities, presented based on amounts outstanding at the end of each reporting period, have been excluded from the calculation of diluted net loss per share because including them would have had an anti-dilutive impact: As of June 30, 2021 2020 Options to purchase common stock 6,798,894 7,073,775 Unvested restricted common stock units 814,277 466,955 Unvested employee stock purchase plan shares 34,183 39,600 Total 7,647,354 7,580,330 Comprehensive Loss and Accumulated Other Comprehensive Income (Loss) Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with shareholders. For the three and six months ended June 30, 2021, the Company's other comprehensive income (loss) consisted of unrealized gains (losses) on marketable securities and foreign currency translation adjustments. For the three and six months ended June 30, 2020, the Company's other comprehensive income (loss) consisted of unrealized gains (losses) on marketable securities. As of June 30, 2021, accumulated other comprehensive income (loss) primarily consisted of unrealized gains (losses) on marketable securities. As of December 31, 2020, accumulated other comprehensive income (loss) consisted of unrealized gains (losses) on marketable securities. |
Revenues
Revenues | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenues | Revenues Net Product Revenues To date, the Company's only source of product revenues has been from the sales of QINLOCK, which began in May 2020, following the approval of QINLOCK by the FDA on May 15, 2020 for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. Net product revenues by geography consisted of the following: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2021 2020 2021 2020 U.S. $ 20,732 $ 4,825 $ 40,019 $ 4,825 Rest of world 1,316 — 1,991 — Total product revenues, net $ 22,048 $ 4,825 $ 42,010 $ 4,825 Activity in each of the product revenue allowance and reserve categories is summarized as follows: (in thousands) Trade discounts and allowances Chargebacks and administrative fees Government rebates and other incentives Returns Total Balance as of December 31, 2020 $ 152 $ 264 $ 2,433 $ 532 $ 3,381 Provision related to sales in the current year 1,150 1,580 3,953 800 7,483 Adjustments related to prior period sales 83 57 (22) (395) (277) Credits and payments made during the period for current year sales (1,022) (1,515) (770) (335) (3,642) Credits and payments made during the period for prior period sales (205) (97) (645) (95) (1,042) Balance as of June 30, 2021 $ 158 $ 289 $ 4,949 $ 507 $ 5,903 The total reserves described above are summarized as components of the Company's consolidated balance sheets as follows: (in thousands) As of June 30, 2021 As of December 31, 2020 Reduction of accounts receivable, net $ 414 $ 363 Component of accrued expenses and other current liabilities 5,489 3,018 Total revenue-related reserves $ 5,903 $ 3,381 Collaboration Revenues Zai License Agreement In June 2019, the Company entered into a License Agreement (the Zai License Agreement) with an affiliate of Zai Lab (Shanghai) Co., Ltd. (Zai), pursuant to which the Company granted Zai exclusive rights to develop and commercialize QINLOCK, including certain follow-on compounds (the Licensed Products), in Greater China (the Territory). The Company retains exclusive rights to, among other things, develop, manufacture, and commercialize the Licensed Products outside the Territory. Pursuant to the terms of the Zai License Agreement, the Company received an upfront cash payment of $20.0 million and became eligible to receive up to $185.0 million in potential development and commercial milestone payments, consisting of up to $50.0 million of development milestones and up to $135.0 million of commercial milestones. In addition, during the term of the Zai License Agreement, Zai will be obligated to pay the Company tiered percentage royalties ranging from low to high teens on annual net sales of the Licensed Products in the Territory, subject to adjustments in specified circumstances. Additionally, certain costs incurred by the Company associated with the Zai License Agreement are reimbursed by Zai. During the three and six months ended June 30, 2020, revenues recognized under the Zai License Agreement included the achievement of a $2.0 million development milestone in the second quarter of 2020. During the six months ended June 30, 2021, revenues recognized under the Zai License Agreement included the achievement of a $5.0 million development milestone in the first quarter of 2021 associated with the approval of QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib, by the China NMPA in March 2021. Additionally, during the second quarter of 2021, following the approvals of QINLOCK in the PRC and Hong Kong in March 2021, the Company began recognizing royalty revenues under the Zai License Agreement. Please read Note 3, Revenues , to the consolidated financial statements in the Company's Form 10-K for the year ended December 31, 2020 for further details on the Zai License Agreement. Zai Supply Agreement In February 2020, the Company entered into a Supply Agreement (the Zai Supply Agreement) with Zai, as required by terms in the Zai License Agreement, pursuant to which the Company will supply the Licensed Products to Zai for use in the Territory for clinical trials as well as commercial inventory, if QINLOCK obtained regulatory approval in the Territory. In March 2021, QINLOCK was approved in the PRC and in Hong Kong. Subject to the Zai Supply Agreement, costs incurred by the Company for clinical and commercial supply are reimbursed by Zai. During the second quarter of 2021, following the approvals of QINLOCK in the PRC and Hong Kong in March 2021, the Company began recognizing revenues associated with sales of commercial inventory of QINLOCK under the Zai Supply Agreement. |
Marketable Securities and Fair
Marketable Securities and Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Investments, All Other Investments [Abstract] | |
Marketable Securities and Fair Value Measurements | Marketable Securities and Fair Value Measurements The following tables present marketable securities by contractual maturity and security type: As of June 30, 2021 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Due within one year: Commercial paper $ 137,536 $ 18 $ (12) $ 137,542 U.S. government securities 76,556 16 (1) 76,571 Corporate debt securities 58,029 2 (18) 58,013 Certificates of deposit 32,267 12 — 32,279 Due after one year through five years: Corporate debt securities 51,348 5 (39) 51,314 U.S. government securities 4,288 3 — 4,291 Total $ 360,024 $ 56 $ (70) $ 360,010 As of December 31, 2020 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Due within one year: U.S. government securities $ 298,335 $ 49 $ (1) $ 298,383 Commercial paper 62,037 9 (15) 62,031 Corporate debt securities 38,309 — (34) 38,275 Certificates of deposit 17,344 1 (1) 17,344 Due after one year through five years: U.S. government securities 9,370 5 — 9,375 Total $ 425,395 $ 64 $ (51) $ 425,408 The following tables present information about the Company's financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values: As of June 30, 2021 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 59,919 $ — $ 59,919 Commercial paper — 2,200 — 2,200 Marketable securities: Commercial paper — 137,542 — 137,542 Corporate debt securities — 109,327 — 109,327 U.S. government securities — 80,862 — 80,862 Certificates of deposit — 32,279 — 32,279 Total $ — $ 422,129 $ — $ 422,129 As of December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 46,676 $ — $ 46,676 U.S. government securities — 30,000 — 30,000 Marketable securities: U.S. government securities — 307,758 — 307,758 Commercial paper — 62,031 — 62,031 Corporate debt securities — 38,275 — 38,275 Certificates of deposit — 17,344 — 17,344 Total $ — $ 502,084 $ — $ 502,084 The table above excludes certificates of deposit totaling $3.1 million as of both June 30, 2021 and December 31, 2020 that the Company held to secure a letter of credit associated with its leases and to secure a credit card account. The certificates of deposit are Level 2 instruments and are measured at carrying value in the consolidated balance sheets in long-term investments—restricted and approximate fair value. For additional information on the letter of credit associated with the Company's leases, please read Note 7, Leases , to the consolidated financial statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2020. The fair value of Level 2 instruments classified as cash equivalents and marketable securities were determined through third-party pricing services. The pricing services use many observable market inputs to determine value, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates, and other industry and economic events. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | InventoryThe Company commenced the capitalization of inventory related to QINLOCK in May 2020 upon receiving FDA approval of QINLOCK. Capitalized inventory consisted of the following: (in thousands) As of June 30, 2021 As of December 31, 2020 Raw materials $ 1,352 $ 1,352 Work in process 6,543 4,142 Finished goods 311 222 Total inventory $ 8,206 $ 5,716 Inventory written down as a result of excess, obsolescence, unmarketability, or other reasons is charged to cost of sales, and totaled less than $0.1 million during the six months ended June 30, 2021. There were no inventory amounts written down and charged to cost of sales during the three months ended June 30, 2021 or during the three and six months ended June 30, 2020. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: (in thousands) As of June 30, 2021 As of December 31, 2020 Accrued research and development $ 29,214 $ 31,259 Payroll and related expenses 8,886 17,255 Professional fees 5,433 3,306 Revenue-related reserves 5,489 3,018 Other 406 389 Total accrued expenses and other current liabilities $ 49,428 $ 55,227 |
Stock-Based Awards
Stock-Based Awards | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Awards | Stock-Based Awards The Company grants stock-based awards under its 2017 Stock Option and Incentive Plan (the 2017 Plan) and is authorized to issue common stock under its 2017 Employee Stock Purchase Plan (ESPP). The Company also has outstanding stock options under its 2015 Equity Incentive Plan but is no longer granting awards under this plan. As of June 30, 2021, 2,449,611 shares of common stock were available for issuance under the 2017 Plan. As of June 30, 2021, 1,729,854 shares of common stock were available for issuance to participating employees under the ESPP. Employees began participating in the ESPP program during the second quarter of 2020. Stock-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2021 2020 2021 2020 Research and development expenses $ 5,594 $ 5,293 $ 10,553 $ 8,564 Selling, general, and administrative expenses 6,777 5,316 12,937 9,039 Total stock-based compensation $ 12,371 $ 10,609 $ 23,490 $ 17,603 As of June 30, 2021, total unrecognized compensation cost related to the unvested share-based awards was $121.7 million, which is expected to be recognized over a weighted average of 2.7 years. During the three and six months ended June 30, 2020, the Company recorded $1.3 million of stock-based compensation expense related to vesting events associated with performance-based restricted stock units that became probable and were achieved during the second quarter of 2020. These expenses were classified as research and development expenses within the consolidated statements of operations and comprehensive loss. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Purchase Commitments Associated with Commercial Supply Agreements The Company has entered into commercial supply agreements related to the supply of QINLOCK that require the Company to make binding forecasts for a certain amount of purchases. The related cancellation clauses would as a general matter require the Company to pay the full amount of these binding forecasts. As of June 30, 2021, the Company's contractual commitments for its commercial supply agreements were $8.6 million, which are expected to be paid within one year. Legal Proceedings The Company is not currently a party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses the costs related to its legal proceedings as they are incurred. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and senior management that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of June 30, 2021 or December 31, 2020. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event In August 2021, the Company entered into an agreement with Sprint Bioscience (Sprint) to exclusively in-license worldwide rights to a research-stage program targeting VPS34, a key kinase in the autophagy pathway for the potential treatment of cancer. Pursuant to the terms of the agreement, the Company will make an upfront payment of $4.0 million during the third quarter of 2021. Sprint would also be eligible to receive from the Company up to an additional $273.0 million in potential development and commercial milestone payments as well as tiered percentage royalties ranging from the mid-single-digits to the low-double-digits on the sales of a future drug from the program, if approved. |
Nature of the Business and Su_2
Nature of the Business and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in the ordinary course of business. Since inception, the Company has incurred recurring losses including net losses of $131.7 million and $266.5 million for the six months ended June 30, 2021 and the year ended December 31, 2020, respectively. As of June 30, 2021, the Company had an accumulated deficit of $886.2 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company expects that its cash, cash equivalents, and marketable securities of $451.0 million as of June 30, 2021 will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance date of these consolidated financial statements. The future viability of the Company is dependent on its ability to raise additional capital to fund its operations. The Company will need to obtain substantial additional funding in connection with continuing operations. If the Company is unable to raise capital when needed, or on attractive terms, it could be forced to delay, reduce, or eliminate its research or drug development programs or certain commercialization efforts. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). The consolidated balance sheet as of December 31, 2020 was derived from audited financial statements, but does not include all disclosures required by GAAP. The accompanying unaudited consolidated financial statements as of June 30, 2021 and for the three and six months ended June 30, 2021 and 2020 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company's audited financial statements and the notes thereto for the year ended December 31, 2020 included in the Company's Annual Report on Form 10-K (Form 10-K) on file with the SEC. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, product revenue reserves, the accrual for research and development expenses, and the valuation of stock-based option awards. Estimates are periodically reviewed in light of changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. |
Net Loss per Share | Net Loss per Share Basic net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of common shares outstanding for the period. Diluted net income (loss) per share is computed by dividing the diluted net income (loss) by the weighted average number of common shares, including potential dilutive common shares assuming the dilutive effect as determined using the treasury stock method. |
Comprehensive Loss and Accumulated Other Comprehensive Income (Loss) | Comprehensive Loss and Accumulated Other Comprehensive Income (Loss) Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with shareholders. For the three and six months ended June 30, 2021, the Company's other comprehensive income (loss) consisted of unrealized gains (losses) on marketable securities and foreign currency translation adjustments. For the three and six months ended June 30, 2020, the Company's other comprehensive income (loss) consisted of unrealized gains (losses) on marketable securities. As of June 30, 2021, accumulated other comprehensive income (loss) primarily consisted of unrealized gains (losses) on marketable securities. As of December 31, 2020, accumulated other comprehensive income (loss) consisted of unrealized gains (losses) on marketable securities. |
Nature of the Business and Su_3
Nature of the Business and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Potential Dilutive Securities | The following potential dilutive securities, presented based on amounts outstanding at the end of each reporting period, have been excluded from the calculation of diluted net loss per share because including them would have had an anti-dilutive impact: As of June 30, 2021 2020 Options to purchase common stock 6,798,894 7,073,775 Unvested restricted common stock units 814,277 466,955 Unvested employee stock purchase plan shares 34,183 39,600 Total 7,647,354 7,580,330 |
Revenues (Tables)
Revenues (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Disaggregation of Product Revenues, Net [Line Items] | |
Analysis Of Amount Of And Change In Product Revenue Reserves. | Activity in each of the product revenue allowance and reserve categories is summarized as follows: (in thousands) Trade discounts and allowances Chargebacks and administrative fees Government rebates and other incentives Returns Total Balance as of December 31, 2020 $ 152 $ 264 $ 2,433 $ 532 $ 3,381 Provision related to sales in the current year 1,150 1,580 3,953 800 7,483 Adjustments related to prior period sales 83 57 (22) (395) (277) Credits and payments made during the period for current year sales (1,022) (1,515) (770) (335) (3,642) Credits and payments made during the period for prior period sales (205) (97) (645) (95) (1,042) Balance as of June 30, 2021 $ 158 $ 289 $ 4,949 $ 507 $ 5,903 |
Summary Of Total Product Revenue Reserves Included In The Consolidated Balance Sheets | The total reserves described above are summarized as components of the Company's consolidated balance sheets as follows: (in thousands) As of June 30, 2021 As of December 31, 2020 Reduction of accounts receivable, net $ 414 $ 363 Component of accrued expenses and other current liabilities 5,489 3,018 Total revenue-related reserves $ 5,903 $ 3,381 |
Product revenues, net | |
Disaggregation of Product Revenues, Net [Line Items] | |
Disaggregation of Product Revenue | Net product revenues by geography consisted of the following: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2021 2020 2021 2020 U.S. $ 20,732 $ 4,825 $ 40,019 $ 4,825 Rest of world 1,316 — 1,991 — Total product revenues, net $ 22,048 $ 4,825 $ 42,010 $ 4,825 |
Marketable Securities and Fai_2
Marketable Securities and Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments, All Other Investments [Abstract] | |
Schedule of Marketable Securities | The following tables present marketable securities by contractual maturity and security type: As of June 30, 2021 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Due within one year: Commercial paper $ 137,536 $ 18 $ (12) $ 137,542 U.S. government securities 76,556 16 (1) 76,571 Corporate debt securities 58,029 2 (18) 58,013 Certificates of deposit 32,267 12 — 32,279 Due after one year through five years: Corporate debt securities 51,348 5 (39) 51,314 U.S. government securities 4,288 3 — 4,291 Total $ 360,024 $ 56 $ (70) $ 360,010 As of December 31, 2020 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Due within one year: U.S. government securities $ 298,335 $ 49 $ (1) $ 298,383 Commercial paper 62,037 9 (15) 62,031 Corporate debt securities 38,309 — (34) 38,275 Certificates of deposit 17,344 1 (1) 17,344 Due after one year through five years: U.S. government securities 9,370 5 — 9,375 Total $ 425,395 $ 64 $ (51) $ 425,408 |
Schedule of Financial Assets Measured at Fair Value on a Recurring Basis | The following tables present information about the Company's financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values: As of June 30, 2021 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 59,919 $ — $ 59,919 Commercial paper — 2,200 — 2,200 Marketable securities: Commercial paper — 137,542 — 137,542 Corporate debt securities — 109,327 — 109,327 U.S. government securities — 80,862 — 80,862 Certificates of deposit — 32,279 — 32,279 Total $ — $ 422,129 $ — $ 422,129 As of December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 46,676 $ — $ 46,676 U.S. government securities — 30,000 — 30,000 Marketable securities: U.S. government securities — 307,758 — 307,758 Commercial paper — 62,031 — 62,031 Corporate debt securities — 38,275 — 38,275 Certificates of deposit — 17,344 — 17,344 Total $ — $ 502,084 $ — $ 502,084 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Capitalized inventory consisted of the following: (in thousands) As of June 30, 2021 As of December 31, 2020 Raw materials $ 1,352 $ 1,352 Work in process 6,543 4,142 Finished goods 311 222 Total inventory $ 8,206 $ 5,716 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: (in thousands) As of June 30, 2021 As of December 31, 2020 Accrued research and development $ 29,214 $ 31,259 Payroll and related expenses 8,886 17,255 Professional fees 5,433 3,306 Revenue-related reserves 5,489 3,018 Other 406 389 Total accrued expenses and other current liabilities $ 49,428 $ 55,227 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Classification of Stock-Based Compensation Expense | Stock-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2021 2020 2021 2020 Research and development expenses $ 5,594 $ 5,293 $ 10,553 $ 8,564 Selling, general, and administrative expenses 6,777 5,316 12,937 9,039 Total stock-based compensation $ 12,371 $ 10,609 $ 23,490 $ 17,603 |
Nature of the Business and Su_4
Nature of the Business and Summary of Significant Accounting Policies - Summary of Potential Dilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from computation of diluted net loss per common share (in shares) | 7,647,354 | 7,580,330 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from computation of diluted net loss per common share (in shares) | 6,798,894 | 7,073,775 |
Unvested restricted common stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from computation of diluted net loss per common share (in shares) | 814,277 | 466,955 |
Unvested employee stock purchase plan shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from computation of diluted net loss per common share (in shares) | 34,183 | 39,600 |
Nature of the Business and Su_5
Nature of the Business and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Aug. 31, 2020 | Feb. 29, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Nature Of Business And Basis Of Presentation [Line Items] | |||||||
Issuance of common stock sold in public offering, net of underwriting discounts, commissions and offering costs | $ 8,548 | $ 188,385 | |||||
Net loss | $ (70,433) | $ (67,241) | (131,731) | $ (140,048) | $ (266,500) | ||
Accumulated deficit | (886,199) | (886,199) | $ (754,468) | ||||
Investments and cash | 451,000 | $ 451,000 | |||||
Common Stock | |||||||
Nature Of Business And Basis Of Presentation [Line Items] | |||||||
Number of shares issued and sold (in shares) | 172,094 | 3,659,090 | |||||
Issuance of common stock sold in public offering, net of underwriting discounts, commissions and offering costs | $ 2 | $ 37 | |||||
Follow on Offering | Common Stock | |||||||
Nature Of Business And Basis Of Presentation [Line Items] | |||||||
Number of shares issued and sold (in shares) | 3,659,090 | ||||||
Additional offering price of common stock (in dollars per share) | $ 55 | ||||||
Issuance of common stock sold in public offering, net of underwriting discounts, commissions and offering costs | $ 188,400 | ||||||
Open Market Sale Agreement | |||||||
Nature Of Business And Basis Of Presentation [Line Items] | |||||||
Offering proceeds | $ 200,000 | ||||||
Shares available for future issuance (in shares) | $ 172,500 | $ 172,500 | |||||
Open Market Sale Agreement | Common Stock | |||||||
Nature Of Business And Basis Of Presentation [Line Items] | |||||||
Number of shares issued and sold (in shares) | 172,094 | ||||||
Issuance of common stock sold in public offering, net of underwriting discounts, commissions and offering costs | $ 8,500 |
Revenues - Net Product Revenues
Revenues - Net Product Revenues by Geography (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Product Revenues, Net [Line Items] | ||||
Total revenues | $ 23,573 | $ 7,090 | $ 48,729 | $ 7,152 |
Product revenues, net | ||||
Disaggregation of Product Revenues, Net [Line Items] | ||||
Total revenues | 22,048 | 4,825 | 42,010 | 4,825 |
Product revenues, net | U.S. | ||||
Disaggregation of Product Revenues, Net [Line Items] | ||||
Total revenues | 20,732 | 4,825 | 40,019 | 4,825 |
Product revenues, net | Rest of world | ||||
Disaggregation of Product Revenues, Net [Line Items] | ||||
Total revenues | $ 1,316 | $ 0 | $ 1,991 | $ 0 |
Revenues - Product Revenue Allo
Revenues - Product Revenue Allowance and Reserve Categories (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Beginning balance | $ 3,381 |
Provision related to sales in the current year | 7,483 |
Adjustments related to prior period sales | (277) |
Credits and payments made during the period for current year sales | 3,642 |
Credits and payments made during the period for prior period sales | 1,042 |
Ending balance | 5,903 |
Trade discounts and allowances | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Beginning balance | 152 |
Provision related to sales in the current year | 1,150 |
Adjustments related to prior period sales | 83 |
Credits and payments made during the period for current year sales | 1,022 |
Credits and payments made during the period for prior period sales | 205 |
Ending balance | 158 |
Chargebacks and administrative fees | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Beginning balance | 264 |
Provision related to sales in the current year | 1,580 |
Adjustments related to prior period sales | 57 |
Credits and payments made during the period for current year sales | 1,515 |
Credits and payments made during the period for prior period sales | 97 |
Ending balance | 289 |
Government rebates and other incentives | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Beginning balance | 2,433 |
Provision related to sales in the current year | 3,953 |
Adjustments related to prior period sales | (22) |
Credits and payments made during the period for current year sales | 770 |
Credits and payments made during the period for prior period sales | 645 |
Ending balance | 4,949 |
Returns | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Beginning balance | 532 |
Provision related to sales in the current year | 800 |
Adjustments related to prior period sales | (395) |
Credits and payments made during the period for current year sales | 335 |
Credits and payments made during the period for prior period sales | 95 |
Ending balance | $ 507 |
Revenues - Total Reserves Summa
Revenues - Total Reserves Summarized (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Revenue from Contract with Customer [Abstract] | ||
Revenue-related reserves | $ 5,903 | $ 3,381 |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Revenue-related reserves | 5,903 | 3,381 |
Accounts Receivable | ||
Revenue from Contract with Customer [Abstract] | ||
Revenue-related reserves | 414 | 363 |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Revenue-related reserves | 414 | 363 |
Accrued Expenses And Other Current Liabilities | ||
Revenue from Contract with Customer [Abstract] | ||
Revenue-related reserves | 5,489 | 3,018 |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Revenue-related reserves | $ 5,489 | $ 3,018 |
Revenues - Additional Informati
Revenues - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue from External Customer [Line Items] | ||||||
Revenues | $ 23,573 | $ 7,090 | $ 48,729 | $ 7,152 | ||
Zai License Agreement | Upfront Payment | ||||||
Revenue from External Customer [Line Items] | ||||||
Upfront cash payment | $ 20,000 | |||||
Zai License Agreement | Development And Commercial Milestones | Maximum | ||||||
Revenue from External Customer [Line Items] | ||||||
License agreement milestone | 185,000 | |||||
Zai License Agreement | Development Milestone | Maximum | ||||||
Revenue from External Customer [Line Items] | ||||||
License agreement milestone | 50,000 | |||||
Zai License Agreement | Commercial Milestone | Maximum | ||||||
Revenue from External Customer [Line Items] | ||||||
License agreement milestone | $ 135,000 | |||||
Product revenues, net | ||||||
Revenue from External Customer [Line Items] | ||||||
Revenues | 22,048 | 4,825 | 42,010 | 4,825 | ||
Collaboration revenues | ||||||
Revenue from External Customer [Line Items] | ||||||
Revenues | $ 1,525 | 2,265 | $ 6,719 | $ 2,327 | ||
Collaboration revenues | Zai License Agreement | Development Milestone | ||||||
Revenue from External Customer [Line Items] | ||||||
Revenues | $ 5,000 | $ 2,000 |
Marketable Securities and Fai_3
Marketable Securities and Fair Value Measurements - Schedule of Marketable Securities (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 360,024 | $ 425,395 |
Gross Unrealized Gains | 56 | 64 |
Gross Unrealized Losses | (70) | (51) |
Estimated Fair Value | 360,010 | 425,408 |
Commercial paper | ||
Marketable Securities [Line Items] | ||
Amortized Cost, due within one year | 137,536 | 62,037 |
Gross Unrealized Gains, due within one year | 18 | 9 |
Gross Unrealized Losses, due within one year | (12) | (15) |
Estimated Fair Value, due within one year | 137,542 | 62,031 |
U.S. government securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost, due within one year | 76,556 | 298,335 |
Amortized Cost, due after one year through five years | 4,288 | 9,370 |
Gross Unrealized Gains, due within one year | 16 | 49 |
Gross Unrealized Gains, due after one year through five years | 3 | 5 |
Gross Unrealized Losses, due within one year | (1) | (1) |
Gross Unrealized Losses, due after one year through five years | 0 | 0 |
Estimated Fair Value, due within one year | 76,571 | 298,383 |
Estimated Fair Value, due after one year through five years | 4,291 | 9,375 |
Estimated Fair Value | 80,862 | 307,758 |
Corporate debt securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost, due within one year | 58,029 | 38,309 |
Amortized Cost, due after one year through five years | 51,348 | |
Gross Unrealized Gains, due within one year | 2 | 0 |
Gross Unrealized Gains, due after one year through five years | 5 | |
Gross Unrealized Losses, due within one year | (18) | (34) |
Gross Unrealized Losses, due after one year through five years | (39) | |
Estimated Fair Value, due within one year | 58,013 | 38,275 |
Estimated Fair Value, due after one year through five years | 51,314 | |
Estimated Fair Value | 109,327 | 38,275 |
Certificates of deposit | ||
Marketable Securities [Line Items] | ||
Amortized Cost, due within one year | 32,267 | 17,344 |
Gross Unrealized Gains, due within one year | 12 | 1 |
Gross Unrealized Losses, due within one year | 0 | (1) |
Estimated Fair Value, due within one year | $ 32,279 | $ 17,344 |
Marketable Securities and Fai_4
Marketable Securities and Fair Value Measurements - Schedule of Financial Assets Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Marketable securities: | ||
Total Marketable Securities | $ 360,010 | $ 425,408 |
Total | 422,129 | 502,084 |
U.S. government securities | ||
Cash equivalents: | ||
Total Cash equivalents | 30,000 | |
Marketable securities: | ||
Total Marketable Securities | 80,862 | 307,758 |
Corporate debt securities | ||
Marketable securities: | ||
Total Marketable Securities | 109,327 | 38,275 |
Commercial paper | ||
Cash equivalents: | ||
Total Cash equivalents | 2,200 | |
Marketable securities: | ||
Total Marketable Securities | 137,542 | 62,031 |
Money market funds | ||
Cash equivalents: | ||
Total Cash equivalents | 59,919 | 46,676 |
Certificates of deposit | ||
Marketable securities: | ||
Total Marketable Securities | 32,279 | 17,344 |
Level 1 | ||
Marketable securities: | ||
Total | 0 | 0 |
Level 1 | U.S. government securities | ||
Cash equivalents: | ||
Total Cash equivalents | 0 | |
Marketable securities: | ||
Total Marketable Securities | 0 | 0 |
Level 1 | Corporate debt securities | ||
Marketable securities: | ||
Total Marketable Securities | 0 | 0 |
Level 1 | Commercial paper | ||
Cash equivalents: | ||
Total Cash equivalents | 0 | |
Marketable securities: | ||
Total Marketable Securities | 0 | 0 |
Level 1 | Money market funds | ||
Cash equivalents: | ||
Total Cash equivalents | 0 | 0 |
Level 1 | Certificates of deposit | ||
Marketable securities: | ||
Total Marketable Securities | 0 | 0 |
Level 2 | ||
Marketable securities: | ||
Total | 422,129 | 502,084 |
Level 2 | U.S. government securities | ||
Cash equivalents: | ||
Total Cash equivalents | 30,000 | |
Marketable securities: | ||
Total Marketable Securities | 80,862 | 307,758 |
Level 2 | Corporate debt securities | ||
Marketable securities: | ||
Total Marketable Securities | 109,327 | 38,275 |
Level 2 | Commercial paper | ||
Cash equivalents: | ||
Total Cash equivalents | 2,200 | |
Marketable securities: | ||
Total Marketable Securities | 137,542 | 62,031 |
Level 2 | Money market funds | ||
Cash equivalents: | ||
Total Cash equivalents | 59,919 | 46,676 |
Level 2 | Certificates of deposit | ||
Marketable securities: | ||
Total Marketable Securities | 32,279 | 17,344 |
Level 3 | ||
Marketable securities: | ||
Total | 0 | 0 |
Level 3 | U.S. government securities | ||
Cash equivalents: | ||
Total Cash equivalents | 0 | |
Marketable securities: | ||
Total Marketable Securities | 0 | 0 |
Level 3 | Corporate debt securities | ||
Marketable securities: | ||
Total Marketable Securities | 0 | 0 |
Level 3 | Commercial paper | ||
Cash equivalents: | ||
Total Cash equivalents | 0 | |
Marketable securities: | ||
Total Marketable Securities | 0 | 0 |
Level 3 | Money market funds | ||
Cash equivalents: | ||
Total Cash equivalents | 0 | 0 |
Level 3 | Certificates of deposit | ||
Marketable securities: | ||
Total Marketable Securities | $ 0 | $ 0 |
Marketable Securities and Fai_5
Marketable Securities and Fair Value Measurements - Additional Information (Details) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Certificates of deposit | Letter of Credit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Certificate of deposit held to secure letter of credit associated with lease and credit card | $ 3.1 | $ 3.1 |
Inventory (Details)
Inventory (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |||||
Raw materials | $ 1,352,000 | $ 1,352,000 | $ 1,352,000 | ||
Work in process | 6,543,000 | 6,543,000 | 4,142,000 | ||
Total inventory | 311,000 | 311,000 | 222,000 | ||
Inventory | 8,206,000 | 8,206,000 | $ 5,716,000 | ||
Inventory written down | $ 0 | $ 0 | $ 100,000 | $ 0 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Schedule of Accrued Expenses and Other Current Liabilities | ||
Accrued research and development | $ 29,214 | $ 31,259 |
Payroll and related expenses | 8,886 | 17,255 |
Professional fees | 5,433 | 3,306 |
Revenue-related reserves | 5,903 | 3,381 |
Other | 406 | 389 |
Total accrued expenses and other current liabilities | 49,428 | 55,227 |
Accrued Expenses And Other Current Liabilities | ||
Schedule of Accrued Expenses and Other Current Liabilities | ||
Revenue-related reserves | $ 5,489 | $ 3,018 |
Stock-Based Awards - Classifica
Stock-Based Awards - Classification of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 12,371 | $ 10,609 | $ 23,490 | $ 17,603 |
Research and development expenses | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 5,594 | 5,293 | 10,553 | 8,564 |
Selling, general, and administrative expenses | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 6,777 | $ 5,316 | $ 12,937 | $ 9,039 |
Stock-Based Awards - Additional
Stock-Based Awards - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost related to unvested share-based awards | $ 121,700,000 | $ 121,700,000 | ||
Unrecognized compensation cost related to unvested share-based awards, period for recognition | 2 years 8 months 12 days | |||
Share-based compensation expense | $ 12,371,000 | $ 10,609,000 | $ 23,490,000 | $ 17,603,000 |
Performance Shares [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 1,300,000 | $ 1,300,000 | ||
2017 Stock Option and Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for issuance (in shares) | 2,449,611 | 2,449,611 | ||
Employee Stock Purchase Plan (ESPP) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for issuance (in shares) | 1,729,854 | 1,729,854 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | Jun. 30, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Supply commitment amount | $ 8.6 |
Subsequent Event (Details)
Subsequent Event (Details) - Sprint Bioscience - Collaboration revenues - Subsequent Event - Forecast - Collaborative Arrangement, Transaction with Party to Collaborative Arrangement - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended |
Aug. 31, 2021 | Sep. 30, 2021 | |
Subsequent Event [Line Items] | ||
Upfront payment | $ 4 | |
Additional payment | $ 273 |