Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2021 | |
Entity Registrant Name | Global Blood Therapeutics, Inc. | |
Entity Filer Category | Large Accelerated Filer | |
Trading Symbol | GBT | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Document Transition Report | false | |
Entity Common Stock, Shares Outstanding | 62,412,062 | |
Document Quarterly Report | true | |
Entity Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes | |
Entity File Number | 001-37539 | |
Entity Tax Identification Number | 27-4825712 | |
Entity Shell Company | false | |
Entity Address, Address Line One | 181 Oyster Point Boulevard | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
City Area Code | 650 | |
Local Phone Number | 741-7700 | |
Entity Address, Postal Zip Code | 94080 | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001629137 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 419,311 | $ 494,766 |
Short-term marketable securities | 18,085 | 66,126 |
Accounts receivable, net | 19,544 | 17,500 |
Inventories | 47,991 | 40,223 |
Prepaid expenses and other current assets | 19,928 | 13,548 |
Total current assets | 524,859 | 632,163 |
Property and equipment, net | 36,775 | 37,882 |
Operating lease right-of-use assets | 49,421 | 50,722 |
Restricted cash | 2,395 | 2,436 |
Other assets, noncurrent | 1,522 | 799 |
Total assets | 614,972 | 724,002 |
Current liabilities: | ||
Accounts payable | 9,198 | 19,078 |
Accrued liabilities | 38,904 | 31,133 |
Accrued compensation | 19,330 | 23,985 |
Operating lease liabilities, current | 5,243 | 4,836 |
Total current liabilities | 72,675 | 79,032 |
Long-term debt | 149,268 | 148,815 |
Operating lease liabilities, noncurrent | 76,441 | 79,176 |
Other liabilities, noncurrent | 822 | 822 |
Total liabilities | 299,206 | 307,845 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of June 30, 2021 (unaudited) and December 31, 2020; no shares issued and outstanding | ||
Common stock, $0.001 par value, 150,000,000 shares authorized as of June 30, 2021 (unaudited) and December 31, 2020, respectively; 62,379,118 and 61,898,090 shares issued and outstanding as of June 30, 2021 (unaudited) and December 31, 2020, respectively | 62 | 62 |
Additional paid-in capital | 1,446,393 | 1,402,262 |
Accumulated other comprehensive loss | 302 | 302 |
Accumulated deficit | (1,130,991) | (986,469) |
Total stockholders' equity | 315,766 | 416,157 |
Total liabilities and stockholders' equity | $ 614,972 | $ 724,002 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 62,379,118 | 61,898,090 |
Common stock, shares outstanding | 62,379,118 | 61,898,090 |
Condensed Consolidated Statemen
Condensed 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 | |
Revenues [Abstract] | ||||
Product sales, net | $ 47,555 | $ 31,501 | $ 86,598 | $ 45,619 |
Costs and operating expenses: | ||||
Cost of sales | 748 | 377 | 1,332 | 512 |
Research and development | 51,784 | 34,085 | 102,641 | 73,858 |
Selling, general and administrative | 61,093 | 49,075 | 120,059 | 96,736 |
Total costs and operating expenses | 113,625 | 83,537 | 224,032 | 171,106 |
Loss from operations | (66,070) | (52,036) | (137,434) | (125,487) |
Other income (expense): | ||||
Interest income | 164 | 1,514 | 493 | 4,370 |
Interest expense | (3,677) | (2,282) | (7,366) | (4,596) |
Other expenses, net | (9) | (36) | (215) | (153) |
Total other income, net | (3,522) | (804) | (7,088) | (379) |
Net loss | (69,592) | (52,840) | (144,522) | (125,866) |
Other comprehensive loss: | ||||
Net unrealized gain (loss) on marketable securities, net of tax | (78) | 12 | (259) | 472 |
Cumulative translation adjustment | 259 | 0 | 259 | 0 |
Comprehensive loss | $ (69,411) | $ (52,828) | $ (144,522) | $ (125,394) |
Basic and diluted net loss per common share | $ (1.12) | $ (0.86) | $ (2.32) | $ (2.06) |
Weighted-average number of shares used in computing basic and diluted net loss per common share | 62,312,418 | 62,207,328 | 61,116,707 | 60,952,269 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2019 | $ 578,694 | $ 61 | $ 1,316,795 | $ 754 | $ (738,916) |
Beginning Balance, Shares at Dec. 31, 2019 | 60,644,380 | ||||
Issuance of common stock upon exercise of stock options | 967 | 967 | |||
Issuance of common stock upon exercise of stock options, Shares | 33,937 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (2,099) | (2,099) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 160,594 | ||||
Issuance of common stock pursuant to ESPP purchases | 1,870 | 1,870 | |||
Issuance of common stock pursuant to ESPP purchases, Shares | 47,460 | ||||
Stock-based compensation | 16,705 | 16,705 | |||
Net unrealized gain (loss) on marketable securities | 461 | 461 | |||
Net loss | (73,026) | (73,026) | |||
Ending Balance at Mar. 31, 2020 | 523,572 | $ 61 | 1,334,238 | 1,215 | (811,942) |
Ending Balance, Shares at Mar. 31, 2020 | 60,886,371 | ||||
Beginning Balance at Dec. 31, 2019 | 578,694 | $ 61 | 1,316,795 | 754 | (738,916) |
Beginning Balance, Shares at Dec. 31, 2019 | 60,644,380 | ||||
Cumulative translation adjustment | 0 | ||||
Net loss | (125,866) | ||||
Ending Balance at Jun. 30, 2020 | 495,816 | $ 61 | 1,359,310 | 1,227 | (864,782) |
Ending Balance, Shares at Jun. 30, 2020 | 61,330,987 | ||||
Beginning Balance at Mar. 31, 2020 | 523,572 | $ 61 | 1,334,238 | 1,215 | (811,942) |
Beginning Balance, Shares at Mar. 31, 2020 | 60,886,371 | ||||
Issuance of common stock upon exercise of stock options | 8,018 | 8,018 | |||
Issuance of common stock upon exercise of stock options, Shares | 334,454 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (74) | (74) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 110,162 | ||||
Stock-based compensation | 17,128 | 17,128 | |||
Net unrealized gain (loss) on marketable securities | 12 | 12 | |||
Cumulative translation adjustment | 0 | ||||
Net loss | (52,840) | (52,840) | |||
Ending Balance at Jun. 30, 2020 | 495,816 | $ 61 | 1,359,310 | 1,227 | (864,782) |
Ending Balance, Shares at Jun. 30, 2020 | 61,330,987 | ||||
Beginning Balance at Dec. 31, 2020 | 416,157 | $ 62 | 1,402,262 | 302 | (986,469) |
Beginning Balance, Shares at Dec. 31, 2020 | 61,898,090 | ||||
Issuance of common stock upon exercise of stock options | 1,110 | 1,110 | |||
Issuance of common stock upon exercise of stock options, Shares | 47,763 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (1,897) | (1,897) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 229,087 | ||||
Issuance of common stock pursuant to ESPP purchases | 2,558 | 2,558 | |||
Issuance of common stock pursuant to ESPP purchases, Shares | 65,110 | ||||
Stock-based compensation | 20,378 | 20,378 | |||
Net unrealized gain (loss) on marketable securities | (181) | (181) | |||
Net loss | (74,930) | (74,930) | |||
Ending Balance at Mar. 31, 2021 | 363,195 | $ 62 | 1,424,411 | 121 | (1,061,399) |
Ending Balance, Shares at Mar. 31, 2021 | 62,240,050 | ||||
Beginning Balance at Dec. 31, 2020 | $ 416,157 | $ 62 | 1,402,262 | 302 | (986,469) |
Beginning Balance, Shares at Dec. 31, 2020 | 61,898,090 | ||||
Issuance of common stock upon exercise of stock options, Shares | 76,338 | ||||
Cumulative translation adjustment | $ 259 | ||||
Net loss | (144,522) | ||||
Ending Balance at Jun. 30, 2021 | 315,766 | $ 62 | 1,446,393 | 302 | (1,130,991) |
Ending Balance, Shares at Jun. 30, 2021 | 62,379,118 | ||||
Beginning Balance at Mar. 31, 2021 | 363,195 | $ 62 | 1,424,411 | 121 | (1,061,399) |
Beginning Balance, Shares at Mar. 31, 2021 | 62,240,050 | ||||
Issuance of common stock upon exercise of stock options | 403 | 403 | |||
Issuance of common stock upon exercise of stock options, Shares | 28,575 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (65) | (65) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 110,493 | ||||
Stock-based compensation | 21,644 | 21,644 | |||
Cumulative translation adjustment | 259 | 259 | |||
Other comprehensive losses | (78) | (78) | |||
Net loss | (69,592) | (69,592) | |||
Ending Balance at Jun. 30, 2021 | $ 315,766 | $ 62 | $ 1,446,393 | $ 302 | $ (1,130,991) |
Ending Balance, Shares at Jun. 30, 2021 | 62,379,118 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (144,522) | $ (125,866) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,908 | 5,577 |
Amortization (accretion) of premium (discount) on marketable securities | 112 | (61) |
Non-cash interest expense | 476 | 824 |
Amortization of operating lease right-of-use assets | 1,301 | 580 |
Stock-based compensation | 41,184 | 32,938 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,044) | (9,834) |
Inventories | (6,841) | (24,926) |
Prepaid expenses and other assets | (7,121) | 181 |
Accounts payable | (9,730) | (4,918) |
Accrued liabilities | 7,683 | (1,326) |
Accrued compensation | (4,655) | (1,114) |
Other liabilities | 156 | |
Operating lease liabilities | (2,328) | 1,686 |
Net cash used in operating activities | (123,577) | (126,103) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (1,920) | (3,918) |
Purchase of marketable securities | (57,936) | |
Maturities of marketable securities | 47,670 | 261,738 |
Net cash provided by investing activities | 45,750 | 199,884 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options | 4,083 | 11,000 |
Payments of debt issuance costs | (49) | (130) |
Tax paid related to net share settlement of equity awards | (1,962) | (2,172) |
Net cash provided by financing activities | 2,072 | 8,698 |
Effect of exchange rate changes on cash and cash equivalents | 259 | |
Net (decrease) increase in cash, cash equivalents and restricted cash | (75,496) | 82,479 |
Cash, cash equivalents and restricted cash at beginning of period | 497,202 | 304,632 |
Cash, cash equivalents and restricted cash at end of period | 421,706 | 387,111 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 6,788 | 3,419 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | ||
Leasehold improvements paid for by landlord | 10,709 | |
Accrued purchase of property and equipment | (36) | 3,773 |
Accrued issuance costs | (26) | (85) |
RECONCILIATION OF CASH, CASH EQUIVALENTS, AND RESTRICTED CASH TO THE CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Cash and cash equivalents | 419,311 | 384,716 |
Restricted cash | 2,395 | 2,395 |
Total cash and cash equivalents and restricted cash | $ 421,706 | $ 387,111 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Global Blood Therapeutics, Inc., or the Company, we, us, or our, was incorporated in Delaware in February 2011 and commenced operations in May 2012. We are a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities. In late November 2019, we received U.S. Food and Drug Administration, or FDA, accelerated approval for our first medicine, Oxbryta ® Need for Additional Capital In the course of our development activities, we have sustained operating losses and we expect such losses to continue over the next several years. Our ultimate success depends on the outcome of our commercialization of Oxbryta and research and development activities. Since inception through June 30, 2021, we have incurred cumulative net losses of $1.13 billion. We expect to incur additional losses for the foreseeable future to commercialize Oxbryta and conduct product research and development, and expect to potentially raise additional capital to fully implement our business plan. If needed, we intend to raise such capital through borrowings, the issuance of additional equity, and potentially through strategic alliances with partner companies or other transactions. However, if such financing is not available at adequate levels, we will need to re-evaluate |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation and Presentation of Financial Information The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and, accordingly, the balance sheet as of December 31, 2020, has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of our financial information. The results of operations for the six months ended June 30, 2021, are not necessarily indicative of the results to be expected for the year ending December 31, 2021, or for any other interim period or for any other future year. The accompanying unaudited interim condensed consolidated financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2020, included in our Annual Report on Form 10-K, Use of Estimates The preparation of the accompanying unaudited interim condensed consolidated financial statements in accordance with U.S. GAAP requires us 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 consolidated financial statements, and the reported amounts of variable consideration and costs and expenses during the reporting period. We base our estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results could differ from these estimates under different assumptions or conditions. Concentration of Risk Credit Risk We invest in a variety of financial instruments and, by our Board approved investment policy, limit the amount of credit exposure with any one issuer, industry or geographic area for investments other than instruments backed by the U.S. federal government. Major Customers We have entered into distribution agreements with certain limited specialty pharmacies and specialty distributors. For the six months ended June 30, 2021, our two largest customers represented approximately 85% of our product revenue and approximately 81% of our accounts receivable balance at June 30, 2021. Major Suppliers We do not currently have any of our own manufacturing facilities, and, therefore, depend on an outsourced manufacturing strategy for the production of Oxbryta for commercial use and for the production of our product candidates for clinical trials. We have contracts in place with one third-party manufacturer that is approved for the commercial production of Oxbryta and two third-party suppliers that are approved for Oxbryta’s active pharmaceutical ingredient. Although there are potential sources of supply other than our existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. Significant Accounting Policies Except as noted below, there have been no material revisions in our significant accounting policies described in Note 2 to the consolidated financial statements included in our Annual Report on Form 10-K Accounting Pronouncements Adopted In December 2019, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes 2019-12 No. 2019-12 2019-12 2019-12, In August 2020, FASB issued ASU No. 2020-08, Codification Improvement to Subtopic 310-20, 310-20. 2020-08 No. 2020-08 Accounting Pronouncement Issued But Not Yet Adopted In March 2020, FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) 2020-04 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at f a Assets and liabilities recorded at fair value on a recurring basis in the condensed consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 Level 2 Level 3 The following table summarizes our financial assets measured at fair value on a recurring basis (in thousands): June 30, 2021 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 358,206 $ 358,206 $ — $ — Corporate debt securities 11,272 — 11,272 — U.S. government agency securities 1,800 — 1,800 — U.S. government securities 5,013 — 5,013 — Total financial assets $ 376,291 $ 358,206 $ 18,085 $ — December 31, 2020 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 486,174 $ 486,174 $ — $ — Corporate debt securities 29,804 — 29,804 — U.S. government agency securities 15,943 — 15,943 — Certificates of deposits 243 — 243 — U.S. government securities 20,136 — 20,136 — Total financial assets $ 552,300 $ 486,174 $ 66,126 $ — We estimate the fair values of our investments in corporate debt securities, government and government related securities and certificates of deposits by taking into consideration valuations obtained from third-party pricing services. The fair value of our marketable securities classified within Level 2 is based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided A-1/P-1 |
Available-for-Sale Securities
Available-for-Sale Securities | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-Sale Securities | 4. Available-for-Sale Estimated fair values of available-for-sale available-for-sale June 30,2021 December 31, 2020 Amortized Unrealized Unrealized Estimated Amortized Unrealized Unrealized Estimated Cost Gains (Losses) Value Cost Gains (Losses) Value Financial Assets: Money market funds $ 358,206 $ — $ — $ 358,206 $ 486,174 $ — $ — $ 486,174 Corporate debt securities 11,239 33 — 11,272 29,641 163 — 29,804 U.S. government agency securities 1,800 — — 1,800 15,906 37 — 15,943 Certificates of deposits — — — — 241 2 — 243 U.S. government securities 5,003 10 — 5,013 20,036 100 — 20,136 Total $ 376,248 $ 43 $ — $ 376,291 $ 551,998 $ 302 $ — $ 552,300 The following table summarizes the classification of the available-for-sale June 30, 2021 December 31, 2020 Cash and cash equivalents $ 358,206 $ 486,174 Short-term marketable securities 18,085 66,126 Total $ 376,291 $ 552,300 We do not intend to sell the investments that are in an unrealized loss position, and it is unlikely that we will be required to sell the investments before recovery of their amortized cost basis, which may be maturity. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Inventories Inventories consist of the following (in thousands): June 30, 2021 December 31, 2020 Raw materials $ 9,013 $ 11,273 Work-in-process 36,389 26,994 Finished goods 2,589 1,956 Total inventories $ 47,991 $ 40,223 We have capitalized $408,000 and $557,000 of share-based compensation expense to our inventories for the three months ended June 30, 2021 and 2020, respectively; and $838,000 and $894,000 for the six months ended June 30, 2021 and 2020, respectively. We also have capitalized $45,000 and $141,000 of depreciation expense to our inventories for the three months ended June 30, 2021 and 2020, respectively; and $89,000 and $237,000 for the six months ended June 30, 2021 and 2020, respectively. See Note 8—Share-based Compensation for details on share-based compensation expenses recognized during the three- and six-months Property and Equipment Property and equipment consists of the following (in thousands): June 30, 2021 December 31, 2020 Laboratory equipment $ 13,649 $ 11,922 Computer equipment 3,241 3,023 Leasehold improvements 32,281 32,281 Construction-in-progress 456 517 Total property and equipment 49,627 47,743 Less: accumulated depreciation and amortization (12,852 ) (9,861 ) Property and equipment, net $ 36,775 $ 37,882 Accrued liabilities Accrued liabilities consist of the following (in thousands): June 30, 2021 December 31, 2020 Accrued research and development costs $ 11,976 $ 10,677 Accrued manufacturing costs 13,633 9,125 Accrued professional and consulting services 4,771 4,107 Accrued sales deductions 7,635 6,405 Other 889 819 Total accrued liabilities $ 38,904 $ 31,133 |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Text Block [Abstract] | |
Long-term Debt | 6. Long-term Debt Term Loan On December 17, 2019, we entered into the Loan Agreement, or Term Loan, with funds managed by Pharmakon Advisors LP, which are BioPharma Credit PLC, as collateral agent, Biopharma Credit Investments V (Master) LP, as a lender, and BPCR Limited Partnership, as a lender, and collectively, the Lenders, for a senior secured credit facility consisting of an initial tranche of $75.0 million and the option to draw an additional $75.0 million until December 31, 2020. The first tranche, in the amount of $75.0 million, was funded in connection with the closing date of the Term Loan in December 2019, and the second tranche in the amount of $75.0 million was funded in November 2020. The Term Loan carries a 72-month 3-month We have the option to prepay all or a portion of the borrowed amounts under the Term Loan. If we exercise this option, we must pay a prepayment fee between 1% and 3% of the principal amount being prepaid depending on the timing of the prepayment, or Prepayment Fee. If the prepayment occurs before December 2022, we must also pay an amount equal to the sum of all interest that would have accrued and been payable from date of prepayment through December 2022, or Make Whole Amount. We are obligated to pay an additional fee to the Lenders determined by multiplying the principal amount being paid or prepaid multiplied by 2%, or Paydown Fee, when such payments are made. In the event of default or change in control, all unpaid principal and all accrued and unpaid interest amounts (if any) become immediately due and payable, at which point, we will be subject to the Prepayment Fee, the Make Whole Amount (if any) and the Paydown Fee. Events of default include, but are not limited to, a payment default, a material adverse change, and insolvency. The obligations under the Term Loan are secured by a first priority security interest in and a lien on substantially all of our assets, subject to certain exceptions. Debt issuance costs paid directly to the Lenders of $1.1 million and the other debt issuance costs of $0.5 million were treated as discounts on the Term Loan. These debt discounts along with the Paydown Fee are being amortized or accreted to interest expenses throughout the life of the Term Loan using the effective interest rate method. In addition, we paid the Lenders $1.1 million for the option to draw the additional $75.0 million, which was capitalized as a deferred asset and amortized on a straight-line basis through December 31, 2020. Any remaining unamortized amount was reclassed to debt discount at the time of closing of the second tranche of the Term Loan. We closed the second tranche of the Term Loan in November 2020, and $0.2 million of the unamortized deferred asset related to the option to draw the second tranche was reclassed as the discount on the notes payable. As of June 30, 2021, there were unamortized issuance costs and debt discounts of $1.5 million, which were recorded as a direct deduction from the Term Loan on the condensed consolidated balance sheet. Future payments of principal and interest on the Term Loan as of June 30, 2021 (in thousands): 2021 (six months) $ 6,750 2022 13,500 2023 62,813 2024 58,313 2025 53,813 Total minimum payments 195,189 Less amount representing interest (42,189 ) Less amount representing Paydown Fee (3,000 ) Long-term debt, gross 150,000 Discount on notes payable (1,501 ) Accretion of Paydown Fee 769 Long-term debt $ 149,268 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Leases We have operating leases for our headquarters in South San Francisco, where we have office and research and development laboratory facilities, and equipment. Our leases have remaining lease terms of 1 to 10 years. Most of these leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases include renewal options at our election, with renewal terms that can extend the lease term from 1 to 10 years. These optional periods have not been considered in the determination of the right-of-use Lease costs included in operating expense in the condensed consolidated statement of operations and comprehensive loss in relation to these operating leases were $2.4 million and $3.1 million for the three months ended June 30, 2021, and 2020, respectively ; non-lease Supplemental information related to leases for the period reported is as follows (in thousands, except weighted-average remaining lease term and weighted-average discount rate): Six Months Ended 2021 2020 ROU assets obtained in exchange for new operating lease $ — $ 205 Cash paid for amounts included in the measurement of lease liabilities 5,883 2,590 Weighted-average remaining lease term of operating leases (in years) 8.7 9.7 Weighted-average discount rate of operating leases 8.7 % 8.7 % The majority of our lease costs are driven by our operating lease for our headquarters, where we have office and research and development laboratory facilities. In March 2017, we entered into a noncancelable operating lease, or Original Lease, for approximately 67,185 square feet of space in South San Francisco, California, or Prior Premises. The Original Lease term commenced in November 2017 as we gained control over physical access to the Prior Premises for a 10-year In August 2018, we entered into an amendment to the Original Lease, or Lease Amendment, to relocate the leased premises from the Prior Premises to a to-be-constructed 10-year 10-year After relocating to the Substitute Premises, we surrendered and delivered the Prior Premises to the landlord in May 2020, upon which time we had no further obligations with respect to the Prior Premises other than with respect to the Initial Allowance, which we will repay to the landlord in the form of additional monthly rent with interest applied over the term of the Original Lease through November 2027. Upon signing of the Lease Amendment, we re-evaluated As of June 30, 2021, the maturities of our operating lease liabilities were as follows (in thousands): Year ending December 31, Amount 2021 (six months) $ 5,958 2022 12,222 2023 12,584 2024 12,948 2025 13,368 Thereafter 60,507 Total lease payments 117,587 Less: Imputed interest (35,903 ) Present value of operating lease liabilities $ 81,684 The operating leases require us to share in prorated operating expenses and property taxes based upon actual amounts incurred; those amounts are not fixed for future periods and, therefore, are not included in the future commitments listed above. Contingencies In the ordinary course of business, we may be subject to legal claims and regulatory actions that could have a material adverse effect on our business or financial position. We assess our potential liability in such situations by analyzing potential outcomes, assuming various litigation, regulatory and settlement strategies. If we determine a loss is probable and its amount can be reasonably estimated, we accrue an amount equal to the estimated loss. No losses and no provision for a loss contingency have been recorded to date. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation We have three stock-based compensation plans – the Amended and Restated 2017 Inducement Equity Plan, or 2017 Inducement Plan, the Amended and Restated 2015 Stock Option and Incentive Plan, or 2015 Plan, and the 2012 Stock Option and Grant Plan, or 2012 Plan. As of June 30, 2021, there were 2,006,772 shares reserved under the 2017 Inducement Plan and 4,964,617 shares reserved under the 2015 Plan for the future issuance of equity awards. Upon adoption of the 2015 Plan in July 2015, no new awards or grants are permitted under the 2012 Plan. See Note 10 to the Consolidated Financial Statements included in our Annual Report on Form 10-K Stock Options The following summarizes option activity under the 2017 Inducement Plan, 2015 Plan and 2012 Plan: Number of Weighted- Outstanding — December 31, 2020 3,327,330 $ 42.07 Options granted 658,480 43.57 Options exercised (76,338 ) 19.82 Options canceled (170,068 ) 52.52 Outstanding — June 30, 2021 3,739,404 $ 42.32 The fair values of stock options granted to employees were calculated using the following assumptions: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Expected term (in years) 5.3-6.1 5.1-6.1 5.3-6.1 5.1-6.1 Volatility 68.1%-72.2% 71.0%-71.8% 68.1%-72.7% 69.6%-71.8% Risk-free interest rate 1.0%-1.1% 0.4% 0.9%-1.1% 0.4%-1.8% Dividend yield — — — — Restricted Stock Units The following table summarizes activity of restricted stock units, or RSUs, granted to employees with service-based vesting under the 2017 Inducement Plan and 2015 Plan and related information: Number Weighted- Fair Value Non-vested 2,210,356 $ 57.80 RSUs granted 1,409,417 44.28 RSUs vested (379,635 ) 55.06 RSUs forfeited (302,565 ) 53.34 Non-vested 2,937,573 $ 52.13 Market-Condition Awards Granted to Employees Market-Condition RSU Awards Beginning in June 2020, the Compensation Committee of our Board of Directors has granted awards of RSUs to certain of our senior management, including our executive officers, under the 2015 Plan, the vesting of which is contingent upon the achievement of three escalating stock price targets, which we refer to as the Market-Condition RSU Awards. Since June 1, 2020, certain awards have been forfeited in connection with employee terminations and new awards have been granted in connection with new appointments, respectively, with awards for up to an aggregate of 414,700 RSUs outstanding as of June 30, 2021. Upon the achievement of the respective stock price targets, 50% of the RSUs allotted to that tranche will vest, while the remaining 50% will vest on the first anniversary of the date the stock price target was achieved, subject to the employee’s continued employment or other service relationship with us through such vesting date. Under the terms of the awards, if the stock price targets are not achieved for all or some of the tranches on or before June 30, 2024, the unvested awards will be automatically terminated and forfeited. The compensation cost for the RSUs with a market condition is not reversed when the market condition is not satisfied. Stock Price Targets Number of Units Allowed $ 109.20 82,940 $ 145.60 145,145 $ 182.00 186,615 The grant date fair value of the Market-Condition RSU Awards was estimated using a Monte Carlo simulation model, which includes variables such as the expected volatility of the Company’s share price and interest rates to generate potential future outcomes. We recognize the related compensation expense on a straight-line basis over the applicable derived service periods, which are the estimated periods of time that would be required to satisfy the market conditions. The following table summarizes the Market-Condition RSU Awards granted and forfeited during the six months ended June 30, 2021: Number Weighted- Weighted- Aggregate Non-vested 414,700 $ 49.95 1.21 Granted 42,400 13.80 2.23 Forfeited (42,400 ) 49.95 0.71 Non-vested 414,700 $ 46.26 0.76 $ 14,523 The following table summarizes the assumptions used to estimate the fair value of the Market-Condition RSU Awards as of the grant date: Valuation date stock price $ 37.20 Expected term 3.1 years Volatility 66.6 % Risk-free interest rate 0.3 % Dividend yield — At June 30, 2021, total unrecognized compensation expense related to non-vested The weighted average remaining derived service period is million, respectively, in stock-based compensation expense related to the Market-Condition RSU Awards. Stock-Based Compensation Expense Total stock-based compensation recognized by function included in the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): Three Months Ended Six Months Ended 2021 2020 2021 2020 Research and development $ 4,906 $ 3,430 $ 10,216 $ 8,780 Selling, general and administrative 15,064 13,141 30,134 24,158 Total stock-based compensation expense $ 19,970 $ 16,571 $ 40,350 $ 32,938 |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 9. Net Loss per Share Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period. Since we were in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. The following securities were not included in the diluted net loss per share calculations because their effect was anti-dilutive: Three Months Ended Six Months Ended June 30, 2021 2020 2021 2020 Options to purchase common stock 3,739,404 3,574,452 3,739,404 3,574,452 Restricted stock units 3,352,273 2,866,882 3,352,273 2,866,882 Total 7,091,677 6,441,334 7,091,677 6,441,334 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Preparation and Presentation of Financial Information | Basis of Preparation and Presentation of Financial Information The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and, accordingly, the balance sheet as of December 31, 2020, has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of our financial information. The results of operations for the six months ended June 30, 2021, are not necessarily indicative of the results to be expected for the year ending December 31, 2021, or for any other interim period or for any other future year. The accompanying unaudited interim condensed consolidated financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2020, included in our Annual Report on Form 10-K, |
Use of Estimates | Use of Estimates The preparation of the accompanying unaudited interim condensed consolidated financial statements in accordance with U.S. GAAP requires us 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 consolidated financial statements, and the reported amounts of variable consideration and costs and expenses during the reporting period. We base our estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results could differ from these estimates under different assumptions or conditions. |
Concentration of Risk | Concentration of Risk Credit Risk We invest in a variety of financial instruments and, by our Board approved investment policy, limit the amount of credit exposure with any one issuer, industry or geographic area for investments other than instruments backed by the U.S. federal government. Major Customers We have entered into distribution agreements with certain limited specialty pharmacies and specialty distributors. For the six months ended June 30, 2021, our two largest customers represented approximately 85% of our product revenue and approximately 81% of our accounts receivable balance at June 30, 2021. Major Suppliers We do not currently have any of our own manufacturing facilities, and, therefore, depend on an outsourced manufacturing strategy for the production of Oxbryta for commercial use and for the production of our product candidates for clinical trials. We have contracts in place with one third-party manufacturer that is approved for the commercial production of Oxbryta and two third-party suppliers that are approved for Oxbryta’s active pharmaceutical ingredient. Although there are potential sources of supply other than our existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. |
Principles of Consolidation | Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. |
Significant Accounting Policies | Significant Accounting Policies Except as noted below, there have been no material revisions in our significant accounting policies described in Note 2 to the consolidated financial statements included in our Annual Report on Form 10-K |
Accounting Pronouncements Adopted | Accounting Pronouncements Adopted In December 2019, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes 2019-12 No. 2019-12 2019-12 2019-12, In August 2020, FASB issued ASU No. 2020-08, Codification Improvement to Subtopic 310-20, 310-20. 2020-08 No. 2020-08 |
Accounting Pronouncement Issued But Not Yet Adopted | Accounting Pronouncement Issued But Not Yet Adopted In March 2020, FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) 2020-04 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Assets Measured on Recurring Basis | The following table summarizes our financial assets measured at fair value on a recurring basis (in thousands): June 30, 2021 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 358,206 $ 358,206 $ — $ — Corporate debt securities 11,272 — 11,272 — U.S. government agency securities 1,800 — 1,800 — U.S. government securities 5,013 — 5,013 — Total financial assets $ 376,291 $ 358,206 $ 18,085 $ — December 31, 2020 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 486,174 $ 486,174 $ — $ — Corporate debt securities 29,804 — 29,804 — U.S. government agency securities 15,943 — 15,943 — Certificates of deposits 243 — 243 — U.S. government securities 20,136 — 20,136 — Total financial assets $ 552,300 $ 486,174 $ 66,126 $ — |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Securities | The following table is a summary of available-for-sale June 30,2021 December 31, 2020 Amortized Unrealized Unrealized Estimated Amortized Unrealized Unrealized Estimated Cost Gains (Losses) Value Cost Gains (Losses) Value Financial Assets: Money market funds $ 358,206 $ — $ — $ 358,206 $ 486,174 $ — $ — $ 486,174 Corporate debt securities 11,239 33 — 11,272 29,641 163 — 29,804 U.S. government agency securities 1,800 — — 1,800 15,906 37 — 15,943 Certificates of deposits — — — — 241 2 — 243 U.S. government securities 5,003 10 — 5,013 20,036 100 — 20,136 Total $ 376,248 $ 43 $ — $ 376,291 $ 551,998 $ 302 $ — $ 552,300 |
Summary of Classification of Available-for-Sale Securities on Consolidated Balance Sheets | The following table summarizes the classification of the available-for-sale June 30, 2021 December 31, 2020 Cash and cash equivalents $ 358,206 $ 486,174 Short-term marketable securities 18,085 66,126 Total $ 376,291 $ 552,300 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Inventories | Inventories consist of the following (in thousands): June 30, 2021 December 31, 2020 Raw materials $ 9,013 $ 11,273 Work-in-process 36,389 26,994 Finished goods 2,589 1,956 Total inventories $ 47,991 $ 40,223 |
Property and Equipment, Net | Property and equipment consists of the following (in thousands): June 30, 2021 December 31, 2020 Laboratory equipment $ 13,649 $ 11,922 Computer equipment 3,241 3,023 Leasehold improvements 32,281 32,281 Construction-in-progress 456 517 Total property and equipment 49,627 47,743 Less: accumulated depreciation and amortization (12,852 ) (9,861 ) Property and equipment, net $ 36,775 $ 37,882 |
Accrued Liabilities | Accrued liabilities consist of the following (in thousands): June 30, 2021 December 31, 2020 Accrued research and development costs $ 11,976 $ 10,677 Accrued manufacturing costs 13,633 9,125 Accrued professional and consulting services 4,771 4,107 Accrued sales deductions 7,635 6,405 Other 889 819 Total accrued liabilities $ 38,904 $ 31,133 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Text Block [Abstract] | |
Schedule of Future payments of principal and interest on the Term Loan | Future payments of principal and interest on the Term Loan as of June 30, 2021 (in thousands): 2021 (six months) $ 6,750 2022 13,500 2023 62,813 2024 58,313 2025 53,813 Total minimum payments 195,189 Less amount representing interest (42,189 ) Less amount representing Paydown Fee (3,000 ) Long-term debt, gross 150,000 Discount on notes payable (1,501 ) Accretion of Paydown Fee 769 Long-term debt $ 149,268 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of supplemental information related to leases | Supplemental information related to leases for the period reported is as follows (in thousands, except weighted-average remaining lease term and weighted-average discount rate): Six Months Ended 2021 2020 ROU assets obtained in exchange for new operating lease $ — $ 205 Cash paid for amounts included in the measurement of lease liabilities 5,883 2,590 Weighted-average remaining lease term of operating leases (in years) 8.7 9.7 Weighted-average discount rate of operating leases 8.7 % 8.7 % |
Schedule of Lessee, Operating Lease, Liability, Maturity | As of June 30, 2021, the maturities of our operating lease liabilities were as follows (in thousands): Year ending December 31, Amount 2021 (six months) $ 5,958 2022 12,222 2023 12,584 2024 12,948 2025 13,368 Thereafter 60,507 Total lease payments 117,587 Less: Imputed interest (35,903 ) Present value of operating lease liabilities $ 81,684 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Stock Option Activity | The following summarizes option activity under the 2017 Inducement Plan, 2015 Plan and 2012 Plan: Number of Weighted- Outstanding — December 31, 2020 3,327,330 $ 42.07 Options granted 658,480 43.57 Options exercised (76,338 ) 19.82 Options canceled (170,068 ) 52.52 Outstanding — June 30, 2021 3,739,404 $ 42.32 |
Valuation Assumptions for Stock Awards | The fair values of stock options granted to employees were calculated using the following assumptions: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Expected term (in years) 5.3-6.1 5.1-6.1 5.3-6.1 5.1-6.1 Volatility 68.1%-72.2% 71.0%-71.8% 68.1%-72.7% 69.6%-71.8% Risk-free interest rate 1.0%-1.1% 0.4% 0.9%-1.1% 0.4%-1.8% Dividend yield — — — — |
Stock-based Compensation Expense Recognized | Total stock-based compensation recognized by function included in the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): Three Months Ended Six Months Ended 2021 2020 2021 2020 Research and development $ 4,906 $ 3,430 $ 10,216 $ 8,780 Selling, general and administrative 15,064 13,141 30,134 24,158 Total stock-based compensation expense $ 19,970 $ 16,571 $ 40,350 $ 32,938 |
Summary of Share-based Compensation Arrangements by Share-based Payment Award | The target prices and vesting tranches are set forth in the table below: Stock Price Targets Number of Units Allowed $ 109.20 82,940 $ 145.60 145,145 $ 182.00 186,615 |
Restricted Stock Units [Member] | |
Non-Vested Restricted Stock Activity | The following table summarizes activity of restricted stock units, or RSUs, granted to employees with service-based vesting under the 2017 Inducement Plan and 2015 Plan and related information: Number Weighted- Fair Value Non-vested 2,210,356 $ 57.80 RSUs granted 1,409,417 44.28 RSUs vested (379,635 ) 55.06 RSUs forfeited (302,565 ) 53.34 Non-vested 2,937,573 $ 52.13 |
Market Condition Awards Granted to Employees [Member] | |
Summary of Activity of Market-Condition Awards | The following table summarizes the Market-Condition RSU Awards granted and forfeited during the six months ended June 30, 2021: Number Weighted- Weighted- Aggregate Non-vested 414,700 $ 49.95 1.21 Granted 42,400 13.80 2.23 Forfeited (42,400 ) 49.95 0.71 Non-vested 414,700 $ 46.26 0.76 $ 14,523 |
Valuation Assumptions of Market-Condition Awards | The following table summarizes the assumptions used to estimate the fair value of the Market-Condition RSU Awards as of the grant date: Valuation date stock price $ 37.20 Expected term 3.1 years Volatility 66.6 % Risk-free interest rate 0.3 % Dividend yield — |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Potentially Dilutive Securities that were Not Included in Diluted Net Loss per Share Calculations | The following securities were not included in the diluted net loss per share calculations because their effect was anti-dilutive: Three Months Ended Six Months Ended June 30, 2021 2020 2021 2020 Options to purchase common stock 3,739,404 3,574,452 3,739,404 3,574,452 Restricted stock units 3,352,273 2,866,882 3,352,273 2,866,882 Total 7,091,677 6,441,334 7,091,677 6,441,334 |
Organization and Basis of Prese
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||
Cumulative net losses | $ (1,130,991) | $ (986,469) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - Customer Concentration Risk [Member] - Two Major Customers [Member] | 6 Months Ended |
Jun. 30, 2021 | |
Revenue, Product and Service Benchmark [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 85.00% |
Accounts Receivable [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 81.00% |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Assets Measured on Recurring Basis (Detail) - Fair Value Measurements, Recurring [Member] - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | $ 376,291 | $ 552,300 |
U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 5,013 | 20,136 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 358,206 | 486,174 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 18,085 | 66,126 |
Level 2 [Member] | U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 5,013 | 20,136 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 358,206 | 486,174 |
Money Market Funds [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 358,206 | 486,174 |
Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 11,272 | 29,804 |
Corporate Debt Securities [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 11,272 | 29,804 |
U.S. Government Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 1,800 | 15,943 |
U.S. Government Agency Securities [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | $ 1,800 | 15,943 |
Certificates of Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 243 | |
Certificates of Deposits [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | $ 243 |
Available-for-Sale Securities -
Available-for-Sale Securities - Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | $ 376,248 | $ 551,998 |
Available for sale securities, Unrealized Gains | 43 | 302 |
Available for sale securities, Estimated Fair Value | 376,291 | 552,300 |
Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 11,239 | 29,641 |
Available for sale securities, Unrealized Gains | 33 | 163 |
Available for sale securities, Estimated Fair Value | 11,272 | 29,804 |
U.S. Government Agency Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 1,800 | 15,906 |
Available for sale securities, Unrealized Gains | 37 | |
Available for sale securities, Estimated Fair Value | 1,800 | 15,943 |
Money Market Funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 358,206 | 486,174 |
Available for sale securities, Estimated Fair Value | 358,206 | 486,174 |
Certificates of Deposits [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 241 | |
Available for sale securities, Unrealized Gains | 2 | |
Available for sale securities, Estimated Fair Value | 243 | |
U.S. Government Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 5,003 | 20,036 |
Available for sale securities, Unrealized Gains | 10 | 100 |
Available for sale securities, Estimated Fair Value | $ 5,013 | $ 20,136 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Summary of Classification of Available-for-Sale Securities on Consolidated Balance Sheets (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Cash and cash equivalents | $ 358,206 | $ 486,174 |
Short-term marketable securities | 18,085 | 66,126 |
Total | $ 376,291 | $ 552,300 |
Balance Sheet Components - Inve
Balance Sheet Components - Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
Raw materials | $ 9,013 | $ 11,273 |
Work-in-process | 36,389 | 26,994 |
Finished goods | 2,589 | 1,956 |
Total inventories | $ 47,991 | $ 40,223 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 49,627 | $ 47,743 |
Less: accumulated depreciation and amortization | (12,852) | (9,861) |
Property and equipment, net | 36,775 | 37,882 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 13,649 | 11,922 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 3,241 | 3,023 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 32,281 | 32,281 |
Construction-in-Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 456 | $ 517 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Balance Sheet Components [Abstract] | ||||
Share based compensation expense capitalized | $ 408,000 | $ 557,000 | $ 838,000 | $ 894,000 |
Capitalized depreciation expenses | $ 45,000 | $ 141,000 | $ 89,000 | $ 237,000 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
Accrued research and development costs | $ 11,976 | $ 10,677 |
Accrued manufacturing costs | 13,633 | 9,125 |
Accrued professional and consulting services | 4,771 | 4,107 |
Accrued sales deductions | 7,635 | 6,405 |
Other | 889 | 819 |
Total accrued liabilities | $ 38,904 | $ 31,133 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | |||||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Nov. 30, 2020 | Dec. 31, 2019 | Dec. 17, 2019 | |
Long term debt | $ 149,268 | $ 148,815 | ||||
Debt issuance costs paid | $ 49 | $ 130 | ||||
Unamortized dedt discount | $ 200 | |||||
Term Loan | ||||||
Debt additional borrowing capacity | 75,000 | |||||
Debt Instrument, Term | 72 months | |||||
Debt Instrument, Basis Spread on Variable Rate | 7.00% | |||||
Long-term Debt, Percentage Bearing Variable Interest, Percentage Rate | 2.00% | |||||
Debt Instrument Additional Interest Rate On Debt Default | 3.00% | |||||
Debt Instrument Periodic Payment Of Interest | Interest on amounts outstanding are payable quarterly in arrears | |||||
Debt Instrument Periodic Payment Of Interest Term | 39 months | |||||
Debt additional paydown fee | 2.00% | |||||
Debt issuance costs paid | $ 1,100 | |||||
Other debt issuance cost paid | 500 | |||||
Unamortized issuance costs and debt discounts | 1,500 | |||||
Debt additional paydown fee | $ 1,100 | |||||
Term Loan | Maximum | ||||||
Debt prepayment fee | 3.00% | |||||
Term Loan | Minimum | ||||||
Debt prepayment fee | 1.00% | |||||
Secured Debt | ||||||
Debt maximum borrowing capacity | $ 75,000 | |||||
Debt additional borrowing capacity | $ 75,000 | |||||
Long term debt | $ 75,000 | $ 75,000 |
Long-term Debt-Schedule of Futu
Long-term Debt-Schedule of Future payments of principal and interest on the Term Loan (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
2021 (six months) | $ 6,750 | |
2022 | 13,500 | |
2023 | 62,813 | |
2024 | 58,313 | |
2025 | 53,813 | |
Total minimum payments | 195,189 | |
Less amount representing interest | (42,189) | |
Less amount representing Paydown Fee | (3,000) | |
Long-term debt, gross | 150,000 | |
Discount on notes payable | (1,501) | |
Accretion of Paydown Fee | 769 | |
Long-term debt | $ 149,268 | $ 148,815 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Aug. 31, 2018USD ($)ft² | Mar. 31, 2017ft² | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | |
Commitment And Contingencies [Line Items] | ||||||
Facility size | ft² | 164,150 | 67,185 | ||||
Initial term | 10 years | |||||
Future minimum rental payments under the Lease term | $ 121,500,000 | |||||
Operating lease term | 10 years | |||||
Operating lease term, optional extension | 10 years | |||||
Repayment of tenant inducement allowance | $ 4,100,000 | |||||
Contingency losses | $ 0 | |||||
Provisions for loss contingency | 0 | |||||
Operating Lease Cost | $ 2,400,000 | $ 3,100,000 | 5,600,000 | $ 6,200,000 | ||
variable lease cost | 1,200,000 | 600,000 | 2,000,000 | 1,300,000 | ||
Acceleration of depreciation expenses | $ 0 | $ 0 | ||||
Maximum [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Operating lease remaining lease term | 10 years | |||||
Minimum [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Operating lease remaining lease term | 1 year | |||||
Leasehold Improvements [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Property palnt and equipment additions | $ 32,300,000 | |||||
Depreciation expense | $ 1,900,000 | $ 3,800,000 | ||||
Lease Agreements [Member] | Maximum [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Tenant inducement | $ 27,900,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Supplemental cash flow information (Detail) - Accounting Standards Update 2016-02 [Member] - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Commitment And Contingencies [Line Items] | ||
ROU assets obtained in exchange for new operating lease | $ 205 | |
Cash paid for amounts included in the measurement of lease liabilities | $ 5,883 | $ 2,590 |
Weighted-average remaining lease term of operating leases (in years) | 8 years 8 months 12 days | 9 years 8 months 12 days |
Weighted-average discount rate of operating leases | 8.70% | 8.70% |
Commitments and Contingencies_3
Commitments and Contingencies - Lessee Operating Lease Liability Maturity (Detail) $ in Thousands | Jun. 30, 2021USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2021 (six months) | $ 5,958 |
2022 | 12,222 |
2023 | 12,584 |
2024 | 12,948 |
2025 | 13,368 |
Thereafter | 60,507 |
Total lease payments | 117,587 |
Less: Imputed interest | (35,903) |
Present value of operating lease liabilities | $ 81,684 |
Stock-Based Compensation - Plan
Stock-Based Compensation - Plan Summary - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average derived service period | 9 months 3 days | |||
Stock-based compensation | $ 41,184 | $ 32,938 | ||
Market Condition Awards Granted to Employees [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation expense | $ 7,100 | 7,100 | ||
Stock-based compensation | $ 1,500 | $ 4,600 | ||
2017 Inducement Equity Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares authorized for issuance | 2,006,772 | 2,006,772 | ||
2015 Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares authorized for issuance | 4,964,617 | 4,964,617 | ||
2015 Plan [Member] | Market Condition Awards Granted to Employees [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares Non-vested period | 414,700 | 414,700 | 414,700 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Detail) | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |
Beginning balance, outstanding, Number of Options | shares | 3,327,330 |
Options granted, Number of Options | shares | 658,480 |
Options exercised, Number of Options | shares | (76,338) |
Options canceled, Number of Options | shares | (170,068) |
Ending balance, outstanding, Number of Options | shares | 3,739,404 |
Weighted- Average Exercise Price | |
Beginning balance, Outstanding, Weighted-Average Exercise Price | $ / shares | $ 42.07 |
Options granted, Weighted-Average Exercise Price | $ / shares | 43.57 |
Options exercised, Weighted-Average Exercise Price | $ / shares | 19.82 |
Options canceled, Weighted-Average Exercise Price | $ / shares | 52.52 |
Ending balance, Outstanding, Weighted-Average Exercise Price | $ / shares | $ 42.32 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation Assumptions for Stock Options Granted (Detail) - Stock Options [Member] | 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] | ||||
Volatility, minimum | 68.10% | 71.00% | 68.10% | 69.60% |
Volatility, maximum | 72.20% | 71.80% | 72.70% | 71.80% |
Risk-free interest rate, minimum | 1.00% | 0.90% | 0.40% | |
Risk-free interest rate, maximum | 1.10% | 1.10% | 1.80% | |
Risk-free interest rate | 0.40% | |||
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 3 months 18 days | 5 years 1 month 6 days | 5 years 3 months 18 days | 5 years 1 month 6 days |
Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of RSU Activity Granted to Employees with Service-Based Vesting (Detail) - 2017 Inducement Plan and 2015 Plan [Member] - RSU [Member] | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Beginning Balance - Non-vested market-condition awards | shares | 2,210,356 |
RSUs granted, Number of RSUs | shares | 1,409,417 |
RSUs vested, Number of RSUs | shares | (379,635) |
RSUs forfeited, Number of RSUs | shares | (302,565) |
Ending Balance - Non-vested market-condition awards | shares | 2,937,573 |
Beginning Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ / shares | $ 57.80 |
RSUs granted, Weighted-Average Grant Date Fair Value | $ / shares | 44.28 |
RSUs vested, Weighted-Average Grant Date Fair Value | $ / shares | 55.06 |
RSUs forfeited, Weighted-Average Grant Date Fair Value | $ / shares | 53.34 |
Ending Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ / shares | $ 52.13 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Share-based Compensation Arrangements by Share-based Payment Award (Detail) - Market-Condition RSU Awards [Member] | Jun. 30, 2021$ / sharesshares |
Tranche One [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock Price Targets | $ / shares | $ 109.20 |
Number of Units Allowed | shares | 82,940 |
Tranche Two [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock Price Targets | $ / shares | $ 145.60 |
Number of Units Allowed | shares | 145,145 |
Tranche Three [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock Price Targets | $ / shares | $ 182 |
Number of Units Allowed | shares | 186,615 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Activity of Market-Condition Awards (Detail) - Market Condition Awards Granted to Employees [Member] - 2015 Plan [Member] - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Beginning Balance - Non-vested market-condition awards | 414,700 | |
Number of Units granted | 42,400 | |
Number of Units forfeited | (42,400) | |
Ending Balance - Non-vested market-condition awards | 414,700 | 414,700 |
Beginning Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ 49.95 | |
Weighted-Average Grant Date Fair Value granted | 13.80 | |
Weighted-Average Grant Date Fair Value forfeited | 49.95 | |
Ending Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ 46.26 | $ 49.95 |
Non-vested units, Weighted-Average remaining vesting period(years) | 9 months 3 days | 1 year 2 months 15 days |
Non-vested units, Weighted-Average remaining vesting period (years) granted | 2 years 2 months 23 days | |
Non-vested units, Weighted-Average remaining vesting period (years) forfeited | 8 months 15 days | |
Non-vested units, Aggregate Intrinsic Value | $ 14,523 |
Stock-Based Compensation - Va_2
Stock-Based Compensation - Valuation Assumptions of Market-Condition Awards (Detail) - Market Condition Awards Granted To Employees [Member] | 6 Months Ended |
Jun. 30, 2021$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Valuation date stock price | $ 37.20 |
Expected term | 3 years 1 month 6 days |
Volatility | 66.60% |
Risk-free interest rate | 0.30% |
Dividend yield | 0.00% |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock-Based Compensation Expense Recognized (Detail) - 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, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 19,970 | $ 16,571 | $ 40,350 | $ 32,938 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 4,906 | 3,430 | 10,216 | 8,780 |
Selling, general and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 15,064 | $ 13,141 | $ 30,134 | $ 24,158 |
Net Loss per Share - Potentiall
Net Loss per Share - Potentially Dilutive Securities that were Not Included in Diluted Net Loss per Share Calculations (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 7,091,677 | 6,441,334 | 7,091,677 | 6,441,334 |
Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 3,739,404 | 3,574,452 | 3,739,404 | 3,574,452 |
RSU [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 3,352,273 | 2,866,882 | 3,352,273 | 2,866,882 |