Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2020 | |
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 | 61,360,776 | |
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 | 2020 | |
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, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 384,716 | $ 302,237 |
Short-term marketable securities | 156,014 | 307,732 |
Accounts receivable, net | 12,471 | 2,637 |
Inventories | 27,334 | 1,277 |
Prepaid expenses and other current assets | 13,498 | 14,114 |
Total current assets | 594,033 | 627,997 |
Property and equipment, net | 39,668 | 27,113 |
Long-term marketable securities | 33,479 | 85,030 |
Operating lease right-of-use assets | 51,580 | 52,775 |
Restricted cash | 2,395 | 2,395 |
Other assets, noncurrent | 512 | 789 |
Total assets | 721,667 | 796,099 |
Current liabilities: | ||
Accounts payable | 5,690 | 10,621 |
Accrued liabilities | 43,733 | 41,358 |
Accrued compensation | 16,463 | 17,578 |
Other liabilities, current | 3,516 | 1,896 |
Total current liabilities | 69,402 | 71,453 |
Long-term debt | 73,775 | 73,559 |
Operating lease liabilities, noncurrent | 81,903 | 72,359 |
Other liabilities, noncurrent | 771 | 34 |
Total liabilities | 225,851 | 217,405 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of June 30, 2020 (unaudited) and December 31, 2019; no shares issued and outstanding | ||
Common stock, $0.001 par value, 150,000,000 shares authorized as of June 30, 2020 (unaudited) and December 31, 2019, respectively; 61,330,987 and 60,644,380 shares issued and outstanding as of June 30, 2020 (unaudited) and December 31, 2019, respectively | 61 | 61 |
Additional paid-in capital | 1,359,310 | 1,316,795 |
Accumulated other comprehensive income | 1,227 | 754 |
Accumulated deficit | (864,782) | (738,916) |
Total stockholders' equity | 495,816 | 578,694 |
Total liabilities and stockholders' equity | $ 721,667 | $ 796,099 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
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 | 61,330,987 | 60,644,380 |
Common stock, shares outstanding | 61,330,987 | 60,644,380 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues [Abstract] | ||||
Product sales, net | $ 31,501 | $ 45,619 | ||
Costs and operating expenses: | ||||
Cost of sales | 377 | 512 | ||
Research and development | 34,085 | $ 36,010 | 73,858 | $ 70,476 |
Selling, general and administrative | 49,075 | 24,794 | 96,736 | 42,849 |
Total costs and operating expenses | 83,537 | 60,804 | 171,106 | 113,325 |
Loss from operations | (52,036) | (60,804) | (125,487) | (113,325) |
Other income (expense): | ||||
Interest income | 1,514 | 3,706 | 4,370 | 7,537 |
Interest expense | (2,282) | (160) | (4,596) | (341) |
Other expenses, net | (36) | (63) | (153) | (115) |
Total other income (loss), net | (804) | 3,483 | (379) | 7,081 |
Net loss | (52,840) | (57,321) | (125,866) | (106,244) |
Other comprehensive loss: | ||||
Net unrealized gain on marketable securities, net of tax | 12 | 615 | 472 | 1,239 |
Comprehensive loss | $ (52,828) | $ (56,706) | $ (125,394) | $ (105,005) |
Basic and diluted net loss per common share | $ (0.86) | $ (1.01) | $ (2.06) | $ (1.88) |
Weighted-average number of shares used in computing basic and diluted net loss per common share | 61,116,707 | 56,539,760 | 60,952,269 | 56,386,560 |
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 (Loss) [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2018 | $ 572,799 | $ 56 | $ 1,044,941 | $ (48) | $ (472,150) |
Beginning Balance, Shares at Dec. 31, 2018 | 55,640,299 | ||||
Issuance of common stock upon equity offerings, net of issuance costs | 21,246 | 21,246 | |||
Issuance of common stock upon equity offerings, net of issuance costs, Shares | 511,363 | ||||
Issuance of common stock upon exercise of stock options | 817 | 817 | |||
Issuance of common stock upon exercise of stock options, Shares | 52,288 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (686) | (686) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 78,155 | ||||
Issuance of common stock pursuant to ESPP purchases | 1,128 | 1,128 | |||
Issuance of common stock pursuant to ESPP purchases, Shares | 30,745 | ||||
Vesting of restricted stock purchases | 80 | 80 | |||
Vesting of restricted stock purchases, Shares | 24,195 | ||||
Stock-based compensation expense | 9,453 | 9,453 | |||
Net unrealized gain on marketable securities | 624 | 624 | |||
Net loss | (48,923) | (48,923) | |||
Ending Balance at Mar. 31, 2019 | 556,538 | $ 56 | 1,076,979 | 576 | (521,073) |
Ending Balance, Shares at Mar. 31, 2019 | 56,337,045 | ||||
Beginning Balance at Dec. 31, 2018 | 572,799 | $ 56 | 1,044,941 | (48) | (472,150) |
Beginning Balance, Shares at Dec. 31, 2018 | 55,640,299 | ||||
Net loss | (106,244) | ||||
Ending Balance at Jun. 30, 2019 | 704,190 | $ 60 | 1,281,333 | 1,191 | (578,394) |
Ending Balance, Shares at Jun. 30, 2019 | 59,906,199 | ||||
Beginning Balance at Mar. 31, 2019 | 556,538 | $ 56 | 1,076,979 | 576 | (521,073) |
Beginning Balance, Shares at Mar. 31, 2019 | 56,337,045 | ||||
Issuance of common stock upon equity offerings, net of issuance costs | 192,297 | $ 3 | 192,294 | ||
Issuance of common stock upon equity offerings, net of issuance costs, Shares | 3,375,527 | ||||
Issuance of common stock upon exercise of stock options | 2,332 | $ 1 | 2,331 | ||
Issuance of common stock upon exercise of stock options, Shares | 123,513 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (1,297) | (1,297) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 47,258 | ||||
Vesting of restricted stock purchases | 78 | 78 | |||
Vesting of restricted stock purchases, Shares | 22,856 | ||||
Stock-based compensation expense | 10,948 | 10,948 | |||
Net unrealized gain on marketable securities | 615 | 615 | |||
Net loss | (57,321) | (57,321) | |||
Ending Balance at Jun. 30, 2019 | 704,190 | $ 60 | 1,281,333 | 1,191 | (578,394) |
Ending Balance, Shares at Jun. 30, 2019 | 59,906,199 | ||||
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 expense | 16,705 | 16,705 | |||
Net unrealized gain 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 | ||||
Issuance of common stock upon exercise of stock options, Shares | 368,391 | ||||
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 expense | 17,128 | 17,128 | |||
Net unrealized gain on marketable securities | 12 | 12 | |||
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 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (125,866) | $ (106,244) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 5,577 | 4,187 |
Amortization (accretion) of premium (discount) on marketable securities | (61) | (1,204) |
Non-cash interest expense | 824 | |
Amortization of operating lease right-of-use assets | 580 | 212 |
Stock-based compensation | 32,938 | 20,401 |
Changes in operating assets and liabilities: | ||
Accounts receivables | (9,834) | |
Inventories | (24,926) | |
Prepaid expenses and other assets | 181 | 59 |
Accounts payable | (4,918) | 558 |
Accrued liabilities | (1,326) | 6,136 |
Accrued compensation | (1,114) | (1,795) |
Other liabilities, current | 156 | |
Operating lease liabilities | 1,686 | (563) |
Net cash used in operating activities | (126,103) | (78,253) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (3,918) | (548) |
Purchase of marketable securities | (57,936) | (195,297) |
Maturities of marketable securities | 261,738 | 120,923 |
Net cash provided by (used in) investing activities | 199,884 | (74,922) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock in public offering, net of issuance costs | 213,989 | |
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options | 11,000 | 4,266 |
Payments of debt issuance costs | (130) | |
Tax paid related to net share settlement of equity awards | (2,172) | (1,983) |
Net cash provided by financing activities | 8,698 | 216,272 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 82,479 | 63,097 |
Cash, cash equivalents and restricted cash at beginning of period | 304,632 | 277,752 |
Cash, cash equivalents and restricted cash at end of period | 387,111 | 340,849 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 3,419 | |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | ||
Leasehold improvements paid for by landlord | 10,709 | 851 |
Accrued purchase of property and equipment | 3,773 | 147 |
Accrued issuance costs | $ (85) | $ 446 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation 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 commercial launch of Oxbryta, research and development and business development activities. Since inception through June 30, 2020, we have incurred cumulative net losses of $864.8 million. 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, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation 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, 2019 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, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 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, 2019 included in our Annual Report on Form 10-K, Use of Estimates The preparation of the accompanying 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 revenues 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 a specialty distributor. For the six months ended June 30, 2020, our two largest customers represented approximately 95% of our product revenue and approximately 94% of our accounts receivable balance at June 30, 2020. 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 one third-party supplier that is 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 August 2018, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2018-15, Intangibles—Goodwill and Other—Internal-Use 350-40), Arrangement That Is a Service Contract 2018-15. No. 2018-15 internal-use 350-40 No. 2018-15 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) No. 2018-13 No. 2018-13. No. 2018-13 In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326) Available-for-sale available-for-sale No. 2016-13 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2020 | |
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 fair value in the consolidated financial statements on a recurring basis (at least annually). Our financial instruments consist of cash and cash equivalents, marketable securities, accounts receivables, accounts payable and accrued liabilities. Cash and cash equivalents, marketable securities and restricted cash are reported at their respective fair values on our condensed consolidated balance sheets. The remaining financial instruments are reported on our condensed consolidated balance sheets at cost that approximate current fair values due to their relatively short maturities. 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 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 – Level 3 – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. The following table summarizes our financial assets measured at fair value on a recurring basis (in thousands): June 30, 2020 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 384,515 $ 384,515 $ — $ — Corporate debt securities 84,046 — 84,046 — U.S. government agency securities 43,524 — 43,524 — Certificates of deposits 3,899 — 3,899 — U.S. government securities 58,025 — 58,025 — Total financial assets $ 574,009 $ 384,515 $ 189,494 $ — December 31, 2019 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 250,535 $ 250,535 $ — $ — Corporate debt securities 152,149 — 152,149 — U.S. government agency securities 95,032 — 95,032 — Certificates of deposits 6,282 — 6,282 — U.S. government securities 140,244 — 140,244 — Total financial assets $ 644,242 $ 250,535 $ 393,707 $ — 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, 2020 | |
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, 2020 December 31, 2019 Amortized Unrealized Unrealized Estimated Fair Amortized Unrealized Unrealized Estimated Fair Financial Assets: Money market funds $ 384,515 $ — $ — $ 384,515 $ 250,535 $ — $ — $ 250,535 Corporate debt securities 83,385 661 — 84,046 151,773 384 (8 ) 152,149 U.S. government agency securities 43,418 108 (2 ) 43,524 94,963 73 (4 ) 95,032 Certificates of deposits 3,868 31 — 3,899 6,239 43 — 6,282 U.S. government securities 57,596 429 — 58,025 139,978 266 — 140,244 Total $ 572,782 $ 1,229 $ (2 ) $ 574,009 $ 643,488 $ 766 $ (12 ) $ 644,242 The following table summarizes the classification of the available-for-sale June 30, 2020 December 31, 2019 Cash and cash equivalents $ 384,516 $ 251,480 Short-term marketable securities 156,014 307,732 Long-term marketable securities 33,479 85,030 Total $ 574,009 $ 644,242 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. We have determined that the gross unrealized losses on our marketable securities were temporary in nature during the periods presented. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Inventories We began capitalizing inventories in November 2019 once the FDA approved Oxbryta. Inventories consist of the following (in thousands): June 30, 2020 December 31, 2019 Raw materials $ 10,210 $ 700 Work-in-process 15,617 525 Finished goods 1,507 52 Total inventories $ 27,334 $ 1,277 Property and Equipment, Net Property and equipment consists of the following June 30, 2020 December 31, 2019 Laboratory equipment $ 11,612 $ 8,314 Computer equipment 2,600 2,224 Leasehold improvements 32,231 13,785 Construction-in-progress 515 19,289 Total property and equipment 46,958 43,612 Less: accumulated depreciation and amortization (7,290 ) (16,499 ) Property and equipment, net $ 39,668 $ 27,113 Accrued liabilities Accrued liabilities consist of the following (in thousands): June 30, 2020 December 31, 2019 Accrued research and development costs $ 6,951 $ 26,480 Accrued manufacturing costs 23,782 9,466 Accrued professional and consulting services 3,283 4,564 Accrued sales deductions 5,302 529 Other 4,415 319 Total accrued liabilities $ 43,733 $ 41,358 Other liabilities, current Other liabilities consist of the following (in thousands): June 30, 2020 December 31, 2019 Operating lease liabilities, current $ 3,486 $ 1,866 Other payable 30 30 Total other liabilities, current $ 3,516 $ 1,896 |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2020 | |
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. In June 2020, in accordance with the terms of the Loan Agreement, we provided notification to Lenders of our intention to draw the second tranche of the Term Loan, in the amount of $75.0 million, prior to December 31, 2020, subject to certain closing conditions. As of June 30, 2020, the second tranche of the Term Loan has not been drawn. The Term Loan carries a 72-month annum 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 $0.4 million were accounted for 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. As of June 30, 2020, there were unamortized issuance costs and debt discounts of $1.4 million, which were recorded as a direct deduction from the Term Loan on the condensed consolidated balance sheet. In addition, we paid the Lenders $1.1 million for the option to draw the additional $75 million, which was capitalized as a deferred asset and which is included in other assets, current and amortized on a straight-line basis through December 31, 2020. As of June 30, 2020, the unamortized fee for the option to draw the additional funds was $0.6 million. Future payments of principal and interest on the Term Loan as of June 30, 2020 were as follows (in thousands): Year ending December 31, Amount 2020 (six months) $ 3,375 2021 6,750 2022 6,750 2023 31,406 2024 29,156 2025 26,906 Total minimum payments 104,343 Less amount representing interest (27,843 ) Less amount representing Paydown Fee (1,500 ) Long-term debt, gross 75,000 Discount on notes payable (1,411 ) Accretion of Paydown Fee 186 Long-term debt $ 73,775 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Leases We have operating leases for our headquarters, 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 expenses in the consolidated statement of operations in relation to these operating leases were $3.1 million and $1.4 million for the three months ended June 30, 2020 and 2019, respectively; and $6.2 million and $3.3 million for the six months ended June 30, 2020 and 2019, respectively. Included in these lease costs were variable lease costs, which were not included within the measurement of our operating ROU assets and operating lease liabilities in the amount of $0.6 million and $0.4 million for the three months ended June 30, 2020 and 2019, respectively; and $1.3 million and $1.3 million for the six months ended June 30, 2020 and 2019, respectively. The variable lease cost is comprised primarily of our proportionate share of operating expenses, property taxes, and insurance in relation with our facility lease. These costs are classified as operating lease expense due to our election to not separate lease and non-lease components. Supplemental cash flow 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 June 30, 2020 2019 ROU assets obtained in exchange for new operating lease $ 205 $ 14,177 Cash paid for amounts included in the measurement of lease liabilities 2,590 2,235 Weighted-average remaining lease term of operating leases (in years) 9.7 8.4 Weighted-average discount rate of operating leases 8.7 % 13.2 % The majority of our lease costs are driven by our operating lease for our headquarters in South San Francisco, 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. We acquired $11.1 million of leasehold improvements at the Prior Premises with the tenant inducement allowance provided under the Original Lease. We are required to repay $1.7 million of the tenant inducement allowance , or Initial Allowance, to the landlord in the form of additional monthly rent with interest applied over the term of the Original Lease. In August 2018, we entered into an amendment to the Original to-be-constructed 10-year 10-year We vacated the Prior Premises and 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 As of June 30, 2020, the maturities of our operating lease liabilities were as follows (in thousands): Year ending December 31, Amount 2020 ( six $ 4,837 2021 11,822 2022 12,202 2023 12,564 2024 12,927 2025 13,347 Thereafter 61,146 Total lease payments 128,845 Less: Imputed interest (43,456 ) Present value of operating lease liabilities $ 85,389 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, 2020 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation | 8. Stock-Based Compensation We have three stock-based compensation plans – Amended and Restated 10-K Stock Options The following summarizes option activity under the 2017 Inducement Plan, 2015 Plan and 2012 Plan: Number of Weighted- Outstanding 3,573,860 $ 36.24 Options granted 666,633 65.91 Options exercised (368,391 ) 24.39 Options canceled (297,650 ) 52.93 Outstanding 3,574,452 $ 41.61 The fair values of stock options granted to employees were calculated using the following assumptions: Three Months Ended Six Months Ended 2020 2019 2020 2019 Expected term (in years) 5.1-6.1 5.3-6.1 5.1-6.1 5.3-6.1 Volatility 71.0%-71.8% 70.5%-71.7% 69.6%-71.8% 70.5%-72.2% Risk-free interest rate 0.4% 1.8%-2.4% 0.4%-1.8% 1.8%-2.6% 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- Non-vested 1,848,772 $ 49.19 RSUs granted 1,183,637 66.28 RSUs vested (304,495 ) 48.25 RSUs forfeited (275,732 ) 54.75 Non-vested 2,452,182 $ 56.93 Market-Condition RSUs Granted to Employees The Compensation Committee of granted, effective June 1, 2020, an aggregate 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. Upon the achievement of the respective stock price targets, fifty percent of the RSUs allotted to that tranche will vest, while the remaining fifty percent 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 the Company 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. The target prices and vesting tranches are set forth in the table below: Stock Price Targets Number of Units Allotted $109.20 82,940 $145.60 145,145 $182.00 186,615 The grant date fair value of the market-condition 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 activity of the market-condition awards under the 2015 Plan and related information (in thousands, except share, per share amounts and vesting period): Number U Weighted- Weighted- Aggregate Non-vested — $ — — Granted 414,700 49.95 Vested — — Forfeited — — Non-vested 414,700 $ 49.95 1.71 $ 26,180 The following table summarizes the assumptions used to estimate the fair value of the market-condition awards as of the grant date Valuation date stock price $ 68.67 Volatility 68.1 % Risk-free interest rate 0.26 % Dividend yield — At June 30, 2020 , non-vested three months 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 2020 2019 2020 2019 Research and development $ 3,430 $ 4,715 $ 8,780 $ 8,738 Selling, general and administrative 13,141 6,233 24,158 11,663 Total stock-based compensation expense $ 16,571 $ 10,948 $ 32,938 $ 20,401 |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2020 | |
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 2020 2019 2020 2019 Options to purchase common stock 3,574,452 3,758,846 3,574,452 3,758,846 Restricted stock units 2,866,882 1,730,348 2,866,882 1,730,348 Total 6,441,334 5,489,194 6,441,334 5,489,194 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Preparation 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, 2019 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, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 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, 2019 included in our Annual Report on Form 10-K, |
Use of Estimates | Use of Estimates The preparation of the accompanying 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 revenues 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 a specialty distributor. For the six months ended June 30, 2020, our two largest customers represented approximately 95% of our product revenue and approximately 94% of our accounts receivable balance at June 30, 2020. 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 one third-party supplier that is 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 August 2018, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2018-15, Intangibles—Goodwill and Other—Internal-Use 350-40), Arrangement That Is a Service Contract 2018-15. No. 2018-15 internal-use 350-40 No. 2018-15 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) No. 2018-13 No. 2018-13. No. 2018-13 In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326) Available-for-sale available-for-sale No. 2016-13 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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, 2020 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 384,515 $ 384,515 $ — $ — Corporate debt securities 84,046 — 84,046 — U.S. government agency securities 43,524 — 43,524 — Certificates of deposits 3,899 — 3,899 — U.S. government securities 58,025 — 58,025 — Total financial assets $ 574,009 $ 384,515 $ 189,494 $ — December 31, 2019 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 250,535 $ 250,535 $ — $ — Corporate debt securities 152,149 — 152,149 — U.S. government agency securities 95,032 — 95,032 — Certificates of deposits 6,282 — 6,282 — U.S. government securities 140,244 — 140,244 — Total financial assets $ 644,242 $ 250,535 $ 393,707 $ — |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Securities | The following table is a summary of available-for-sale June 30, 2020 December 31, 2019 Amortized Unrealized Unrealized Estimated Fair Amortized Unrealized Unrealized Estimated Fair Financial Assets: Money market funds $ 384,515 $ — $ — $ 384,515 $ 250,535 $ — $ — $ 250,535 Corporate debt securities 83,385 661 — 84,046 151,773 384 (8 ) 152,149 U.S. government agency securities 43,418 108 (2 ) 43,524 94,963 73 (4 ) 95,032 Certificates of deposits 3,868 31 — 3,899 6,239 43 — 6,282 U.S. government securities 57,596 429 — 58,025 139,978 266 — 140,244 Total $ 572,782 $ 1,229 $ (2 ) $ 574,009 $ 643,488 $ 766 $ (12 ) $ 644,242 |
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, 2020 December 31, 2019 Cash and cash equivalents $ 384,516 $ 251,480 Short-term marketable securities 156,014 307,732 Long-term marketable securities 33,479 85,030 Total $ 574,009 $ 644,242 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Inventories | We began capitalizing inventories in November 2019 once the FDA approved Oxbryta. Inventories consist of the following (in thousands): June 30, 2020 December 31, 2019 Raw materials $ 10,210 $ 700 Work-in-process 15,617 525 Finished goods 1,507 52 Total inventories $ 27,334 $ 1,277 |
Property and Equipment, Net | Property and Equipment, Net Property and equipment consists of the following June 30, 2020 December 31, 2019 Laboratory equipment $ 11,612 $ 8,314 Computer equipment 2,600 2,224 Leasehold improvements 32,231 13,785 Construction-in-progress 515 19,289 Total property and equipment 46,958 43,612 Less: accumulated depreciation and amortization (7,290 ) (16,499 ) Property and equipment, net $ 39,668 $ 27,113 |
Accrued Liabilities | Accrued liabilities Accrued liabilities consist of the following (in thousands): June 30, 2020 December 31, 2019 Accrued research and development costs $ 6,951 $ 26,480 Accrued manufacturing costs 23,782 9,466 Accrued professional and consulting services 3,283 4,564 Accrued sales deductions 5,302 529 Other 4,415 319 Total accrued liabilities $ 43,733 $ 41,358 |
Other Liabilities | Other liabilities, current Other liabilities consist of the following (in thousands): June 30, 2020 December 31, 2019 Operating lease liabilities, current $ 3,486 $ 1,866 Other payable 30 30 Total other liabilities, current $ 3,516 $ 1,896 |
Long-term Debt (Table)
Long-term Debt (Table) | 6 Months Ended |
Jun. 30, 2020 | |
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, 2020 were as follows (in thousands): Year ending December 31, Amount 2020 (six months) $ 3,375 2021 6,750 2022 6,750 2023 31,406 2024 29,156 2025 26,906 Total minimum payments 104,343 Less amount representing interest (27,843 ) Less amount representing Paydown Fee (1,500 ) Long-term debt, gross 75,000 Discount on notes payable (1,411 ) Accretion of Paydown Fee 186 Long-term debt $ 73,775 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of supplemental cash flow information related to leases | Supplemental cash flow 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 June 30, 2020 2019 ROU assets obtained in exchange for new operating lease $ 205 $ 14,177 Cash paid for amounts included in the measurement of lease liabilities 2,590 2,235 Weighted-average remaining lease term of operating leases (in years) 9.7 8.4 Weighted-average discount rate of operating leases 8.7 % 13.2 % |
Schedule of Lessee, Operating Lease, Liability, Maturity | As of June 30, 2020, the maturities of our operating lease liabilities were as follows (in thousands): Year ending December 31, Amount 2020 ( six $ 4,837 2021 11,822 2022 12,202 2023 12,564 2024 12,927 2025 13,347 Thereafter 61,146 Total lease payments 128,845 Less: Imputed interest (43,456 ) Present value of operating lease liabilities $ 85,389 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Stock Option Activity | The following summarizes option activity under the 2017 Inducement Plan, 2015 Plan and 2012 Plan: Number of Weighted- Outstanding 3,573,860 $ 36.24 Options granted 666,633 65.91 Options exercised (368,391 ) 24.39 Options canceled (297,650 ) 52.93 Outstanding 3,574,452 $ 41.61 |
Valuation Assumptions for Stock Awards | The fair values of stock options granted to employees were calculated using the following assumptions: Three Months Ended Six Months Ended 2020 2019 2020 2019 Expected term (in years) 5.1-6.1 5.3-6.1 5.1-6.1 5.3-6.1 Volatility 71.0%-71.8% 70.5%-71.7% 69.6%-71.8% 70.5%-72.2% Risk-free interest rate 0.4% 1.8%-2.4% 0.4%-1.8% 1.8%-2.6% Dividend yield — — — — |
Summary of Activity of Market-Condition Awards | The following table summarizes activity of the market-condition awards under the 2015 Plan and related information (in thousands, except share, per share amounts and vesting period): Number U Weighted- Weighted- Aggregate Non-vested — $ — — Granted 414,700 49.95 Vested — — Forfeited — — Non-vested 414,700 $ 49.95 1.71 $ 26,180 |
Valuation Assumptions of Market-Condition Awards | The following table summarizes the assumptions used to estimate the fair value of the market-condition awards as of the grant date Valuation date stock price $ 68.67 Volatility 68.1 % Risk-free interest rate 0.26 % 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 2020 2019 2020 2019 Research and development $ 3,430 $ 4,715 $ 8,780 $ 8,738 Selling, general and administrative 13,141 6,233 24,158 11,663 Total stock-based compensation expense $ 16,571 $ 10,948 $ 32,938 $ 20,401 |
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 Allotted $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- Non-vested 1,848,772 $ 49.19 RSUs granted 1,183,637 66.28 RSUs vested (304,495 ) 48.25 RSUs forfeited (275,732 ) 54.75 Non-vested 2,452,182 $ 56.93 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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 2020 2019 2020 2019 Options to purchase common stock 3,574,452 3,758,846 3,574,452 3,758,846 Restricted stock units 2,866,882 1,730,348 2,866,882 1,730,348 Total 6,441,334 5,489,194 6,441,334 5,489,194 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | ||
Cumulative net losses | $ 864,782 | $ 738,916 |
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, 2020 | |
Revenue, Product and Service Benchmark [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 95.00% |
Accounts Receivable [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 94.00% |
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, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | $ 574,009 | $ 644,242 |
U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 58,025 | 140,244 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 384,515 | 250,535 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 189,494 | 393,707 |
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 | 58,025 | 140,244 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 384,515 | 250,535 |
Money Market Funds [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 384,515 | 250,535 |
Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 84,046 | 152,149 |
Corporate Debt Securities [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 84,046 | 152,149 |
U.S. Government Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 43,524 | 95,032 |
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 | 43,524 | 95,032 |
Certificates of Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 3,899 | 6,282 |
Certificates of Deposits [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | $ 3,899 | $ 6,282 |
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, 2020 | Dec. 31, 2019 | |
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | $ 572,782 | $ 643,488 |
Available for sale securities, Unrealized Gains | 1,229 | 766 |
Available for sale securities, Unrealized (Losses) | (2) | (12) |
Available for sale securities, Estimated Fair Value | 574,009 | 644,242 |
Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 83,385 | 151,773 |
Available for sale securities, Unrealized Gains | 661 | 384 |
Available for sale securities, Unrealized (Losses) | (8) | |
Available for sale securities, Estimated Fair Value | 84,046 | 152,149 |
U.S. Government Agency Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 43,418 | 94,963 |
Available for sale securities, Unrealized Gains | 108 | 73 |
Available for sale securities, Unrealized (Losses) | (2) | (4) |
Available for sale securities, Estimated Fair Value | 43,524 | 95,032 |
Money Market Funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 384,515 | 250,535 |
Available for sale securities, Estimated Fair Value | 384,515 | 250,535 |
Certificates of Deposits [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 3,868 | 6,239 |
Available for sale securities, Unrealized Gains | 31 | 43 |
Available for sale securities, Unrealized (Losses) | ||
Available for sale securities, Estimated Fair Value | 3,899 | 6,282 |
U.S. Government Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 57,596 | 139,978 |
Available for sale securities, Unrealized Gains | 429 | 266 |
Available for sale securities, Unrealized (Losses) | ||
Available for sale securities, Estimated Fair Value | $ 58,025 | $ 140,244 |
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, 2020 | Dec. 31, 2019 |
Investments, Debt and Equity Securities [Abstract] | ||
Cash and cash equivalents | $ 384,516 | $ 251,480 |
Short-term marketable securities | 156,014 | 307,732 |
Long-term marketable securities | 33,479 | 85,030 |
Total | $ 574,009 | $ 644,242 |
Balance Sheet Components - Inve
Balance Sheet Components - Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Balance Sheet Components [Abstract] | ||
Raw materials | $ 10,210 | $ 700 |
Work-in-process | 15,617 | 525 |
Finished goods | 1,507 | 52 |
Inventories | $ 27,334 | $ 1,277 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 46,958 | $ 43,612 |
Less: accumulated depreciation and amortization | (7,290) | (16,499) |
Property and equipment, net | 39,668 | 27,113 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 11,612 | 8,314 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 2,600 | 2,224 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 32,231 | 13,785 |
Construction-in-Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 515 | $ 19,289 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Balance Sheet Components [Abstract] | ||
Accrued research and development costs | $ 6,951 | $ 26,480 |
Accrued manufacturing costs | 23,782 | 9,466 |
Accrued professional and consulting services | 3,283 | 4,564 |
Accrued sales deductions | 5,302 | 529 |
Other | 4,415 | 319 |
Total accrued liabilities | $ 43,733 | $ 41,358 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Balance Sheet Components [Abstract] | ||
Operating lease liabilities, current | $ 3,486 | $ 1,866 |
Other payable | 30 | 30 |
Total other liabilities, current | $ 3,516 | $ 1,896 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2020 | Dec. 31, 2019 | Dec. 17, 2019 | |
Long term debt | $ 73,775 | $ 73,559 | |
Debt issuance costs paid | 130 | ||
Unamortized fee | 600 | ||
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 | 400 | ||
Unamortized issuance costs and debt discounts | 1,400 | ||
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, 2020 | Dec. 31, 2019 | |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
2020 (six months) | $ 3,375 | |
2021 | 6,750 | |
2022 | 6,750 | |
2023 | 31,406 | |
2024 | 29,156 | |
2025 | 26,906 | |
Total minimum payments | 104,343 | |
Less amount representing interest | (27,843) | |
Less amount representing Paydown Fee | (1,500) | |
Long-term debt, gross | 75,000 | |
Discount on notes payable | (1,411) | |
Accretion of Paydown Fee | 186 | |
Long-term debt | $ 73,775 | $ 73,559 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Aug. 31, 2018USD ($)ft² | Mar. 31, 2017USD ($)ft² | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | |
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 | $ 3,100,000 | $ 1,400,000 | 6,200,000 | $ 3,300,000 | ||
variable lease cost | $ 600,000 | $ 400,000 | 1,300,000 | 1,300,000 | ||
Repayemnt of tenant inducement allowance to the landlord | $ 1,700,000 | |||||
Acceleration of depreciation expenses | $ 3,800,000 | $ 3,400,000 | ||||
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 | $ 32,200,000 | |||||
Lease Agreements [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
leasehold improvements Acquired | $ 11,100,000 | |||||
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) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Commitment And Contingencies [Line Items] | ||
ROU assets obtained in exchange for new operating lease | $ 205 | $ 14,177 |
Cash paid for amounts included in the measurement of lease liabilities | $ 2,590 | $ 2,235 |
Weighted-average remaining lease term of operating leases (in years) | 9 years 8 months 12 days | 8 years 4 months 24 days |
Weighted-average discount rate of operating leases | 8.70% | 13.20% |
Commitments and Contingencies_3
Commitments and Contingencies - Lessee Operating Lease Liability Maturity (Detail) $ in Thousands | Jun. 30, 2020USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2020 (six months) | $ 4,837 |
2021 | 11,822 |
2022 | 12,202 |
2023 | 12,564 |
2024 | 12,927 |
2025 | 13,347 |
Thereafter | 61,146 |
Total lease payments | 128,845 |
Less: Imputed interest | (43,456) |
Present value of operating lease liabilities | $ 85,389 |
Stock-based Compensation - Plan
Stock-based Compensation - Plan Summary - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 01, 2020 | Jun. 30, 2020 | Jun. 30, 2020 | Jun. 30, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
weighted average derived service period | 1 year 9 months 14 days | |||
Stock-based compensation | $ 32,938 | $ 20,401 | ||
Market Condition Awards Granted to Employees [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation expense | $ 19,700 | $ 19,700 | ||
Stock-based compensation | $ 1,100 | |||
2017 Inducement Equity Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares authorized for issuance | 1,628,836 | 1,628,836 | ||
2015 Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares authorized for issuance | 4,522,527 | 4,522,527 | ||
2015 Plan [Member] | RSU [Member] | Senior Management [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted shares granted in period | 414,700 | |||
2015 Plan [Member] | Market Condition Awards Granted to Employees [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted shares granted in period | 414,700 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock Option Activity (Detail) | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |
Beginning balance, outstanding, Number of Options | shares | 3,573,860 |
Options granted, Number of Options | shares | 666,633 |
Options exercised, Number of Options | shares | (368,391) |
Options canceled, Number of Options | shares | (297,650) |
Ending balance, outstanding, Number of Options | shares | 3,574,452 |
Weighted- Average Exercise Price | |
Beginning balance, Outstanding, Weighted-Average Exercise Price | $ / shares | $ 36.24 |
Options granted, Weighted-Average Exercise Price | $ / shares | 65.91 |
Options exercised, Weighted-Average Exercise Price | $ / shares | 24.39 |
Options canceled, Weighted-Average Exercise Price | $ / shares | 52.93 |
Ending balance, Outstanding, Weighted-Average Exercise Price | $ / shares | $ 41.61 |
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, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Volatility, minimum | 71.00% | 70.50% | 69.60% | 70.50% |
Volatility, maximum | 71.80% | 71.70% | 71.80% | 72.20% |
Risk-free interest rate | 0.40% | |||
Risk-free interest rate, minimum | 1.80% | 0.40% | 1.80% | |
Risk-free interest rate, maximum | 2.40% | 1.80% | 2.60% | |
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 1 month 6 days | 5 years 3 months 18 days | 5 years 1 month 6 days | 5 years 3 months 18 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, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Beginning Balance - Non-vested market-condition awards | shares | 1,848,772 |
RSUs granted, Number of RSUs | shares | 1,183,637 |
RSUs vested, Number of RSUs | shares | (304,495) |
RSUs forfeited, Number of RSUs | shares | (275,732) |
Ending Balance - Non-vested market-condition awards | shares | 2,452,182 |
Beginning Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ / shares | $ 49.19 |
RSUs granted, Weighted-Average Grant Date Fair Value | $ / shares | 66.28 |
RSUs vested, Weighted-Average Grant Date Fair Value | $ / shares | 48.25 |
RSUs forfeited, Weighted-Average Grant Date Fair Value | $ / shares | 54.75 |
Ending Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ / shares | $ 56.93 |
Stock-based Compensation - Su_2
Stock-based Compensation - Summary of Share-based Compensation Arrangements by Share-based Payment Award (Detail) | Jun. 30, 2020$ / sharesshares |
Tranche One [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock Price Targets | $ / shares | $ 109.20 |
Number of Units Allotted | 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 Allotted | 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 Allotted | 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] $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2020USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Beginning Balance - Non-vested market-condition awards | 0 |
Number of Units granted | 414,700 |
Ending Balance - Non-vested market-condition awards | 414,700 |
Weighted-Average Grant Date Fair Value granted | $ / shares | $ 49.95 |
Ending Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ / shares | $ 49.95 |
Non-vested units, Weighted-Average remaining vesting period(years) | 1 year 8 months 15 days |
Non-vested units, Aggregate Intrinsic Value | $ | $ 26,180 |
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 | 9 Months Ended |
Jun. 30, 2020$ / shares | Jun. 30, 2020$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Valuation date stock price | $ 68,670 | $ 68,670 |
Volatility | 68.10% | |
Risk-free interest rate | 0.26% | |
Dividend yield |
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, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 16,571 | $ 10,948 | $ 32,938 | $ 20,401 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 3,430 | 4,715 | 8,780 | 8,738 |
General and Administrative Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 13,141 | $ 6,233 | $ 24,158 | $ 11,663 |
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, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 6,441,334 | 5,489,194 | 6,441,334 | 5,489,194 |
Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 3,574,452 | 3,758,846 | 3,574,452 | 3,758,846 |
RSU [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 2,866,882 | 1,730,348 | 2,866,882 | 1,730,348 |