Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 18, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 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 | 64,821,441 | ||
Document Annual 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 | FY | ||
Entity Central Index Key | 0001629137 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Public Float | $ 888.3 | ||
Entity Voluntary Filers | No | ||
ICFR Auditor Attestation Flag | true | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement for the registrant’s 2022 Annual Meeting of Stockholders, to be filed subsequent to the date hereof with the Securities and Exchange Commission, or SEC, are incorporated by reference into Part III of this report. Such proxy statement will be filed with the SEC not later than 120 days after the end of the registrant’s fiscal year ended December 31, 2021. | ||
Auditor Firm ID | 185 | ||
Auditor Name | KPMG, LLP | ||
Auditor Location | San Francisco, California |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 684,717 | $ 494,766 |
Short-term marketable securities | 0 | 66,126 |
Accounts receivable, net | 28,800 | 17,500 |
Inventories | 58,202 | 40,223 |
Prepaid expenses and other current assets | 30,251 | 13,548 |
Total current assets | 801,970 | 632,163 |
Property and equipment, net | 34,918 | 37,882 |
Long-term marketable securities | 50,057 | 0 |
Operating lease right-of-use assets | 48,015 | 50,722 |
Restricted cash | 2,436 | 2,436 |
Other assets, noncurrent | 1,812 | 799 |
Total assets | 939,208 | 724,002 |
Current liabilities: | ||
Accounts payable | 15,097 | 19,078 |
Accrued liabilities | 39,297 | 31,133 |
Accrued compensation | 27,712 | 23,985 |
Other current liabilities | 5,892 | 4,836 |
Total current liabilities | 87,998 | 79,032 |
Convertible debt, net | 334,089 | 0 |
Long-term debt | 246,352 | 148,815 |
Operating lease liabilities, noncurrent | 73,506 | 79,176 |
Other liabilities, noncurrent | 853 | 822 |
Total liabilities | 742,798 | 307,845 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized at December 31, 2021 and 2020, respectively, and none issued and outstanding as of December 31, 2021 and 2020 | 0 | 0 |
Common stock, $0.001 par value, 150,000,000 shares authorized at December 31, 2020 and 2019, respectively; 61,898,090 and 60,644,380 shares issued and outstanding at December 31, 2020 and 2019, respectively | 65 | 62 |
Additional paid-in capital | 1,485,805 | 1,402,262 |
Accumulated other comprehensive income | 100 | 302 |
Accumulated deficit | (1,289,560) | (986,469) |
Total stockholders' equity | 196,410 | 416,157 |
Total liabilities and stockholders' equity | $ 939,208 | $ 724,002 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 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 | 64,636,641 | 61,898,090 |
Common stock, shares outstanding | 64,636,641 | 61,898,090 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues [Abstract] | |||
Product sales, net | $ 194,749,000 | $ 123,803,000 | $ 2,108,000 |
Costs and operating expenses: | |||
Cost of sales | 3,316,000 | 1,986,000 | 48,000 |
Research and development | 212,135,000 | 155,122,000 | 174,556,000 |
Selling, general and administrative | 266,988,000 | 210,851,000 | 117,088,000 |
Gain on lease modification | 0 | (984,000) | (8,301,000) |
Total costs and operating expenses | 482,439,000 | 366,975,000 | 283,391,000 |
Loss from operations | (287,690,000) | (243,172,000) | (281,283,000) |
Other income (expense): | |||
Interest income | 720,000 | 5,834,000 | 15,591,000 |
Interest expense | (15,467,000) | (9,809,000) | (894,000) |
Other expenses, net | (177,000) | (406,000) | (176,000) |
Loss before income taxes | (302,614,000) | (247,553,000) | (266,762,000) |
Provision for income taxes | 477,000 | 0 | 4,000 |
Total other income (expense), net | (14,924,000) | (4,381,000) | 14,521,000 |
Net loss | (303,091,000) | (247,553,000) | (266,766,000) |
Other comprehensive loss: | |||
Net unrealized gain (loss) on marketable securities, net of tax | (521,000) | (452,000) | 802,000 |
Cumulative translation adjustment | 319,000 | 0 | 0 |
Total other comprehensive income (expense), net | (202,000) | (452,000) | 802,000 |
Comprehensive loss | $ (303,293,000) | $ (248,005,000) | $ (265,964,000) |
Basic and diluted net loss per common share | $ (4.81) | $ (4.04) | $ (4.57) |
Weighted-average number of shares used in computing basic and diluted net loss per common share | 62,963,317 | 61,334,037 | 58,321,612 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Private Placement Member | Call Option [Member] | Market Finance Member | Common Stock [Member] | Common Stock [Member]Private Placement Member | Common Stock [Member]Market Finance Member | Additional Paid-In Capital [Member] | Additional Paid-In Capital [Member]Private Placement Member | Additional Paid-In Capital [Member]Call Option [Member] | Additional Paid-In Capital [Member]Market Finance Member | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Other Comprehensive Income (Loss) [Member]Private Placement Member | Accumulated Other Comprehensive Income (Loss) [Member]Call Option [Member] | Accumulated Other Comprehensive Income (Loss) [Member]Market Finance Member | Accumulated Deficit [Member] | Accumulated Deficit [Member]Private Placement Member | Accumulated Deficit [Member]Call Option [Member] | Accumulated Deficit [Member]Market Finance 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 | 219,671 | $ 4 | 219,667 | 0 | 0 | ||||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs, Shares | 3,986,890 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 11,636 | $ 1 | 11,635 | 0 | 0 | ||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 538,503 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (7,617) | $ 0 | (7,617) | 0 | 0 | ||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 368,357 | ||||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 2,361 | $ 0 | 2,361 | 0 | 0 | ||||||||||||||
Issuance of common stock pursuant to ESPP purchases, Shares | 63,280 | ||||||||||||||||||
Vesting of restricted stock purchases | 157 | $ 0 | 157 | 0 | 0 | ||||||||||||||
Vesting of restricted stock purchases, Shares | 47,051 | ||||||||||||||||||
Stock-based compensation expense | 45,651 | $ 0 | 45,651 | 0 | 0 | ||||||||||||||
Other comprehensive income | 802 | ||||||||||||||||||
Net unrealized gain (loss) on marketable securities | 802 | 0 | 0 | 802 | 0 | ||||||||||||||
Net loss | (266,766) | 0 | 0 | 0 | (266,766) | ||||||||||||||
Ending Balance at Dec. 31, 2019 | 578,694 | $ 61 | 1,316,795 | 754 | (738,916) | ||||||||||||||
Ending Balance, Shares at Dec. 31, 2019 | 60,644,380 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 13,328 | $ 0 | 13,328 | 0 | 0 | ||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 525,788 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (5,287) | $ 1 | (5,288) | 0 | 0 | ||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 629,857 | ||||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 4,137 | $ 0 | 4,137 | 0 | 0 | ||||||||||||||
Issuance of common stock pursuant to ESPP purchases, Shares | 98,065 | ||||||||||||||||||
Stock-based compensation expense | 73,290 | $ 0 | 73,290 | 0 | 0 | ||||||||||||||
Other comprehensive income | (452) | ||||||||||||||||||
Net unrealized gain (loss) on marketable securities | (452) | 0 | 0 | (452) | 0 | ||||||||||||||
Net loss | (247,553) | 0 | 0 | 0 | (247,553) | ||||||||||||||
Ending Balance at Dec. 31, 2020 | 416,157 | $ 62 | 1,402,262 | 302 | (986,469) | ||||||||||||||
Ending Balance, Shares at Dec. 31, 2020 | 61,898,090 | ||||||||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs | $ 2,070 | $ (46,817) | $ 44,073 | $ 0 | $ 2 | $ 2,070 | $ (46,817) | $ 44,071 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | |||||
Issuance of common stock upon equity offerings, net of issuance costs, Shares | 83,132 | 1,601,884 | |||||||||||||||||
Issuance of common stock upon exercise of stock options | $ 2,746 | $ 1 | 2,745 | 0 | 0 | ||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 136,929 | 136,929 | |||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | $ (3,113) | $ 0 | (3,113) | 0 | 0 | ||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 782,019 | ||||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 4,253 | $ 0 | 4,253 | 0 | 0 | ||||||||||||||
Issuance of common stock pursuant to ESPP purchases, Shares | 134,587 | ||||||||||||||||||
Stock-based compensation expense | 80,334 | $ 0 | 80,334 | 0 | 0 | ||||||||||||||
Other comprehensive income | (202) | 0 | (202) | 0 | |||||||||||||||
Net loss | (303,091) | 0 | 0 | (303,091) | |||||||||||||||
Ending Balance at Dec. 31, 2021 | $ 196,410 | $ 65 | $ 1,485,805 | $ 100 | $ (1,289,560) | ||||||||||||||
Ending Balance, Shares at Dec. 31, 2021 | 64,636,641 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (303,091) | $ (247,553) | $ (266,766) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 5,909 | 8,323 | 8,605 |
Amortization (accretion) of premium (discount) on marketable securities | 205 | 119 | (2,057) |
Non-cash interest expense | 1,223 | 1,523 | 43 |
Operating Lease Right Of Use Asset Amortization | 2,707 | 2,500 | 1,327 |
Stock-based compensation | 78,670 | 71,477 | 45,651 |
Gain on lease modification | 0 | (984) | (8,301) |
Changes in operating assets and liabilities: | |||
Accounts receivables | (11,300) | (14,863) | (2,637) |
Inventories | (16,148) | (36,779) | (1,277) |
Prepaid expenses | (17,728) | (725) | (5,197) |
Accounts payable | (3,722) | 8,374 | 4,499 |
Accrued liabilities | 7,552 | (10,089) | 24,706 |
Accrued compensation | 3,727 | 6,407 | 7,543 |
Other liabilities, current | (12) | (587) | (1,482) |
Operating lease liabilities | (4,836) | 173 | 893 |
Other liabilities, noncurrent | 31 | 822 | 33 |
Net cash used in operating activities | (256,813) | (211,862) | (194,417) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property and equipment | (3,233) | (8,754) | (3,460) |
Proceeds from sale of property and equipment | 0 | 0 | 45 |
Purchases of marketable securities | (50,353) | (57,936) | (434,919) |
Maturities of marketable securities | 65,696 | 384,002 | 361,473 |
Net cash provided by (used in) investing activities | 12,110 | 317,312 | (76,861) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from Issuance of Common Stock | 46,143 | 0 | 219,443 |
Proceeds from issuance of long-term debt, net of debt issuance costs | 96,473 | 74,799 | 72,475 |
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options | 6,999 | 17,608 | 13,857 |
Taxes paid related to net share settlement of equity awards | (3,113) | (5,287) | (7,617) |
Proceeds from issuance of Convertible Notes, net | 334,650 | 0 | 0 |
Purchases of capped call options | (46,817) | 0 | 0 |
Net cash provided by financing activities | 434,335 | 87,120 | 298,158 |
Effect of Exchange Rate on Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | 319 | 0 | 0 |
Net increase in cash, cash equivalents and restricted cash | 189,951 | 192,570 | 26,880 |
Cash, cash equivalents and restricted cash at beginning of period | 497,202 | 304,632 | 277,752 |
Cash, cash equivalents and restricted cash at end of period | 687,153 | 497,202 | 304,632 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||
Cash paid for interest | 13,938 | 6,283 | 0 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH FINANCING INFORMATION: | |||
Accrued issuance costs | 486 | (59) | 85 |
Leasehold improvements paid for by landlord | 0 | 10,709 | 17,231 |
Accrued purchase of property and equipment | (132) | 6 | 78 |
RECONCILIATION OF CASH, CASH EQUIVALENTS, AND RESTRICTED CASH TO THE CONDENSED CONSOLIDATED BALANCE SHEETS | |||
Cash, cash equivalents | 684,717 | 494,766 | 302,237 |
Restricted cash | 2,436 | 2,436 | 2,395 |
Total cash and cash equivalents and restricted cash | $ 687,153 | $ 497,202 | $ 304,632 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
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 ® (voxelotor) tablets for the treatment of sickle cell disease, or SCD, in adults and children 12 years of age and older, and in early December 2019, we began to make Oxbryta available to patients through our specialty pharmacy partner network. In December 2021, we received FDA accelerated approval to expand Oxbryta’s indication for the treatment of SCD to children ages 4 to less than 12 years. Our principal operations are based in South San Francisco, California. Liquidity We have incurred significant operating losses since inception and have cumulative net losses of $ 1.3 billion. Our ultimate success depends on the outcome of our commercialization of Oxbryta and research and development activities. We expect to incur additional losses for the foreseeable future to commercialize Oxbryta and conduct product research and development. 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 our operating plans. We believe that our existing cash and cash equivalents and investments of $ 734.8 million as of December 31, 2021 will be sufficient to fund our cash requirements for at least twelve months subsequent to the issuance of these financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. Certain reclassifications have been made to prior period financials to conform to the current year presentation. These reclassifications have no impact on previous reported total assets, total liabilities, net loss, stockholders’ equity or operating cash flows. 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 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. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and balances have been eliminated upon consolidation. Segment Reporting We operate in a single segment which is development of pharmaceutical products and this is based upon the way the business is organized for making operating decisions and assessing performance. All property and equipment is maintained in the United States. Our product sales are primarily in the United States. Cash and Cash Equivalents We consider all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents, which consist primarily of amounts invested in money market accounts, are stated at fair value. Investments in Marketable Securities We invest in marketable securities, primarily money market funds, corporate debt securities, government securities, government agency securities, and certificates of deposits. We classify our marketable securities as available-for-sale securities and report them at fair value in cash equivalents or marketable securities on the consolidated balance sheets with related unrealized gains and losses included within accumulated other comprehensive income (loss) on the consolidated balance sheets. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income on the consolidated statements of operations and comprehensive loss. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in interest and other income (loss). The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. We regularly review all of our investments to determine whether unrealized losses have resulted from a credit loss or other factors under ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326). Our review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether we have the intent to sell the securities and whether it is more likely than not that we will be required to sell the securities before the recovery of their amortized cost basis. The unrealized losses on the Company’s available-for-sale securities for the years ended December 31, 2021, 2020 or 2019, were caused by fluctuations in market value and interest rates as a result of the economic environment. The Company concluded that an allowance for credit losses was unnecessary as of December 31, 2021 and that there were no impairments as of December 31, 2021, 2020 or 2019 considered as other-than-temporary because the decline in the market value was attributable to changes in market conditions and not credit quality, and that it is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell these investments prior to recovery of their cost basis or recovery of fair value. When we determine that the decline in estimated fair value of an investment is below the amortized cost basis and the decline is other than temporary, we reduce the carrying value of the security and record a loss for the amount of such decline. Fair Value Measurement The carrying amounts of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. 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 year ended December 31, 2021 , our three largest customers represented approximately 99.8 % of our product revenue and 100.0 % of our accounts receivable balance at December 31, 2021. Major Suppliers We do not currently have any of our own manufacturing facilities, and therefore we 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 two third-party manufacturers that are 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. Accounts Receivables, net Accounts receivables are recorded net of estimates of variable consideration for which reserves are established and which result from discounts and chargebacks that are offered within contracts between us and a limited number of specialty pharmacies and a specialty distributor in the United States. These reserves are classified as reductions of accounts receivable. We estimate the allowance for doubtful accounts using the current expected credit loss model, or CECL model. Under the CECL model, the allowance for doubtful accounts reflects the net amount expected to be collected from the account receivables. We evaluate the collectability of these cash flow based on the asset’s amortized cost, the risk of loss even when that risk is remote, losses over an asset’s contractual life, and other relevant information available to us. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature and history of our accounts receivable, we determined that an allowance for doubtful accounts was not required at December 31, 2021 . Inventories Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, first out, or FIFO, basis. We use actual costs to determine our cost basis for inventories. Inventories consist of raw materials, work-in-process, and finished goods. We began capitalizing costs as inventory when the product candidate received regulatory approval. Prior to regulatory approval, we recorded inventory costs related to product candidates as research and development expenses. We periodically assess the recoverability of our inventory and reduce the carrying value of the inventory when items are determined to be obsolete, defective or in excess of forecasted sales requirements. Inventory write-downs for excess, defective and obsolete inventory are recorded as a cost of sales. There have been no write-downs of our inventories for the periods presented. Property and Equipment, Net Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is provided using the straight-line method over the estimated useful lives of the assets, which is three years for computer equipment and five years for laboratory equipment. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the improvements. Depreciation and amortization begins at the time the asset is placed in service. Maintenance and repairs are charged as expense in the statements of operations and comprehensive loss as incurred. Upon sale or retirement of assets, the cost and related accumulated depreciation and amortization are removed from the consolidated balance sheet and any resulting gain or loss is reflected in operations. Impairment of Long-Lived Assets We evaluate our long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. Recoverability of these assets is measured by comparison of the carrying amount of each asset to the future undiscounted cash flows the asset is expected to generate over its remaining life. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset. There have been no impairments of our long-lived assets for the periods presented. Restricted Cash Restricted cash consists of cash deposits held by our financial institution as collateral for our letter of credit under our facility lease. Accruals of Research and Development and Manufacturing Costs We record accruals for estimated costs of research, nonclinical and clinical studies and manufacturing development. These costs are a significant component of our research and development expenses. A substantial portion of our ongoing research and development activities are conducted by third-party service providers, including contract research organizations and contract manufacturing organizations. We also accrue for estimated costs of manufacturing activities for inventories which are a significant component of the cost of our inventory. We accrue the costs incurred under our agreements with these third parties based on actual work completed in accordance with agreements established with these third parties. We determine the accruals for research and development costs through discussions with internal personnel and external service providers as to the progress or stage of completion of the clinical studies and the agreed-upon fee to be paid for such services. The accrual for contract manufacturing activities is based on an estimate of manufacturing activities completed to date, contractual rates, and amounts invoiced and paid to date at the end of each reporting period. We determine the percentage of manufacturing activities completed to date based on discussions with the contract manufacturing organizations, oversight of the manufacturing activities and anticipated timeline. Actual clinical and manufacturing services performed, number of subjects enrolled, and the rate of subject enrollment may vary from our estimates, resulting in adjustments to research and development costs or inventories in future periods. Changes in these estimates that result in material changes to our accruals of research and development and manufacturing costs could materially affect our results of operations or amounts of inventories capitalized. Revenue Recognition Pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers , or ASC 606 , we recognize revenue upon transfer of control of promised products or services to customers in an amount that reflects the consideration we expect to receive in exchange for those products or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect substantially all of the consideration we are entitled to in exchange for the goods or services we transfer to the customer. Product sales, net Our product sales consist of U.S. sales of Oxbryta, which we began shipping to customers in December 2019. Prior to December 2019, we had no product sales. We sell Oxbryta in the United States to a limited number of specialty pharmacies and a specialty distributor ( each a “Customer” or collectively our “Customers) . These agreements with our Customers provide for transfer of title to the product at the time the product has been delivered to the Customers. The Customers subsequently dispense our products directly to a patient or resell our products to hospitals and certain pharmacies. We recognize revenue on product sales when the Customers obtain control of our product, which occurs at a point in time, typically upon delivery to our Customers. It is at that point that we have a right to payment and that our Customers obtain title and the risks and rewards of ownership. Shipping and handling activities are considered to be fulfillment activities rather than a separate performance obligation. Payment terms are typically 30-60 days following delivery to our Customers. We consider the effects of items that can decrease the transaction price, such as variable consideration and consideration payable to Customers or payor. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. We record revenue from product sales after considering the impact of various forms of variable considerations. Each of these items of variable consideration we record at the time of revenue recognition and requires significant estimates, judgment and information obtained from external sources. If management’s estimates differ from actual results, we will record adjustments that would affect product sales in the period of adjustment: Rebates: We are subject to government mandated rebates for Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, and other government health care programs in the United States. Rebate amounts are based upon contractual agreements or legal requirements with public sector benefit providers. We use the expected-value method for estimating these rebates based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on third party data from the specialty pharmacies and specialty distributor. Estimates for these rebates are adjusted quarterly to reflect the most recent information. We record an accrued liability for unpaid rebates related to products for which control has been transferred to Customers. Prompt payment discounts : We provide discounts to our Customers if they pay for our products within a defined period of time after title transfers, which terms are explicitly stated in the contract. We use the most-likely-amount method for estimating prompt payment discounts. We expect that our Customers will earn prompt payment discounts. As a result, we deduct the full amount of those discounts from total product sales when revenues are recognized and record these discounts as a reduction of accounts receivable. Co-payment assistance: We provide co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. We use the expected-value method for estimating co-payment assistance based on estimates of program redemption using data provided by third-party administrators. Estimates for the co-payment assistance are adjusted quarterly to reflect actual experience. We record an accrued liability for unredeemed co-payment assistance related to products for which control has been transferred to Customers. Medicare Part D Coverage Gap: The Medicare Part D coverage gap is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States, which mandates manufacturers to fund a portion of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Funding of the coverage gap is generally invoiced and paid in arrears. We estimate the impact of the Medicare Part D coverage gap using the expected-value method based on an amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters. Estimates for the impact of the Medicare Part D coverage gap are adjusted quarterly to reflect actual experience. We record an accrued liability for unpaid reserves related to the Medicare Part D coverage gap. Product returns: Consistent with industry practice, we offer limited product return rights and generally allow for the return of product that is damaged or defective, or within a few months prior to and up to a few months after the product expiration date. We consider several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, prescription trends, and other relevant factors. We expect product returns to be immaterial. Other than these limited returns, we do not provide any product warranties. Chargebacks : Chargebacks are discounts that occur when contracted parties purchase directly from a specialty distributor. Contracted parties, which currently consist primarily of Public Health Service Institutions and federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty distributor, in turn, charge back the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the contracted parties to us. The reserves for chargeback are based on known sales to contracted parties. We establish the reserves for chargebacks in the same period that the related revenue is recognized, resulting in a reduction of product revenue and receivables. Distributor fees: Our specialty distributor provides distribution services to us for a fee, based on a contractually determined fixed percentage of sales. We estimate these distributor fees and record such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue. We record an accrued liability for unpaid distributor fees. Cost of Sales Cost of sales consists primarily of direct and indirect costs related to the manufacturing of Oxbryta products sold, including third-party manufacturing costs, packaging services, freight, storage costs, allocation of overhead costs of employees involved with production, and Oxbryta net sales-based royalties payable to the Regents of the University of California. Costs incurred prior to the FDA’ s initial approval of Oxbryta in November 2019 have been recorded as research and development expense in our consolidated statement of operations and comprehensive loss. Leases In accordance with Accounting Standards Codification, Topic 842, Leases , or ASC 842, we determine if an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether we have the right to control the identified asset. Right-of-use, or ROU, assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and exclude lease incentives received and initial direct costs incurred, as applicable. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. We consider our credit risk, term of the lease, and total lease payments and adjust for the impact of collateral, as necessary, when calculating our incremental borrowing rates. The lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise any such options. Lease cost for our operating leases is recognized on a straight-line basis over the lease term. We have elected to not separate lease and non-lease components for any leases within its existing classes of assets and, as a result, account for any lease and non-lease components as a single lease component. We have also elected to not recognize any leases within its existing classes of assets with a term of 12 months or less. ROU assets and operating lease liabilities are remeasured upon certain modifications to leases using the present value of remaining lease payments and estimated incremental borrowing rate upon lease modification. Comprehensive Income (Loss) Comprehensive income (loss) is defined as a change in equity of a business enterprise during a period, resulting from transactions from non-owner sources. Our comprehensive income (loss) is comprised of net loss and changes in unrealized gains and losses on our marketable securities and cumulative translation adjustment. Research and Development Research and development costs are expensed as incurred and consist of salaries and benefits, stock-based compensation expense, lab supplies and facility costs, as well as fees paid to other nonemployees and entities that conduct certain research and development activities on our behalf. Amounts incurred in connection with license agreements are also included in research and development expense. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are delivered or the services are performed. Long-term Debt Long-term debt consists of our loan agreement, or Term Loan, with funds managed by Pharmakon Advisors LP, which are BioPharma Credit PLC, as collateral agent and a lender, and Biopharma Credit Investments V (Master) LP, as a lender, and collectively, the Lenders. We accounted for the Term Loan as a debt financing arrangement. Interest expense is accrued using the effective interest rate method over the estimated period the debt will be repaid. Debt issuance costs have been recorded as a debt discount in our consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the Term Loan using the effective interest rate method. We consider whether there are any embedded features in our debt instruments that require bifurcation and separate accounting as derivative financial instruments pursuant to Accounting Standards Codification, or ASC, Topic 815, Derivatives and Hedging . There are no embedded features identified from our Term Loan that require bifurcation and separating accounting. Convertible Notes We evaluate all conversion, repurchase and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative. We accounted for the 2028 Notes (see Note 8) as a long-term liability equal to the proceeds received from issuance, including the embedded conversion feature, net of the unamortized debt issuance and offering costs on the consolidated balance sheets. The conversion feature is not required to be accounted for separately as an embedded derivative. We amortize debt issuance and offering costs over the contractual term of the 2028 Notes, using the effective interest method, as interest expense on the consolidated statements of operations. Capped Calls We evaluate financial instruments under ASC 815. In December 2021, in connection with the issuance of the Convertible Notes, we entered into the Capped Calls (see Note 8). The Capped Calls cover the same number of shares of common stocks that initially underlie the 2028 Notes (subject to anti-dilution and certain other adjustments). The Capped Calls meet the definition of derivative under ASC 815. In addition, the Capped Calls meet the conditions in ASC 815 to be recorded as a reduction to additional paid-in capital in stockholders’ equity and are not subsequently remeasured as long as the conditions for equity classification continue to be met. Stock-Based Compensation We measure and recognize stock-based compensation expense, including employee and non-employee equity awards, based on fair value at the grant date. We use the Black-Scholes-Merton option-pricing model to calculate fair value. Stock-based compensation expense recognized in the consolidated statements of operations is based on stock awards ultimately vested, taking into consideration actual forfeitures. Income Taxes We use the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to our lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. We recognize benefits of uncertain tax positions if it is more likely than not that such positions will be sustained upon examination based solely on their technical merits, as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. It is our policy to include penalties and interest expense related to income taxes as a component of other expense and interest expense, respectively, as necessary. To date, there have been no interest or penalties incurred in relation to the unrecognized tax benefits. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given our net loss. In calculating dilutive instruments we use the if-converted method for the convertible debt upon adopting ASU No.2020-06. 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 . The guidance eliminates certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period, and the recognition of deferred tax liabilities for outside basis differences. It also clarifies and simplifies other aspects of the accounting for income taxes. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, and the applicable amendments will be applied on a prospective basis. We adopted ASU No. 2019-12 in the first quarter of 2021 and applied the guidance prospectively. The only aspect of ASU 2019-12 that is currently applicable to us is the removal of the exception related to intraperiod tax allocation. We began applying the general methodology regarding the intraperiod allocation of tax expense in 2021. After the adoption of ASU 2019-12, in periods where we have a loss from continuing operations, the amount of taxes attributable to continuing operations will be determined without regard to the tax effect of other items, including changes in unrealized gains related to marketable securities. The adoption of this standard did not have a material impact on our consolidated financial statements. In August 2020, FASB issued ASU No. 2020-08, Codification Improvement to Subtopic 310-20, Receivables – Nonrefundable Fees and Other Costs . The new guidance states that an entity should reevaluate whether a callable debt security is within scope of Topic 310-20. ASU 2020-08 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. We adopted ASU No. 2020-08 in the first quarter of 2021 and applied the guidance prospectively. The adoption of this new standard did not have a material impact on our consolidated financial statements. In August 2020, FASB, issued ASU No.2020-06 Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) . This ASU simplifies the accounting for convertible instruments and requires entities to use the if-converted method for all convertible instruments in calculating diluted earnings-per-share. We early adopted ASU No. 2020-06 on January 1, 2021 using the modified retrospective method. We applied this ASU to the convertible debt transaction entered into in December 2021 (see Note 8). The adoption of this ASU did not have a material impact to our consolidated financial statements as there were no outstanding financial instruments that require recombination at January 1, 2021. Accounting P r onouncement Issued But Not Yet Adopted In March 2020, FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) . The new guidance contains practical expedients for reference rate reform related activities that impact debt, leases, derivatives, and other contracts. The guidance in ASU 2020-04 is optional and may be elected over time as reference rate reform activities occur. We continue to evaluate the impact of the guidance and may apply the elections as applicable as changes occur. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 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 and marketable securities reported at their respective fair values on our consolidated balance sheets. The remaining financial instruments are reported on our 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 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. In accordance with ASC 820-10 , Fair Value Measurements and Disclosures, the Company determines the fair value of financial and non-financial assets liabilities using the 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— Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and 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 (cash equivalents and marketable securities) measured at fair value on a recurring basis (in thousands): December 31, 2021 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 671,845 $ 671,845 $ — $ — Corporate debt securities 10,006 — 10,006 — U.S. government agency securities 4,843 — 4,843 — Certificates of deposits 244 — 244 — U.S. government securities 34,964 — 34,964 — Total financial assets $ 721,902 $ 671,845 $ 50,057 $ — 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 markets, benchmark securities, bids, offers and reference data including market research publications. At December 31, 2021, the weighted average remaining contractual maturities of our Level 2 investments was eighteen months and all of these investments are rated A-1/P-1/F1 or A/A2, or higher by Moody’s and S&P. There were no transfers between Level 1 and Level 2 during the periods presented. There were no sales of available-for-sale securities in any of the periods presented. No credit loss allowance was recorded as of December 31, 2021 as we do not believe the unrealized loss is a result of a credit loss. We also considered the current and expected future economic and market conditions surrounding the COVID-19 pandemic and determined that the estimate of credit losses was not significantly impacted. |
Available-for-Sale Securities
Available-for-Sale Securities | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-Sale Securities | 4. Available-for-Sale Securities Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. The following table is a summary of available-for-sale securities recorded in cash and cash equivalents, or marketable securities in our Consolidated Balance Sheets (in thousands): December 31, 2021 Amortized Unrealized Unrealized Estimated Fair Cost Gains (Losses) Value Financial Assets: Money market funds $ 671,845 $ — $ — $ 671,845 Corporate debt securities 10,037 — ( 31 ) 10,006 U.S. government agency securities 4,862 — ( 19 ) 4,843 Certificates of deposits 245 — ( 1 ) 244 U.S. government securities 35,133 — ( 169 ) 34,964 Total $ 722,122 $ — $ ( 220 ) $ 721,902 December 31, 2020 Amortized Unrealized Unrealized Estimated Fair Cost Gains (Losses) Value Financial Assets: Money market funds $ 486,174 $ — $ — $ 486,174 Corporate debt securities 29,641 163 — 29,804 U.S. government agency securities 15,906 37 — 15,943 Certificates of deposits 241 2 — 243 U.S. government securities 20,036 100 — 20,136 Total $ 551,998 $ 302 $ — $ 552,300 The following table summarizes the classification of the available-for-sale securities on our consolidated balance sheets (in thousands): December 31, 2021 2020 Cash and cash equivalents $ 671,845 $ 486,174 Short-term marketable securities — 66,126 Long-term marketable securities 50,057 — Total $ 721,902 $ 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. We have determined that the gross unrealized losses on our marketable securities at December 31, 2021 were temporary in nature. All unrealized losses from all marketable securities at December 31, 2021 are not material. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Property and Equipment Property and equipment consist of the following (in thousands): December 31, 2021 2020 Laboratory equipment $ 14,373 $ 11,922 Computer equipment 2,841 3,023 Leasehold improvements 32,281 32,281 Construction-in-progress 934 517 Total property and equipment 50,429 47,743 Less: accumulated depreciation and amortization ( 15,511 ) ( 9,861 ) Property and equipment, net $ 34,918 $ 37,882 Depreciation expense was $ 5.9 million for the year ended December 31, 2021, $ 8.3 million for the year ended December 31, 2020 and $ 8.6 million for the year ended December 31, 2019. Refer to Note 9—Commitments and Contingencies for details on acceleration of depreciation expense recognized during the years ended December 31, 2020 and 2019. Accrued Liabilities Accrued liabilities consist of the following (in thousands): December 31, 2021 2020 Accrued research and development costs $ 8,525 $ 10,677 Accrued manufacturing costs 11,327 9,125 Accrued professional and consulting services 7,863 4,107 Accrued sales deductions 10,205 6,405 Other 1,377 819 Total accrued liabilities $ 39,297 $ 31,133 Other liabilities, current Other liabilities consist of the following (in thousands): December 31, 2021 2020 Operating lease liabilities, current $ 5,670 $ 4,836 Other current liabilities $ 222 — Total other liabilities, current $ 5,892 $ 4,836 |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Text Block [Abstract] | |
inventories | Inventories I nventories consist of the following (in thousands): December 31, 2021 2020 Raw materials $ 10,616 $ 11,273 Work-in-process 45,662 26,994 Finished goods 1,924 1,956 Total inventories $ 58,202 $ 40,223 For the year ended December 31, 2021, and 2020, we have capitalized $ 1.7 million and $ 1.8 million of share-based compensation expense to our inventories, respectively. See Note 11 - Share-based Compensation for details on share-based compensation expenses recognized during the year ended December 31, 2021. |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Text Block [Abstract] | |
Long-term Debt | 7. Long-term Debt Amended and Restated Loan Agreement In December 2019, we entered into the 2019 Term Loan for a senior secured credit facility consisting of an initial term loan of $ 75.0 million, with an option to draw an additional $ 75.0 million until December 31, 2020. The first tranche of $ 75.0 million was funded in December 2019 and the second tranche of the $ 75.0 million was funded in November 2020. In December 2021, we entered into the A&R Term Loan. The A&R Term Loan superseded in its entirety the 2019 Term Loan, and provided us with an additional term loan commitment from the Lenders in the aggregate principal amount of $ 100.0 million, or “Tranche C Loan”. Further, the A&R term loan agreement extended the maturity date and interest payments for the previous tranches under the 2019 Term Loan to conform with the new Tranche C Loan. The Tranche C Loan is in addition to the initial term loan tranche in an aggregate principal amount of $ 75.0 million that was drawn upon execution of the 2019 Term Loan Agreement and a subsequent term loan tranche in an aggregate principal amount of $ 75.0 million that was drawn under the Prior Loan Agreement in November 2020. The maturity date of the A&R Term Loan was extended to December 17, 2027 , with interest-only payments extended to March 31, 2025. The Term Loan bears interest at a floating per annum interest rate equal to 7.00 % plus the greater of (a) the 3-month LIBOR rate and (b) 2 %. Interest on amounts outstanding are payable quarterly in arrears. The obligations under the A&R Term Loan are secured by a first priority security interest in and a lien on substantially all of our assets, subject to certain exceptions. In the event we default, the interest rate would be 3 % above the rate that is otherwise applicable thereto. Interest on amounts outstanding are payable quarterly in arrears. We have the option to prepay all or a portion of the borrowed amounts under the A&R 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 2024, 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 2026, 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. Using the net present value method, we concluded the amendment and restatement of the 2019 Term Loan should be accounted for as a debt modification as the present value of the remaining cash flows of the A&R Term Loan are not substantially different from the present value of the remaining cash flows of the 2019 Term Loan. As the amendment was accounted for as a debt modification, no gain or loss was recognized. Debt issuance costs associated with the Tranche C Loan paid directly to the Lenders of $ 3.4 million were treated as discounts on the A&R Term Loan and the other debt issuance costs of $ 0.1 million were expensed as incurred. The debt discounts associated with the Tranche C Loan and the remaining unamortized debt discounts associated with the 2019 Term Loan as of the debt amendment date, along with the Paydown Fee are being amortized or accreted to interest expenses throughout the remaining life of the A&R Term Loan using the effective interest rate method. As of December 31, 2021 , there were unamortized issuance costs and debt discounts of $ 4.8 million, which were recorded as a direct deduction from the A&R Term Loan on the consolidated balance sheet. Future payments of principal and interest on the A&R Term Loan as of December 31, 2021 (in thousands): 2022 $ 22,500 2023 22,500 2024 22,500 2025 104,688 2026 97,188 2027 89,688 Total minimum payments 359,063 Less: amount representing interest ( 104,063 ) Less: amount representing Paydown Fee ( 5,000 ) Long-term debt, gross 250,000 Discount on notes payable ( 4,779 ) Accretion of Paydown Fee 1,131 Long-term debt $ 246,352 |
Convertible Debt
Convertible Debt | 12 Months Ended |
Dec. 31, 2021 | |
Convertible Debt [Abstract] | |
Convertible Debt | 8. Convertible Debt Convertible Note In December 2021, we issued an aggregate of $ 345.0 million principal amount of 1.875 % convertible senior notes due 2028, or 2028 Notes, in a private placement. The aggregate principal amount on the 2028 Notes sold reflects the full exercise by the initial purchasers of their option to purchase an additional $ 45.0 million in aggregate principal amount of the 2028 Notes. We received total proceeds, net of debt issuance and offering costs of $ 11.0 million, of $ 334.0 million from the offering. We used $ 46.8 million of the net proceeds to pay the costs of the capped call transactions described below. The 2028 Notes are senior unsecured obligations and accrue interest at a rate of 1.875% per annum payable semiannually in arrears on June 15 and December 15 of each year, beginning on June 15, 2022. The 2028 Notes mature on December 15, 2028 , unless converted, redeemed or repurchased in accordance with their terms prior to such date. The 2028 Notes are convertible into cash, shares of our common stock or a combination of cash and shares of our common stock, at our election, on or after December 20, 2027 and prior to the 31st scheduled trading day immediately preceding the maturity date, at an initial conversion rate of 31.4985 shares of our common stock per $ 1,000 principal amount of the 2028 Notes, which is equivalent to an initial conversion price of approximately $ 31.75 per share of our common stock. The 2028 Notes are convertible at the option of the holders prior to the close of business on the second scheduled trading day immediately preceding the maturity date. We may redeem for cash all or any portion of the 2028 Notes, at our option, on or after December 20, 2027 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130 % of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100 % of the principal amount of the 2028 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If we elect to redeem fewer than all the outstanding notes, at least $ 100.0 million aggregate principal amount of notes must be outstanding and not subject to redemption as of, and after giving effect to, delivery of the relevant notice of redemption. We have elected to irrevocably fix the settlement method to physical settlement in the indenture governing the 2028 Notes. No “sinking fund” is provided for the 2028 Notes, which means that we are not required to redeem or retire the 2028 Notes periodically. If we undergo a fundamental change (as set forth in the indenture governing the 2028 Notes), noteholders may require us to repurchase for cash all or any portion of their 2028 Notes at a repurchase price equal to 100% of the principal amount of the 2028 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. As a result of adopting ASU 2020-06, we accounted for the 2028 Notes as a single liability. As of December 31, 2021, the 2028 Notes were recorded at the aggregate principal amount of $ 345.0 million less unamortized issuance costs of $ 10.9 million as a long-term liability on the consolidated balance sheets. The debt issuance costs are amortized to interest expense over the contractual term of the 2028 Notes at an effective interest rate of 2.37 %. The following table presents the components of interest expense related to 2028 Notes (in thousands): For the Year Ended December 31, 2021 Stated coupon interest $ 234 Amortization of debt issuance cost 52 Total interest expense $ 286 As of December 31, 2021, the fair value of the 2028 Notes was $ 431.4 million . The fair value was estimated using a reputable third-party valuation model based on observable inputs and is considered Level 2 in the fair value hierarchy. Capped Calls In connection with the issuance of the 2028 Notes, we entered into capped call transactions with certain of the initial purchasers of the 2028 Notes and other financial institutions, totaling $46.8 million, which we refer to as the Capped Calls. The Capped Calls cover, subject to customary adjustments, the number of shares of our common stock that initially underlie the 2028 Notes (or 10,866,983 shares of our common stock). The Capped Calls have an initial strike price and an initial cap price of $ 31.7475 per share and $ 49.80 per share, respectively, subject to certain adjustments. Conditions that cause adjustments to the initial strike price of the Capped Calls mirror conditions that result in corresponding adjustments to the conversion price of the 2028 Notes. The Capped Calls are expected to offset the potential dilution to our common stock as a result of any conversion of the 2028 Notes, subject to a cap based on the cap price. We considered the Capped Calls as separate financial instruments and not part of the 2028 Notes. We recorded the cost of the Capped Calls, totaling $ 46.8 million, as a reduction to additional paid-in capital within the consolidated statements of stockholders’ equity. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. 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 assets, or ROU assets, or lease liabilities associated with these leases as we did not consider it reasonably certain that we would exercise the options. Lease costs included in operating expense in the consolidated statement of operations and comprehensive loss in relation to these operating leases we re $ 10.5 million and $ 12.4 million for the year ended December 31, 2021 and 2020, respectively. These lease costs included variable lease costs, which were not included within the measurement of our operating ROU assets and operating lease liabilities in the amo unt of $ 3.5 million an d $ 2.6 million for the year ended December 31, 2021 and 2020, respectively. The variable lease cost is comprised primarily of our cost in certain research and development arrangements that contain embedded equipment, and 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 information related to leases for the period reported is as follows (in thousands, except weighted-average remaining lease term and weighted-average discount rate): For the Year Ended December 31, 2021 2020 ROU assets obtained for new operating lease liabilities $ — 205 Adjustment to ROU assets as a result of the lease modification for the Prior Premises — ( 106 ) Operating lease liabilities arising from obtaining ROU assets — 205 Cash paid for amounts included in the measurement of lease liabilities 11,841 7,696 Weighted-average remaining lease term of operating leases (in years) 8.2 9.2 Weighted-average discount rate of operating leases 8.66 % 8.66 % 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 our Prior Premises. 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 building consisting of approximately 164,150 rentable square feet of space, or Substitute Premises, when the Substitute Premises are ready for occupancy, or Substitute Premises Payment Commencement Date. The Lease Amendment has a contractual term, or Substitute Premises Term, of 10 years from the Substitute Premises Payment Commencement Date. The Lease Amendment grants us an option to extend the Lease Amendment for an additional 10 -year period. Future minimum rental payments under the Lease Amendment during the 10 -year term are $ 121.5 million in the aggregate. Under the Lease Amendment, we are obligated to pay to the landlord certain costs, including taxes and operating expenses. The Lease Amendment also provides a tenant inducement allowance of up to $ 27.9 million, of which $ 4.1 million, if utilized, would be repaid to the landlord in the form of additional monthly rent with interest applied. As of December 31, 2020, we have capitalized $ 32.3 million of costs within property and equipment, net for construction of leasehold improvements at the Substitute Premises, which were mostly acquired with the tenant inducement provided under the Lease Amendment. No additional costs were capitalized for the year ended December 31, 2021. On October 1, 2019, we determined that the Lease Amendment for the Substitute Premises had commenced as we had the right to control the Substitute Premises, which was deemed to be a lease modification. We determined the Lease Amendment consisted of two separate contracts under ASC 842. One contract was related to a new ROU asset for the Substitute Premises, which was to be accounted for as a new lease, and the other was related to the modification of the lease term of the Prior Premises. With the commencement of the Lease Amendment, the lease term for the Original Lease was reduced, with the modified lease term expiring on June 1, 2020. We determined that the reduction of the lease term would be accounted for as a lease modification to the Prior Lease. On October 1, 2019, we remeasured the present value of future lease payments during the modified lease term to be $ 2.9 million, using an incremental borrowing rate of approximately 8.78 %. We recognized the amount of remeasurement of the lease liability as an adjustment to the ROU asset, reducing the carrying amount of the ROU asset to zero , and recognized a gain on lease modification of $ 8.3 million for the year ended December 31, 2019. An additional gain on lease modification of $ 1.0 million was recognized for the year ended December 31, 2020 to write off the remaining lease liability related to the Original Lease when we vacated the building. As of December 31, 2021, and 2020, there were no unamortized operating lease liability associated with the Prior Premises. On October 1, 2019, or the Substitute Premises Commencement Date, we measured the present value of future lease payments that included the expected utilization of tenant inducements, using an incremental borrowing rate of approximately 8.66 %. During the year ended December 31, 2020, the landlord paid approximately $ 10.7 million, out of tenant inducement allowances for construction of leasehold improvements at the Substitute Premises, which was recognized as an increase in the operating lease liability. No such payments were received from the landlord for the year ended December 31, 2021. The balances of the ROU asset were approximately $ 48.0 million and $ 50.6 million as of December 31, 2021 and 2020, respectively. The balances for the operating lease liability were approximately $ 79.2 million and $ 83.8 million as of December 31, 2021 and 2020, respectively. After relocating to the Substitute Premise, 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. Upon signing of the Lease Amendment, we re-evaluated the remaining useful life of the leasehold improvements at the Prior Pre mises and started to amortize the leasehold improvements over the remaining period of expected use, resulting in an acceleration of depreciation expenses for approximately zero and $ 3.8 million for the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, the maturities of our operating lease liabilities under Topic 842 were as follows (in thousands): Year ending December 31, Amount 2022 12,222 2023 12,584 2024 12,948 2025 13,368 2026 13,803 Thereafter 46,703 Total lease payments 111,628 Less: Imputed interest ( 32,452 ) Present value of operating lease liabilities $ 79,176 Rent expense was $ 9.9 million f or the year ended December 31, 2021, $ 9.8 million for the year ended December 31, 2020, and $ 5.2 million for the year ended December 31, 2019. 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. Indemnifications We indemnify each of our directors and officers for certain events or occurrences, subject to certain limits, while the director or the officer is or was serving at our request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and bylaws. The term of the indemnification period lasts as long as a director or an officer may be subject to any proceeding arising out of acts or omissions of such director in such capacity. The maximum amount of potential future indemnification is unlimited; however, we currently hold director and officer liability insurance. This insurance allows the transfer of risk associated with our exposure and may enable us to recover a portion of any future amounts paid. We believe that the fair value of these indemnification obligations is minimal. Accordingly, we have not recognized any liabilities relating to these obligations for any period presented. 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. Contingent Payments In December 2019, we entered into an agreement, or Syros Agreement, with Syros Pharmaceuticals, Inc., “Syros”, to discover, develop and commercialize novel therapies for SCD and beta thalassemia. Under the agreement, Syros will use its leading gene control platform to identify therapeutic targets and discover drugs that potentially induce fetal hemoglobin, and we have an option to obtain an exclusive worldwide license to develop, manufacture and commercialize any compounds or products resulting from the agreement, subject to Syros’ option to co-promote the first product in the United States. If we exercise the option, we will be responsible for all development, manufacture, regulatory activities and commercialization of the compound or product. Syros and we will be responsible for our own costs incurred to conduct research activities, except that we will fund up to a total of $ 40.0 million in preclinical research for at least three years. Unless earlier terminated or extended, the research program under the agreement will end on the third anniversary of the agreement. Under the terms of the Syros Agreement, we paid Syros an upfront payment of $ 20.0 million in January 2020, and, if we exercise our option under the agreement, we may be obligated to pay Syros up to $ 315.0 million in option exercise, development, regulatory, commercialization and sales-based milestones per product candidate and product resulting from the agreement. We will also be obligated to pay Syros, subject to certain reductions, tiered mid- to high-single digit royalties as percentages of calendar year net sales on any product resulting from the agreement. No milestone payments were recognized for the year ended December 31, 2020 and 2021. We have recognized $ 11.5 million of research reimbursement to Syros in our research and development cost for the year ended December 31, 2021. In March 2021, we entered into a license agreement with Sanofi, or the Sanofi Agreement, pursuant to which Sanofi granted us an exclusive and sublicensable license under certain patent rights and know-how controlled by Sanofi to use, develop, manufacture, commercialize and otherwise exploit certain compounds, including compounds directed against or that modulate one of two specified targets and any product containing a licensed compound for the diagnosis, prevention and/or treatment of human diseases worldwide. Sanofi retains rights to use its know-how to conduct non-clinical development of, and to manufacture, compounds other than the licensed compounds or licensed products under the Sanofi Agreement. Under the Sanofi Agreement, we paid to Sanofi an upfront payment of $ 2.25 million and have agreed to pay up to an aggregate of $ 351.0 million in milestone payments upon the achievement of certain development, regulatory, commercial and sales-based milestones relating to the licensed products. We also agreed to pay Sanofi royalties in the low single-digit to mid-single-digit percentages of annual net sales of licensed products, which are payable on a licensed product-by-licensed product and country-by-country basis commencing on the first commercial sale of a licensed product in such country and continuing until the latest of (i) ten years after the first commercial sale of such licensed product in such country, (ii) the expiration of the last valid claim under the licensed patent rights or certain derived patent rights that cover such licensed product in such country, and (iii) the expiration of regulatory exclusivity for such licensed product in such country. The royalty rate is subject to reduction under certain circumstances . In August 2018, we entered into the License Agreement, or Roche Agreement, with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (together, “Roche”), pursuant to which Roche granted us an exclusive and sublicensable worldwide license under certain patent rights and know-how to develop and commercialize inclacumab for all indications and uses, except diagnostic use. Roche retained a non-exclusive, worldwide, perpetual, royalty-free license to inclacumab solely for any diagnostic use. We have paid Roche an upfront payment of $ 2.0 million in the year ended December 31, 2019, which was recognized in our research and development costs for year ended December 31, 2018. In addition, we have recognized $ 5.3 million and $ 2.0 million clinical development milestone payments in our research and development costs for the years ended December 31, 2021 and 2020, respectively. Under our agreement, we are obligated to make contingent payments to Roche totaling approximately $ 125.5 million in milestone payments for the SCD indication, including up to $ 40.5 million based on achievement of certain clinical development and regulatory milestones for inclacumab in the SCD indication and up to $ 85.0 million based on achievement of certain thresholds for annual net sales of inclacumab. In addition, we are obligated to make contingent payments to Roche of up to an aggregate of $ 6.4 million in milestone payments that are owed to third parties based on achievement of such clinical development and regulatory milestones for inclacumab. We are also obligated to make contingent payments to Roche up to $ 19.25 million in milestone payments based on achievement of certain clinical development and regulatory milestones for inclacumab for any indication other than the SCD indication. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | 10. Stockholders’ Equity Common Stock Reserved for Issuance We have reserved sufficient shares of common stock for issuance upon the exercise of stock options, vesting of restricted stock units and restricted shares subject to future vesting. Common stockholders are entitled to dividends if and when declared by the board of directors, subject to the prior rights of any preferred stockholders. As of December 31, 2021 , no common stock dividends had been declared by the board of directors. We have reserved shares of common stock for future issuance as follows: December 31, 2021 2020 Restricted stock units 3,437,069 2,625,056 Options issued and outstanding 3,553,763 3,327,330 Shares available for future grant under the 2015 Plan and 2017 Inducement Equity Plan 6,473,318 6,018,567 Employee stock purchase plan 320,003 254,590 2028 Notes 13,855,407 — Total 27,639,560 12,225,543 |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-based Compensation | 11. Share-based Compensation Amended and Restated 2017 Inducement Equity Plan In January 2017, we adopted the 2017 Inducement Equity Plan and thereafter amended and restated the plan, or the 2017 Inducement Plan. Under the 2017 Inducement Plan, shares of our common stock are reserved for the issuance of non-qualified stock options and other equity-based awards to induce highly-qualified prospective officers and employees who are not currently employed by us or our subsidiaries to become employed with our company. Awards granted under the 2017 Inducement Plan expire no later than 10 years from the date of grant. For non-statutory stock options, the option price shall not be less than 100 % of the fair market value on the day of grant. Options granted generally vest over four years and vest at a rate of 25 % upon the first anniversary of the issuance date and 1 /16 th per quarter over the following three years thereafter. Restricted stock units granted generally vest at a rate of 25 % upon the first anniversary of the issuance date and 1 /8 th per half year over the following three years thereafter. The number of shares initially reserved for grant is subject to adjustment for reorganization, recapitalization, stock dividend, stock split, or similar changes in our capital stock. As of December 31, 2021 , there were 1,662,072 shares reserved for the future issuance of equity awards under the 2017 Inducement Plan. Amended and Restated 2015 Stock Option and Incentive Plan In 2015, we adopted 2015 Stock Option and Incentive Plan, which was thereafter amended and restated as the Amended and Restated 2015 Stock Option and Incentive Plan, or 2015 Plan. Under the 2015 Plan, shares of our common stock are reserved for the issuance of stock options, restricted stock, and other equity-based awards to employees, non-employee directors, and consultants under terms and provisions established by the Board of Directors and approved by our stockholders at inception. Awards granted under the 2015 Plan expire no later than 10 years from the date of grant. For incentive stock options and non-statutory stock options, the option price shall not be less than 100 % of the fair market value on the day of grant. If at the time we grant an option and the optionee directly or by attribution owns stock possessing more than 10% of the total combined voting power of all our classes of stock, the option price is required to be at least 110 % of the fair market value on the day of grant. Options granted typically vest over a 4 -year period but may be granted with different vesting terms. Restricted stock units granted generally vest at a rate of 1/8 th per half year over the 4 -year period. As of December 31, 2021 , there were 4,811,246 shares reserved for the future issuance of equity awards under the 2015 Plan. 2012 Stock Option and Grant Plan In 2012, we adopted the 2012 Stock Option and Grant Plan, or 2012 Plan, under which our Board of Directors was authorized to grant incentive stock options to employees, including officers and members of the Board of Directors who are also employees of ours, and non-statutory stock options (options that do not qualify as incentive options) and/or our restricted stock and other equity-based awards to our employees, officers, directors, or consultants. Awards granted under the 2012 Plan expire no later than 10 years from the date of grant. Upon adoption of the 2015 Plan, no new awards or grants are permitted under the 2012 Plan. Stock Option Activity The following table summarizes activity under our stock option plans, including the 2017 Inducement Plan, 2015 Plan and the 2012 Plan and related information (in thousands, except share and per share amounts and term): Number of Options Weighted-Average Exercise Price Weighted-Average remaining contractual term (years) Aggregate Intrinsic Value Outstanding—December 31, 2020 3,327,330 $ 42.07 7.02 Options granted 722,280 42.43 Options exercised ( 136,929 ) 20.05 Options canceled ( 358,918 ) 51.94 Outstanding—December 31, 2021 3,553,763 $ 42.00 6.68 $ 11,763 Vested and exercisable—December 31, 2021 2,504,984 $ 38.79 5.92 $ 11,749 The aggregate intrinsic value was calculated as the difference between the exercise price of the options and the fair value of our common stock as of December 31, 2021. The total intrinsic value of options exercised was $ 2.4 million for the year ended December 31, 2021, $ 23.0 million for the year ended December 31, 2020, and $ 23.5 million for the year ended December 31, 2019. The weighted-average estimated fair value of stock options granted was $ 26.97 for the year ended December 31, 2021, $ 40.76 for the year ended December 31, 2020, and $ 32.30 for the year ended December 3 1, 2019. Stock Options Granted to Employees with Service-based Vesting Valuation Assumptions The fair values of stock options granted to employees were calculated using the following assumptions: Year Ended December 31, 2021 2020 2019 Expected term (in years) 5.3 - 6.1 5.1 - 6.1 5.3 - 6.1 Volatility 68.1 %- 72.7 % 69.6 %- 71.8 % 69.8 %- 72.2 % Risk-free interest rate 0.9 %- 1.1 % 0.3 %- 1.8 % 1.4 %- 2.6 % Dividend yield — — — In determining the fair value of the options granted, we used the Black-Scholes-Merton option-pricing model and assumptions discussed below. Expected Term —Our expected term represents the period that the options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). We have limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for our stock option grants. Expected Volatility —We use peer company price volatility as well as the historical volatility of our own common stock to estimate expected stock price volatility due to the limited trading history for our common stock since our IPO in August 2015. When selecting comparable publicly traded biopharmaceutical companies on which we have based our expected stock price volatility, we selected companies with comparable characteristics to us, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected life of the stock-based awards. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. We will continue to apply this process until a sufficient amount of historical information regarding the volatility of our own stock price becomes available. Risk-Free Interest Rate —The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of option. Expected Dividend —We have never paid dividends on our common stock and have no plans to pay dividends on our common stock. Therefore, we used an expected dividend yield of zero . Restricted Stock Units The Compensation Committee of our Board of Directors has granted restricted stock units, or RSUs, to our employees. RSUs are share awards that entitle the holder to receive freely tradable shares of our common stock upon the completion of a specific period of continued service. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. RSUs granted are valued at the market price of our common stock on the date of grant. We recognize noncash compensation expense for the fair value of RSUs on a straight-line basis over the requisite service period of these awards. The following table summarizes activity of RSUs granted to employees with service-based vesting under the 2017 Inducement Plan and 2015 Plan and related information (in thousands, except share, per share amounts and vesting period): Weighted- Weighted- Average Average Remaining Aggregate Number Grant Date Vesting Intrinsic of RSUs Fair Value Period (years) Value Non-vested units — December 31, 2020 2,210,356 $ 57.80 1.45 $ 95,731 RSUs granted 2,222,428 38.63 RSUs vested ( 863,373 ) 54.39 RSUs forfeited ( 583,142 ) 53.46 Non-vested units — December 31, 2021 2,986,269 $ 45.37 1.45 $ 87,048 Market-Condition Awards Granted to Employees Beginning in June 2020, the Compensation Committee of our Board of Directors has granted awards of RSUs to certain of our senior man agement, 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 450,800 RSUs outstanding as of December 31, 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. The target prices and vesting tranches are set forth in the table below: Stock Price Targets Number of Units Allowed $ 109.20 90,160 $ 145.60 157,780 $ 182.00 202,860 The grant date fair value of the 2020 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 activity of the Market-Condition RSU Awards under the 2015 Plan and related information (in thousands, except share, per share amounts and vesting period): Weighted- Weighted- Average Average Remaining Aggregate Number Grant Date Vesting Intrinsic of RSUs Fair Value Period (years) Value Non-vested market-condition awards — December 31, 2020 414,700 $ 49.95 1.21 $ 17,961 Granted 84,800 13.88 1.73 Vested — — — Forfeited ( 48,700 ) 49.95 0.21 Non-vested market condition awards — December 31, 2021 450,800 $ 43.17 0.30 $ 13,195 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 $ 37.20 Expected term 3.1 years Volatility 66.6 % Risk-free interest rate 0.3 % Dividend yield — At December 31, 2021 , total unrecognized compensation expense related to non-vested market-condition awards was $ 3.7 million, which is expected to be recognized over their respective remaining derived service periods. The weighted average derived service period is 0.30 years. For the year ended December 31, 2021 , we recognized $ 8.4 million in stock-based compensation expense related to the Market-Condition RSU Awards. Employee Stock Purchase Plan In July 2015, we adopted 2015 Employee Stock Purchase Plan, which was thereafter amended and restated as the Amended and Restated 2015 Employee Stock Purchase Plan, or 2015 ESPP. Under the 2015 ESPP, our employees may purchase common stock through payroll deductions at a price equal to 85 % of the lower of the fair market value of the stock at the beginning of the offering period or at the end of each applicable purchase period. The 2015 ESPP provided for offering periods of six months in duration. As approved by the Compensation Committee of the Board of Directors in December 2017, the 2015 ESPP provides for offering periods of two years in duration with purchase periods occurring every six months during an offering period. The purchase periods end on either January 31 or July 31. Contributions under the 2015 ESPP are limited to a maximum of 15 % of an employee’s eligible compensation. ESPP purchases are settled with common stock from the ESPP’s previously authorized and available pool of shares. The 2015 ESPP was amended and restated in March 2020. The amended 2015 ESPP moves the timing of the purchase periods end on either February 28 (or February 29, if applicable) or August 31. Once each of the existing offering period ends, the next offering period immediately following will be a one-time transitional offering period, starting with one 7-month purchase period followed by three 6-month purchase periods. After this one-time transition offering period, all following offering periods will remain for two years with four equal six-month purchase periods. During the year ended December 31, 2021, 134,587 shares were issued under the ESPP for $ 4.3 million. The fair values of the rights granted under the 2015 ESPP were calculated using the following assumptions: Year Ended December 31, 2021 2020 Expected term (in years) 0.5 – 2.1 0.5 – 2.1 Volatility 54.4 - 84.8 % 47.0 - 77.0 % Risk-free interest rate 0.1 - 0.2 % 0.1 - 1.5 % Dividend yield — % — % Stock-Based Compensation Expense Total stock-based compensation recognized by functions was as follows (in thousands): Year Ended December 31, 2021 2020 2019 Research and development $ 21,297 $ 18,061 $ 19,140 Selling, general and administrative 57,374 53,416 26,511 Total stock-based compensation expense $ 78,671 $ 71,477 $ 45,651 Unrecognized Stock-Based Compensation Expense and Weighted-Average Remaining Amortization Period As of December 31, 2021, the unrecognized stock-based compensation cost, and the estimated weighted-average amortization period, using the straight-line attribution method, was as follows (in thousands, except amortization period): Weighted- average Unrecognized remaining Compensation amortization Cost period (years) Stock Options $ 30,278 2.3 Restricted stock units 116,677 2.6 Market-Condition restricted stock units 3,672 2.5 ESPP 689 — Total unrecognized stock-based compensation expense $ 151,316 2.5 |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2021 | |
Postemployment Benefits [Abstract] | |
Defined Contribution Plan | Defined Contribution Plan In 2013, we began to sponsor a 401(k) retirement plan, in which substantially all of our full-time employees in United States are eligible to participate. Eligible participants may contribute a percentage of their annual compensation to this plan, subject to statutory limitations. We also contributed to employee pension plan for our employees in Switzerland and defined contribution plans for other European employees. We recorded contribution expenses of $ 3.2 million for the year ended December 31, 2021, $ 2.1 million for the year ended December 31, 2020, and $ 1.4 million for the year ended December 31, 2019, for our contributions made to the plans for eligible participants. |
Related Parties Transaction
Related Parties Transaction | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Parties Transaction | 14. Related Parties Transaction In October 2021, we donated $ 0.5 million to The GBT Foundation, a California nonprofit public benefit corporation we established earlier in 2021. The GBT Foundation is a related party affiliate as certain of our officers also serve, without additional compensation, as directors or officers of The GBT Foundation. The purpose of The GBT Foundation is to fund programs that will support people within the sickle cell disease community and beyond through education, empowerment, improved healthcare access and enhanced health equity. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes The components of the loss before income taxes were as follows (in thousands): Year Ended December 31, 2021 2020 2019 Loss before provision for income taxes: United States $ ( 305,217 ) $ ( 247,327 ) $ ( 266,595 ) International 2,603 ( 226 ) ( 167 ) $ ( 302,614 ) $ ( 247,553 ) $ ( 266,762 ) The components of our income tax expense were as follows (in thousands): Year Ended December 31, 2021 2020 2019 Current expense (benefit) $ — $ — $ — Federal — — — State — — — Foreign 477 — — — — — Deferred tax expense — — — Federal — — — State — — — Foreign — — — Total income tax expense $ 477 $ — $ — We recorded an income tax expense of $ 0.5 million for the year ended December 31, 2021. The 2021 income tax expense was primarily related to the foreign tax expenses on earnings of our foreign subsidiaries. No provision for income taxes was recorded for the years ended December 31, 2020 and December 31, 2019. We have incurred net operating losses for all the periods presented. We have not reflected any benefit of such net operating loss (NOL) carryforwards in the accompanying consolidated financial statements. We have established a full valuation allowance against the related deferred tax assets due to the uncertainty surrounding the realization of such assets. The effective tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2021 2020 2019 Federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes 5.7 7.4 9.7 Federal and state tax credits 2.2 4.3 4.9 Change in valuation allowance ( 25.6 ) ( 32.4 ) ( 37.2 ) Foreign rate differential — — — Officer compensation limitation ( 1.3 ) ( 0.8 ) ( 1.0 ) Stock based compensation/Non-deductible changes in fair value ( 1.8 ) 0.6 1.7 Liquidation of foreign entities — — 0.9 Other ( 0.4 ) ( 0.1 ) — Provision for Taxes - 0.2 % 0.0 % 0.0 % The components of the deferred tax assets and liabilities are as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 275,367 $ 216,092 Tax credits 85,542 76,684 Operating lease liability 21,422 23,147 Accruals and reserves 7,517 6,503 Stock based compensation 17,445 14,981 Deferred Interest Expense 3,938 — Intangibles 9,629 8,507 Other 1,391 904 Gross deferred tax assets 422,251 346,818 Valuation allowance ( 403,095 ) ( 325,710 ) Net deferred tax assets 19,156 21,108 Operating lease – ROU asset ( 12,991 ) ( 13,975 ) Property and equipment ( 6,165 ) ( 7,050 ) Other — ( 83 ) Gross deferred tax liabilities ( 19,156 ) ( 21,108 ) Net deferred tax assets $ — $ — Realization of the deferred tax assets is dependent upon future taxable income, if any, the amount and timing of which are uncertain. We have established a valuation allowance to offset deferred tax assets as of December 31, 2021 and 2020 due to the uncertainty of realizing future tax benefits from our net operating loss carryforwards and other deferred tax assets. The valuation allowance increased approximately $ 77.4 million and $ 80.7 million during the years ended December 31, 2021 and 2020, respectively. The increase in the valuation allowance is mainly related to the increase in net operating loss carryforwards and the increase in tax credits generated during the respective taxable years. As of December 31, 2021, we had federal net operating loss carryforwards of approximately $ 1.0 billion to offset future federal taxable income, with $ 207.3 million available through 2037 and $ 840.2 million available indefinitely. We also had state net operating loss carryforwards of approximately $ 787.0 million that may offset future state taxable income through 2040 . Current federal and state tax laws include substantial restrictions on the utilization of net operating losses and tax credits in the event of an ownership change. Even if the carryforwards are available, they may be subject to annual limitations, lack of future taxable income, or future ownership changes that could result in the expiration of the carryforwards before they are utilized. At December 31, 2021, we recorded a 100 % valuation allowance against our net deferred tax assets of approximately $ 403.1 million, as at that time our management believed it was uncertain that they would be fully realized. If we determine in the future that we will be able to realize all or a portion of our net operating loss carryforwards, an adjustment to valuation allowance would increase net income in the period in which we make such a determination. In general, if we experience a greater than 50 percentage point aggregate change in ownership over a three-year period (a Section 382 ownership change), utilization of our pre-change NOL carryforwards are subject to an annual limitation under Section 382 of the Internal Revenue Code (California and certain other states have similar laws). The annual limitation generally is determined by multiplying the value of our stock at the time of such ownership change (subject to certain adjustments) by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the NOL carryforwards that were generated prior to 2018 before utilization. We have not utilized any NOL carryovers through December 31, 2021. No liability related to uncertain tax positions is recorded on the consolidated financial statements. All uncertain tax positions are currently recorded as a reduction to our deferred tax asset. It is our policy to include penalties and interest expense related to income taxes as a component of other expense and interest expense, respectively, as necessary. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): December 31, 2021 2020 Balance at beginning of year $ 24,446 $ 21,598 Additions based on tax positions related to current year 3,060 3,346 Decreased for prior period positions ( 238 ) ( 498 ) Unrecognized tax benefit—December 31 $ 27,268 $ 24,446 We do not expect that our uncertain tax positions will materially change in the next twelve months. The reversal of the uncertain tax benefits will not impact our effective tax rate as we continue to maintain a full valuation allowance against our deferred tax assets. We file federal, state and foreign income tax returns in the United States and in multiple foreign jurisdictions. We are not currently under examination by income tax authorities in federal, state or other jurisdictions. All tax returns will remain open for examination by the federal and state authorities for three and four years, respectively, from the date of utilization of any net operating loss or credits. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 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: Year Ended December 31, 2021 2020 2019 Options to purchase common stock 3,553,763 3,327,330 3,573,860 Convertible Notes (as converted to common stock) 10,866,983 — — Restricted stock units 3,437,069 2,625,056 1,848,772 Total 17,857,815 5,952,386 5,422,632 |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | 16. Subsequent Event In February 2022, the European Commissions granted marketing authorization for Oxbryta for the treatment of hemolytic anemia (which is low hemoglobin due to red blood cell destruction) due to SCD in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea), and such authorization includes all Member States of the European Union, as well as the additional Member States of the European Economic Area ( Iceland, Liechtenstein and Norway). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. Certain reclassifications have been made to prior period financials to conform to the current year presentation. These reclassifications have no impact on previous reported total assets, total liabilities, net loss, stockholders’ equity or operating cash flows. |
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 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. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and balances have been eliminated upon consolidation. |
Segment Reporting | Segment Reporting We operate in a single segment which is development of pharmaceutical products and this is based upon the way the business is organized for making operating decisions and assessing performance. All property and equipment is maintained in the United States. Our product sales are primarily in the United States. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents, which consist primarily of amounts invested in money market accounts, are stated at fair value. |
Investments in Marketable Securities | Investments in Marketable Securities We invest in marketable securities, primarily money market funds, corporate debt securities, government securities, government agency securities, and certificates of deposits. We classify our marketable securities as available-for-sale securities and report them at fair value in cash equivalents or marketable securities on the consolidated balance sheets with related unrealized gains and losses included within accumulated other comprehensive income (loss) on the consolidated balance sheets. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income on the consolidated statements of operations and comprehensive loss. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in interest and other income (loss). The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. We regularly review all of our investments to determine whether unrealized losses have resulted from a credit loss or other factors under ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326). Our review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether we have the intent to sell the securities and whether it is more likely than not that we will be required to sell the securities before the recovery of their amortized cost basis. The unrealized losses on the Company’s available-for-sale securities for the years ended December 31, 2021, 2020 or 2019, were caused by fluctuations in market value and interest rates as a result of the economic environment. The Company concluded that an allowance for credit losses was unnecessary as of December 31, 2021 and that there were no impairments as of December 31, 2021, 2020 or 2019 considered as other-than-temporary because the decline in the market value was attributable to changes in market conditions and not credit quality, and that it is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell these investments prior to recovery of their cost basis or recovery of fair value. When we determine that the decline in estimated fair value of an investment is below the amortized cost basis and the decline is other than temporary, we reduce the carrying value of the security and record a loss for the amount of such decline. |
Fair Value Measurement | Fair Value Measurement The carrying amounts of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. |
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 year ended December 31, 2021 , our three largest customers represented approximately 99.8 % of our product revenue and 100.0 % of our accounts receivable balance at December 31, 2021. Major Suppliers We do not currently have any of our own manufacturing facilities, and therefore we 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 two third-party manufacturers that are 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. |
Accounts Receivables, net | Accounts Receivables, net Accounts receivables are recorded net of estimates of variable consideration for which reserves are established and which result from discounts and chargebacks that are offered within contracts between us and a limited number of specialty pharmacies and a specialty distributor in the United States. These reserves are classified as reductions of accounts receivable. We estimate the allowance for doubtful accounts using the current expected credit loss model, or CECL model. Under the CECL model, the allowance for doubtful accounts reflects the net amount expected to be collected from the account receivables. We evaluate the collectability of these cash flow based on the asset’s amortized cost, the risk of loss even when that risk is remote, losses over an asset’s contractual life, and other relevant information available to us. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature and history of our accounts receivable, we determined that an allowance for doubtful accounts was not required at December 31, 2021 . |
Inventories | Inventories Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, first out, or FIFO, basis. We use actual costs to determine our cost basis for inventories. Inventories consist of raw materials, work-in-process, and finished goods. We began capitalizing costs as inventory when the product candidate received regulatory approval. Prior to regulatory approval, we recorded inventory costs related to product candidates as research and development expenses. We periodically assess the recoverability of our inventory and reduce the carrying value of the inventory when items are determined to be obsolete, defective or in excess of forecasted sales requirements. Inventory write-downs for excess, defective and obsolete inventory are recorded as a cost of sales. There have been no write-downs of our inventories for the periods presented. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is provided using the straight-line method over the estimated useful lives of the assets, which is three years for computer equipment and five years for laboratory equipment. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the improvements. Depreciation and amortization begins at the time the asset is placed in service. Maintenance and repairs are charged as expense in the statements of operations and comprehensive loss as incurred. Upon sale or retirement of assets, the cost and related accumulated depreciation and amortization are removed from the consolidated balance sheet and any resulting gain or loss is reflected in operations. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets We evaluate our long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. Recoverability of these assets is measured by comparison of the carrying amount of each asset to the future undiscounted cash flows the asset is expected to generate over its remaining life. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset. There have been no impairments of our long-lived assets for the periods presented. |
Restricted Cash | Restricted Cash Restricted cash consists of cash deposits held by our financial institution as collateral for our letter of credit under our facility lease. |
Accruals of Research and Development and Manufacturing Costs | Accruals of Research and Development and Manufacturing Costs We record accruals for estimated costs of research, nonclinical and clinical studies and manufacturing development. These costs are a significant component of our research and development expenses. A substantial portion of our ongoing research and development activities are conducted by third-party service providers, including contract research organizations and contract manufacturing organizations. We also accrue for estimated costs of manufacturing activities for inventories which are a significant component of the cost of our inventory. We accrue the costs incurred under our agreements with these third parties based on actual work completed in accordance with agreements established with these third parties. We determine the accruals for research and development costs through discussions with internal personnel and external service providers as to the progress or stage of completion of the clinical studies and the agreed-upon fee to be paid for such services. The accrual for contract manufacturing activities is based on an estimate of manufacturing activities completed to date, contractual rates, and amounts invoiced and paid to date at the end of each reporting period. We determine the percentage of manufacturing activities completed to date based on discussions with the contract manufacturing organizations, oversight of the manufacturing activities and anticipated timeline. Actual clinical and manufacturing services performed, number of subjects enrolled, and the rate of subject enrollment may vary from our estimates, resulting in adjustments to research and development costs or inventories in future periods. Changes in these estimates that result in material changes to our accruals of research and development and manufacturing costs could materially affect our results of operations or amounts of inventories capitalized. |
Revenue Recognition | Revenue Recognition Pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers , or ASC 606 , we recognize revenue upon transfer of control of promised products or services to customers in an amount that reflects the consideration we expect to receive in exchange for those products or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect substantially all of the consideration we are entitled to in exchange for the goods or services we transfer to the customer. Product sales, net Our product sales consist of U.S. sales of Oxbryta, which we began shipping to customers in December 2019. Prior to December 2019, we had no product sales. We sell Oxbryta in the United States to a limited number of specialty pharmacies and a specialty distributor ( each a “Customer” or collectively our “Customers) . These agreements with our Customers provide for transfer of title to the product at the time the product has been delivered to the Customers. The Customers subsequently dispense our products directly to a patient or resell our products to hospitals and certain pharmacies. We recognize revenue on product sales when the Customers obtain control of our product, which occurs at a point in time, typically upon delivery to our Customers. It is at that point that we have a right to payment and that our Customers obtain title and the risks and rewards of ownership. Shipping and handling activities are considered to be fulfillment activities rather than a separate performance obligation. Payment terms are typically 30-60 days following delivery to our Customers. We consider the effects of items that can decrease the transaction price, such as variable consideration and consideration payable to Customers or payor. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. We record revenue from product sales after considering the impact of various forms of variable considerations. Each of these items of variable consideration we record at the time of revenue recognition and requires significant estimates, judgment and information obtained from external sources. If management’s estimates differ from actual results, we will record adjustments that would affect product sales in the period of adjustment: Rebates: We are subject to government mandated rebates for Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, and other government health care programs in the United States. Rebate amounts are based upon contractual agreements or legal requirements with public sector benefit providers. We use the expected-value method for estimating these rebates based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on third party data from the specialty pharmacies and specialty distributor. Estimates for these rebates are adjusted quarterly to reflect the most recent information. We record an accrued liability for unpaid rebates related to products for which control has been transferred to Customers. Prompt payment discounts : We provide discounts to our Customers if they pay for our products within a defined period of time after title transfers, which terms are explicitly stated in the contract. We use the most-likely-amount method for estimating prompt payment discounts. We expect that our Customers will earn prompt payment discounts. As a result, we deduct the full amount of those discounts from total product sales when revenues are recognized and record these discounts as a reduction of accounts receivable. Co-payment assistance: We provide co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. We use the expected-value method for estimating co-payment assistance based on estimates of program redemption using data provided by third-party administrators. Estimates for the co-payment assistance are adjusted quarterly to reflect actual experience. We record an accrued liability for unredeemed co-payment assistance related to products for which control has been transferred to Customers. Medicare Part D Coverage Gap: The Medicare Part D coverage gap is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States, which mandates manufacturers to fund a portion of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Funding of the coverage gap is generally invoiced and paid in arrears. We estimate the impact of the Medicare Part D coverage gap using the expected-value method based on an amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters. Estimates for the impact of the Medicare Part D coverage gap are adjusted quarterly to reflect actual experience. We record an accrued liability for unpaid reserves related to the Medicare Part D coverage gap. Product returns: Consistent with industry practice, we offer limited product return rights and generally allow for the return of product that is damaged or defective, or within a few months prior to and up to a few months after the product expiration date. We consider several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, prescription trends, and other relevant factors. We expect product returns to be immaterial. Other than these limited returns, we do not provide any product warranties. Chargebacks : Chargebacks are discounts that occur when contracted parties purchase directly from a specialty distributor. Contracted parties, which currently consist primarily of Public Health Service Institutions and federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty distributor, in turn, charge back the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the contracted parties to us. The reserves for chargeback are based on known sales to contracted parties. We establish the reserves for chargebacks in the same period that the related revenue is recognized, resulting in a reduction of product revenue and receivables. Distributor fees: Our specialty distributor provides distribution services to us for a fee, based on a contractually determined fixed percentage of sales. We estimate these distributor fees and record such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue. We record an accrued liability for unpaid distributor fees. |
Cost of Sales | Cost of Sales Cost of sales consists primarily of direct and indirect costs related to the manufacturing of Oxbryta products sold, including third-party manufacturing costs, packaging services, freight, storage costs, allocation of overhead costs of employees involved with production, and Oxbryta net sales-based royalties payable to the Regents of the University of California. Costs incurred prior to the FDA’ s initial approval of Oxbryta in November 2019 have been recorded as research and development expense in our consolidated statement of operations and comprehensive loss. |
Leases | Leases In accordance with Accounting Standards Codification, Topic 842, Leases , or ASC 842, we determine if an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether we have the right to control the identified asset. Right-of-use, or ROU, assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and exclude lease incentives received and initial direct costs incurred, as applicable. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. We consider our credit risk, term of the lease, and total lease payments and adjust for the impact of collateral, as necessary, when calculating our incremental borrowing rates. The lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise any such options. Lease cost for our operating leases is recognized on a straight-line basis over the lease term. We have elected to not separate lease and non-lease components for any leases within its existing classes of assets and, as a result, account for any lease and non-lease components as a single lease component. We have also elected to not recognize any leases within its existing classes of assets with a term of 12 months or less. ROU assets and operating lease liabilities are remeasured upon certain modifications to leases using the present value of remaining lease payments and estimated incremental borrowing rate upon lease modification. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as a change in equity of a business enterprise during a period, resulting from transactions from non-owner sources. Our comprehensive income (loss) is comprised of net loss and changes in unrealized gains and losses on our marketable securities and cumulative translation adjustment. |
Research and Development | Research and Development Research and development costs are expensed as incurred and consist of salaries and benefits, stock-based compensation expense, lab supplies and facility costs, as well as fees paid to other nonemployees and entities that conduct certain research and development activities on our behalf. Amounts incurred in connection with license agreements are also included in research and development expense. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are delivered or the services are performed. |
Long-term Debt | Long-term Debt Long-term debt consists of our loan agreement, or Term Loan, with funds managed by Pharmakon Advisors LP, which are BioPharma Credit PLC, as collateral agent and a lender, and Biopharma Credit Investments V (Master) LP, as a lender, and collectively, the Lenders. We accounted for the Term Loan as a debt financing arrangement. Interest expense is accrued using the effective interest rate method over the estimated period the debt will be repaid. Debt issuance costs have been recorded as a debt discount in our consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the Term Loan using the effective interest rate method. We consider whether there are any embedded features in our debt instruments that require bifurcation and separate accounting as derivative financial instruments pursuant to Accounting Standards Codification, or ASC, Topic 815, Derivatives and Hedging . There are no embedded features identified from our Term Loan that require bifurcation and separating accounting. |
Convertible Notes | Convertible Notes We evaluate all conversion, repurchase and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative. We accounted for the 2028 Notes (see Note 8) as a long-term liability equal to the proceeds received from issuance, including the embedded conversion feature, net of the unamortized debt issuance and offering costs on the consolidated balance sheets. The conversion feature is not required to be accounted for separately as an embedded derivative. We amortize debt issuance and offering costs over the contractual term of the 2028 Notes, using the effective interest method, as interest expense on the consolidated statements of operations. |
Capped Calls | Capped Calls We evaluate financial instruments under ASC 815. In December 2021, in connection with the issuance of the Convertible Notes, we entered into the Capped Calls (see Note 8). The Capped Calls cover the same number of shares of common stocks that initially underlie the 2028 Notes (subject to anti-dilution and certain other adjustments). The Capped Calls meet the definition of derivative under ASC 815. In addition, the Capped Calls meet the conditions in ASC 815 to be recorded as a reduction to additional paid-in capital in stockholders’ equity and are not subsequently remeasured as long as the conditions for equity classification continue to be met. |
Stock-based Compensation | Stock-Based Compensation We measure and recognize stock-based compensation expense, including employee and non-employee equity awards, based on fair value at the grant date. We use the Black-Scholes-Merton option-pricing model to calculate fair value. Stock-based compensation expense recognized in the consolidated statements of operations is based on stock awards ultimately vested, taking into consideration actual forfeitures. |
Income Taxes | Income Taxes We use the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to our lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. We recognize benefits of uncertain tax positions if it is more likely than not that such positions will be sustained upon examination based solely on their technical merits, as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. It is our policy to include penalties and interest expense related to income taxes as a component of other expense and interest expense, respectively, as necessary. To date, there have been no interest or penalties incurred in relation to the unrecognized tax benefits. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given our net loss. In calculating dilutive instruments we use the if-converted method for the convertible debt upon adopting ASU No.2020-06. |
Recent Accounting Pronouncements | 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 . The guidance eliminates certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period, and the recognition of deferred tax liabilities for outside basis differences. It also clarifies and simplifies other aspects of the accounting for income taxes. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, and the applicable amendments will be applied on a prospective basis. We adopted ASU No. 2019-12 in the first quarter of 2021 and applied the guidance prospectively. The only aspect of ASU 2019-12 that is currently applicable to us is the removal of the exception related to intraperiod tax allocation. We began applying the general methodology regarding the intraperiod allocation of tax expense in 2021. After the adoption of ASU 2019-12, in periods where we have a loss from continuing operations, the amount of taxes attributable to continuing operations will be determined without regard to the tax effect of other items, including changes in unrealized gains related to marketable securities. The adoption of this standard did not have a material impact on our consolidated financial statements. In August 2020, FASB issued ASU No. 2020-08, Codification Improvement to Subtopic 310-20, Receivables – Nonrefundable Fees and Other Costs . The new guidance states that an entity should reevaluate whether a callable debt security is within scope of Topic 310-20. ASU 2020-08 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. We adopted ASU No. 2020-08 in the first quarter of 2021 and applied the guidance prospectively. The adoption of this new standard did not have a material impact on our consolidated financial statements. In August 2020, FASB, issued ASU No.2020-06 Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) . This ASU simplifies the accounting for convertible instruments and requires entities to use the if-converted method for all convertible instruments in calculating diluted earnings-per-share. We early adopted ASU No. 2020-06 on January 1, 2021 using the modified retrospective method. We applied this ASU to the convertible debt transaction entered into in December 2021 (see Note 8). The adoption of this ASU did not have a material impact to our consolidated financial statements as there were no outstanding financial instruments that require recombination at January 1, 2021. Accounting P r onouncement Issued But Not Yet Adopted In March 2020, FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) . The new guidance contains practical expedients for reference rate reform related activities that impact debt, leases, derivatives, and other contracts. The guidance in ASU 2020-04 is optional and may be elected over time as reference rate reform activities occur. We continue to evaluate the impact of the guidance and may apply the elections as applicable as changes occur. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Assets Measured on Recurring Basis | The following table summarizes our financial assets (cash equivalents and marketable securities) measured at fair value on a recurring basis (in thousands): December 31, 2021 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 671,845 $ 671,845 $ — $ — Corporate debt securities 10,006 — 10,006 — U.S. government agency securities 4,843 — 4,843 — Certificates of deposits 244 — 244 — U.S. government securities 34,964 — 34,964 — Total financial assets $ 721,902 $ 671,845 $ 50,057 $ — 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) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Securities | The following table is a summary of available-for-sale securities recorded in cash and cash equivalents, or marketable securities in our Consolidated Balance Sheets (in thousands): December 31, 2021 Amortized Unrealized Unrealized Estimated Fair Cost Gains (Losses) Value Financial Assets: Money market funds $ 671,845 $ — $ — $ 671,845 Corporate debt securities 10,037 — ( 31 ) 10,006 U.S. government agency securities 4,862 — ( 19 ) 4,843 Certificates of deposits 245 — ( 1 ) 244 U.S. government securities 35,133 — ( 169 ) 34,964 Total $ 722,122 $ — $ ( 220 ) $ 721,902 December 31, 2020 Amortized Unrealized Unrealized Estimated Fair Cost Gains (Losses) Value Financial Assets: Money market funds $ 486,174 $ — $ — $ 486,174 Corporate debt securities 29,641 163 — 29,804 U.S. government agency securities 15,906 37 — 15,943 Certificates of deposits 241 2 — 243 U.S. government securities 20,036 100 — 20,136 Total $ 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 securities on our consolidated balance sheets (in thousands): December 31, 2021 2020 Cash and cash equivalents $ 671,845 $ 486,174 Short-term marketable securities — 66,126 Long-term marketable securities 50,057 — Total $ 721,902 $ 552,300 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Property and Equipment, Net | Property and Equipment Property and equipment consist of the following (in thousands): December 31, 2021 2020 Laboratory equipment $ 14,373 $ 11,922 Computer equipment 2,841 3,023 Leasehold improvements 32,281 32,281 Construction-in-progress 934 517 Total property and equipment 50,429 47,743 Less: accumulated depreciation and amortization ( 15,511 ) ( 9,861 ) Property and equipment, net $ 34,918 $ 37,882 |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consist of the following (in thousands): December 31, 2021 2020 Accrued research and development costs $ 8,525 $ 10,677 Accrued manufacturing costs 11,327 9,125 Accrued professional and consulting services 7,863 4,107 Accrued sales deductions 10,205 6,405 Other 1,377 819 Total accrued liabilities $ 39,297 $ 31,133 |
Other Liabilities | Other liabilities, current Other liabilities consist of the following (in thousands): December 31, 2021 2020 Operating lease liabilities, current $ 5,670 $ 4,836 Other current liabilities $ 222 — Total other liabilities, current $ 5,892 $ 4,836 |
Inventories (Table)
Inventories (Table) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Text Block [Abstract] | |
Inventories | nventories consist of the following (in thousands): December 31, 2021 2020 Raw materials $ 10,616 $ 11,273 Work-in-process 45,662 26,994 Finished goods 1,924 1,956 Total inventories $ 58,202 $ 40,223 |
Long-term Debt (Table)
Long-term Debt (Table) | 12 Months Ended |
Dec. 31, 2021 | |
Text Block [Abstract] | |
Schedule of Future payments of principal and interest on the Term Loan | Future payments of principal and interest on the A&R Term Loan as of December 31, 2021 (in thousands): 2022 $ 22,500 2023 22,500 2024 22,500 2025 104,688 2026 97,188 2027 89,688 Total minimum payments 359,063 Less: amount representing interest ( 104,063 ) Less: amount representing Paydown Fee ( 5,000 ) Long-term debt, gross 250,000 Discount on notes payable ( 4,779 ) Accretion of Paydown Fee 1,131 Long-term debt $ 246,352 |
Convertible Debt (Tables)
Convertible Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Convertible Debt [Abstract] | |
Schedule of debt interest expense | The following table presents the components of interest expense related to 2028 Notes (in thousands): For the Year Ended December 31, 2021 Stated coupon interest $ 234 Amortization of debt issuance cost 52 Total interest expense $ 286 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 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): For the Year Ended December 31, 2021 2020 ROU assets obtained for new operating lease liabilities $ — 205 Adjustment to ROU assets as a result of the lease modification for the Prior Premises — ( 106 ) Operating lease liabilities arising from obtaining ROU assets — 205 Cash paid for amounts included in the measurement of lease liabilities 11,841 7,696 Weighted-average remaining lease term of operating leases (in years) 8.2 9.2 Weighted-average discount rate of operating leases 8.66 % 8.66 % |
Schedule of Lessee, Operating Lease, Liability, Maturity | As of December 31, 2021, the maturities of our operating lease liabilities under Topic 842 were as follows (in thousands): Year ending December 31, Amount 2022 12,222 2023 12,584 2024 12,948 2025 13,368 2026 13,803 Thereafter 46,703 Total lease payments 111,628 Less: Imputed interest ( 32,452 ) Present value of operating lease liabilities $ 79,176 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved For Future Issuance | We have reserved shares of common stock for future issuance as follows: December 31, 2021 2020 Restricted stock units 3,437,069 2,625,056 Options issued and outstanding 3,553,763 3,327,330 Shares available for future grant under the 2015 Plan and 2017 Inducement Equity Plan 6,473,318 6,018,567 Employee stock purchase plan 320,003 254,590 2028 Notes 13,855,407 — Total 27,639,560 12,225,543 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stock Option Activity | Stock Option Activity The following table summarizes activity under our stock option plans, including the 2017 Inducement Plan, 2015 Plan and the 2012 Plan and related information (in thousands, except share and per share amounts and term): Number of Options Weighted-Average Exercise Price Weighted-Average remaining contractual term (years) Aggregate Intrinsic Value Outstanding—December 31, 2020 3,327,330 $ 42.07 7.02 Options granted 722,280 42.43 Options exercised ( 136,929 ) 20.05 Options canceled ( 358,918 ) 51.94 Outstanding—December 31, 2021 3,553,763 $ 42.00 6.68 $ 11,763 Vested and exercisable—December 31, 2021 2,504,984 $ 38.79 5.92 $ 11,749 |
Valuation Assumptions for Stock Awards | The fair values of stock options granted to employees were calculated using the following assumptions: Year Ended December 31, 2021 2020 2019 Expected term (in years) 5.3 - 6.1 5.1 - 6.1 5.3 - 6.1 Volatility 68.1 %- 72.7 % 69.6 %- 71.8 % 69.8 %- 72.2 % Risk-free interest rate 0.9 %- 1.1 % 0.3 %- 1.8 % 1.4 %- 2.6 % Dividend yield — — — |
Non-Vested Restricted Stock Activity | The following table summarizes activity of RSUs granted to employees with service-based vesting under the 2017 Inducement Plan and 2015 Plan and related information (in thousands, except share, per share amounts and vesting period): Weighted- Weighted- Average Average Remaining Aggregate Number Grant Date Vesting Intrinsic of RSUs Fair Value Period (years) Value Non-vested units — December 31, 2020 2,210,356 $ 57.80 1.45 $ 95,731 RSUs granted 2,222,428 38.63 RSUs vested ( 863,373 ) 54.39 RSUs forfeited ( 583,142 ) 53.46 Non-vested units — December 31, 2021 2,986,269 $ 45.37 1.45 $ 87,048 |
Summary of Activity of Market-Condition Awards | The target prices and vesting tranches are set forth in the table below: Stock Price Targets Number of Units Allowed $ 109.20 90,160 $ 145.60 157,780 $ 182.00 202,860 |
Valuation Assumptions of Market-Condition Awards | The following table summarizes activity of the Market-Condition RSU Awards under the 2015 Plan and related information (in thousands, except share, per share amounts and vesting period): Weighted- Weighted- Average Average Remaining Aggregate Number Grant Date Vesting Intrinsic of RSUs Fair Value Period (years) Value Non-vested market-condition awards — December 31, 2020 414,700 $ 49.95 1.21 $ 17,961 Granted 84,800 13.88 1.73 Vested — — — Forfeited ( 48,700 ) 49.95 0.21 Non-vested market condition awards — December 31, 2021 450,800 $ 43.17 0.30 $ 13,195 |
Fair Value Assumptions for Employee Stock Purchase Plan | The fair values of the rights granted under the 2015 ESPP were calculated using the following assumptions: Year Ended December 31, 2021 2020 Expected term (in years) 0.5 – 2.1 0.5 – 2.1 Volatility 54.4 - 84.8 % 47.0 - 77.0 % Risk-free interest rate 0.1 - 0.2 % 0.1 - 1.5 % Dividend yield — % — % |
Stock-based Compensation Expense Recognized | Stock-Based Compensation Expense Total stock-based compensation recognized by functions was as follows (in thousands): Year Ended December 31, 2021 2020 2019 Research and development $ 21,297 $ 18,061 $ 19,140 Selling, general and administrative 57,374 53,416 26,511 Total stock-based compensation expense $ 78,671 $ 71,477 $ 45,651 |
Unrecognized Stock-based Compensation Cost | As of December 31, 2021, the unrecognized stock-based compensation cost, and the estimated weighted-average amortization period, using the straight-line attribution method, was as follows (in thousands, except amortization period): Weighted- average Unrecognized remaining Compensation amortization Cost period (years) Stock Options $ 30,278 2.3 Restricted stock units 116,677 2.6 Market-Condition restricted stock units 3,672 2.5 ESPP 689 — Total unrecognized stock-based compensation expense $ 151,316 2.5 |
Summary of Share-based Compensation Arrangements by Share-based Payment Award | 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 $ 37.20 Expected term 3.1 years Volatility 66.6 % Risk-free interest rate 0.3 % Dividend yield — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Components of Loss Before Income Taxes | The components of the loss before income taxes were as follows (in thousands): Year Ended December 31, 2021 2020 2019 Loss before provision for income taxes: United States $ ( 305,217 ) $ ( 247,327 ) $ ( 266,595 ) International 2,603 ( 226 ) ( 167 ) $ ( 302,614 ) $ ( 247,553 ) $ ( 266,762 ) |
The components of the Company's provision for income taxes | The components of our income tax expense were as follows (in thousands): Year Ended December 31, 2021 2020 2019 Current expense (benefit) $ — $ — $ — Federal — — — State — — — Foreign 477 — — — — — Deferred tax expense — — — Federal — — — State — — — Foreign — — — Total income tax expense $ 477 $ — $ — |
Effective Income Tax Rate Reconciliation | The effective tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2021 2020 2019 Federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes 5.7 7.4 9.7 Federal and state tax credits 2.2 4.3 4.9 Change in valuation allowance ( 25.6 ) ( 32.4 ) ( 37.2 ) Foreign rate differential — — — Officer compensation limitation ( 1.3 ) ( 0.8 ) ( 1.0 ) Stock based compensation/Non-deductible changes in fair value ( 1.8 ) 0.6 1.7 Liquidation of foreign entities — — 0.9 Other ( 0.4 ) ( 0.1 ) — Provision for Taxes - 0.2 % 0.0 % 0.0 % |
Components of Deferred Tax Assets and Liabilities | The components of the deferred tax assets and liabilities are as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 275,367 $ 216,092 Tax credits 85,542 76,684 Operating lease liability 21,422 23,147 Accruals and reserves 7,517 6,503 Stock based compensation 17,445 14,981 Deferred Interest Expense 3,938 — Intangibles 9,629 8,507 Other 1,391 904 Gross deferred tax assets 422,251 346,818 Valuation allowance ( 403,095 ) ( 325,710 ) Net deferred tax assets 19,156 21,108 Operating lease – ROU asset ( 12,991 ) ( 13,975 ) Property and equipment ( 6,165 ) ( 7,050 ) Other — ( 83 ) Gross deferred tax liabilities ( 19,156 ) ( 21,108 ) Net deferred tax assets $ — $ — |
Reconciliation of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): December 31, 2021 2020 Balance at beginning of year $ 24,446 $ 21,598 Additions based on tax positions related to current year 3,060 3,346 Decreased for prior period positions ( 238 ) ( 498 ) Unrecognized tax benefit—December 31 $ 27,268 $ 24,446 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 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: Year Ended December 31, 2021 2020 2019 Options to purchase common stock 3,553,763 3,327,330 3,573,860 Convertible Notes (as converted to common stock) 10,866,983 — — Restricted stock units 3,437,069 2,625,056 1,848,772 Total 17,857,815 5,952,386 5,422,632 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||
Cumulative net losses | $ 1,289,560 | $ 986,469 |
Cash and cash equivalents and investments | $ 734,800 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - Customer Concentration Risk [Member] - Two Major Customers [Member] | 12 Months Ended |
Dec. 31, 2021 | |
Revenue, Product and Service Benchmark [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 99.80% |
Accounts Receivable [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 100.00% |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Assets Measured on Recurring Basis (Detail) - Fair Value Measurements, Recurring [Member] - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | $ 721,902 | $ 552,300 |
U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 34,964 | 20,136 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 671,845 | 486,174 |
Level 1 [Member] | U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 50,057 | 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 | 34,964 | 20,136 |
Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
Level 3 [Member] | U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 671,845 | 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 | 671,845 | 486,174 |
Money Market Funds [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
Money Market Funds [Member] | Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 10,006 | 29,804 |
Corporate Debt Securities [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
Corporate Debt Securities [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 10,006 | 29,804 |
Corporate Debt Securities [Member] | Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
U.S. Government Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 4,843 | 15,943 |
U.S. Government Agency Securities [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
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 | 4,843 | 15,943 |
U.S. Government Agency Securities [Member] | Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
Certificates of Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 244 | 243 |
Certificates of Deposits [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
Certificates of Deposits [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 244 | $ 243 |
Certificates of Deposits [Member] | Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | $ 0 |
Available-for-Sale Securities -
Available-for-Sale Securities - Summary of Available-for-Sale Securities (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | $ 722,122,000 | $ 551,998,000 |
Available for sale securities, Unrealized Gains | 0 | 302 |
Available for sale securities, Unrealized (Losses) | (220,000) | 0 |
Available for sale securities, Estimated Fair Value | 721,902,000 | 552,300,000 |
Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 10,037,000 | 29,641,000 |
Available for sale securities, Unrealized Gains | 0 | 163 |
Available for sale securities, Unrealized (Losses) | (31,000) | 0 |
Available for sale securities, Estimated Fair Value | 10,006,000 | 29,804,000 |
U.S. Government Agency Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 4,862,000 | 15,906,000 |
Available for sale securities, Unrealized Gains | 0 | 37 |
Available for sale securities, Unrealized (Losses) | (19,000) | 0 |
Available for sale securities, Estimated Fair Value | 4,843,000 | 15,943,000 |
Money Market Funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 671,845,000 | 486,174,000 |
Available for sale securities, Unrealized Gains | 0 | 0 |
Available for sale securities, Unrealized (Losses) | 0 | 0 |
Available for sale securities, Estimated Fair Value | 671,845,000 | 486,174,000 |
Certificates of Deposits [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 245,000 | 241,000 |
Available for sale securities, Unrealized Gains | 0 | 2 |
Available for sale securities, Unrealized (Losses) | (1,000) | 0 |
Available for sale securities, Estimated Fair Value | 244,000 | 243,000 |
U.S. Government Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available for sale securities, Amortized Cost | 35,133,000 | 20,036,000 |
Available for sale securities, Unrealized Gains | 0 | 100 |
Available for sale securities, Unrealized (Losses) | (169,000) | 0 |
Available for sale securities, Estimated Fair Value | $ 34,964,000 | $ 20,136,000 |
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 | Dec. 31, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Cash and cash equivalents | $ 671,845 | $ 486,174 |
Short-term marketable securities | 0 | 66,126 |
Long-term marketable securities | 50,057 | 0 |
Total | $ 721,902 | $ 552,300 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 50,429 | $ 47,743 |
Less: accumulated depreciation and amortization | (15,511) | (9,861) |
Property and equipment, net | 34,918 | 37,882 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 14,373 | 11,922 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 2,841 | 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 | $ 934 | $ 517 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Balance Sheet Components [Abstract] | |||
Depreciation expense | $ 5.9 | $ 8.3 | $ 8.6 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
Accrued research and development costs | $ 8,525 | $ 10,677 |
Accrued manufacturing costs | 11,327 | 9,125 |
Accrued professional and consulting services | 7,863 | 4,107 |
Accrued sales deductions | 10,205 | 6,405 |
Other | 1,377 | 819 |
Total accrued liabilities | $ 39,297 | $ 31,133 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
Operating lease liabilities, current | $ 5,670 | $ 4,836 |
Other current liabilities | $ 222 | $ 0 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Total other liabilities, current | Total other liabilities, current |
Total other liabilities, current | $ 5,892 | $ 4,836 |
Inventories - Summary of Capita
Inventories - Summary of Capitalizing Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory, Raw Materials and Supplies, Gross [Abstract] | ||
Raw materials | $ 10,616 | $ 11,273 |
Work-in-process | 45,662 | 26,994 |
Finished goods | 1,924 | 1,956 |
Total inventories | $ 58,202 | $ 40,223 |
Inventories - Additional inform
Inventories - Additional information (Detail) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Disclosure Text Block [Abstract] | ||
Share-based Compensation | $ 1.7 | $ 1.8 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Nov. 30, 2020 | Dec. 17, 2019 | |
Long term debt | $ 246,352,000 | $ 148,815,000 | ||
Secured Debt | ||||
Debt maximum borrowing capacity | 75,000,000 | |||
Debt additional borrowing capacity | 75,000,000 | |||
Long term debt | $ 75,000,000 | $ 75,000,000 | ||
Term Loan | ||||
Debt maximum borrowing capacity | $ 100,000,000 | $ 75,000,000 | ||
Debt additional borrowing capacity | $ 75 | |||
Debt Instrument, Maturity Date | Dec. 17, 2027 | |||
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 additional paydown fee | 2.00% | |||
Less: imputed interest income on related party loan | $ 3,400,000 | |||
Other debt issuance cost paid | 100,000 | |||
Unamortized issuance costs and debt discounts | $ 4,800,000 | |||
Term Loan | Maximum | ||||
Debt prepayment fee | 3.00% | |||
Term Loan | Minimum | ||||
Debt prepayment fee | 1.00% |
Long-term Debt - Schedule of Fu
Long-term Debt - Schedule of Future payments of principal and interest on the Term Loan (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
2022 | $ 22,500 | |
2023 | 22,500 | |
2024 | 22,500 | |
2025 | 104,688 | |
2026 | 97,188 | |
2027 | 89,688 | |
Total minimum payments | 359,063 | |
Less amount representing interest | (104,063) | |
Less amount representing Paydown Fee | (5,000) | |
Long-term Debt, Gross | 250,000 | |
Discount on notes payable | (4,779) | |
Accretion of Paydown Fee | 1,131 | |
Long-term debt | $ 246,352 | $ 148,815 |
Convertible Debt - Additional I
Convertible Debt - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2021USD ($)dshares$ / shares | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Debt Instrument [Line Items] | |||
Debt instrument principal amount | $ 345,000 | ||
Unamortized debt issuance costs | 10,900,000 | ||
Proceeds from issuance of long-term debt, net of debt issuance costs | 96,473,000 | $ 74,799,000 | $ 72,475,000 |
Long-term Debt, Gross | $ 250,000,000 | ||
1.875% Convertible senior Notes Due 2028 [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, interest rate, stated percentage | 2.37% | ||
Debt Instrument, Fair Value | $ 431,400,000 | ||
Convertible Debt [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, interest rate, stated percentage | 1.875% | ||
Convertible Debt [Member] | 1.875% Convertible senior Notes Due 2028 [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument principal amount | $ 345,000,000 | ||
Payments Of Debt Issuance Costs | 11,000,000 | ||
Proceeds From Convertible Debt | $ 334,000,000 | ||
Maturity date | Dec. 15, 2028 | ||
Capped Calls Transactions | $ 46,800,000 | ||
Debt Instrument Convertible Conversion Ratio | 31.4985 | ||
Debt Instrument Repurchase Amount | $ 1,000 | ||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 31.75 | ||
Debt Instrument, Convertible, Threshold Percentage of Stock Price Trigger | 130.00% | ||
Debt Instrument, Convertible, Threshold Trading Days | d | 20 | ||
Debt Instrument, Convertible, Threshold Consecutive Trading Days | d | 30 | ||
Debt Instrument, Redemption Price, Percentage of Principal Amount Redeemed | 100.00% | ||
Derivative Cap Price Per Share | $ / shares | $ 31.7475 | ||
Number of shares of common stock underlying notes | shares | 10,866,983 | ||
Non Convertible Debt [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument principal amount | $ 100,000,000 | ||
Call Option [Member] | Convertible Debt [Member] | 1.875% Convertible senior Notes Due 2028 [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument principal amount | $ 45,000,000 | ||
Share Price | $ / shares | $ 49.80 |
Convertible Debt - Interest Exp
Convertible Debt - Interest Expense (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Short-term Debt [Line Items] | |
Total interest expense | $ 104,063 |
2.37% Convertible Senior Notes [Member] | |
Short-term Debt [Line Items] | |
Stated coupon interest | 234 |
Amortization of debt issuance cost | 52 |
Total interest expense | $ 286 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||||
Mar. 31, 2021USD ($) | Jan. 31, 2020USD ($) | Aug. 31, 2018USD ($)ft² | Mar. 31, 2017ft² | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Oct. 01, 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 | 10 years | ||||||
Repayment of tenant inducement allowance | $ 4,100,000 | |||||||
Contingency losses | $ 0 | |||||||
Provisions for loss contingency | 0 | |||||||
Operating Lease Cost | 10,500,000 | $ 12,400,000 | ||||||
variable lease cost | 3,500,000 | 2,600,000 | ||||||
Rent expense | 9,900,000 | $ 9,800,000 | $ 5,200,000 | |||||
Operating liabilities | 79,176,000 | $ 2,900,000 | ||||||
Additional costs capitalized | 0 | |||||||
Operating lease liabilities | $ 79,176,000 | $ 2,900,000 | ||||||
Incremental borrowing rate | 8.66% | 8.66% | 8.78% | |||||
Operating lease right of use asset | $ 48,015,000 | $ 50,722,000 | $ 0 | |||||
Gain loss on modification of lease | 0 | 984,000 | 8,301,000 | |||||
Unamortized operating lease liability | 0 | 0 | ||||||
Tenant inducement allowances received | 0 | 10,700,000 | ||||||
Depreciation expense | 5,900,000 | 8,300,000 | 8,600,000 | |||||
Substitute Premises [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Operating liabilities | 79,200,000 | 83,800,000 | ||||||
Operating lease liabilities | 79,200,000 | 83,800,000 | ||||||
Operating lease right of use asset | 48,000,000 | 50,600,000 | ||||||
F. Hoffmann-La Roche Ltd. And Hoffmann-La Roche Inc. [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Upfront payments | $ 2,000,000 | |||||||
Contingent payment obligations | 125,500,000 | |||||||
Contingent Payment Milestone Additional Obligations | 6,400,000 | |||||||
F. Hoffmann-La Roche Ltd. And Hoffmann-La Roche Inc. [Member] | Develpment And Regulatory Milestones [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Contingent Payment Milestone Additional Obligations | 19,250,000 | |||||||
F. Hoffmann-La Roche Ltd. And Hoffmann-La Roche Inc. [Member] | Net Sales Achievement [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Contingent payment obligations | 85,000,000 | |||||||
F. Hoffmann-La Roche Ltd. And Hoffmann-La Roche Inc. [Member] | Research And Development Milestones [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Contingent payment obligations | 40,500,000 | |||||||
Syros Pharmaceuticals [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Upfront payments | $ 20,000,000 | |||||||
Preclinical research payable | 40,000,000 | |||||||
Payable for exercise of options | 315,000,000 | |||||||
Repayment of Research and Development Cost | 11,500,000 | |||||||
Syros Pharmaceuticals [Member] | Research And Development Milestones [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Contingent Payment Milestone Additional Obligations | 0 | 0 | ||||||
Sanofi Pharmaceutical [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Upfront payments | $ 2,250,000 | |||||||
Contingent Payment Milestone Additional Obligations | 351,000,000 | |||||||
2.0 research and development costs member | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Contingent Payment Milestone Additional Obligations | $ 5,300,000 | 2,000,000 | ||||||
Maximum [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Operating lease remaining lease term | 10 years | |||||||
Operating Lease Extend the Lease Term | 10 years | |||||||
Minimum [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Operating lease remaining lease term | 1 year | |||||||
Operating Lease Extend the Lease Term | 1 year | |||||||
Leasehold Improvements [Member] | ||||||||
Commitment And Contingencies [Line Items] | ||||||||
Property plant and equipment additions | 32,300,000 | |||||||
Depreciation expense | $ 0 | $ 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) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Oct. 01, 2019 | |
Commitment And Contingencies [Line Items] | |||
Weighted-average discount rate of operating leases | 8.66% | 8.66% | 8.78% |
Accounting Standards Update 2016-02 [Member] | |||
Commitment And Contingencies [Line Items] | |||
ROU assets obtained for new operating lease liabilities | $ 0 | $ 205 | |
Adjustment to ROU assets as a result of the lease modification for the Prior Premises | 0 | (106) | |
Operating lease liabilities arising from obtaining ROU assets | 0 | 205 | |
Cash paid for amounts included in the measurement of lease liabilities | $ 11,841 | $ 7,696 | |
Weighted-average remaining lease term of operating leases (in years) | 8 years 2 months 12 days | 9 years 2 months 12 days | |
Weighted-average discount rate of operating leases | 8.66% | 8.66% |
Commitments and Contingencies_3
Commitments and Contingencies - Lessee Operating Lease Liability Maturity (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Oct. 01, 2019 |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | ||
2022 | $ 12,222 | |
2023 | 12,584 | |
2024 | 12,948 | |
2025 | 13,368 | |
2026 | 13,803 | |
Thereafter | 46,703 | |
Total lease payments | 111,628 | |
Less: Imputed interest | (32,452) | |
Operating liabilities | $ 79,176 | $ 2,900 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Class of Stock [Line Items] | |||
Common stock dividend declared | $ 0 | ||
Proceeds from Issuance of Common Stock,Net of Expenses | $ 46,143 | $ 0 | $ 219,443 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Reserved for Issuance on Converted basis (Detail) - shares | Dec. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||
Shares reserved for future issuance | 27,639,560 | 12,225,543 |
RSU [Member] | ||
Class of Stock [Line Items] | ||
Shares reserved for future issuance | 3,437,069 | 2,625,056 |
Stock Options [Member] | ||
Class of Stock [Line Items] | ||
Shares reserved for future issuance | 3,553,763 | 3,327,330 |
Shares Available for Future Grant Under the 2015 Plan and 2017 Inducement Equity Plan [Member] | ||
Class of Stock [Line Items] | ||
Shares reserved for future issuance | 6,473,318 | 6,018,567 |
ESPP [Member] | ||
Class of Stock [Line Items] | ||
Shares reserved for future issuance | 320,003 | 254,590 |
2028 Notes [Member] | ||
Class of Stock [Line Items] | ||
Shares reserved for future issuance | 13,855,407 | 0 |
Share-based Compensation - Plan
Share-based Compensation - Plan Summary - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 27,639,560 | 12,225,543 | ||
Intrinsic value of options exercised | $ 2,400,000 | $ 23,000,000 | $ 23,500,000 | |
Estimated weighted-average grant-date fair value of common stock underlying options granted | $ 26.97 | $ 40.76 | $ 32.30 | |
Dividend yield | 0.00% | |||
Unrecognized compensation expense | $ 151,316,000 | |||
weighted average derived service period | 2 years 6 months | |||
Stock-based compensation | $ 78,670,000 | $ 71,477,000 | $ 45,651,000 | |
Shares issued, value | $ 4,253,000 | $ 4,137,000 | $ 2,361,000 | |
Number of shares Non-vested period | 450,800 | |||
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 3,553,763 | 3,327,330 | ||
Dividend yield | 0.00% | 0.00% | 0.00% | |
weighted average derived service period | 2 years 3 months 18 days | |||
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 320,003 | 254,590 | ||
Dividend yield | 0.00% | 0.00% | ||
weighted average derived service period | 0 years | |||
RSU [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 3,437,069 | 2,625,056 | ||
weighted average derived service period | 2 years 7 months 6 days | |||
Market Condition Awards Granted to Employees [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Dividend yield | 0.00% | |||
Unrecognized compensation expense | $ 3,700,000 | |||
weighted average derived service period | 3 months 18 days | |||
Stock-based compensation | $ 8.4 | |||
2017 Inducement Equity Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 1,662,072 | |||
2017 Inducement Equity Plan [Member] | Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expiration period | 10 years | |||
Exercise price as a percentage of the fair market value | 100.00% | |||
2017 Inducement Equity Plan [Member] | Stock Options [Member] | Tranche One [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Vesting Percentage | 25.00% | |||
2017 Inducement Equity Plan [Member] | RSU [Member] | Tranche One [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting Percentage | 25.00% | |||
2017 Inducement Equity Plan [Member] | RSU [Member] | Tranche Two [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
2015 Plan [Member] | Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 4,811,246 | |||
Expiration period | 10 years | |||
Exercise price as a percentage of the fair market value | 100.00% | |||
Exercise price as a percentage of the fair market value for option holding more than 10% total combined voting power | 110.00% | |||
Vesting period | 4 years | |||
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 | 84,800 | |||
Number of shares vesting Period | 0 | |||
Number of shares forfeited | 48,700 | |||
Number of shares Non-vested period | 450,800 | 414,700 | ||
2012 Stock Option and Grant Plan [Member] | ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expiration period | 10 years | |||
2015 ESPP [Member] | ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise price as a percentage of the fair market value | 85.00% | |||
Maximum contribution to plan as a percent of employee's eligible compensation | 15.00% | |||
2015 Inducement Equity Plan [Member] | Stock Options [Member] | Tranche Two [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting Percentage | 0.01% | |||
2015 Inducement Equity Plan [Member] | RSU [Member] | Tranche One [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Vesting Percentage | 0.00125% | |||
2015 Inducement Equity Plan [Member] | RSU [Member] | Tranche Two [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting Percentage | 0.01% | |||
2015 ESPAP [Member] | ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares issued | 134,587 | |||
Shares issued, value | $ 4.3 |
Share-based Compensation - Stoc
Share-based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Beginning balance, outstanding, Number of Options | 3,327,330 | |
Options granted, Number of Options | 722,280 | |
Options exercised, Number of Options | (136,929) | |
Options canceled, Number of Options | (358,918) | |
Ending balance, outstanding, Number of Options | 3,553,763 | 3,327,330 |
Vested and exercisable, Number of Options | 2,504,984 | |
Weighted- Average Exercise Price | ||
Beginning balance, Outstanding, Weighted-Average Exercise Price | $ 42.07 | |
Options granted, Weighted-Average Exercise Price | 42.43 | |
Options exercised, Weighted-Average Exercise Price | 20.05 | |
Options canceled, Weighted-Average Exercise Price | 51.94 | |
Ending balance, Outstanding, Weighted-Average Exercise Price | 42 | $ 42.07 |
Vested and exercisable, Weighted-Average Exercise Price | $ 38.79 | |
Beginning, Outstanding, Weighted-Average remaining contractual term | 6 years 8 months 4 days | 7 years 7 days |
Vested and exercisable, Weighted-Average remaining contractual term | 5 years 11 months 1 day | |
Balance Outstanding, Aggregate Intrinsic Value | $ 11,763 | |
Vested and exercisable, Aggregate Intrinsic Value | $ 11,749 |
Share-based Compensation - Valu
Share-based Compensation - Valuation Assumptions for Stock Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Dividend yield | 0.00% | ||
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Volatility, minimum | 68.10% | 69.60% | 69.80% |
Volatility, maximum | 72.70% | 71.80% | 72.20% |
Risk-free interest rate, minimum | 0.90% | 0.30% | 1.40% |
Risk-free interest rate, maximum | 1.10% | 1.80% | 2.60% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Stock Options [Member] | 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 |
Stock Options [Member] | 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 |
Share-based Compensation - Summ
Share-based Compensation - Summary of RSU Activity Granted to Employees with Service-Based Vesting (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Ending Balance - Non-vested market-condition awards | 450,800 | |
2017 Inducement Plan and 2015 Plan [Member] | RSU [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Beginning Balance - Non-vested market-condition awards | 2,210,356 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 2,222,428 | |
RSUs vested, Number of RSUs | (863,373) | |
RSUs forfeited, Number of RSUs | (583,142) | |
Ending Balance - Non-vested market-condition awards | 2,986,269 | 2,210,356 |
Beginning Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ 57.80 | |
RSUs granted, Weighted-Average Grant Date Fair Value | 38.63 | |
RSUs vested, Weighted-Average Grant Date Fair Value | 54.39 | |
RSUs forfeited, Weighted-Average Grant Date Fair Value | 53.46 | |
Ending Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ 45.37 | $ 57.80 |
Non-vested units, Weighted-Average remaining vesting period(years) | 1 year 5 months 12 days | 1 year 5 months 12 days |
Non-vested units, Aggregate Intrinsic Value | $ 87,048 | $ 95,731 |
Share-based Compensation - Su_2
Share-based Compensation - Summary of Share-based Compensation Arrangements by Share-based Payment Award (Detail) | Dec. 31, 2021$ / sharesshares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock Price Targets | $ 38.79 |
Tranche One [Member] | 2020 Market Condition RSU Awards [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock Price Targets | $ 109.20 |
Number of Units Allotted | shares | 90,160 |
Tranche Two [Member] | 2020 Market Condition RSU Awards [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock Price Targets | $ 145.60 |
Number of Units Allotted | shares | 157,780 |
Tranche Three [Member] | 2020 Market Condition RSU Awards [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock Price Targets | $ 182 |
Number of Units Allotted | shares | 202,860 |
Share-based Compensation - Su_3
Share-based Compensation - Summary of Activity of Market-Condition Awards (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Ending Balance - Non-vested market-condition awards | 450,800 | |
Market Condition Awards Granted to Employees [Member] | 2015 Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Beginning Balance - Non-vested market-condition awards | 414,700 | |
Number of Units granted | 84,800 | |
Number of Units vested | 0 | |
Number of Units forfeited | (48,700) | |
Ending Balance - Non-vested market-condition awards | 450,800 | 414,700 |
Beginning Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ 49.95 | |
Weighted-Average Grant Date Fair Value granted | 13.88 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period, Weighted Average Grant Date Fair Value | 0 | |
Weighted-Average Grant Date Fair Value forfeited | $ 49.95 | |
Non-vested units, Weighted-Average remaining vesting period (years) forfeited | 2 months 15 days | |
Ending Balance - Non-vested units, Weighted-Average Grant Date Fair Value | $ 43.17 | $ 49.95 |
Non-vested units, Weighted-Average remaining vesting period(years) | 3 months 18 days | 1 year 2 months 15 days |
Non-vested units, Weighted-Average remaining vesting period (years) granted | 1 year 8 months 23 days | |
Non-vested units, Aggregate Intrinsic Value | $ 13,195 | $ 17,961 |
Share-based Compensation - Va_2
Share-based Compensation - Valuation Assumptions of Market-Condition Awards (Detail) | 12 Months Ended |
Dec. 31, 2021$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Dividend yield | 0.00% |
Market Condition Awards Granted To Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share price | $ 37.20 |
Expected term | 3 years 1 month 6 days |
Volatility | 66.60% |
Risk-free interest rate | 0.30% |
Dividend yield | 0.00% |
Share-based Compensation - Fair
Share-based Compensation - Fair Value Assumptions for Employee Stock Purchase Plan (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield | 0.00% | |
ESPP [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Volatility, minimum | 54.40% | 47.00% |
Volatility, maximum | 84.80% | 77.00% |
Risk-free interest rate, minimum | 0.10% | 0.10% |
Risk-free interest rate, maximum | 0.20% | 1.50% |
Dividend yield | 0.00% | 0.00% |
ESPP [Member] | Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 2 years 1 month 6 days | 2 years 1 month 6 days |
ESPP [Member] | Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 months | 6 months |
Share-based Compensation - St_2
Share-based Compensation - Stock-based Compensation Expense Recognized (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 78,671 | $ 71,477 | $ 45,651 |
Research and Development Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 21,297 | 18,061 | 19,140 |
Selling, general and administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 57,374 | $ 53,416 | $ 26,511 |
Stock-based Compensation - Unre
Stock-based Compensation - Unrecognized Stock-based Compensation Cost (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Total unrecognized stock-based compensation expense | $ 151,316 |
Weighted-average remaining amortization period | 2 years 6 months |
Stock Options [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost, options | $ 30,278 |
Weighted-average remaining amortization period | 2 years 3 months 18 days |
RSU [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 116,677 |
Weighted-average remaining amortization period | 2 years 7 months 6 days |
ESPP [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 689 |
Weighted-average remaining amortization period | 0 years |
Market-Condition RSU [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 3,672 |
Weighted-average remaining amortization period | 2 years 6 months |
Defined Contribution Plan - Add
Defined Contribution Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |||
Contribution expenses | $ 3.2 | $ 2.1 | $ 1.4 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes [Line Items] | |||
Provision for income taxes | $ 477,000 | $ 0 | $ 4,000 |
Increase in valuation allowance | 77,400,000 | 80,700,000 | |
Deferred tax assets, valuation allowance | $ 403,095,000 | $ 325,710,000 | |
valuation allowance charged on deferred tax assets | 100.00% | ||
State [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carry forward, expiration year | 2040 | ||
State [Member] | Operating Loss Carryforward Expiration Year 2040 [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards | $ 787,000,000 | ||
Domestic Tax Authority [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards | $ 1,000,000,000 | ||
Operating loss carry forward, expiration year | 2037 | ||
Domestic Tax Authority [Member] | Tax period 2037 [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards | $ 207,300,000 | ||
Domestic Tax Authority [Member] | Operating Loss Carryforward With Indefinite Expiry Period [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards | $ 840,200,000 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Loss before provision for income taxes: | |||
United States | $ (305,217) | $ (247,327) | $ (266,595) |
International | 2,603 | (226) | (167) |
Loss before provision for income taxes | $ (302,614) | $ (247,553) | $ (266,762) |
Income Taxes - Schedule Of The
Income Taxes - Schedule Of The components of the Company's provision for income taxes (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current expense (benefit) | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Foreign | 477,000 | 0 | 0 |
Current Income Tax Expense (Benefit), Total | 0 | 0 | 0 |
Deferred tax expense | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total income tax expense | $ 477,000 | $ 0 | $ 4,000 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory income tax rate | 21.00% | 21.00% | 21.00% |
State taxes | 5.70% | 7.40% | 9.70% |
Federal and state tax credits | 2.20% | 4.30% | 4.90% |
Change in valuation allowance | (25.60%) | (32.40%) | (37.20%) |
Foreign rate differential | 0.00% | 0.00% | 0.00% |
Officer compensation limitation | (1.30%) | (0.80%) | (1.00%) |
Stock based compensation/Non-deductible changes in fair value | (1.80%) | 0.60% | 1.70% |
Liquidation of foreign entities | 0.00% | 0.00% | 0.90% |
Other | (0.40%) | (0.10%) | 0.00% |
Provision for Taxes | (0.20%) | 0.00% | 0.00% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 275,367 | $ 216,092 |
Tax credits | 85,542 | 76,684 |
Operating lease liability | 21,422 | 23,147 |
Accruals and reserves | 7,517 | 6,503 |
Stock based compensation | 17,445 | 14,981 |
Deferred Interest Expense | 3,938 | 0 |
Intangibles | 9,629 | 8,507 |
Other | 1,391 | 904 |
Gross deferred tax assets | 422,251 | 346,818 |
Valuation allowance | (403,095) | (325,710) |
Net deferred tax assets | 19,156 | 21,108 |
Operating lease – ROU asset | (12,991) | (13,975) |
Property and equipment | (6,165) | (7,050) |
Other | 0 | (83) |
Gross deferred tax liabilities | (19,156) | (21,108) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Balance at beginning of year | $ 24,446 | $ 21,598 |
Additions based on tax positions related to current year | 3,060 | 3,346 |
Decreased for prior period positions | (238) | (498) |
Unrecognized tax benefit - December 31 | $ 27,268 | $ 24,446 |
Related Parties Transaction (Ad
Related Parties Transaction (Additional Information) (Details) $ in Millions | 1 Months Ended |
Oct. 31, 2021USD ($) | |
Related Party Transactions [Abstract] | |
Donations To Related Party | $ 0.5 |
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 | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from earnings per share | 17,857,815 | 5,952,386 | 5,422,632 |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from earnings per share | 3,553,763 | 3,327,330 | 3,573,860 |
Convertible Notes [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from earnings per share | 10,866,983 | 0 | 0 |
Restricted Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from earnings per share | 3,437,069 | 2,625,056 | 1,848,772 |