Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 04, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2022 | |
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 | 67,463,704 | |
Document Quarterly Report | true | |
Entity Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes | |
Entity File Number | 001-37539 | |
Entity Tax Identification Number | 27-4825712 | |
Entity Shell Company | false | |
Entity Address, Address Line One | 181 Oyster Point Boulevard | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
City Area Code | 650 | |
Local Phone Number | 741-7700 | |
Entity Address, Postal Zip Code | 94080 | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001629137 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 261,152 | $ 684,717 |
Short-term marketable securities | 256,006 | 0 |
Accounts receivable, net | 29,765 | 28,800 |
Inventories | 65,816 | 58,202 |
Prepaid expenses and other current assets | 27,272 | 30,251 |
Total current assets | 640,011 | 801,970 |
Long-term marketable securities | 146,863 | 50,057 |
Property and equipment, net | 32,425 | 34,918 |
Operating lease right-of-use assets | 46,497 | 48,015 |
Restricted cash | 2,432 | 2,436 |
Other assets, noncurrent | 2,214 | 1,812 |
Total assets | 870,442 | 939,208 |
Current liabilities: | ||
Accounts payable | 8,260 | 15,097 |
Accrued liabilities | 53,266 | 39,297 |
Accrued compensation | 25,187 | 27,712 |
Other liabilities, current | 6,379 | 5,892 |
Total current liabilities | 93,092 | 87,998 |
Long-term debt, net | 247,130 | 246,352 |
Convertible debt, net | 334,815 | 334,089 |
Operating lease liabilities, noncurrent | 70,322 | 73,506 |
Other liabilities, noncurrent | 6,723 | 853 |
Total liabilities | 752,082 | 742,798 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of June 30, 2022 (unaudited) and December 31, 2021; no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value, 150,000,000 shares authorized as of June 30, 2022 (unaudited) and December 31, 2021, respectively; 67,257,761 and 64,636,641 shares issued and outstanding as of June 30, 2022 (unaudited) and December 31, 2021, respectively | 67 | 65 |
Additional paid-in capital | 1,575,719 | 1,485,805 |
Accumulated other comprehensive income | (3,973) | 100 |
Accumulated deficit | (1,453,453) | (1,289,560) |
Total stockholders' equity | 118,360 | 196,410 |
Total liabilities and stockholders' equity | $ 870,442 | $ 939,208 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 67,272,761 | 64,636,641 |
Common stock, shares outstanding | 67,272,761 | 64,636,641 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues [Abstract] | ||||
Product sales, net | $ 71,550 | $ 47,555 | $ 126,710 | $ 86,598 |
Costs and operating expenses: | ||||
Cost of sales | 1,413 | 748 | 2,468 | 1,332 |
Research and development | 64,775 | 51,784 | 117,608 | 102,641 |
Selling, general and administrative | 81,088 | 61,093 | 155,622 | 120,059 |
Total costs and operating expenses | 147,276 | 113,625 | 275,698 | 224,032 |
Loss from operations | (75,726) | (66,070) | (148,988) | (137,434) |
Other income (expense): | ||||
Interest income | 1,664 | 164 | 2,164 | 493 |
Interest expense | (8,402) | (3,677) | (16,607) | (7,366) |
Other income (expense), net | 186 | 21 | (100) | (62) |
Total other income (expense,), net | (6,552) | (3,492) | (14,543) | (6,935) |
Loss before income taxes | (82,278) | (69,562) | (163,531) | (144,369) |
Provision for income taxes | 192 | 30 | 362 | 153 |
Net loss | (82,470) | (69,592) | (163,893) | (144,522) |
Other comprehensive loss: | ||||
Net unrealized gain on marketable securities, net of tax | (1,711) | (78) | (3,626) | (259) |
Cumulative translation adjustment | (300) | 259 | (446) | 259 |
Total other comprehensive expense, net | (2,011) | 181 | (4,072) | 0 |
Comprehensive loss | $ (84,481) | $ (69,411) | $ (167,965) | $ (144,522) |
Basic net loss per common share | $ (1.26) | $ (1.12) | $ (2.51) | $ (2.32) |
Diluted net loss per common share | $ (1.26) | $ (1.12) | $ (2.51) | $ (2.32) |
Weighted-average number of shares used in computing basic net loss per common share | 65,594,792 | 62,312,418 | 65,220,518 | 62,207,328 |
Weighted-average number of shares used in computing diluted net loss per common share | 65,594,792 | 62,312,418 | 65,220,518 | 62,207,328 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2020 | $ 416,157 | $ 62 | $ 1,402,262 | $ 302 | $ (986,469) |
Beginning Balance, Shares at Dec. 31, 2020 | 61,898,090 | ||||
Issuance of common stock upon exercise of stock options | 1,110 | 1,110 | |||
Issuance of common stock upon exercise of stock options, Shares | 47,763 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (1,897) | (1,897) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 229,087 | ||||
Issuance of common stock pursuant to ESPP purchases | 2,558 | 2,558 | |||
Issuance of common stock pursuant to ESPP purchases, Shares | 65,110 | ||||
Stock-based compensation | 20,378 | 20,378 | |||
Other comprehensive income | (181) | (181) | |||
Net loss | (74,930) | (74,930) | |||
Ending Balance at Mar. 31, 2021 | 363,195 | $ 62 | 1,424,411 | 121 | (1,061,399) |
Ending Balance, Shares at Mar. 31, 2021 | 62,240,050 | ||||
Beginning Balance at Dec. 31, 2020 | 416,157 | $ 62 | 1,402,262 | 302 | (986,469) |
Beginning Balance, Shares at Dec. 31, 2020 | 61,898,090 | ||||
Other comprehensive income | 0 | ||||
Net loss | (144,522) | ||||
Ending Balance at Jun. 30, 2021 | 315,766 | $ 62 | 1,446,393 | 302 | (1,130,991) |
Ending Balance, Shares at Jun. 30, 2021 | 62,379,118 | ||||
Beginning Balance at Mar. 31, 2021 | 363,195 | $ 62 | 1,424,411 | 121 | (1,061,399) |
Beginning Balance, Shares at Mar. 31, 2021 | 62,240,050 | ||||
Issuance of common stock upon exercise of stock options | 403 | 403 | |||
Issuance of common stock upon exercise of stock options, Shares | 28,575 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (65) | (65) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 110,493 | ||||
Stock-based compensation | 21,644 | 21,644 | |||
Other comprehensive income | 181 | 181 | |||
Net loss | (69,592) | (69,592) | |||
Ending Balance at Jun. 30, 2021 | 315,766 | $ 62 | 1,446,393 | 302 | (1,130,991) |
Ending Balance, Shares at Jun. 30, 2021 | 62,379,118 | ||||
Beginning Balance at Dec. 31, 2021 | 196,410 | $ 65 | 1,485,805 | 100 | (1,289,560) |
Beginning Balance, Shares at Dec. 31, 2021 | 64,636,641 | ||||
Issuance of common stock upon exercise of stock options | 324 | 324 | |||
Issuance of common stock upon exercise of stock options, Shares | 21,653 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (981) | (981) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 308,118 | ||||
Issuance of common stock pursuant to ESPP purchases | 2,259 | 2,259 | |||
Issuance of common stock pursuant to ESPP purchases, Shares | 89,050 | ||||
Stock-based compensation | 19,475 | 19,475 | |||
Other comprehensive income | (2,062) | (2,062) | |||
Net loss | (81,423) | (81,423) | |||
Ending Balance at Mar. 31, 2022 | 134,002 | $ 65 | 1,506,882 | (1,962) | (1,370,983) |
Ending Balance, Shares at Mar. 31, 2022 | 65,055,462 | ||||
Beginning Balance at Dec. 31, 2021 | $ 196,410 | $ 65 | 1,485,805 | 100 | (1,289,560) |
Beginning Balance, Shares at Dec. 31, 2021 | 64,636,641 | ||||
Issuance of common stock upon exercise of stock options, Shares | 36,668 | ||||
Stock Issued During Period, Shares, New Issues | 2,065,358 | ||||
Other comprehensive income | $ (4,072) | ||||
Net loss | (163,893) | ||||
Ending Balance at Jun. 30, 2022 | 118,360 | $ 67 | 1,575,719 | (3,973) | (1,453,453) |
Ending Balance, Shares at Jun. 30, 2022 | 67,272,761 | ||||
Beginning Balance at Mar. 31, 2022 | 134,002 | $ 65 | 1,506,882 | (1,962) | (1,370,983) |
Beginning Balance, Shares at Mar. 31, 2022 | 65,055,462 | ||||
Issuance of common stock upon exercise of stock options | 216 | 216 | |||
Issuance of common stock upon exercise of stock options, Shares | 15,015 | ||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | (114) | (114) | |||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes, Shares | 136,916 | ||||
Stock Issued During Period, Shares, New Issues | 2,065,368 | ||||
Stock Issued During Period, Value, New Issues | 48,495 | $ 2 | 48,493 | ||
Stock-based compensation | 20,242 | 20,242 | |||
Other comprehensive income | (2,011) | (2,011) | |||
Net loss | (82,470) | (82,470) | |||
Ending Balance at Jun. 30, 2022 | $ 118,360 | $ 67 | $ 1,575,719 | $ (3,973) | $ (1,453,453) |
Ending Balance, Shares at Jun. 30, 2022 | 67,272,761 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
Net loss | $ (82,470) | $ (81,423) | $ (69,592) | $ (74,930) | $ (163,893) | $ (144,522) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 3,052 | 2,908 | |||||
Amortization (accretion) of premium (discount) on marketable securities | 88 | 112 | |||||
Non-cash interest expense | 1,541 | 476 | |||||
Amortization of operating lease right-of-use assets | 1,518 | 1,301 | |||||
Stock-based compensation | 38,984 | 41,184 | |||||
Changes in operating assets and liabilities: | |||||||
Accounts receivables | (965) | (2,044) | |||||
Inventories | (6,806) | (6,841) | |||||
Prepaid expenses and other assets, current | 2,977 | (7,121) | |||||
Other assets, non-current | (394) | 0 | |||||
Accounts payable | (6,844) | (9,730) | |||||
Accrued liabilities | 13,971 | 7,683 | |||||
Accrued compensation | (2,525) | (4,655) | |||||
Operating lease liabilities | (2,735) | (2,328) | |||||
Other liabilities, noncurrent | 5,870 | 0 | |||||
Net cash used in operating activities | (116,161) | (123,577) | |||||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
Purchases of property and equipment | (636) | (1,920) | |||||
Purchases of marketable securities | (386,025) | 0 | |||||
Maturities of marketable securities | 29,500 | 47,670 | |||||
Net cash provided by (used in) investing activities | (357,161) | 45,750 | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options | 2,799 | 4,083 | |||||
Proceeds from issuance of common stock upon at-the-market offering, net of issuance cost | 48,495 | 0 | |||||
Taxes paid related to net share settlement of equity awards | (1,095) | (1,962) | |||||
Payments of debt issuance costs | 0 | (49) | |||||
Net cash provided by financing activities | 50,199 | 2,072 | |||||
Effect of exchange rate changes on cash and cash equivalents | (446) | 259 | |||||
Net decrease in cash, cash equivalents and restricted cash | (423,569) | (75,496) | |||||
Cash, cash equivalents and restricted cash at beginning of period | $ 687,153 | $ 497,202 | 687,153 | 497,202 | $ 497,202 | ||
Cash, cash equivalents and restricted cash at end of period | 263,584 | 421,706 | 263,584 | 421,706 | 687,153 | ||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||||||
Cash paid for interest | 14,511 | 6,788 | |||||
Cash paid for income taxes | 80 | 0 | |||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | |||||||
Accrued issuance costs | 0 | (26) | |||||
Accrued purchase of property and equipment | 7 | (36) | |||||
RECONCILIATION OF CASH, CASH EQUIVALENTS, AND RESTRICTED CASH TO THE CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
Cash and cash equivalents | 261,152 | 419,311 | 261,152 | 419,311 | $ 684,717 | ||
Restricted cash | 2,432 | 2,395 | 2,432 | 2,395 | |||
Total cash and cash equivalents and restricted cash | $ 263,584 | $ 421,706 | $ 263,584 | $ 421,706 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Global Blood Therapeutics, Inc., or the Company, we, us or our, was incorporated in Delaware in February 2011 and commenced operations in May 2012. We are a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities, starting with sickle cell disease, or SCD. In 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 SCD in adults and children 12 years of age and older, and we began to make Oxbryta available to patients through our specialty pharmacy partner network in December 2019. We have since received additional regulatory approvals of Oxbryta in and outside of the United States, including the accelerated approval we received from the FDA in December 2021 to expand Oxbryta’s indication for the treatment of SCD to children ages 4 to less than 12 years. In addition, in February 2022, we received Marketing Authorization from the European Commission for the use of 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). 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 $ 1.453 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 additional 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 $ 664.0 million as of June 30, 2022 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 | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation and Presentation of Financial Information The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and, accordingly, the balance sheet as of December 31, 2021, has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of our financial information. The results of operations for the six months ended June 30, 2022, are not necessarily indicative of the results to be expected for the year ending December 31, 2022, or for any other interim period or for any other future year. The accompanying unaudited interim condensed consolidated financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2021 , included in the Annual Report on Form 10-K we filed with the SEC on February 23, 2022. Use of Estimates The preparation of the accompanying unaudited interim condensed consolidated financial statements in accordance with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of variable consideration and costs and expenses during the reporting period. We base our estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results could differ from these estimates under different assumptions or conditions. Concentration of Risk Credit Risk We invest in a variety of financial instruments and, by our Board approved investment policy, limit the amount of credit exposure with any one issuer, industry or geographic area for investments other than instruments backed by the U.S. federal government. Major Customers We have entered into agreements with certain limited specialty pharmacies and specialty distributors for the distribution of Oxbryta in the United States. For the six months ended June 30, 2022 , our three largest customers represented approximately 98 % of our product revenue and approximately 97 % of our accounts receivable balance at June 30, 2022. Major Suppliers We do not currently have any of our own manufacturing facilities, and, therefore, depend on an outsourced manufacturing strategy for the production of Oxbryta for commercial use and for the production of Oxbryta and our product candidates for clinical trials. We have contracts in place with third-party manufacturers that are approved for the commercial production of Oxbryta and third-party suppliers that are approved for Oxbryta’s active pharmaceutical ingredient. Although there are potential sources of supply other than our existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and our wholly owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. Significant Accounting Policies Except as noted below, there have been no material revisions in our significant accounting policies described in Note 2 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 . 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 grant date fair value. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based award is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether the awards are probable of achievement. For awards with market-based performance conditions, we use a Monte-Carlo simulation model to estimate grant date fair value and we recognize the share-based compensation expense of the award over the derived service period regardless of whether the underlying performance condition is met. Stock-based compensation expense recognized in the consolidated statements of operations is based on stock awards ultimately vested, taking into consideration actual forfeitures. Accounting Pronouncement Issued But Not Yet Adopted In March 2020, Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, ASU, No. 2020-04, Reference Rate Reform (Topic 848). The 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 | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the interim condensed 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, accrued liabilities, convertible debt and long-term debt. Long-term debt and convertible debt are reported at amortized cost on our interim condensed consolidated balance sheets. Cash and cash equivalents, marketable securities and restricted cash are reported at their respective fair values on our interim condensed consolidated balance sheets. The remaining financial instruments are reported on our interim condensed consolidated balance sheets at cost that approximate current fair values due to their relatively short maturities. Assets and liabilities recorded at fair value on a recurring basis in the interim condensed consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. In accordance with ASC 820-10, Fair Value Measurements and Disclosures, we determine 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 measured at fair value on a recurring basis (in thousands): June 30, 2022 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 224,325 $ 224,325 $ — $ — Corporate debt securities 63,362 — 63,362 — U.S. government agency securities 49,124 — 49,124 — Certificates of deposits 1,942 — 1,942 — U.S. government securities 192,485 — 192,485 — U.S. treasury bills 100,956 5,000 95,956 — Total financial assets $ 632,194 $ 229,325 $ 402,869 $ — 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 $ — 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 June 30, 2022, and December 31, 2021, the weighted average remaining contractual maturities of our Level 2 investments were 15 months and 18 months, respectively, and all of these investments are rated A-1/P-1 or A/A2, or higher, by Moody’s and Standard & Poor’s. There were no transfers between Level 1 and Level 2 during the periods presented. There were no sales of available-for-sale securities except for money market funds in the periods presented. No credit loss allowance was recorded as of June 30, 2022 , as we do not believe the unrealized loss is a result of a credit loss due to the nature of our investments. We also considered the current and expected future economic and market conditions and determined that the estimate of credit losses was not significantly impacted. |
Available-for-Sale Securities
Available-for-Sale Securities | 6 Months Ended |
Jun. 30, 2022 | |
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, restricted cash, or marketable securities in our interim condensed consolidated balance sheets (in thousands): June 30, 2022 Amortized Unrealized Unrealized Estimated Fair Cost Gains (Losses) Value Financial Assets: Money market funds $ 224,325 $ — $ — $ 224,325 Corporate debt securities 64,089 2 ( 729 ) 63,362 U.S. government agency securities 49,891 4 ( 771 ) 49,124 Certificates of deposits 1,959 — ( 17 ) 1,942 U.S. government securities 194,572 39 ( 2,126 ) 192,485 U.S. treasury bills 101,202 — ( 246 ) 100,956 Total $ 636,038 $ 45 $ ( 3,889 ) $ 632,194 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 The following table summarizes the classification of the available-for-sale securities on our interim condensed consolidated balance sheets (in thousands): June 30, 2022 December 31, 2021 Cash and cash equivalents $ 229,325 $ 671,845 Short-term marketable securities 256,006 — Long-term marketable securities 146,863 50,057 Total $ 632,194 $ 721,902 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 June 30, 2022 , were temporary in nature. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Inventories Inventories consist of the following (in thousands): June 30, 2022 December 31, 2021 Raw materials $ 5,425 $ 10,616 Work-in-process $ 57,753 45,662 Finished goods $ 2,638 1,924 Total inventories $ 65,816 $ 58,202 We have capitalized $ 400,000 and $ 408,000 of stock-based compensation expense to our inventories for the three months ended June 30, 2022, and 2021, respectively; and $ 733,000 and $ 838,000 for the six months ended June 30, 2022 and 2021, respectively. The depreciation expense capitalized into inventories are not material for the three- and six-months ended June 30, 2022 and 2021. See Note 9—Stock-based Compensation for details on stock-based compensation expenses recognized during the three- and six-months ended June 30, 2022, and 2021. Property and Equipment Property and equipment consists of the following (in thousands): June 30, 2022 December 31, 2021 Laboratory equipment $ 15,041 $ 14,373 Computer equipment 2,850 2,841 Leasehold improvements 32,281 32,281 Construction-in-progress 257 934 Total property and equipment 50,429 50,429 Less: accumulated depreciation and amortization ( 18,004 ) ( 15,511 ) Property and equipment, net $ 32,425 $ 34,918 Accrued liabilities Accrued liabilities consist of the following (in thousands): June 30, 2022 December 31, 2021 Accrued research and development costs $ 11,184 $ 8,525 Accrued manufacturing costs 13,599 11,327 Accrued professional and consulting services 12,134 7,863 Accrued sales deductions 14,956 10,205 Other 1,393 1,377 Total accrued liabilities $ 53,266 $ 39,297 Other liabilities, current Other liabilities consist of the following (in thousands): June 30, 2022 December 31, 2021 Operating lease liabilities, current $ 6,119 $ 5,670 Other current liabilities $ 260 222 Total other liabilities, current $ 6,379 $ 5,892 |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2022 | |
Disclosure Text Block [Abstract] | |
Long-term Debt | 6. Long-term Debt Amended and Restated Loan Agreement In December 2019, we entered into a term loan agreement, or 2019 Term Loan, with funds managed by Pharmakon Advisors LP, which are BioPharma Credit PLC, as collateral agent, Biopharma Credit Investments V (Master) LP, as a lender, and BPCR Limited Partnership, as a lender, and collectively with Biopharma Credit Investments V (Master) LP, the Lenders, 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 $ 75.0 million was funded in November 2020. In December 2021, we entered into an amended and restated loan agreement, or A&R Term Loan, which 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 which we refer to as the Tranche C Loan. Further, the A&R Term Loan 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 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. The Tranche C Loan was funded in December 2021. 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, or Prepayment Fee, depending on the timing of the prepayment. 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, the remaining unamortized debt discounts associated with the 2019 Term Loan as of the debt amendment date, and 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 June 30, 2022 , there were unamortized issuance costs and debt discounts of $ 4.4 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 June 30, 2022 (in thousands): 2022 (six months) $ 11,250 2023 22,500 2024 22,500 2025 104,688 2026 97,188 2027 89,688 Total minimum payments 347,814 Less: amount representing interest ( 92,814 ) Less: amount representing Paydown Fee ( 5,000 ) Long-term debt, gross 250,000 Discount on notes payable ( 4,419 ) Accretion of Paydown Fee 1,549 Long-term debt $ 247,130 |
Convertible Debt
Convertible Debt | 6 Months Ended |
Jun. 30, 2022 | |
Convertible Debt [Abstract] | |
Convertible Debt | 7. Convertible Debt Convertible Notes In December 2021, we issued in a private placement an aggregate principal amount of $ 345.0 million of 1.875 % convertible senior notes due 2028, or 2028 Notes. 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, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40), we accounted for the 2028 Notes as a single liability. As of June 30, 2022 , the 2028 Notes were recorded at the aggregate principal amount of $ 345.0 million less unamortized issuance costs of $ 10.2 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): Three months ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Stated coupon interest $ 1,617 $ — $ 3,234 $ — Amortization of debt issuance cost 364 — 726 — Total interest expense $ 1,981 $ — $ 3,960 $ — As of June 30, 2022, the fair value of the 2028 Notes was $40 7.2 million . The fair value was estimated using a 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 for the year ended December 31, 2021. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Leases We have operating leases for our headquarters in South San Francisco, where we have office and research and development laboratory facilities and equipment. Our leases have remaining lease terms of 1 to 10 years. Most of these leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases include renewal options at our election, with renewal terms that can extend the lease term from 1 to 10 years. These optional periods have not been considered in the determination of the right-of-use 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 interim condensed consolidated statement of operations and comprehensive loss in relation to these operating leases were $ 2.4 million and $ 2.4 million for the three months ended June 30, 2022, and 2021, respectively and $ 4.9 million and $ 5.6 million for the six months ended June 30, 2022 and 2021, respectively. Included in these lease costs were variable lease costs, which were not included within the measurement of our operating ROU assets and operating lease liabilities in the amount of $ 1.0 million and $ 1.2 million for the three months ended June 30, 2022, and 2021, respectively; and $ 2.0 million and $ 2.0 million for the six months ended June 30, 2022 and 2021, 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 periods reported is as follows (in thousands, except weighted-average remaining lease term and weighted-average discount rate): Six Months Ended June 30, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities $ 6,073 $ 5,883 Weighted-average remaining lease term of operating leases (in years) 7.8 8.7 Weighted-average discount rate of operating leases 8.7 % 8.7 % The majority of our lease costs are driven by our operating lease for our headquarters, where we have office and research and development laboratory space. In March 2017, we entered into a noncancelable operating lease for our headquarters, or Original Lease, for approximately 67,185 square feet of space in South San Francisco, California, or the Prior Premises. The Original Lease term commenced in November 2017 when we gained control over physical access to the Prior Premises for a 10-year period. In August 2018, we entered into an amendment to the Original Lease, or Lease Amendment, to relocate our headquarters from the Prior Premises to a then to-be-constructed building consisting of approximately 164,150 rentable square feet of space in South San Francisco, California, or the Substitute Premises, when the Substitute Premises were 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 was repaid to the landlord in the form of additional monthly rent with interest applied. As of June 30, 2022, we have capitalized $ 32.3 million 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. After relocating to the Substitute Premises, we surrendered and delivered the Prior Premises to the landlord in May 2020, upon which time we had no further obligations with respect to the Prior Premises other than with respect to the Initial Allowance, which we will repay to the landlord in the form of additional monthly rent with interest applied over the term of the Original Lease through November 2027. As of June 30, 2022, the maturities of our operating lease liabilities were as follows (in thousands): Year ending December 31, Amount 2022 (six months) 6,149 2023 12,584 2024 12,948 2025 13,368 2026 13,803 Thereafter 46,703 Total lease payments 105,555 Less: Imputed interest ( 29,114 ) Present value of operating lease liabilities $ 76,441 The operating leases require us to share in prorated operating expenses and property taxes based upon actual amounts incurred. These amounts are not fixed for future periods and, therefore, are not included in the future commitments listed above. Other commitments In the ordinary course of business, we enter into various firm purchase commitments related to research and development activities and manufacturing activities. As of June 30, 2022, we have noncancelable contractual obligations under the terms of a manufacturing agreement of approximately $ 1.3 million. 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. |
Stockholder's Equity
Stockholder's Equity | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholder's Equity | 9. Stockholder's Equity In August 2020, we entered into an at-the-market offering program, or “ATM”, which provides for the offering, issuance and sale by us of shares of our common stock from time to time for aggregate gross proceeds of up to $ 200.0 million. In the six months ended June 30, 2022, we have sold and issued 2,065,358 shares of common stock pursuant to the ATM, with total gross proceeds of $ 50.0 million before deducting underwriting discounts, commissions, and other offering expenses payable by us of $ 1.5 million. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation We have three stock-based compensation plans – the Amended and Restated 2017 Inducement Equity Plan, or the 2017 Inducement Plan, the Amended and Restated 2015 Stock Option and Incentive Plan, or 2015 Plan, and the 2012 Stock Option and Grant Plan, or 2012 Plan. As of June 30, 2022 , there were 2,329,397 shares reserved under the 2017 Inducement Plan and 5,396,563 shares reserved under the 2015 Plan for the future issuance of equity awards. Upon adoption of the 2015 Plan in July 2015, no new awards or grants are permitted under the 2012 Plan. See Note 11 to the Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2021, for additional information related to these stock-based compensation plans. Stock Options The following summarizes stock option activity under the 2017 Inducement Plan, 2015 Plan and 2012 Plan: Number of Options Weighted-Average Exercise Price Outstanding—December 31, 2021 3,553,763 $ 42.0 0 Options granted 671,701 29.32 Options exercised ( 36,668 ) 14.73 Options canceled ( 150,247 ) 50.13 Outstanding—June 30, 2022 4,038,549 $ 39.84 The fair values of stock options granted to employees were calculated using the following assumptions: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Expected term (in years) 5.3 5.3 - 6.1 5.3 - 6.1 5.3 - 6.1 Volatility 65.50 % 68.1 %- 72.2 % 65.5 %- 70.5 % 68.1 %- 72.7 % Risk-free interest rate 3.6 % 1.0 %- 1.1 % 1.4 %- 3.6 % 0.9 %- 1.1 % Dividend yield — — — — Restricted Stock Units The following table summarizes activity of restricted stock units, or RSUs, granted to employees with service-based vesting under the 2017 Inducement Plan and 2015 Plan and related information: Weighted- Average Number Grant Date of RSUs Fair Value Non-vested units — December 31, 2021 2,986,269 $ 45.37 RSUs granted 1,886,774 29.83 RSUs vested ( 482,023 ) 51.13 RSUs forfeited ( 300,044 ) 40.03 Non-vested units — June 30, 2022 4,090,976 $ 37.92 Performance-based RSU Awards 2020 Market-Condition RSU Awards Beginning in June 2020, the Compensation Committee of our Board of Directors has granted awards of performance-based RSUs to certain of our senior management, including our executive officers, under the 2015 Plan, the vesting of which is contingent upon the achievement of three escalating stock price targets, which we refer to as the 2020 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, with awards for up to an aggregate of 450,800 RSUs outstanding as of June 30, 2022 . 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 following table: 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 our share price and interest rates to generate potential future outcomes. We recognize the related compensation expense on a straight-line basis over the applicable derived service periods, which are the estimated periods of time that would be required to satisfy the market conditions. The following table summarizes the 2020 Market-Condition RSU Awards granted and forfeited during the six months ended June 30, 2022: 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, 2021 450,800 $ 43.17 0.30 $ 13,195 Granted — — — Vested — — — Forfeited — — — Non-vested market condition awards — June 30, 2022 450,800 $ 43.15 0.21 $ 14,403 At June 30, 2022 , total unrecognized compensation expense related to non-vested 2020 Market-Condition RSU Awards was $ 1.6 million, which is expected to be recognized over their respective remaining derived service periods. The weighted average remaining derived service period is 0.21 years. For the three and six months ended June 30, 2022 , and 2021, we recognized $ 0.9 million, $ 2.0 million, $ 1.5 million, and $ 4.6 million, respectively, in stock-based compensation expense related to the 2020 Market-Condition RSU Awards. Total Shareholder Return and Patient Share RSU Awards In March 2022, the Compensation Committee of our Board of Directors granted two types of performance-based RSU awards to our executive officers under the 2015 Plan that are milestone based, with 50 % of the awards earned based on relative total stockholder return, or TSR (which we refer to as the TSR RSU Awards), and 50 % of the awards earned based on patient market share (which we refer to as the Patient Share RSU Awards). Each of these awards are measured over a three-year performance period beginning on January 1, 2022. TSR RSU awards The vesting of the TSR RSU Awards is contingent upon our TSR percentile ranking relative to the companies within the NASDAQ Biotechnology Index over the three-year cumulative performance period of January 1, 2022 through December 31, 2024. Vesting is also subject to continued service requirements through the date that the Compensation Committee of our Board of Directors determines achievement of the applicable performance condition following the end of the performance period. The number of shares of common stock that could be distributed at the end of the three-year performance period may range from 0 % to 200 % of the target number of shares granted. The TSR percentile rankings and performance multipliers for the TSR RSU Awards are set forth in the following table: Total Shareholder Return Percentile Rank within the Performance Measurement Index Performance Multiplier if Total Shareholder Return is ≥ 0% Performance Multiplier if Total Shareholder Return is < 0% 100 th Percentile or higher 200 % 100 % 50 th Percentile 100 % 100 % 25 th Percentile 50 % 50 % Below 25 th Percentile 0 % 0 % The grant date fair value of the TSR RSU Awards was estimated using a Monte Carlo simulation model, which includes variables such as the expected volatility of our share price and interest rates to generate potential future outcomes. We recognize the related compensation expense on a straight-line basis over the applicable derived service periods, which are the estimated periods of time that would be required to satisfy the market conditions. The following table summarizes the TSR RSU Awards granted during the six months ended June 30, 2022: Weighted- Weighted- Average Average Remaining Aggregate Number Grant Date Vesting Intrinsic of RSUs Fair Value Period (years) Value Total Shareholder Return awards — December 31, 2021 — $ — — $ — Granted 98,276 47.34 2.59 Vested — — — Forfeited — — — Total Shareholder Return awards— June 30, 2022 98,276 $ 47.34 2.59 $ 3,140 The following table summarizes the assumptions used to estimate the fair value of the TSR RSU Awards as of the grant date: Six Months Ended June 30, 2022 Expected term (in years) 2.84 Volatility 66.01 % Risk-free interest rate 1.4 % Dividend yield — At June 30, 2022 , total unrecognized compensation expense related to TSR RSU Awards was $ 4.1 million, which is expected to be recognized over their respective remaining derived service periods. The weighted average remaining derived service period is 2.59 years. For the three and six months ended June 30, 2022 , we recognized $ 0.4 million and $ 0.5 million in stock-based compensation expense related to the TSR RSU Awards. Patient Share RSU Awards The vesting of the Patient Share RSU Awards is contingent upon our percentage of patient share within a comparator group consisting of all U.S.-based SCD patients (including pediatric patients) during a three-year cumulative performance period of January 1, 2022 through December 31, 2024. Vesting is also subject to continued service requirements through the date that the Compensation Committee of our Board of Directors determines achievement of the applicable performance condition following the end of the performance period. The number of shares of common stock that could be distributed at the end of the three-year performance period may range from 0 % to 200 % of the target number of shares granted. The patient share percentages and performance multipliers for the Patient Share RSU Awards are set forth in the following table: Patient Share Performance Multiplier 19.80% 200 % 18% 100 % 16.20% 50 % Below 16.2% 0 % The following table summarizes the Patient Share RSU Awards granted during the six months ended June 30, 2022: Weighted- Weighted- Average Average Remaining Aggregate Number Grant Date Vesting Intrinsic of RSUs Fair Value Period (years) Value Performance-based awards — December 31, 2021 — $ — — $ — Granted 98,277 29.87 2.59 Vested — — — Forfeited — — — Performance-based awards— June 30, 2022 98,277 $ 29.87 2.59 $ 3,140 Expense for these grants is based on the fair value on the date of the grant and will be recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met. If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if at all. As of June 30, 2022, the performance conditions were not deemed probable of achievement, and as a result no stock compensation expense was recognized for these awards. The total unrecognized compensation expense related to unvested Patient Share RSU Awards was $ 2.9 million. Stock-Based Compensation Expense Total stock-based compensation recognized by function included in the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 5,926 $ 4,906 $ 11,457 $ 10,216 Selling, general and administrative 13,917 15,064 27,527 30,134 Total stock-based compensation expense $ 19,843 $ 19,970 $ 38,984 $ 40,350 |
Related Parties Transaction
Related Parties Transaction | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Parties Transaction | 11. Related Parties Transaction In the six months ended June 30, 2022, we donated $ 0.3 million to The GBT Foundation, a California nonprofit public benefit corporation we established in August 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. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 12. Net Loss per Share Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period. Since we were in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. The following securities were not included in the diluted net loss per share calculations because their effect was anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Options to purchase common stock 4,038,549 3,739,404 4,038,549 3,739,404 Convertible Notes (as converted to common stock) 10,866,983 — 10,866,983 — Restricted stock units 4,738,329 3,352,273 4,738,329 3,352,273 Total 19,643,861 7,091,677 19,643,861 7,091,677 |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | 13. Subsequent Events In July 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) granted Great Britain marketing authorization for Oxbryta for the treatment of hemolytic anemia due to SCD in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxyurea. On August 7, 2022, we entered into an Agreement and Plan of Merger, or Merger Agreement, with Pfizer Inc., a Delaware corporation, or Pfizer, and Ribeye Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Pfizer, or Merger Sub, pursuant to which, and upon the terms and subject to the conditions described therein, Merger Sub will merge with and into the Company, with the Company surviving the merger as a wholly owned subsidiary of Pfizer, which we refer to as the Merger. Under the Merger Agreement, at the closing of the Merger, each issued and outstanding share of our common stock (other than shares owned by the Company, any subsidiary of the Company, Pfizer, Merger Sub or any other subsidiary of Pfizer and other than stockholders of the Company who have validly exercised their statutory rights of appraisal under the DGCL) will be converted into the right to receive $ 68.50 per share, net to the seller in cash, without interest and subject to any required withholding of taxes. The Merger is expected to close as early as the fourth quarter of 2022 . If the Merger Agreement is terminated under specified circumstances, we will be required to pay Pfizer a termination fee of $ 217 million. The Merger Agreement also provides that, in connection with the termination of the Merger Agreement under specified antitrust related circumstances, Pfizer will be required to pay us a “reverse termination fee” of $ 326 million. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Preparation and Presentation of Financial Information | Basis of Preparation and Presentation of Financial Information The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and, accordingly, the balance sheet as of December 31, 2021, has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of our financial information. The results of operations for the six months ended June 30, 2022, are not necessarily indicative of the results to be expected for the year ending December 31, 2022, or for any other interim period or for any other future year. The accompanying unaudited interim condensed consolidated financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2021 , included in the Annual Report on Form 10-K we filed with the SEC on February 23, 2022. |
Use of Estimates | Use of Estimates The preparation of the accompanying unaudited interim condensed consolidated financial statements in accordance with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of variable consideration and costs and expenses during the reporting period. We base our estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results could differ from these estimates under different assumptions or conditions. |
Concentration of Risk | Concentration of Risk Credit Risk We invest in a variety of financial instruments and, by our Board approved investment policy, limit the amount of credit exposure with any one issuer, industry or geographic area for investments other than instruments backed by the U.S. federal government. Major Customers We have entered into agreements with certain limited specialty pharmacies and specialty distributors for the distribution of Oxbryta in the United States. For the six months ended June 30, 2022 , our three largest customers represented approximately 98 % of our product revenue and approximately 97 % of our accounts receivable balance at June 30, 2022. Major Suppliers We do not currently have any of our own manufacturing facilities, and, therefore, depend on an outsourced manufacturing strategy for the production of Oxbryta for commercial use and for the production of Oxbryta and our product candidates for clinical trials. We have contracts in place with third-party manufacturers that are approved for the commercial production of Oxbryta and third-party suppliers that are approved for Oxbryta’s active pharmaceutical ingredient. Although there are potential sources of supply other than our existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. |
Principles of Consolidation | Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and our wholly owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. |
Significant Accounting Policies | Significant Accounting Policies Except as noted below, there have been no material revisions in our significant accounting policies described in Note 2 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 . |
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 grant date fair value. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based award is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether the awards are probable of achievement. For awards with market-based performance conditions, we use a Monte-Carlo simulation model to estimate grant date fair value and we recognize the share-based compensation expense of the award over the derived service period regardless of whether the underlying performance condition is met. Stock-based compensation expense recognized in the consolidated statements of operations is based on stock awards ultimately vested, taking into consideration actual forfeitures. |
Accounting Pronouncement Issued But Not Yet Adopted | Accounting Pronouncement Issued But Not Yet Adopted In March 2020, Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, ASU, No. 2020-04, Reference Rate Reform (Topic 848). The 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) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Assets Measured on Recurring Basis | The following table summarizes our financial assets measured at fair value on a recurring basis (in thousands): June 30, 2022 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 224,325 $ 224,325 $ — $ — Corporate debt securities 63,362 — 63,362 — U.S. government agency securities 49,124 — 49,124 — Certificates of deposits 1,942 — 1,942 — U.S. government securities 192,485 — 192,485 — U.S. treasury bills 100,956 5,000 95,956 — Total financial assets $ 632,194 $ 229,325 $ 402,869 $ — 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 $ — |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, restricted cash, or marketable securities in our interim condensed consolidated balance sheets (in thousands): June 30, 2022 Amortized Unrealized Unrealized Estimated Fair Cost Gains (Losses) Value Financial Assets: Money market funds $ 224,325 $ — $ — $ 224,325 Corporate debt securities 64,089 2 ( 729 ) 63,362 U.S. government agency securities 49,891 4 ( 771 ) 49,124 Certificates of deposits 1,959 — ( 17 ) 1,942 U.S. government securities 194,572 39 ( 2,126 ) 192,485 U.S. treasury bills 101,202 — ( 246 ) 100,956 Total $ 636,038 $ 45 $ ( 3,889 ) $ 632,194 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 |
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 interim condensed consolidated balance sheets (in thousands): June 30, 2022 December 31, 2021 Cash and cash equivalents $ 229,325 $ 671,845 Short-term marketable securities 256,006 — Long-term marketable securities 146,863 50,057 Total $ 632,194 $ 721,902 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Inventories | Inventories consist of the following (in thousands): June 30, 2022 December 31, 2021 Raw materials $ 5,425 $ 10,616 Work-in-process $ 57,753 45,662 Finished goods $ 2,638 1,924 Total inventories $ 65,816 $ 58,202 |
Property and Equipment | Property and equipment consists of the following (in thousands): June 30, 2022 December 31, 2021 Laboratory equipment $ 15,041 $ 14,373 Computer equipment 2,850 2,841 Leasehold improvements 32,281 32,281 Construction-in-progress 257 934 Total property and equipment 50,429 50,429 Less: accumulated depreciation and amortization ( 18,004 ) ( 15,511 ) Property and equipment, net $ 32,425 $ 34,918 |
Accrued Liabilities | Accrued liabilities consist of the following (in thousands): June 30, 2022 December 31, 2021 Accrued research and development costs $ 11,184 $ 8,525 Accrued manufacturing costs 13,599 11,327 Accrued professional and consulting services 12,134 7,863 Accrued sales deductions 14,956 10,205 Other 1,393 1,377 Total accrued liabilities $ 53,266 $ 39,297 |
Other Liabilities, current | Other liabilities consist of the following (in thousands): June 30, 2022 December 31, 2021 Operating lease liabilities, current $ 6,119 $ 5,670 Other current liabilities $ 260 222 Total other liabilities, current $ 6,379 $ 5,892 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 (in thousands): 2022 (six months) $ 11,250 2023 22,500 2024 22,500 2025 104,688 2026 97,188 2027 89,688 Total minimum payments 347,814 Less: amount representing interest ( 92,814 ) Less: amount representing Paydown Fee ( 5,000 ) Long-term debt, gross 250,000 Discount on notes payable ( 4,419 ) Accretion of Paydown Fee 1,549 Long-term debt $ 247,130 |
Convertible Debt (Tables)
Convertible Debt (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Convertible Debt [Abstract] | |
Schedule of debt interest expense | The following table presents the components of interest expense related to 2028 Notes (in thousands): Three months ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Stated coupon interest $ 1,617 $ — $ 3,234 $ — Amortization of debt issuance cost 364 — 726 — Total interest expense $ 1,981 $ — $ 3,960 $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of supplemental information related to leases | Supplemental information related to leases for the periods reported is as follows (in thousands, except weighted-average remaining lease term and weighted-average discount rate): Six Months Ended June 30, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities $ 6,073 $ 5,883 Weighted-average remaining lease term of operating leases (in years) 7.8 8.7 Weighted-average discount rate of operating leases 8.7 % 8.7 % |
Schedule of Lessee, Operating Lease, Liability, Maturity | As of June 30, 2022, the maturities of our operating lease liabilities were as follows (in thousands): Year ending December 31, Amount 2022 (six months) 6,149 2023 12,584 2024 12,948 2025 13,368 2026 13,803 Thereafter 46,703 Total lease payments 105,555 Less: Imputed interest ( 29,114 ) Present value of operating lease liabilities $ 76,441 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stock Option Activity | The following summarizes stock option activity under the 2017 Inducement Plan, 2015 Plan and 2012 Plan: Number of Options Weighted-Average Exercise Price Outstanding—December 31, 2021 3,553,763 $ 42.0 0 Options granted 671,701 29.32 Options exercised ( 36,668 ) 14.73 Options canceled ( 150,247 ) 50.13 Outstanding—June 30, 2022 4,038,549 $ 39.84 |
Valuation Assumptions for Stock Awards | The fair values of stock options granted to employees were calculated using the following assumptions: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Expected term (in years) 5.3 5.3 - 6.1 5.3 - 6.1 5.3 - 6.1 Volatility 65.50 % 68.1 %- 72.2 % 65.5 %- 70.5 % 68.1 %- 72.7 % Risk-free interest rate 3.6 % 1.0 %- 1.1 % 1.4 %- 3.6 % 0.9 %- 1.1 % Dividend yield — — — — |
Non-Vested Restricted Stock Activity | The following table summarizes activity of restricted stock units, or RSUs, granted to employees with service-based vesting under the 2017 Inducement Plan and 2015 Plan and related information: Weighted- Average Number Grant Date of RSUs Fair Value Non-vested units — December 31, 2021 2,986,269 $ 45.37 RSUs granted 1,886,774 29.83 RSUs vested ( 482,023 ) 51.13 RSUs forfeited ( 300,044 ) 40.03 Non-vested units — June 30, 2022 4,090,976 $ 37.92 |
Summary of Activity of Market-Condition Awards | 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 following table: Stock Price Targets Number of Units Allowed $ 109.20 90,160 $ 145.60 157,780 $ 182.00 202,860 |
Valuation Assumptions of Total Shareholder Return RSU Awards | The following table summarizes the 2020 Market-Condition RSU Awards granted and forfeited during the six months ended June 30, 2022: 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, 2021 450,800 $ 43.17 0.30 $ 13,195 Granted — — — Vested — — — Forfeited — — — Non-vested market condition awards — June 30, 2022 450,800 $ 43.15 0.21 $ 14,403 |
Stock-based Compensation Expense Recognized | Total stock-based compensation recognized by function included in the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 5,926 $ 4,906 $ 11,457 $ 10,216 Selling, general and administrative 13,917 15,064 27,527 30,134 Total stock-based compensation expense $ 19,843 $ 19,970 $ 38,984 $ 40,350 |
Schedule of Market - Based Share Awards | The TSR percentile rankings and performance multipliers for the TSR RSU Awards are set forth in the following table: Total Shareholder Return Percentile Rank within the Performance Measurement Index Performance Multiplier if Total Shareholder Return is ≥ 0% Performance Multiplier if Total Shareholder Return is < 0% 100 th Percentile or higher 200 % 100 % 50 th Percentile 100 % 100 % 25 th Percentile 50 % 50 % Below 25 th Percentile 0 % 0 % |
Summary of the TSR RSU Awards Granted | The following table summarizes the TSR RSU Awards granted during the six months ended June 30, 2022: Weighted- Weighted- Average Average Remaining Aggregate Number Grant Date Vesting Intrinsic of RSUs Fair Value Period (years) Value Total Shareholder Return awards — December 31, 2021 — $ — — $ — Granted 98,276 47.34 2.59 Vested — — — Forfeited — — — Total Shareholder Return awards— June 30, 2022 98,276 $ 47.34 2.59 $ 3,140 |
Schedule of Performance Based RSU Awards Granted | The following table summarizes the Patient Share RSU Awards granted during the six months ended June 30, 2022: Weighted- Weighted- Average Average Remaining Aggregate Number Grant Date Vesting Intrinsic of RSUs Fair Value Period (years) Value Performance-based awards — December 31, 2021 — $ — — $ — Granted 98,277 29.87 2.59 Vested — — — Forfeited — — — Performance-based awards— June 30, 2022 98,277 $ 29.87 2.59 $ 3,140 |
Summary of Assumptions used to Estimate the Fair Value of the TSR RSU Awards | The following table summarizes the assumptions used to estimate the fair value of the TSR RSU Awards as of the grant date: Six Months Ended June 30, 2022 Expected term (in years) 2.84 Volatility 66.01 % Risk-free interest rate 1.4 % Dividend yield — |
Schedule of Patient Share Percentage And Performance Multiplier | The patient share percentages and performance multipliers for the Patient Share RSU Awards are set forth in the following table: Patient Share Performance Multiplier 19.80% 200 % 18% 100 % 16.20% 50 % Below 16.2% 0 % |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Potentially Dilutive Securities that were Not Included in Diluted Net Loss per Share Calculations | The following securities were not included in the diluted net loss per share calculations because their effect was anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Options to purchase common stock 4,038,549 3,739,404 4,038,549 3,739,404 Convertible Notes (as converted to common stock) 10,866,983 — 10,866,983 — Restricted stock units 4,738,329 3,352,273 4,738,329 3,352,273 Total 19,643,861 7,091,677 19,643,861 7,091,677 |
Organization and Basis of Prese
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||
Cumulative net losses | $ (1,453,453) | $ (1,289,560) |
Cash and cash equivalents and investments | $ 664,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - Customer Concentration Risk [Member] - Two Major Customers [Member] | 6 Months Ended |
Jun. 30, 2022 | |
Revenue, Product and Service Benchmark [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 98% |
Accounts Receivable [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk percentage | 97% |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | $ 632,194 | $ 721,902 |
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 | |
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 | |
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 | |
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 | |
Fair Value Measurements, Recurring [Member] | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 100,956 | |
Fair Value Measurements, Recurring [Member] | U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 192,485 | 34,964 |
Fair Value Measurements, Recurring [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 229,325 | 671,845 |
Fair Value Measurements, Recurring [Member] | Level 1 [Member] | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 5,000 | |
Fair Value Measurements, Recurring [Member] | 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 | |
Fair Value Measurements, Recurring [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 402,869 | 50,057 |
Fair Value Measurements, Recurring [Member] | Level 2 [Member] | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 95,956 | |
Fair Value Measurements, Recurring [Member] | 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 | 192,485 | 34,964 |
Fair Value Measurements, Recurring [Member] | Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | 0 |
Fair Value Measurements, Recurring [Member] | Level 3 [Member] | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 0 | |
Fair Value Measurements, Recurring [Member] | 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 | 0 |
Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 224,325 | 671,845 |
Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 224,325 | 671,845 |
Fair Value Measurements, Recurring [Member] | 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 |
Fair Value Measurements, Recurring [Member] | 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 |
Fair Value Measurements, Recurring [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 63,362 | 10,006 |
Fair Value Measurements, Recurring [Member] | 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 | |
Fair Value Measurements, Recurring [Member] | Corporate Debt Securities [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 63,362 | 10,006 |
Fair Value Measurements, Recurring [Member] | 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 |
Fair Value Measurements, Recurring [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 49,124 | 4,843 |
Fair Value Measurements, Recurring [Member] | 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 | |
Fair Value Measurements, Recurring [Member] | 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 | 49,124 | 4,843 |
Fair Value Measurements, Recurring [Member] | 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 |
Fair Value Measurements, Recurring [Member] | Certificates of Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 1,942 | 244 |
Fair Value Measurements, Recurring [Member] | 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 | |
Fair Value Measurements, Recurring [Member] | Certificates of Deposits [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, fair value | 1,942 | 244 |
Fair Value Measurements, Recurring [Member] | 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 | $ 0 |
Available-for-Sale Securities -
Available-for-Sale Securities - Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Debt Securities, Available-for-Sale [Line Items] | ||
Available for sale securities, Amortized Cost | $ 636,038 | $ 722,122 |
Available for sale securities, Unrealized Gains | 45 | 0 |
Available for sale securities, Unrealized (Losses) | (3,889) | (220) |
Available for sale securities, Estimated Fair Value | 632,194 | 721,902 |
US Treasury Bill Securities [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Available for sale securities, Amortized Cost | 101,202 | |
Available for sale securities, Unrealized Gains | 0 | |
Available for sale securities, Unrealized (Losses) | (246) | |
Available for sale securities, Estimated Fair Value | 100,956 | |
Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Available for sale securities, Amortized Cost | 64,089 | 10,037 |
Available for sale securities, Unrealized Gains | 2 | 0 |
Available for sale securities, Unrealized (Losses) | (729) | (31) |
Available for sale securities, Estimated Fair Value | 63,362 | 10,006 |
U.S. Government Agency Securities [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Available for sale securities, Amortized Cost | 49,891 | 4,862 |
Available for sale securities, Unrealized Gains | 4 | 0 |
Available for sale securities, Unrealized (Losses) | (771) | (19) |
Available for sale securities, Estimated Fair Value | 49,124 | 4,843 |
Money Market Funds [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Available for sale securities, Amortized Cost | 224,325 | 671,845 |
Available for sale securities, Unrealized Gains | 0 | 0 |
Available for sale securities, Unrealized (Losses) | 0 | |
Available for sale securities, Estimated Fair Value | 224,325 | 671,845 |
Certificates of Deposits [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Available for sale securities, Amortized Cost | 1,959 | 245 |
Available for sale securities, Unrealized Gains | 0 | 0 |
Available for sale securities, Unrealized (Losses) | (17) | (1) |
Available for sale securities, Estimated Fair Value | 1,942 | 244 |
U.S. Government Securities [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Available for sale securities, Amortized Cost | 194,572 | 35,133 |
Available for sale securities, Unrealized Gains | 39 | 0 |
Available for sale securities, Unrealized (Losses) | (2,126) | (169) |
Available for sale securities, Estimated Fair Value | $ 192,485 | $ 34,964 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Summary of Classification of Available-for-Sale Securities on Consolidated Balance Sheets (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Investments, Debt and Equity Securities [Abstract] | ||
Cash and cash equivalents | $ 229,325 | $ 671,845 |
Short-term marketable securities | 256,006 | 0 |
Long-term marketable securities | 146,863 | 50,057 |
Total | $ 632,194 | $ 721,902 |
Balance Sheet Components - Inve
Balance Sheet Components - Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Components [Abstract] | ||
Raw materials | $ 5,425 | $ 10,616 |
Work-in-process | 57,753 | 45,662 |
Finished goods | 2,638 | 1,924 |
Total inventories | $ 65,816 | $ 58,202 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 50,429 | $ 50,429 |
Less: accumulated depreciation and amortization | (18,004) | (15,511) |
Property and equipment, net | 32,425 | 34,918 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 15,041 | 14,373 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 2,850 | 2,841 |
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 | $ 257 | $ 934 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Balance Sheet Components [Abstract] | ||||
Share based compensation expense capitalized | $ 400,000 | $ 408,000 | $ 733,000 | $ 838,000 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Components [Abstract] | ||
Accrued research and development costs | $ 11,184 | $ 8,525 |
Accrued manufacturing costs | 13,599 | 11,327 |
Accrued professional and consulting services | 12,134 | 7,863 |
Accrued sales deductions | 14,956 | 10,205 |
Other | 1,393 | 1,377 |
Total accrued liabilities | $ 53,266 | $ 39,297 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Components [Abstract] | ||
Operating lease liabilities, current | $ 6,119 | $ 5,670 |
Other current liabilities | 260 | 222 |
Total other liabilities, current | $ 6,379 | $ 5,892 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Nov. 30, 2020 | Dec. 31, 2019 | |
Long term debt | $ 247,130 | $ 246,352 | |||
Debt issuance costs paid | 0 | $ 49 | |||
Term Loan | |||||
Debt maximum borrowing capacity | $ 100,000 | ||||
Debt Instrument, Maturity Date | Dec. 17, 2027 | ||||
Debt Instrument, Basis Spread on Variable Rate | 7% | ||||
Long-term Debt, Percentage Bearing Variable Interest, Percentage Rate | 2% | ||||
Debt Instrument Additional Interest Rate On Debt Default | 3% | ||||
Debt additional paydown fee | 2% | ||||
Debt issuance costs paid | $ 3,400 | ||||
Other debt issuance cost paid | 100 | ||||
Unamortized issuance costs and debt discounts | $ 4,400 | ||||
Term Loan | Maximum | |||||
Debt prepayment fee | 3% | ||||
Term Loan | Minimum | |||||
Debt prepayment fee | 1% | ||||
Secured Debt | |||||
Debt maximum borrowing capacity | $ 75,000 | ||||
Debt additional borrowing capacity | $ 75,000 | ||||
Long term debt | $ 75,000 | $ 75,000 |
Long-term Debt-Schedule of Futu
Long-term Debt-Schedule of Future payments of principal and interest on the Term Loan (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
2022 (nine months) | $ 11,250 | |
2023 | 22,500 | |
2024 | 22,500 | |
2025 | 104,688 | |
2026 | 97,188 | |
2027 | 89,688 | |
Total minimum payments | 347,814 | |
Less amount representing interest | (92,814) | |
Less amount representing Paydown Fee | (5,000) | |
Long-term debt, gross | 250,000 | |
Discount on notes payable | (4,419) | |
Accretion of Paydown Fee | 1,549 | |
Long-term debt, net | $ 247,130 | $ 246,352 |
Convertible Debt (Additional In
Convertible Debt (Additional Information) (Details) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 USD ($) Days $ / shares | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) $ / shares | |
Debt Instrument [Line Items] | |||
Debt instrument principal amount | $ 345,000,000 | ||
Payments Of Debt Issuance Costs | 0 | $ 49,000 | |
Unamortized debt issuance costs | 10,200,000 | ||
Long-term debt, gross | $ 250,000,000 | ||
One Point Eight Seven Five Percent Convertible Senior Notes Due 2028 [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, interest rate, stated percentage | 2.37% | ||
Debt instrument, fair value | $ 7,200,000 | ||
Convertible Debt [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, interest rate, stated percentage | 1.875% | 1.875% | |
Convertible Debt [Member] | One Point Eight Seven Five Percent 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 | ||
Capped calls transactions | $ 46,800,000 | $ 46,800,000 | |
Maturity date | Dec. 15, 2028 | ||
Debt instrument convertible conversion ratio | 31.4985 | ||
Debt instrument repurchase amount | $ 1,000,000 | ||
Debt instrument, convertible, conversion price | $ / shares | $ 31.75 | ||
Debt instrument, convertible, threshold percentage of stock price trigger | 130% | ||
Debt instrument, convertible, threshold trading days | Days | 20 | ||
Debt instrument, convertible, threshold consecutive trading days | Days | 30 | ||
Debt instrument, redemption price, percentage of principal amount redeemed | 100% | ||
Derivative cap price per share | $ / shares | $ 31.7475 | ||
Number of shares of common stock underlying notes | Days | 10,866,983 | ||
Convertible Debt [Member] | One Point Eight Seven Five Percent Convertible Senior Notes Due 2028 [Member] | Call Option [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument principal amount | $ 45,000,000 | ||
Share price | $ / shares | $ 49.80 | ||
Non Convertible Debt [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument principal amount | $ 100,000,000 |
Convertible Debt - Schedule of
Convertible Debt - Schedule of debt interest expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Short-Term Debt [Line Items] | ||||
Total interest expense | $ 92,814 | |||
2.37% Convertible Senior Notes [Member] | ||||
Short-Term Debt [Line Items] | ||||
Stated coupon interest | $ 1,617 | $ 0 | 3,234 | |
Amortization of debt issuance costs | 364 | 0 | 726 | |
Total interest expense | $ 1,981 | $ 0 | $ 3,960 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Aug. 31, 2018 USD ($) ft² | Mar. 31, 2017 ft² | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | |
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 | $ 121,500,000 | ||||
Operating lease term | 10 years | 10 years | ||||
Operating Lease Lease Expiration Period | 10 years | 10 years | ||||
Repayment of tenant inducement allowance | $ 4,100,000 | |||||
Loss Contingency, Loss in Period | $ 0 | |||||
Loss Contingency Accrual, Provision | 0 | |||||
Operating Lease Cost | 2,400,000 | $ 2,400,000 | 4,900,000 | $ 5,600,000 | ||
variable lease cost | 1,000 | $ 1,200,000 | $ 2,000,000 | $ 2,000,000 | ||
Maximum [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Operating lease remaining lease term | 10 years | |||||
Minimum [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Operating lease remaining lease term | 1 year | |||||
Leasehold Improvements [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Property palnt and equipment additions | $ 32,300,000 | |||||
Lease Agreements [Member] | Maximum [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Tenant inducement | $ 27,900,000 | |||||
Manufacturing Agreement [Member] | ||||||
Commitment And Contingencies [Line Items] | ||||||
Noncancelable contractual obligations | $ 1,300,000 | $ 1,300,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Supplemental cash flow information (Detail) - Accounting Standards Update 2016-02 [Member] - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Commitment And Contingencies [Line Items] | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 6,073 | $ 5,883 |
Weighted-average remaining lease term of operating leases (in years) | 7 years 9 months 18 days | 8 years 8 months 12 days |
Weighted-average discount rate of operating leases | 8.70% | 8.70% |
Commitments and Contingencies_3
Commitments and Contingencies - Lessee Operating Lease Liability Maturity (Detail) $ in Thousands | Jun. 30, 2022 USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2022 (six months) | $ 6,149 |
2023 | 12,584 |
2024 | 12,948 |
2025 | 13,368 |
2026 | 13,803 |
Thereafter | 46,703 |
Total lease payments | 105,555 |
Less: Imputed interest | (29,114) |
Present value of operating lease liabilities | $ 76,441 |
Stockholder's Equity - Addition
Stockholder's Equity - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | 23 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | |
Class of Stock [Line Items] | |||
Proceeds from Issuance of Common Stock | $ 48,495 | $ 0 | |
Issuance of common stock upon at-the-market financing, Shares | 2,065,358 | ||
Proceeds from issuance of common stock before offering expenses | $ 50,000 | $ 50,000 | |
Underwriting discounts, commissions, and other offering expenses payable | $ 1,500 | ||
Maximum [Member] | |||
Class of Stock [Line Items] | |||
Proceeds from Issuance of Common Stock | $ 200,000 |
Stock-Based Compensation - Plan
Stock-Based Compensation - Plan Summary - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation | $ 38,984 | $ 41,184 | |||
Market Condition Awards Granted to Employees [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense | $ 1,600 | $ 1,600 | |||
Weighted average derived service period | 2 months 15 days | ||||
Stock-based compensation | $ 900 | $ 2,000 | $ 1,500 | $ 4,600 | |
TSR RSU Awards [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares Non-vested period | 98,276 | 98,276 | 0 | ||
TSR RSU Awards [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 200% | ||||
TSR RSU Awards [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 0% | ||||
Patient Share RSU Awards [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation | $ 2,900 | ||||
Patient Share RSU Awards [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares Granted Percentage | 200% | ||||
Patient Share RSU Awards [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares Granted Percentage | 0% | ||||
2017 Inducement Equity Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares authorized for issuance | 2,329,397 | 2,329,397 | |||
2015 Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares authorized for issuance | 5,396,563 | 5,396,563 | |||
Percentage of patient market share | 50% | ||||
2015 Plan [Member] | Market Condition Awards Granted to Employees [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares Non-vested period | 450,800 | 450,800 | 450,800 | ||
2015 Plan [Member] | TSR RSU Awards [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense | $ 4,100 | $ 4,100 | |||
Weighted average derived service period | 2 years 7 months 2 days | ||||
Stock-based compensation | $ 400 | $ 500 | |||
2015 Plan [Member] | Performance Based RSU Awards [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares Non-vested period | 450,800 | 450,800 | |||
Percentage of total stockholder return | 50% | ||||
2015 Plan [Member] | Patient Share RSU Awards [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares Non-vested period | 98,277 | 98,277 | 0 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Detail) | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding [Roll Forward] | |
Beginning balance, outstanding, Number of Options | shares | 3,553,763 |
Options granted, Number of Options | shares | 671,701 |
Options exercised, Number of Options | shares | (36,668) |
Options canceled, Number of Options | shares | (150,247) |
Ending balance, outstanding, Number of Options | shares | 4,038,549 |
Weighted- Average Exercise Price | |
Beginning balance, Outstanding, Weighted-Average Exercise Price | $ / shares | $ 42 |
Options granted, Weighted-Average Exercise Price | $ / shares | 29.32 |
Options exercised, Weighted-Average Exercise Price | $ / shares | 14.73 |
Options canceled, Weighted-Average Exercise Price | $ / shares | 50.13 |
Ending balance, Outstanding, Weighted-Average Exercise Price | $ / shares | $ 39.84 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation Assumptions for Stock Options Granted (Detail) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
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 3 months 18 days | 5 years 3 months 18 days | |
Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days | |
Employee Stock Option Member | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 3 months 18 days | |||
Volatility | 65.50% | |||
Volatility, minimum | 68.10% | 65.50% | 68.10% | |
Volatility, maximum | 72.20% | 70.50% | 72.70% | |
Risk-free interest rate | 3.60% | |||
Risk-free interest rate, minimum | 1% | 1.40% | 0.90% | |
Risk-free interest rate, maximum | 1.10% | 3.60% | 1.10% | |
Dividend yield | 0% | 0% | 0% | 0% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of RSU Activity Granted to Employees with Service-Based Vesting (Detail) - 2017 Inducement Plan and 2015 Plan [Member] - RSU [Member] | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Units, Beginning Balance | shares | 2,986,269 |
RSUs granted, Number of RSUs | shares | 1,886,774 |
RSUs vested, Number of RSUs | shares | (482,023) |
RSUs forfeited, Number of RSUs | shares | (300,044) |
Number of Units, Ending Balance | shares | 4,090,976 |
Weighted-Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 45.37 |
RSUs granted, Weighted-Average Grant Date Fair Value | $ / shares | 29.83 |
RSUs vested, Weighted-Average Grant Date Fair Value | $ / shares | 51.13 |
RSUs forfeited, Weighted-Average Grant Date Fair Value | $ / shares | 40.03 |
Weighted-Average Grant Date Fair Value, Ending Balance | $ / shares | $ 37.92 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Share-based Compensation Arrangements by Share-based Payment Award (Detail) - 2020 Market Condition RSU Awards [Member] | Jun. 30, 2022 $ / shares shares |
Tranche One [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Stock Price Targets | $ / shares | $ 109.20 |
Number of Units Allowed | shares | 90,160 |
Tranche Two [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Stock Price Targets | $ / shares | $ 145.60 |
Number of Units Allowed | shares | 157,780 |
Tranche Three [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Stock Price Targets | $ / shares | $ 182 |
Number of Units Allowed | shares | 202,860 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Activity Awards (Detail) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Market Condition Awards Granted to Employees [Member] | 2015 Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Units, Beginning Balance | 450,800 | |
Number of Units granted | 0 | |
Number of Units vested | 0 | |
Number of Units forfeited | 0 | |
Number of Units, Ending Balance | 450,800 | 450,800 |
Weighted-Average Grant Date Fair Value, Beginning Balance | $ 43.17 | |
Weighted-Average Grant Date Fair Value granted | 0 | |
Weighted-Average Grant Date Fair Value vested | 0 | |
Weighted-Average Grant Date Fair Value forfeited | 0 | |
Weighted-Average Grant Date Fair Value, Ending Balance | $ 43.15 | $ 43.17 |
Weighted-Average remaining vesting period (years), Beginning Balance | 2 months 15 days | 3 months 18 days |
Weighted-Average remaining vesting period (years), Ending Balance | 2 months 15 days | 3 months 18 days |
Non-vested units, Aggregate Intrinsic Value | $ 14,403 | $ 13,195 |
TSR RSU Awards [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Units, Beginning Balance | 0 | |
Number of Units granted | 98,276 | |
Number of Units vested | 0 | |
Number of Units forfeited | 0 | |
Number of Units, Ending Balance | 98,276 | 0 |
Weighted-Average Grant Date Fair Value, Beginning Balance | $ 0 | |
Weighted-Average Grant Date Fair Value granted | 47.34 | |
Weighted-Average Grant Date Fair Value vested | 0 | |
Weighted-Average Grant Date Fair Value forfeited | 0 | |
Weighted-Average Grant Date Fair Value, Ending Balance | $ 47.34 | $ 0 |
Weighted-Average remaining vesting period (years), Beginning Balance | 2 years 7 months 2 days | |
Non-vested units, Weighted-Average remaining vesting period (years) granted | 2 years 7 months 2 days | |
Weighted-Average remaining vesting period (years), Ending Balance | 2 years 7 months 2 days | |
Non-vested units, Aggregate Intrinsic Value | $ 3,140 | $ 0 |
Performance-based RSU Awards [Member] | 2015 Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Units, Ending Balance | 450,800 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Market-Based Share Awards (Detail) - TSR RSU Awards [Member] | 6 Months Ended |
Jun. 30, 2022 shares | |
100th Percentile or Higher [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Performance Multiplier if Total Shareholder Return is Greater Than or Equal to 0% | 200 |
Performance Multiplier if Total Shareholder Return is Less Than 0% | 100 |
50th Percentile [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Performance Multiplier if Total Shareholder Return is Greater Than or Equal to 0% | 100 |
Performance Multiplier if Total Shareholder Return is Less Than 0% | 100 |
25th Percentile [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Performance Multiplier if Total Shareholder Return is Greater Than or Equal to 0% | 50 |
Performance Multiplier if Total Shareholder Return is Less Than 0% | 50 |
Below 25th Percentile [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Performance Multiplier if Total Shareholder Return is Greater Than or Equal to 0% | 0 |
Performance Multiplier if Total Shareholder Return is Less Than 0% | 0 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Assumptions used to Estimate the Fair Value of the TSR RSU Awards (Detail) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Total Shareholder Return RSU Awards [Member] | Two Thousand Fifteen Stock Option And Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 2 years 10 months 2 days | |||
Volatility | 66.01% | |||
Risk-free interest rate | 1.40% | |||
Dividend yield | 0% | |||
Employee Stock Option Member | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 3 months 18 days | |||
Volatility | 65.50% | |||
Risk-free interest rate | 3.60% | |||
Dividend yield | 0% | 0% | 0% | 0% |
Stock Based Compensation - Sche
Stock Based Compensation - Schedule of Patient Share Percentage And Performance Multiplier (Detail) - Patient Share RSU Awards | 6 Months Ended |
Jun. 30, 2022 | |
Patient Share 19.80% | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Percentage Of Performance Multiplier | 200% |
Patient Share 18% | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Percentage Of Performance Multiplier | 100% |
Patient Share 16.20% | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Percentage Of Performance Multiplier | 50% |
Patient Share below 16.20% | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Percentage Of Performance Multiplier | 0% |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Performance Based Awards (Details) - Two Thousand Fifteen Stock Option And Incentive Plan [Member] - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Performance Based RSU Awards [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Units, Ending Balance | 450,800 | |
Patient Share RSU Awards [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Units, Beginning Balance | 0 | |
Number of Units granted | 98,277 | |
Number of Units vested | 0 | |
Number of Units forfeited | 0 | |
Number of Units, Ending Balance | 98,277 | 0 |
Weighted-Average Grant Date Fair Value, Beginning Balance | $ 0 | |
Weighted-Average Grant Date Fair Value granted | 29.87 | |
Weighted-Average Grant Date Fair Value vested | 0 | |
Weighted-Average Grant Date Fair Value forfeited | 0 | |
Weighted-Average Grant Date Fair Value, Ending Balance | $ 29.87 | $ 0 |
Weighted-Average remaining vesting period (years), Beginning Balance | 2 years 7 months 2 days | |
Weighted-Average remaining vesting period (years), granted | 2 years 7 months 2 days | |
Weighted-Average remaining vesting period (years), Ending Balance | 2 years 7 months 2 days | |
Aggregate Intrinsic Value, Beginning Balance, | $ 0 | |
Aggregate Intrinsic Value, Ending Balance | $ 3,140 | $ 0 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock-Based Compensation Expense Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 19,843 | $ 19,970 | $ 38,984 | $ 40,350 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 5,926 | 4,906 | 11,457 | 10,216 |
Selling, general and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 13,917 | $ 15,064 | $ 27,527 | $ 30,134 |
Related Parties Transaction (Ad
Related Parties Transaction (Additional Information) (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Related Party Transactions [Abstract] | |
Donations To Related Party | $ 0.3 |
Net Loss per Share - Potentiall
Net Loss per Share - Potentially Dilutive Securities that were Not Included in Diluted Net Loss per Share Calculations (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 19,643,861 | 7,091,677 | 19,643,861 | 7,091,677 |
Employee Stock Option Member | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 4,038,549 | 3,739,404 | 4,038,549 | 3,739,404 |
RSU [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 4,738,329 | 3,352,273 | 4,738,329 | 3,352,273 |
Convertible Debt Securities [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from earnings per share | 10,866,983 | 0 | 10,866,983 | 0 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) - Subsequent Event - Pfizer Inc Merger Agreement $ / shares in Units, $ in Millions | Aug. 07, 2022 USD ($) $ / shares |
Subsequent Event [Line Items] | |
Termination fee | $ 217 |
Stock converted right to receive in cash consideration | $ / shares | $ 68.50 |
Reverse termination fee | $ 326 |