Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36352 | |
Entity Registrant Name | AKEBIA THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-8756903 | |
Entity Address, Address Line One | 245 First Street | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 617 | |
Local Phone Number | 871-2098 | |
Title of 12(b) Security | Common Stock, par value $0.00001 per share | |
Trading Symbol | AKBA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 174,537,458 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Current Fiscal Year End Date | --12-31 | |
Entity Central Index Key | 0001517022 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 246,992 | $ 228,698 |
Available for sale securities | 0 | 39,992 |
Inventory | 37,898 | 61,017 |
Accounts receivable, net | 35,005 | 26,853 |
Prepaid expenses and other current assets | 11,181 | 14,877 |
Total current assets | 331,076 | 371,437 |
Property and equipment, net | 7,670 | 8,622 |
Operating lease assets | 24,442 | 26,876 |
Goodwill | 55,053 | 55,053 |
Other intangible assets, net | 126,148 | 144,170 |
Other assets | 67,474 | 37,981 |
Total assets | 611,863 | 644,139 |
Current liabilities: | ||
Accounts payable | 41,984 | 41,308 |
Accrued expenses and other current liabilities | 111,742 | 130,624 |
Short-term deferred revenue | 11,869 | 15,214 |
Total current liabilities | 165,595 | 187,146 |
Deferred revenue, net of current portion | 16,598 | 25,345 |
Operating lease liabilities, net of current portion | 21,735 | 24,621 |
Derivative liability | 1,930 | 2,420 |
Long-term debt, net | 96,917 | 96,378 |
Liability related to sale of future royalties, net | 49,094 | 0 |
Other non-current liabilities | 85,363 | 60,611 |
Total liabilities | 437,232 | 396,521 |
Commitments and contingencies (Note 14) | ||
Stockholders' equity: | ||
Preferred stock $0.00001 par value, 25,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2021 and December 31, 2020 | 0 | 0 |
Common stock $0.00001 par value; 350,000,000 shares authorized at June 30, 2021 and December 31, 2020; 169,651,423 and 148,074,085 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 2 | 1 |
Additional paid-in capital | 1,504,752 | 1,425,115 |
Accumulated other comprehensive loss | 6 | 13 |
Accumulated deficit | (1,330,129) | (1,177,511) |
Total stockholders' equity | 174,631 | 247,618 |
Total liabilities and stockholders' equity | $ 611,863 | $ 644,139 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 04, 2020 |
Statement of Financial Position [Abstract] | |||
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | |
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 | |
Preferred stock, shares issued (in shares) | 0 | 0 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | |
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 | 175,000,000 |
Common stock, shares issued (in shares) | 169,651,423 | 148,074,085 | |
Common stock, shares outstanding (in shares) | 169,651,423 | 148,074,085 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues: | ||||
Total revenues | $ 52,913 | $ 90,142 | $ 105,217 | $ 178,620 |
Cost of goods sold: | ||||
Product | 43,484 | 49,988 | 69,079 | 68,601 |
Amortization of intangibles | 9,011 | 9,101 | 18,021 | 18,201 |
Impairment of intangible asset | 0 | 115,527 | 0 | 115,527 |
Total cost of goods sold | 52,495 | 174,616 | 87,100 | 202,329 |
Operating expenses: | ||||
Research and development | 37,214 | 52,819 | 77,825 | 134,050 |
Selling, general and administrative | 41,651 | 35,482 | 82,979 | 73,465 |
License expense | 894 | 1,044 | 1,590 | 1,720 |
Total operating expenses | 79,759 | 89,345 | 162,394 | 209,235 |
Operating loss | (79,341) | (173,819) | (144,277) | (232,944) |
Other income (expense): | ||||
Interest expense | (4,962) | (2,308) | (9,768) | (4,280) |
Other income | 1,265 | 376 | 1,427 | 726 |
Net loss | $ (83,038) | $ (175,751) | $ (152,618) | $ (236,498) |
Net loss per share - basic (in dollars per share) | $ (0.51) | $ (1.28) | $ (0.97) | $ (1.78) |
Net loss per share - diluted (in dollars per share) | $ (0.51) | $ (1.28) | $ (0.97) | $ (1.78) |
Weighted-average number of common shares - basic and diluted (in shares) | 161,329,990 | 136,906,968 | 157,596,143 | 132,651,066 |
Comprehensive loss: | ||||
Net loss | $ (83,038) | $ (175,751) | $ (152,618) | $ (236,498) |
Other comprehensive loss - unrealized loss on debt securities | (3) | (9) | (7) | (9) |
Total comprehensive loss | (83,041) | (175,760) | (152,625) | (236,507) |
Product revenue, net | ||||
Revenues: | ||||
Total revenues | 32,959 | 30,696 | 63,367 | 59,905 |
License, collaboration and other revenue | ||||
Revenues: | ||||
Total revenues | $ 19,954 | $ 59,446 | $ 41,850 | $ 118,715 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Unrealized Gain/(Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 121,674,568 | ||||
Beginning balance at Dec. 31, 2019 | $ 394,757 | $ 1 | $ 1,188,810 | $ 0 | $ (794,054) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net of issuance costs (in shares) | 7,973,967 | ||||
Issuance of common stock, net of issuance costs | 56,575 | 56,575 | |||
Proceeds from sale of stock under employee stock purchase plan (in shares) | 115,024 | ||||
Proceeds from sale of stock under employee stock purchase plan | 451 | 451 | |||
Share-based compensation expense | 4,916 | 4,916 | |||
Exercise of options (in shares) | 64,126 | ||||
Exercise of options | 412 | 412 | |||
Restricted stock unit vesting (in shares) | 423,755 | ||||
Net loss | (60,747) | (60,747) | |||
Ending balance (in shares) at Mar. 31, 2020 | 130,251,440 | ||||
Ending balance at Mar. 31, 2020 | 396,364 | $ 1 | 1,251,164 | 0 | (854,801) |
Beginning balance (in shares) at Dec. 31, 2019 | 121,674,568 | ||||
Beginning balance at Dec. 31, 2019 | 394,757 | $ 1 | 1,188,810 | 0 | (794,054) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Unrealized loss | (9) | ||||
Net loss | (236,498) | ||||
Ending balance (in shares) at Jun. 30, 2020 | 143,129,409 | ||||
Ending balance at Jun. 30, 2020 | 370,260 | $ 1 | 1,400,820 | (9) | (1,030,552) |
Beginning balance (in shares) at Dec. 31, 2019 | 121,674,568 | ||||
Beginning balance at Dec. 31, 2019 | $ 394,757 | $ 1 | 1,188,810 | 0 | (794,054) |
Ending balance (in shares) at Dec. 31, 2020 | 148,074,085 | 148,074,085 | |||
Ending balance at Dec. 31, 2020 | $ 247,618 | $ 1 | 1,425,115 | 13 | (1,177,511) |
Beginning balance (in shares) at Mar. 31, 2020 | 130,251,440 | ||||
Beginning balance at Mar. 31, 2020 | 396,364 | $ 1 | 1,251,164 | 0 | (854,801) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net of issuance costs (in shares) | 12,650,000 | ||||
Issuance of common stock, net of issuance costs | 142,383 | 142,383 | |||
Share-based compensation expense | 6,864 | 6,864 | |||
Exercise of options (in shares) | 48,103 | ||||
Exercise of options | 409 | 409 | |||
Restricted stock unit vesting (in shares) | 179,866 | ||||
Unrealized loss | (9) | (9) | |||
Net loss | (175,751) | (175,751) | |||
Ending balance (in shares) at Jun. 30, 2020 | 143,129,409 | ||||
Ending balance at Jun. 30, 2020 | $ 370,260 | $ 1 | 1,400,820 | (9) | (1,030,552) |
Beginning balance (in shares) at Dec. 31, 2020 | 148,074,085 | 148,074,085 | |||
Beginning balance at Dec. 31, 2020 | $ 247,618 | $ 1 | 1,425,115 | 13 | (1,177,511) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net of issuance costs (in shares) | 9,228,017 | ||||
Issuance of common stock, net of issuance costs | 29,498 | $ 1 | 29,497 | ||
Proceeds from sale of stock under employee stock purchase plan (in shares) | 154,276 | ||||
Proceeds from sale of stock under employee stock purchase plan | 367 | 367 | |||
Share-based compensation expense | 5,992 | 5,992 | |||
Restricted stock unit vesting (in shares) | 1,063,711 | ||||
Unrealized loss | (4) | (4) | |||
Net loss | (69,580) | (69,580) | |||
Ending balance (in shares) at Mar. 31, 2021 | 158,520,089 | ||||
Ending balance at Mar. 31, 2021 | $ 213,891 | $ 2 | 1,460,971 | 9 | (1,247,091) |
Beginning balance (in shares) at Dec. 31, 2020 | 148,074,085 | 148,074,085 | |||
Beginning balance at Dec. 31, 2020 | $ 247,618 | $ 1 | 1,425,115 | 13 | (1,177,511) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Unrealized loss | (7) | ||||
Net loss | $ (152,618) | ||||
Ending balance (in shares) at Jun. 30, 2021 | 169,651,423 | 169,651,423 | |||
Ending balance at Jun. 30, 2021 | $ 174,631 | $ 2 | 1,504,752 | 6 | (1,330,129) |
Beginning balance (in shares) at Mar. 31, 2021 | 158,520,089 | ||||
Beginning balance at Mar. 31, 2021 | 213,891 | $ 2 | 1,460,971 | 9 | (1,247,091) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net of issuance costs (in shares) | 10,446,160 | ||||
Issuance of common stock, net of issuance costs | 37,266 | 37,266 | |||
Share-based compensation expense | 6,515 | 6,515 | |||
Restricted stock unit vesting (in shares) | 685,174 | ||||
Unrealized loss | (3) | (3) | |||
Net loss | $ (83,038) | (83,038) | |||
Ending balance (in shares) at Jun. 30, 2021 | 169,651,423 | 169,651,423 | |||
Ending balance at Jun. 30, 2021 | $ 174,631 | $ 2 | $ 1,504,752 | $ 6 | $ (1,330,129) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Stockholders' Equity [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Operating activities: | |||||||
Net loss | $ (83,038) | $ (69,580) | $ (175,751) | $ (60,747) | $ (152,618) | $ (236,498) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 1,012 | 1,045 | |||||
Amortization of intangibles | 9,000 | 9,100 | 18,021 | 18,201 | |||
Intangible asset impairment charge | 0 | 115,527 | |||||
Amortization of premium/discount on investments | (15) | (2) | |||||
Non-cash interest expense related to sale of future royalties | 4,427 | 0 | |||||
Non-cash royalty revenue related to sale of future royalties | (116) | 0 | |||||
Non-cash interest expense | 539 | 872 | |||||
Non-cash operating lease expense | (965) | (1,164) | |||||
Fair value step-up of inventory sold or written off | 21,575 | 31,116 | |||||
Write-down of inventory | 400 | 9,900 | 5,425 | 10,089 | |||
Change in excess inventory purchase commitments | 21,338 | 10,954 | |||||
Stock-based compensation | 12,506 | 11,780 | |||||
Change in fair value of derivative liability | (570) | 80 | (490) | 240 | |||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | (8,152) | (251) | |||||
Inventory | (35,710) | (5,680) | |||||
Prepaid expenses and other current assets | 3,301 | (3,277) | |||||
Other long-term assets | 4,149 | 57 | |||||
Accounts payable | (1,120) | (4,979) | |||||
Accrued expense | (15,706) | 13,611 | |||||
Operating lease liabilities | 804 | 869 | |||||
Deferred revenue | (12,092) | (14,879) | |||||
Net cash used in operating activities | (133,887) | (52,369) | |||||
Investing activities: | |||||||
Purchase of equipment | (59) | (45) | |||||
Purchase of available for sale securities | 0 | (49,950) | |||||
Proceeds from the maturities of available for sale securities | 40,000 | 245 | |||||
Net cash provided by investing activities | 39,941 | (49,750) | |||||
Financing activities: | |||||||
Proceeds from sale of future royalties, net | 44,783 | 0 | |||||
Proceeds from the issuance of common stock, net of issuance costs | 66,696 | 198,883 | |||||
Proceeds from the sale of stock under employee stock purchase plan | 367 | 451 | |||||
Proceeds from the exercise of stock options | 0 | 821 | |||||
Net cash provided by financing activities | 111,846 | 200,155 | |||||
Increase in cash, cash equivalents, and restricted cash | 17,900 | 98,036 | |||||
Cash, cash equivalents, and restricted cash at beginning of the period | $ 231,132 | $ 149,804 | 231,132 | 149,804 | $ 149,804 | ||
Cash, cash equivalents, and restricted cash at end of the period | $ 249,032 | $ 247,840 | 249,032 | 247,840 | $ 231,132 | ||
Non-cash financing activities | |||||||
Unpaid offering costs | $ 68 | $ 75 |
Nature of Organization and Oper
Nature of Organization and Operations | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Organization and Operations | Nature of Organization and Operations Akebia Therapeutics, Inc., referred to as Akebia or the Company, was incorporated in the State of Delaware in 2007. Akebia is a biopharmaceutical company with the purpose of bettering the lives of people living with kidney disease. Akebia’s lead investigational product candidate, vadadustat, is an oral therapy in development for the treatment of anemia due to chronic kidney disease, or CKD. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, or HIF-PHI, designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, or HIF, which can lead to red blood cell, or RBC, production and improved oxygen delivery to tissues. Vadadustat is approved and marketed in Japan as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients under the trade name Vafseo TM . The Company submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for vadadustat in March of 2021 for the treatment of anemia due to CKD in adult patients with CKD on dialysis, or DD-CKD, and adult patients with CKD not on dialysis, or NDD-CKD. The Company's NDA submission was accepted for filing by the FDA in May 2021 and at the time of filing the NDA, the FDA indicated that they were not currently planning to hold an Advisory Committee meeting to discuss the application for vadadustat. The FDA also assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022. In addition, the Company has a commercial product, Auryxia ® (ferric citrate), which is currently approved by the FDA and marketed for two indications in the United States: the control of serum phosphorus levels in DD-CKD adult patients and the treatment of iron deficiency anemia, or IDA, in NDD-CKD adult patients. Ferric citrate is also approved and marketed in Japan as an oral treatment for IDA in adult patients and the improvement of hyperphosphatemia in adult patients with DD-CKD and NDD-CKD under the trade name Riona (ferric citrate hydrate). Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities, and providing general and administrative support for these operations. The Company began recording revenue from the U.S. sales of Auryxia and revenue from sublicensing rights to Auryxia in Japan to the Company’s Japanese partners Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., collectively JT and Torii, on December 12, 2018 following the consummation of a merger with Keryx Biopharmaceuticals, Inc., or Keryx, or the Merger. Additionally, following regulatory approval of vadadustat in Japan, the Company began recognizing royalty revenues from Mitsubishi Tanabe Pharma Corporation, or MTPC, from the sale of Vafseo in August 2020. In February 2021, the Company entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P., or the Royalty Agreement, whereby the Company sold its right to receive royalties and sales milestones under its Collaboration Agreement with MTPC, or the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information). The Company has not generated a profit to date and may never generate profits from product sales. Vadadustat and the Company’s other potential product candidates are subject to long development cycles, and the Company may be unsuccessful in its efforts to develop, obtain marketing approval for or market vadadustat and its other potential product candidates. If the Company does not successfully commercialize Auryxia, vadadustat or any other potential product candidate, it may be unable to achieve profitability. The Company’s management completed its going concern assessment in accordance with ASC 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , or ASC 205-40. The Company believes that its cash resources will be sufficient to allow the Company to fund its current operating plan through at least the next twelve months from the filing of this Quarterly Report on Form 10-Q. There can be no assurance, however, that the current operating plan will be achieved in the time frame anticipated by the Company, or that its cash resources will fund the Company’s operating plan for the period anticipated by the Company or that additional funding will be available on terms acceptable to the Company, or at all. The Company will require additional capital to pursue development and commercial activities related to Auryxia and vadadustat or any additional products and product candidates, including those that may be in-licensed or acquired. The Company expects to finance future cash needs through product revenue, public or private equity or debt transactions, payments from its collaborators, strategic transactions, or a combination of these approaches. However, adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital in sufficient amounts when needed or on attractive terms, it may not be able to pursue development and commercial activities related to Auryxia and vadadustat or any additional products and product candidates, including those that may be in-licensed or acquired. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP, for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the unaudited condensed consolidated financial statements have been included. Interim results for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021 or any other future period. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Management has determined that the Company operates in one segment, which is the business of developing and commercializing novel therapeutics for people with kidney disease. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission on February 25, 2021, or the 2020 Annual Report on Form 10-K. The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements for the three and six months ended June 30, 2021 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s 2020 Annual Report on Form 10-K and are updated below as necessary. New Accounting Pronouncements – Recently Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This standard became effective for the Company on January 1, 2021. ASU 2019-12 requires certain amendments to be applied using a modified retrospective approach, which requires a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption, while other amendments should be applied on a prospective basis. The adoption of this standard did not have a material impact on the Company’s unaudited condensed consolidated financial statements and related disclosures. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: prepaid and accrued research and development expense, operating lease assets and liabilities, derivative liabilities, other non-current liabilities, including the excess purchase commitment liability, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, non-cash interest expense on the liability related to sale of future royalties, inventories, income taxes, intangible assets and goodwill. The Company has made estimates of the impact of COVID-19 within the unaudited condensed consolidated financial statements and there may be changes to those estimates in future periods including changes to sales, payor mix, reserves and allowances, intangible assets and goodwill. Although the Company regularly assesses these estimates, actual results could differ materially from these estimates. Changes in estimates are recorded in the period they become known. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. Liability Related to Sale of Future Royalties The Company treats the liability related to sale of future royalties, see Note 5, as a debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liability related to sale of future royalties and the debt amortization are based on the Company’s current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments. To the extent the Company’s estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. Non-cash royalty revenue is reflected as royalty revenue within license, collaboration and other revenue, and non-cash amortization of debt is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss. |
Product Revenue and Reserves fo
Product Revenue and Reserves for Variable Consideration | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue and Reserves for Variable Consideration | Product Revenue and Reserves for Variable Consideration To date, the Company’s only source of product revenue has been from the U.S. sales of Auryxia. Total net product revenue was $33.0 million and $30.7 million for the three months ended June 30, 2021 and 2020, respectively, and $63.4 million and $59.9 million for the six months ended June 30, 2021 and 2020, respectively. The following table summarizes activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2021 and 2020 (in thousands): Chargebacks Rebates, Fees Returns Total Balance at December 31, 2020 $ 802 $ 39,912 $ 649 $ 41,363 Current provisions related to sales in current year 6,084 69,163 3,616 78,863 Adjustments related to prior year sales (6) 812 — 806 Credits/payments made (5,588) (63,795) (3,715) (73,098) Balance at June 30, 2021 $ 1,292 $ 46,092 $ 550 $ 47,934 Balance at December 31, 2019 $ 738 $ 30,552 $ 253 $ 31,543 Current provisions related to sales in current year 5,055 66,348 2,684 74,087 Adjustments related to prior year sales (31) 638 44 651 Credits/payments made (4,995) (54,945) (2,237) (62,177) Balance at June 30, 2020 $ 767 $ 42,593 $ 744 $ 44,104 Chargebacks, discounts and returns are recorded as a direct reduction of revenue on the unaudited condensed consolidated statement of operations with a corresponding reduction to accounts receivable on the unaudited condensed consolidated balance sheets. Rebates, distribution-related fees, and other sales-related deductions are recorded as a reduction in revenue on the unaudited condensed consolidated statement of operations with a corresponding increase to accrued liabilities or accounts payable on the unaudited condensed consolidated balance sheets. Accounts receivable, net related to product sales was approximately $35.0 million and $21.9 million as of June 30, 2021 and December 31, 2020, respectively. |
License, Collaboration and Othe
License, Collaboration and Other Significant Agreements | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License, Collaboration and Other Significant Agreements | License, Collaboration and Other Significant Agreements During the three and six months ended June 30, 2021 and 2020, the Company recognized the following revenues from its license, collaboration and other significant agreements and had the following deferred revenue balances as of June 30, 2021: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 License, Collaboration and Other Revenue: (in thousands) (in thousands) MTPC Agreement $ 4,594 $ 15,000 $ 4,612 $ 15,000 Otsuka U.S. Agreement 9,170 25,888 22,844 64,465 Otsuka International Agreement 4,700 12,832 11,672 32,202 Total Proportional Performance Revenue $ 18,464 $ 53,720 $ 39,128 $ 111,667 JT and Torii 1,490 1,740 2,649 2,866 MTPC Other Revenue — 3,986 73 4,182 Total License, Collaboration and Other Revenue $ 19,954 $ 59,446 $ 41,850 $ 118,715 June 30, 2021 Short-Term Long-Term Total Deferred Revenue: (in thousands) MTPC Agreement $ 1,400 $ — $ 1,400 Otsuka U.S. Agreement $ 6,089 $ 9,485 $ 15,574 Otsuka International Agreement 4,380 2,435 6,815 Vifor Agreement — 4,678 4,678 Total $ 11,869 $ 16,598 $ 28,467 The following table presents changes in the Company’s contract assets and liabilities during the six months ended June 30, 2021 and 2020 (in thousands): Six Months Ended June 30, 2021 Balance at Additions Deductions Balance at End Contract assets: Accounts receivable(1) $ 3,045 $ 18,884 $ (19,112) $ 2,817 Prepaid expenses and other current assets $ 1,722 $ 211 $ (5) $ 1,928 Contract liabilities: Deferred revenue $ 40,559 $ 36,679 $ (48,770) $ 28,468 Accounts payable $ 7,227 $ — $ (7,227) $ — Accrued expenses and other current liabilities $ 10,000 $ — $ — $ 10,000 Six Months Ended June 30, 2020 Contract assets: Accounts receivable(1) $ 15,822 $ 118,368 $ (115,382) $ 18,808 Prepaid expenses and other current assets $ — $ 756 $ — $ 756 Contract liabilities: Deferred revenue $ 72,950 $ 90,471 $ (105,350) $ 58,071 Accounts payable $ — $ 5,651 $ — $ 5,651 Accrued expenses and other current liabilities $ — $ 615 $ (615) $ — (1) Excludes accounts receivable from other services related to clinical and regulatory activities performed by the Company on behalf of MTPC that are not included in the performance obligations identified under the MTPC Agreement as of June 30, 2021 and 2020 and December 31, 2020 and 2019. Also excludes accounts receivable related to amounts due to the Company from product sales which are included in the accompanying unaudited condensed consolidated balance sheet as of June 30, 2021 and December 31, 2020. During the three and six months ended June 30, 2021 and 2020, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods (in thousands): Three Months Ended June 30, Six Months Ended June 30, Revenue Recognized in the Period from: 2021 2020 2021 2020 Amounts included in deferred revenue at the beginning of the period $ 5,822 $ 16,964 $ 10,895 $ 22,186 Performance obligations satisfied in previous periods $ — $ 3,555 $ — $ 3,263 Mitsubishi Tanabe Pharma Corporation Collaboration Agreement Summary of Agreement On December 11, 2015, the Company and MTPC entered into a collaboration agreement, or the MTPC Agreement, providing MTPC with exclusive development and commercialization rights to vadadustat in Japan and certain other Asian countries, collectively, the MTPC Territory. In addition, the Company will supply vadadustat for both clinical and commercial use in the MTPC Territory, subject to MTPC’s option to manufacture commercial drug product in the MTPC Territory. A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. In February 2021, the Company entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P., or the Royalty Agreement, whereby the Company sold its right to receive royalties and sales milestones under the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information). Revenue Recognition The Company evaluated the elements of the MTPC Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, MTPC, is a customer. The Company’s arrangement with MTPC contains the following material promises under the contract at inception: (i) license under certain of the Company’s intellectual property to develop and commercialize vadadustat (the License Deliverable) in the MTPC Territory, (ii) clinical supply of vadadustat (the Clinical Supply Deliverable), (iii) knowledge transfer, (iv) Phase 2 dosing study research services (the Research Deliverable), and (v) rights to future know-how. The Company identified two performance obligations in connection with its material promises under the MTPC Agreement as follows: (i) License, Research and Clinical Supply Performance Obligation and (ii) Rights to Future Know-How Performance Obligation . Factors considered in making the assessment of which material promises will be accounted for as separate performance obligations included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the good or service is highly interdependent or highly interrelated to the other elements in the arrangement, and whether there are other vendors that can provide the items. Additionally, the MTPC Agreement does not include a general right of return. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of the standalone selling price for the Rights to Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement and determined it is immaterial. As such, the Company did not develop a best estimate of standalone selling price for the License, Research and Clinical Supply Performance Obligation and allocated the entire transaction price to this performance obligation. The deliverables associated with the License, Research and Clinical Supply Performance Obligation were satisfied as of June 30, 2018. The transaction price at inception was comprised of: (i) the up-front payment, (ii) the estimated cost for the Phase 2 studies, (iii) a non-substantive milestone associated with the first patient enrolled in the NDD-CKD Phase 3 study, and (iv) the cost of all clinical supply provided to MTPC for the Phase 3 studies. No other development and no regulatory milestones were included in the transaction price at inception, as all other milestone amounts were fully constrained. Subsequent to inception, the transaction price also included certain development and regulatory milestones, as described below. As part of its evaluation of the constraint, the Company considers numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to MTPC and therefore have also been excluded from the transaction price. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The Company determined that the remaining consideration that may be payable to the Company subsequent to MTPC's commercial launch of Vafseo TM in the third quarter of 2020 is quarterly royalties on net sales, sales milestones, and certain regulatory milestones. As of June 30, 2021, the transaction price was comprised of: (i) the up-front payment of $20.0 million, (ii) the cost for the Phase 2 studies of $20.5 million, (iii) the cost of all clinical supply provided to MTPC for the Phase 3 studies, (iv) $10.0 million in development milestones received, (v) $25.0 million in regulatory milestones received, comprised of $10.0 million relating to the JNDA filing and $15.0 million relating to regulatory approval of vadadustat in Japan, and (vi) $0.5 million in royalties from net sales of Vafseo. As of June 30, 2021, all development milestones and $25.0 million in regulatory milestones have been achieved. No other regulatory milestones have been assessed as probable of being achieved and as a result have been fully constrained. Revenue for the License, Research and Clinical Supply Performance Obligation for the MTPC Agreement is being recognized using a proportional performance method, for which all deliverables have been completed. The Company recognized $0.1 million of revenue from MTPC royalties for each of the three and six months ended June 30, 2021. The Company recognized a $15.0 million regulatory milestone relating to regulatory approval of vadadustat in Japan as revenue during the three and six months ended June 30, 2020. As noted above, in February 2021, the Company entered into the Royalty Agreement, whereby the Company sold its right to receive these royalties and sales milestones under the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information). The revenue is classified as collaboration revenue in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss. As of June 30, 2021, there was an immaterial amount in accounts receivable, no deferred revenue, and no contract assets. There were no asset or liability balances classified as long-term in the unaudited condensed consolidated balance sheet as of June 30, 2021. Supply of Drug Product to MTPC In March 2020, in connection with the MTPC Agreement, the Company and MTPC executed an amendment that agreed to supply MTPC with certain vadadustat process validation drug product for commercial use and MTPC agreed to reimburse the Company for certain manufacturing-related expenses. In connection with this arrangement, the Company invoiced the upfront payment of $10.4 million, which it received during the three months ended June 30, 2020. The Company does not recognize revenue under this arrangement until risk of loss passes to MTPC and delivery has occurred. No revenues were recognized for either of the three or six months ended June 30, 2021 and 2020 for drug product that was delivered under the MTPC Agreement. As of June 30, 2021, the Company recorded no accounts receivable, no deferred revenue, and $3.0 million in other current liabilities and $0.6 million in other non-current liabilities for drug product that was subject to return by MTPC. On July 15, 2020, the Company and its collaboration partner MTPC entered into a supply agreement, or the MTPC Supply Agreement. The MTPC Supply Agreement includes the terms and conditions under which the Company will supply vadadustat drug product to MTPC for commercial use in Japan and certain other Asian countries, as contemplated by the MTPC Agreement. A more detailed description of this supply agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2020. The Company recognized $4.5 million of revenue under the MTPC Supply Agreement during the three and six months ended June 30, 2021. During the six months ended June 30, 2021, the Company invoiced MTPC for $9.5 million in payments for vadadustat drug product ordered by MTPC. As of June 30, 2021, the Company recorded $0.9 million in accounts receivable, $1.4 million in deferred revenue, $15.1 million in other current liabilities and $7.6 million in other non-current liabilities. U.S. Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. Summary of Agreement On December 18, 2016, the Company entered into a collaboration and license agreement with Otsuka, or the Otsuka U.S. Agreement. The collaboration is focused on the development and commercialization of vadadustat in the United States. Under the terms of the Otsuka U.S. Agreement, the Company granted to Otsuka a co-exclusive, non-sublicensable license under certain intellectual property controlled by the Company solely to perform medical affairs activities and to conduct non-promotional and commercialization activities related to vadadustat in accordance with the associated plans. The co-exclusive license relates to activities that will be jointly conducted by the Company and Otsuka pursuant to the terms of the Otsuka U.S. Agreement. Additionally, the parties agreed not to promote, market or sell any competing product in the territory covered by the Otsuka U.S. Agreement. A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Revenue Recognition The Company evaluated the elements of the Otsuka U.S. Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, Otsuka, is a customer. The Company’s arrangement with Otsuka contains the following material promises under the contract at inception: (i) license under certain of the Company’s intellectual property to develop, perform medical affairs activities with respect to and conduct non-promotional and commercialization activities related to vadadustat and products containing or comprising vadadustat (the License Deliverable), (ii) development services to be performed pursuant to the current global development plan (the Development Services Deliverable), (iii) rights to future intellectual property (the Future IP Deliverable), and (iv) joint committee services (the Committee Deliverable). The Company has identified three performance obligations in connection with its obligations under the Otsuka U.S. Agreement as follows: i) License and Development Services Combined (License Performance Obligation); (ii) Rights to Future Intellectual Property (Future IP Performance Obligation) and (iii) Joint Committee Services (Committee Performance Obligation). Factors considered in making the assessment of which material promises will be accounted for as separate performance obligations included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the good or service is highly interdependent or highly interrelated to the other elements in the arrangement, and whether there are other vendors that can provide the items. Additionally, the Otsuka U.S. Agreement does not include a general right of return. A more detailed description of the performance obligations under this agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2020. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of standalone selling price for the Committee Performance Obligation after considering the nature of the services to be performed and estimates of the associated effort and rates applicable to such services that would be expected to be realized under similar contracts. The Company developed a best estimate of standalone selling price for the Future IP Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement. The Company did not develop a best estimate of standalone selling price for the License Performance Obligation due to the following: (i) the best estimates of standalone selling price associated with the Future IP Performance Obligation was determined to be immaterial and (ii) the period of performance and pattern of recognition for the License Performance Obligation and the Committee Performance Obligation was determined to be similar. The Company has concluded that a change in the key assumptions used to determine the best estimate of standalone selling price for each performance obligation would not have a significant impact on the allocation of arrangement consideration. The transaction price at inception was comprised of: (i) the up-front payment, (ii) the cost share payment with respect to amounts incurred by the Company through December 31, 2016, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to December 31, 2016. No development or regulatory milestones were included in the transaction price at inception, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Otsuka and therefore have also been excluded from the transaction price. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The Company determined that under ASC 606, the contract was modified in the second quarter of 2019 when the Otsuka Funding Option became effective and the Company became eligible to receive the Additional Funding amount. In connection with the modification, the Company adjusted the transaction price to include the Additional Funding amount as additional variable consideration. The Company constrains the variable consideration to an amount for which a significant revenue reversal is not probable. In the event that there is consideration received by a customer in the form of activities performed by such customer under the global development plan, such consideration is reflected as a reduction to the transaction price as contra revenue rather than as an expense because the associated services are not distinct from the License Performance Obligation. The Company estimates the additional funding as a result of exercising the Otsuka Funding Option, or the Additional Funding, to total approximately $122.2 million or more, depending on the actual costs incurred toward the current global development plan. The Additional Funding is fully creditable against future payments due to the Company under the arrangement, provided that future payments due to the Company may not be reduced by more than 50% in any calendar year and any remaining creditable amount above 50% in any calendar year will be applied to subsequent future payments until fully credited. As of June 30, 2021, the Additional Funding was $100.0 million. No amounts were allocated to the Future IP Performance Obligation because the associated best estimate of standalone selling price was determined to be immaterial. Due to the similar performance period and recognition pattern between the License Performance Obligation and the Committee Performance Obligation, the transaction price has been allocated to the License Performance Obligation and the Committee Performance Obligation on a combined basis. Accordingly, the Company will recognize revenue related to the allocable arrangement consideration on a proportional performance basis as the underlying development services are performed pursuant to the current global development plan which is commensurate with the period and consistent with the pattern over which the Company’s obligations are satisfied for both the License Performance Obligation and the Committee Performance Obligation. Effectively, the Company has treated the arrangement as if the License Performance Obligation and the Committee Performance Obligation are a single performance obligation. As of June 30, 2021, the transaction price totaling $479.1 million was comprised of: (i) the up-front payment of $125.0 million, (ii) the cost share payment with respect to amounts incurred by the Company through December 31, 2016 of $33.8 million, and (iii) the estimate of the net cost share consideration to be received of approximately $320.3 million with respect to amounts incurred by the Company subsequent to December 31, 2016. As of June 30, 2021, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained. During the three months ended June 30, 2021 and 2020 the Company recognized revenue totaling approximately $9.2 million and $25.9 million, respectively, and approximately $22.8 million and $64.5 million, during the six months ended June 30, 2021 and 2020, respectively, with respect to the Otsuka U.S. Agreement. The revenue is classified as collaboration revenue in the accompanying unaudited condensed consolidated statements of operations. As of June 30, 2021, there was approximately $15.6 million of deferred revenue related to the Otsuka U.S. Agreement of which $6.1 million is classified as current and $9.5 million is classified as long-term in the accompanying unaudited condensed consolidated balance sheet based on the performance period of the underlying obligations. Additionally, as of June 30, 2021, there was an immaterial amount in accounts receivable and $1.3 million in prepaid expenses and other current assets in the accompanying unaudited condensed consolidated balance sheet. As of December 31, 2020, there was approximately $5.0 million in contract liabilities (included in accounts payable) and $1.2 million in prepaid expenses and other current assets in the consolidated balance sheet. The Company determined that the medical affairs, commercialization and non-promotional activities elements of the Otsuka U.S. Agreement represent joint operating activities in which both parties are active participants and of which both parties are exposed to significant risks and rewards that are dependent on the success of the activities. Accordingly, the Company is accounting for the joint medical affairs, commercialization and non-promotional activities in accordance with ASC No. 808, Collaborative Arrangements (ASC 808). Additionally, the Company has determined that in the context of the medical affairs, commercialization and non-promotional activities, Otsuka does not represent a customer as contemplated by ASC 606-10-15, Revenue from Contracts with Customers – Scope and Scope Exceptions . As a result, the activities conducted pursuant to the medical affairs, commercialization and non-promotional activities plans will be accounted for as a component of the related expense in the period incurred. During the three months ended June 30, 2021 and 2020, the Company incurred approximately $2.9 million and $0.2 million, respectively, of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement, of which approximately $1.4 million and $0.1 million are reimbursable by Otsuka and recorded as a reduction to research and development expense during the three months ended June 30, 2021 and 2020, respectively. During the three months ended June 30, 2021 and 2020, Otsuka incurred approximately $0.3 million and $0.4 million, respectively, of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement, of which approximately $0.1 million and $0.2 million are reimbursable by the Company and recorded as an increase to research and development expense during each of the three months ended June 30, 2021 and 2020. International Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. Summary of Agreement On April 25, 2017, the Company entered into a collaboration and license agreement with Otsuka, or the Otsuka International Agreement. The collaboration is focused on the development and commercialization of vadadustat in Europe, Russia, China, Canada, Australia, the Middle East and certain other territories, collectively, the Otsuka International Territory. Under the terms of the Otsuka International Agreement, the Company granted to Otsuka an exclusive, sublicensable license under certain intellectual property controlled by the Company to develop and commercialize vadadustat and products containing or comprising vadadustat in the Otsuka International Territory. Additionally, under the terms of this agreement, the Company is responsible for leading the development of vadadustat, including the ongoing global Phase 3 development program. Otsuka has the sole responsibility, at its own cost, for the commercialization of vadadustat in the Otsuka International Territory, subject to the approval by the relevant regulatory authorities. A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Revenue Recognition The Company has accounted for the Otsuka International Agreement separately from the collaboration arrangement with Otsuka with respect to the U.S. due to the lack of interrelationship and interdependence of the elements and payment terms within each of the contracts as they relate to the respective territories. Accordingly, the Company has applied the guidance in ASC 606 solely in reference to the terms and conditions of the Otsuka International Agreement, while the Otsuka U.S. Agreement has continued to be accounted for as a discrete agreement in its own right. The Company evaluated the Otsuka International Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, Otsuka, is a customer. The Company’s arrangement with Otsuka related to the Otsuka International Territory contains the following material promises under the contract at inception: (i) license under certain of the Company’s intellectual property to develop and commercialize (including the associated packaging) vadadustat and products containing or comprising vadadustat and development services to be performed pursuant to the current global development plan (the License and Development Services Deliverable), (ii) rights to future intellectual property (the Future IP Deliverable) and (iii) joint committee services (the Committee Deliverable). The Company has identified three performance obligations in connection with its obligations under the Otsuka International Agreement as follows: i) License and Development Services Combined (License Performance Obligation); (ii) Rights to Future Intellectual Property (Future IP Performance Obligation) and (iii) Joint Committee Services (Committee Performance Obligation). Factors considered in making this assessment of which material promises will be accounted for as a separate performance obligation included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the good or service is highly interdependent or highly interrelated to the other elements in the arrangement, and whether there are other vendors that can provide the items. Additionally, the Otsuka International Agreement does not include a general right of return. A more detailed description of the performance obligations under this agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of standalone selling price for the Committee Performance Obligation after considering the nature of the services to be performed and estimates of the associated effort and rates applicable to such services that would be expected to be realized under similar contracts. The Company developed a best estimate of standalone selling price for the Future IP Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement. The Company did not develop a best estimate of standalone selling price for the License Performance Obligation due to the following: (i) the best estimates of standalone selling price associated with the Future IP Performance Obligation was determined to be immaterial and (ii) the period of performance and pattern of recognition for the License Performance Obligation and the Committee Performance Obligation was determined to be similar. The Company has concluded that a change in the key assumptions used to determine the best estimate of standalone selling price for each performance obligation would not have a significant impact on the allocation of arrangement consideration. The transaction price at inception was comprised of: (i) the up-front payment, (ii) the cost share payment with respect to amounts incurred by the Company during the quarter ended March 31, 2017, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to March 31, 2017. No development or regulatory milestones were included in the transaction price at inception, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including whether the receipt of the milestone payment is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Otsuka and therefore have also been excluded from the transaction price. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. In the event that there is consideration received by a customer in the form of activities performed by such customer under the global development plan, such consideration is reflected as a reduction to the transaction price as contra revenue rather than as an expense because the associated services are not distinct from the License Performance Obligation. As of June 30, 2021, the transaction price totaling $296.3 million was comprised of: (i) the up-front payment of $73.0 million, (ii) the cost share payment with respect to amounts incurred by the Company during the quarter ended March 31, 2017 of $0.2 million, and (iii) an estimate of the net cost share consideration to be received with respect to amounts incurred by the Company subsequent to March 31, 2017 of $223.1 million. As of June 30, 2021, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained. During the three months ended June 30, 2021 and 2020, the Company recognized revenue totaling approximately $4.7 million and $12.8 million, respectively, and approximately $11.7 million and $32.2 million, respectively, during the six months ended June 30, 2021 and 2020, with respect to the Otsuka International Agreement. The revenue is classified as collaboration revenue in the accompanying unaudited condensed consolidated statements of operations. As of June 30, 2021, there was approximately $6.8 million of deferred revenue related to the Otsuka International Agreement of which $4.4 million is classified as current and $2.4 million is classified as long-term in the accompanying unaudited condensed consolidated balance sheet based on the performance period of the underlying obligations. Additionally, as of June 30, 2021, there was an immaterial amount in accounts receivable and $0.6 million in prepaid expenses and other current assets in the accompanying unaudited condensed consolidated balance sheet. As of December 31, 2020, there was approximately $2.3 million in contract liabilities (included in accounts payable) and $0.5 million in prepaid expenses and other current assets in the consolidated balance sheet. Janssen Pharmaceutica NV Research and License Agreement Summary of Agreement On February 9, 2017, the Company entered into a Research and License Agreement, the |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 6 Months Ended |
Jun. 30, 2021 | |
Other Liabilities Disclosure [Abstract] | |
Liability Related to Sale of Future Royalties | Liability Related to Sale of Future Royalties On February 25, 2021, the Company entered into the Royalty Agreement with HealthCare Royalty Partners IV, L.P., or HCR, pursuant to which the Company sold to HCR its right to receive royalties and sales milestones for vadadustat in Japan and certain other Asian countries, such countries collectively, the MTPC Territory, and such payments collectively the Royalty Interest Payments, in each case, payable to the Company under the MTPC Agreement, subject to an annual maximum “cap” of $13.0 million, or the Annual Cap, and an aggregate maximum “cap” of $150.0 million, or the Aggregate Cap. After HCR receives Royalty Interest Payments equal to the Annual Cap in a given calendar year, the Company will receive 85% of the Royalty Interest Payments for the remainder of that year. After HCR receives Royalty Interest Payments equal to the Aggregate Cap, or the Company pays the Aggregate Cap to HCR (net of the Royalty Interest Payments already received by HCR), the Royalty Interest Payments will revert back to the Company, and HCR would have no further right to any Royalty Interest Payments. The Company received $44.8 million from HCR (net of certain transaction expenses) under the Royalty Agreement, and the Company is eligible to receive an additional $5.0 million in each year from 2021 through 2023 under the Royalty Agreement if specified annual sales milestones are achieved for vadadustat in the MTPC Territory, subject to the satisfaction of certain customary conditions. The Company retains the right to receive all potential future regulatory milestones for vadadustat under the MTPC Agreement. The Royalty Agreement will terminate on the earlier of the date on which HCR has received (i) the last Royalty Interest Payment or (ii) payment by the Company of an amount equal to the Aggregate Cap minus the aggregate amount of all Royalty Interest Payments actually received by HCR. Although the Company sold its right to receive royalties and sales milestones for vadadustat in the MTPC Territory as described above, as a result of its ongoing involvement in the cash flows related to these royalties, the Company will continue to account for these royalties as revenue. The Company recognized the proceeds received from HCR as a liability that is being amortized using the effective interest method over the life of the arrangement. At the transaction date, the Company recorded the net proceeds of $44.8 million as a liability. In order to determine the amortization of the liability, the Company is required to estimate the total amount of future net royalty payments to be made to HCR over the term of the Royalty Agreement. The total threshold of net royalties to be paid, less the net proceeds received, will be recorded as interest expense over the life of the liability. The Company imputes interest on the unamortized portion of the liability using the effective interest method. The annual effective interest rate as of June 30, 2021 was 19.3% which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss. Over the course of the Royalty Agreement, the actual interest rate will be affected by the amount and timing of royalty revenue recognized and changes in forecasted royalty revenue. There are a number of factors that could materially affect the amount and timing of royalty payments from MTPC, none of which are within the Company's control. On a quarterly basis, the Company reassesses the effective interest rate and adjusts the rate prospectively as needed. The following table shows the activity within the liability account for the six months ended June 30, 2021: June 30, 2021 (in thousands) Liability related to sale of future royalties, net — beginning balance $ — Proceeds from sale of future royalties, net 44,783 MTPC royalties payable (116) Non-cash interest expense recognized 4,427 Liability related to sale of future royalties, net — ending balance $ 49,094 |
Available for Sale Securities
Available for Sale Securities | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Available for Sale Securities | Available For Sale Securities Cash, cash equivalents, and available for sale securities at June 30, 2021 and December 31, 2020 consisted of the following: Amortized Cost Gross Gross Fair Value (in thousands) June 30, 2021 Cash and cash equivalents $ 246,992 $ — $ — $ 246,992 Available for sale securities: U.S. government debt securities $ — $ — $ — $ — Total available for sale securities $ — $ — $ — $ — Total cash, cash equivalents, and available for sale securities $ 246,992 $ — $ — $ 246,992 Amortized Cost Gross Gross Fair Value (in thousands) December 31, 2020 Cash and cash equivalents $ 228,698 $ — $ — $ 228,698 Available for sale securities: U.S. government debt securities $ 39,979 $ 13 $ — $ 39,992 Total available for sale securities $ 39,979 $ 13 $ — $ 39,992 Total cash, cash equivalents, and available for sale securities $ 268,677 $ 13 $ — $ 268,690 There were no realized gains or losses on available for sale securities for the three and six months ended June 30, 2021 and 2020 and the Company did not recognize any credit losses during the three and six months ended June 30, 2021 and 2020. Additionally, the Company did not have any available for sale securities that were in an unrealized loss position as of June 30, 2021 and December 31, 2020. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company utilizes a portfolio management company for the valuation of the majority of its investments. This company is an independent, third-party vendor recognized to be an industry leader with access to market information that obtains or computes fair market values from quoted market prices, pricing for similar securities, recently executed transactions, cash flow models with yield curves and other pricing models. For valuations obtained from the pricing service, the Company performs due diligence to understand how the valuation was calculated or derived, focusing on the valuation technique used and the nature of the inputs. Based on the fair value hierarchy, the Company classifies its cash equivalents and available for sale securities within Level 1 or Level 2. This is because the Company values its cash equivalents and available for sale securities using quoted market prices or alternative pricing sources and models utilizing market observable inputs. Assets measured or disclosed at fair value on a recurring basis as of June 30, 2021 and December 31, 2020 are summarized below: Fair Value Measurements Using Level 1 Level 2 Level 3 Total (in thousands) June 30, 2021 Assets: Cash and cash equivalents $ 246,992 $ — $ — $ 246,992 $ 246,992 $ — $ — $ 246,992 Liabilities: Derivative liability $ — $ — $ 1,930 $ 1,930 $ — $ — $ 1,930 $ 1,930 Fair Value Measurements Using Level 1 Level 2 Level 3 Total (in thousands) December 31, 2020 Assets: Cash and cash equivalents $ 228,698 $ — $ — $ 228,698 U.S. government debt securities — 39,992 — 39,992 $ 228,698 $ 39,992 $ — $ 268,690 Liabilities: Derivative liability $ — $ — $ 2,420 $ 2,420 $ — $ — $ 2,420 $ 2,420 The Company’s Loan Agreement with Pharmakon (see Note 11) contains certain provisions that change the underlying cash flows of the debt instrument, including a potential extension to the interest-only period dependent on both no event of default having occurred and continuing and on the Company achieving certain regulatory and revenue conditions. The Company also assessed the acceleration of the obligations under the Loan Agreement under an event of default. In addition, under certain circumstances, a default interest rate will apply on all outstanding obligations during the occurrence and continuance of an event of default. In accordance with ASC 815, the Company concluded that these features are not clearly and closely related to the host instrument, and represent a single compound derivative that is required to be re-measured at fair value on a quarterly basis. The events of default include maintaining, on an annual basis, a minimum liquidity threshold which started in 2021, and on a quarterly basis, a minimum net sales threshold for Auryxia which started in the fourth quarter of 2020. The Company recorded a derivative liability related to the Company’s Loan Agreement with Pharmakon of $1.9 million and $2.4 million as of June 30, 2021 and December 31, 2020, respectively. The Company classified the derivative liability as a non-current liability on the unaudited condensed consolidated balance sheet as of June 30, 2021 and December 31, 2020. The estimated fair value of the derivative liability on both June 30, 2021 and December 31, 2020 was determined using a scenario-based approach and discounted cash flow model that includes principal and interest payments under various scenarios involving clinical development success for vadadustat and various cash flow assumptions. Probabilities surrounding clinical development success were derived using industry benchmarks. Should the Company’s assessment of the probabilities around these scenarios change, including for changes in market conditions, there could be a change to the fair value of the derivative liability. The following table provides a roll-forward of the fair value of the derivative liability (in thousands): Balance at December 31, 2020 $ 2,420 Change in fair value of derivative liability, recorded as other expense 80 Balance at March 31, 2021 $ 2,500 Change in fair value of derivative liability, recorded as other income (570) Balance at June 30, 2021 $ 1,930 The Company had no other assets or liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) at June 30, 2021 and December 31, 2020. Investment securities are exposed to various risks such as interest rate, market and credit risks. When the Company holds investment securities, due to the level of risk associated with certain investment securities and the level of uncertainty related to changes in the value of investment securities, the Company considers if changes in risks in the near term would result in material changes in the fair value of investments. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The components of inventory are summarized as follows: June 30, 2021 December 31, 2020 (in thousands) Raw materials $ 2,060 $ 2,542 Work in process 78,287 64,076 Finished goods 16,716 19,691 Total inventory $ 97,063 $ 86,309 Long-term inventory, which primarily consists of raw materials and work in process, is included in other assets in the Company’s unaudited condensed consolidated balance sheets. June 30, 2021 December 31, 2020 (in thousands) Balance Sheet Classification: Inventory $ 37,898 $ 61,017 Other assets 59,165 25,292 Total inventory $ 97,063 $ 86,309 Inventory amounts written down as a result of excess, obsolescence, scrap or other reasons and charged to cost of goods sold totaled $0.4 million and $5.4 million during the three and six months ended June 30, 2021, in addition to related step-up charges of $8.7 million during the six months ended June 30, 2021. Inventory write-downs charged to cost of goods sold totaled $9.9 million and $10.1 million during the three and six months ended June 30, 2020. The decrease for the three and six months ended June 30, 2021 as compared to the three and six months ended June 30, 2020 was primarily due to lower write-downs to inventory reserves related to a previously disclosed manufacturing quality issue related to Auryxia during 2020. If future sales of Auryxia are lower than expected, the Company may be required to write-down the value of such inventories. Inventory write-downs and losses on purchase commitments are recorded as a component of cost of sales in the unaudited condensed consolidated statement of operations. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets and Goodwill | Intangible Assets and Goodwill Intangible Assets The following table presents the Company’s intangible assets at June 30, 2021 and December 31, 2020 (in thousands): June 30, 2021 Gross Carrying Accumulated Amortization Total Estimated Acquired intangible assets: Developed product rights for Auryxia $ 213,603 $ (87,455) $ 126,148 6 years December 31, 2020 Gross Carrying Accumulated ASC 842 Total Estimated Acquired intangible assets: Developed product rights for Auryxia $ 213,603 $ (69,433) — $ 144,170 6 years Favorable lease 545 (5) (540) — N/A Total $ 214,148 $ (69,438) $ (540) $ 144,170 On December 12, 2018, the Company completed the Merger, whereby it acquired certain definite-lived intangible assets, including the developed product rights for Auryxia and a favorable lease. The Company amortizes its definite-lived intangible assets acquired as part of the Merger using the straight-line method, which is considered the best estimate of economic benefit, over its estimated useful life. The Company recorded $9.0 million and $9.1 million in amortization expense related to the developed product rights for Auryxia during the three months ended June 30, 2021 and 2020, respectively, and $18.0 million and $18.2 million during the six months ended June 30, 2021 and 2020, respectively. Goodwill Goodwill was $55.1 million as of June 30, 2021 and December 31, 2020. The Company operates in one operating segment which the Company considers to be the only reporting unit. Goodwill is evaluated for impairment at the reporting unit level on an annual basis as of October 1, and more frequently if indicators are present or changes in circumstances suggest that an impairment may exist. There were no impairments of goodwill during the three and six months ended June 30, 2021 or 2020. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses as of June 30, 2021 and December 31, 2020 are as follows: June 30, 2021 December 31, 2020 (in thousands) Product revenue allowances $ 38,433 $ 38,049 Accrued clinical 16,034 28,986 MTPC - Supply of commercial drug product 15,069 13,887 Otsuka PRV contribution 10,000 10,000 Accrued payroll 8,238 14,402 Lease liability 5,575 5,286 MTPC - Supply of validation drug product 2,994 4,090 Royalties 2,807 2,998 Professional fees 1,416 3,271 Accrued commercial manufacturing 1,288 514 Accrued severance 649 497 Accrued other 9,239 8,644 Total accrued expenses $ 111,742 $ 130,624 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Debt Term Loans On November 11, 2019, the Company, with Keryx as guarantor, entered into a loan agreement, or the Loan Agreement, with BioPharma Credit PLC as collateral agent and a lender, or the Collateral Agent, and BioPharma Credit Investments V (Master) LP as a lender, pursuant to which term loans in an aggregate principal amount of $100.0 million were made available to the Company in two tranches, subject to certain terms and conditions, or the Term Loans. BioPharma Credit PLC subsequently transferred its interest in the Term Loans, solely in its capacity as a lender, to its affiliate, BPCR Limited Partnership. The Collateral Agent and the lenders are collectively referred to as Pharmakon. The first tranche of $80.0 million, or Tranche A, was drawn on November 25, 2019, or the Tranche A Funding Date, and the second tranche of $20.0 million, or Tranche B, was drawn on December 10, 2020, or the Tranche B Funding Date. Each of the Tranche A Funding Date and the Tranche B Funding Date, a Funding Date. Proceeds from the Term Loans may be used for general corporate purposes. The Company and Keryx entered into a Guaranty and Security Agreement with the Collateral Agent, or the Guaranty and Security Agreement, on the Tranche A Funding Date. Pursuant to the Guaranty and Security Agreement, the Company’s obligations under the Term Loans are unconditionally guaranteed by Keryx, or the Guarantee. Additionally, the obligations of the Company and Keryx under the Term Loans and the Guarantee are secured by a first priority lien on certain assets of the Company and Keryx, including Auryxia and certain related assets, cash, and certain equity interests held by the Company and Keryx, collectively the Collateral. The Term Loans bear interest at a floating rate per annum equal to the three-month LIBOR rate plus 7.50%, subject to a 2.00% LIBOR floor and a 3.35% LIBOR cap, payable quarterly in arrears. The Term Loans will mature on the fifth anniversary of the Tranche A Funding Date, or the Maturity Date. The Company will repay the principal under the Term Loans in equal quarterly payments starting on the 33rd-month anniversary of the applicable Funding Date or, if certain conditions are met, it will have the option to repay the principal in equal quarterly payments starting on the 48th-month anniversary of the applicable Funding Date, or collectively the Amortization Schedule. Under certain circumstances, unless certain liquidity conditions are met, the Maturity Date may decrease by up to one year, and the Amortization Schedule may correspondingly commence up to one year earlier. On the Tranche A Funding Date, the Company paid to Pharmakon a facility fee equal to 2.00% of the aggregate principal amount of the Term Loans, or $2.0 million, in addition to other expenses incurred by Pharmakon and reimbursed by the Company, or Lender Expenses. The Tranche A draw was $77.3 million, net of facility fee, Lender Expenses and issuance costs. The Tranche B draw was $20.0 million, net of immaterial Lender Expenses and issuance costs. The Loan Agreement permits voluntary prepayment at any time in whole or in part, subject to a prepayment premium. The prepayment premium would be 2.00% of the principal amount being prepaid prior to the third anniversary of the applicable Funding Date, 1.00% on or after the third anniversary, but prior to the fourth anniversary, of the applicable Funding Date, and 0.50% on or after the fourth anniversary of the applicable Funding Date but prior to the Maturity Date, and a make-whole premium on or prior to the second anniversary of the applicable Funding Date in an amount equal to foregone interest through the second anniversary of the applicable Funding Date. A change of control triggers a mandatory prepayment of the Term Loans. The Loan Agreement contains customary representations, warranties, events of default and covenants of the Company and its subsidiaries, including maintaining, on an annual basis, a minimum liquidity threshold which started in 2021, and on a quarterly basis, a minimum net sales threshold for Auryxia which started in the fourth quarter of 2020. If an event of default occurs and is continuing under the Loan Agreement, the Collateral Agent is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement. Under certain circumstances, a default interest rate will apply on all outstanding obligations during the occurrence and continuance of an event of default. As of June 30, 2021 and December 31, 2020, the Company determined that no events of default had occurred. The Company assessed the terms and features of the Loan Agreement in order to identify any potential embedded features that would require bifurcation or any beneficial conversion feature. As part of this analysis, the Company assessed the economic characteristics and risks of the Loan Agreement, including put and call features. The terms and features assessed include a potential extension to the interest-only period dependent on both no event of default having occurred and continuing and on the Company achieving certain regulatory and revenue conditions. The Company also assessed the acceleration of the obligations under the Loan Agreement under an event of default. In addition, under certain circumstances, a default interest rate will apply on all outstanding obligations during the occurrence and continuance of an event of default. In accordance with ASC 815, the Company concluded that these features are not clearly and closely related to the host instrument, and represent a single compound derivative that is required to be re-measured at fair value on a quarterly basis. The fair value of the derivative liability related to the Company’s Loan Agreement with Pharmakon was $1.9 million and $2.4 million as of June 30, 2021 and December 31, 2020, respectively. The Company classified the derivative liability as a non-current liability on the unaudited condensed consolidated balance sheet as of June 30, 2021. The Company recognized interest expense related to the Loan Agreement of $2.7 million and $2.2 million, respectively, during the three months ended June 30, 2021 and 2020, and $5.4 million and $4.4 million for the first six months ended June 30, 2021 and 2020, respectively. |
Warrant
Warrant | 6 Months Ended |
Jun. 30, 2021 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrant | WarrantIn connection with the Janssen Agreement, in February 2017, the Company issued a warrant to purchase 509,611 shares of the Company’s common stock at an exercise price of $9.81 per share. The warrant was fully vested upon issuance and exercisable in whole or in part, at any time prior to February 9, 2022. The warrant satisfied the equity classification criteria of ASC 815, and is therefore classified as an equity instrument. The fair value at issuance of $3.4 million was calculated using the Black Scholes option pricing model and was charged to research and development expense as it represented consideration for a license for which the underlying intellectual property was deemed to have no alternative future use. As of June 30, 2021, the warrant remains outstanding and expires on February 9, 2022. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Authorized and Outstanding Capital Stock On June 5, 2020, the Company filed a Certificate of Amendment to its Ninth Amended and Restated Certificate of Incorporation, or its Charter, to increase the number of authorized shares of common stock from 175,000,000 to 350,000,000. As of June 30, 2021, the authorized capital stock of the Company included 350,000,000 shares of common stock, par value $0.00001 per share, of which 169,651,423 and 148,074,085 shares were issued and outstanding as of June 30, 2021 and December 31, 2020, respectively; and 25,000,000 shares of undesignated preferred stock, par value $0.00001 per share, of which no shares were issued and outstanding as of June 30, 2021 and December 31, 2020. At-the-Market Facility On November 12, 2019, the Company entered into an Amended and Restated Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co. for the offer and sale of common stock at the then current market prices in amounts to be determined from time to time. Also, on November 12, 2019, the Company filed a prospectus supplement pursuant to which it was able to offer and sell under the sales agreement up to $75.0 million of its common stock at the then current market prices from time to time. Through December 31, 2019, the Company sold 2,684,392 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $16.8 million. During the three months ended March 31, 2020, the Company sold 7,973,967 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $56.7 million. On March 12, 2020, the Company filed a prospectus supplement relating to the sales agreement, pursuant to which it is able to offer and sell up to $65.0 million of its common stock at current market prices from time to time. Through December 31, 2020, the Company sold 3,509,381 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $10.6 million. During the three months ended March 31, 2021, the Company sold 5,224,278 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $15.9 million. On February 25, 2021, the Company filed a prospectus relating to the sales agreement with its new shelf registration statement (which replaced the prior shelf registration statement and the sales agreement prospectus supplement), pursuant to which it is able to offer and sell up to $100.0 million of its common stock at current market prices from time to time. During the three and six months ended June 30, 2021 and through the date of this Quarterly Report on Form 10-Q, the Company sold 10,446,160 and 24,404,643 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $37.3 million and $67.2 million, respectively. Equity Plans The Company maintains one stock incentive plan, the 2014 Incentive Plan, or the 2014 Plan as well as the 2014 Employee Stock Purchase Plan, or the 2014 ESPP. The 2014 Plan replaced the Company’s Amended and Restated 2008 Equity Incentive Plan, or the 2008 Plan, however, options or other awards granted under the 2008 Plan prior to the adoption of the 2014 Plan that have not been settled or forfeited remain outstanding and effective. On June 6, 2019, the Company’s shareholders approved the Amended and Restated 2014 Employee Stock Purchase Plan, or the ESPP. The Company also maintains an inducement award program that is separate from the Company's equity plans under which inducement awards may be granted consistent with Nasdaq Listing Rule 5635(c)(4). During the six months ended June 30, 2021, the Company granted 864,200 options to purchase shares of the Company’s common stock to new hires as inducements material to such employees' entering into employment with the Company, of which 845,200 options to purchase Akebia Shares remained outstanding as of June 30, 2021. The 2014 Plan allows for the granting of stock options, stock appreciation rights, or SARs, restricted stock, unrestricted stock, RSUs, performance awards and other awards convertible into or otherwise based on shares of the Company’s common stock. Dividend equivalents may also be provided in connection with an award under the 2014 Plan. The Company’s employees, officers, directors and consultants and advisors are eligible to receive awards under the 2014 Plan. The Company initially reserved 1,785,000 shares of its common stock for the issuance of awards under the 2014 Plan. The 2014 Plan provides that the number of shares reserved and available for issuance under the 2014 Plan will automatically increase annually on January 1 of each calendar year, by an amount equal to three percent (3%) of the number of Akebia Shares outstanding on a fully diluted basis as of the close of business on the immediately preceding December 31, or the 2014 Plan Evergreen Provision. The Company’s Board of Directors may act prior to January 1 of any year to provide that there will be no automatic increase in the number of Akebia Shares available for grant under the 2014 Plan for that year (or that the increase will be less than the amount that would otherwise have automatically been made). On December 12, 2018, in connection with the consummation of the Merger, the Company assumed outstanding and unexercised options to purchase Keryx Shares, as adjusted by the Exchange Multiplier pursuant to the terms of the Merger Agreement, under the following Keryx equity plans, or the Keryx Equity Plans: the Keryx 1999 Share Option Plan, the Keryx 2004 Long-Term Incentive Plan, the Keryx 2007 Incentive Plan, the Keryx Amended and Restated 2013 Incentive Plan, and the Keryx 2018 Equity Incentive Plan, or the Keryx 2018 Plan. In addition, the number of Keryx Shares available for issuance under the Keryx 2018 Plan, as adjusted by the Exchange Multiplier pursuant to the terms of the Merger Agreement, may be used for awards granted by the Company under its 2014 Plan, or the Assumed Shares, provided that the Company uses the Assumed Shares for individuals who were not employees or directors of the Company prior to the consummation of the Merger. The Company grants service-based stock options to employees under the 2014 Plan. During the six months ended June 30, 2021, the Company issued 1,797,200 options to employees. In addition, the Company issues stock options to directors, new hires and occasionally to other employees not in connection with the annual grant process. During the first six months ended June 30, 2021, the Company issued 200,800 options to directors under the 2014 Plan. Options granted by the Company vest over periods of between 12 and 48 months, subject, in each case, to the individual’s continued service through the applicable vesting date. Options vest either 100% on the first anniversary of the grant date or in installments of (i) 25% at the one year anniversary and (ii) 12 equal quarterly installments beginning after the one year anniversary of the grant date, subject to the individual’s continuous service with the Company. Options generally expire 10 years after the date of grant. The Company also grants service-based restricted stock units, or RSUs to employees under the 2014 Plan. During the six months ended June 30, 2021, the Com pany issued 3,372,212 RSUs to employees. In addition, the Company issued 82,200 RSUs to directors under the 2014 Plan during the six months ended June 30, 2021. The Company also occasionally issues RSUs not in connection with the annual grant process to employees. Generally, RSUs granted by the Company vest in one of the following ways: (i) 100% of each RSU grant vests on either the first or the third anniversary of the grant date, (ii) one third of each RSU grant vests on the first, second and third anniversaries of the grant date, subject, in each case, to the individual’s continued service through the applicable vesting date, or (iii) 50% of each RSU grant vests on the first anniversary and 25% of each RSU grant vests every six months after the one year anniversary of the grant date. The expense recognized for these awards is based on the grant date fair value of the Company’s common stock multiplied by the number of units granted and recognized on a straight-line basis over the vesting period. The Company also grants performance-based restricted stock units, or PSUs to employees under the 2014 Plan. The PSUs granted by the Company vest in connection with the achievement of specified commercial and regulatory milestones. The PSUs also feature a time-based vesting component. The expense recognized for these awards is based on the grant date fair value of the Company’s common stock multiplied by the number of units granted and recognized over time based on the probability of meeting such commercial and regulatory milestones. The Company did not grant any PSUs during the six months ended June 30, 2021. The ESPP provides for the issuance of options to purchase shares of the Company’s common stock to participating employees at a discount to their fair market value. As noted above, the Company’s stockholders approved the ESPP, which amended and restated the Company’s 2014 ESPP, on June 6, 2019. The maximum aggregate number of shares at June 30, 2021 of the Company’s common stock available for future issuance under the ESPP is 5,326,058. Under the ESPP, each offering period is six months, at the end of which employees may purchase shares of the Company’s common stock through payroll deductions made over the term of the offering. The per-share purchase price at the end of each offering period is equal to the lesser of |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases The Company leases approximately 65,167 square feet of office and lab space in Cambridge, Massachusetts under a lease which was most recently amended in November 2020, collectively the Cambridge Lease. Under the Third Amendment to the Cambridge Lease, or the Third Amendment, executed in July 2016, total monthly lease payments under the initial base rent were approximately $242,000 and are subject to annual rent escalations. In addition to such annual rent escalations, base rent payments for a portion of said premises commenced on January 1, 2017 in the monthly amount of approximately $22,000. The Fourth Amendment to the Cambridge Lease, executed in May 2017, provided additional storage space to the Company and did not impact rent payments. In April 2018, the Company entered into a Fifth Amendment to the Cambridge Lease, or the Fifth Amendment, for an additional 19,805 square feet of office space on the 12t h floor. Monthly lease payments for the existing 45,362 square feet of office and lab space, under the Third Amendment, remain unchanged. The new space leased by the Company was delivered in September 2018 and additional monthly lease payments of approximately $135,000 commenced in February 2019 and are subject to annual rent escalations, which commenced in September 2019. In November 2020, the Company entered into a Sixth Amendment to the Cambridge Lease, or the Sixth Amendment, to extend the term of the Cambridge Lease with respect to the lab space from November 30, 2021 to January 31, 2025. The Sixth Amendment includes two months of free rent starting in December 2020 and additional monthly lease payments of approximately $48,000 commencing in December 2021, and is subject to annual rent escalations, which commence in December 2022. Additionally, as a result of the Merger, the Company has a lease for 27,300 square feet of office space in Boston, Massachusetts, or the Boston Lease, which expires in February 2023. The total monthly lease payments under the base rent are approximately $136,000 and are subject to annual rent escalations. The term of the Cambridge Lease with respect to the office space expires on September 11, 2026, with one five-year extension option available. The term of the Boston Lease office space expires on February 28, 2023, with an extension option for one additional five-year term available. The renewal options in these real estate leases were not included in the calculation of the operating lease assets and operating lease liabilities as the renewal is not reasonably certain. The term of the Cambridge Lease with respect to the lab space expires on January 31, 2025, with an extension option for one additional period through September 11, 2026. The renewal option in this real estate lease was included in the calculation of the operating lease assets and operating lease liabilities as the renewal is reasonably certain. The lease agreements do not contain residual value guarantees. Operating lease costs were $1.7 million for each of the three months ended June 30, 2021 and 2020 and $3.3 million for each of the six months ended June 30, 2021 and 2020. Cash paid for amounts included in the measurement of operating lease liabilities was $1.8 million for each of the three months ended June 30, 2021 and 2020 and $3.5 million for each of the six months ended June 30, 2021 and 2020, respectively. In September 2019, Keryx entered into an agreement to sublease the Boston office space to Foundation Medicine, Inc., or Foundation. The sublease is subject and subordinate to the Boston Lease between Keryx and the landlord. The term of the sublease commenced on October 16, 2019, upon receipt of the required consent from the landlord for the sublease agreement, and expires on February 27, 2023. Foundation is obligated to pay Keryx rent that approximates the rent due from Keryx to its landlord with respect to the Boston Lease. Sublease rental income is recorded to other income. Keryx continues to be obligated for all payment terms pursuant to the Boston Lease, and the Company will guaranty Keryx’s obligations under the sublease. Keryx recorded $0.4 million in sublease rental income from Foundation during each of the three months ended June 30, 2021 and 2020 and $0.9 million during each of the six months ended June 30, 2021 and 2020. The Company has not entered into any material short-term leases or financing leases as of June 30, 2021. The total security deposit in connection with the Cambridge Lease is $1.6 million as of June 30, 2021. Additionally, the Company recorded $0.4 million for the security deposit under the Boston Lease. Both the Cambridge Lease and the Boston Lease have their security deposits in the form of a letter of credit, all of which are included as restricted cash in other assets in the Company’s unaudited condensed consolidated balance sheets as of June 30, 2021. As of June 30, 2021, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter are as follows: Operating Lease Payments Net Operating (in thousands) Remaining 2021 $ 3,582 $ 902 $ 2,680 2022 7,328 1,824 5,504 2023 5,954 307 5,647 2024 5,746 — 5,746 2025 5,823 — 5,823 Thereafter 4,052 — 4,052 Total $ 32,485 $ 3,033 $ 29,452 In arriving at the operating lease liabilities, the Company applied incremental borrowing rates ranging from 6.22% to 6.94%, which were based on the remaining lease term at either the date of adoption of ASC 842 or the effective date of any subsequent lease term extensions. As of June 30, 2021, the remaining lease terms ranged from 1.67 years to 5.20 years. As of June 30, 2021, the following represents the difference between the remaining undiscounted minimum rental commitments under non-cancelable leases and the operating lease liabilities: Operating (in thousands) Undiscounted minimum rental commitments $ 32,485 Present value adjustment using incremental borrowing rate (4,836) Operating lease liabilities $ 27,649 Manufacturing Agreements As a result of the Merger, the Company's contractual obligations include Keryx’s commercial supply agreements with BioVectra Inc., or BioVectra, and Siegfried Evionnaz SA, or Siegfried, to supply commercial drug substance for Auryxia. Pursuant to the Manufacture and Supply Agreement with BioVectra and the Product Manufacture and Supply and Facility Construction Agreement with BioVectra, collectively the BioVectra Agreement, the Company agreed to purchase minimum quantities of Auryxia drug substance annually at predetermined prices. On September 4, 2020, the Company and BioVectra entered into an Amended and Restated Product Manufacture and Supply and Facility Construction Agreement, which provided for reduced minimum quantity commitments and revised the predetermined prices. The price per kilogram decreases with an increase in quantity above the predetermined purchase quantity tiers. In addition, the Manufacture and Supply Agreement with BioVectra and the Amended and Restated Product Manufacture and Supply and Facility Construction Agreement with BioVectra, collectively the Amended BioVectra Agreement, requires the Company to reimburse BioVectra for certain costs in connection with construction of a new facility for the manufacture and supply of Auryxia drug substance. These construction costs are recorded in other assets and amortized into drug substance as inventory is released to the Company from BioVectra. The term of the Manufacture and Supply Agreement with BioVectra expires on December 31, 2022. The term of the Amended and Restated Product Manufacture and Supply and Facility Construction Agreement expires on December 31, 2026, after which it automatically renews for successive one-year terms unless either party gives notice of its intention to terminate within a specified time prior to the end of the then-current term. In addition, the Company and BioVectra each have the ability to terminate these agreements upon the occurrence of certain conditions. As of June 30, 2021, the Company is required to reimburse BioVectra for certain costs in connection with the construction of the new facility and to purchase minimum quantities of Auryxia drug substance annually for a total cost of approximately $84.3 million through the end of the contract term. Pursuant to the Siegfried Master Manufacturing Services and Supply Agreement, as amended (the most recent amendment having been executed on February 11, 2021), or the Siegfried Agreement, the Company has agreed to purchase a minimum quantity of drug substance of Auryxia at predetermined prices. The term of the Siegfried Agreement expires on December 31, 2022, subject to our option to extend the term through December 31, 2023 by providing 12 months’ prior written notice to Siegfried. The Siegfried Agreement provides the Company and Siegfried with certain early termination rights. As of June 30, 2021, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $32.4 million through the year ending December 31, 2022. As part of purchase accounting, the Company identified executory contracts in the commercial supply agreements between Keryx and its contract manufacturers for Auryxia, which include future firm purchase commitments. These executory contracts were deemed to have an off-market element related to the amount of purchase commitments that exceed the current forecast. The Company regularly reviews its estimate of the excess purchase commitment liability including a review of assumptions of expected future demand, estimates of anticipated expiry of inventory under firm purchase commitments that are estimated to expire before they could be sold as well as any modifications to supply agreements during each reporting period. During the second quarter ended June 30, 2021, the Company completed a routine update of its long-range plan and related estimates of expiry. This routine update included the impact of recent activity with regards to our long-term payor contract strategy which continues to focus on contract economics and net revenue growth and resulted in a $30.3 million increase in the estimated excess purchase commitments liability with an associated charge to cost of goods sold during the quarter ended June 30, 2021. The liability related to the amount of purchase commitments that exceed the current forecast or were estimated to expire prior to sale was $77.1 million and $55.8 million as of June 30, 2021 and December 31, 2020, respectively. As of June 30, 2021, the Company also considered whether this increase was a potential indicator of impairment of the Auryxia asset group as of June 30, 2021. As part of its assessment, the Company reviewed the Auryxia net sales and estimated future cash flows included in its long-range plan and concluded that the increase in excess purchase commitment liability was not an indicator of impairment of the Auryxia asset group as of June 30, 2021. In addition, during the first quarter ended March 31, 2021, the Company recorded a non-cash gain to cost of goods sold of $9.0 million driven largely by a reduction in purchase commitments due to the amendment to the Siegfried Agreement during the first quarter of 2021. On April 9, 2019, the Company entered into a Supply Agreement with Esteve Química, S.A., or Esteve, or the Esteve Agreement. The Esteve Agreement includes the terms and conditions under which Esteve will manufacture vadadustat drug substance for commercial use. Pursuant to the Esteve Agreement, the Company provides rolling forecasts to Esteve on a quarterly basis, or the Esteve Forecast. The Esteve Forecast reflects the Company’s needs for vadadustat drug substance produced by Esteve over a certain number of months, represented as a quantity of vadadustat drug substance per calendar quarter. The parties have agreed to a volume-based pricing structure under the Esteve Agreement. The Esteve Agreement has an initial term of four years, beginning April 9, 2019 and ending April 9, 2023. Pursuant to the Esteve Agreement, the Company has agreed to purchase a certain percentage of the global demand for vadadustat drug substance from Esteve. As of June 30, 2021, the Company has committed to purchase $36.7 million of vadadustat drug substance from Esteve through the fourth quarter of 2022. On March 11, 2020, the Company entered into a Supply Agreement with Patheon Inc., or Patheon, or the Patheon Agreement. The Patheon Agreement includes the terms and conditions under which Patheon will manufacture vadadustat drug product for commercial use. Pursuant to the Patheon Agreement, the Company provides Patheon a long-term forecast on an annual basis, as well as short-term forecasts on a quarterly basis, or the Patheon Forecast. The Patheon Forecast reflects the Company’s needs for commercial supply of vadadustat drug product produced by Patheon, represented as a quantity of drug product per calendar quarter. The parties have agreed to a volume-based pricing structure under the Patheon Agreement. The Patheon Agreement has an initial term beginning March 11, 2020 and ending June 30, 2023. Pursuant to the Patheon Agreement, the Company has agreed to purchase a certain percentage of the global demand for vadadustat drug product from Patheon. As of June 30, 2021, the Company had a minimum commitment with Patheon for $2.6 million through the third quarter of 2021. On April 2, 2020, the Company entered into a Supply Agreement with STA Pharmaceutical Hong Kong Limited, a subsidiary of WuXi AppTec, or WuXi STA, or the WuXi STA DS Agreement. The WuXi STA DS Agreement includes the terms and conditions under which WuXi STA will manufacture vadadustat drug substance for commercial use. Pursuant to the WuXi STA DS Agreement, the Company provides rolling forecasts to WuXi STA on a quarterly basis, or the WuXi STA DS Forecast. The WuXi STA DS Forecast reflects the Company’s needs for vadadustat drug substance produced by WuXi STA over a certain number of quarters. The parties have agreed to a volume-based pricing structure under the WuXi STA DS Agreement. The WuXi STA DS Agreement has an initial term of four years, beginning April 2, 2020 and ending April 2, 2024. Pursuant to the WuXi STA DS Agreement, the Company has agreed to purchase a certain percentage of the global demand for vadadustat drug substance from WuXi STA. As of June 30, 2021, the Company has committed to purchase $45.5 million of vadadustat drug substance from WuXi STA through the first quarter of 2022. On February 10, 2021, the Company entered into a Supply Agreement with WuXi STA, or the WuXi STA DP Agreement. The WuXi STA DP Agreement includes the terms and conditions under which WuXi STA will manufacture and supply vadadustat drug product for commercial purposes. Pursuant to the WuXi STA DP Agreement, the Company will provide rolling forecasts to WuXi STA on a quarterly basis, or the WuXi STA DP Forecast. Each WuXi STA DP Forecast will reflect the quantities of vadadustat drug product that the Company expects to order from WuXi STA over a certain number of months, represented as a quantity of vadadustat drug product per calendar quarter. Pursuant to the WuXi STA DP Agreement, the Company has agreed to purchase a certain percentage of global demand for vadadustat drug product from WuXi STA. The parties have agreed to a volume-based pricing structure under the WuXi STA DP Agreement. The vadadustat drug product price will remain fixed for the first 12 months and thereafter shall be annually reviewed by the Company and WuXi STA. The Company will also reimburse WuXi STA for certain reasonable expenses. The WuXi STA DP Agreement has an initial term of four years, beginning February 10, 2021 and ending February 10, 2025. The WuXi STA DP Agreement may be renewed or extended by mutual agreement of the Company and WuXi STA with at least 18 months’ prior written notice. The WuXi STA DP Agreement allows the Company to terminate the agreement on 180 calendar days’ prior written notice to WuXi STA for any reason. In addition, each party has the ability to terminate the WuXi STA DP Agreement upon the occurrence of certain conditions. Other Third Party Contracts Under the Company’s agreement with IQVIA to provide contract research organization services for the PRO 2 TECT and INNO 2 VATE programs, the total remaining contract costs as of June 30, 2021 were approximately $8.3 million, of which Otsuka reimburses a significant portion back to the Company. Substantive performance for the committed work with IQVIA was completed in 2020 and close out activities will be performed throughout 2021. The Company also contracts with various other organizations to conduct research and development activities with remaining contract costs to the Company of approximately $187.6 million at June 30, 2021. The scope of the services under these research and development contracts can be modified and the contracts cancelled by the Company upon written notice. In some instances, the contracts may be cancelled by the third party upon written notice. Litigation and Related Matters From time to time, the Company may become subject to legal proceedings and claims which arise in the ordinary course of its business. Consistent with ASC 450, Contingencies , the Company’s policy is to record a liability if a loss in a significant legal dispute is considered probable and an amount can be reasonably estimated. The Company provides disclosure when a loss in excess of any reserve is reasonably possible, and if estimable, the Company discloses the potential loss or range of possible loss. Significant judgment is required to assess the likelihood of various potential outcomes and the quantification of loss in those scenarios. The Company’s estimates change as litigation progresses and new information comes to light. Changes in Company estimates could have a material impact on the Company’s results and financial position. As of June 30, 2021, the Company does not have any significant legal disputes that require a loss liability to be recorded. The Company continually monitors the need for a loss liability for litigation and related matters. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Net Loss per Share For purposes of the diluted net loss per share calculation, preferred stock, stock options, warrants, restricted stock and RSUs are considered to be common stock equivalents and have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for periods presented. Therefore, basic and diluted net loss per share were the same for all periods presented in the unaudited Condensed Consolidated Statement of Operations and Comprehensive Loss. The shares in the table below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, due to their anti-dilutive effect: As of June 30, 2021 2020 Warrant 509,611 509,611 Outstanding stock options 11,532,673 9,632,240 Unvested restricted stock units 5,574,476 6,399,834 Total 17,616,760 16,541,685 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP, for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB. |
Consolidation | In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the unaudited condensed consolidated financial statements have been included. Interim results for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021 or any other future period.The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
New Accounting Pronouncements - Recently Adopted | New Accounting Pronouncements – Recently Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This standard became effective for the Company on January 1, 2021. ASU 2019-12 requires certain amendments to be applied using a modified retrospective approach, which requires a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption, while other amendments should be applied on a prospective basis. The adoption of this standard did not have a material impact on the Company’s unaudited condensed consolidated financial statements and related disclosures. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: prepaid and accrued research and development expense, operating lease assets and liabilities, derivative liabilities, other non-current liabilities, including the excess purchase commitment liability, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, non-cash interest expense on the liability related to sale of future royalties, inventories, income taxes, intangible assets and goodwill. The Company has made estimates of the impact of COVID-19 within the unaudited condensed consolidated financial statements and there may be changes to those estimates in future periods including changes to sales, payor mix, reserves and allowances, intangible assets and goodwill. Although the Company regularly assesses these estimates, actual results could differ materially from these estimates. Changes in estimates are recorded in the period they become known. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. |
Liability Related to Sale of Future Royalties | Liability Related to Sale of Future Royalties The Company treats the liability related to sale of future royalties, see Note 5, as a debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liability related to sale of future royalties and the debt amortization are based on the Company’s current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments. To the extent the Company’s estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. Non-cash royalty revenue is reflected as royalty revenue within license, collaboration and other revenue, and non-cash amortization of debt is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss. |
Product Revenue and Reserves _2
Product Revenue and Reserves for Variable Consideration (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Product Revenue Allowance and Reserve Categories | The following table summarizes activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2021 and 2020 (in thousands): Chargebacks Rebates, Fees Returns Total Balance at December 31, 2020 $ 802 $ 39,912 $ 649 $ 41,363 Current provisions related to sales in current year 6,084 69,163 3,616 78,863 Adjustments related to prior year sales (6) 812 — 806 Credits/payments made (5,588) (63,795) (3,715) (73,098) Balance at June 30, 2021 $ 1,292 $ 46,092 $ 550 $ 47,934 Balance at December 31, 2019 $ 738 $ 30,552 $ 253 $ 31,543 Current provisions related to sales in current year 5,055 66,348 2,684 74,087 Adjustments related to prior year sales (31) 638 44 651 Credits/payments made (4,995) (54,945) (2,237) (62,177) Balance at June 30, 2020 $ 767 $ 42,593 $ 744 $ 44,104 |
License, Collaboration and Ot_2
License, Collaboration and Other Significant Agreements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Revenues Recognized from License, Collaboration and Other Significant Agreements | During the three and six months ended June 30, 2021 and 2020, the Company recognized the following revenues from its license, collaboration and other significant agreements and had the following deferred revenue balances as of June 30, 2021: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 License, Collaboration and Other Revenue: (in thousands) (in thousands) MTPC Agreement $ 4,594 $ 15,000 $ 4,612 $ 15,000 Otsuka U.S. Agreement 9,170 25,888 22,844 64,465 Otsuka International Agreement 4,700 12,832 11,672 32,202 Total Proportional Performance Revenue $ 18,464 $ 53,720 $ 39,128 $ 111,667 JT and Torii 1,490 1,740 2,649 2,866 MTPC Other Revenue — 3,986 73 4,182 Total License, Collaboration and Other Revenue $ 19,954 $ 59,446 $ 41,850 $ 118,715 |
Schedule of Deferred Revenues | During the three and six months ended June 30, 2021 and 2020, the Company recognized the following revenues from its license, collaboration and other significant agreements and had the following deferred revenue balances as of June 30, 2021: June 30, 2021 Short-Term Long-Term Total Deferred Revenue: (in thousands) MTPC Agreement $ 1,400 $ — $ 1,400 Otsuka U.S. Agreement $ 6,089 $ 9,485 $ 15,574 Otsuka International Agreement 4,380 2,435 6,815 Vifor Agreement — 4,678 4,678 Total $ 11,869 $ 16,598 $ 28,467 |
Schedule of Changes in Contract Assets and Liabilities | The following table presents changes in the Company’s contract assets and liabilities during the six months ended June 30, 2021 and 2020 (in thousands): Six Months Ended June 30, 2021 Balance at Additions Deductions Balance at End Contract assets: Accounts receivable(1) $ 3,045 $ 18,884 $ (19,112) $ 2,817 Prepaid expenses and other current assets $ 1,722 $ 211 $ (5) $ 1,928 Contract liabilities: Deferred revenue $ 40,559 $ 36,679 $ (48,770) $ 28,468 Accounts payable $ 7,227 $ — $ (7,227) $ — Accrued expenses and other current liabilities $ 10,000 $ — $ — $ 10,000 Six Months Ended June 30, 2020 Contract assets: Accounts receivable(1) $ 15,822 $ 118,368 $ (115,382) $ 18,808 Prepaid expenses and other current assets $ — $ 756 $ — $ 756 Contract liabilities: Deferred revenue $ 72,950 $ 90,471 $ (105,350) $ 58,071 Accounts payable $ — $ 5,651 $ — $ 5,651 Accrued expenses and other current liabilities $ — $ 615 $ (615) $ — (1) Excludes accounts receivable from other services related to clinical and regulatory activities performed by the Company on behalf of MTPC that are not included in the performance obligations identified under the MTPC Agreement as of June 30, 2021 and 2020 and December 31, 2020 and 2019. Also excludes accounts receivable related to amounts due to the Company from product sales which are included in the accompanying unaudited condensed consolidated balance sheet as of June 30, 2021 and December 31, 2020. |
Schedule of Revenue Recognized Resulting from Changes in Contract Assets and Contract Liabilities | During the three and six months ended June 30, 2021 and 2020, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods (in thousands): Three Months Ended June 30, Six Months Ended June 30, Revenue Recognized in the Period from: 2021 2020 2021 2020 Amounts included in deferred revenue at the beginning of the period $ 5,822 $ 16,964 $ 10,895 $ 22,186 Performance obligations satisfied in previous periods $ — $ 3,555 $ — $ 3,263 |
Liability Related to Sale of _2
Liability Related to Sale of Future Royalties (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Other Liabilities Disclosure [Abstract] | |
Activity within Liability Related to Sale of Future Royalties, net | The following table shows the activity within the liability account for the six months ended June 30, 2021: June 30, 2021 (in thousands) Liability related to sale of future royalties, net — beginning balance $ — Proceeds from sale of future royalties, net 44,783 MTPC royalties payable (116) Non-cash interest expense recognized 4,427 Liability related to sale of future royalties, net — ending balance $ 49,094 |
Available For Sale Securities (
Available For Sale Securities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Cash, Cash Equivalents, and Available for Sale Securities | Cash, cash equivalents, and available for sale securities at June 30, 2021 and December 31, 2020 consisted of the following: Amortized Cost Gross Gross Fair Value (in thousands) June 30, 2021 Cash and cash equivalents $ 246,992 $ — $ — $ 246,992 Available for sale securities: U.S. government debt securities $ — $ — $ — $ — Total available for sale securities $ — $ — $ — $ — Total cash, cash equivalents, and available for sale securities $ 246,992 $ — $ — $ 246,992 Amortized Cost Gross Gross Fair Value (in thousands) December 31, 2020 Cash and cash equivalents $ 228,698 $ — $ — $ 228,698 Available for sale securities: U.S. government debt securities $ 39,979 $ 13 $ — $ 39,992 Total available for sale securities $ 39,979 $ 13 $ — $ 39,992 Total cash, cash equivalents, and available for sale securities $ 268,677 $ 13 $ — $ 268,690 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured or Disclosed at Fair Value on Recurring Basis | Assets measured or disclosed at fair value on a recurring basis as of June 30, 2021 and December 31, 2020 are summarized below: Fair Value Measurements Using Level 1 Level 2 Level 3 Total (in thousands) June 30, 2021 Assets: Cash and cash equivalents $ 246,992 $ — $ — $ 246,992 $ 246,992 $ — $ — $ 246,992 Liabilities: Derivative liability $ — $ — $ 1,930 $ 1,930 $ — $ — $ 1,930 $ 1,930 Fair Value Measurements Using Level 1 Level 2 Level 3 Total (in thousands) December 31, 2020 Assets: Cash and cash equivalents $ 228,698 $ — $ — $ 228,698 U.S. government debt securities — 39,992 — 39,992 $ 228,698 $ 39,992 $ — $ 268,690 Liabilities: Derivative liability $ — $ — $ 2,420 $ 2,420 $ — $ — $ 2,420 $ 2,420 |
Schedule of Fair Value Derivative Liability | The following table provides a roll-forward of the fair value of the derivative liability (in thousands): Balance at December 31, 2020 $ 2,420 Change in fair value of derivative liability, recorded as other expense 80 Balance at March 31, 2021 $ 2,500 Change in fair value of derivative liability, recorded as other income (570) Balance at June 30, 2021 $ 1,930 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory Components | The components of inventory are summarized as follows: June 30, 2021 December 31, 2020 (in thousands) Raw materials $ 2,060 $ 2,542 Work in process 78,287 64,076 Finished goods 16,716 19,691 Total inventory $ 97,063 $ 86,309 Long-term inventory, which primarily consists of raw materials and work in process, is included in other assets in the Company’s unaudited condensed consolidated balance sheets. June 30, 2021 December 31, 2020 (in thousands) Balance Sheet Classification: Inventory $ 37,898 $ 61,017 Other assets 59,165 25,292 Total inventory $ 97,063 $ 86,309 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | The following table presents the Company’s intangible assets at June 30, 2021 and December 31, 2020 (in thousands): June 30, 2021 Gross Carrying Accumulated Amortization Total Estimated Acquired intangible assets: Developed product rights for Auryxia $ 213,603 $ (87,455) $ 126,148 6 years December 31, 2020 Gross Carrying Accumulated ASC 842 Total Estimated Acquired intangible assets: Developed product rights for Auryxia $ 213,603 $ (69,433) — $ 144,170 6 years Favorable lease 545 (5) (540) — N/A Total $ 214,148 $ (69,438) $ (540) $ 144,170 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses as of June 30, 2021 and December 31, 2020 are as follows: June 30, 2021 December 31, 2020 (in thousands) Product revenue allowances $ 38,433 $ 38,049 Accrued clinical 16,034 28,986 MTPC - Supply of commercial drug product 15,069 13,887 Otsuka PRV contribution 10,000 10,000 Accrued payroll 8,238 14,402 Lease liability 5,575 5,286 MTPC - Supply of validation drug product 2,994 4,090 Royalties 2,807 2,998 Professional fees 1,416 3,271 Accrued commercial manufacturing 1,288 514 Accrued severance 649 497 Accrued other 9,239 8,644 Total accrued expenses $ 111,742 $ 130,624 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Undiscounted Minimum Rental Commitments Under Non-Cancelable Leases | As of June 30, 2021, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter are as follows: Operating Lease Payments Net Operating (in thousands) Remaining 2021 $ 3,582 $ 902 $ 2,680 2022 7,328 1,824 5,504 2023 5,954 307 5,647 2024 5,746 — 5,746 2025 5,823 — 5,823 Thereafter 4,052 — 4,052 Total $ 32,485 $ 3,033 $ 29,452 |
Schedule of Difference Between Undiscounted Minimum Rental Commitments Under Non-Cancelable Leases and Operating Leases Liabilities | As of June 30, 2021, the following represents the difference between the remaining undiscounted minimum rental commitments under non-cancelable leases and the operating lease liabilities: Operating (in thousands) Undiscounted minimum rental commitments $ 32,485 Present value adjustment using incremental borrowing rate (4,836) Operating lease liabilities $ 27,649 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss per Share | The shares in the table below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, due to their anti-dilutive effect: As of June 30, 2021 2020 Warrant 509,611 509,611 Outstanding stock options 11,532,673 9,632,240 Unvested restricted stock units 5,574,476 6,399,834 Total 17,616,760 16,541,685 |
Nature of Organization and Op_2
Nature of Organization and Operations - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Period where operating plan is sufficiently funded by cash resources | 12 months |
Product Revenue and Reserves _3
Product Revenue and Reserves for Variable Consideration - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | |||||
Total revenues | $ 52,913 | $ 90,142 | $ 105,217 | $ 178,620 | |
Product revenue, net | |||||
Disaggregation of Revenue [Line Items] | |||||
Total revenues | 32,959 | $ 30,696 | 63,367 | $ 59,905 | |
Accounts receivable, net | $ 35,000 | $ 35,000 | $ 21,900 |
Product Revenue and Reserves _4
Product Revenue and Reserves for Variable Consideration - Product Revenue Allowance and Reserve Categories (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Beginning balance | $ 41,363 | $ 31,543 |
Current provisions related to sales in current year | 78,863 | 74,087 |
Adjustments related to prior year sales | 806 | 651 |
Credits/payments made | (73,098) | (62,177) |
Ending balance | 47,934 | 44,104 |
Chargebacks and Discounts | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Beginning balance | 802 | 738 |
Current provisions related to sales in current year | 6,084 | 5,055 |
Adjustments related to prior year sales | (6) | (31) |
Credits/payments made | (5,588) | (4,995) |
Ending balance | 1,292 | 767 |
Rebates, Fees and other Deductions | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Beginning balance | 39,912 | 30,552 |
Current provisions related to sales in current year | 69,163 | 66,348 |
Adjustments related to prior year sales | 812 | 638 |
Credits/payments made | (63,795) | (54,945) |
Ending balance | 46,092 | 42,593 |
Returns | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Beginning balance | 649 | 253 |
Current provisions related to sales in current year | 3,616 | 2,684 |
Adjustments related to prior year sales | 0 | 44 |
Credits/payments made | (3,715) | (2,237) |
Ending balance | $ 550 | $ 744 |
License, Collaboration and Ot_3
License, Collaboration and Other Significant Agreements - Revenues Recognized From License, Collaboration and Other Significant Agreements (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
License, Collaboration and Other Revenue: | ||||
Total revenues | $ 52,913 | $ 90,142 | $ 105,217 | $ 178,620 |
Mitsubishi Tanabe Pharma Corporation | ||||
License, Collaboration and Other Revenue: | ||||
Total revenues | 500 | |||
License, collaboration and other revenue | ||||
License, Collaboration and Other Revenue: | ||||
Total revenues | 19,954 | 59,446 | 41,850 | 118,715 |
License, collaboration and other revenue | Mitsubishi Tanabe Pharma Corporation | ||||
License, Collaboration and Other Revenue: | ||||
Total revenues | 4,594 | 15,000 | 4,612 | 15,000 |
License, collaboration and other revenue | Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | ||||
License, Collaboration and Other Revenue: | ||||
Total revenues | 9,170 | 25,888 | 22,844 | 64,465 |
License, collaboration and other revenue | Otsuka Pharmaceutical Company. Ltd. | Otsuka International Agreement | ||||
License, Collaboration and Other Revenue: | ||||
Total revenues | 4,700 | 12,832 | 11,672 | 32,202 |
License, collaboration and other revenue | Total Proportional Performance Revenue | ||||
License, Collaboration and Other Revenue: | ||||
Total revenues | 18,464 | 53,720 | 39,128 | 111,667 |
License, collaboration and other revenue | JT and Torii | ||||
License, Collaboration and Other Revenue: | ||||
Total revenues | 1,490 | 1,740 | 2,649 | 2,866 |
License, collaboration and other revenue | MTPC Other Revenue | Mitsubishi Tanabe Pharma Corporation | ||||
License, Collaboration and Other Revenue: | ||||
Total revenues | $ 0 | $ 3,986 | $ 73 | $ 4,182 |
License, Collaboration and Ot_4
License, Collaboration and Other Significant Agreements - Deferred Revenue (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Deferred Revenue: | ||
Short-Term | $ 11,869 | $ 15,214 |
Long-Term | 16,598 | $ 25,345 |
Total | 28,467 | |
Mitsubishi Tanabe Pharma Corporation | MTPC Agreement | ||
Deferred Revenue: | ||
Short-Term | 1,400 | |
Long-Term | 0 | |
Total | 1,400 | |
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | ||
Deferred Revenue: | ||
Short-Term | 6,089 | |
Long-Term | 9,485 | |
Total | 15,574 | |
Otsuka Pharmaceutical Company. Ltd. | Otsuka International Agreement | ||
Deferred Revenue: | ||
Short-Term | 4,380 | |
Long-Term | 2,435 | |
Total | 6,815 | |
Vifor Pharma | ||
Deferred Revenue: | ||
Short-Term | 0 | |
Long-Term | 4,678 | |
Total | $ 4,678 |
License, Collaboration and Ot_5
License, Collaboration and Other Significant Agreements - Changes in Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Contract liabilities: | ||
Balance at End of Period | $ 28,467 | |
Accounts receivable | ||
Contract assets: | ||
Balance at Beginning of Period | 3,045 | $ 15,822 |
Additions | 18,884 | 118,368 |
Deductions | (19,112) | (115,382) |
Balance at End of Period | 2,817 | 18,808 |
Prepaid expenses and other current assets | ||
Contract assets: | ||
Balance at Beginning of Period | 1,722 | 0 |
Additions | 211 | 756 |
Deductions | (5) | 0 |
Balance at End of Period | 1,928 | 756 |
Deferred revenue | ||
Contract liabilities: | ||
Balance at Beginning of Period | 40,559 | 72,950 |
Additions | 36,679 | 90,471 |
Deductions | (48,770) | (105,350) |
Balance at End of Period | 28,468 | 58,071 |
Accounts payable | ||
Contract liabilities: | ||
Balance at Beginning of Period | 7,227 | 0 |
Additions | 0 | 5,651 |
Deductions | (7,227) | 0 |
Balance at End of Period | 0 | 5,651 |
Accrued expenses and other current liabilities | ||
Contract liabilities: | ||
Balance at Beginning of Period | 10,000 | 0 |
Additions | 0 | 615 |
Deductions | 0 | (615) |
Balance at End of Period | $ 10,000 | $ 0 |
License, Collaboration and Ot_6
License, Collaboration and Other Significant Agreements - Revenue Recognized Resulting from Changes in Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue Recognized in the Period from: | ||||
Amounts included in deferred revenue at the beginning of the period | $ 5,822 | $ 16,964 | $ 10,895 | $ 22,186 |
Performance obligations satisfied in previous periods | $ 0 | $ 3,555 | $ 0 | $ 3,263 |
License, Collaboration and Ot_7
License, Collaboration and Other Significant Agreements - Mitsubishi Tanabe Pharma Corporation Collaboration Agreement (Details) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)performance_obligation | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Recognized revenue | $ 52,913,000 | $ 90,142,000 | $ 105,217,000 | $ 178,620,000 | ||
Deferred revenue | 28,467,000 | 28,467,000 | ||||
Revenue recognized | 5,822,000 | 16,964,000 | 10,895,000 | 22,186,000 | ||
Deferred revenue, net of current portion | 16,598,000 | 16,598,000 | $ 25,345,000 | |||
Short-term deferred revenue | 11,869,000 | 11,869,000 | 15,214,000 | |||
Accounts receivable | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Accounts receivable | 2,817,000 | 18,808,000 | 2,817,000 | 18,808,000 | $ 3,045,000 | $ 15,822,000 |
License, collaboration and other revenue | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Recognized revenue | 19,954,000 | 59,446,000 | 41,850,000 | 118,715,000 | ||
Mitsubishi Tanabe Pharma Corporation | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Recognized revenue | 500,000 | |||||
Mitsubishi Tanabe Pharma Corporation | License, collaboration and other revenue | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Recognized revenue | 4,594,000 | 15,000,000 | 4,612,000 | 15,000,000 | ||
Mitsubishi Tanabe Pharma Corporation | License Collaboration And Other Revenue, Royalties | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Recognized revenue | 100,000 | 100,000 | ||||
Mitsubishi Tanabe Pharma Corporation | Regulatory Milestone Payments | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Milestone revenue | $ 25,000,000 | |||||
Mitsubishi Tanabe Pharma Corporation | MTPC Agreement | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Number of performance obligations | performance_obligation | 2 | |||||
Deferred revenue | 1,400,000 | $ 1,400,000 | ||||
Deferred revenue, net of current portion | 0 | 0 | ||||
Short-term deferred revenue | 1,400,000 | 1,400,000 | ||||
Mitsubishi Tanabe Pharma Corporation | MTPC Agreement | Regulatory Milestone Payments | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Milestone revenue | 15,000,000 | 15,000,000 | ||||
Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Research And License Agreement | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Upfront cash payment received | 20,000,000 | |||||
Cost of research services | 20,500,000 | |||||
Milestone revenue | 10,000,000 | |||||
Deferred revenue | 0 | 0 | ||||
Accounts receivable | 0 | 0 | ||||
Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Research And License Agreement | Regulatory Milestone Payments | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Milestone revenue | 10,000,000 | |||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation And Otsuka Pharmaceutical Company Limited | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Upfront cash payment received | 10,400,000 | |||||
Revenue recognized | 0 | $ 0 | 0 | $ 0 | ||
Deferred revenue, net of current portion | 0 | 0 | ||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation And Otsuka Pharmaceutical Company Limited | Accounts receivable | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Accounts receivable | 0 | 0 | ||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation And Otsuka Pharmaceutical Company Limited | Other Current Liabilities | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Short-term deferred revenue | 3,000,000 | 3,000,000 | ||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation And Otsuka Pharmaceutical Company Limited | Other Noncurrent Liabilities | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Deferred revenue, net of current portion | 600,000 | 600,000 | ||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation Supply Agreement | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | 4,500,000 | 4,500,000 | ||||
Up-front payments invoiced | 9,500,000 | 9,500,000 | ||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation Supply Agreement | Accounts receivable | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Up-front payments invoiced | 900,000 | 900,000 | ||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation Supply Agreement | Other Current Liabilities | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Up-front payments invoiced | 15,100,000 | 15,100,000 | ||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation Supply Agreement | Other Noncurrent Liabilities | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Up-front payments invoiced | 7,600,000 | 7,600,000 | ||||
Mitsubishi Tanabe Pharma Corporation | Mitsubishi Tanabe Pharma Corporation Supply Agreement | Contract With Customer, Liability | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Up-front payments invoiced | $ 1,400,000 | $ 1,400,000 |
License, Collaboration and Ot_8
License, Collaboration and Other Significant Agreements - U.S. Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Dec. 31, 2016USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)performance_obligation | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Recognized revenue | $ 52,913,000 | $ 90,142,000 | $ 105,217,000 | $ 178,620,000 | |||
Deferred revenue | 28,467,000 | 28,467,000 | |||||
Short-term deferred revenue | 11,869,000 | 11,869,000 | $ 15,214,000 | ||||
Deferred revenue, net of current portion | 16,598,000 | 16,598,000 | 25,345,000 | ||||
Accounts receivable | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accounts receivable | 2,817,000 | 18,808,000 | 2,817,000 | 18,808,000 | 3,045,000 | $ 15,822,000 | |
Prepaid expenses and other current assets | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accounts receivable | 1,928,000 | 756,000 | 1,928,000 | 756,000 | 1,722,000 | 0 | |
Accounts payable | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Deferred revenue | 0 | 5,651,000 | 0 | 5,651,000 | 7,227,000 | $ 0 | |
License, collaboration and other revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Recognized revenue | 19,954,000 | 59,446,000 | $ 41,850,000 | 118,715,000 | |||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Number of performance obligations | performance_obligation | 3 | ||||||
Collaborative arrangements additional cost sharing payments amount | $ 100,000,000 | ||||||
Transaction price | 479,100,000 | ||||||
Reimbursement of costs | $ 33,800,000 | ||||||
Collaborative arrangements cost sharing payments | 320,300,000 | ||||||
Deferred revenue | 15,574,000 | 15,574,000 | |||||
Short-term deferred revenue | 6,089,000 | 6,089,000 | |||||
Deferred revenue, net of current portion | 9,485,000 | 9,485,000 | |||||
Cost share costs incurred | 2,900,000 | 200,000 | |||||
Reimbursable costs | 1,400,000 | 100,000 | |||||
Cost share costs by partner for license agreement | 300,000 | 400,000 | |||||
Costs reimbursed | 100,000 | 200,000 | |||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | Global Development Plan | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Collaborative arrangements additional cost sharing payments expected amount | $ 122,200,000 | ||||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | Minimum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Reduction in percentage of future payments due upon current global development costs creditable | 50.00% | ||||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Percentage of remaining creditable amount applied to future payments | 50.00% | ||||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | Prepaid expenses and other current assets | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accounts receivable | 1,300,000 | $ 1,300,000 | 1,200,000 | ||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | Accounts payable | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Deferred revenue | $ 5,000,000 | ||||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | License, collaboration and other revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Recognized revenue | $ 9,170,000 | $ 25,888,000 | 22,844,000 | $ 64,465,000 | |||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | Up Front Non Refundable And Non Creditable | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Upfront cash payment received | $ 125,000,000 | ||||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | Development And Regulatory Milestones | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Milestone revenue | $ 0 |
License, Collaboration and Ot_9
License, Collaboration and Other Significant Agreements - International Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. (Details) $ in Thousands | Apr. 25, 2017USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2017USD ($) | Jun. 30, 2021USD ($)performance_obligation | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Recognized revenue | $ 52,913 | $ 90,142 | $ 105,217 | $ 178,620 | ||||
Deferred revenue | 28,467 | 28,467 | ||||||
Short-term deferred revenue | 11,869 | 11,869 | $ 15,214 | |||||
Deferred revenue, net of current portion | 16,598 | 16,598 | 25,345 | |||||
Prepaid expenses and other current assets | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Accounts receivable | 1,928 | 756 | 1,928 | 756 | 1,722 | $ 0 | ||
Accounts payable | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Deferred revenue | 0 | 5,651 | 0 | 5,651 | 7,227 | $ 0 | ||
License, collaboration and other revenue | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Recognized revenue | 19,954 | 59,446 | $ 41,850 | 118,715 | ||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka International Agreement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of performance obligations | performance_obligation | 3 | |||||||
Transaction price | $ 296,300 | |||||||
Reimbursement of costs | $ 200 | |||||||
Estimated current global development costs subsequent to March 31, 2017 | $ 223,100 | |||||||
Deferred revenue | 6,815 | 6,815 | ||||||
Short-term deferred revenue | 4,380 | 4,380 | ||||||
Deferred revenue, net of current portion | 2,435 | 2,435 | ||||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka International Agreement | Prepaid expenses and other current assets | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Accounts receivable | 600 | 600 | 500 | |||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka International Agreement | Accounts payable | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Deferred revenue | $ 2,300 | |||||||
Otsuka Pharmaceutical Company. Ltd. | Otsuka International Agreement | License, collaboration and other revenue | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Recognized revenue | $ 4,700 | $ 12,832 | $ 11,672 | $ 32,202 | ||||
Otsuka Pharmaceutical Company. Ltd. | Up Front Non Refundable And Non Creditable | Otsuka International Agreement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront cash payment received | $ 73,000 |
License, Collaboration and O_10
License, Collaboration and Other Significant Agreements - Janssen Pharmaceutica NV Research and License Agreement (Details) - Development And Commercialize Research And License Agreement - USD ($) $ / shares in Units, $ in Millions | Feb. 09, 2017 | Mar. 31, 2017 |
Janssen Pharmaceutica NV | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaborative arrangement, term | 3 years | |
Upfront payment made in cash | $ 1 | |
Potential milestone revenue from developmental milestones (up to) | 16.5 | |
Potential milestone revenue from commercial milestones (up to) | $ 215 | |
Johnson & Johnson Innovation | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Warrant to purchase common stock (in shares) | 509,611 | |
Exercise price (in dollars per share) | $ 9.81 | |
Fair value of warrant at issuance | $ 3.4 |
License, Collaboration and O_11
License, Collaboration and Other Significant Agreements - Cyclerion Therapeutics License Agreement (Details) - USD ($) $ in Thousands | Jun. 04, 2021 | Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Asset Acquisition [Line Items] | ||||||
Research and development expense | $ 37,214 | $ 52,819 | $ 77,825 | $ 134,050 | ||
Cyclerion Therapeutics License Agreement | ||||||
Asset Acquisition [Line Items] | ||||||
Upfront payment for asset acquisition | $ 3,000 | |||||
Contingent consideration from developmental and regulatory milestones | $ 222,000 | |||||
Agreement expiration, after first commercial sale, period | 10 years | |||||
Agreement termination notice period | 180 days | |||||
Research and development expense | $ 3,000 |
License, Collaboration and O_12
License, Collaboration and Other Significant Agreements - Vifor Pharma License Agreement (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 14, 2020 | May 12, 2017 | Mar. 31, 2020 | Jun. 30, 2021 | Dec. 31, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Common stock, shares issued (in shares) | 169,651,423 | 148,074,085 | |||
Deferred revenue, net of current portion | $ 16,598 | $ 25,345 | |||
Vifor (International) Ltd. | Research and Development Expense | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Payments for closing Priority Review Voucher purchase | $ 10,000 | ||||
Vifor (International) Ltd. | License Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Common stock, shares issued (in shares) | 3,571,429 | ||||
Sale of stock, price per share (in dollars per share) | $ 14 | ||||
Proceeds from common stock sold | $ 50,000 | ||||
Premium over the closing stock price of common stock (in dollars per share) | $ 12.69 | ||||
Premium amount over the closing stock price of common stock | $ 4,700 | ||||
Potential milestone revenue | 25,000 | ||||
Deferred revenue, net of current portion | $ 4,700 | ||||
Vifor (International) Ltd. | Priority Review Voucher Letter Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Payments for closing Priority Review Voucher purchase | $ 10,000 |
License, Collaboration and O_13
License, Collaboration and Other Significant Agreements - License Agreement with Panion & BF Biotech, Inc. (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
JT and Torii | Panion & BF Biotech, Incorporation | License Agreement | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Royalty payments | $ 2.8 | $ 2.8 | $ 5.3 | $ 5.3 |
License, Collaboration and O_14
License, Collaboration and Other Significant Agreements - Sublicense Agreement with Japan Tobacco, Inc. and its subsidiary, Torii Pharmaceutical Co., Ltd. (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)performance_obligation | Jun. 30, 2020USD ($) | |
License, Collaboration and Other Revenue: | ||||
Recognized revenue | $ 52,913 | $ 90,142 | $ 105,217 | $ 178,620 |
JT and Torii | Sublicense Agreement | ||||
License, Collaboration and Other Revenue: | ||||
Number of performance obligations | performance_obligation | 2 | |||
Recognized revenue | $ 1,500 | $ 1,700 | $ 2,600 | $ 2,900 |
Liability Related to Sale of _3
Liability Related to Sale of Future Royalties - Narrative (Details) - USD ($) $ in Thousands | Feb. 25, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 |
Other Liabilities Disclosure [Abstract] | ||||
Maximum annual royalty payout capacity | $ 13,000 | |||
Maximum aggregate royalty payout capacity | $ 150,000 | |||
Percentage of royalty payment to be received once maximum annual royalty payout has been paid | 85.00% | |||
Proceeds from sale of future royalties, net | $ 44,800 | $ 44,783 | $ 0 | |
Eligible proceeds to be received, contingent on annual sales milestones | 5,000 | |||
Liability related to sale of future royalties, net | $ 44,800 | $ 49,094 | $ 0 | |
Annual effective interest rate | 19.30% |
Liability Related to Sale of _4
Liability Related to Sale of Future Royalties - Rollforward of Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | Feb. 25, 2021 | Jun. 30, 2021 | Jun. 30, 2020 |
Contractual Arrangement, Royalties Agreement, Liability, Noncurrent [Roll Forward] | |||
Liability related to sale of future royalties, net — beginning balance | $ 0 | ||
Proceeds from sale of future royalties, net | $ 44,800 | 44,783 | $ 0 |
MTPC royalties payable | (116) | ||
Non-cash interest expense recognized | 4,427 | $ 0 | |
Liability related to sale of future royalties, net — ending balance | $ 44,800 | $ 49,094 |
Available For Sale Securities -
Available For Sale Securities - Cash Cash Equivalents and Available for Sale Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Cash and cash equivalents, amortized cost | $ 246,992 | $ 228,698 |
Cash and cash equivalents, fair value | 246,992 | 228,698 |
Available for sale securities: | ||
Available for sale securities, amortized cost | 0 | 39,979 |
Available for sale securities, gross unrealized gains | 0 | 13 |
Available for sale securities, gross unrealized losses | 0 | 0 |
Available for sale securities, fair value | 0 | 39,992 |
Total cash, cash equivalents, and available for sale securities, amortized cost | 246,992 | 268,677 |
Total cash, cash equivalents, and available for sale securities, fair value | 246,992 | 268,690 |
U.S. government debt securities | ||
Available for sale securities: | ||
Available for sale securities, amortized cost | 0 | 39,979 |
Available for sale securities, gross unrealized gains | 0 | 13 |
Available for sale securities, gross unrealized losses | 0 | 0 |
Available for sale securities, fair value | $ 0 | $ 39,992 |
Available For Sale Securities_2
Available For Sale Securities - Additional Information (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021USD ($)security | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)security | Jun. 30, 2020USD ($) | Dec. 31, 2020security | |
Investments, Debt and Equity Securities [Abstract] | |||||
Realized gains (losses) on available for sale securities | $ 0 | $ 0 | $ 0 | $ 0 | |
Available-for-sale securities, recognized credit losses during period | $ 0 | $ 0 | $ 0 | $ 0 | |
Number of available-for-sale securities in a unrealized loss position | security | 0 | 0 | 0 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Assets Measured or Disclosed at Fair Value on Recurring Basis (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Assets: | ||
Cash and cash equivalents | $ 246,992,000 | $ 228,698,000 |
Available for sale securities | 0 | 39,992,000 |
Liabilities: | ||
Derivative liability | 1,930,000 | 2,420,000 |
U.S. government debt securities | ||
Assets: | ||
Available for sale securities | 0 | 39,992,000 |
Level 3 | ||
Assets: | ||
Total assets fair value disclosure | 0 | 0 |
Fair value measurements recurring | ||
Assets: | ||
Cash and cash equivalents | 246,992,000 | 228,698,000 |
Total assets fair value disclosure | 246,992,000 | 268,690,000 |
Liabilities: | ||
Derivative liability | 1,930,000 | 2,420,000 |
Total liabilities fair value disclosure | 1,930,000 | 2,420,000 |
Fair value measurements recurring | U.S. government debt securities | ||
Assets: | ||
Available for sale securities | 39,992,000 | |
Fair value measurements recurring | Level 1 | ||
Assets: | ||
Cash and cash equivalents | 246,992,000 | 228,698,000 |
Total assets fair value disclosure | 246,992,000 | 228,698,000 |
Liabilities: | ||
Derivative liability | 0 | 0 |
Total liabilities fair value disclosure | 0 | 0 |
Fair value measurements recurring | Level 1 | U.S. government debt securities | ||
Assets: | ||
Available for sale securities | 0 | |
Fair value measurements recurring | Level 2 | ||
Assets: | ||
Cash and cash equivalents | 0 | 0 |
Total assets fair value disclosure | 0 | 39,992,000 |
Liabilities: | ||
Derivative liability | 0 | 0 |
Total liabilities fair value disclosure | 0 | 0 |
Fair value measurements recurring | Level 2 | U.S. government debt securities | ||
Assets: | ||
Available for sale securities | 39,992,000 | |
Fair value measurements recurring | Level 3 | ||
Assets: | ||
Cash and cash equivalents | 0 | 0 |
Total assets fair value disclosure | 0 | 0 |
Liabilities: | ||
Derivative liability | 1,930,000 | 2,420,000 |
Total liabilities fair value disclosure | $ 1,930,000 | 2,420,000 |
Fair value measurements recurring | Level 3 | U.S. government debt securities | ||
Assets: | ||
Available for sale securities | $ 0 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Additional Information (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability | $ 1,930,000 | $ 2,420,000 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value on recurring basis | 0 | 0 |
Level 3 | Other than Derivative Liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities measured at fair value on recurring basis | 0 | 0 |
Collateral Agent, Pharmakon | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability | $ 1,900,000 | $ 2,400,000 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Fair Value Derivative Liability (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | |
Derivative Liability, Fair Value, Gross Liability [Roll Forward] | ||||
Balance at beginning of period | $ 2,500 | $ 2,420 | $ 2,420 | |
Change in fair value of derivative liability, recorded as other expense | (570) | 80 | (490) | $ 240 |
Balance at end of period | $ 1,930 | $ 2,500 | $ 1,930 |
Inventory - Components of Inven
Inventory - Components of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,060 | $ 2,542 |
Work in process | 78,287 | 64,076 |
Finished goods | 16,716 | 19,691 |
Total inventory | 97,063 | 86,309 |
Balance Sheet Classification: | ||
Inventory | 37,898 | 61,017 |
Other assets | $ 59,165 | $ 25,292 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Business Acquisition [Line Items] | ||||
Inventory amounts written down | $ 400 | $ 9,900 | $ 5,425 | $ 10,089 |
Keryx Biopharmaceuticals, Inc. | ||||
Business Acquisition [Line Items] | ||||
Inventory step-up charges | $ 8,700 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill - Intangible Assets (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 214,148 | |
Accumulated Amortization | (69,438) | |
ASC 842 Adjustment | (540) | |
Total | 144,170 | |
Developed product rights for Auryxia | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 213,603 | 213,603 |
Accumulated Amortization | (87,455) | (69,433) |
Total | $ 126,148 | $ 144,170 |
Estimated useful life | 6 years | 6 years |
Favorable lease | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 545 | |
Accumulated Amortization | (5) | |
ASC 842 Adjustment | (540) | |
Total | $ 0 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill - Additional Information (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)segment | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||||
Amortization expense | $ 9,000,000 | $ 9,100,000 | $ 18,021,000 | $ 18,201,000 | |
Goodwill | 55,053,000 | $ 55,053,000 | $ 55,053,000 | ||
Number of operating segments | segment | 1 | ||||
Goodwill impairment | $ 0 | $ 0 | $ 0 | $ 0 |
Accrued Expenses - Components o
Accrued Expenses - Components of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
License, Collaboration and Other Revenue: | ||
Product revenue allowances | $ 38,433 | $ 38,049 |
Accrued clinical | 16,034 | 28,986 |
Accrued payroll | 8,238 | 14,402 |
Lease liability | $ 5,575 | $ 5,286 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total accrued expenses | Total accrued expenses |
Royalties | $ 2,807 | $ 2,998 |
Professional fees | 1,416 | 3,271 |
Accrued commercial manufacturing | 1,288 | 514 |
Accrued severance | 649 | 497 |
Accrued other | 9,239 | 8,644 |
Total accrued expenses | 111,742 | 130,624 |
MTPC - Supply of commercial drug product | ||
License, Collaboration and Other Revenue: | ||
Collaborative arrangement accrued liability | 15,069 | 13,887 |
Otsuka PRV contribution | ||
License, Collaboration and Other Revenue: | ||
Collaborative arrangement accrued liability | 10,000 | 10,000 |
MTPC - Supply of validation drug product | ||
License, Collaboration and Other Revenue: | ||
Collaborative arrangement accrued liability | $ 2,994 | $ 4,090 |
Debt (Details)
Debt (Details) | Dec. 10, 2020USD ($) | Nov. 11, 2019USD ($)tranche | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Nov. 25, 2019USD ($) |
Line of Credit Facility [Line Items] | ||||||||
Derivative liability | $ 1,930,000 | $ 1,930,000 | $ 2,420,000 | |||||
Collateral Agent, Pharmakon | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Derivative liability | 1,900,000 | 1,900,000 | $ 2,400,000 | |||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Line of credit, maximum borrowing capacity | $ 100,000,000 | |||||||
Line of credit, maximum borrowing capacity, number of available tranches | tranche | 2 | |||||||
Term loan, maturity term | 5 years | |||||||
Term loan, maturity term, potential reduction (up to) | 1 year | |||||||
Term loan, amortization period, potential reduction (up to) | 1 year | |||||||
Facility fee percentage on principal amount | 2.00% | |||||||
Facility fee paid, amount | $ 2,000,000 | |||||||
Prepayment premium percentage on principal if prepaid prior to third anniversary of funding | 2.00% | |||||||
Prepayment premium percentage on principal if prepaid prior to fourth anniversary and after third anniversary of funding | 1.00% | |||||||
Prepayment premium percentage on principal if prepaid after fourth anniversary of funding | 0.50% | |||||||
Interest expense | $ 2,700,000 | $ 2,200,000 | $ 5,400,000 | $ 4,400,000 | ||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | Debt Instrument, Quarterly Periodic Payment, Period One | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Term loan, first quarterly principal payment due in | 33 months | |||||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | Debt Instrument, Quarterly Periodic Payment, Period Two | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Term loan, first quarterly principal payment due in | 48 months | |||||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | Three-month LIBOR | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Basis spread on floating interest rate | 7.50% | |||||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | LIBOR | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Debt instrument, floor rate | 2.00% | |||||||
Debt instrument, cap rate | 3.35% | |||||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | Tranche A | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Line of credit, maximum borrowing capacity | $ 80,000,000 | |||||||
Term loan, net of facility fees, lender expenses and issuance costs | $ 77,300,000 | |||||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | Tranche B | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Line of credit, maximum borrowing capacity | $ 20,000,000 | |||||||
BPCR Limited Partnership | Keryx | Term Loan | Collateral Agent, Pharmakon | Tranche B | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Proceeds from line of credit | $ 20,000,000 |
Warrant (Details)
Warrant (Details) - Janssen Agreement $ / shares in Units, $ in Millions | Feb. 28, 2017USD ($)$ / sharesshares |
Class of Warrant or Right [Line Items] | |
Warrant to purchase common stock (in shares) | shares | 509,611 |
Exercise price (in dollars per share) | $ / shares | $ 9.81 |
Fair value of warrant at issuance | $ | $ 3.4 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Thousands | Feb. 25, 2021USD ($) | Mar. 12, 2020USD ($) | Nov. 12, 2019USD ($) | Jun. 30, 2021USD ($)$ / sharesshares | Mar. 31, 2021USD ($)shares | Jun. 30, 2020shares | Mar. 31, 2020USD ($)shares | Jun. 30, 2021USD ($)installment$ / sharesshares | Jun. 30, 2020USD ($)shares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)shares | Jun. 04, 2020shares | Feb. 28, 2014shares |
Class of Stock [Line Items] | |||||||||||||
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 | 350,000,000 | 175,000,000 | |||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||||||||
Common stock, shares issued (in shares) | 169,651,423 | 169,651,423 | 148,074,085 | ||||||||||
Common stock, shares outstanding (in shares) | 169,651,423 | 169,651,423 | 148,074,085 | ||||||||||
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 | 25,000,000 | ||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | ||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | ||||||||||
Proceeds from the issuance of common stock, net of issuance costs | $ | $ 66,696 | $ 198,883 | |||||||||||
Inducement Award Program | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares granted (in shares) | 864,200 | ||||||||||||
Number of shares outstanding (in shares) | 845,200 | 845,200 | |||||||||||
Share-based Payment Arrangement, Option | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Expiration period | 10 years | ||||||||||||
Share-based Payment Arrangement, Option | Share-based Compensation Award, Tranche, First Anniversary of Grant Date | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting percentage | 100.00% | ||||||||||||
Share-based Payment Arrangement, Option | Share Based Compensation Award Tranche One | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 1 year | ||||||||||||
Vesting percentage | 25.00% | ||||||||||||
Share-based Payment Arrangement, Option | Share Based Compensation Award Tranche Two | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 1 year | ||||||||||||
Number of equal quarterly installments | installment | 12 | ||||||||||||
Service-Based Restricted Stock Units | Share Based Compensation Award Tranche One | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 1 year | ||||||||||||
Vesting percentage | 50.00% | ||||||||||||
Service-Based Restricted Stock Units | Share Based Compensation Award Tranche Two | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 6 months | ||||||||||||
Vesting percentage | 25.00% | ||||||||||||
Award vesting grace period | 1 year | ||||||||||||
Service-Based Restricted Stock Units | Share-based Compensation Award, Tranche, First Or Third Anniversary of Grant Date | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting percentage | 100.00% | ||||||||||||
Service-Based Restricted Stock Units | Share-Based Payment Arrangement, Tranche One, First Anniversary After Grant Date, Subjected To Individual Continued Service | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 1 year | ||||||||||||
Vesting percentage | 33.33% | ||||||||||||
Service-Based Restricted Stock Units | Share-Based Payment Arrangement, Tranche Two, Second Anniversary After Grant Date, Subjected To Individual Continued Service | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 2 years | ||||||||||||
Vesting percentage | 33.33% | ||||||||||||
Service-Based Restricted Stock Units | Share-Based Payment Arrangement, Tranche Three, Third Anniversary After Grant Date, Subjected To Individual Continued Service | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 3 years | ||||||||||||
Vesting percentage | 33.33% | ||||||||||||
Common Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares outstanding (in shares) | 169,651,423 | 158,520,089 | 143,129,409 | 130,251,440 | 169,651,423 | 143,129,409 | 148,074,085 | 121,674,568 | |||||
Issuance of common stock, net of issuance costs (in shares) | 10,446,160 | 9,228,017 | 12,650,000 | 7,973,967 | |||||||||
Common Stock | At The Market Equity Offering Program Authorized February 2021 | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 10,446,160 | 24,404,643 | |||||||||||
Proceeds from the issuance of common stock, net of issuance costs | $ | $ 37,300 | $ 67,200 | |||||||||||
Minimum | Share-based Payment Arrangement, Option | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 12 months | ||||||||||||
Minimum | Service-Based Restricted Stock Units | Share-based Compensation Award, Tranche, First Or Third Anniversary of Grant Date | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 1 year | ||||||||||||
Maximum | At The Market Equity Offering Program Authorized February 2021 | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock sales agreement amount | $ | $ 100,000 | ||||||||||||
Maximum | Share-based Payment Arrangement, Option | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 48 months | ||||||||||||
Maximum | Service-Based Restricted Stock Units | Share-based Compensation Award, Tranche, First Or Third Anniversary of Grant Date | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 3 years | ||||||||||||
At The Market Equity Offering Program | Common Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 5,224,278 | 7,973,967 | 3,509,381 | 2,684,392 | |||||||||
Proceeds from the issuance of common stock, net of issuance costs | $ | $ 15,900 | $ 56,700 | $ 10,600 | $ 16,800 | |||||||||
At The Market Equity Offering Program | Maximum | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock sales agreement amount | $ | $ 65,000 | $ 75,000 | |||||||||||
2014 Plans | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares reserved for future issuance (in shares) | 1,785,000 | ||||||||||||
Incremental rate at which the shares reserved for issuance increase | 3.00% | ||||||||||||
2014 Plans | Share-based Payment Arrangement, Option | Employees | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares granted (in shares) | 1,797,200 | ||||||||||||
2014 Plans | Share-based Payment Arrangement, Option | Director | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares granted (in shares) | 200,800 | ||||||||||||
2014 Plans | Service-Based Restricted Stock Units | Employees | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares granted (in shares) | 3,372,212 | ||||||||||||
2014 Plans | Service-Based Restricted Stock Units | Director | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares granted (in shares) | 82,200 | ||||||||||||
2014 Employee Stock Purchase Plan | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares reserved for future issuance (in shares) | 5,326,058 | 5,326,058 | |||||||||||
Offering period | 6 months | ||||||||||||
Purchase price at the end of offering period | 85.00% | ||||||||||||
Number of shares issued (in shares) | 154,276 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Feb. 10, 2021 | Sep. 04, 2020 | Apr. 02, 2020 | Apr. 09, 2019 | Jan. 01, 2017USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Feb. 28, 2019USD ($) | Jul. 31, 2016USD ($)ft² | Jun. 30, 2021USD ($)ft²extensionOption | Mar. 31, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)ft²extensionOption | Jun. 30, 2020USD ($) | Apr. 30, 2018ft² |
Commitments And Contingencies [Line Items] | |||||||||||||||
Operating lease, cost | $ 1,700,000 | $ 1,700,000 | $ 3,300,000 | $ 3,300,000 | |||||||||||
Operating lease, payments | 1,800,000 | 1,800,000 | 3,500,000 | 3,500,000 | |||||||||||
Increase (decrease) in purchase commitments | 21,338,000 | 10,954,000 | |||||||||||||
Total remaining contract costs | 8,300,000 | 8,300,000 | |||||||||||||
Contract cost incurred in research and development activities | 187,600,000 | ||||||||||||||
Supply Agreement, Patheon Inc. | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Minimum purchase commitment | 2,600,000 | 2,600,000 | |||||||||||||
BioVectra Inc | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Long-term minimum purchase commitment renewal term | 1 year | ||||||||||||||
Cost of purchased minimum quantity product | 84,300,000 | 84,300,000 | |||||||||||||
Siegfried Evionnaz SA | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Cost of purchased minimum quantity product | $ 32,400,000 | $ 32,400,000 | |||||||||||||
Purchase commitment, option to extend, prior notice period | 12 months | ||||||||||||||
Esteve Química, S.A | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Initial term of supply agreement | 4 years | ||||||||||||||
Long-term minimum purchase commitment | $ 36,700,000 | ||||||||||||||
STA Pharmaceutical Hong Kong Limited | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Long-term minimum purchase commitment | $ 45,500,000 | ||||||||||||||
Minimum purchase commitment, initial term | 4 years | ||||||||||||||
WuXi STA | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Purchase commitment, option to extend, prior notice period | 18 months | ||||||||||||||
Minimum purchase commitment, initial term | 4 years | ||||||||||||||
Long-term purchase commitment, fixed price, period | 12 months | ||||||||||||||
Long-term purchase commitment, option to terminate, prior notice period (at least) | 180 days | ||||||||||||||
Minimum | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Operating lease, incremental borrowing rates based on remaining lease term | 6.22% | 6.22% | |||||||||||||
Operating lease, remaining lease term | 1 year 8 months 1 day | 1 year 8 months 1 day | |||||||||||||
Maximum | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Operating lease, incremental borrowing rates based on remaining lease term | 6.94% | 6.94% | |||||||||||||
Operating lease, remaining lease term | 5 years 2 months 12 days | 5 years 2 months 12 days | |||||||||||||
Keryx Biopharmaceuticals, Inc. | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Preliminary fair value of the off-market element | $ 55,800,000 | $ 77,100,000 | $ 77,100,000 | ||||||||||||
Increase (decrease) in purchase commitments | 30,300,000 | $ (9,000,000) | |||||||||||||
Cambridge | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Area of property leased (in square feet) | ft² | 45,362 | 65,167 | |||||||||||||
Annual lease expense | $ 242,000 | ||||||||||||||
Monthly lease expense | $ 22,000 | ||||||||||||||
Cambridge | Letter of Credit | Accounts receivable(1) | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Total security deposit in connection with lease | $ 1,600,000 | $ 1,600,000 | |||||||||||||
Cambridge | Office Space | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Area of property leased (in square feet) | ft² | 19,805 | ||||||||||||||
Monthly lease expense | $ 135,000 | ||||||||||||||
Operating lease, free monthly rent, period | 2 months | ||||||||||||||
Lease period, number of extension options | extensionOption | 1 | 1 | |||||||||||||
Lease extension period | 5 years | 5 years | |||||||||||||
Cambridge | Office Space | Scenario Forecast | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Monthly lease expense | $ 48,000 | ||||||||||||||
Boston | Keryx Biopharmaceuticals, Inc. | Letter of Credit | Accounts receivable(1) | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Total security deposit in connection with lease | $ 400,000 | $ 400,000 | |||||||||||||
Boston | Office Space | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Area of property leased (in square feet) | ft² | 27,300 | 27,300 | |||||||||||||
Monthly lease expense | $ 136,000 | ||||||||||||||
Boston | Office Space | Keryx Biopharmaceuticals, Inc. | |||||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||||
Lease period, number of extension options | extensionOption | 1 | 1 | |||||||||||||
Lease extension period | 5 years | 5 years | |||||||||||||
Sublease rental income | $ 400,000 | $ 400,000 | $ 900,000 | $ 900,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Undiscounted Minimum Rental Commitments Under Non-Cancelable Leases (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Operating Leases | |
Remaining 2021 | $ 3,582 |
2022 | 7,328 |
2023 | 5,954 |
2024 | 5,746 |
2025 | 5,823 |
Thereafter | 4,052 |
Total | 32,485 |
Lease Payments to be Received from Sublease | |
Remaining 2021 | 902 |
2022 | 1,824 |
2023 | 307 |
2024 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | 3,033 |
Net Operating Lease Payments | |
Remaining 2021 | 2,680 |
2022 | 5,504 |
2023 | 5,647 |
2024 | 5,746 |
2025 | 5,823 |
Thereafter | 4,052 |
Total | $ 29,452 |
Commitments and Contingencies_3
Commitments and Contingencies - Difference Between Undiscounted Minimum Rental Commitments Under Non-Cancelable Leases and Operating Leases Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
Total | $ 32,485 | |
Present value adjustment using incremental borrowing rate | (4,836) | |
Operating lease liabilities | $ 27,649 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued expenses and other current liabilities | Accrued expenses and other current liabilities |
Net Loss per Share - Anti-Dilut
Net Loss per Share - Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 17,616,760 | 16,541,685 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 509,611 | 509,611 |
Share-based Payment Arrangement, Option | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 11,532,673 | 9,632,240 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 5,574,476 | 6,399,834 |