Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 06, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
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, $0.00001 par value per share | |
Trading Symbol | AKBA | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 188,389,415 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Entity Central Index Key | 0001517022 | |
Security Exchange Name | NASDAQ |
UNAUDITED CONDENSED CONSOLIDATE
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 46,529 | $ 90,466 |
Inventories | 18,442 | 21,568 |
Accounts receivable, net | 22,592 | 40,284 |
Prepaid expenses and other current assets | 22,039 | 32,864 |
Total current assets | 109,602 | 185,182 |
Property and equipment, net | 4,023 | 5,214 |
Operating right-of-use assets | 13,414 | 29,158 |
Intangible asset, net | 45,053 | 72,084 |
Goodwill | 59,044 | 59,044 |
Other long-term assets | 3,862 | 5,372 |
Total assets | 234,998 | 356,054 |
Current liabilities: | ||
Accounts payable | 9,038 | 18,021 |
Accrued expenses and other current liabilities | 62,664 | 75,777 |
Short-term deferred revenue | 0 | 3,738 |
Current portion of long-term debt | 8,000 | 32,000 |
Total current liabilities | 79,702 | 129,536 |
Deferred revenue, net of current portion | 43,296 | 43,296 |
Long-term operating lease liabilities | 10,227 | 28,961 |
Embedded debt derivative | 760 | 760 |
Long-term debt, net | 34,613 | 34,078 |
Liability related to sale of future royalties | 56,061 | 57,484 |
Refund liability to customer | 40,346 | 40,992 |
Other long-term liabilities | 9,415 | 15,717 |
Total liabilities | 274,420 | 350,824 |
Commitments and contingencies (Note 12) | ||
Stockholders' (deficit) equity: | ||
Preferred stock $0.00001 par value, 25,000,000 shares authorized; no shares issued and outstanding at September 30, 2023 and December 31, 2022 | 0 | 0 |
Common stock $0.00001 par value; 350,000,000 shares authorized at September 30, 2023 and December 31, 2022; 188,313,807 and 184,135,714 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 2 | 2 |
Additional paid-in capital | 1,570,134 | 1,562,247 |
Accumulated other comprehensive income | 6 | 6 |
Accumulated deficit | (1,609,564) | (1,557,025) |
Total stockholders' (deficit) equity | (39,422) | 5,230 |
Total liabilities and stockholders' (deficit) equity | $ 234,998 | $ 356,054 |
UNAUDITED CONDENSED CONSOLIDA_2
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Jun. 04, 2020 |
Statement of Financial Position [Abstract] | |||
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | |
Preferred stock, authorized (in shares) | 25,000,000 | 25,000,000 | |
Preferred stock, issued (in shares) | 0 | 0 | |
Preferred stock, outstanding (in shares) | 0 | 0 | |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | |
Common stock, authorized (in shares) | 350,000,000 | 350,000,000 | 175,000,000 |
Common stock, issued (in shares) | 188,313,807 | 184,135,714 | |
Common stock, outstanding (in shares) | 188,313,807 | 184,135,714 |
UNAUDITED CONDENSED CONSOLIDA_3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues | ||||
Total revenues | $ 42,046 | $ 48,714 | $ 138,427 | $ 236,702 |
Cost of goods sold | ||||
Product | 8,998 | 29,270 | 28,452 | 61,965 |
Amortization of intangible asset | 9,011 | 9,011 | 27,032 | 27,032 |
Total cost of goods sold | 18,009 | 38,281 | 55,484 | 88,997 |
Operating expenses: | ||||
Research and development | 13,330 | 28,028 | 53,214 | 97,888 |
Selling, general and administrative | 22,710 | 31,887 | 74,797 | 108,693 |
License expense | 864 | 743 | 2,381 | 2,323 |
Restructuring | 169 | 180 | 181 | 14,711 |
Total operating expenses | 37,073 | 60,838 | 130,573 | 223,615 |
Loss from operations | (13,036) | (50,405) | (47,630) | (75,910) |
Other income (expense) | ||||
Interest expense | (1,410) | (3,952) | (4,614) | (14,051) |
Other (expense) income | (43) | 1,167 | 229 | 2,712 |
Loss on extinguishment of debt | 0 | (906) | 0 | (906) |
Loss on termination of lease | 0 | 0 | (524) | 0 |
Net (loss) income, basic | (14,489) | (54,096) | (52,539) | (88,155) |
Net (loss) income, diluted | (14,489) | (54,096) | (52,539) | (88,155) |
Comprehensive loss | $ (14,489) | $ (54,096) | $ (52,539) | $ (88,155) |
Net loss per share: | ||||
Basic (in dollars per share) | $ (0.08) | $ (0.29) | $ (0.28) | $ (0.48) |
Diluted (in dollars per share) | $ (0.08) | $ (0.29) | $ (0.28) | $ (0.48) |
Weighted average common shares outstanding: | ||||
Basic (in shares) | 188,306,350 | 183,882,446 | 186,643,878 | 182,375,443 |
Diluted (in shares) | 188,306,350 | 183,882,446 | 186,643,878 | 182,375,443 |
Product revenue, net | ||||
Revenues | ||||
Total revenues | $ 40,118 | $ 41,989 | $ 117,068 | $ 126,670 |
License, collaboration and other revenue | ||||
Revenues | ||||
Total revenues | $ 1,928 | $ 6,725 | $ 21,359 | $ 110,032 |
UNAUDITED CONDENSED CONSOLIDA_4
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 177,000,963 | ||||
Beginning balance at Dec. 31, 2021 | $ 74,008 | $ 1 | $ 1,536,800 | $ 6 | $ (1,462,799) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net of issuance costs (in shares) | 4,404,600 | ||||
Issuance of common stock, net of issuance costs | 7,178 | $ 1 | 7,177 | ||
Proceeds from sale of stock under employee stock purchase plan (in shares) | 191,146 | ||||
Proceeds from sale of stock under employee stock purchase plan | 367 | 367 | |||
Stock-based compensation expense | 4,536 | 4,536 | |||
Restricted stock unit vesting (in shares) | 1,789,326 | ||||
Net income (loss) | (63,509) | (63,509) | |||
Ending balance (in shares) at Mar. 31, 2022 | 183,386,035 | ||||
Ending balance at Mar. 31, 2022 | 22,580 | $ 2 | 1,548,880 | 6 | (1,526,308) |
Beginning balance (in shares) at Dec. 31, 2021 | 177,000,963 | ||||
Beginning balance at Dec. 31, 2021 | 74,008 | $ 1 | 1,536,800 | 6 | (1,462,799) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income (loss) | (88,155) | ||||
Ending balance (in shares) at Sep. 30, 2022 | 183,951,583 | ||||
Ending balance at Sep. 30, 2022 | 8,259 | $ 2 | 1,559,206 | 6 | (1,550,955) |
Beginning balance (in shares) at Mar. 31, 2022 | 183,386,035 | ||||
Beginning balance at Mar. 31, 2022 | 22,580 | $ 2 | 1,548,880 | 6 | (1,526,308) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 6,841 | 6,841 | |||
Exercise of options (in shares) | 142,440 | ||||
Exercise of options | 67 | 67 | |||
Restricted stock unit vesting (in shares) | 176,179 | ||||
Net income (loss) | 29,449 | 29,449 | |||
Ending balance (in shares) at Jun. 30, 2022 | 183,704,654 | ||||
Ending balance at Jun. 30, 2022 | 58,937 | $ 2 | 1,555,788 | 6 | (1,496,859) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Proceeds from sale of stock under employee stock purchase plan (in shares) | 144,000 | ||||
Proceeds from sale of stock under employee stock purchase plan | 43 | 43 | |||
Stock-based compensation expense | 3,375 | 3,375 | |||
Restricted stock unit vesting (in shares) | 102,929 | ||||
Net income (loss) | (54,096) | (54,096) | |||
Ending balance (in shares) at Sep. 30, 2022 | 183,951,583 | ||||
Ending balance at Sep. 30, 2022 | $ 8,259 | $ 2 | 1,559,206 | 6 | (1,550,955) |
Beginning balance (in shares) at Dec. 31, 2022 | 184,135,714 | 184,135,714 | |||
Beginning balance at Dec. 31, 2022 | $ 5,230 | $ 2 | 1,562,247 | 6 | (1,557,025) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Proceeds from sale of stock under employee stock purchase plan (in shares) | 103,500 | ||||
Proceeds from sale of stock under employee stock purchase plan | 34 | 34 | |||
Stock-based compensation expense | 2,489 | 2,489 | |||
Restricted stock unit vesting (in shares) | 1,596,732 | ||||
Net income (loss) | (26,878) | (26,878) | |||
Ending balance (in shares) at Mar. 31, 2023 | 185,835,946 | ||||
Ending balance at Mar. 31, 2023 | $ (19,125) | $ 2 | 1,564,770 | 6 | (1,583,903) |
Beginning balance (in shares) at Dec. 31, 2022 | 184,135,714 | 184,135,714 | |||
Beginning balance at Dec. 31, 2022 | $ 5,230 | $ 2 | 1,562,247 | 6 | (1,557,025) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income (loss) | $ (52,539) | ||||
Ending balance (in shares) at Sep. 30, 2023 | 188,313,807 | 188,313,807 | |||
Ending balance at Sep. 30, 2023 | $ (39,422) | $ 2 | 1,570,134 | 6 | (1,609,564) |
Beginning balance (in shares) at Mar. 31, 2023 | 185,835,946 | ||||
Beginning balance at Mar. 31, 2023 | (19,125) | $ 2 | 1,564,770 | 6 | (1,583,903) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 3,490 | 3,490 | |||
Restricted stock unit vesting (in shares) | 2,292,923 | ||||
Net income (loss) | (11,172) | (11,172) | |||
Ending balance (in shares) at Jun. 30, 2023 | 188,128,869 | ||||
Ending balance at Jun. 30, 2023 | (26,807) | $ 2 | 1,568,260 | 6 | (1,595,075) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Proceeds from sale of stock under employee stock purchase plan (in shares) | 96,694 | ||||
Proceeds from sale of stock under employee stock purchase plan | 50 | 50 | |||
Stock-based compensation expense | 1,824 | 1,824 | |||
Restricted stock unit vesting (in shares) | 88,244 | ||||
Net income (loss) | $ (14,489) | (14,489) | |||
Ending balance (in shares) at Sep. 30, 2023 | 188,313,807 | 188,313,807 | |||
Ending balance at Sep. 30, 2023 | $ (39,422) | $ 2 | $ 1,570,134 | $ 6 | $ (1,609,564) |
UNAUDITED CONDENSED CONSOLIDA_5
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Activities: | ||
Net loss | $ (52,539) | $ (88,155) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,191 | 1,246 |
Amortization of intangible asset | 27,032 | 27,032 |
Non-cash interest expense related to sale of future royalties | 0 | 6,352 |
Non-cash royalty revenue related to sale of future royalties | (1,423) | (1,195) |
Non-cash collaboration revenue | 0 | (9,550) |
Non-cash research and development expense | 782 | 3,941 |
Non-cash interest expense | 1,318 | 1,467 |
Non-cash operating lease expense | (1,221) | (1,818) |
Non-cash write-off from termination of lease | (825) | 0 |
Non-cash loss on extinguishment of debt | 0 | 406 |
Write-down of inventory | 1,327 | 10,002 |
Change in excess inventory purchase commitments | 0 | 14,095 |
Stock-based compensation expense | 7,803 | 14,808 |
Change in fair value of embedded debt derivative | 0 | (1,060) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 17,692 | 28,312 |
Inventory | 9,238 | (5,365) |
Prepaid expenses and other current assets | 10,043 | 9,798 |
Other long-term assets | (8,175) | 21,031 |
Accounts payable | (9,747) | (17,420) |
Accrued expense and other current liabilities | (13,735) | (21,534) |
Operating lease liabilities | 1,128 | 1,771 |
Deferred revenue | (3,738) | 2,181 |
Other long-term liabilities | (7,227) | (14,820) |
Net cash used in operating activities | (21,076) | (18,475) |
Investing Activities: | ||
Purchases of equipment | 0 | (114) |
Net cash used in investing activities | 0 | (114) |
Financing Activities: | ||
Proceeds from refund liabilities to customers | 0 | 40,000 |
Proceeds from issuance of common stock, net of issuance costs | 0 | 7,122 |
Proceeds from issuances of stock under employee stock purchase plan | 84 | 410 |
Proceeds from the exercise of stock options | 0 | 67 |
Repayments of term debt | (24,000) | (33,000) |
Net cash (used in) provided by financing activities | (23,916) | 14,599 |
Decrease in cash, cash equivalents and restricted cash | (44,992) | (3,990) |
Cash, cash equivalents and restricted cash — beginning of period | 93,169 | 151,839 |
Cash, cash equivalents and restricted cash — end of period | $ 48,177 | $ 147,849 |
NATURE OF BUSINESS
NATURE OF BUSINESS | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF BUSINESS | NATURE OF BUSINESS Organization Akebia Therapeutics, Inc., and it's subsidiaries, referred to as Akebia or the Company , was incorporated in the State of Delaware in 2007. Akebia is a fully integrated biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease. The Company has one commercial product, Auryxia ® (ferric citrate), which is approved by the U.S. Food and Drug Administration, or FDA , and marketed for two indications in the United States: the control of serum phosphorus levels in adult patients with chronic kidney disease, or CKD, on dialysis, or DD-CKD , and the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or NDD-CKD . Ferric citrate is also approved and marketed in Japan as an oral treatment for IDA in adult patients for the improvement of hyperphosphatemia in such patients with DD-CKD and NDD-CKD under the trade name Riona (ferric citrate hydrate). Vadadustat, the Company’s lead investigational product candidate, is an investigational oral hypoxia-inducible factor prolyl hydroxylase, or HIF-PH , inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. On March 29, 2022, the Company received a complete response letter, or CRL , from the FDA, which provided that it could not approve the new drug application, or NDA , for vadadustat for the treatment of anemia due to CKD in adult patients in its present form. In October 2022, the Company submitted a Formal Dispute Resolution Request with the FDA and in May 2023, the Office of New Drugs, or OND , denied the Company's appeal but provided a path forward for the Company to resubmit the NDA for vadadustat for the treatment of anemia due to CKD for dialysis dependent patients without the need for the Company to generate additional clinical data. In September 2023, the Company completed its resubmission to its NDA for vadadustat for the treatment of anemia due to CKD for dialysis dependent patients. In October 2023, the FDA acknowledged that the resubmission was complete, classified it as a Class 2 response and set a user fee goal date, or PDUFA date , of March 27, 2024. In April 2023, the European Commission, or EC , approved the marketing authorization of vadadustat under the trade name Vafseo for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. The marketing authorization of vadadustat under the trade name Vafseo for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis was subsequently approved in May 2023 in the United Kingdom, or UK , by the Medicines and Healthcare products Regulatory Agency, in June 2023 in Switzerland by the Swiss Agency for Therapeutics Products, in March 2023 in Korea by the Ministry of Food and Drug Safety (under trade name Vadanem) and in September 2023 in Australia and Taiwan by the Therapeutic Goods Administration, or TGA, and Taiwan Food and Drug Administration, respectively. In May 2023, the Company entered into a License Agreement, or the Medice License Agreement, with MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, pursuant to which the Company granted Medice an exclusive license to develop and commercialize vadadustat for the treatment of anemia in patients with CKD in the European Economic Area, the UK, Switzerland and Australia, or the Medice Territory. Vadadustat is also approved in Japan as a treatment for anemia due to CKD in both DD-CKD and NDD-CKD patients under the trade name Vafseo, and marketed and sold in Japan by Mitsubishi Tanabe Pharma Corporation, or MTPC. Additionally, following regulatory approval of vadadustat in Japan, the Company began recognizing royalty revenues from 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 HCR, or Royalty Agreement , whereby the Company sold its right to receive royalties and sales milestones under its Collaboration Agreement with MTPC, or MTPC Agreement , subject to certain caps and other terms and conditions (see Note 4 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. Going Concern Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities, commercializing Auryxia and providing general and administrative support for these operations. The Company began recording revenue from the U.S. sales of Auryxia in 2014 and revenue from sublicensing rights to Auryxia in Japan from the Company’s Japanese partners, Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., collectively, JT and Torii, in December 2018. In addition, the Company continues to explore additional development opportunities to expand its pipeline and portfolio of novel therapeutics. If the Company does not successfully commercialize vadadustat, if approved, or any other potential product candidate, it may be unable to achieve profitability. As of September 30, 2023, the Company had cash and cash equivalents of approximately $46.5 million. Based on its current operating plan, the Company believes its cash resources and the cash the Company expects to generate from product, royalty and license revenues will be sufficient to fund its current operating plan for at least twelve months from the filing of this Quarterly Report on Form 10-Q. However, if the Company’s operating performance deteriorates significantly from the levels expected in the Company’s operating plan, or if vadadustat is not approved in the U.S., it would affect the Company’s liquidity and its ability to continue as a going concern in the future. The Company expects to finance future cash needs through |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company's significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2022, and notes thereto, which are included in the Company's Annual Report on Form 10-K, as amended by Amendment No. 1 on Form 10-K/A that was filed with the Securities and Exchange Commission, or SEC, on August 28, 2023, or 2022 Annual Report on Form 10-K/A . Since the date of those financial statements, there have been no material changes to the Company's significant accounting policies. 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 nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2023 or any other future period. Basis of Presentation and Principals of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the ASC and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB . The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated in the consolidated financial statements herein. Certain monetary amounts, percentages, and other figures included elsewhere in these unaudited condensed consolidated financial statements have been subject to rounding adjustments. Accordingly, figures shown as totals in certain tables may not be the arithmetic aggregation of the figures that precede them, and figures expressed as percentages in the text may not total 100% or, as applicable, when aggregated may not be the arithmetic aggregation of the percentages that precede them. 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, revenue and expenses, and the disclosure of contingent assets and liabilities as of and during the reported period. On an ongoing basis, management evaluates its estimates. Management bases its estimates and assumptions on historical experience when available and on various factors, including expected business and operational changes, sensitivity and volatility associated with the assumption that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of the assets and liabilities that are not readily apparent from other sources. In certain circumstances, management must apply significant judgment in this process. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management selects an amount that falls within that range of reasonable estimates. 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. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to: accrued expenses, right-of-use assets and liabilities, embedded debt derivative, refund liabilities to customers, other long-term liabilities, stock-based compensation expense and certain judgments regarding product and collaboration revenues. including various rebates, returns and reserves related to product sales, non-cash interest expense on the liability related to sale of future royalties, inventories, income taxes, intangible asset and goodwill. Reconciliation of Cash, Cash Equivalents and Restricted Cash In determining its cash, cash equivalents and restricted cash, the Company considers only those highly liquid investments, readily convertible to cash which as of September 30, 2023 primarily included funds invested in money market funds. The following table reconciles cash, cash equivalents and restricted cash reported within the Company's consolidated balance sheet to the total amounts showing in the consolidated statement of cash flows: (in thousands) September 30, 2023 December 31, 2022 Cash and cash equivalents $ 46,529 $ 90,466 Restricted cash included in other long-term assets 1,648 2,703 Total cash, cash equivalents and restricted cash $ 48,177 $ 93,169 |
PRODUCT REVENUE AND RESERVES FO
PRODUCT REVENUE AND RESERVES FOR VARIABLE CONSIDERATION | 9 Months Ended |
Sep. 30, 2023 | |
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 $40.1 million and $42.0 million for the three months ended September 30, 2023 and 2022, respectively, and $117.1 million and $126.7 million for the nine months ended September 30, 2023 and 2022, respectively. Product revenue allowance and reserve categories were as follows: (in thousands) Chargebacks Rebates, Fees Product Returns Total Balance at December 31, 2022 $ 1,259 $ 25,947 $ 10,896 $ 38,102 Current provisions related to sales in current year 7,485 58,824 3,513 69,822 Adjustments related to prior year sales 92 (1,924) (56) (1,888) Credits/payments made (7,993) (59,318) (9,736) (77,047) Balance at September 30, 2023 $ 843 $ 23,529 $ 4,617 $ 28,989 (in thousands) Chargebacks Rebates, Fees Product Returns Total Balance at December 31, 2021 $ 1,047 $ 24,173 $ 10,038 $ 35,258 Current provisions related to sales in current year 8,544 63,938 4,056 76,538 Adjustments related to prior year sales (248) 33 (194) (409) Credits/payments made (8,194) (65,611) (3,669) (77,474) Balance at September 30, 2022 $ 1,149 $ 22,533 $ 10,231 $ 33,913 Chargebacks, discounts and estimated product returns are recorded as a reduction of revenue in the period the related product revenue is recognized in the unaudited condensed consolidated statement of operations and comprehensive loss. Chargebacks are recorded as a reduction to accounts receivable while discounts, rebates, fees and other deductions are recorded with a corresponding increase to accrued expenses and other current liabilities or accounts payable on the unaudited condensed consolidated balance sheets. Estimated product returns for the period related to product sales are recorded as other long-term liabilities in the unaudited condensed consolidated balance sheet. Accounts receivable, net related to product sales, was approximately $21.3 million and $37.3 million as of September 30, 2023 and December 31, 2022, respectively. |
LICENSE, COLLABORATION AND OTHE
LICENSE, COLLABORATION AND OTHER REVENUE | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE, COLLABORATION AND OTHER REVENUE | LICENSE, COLLABORATION AND OTHER REVENUE The Company recognized the following revenues from its license, collaboration and other revenue agreements (in thousands): Three Months Ended September 30, Nine Months Ended September 30, License, collaboration and other revenue: 2023 2022 2023 2022 MTPC Collaboration Agreement $ 487 $ 5,487 $ 5,165 $ 13,885 Otsuka U.S. Agreement — — 2,225 86,773 Otsuka International Agreement — — — 5,503 Total collaboration revenue $ 487 $ 5,487 $ 7,390 $ 106,161 JT and Torii Sublicense Agreement 1,441 1,238 3,969 3,871 Medice License Agreement — — 10,000 — Total license, collaboration and other revenue $ 1,928 $ 6,725 $ 21,359 $ 110,032 The following tables present changes in the Company’s contract assets and liabilities (in thousands): Nine Months Ended September 30, 2023 Balance at Additions Deductions Balance Contract assets: Accounts receivable (1) $ 1,901 $ 1,426 $ (2,847) $ 480 Prepaid expenses and other current assets $ 781 $ — $ (781) $ — Contract liability: Deferred revenue $ 47,034 $ — $ (3,738) $ 43,296 Nine Months Ended September 30, 2022 Balance at Additions Deductions Balance Contract assets: Accounts receivable (1) $ 19,094 $ 92,612 $ (109,836) $ 1,870 Prepaid expenses and other current assets $ 4,309 $ 9,550 $ (8,250) $ 5,609 Contract liabilities: Deferred revenue $ 42,380 $ 66,307 $ (64,126) $ 44,561 Accounts payable $ 3,171 $ — $ (3,171) $ — (1) Excludes accounts receivable related to amounts due to the Company from product sales of Auryxia which are included in the accompanying unaudited condensed consolidated balance sheet as of September 30, 2023 and 2022. 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 September 30, Nine Months Ended September 30, Revenue Recognized in the Period: 2023 2022 2023 2022 Deferred revenue — beginning of the period $ — $ 5,047 $ — $ 29,574 During the three and nine months ended September 30, 2023 and 2022, the Company recognized no revenue from performance obligations satisfied in previous periods. MTPC Collaboration Agreement On December 11, 2015, the Company and MTPC entered into the MTPC Agreement, providing MTPC with exclusive development and commercialization rights to vadadustat in Japan and certain other Asian countries, collectively, the MTPC Territory , which was amended effective as of December 2, 2022. In addition, the Company supplies vadadustat to MTPC for both clinical and commercial use in the MTPC Territory. In February 2021, the Company entered into the Royalty Agreement with HCR, 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 and Note 5 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A for a more detailed description of the MTPC Agreement. 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 . 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 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 NDA filing in Japan and $15.0 million relating to regulatory approval of vadadustat in Japan, and (vi) $4.4 million in royalties from net sales of Vafseo. As of September 30, 2023, 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. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. 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. During the three and nine months ended September 30, 2023, the Company recognized revenue from MTPC royalties totaling approximately $0.5 million and $1.4 million, respectively, and approximately $0.4 million and $1.2 million during the three and nine months ended September 30, 2022, respectively. 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 license, collaboration and other revenue in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss. As of September 30, 2023, there were no accounts receivable, contract assets, payables or deferred revenue recorded in connection with the MTPC Agreement. Supply of Drug Product to MTPC On July 15, 2020, the Company and MTPC entered into a supply agreement, or MTPC Supply Agreement , under which the Company supplies vadadustat drug product to MTPC for commercial use in Japan and certain other Asian countries, as contemplated by the MTPC Agreement. See Note 5 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A for a more detailed description of this supply agreement. On December 16, 2022, the Company, MTPC and Esteve Química, S.A., or Esteve, executed an Assignment of Supply Agreement, or Esteve Assignment Agreement , pursuant to which the Supply Agreement between the Company and Esteve, or Esteve Agreement (see Note 12) was assigned to MTPC. The Esteve Assignment Agreement transferred the rights and obligations of the Company under the Esteve Agreement to MTPC, including the obligations under certain purchase orders issued by the Company and accepted by Esteve that will continue to have a binding effect on MTPC to take delivery of the product from Esteve in accordance with the terms of the Esteve Agreement. The Company has no further obligation to take delivery of, or pay for, product delivered by Esteve. The Company recognized no revenue and $3.7 million in revenue under the MTPC Supply Agreement during the three and nine months ended September 30, 2023, respectively, and $5.1 million and $12.7 million in revenue during the three and nine months ended September 30, 2022, respectively. Due to the Esteve Agreement, the Company no longer records accounts receivable, deferred revenue or other current liabilities relating to the MTPC Supply Agreement. Cyclerion License Agreement On June 4, 2021, the Company entered into a License Agreement, or Cyclerion Agreement, with Cyclerion Therapeutics Inc., or Cyclerion , pursuant to which Cyclerion granted the Company an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oral soluble guanylate stimulator. Under the terms of the Cyclerion Agreement, the Company made an upfront payment of $3.0 million in cash to Cyclerion, which was paid and recorded to research and development expense in June 2021. Substantially all of the fair value of the assets acquired in conjunction with the Cyclerion Agreement was concentrated in the acquired license. As a result, the Company accounted for this transaction as an asset acquisition under ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business . The upfront payment was charged to expense at acquisition, as it relates to a development stage compound with no alternative future use. In addition, Cyclerion is eligible to receive up to an aggregate of $222.0 million from the Company in specified development and regulatory milestone payments on a product-by-product basis. Cyclerion will also be eligible to receive specified commercial milestones as well as tiered royalties ranging from a low-single-digit- to mid-double-digit percentage of net sales, on a product-by-product basis, and subject to reduction upon expiration of patent rights or the launch of a generic product in the territory. A more detailed description of this agreement can be found in Note 5 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A. CSL Vifor License Agreement O n May 12, 2017, the Company entered into a License Agreement, as amended and restated on February 18, 2022, or the Vifor Agreement, with Vifor (International) Ltd. (now a part of CSL Limited), or CSL Vifor , which grants CSL Vifor an exclusive license to sell vadadustat to Fresenius Kidney Care Group LLC, an affiliate of Fresenius Medical Care North America, or FMCNA , and its affiliates, including Fresenius Kidney Care Group LLC, to certain third-party dialysis organizations approved by the Company, to independent dialysis organizations that are members of certain group purchasing organizations and certain non-retail specialty pharmacies, collectively, the Supply Group , in the United States, or Vifor Territory . CSL Vifor has agreed not to sell or otherwise supply vadadustat until the FDA has granted regulatory approval for vadadustat for the treatment of anemia due to CKD in adult patients with DD-CKD in the Vifor Territory and until CSL Vifor has entered a supply agreement with the applicable member of the Supply Group. The Vifor Agreement is structured as a profit share arrangement between the Company and CSL Vifor in which the Company will receive approximately 66% of the profits, net of certain pre-specified costs. In addition, CSL Vifor made an upfront payment to the Company of $25.0 million in February 2022 in connection with the amendment and restatement of the Vifor Agreement, which was recorded as long-term deferred revenue in the accompanying unaudited condensed consolidated balance sheet. Unless earlier terminated, the Vifor Agreement will expire upon the later of the expiration of all patents that claim or cover vadadustat or expiration of marketing or regulatory exclusivity for vadadustat in the Vifor Territory. CSL Vifor may terminate the Vifor Agreement in its entirety upon 30 months' prior written notice after the first anniversary of the receipt of regulatory approval, if approved from the FDA for vadadustat for dialysis-dependent CKD patients. The Company may terminate the Vifor Agreement in its entirety for convenience, following the earlier of a certain period of time elapsing or following certain specified regulatory events and upon six months’ prior written notice. If the Company so terminates for convenience, subject to specified exceptions, the Company will pay a termination fee to CSL Vifor. In addition, either party may, subject to a cure period, terminate the Vifor Agreement in the event of the other party’s uncured material breach or bankruptcy. Investment Agreement In connection with the Vifor Agreement, in May 2017, the Company and CSL Vifor entered into an investment agreement, or First Investment Agreement , pursuant to which the Company sold an aggregate of 3,571,429 shares of the Company’s common stock, or 2017 Shares, to CSL Vifor at a price per share of $14.00 for a total of $50.0 million. On February 18, 2022, in connection with the amendment and restatement, the Company and CSL Vifor entered into an investment agreement, or Second Investment Agreement , pursuant to which the Company sold an aggregate of 4,000,000 shares of its common stock, or 2022 Shares, to CSL Vifor at a price per share of $5.00 for a total of $20 million on February 22, 2022. The amounts representing the premium over the closing stock price and the amount paid of $4.7 million under the First Investment Amendment and $13.6 million under the Second Investment Amendment were determined by the Company to represent consideration related to the Vifor Agreement and recorded as long-term deferred revenue in long-term liabilities on the unaudited condensed consolidated financial statements. CSL Vifor agreed to a lock-up restriction not to sell the 2017 Shares or the 2022 Shares for a period of time following the effective date of the First Investment Agreement and Second Investment Agreement, respectively, which restriction with respect to the 2017 Shares has expired. The First Investment Agreement and the Second Investment Agreement each contain a customary standstill agreement. In addition, the First Investment Agreement and Second Investment Agreement contain voting agreements made by CSL Vifor with respect to the 2017 Shares and 2022 Shares, respectively. The 2017 Shares and 2022 Shares have not been registered pursuant to the Securities Act of 1933, as amended, or the Securities Act , and were issued and sold in reliance upon the exemption from registration contained in Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder as the transaction did not involve any public offering within the meaning of Section 4(a)(2) of the Securities Act. See Note 5 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A for a more detailed description of the Vifor Agreement. Revenue Recognition The Company identified one performance obligation under the Vifor Agreement, as amended, the deliverable of the license. Thus until the license is delivered, the transaction price of $43.3 million which is comprised of the up-front payment of $25.0 million and the premiums paid by CSL Vifor on the First Investment Agreement and Second Investment Agreement of $4.7 million and $13.6 million, respectively, will remain in long-term deferred revenue in the accompanying unaudited condensed consolidated balance sheet. Under the Vifor Agreement, these payments from CSL Vifor are non-refundable and non-creditable against any other amount due to the Company. In addition, if the Centers for Medicare & Medicaid Services, or CMS, determines that vadadustat is excluded from the Transitional Drug Add-on Payment Adjustment, or TDAPA , the Company can terminate the Vifor Agreement and will be required to repay the up-front payment of $25.0 million and the premiums paid by CSL Vifor of $18.3 million. Refund Liability to Customer Pursuant to the Vifor Agreement, CSL Vifor contributed $40.0 million to a working capital fund established to fund approximately 50% of the Company’s costs of purchasing vadadustat from its contract manufacturers, or Working Capital Fund , for the supply of vadadustat for the Vifor Territory already delivered or to be delivered to the Company through the end of 2023. The amount of the Working Capital Fund can be reviewed at specified intervals and may be adjusted based on a number of factors including outstanding supply commitments for vadadustat and agreed upon vadadustat inventory levels held by the Company for the Vifor Territory. Upon termination or expiration of the Vifor Agreement for any reason other than convenience by CSL Vifor (including following receipt of the CRL for vadadustat), the Company will be required to refund the outstanding balance of the Working Capital Fund on the date of termination or expiration. The Company has determined the Working Capital Fund itself does not represent an obligation to transfer goods or services to CSL Vifor in the future and thus under ASC 606 was recorded as a refund liability. The refund liability is considered a debt arrangement with zero coupon interest and the Company imputes interest on the refund liability at a rate of 15.0% per annum, which was determined based on certain factors, including the Company's credit rating, comparable securities yield and the expected repayment period. On March 18, 2022, when the $40.0 million was received from CSL Vifor, the Company recorded an initial discount on the refund liability and a corresponding deferred gain on the condensed consolidated balance sheet. The discount on the refund liability is being amortized to interest expense using the effective interest method over the expected term of the Vifor Agreement. The deferred gain is being amortized to interest income on a straight-line basis over the expected term of the Vifor Agreement. The amortization of the discount was $0.7 million and $2.4 million for the three and nine months ended September 30, 2023, respectively, and $1.1 million and $2.3 million for the three and nine months ended September 30, 2022, respectively. The amortization of the deferred gain was $1.0 million and $3.0 million for the three and nine months ended September 30, 2023, respectively, and $0.9 million and $1.8 million for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023, the $40.3 million refund liability is classified as a long-term liability based on management's estimated timing of the repayment of the refund liability to Vifor exceeding one-year. Panion License Agreement The Company had a license agreement, which was amended from time to time, with Panion & BF Biotech, Inc., or Panion , under which Keryx Biopharmaceuticals, Inc., or Keryx , the Company's wholly owned subsidiary, was the contracting party, or Panion License Agreement , pursuant to which Keryx in-licensed the exclusive worldwide rights, excluding certain Asian-Pacific countries, or Licensor Territory, for the development and commercialization of ferric citrate. On April 17, 2019, the Company and Panion entered into a second amended and restated license agreement, or Panion Amended License Agreement , which amends and restates in full the Panion License Agreement, effective as of April 17, 2019. The Panion Amended License Agreement provides Keryx with an exclusive license under Panion-owned know-how and patents with the right to sublicense, develop, make, use, sell, offer for sale, import and export ferric citrate worldwide, excluding the Licensor Territory. The Panion Amended License Agreement also provides Panion with an exclusive license under the Keryx-owned patents, with the right to sublicense (with the Company’s written consent), develop, make, use, sell, offer for sale, import and export ferric citrate in certain countries in the Licensor Territory. Under the Panion Amended License Agreement, Panion is eligible to receive from the Company or any sublicensee royalty payments based on a mid-single digit percentage of sales of ferric citrate in the Company’s licensed territories. The Company is eligible to receive from Panion or any sublicensee royalty payments based on a mid-single digit percentage of net sales of ferric citrate in Panion’s licensed territories. See Note 5 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A for a more detailed description of this license agreement. The Company recognized royalty payments due to Panion of approximately $3.1 million and $9.3 million during the three and nine months ended September 30, 2023, respectively, and $2.9 million and $9.5 million during the three and nine months ended September 30, 2022, respectively, relating to the Company’s sales of Auryxia in the United States and JT and Torii’s net sales of Riona in Japan. JT and Torii Sublicense Agreement The Company has an Amended and Restated Sublicense Agreement, which was amended in June 2013, with JT and Torii, or JT and Torii Sublicense Agreement , under which Keryx, the Company’s wholly owned subsidiary, remains the contracting party. Under the JT and Torii Sublicense Agreement, JT and Torii obtained the exclusive sublicense rights for the development and commercialization of ferric citrate hydrate in Japan. JT and Torii are responsible for the future development and commercialization costs in Japan. See Note 5 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A for a more detailed description of this sublicense agreement. The Company identified two performance obligations in connection with its obligations under the JT and Torii Sublicense Agreement: (i) License and Supply Performance Obligation and (ii) Rights to Future Know-How Performance Obligation . The Company allocated 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 immaterial. As such, the Company did not develop a best estimate of standalone selling price for the License and Supply Performance Obligation and allocated the entire transaction price to this performance obligation. The Company recognized license revenue of $1.4 million and $4.0 million during the three and nine months ended September 30, 2023, respectively, and $1.2 million and $3.9 million during the three and nine months ended September 30, 2022, respectively, related to royalties earned on net sales of Riona in Japan. The Company records the associated mid-single digit percentage of net sales royalty expense due to Panion, the licensor of Riona, in the same period as the royalty revenue from JT and Torii is recorded. Averoa License Agreement On December 22, 2022, the Company and Averoa SAS, or Averoa, entered into a license agreement, or Averoa License Agreement , pursuant to which the Company granted to Averoa an exclusive license to develop and commercialize ferric citrate, or Averoa Licensed Product , in the European Economic Area, Turkey, Switzerland and the United Kingdom, or Averoa Territory . Under the Averoa License Agreement, the Company is entitled to receive tiered escalating royalties ranging from a mid-single digit percentage to a low double-digit percentage of Averoa's annual net sales in the Averoa Territory, including certain minimum royalty amounts in certain years, and subject to reduction in certain circumstances. The Company and Averoa have established a joint steering committee to oversee the development, manufacturing and commercialization of the Averoa Licensed Product in the Averoa Territory. The Averoa License Agreement expires on the date of expiration of all royalty obligations due thereunder with respect to the Averoa Licensed Product on a country-by-country basis in the Averoa Territory, unless earlier terminated in accordance with the Averoa License Agreement . The Averoa License Agreement provides that the Company and Averoa will enter into a supply agreement pursuant to which the Company will supply the Averoa Licensed Product to Averoa for commercial use in the Averoa Territory. The Company will have the right to terminate the supply agreement upon 24 months' notice, which may be provided on or after January 1, 2024. As of September 30, 2023, the Company and Averoa have not yet entered into a supply agreement. A more detailed description of the Averoa License Agreement can be found in Note 5 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A. Medice License Agreement On May 24, 2023, or Medice Effective Date , the Company and Medice entered into the Medice License Agreement, pursuant to which the Company granted to Medice an exclusive license to develop and commercialize vadadustat, or Medice Licensed Product, for the treatment of anemia in adult patients with chronic kidney disease in the Medice Territory. Under the Medice License Agreement, the Company received an up-front payment of $10.0 million and is entitled to receive the following payments: (i) commercial milestone payments up to an aggregate of $100.0 million, and (ii) tiered royalties ranging from 10% to 30% of Medice's annual net sales of the Medice Licensed Product in the Medice Territory, subject to reduction in certain circumstances. The royalties will expire on a country-by-country basis upon the latest to occur of (a) the date of expiration of the last-to-expire valid claim of any Company, Medice or joint patent that covers the Medice Licensed Product in such country in the Medice Territory, (b) the date of expiration of data or regulatory exclusivity for the Medice Licensed Product in such country in the Medice Territory and (c) the date that is 12 years from first commercial sale of the Medice Licensed Product in such country in the Medice Territory. Under the Medice License Agreement, the Company retains the right to develop the Medice Licensed Product for non-dialysis patients with anemia due to chronic kidney disease in the Medice Territory. If the Company develops the Medice Licensed Product for non-dialysis patients and such Medice Licensed Product receives marketing approval in the Medice Territory, Medice will commercialize the Medice Licensed Product for both indications in the Medice Territory. In this instance, the Company would receive 70% of the net product margin of any sales of the Medice Licensed Product in the non-dialysis patient population, unless Medice requests to share the cost of the development necessary to gain approval to market the Medice Licensed Product for non-dialysis patients in the Medice Territory and the parties agree on alternative financial terms. If the Company develops the licensed product for non-dialysis patients, the Company has determined that the activities under the Medice License 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, if the Company develops the Medice Licensed Product for non-dialysis patients the Company will account for the joint activities in accordance with ASC No. 808, Collaborative Arrangements, or ASC 808 . Additionally, the Company has determined that in the context of the development of the Medice Licensed Product for non-dialysis patients, Medice 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 development activities for the Medice Licensed Product for non-dialysis patients will be accounted for as a component of the related expense in the period incurred. The Company and Medice expect in the future to establish a joint steering committee to oversee the development and commercialization of the Medice Licensed Product in the Medice Territory. The Medice License Agreement expires on the date of expiration of all payment obligations due thereunder with respect to the Medice Licensed Product in the last country in the Medice Territory, unless earlier terminated in accordance with the terms of the Medice License Agreement. Either party may, subject to a cure period, terminate the Medice License Agreement in the event of the other party's uncured material breach. Medice has the right to terminate the Medice License Agreement in its entirety for convenience upon 12 months' prior written notice delivered on or after the date that is 12 months after the Medice Effective Date. The Medice License Agreement includes customary terms relating to, among others, indemnification, confidentiality, remedies, and representations and warranties. The Medice License Agreement provides that the Company and Medice will enter into a supply agreement pursuant to which the Company will supply the Medice Licensed Product to Medice for commercial use in the Medice Territory. Revenue Recognition The Company evaluated the elements of the Medice License Agreement in accordance with the provisions of ASC 606 and concluded Medice is a customer. The Company's arrangement with Medice contains one material promise under the contract at inception, which is the exclusive license under the Company's intellectual property to develop and commercialize the Medice Licensed Product in the Medice Territory during the term of the Medice License Agreement and use the Akebia Trademark solely in connection with the commercialization of the Medice Licensed Product, or License Deliverable . The Company identified one performance obligation in connection with its obligations under the Medice License Agreement, which is the License Deliverable, or License Performance Obligation . The transaction price at inception was comprised of the up-front payment of $10.0 million, of which the Company received $8.6 million during the quarter ended June 30, 2023. The remaining $1.4 million was withheld by the German Federal Tax Office and is included in other long-term assets on the condensed consolidated balance sheet as of September 30, 2023. Pursuant to the terms of the Medice License Agreement, the up-front payment of $10.0 million is non-refundable and non-creditable against any other amount due to the Company and was allocated to the License Performance Obligation, which was satisfied as of the Medice Effective Date. As such, the Company recognized the $10.0 million up-front payment as License, collaboration and other revenue in the condensed consolidated statement of operations and comprehensive loss during the nine months ended September 30, 2023. In accordance with ASC 606, the Company will recognize sales-based royalties and milestone payments at the later of when the performance obligation is satisfied or the related sales occur. Past Collaboration and License Agreements U.S. Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. On December 18, 2016, the Company entered into a collaboration and license agreement, or Otsuka U.S. Agreement, with Otsuka Pharmaceutical Co. Ltd., or Otsuka . The collaboration was focused on the development and commercialization of vadadustat in the United States. The Company was responsible for leading the development of vadadustat, for which it submitted an NDA to the FDA in March 2021, and for which it received the CRL in March 2022. On May 12, 2022, the Company received notice from Otsuka that Otsuka had elected to terminate the Otsuka U.S. Agreement and the April 25, 2017 collaboration and license agreement with Otsuka, or Otsuka International Agreement . On June 30, 2022, the Company and Otsuka entered into the Termination and Settlement Agreement, or Termination Agreement , pursuant to which, among other things, the Company and Otsuka agreed to terminate the Otsuka U.S. Agreement and the Otsuka International Agreement as of June 30, 2022. The Company did not recognize collaboration revenue with respect to the Otsuka U.S. Agreement during the three months ended September 30, 2023 or 2022. During the nine months ended September 30, 2022, the Company recognized collaboration revenue totaling $86.8 million with respect to the Otsuka U.S. Agreement. During the nine months ended September 30, 2023, the Company recognized $2.2 million in collaboration revenue in connection with the Packaging Validation Transfer Agreement entered into with Otsuka on April 20, 2023. The Company evaluated the agreement under ASC 606 and concluded it was closely tied to the prior collaboration revenue agreements and under ASC606 recognized collaboration revenue in the current quarter. A more detailed description of the Otsuka U.S. Agreement can be found in Note 5 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A. International Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. On April 25, 2017, the Company entered into the Otsuka International |
LIABILITY RELATED TO SALE OF FU
LIABILITY RELATED TO SALE OF FUTURE ROYALTIES | 9 Months Ended |
Sep. 30, 2023 | |
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 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 Annual Cap, and an aggregate maximum “cap” of $150.0 million, or Aggregate Cap . The Company received $44.8 million from HCR (net of certain transaction expenses) under the Royalty Agreement. The Company retains the right to receive all potential future regulatory milestones for vadadustat under the MTPC Agreement. 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 and is amortizing it 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, is 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 September 30, 2023 was 0% which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss. On a quarterly basis, the Company reassesses the effective interest rate and adjusts the rate prospectively as needed. A more detailed description of Royalty Agreement can be found in Note 7 of the Notes to the Consolidated Financial Statements in the 2022 Annual Report on Form 10-K/A. The activity within the long-term liability account for the nine months ended September 30, 2023 is as follows (in thousands): Liability related to sale of future royalties, beginning balance at December 31, 2022 $ 57,484 MTPC royalties payable (1,423) Liability related to sale of future royalties, ending balance at September 30, 2023 $ 56,061 |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | FAIR VALUE OF FINANCIAL INSTRUMENTS The tables below present certain assets and liabilities measured at fair value categorized by the level of input used in the valuation of each asset and liability (in thousands): September 30, 2023 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 6,069 $ — $ — $ 6,069 Long-term liability: Embedded debt derivative $ — $ — $ 760 $ 760 December 31, 2022 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 52,442 $ — $ — $ 52,442 Long-term liability: Embedded debt derivative $ — $ — $ 760 $ 760 Cash and cash equivalents —Money market funds included within cash and cash equivalents are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets. Embedded debt derivative —As described in Note 10, the Company’s Loan Agreement with Pharmakon 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 (i) no event of default having occurred and continuing and (ii) the Company achieving certain regulatory and revenue conditions. The Company did not meet one of the regulatory conditions and therefore, the Company is no longer eligible for the interest-only extension period and this no longer changes the underlying cash flows of the debt instrument. The Company concluded the acceleration of the obligations under the Loan Agreement under certain events of default, and under certain circumstances, the application of a default interest rate on all outstanding obligations during the occurrence and continuance of an event of default represent a single compound embedded debt derivative required to be bifurcated from the debt host instrument that is required to be re-measured at fair value on a quarterly basis. The estimated fair value of the embedded debt derivative on both September 30, 2023 and December 31, 2022 was determined using a scenario-based approach and discounted cash flow model that includes principal and interest payments under various cash flow assumptions. 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 embedded debt derivative. The determination of the fair value of the embedded debt derivative includes inputs not observable in the market and as such, represents Level 3 measurement. The methodology utilized requires inputs based on certain subjective assumptions, specifically, probabilities of acceleration of the obligations under the Loan Agreement by Pharmakon under certain events of default. The probabilities used in the valuation of the embedded debt derivative included a 95% probability that the obligations under the Loan Agreement will not be accelerated due to an event of default under the Loan Agreement. |
INVENTORIES
INVENTORIES | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | INVENTORIES Inventories consists of the following (in thousands): September 30, 2023 December 31, 2022 Work-in-process $ 2,640 $ 7,892 Finished goods 15,802 13,676 Inventories, current $ 18,442 $ 21,568 Raw materials included in other long-term assets 848 610 Total inventories $ 19,290 $ 22,178 For the period ended December 31, 2022, inventory consisted only of inventory related to our commercial product, Auryxia. On April 24, 2023, or the EC Marketing Authorization Date , vadadustat received marketing authorization from the EC under the trade name Vafseo. Costs associated with converting the vadadustat drug substance to finished goods after the EC Marketing Authorization Date, which will be used to supply Europe, have been capitalized as inventory on the condensed consolidated balance sheet of the Company as of September 30, 2023. Inventory written down for Auryxia as a result of excess, obsolescence, scrap or other reasons charged to cost of goods in the unaudited condensed consolidated statement of operations and comprehensive loss totaled approximately $0.7 million and $2.6 million during the three months ended September 30, 2023 and 2022, respectively, and $1.3 million and $10.0 million during the nine months ended September 30, 2023 and 2022, respectively. The Company records advance payments for vadadustat drug substance that it expects to use for the potential US launch as prepaid manufacturing costs. Upon the quality release of the vadadustat batches and transfer of title to the Company, the Company records the cost as research and development expense. As of September 30, 2023 and December 31, 2022, the Company had $15.6 million of prepaid manufacturing costs for vadadustat drug substance expected to be used in the potential U.S. launch of vadadustat included in other current assets on the condensed consolidated balance sheet. |
INTANGIBLE ASSET AND GOODWILL
INTANGIBLE ASSET AND GOODWILL | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSET AND GOODWILL | INTANGIBLE ASSET AND GOODWILL Intangible Asset Intangible asset, net of accumulated amortization, prior impairments and adjustments as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, 2023 December 31, 2022 Intangible asset: Gross Carrying Accumulated Amortization Net Book Value Net Book Value Estimated Useful Life Developed product rights for Auryxia $ 214,705 $ (169,652) $ 45,053 $ 72,084 6 years The Company recorded $9.0 million in amortization expense for each of the three month periods ended September 30, 2023 and 2022, and $27.0 million for each of the nine month periods ended September 30, 2023 and 2022. Goodwill |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | ACCRUED EXPENSES AND OTHER CURRENT LIABILITIESAccrued expenses and other current liabilities consists of the following (in thousands): September 30, 2023 December 31, 2022 Product revenue allowances $ 23,834 $ 26,268 Product return reserves, current portion 3,312 7,789 Compensation and related benefits 7,204 11,481 Operating lease liabilities, current portion 4,861 4,744 Royalties 3,076 3,804 Professional fees 4,648 1,886 Accrued manufacturing costs 4,156 4,310 BioVectra termination fees 5,000 — Clinical trial costs 312 5,755 Restructuring costs 617 2,751 Other 5,644 6,989 Total accrued expenses and other current liabilities $ 62,664 $ 75,777 |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT Pharmakon Term Loans On November 11, 2019, the Company, with Keryx as guarantor, entered into a loan agreement, or Loan Agreement , with BioPharma Credit PLC as collateral agent and a lender, or Collateral Agent, and BioPharma Credit Investments V (Master) LP as a lender, and a Guaranty and Security Agreement with the Collateral Agent. BioPharma Credit PLC subsequently transferred its interest in the 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 Loan Agreement, as amended, consists of a secured term loan facility in an aggregate amount of up to $100.0 million, or Term Loans , which was made available under two tranches: (i) the first tranche of $80.0 million, or Tranche A , and (ii) the second tranche of $20.0 million, or Tranche B . On November 25, 2019, the Company drew $77.3 million on Tranche A, net of fees and expenses of $2.7 million. On December 10, 2020, the Company drew $20.0 million on Tranche B, net of immaterial lender expenses and issuance costs. On July 15, 2022, or Second Amendment Effective Date , the Company prepaid $25.0 million of the then outstanding principal, $5.0 million on Tranche A and a $20.0 million on Tranche B as well as a $0.5 million prepayment fees under the terms of the Loan Agreement. During the three months ended September 30, 2022, the Company recorded a debt extinguishment loss of $0.9 million. As of September 30, 2023, the Company had $43.0 million of principal outstanding. The Term Loans, as amended, bear interest through maturity at a variable rate based on the three month Secured Overnight Financing Rate, or SOFR, plus a SOFR adjustment of 0.30% plus 7.50%. The SOFR interest rate was capped at 3.35% through October 31, 2023, the date of the Fourth Amendment to the Loan Agreement, or Fourth Amendment . As of September 30, 2023, the three-month SOFR rate was above the SOFR cap, therefore, the Company's interest rate was 11.15%. The Company recognized interest expense related to the Loan Agreement of $1.4 million and $2.1 million during the three months ended September 30, 2023 and 2022, respectively, and $4.7 million and $7.5 million during the nine months ended September 30, 2023 and 2022, respectively. Unamortized discount and issuance costs were $0.4 million as of September 30, 2023. The Company was required to make equal quarterly principal payments that started on the 33rd-month anniversary of the applicable Funding Date until November 25, 2024, or Original Maturity Date. The Fourth Amendment, which the Company entered into on October 31, 2023, extended the maturity date to March 31, 2025, or New Maturity Date , and revised the principal payments to monthly principal payments starting in October 2024 on the remaining principal balance of $35.0 million. During the three months ended September 30, 2023, the Company made no quarterly principal payments under the Term Loans. During the nine months ended September 30, 2023, the Company made quarterly principal payments under the Term Loans totaling $24.0 million. 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. If the Company prepays the loan prior to the New Maturity Date, it will be required to make a prepayment fee of 0.50% of such prepayment amount. A change of control, which includes a new entity or group owning a majority (greater than 50%) of the Company's voting stock, triggers a mandatory prepayment of the Term Loans. The obligations of the Company and Keryx under the Loan Agreement 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. The Loan Agreement contains various affirmative and negative covenants, including that limit the Company's ability to engage in specified types of transactions and require the Company to maintain one or more controlled cash accounts. In addition, the Loan Agreement, as amended, requires the Company to (i) report quarterly minimum net Auryxia sales for the trailing twelve-month period of $85.0 million, (ii) in certain instances maintain an annual minimum liquidity threshold and (iii) not be subject to any qualification as to going concern in its Annual Reports on Form 10-K. If an event of default occurs, including a qualification as a going concern, 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 September 30, 2023 and December 31, 2022, the Company was in compliance with the covenants under the Pharmakon Loan Agreement. The Company concluded the contingent put and call features that could require mandatory repayment upon the occurrence of an event of default, default interest rates to be payable and certain other events represent an embedded derivative required to be bifurcated from the debt host instrument and accounted for separately and re-measured at fair value on a quarterly basis. The fair value of the embedded debt derivative related to the Company’s Loan Agreement with Pharmakon was $0.8 million on September 30, 2023 and December 31, 2022. During the nine months ended September 30, 2023, there was no change in fair value of the embedded debt derivative. During the nine months ended September 30, 2022, we recognized a $1.1 million gain in other (expense) income in the consolidated statements of operations and comprehensive loss related to the decrease in the fair value of the embedded debt derivative. |
CAPITAL STOCK, STOCK-BASED COMP
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN | CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN 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 September 30, 2023, the authorized capital stock of the Company included 350,000,000 shares of common stock, $0.00001 par value per share, of which 188,313,807 and 184,135,714 shares were issued and outstanding as of September 30, 2023 and December 31, 2022, respectively; and 25,000,000 shares of undesignated preferred stock, $0.00001 par value per share, of which no shares were issued and outstanding as of September 30, 2023 and December 31, 2022. At-the-Market Facility On April 7, 2022, the Company entered into an Open Market Sale Agreement, or Sales Agreement , with Jefferies LLC, or Jefferies, as agent, for the offer and sale of common stock at current market prices in amounts to be determined from time to time. Also, on April 7, 2022, the Company filed a prospectus supplement relating to the Sales Agreement, pursuant to which it is able to offer and sell under the Sales Agreement up to $26.0 million of its common stock at current market prices from time to time. From the date of filing of the prospectus supplement through the date of the filing of this Quarterly Report on Form 10-Q, the Company has not sold any shares of its common stock under this program. Terminated At-the-Market Facility On March 12, 2020, the Company filed a prospectus supplement relating to the Company's sales agreement with Cantor Fitzgerald & Co., or Prior Sales Agreement , pursuant to which it was able to offer and sell up to $65.0 million of its common stock at current market prices from time to time. On February 25, 2021, the Company filed a prospectus relating to the Prior 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 was able to offer and sell up to $100.0 million of its common stock at current market prices from time to time. On March 1, 2022, the Company filed a prospectus relating to the Prior Sales Agreement, pursuant to which it was authorized to offer and sell up to $25.3 million of its common stock at current market prices from time to time. On March 16, 2022, the Company terminated the Prior Sales Agreement. During the three months ended March 31, 2022, the Company sold 404,600 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $0.8 million. Stock-Based Compensation and Benefit Plans The Company incurred stock-based compensation expenses of $1.8 million and $7.8 million for the three and nine months ended September 30, 2023, respectively, and $3.4 million and $14.8 million for the three and nine months ended September 30, 2022, respectively. Equity Incentive Plans The following table contains information about our equity plans: September 30, 2023 Title of Plan Group Eligible Type of Award Granted (or to be Granted) Awards Outstanding Additional Awards Authorized for Grant Keryx Equity Plans (1)(2) * Employees, directors and consultants Stock options and RSUs 284,556 — Akebia Therapeutics, Inc. Amended and Restated 2008 Equity Incentive Plan ( the 2008 Plan ) (2) Employees, directors and consultants Stock options and RSUs 419 — Akebia Therapeutics, Inc. 2014 Incentive Plan, as amended (2) (3) ( the 2014 Plan ) (replaces 2008 Plan) Employees, directors, consultants and advisors Stock options, RSUs, SARs and performance awards 17,033,234 — Akebia Therapeutics, Inc. 2023 Stock Incentive Plan (3) ( the 2023 Plan ) (replaces 2014 Plan) Employees, officers, directors, consultants and advisors Stock options, SARs, restricted stock, unrestricted stock, RSUs, performance awards, other share-based awards and dividend equivalents 1,558,500 16,169,791 (1) The Keryx Equity Plans consist of the Keryx Biopharmaceuticals, Inc. 1999 Share Option Plan, Keryx Biopharmaceuticals, Inc., as amended, the 2004 Long-Term Incentive Plan, as amended, the Keryx Biopharmaceuticals, Inc. 2007 Incentive Plan, the Keryx Biopharmaceuticals Inc. Amended and Restated 2013 Incentive Plan and the Keryx Biopharmaceuticals, Inc. 2018 Equity Incentive Plan. (2) Shares are no longer being issued under these plans. (3) Includes inducement awards that are subject to the terms and conditions of the applicable plan but were granted as inducement awards consistent with Nasdaq Listing Rule 5635(c)(4): 2,035,832 options outstanding under the 2014 Plan and 653,000 options outstanding under the 2023 Plan. Common Stock Options and SARs During the nine months ended September 30, 2023, the Company issued 2,489,500 options to employees under the 2014 Plan and 315,000 options to directors under the 2023 Plan. During the nine months ended September 30, 2023, the Company issued 635,313 SARs to one executive under the 2014 Plan. In addition, the Company issues stock options to directors, new hires and occasionally to other employees not in connection with the annual grant process. Options and SARs granted by the Company generally 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 and SARs generally 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 and SARs generally expire 10 years after the date of grant. The Company also maintains an inducement award program with a share pool 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 nine months ended September 30, 2023, the Company granted 704,000 options to purchase shares of the Company’s common stock to new hires as inducements to such employees' entering into employment with the Company, of which 701,000 options remained outstanding as of September 30, 2023. The Company grants annual service-based stock options to employees and directors and SARs to certain executives under the 2023 and 2014 Plans. 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 nine months ended September 30, 2023, the Company granted options not in connection with the annual grant process with an aggregate grant date fair values of $1.2 million calculated using the Black-Scholes option-pricing model. The fair value of stock options that vested during the nine months ended September 30, 2023 was $5.3 million. The combined stock option activity for the nine months ended September 30, 2023, is as follows: Stock Weighted Average Exercise Price Weighted-Average Remaining Contractual Life (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2022 11,775,411 $ 5.82 7.26 years — Granted 4,143,813 $ 0.83 — — Expired (5,989) $ 7.43 Canceled and forfeited (1,299,122) $ 5.82 — — Outstanding at September 30, 2023 14,614,113 $ 4.40 7.17 years $ 2,345 Exercisable at September 30, 2023 8,215,979 $ 6.52 5.80 years Performance Awards The performance-based stock options granted by the Company generally vest in connection with the achievement of specified commercial, regulatory and corporate milestones. The performance-based stock options also generally 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 options granted and recognized over time based on the probability of meeting such commercial, regulatory and corporate milestones. The Company also grants performance-based restricted stock units, or PSUs , to employees under the 2023 Plan and the 2014 Plan. The PSUs granted by the Company generally vest in connection with the achievement of specified commercial, regulatory and corporate milestones. The PSUs also generally 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, regulatory and corporate milestones. The Company did not issue any performance-based stock options under the 2023 Plan or the 2014 Plan during the nine months ended September 30, 2023. Restricted Stock Units Generally, restricted stock units, or RSUs , granted by the Company vest in one of the following ways: (i) 100% of each RSU grant vests on the first anniversary of the grant date, (ii) one third of each RSU grant vests on the first, second and third anniversaries of the grant date, (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, or (iv) one third of each RSU grant vests on the first anniversary and the remaining two thirds vests in eight substantially equal quarterly installments beginning after the one year anniversary, subject, in each case, to the individual’s continued service through the applicable vesting date. The grant-date fair value of the RSUs is recognized as expense on a straight-line basis. The Company determines the fair value of the RSUs based on the closing price of the common stock on the date of the grants. RSU activity is as follows: 2014 Plan 2023 Plan Number of Shares Weighted Average Fair Value Number of Shares Weighted Average Fair Value Outstanding as of December 31, 2022 5,674,406 $ 2.10 — — Granted 2,759,675 $ 0.68 590,500 $ 1.50 Vested (3,971,168) $ 1.02 — — Forfeited and canceled (790,817) $ 1.05 — — Outstanding as of September 30, 2023 3,672,096 $ 1.31 590,500 $ 1.50 As of September 30, 2023, there was $4.0 million of unrecognized compensation costs related to time-based RSUs which is expected to be recognized over a weighted-average period of 1.75 years. Employee Stock Purchase Plan On June 6, 2019, the Company's stockholders approved the Amended and Restated 2014 Employee Stock Purchase Plan, or ESPP . Under the ESPP substantially all employees may voluntarily enroll to purchase shares of the Company’s common stock through payroll deductions at a price equal to 85% of the lower of the fair market values of the stock as of the beginning or the end of the six-month offering period. An employee's payroll deductions under the ESPP are limited to 15% of the employee's compensation, and an employee may not purchase more than $25,000 worth of stock during any calendar year. In addition, an employee may not purchase more than 1,500 shares in any offering period. As of September 30, 2023, a total of 4,637,801 shares of the Company’s common stock are available for future issuance under the ESPP. The Company issued 200,194 shares under the ESPP during the nine months ended September 30, 2023. Stock-Based Compensation Expense The Black-Scholes option pricing model is used to estimate the fair value of the stock options. The weighted-average assumptions used in calculating the fair values of the rights to acquire stock under the 2023 Plan, the 2014 Plan and inducement awards were as follows: Three Months Ended September 30, Nine Months Ended September 30, Stock Options 2023 2022 2023 2022 Risk-free interest rate 4.08 % - 4.55% 2.68 % - 3.96% 3.54 % - 4.55% 1.69 % - 3.96% Expected volatility 102.41 % - 107.01% 87.34 % - 88.92% 100.97 % - 111.71% 79.77 % - 91.57% Expected term (years) 6.25 years - 6.25 years 6.25 years - 6.25 years 5.51 years - 6.25 years 5.51 years - 6.25 years Expected dividend yield —% —% —% —% Fair value at grant date $1.38 $0.26 $0.69 $1.19 The Company has classified stock-based compensation in its condensed consolidated statement of operations and comprehensive loss as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of goods sold $ 74 $ 227 $ 214 $ 386 Research and development 403 644 1,604 2,579 Selling, general and administrative 1,135 2,534 5,355 8,590 Restructuring 212 (50) 630 3,253 Total stock-based compensation $ 1,824 $ 3,355 $ 7,803 $ 14,808 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Cambridge 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, or, collectively, the Cambridge Lease . Under the Third Amendment to the Cambridge Lease, or Third Amendment , executed in July 2016, total monthly lease payments under the initial base rent were approximately $0.2 million 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 (Fifth Amendment) for an additional 19,805 square feet of office space on the 12th 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 $0.1 million 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 (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, which commenced in December 2021, and is subject to annual rent escalations, which commenced in December 2022. 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 renewal option in this real estate lease was not included in the calculation of the right-of-use asset and operating lease liability 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 right-of-use assets and operating lease liabilities as the renewal is reasonably certain. The lease agreements do not contain residual value guarantees. Operating lease costs were $1.2 million and $1.8 million for the three months ended September 30, 2023 and 2022, respectively, and $4.4 million and $5.4 million for the nine months ended September 30, 2023 and 2022, respectively. Cash paid for amounts included in the measurement of operating lease liabilities was $1.4 million and $1.8 million for the three months ended September 30, 2023 and 2022, respectively, and $4.5 million and $5.5 million for the nine months ended September 30, 2023 and 2022, respectively. The security deposit in connection with the Cambridge Lease is $1.6 million in the form of a letter of credit, which is included as restricted cash in prepaid expenses and other current assets in the Company’s unaudited condensed consolidated balance sheets as of September 30, 2023. The Company has not entered into any material short-term leases or financing leases as of September 30, 2023. Former Boston Lease Previously, the Company leased 27,924 square feet of office space in Boston, Massachusetts, or Boston Lease . In February 2022, the Company entered into the First Amendment to the Boston Lease, or First Lease Amendment, to extend the term of the Boston Lease from February 2023 to July 2031. The First Lease Amendment included five months of free rent starting in March 2023 and monthly lease payments of $0.2 million commencing on August 1, 2023, with an annual rent escalation of approximately 2% commencing on August 1, 2024. In May 2023, the Company entered into an Assignment and Assumption of Lease Agreement, or Lease Assignment Agreement, with LG Chem Life Sciences Innovation Center, Inc., or LG Chem , pursuant to which the Company assigned all of its rights, title, and interest in, to, and under the Boston Lease to LG Chem, or the Assignment . As part of the Lease Assignment Agreement, the Company made a payment to LG Chem of $1.3 million, or Lease Assignment Amount, and LG Chem assumed all of the rights and obligations of the Company under the Boston Lease. Subsequent to the Assignment, the Company has no further obligations for rent or other payments under the Boston Lease. In accordance with ASC 842, Leases, the Company wrote off the right-of-use asset and lease liability associated with the Boston Lease, and recognized the difference between the right-of-use asset and the lease liability offset by the Assignment Amount as a loss on lease termination in the condensed consolidated statement of operations and comprehensive loss of $0.5 million during the three and six months ended June 30, 2023. Under the terms of the Lease Assignment Agreement the Company was entitled to, and received back, its security deposit of $1.0 million as of June 30, 2023, which had been recorded as restricted cash in prepaid expenses and other current assets in the Company's condensed consolidated balance sheet as of December 31, 2022. In September 2019, the Company entered into an agreement to sublease the Boston office space to Foundation Medicine, Inc., or Foundation . The sublease was subject and subordinate to the Boston Lease between the Company 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 expired on February 27, 2023. Foundation was obligated to pay the Company rent that approximated the rent due from the Company to its landlord with respect to the Boston Lease. Sublease rental income is recorded to other income in the condensed consolidated statement of operations and other comprehensive loss. The Company was obligated for all payment terms pursuant to the Boston Lease, and the Company guaranteed the obligations under the sublease. The Company did not record any sublease rental income for the three months ended September 30, 2023 and recorded $0.3 million in sublease rental income from Foundation during the nine months ended September 30, 2023. The Company recorded sublease rental income of $0.5 million and $1.4 million during the three and nine months ended September 30, 2022, respectively. Future Lease Commitments Future commitments under non-cancelable lease agreements are as follows: Years ending December 31, Operating Remainder of 2023 $ 1,421 2024 5,741 2025 5,819 2026 3,613 Total lease commitments $ 16,594 Less: present value adjustment (1,501) Current and long-term operating lease liabilities $ 15,093 In arriving at the operating lease liabilities, the Company applied incremental borrowing rates ranging from 6.65% 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 September 30, 2023, the remaining lease term for the Cambridge Lease was 2.95 years. Manufacturing and Unconditional Purchase Commitment Agreements The Company's contractual obligations include a commercial supply agreement with Siegfried Evionnaz SA, or Siegfried, to supply commercial drug substance for Auryxia. Pursuant to the Master Manufacturing Services and Supply Agreement between the Company and Siegfried, as amended (the most recent amendment having been executed on February 28, 2023), or Siegfried Agreement , the Company has agreed to purchase a minimum quantity of drug substance of Auryxia at a predetermined price. The term of the Siegfried Agreement expires on December 31, 2024, unless otherwise agreed by the parties and subject to the Company's option to extend the term through December 31, 2026 by providing 12 months’ prior written notice to Siegfried. The Siegfried Agreement provides the Company and Siegfried with certain early termination rights. As of September 30, 2023, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $18.1 million through the end of 2024. On April 9, 2019, the Company and Esteve entered into the Esteve Agreement, which included the terms and conditions under which Esteve would manufacture vadadustat drug substance for commercial use. Pursuant to the Esteve Agreement, the Company provided rolling forecasts to Esteve on a quarterly basis, or the Esteve Forecast . The Esteve Forecast reflected 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 agreed to a volume-based pricing structure under the Esteve Agreement. On December 16, 2022, the Company, MTPC, and Esteve executed the Esteve Assignment Agreement, pursuant to which the Supply Agreement between the Company and Esteve was assigned to MTPC. The Esteve Assignment Agreement transferred the rights and obligations of the Supply Agreement to MTPC, specifically including the obligations under certain purchase orders issued by the Company and accepted by Esteve. As such, the Company will have no further obligation to take delivery of or pay for product delivered by Esteve under the transferred Esteve Agreement. On March 11, 2020, the Company entered into a Supply Agreement with Patheon Inc., or Patheon, or the Patheon Agreement , under which Patheon will manufacture vadadustat drug product for commercial use under a volume-based pricing structure through June 30, 2025, renewing annually unless either party gives the other party eighteen months' prior written notice. Pursuant to the Patheon Agreement, the Company has agreed to purchase from Patheon a certain percentage of the estimated global demand for vadadustat drug product based on certain quarterly and annual forecasts provided by the Company. As of September 30, 2023, the Company had no minimum commitments with Patheon, however, as estimated global demand fluctuates, the Company may have future obligations under the Patheon Agreement. 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 , as amended on April 15, 2021, or 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 September 30, 2023, the Company has committed to purchase $14.9 million of vadadustat drug substance from WuXi STA through the second quarter of 2024. 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 relationship 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. Former Manufacturing and Unconditional Purchase Commitments Pursuant to the Manufacture and Supply Agreement with BioVectra and the Amended and Restated Product Manufacture and Supply and Facility Construction Agreement with BioVectra, the Company agreed to purchase minimum quantities of Auryxia drug substance annually at predetermined prices as well as reimburse BioVectra for certain costs in connection with construction of a new facility for the manufacture and supply of Auryxia drug substance. On December 22, 2022, the Company and BioVectra entered into a termination agreement, or B ioVectra Termination Agreement , pursuant to which the parties agreed, among other things, to terminate, effective immediately, any and all existing agreements entered into between the parties in connection with the manufacture and supply, by BioVectra to the Company, of Auryxia drug substance. Under the terms of the BioVectra Termination Agreement, each of the Company and BioVectra have released one another from all existing and future claims and liabilities and the return of certain materials and documents. Furthermore, as it relates to all open purchase orders, BioVectra is relieved from any obligations to manufacture any product or perform services under any such open purchase orders, and the Company is relieved from any obligations to purchase any product under such open purchase orders. The Company is also relieved from any obligations to pay any outstanding invoices related to performance by BioVectra of services and all other obligations under the agreements. In addition, the Company agreed to pay BioVectra a total of $32.5 million consisting of (i) an upfront payment of $17.5 million and (ii) six quarterly payments of $2.5 million commencing in April 2024, totaling $15.0 million. The upfront payment of $17.5 million was made during the quarter ended December 31, 2022 and was recognized to cost of goods sold. In accordance with ASC 420, Exit or Disposal Cost Obligations, the Company recognized a liability and corresponding expense for the remaining termination fees based on estimated fair value as of December 22, 2022, or BioVectra Effective Date . The Company imputed interest on the liability for the remaining termination fees at a rate of 17.0% per annum, which was determined based on certain factors, including the Company's credit rating, comparable securities yield, and expected repayment period of the remaining termination fees. The Company recorded an initial discount on the remaining termination fees on the consolidated balance sheet as of the BioVectra Effective Date. This resulted in the recording of a liability and corresponding charge to cost of goods sold of $11.2 million during the quarter ended December 31, 2022. The discount on the liability balance is being amortized to interest expense using the effective interest rate method over the term of the liability. The amortization of the discount was $0.5 million and $1.4 million for the three and nine months ended September 30, 2023, respectively. Other Third-Party Contracts The Company contracts with various organizations to conduct research and development activities with remaining contract costs to the Company of approximately $45.4 million at September 30, 2023. 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 The Company is involved from time to time in various legal proceedings arising in the normal course of business. 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. Changes in the Company’s estimates could have a material impact and are recorded as litigation progresses and new information comes to light. Although the outcomes of potential legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these occasional legal proceedings to have a material adverse effect on its financial position, results of operations or cash flows. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | NET LOSS PER SHARE Potentially dilutive securities, common stock options, RSUs and SARs have been excluded from the calculation of diluted net loss per share as their effects would be anti-dilutive. For periods in which the Company reports a net loss, the weighted average number of shares outstanding used to calculate both basic and diluted net loss per share were the same except for the three months ended September 30, 2022, as the Company had net income for that period. 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: Three Months Ended September 30, 2023 2022 Outstanding common stock options and SARs 14,214,113 11,844,609 Unvested RSUs 4,662,596 6,971,930 Total 18,876,709 18,816,539 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTSThe Company has completed an evaluation of all subsequent events after the balance sheet date of September 30, 2023, through the filing date of this Quarterly Report on Form 10-Q with the SEC, to ensure that the condensed consolidated financial statements include appropriate disclose of events both recognized in the consolidated financial statements as of September 30, 2023, and events which occurred subsequently but were not recognized in the consolidated financial statements. The Company has concluded that no subsequent events have occurred that require disclosure other than the amendment to the Company's Loan Agreement as disclosed in Note 10. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||||||
Net loss | $ (14,489) | $ (11,172) | $ (26,878) | $ (54,096) | $ 29,449 | $ (63,509) | $ (52,539) | $ (88,155) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation and Principals of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the ASC and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB . |
Principals of Consolidation | The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated in the consolidated financial statements herein. |
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, revenue and expenses, and the disclosure of contingent assets and liabilities as of and during the reported period. On an ongoing basis, management evaluates its estimates. Management bases its estimates and assumptions on historical experience when available and on various factors, including expected business and operational changes, sensitivity and volatility associated with the assumption that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of the assets and liabilities that are not readily apparent from other sources. In certain circumstances, management must apply significant judgment in this process. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management selects an amount that falls within that range of reasonable estimates. 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. |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | Reconciliation of Cash, Cash Equivalents and Restricted CashIn determining its cash, cash equivalents and restricted cash, the Company considers only those highly liquid investments, readily convertible to cash which as of September 30, 2023 primarily included funds invested in money market funds. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table reconciles cash, cash equivalents and restricted cash reported within the Company's consolidated balance sheet to the total amounts showing in the consolidated statement of cash flows: (in thousands) September 30, 2023 December 31, 2022 Cash and cash equivalents $ 46,529 $ 90,466 Restricted cash included in other long-term assets 1,648 2,703 Total cash, cash equivalents and restricted cash $ 48,177 $ 93,169 |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table reconciles cash, cash equivalents and restricted cash reported within the Company's consolidated balance sheet to the total amounts showing in the consolidated statement of cash flows: (in thousands) September 30, 2023 December 31, 2022 Cash and cash equivalents $ 46,529 $ 90,466 Restricted cash included in other long-term assets 1,648 2,703 Total cash, cash equivalents and restricted cash $ 48,177 $ 93,169 |
PRODUCT REVENUE AND RESERVES _2
PRODUCT REVENUE AND RESERVES FOR VARIABLE CONSIDERATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue Allowance and Reserve Categories | Product revenue allowance and reserve categories were as follows: (in thousands) Chargebacks Rebates, Fees Product Returns Total Balance at December 31, 2022 $ 1,259 $ 25,947 $ 10,896 $ 38,102 Current provisions related to sales in current year 7,485 58,824 3,513 69,822 Adjustments related to prior year sales 92 (1,924) (56) (1,888) Credits/payments made (7,993) (59,318) (9,736) (77,047) Balance at September 30, 2023 $ 843 $ 23,529 $ 4,617 $ 28,989 (in thousands) Chargebacks Rebates, Fees Product Returns Total Balance at December 31, 2021 $ 1,047 $ 24,173 $ 10,038 $ 35,258 Current provisions related to sales in current year 8,544 63,938 4,056 76,538 Adjustments related to prior year sales (248) 33 (194) (409) Credits/payments made (8,194) (65,611) (3,669) (77,474) Balance at September 30, 2022 $ 1,149 $ 22,533 $ 10,231 $ 33,913 |
LICENSE, COLLABORATION AND OT_2
LICENSE, COLLABORATION AND OTHER REVENUE (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Revenues Recognized from License, Collaboration and Other Significant Agreements | The Company recognized the following revenues from its license, collaboration and other revenue agreements (in thousands): Three Months Ended September 30, Nine Months Ended September 30, License, collaboration and other revenue: 2023 2022 2023 2022 MTPC Collaboration Agreement $ 487 $ 5,487 $ 5,165 $ 13,885 Otsuka U.S. Agreement — — 2,225 86,773 Otsuka International Agreement — — — 5,503 Total collaboration revenue $ 487 $ 5,487 $ 7,390 $ 106,161 JT and Torii Sublicense Agreement 1,441 1,238 3,969 3,871 Medice License Agreement — — 10,000 — Total license, collaboration and other revenue $ 1,928 $ 6,725 $ 21,359 $ 110,032 |
Changes in Contract Assets and Liabilities | The following tables present changes in the Company’s contract assets and liabilities (in thousands): Nine Months Ended September 30, 2023 Balance at Additions Deductions Balance Contract assets: Accounts receivable (1) $ 1,901 $ 1,426 $ (2,847) $ 480 Prepaid expenses and other current assets $ 781 $ — $ (781) $ — Contract liability: Deferred revenue $ 47,034 $ — $ (3,738) $ 43,296 Nine Months Ended September 30, 2022 Balance at Additions Deductions Balance Contract assets: Accounts receivable (1) $ 19,094 $ 92,612 $ (109,836) $ 1,870 Prepaid expenses and other current assets $ 4,309 $ 9,550 $ (8,250) $ 5,609 Contract liabilities: Deferred revenue $ 42,380 $ 66,307 $ (64,126) $ 44,561 Accounts payable $ 3,171 $ — $ (3,171) $ — (1) Excludes accounts receivable related to amounts due to the Company from product sales of Auryxia which are included in the accompanying unaudited condensed consolidated balance sheet as of September 30, 2023 and 2022. |
Revenue Recognized Resulting from Changes in Contract Assets and Contract Liabilities | 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 September 30, Nine Months Ended September 30, Revenue Recognized in the Period: 2023 2022 2023 2022 Deferred revenue — beginning of the period $ — $ 5,047 $ — $ 29,574 |
LIABILITY RELATED TO SALE OF _2
LIABILITY RELATED TO SALE OF FUTURE ROYALTIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Activity within Liability Related to Sale of Future Royalties, net | The activity within the long-term liability account for the nine months ended September 30, 2023 is as follows (in thousands): Liability related to sale of future royalties, beginning balance at December 31, 2022 $ 57,484 MTPC royalties payable (1,423) Liability related to sale of future royalties, ending balance at September 30, 2023 $ 56,061 |
FAIR VALUE OF FINANCIAL INSTR_2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Assets Measured or Disclosed at Fair Value on Recurring Basis | The tables below present certain assets and liabilities measured at fair value categorized by the level of input used in the valuation of each asset and liability (in thousands): September 30, 2023 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 6,069 $ — $ — $ 6,069 Long-term liability: Embedded debt derivative $ — $ — $ 760 $ 760 December 31, 2022 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 52,442 $ — $ — $ 52,442 Long-term liability: Embedded debt derivative $ — $ — $ 760 $ 760 |
Fair Value Derivative Liability | The tables below present certain assets and liabilities measured at fair value categorized by the level of input used in the valuation of each asset and liability (in thousands): September 30, 2023 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 6,069 $ — $ — $ 6,069 Long-term liability: Embedded debt derivative $ — $ — $ 760 $ 760 December 31, 2022 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 52,442 $ — $ — $ 52,442 Long-term liability: Embedded debt derivative $ — $ — $ 760 $ 760 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory Components | Inventories consists of the following (in thousands): September 30, 2023 December 31, 2022 Work-in-process $ 2,640 $ 7,892 Finished goods 15,802 13,676 Inventories, current $ 18,442 $ 21,568 Raw materials included in other long-term assets 848 610 Total inventories $ 19,290 $ 22,178 |
INTANGIBLE ASSET AND GOODWILL (
INTANGIBLE ASSET AND GOODWILL (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible asset, net of accumulated amortization, prior impairments and adjustments as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, 2023 December 31, 2022 Intangible asset: Gross Carrying Accumulated Amortization Net Book Value Net Book Value Estimated Useful Life Developed product rights for Auryxia $ 214,705 $ (169,652) $ 45,053 $ 72,084 6 years |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued expenses and other current liabilities consists of the following (in thousands): September 30, 2023 December 31, 2022 Product revenue allowances $ 23,834 $ 26,268 Product return reserves, current portion 3,312 7,789 Compensation and related benefits 7,204 11,481 Operating lease liabilities, current portion 4,861 4,744 Royalties 3,076 3,804 Professional fees 4,648 1,886 Accrued manufacturing costs 4,156 4,310 BioVectra termination fees 5,000 — Clinical trial costs 312 5,755 Restructuring costs 617 2,751 Other 5,644 6,989 Total accrued expenses and other current liabilities $ 62,664 $ 75,777 |
CAPITAL STOCK, STOCK-BASED CO_2
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Equity Plans | The following table contains information about our equity plans: September 30, 2023 Title of Plan Group Eligible Type of Award Granted (or to be Granted) Awards Outstanding Additional Awards Authorized for Grant Keryx Equity Plans (1)(2) * Employees, directors and consultants Stock options and RSUs 284,556 — Akebia Therapeutics, Inc. Amended and Restated 2008 Equity Incentive Plan ( the 2008 Plan ) (2) Employees, directors and consultants Stock options and RSUs 419 — Akebia Therapeutics, Inc. 2014 Incentive Plan, as amended (2) (3) ( the 2014 Plan ) (replaces 2008 Plan) Employees, directors, consultants and advisors Stock options, RSUs, SARs and performance awards 17,033,234 — Akebia Therapeutics, Inc. 2023 Stock Incentive Plan (3) ( the 2023 Plan ) (replaces 2014 Plan) Employees, officers, directors, consultants and advisors Stock options, SARs, restricted stock, unrestricted stock, RSUs, performance awards, other share-based awards and dividend equivalents 1,558,500 16,169,791 (1) The Keryx Equity Plans consist of the Keryx Biopharmaceuticals, Inc. 1999 Share Option Plan, Keryx Biopharmaceuticals, Inc., as amended, the 2004 Long-Term Incentive Plan, as amended, the Keryx Biopharmaceuticals, Inc. 2007 Incentive Plan, the Keryx Biopharmaceuticals Inc. Amended and Restated 2013 Incentive Plan and the Keryx Biopharmaceuticals, Inc. 2018 Equity Incentive Plan. (2) Shares are no longer being issued under these plans. (3) Includes inducement awards that are subject to the terms and conditions of the applicable plan but were granted as inducement awards consistent with Nasdaq Listing Rule 5635(c)(4): 2,035,832 options outstanding under the 2014 Plan and 653,000 options outstanding under the 2023 Plan. |
Stock Option Activity | The combined stock option activity for the nine months ended September 30, 2023, is as follows: Stock Weighted Average Exercise Price Weighted-Average Remaining Contractual Life (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2022 11,775,411 $ 5.82 7.26 years — Granted 4,143,813 $ 0.83 — — Expired (5,989) $ 7.43 Canceled and forfeited (1,299,122) $ 5.82 — — Outstanding at September 30, 2023 14,614,113 $ 4.40 7.17 years $ 2,345 Exercisable at September 30, 2023 8,215,979 $ 6.52 5.80 years |
Restricted Stock Units Activity | RSU activity is as follows: 2014 Plan 2023 Plan Number of Shares Weighted Average Fair Value Number of Shares Weighted Average Fair Value Outstanding as of December 31, 2022 5,674,406 $ 2.10 — — Granted 2,759,675 $ 0.68 590,500 $ 1.50 Vested (3,971,168) $ 1.02 — — Forfeited and canceled (790,817) $ 1.05 — — Outstanding as of September 30, 2023 3,672,096 $ 1.31 590,500 $ 1.50 |
Assumptions Used in Black-Scholes Option Pricing Model | The weighted-average assumptions used in calculating the fair values of the rights to acquire stock under the 2023 Plan, the 2014 Plan and inducement awards were as follows: Three Months Ended September 30, Nine Months Ended September 30, Stock Options 2023 2022 2023 2022 Risk-free interest rate 4.08 % - 4.55% 2.68 % - 3.96% 3.54 % - 4.55% 1.69 % - 3.96% Expected volatility 102.41 % - 107.01% 87.34 % - 88.92% 100.97 % - 111.71% 79.77 % - 91.57% Expected term (years) 6.25 years - 6.25 years 6.25 years - 6.25 years 5.51 years - 6.25 years 5.51 years - 6.25 years Expected dividend yield —% —% —% —% Fair value at grant date $1.38 $0.26 $0.69 $1.19 |
Stock-Based Compensation Expense in Consolidated Statement of Operations and Comprehensive Loss | The Company has classified stock-based compensation in its condensed consolidated statement of operations and comprehensive loss as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of goods sold $ 74 $ 227 $ 214 $ 386 Research and development 403 644 1,604 2,579 Selling, general and administrative 1,135 2,534 5,355 8,590 Restructuring 212 (50) 630 3,253 Total stock-based compensation $ 1,824 $ 3,355 $ 7,803 $ 14,808 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Commitments under Non-Cancelable Leases | Future commitments under non-cancelable lease agreements are as follows: Years ending December 31, Operating Remainder of 2023 $ 1,421 2024 5,741 2025 5,819 2026 3,613 Total lease commitments $ 16,594 Less: present value adjustment (1,501) Current and long-term operating lease liabilities $ 15,093 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
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: Three Months Ended September 30, 2023 2022 Outstanding common stock options and SARs 14,214,113 11,844,609 Unvested RSUs 4,662,596 6,971,930 Total 18,876,709 18,816,539 |
NATURE OF BUSINESS (Details)
NATURE OF BUSINESS (Details) $ in Thousands | Sep. 30, 2023 USD ($) commercialProduct | Dec. 31, 2022 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of commercial products | commercialProduct | 1 | |
Cash and cash equivalents | $ | $ 46,529 | $ 90,466 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 46,529 | $ 90,466 | ||
Restricted cash included in other long-term assets | 1,648 | 2,703 | ||
Total cash, cash equivalents and restricted cash | $ 48,177 | $ 93,169 | $ 147,849 | $ 151,839 |
PRODUCT REVENUE AND RESERVES _3
PRODUCT REVENUE AND RESERVES FOR VARIABLE CONSIDERATION - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | |||||
Total revenues | $ 42,046 | $ 48,714 | $ 138,427 | $ 236,702 | |
Product revenue, net | |||||
Disaggregation of Revenue [Line Items] | |||||
Total revenues | 40,118 | $ 41,989 | 117,068 | $ 126,670 | |
Accounts receivable, net | $ 21,300 | $ 21,300 | $ 37,300 |
PRODUCT REVENUE AND RESERVES _4
PRODUCT REVENUE AND RESERVES FOR VARIABLE CONSIDERATION - Product Revenue Allowance and Reserve Categories (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Beginning balance | $ 38,102 | $ 35,258 |
Current provisions related to sales in current year | 69,822 | 76,538 |
Adjustments related to prior year sales | (1,888) | (409) |
Credits/payments made | (77,047) | (77,474) |
Ending balance | 28,989 | 33,913 |
Chargebacks and Discounts | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Beginning balance | 1,259 | 1,047 |
Current provisions related to sales in current year | 7,485 | 8,544 |
Adjustments related to prior year sales | 92 | (248) |
Credits/payments made | (7,993) | (8,194) |
Ending balance | 843 | 1,149 |
Rebates, Fees and other Deductions | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Beginning balance | 25,947 | 24,173 |
Current provisions related to sales in current year | 58,824 | 63,938 |
Adjustments related to prior year sales | (1,924) | 33 |
Credits/payments made | (59,318) | (65,611) |
Ending balance | 23,529 | 22,533 |
Product Returns | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Beginning balance | 10,896 | 10,038 |
Current provisions related to sales in current year | 3,513 | 4,056 |
Adjustments related to prior year sales | (56) | (194) |
Credits/payments made | (9,736) | (3,669) |
Ending balance | $ 4,617 | $ 10,231 |
LICENSE, COLLABORATION AND OT_3
LICENSE, COLLABORATION AND OTHER REVENUE - Revenues Recognized From License, Collaboration and Other Significant Agreements (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
License, collaboration and other revenue: | |||||
Total revenues | $ 42,046 | $ 48,714 | $ 138,427 | $ 236,702 | |
Mitsubishi Tanabe Pharma Corporation | |||||
License, collaboration and other revenue: | |||||
Total revenues | $ 4,400 | ||||
License, collaboration and other revenue | |||||
License, collaboration and other revenue: | |||||
Total revenues | 1,928 | 6,725 | 21,359 | 110,032 | |
License, collaboration and other revenue | Mitsubishi Tanabe Pharma Corporation | |||||
License, collaboration and other revenue: | |||||
Total revenues | 487 | 5,487 | 5,165 | 13,885 | |
License, collaboration and other revenue | Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | |||||
License, collaboration and other revenue: | |||||
Total revenues | 0 | 0 | 2,225 | 86,773 | |
License, collaboration and other revenue | Otsuka Pharmaceutical Company. Ltd. | Otsuka International Agreement | |||||
License, collaboration and other revenue: | |||||
Total revenues | 0 | 0 | 0 | 5,503 | |
License, collaboration and other revenue | Total collaboration revenue | |||||
License, collaboration and other revenue: | |||||
Total revenues | 487 | 5,487 | 7,390 | 106,161 | |
License, collaboration and other revenue | JT and Torii Sublicense Agreement | |||||
License, collaboration and other revenue: | |||||
Total revenues | 1,441 | 1,238 | 3,969 | 3,871 | |
License, collaboration and other revenue | Medice License Agreement | |||||
License, collaboration and other revenue: | |||||
Total revenues | $ 0 | $ 0 | $ 10,000 | $ 0 |
LICENSE, COLLABORATION AND OT_4
LICENSE, COLLABORATION AND OTHER REVENUE - Changes in Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Accounts receivable | ||
Contract assets: | ||
Balance at Beginning of Period | $ 1,901 | $ 19,094 |
Additions | 1,426 | 92,612 |
Deductions | (2,847) | (109,836) |
Balance at End of Period | 480 | 1,870 |
Prepaid expenses and other current assets | ||
Contract assets: | ||
Balance at Beginning of Period | 781 | 4,309 |
Additions | 0 | 9,550 |
Deductions | (781) | (8,250) |
Balance at End of Period | 0 | 5,609 |
Deferred revenue | ||
Contract liability: | ||
Balance at Beginning of Period | 47,034 | 42,380 |
Additions | 0 | 66,307 |
Deductions | (3,738) | (64,126) |
Balance at End of Period | $ 43,296 | 44,561 |
Accounts payable | ||
Contract liability: | ||
Balance at Beginning of Period | 3,171 | |
Additions | 0 | |
Deductions | (3,171) | |
Balance at End of Period | $ 0 |
LICENSE, COLLABORATION AND OT_5
LICENSE, COLLABORATION AND OTHER REVENUE - Revenue Recognized Resulting from Changes in Contract Assets and Liabilities (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue Recognized in the Period: | ||||
Deferred revenue — beginning of the period | $ 0 | $ 5,047,000 | $ 0 | $ 29,574,000 |
Revenue recognized from performance obligations satisfied in previous periods | $ 0 | $ 0 | $ 0 | $ 0 |
LICENSE, COLLABORATION AND OT_6
LICENSE, COLLABORATION AND OTHER REVENUE - Mitsubishi Tanabe Pharma Corporation Collaboration Agreement (Details) | 3 Months Ended | 9 Months Ended | |||||
Jun. 30, 2018 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) performanceObligation | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Recognized revenue | $ 42,046,000 | $ 48,714,000 | $ 138,427,000 | $ 236,702,000 | |||
Revenue recognized | 0 | 5,047,000 | 0 | 29,574,000 | |||
Accounts receivable | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accounts receivable | 480,000 | 1,870,000 | 480,000 | 1,870,000 | $ 1,901,000 | $ 19,094,000 | |
Mitsubishi Tanabe Pharma Corporation | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Recognized revenue | $ 4,400,000 | ||||||
Mitsubishi Tanabe Pharma Corporation | License Collaboration And Other Revenue, Royalties | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Recognized revenue | 500,000 | 400,000 | 1,400,000 | 1,200,000 | |||
Mitsubishi Tanabe Pharma Corporation | Regulatory Milestone Payments | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Milestone revenue | 25,000,000 | $ 25,000,000 | |||||
Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Collaboration Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Number of performance obligations | performanceObligation | 2 | ||||||
Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Collaboration Agreement | Regulatory Milestone Payments | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Milestone revenue | 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 | |||||
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] | |||||||
Accounts receivable | 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 Supply Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue recognized | $ 0 | $ 5,100,000 | $ 3,700,000 | $ 12,700,000 |
LICENSE, COLLABORATION AND OT_7
LICENSE, COLLABORATION AND OTHER REVENUE - Cyclerion License Agreement (Details) - Cyclerion Therapeutics License Agreement $ in Millions | Jun. 04, 2021 USD ($) |
Asset Acquisition [Line Items] | |
Upfront payment for asset acquisition | $ 3 |
Contingent consideration from developmental and regulatory milestones | $ 222 |
LICENSE, COLLABORATION AND OT_8
LICENSE, COLLABORATION AND OTHER REVENUE - CSL Vifor License Agreement (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Feb. 18, 2022 USD ($) $ / shares | May 31, 2017 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) performanceObligation shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) shares | Mar. 18, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Common stock, issued (in shares) | shares | 188,313,807 | 188,313,807 | 184,135,714 | |||||
Deferred revenue, net of current portion | $ 43,296 | $ 43,296 | $ 43,296 | |||||
Refund liability to customer, amortization of discount | 700 | $ 1,100 | 2,400 | $ 2,300 | ||||
Refund liability to customer, amortization of deferred gain | 1,000 | $ 900 | 3,000 | $ 1,800 | ||||
Refund liability to customer | 40,346 | 40,346 | $ 40,992 | |||||
Vifor (International) Ltd. | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Contract termination, prior written notice period | 30 months | |||||||
Private Placement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Sale of stock, price per share (in dollars per share) | $ / shares | $ 5 | |||||||
Vifor (International) Ltd. | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Contract termination, prior written notice period | 6 months | |||||||
Refund liability to customer, gross | $ 40,000 | |||||||
Refund liability to customer | 40,300 | 40,300 | ||||||
Vifor (International) Ltd. | License | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Revenue, remaining performance obligation, profit share percentage | 66% | |||||||
Upfront payment | $ 25,000 | |||||||
Deferred revenue, net of current portion | $ 4,700 | 18,300 | $ 18,300 | |||||
Number of performance obligations | performanceObligation | 1 | |||||||
Transaction price | 43,300 | $ 43,300 | ||||||
Refund liability, percentage | 50% | |||||||
Refund liability to customer, interest rate | 15% | |||||||
Vifor (International) Ltd. | License Agreement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Common stock, issued (in shares) | shares | 3,571,429 | |||||||
Sale of stock, price per share (in dollars per share) | $ / shares | $ 14 | |||||||
Proceeds from common stock sold | $ 50,000 | |||||||
Vifor International Limited, First Investment | License | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Deferred revenue, net of current portion | 4,700 | 4,700 | ||||||
Vifor International Limited, Second Investment | License | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Deferred revenue, net of current portion | $ 13,600 | $ 13,600 |
LICENSE, COLLABORATION AND OT_9
LICENSE, COLLABORATION AND OTHER REVENUE - Panion License Agreement (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
JT and Torii Sublicense Agreement | License Agreement | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Royalty payments | $ 3.1 | $ 2.9 | $ 9.3 | $ 9.5 |
LICENSE, COLLABORATION AND O_10
LICENSE, COLLABORATION AND OTHER REVENUE - Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd. Sublicense Agreement (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) performanceObligation | Sep. 30, 2022 USD ($) | |
License, collaboration and other revenue: | ||||
Recognized revenue | $ 42,046 | $ 48,714 | $ 138,427 | $ 236,702 |
JT and Torii Sublicense Agreement | Sublicense Agreement | ||||
License, collaboration and other revenue: | ||||
Number of performance obligations | performanceObligation | 2 | |||
Recognized revenue | $ 1,400 | $ 1,200 | $ 4,000 | $ 3,900 |
LICENSE, COLLABORATION AND O_11
LICENSE, COLLABORATION AND OTHER REVENUE - Averoa License Agreement (Details) | Dec. 22, 2022 |
Averoa SAS | |
License, collaboration and other revenue: | |
Supply commitment, termination, notice period | 24 months |
LICENSE, COLLABORATION AND O_12
LICENSE, COLLABORATION AND OTHER REVENUE - Medice License Agreement (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
May 24, 2023 USD ($) performanceObligation | Sep. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Disaggregation of Revenue [Line Items] | |||||||
Other long-term assets | $ 3,862 | $ 3,862 | $ 5,372 | ||||
Revenue recognized | 0 | $ 5,047 | 0 | $ 29,574 | |||
MEDICE Arzneimittel Pütter GmbH & Co. KG | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Percentage of net product margin on sales in collaborative arrangement | 70% | ||||||
License | MEDICE Arzneimittel Pütter GmbH & Co. KG | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Upfront payment | $ 10,000 | ||||||
Eligible milestone payments (up to) | $ 100,000 | ||||||
Tiered royalties, expected timing of satisfaction period | 12 years | ||||||
Termination of agreement by counterparty, written notice period | 12 months | ||||||
Termination of agreement eligible by counterparty, period after effective agreement date | 12 months | ||||||
Number of performance obligations | performanceObligation | 1 | ||||||
Proceeds from customers | $ 8,600 | ||||||
Other long-term assets | $ 1,400 | 1,400 | |||||
Revenue recognized | $ 10,000 | ||||||
License | MEDICE Arzneimittel Pütter GmbH & Co. KG | Minimum | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Tiered royalties | 10% | ||||||
License | MEDICE Arzneimittel Pütter GmbH & Co. KG | Maximum | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Tiered royalties | 30% |
LICENSE, COLLABORATION AND O_13
LICENSE, COLLABORATION AND OTHER REVENUE - U.S. Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Recognized revenue | $ 42,046 | $ 48,714 | $ 138,427 | $ 236,702 |
License, collaboration and other revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Recognized revenue | 1,928 | 6,725 | 21,359 | 110,032 |
Otsuka Pharmaceutical Company. Ltd. | Otsuka U.S. Agreement | License, collaboration and other revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Recognized revenue | $ 0 | $ 0 | 2,225 | $ 86,773 |
Otsuka Pharmaceutical Company. Ltd. | Packaging Validation Transfer Agreement | License, collaboration and other revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Recognized revenue | $ 2,200 |
LICENSE, COLLABORATION AND O_14
LICENSE, COLLABORATION AND OTHER REVENUE - International Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Recognized revenue | $ 42,046 | $ 48,714 | $ 138,427 | $ 236,702 |
License, collaboration and other revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Recognized revenue | 1,928 | 6,725 | 21,359 | 110,032 |
Otsuka Pharmaceutical Company. Ltd. | Otsuka International Agreement | License, collaboration and other revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Recognized revenue | $ 0 | $ 0 | $ 0 | $ 5,503 |
LIABILITY RELATED TO SALE OF _3
LIABILITY RELATED TO SALE OF FUTURE ROYALTIES - Additional Information (Details) - USD ($) $ in Thousands | Feb. 25, 2021 | Sep. 30, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | |||
Maximum annual royalty payout capacity | $ 13,000 | ||
Maximum aggregate royalty payout capacity | 150,000 | ||
Proceeds from sale of future royalties, net | 44,800 | ||
Liability related to sale of future royalties | $ 44,800 | $ 56,061 | $ 57,484 |
Annual effective interest rate | 0% |
LIABILITY RELATED TO SALE OF _4
LIABILITY RELATED TO SALE OF FUTURE ROYALTIES - Activity within Liability Related to Sale of Future Royalties, net (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Contractual Arrangement, Royalties Agreement, Liability, Noncurrent [Roll Forward] | |
Liability related to sale of future royalties, beginning balance at December 31, 2022 | $ 57,484 |
MTPC royalties payable | (1,423) |
Liability related to sale of future royalties, ending balance at September 30, 2023 | $ 56,061 |
FAIR VALUE OF FINANCIAL INSTR_3
FAIR VALUE OF FINANCIAL INSTRUMENTS - Assets Measured or Disclosed at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Long-term liability: | ||
Embedded debt derivative | $ 760 | $ 760 |
Fair value measurements recurring | ||
Cash equivalents: | ||
Money market funds | 6,069 | 52,442 |
Long-term liability: | ||
Embedded debt derivative | 760 | 760 |
Fair value measurements recurring | Level 1 | ||
Cash equivalents: | ||
Money market funds | 6,069 | 52,442 |
Long-term liability: | ||
Embedded debt derivative | 0 | 0 |
Fair value measurements recurring | Level 2 | ||
Cash equivalents: | ||
Money market funds | 0 | 0 |
Long-term liability: | ||
Embedded debt derivative | 0 | 0 |
Fair value measurements recurring | Level 3 | ||
Cash equivalents: | ||
Money market funds | 0 | 0 |
Long-term liability: | ||
Embedded debt derivative | $ 760 | $ 760 |
FAIR VALUE OF FINANCIAL INSTR_4
FAIR VALUE OF FINANCIAL INSTRUMENTS - Additional Information (Details) $ in Thousands | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Embedded debt derivative | $ 760 | $ 760 |
Level 3 | Measurement Input, Obligations In Loan Agreement Would Not Accelerate Due to Default | Valuation Technique, Scenario-Based And Discounted Cash Flow | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability, measurement input | 0.95 | 0.95 |
INVENTORIES - Components of Inv
INVENTORIES - Components of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Work-in-process | $ 2,640 | $ 7,892 |
Finished goods | 15,802 | 13,676 |
Inventories, current | 18,442 | 21,568 |
Raw materials included in other long-term assets | 848 | 610 |
Total inventories | $ 19,290 | $ 22,178 |
INVENTORIES - Additional Inform
INVENTORIES - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | ||||
Write-down of inventory | $ 700 | $ 2,600 | $ 1,327 | $ 10,002 |
INTANGIBLE ASSET AND GOODWILL -
INTANGIBLE ASSET AND GOODWILL - Intangible Assets (Details) - Developed product rights for Auryxia - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 214,705 | |
Accumulated Amortization | (169,652) | |
Net Book Value | $ 45,053 | $ 72,084 |
Estimated Useful Life | 6 years |
INTANGIBLE ASSET AND GOODWILL_2
INTANGIBLE ASSET AND GOODWILL - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||||
Amortization expense | $ 9,000,000 | $ 9,000,000 | $ 27,032,000 | $ 27,032,000 | |
Goodwill | 59,044,000 | 59,044,000 | $ 59,044,000 | ||
Goodwill, accumulated impairment losses | $ 0 | $ 0 | $ 0 |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Product revenue allowances | $ 23,834 | $ 26,268 |
Product return reserves, current portion | 3,312 | 7,789 |
Compensation and related benefits | 7,204 | 11,481 |
Operating lease liabilities, current portion | $ 4,861 | 4,744 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total accrued expenses and other current liabilities | |
Royalties | $ 3,076 | 3,804 |
Professional fees | 4,648 | 1,886 |
Accrued manufacturing costs | 4,156 | 4,310 |
BioVectra termination fees | 5,000 | 0 |
Clinical trial costs | 312 | 5,755 |
Restructuring costs | 617 | 2,751 |
Other | 5,644 | 6,989 |
Total accrued expenses and other current liabilities | $ 62,664 | $ 75,777 |
DEBT (Details)
DEBT (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||||
Jul. 15, 2022 USD ($) | Dec. 10, 2020 USD ($) | Nov. 25, 2019 USD ($) | Nov. 11, 2019 USD ($) tranche | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Oct. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Line of Credit Facility [Line Items] | ||||||||||
Debt extinguishment loss | $ 0 | $ 906 | $ 0 | $ 906 | ||||||
Embedded debt derivative | 760 | 760 | $ 760 | |||||||
Gain from decrease in the fair value of the embedded debt derivative | 1,100 | |||||||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | Tranche A and B | ||||||||||
Line of Credit Facility [Line Items] | ||||||||||
Line of credit, maximum borrowing capacity | $ 100,000 | |||||||||
Line of credit, maximum borrowing capacity, number of available tranches | tranche | 2 | |||||||||
Payment for debt prepayment | $ 25,000 | |||||||||
Payment for debt prepayment premium, including accrued and unpaid interest | $ 500 | |||||||||
Debt extinguishment loss | 900 | |||||||||
Principal outstanding | 43,000 | 43,000 | ||||||||
Interest expense | 1,400 | $ 2,100 | 4,700 | $ 7,500 | ||||||
Unamortized discount and issuance costs | 400 | 400 | ||||||||
Term loan, principal payment | 0 | 24,000 | ||||||||
Term loan, maturity term, potential reduction (up to) | 1 year | |||||||||
Term loan, amortization period, potential reduction (up to) | 1 year | |||||||||
Prepayment premium percentage on principal if prepaid before maturity date | 0.50% | |||||||||
Minimum net sales threshold, trailing period | 12 months | |||||||||
Minimum net sales threshold | $ 85,000 | |||||||||
Embedded debt derivative | $ 800 | $ 800 | $ 800 | |||||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | Tranche A and B | Subsequent Event | ||||||||||
Line of Credit Facility [Line Items] | ||||||||||
Principal outstanding | $ 35,000 | |||||||||
Biopharma Credit Investments V (Master) LP | Keryx | Term Loan | Collateral Agent, Pharmakon | Tranche A and B | 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 | Tranche A and B | Secured Overnight Financing Rate (SOFR) | ||||||||||
Line of Credit Facility [Line Items] | ||||||||||
Basis spread on variable rate | 7.50% | |||||||||
Interest rate | 11.15% | 11.15% | ||||||||
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 | |||||||||
Proceeds from line of credit, net | $ 77,300 | |||||||||
Debt fees and expenses | $ 2,700 | |||||||||
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 | |||||||||
Proceeds from line of credit, net | $ 20,000 | |||||||||
Payment for debt prepayment | $ 20,000 |
CAPITAL STOCK, STOCK-BASED CO_3
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||||||||||||||
Apr. 07, 2022 USD ($) | Mar. 01, 2022 USD ($) | Feb. 25, 2021 USD ($) | Mar. 12, 2020 USD ($) | Jun. 06, 2019 USD ($) shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) shares | Mar. 31, 2022 USD ($) shares | Sep. 30, 2023 USD ($) installment executiveOfficer $ / shares shares | Sep. 30, 2022 USD ($) shares | Jun. 30, 2023 shares | Mar. 31, 2023 shares | Dec. 31, 2022 $ / shares shares | Jun. 30, 2022 shares | Dec. 31, 2021 shares | Jun. 04, 2020 shares | |
Class of Stock [Line Items] | ||||||||||||||||
Common stock, 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, issued (in shares) | 188,313,807 | 188,313,807 | 184,135,714 | |||||||||||||
Common stock, outstanding (in shares) | 188,313,807 | 188,313,807 | 184,135,714 | |||||||||||||
Preferred stock, 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, issued (in shares) | 0 | 0 | 0 | |||||||||||||
Preferred stock, outstanding (in shares) | 0 | 0 | 0 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 0 | $ 7,122,000 | ||||||||||||||
Stock-based compensation expense | $ | $ 1,824,000 | $ 3,355,000 | $ 7,803,000 | $ 14,808,000 | ||||||||||||
Number of shares granted | 4,143,813 | |||||||||||||||
Number of shares outstanding | 14,614,113 | 14,614,113 | 11,775,411 | |||||||||||||
Open Market Sale Agreement, Authorized April 2022 | Maximum | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Common stock sales agreement amount | $ | $ 26,000,000 | |||||||||||||||
At The Market Equity Offering Program Authorized February 2021 | Maximum | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Common stock sales agreement amount | $ | $ 100,000,000 | |||||||||||||||
At The Market Equity Offering Program Authorized March 2022 | Maximum | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Common stock sales agreement amount | $ | $ 25,300,000 | |||||||||||||||
Share-based Payment Arrangement, Option | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Expiration period | 10 years | |||||||||||||||
Share-based Payment Arrangement, Option | Maximum | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 48 months | |||||||||||||||
Share-based Payment Arrangement, Option | Minimum | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 12 months | |||||||||||||||
Share-based Payment Arrangement, Option | Share-based Compensation Award, Tranche, First Anniversary of Grant Date | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting percentage | 100% | |||||||||||||||
Share-based Payment Arrangement, Option | Share Based Compensation Award Tranche One | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 1 year | |||||||||||||||
Vesting percentage | 25% | |||||||||||||||
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 | |||||||||||||||
Stock Appreciation Rights (SARs) | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Expiration period | 10 years | |||||||||||||||
Stock Appreciation Rights (SARs) | Maximum | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 48 months | |||||||||||||||
Stock Appreciation Rights (SARs) | Minimum | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 12 months | |||||||||||||||
Stock Appreciation Rights (SARs) | Share-based Compensation Award, Tranche, First Anniversary of Grant Date | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting percentage | 100% | |||||||||||||||
Stock Appreciation Rights (SARs) | Share Based Compensation Award Tranche One | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 1 year | |||||||||||||||
Vesting percentage | 25% | |||||||||||||||
Stock Appreciation Rights (SARs) | Share Based Compensation Award Tranche Two | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 1 year | |||||||||||||||
Number of equal quarterly installments | installment | 12 | |||||||||||||||
Inducement Award Program | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of shares granted | 704,000 | |||||||||||||||
Number of shares outstanding | 701,000 | 701,000 | ||||||||||||||
Service-Based Restricted Stock Units | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Unrecognized compensation costs | $ | $ 4,000,000 | $ 4,000,000 | ||||||||||||||
Unrecognized compensation costs, period for recognition | 1 year 9 months | |||||||||||||||
Service-Based Restricted Stock Units | Share-based Compensation Award, Tranche, First Anniversary of Grant Date | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 1 year | |||||||||||||||
Vesting percentage | 100% | |||||||||||||||
Service-Based Restricted Stock Units | Share Based Compensation Award Tranche One | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 1 year | |||||||||||||||
Vesting percentage | 50% | |||||||||||||||
Service-Based Restricted Stock Units | Share Based Compensation Award Tranche Two | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 6 months | |||||||||||||||
Vesting percentage | 25% | |||||||||||||||
Award vesting grace period | 1 year | |||||||||||||||
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% | |||||||||||||||
Service-Based Restricted Stock Units | Share-Based Payment Arrangement, Tranche One, First Anniversary After Grant Date | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 1 year | |||||||||||||||
Vesting percentage | 33.33% | |||||||||||||||
Service-Based Restricted Stock Units | Share-Based Payment Arrangement, Tranche Two, Following First Anniversary After Grant Date | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Vesting period | 2 years | |||||||||||||||
Vesting percentage | 66.67% | |||||||||||||||
Award vesting grace period | 1 year | |||||||||||||||
Common Stock | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Common stock, outstanding (in shares) | 188,313,807 | 183,951,583 | 183,386,035 | 188,313,807 | 183,951,583 | 188,128,869 | 185,835,946 | 184,135,714 | 183,704,654 | 177,000,963 | ||||||
Issuance of common stock, net of issuance costs (in shares) | 4,404,600 | |||||||||||||||
Common Stock | At The Market Equity Offering Program Authorized March 2022 | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 404,600 | |||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 800,000 | |||||||||||||||
At The Market Equity Offering Program | Maximum | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Common stock sales agreement amount | $ | $ 65,000,000 | |||||||||||||||
Stock Incentive Plans, 2023 And 2014 | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Grant date fair value of stock options not in connection with the annual grant process | $ | $ 1,200,000 | |||||||||||||||
2023 Stock Incentive Plan | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Stock options, vested in period, fair value | $ | $ 5,300,000 | |||||||||||||||
2023 Stock Incentive Plan | Share-based Payment Arrangement, Option | Director | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of shares granted | 315,000 | |||||||||||||||
2023 Stock Incentive Plan | Inducement Award Program | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of shares outstanding | 653,000 | 653,000 | ||||||||||||||
2023 Stock Incentive Plan | Performance Based Stock Options | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of shares granted | 0 | |||||||||||||||
2014 Stock Incentive Plan | Share-based Payment Arrangement, Option | Employees | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of shares granted | 2,489,500 | |||||||||||||||
2014 Stock Incentive Plan | Stock Appreciation Rights (SARs) | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of executives shares granted to | executiveOfficer | 1 | |||||||||||||||
2014 Stock Incentive Plan | Stock Appreciation Rights (SARs) | Executive Officer | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of shares granted | 635,313 | |||||||||||||||
2014 Stock Incentive Plan | Inducement Award Program | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of shares outstanding | 2,035,832 | 2,035,832 | ||||||||||||||
2014 Stock Incentive Plan | Performance Based Stock Options | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Number of shares granted | 0 | |||||||||||||||
2014 Employee Stock Purchase Plan | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Purchase price at the end of offering period | 85% | |||||||||||||||
Offering period | 6 months | |||||||||||||||
Maximum employee subscription rate | 15% | |||||||||||||||
Maximum employee subscription amount | $ | $ 25,000 | |||||||||||||||
Maximum number of shares per employee in any offering period | 1,500 | |||||||||||||||
Common stock, reserved for future issuance (in shares) | 4,637,801 | 4,637,801 | ||||||||||||||
Number of shares issued | 200,194 |
CAPITAL STOCK, STOCK-BASED CO_4
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN - Equity Plans (Details) - shares | Sep. 30, 2023 | Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of shares outstanding | 14,614,113 | 11,775,411 |
Inducement Award Program | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of shares outstanding | 701,000 | |
Keryx Equity Plans | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Awards outstanding (in shares) | 284,556 | |
Additional awards authorized for grant (in shares) | 0 | |
Akebia Therapeutics, Inc. Amended and Restated 2008 Equity Incentive Plan (the 2008 Plan) | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Awards outstanding (in shares) | 419 | |
Additional awards authorized for grant (in shares) | 0 | |
Akebia Therapeutics, Inc. 2014 Incentive Plan, as amended (the 2014 Plan) (replaces 2008 Plan) | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Awards outstanding (in shares) | 17,033,234 | |
Additional awards authorized for grant (in shares) | 0 | |
Akebia Therapeutics, Inc. 2014 Incentive Plan, as amended (the 2014 Plan) (replaces 2008 Plan) | Inducement Award Program | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of shares outstanding | 2,035,832 | |
Akebia Therapeutics, Inc. 2023 Stock Incentive Plan (the 2023 Plan) (replaces 2014 Plan) | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Awards outstanding (in shares) | 1,558,500 | |
Additional awards authorized for grant (in shares) | 16,169,791 | |
Akebia Therapeutics, Inc. 2023 Stock Incentive Plan (the 2023 Plan) (replaces 2014 Plan) | Inducement Award Program | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of shares outstanding | 653,000 |
CAPITAL STOCK, STOCK-BASED CO_5
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Stock Options | ||
Outstanding beginning balance (in shares) | 11,775,411 | |
Granted (in shares) | 4,143,813 | |
Expired (in shares) | (5,989) | |
Canceled and forfeited (in shares) | (1,299,122) | |
Outstanding ending balance (in shares) | 14,614,113 | 11,775,411 |
Options exercisable at end of period (in shares) | 8,215,979 | |
Weighted Average Exercise Price | ||
Outstanding beginning balance (in dollars per share) | $ 5.82 | |
Granted (in dollars per share) | 0.83 | |
Expired (in dollars per share) | 5.82 | |
Canceled and forfeited (in dollars per share) | 7.43 | |
Outstanding ending balance (in dollars per share) | 4.40 | $ 5.82 |
Options exercisable at end of period, weighted-average exercise price (in dollars per share) | $ 6.52 | |
Weighted-Average Remaining Contractual Life (years) | ||
Options outstanding, weighted-average remaining contractual life (in years) | 7 years 2 months 1 day | 7 years 3 months 3 days |
Options exercisable at end of period, weighted-average remaining contractual life (in years) | 5 years 9 months 18 days | |
Options outstanding, aggregate intrinsic value | $ 2,345 |
CAPITAL STOCK, STOCK-BASED CO_6
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN - Restricted Stock Units Activity (Details) - Service-Based Restricted Stock Units | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
2014 Stock Incentive Plan | |
Shares | |
Outstanding beginning balance (in shares) | shares | 5,674,406 |
Granted (in shares) | shares | 2,759,675 |
Vested (in shares) | shares | (3,971,168) |
Forfeited and canceled (in shares) | shares | (790,817) |
Outstanding ending balance (in shares) | shares | 3,672,096 |
Weighted- Average Grant Date Fair Value | |
Outstanding beginning balance, weighted average fair value (in dollars per share) | $ / shares | $ 2.10 |
Granted, weighted average fair value (in dollars per share) | $ / shares | 0.68 |
Vested, weighted-average grant date fair value (in dollars per share) | $ / shares | 1.02 |
Forfeited and canceled, weighted average fair value (in dollars per share) | $ / shares | 1.05 |
Outstanding ending balance, weighted average fair value (in dollars per share) | $ / shares | $ 1.31 |
2023 Stock Incentive Plan | |
Shares | |
Granted (in shares) | shares | 590,500 |
Outstanding ending balance (in shares) | shares | 590,500 |
Weighted- Average Grant Date Fair Value | |
Granted, weighted average fair value (in dollars per share) | $ / shares | $ 1.50 |
Outstanding ending balance, weighted average fair value (in dollars per share) | $ / shares | $ 1.50 |
CAPITAL STOCK, STOCK-BASED CO_7
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN - Assumptions Used in Black-Scholes Option Pricing Model (Details) - Stock Incentive Plan 2023, Incentive Plan 2014 And Inducement Award Program - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Risk-free interest rate, minimum | 4.08% | 2.68% | 3.54% | 1.69% |
Risk-free interest rate, maximum | 4.55% | 3.96% | 4.55% | 3.96% |
Expected volatility, minimum | 102.41% | 87.34% | 100.97% | 79.77% |
Expected volatility, maximum | 107.01% | 88.92% | 111.71% | 91.57% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Fair value at grant date (in dollars per share) | $ 1.38 | $ 0.26 | $ 0.69 | $ 1.19 |
Minimum | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term (years) | 6 years 3 months | 6 years 3 months | 5 years 6 months 3 days | 5 years 6 months 3 days |
Maximum | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term (years) | 6 years 3 months | 6 years 3 months | 6 years 3 months | 6 years 3 months |
CAPITAL STOCK, STOCK-BASED CO_8
CAPITAL STOCK, STOCK-BASED COMPENSATION AND BENEFIT PLAN - Stock-Based Compensation Expense in Consolidated Statement of Operations and Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 1,824 | $ 3,355 | $ 7,803 | $ 14,808 |
Cost of goods sold | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 74 | 227 | 214 | 386 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 403 | 644 | 1,604 | 2,579 |
Selling, general and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 1,135 | 2,534 | 5,355 | 8,590 |
Restructuring | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 212 | $ (50) | $ 630 | $ 3,253 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||||||||||||||||
Feb. 10, 2021 | Apr. 02, 2020 | Mar. 11, 2020 | Jan. 01, 2017 USD ($) | May 31, 2023 USD ($) | Feb. 28, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 | Feb. 28, 2019 USD ($) | Jul. 31, 2016 USD ($) ft² | Sep. 30, 2023 USD ($) ft² extensionOption | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) ft² extensionOption | Sep. 30, 2022 USD ($) | Dec. 22, 2022 USD ($) quarterPeriod | Nov. 30, 2020 ft² | Apr. 30, 2018 ft² | |
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Operating lease, cost | $ 1,200,000 | $ 1,800,000 | $ 4,400,000 | $ 5,400,000 | ||||||||||||||||
Operating lease, payments | 1,400,000 | 1,800,000 | 4,500,000 | 5,500,000 | ||||||||||||||||
Loss on termination of lease | $ 0 | $ 500,000 | 0 | $ 500,000 | $ 524,000 | 0 | ||||||||||||||
Operating lease, remaining lease term | 2 years 11 months 12 days | 2 years 11 months 12 days | ||||||||||||||||||
Contract cost incurred in research and development activities | $ 45,400,000 | |||||||||||||||||||
Supply Agreement, Patheon Inc. | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Purchase commitment, option for non-auto renewal, prior written notice period | 18 months | |||||||||||||||||||
Minimum purchase commitment | $ 0 | $ 0 | ||||||||||||||||||
Siegfried Evionnaz SA | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Purchase commitment, option to extend, prior notice period | 12 months | |||||||||||||||||||
Cost of purchased minimum quantity product | 18,100,000 | $ 18,100,000 | ||||||||||||||||||
STA Pharmaceutical Hong Kong Limited | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Minimum purchase commitment, initial term | 4 years | |||||||||||||||||||
Long-term minimum purchase commitment | 14,900,000 | |||||||||||||||||||
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 | |||||||||||||||||||
BioVectra Inc | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Long-term purchase commitment, termination amount payable | $ 32,500,000 | |||||||||||||||||||
Long-term purchase commitment, upfront payment termination amount | $ 17,500,000 | |||||||||||||||||||
Long-term purchase commitment, termination amount payable after upfront payment, number of quarterly periods | quarterPeriod | 6 | |||||||||||||||||||
Long-term purchase commitment, termination amount payable after upfront payment, per quarter | $ 2,500,000 | |||||||||||||||||||
Long-term purchase commitment, termination amount payable after upfront payment | $ 15,000,000 | |||||||||||||||||||
Long-term purchase commitment, imputed interest on termination amount payable | 17% | |||||||||||||||||||
Long-term purchase commitment, upfront termination amount classified as cost of goods sold | $ 11,200,000 | |||||||||||||||||||
Amortization discount | $ 500,000 | $ 1,400,000 | ||||||||||||||||||
Minimum | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Operating lease, incremental borrowing rates based on remaining lease term | 6.65% | 6.65% | ||||||||||||||||||
Maximum | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Operating lease, incremental borrowing rates based on remaining lease term | 6.94% | 6.94% | ||||||||||||||||||
Cambridge | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Area of property leased (in square feet) | ft² | 45,362 | 65,167 | ||||||||||||||||||
Annual lease expense | $ 200,000 | |||||||||||||||||||
Monthly lease expense | $ 22,000 | |||||||||||||||||||
Cambridge | Letter of Credit | Other Assets | ||||||||||||||||||||
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 | $ 48,000 | $ 100,000 | ||||||||||||||||||
Operating lease, free monthly rent, period | 2 months | |||||||||||||||||||
Lease period, number of extension options | extensionOption | 1 | 1 | ||||||||||||||||||
Lease extension period | 5 years | 5 years | ||||||||||||||||||
Boston | Office Space | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Area of property leased (in square feet) | ft² | 27,924 | 27,924 | ||||||||||||||||||
Monthly lease expense | $ 200,000 | |||||||||||||||||||
Operating lease, free monthly rent, period | 5 months | |||||||||||||||||||
Operating lease, annual rent escalation, percentage | 2% | |||||||||||||||||||
Payments to transfer rights and obligations of operating lease | $ 1,300,000 | |||||||||||||||||||
Proceeds from return of security deposit in connection with lease | $ 1,000,000 | |||||||||||||||||||
Boston | Office Space | Keryx Biopharmaceuticals, Inc. | ||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||
Sublease rental income | $ 500,000 | $ 300,000 | $ 1,400,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Future Commitments under Non-Cancelable Leases (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | |
Remainder of 2023 | $ 1,421 |
2024 | 5,741 |
2025 | 5,819 |
2026 | 3,613 |
Total lease commitments | 16,594 |
Less: present value adjustment | (1,501) |
Current and long-term operating lease liabilities | $ 15,093 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued expenses and other current liabilities |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 3 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
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) | 18,876,709 | 18,816,539 |
Outstanding common stock options and SARs | ||
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) | 14,214,113 | 11,844,609 |
Unvested RSUs | ||
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) | 4,662,596 | 6,971,930 |