Revisions of Previously Issued Financial Statements | Revisions of Previously Issued Financial Statements In the course of preparing the consolidated financial statements for the three and six months ended June 30, 2023, Akebia Therapeutics, Inc., referred to as Akebia or the Company, identified certain accounting errors relating to the recording and reporting of reserves for returns of the Company’s product, Auryxia® (ferric citrate) at the time the Company acquired Keryx Biopharmaceuticals, Inc. ("Keryx") on December 12, 2018 and when calculating the product return reserves for subsequent annual and quarterly periods through March 31, 2023 (collectively, the "Product Return Reserve Errors"). This resulted in errors in the Company's consolidated financial statements previously filed by the Company with the SEC for each of the fiscal years ended December 31, 2022, 2021 and 2020. Specifically, the Company utilized an incorrect methodology to calculate, record and report the Auryxia product return reserves at the time the Company acquired Keryx on December 12, 2018, which resulted in errors in the calculation of and understatement of goodwill of $2.6 million in each of the subsequent annual periods. The Company continued to utilize the incorrect methodology to calculate, record and report the product return reserves in the consolidated financial statements it issued with respect to its fiscal years ended December 31, 2022, 2021 and 2020, which resulted in the product return reserves and other product revenue allowances being understated by $8.2 million, $7.9 million and $6.0 million as of December 31, 2022, 2021 and 2020, respectively. A breakdown of the understatement of the product return reserves between current and long-term in the consolidated balance sheet are as follows: December 31, (in thousands) 2020 2021 2022 Included in accrued expenses and other current liabilities: Product return reserves and other product revenue allowances $ 1,956 $ 4,557 $ 5,051 Included in other long-term liabilities: Product return reserves 4,048 3,360 3,132 Total understatement of product return reserves and other product revenue allowances $ 6,004 $ 7,917 $ 8,183 Further, as a result of the Product Return Reserve Errors, revenue was overstated by $0.1 million, $1.9 million and $0.6 million, and accounts receivable was understated by $1.1 million, $0.7 million and $0.7 million as of and for the years ended December 31, 2022, 2021 and 2020, respectively. The changes did not impact cash or ending cash balances in the Company’s consolidated balance sheets in the periods presented in this report or in previously issued annual and quarterly financial statements. In addition to the Product Return Reserve Errors, the Company has corrected other immaterial misstatements in the revised consolidated financial statements for the years ended December 31, 2022, 2021 and 2020 and related quarterly periods, including an understatement of $1.4 million to goodwill in each of the years ended December 31, 2022, 2021 and 2020 related to an excess purchase commitment recorded in connection with the Keryx acquisition. The Company assessed the materiality of the impact of the Product Return Reserve Errors both quantitatively and qualitatively and determined the impact to be immaterial to the consolidated financial statements for the years ended December 31, 2022, 2021 and 2020 as well as the quarterly interim periods. However, the Company concluded that the effect of correcting the Product Return Reserve Errors in the quarter ended June 30, 2023 would materially misstate the Company’s unaudited consolidated financial statements for the three and six months ended June 30, 2023 and, accordingly, determined that it was necessary to revise the consolidated financial statements it previously issued with respect to the fiscal years ended December 31, 2022, 2021 and 2020. The remainder of the Notes to the Company's consolidated financial statements have been updated and revised, as applicable, to reflect the impact of the corrections described in this Note 1. The following tables reflect the impact of the revision for the Product Return Reserve Errors as well as other immaterial corrections on the Company’s consolidated financial statements as of and for the fiscal year ended December 31, 2022, 2021 and 2020: FISCAL YEAR ENDED DECEMBER 31, 2022 (in thousands, except per share data) December 31, 2022 Consolidated Balance Sheet As Previously Reported Adjustment As Revised Inventories $ 21,762 $ (194) $ 21,568 Accounts receivable, net 39,180 1,104 40,284 Prepaid expenses and other current assets 33,541 (677) 32,864 Total current assets 184,949 233 185,182 Goodwill 55,053 3,991 59,044 Total assets $ 351,830 $ 4,224 $ 356,054 Accrued expenses and other current liabilities $ 70,997 $ 4,780 $ 75,777 Total current liabilities 124,756 4,780 129,536 Other long-term liabilities 12,161 3,556 15,717 Total liabilities 342,488 8,336 350,824 Accumulated deficit (1,552,913) (4,112) (1,557,025) Total stockholder' equity 9,342 (4,112) 5,230 Total liabilities and stockholders' equity $ 351,830 $ 4,224 $ 356,054 Year Ended December 31, 2022 Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Adjustment As Revised Product revenue, net $ 177,067 $ (118) $ 176,949 Cost of goods sold, product 48,754 772 49,526 Research and development 129,114 872 129,986 Selling, general and administrative 138,699 (98) 138,601 Operating loss (79,115) (1,664) (80,779) Net loss $ (92,562) (1,664) (94,226) Comprehensive loss $ (92,562) (1,664) (94,226) Earnings per share - basic and diluted $(0.51) $0.01 $(0.52) December 31, 2022 Condensed Consolidated Statement of Stockholders' (Deficit) Equity As Previously Reported Adjustment As Revised Accumulated deficit $ (1,552,913) $ (4,112) $ (1,557,025) Net loss $ (92,562) $ (1,664) $ (94,226) Year Ended December 31, 2022 Consolidated Statement of Cash Flows As Previously Reported Adjustment As Revised Net loss $ (92,562) $ (1,664) $ (94,226) Adjustments to reconcile net loss to net cash used in operating activities: Change in excess inventory purchase commitments (67,618) 1,672 (65,946) Changes in operating assets and liabilities: Accounts receivable 11,695 (398) 11,297 Inventories 19,793 (706) 19,087 Prepaid expenses and other current assets 381 677 1,058 Accrued expenses and other current liabilities (38,227) 222 (38,005) Other non-current liabilities 2,080 197 2,277 Net cash used in operating activities $ (73,154) $ — $ (73,154) FISCAL YEAR ENDED DECEMBER 31, 2021 (in thousands, except per share data) December 31, 2021 Consolidated Balance Sheet As Previously Reported Adjustment As Revised Inventories $ 38,195 $ (1,567) $ 36,628 Accounts receivable, net 50,875 706 51,581 Total current assets 272,010 (861) 271,149 Goodwill 55,053 3,991 59,044 Other long-term assets, net 49,754 667 50,421 Total assets $ 525,550 $ 3,797 $ 529,347 Accrued expenses and other current liabilities $ 104,456 $ 4,558 $ 109,014 Total current liabilities 256,493 4,558 261,051 Other long-term liabilities 82,525 1,687 84,212 Total liabilities 449,094 6,245 455,339 Accumulated deficit (1,460,351) (2,448) (1,462,799) Total stockholder' equity 76,456 (2,448) 74,008 Total liabilities and stockholders' equity $ 525,550 $ 3,797 $ 529,347 For the Year Ended December 31, 2021 Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Adjustment As Revised Product revenue, net $ 142,216 $ (1,928) $ 140,288 Cost of goods sold, product 117,352 (2,723) 114,629 Selling, general and administrative 174,161 (21) 174,140 Operating loss (265,318) 816 (264,502) Net loss $ (282,840) $ 816 $ (282,024) Comprehensive loss $ (282,847) $ 816 $ (282,031) Earnings per share - basic and diluted $(1.70) $ — $(1.70) December 31, 2021 Condensed Consolidated Statement of Stockholders' (Deficit) Equity As Previously Reported Adjustment As Revised Accumulated deficit $ (1,460,351) $ (2,448) $ (1,462,799) Net loss $ (282,840) $ 816 $ (282,024) For the Year Ended December 31, 2021 Consolidated Statement of Cash Flows As Previously Reported Adjustment As Revised Net loss $ (282,840) $ 816 $ (282,024) Adjustments to reconcile net loss to net cash used in operating activities: Change in excess inventory purchase commitments 33,391 (3,054) 30,337 Write-down of inventories 15,618 (569) 15,049 Changes in operating assets and liabilities: Accounts receivable (24,022) (5) (24,027) Inventories (25,847) 900 (24,947) Accrued expenses and other current liabilities (24,680) 2,600 (22,080) Other non-current liabilities (12,481) (688) (13,169) Net cash used in operating activities $ (252,965) $ — $ (252,965) FISCAL YEAR ENDED DECEMBER 31, 2020 (in thousands, except per share data) For the Year Ended December 31, 2020 Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Adjustment As Revised Product revenue, net $ 128,901 $ (663) $ 128,238 Cost of goods sold, product 148,866 569 149,435 Cost of goods sold, amortization of intangible asset 31,515 1,102 32,617 Cost of goods sold, impairment of intangible asset 115,527 (1,102) 114,425 Operating loss (376,442) (1,384) (377,826) Net loss $ (383,457) $ (1,384) $ (384,841) Comprehensive loss $ (383,444) $ (1,384) $ (384,828) Earnings per share - basic and diluted $(2.77) $(0.01) $(2.78) December 31, 2020 Condensed Consolidated Statement of Stockholders' (Deficit) Equity As Previously Reported Adjustment As Revised Accumulated deficit $ (1,177,511) $ (3,264) $ (1,180,775) Net loss $ (383,457) $ (1,384) $ (384,841) For the Year Ended December 31, 2020 Consolidated Statement of Cash Flows As Previously Reported Adjustment As Revised Net loss $ (383,457) $ (1,384) $ (384,841) Adjustments to reconcile net loss to net cash used in operating activities: Amortization of intangible asset 31,515 1,102 32,617 Intangible asset impairment charge 115,527 (1,102) 114,425 Write-down of inventories 20,072 569 20,641 Changes in operating assets and liabilities: Accounts receivable 12,011 (342) 11,669 Accrued expenses and other current liabilities 6,356 (97) 6,259 Other non-current liabilities — 1,254 1,254 Net cash used in operating activities $ (110,388) $ — $ (110,388) December 31, 2019 Condensed Consolidated Statement of Stockholders' (Deficit) Equity As Previously Reported Adjustment As Revised Accumulated deficit (794,054) (1,880) (795,934) The following tables reflect the impact of this revision on the Company’s unaudited condensed consolidated financial statements as of and for the three and nine months ended September 30, 2022: QUARTER ENDED SEPTEMBER 30, 2022 ( dollars in thousands, except per share amounts ) September 30, 2022 Unaudited Condensed Consolidated Balance Sheet As Previously Reported Adjustment As Revised Inventories $ 40,039 $ 5,203 $ 45,242 Accounts receivable, net 23,094 175 23,269 Prepaid expenses and other current assets 29,618 (678) 28,940 Total current assets 237,512 4,700 242,212 Goodwill 55,053 3,991 59,044 Other long-term assets, net 26,275 (334) 25,941 Total assets $ 435,894 $ 8,357 $ 444,251 Accrued expenses and other current liabilities $ 87,364 $ 5,164 $ 92,528 Total current liabilities 187,965 5,164 193,129 Other non-current liabilities 74,313 8,787 83,100 Total liabilities 422,041 13,951 435,992 Accumulated deficit (1,545,361) (5,594) (1,550,955) Total liabilities and stockholders' equity $ 435,894 $ 8,357 $ 444,251 Three Months Ended September 30, 2022 Unaudited Condensed Consolidated Statement of As Previously Reported Adjustment As Revised Product revenue, net $ 42,239 $ (250) $ 41,989 Cost of goods sold, product 28,936 334 29,270 Research and development 27,350 678 28,028 Selling, general and administrative 30,918 969 31,887 Operating loss (48,174) (2,230) (50,404) Net loss $ (51,865) $ (2,230) $ (54,095) Comprehensive loss $ (51,865) $ (2,230) $ (54,095) Earnings per share - basic and diluted $(0.28) $(0.01) $(0.29) Nine Months Ended September 30, 2022 Unaudited Condensed Consolidated Statement of As Previously Reported Adjustment As Revised Product revenue, net $ 127,390 $ (720) $ 126,670 Cost of goods sold, product 60,859 1,106 61,965 Research and development 97,210 678 97,888 Selling, general and administrative 108,052 641 108,693 Operating loss (72,765) (3,146) (75,911) Net loss $ (85,010) $ (3,146) $ (88,156) Comprehensive loss $ (85,010) $ (3,146) $ (88,156) Earnings per share - basic and diluted $(0.47) $(0.01) $(0.48) September 30, 2022 Unaudited Condensed Consolidated Statement of Stockholders' (Deficit) Equity As Previously Reported Adjustment As Revised Accumulated deficit $ (1,545,361) $ (5,594) $ (1,550,955) Net loss $ (51,865) $ (2,230) $ (54,095) Nine Months Ended September 30, 2022 Unaudited Condensed Consolidated Statement of Cash Flows As Previously Reported Adjustment As Revised Net loss $ (85,010) $ (3,146) $ (88,156) Adjustments to reconcile net loss to net cash used in operating activities: Change in excess inventory purchase commitments 12,422 1,673 14,095 Changes in operating assets and liabilities: Accounts receivable 27,781 531 28,312 Inventory 1,405 (6,770) (5,365) Prepaid expenses and other current assets 9,131 667 9,798 Other long-term assets 14,817 6,214 21,031 Accrued expenses and other current liabilities (22,364) 831 (21,533) Net cash used in operating activities $ (18,475) $ — $ (18,475) The following tables reflect the impact of this revision on the Company’s unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2022: QUARTER ENDED JUNE 30, 2022 ( dollars in thousands, except per share amounts ) June 30, 2022 Unaudited Condensed Consolidated Balance Sheet As Previously Reported Adjustment As Revised Inventories $ 36,272 $ 3,954 $ 40,226 Accounts receivable, net 81,869 133 82,002 Total current assets 304,163 4,087 308,250 Goodwill 55,053 3,991 59,044 Total assets $ 521,804 $ 8,078 $ 529,882 Accrued expenses and other current liabilities $ 91,284 $ 3,721 $ 95,005 Total current liabilities 233,680 3,721 237,401 Other non-current liabilities 66,889 7,721 74,610 Total liabilities 459,504 11,442 470,946 Accumulated deficit $ (1,493,496) $ (3,363) $ (1,496,859) Total liabilities and stockholders' equity $ 521,804 $ 8,078 $ 529,882 Unaudited Condensed Consolidated Statement Three Months Ended June 30, 2022 As Previously Reported Adjustment As Revised Product revenue, net $ 43,703 $ (394) $ 43,309 Selling, general and administrative 32,807 (567) 32,240 Operating income 33,902 173 34,075 Net income $ 29,276 $ 173 $ 29,449 Comprehensive Income $ 29,276 $ 173 $ 29,449 Earnings per share - basic $0.16 $ — $0.16 Earnings per share - diluted $0.15 $ — $0.15 Six Months Ended June 30, 2022 Unaudited Condensed Consolidated Statement of As Previously Reported Adjustment As Revised Product revenue, net $ 85,151 $ (470) $ 84,681 Cost of goods sold, product 31,923 771 32,694 Selling, general and administrative 77,134 (328) 76,806 Operating loss (24,591) (913) (25,504) Net loss $ (33,145) $ (913) $ (34,058) Comprehensive loss $ (33,145) $ (913) $ (34,058) Net loss per share - basic and diluted $(0.18) $(0.01) $(0.19) June 30, 2022 Unaudited Condensed Consolidated Statement of Stockholders' (Deficit) Equity As Previously Reported Adjustment As Revised Accumulated deficit $ (1,493,496) $ (3,363) $ (1,496,859) Net income $ 29,276 $ 173 $ 29,449 Six Months Ended June 30, 2022 Unaudited Condensed Consolidated Statement of Cash Flows As Previously Reported Adjustment As Revised Net loss $ (33,145) $ (913) $ (34,058) Adjustments to reconcile net loss to net cash used in operating activities: Change in excess inventory purchase commitments (773) 5,627 4,854 Changes in operating assets and liabilities: Accounts receivable (30,994) 573 (30,421) Inventory 1,159 (5,521) (4,362) Other long-term assets 9,347 665 10,012 Accrued expenses and other current liabilities (18,625) (839) (19,464) Other non-current liabilities (9,030) 408 (8,622) Net cash used in operating activities $ (52,280) $ — $ (52,280) The following tables reflect the impact of this revision on the Company’s unaudited condensed consolidated financial statements as of and for the three months ended March 31, 2022: QUARTER ENDED MARCH 31, 2022 ( dollars in thousands, except per share amounts ) March 31, 2022 Unaudited Condensed Consolidated Balance Sheet As Previously Reported Adjustment As Revised Inventories $ 39,422 $ 1,676 $ 41,098 Accounts receivable, net 64,582 $ 776 65,358 Total current assets 302,687 2,452 305,139 Goodwill 55,053 3,991 59,044 Total assets $ 535,356 $ 6,443 $ 541,799 Accrued expenses and other current liabilities $ 109,660 $ 4,583 $ 114,243 Total current liabilities 253,914 4,583 258,497 Other non-current liabilities 77,743 5,398 83,141 Total liabilities 509,240 9,981 519,221 Accumulated deficit (1,522,772) (3,536) (1,526,308) Total liabilities and stockholders' equity $ 535,356 $ 6,443 $ 541,799 Three Months Ended March 31, 2022 Unaudited Condensed Consolidated Statement of As Previously Reported Adjustment As Revised Product revenue, net $ 41,448 $ (76) $ 41,372 Cost of goods sold, product 22,333 772 23,105 Selling, general and administrative 44,327 239 44,566 Operating loss (58,493) (1,088) (59,581) Net loss (62,421) (1,088) (63,509) Comprehensive loss (62,421) (1,088) (63,509) Earnings per share - basic and diluted $ (0.35) $ — $ (0.35) March 31, 2022 Unaudited Condensed Consolidated Statement of Stockholders' (Deficit) Equity As Previously Reported Adjustment As Revised Accumulated deficit $ (1,522,772) $ (3,536) $ (1,526,308) Net loss $ (62,421) $ (1,088) $ (63,509) Three Months Ended March 31, 2022 Unaudited Condensed Consolidated Statement of Cash Flows As Previously Reported Adjustment As Revised Net loss $ (62,421) $ (1,088) $ (63,509) Adjustments to reconcile net loss to net cash used in operating activities: Change in excess inventory purchase commitments (773) 773 — Changes in operating assets and liabilities: Accounts receivable (13,707) (71) (13,778) Inventory (5,247) (3,243) (8,490) Other long-term assets 3,297 669 3,966 Accrued expenses and other current liabilities 4,426 2,960 7,386 Other non-current liabilities (3,191) (3,191) Net cash used in operating activities $ (21,620) $ — $ (21,620) |