Item 1. Financial Statements
Item 1. Financial Statements.
Akebia Therapeutics, Inc.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(dollars in thousands, except per share amounts) September 30,
2025 December 31,
2024
Assets
Current assets:
Cash and cash equivalents $ 166,444 $ 51,870
Inventories 18,643 16,243
Accounts receivable, net 66,223 34,368
Prepaid expenses and other current assets 7,026 11,350
Total current assets 258,336 113,831
Property and equipment, net 1,473 2,200
Operating right-of-use assets 4,837 8,218
Goodwill 59,044 59,044
Other long-term assets 40,462 37,377
Total assets $ 364,152 $ 220,670
Liabilities and stockholders' equity (deficit)
Current liabilities:
Accounts payable $ 10,087 $ 15,180
Accrued expenses and other current liabilities 106,420 63,460
Current portion of deferred revenue 3,881 —
Working Capital Fund liability, current portion 12,991 2,274
Total current liabilities 133,379 80,914
Long-term operating lease liabilities — 3,547
Long-term debt, net 47,641 38,693
Liability related to settlement royalties, net of current portion 52,994 46,697
Liability related to sale of future royalties, net of current portion 50,576 52,066
Working Capital Fund liability, net of current portion 27,726 38,013
Warrant liability 5,242 5,176
Other long-term liabilities 5,002 4,749
Total liabilities 322,560 269,855
Commitments and contingencies (Note 10)
Stockholders' equity (deficit):
Preferred stock $ 0.00001 par value; 25,000,000 shares authorized at September 30, 2025 and December 31, 2024; no shares issued and outstanding at September 30, 2025 and December 31, 2024
— —
Common stock $ 0.00001 par value; 350,000,000 shares authorized at September 30, 2025 and December 31, 2024; 265,226,038 and 224,848,992 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively
2 2
Additional paid-in capital 1,713,045 1,629,167
Accumulated other comprehensive income 6 6
Accumulated deficit ( 1,671,461 ) ( 1,678,360 )
Total stockholders' equity (deficit) 41,592 ( 49,185 )
Total liabilities and stockholders' equity (deficit) $ 364,152 $ 220,670
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Akebia Therapeutics, Inc.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
Three Months Ended September 30, Nine Months Ended September 30,
(dollars in thousands, except per share amounts) 2025 2024 2025 2024
Revenues
Product revenue, net $ 56,789 $ 35,592 $ 173,041 $ 107,810
License, collaboration and other revenue 1,977 1,836 5,533 5,873
Total revenues 58,766 37,428 178,574 113,683
Cost of goods sold
Cost of product and other revenue 9,383 5,150 26,927 15,780
Amortization of intangible asset — 9,011 — 27,032
Total cost of goods sold 9,383 14,161 26,927 42,812
Operating expenses:
Research and development 14,944 8,487 35,711 25,866
Selling, general and administrative 29,094 26,516 81,391 78,870
License 896 769 2,493 2,242
Restructuring — — — 58
Total operating expenses 44,934 35,772 119,595 107,036
Income (loss) from operations 4,449 ( 12,505 ) 32,052 ( 36,165 )
Other income (expense)
Interest expense ( 4,748 ) ( 6,661 ) ( 19,352 ) ( 11,308 )
Other income (expense) ( 10 ) ( 17 ) 175 39
Change in fair value of warrant liability 1,464 ( 856 ) ( 5,361 ) 1,345
Loss on extinguishment of debt — — — ( 517 )
Income (loss) before income taxes 1,155 ( 20,039 ) 7,514 ( 46,606 )
Income tax expense ( 615 ) — ( 615 ) —
Net income (loss) $ 540 $ ( 20,039 ) $ 6,899 $ ( 46,606 )
Comprehensive income (loss) $ 540 $ ( 20,039 ) $ 6,899 $ ( 46,606 )
Net income (loss) per share:
Basic $ 0.00 $( 0.10 ) $ 0.03 $( 0.22 )
Diluted $ 0.00 $( 0.10 ) $ 0.03 $( 0.22 )
Weighted average shares of common stock outstanding:
Basic 264,786,432 210,348,459 254,390,502 208,343,679
Diluted 274,372,722 210,348,459 262,680,943 208,343,679
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Akebia Therapeutics, Inc.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
Common Stock Additional Paid-In Capital Accumulated Other Comprehensive Income Accumulated
Deficit Total Stockholders'
(Deficit)
(dollars in thousands) Shares Amount
Balance at December 31, 2023 194,582,539 $ 2 $ 1,578,358 $ 6 $ ( 1,608,950 ) $ ( 30,584 )
Issuance of common stock, net of
issuance costs 13,261,311 — 18,740 — — 18,740
Proceeds from sale of stock under
employee stock purchase plan 92,321 — 70 — — 70
Exercise of options 280,260 — 141 — — 141
Stock-based compensation expense — — 2,360 — — 2,360
Restricted stock unit vesting 1,237,718 — — — — —
Net loss — — — — ( 17,985 ) ( 17,985 )
Balance at March 31, 2024 209,454,149 $ 2 $ 1,599,669 $ 6 $ ( 1,626,935 ) $ ( 27,258 )
Exercise of options 23,892 — 14 — — 14
Stock-based compensation expense — — 2,072 — — 2,072
Restricted stock unit vesting 451,104 — — — — —
Net loss — — — — ( 8,582 ) ( 8,582 )
Balance at June 30, 2024 209,929,145 $ 2 $ 1,601,755 $ 6 $ ( 1,635,517 ) $ ( 33,754 )
Issuance of common stock, net of
issuance costs 1,242,662 — 1,662 — — 1,662
Proceeds from sale of stock under
employee stock purchase plan 97,411 — 83 — — 83
Exercise of options 2,312 — — — — —
Stock-based compensation expense — — 1,646 — — 1,646
Restricted stock unit vesting 270,592 — — — — —
Net loss — — — — ( 20,039 ) ( 20,039 )
Balance at September 30, 2024 211,542,122 $ 2 $ 1,605,146 $ 6 $ ( 1,655,556 ) $ ( 50,402 )
Common Stock Additional Paid-In
Capital Accumulated Other Comprehensive Income Accumulated
Deficit Total Stockholders'
Equity (Deficit)
(dollars in thousands) Shares Amount
Balance at December 31, 2024 224,848,992 $ 2 $ 1,629,167 $ 6 $ ( 1,678,360 ) $ ( 49,185 )
Issuance of common stock, net of
issuance costs 34,437,364 — 64,907 — — 64,907
Proceeds from sale of stock under
employee stock purchase plan 93,362 — 78 — — 78
Exercise of options 604,325 — 482 — — 482
Stock-based compensation expense — — 2,187 — — 2,187
Restricted stock unit vesting 1,660,547 — — — — —
Net income — — — — 6,112 6,112
Balance at March 31, 2025 261,644,590 $ 2 $ 1,696,821 $ 6 $ ( 1,672,248 ) $ 24,581
Issuance of common stock, net of
issuance costs 850,000 — 1,542 — — 1,542
Exercise of options 95,996 — 178 — — 178
Stock-based compensation expense — — 2,676 — — 2,676
Restricted stock unit vesting 451,246 — — — — —
Net income — — — — 247 247
Balance at June 30, 2025 263,041,832 $ 2 $ 1,701,217 $ 6 $ ( 1,672,001 ) $ 29,224
Warrants exercised, cashless
1,408,588 — 7,494 — — 7,494
Proceeds from sale of stock under
employee stock purchase plan 94,060 — 151 — — 151
Exercise of options 438,300 — 962 — — 962
Stock-based compensation expense — — 3,221 — — 3,221
Restricted stock unit vesting 243,258 — — — — —
Net income
— — — — 540 540
Balance at September 30, 2025 265,226,038 $ 2 $ 1,713,045 $ 6 $ ( 1,671,461 ) $ 41,592
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Akebia Therapeutics, Inc.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Nine Months Ended September 30,
(dollars in thousands) 2025 2024
Operating Activities:
Net income (loss) $ 6,899 $ ( 46,606 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation 948 1,127
Amortization of intangible asset — 27,032
Bad debt expense 1,385 —
Change in fair value of warrant liability 5,361 ( 1,345 )
Non-cash royalty revenue related to sale of future royalties ( 1,325 ) ( 1,390 )
Non-cash interest expense 17,056 7,475
Non-cash operating lease expense 3,381 3,116
Non-cash loss on extinguishment of debt — 294
Write-down of inventory 645 2,403
Change in excess inventory purchase commitments — 2,068
Gain on the sale of property and equipment ( 172 ) —
Stock-based compensation expense 8,084 6,078
Changes in operating assets and liabilities:
Accounts receivable ( 33,240 ) 7,120
Inventory ( 5,707 ) ( 19,905 )
Prepaid expenses and other current assets 6,019 6,805
Other long-term assets 141 625
Accounts payable ( 7,337 ) ( 3,758 )
Accrued expense and other current liabilities 34,602 ( 17,652 )
Operating lease liabilities ( 4,011 ) ( 3,212 )
Deferred revenue 3,881 —
Other long-term liabilities 253 ( 6,468 )
Net cash provided by (used in) operating activities 36,863 ( 36,193 )
Investing Activities:
Purchases of equipment ( 221 ) ( 31 )
Proceeds from the sale of property and equipment 172 —
Net cash used in investing activities ( 49 ) ( 31 )
Financing Activities:
Proceeds from the issuance of debt 10,000 45,000
Payments of issuance costs related to BlackRock Credit Agreement ( 63 ) ( 1,272 )
Proceeds from issuance of common stock, net of issuance costs 66,449 20,402
Proceeds from issuance of stock under employee stock purchase plan 230 153
Proceeds from the exercise of stock options 1,621 155
Repayment of term debt ( 462 ) ( 37,100 )
Net cash provided by financing activities 77,775 27,338
Increase (decrease) in cash, cash equivalents and restricted cash 114,589 ( 8,886 )
Cash, cash equivalents and restricted cash — beginning of period 53,550 44,579
Cash, cash equivalents and restricted cash — end of period $ 168,139 $ 35,693
Non-cash financing activities
Issuance of warrants in connection with BlackRock Credit Agreement $ 2,199 $ 4,846
Cashless exercise of warrants in connection with BlackRock Credit Agreement $ 7,494 $ —
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Akebia Therapeutics, Inc.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. NATURE OF BUSINESS
Organization
Akebia Therapeutics, Inc., referred to as Akebia or the Company , was incorporated in the State of Delaware in 2007 and became a public company in 2014. Akebia is a fully integrated commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics.
The Company has two products approved by the Food and Drug Administration, or FDA , in the United States, or U.S. Vafseo® (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase, or HIF-PH , inhibitor. Vafseo (vadadustat) Tablets were approved in the U.S. in March 2024 for the treatment of anemia due to chronic kidney disease, or CKD , in adults who have been receiving dialysis for at least three months. Vafseo entered the U.S. market in January 2025. Auryxia ® (ferric citrate) is marketed for two indications: (i) the control of serum phosphorus levels in adult patients with dialysis dependent chronic kidney disease, or DD-CKD , and (ii) the treatment of iron deficiency anemia, or IDA , in adult patients with non-dialysis dependent chronic kidney disease, or NDD-CKD . Auryxia lost exclusivity in the U.S. in March 2025.
Vafseo is also approved for the treatment of symptomatic anemia associated with CKD in the European Economic Area, or EEA , the United Kingdom, or the UK , Switzerland, Australia, South Korea and Taiwan in adult patients on chronic maintenance dialysis and in Japan for adult dialysis-dependent and non-dialysis patients. Vafseo is marketed and sold by the Company's collaboration partners in certain countries.
Ferric citrate is also approved in Japan, and is marketed and sold by the Company's collaboration partner, as an oral treatment for the improvement of hyperphosphatemia in patients with CKD, including DD-CKD and NDD-CKD, and for the treatment of adult patients with IDA under the trade name Riona (ferric citrate hydrate).
Since its inception, the Company has devoted most of its resources to research and development, or R&D , including its preclinical and clinical development activities, commercializing Auryxia and Vafseo and providing general and administrative support for these operations. In addition, the Company continues to explore additional development opportunities to expand its pipeline and portfolio of novel therapeutics.
As of September 30, 2025, the Company had cash and cash equivalents of approximately $ 166.4 million. Based on its current operating plan, the Company believes that its cash resources and the cash the Company expects to generate from product, royalty, supply 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, or Form 10-Q . However, if the Company’s operating performance deteriorates significantly from the levels expected in the Company’s operating plan, including if the Company does not achieve its future anticipated Vafseo revenue projections, 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 product and license, collaboration and other revenue, including royalties and revenue from supply agreements. In addition, the Company may seek to sell public or private equity, enter into new debt transactions, explore potential strategic transactions, consider other cash-generating or saving measures or a combination of these approaches or other strategic alternatives. There can be no assurance that the current operating plan will be achieved in the time frame anticipated by the Company or that its cash resources will fund its operating plan for the period of time anticipated by the Company, or that additional funding will be available on terms acceptable to the Company, or at all.
2. 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, 2024, and notes thereto, which are included in the Company's Annual Report on Form 10-K, that was filed with the Securities and Exchange Commission, or SEC , on March 13, 2025, or the 2024 Form 10-K . 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, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025 or any other future period.
Basis of Presentation and Principles 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 Accounting Standards Codification, or ASC , and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB .
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Akebia Therapeutics, Inc.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 condensed 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, classification of the expenses, assets and liabilities 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 judgments reflected in these unaudited condensed consolidated financial statements include, but are not limited to: accrued expenses, other long-term liabilities, a liability related to settlement royalties, revenues, including various rebates, returns and reserves related to product sales, inventories, classification of expenses between cost of goods sold, R&D and selling, general and administrative, long-term assets, including the Company's right-of-use assets and goodwill.
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 within 90 days from the date of purchase to be cash equivalents. As of September 30, 2025, cash and cash equivalents primarily included cash on hand and money market funds.
Restricted cash represents amounts required to secure the outstanding letter of credit in connection with the Company’s office and laboratory space in Cambridge, Massachusetts, or the Cambridge Lease . Restricted cash is included in "prepaid expenses and other current assets" in the consolidated balance sheet as of September 30, 2025 and in “other long-term assets” in the consolidated balance sheet as of December 31, 2024.
The following table reconciles cash, cash equivalents and restricted cash reported within the Company's consolidated balance sheets to the total amounts shown in the consolidated statements of cash flows:
(in thousands) September 30, 2025 December 31, 2024
Cash and cash equivalents $ 166,444 $ 51,870
Restricted cash 1,695 1,680
Total cash, cash equivalents and restricted cash $ 168,139 $ 53,550
Concentration of Credit Risk
Cash, cash equivalents and accounts receivable are the only financial instruments that potentially subject the Company to concentrations of credit risk. The Company maintains cash accounts principally at two financial institutions in the U.S., which at times, may exceed the Federal Deposit Insurance Corporation's limits. The Company has not experienced any losses from cash balances in excess of the insurance limit. The Company's management does not believe the Company is exposed to significant credit risk at this time due to the financial condition of the financial institutions where its cash is held.
The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for receivables when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding receivables and the overall quality and age of those invoices not specifically reviewed as well as historical payment patterns and existing economic factors. The Company believes that credit risks associated with its customers and collaboration partners are not significant. The Company's allowance for credit losses was $ 2.6 million and $ 1.2 million as of September 30, 2025 and December 31, 2024, respectively.
The following table summarizes the activity related to the Company's allowance for credit losses (in thousands):
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Akebia Therapeutics, Inc.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Nine Months Ended September 30,
2025 2024
Beginning balance $ 1,212 $ 1,029
Provision for bad debts 1,385 194
Recoveries/(write-offs)
— ( 695 )
Ending balance $ 2,597 $ 528
Manufacturing and Distribution Risk
The Company is dependent on third-party manufacturers, logistics companies and distributors to supply products for commercial activities associated with its products and product candidates, as applicable. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients, or APIs , and formulated drugs related to the Company's product and product candidate activities. These activities, including the commercialization of Auryxia and Vafseo, could be adversely affected by a significant interruption in the supply of APIs and formulated drugs or distribution of finished product to the market.
Recent Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . ASU 2023-09 requires public companies to annually (i) disclose specific categories in the rate reconciliation and (ii) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate). ASU 2023-09 will be effective for the annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating ASU 2023-09 and does not expect it to have a material effect on the Company’s consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses , which requires new tabular disclosures in the notes to consolidated financial statements, disaggregating certain cost and expense categories within relevant captions on the consolidated statements of operations and comprehensive income (loss). The prescribed cost and expense categories requiring disaggregated disclosures include purchases of inventory, employee compensation, depreciation and intangible asset amortization, along with certain other expense disclosures already required by GAAP that would need to be integrated within the new tabular disaggregated expense disclosures. Additionally, the amendments require the disclosure of total selling expenses and an entity's definition of those expenses. ASU 2024-03 will be effective for annual reporting periods in fiscal years beginning after December 15, 2026, and interim reporting periods in fiscal years beginning after December 31, 2027. Early adoption is permitted and the amendments should be applied on a prospective basis. Retrospective application is permitted. The Company is currently reviewing the impact that the adoption of ASU 2024-03 may have on its expense disclosures in the notes to the consolidated financial statements.
In July 2025, the FASB issued ASU 2025-05, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets . ASU 2025-05 provides a practical expedient that all entities can use when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under ASC 606, Revenue from Contracts with Customers . Under this practical expedient, an entity is allowed to assume that the current conditions it has applied in determining credit loss allowances for current accounts receivable and current contract assets remain unchanged for the remaining life of those assets. ASU 2025-05 is effective for fiscal years beginning after December 15, 2025, and interim reporting periods in those years. Entities that elect the practical expedient and, if applicable, make the accounting policy election are required to apply the amendments prospectively. The Company is currently evaluating ASU 2025-05 and does not expect it to have a material effect on the Company’s consolidated financial statements.
In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software , which removes all references to prescriptive and sequential software development stages (referred to as "project stages"). An entity will be required to start capitalizing software costs when (i) management has authorized and committed to funding the software project and (ii) it is probable that the project will be completed and the software will be used to perform the function intended (referred to as the "probable-to-complete recognition threshold"). ASU 2025-06 is effective for fiscal years beginning after December 15, 2027, and interim reporting periods within those annual periods. Early adoption is permitted as of the beginning of the annual reporting period. The Company is currently evaluating ASU 2025-06 and does not expect it to have a material effect on the Company’s consolidated financial statements.
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Akebia Therapeutics, Inc.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
3. 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, 2025
Level 1 Level 2 Level 3 Total Fair Value
Cash equivalents:
Money market funds $ 154,256 $ — $ — $ 154,256
Long-term liability:
Warrant liability $ — $ 5,242 $ — $ 5,242
December 31, 2024
Level 1 Level 2 Level 3 Total Fair Value
Long-term liability:
Warrant liability $ — $ 5,176 $ — $ 5,176
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.
Warrant liability – The warrant liability is classified within Level 2 of the fair value hierarchy because it is valued using inputs which are observable either directly or indirectly. The fair value was calculated using the Black-Scholes option pricing model using the following key inputs: volatility, risk-free rate, dividend yield and expected term.
4. INVENTORIES
Inventories consists of the following (in thousands):
September 30, 2025 December 31, 2024
Inventories, current:
Work-in-process $ 15,715 $ 12,031
Finished goods 2,928 4,212
Inventories, current $ 18,643 $ 16,243
Long-term inventories included in other long-term assets:
Raw materials $ 900 $ 381
Work-in-process 38,960 34,572
Inventories, long-term $ 39,860 $ 34,953
Total inventories $ 58,503 $ 51,196
Inventory written down as a result of excess, obsolescence, scrap or other reasons charged to cost of product and other revenue in the unaudited condensed consolidated statements of operations and comprehensive income (loss) was $ 0.5 million and $ 0.6 million during the three and nine months ended September 30, 2025, respectively, and $ 1.3 million and $ 2.4 million during the three and nine months ended September 30, 2024, respectively. For the three and nine months ended September 30, 2024, the Company realized lower cost of product and other revenue of $ 3.7 million and $ 12.3 million, respectively, due to the Company's ability to sell inventory previously written down to zero, its then net realizable value.
5. INTANGIBLE ASSET AND GOODWILL
Intangible Asset
The Company maintained a definite-lived intangible asset related to developed product rights for Auryxia. The intangible asset was initially recorded at fair value and was stated net of accumulated amortization. The Company amortized the intangible asset using the straight-line method over the estimated useful life of six years . The intangible asset was fully amortized as of December 31, 2024. The Company recorded $ 9.0 million and $ 27.0 million in amortization expense for the three and nine months ended September 30, 2024, respectively, related to the developed product rights for Auryxia.
Goodwill
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Akebia Therapeutics, Inc.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
As of each of September 30, 2025 and December 31, 2024, the Company had goodwill of $ 59.0 million in connection with the December 2018 merger with Keryx. The Company has not identified any goodwill impairment to date.
6. ADDITIONAL BALANCE SHEET DETAIL
Prepaid expenses and other current assets are as follows (in thousands):
Description September 30, 2025 December 31, 2024
Prepaid manufacturing $ — $ 4,029
Restricted cash
1,695 —
Other 5,331 7,321
Total prepaid expenses and other current assets $ 7,026 $ 11,350
Prepaid manufacturing expenses include advance payments to contract manufacturing organizations, or CMOs , for APIs or drug substance. Such amounts are reclassified to work-in-process inventory upon the quality release of the batches and transfer of title to the Company from the CMO.
Other prepaid expenses and other current assets, among other things, include capitalized implementation costs, prepaid insurance, prepaid clinical trial costs and prepaid information technology costs.
Other long-term assets are as follows (in thousands):
Description September 30, 2025 December 31, 2024
Long-term inventories $ 39,860 $ 34,953
Restricted cash — 1,680
Other 602 744
Total other long-term assets $ 40,462 $ 37,377
See Note 4, Inventories , for further information on long-term inventories.
Accrued expenses and other current liabilities consists of the following (in thousands):
Description
September 30, 2025 December 31, 2024
Product revenue allowances excluding rebates $ 8,972 $ 9,657
Product rebates 50,267 6,070
Product return reserves, current portion 5,076 5,295
Clinical trial costs 1,346 1,885
Compensation and related benefits 9,315 9,194
Operating lease liabilities, current portion 4,936 5,400
Royalties due to Panion & BF Biotech, Inc. 3,628 3,543
Professional fees 1,533 1,452
Accrued manufacturing costs 1,124 1,468
Restructuring costs — 489
BioVectra, Inc. termination fees — 7,204
Liability related to sale of future royalties, current portion 2,144 2,039
Settlement royalties liability, current portion 14,286 5,924
Other 3,793 3,840
Total accrued expenses and other current liabilities $ 106,420 $ 63,460
7. INDEBTEDNESS
Entry into BlackRock Loan Facility
On January 29, 2024, or the Closing Date , the Company entered into the Agreement for the Provision of a Loan Facility, or the BlackRock Credit Agreement, with Kreos Capital VII (UK) Limited , or Kreos , which are funds and accounts managed by BlackRock Inc., collectively, BlackRock , and provides for a senior secured term loan facility in the aggregate principal amount
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Akebia Therapeutics, Inc.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
of up to $ 55.0 million, or the Term Loan Facility . The Term Loan Facility was available in three tranches (i) Tranche A — $ 37.0 million was funded on the Closing Date and used to repay the Pharmakon Term Loans (as defined below); (ii) Tranche B — $ 8.0 million was funded on April 19, 2024, or the Tranche B Closing Date , and (iii) Tranche C — $ 10.0 million was funded on February 3, 2025, or the Tranche C Closing Date , collectively the Term Loans .
On February 3, 2025, the Company and Kreos entered into a Second Amendment to the BlackRock Credit Agreement, or the Second Amendment , which, among other things, extended the expiry date of Tranche C from December 31, 2024 to the Tranche C Closing Date, or the Extended Tranche C . Tranche C was available subject to receipt of a certain amount of cumulative gross cash proceeds after the Closing Date in the form of equity or equity linked securities in one or more series of transactions. The terms of the Extended Tranche C are substantially similar to the terms of the original Tranche C, however, interest accrued on the Extended Tranche C as if it was advanced on December 31, 2024.
On the Closing Date, the Company received $ 34.5 million on Tranche A, after deducting debt issuance costs, fees and expenses. On the Tranche B Closing Date, the Company received $ 7.5 million, after deducting debt issuance costs, fees and expenses. On the Tranche C Closing Date, the Company received $ 9.3 million, after deducting debt issuance costs, interest, fees and expenses.
The BlackRock Term Loan Facility had an initial maturity date of March 31, 2025, which was automatically extended to January 29, 2028, after the Company received FDA approval for Vafseo, or the BlackRock Maturity Date . The Company is required to make interest-only payments until December 31, 2026, or the BlackRock Interest Only Period , after which the Company will begin paying equal monthly principal on the first calendar day of each month. In the event of certain prespecified events, the repayment schedule will be accelerated.
The Term Loan Facility will accrue interest at a floating annual rate equal to the sum of (i) the term Secured Overnight Financing Rate , or SOFR , for a tenor of one month (subject to a floor of 4.25 % per annum) plus (ii) a margin of 6.75 % per annum (subject to an overall cap of 15.00 % per annum on the all-in interest rate). As of September 30, 2025, the Company's interest rate was 11.00 %. The Company recognized interest expense related to the BlackRock Credit Agreement of $ 2.1 million and $ 6.2 million during the three and nine months ended September 30, 2025, respectively, and $ 1.7 million and $ 5.5 million during the three and nine months ended September 30, 2024, respectively.
During the continuance of any payment event of default under the BlackRock Credit Agreement, the interest rate on such overdue sum will automatically increase by an additional 3.0 % per annum, and may be subject to an additional late fee of 2.0 % of such overdue sum. The Term Loan Facility also includes transaction fees ranging from 1.00 % to 1.25 % of the draw down amount as well as exit fees of 0.75 % of the amount funded to the relevant tranche.
If the Company prepays the outstanding loan prior to maturity, it will be required to pay a prepayment fee ranging from 1.0 % to 4.0 % of the amount prepaid. If prepayment is made during the first year, the Company also is required to pay the amount of otherwise due interest payments for the twelve-month period following prepayment.
As of September 30, 2025, future principal payments under the BlackRock Credit Agreement are as follows (in thousands):
Principal Payments
2025
$ —
2026
—
2027
50,558
2028
1,881
Total before unamortized discount and issuance costs $ 52,439
Less: unamortized discount and issuance costs ( 4,798 )
Total term loans $ 47,641
The BlackRock Term Loan Facility is secured by substantially all of the existing and after-acquired assets of the Company, including intellectual property. The BlackRock Credit Agreement requires the Company to (i) maintain a minimum aggregate cash balance of $ 15.0 million in one or more controlled accounts or (ii) trailing twelve-month revenue of $ 150.0 million, both of which are measured monthly. The BlackRock Credit Agreement contains certain representations and warranties, affirmative and negative covenants that limit the Company's ability to engage in specified types of transactions and other provisions typical within a credit agreement. If an event of default occurs and is continuing under the BlackRock Credit Agreement, BlackRock is entitled to take enforcement action, including acceleration of amounts due and it could limit the Company's ability to make certain payments under the Vifor Termination Agreement (as defined below).
On July 10, 2024, in connection with the Termination and Settlement Agreement entered into between the Company and CSL Vifor (as defined below), or the Vifor Termination Agreement , the Company and Kreos entered into a First Amendment to the
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BlackRock Credit Agreement, which amended certain provisions of the BlackRock Credit Agreement. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , for further information on the Vifor Termination Agreement.
Warrants
On the Closing Date, Kreos Capital VII Aggregator SCSp, an affiliate of Kreos, or the Warrant Holder , received a warrant to purchase 3,076,923 shares of the Company’s common stock, at an exercise price per share of $ 1.30 , or the Initial Warrant . On the Tranche C Closing Date, the Company issued the Warrant Holder additional warrants to purchase 1,153,846 shares of the Company’s common stock at an exercise price per share of $ 1.30 , or the Tranche C Warrant . Each warrant shall be exercisable for eight years from the date of issuance.
The Initial Warrant and the Tranche C Warrant are liabilities classified under ASC 815, Derivatives and Hedging , as they could potentially require net cash settlement outside of the Company’s control. The Initial Warrant and the Tranche C Warrant are measured at fair value each reporting period and when a warrant is exercised, with the changes in fair value presented within the unaudited condensed consolidated statements of operations and comprehensive income (loss). The fair value of the warrant liability was $ 5.2 million as of September 30, 2025 and December 31, 2024. See Note 3, Fair Value of Financial Instruments , for information on the fair value determination.
On July 21, 2025, the Warrant Holder exercised its option to purchase 2,115,384 shares of the Company's common stock under the Initial Warrant on a cashless basis at an exercise price per share of $ 1.30 . A cashless exercise allows the Warrant Holder to convert the warrants into shares of the Company's common stock without the need for a cash payment. Instead of paying cash upon exercise, the Warrant Holder received a reduced number of shares based on a predetermined formula. On July 23, 2025, as a result of the cashless exercise, the Company issued 1,408,588 shares to the Warrant Holder under the Initial Warrant.
Other Agreements Accounted for as Debt
The Company has a liability related to settlement royalties and a Working Capital Fund liability with Vifor (International) Ltd. (now a part of CSL Limited), or CSL Vifor , and a liability related to the sale of future royalties, which are each accounted for as debt arrangements. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , for further information.
Pharmakon Term Loans (Extinguished January 29, 2024)
On November 11, 2019, the Company, with Keryx as guarantor, entered into a loan agreement, or Pharmakon Loan Agreement , which consisted of a secured term loan facility in an aggregate amount of up to $ 100.0 million, or Pharmakon Term Loans .
On the Closing Date, using the proceeds from the BlackRock Credit Agreement, the Company paid the then outstanding principal balance on the Pharmakon Term Loans of $ 35.0 million, plus the outstanding interest and a prepayment fee of $ 0.2 million. During the nine months ended September 30, 2024, the Company recorded a debt extinguishment loss of $ 0.5 million.
The Company recognized no interest expense during the three and nine months ended September 30, 2025 and immaterial interest expense during the nine months ended September 30, 2024, in each case related to the Pharmakon Loan Agreement.
See Note 7, Indebtedness , of the Notes to the Consolidated Financial Statements in the 2024 Form 10-K for further details.
8. LIABILITY RELATED TO SETTLEMENT ROYALTIES, WORKING CAPITAL FUND LIABILITY AND LIABILITY RELATED TO SALE OF FUTURE ROYALTIES
Vifor License Agreement
Summary of Agreement
O n February 18, 2022, the Company entered into a Second Amended and Restated License Agreement, or the Vifor License Agreement , with CSL Vifor, which amended and restated the License Agreement dated as of May 12, 2017, or the Original License Agreement . The Vifor License Agreement granted CSL Vifor an exclusive license to sell Vafseo to Fresenius Medical Care North America 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 U.S.
The Vifor License Agreement was structured as a profit share arrangement between the Company and CSL Vifor in which the Company would receive approximately 66 % of the profits, net of certain pre-specified costs. In addition, CSL Vifor made an
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upfront payment to the Company of $ 25.0 million in February 2022 in connection with the amendment and restatement of the Vifor License Agreement, which was previously recorded as long-term deferred revenue in the consolidated balance sheets.
See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , of the Notes to the Consolidated Financial Statements in the 2024 Form 10-K for a more detailed description of the Vifor License Agreement.
Investment Agreements
In connection with the Original License Agreement, in May 2017, 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.
In February 2022, in connection with the Vifor License Agreement, 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 $ 20.0 million.
The $ 18.3 million, which represented the premium over the closing stock price, or $ 4.7 million for the 2017 Shares and $ 13.6 million for the 2022 Shares, was previously recorded as long-term deferred revenue in the consolidated balance sheets as it represented consideration related to the Vifor License Agreement.
The 2017 Shares and 2022 Shares are subject to standstill agreements and are subject to voting agreements. 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.
Vifor Termination Agreement
On July 10, 2024, the Company and CSL Vifor entered into the Vifor Termination Agreement, pursuant to which the Company and CSL Vifor agreed, among other things, to terminate, effective immediately, the Vifor License Agreement.
Pursuant to the terms of the Vifor Termination Agreement, the Company will pay CSL Vifor decreasing quarterly tiered royalty payments ranging from a high single-digit percentage of the Company’s net sales of Vafseo up to $ 450.0 million to mid-single digit percentage of the Company’s net sales of Vafseo above $ 450.0 million, in each case, in the U.S. during a calendar year, or the Settlement Royalty Payments . The Settlement Royalty Payments commenced upon the first sale of Vafseo by the Company, its affiliates or third-party licensees to a third party for use in the U.S., and will continue until the later of the (i) expiration of the last-to-expire valid claim listed in the FDA Orange Book, or OB , that would be infringed by the making, using, selling or importing of Vafseo in the U.S. or (ii) the expiration of marketing or regulatory exclusivity for Vafseo in the U.S., or the Settlement Royalty Term . Beginning on July 1, 2027 and throughout the Settlement Royalty Term, the Company has the option to make a one-time payment to CSL Vifor, or the Royalty Buy-Down Option , upon which the Settlement Royalty Payments will be adjusted as of the date of exercise of the Royalty Buy-Down Option such that the Company will then only pay CSL Vifor quarterly royalty payments based on a mid-single digit percentage of the Company’s net sales of Vafseo up to $ 450.0 million in the U.S. during a calendar year in lieu of the above Settlement Royalty Payments. If the Company exercises the Royalty Buy-Down Option, the WCF Royalty Payments, as described below, will continue as described below.
The WCF Royalty Payments, as described below, the Settlement Royalty Payments and the Royalty Buy-Down Option are in consideration for the termination of the Vifor License Agreement and all obligations thereunder, and the covenants and agreements set forth in the Vifor Termination Agreement, including the settlement and release of all disputes and claims arising from the Vifor License Agreement.
As a result of the Vifor Termination Agreement, the Company reassessed whether the Vifor License Agreement still met the criteria to be considered a contract within the scope of ASC 606, Revenue from Contracts with Customers, and concluded that CSL Vifor no longer met the definition of a customer and, therefore, the arrangement should not be considered a revenue contract with a customer under ASC 606. The Company therefore determined that the consideration received from CSL Vifor of $ 43.3 million, comprised of the up-front payment of $ 25.0 million and the premiums paid by CSL Vifor for the 2017 Shares and 2022 Shares of $ 4.7 million and $ 13.6 million, respectively, should be classified as debt. Accordingly, the Company recorded the $ 43.3 million as a liability and is amortizing such amount using the effective interest method over the Settlement Royalty Term. The liability related to settlement royalties and the amortization are based on the Company’s current estimates of future royalties expected to be paid over the life of the arrangement. To the extent the Company’s estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. On a quarterly basis, the Company reassesses the expected royalty payments. The annual effective interest rate as of September 30, 2025 was 24.6 % which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive income (loss). The Company recognized interest expense related to the settlement royalties liability of $ 3.9 million and $ 14.7 million for the three and nine months ended September 30, 2025,
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respectively, and $ 4.4 million for the three and nine months ended September 30, 2024. As of September 30, 2025 and December 31, 2024, the balances related to the settlement royalties liability were as follows (in thousands):
Description
September 30, 2025 December 31, 2024
Current portion (included in accrued expenses and other current liabilities)
$ 14,286 $ 5,924
Long-term portion
52,994 46,697
Total settlement royalties liability
$ 67,280 $ 52,621
Working Capital Fund Liability (Previously Referred to as Refund Liability to Customer)
Pursuant to the Vifor License Agreement, CSL Vifor contributed $ 40.0 million to a working capital fund, or Working Capital Fund , established to partially fund the Company’s costs of purchasing Vafseo from its contract manufacturers.
The Working Capital Fund was considered a debt arrangement with zero coupon interest and the Company imputed interest on the Working Capital Fund 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 Working Capital Fund liability and a corresponding deferred gain on the condensed consolidated balance sheet.
On May 3, 2024, the Company and CSL Vifor entered into Amendment #1 to the Vifor License Agreement, or the Amendment . Pursuant to the Amendment, and as modified by the Vifor Termination Agreement, the Company and CSL Vifor agreed to modify the method of repayment of the Working Capital Fund such that the Working Capital Fund will be repaid through quarterly tiered royalty payments ranging from 8 % to 14 % of the Company's net sales of Vafseo in the U.S., or the WCF Royalty Payments . The WCF Royalty Payments commenced on July 1, 2025, and will continue until the earlier of (i) the cumulative total of the WCF Royalty Payments equals $ 40.0 million, or (ii) May 31, 2028, or the WCF Royalty Term . The WCF Royalty Payments are subject to minimum true-up milestones of $ 10.0 million, $ 20.0 million and $ 40.0 million, or the WCF Royalty True-Up Payments , on each of May 31, 2026, May 31, 2027 and May 31, 2028, respectively, or the WCF Royalty True-Up Dates . If the cumulative total of the WCF Royalty Payments paid to CSL Vifor on any given WCF Royalty True-Up Date is less than the respective WCF Royalty True-Up Payment, the Company will pay CSL Vifor a one-time payment equal to the difference between the WCF Royalty True-Up Payment and the cumulative total of the WCF Royalty Payments paid by the Company through such WCF Royalty True-Up Date. The Company determined that the terms of the Amendment are not substantially different than the terms of the Vifor License Agreement, and therefore the Amendment was accounted for as a modification. The Company concluded that the 15 % discount rate remains appropriate. On a quarterly basis, the Company reassesses the effective rate and will adjust the rate prospectively, if needed.
The discount on the Working Capital Fund liability is amortized to interest expense using the effective interest method over the WCF Royalty Term. The deferred gain is amortized to interest income on a straight-line basis over the WCF Royalty Term. The amortization of the discount was $ 1.2 million and $ 3.5 million for the three and nine months ended September 30, 2025, respectively, and $ 1.1 million and $ 2.7 million for the three and nine months ended September 30, 2024, respectively. The amortization of the deferred gain was $ 1.1 million and $ 3.1 million for the three and nine months ended September 30, 2025, respectively, and $ 0.9 million and $ 2.6 million for the three and nine months ended September 30, 2024, respectively.
As of September 30, 2025 and December 31, 2024, the balances related to the Working Capital Fund liability were as follows (in thousands):
Description
September 30, 2025 December 31, 2024
Current portion
$ 12,991 $ 2,274
Long-term portion
27,726 38,013
Total Working Capital Fund liability
$ 40,717 $ 40,287
Liability Related to Sale of Future Royalties
On February 25, 2021, the Company entered into a royalty interest acquisition agreement, or the Royalty Agreement , with HealthCare Royalty Partners IV, L.P., or HCR , pursuant to which the Company sold to HCR its right to receive royalties and sales milestones for Vafseo 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 (as defined below). The Royalty Interest Payments are subject to an annual maximum “cap” of $ 13.0 million, after which the Company will receive 85 % of the Royalty Interest Payments for the remainder of that year. The Royalty Interest Payments are also subject to an aggregate maximum “cap” of $ 150.0 million, after which the Royalty Interest Payments will revert back to
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the Company. The Company retains the right to receive all potential future regulatory milestones for Vafseo under the MTPC Agreement.
At the transaction date, the Company recorded the proceeds received from HCR of $ 44.8 million (net of certain transaction expenses) as a liability and is amortizing it using the effective interest method over the life of the arrangement. The liability related to sale of future royalties and the debt amortization are based on the Company’s current estimates of future royalties expected to be paid over the life of the arrangement. To the extent the Company’s estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. In the event the Company's estimates of future royalties are less than the proceeds from the sale of future royalties, the Company will not recognize related non-cash interest expense. On a quarterly basis, the Company reassesses the effective interest rate and adjusts the rate prospectively as needed. The annual effective interest rate as of September 30, 2025 was 0 % and, therefore the Company did not recognize any non-cash interest expense in the unaudited condensed consolidated statements of operations and comprehensive income (loss). As a result of its ongoing involvement in the cash flows related to the royalties and sales milestones in the MTPC Territory, the Company will continue to account for these royalties as non-cash royalty revenue which is reflected in license, collaboration and other revenue in the unaudited condensed consolidated statements of operations and comprehensive income (loss). See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , of the Notes to the Consolidated Financial Statements in the 2024 Form 10-K for a more detailed description of the Royalty Agreement.
The Company paid royalties to HCR of $ 0.5 million during each of the three months ended September 30, 2025 and 2024 and $ 1.4 million during each of the nine months ended September 30, 2025 and 2024. As of September 30, 2025 and December 31, 2024 the balances were as follows (in thousands):
Liability related to sale of future royalties September 30, 2025 December 31, 2024
Current portion (included in accrued expenses and other current liabilities) $ 2,144 $ 2,039
Long-term portion 50,576 52,066
Total liability related to sale of future royalties $ 52,720 $ 54,105
9. LEASES
Cambridge Lease
Under the Cambridge Lease, the Company leases approximately 65,167 square feet of office, storage and lab space in Cambridge, Massachusetts. The term of the Cambridge Lease with respect to the 59,216 square feet of office and storage space expires on September 11, 2026, with one five-year extension option available. The term of the Cambridge Lease with respect to the 5,951 square feet of lab space expires on September 11, 2026, with one two-year extension option available.
The Cambridge Lease is non-cancelable and is classified as an operating lease. The renewal options with respect to the office, storage and the lab space of the Cambridge Lease were not included in the calculation of the right-of-use asset and operating lease liability as the renewals are not reasonably certain. The Cambridge Lease does not contain residual value guarantees. 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, 2025, the remaining lease term for the Cambridge Lease was 0.95 years.
Operating lease costs were $ 1.2 million and $ 3.7 million for each of the three and nine months ended September 30, 2025 and 2024, respectively. Cash paid for amounts included in the measurement of operating lease liabilities was $ 1.5 million and $ 4.4 million for the three and nine months ended September 30, 2025, respectively, and $ 1.4 million and $ 4.3 million for the three and nine months ended September 30, 2024, respectively. The security deposit in connection with the Cambridge Lease is $ 1.7 million in the form of a letter of credit, which is included as restricted cash in prepaid expenses and other current assets in the accompanying unaudited condensed consolidated balance sheet as of September 30, 2025 and in other long-term assets in the accompanying unaudited condensed consolidated balance sheet as of December 31, 2024.
Future Lease Commitments
Future commitments under the Cambridge Lease are as follows (in thousands):
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Operating
Lease Commitments
2025 $ 1,460
2026 3,613
Total lease commitments $ 5,073
Less: present value adjustment ( 137 )
Current and long-term operating lease liabilities $ 4,936
10. COMMITMENTS AND CONTINGENCIES
Manufacturing and Unconditional Purchase Commitment Agreements
Siegfried Manufacturing
The Company's contractual obligations include a commercial supply agreement with Siegfried Evionnaz SA, or Siegfried, to supply commercial drug substance for Auryxia. The Company and Siegfried entered into a Master Manufacturing Services and Supply Agreement, most recently amended in February 2023, or the Siegfried Agreement , under which the Company has agreed to purchase a minimum quantity of drug substance of Auryxia at a predetermined price. As of September 30, 2025, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $ 15.3 million through the end of 2026.
The term of the Siegfried Agreement expires on December 31, 2026. The Siegfried Agreement provides the Company and Siegfried with certain early termination rights.
The Company regularly reviews its estimate of the excess firm purchase commitment liability which relates to the amount of minimum purchase commitments under the Siegfried Agreement that exceed the current forecast, including review of assumptions of expected future demand and expiry of inventory. The excess firm commitment liability recorded in other long-term liabilities was $ 3.6 million as of September 30, 2025 and December 31, 2024.
Patheon Manufacturing
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 Vafseo drug product for commercial use under a volume-based pricing structure through June 30, 2026, renewing annually unless either party gives the other party eighteen months ' prior written notice. Under the Patheon Agreement, the Company agreed to purchase from Patheon a certain percentage of the estimated global demand for Vafseo drug product based on certain quarterly and annual forecasts provided by the Company. As of September 30, 2025, the Company has committed to purchase $ 1.1 million of Vafseo drug product from Patheon through the end of 2026, however, as estimated global demand fluctuates, the Company may have additional future obligations under the Patheon Agreement.
WuXi STA Manufacturing
In April 2020, the Company entered into a Supply Agreement with STA Pharmaceutical Hong Kong Limited, a subsidiary of WuXi AppTec, or WuXi STA , or, as amended, the WuXi STA DS Agreement . Under the WuXi STA DS Agreement, WuXi STA will manufacture Vafseo drug substance for commercial use under a volume-based pricing structure through April 2, 2029. Pursuant to the WuXi STA DS Agreement, the Company has agreed to purchase a certain percentage of the global demand for Vafseo drug substance from WuXi STA. As of September 30, 2025, the Company has committed to purchase $ 69.2 million of Vafseo drug substance from WuXi STA through the end of 2027, however, as estimated global demand fluctuates, the Company may have additional future obligations under the WuXi STA DS Agreement.
Additionally, on February 10, 2021, the Company entered into a Supply Agreement with WuXi STA, which was amended on October 15, 2024, or the WuXi STA DP Agreement , under which WuXi STA will manufacture and supply Vafseo drug product for commercial purposes under a volume-based pricing structure through January 1, 2032. The Vafseo drug product price is reviewed annually by the Company and WuXi STA. The Company also reimburses WuXi STA for certain reasonable expenses. Pursuant to the WuXi STA DP Agreement, the Company has agreed to purchase a certain percentage of global demand for Vafseo drug product from WuXi STA. The WuXi STA DP Agreement may be renewed or extended by mutual agreement of the Company and WuXi STA with at least eighteen 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. As of September 30, 2025, the Company has committed to purchase $ 0.8 million of Vafseo drug product from WuXi STA through the first quarter
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of 2026, however, as estimated global demand fluctuates, the Company may have additional future obligations under the WuXi STA DP Agreement.
Esteve - Assigned Supply Agreement
On April 9, 2019, the Company entered into a Supply Agreement with Esteve Química, S.A., or Esteve , or the Esteve Agreement , under which Esteve would manufacture Vafseo drug substance for commercial use under a volume-based pricing structure. On December 16, 2022, the Company, Mitsubishi Tanabe Pharma Corporation, or MTPC , and Esteve executed the Esteve Assignment Agreement, pursuant to which the Esteve Agreement was assigned to MTPC. The Esteve Assignment Agreement transferred the rights and obligations of the Esteve Agreement to MTPC, specifically including the obligations under certain purchase orders issued by the Company and accepted by Esteve.
Although the Esteve Agreement was assigned to MTPC in December 2022, the Company and Esteve have agreed to negotiate the terms of a new commercial supply relationship. As of September 30, 2025, the Company has committed to purchase $ 7.6 million of Vafseo drug substance from Esteve through the end of 2025.
BioVectra - Former Manufacturing and Unconditional Purchase Commitments
Under the Manufacture and Supply Agreement with BioVectra, Inc., or 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 the BioVectra 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 released one another from all existing and future claims and liabilities and the return of certain materials and documents. 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 which commenced in April 2024 and were completed in July 2025, 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 product and other revenue. 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. 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 on the date of the termination. 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 immaterial and $ 0.3 million for the three and nine months ended September 30, 2025, respectively, and $ 0.4 million and $ 1.3 million for the three and nine months ended September 30, 2024, respectively.
License Agreements
Panion License Agreement
On April 17, 2019, the Company and Panion & BF Biotech, Inc., or Panion , entered into a second amended and restated license agreement, or the Panion Amended License Agreement , which amended and restated in full the license agreement between the Company and Panion. The Panion Amended License Agreement provides the Company 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 certain Asian-Pacific countries, or the Licensor Territory . The Panion Amended License Agreement also provides Panion with an exclusive license under the Company-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 10, Commitments and Contingencies , of the Notes to the Consolidated Financial Statements in the 2024 Form 10-K for a more detailed description of this license agreement.
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The Company incurred royalty payments due to Panion of approximately $ 2.7 million and $ 8.4 million during the three and nine months ended September 30, 2025, respectively, and $ 2.1 million and $ 6.4 million during the three and nine months ended September 30, 2024, respectively, relating to the Company’s sales of Auryxia in the U.S. and Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., collectively, JT and Torii’s , net sales of Riona in Japan.
Cyclerion Agreement
In June 2021, the Company entered into a license agreement, or the Cyclerion Agreement , with Cyclerion Therapeutics Inc., or Cyclerion , under which the Company obtained an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oral soluble guanylate cyclase stimulator.
Under the terms of the Cyclerion Agreement, the Company made an upfront payment of $ 3.0 million to Cyclerion, which was paid during the second quarter of 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 $ 3.0 million upfront payment was charged to research and development expense at acquisition in June of 2021, as it relates to a development stage compound with no alternative future use.
In December 2024, the Company and Cyclerion entered into Amendment #1 to the Cyclerion Agreement, pursuant to which the Company agreed to pay Cyclerion (i) $ 1.25 million, which was paid in December 2024, and (ii) $ 0.5 million, which was paid in September 2025. In addition, the parties agreed to the reduction of certain development milestones and the increase of certain royalty rates on net sales and sublicense income. During the year ended December 31, 2024, the Company recorded the $ 1.25 million payment and $ 0.5 million payment to research and development expense in accordance with ASC 730, Research and Development, as praliciguat remains a development stage compound with no alternative future use. Furthermore, the only contingency as it related to the $ 0.5 million payment made in September 2025 was the passage of time.
Under the Cyclerion Agreement, as amended, Cyclerion is eligible to receive up to an aggregate of $ 198.5 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 mid-single-digit percentage to twenty percent 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.
Unless earlier terminated, the Cyclerion Agreement will expire on a product-by-product and country-by-country basis upon the expiration of the last royalty term, which ends upon the longest of (i) the expiration of the patents licensed under the Cyclerion Agreement, (ii) the expiration of regulatory exclusivity for such product and (iii) ten years from first commercial sale of such product. The Company may terminate the Cyclerion Agreement in its entirety or only with respect to a particular licensed compound or product upon 180 days' prior written notice to Cyclerion. The parties also have customary termination rights, subject to a cure period, in the event of the other party’s material breach of the Cyclerion Agreement or in the event of certain additional circumstances.
Other Third-Party Contracts
The Company contracts with various organizations to conduct R&D activities with remaining contract costs to the Company of approximately $ 86.8 million at September 30, 2025. The scope of the services under these R&D contracts can be modified upon mutual agreement of the parties, and the contracts or scope of services can be 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 current legal proceedings to have a material adverse effect on its financial position, results of operations or cash flows.
Guarantees and Indemnifications
As permitted under Delaware law, the Company may indemnify its officers, directors and employees for certain events or occurrences that happen by reason of their relationship with, or position held at, the Company. The Company may also be subject to indemnification obligations by law with respect to the actions of its employees under certain circumstances and in
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certain jurisdictions. The Company maintains director and officer liability insurance coverage that is intended to cover a portion of amounts that may be due with respect to indemnification after a deductible is met. Further, the Company is a party to a variety of agreements in the ordinary course of business under which it may be obligated to indemnify third parties with respect to certain matters. For the three and nine months ended September 30, 2025 and 2024, the Company did not experience any losses related to these indemnification obligations, and no claims were outstanding as of September 30, 2025. The Company does not have any claims related to these indemnification obligations and consequently concluded that the fair value of these obligations is negligible and no related accruals were recorded.
11. PRODUCT REVENUE AND RESERVES FOR VARIABLE CONSIDERATION
Until Vafseo's market entry in January 2025, the Company’s only source of product revenue was from the U.S. sales of Auryxia. The Company recognized the following revenue from Vafseo and Auryxia (in thousands):
Three Months Ended September 30, Nine Months Ended September 30,
Product 2025 2024 2025 2024
Vafseo $ 14,322 $ — $ 39,635 $ —
Auryxia (1)
42,467 35,592 133,406 107,810
Total product revenues $ 56,789 $ 35,592 $ 173,041 $ 107,810
(1) Includes the authorized generic version of Auryxia sold and distributed by the Company's authorized generic distribution partner, Mylan Therapeutics, Inc., or AG Partner , during the three and nine months ended September 30, 2025.
The following table presents changes in the Company’s contract assets and liabilities related to the Company's sales to its AG Partner (in thousands):
Nine Months Ended September 30, 2025
Balance at
Beginning of
Period Additions Deductions Balance
at End
of Period
Contract assets:
Accounts receivable $ — $ 9,255 $ ( 9,255 ) $ —
Contract liabilities:
Deferred revenue $ — $ 8,118 $ ( 5,250 ) $ 2,868
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The Company recognized the following revenues related to the Company's sales to its AG Partner 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: 2025 2024 2025 2024
Deferred revenue — beginning of the period
$ 2,664 $ — $ — $ —
Product revenue allowance and reserve categories were as follows:
(in thousands) Chargebacks
and Discounts Rebates, Fees
and Other
Deductions Product Returns Total
Balance at December 31, 2024 $ 1,436 $ 15,726 $ 6,442 $ 23,604
Current provisions related to sales in current year 2,200 62,571 552 65,323
Adjustments related to prior year sales 69 336 ( 164 ) 241
Credits/payments made ( 3,151 ) ( 19,395 ) ( 359 ) ( 22,905 )
Balance at September 30, 2025 $ 554 $ 59,238 $ 6,471 $ 66,263
(in thousands) Chargebacks
and Discounts Rebates, Fees
and Other
Deductions
Product Returns Total
Balance at December 31, 2023 $ 1,607 $ 22,991 $ 6,916 $ 31,514
Current provisions related to sales in current year 5,990 28,950 3,104 38,044
Adjustments related to prior year sales 377 153 ( 1,336 ) ( 806 )
Credits/payments made ( 6,631 ) ( 36,778 ) ( 4,177 ) ( 47,586 )
Balance at September 30, 2024 $ 1,343 $ 15,316 $ 4,507 $ 21,166
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 statements of operations and comprehensive income (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 condensed consolidated balance sheets. Estimated product returns on product sales that are not expected to be returned within one year are recorded as other long-term liabilities in the unaudited condensed consolidated balance sheets.
Accounts receivable, net related to product sales, was approximately $ 63.2 million and $ 32.4 million as of September 30, 2025 and December 31, 2024, respectively.
12. LICENSE, COLLABORATION AND OTHER REVENUE
The Company recognized the following revenue from its license, collaboration and other revenue agreements (in thousands):
Three Months Ended September 30, Nine Months Ended September 30,
Entity Description 2025 2024 2025 2024
Medice License and royalties related to the sale of Vafseo in the EU
$ 28 $ 29 $ 52 $ 29
MTPC License and Product Supply of Vafseo in Japan 455 525 1,325 2,106
JT and Torii License and royalties related to the sale of Riona in Japan 1,494 1,282 4,156 3,738
Total license and other revenue $ 1,977 $ 1,836 $ 5,533 $ 5,873
The following tables present changes in the Company’s contract assets and liabilities related to license and other revenue (in thousands):
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Nine Months Ended September 30, 2025
Balance at
Beginning of
Period Additions Deductions Balance
at End
of Period
Contract asset:
Accounts receivable (1)
$ 2,010 $ 6,577 $ ( 5,527 ) $ 3,060
Contract liability:
Deferred revenue
$ — $ 1,013 $ — $ 1,013
Nine Months Ended September 30, 2024
Balance at
Beginning of
Period Additions Deductions Balance
at End
of Period
Contract assets:
Accounts receivable (1)
$ 3,333 $ 5,873 $ ( 7,381 ) $ 1,825
Contract liabilities:
Deferred revenue (2)
$ 43,296 $ — $ ( 43,296 ) $ —
(1) Excludes accounts receivable related to amounts due to the Company from product sales of Auryxia and Vafseo which are included in the accompanying unaudited condensed consolidated balance sheets as of September 30, 2025 and 2024.
(2) See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , for further information.
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: 2025 2024 2025 2024
Deferred revenue — beginning of the period $ — $ — $ — $ —
During each of the three and nine months ended September 30, 2025 and 2024, the Company recognized no revenue from performance obligations satisfied in previous periods.
Medice License Agreement
On May 24, 2023, or the Medice Effective Date , the Company and MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice , entered into a License Agreement, or the Medice License Agreement , pursuant to which the Company granted to Medice an exclusive license to develop and commercialize Vafseo for the treatment of anemia in adult patients with CKD in the EEA, the UK, Switzerland and Australia, or collectively the Medice Territory .
Under the Medice License Agreement, the Company received an up-front payment of $ 10.0 million and is eligible 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 Vafseo 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 Vafseo in such country in the Medice Territory, (b) the date of expiration of data or regulatory exclusivity for Vafseo in such country in the Medice Territory and (c) the date that is twelve years from first commercial sale of Vafseo in such country in the Medice Territory.
Under the Medice License Agreement, the Company retains the right to develop Vafseo for non-dialysis patients with anemia due to CKD in the Medice Territory. If the Company develops Vafseo for non-dialysis patients and Vafseo receives marketing approval in the Medice Territory, Medice will commercialize Vafseo for both indications in the Medice Territory. In this instance, the Company would receive 70 % of the net product margin of any sales of Vafseo in the non-dialysis patient population, unless Medice requests to share the cost of the development necessary to gain approval to market Vafseo for non-dialysis patients in the Medice Territory and the parties agree on alternative financial terms. If the Company develops Vafseo 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
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significant risks and rewards that are dependent on the success of the activities. Accordingly, if the Company develops Vafseo 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 Vafseo for non-dialysis patients, Medice does not represent a customer as contemplated by ASC 606. As a result, the activities conducted pursuant to development activities for Vafseo for non-dialysis patients will be accounted for as a component of the related expense in the period incurred.
The Medice License Agreement expires on the date of expiration of all payment obligations due thereunder with respect to Vafseo 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 twelve months ' prior written notice delivered on or after the date that is twelve months after the Medice Effective Date.
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 identified one performance obligation in connection with its obligations under the Medice License Agreement, which is the license, 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 was included in prepaid expenses and other current assets as of December 31, 2024 on the audited consolidated balance sheets. The $ 1.4 million was received during the nine months ended September 30, 2025.
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 unaudited condensed consolidated statements of operations and comprehensive loss during the year ended December 31, 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. During each of the three and nine months ended September 30, 2025 and 2024, the Company recognized immaterial revenue from Medice royalties. As of September 30, 2025, there were $ 0.1 million in contract assets, and no accounts receivable, payables or deferred revenue in connection with the Medice License Agreement.
Supply of Drug Product to Medice
On September 13, 2024, the Company and Medice entered into a supply agreement, or the Medice Supply Agreement , under which the Company will supply Vafseo drug product to Medice for commercial and developmental use in the Medice Territory. The Company recognizes revenue under this arrangement when risk of loss passes to Medice, delivery has occurred, and Medice has accepted the product. The Company did not recognize any revenue under the Medice Supply Agreement during the three and nine months ended September 30, 2025 or 2024.
MTPC Collaboration Agreement
On December 11, 2015, the Company and MTPC entered into a Collaboration Agreement, or the MTPC Agreement , providing MTPC with exclusive development and commercialization rights to Vafseo in the MTPC Territory, which was amended effective as of December 2, 2022. In addition, the Company supplies Vafseo 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 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , for additional information and Note 12, License, Collaboration and Other Revenue , of the Notes to the Consolidated Financial Statements in the 2024 Form 10-K for a more detailed description of the MTPC Agreement.
The Company evaluated the elements of the MTPC Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, MTPC, is a customer. The Company 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 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 and (vi) $ 8.2 million in royalties from net sales of Vafseo. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. As of September 30, 2025, all development milestones and $ 25.0 million in regulatory
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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 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.
Revenue for the License, Research and Clinical Supply Performance Obligation for the MTPC Agreement is being recognized using a proportional performance method, for which all deliverables have been completed. The Company recognizes any revenue from MTPC royalties in the period in which the sales occur. The Company recognized revenue from MTPC royalties of $ 0.5 million during each of the three months ended September 30, 2025 and 2024, and $ 1.3 million and $ 1.4 million during the nine months ended September 30, 2025 and 2024, 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 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , for additional information. The revenue is classified as license and other revenue in the accompanying unaudited condensed consolidated statements of operations and comprehensive income (loss). As of September 30, 2025, there were no accounts receivable, payables or deferred revenue and $ 0.5 million in contract assets 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 the MTPC Supply Agreement , under which the Company supplies Vafseo drug product to MTPC for commercial use in Japan and certain other Asian countries, as contemplated by the MTPC Agreement. See Note 12, License, Collaboration and Other Revenue , of the Notes to the Consolidated Financial Statements in the 2024 Form 10-K for a more detailed description of this supply agreement.
On December 16, 2022, the Company, MTPC and Esteve executed an Assignment of Supply Agreement, or the Esteve Assignment Agreement , pursuant to which the rights and obligations of the Company under the Esteve Agreement were transferred to MTPC. The Company has no further obligation to take delivery of, or pay for, product delivered by Esteve except as disclosed in Note 10, Commitments and Contingencies .
The Company does not recognize revenue under this arrangement until risk of loss on the drug product passes to MTPC and delivery has occurred and MTPC has accepted the product. The Company recognized no revenue under the MTPC Supply Agreement during the three and nine months ended September 30, 2025 and no revenue and $ 0.7 million in revenue under the MTPC Supply Agreement during the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, there was $ 1.0 million in accounts receivable and $ 1.0 million in deferred revenue recorded in connection with the MTPC Supply Agreement.
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 the JT and Torii Sublicense Agreement , under which 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 12, License, Collaboration and Other Revenue , of the Notes to the Consolidated Financial Statements in the 2024 Form 10-K for a more detailed description of this sublicense agreement.
The Company evaluated the elements of the JT and Torii Sublicense Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, JT and Torii, is a customer. 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 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 allocated the entire transaction price to the License and Supply Performance Obligation.
The Company recognized license revenue of $ 1.5 million and $ 4.2 million during the three and nine months ended September 30, 2025, respectively, and $ 1.3 million and $ 3.7 million during the three and nine months ended September 30, 2024, respectively, related to royalties earned on net sales of ferric citrate hydrate in Japan under the trade name Riona. 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.
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13. CAPITAL STOCK
Authorized and Outstanding Capital Stock
As of September 30, 2025, the authorized capital stock of the Company included 350,000,000 shares of common stock, $ 0.00001 par value per share, of which 265,226,038 and 224,848,992 shares were issued and outstanding as of September 30, 2025 and December 31, 2024, 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, 2025 and December 31, 2024.
At-the-Market Facility
On April 7, 2022, the Company entered into an at-the-market, or ATM , sales agreement, or the Original Sales Agreement , with Jefferies LLC, or Jefferies, as the Company's sales agent, under which the Company could offer and sell from time to time up to $ 26.0 million of shares of its common stock at current market prices. During the year ended December 31, 2023, the Company sold 6,189,974 shares of common stock under this program with gross proceeds of $ 6.8 million ($ 6.7 million, net of offering expenses). During the nine months ended September 30, 2024, the Company sold 13,261,311 shares of its common stock under this program with gross proceeds of $ 19.2 million ($ 18.7 million, net of offering expenses).
On September 3, 2024, in connection with the filing of a new shelf registration statement on Form S-3, the Company filed a prospectus related to the Company's amended and restated sales agreement (which amended and restated the Original Sales Agreement), with Jefferies, as the Company’s sales agent, pursuant to which the Company is able to offer and sell up to $ 75.0 million of its common stock at current market prices from time to time. Since September 12, 2024 (the date the Company’s shelf registration statement on Form S-3 went effective) through December 31, 2024, the Company sold 14,271,631 shares of its common stock under this program with gross proceeds of $ 24.3 million ($ 23.8 million, net of offering expenses). During the nine months ended September 30, 2025, the Company sold 9,437,364 shares of its common stock under this program with gross proceeds of $ 18.7 million ($ 18.4 million, net of offering expenses).
Public Offering
On March 19, 2025, the Company entered into an underwriting agreement, or the Underwriting Agreement , with Leerink Partners LLC and Piper Sandler & Co., as representatives of the several underwriters named therein, collectively, the Underwriters , relating to an underwritten public offering, or the Offering , of 25,000,000 shares, or the Shares , of the Company's common stock. The offering price was $ 2.00 per share, and the Underwriters agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $ 1.88 per share. Under the terms of the Underwriting Agreement, the Company granted the Underwriters a 30-day option to purchase up to 3,750,000 additional shares of common stock, or the Additional Shares , at the public offering price per share, and the Underwriters partially exercised their option and purchased 850,000 Additional Shares on April 22, 2025.
Net proceeds from the Offering of the Shares were $ 46.5 million, after deducting underwriting discounts and commissions and estimated offering expenses and net proceeds from the Offering of the Additional Shares were $ 1.6 million, after deducting underwriting discounts and commissions and estimated offering expenses.
Unregistered Common Stock
In connection with the Vifor License Agreement, CSL Vifor owns 7,571,429 shares of common stock that are unregistered under the Securities Act. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , for more information.
Warrants to Purchase Common Stock
In connection with the BlackRock Credit Agreement, described in more detail in Note 7, Indebtedness , the Company issued a warrant to purchase 3,076,923 shares of the Company’s common stock, at an exercise price per share of $ 1.30 , and upon the borrowing of Tranche C in February 2025, the Company issued additional warrants to purchase 1,153,846 shares of the Company’s common stock at an exercise price per share of $ 1.30 . Each warrant is exercisable for eight years from the date of issuance. The warrants and the common stock issuable upon the exercise of such warrants were not registered under the Securities Act and, accordingly, the holder thereof may only sell common stock issued upon exercise of such warrants pursuant to an effective registration statement under the Securities Act covering the resale of those shares, an exemption under Rule 144 under the Securities Act or another applicable exemption under the Securities Act.
On July 21, 2025, the Warrant Holder exercised its option to purchase 2,115,384 shares of the Company's common stock under the Initial Warrant on a cashless basis at an exercise price per share of $ 1.30 . The cashless exercise allowed the Warrant Holder to convert the warrants into shares of the Company's common stock without the need for a cash payment. Instead of paying cash upon exercise, the Warrant Holder received a reduced number of shares based on a predetermined formula. On
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July 23, 2025, as a result of the cashless exercise, the Company issued 1,408,588 shares to the Warrant Holder under the Initial Warrant.
14. STOCK-BASED COMPENSATION AND BENEFIT PLAN
Stock-Based Compensation and Benefit Plans
The Company incurred stock-based compensation expenses of $ 3.2 million and $ 8.1 million during the three and nine months ended September 30, 2025, respectively, and $ 1.6 million and $ 6.1 million for the three and nine months ended September 30, 2024, respectively.
Equity Incentive Plans
The following table contains information about the Company's equity plans:
September 30, 2025 December 31, 2024
Title of Plan Group Eligible Type of Award Granted (or to be Granted) Awards Outstanding Additional Awards Authorized for Grant Awards Outstanding Additional Awards Authorized for Grant
Keryx Equity Plans (1)(2)
Employees, directors and consultants Stock options and restricted stock units ( RSUs )
153,346 — 163,765 —
Akebia Therapeutics, Inc. 2014 Incentive Plan, as amended (2) (3)
(the 2014 Plan )
Employees, directors, consultants and advisors Stock options, RSUs, stock appreciation rights ( SARs ) and performance awards
8,612,119 — 11,559,708 —
Akebia Therapeutics, Inc. 2023 Stock Incentive Plan, as amended (3) (4) (the 2023 Plan )
(replaced 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 16,351,570 24,329,514 10,390,642 11,340,648
(1) The Keryx Equity Plans consist of the Keryx Biopharmaceuticals, Inc. 1999 Share Option Plan, 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) New awards are no longer being granted under these plans.
(3) This table 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) and not under the applicable plan: 1,074,082 options included as outstanding under the 2014 Plan in the table and 3,064,976 options included as outstanding under the 2023 Plan in the table as of September 30, 2025 and 1,151,127 options included as outstanding under the 2014 Plan and 2,534,775 options included as outstanding under the 2023 Plan in the table as of December 31, 2024.
(4) On June 10, 2025, the 2023 Plan was amended to increase the number of shares of common stock available for issuance thereunder by 18,900,000 shares.
Common Stock Options and Stock Appreciation Rights
During the nine months ended September 30, 2025, the Company issued 3,634,400 options to employees and 375,200 options to directors under the 2023 Plan. 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 ten 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, 2025, the Company granted 1,182,176 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 1,133,176 options remained outstanding as of September 30, 2025.
The Company grants annual service-based stock options to employees and directors and SARs to certain executives under the 2023 Plan and previously granted options to employees and directors 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.
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Finally, the Company grants performance-based stock options which 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 combined stock option activity for the nine months ended September 30, 2025, is as follows:
Stock
Options Weighted Average Exercise Price Weighted-Average Contractual Life (years) Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2024
16,684,325 $ 3.19 7.17 years $ 6,797
Granted 5,191,776 $ 2.52 — —
Exercised ( 1,138,621 ) $ 1.42 — —
Expired ( 1,142,350 ) $ 8.72 — —
Canceled and forfeited ( 1,126,622 ) $ 1.74 — —
Outstanding at September 30, 2025 18,468,508 $ 2.86 7.29 years $ 15,160
Exercisable at September 30, 2025 9,360,308 $ 3.68 5.84 years $ 7,746
As of September 30, 2025, there was approximately $ 13.5 million of unrecognized compensation costs related to stock options, which is expected to be recognized over a weighted average period of 2.82 years.
Restricted Stock Units
Generally, 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, or (iii) one third of each RSU grant vests on the first anniversary of the grant date 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.
The Company also periodically grants performance-based restricted stock units, or PSUs , to employees under the 2023 Plan and previously granted PSUs under 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.
In addition, the Company has granted PSUs to certain employees under the 2023 Plan with a market condition. The PSUs also generally feature a time-based vesting component. The Company uses a Monte Carlo simulation to determine fair value of the award at the grant date. The expense recognized for these awards is based on the calculated fair value multiplied by the number of the target units granted and is amortized over the service period.
RSU and PSU activity is as follows:
2014 Plan 2023 Plan
Number of Shares Weighted Average Fair Value Number of Shares Weighted Average Fair Value
Unvested as of December 31, 2024
1,321,423 $ 0.95 4,108,367 $ 1.59
Granted — $ — 4,460,300 $ 2.31
Vested ( 790,281 ) $ 1.10 ( 1,564,770 ) $ 1.55
Forfeited and canceled ( 120,409 ) $ 1.05 ( 766,103 ) $ 1.80
Unvested as of September 30, 2025 410,733 $ 0.63 6,237,794 $ 2.09
As of September 30, 2025, there was $ 9.7 million of unrecognized compensation costs related to time-based RSUs and PSUs, which is expected to be recognized over a weighted-average period of 1.90 years.
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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, 2025 and December 31, 2024, a total of 4,260,647 and 4,448,069 shares of the Company’s common stock were available for future issuance under the ESPP, respectively. The Company issued 187,422 shares under the ESPP during the nine months ended September 30, 2025.
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 2025 2024 2025 2024
Risk-free interest rate 3.79 % - 4.03 % 3.60 % - 3.95 % 3.79 % - 4.38 % 3.60 % - 4.66 %
Expected volatility 111.72 % - 120.16 % 111.37 % - 117.40 % 111.61 % - 123.58 % 109.98 % - 118.61 %
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 — % — % — % — %
Weighted average grant date fair value
$ 2.80 $ 1.17 $ 2.18 $ 1.35
The Company has classified stock-based compensation in its unaudited condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands):
Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Cost of goods sold $ 169 $ 115 $ 491 $ 284
Research and development 677 338 1,675 1,153
Selling, general and administrative 2,375 1,193 5,918 4,603
Restructuring — — — 38
Total stock-based compensation $ 3,221 $ 1,646 $ 8,084 $ 6,078
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15. NET INCOME (LOSS) PER SHARE
The following summarizes the calculation of net income (loss) per share:
Three Months Ended September 30, Nine Months Ended September 30,
(Dollars in thousands, except per share amounts) 2025 2024 2025 2024
Numerator
Net income (loss) $ 540 $ ( 20,039 ) $ 6,899 $ ( 46,606 )
Denominator
Denominator for basic net income (loss) per share - weighted average outstanding shares of common stock 264,786,432 210,348,459 254,390,502 208,343,679
Dilutive effect of common stock options and SARs 4,416,904 — 3,351,562 —
Dilutive effect of RSUs 3,243,785 — 2,995,205 —
Dilutive effect of warrants 1,924,435 — 1,942,508 —
Dilutive effect of ESPP 1,166 — 1,166 —
Denominator for diluted net income (loss) per share - weighted average outstanding shares of common stock and assumed conversions 274,372,722 210,348,459 262,680,943 208,343,679
Basic net income (loss) per share $ 0.00 $ ( 0.10 ) $ 0.03 $ ( 0.22 )
Diluted net income (loss) per share $ 0.00 $ ( 0.10 ) $ 0.03 $ ( 0.22 )
Potentially dilutive securities including common stock options, RSUs, SARs and warrants have been excluded from the calculation of diluted net loss per share as their effects would be anti-dilutive. Therefore, for the three and nine months ended September 30, 2024 in which the Company reported a net loss, the weighted average number of shares outstanding used to calculate both basic and diluted net loss per share were the same. 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 and Nine Months Ended September 30, 2024
Warrants 3,076,923
Outstanding common stock options 16,120,512
Unvested RSUs 5,616,584
Stock appreciation rights 635,313
Total 25,449,332
16. SEGMENT INFORMATION
The Company operates as one operating segment focused on developing and commercializing innovative therapeutics primarily in the U.S. The accounting policies of the segment are the same as those described in the summary of significant accounting policies.
The determination of a single business segment is consistent with the consolidated financial information regularly reviewed by the chief executive officer, who is the Company's chief operating decision maker, or CODM , in assessing segment performance and deciding how to allocate resources on a consolidated basis.
The CODM makes decisions on resource allocation, assesses performance of the business, and monitors budget versus actual results using income from operations. Net income is also a measure that is considered in monitoring budget versus actual results. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.
The following table presents information about reported segment revenues, segment profit and significant segment expenses for the three and nine months ended September 30, 2025 and 2024:
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Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Revenues $ 58,766 $ 37,428 $ 178,574 $ 113,683
Less:
Direct cost of product and other revenue 6,683 3,039 18,569 7,270
Panion royalty 2,700 2,111 8,358 6,442
Excess firm purchase commitment charge — — — 2,068
Amortization of intangible asset — 9,011 — 27,032
Research and development 14,944 8,487 35,711 25,866
Selling, general and administrative 29,094 26,516 81,391 78,870
License 896 769 2,493 2,242
Restructuring — — — 58
Income (loss) from operations 4,449 ( 12,505 ) 32,052 ( 36,165 )
Other income (expense)
Interest expense ( 4,748 ) ( 6,661 ) ( 19,352 ) ( 11,308 )
Other (expense) income ( 10 ) ( 17 ) 175 39
Change in fair value of warrant liability 1,464 ( 856 ) ( 5,361 ) 1,345
Loss on extinguishment of debt — — — ( 517 )
Income (loss) before income taxes 1,155 ( 20,039 ) 7,514 ( 46,606 )
Income tax expense ( 615 ) — ( 615 ) —
Net income (loss) $ 540 $ ( 20,039 ) $ 6,899 $ ( 46,606 )
17. SUBSEQUENT EVENTS
The Company has evaluated events and transactions occurring after the balance sheet date through the filing date of this Form 10-Q with the Securities and Exchange Commission, to ensure that the unaudited condensed consolidated financial statements include appropriate disclosure of events both recognized in the accompanying unaudited condensed consolidated financial statements as of September 30, 2025, and events which occurred subsequently but were not recognized in the consolidated financial statements.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.