What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2024-11-07 compared with 2024-08-08 · 225 added, 219 removed, 694 unchanged (39% of the section changed)

2 unchanged sentences

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(dollars in thousands, except per share amounts) June 30,

(dollars in thousands, except per share amounts) September 30,

2024 December 31,

15 unchanged sentences

Accrued expenses and other current liabilities 52,215 67,735

Current portion of deferred revenue 43,296 —

Current portion of long-term debt — 17,500

Total current liabilities 65,709 99,870

Deferred revenue, net of current portion — 43,296

Long-term deferred revenue — 43,296

Long-term operating lease liabilities 4,937 8,947

Long-term debt, net 38,355 17,183

Liability related to settlement royalties 47,731 —

Liability related to sale of future royalties, net of current portion 52,381 54,013

Refund liability to customer 40,018 40,093

Working Capital Fund liability 40,203 40,093

Warrant liability 3,501 —

5 unchanged sentences

no shares issued and

outstanding at June 30, 2024 and December 31, 2023

outstanding at September 30, 2024 and December 31, 2023

Common stock $ 0.00001 par value;

350,000,000 shares authorized at June 30, 2024 and December 31, 2023;

209,929,145 and 194,582,539 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively

350,000,000 shares authorized at September 30, 2024 and December 31, 2023;

211,542,122 and 194,582,539 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

Additional paid-in capital 1,605,146 1,578,358

8 unchanged sentences

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(dollars in thousands, except per share amounts) 2024 2023 2024 2023

31 unchanged sentences

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

Common Stock Additional Paid-In Capital Accumulated Other Comprehensive Income (Loss) Accumulated

Common Stock Additional Paid-In Capital Accumulated Other Comprehensive Income

Deficit Total Stockholders'

12 unchanged sentences

Balance at June 30, 2023 188,128,869 $ 2 $ 1,568,260 $ 6 $ ( 1,595,073 ) $ ( 26,805 )

Proceeds from sale of stock under

employee stock purchase plan 96,694 — 50 — — 50

Stock-based compensation expense

— — 1,824 — — 1,824

Restricted stock unit vesting 88,244 — — — — —

Net loss — — — — ( 14,489 ) ( 14,489 )

Balance at September 30, 2023 188,313,807 $ 2 $ 1,570,134 $ 6 $ ( 1,609,562 ) $ ( 39,420 )

Common Stock Additional Paid-In

Capital Accumulated Other Comprehensive Income (Loss) Accumulated

Capital Accumulated Other Comprehensive Income

Deficit Total Stockholders'

15 unchanged sentences

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 )

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3 unchanged sentences

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six Months Ended June 30,

Nine Months Ended September 30,

(dollars in thousands) 2024 2023

41 unchanged sentences

Issuance of warrants in connection with BlackRock Credit Agreement $ 4,846 $ —

Unpaid issuance costs related to BlackRock Credit Agreement $ 522 $ —

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

24 unchanged sentences

In addition, the Company continues to explore additional development opportunities to expand its pipeline and portfolio of novel therapeutics.

As of June 30, 2024, the Company had cash and cash equivalents of approximately $ 39.5 million.

As of September 30, 2024, the Company had cash and cash equivalents of approximately $ 34.0 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 .

1 unchanged sentence

The Company expects to finance future cash needs through product and license, collaboration and other revenue, including royalties and revenue from supply agreements.

If the Company believes its resources are insufficient to satisfy its liquidity requirements, it 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.

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.

3 unchanged sentences

In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the unaudited condensed consolidated financial statements have been included.

Interim results for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024 or any other future period.

The Company has experienced seasonality from quarter to quarter.

In general, the first quarter usually has lower revenues than the preceding fourth quarter, the second and third quarters have higher revenues than the first quarter, and the fourth quarter revenues are the highest in the year.

Interim results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024 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 .

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP .

The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.

All significant intercompany balances and transactions have been eliminated in the consolidated financial statements herein.

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.

9 unchanged sentences

Significant estimates and judgments reflected in these unaudited condensed consolidated financial statements include, but are not limited to:

accrued expenses, other long-term liabilities, product 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, intangible asset and goodwill.

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, intangible asset 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 June 30, 2024, cash and cash equivalents primarily included cash on hand.

As of September 30, 2024, cash and cash equivalents primarily included cash on hand.

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 .

1 unchanged sentence

The following table reconciles cash, cash equivalents and restricted cash reported within the Company's consolidated balance sheets to the total amounts showing in the consolidated statements of cash flows:

(in thousands) June 30, 2024 December 31, 2023

(in thousands) September 30, 2024 December 31, 2023

Cash and cash equivalents $ 34,019 $ 42,925

7 unchanged sentences

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

The Company believes that credit risks associated with its customers and collaboration partners are not significant.

The Company's allowance for credit losses was $ 0.5 million and $ 1.0 million as of September 30, 2024 and December 31, 2023, respectively.

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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 $ 0.2 million and $ 1.0 million as of June 30, 2024 and December 31, 2023, respectively.

For the six months ended June 30, 2024, net recoveries were $ 0.2 million, inclusive of an incremental allowance for credit losses of $ 0.2 million for the three months ended June 30, 2024.

Write-offs were $ 0.6 million for the three and six months ended June 30, 2023.

The following table summarizes the activity related to the Company's allowance for credit losses (in thousands):

Nine Months Ended September 30,

Beginning balance $ 1,029 $ 1,106

Provision for bad debts 194 ( 562 )

Recoveries/(write-offs)

Ending balance $ 528 $ 544

Manufacturing and Distribution Risk

14 unchanged sentences

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):

June 30, 2024

September 30, 2024

Level 1 Level 2 Level 3 Total Fair Value

5 unchanged sentences

Money market funds $ 1,504 $ — $ — $ 1,504

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.

As of June 30, 2024, the Company did not have any money market funds included in cash equivalents.

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.

1 unchanged sentence

volatility, risk-free rate, dividend yield and expected term.

As of September 30, 2024, the Company did not have any money market funds included in cash equivalents.

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

INVENTORIES AND PREPAID MANUFACTURING

Inventories consists of the following (in thousands):

June 30, 2024 December 31, 2023

September 30, 2024 December 31, 2023

Inventories, current:

5 unchanged sentences

Work-in-process 23,476 8,260

Finished goods

Inventories, long-term 24,718 9,403

Total inventories $ 45,211 $ 25,094

As of June 30, 2024 and December 31, 2023, inventory consisted primarily of inventory related to the Company's commercial product, Auryxia.

As of June 30, 2024 and December 31, 2023, the Company had no prepaid manufacturing costs and $ 0.5 million of prepaid manufacturing costs for Auryxia drug substance, respectively.

Inventory written down for Auryxia as a result of excess, obsolescence, scrap or other reasons charged to cost of product and other revenue in the unaudited condensed consolidated statement of operations and comprehensive loss totaled approximately $ 0.5 million and $ 1.1 million during the three and six months ended June 30, 2024, respectively, and $ 0.3 million and $ 0.6 million during the three and six months ended June 30, 2023, respectively.

For the three and six months ended June 30, 2024, the Company realized lower cost of product and other revenue of $ 4.9 million and $ 8.6 million, respectively, due to the Company's ability to commercially sell inventory previously written down to zero, its then net realizable value.

Pre-Launch Inventory

The Company records advance payments for Vafseo active pharmaceutical ingredient, or API , or drug substance (raw materials) it expects to use for the U.S.

launch and the EEA, the UK, Switzerland and Australia, or the Medice Territory , as prepaid manufacturing costs.

Upon the quality release of the Vafseo batches and transfer of title to the Company from the contract manufacturing organization, or CMO , the cost of the pre-launch inventory prior to regulatory approval, including the manufacturing costs, was expensed to R&D.

As of June 30, 2024 and December 31, 2023, the Company had $ 11.6 million and $ 14.0 million, respectively, of prepaid manufacturing costs for Vafseo drug substance expected to be used in the U.S.

launch of Vafseo included in prepaid expenses and other current assets on the unaudited condensed consolidated balance sheets.

See Note 6, Additional Balance Sheet Detail , for further information.

Inventory written down for Auryxia 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 loss totaled approximately $ 1.3 million and $ 2.4 million during the three and nine months ended September 30, 2024, respectively, and $ 0.7 million and $ 1.3 million during the three and nine months ended September 30, 2023, 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 commercially sell inventory previously written down to zero, its then net realizable value.

Prior to the FDA’s approval of Vafseo on March 27, 2024, all costs for the manufacture of product to support clinical development and commercial launch, including pre-launch inventory, were expensed as incurred.

Pre-launch inventory manufactured prior to the FDA approval of Vafseo will be used in commercial production until it is depleted.

As of September 30, 2024 and December 31, 2023, the Company had cumulatively expensed $ 28.4 million in pre-launch inventory costs for Vafseo intended for the U.S.

INTANGIBLE ASSET AND GOODWILL

Intangible Asset

Intangible asset, net of accumulated amortization, prior impairments and adjustments as of June 30, 2024 and December 31, 2023 consisted of the following (in thousands):

June 30, 2024 December 31, 2023

Intangible asset, net of accumulated amortization, prior impairments and adjustments as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

September 30, 2024 December 31, 2023

Intangible asset:

2 unchanged sentences

Developed product rights for Auryxia $ 214,705 $ ( 205,694 ) $ 9,011 $ 36,042 6 years

The Company recorded $ 9.0 million in amortization expense for each of the three months ended June 30, 2024 and 2023, and $ 18.0 million for each of the six months ended June 30, 2024 and 2023 related to the developed product rights for Auryxia.

As of June 30, 2024 and December 31, 2023, the Company had goodwill of $ 59.0 million in connection with the December 2018 merger with Keryx.

The Company recorded $ 9.0 million in amortization expense for each of the three months ended September 30, 2024 and 2023, and $ 27.0 million for each of the nine months ended September 30, 2024 and 2023 related to the developed product rights for Auryxia.

As of September 30, 2024 and December 31, 2023, the Company had goodwill of $ 59.0 million in connection with the December 2018 merger with Keryx.

The Company has not i dentified any goodwill impairment to date.

ADDITIONAL BALANCE SHEET DETAIL

Prepaid expenses and other current assets are as follows (in thousands):

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

ADDITIONAL BALANCE SHEET DETAIL

Prepaid expenses and other current assets are as follows (in thousands):

Description June 30, 2024 December 31, 2023

Description September 30, 2024 December 31, 2023

Prepaid manufacturing $ 7,227 $ 14,489

1 unchanged sentence

Total prepaid expenses and other current assets $ 13,438 $ 20,243

See Note 4, Inventories and Prepaid Manufacturing , for further information on prepaid manufacturing expenses.

Prepaid manufacturing expenses include advance payments to contract manufacturing organizations, or CMOs , for active pharmaceutical ingredient, or API , 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.

Prior to receiving regulatory approval for Vafseo, such amounts were expensed to R&D upon the quality release of the batches and transfer of title to the Company from the CMO.

See Note 4, Inventories , for further information on inventories, including pre-launch inventory.

Other long-term assets are as follows (in thousands):

Description June 30, 2024 December 31, 2023

Description September 30, 2024 December 31, 2023

Long-term inventories $ 24,718 $ 9,403

2 unchanged sentences

Total other long-term assets $ 27,134 $ 12,423

See Note 4, Inventories and Prepaid Manufacturing , for further information on long-term inventories.

See Note 4, Inventories , for further information on long-term inventories.

Cloud Computing Implementation Costs

5 unchanged sentences

Post-configuration training and maintenance costs will be expensed as incurred.

Other long-term assets as of June 30, 2024 included approximately $ 0.9 million of capitalized implementation costs.

Prepaid expenses and other current assets and other long-term assets as of September 30, 2024 included approximately $ 0.2 million and $ 0.7 million of capitalized implementation costs, respectively.

There were no implementation costs capitalized as of December 31, 2023.

Amortization expense for the capitalized implementation costs was immaterial for the three and six months ended June 30, 2024.

There was no amortization expense for the three and six months ended June 30, 2023.

Amortization expense for the capitalized implementation costs was $ 0.1 million for the three and nine months ended September 30, 2024.

There was no amortization expense for the three and nine months ended September 30, 2023.

Accrued expenses and other current liabilities consists of the following (in thousands):

June 30, 2024 December 31, 2023

September 30, 2024 December 31, 2023

Product revenue allowances $ 15,361 $ 22,940

27 unchanged sentences

The Term Loan Facility will accrue interest at a floating annual rate equal to the sum of (i) 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 June 30, 2024, the Company's interest rate was 12.09 %.

The Company recognized interest expense related to the BlackRock Credit Agreement of $ 1.6 million and $ 3.8 million during the three and six months ended June 30, 2024, respectively.

As of September 30, 2024, the Company's interest rate was 11.59 %.

The Company recognized interest expense related to the BlackRock Credit Agreement of $ 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.

2 unchanged sentences

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 June 30, 2024, future principal payments under the BlackRock Credit Agreement are as follows (in thousands):

As of September 30, 2024, future principal payments under the BlackRock Credit Agreement are as follows (in thousands):

Principal Payments

10 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

On July 10, 2024, in connection with the Vifor Termination Agreement, the Company and Kreos entered into a First Amendment to the BlackRock Credit Agreement, or the BlackRock Credit Amendment , which amends certain provisions of the BlackRock Credit Agreement.

See Note 16, Subsequent Events , for further information on the BlackRock Credit Amendment.

On July 10, 2024, in connection with the Vifor Termination and Settlement Agreement, or the Vifor Termination Agreement , the Company and Kreos entered into a First Amendment to the BlackRock Credit Agreement, or the BlackRock Credit Amendment , which amended certain provisions of the BlackRock Credit Agreement.

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 , and upon borrowing of Tranche C, the Company would become obligated to issue to 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 .

1 unchanged sentence

The Initial Warrant is liability classified under ASC 815, Derivatives and Hedging , as it could potentially require net cash settlement outside of the Company’s control.

The Initial Warrant is measured at fair value each period with changes in fair value presented within the unaudited condensed consolidated statements of operations.

The fair value of the warrant liability was $ 2.6 million as of June 30, 2024.

The Initial Warrant is measured at fair value each period with changes in fair value presented within the unaudited condensed consolidated statements of operations and comprehensive loss.

The fair value of the warrant liability was $ 3.5 million as of September 30, 2024.

See Note 3, Fair Value of Financial Instruments , for information on the fair value determination.

Other Agreements Accounted for as Debt

The Company has a liability related to the sale of future royalties which is accounted for as a debt arrangement.

See Note 8, Deferred Revenue, Refund Liability and Liability Related to Sale of Future Royalties , for further information.

The Company has a refund liability with Vifor (International) Ltd.

(now a part of CSL Limited), or CSL Vifor , which is also accounted for as a debt arrangement.

See Note 8, Deferred Revenue, Refund Liability and Liability Related to Sale of Future Royalties , for further information.

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)

7 unchanged sentences

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 six months ended June 30, 2024, the Company recorded a debt extinguishment loss of $ 0.5 million.

During the nine months ended September 30, 2024, the Company recorded a debt extinguishment loss of $ 0.5 million.

The Pharmakon Term Loans, as amended, bore interest through maturity at a variable rate based on the three month SOFR plus a SOFR adjustment of 0.30 % plus 7.50 %.

The SOFR interest rate was capped at 3.35 % through October 31, 2023, the date of the Fourth Amendment to the Pharmakon Loan Agreement, or Fourth Amendment .

Interest expense related to the Pharmakon Loan Agreement was immaterial for the three and six months ended June 30, 2024.

The Company recognized $ 1.6 million and $ 3.3 million of interest expense related to the Pharmakon Loan Agreement during the three and six months ended June 30, 2023, respectively.

Interest expense related to the Pharmakon Loan Agreement was immaterial for the three and nine months ended September 30, 2024.

The Company recognized $ 1.4 million and $ 4.7 million of interest expense related to the Pharmakon Loan Agreement during the three and nine months ended September 30, 2023, respectively.

See Note 7, Indebtedness , of the Notes to the Consolidated Financial Statements in the 2023 Form 10-K for further details.

DEFERRED REVENUE, REFUND LIABILITY AND LIABILITY RELATED TO SALE OF FUTURE ROYALTIES

The Company had the following deferred revenue balances as of June 30, 2024 (in thousands):

June 30, 2024

Deferred Revenue:

Short-Term Long-Term Total

CSL Vifor License Agreement $ 43,296 — $ 43,296

Total $ 43,296 $ — $ 43,296

CSL Vifor License Agreement

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 May 12, 2017, or the Original License Agreement .

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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 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, or FMCNA , and its affiliates, including Fresenius Kidney Care Group LLC, to certain third-party dialysis organizations approved by the Company, to independent dialysis organizations that are members of certain group purchasing organizations and certain non-retail specialty pharmacies, collectively, the Supply Group , in the U.S.

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 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 recorded as long-term deferred revenue in the accompanying unaudited condensed consolidated balance sheets.

On July 10, 2024, the Company and CSL Vifor entered into a Termination and Settlement Agreement, or the Vifor Termination Agreement , pursuant to which the Company and CSL Vifor agreed, among other things, to terminate, effective immediately, the Vifor License Agreement.

See Note 16, Subsequent Events , for further information on the Vifor Termination Agreement.

In addition, CSL Vifor made an upfront payment to the Company of $ 25.0 million in February 2022 in connection with the amendment and restatement of the Vifor License Agreement, which was previously recorded as long-term deferred revenue in the consolidated balance sheets.

See Note 8, Deferred Revenue, Refund Liability and Liability Related to Sale of Future Royalties , of the Notes to the Consolidated Financial Statements in the 2023 Form 10-K for a more detailed description of the Vifor License Agreement.

Investment Agreements

1 unchanged sentence

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 representing the premium over the closing stock price, or $ 4.7 million for the 2017 Shares and $ 13.6 million for the 2022 Shares, represents consideration related to the Vifor License Agreement.

The $ 18.3 million representing 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 agreement 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.

See Note 8, Deferred Revenue, Refund Liability and Liability Related to the Sale of Future Royalties , of the Notes to the Consolidated Financial Statements in the 2023 Form 10-K for a more detailed description of the Vifor License Agreement.

Deferred Revenue Recognition

The Company evaluated the elements of the Vifor License Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, CSL Vifor, was a customer.

The Company identified one performance obligation under the Vifor License Agreement at inception which was the non-sublicensable, non-transferrable license under certain of the Company's intellectual property to (i) sell Vafseo solely to the Supply Group, (ii) sell Vafseo to Designated Wholesalers solely for resale to members of the Supply Group, (iii) conduct medical affairs with respect to Vafseo in the U.S.

in the field during the term of the Vifor License Agreement and (iv) use the Akebia trademark solely in connection with the sale of Vafseo.

The transaction price of $ 43.3 million was 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.

Under the Vifor License Agreement, these payments from CSL Vifor were non-refundable and non-creditable against any other amount due to the Company.

In addition, if the Centers for Medicare & Medicaid Services, or CMS, determined that Vafseo was excluded from the Transitional Drug Add-on Payment Adjustment, or TDAPA , the Company had the right to terminate the Vifor License Agreement and would then be required to repay the up-front payment and the premiums paid by CSL Vifor on the 2017 Shares and the 2022 Shares.

Given the previous uncertainty associated with a potential future approval of Vafseo by the FDA, and whether Vafseo would be included in certain reimbursement bundles by CMS, the Company constrained the entire transaction price at inception.

As a result of the Vifor Termination Agreement, there are no remaining performance obligations under the Vifor License Agreement.

Accordingly, the transaction price of $ 43.3 million was classified as short-term deferred revenue in the accompanying unaudited condensed consolidated balance sheets as of June 30, 2024.

Refund Liability to Customer/Working Capital Fund

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.

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 will commence 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 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 above.

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

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The Company determined the Working Capital Fund did not represent an obligation to transfer goods or services to CSL Vifor in the future and thus under ASC 606 was recorded as a refund liability.

The refund liability was considered a debt arrangement with zero coupon interest and the Company imputed interest on the refund liability at a rate of 15.0 % per annum, which was determined based on certain factors, including the Company's credit rating, comparable securities yield and the expected repayment period.

On March 18, 2022, when the $ 40.0 million was received from CSL Vifor, the Company recorded an initial discount on the refund liability and a corresponding deferred gain on the condensed consolidated balance sheet.

The discount on the refund liability was amortized to interest expense using the effective interest method over the expected term of the Vifor License Agreement.

The deferred gain was amortized to interest income on a straight-line basis over the expected term of the Vifor License Agreement.

The amortization of the discount was $ 0.9 million and $ 1.6 million for the three and six months ended June 30, 2024, respectively, and $ 0.9 million and $ 1.7 million for the three and six months ended June 30, 2023, respectively.

The amortization of the deferred gain was $ 0.8 million and $ 1.7 million for the three and six months ended June 30, 2024, respectively, and $ 1.0 million and $ 2.0 million for the three and six months ended June 30, 2023, respectively.

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, 2024 was 41.0 % which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss.

The Company recognized interest expense of $ 4.4 million for the three and nine months ended September 30, 2024.

As of September 30, 2024, the $ 47.7 million liability related to settlement royalties is classified as a long-term liability based on the timing of payments.

Working Capital Fund Liability (Previously Referred to as Refund Liability to Customer)

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 .

5 unchanged sentences

The Company concluded that the 15 % discount rate remains appropriate.

The Company will reassess the effective rate at each reporting period.

As of June 30, 2024, the $ 40.0 million refund liability is classified as a long-term liability based on management's estimated timing of the repayment of the refund liability to Vifor exceeding one-year.

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 $ 1.1 million and $ 2.7 million for the three and nine months ended September 30, 2024, respectively, and $ 0.7 million and $ 2.4 million for the three and nine months ended September 30, 2023, respectively.

The amortization of the deferred gain was $ 0.9 million and $ 2.6 million for the three and nine months ended September 30, 2024, respectively, and $ 1.0 million and $ 3.0 million for the three and nine months ended September 30, 2023, respectively.

As of September 30, 2024, the $ 40.2 million Working Capital Fund liability is classified as a long-term liability based on management's estimated timing of the repayment of the Working Capital Fund liability to CSL Vifor exceeding one-year.

Liability Related to Sale of Future Royalties

5 unchanged sentences

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 June 30, 2024 was 0 % and, therefore the Company did not recognize any non-cash interest expense in the unaudited condensed consolidated statements of operations and comprehensive 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 loss.

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The Company paid $ 0.4 million and $ 0.9 million of royalties to HCR during the three and six months ended June 30, 2024, respectively, and $ 0.4 million and $ 1.0 million during the three and six months ended June 30, 2023, respectively.

As of June 30, 2024 and December 31, 2023 the balances were as follows (in thousands):

Liability related to sale of future royalties June 30, 2024 December 31, 2023

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, 2024 was 0 % and, therefore the Company did not recognize any non-cash interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss.

The Company paid $ 0.5 million and $ 1.4 million of royalties to HCR during the three and nine months ended September 30, 2024, respectively, and $ 0.5 million and $ 1.5 million during the three and nine months ended September 30, 2023, respectively.

As of September 30, 2024 and December 31, 2023 the balances were as follows (in thousands):

Liability related to sale of future royalties September 30, 2024 December 31, 2023

Current portion (included in accrued expenses and other current liabilities) $ 2,235 $ 2,048

9 unchanged sentences

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 June 30, 2024, the remaining lease term for the Cambridge Lease was 2.20 years.

Operating lease costs were $ 1.2 million and $ 2.5 million for the three and six months ended June 30, 2024, respectively, and $ 1.4 million and $ 3.2 million for the three and six months ended June 30, 2023, respectively.

Cash paid for amounts included in the measurement of operating lease liabilities was $ 1.4 million and $ 2.9 million for the three and six months ended June 30, 2024, respectively, and $ 1.4 million and $ 3.1 million for the three and six months ended June 30, 2023, 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 other long-term assets in the accompanying unaudited condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023.

As of September 30, 2024, the remaining lease term for the Cambridge Lease was 1.95 years.

Operating lease costs were $ 1.2 million and $ 3.7 million for the three and nine months ended September 30, 2024, respectively, and $ 1.2 million and $ 4.4 million for the three and nine months ended September 30, 2023, respectively.

Cash paid for amounts included in the measurement of operating lease liabilities was $ 1.4 million and $ 4.3 million for the three and nine months ended September 30, 2024, respectively, and $ 1.4 million and $ 4.5 million for the three and nine months ended September 30, 2023, respectively.

Sublease and Former Boston Lease

1 unchanged sentence

The Company subleased the entire Boston Lease, effective October 2019 through February 2023.

The Company did not record any rental income for the three and six months ended June 30, 2024 and recorded no rental income and $ 0.3 million in rental income as other income in the unaudited condensed consolidated statements of operations and comprehensive loss during the three and six months ended June 30, 2023, respectively.

The Company did not record any rental income for the three and nine months ended September 30, 2024 and recorded no rental income and $ 0.3 million in rental income as other income in the unaudited condensed consolidated statements of operations and comprehensive loss during the three and nine months ended September 30, 2023, respectively.

In May 2023, pursuant to an Assignment and Assumption of Lease Agreement, or Lease Assignment Agreement, the Company assigned all of its rights, title and interest in, to, and under the Boston Lease to LG Chem Life Sciences Innovation Center, Inc., or LG Chem , and made a payment to LG Chem of $ 1.3 million.

As of May 2023, LG Chem assumed all of the rights and obligations of the Company under the Boston Lease and the Company has no further obligations for rent or other payments under the Boston Lease.

In accordance with ASC 842, Leases , the Company wrote off the right-of-use asset and lease liability associated with the Boston Lease, and recognized the difference between the right-of-use asset and the lease liability offset by the $ 1.3 million payment as a loss on lease termination in the unaudited condensed consolidated statements of operations and comprehensive loss of $ 0.5 million during the three and six months ended June 30, 2023.

Future Lease Commitments

Future commitments under the Cambridge Lease are as follows (in thousands):

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

by the $ 1.3 million payment as a loss on lease termination in the unaudited condensed consolidated statements of operations and comprehensive loss of $ 0.5 million during the nine months ended September 30, 2023.

Future Lease Commitments

Future commitments under the Cambridge Lease are as follows (in thousands):

Lease Commitments

8 unchanged sentences

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 June 30, 2024, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $ 21.4 million through the end of 2026.

As of September 30, 2024, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $ 22.3 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 excess firm commitment liability recorded in other long-term liabilities related to the Company's contractual purchase commitments with Siegfried was $ 3.6 million and $ 1.5 million as of June 30, 2024 and December 31, 2023, respectively.

Patheon Manufacturing

1 unchanged sentence

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 June 30, 2024, the Company had no minimum commitments with Patheon, however, as estimated global demand fluctuates, the Company may have future obligations under the Patheon Agreement.

As of September 30, 2024, the Company had no minimum commitments with Patheon, however, as estimated global demand fluctuates, the Company may have future obligations under the Patheon Agreement.

WuXi STA Manufacturing

2 unchanged sentences

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 June 30, 2024, the Company has committed to purchase $ 11.1 million of Vafseo drug substance from WuXi STA through the end of 2024.

On February 10, 2021, the Company entered into a Supply Agreement with WuXi STA, 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 February 10, 2025.

As of September 30, 2024, the Company has committed to purchase $ 6.9 million of Vafseo drug substance from WuXi STA through the first half of 2025.

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.

4 unchanged sentences

In addition, each party has the ability to terminate the WuXi STA DP Agreement upon the occurrence of certain conditions.

BioVectra - Former Manufacturing and Unconditional Purchase Commitments

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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.

September 30, 2024, the Company has committed to purchase $ 1.2 million of Vafseo drug product from WuXi STA 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 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.

7 unchanged sentences

The discount on the liability balance is being amortized to interest expense using the effective interest rate method over the term of the liability.

The amortization of the discount was $ 0.4 million and $ 1.0 million for the three and six months ended June 30, 2024, respectively, and $ 0.5 million and $ 0.9 million for the three and six months ended June 30, 2023, respectively.

The amortization of the discount was $ 0.4 million and $ 1.3 million for the three and nine months ended September 30, 2024, respectively, and $ 0.5 million and $ 1.4 million for the three and nine months ended September 30, 2023, respectively.

In-Licensing - Panion License Agreement

5 unchanged sentences

See Note 10, Commitments and Contingencies , of the Notes to the Consolidated Financial Statements in the 2023 Form 10-K for a more detailed description of this license agreement.

The Company incurred royalty payments due to Panion of approximately $ 2.5 million and $ 4.3 million during the three and six months ended June 30, 2024, respectively, and $ 3.2 million and $ 6.0 million during the three and six months ended June 30, 2023, respectively, relating to the Company’s sales of Auryxia in the U.S.

The Company incurred royalty payments due to Panion of approximately $ 2.1 million and $ 6.4 million during the three and nine months ended September 30, 2024, respectively, and $ 3.1 million and $ 9.3 million during the three and nine months ended September 30, 2023, respectively, relating to the Company’s sales of Auryxia in the U.S.

and JT and Torii’s net sales of Riona in Japan.

Other Third-Party Contracts

The Company contracts with various organizations to conduct R&D activities with remaining contract costs to the Company of approximately $ 46.7 million at June 30, 2024.

The Company contracts with various organizations to conduct R&D activities with remaining contract costs to the Company of approximately $ 47.0 million at September 30, 2024.

The scope of the services under these R&D contracts can be modified and the contracts cancelled by the Company upon written notice.

3 unchanged sentences

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 of the Company.

Significant judgment is required to assess the likelihood of various

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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.

Guarantees and Indemnifications

3 unchanged sentences

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 six months ended June 30, 2024 and 2023, the Company did not experience any losses related to these indemnification obligations, and no claims were outstanding as of June 30, 2024.

For the three and nine months ended September 30, 2024 and 2023, the Company did not experience any losses related to these indemnification obligations, and no claims were outstanding as of September 30, 2024.

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.

2 unchanged sentences

sales of Auryxia.

Total net product revenue was $ 41.2 million and $ 72.2 million for the three and six months ended June 30, 2024, respectively, and $ 42.2 million and $ 77.0 million for the three and six months ended June 30, 2023, respectively.

Total net product revenue was $ 35.6 million and $ 107.8 million for the three and nine months ended September 30, 2024, respectively, and $ 40.1 million and $ 117.1 million for the three and nine months ended September 30, 2023, respectively.

Product revenue allowance and reserve categories were as follows:

6 unchanged sentences

Credits/payments made ( 6,631 ) ( 36,778 ) ( 4,177 ) ( 47,586 )

Balance at June 30, 2024 $ 1,437 $ 14,733 $ 5,329 $ 21,499

Balance at September 30, 2024 $ 1,343 $ 15,316 $ 4,507 $ 21,166

(in thousands) Chargebacks

5 unchanged sentences

Credits/payments made ( 7,993 ) ( 59,318 ) ( 9,736 ) ( 77,047 )

Balance at June 30, 2023 $ 849 $ 23,303 $ 7,876 $ 32,028

Balance at September 30, 2023 $ 843 $ 23,834 $ 4,644 $ 29,321

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 loss.

1 unchanged sentence

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 $ 27.9 million and $ 35.9 million as of June 30, 2024 and December 31, 2023, respectively.

Accounts receivable, net related to product sales, was approximately $ 30.3 million and $ 35.9 million as of September 30, 2024 and December 31, 2023, respectively.

LICENSE, COLLABORATION AND OTHER REVENUE

4 unchanged sentences

The Company recognized the following revenue from its license, collaboration and other revenue agreements (in thousands):

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

Entity Description 2024 2023 2024 2023

Medice License and Product Supply of Vafseo in EU $ — $ 10,000 $ — $ 10,000

Medice License and royalties related to the sale of Vafseo in the EU

$ 29 $ — $ 29 $ 10,000

MTPC License and Product Supply of Vafseo in Japan 525 487 2,106 5,165

4 unchanged sentences

The following tables present changes in the Company’s contract assets and liabilities related to license and other revenue (in thousands):

Six Months Ended June 30, 2024

Nine Months Ended September 30, 2024

Period Additions Deductions Balance

4 unchanged sentences

Deferred revenue (2)

Six Months Ended June 30, 2023

$ 43,296 $ — $ ( 43,296 ) $ —

Nine Months Ended September 30, 2023

Period Additions Deductions Balance

5 unchanged sentences

Deferred revenue $ 47,034 $ — $ ( 3,738 ) $ 43,296

(1) Excludes accounts receivable related to amounts due to the Company from product sales of Auryxia which are included in the accompanying unaudited condensed consolidated balance sheets as of June 30, 2024 and 2023.

(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 June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

Revenue Recognized in the Period:

1 unchanged sentence

Deferred revenue — beginning of the period $ — $ — $ — $ 3,738

During each of the three and six months ended June 30, 2024 and 2023, the Company recognized no revenue from performance obligations satisfied in previous periods.

During each of the three and nine months ended September 30, 2024 and 2023, the Company recognized no revenue from performance obligations satisfied in previous periods.

Medice License Agreement

2 unchanged sentences

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

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(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.

6 unchanged sentences

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 606-10-15, Revenue from Contracts with Customers – Scope and Scope Exceptions .

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.

2 unchanged sentences

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 Medice License Agreement provides that the Company and Medice will enter into a supply agreement pursuant to which the Company will supply Vafseo to Medice for commercial use in the Medice Territory.

As of June 30, 2024, the Company and Medice have not yet entered into a supply agreement.

The Company evaluated the elements of the Medice License Agreement in accordance with the provisions of ASC 606 and concluded Medice is a customer.

1 unchanged sentence

The transaction price at inception was comprised of the up-front payment of $ 10.0 million, of which the Company received $ 8.6 million during the quarter ended June 30, 2023.

The remaining $ 1.4 million was withheld by the German Federal Tax Office and is included in prepaid expenses and other current assets as of June 30, 2024 and other long-term assets as of December 31, 2023 on the unaudited condensed consolidated balance sheets.

The remaining $ 1.4 million was withheld by the German Federal Tax Office and is included in prepaid expenses and other current assets as of September 30, 2024 and other long-term assets as of December 31, 2023 on the unaudited condensed consolidated balance sheets.

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 three and six months ended June 30, 2023.

In accordance with ASC 606, the Company will recognize sales-based royalties and milestone payments at the later of when the performance obligation is satisfied or the related sales occur.

During the three and nine months ended September 30, 2024, the Company recognized immaterial revenue from Medice royalties.

The Company did not recognize any revenue from Medice royalties during the three and nine months ended September 30, 2023.

As of September 30, 2024, there were immaterial contract assets, and no accounts receivable, payables or deferred revenue in connection with the Medice License Agreement.

Medice Letter Agreement

On December 6, 2023, the Company and Medice entered into a letter agreement, or the Medice Letter Agreement , pursuant to which the Company agreed to sell to Medice a partial batch of Vafseo in order to achieve packaging validation for the Medice Territory.

The Company recognizes revenue under this arrangement when risk of loss passes to Medice and delivery has occurred.

As of June 30, 2024, there were immaterial accounts receivable and no contract assets, payables or deferred revenue recorded in connection with the Medice Letter Agreement.

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

The Company previously recognized revenue under this arrangement when risk of loss passed to Medice and delivery occurred.

As of September 30, 2024, there were no accounts receivable, contract assets, payables or deferred revenue recorded in connection with the Medice Letter Agreement.

Supply of Drug Product to Medice

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

effective as of December 2, 2022.

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, 2024 or 2023.

MTPC Collaboration Agreement

In addition, the Company supplies Vafseo to MTPC for both clinical and commercial use in the MTPC Territory.

7 unchanged sentences

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 June 30, 2024, all development milestones and $ 25.0 million in regulatory milestones have been achieved.

As of September 30, 2024, all development milestones and $ 25.0 million in regulatory milestones have been achieved.

No other regulatory milestones have been assessed as probable of being achieved and as a result have been fully constrained.

4 unchanged sentences

The Company recognizes any revenue from MTPC royalties in the period in which the sales occur.

The Company recognized $ 0.5 million and $ 0.9 million of revenue from MTPC royalties during each of the three and six months ended June 30, 2024 and 2023, respectively.

The Company recognized revenue from MTPC royalties of $ 0.5 million during each of the three months ended September 30, 2024 and 2023 and $ 1.4 million during each of the nine months ended September 30, 2024 and 2023.

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, Deferred Revenue, Refund Liability and Liability Related to Sale of Future Royalties , for additional information.

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 loss.

As of June 30, 2024, there were no accounts receivable, payables or deferred revenue and $ 0.5 million in contract assets recorded in connection with the MTPC Agreement.

As of September 30, 2024, 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

4 unchanged sentences

The Company has no further obligation to take delivery of, or pay for, product delivered by Esteve.

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 $ 0.7 million in revenue under the MTPC Supply Agreement during the three and six months ended June 30, 2024, and no revenue and $ 3.7 million in revenue under the MTPC Supply Agreement during the three and six months ended June 30, 2023, respectively.

As of June 30, 2024, there were no accounts receivable, deferred revenue or other current liabilities relating to the MTPC Supply Agreement.

JT and Torii Sublicense Agreement

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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 and $ 0.7 million in revenue under the MTPC Supply Agreement during the three and nine months ended September 30, 2024, respectively, and no revenue and $ 3.7 million in revenue under the MTPC Supply Agreement during the three and nine months ended September 30, 2023, respectively.

As of September 30, 2024, there were no accounts receivable, deferred revenue or other current liabilities relating to 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 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.

6 unchanged sentences

As such, the Company allocated the entire transaction price to the License and Supply Performance Obligation.

The Company recognized license revenue of $ 1.3 million and $ 2.5 million during the three and six months ended June 30, 2024, respectively, and $ 1.4 million and $ 2.5 million during the three and six months ended June 30, 2023, respectively, related to royalties earned on net sales of ferric citrate hydrate in Japan under the trade name Riona.

The Company recognized license revenue of $ 1.3 million and $ 3.7 million during the three and nine months ended September 30, 2024, respectively, and $ 1.4 million and $ 4.0 million during the three and nine months ended September 30, 2023, 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.

1 unchanged sentence

Authorized and Outstanding Capital Stock

On June 5, 2020, the Company filed a Certificate of Amendment to its Ninth Amended and Restated Certificate of Incorporation, or its Charter , to increase the number of authorized shares of common stock from 175,000,000 to 350,000,000 .

As of June 30, 2024, the authorized capital stock of the Company included 350,000,000 shares of common stock, $ 0.00001 par value per share, of which 209,929,145 and 194,582,539 shares were issued and outstanding as of June 30, 2024 and December 31, 2023, 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 June 30, 2024 and December 31, 2023.

As of September 30, 2024, the authorized capital stock of the Company included 350,000,000 shares of common stock, $ 0.00001 par value per share, of which 211,542,122 and 194,582,539 shares were issued and outstanding as of September 30, 2024 and December 31, 2023, 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, 2024 and December 31, 2023.

At-the-Market Facility

On April 7, 2022, the Company entered into an at-the-market, or ATM , 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.

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 six months ended June 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).

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.

During the three and nine months ended September 30, 2024, the Company sold 1,242,662 shares of its common stock under this program with gross proceeds of $ 1.7 million ($ 1.7 million, net of offering expenses).

STOCK-BASED COMPENSATION AND BENEFIT PLAN

Stock-Based Compensation and Benefit Plans

The Company incurred stock-based compensation expenses of $ 2.1 million and $ 4.4 million for the three and six months ended June 30, 2024, respectively, and $ 3.5 million and $ 6.0 million for the three and six months ended June 30, 2023, respectively.

Equity Incentive Plans

The following table contains information about the Company's equity plans:

The Company incurred stock-based compensation expenses of $ 1.6 million and $ 6.1 million for the three and nine months ended September 30, 2024, respectively, and $ 1.8 million and $ 7.8 million for the three and nine months ended September 30, 2023, respectively.

Akebia Therapeutics, Inc.

2 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2024 December 31, 2023

Equity Incentive Plans

The following table contains information about the Company's equity plans:

September 30, 2024 December 31, 2023

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

16 unchanged sentences

(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:

1,496,428 options included as outstanding under the 2014 Plan in the table and 2,374,950 options included as outstanding under the 2023 Plan in the table as of June 30, 2024 and 1,616,019 options included as outstanding under the 2014 Plan and 794,000 options included as outstanding under the 2023 Plan in the table as of December 31, 2023.

1,195,250 options included as outstanding under the 2014 Plan in the table and 2,528,550 options included as outstanding under the 2023 Plan in the table as of September 30, 2024 and 1,616,019 options included as outstanding under the 2014 Plan and 794,000 options included as outstanding under the 2023 Plan in the table as of December 31, 2023.

Common Stock Options and Stock Appreciation Rights

During the six months ended June 30, 2024, the Company issued 3,432,500 options to employees under the 2023 Plan.

During the nine months ended September 30, 2024, the Company issued 3,432,500 options to employees 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.

2 unchanged sentences

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 six months ended June 30, 2024, the Company granted 1,604,950 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 1,604,950 options remained outstanding as of June 30, 2024.

During the nine months ended September 30, 2024, the Company granted 1,767,550 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 1,763,550 options remained outstanding as of September 30, 2024.

The Company grants annual service-based stock options to employees and directors and SARs to certain executives under the 2023 and 2014 Plans.

7 unchanged sentences

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The combined stock option activity for the six months ended June 30, 2024, is as follows:

The combined stock option activity for the nine months ended September 30, 2024, is as follows:

Options Weighted Average Exercise Price Weighted-Average Contractual Life (years) Aggregate Intrinsic Value (in thousands)

4 unchanged sentences

Canceled and forfeited ( 660,270 ) $ 3.09 — —

Outstanding at June 30, 2024 17,278,820 $ 3.42 7.37 years $ 1,521

Exercisable at June 30, 2024 8,559,257 $ 5.40 5.59 years

As of June 30, 2024, there was approximately $ 9.3 million of unrecognized compensation costs related to stock options, which is expected to be recognized over a weighted average period of 2.94 years.

Outstanding at September 30, 2024 16,755,825 $ 3.22 7.41 years $ 2,878

Exercisable at September 30, 2024 8,415,196 $ 4.97 5.89 years

As of September 30, 2024, there was approximately $ 8.5 million of unrecognized compensation costs related to stock options, which is expected to be recognized over a weighted average period of 2.79 years.

Restricted Stock Units

14 unchanged sentences

Forfeited and canceled ( 249,771 ) $ 0.92 ( 106,500 ) $ 1.68

Outstanding as of June 30, 2024 1,650,369 $ 1.07 4,313,400 $ 1.59

As of June 30, 2024, there was $ 7.3 million of unrecognized compensation costs related to time-based RSUs and PSUs, which is expected to be recognized over a weighted-average period of 2.25 years.

Outstanding as of September 30, 2024 1,474,517 $ 1.05 4,142,067 $ 1.59

As of September 30, 2024, there was $ 6.2 million of unrecognized compensation costs related to time-based RSUs and PSUs, which is expected to be recognized over a weighted-average period of 2.07 years.

Employee Stock Purchase Plan

3 unchanged sentences

In addition, an employee may not purchase more than 1,500 shares in any offering period.

As of June 30, 2024 and December 31, 2023, a total of 4,545,480 and 4,637,801 shares of the Company’s common stock were available for future issuance under the ESPP, respectively.

The Company issued 92,321 shares under the ESPP during the six months ended June 30, 2024.

As of September 30, 2024 and December 31, 2023, a total of 4,448,069 and 4,637,801 shares of the Company’s common stock were available for future issuance under the ESPP, respectively.

The Company issued 189,732 shares under the ESPP during the nine months ended September 30, 2024.

Akebia Therapeutics, Inc.

5 unchanged sentences

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 June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

Stock Options 2024 2023 2024 2023

6 unchanged sentences

The Company has classified stock-based compensation in its unaudited condensed consolidated statements of operations and comprehensive loss as follows (in thousands):

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2024 2023 2024 2023

8 unchanged sentences

The shares in the table below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, due to their anti-dilutive effect:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2024 2023 2024 2023

6 unchanged sentences

SUBSEQUENT EVENTS

The Company has evaluated events and transactions occurring after the balance sheet date through the filing date of this Quarterly Report on Form 10-Q with the SEC, to ensure that the unaudited condensed consolidated financial statements include appropriate disclose of events both recognized in the accompanying unaudited condensed consolidated financial statements as of June 30, 2024, and events which occurred subsequently but were not recognized in the consolidated financial statements.

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 disclose of events both recognized in the accompanying unaudited condensed consolidated financial statements as of September 30, 2024, and events which occurred subsequently but were not recognized in the consolidated financial statements.

The Company has concluded that no subsequent events have occurred that require disclosure other than the following:

CSL Vifor Termination and Settlement 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 which the Company granted to CSL Vifor an exclusive license to sell Vafseo to the Supply Group in the U.S.

Akebia Therapeutics, Inc.

| Form 10-Q | Page 25

Akebia Therapeutics, Inc.

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Under the Vifor License Agreement, CSL Vifor contributed $ 40.0 million to the Working Capital Fund, established to partially fund the Company’s costs of purchasing Vafseo from its contract manufacturers.

Pursuant to the terms of the Vifor Termination Agreement, and generally consistent with the terms of the Vifor License Agreement, as amended, the Company has agreed to repay the Working Capital Fund to CSL Vifor through the WCF Royalty Payments.

The WCF Royalty Payments will commence 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.

See Note 8, Deferred Revenue, Refund Liability and Liability Related to Sale of Future Royalties , for further information on the repayment of the Working Capital Fund.

In addition, 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 .

or (ii) the expiration of marketing or regulatory exclusivity for Vafseo in the U.S., or the Settlement Royalty Term .

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 will continue as described above.

The WCF Royalty Payments, 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.

Amendment to BlackRock Credit Agreement

On July 10, 2024, in connection with the Vifor Termination Agreement, the Company and Kreos entered into the BlackRock Credit Amendment.

The BlackRock Credit Amendment includes certain covenants of the Company related to the Vifor Termination Agreement.

See Note 7, Indebtedness , for further information about the BlackRock Credit Agreement.

Amendment to WuXi STA DP Agreement

On October 15, 2024, the Company and WuXi STA entered into Amendment #1 to the WuXi STA DP Agreement pursuant to which the parties agreed to extend the term of the WuXi STA DP Agreement until January 1, 2032.

In addition, the volume-based pricing structure under the WuXi STA DP Agreement was amended.

See Note 10, Commitments and Contingencies , for further information on the WuXi STA DP Agreement.

Akebia Therapeutics, Inc.

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements