What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2022-05-09 compared with 2021-11-04 · 331 added, 412 removed, 563 unchanged (57% of the section changed)

3 unchanged sentences

(in thousands, except share and per share data)

September 30,

2022 December 31,

1 unchanged sentence

Cash and cash equivalents $ 174,562 $ 149,800

Available for sale securities — 39,992

Inventory 39,422 38,195

13 unchanged sentences

Short-term deferred revenue 10,440 20,906

Current portion of refund liability to customer 16,500 —

Current portion of long-term debt 97,848 97,543

Total current liabilities 253,914 256,493

2 unchanged sentences

Derivative liability 1,110 1,820

Long-term debt, net 97,230 96,378

Liability related to sale of future royalties, net 55,095 53,079

Refund liability to customer, net of current portion 23,441 —

Other non-current liabilities 77,743 82,525

4 unchanged sentences

0 shares issued and

outstanding at September 30, 2021 and December 31, 2020

outstanding at March 31, 2022 and December 31, 2021

Common stock $ 0.00001 par value;

350,000,000 shares authorized at September 30, 2021 and December 31, 2020;

174,551,989 and 148,074,085 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

350,000,000 shares authorized at March 31, 2022 and December 31, 2021;

183,386,035 and 177,000,963 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

Additional paid-in capital 1,548,880 1,536,800

8 unchanged sentences

Three Months Ended

September 30, Nine Months Ended

September 30,

2021 2020 2021 2020

Product revenue, net $ 41,448 $ 30,408

4 unchanged sentences

Amortization of intangibles 9,011 9,011

Impairment of intangible asset — — — 115,527

Total cost of goods sold 31,344 34,606

13 unchanged sentences

Net loss $ ( 62,421 ) $ ( 69,580 )

Other comprehensive gain (loss) - unrealized gain (loss) on debt securities — 15 ( 7 ) 6

Other comprehensive loss - unrealized loss on debt securities — ( 4 )

Total comprehensive loss $ ( 62,421 ) $ ( 69,584 )

14 unchanged sentences

Share-based compensation expense — — 5,992 — — 5,992

Exercise of options 64,126 — 412 — — 412

Restricted stock unit vesting 1,063,711 — — — — —

Net loss — — — — ( 60,747 ) ( 60,747 )

Balance at March 31, 2020 130,251,440 $ 1 $ 1,251,164 $ — $ ( 854,801 ) $ 396,364

Issuance of common stock, net of

issuance costs 12,650,000 — 142,383 — — 142,383

Share-based compensation expense — — 6,864 — — 6,864

Exercise of options 48,103 — 409 — — 409

Restricted stock unit vesting 179,866 — — — — —

Unrealized loss — — — ( 4 ) — ( 4 )

Net loss — — — — ( 69,580 ) ( 69,580 )

Balance at June 30, 2020 143,129,409 $ 1 $ 1,400,820 $ ( 9 ) $ ( 1,030,552 ) $ 370,260

Proceeds from sale of stock under

employee stock purchase plan

120,634 — 649 — — 649

Share-based compensation expense — — 6,592 — — 6,592

Exercise of options 54,404 — 405 — — 405

Restricted stock unit vesting 24,205 — — — — —

Unrealized gain — — — 15 — 15

Net loss — — — — ( 59,959 ) ( 59,959 )

Balance at September 30, 2020 143,328,652 $ 1 $ 1,408,466 $ 6 $ ( 1,090,511 ) $ 317,962

Balance at March 31, 2021 158,520,089 $ 2 $ 1,460,971 $ 9 $ ( 1,247,091 ) $ 213,891

Balance at December 31, 2021 177,000,963 $ 1 $ 1,536,800 $ 6 $ ( 1,460,351 ) $ 76,456

5 unchanged sentences

Restricted stock unit vesting 1,789,326 — — — — —

Unrealized loss — — — ( 4 ) — ( 4 )

Net loss — — — — ( 62,421 ) ( 62,421 )

Balance at March 31, 2022 183,386,035 $ 2 $ 1,548,880 $ 6 $ ( 1,522,772 ) $ 26,116

Issuance of common stock, net of

issuance costs 10,446,160 — 37,266 — — 37,266

Share-based compensation expense — — 6,515 — — 6,515

Restricted stock unit vesting 685,174 — — — — —

Unrealized loss — — — ( 3 ) — ( 3 )

Net loss — — — — ( 83,038 ) ( 83,038 )

Balance at June 30, 2021 169,651,423 $ 2 $ 1,504,752 $ 6 $ ( 1,330,129 ) $ 174,631

Issuance of common stock, net of

issuance costs 4,730,466 — 16,092 — — 16,092

Proceeds from sale of stock under

employee stock purchase plan 152,917 — 379 — — 379

Share-based compensation expense — — 5,592 — — 5,592

Restricted stock unit vesting 17,183 — — — — —

Net loss — — — — ( 59,544 ) ( 59,544 )

Balance at September 30, 2021 174,551,989 $ 2 $ 1,526,815 $ 6 $ ( 1,389,673 ) $ 137,150

See accompanying notes to unaudited condensed consolidated financial statements

2 unchanged sentences

(in thousands)

Nine Months Ended

September 30, 2021 September 30, 2020

Three Months Ended

March 31, 2022 March 31, 2021

Operating activities:

3 unchanged sentences

Amortization of intangibles 9,011 9,011

Intangible asset impairment charge — 115,527

Amortization of premium/discount on investments — ( 11 )

17 unchanged sentences

Deferred revenue 33,416 ( 3,007 )

Other non-current liabilities ( 3,191 ) —

Net cash used in operating activities ( 21,620 ) ( 70,746 )

1 unchanged sentence

Purchase of equipment ( 114 ) ( 59 )

Purchase of available for sale securities — ( 99,932 )

Proceeds from the maturities of available for sale securities — 20,000

Net cash provided by (used in) investing activities 39,941 ( 99,687 )

Net cash (used in) provided by investing activities ( 114 ) 19,941

Financing activities:

Proceeds from sale of future royalties, net — 44,783

Proceeds from refund liabilities to customers 40,000 —

Proceeds from the issuance of common stock, net of issuance costs 7,178 29,327

2 unchanged sentences

Net cash provided by financing activities 47,545 74,477

Increase (decrease) in cash, cash equivalents, and restricted cash ( 21,888 ) 21,916

Increase in cash, cash equivalents, and restricted cash 25,811 23,672

Cash, cash equivalents, and restricted cash at beginning of the period 151,839 231,132

8 unchanged sentences

Akebia is a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease.

Akebia’s lead investigational product candidate, vadadustat, is an oral therapy in development for the treatment of anemia due to chronic kidney disease, or CKD.

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, or HIF-PHI, designed to mimic the physiologic effect of altitude on oxygen availability.

At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, or HIF, which stimulates erythropoietin, or EPO, production, and can lead to red blood cell, or RBC, production and improved oxygen delivery to tissues.

Vadadustat is approved and marketed in Japan as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients under the trade name Vafseo TM .

The Company submitted a New Drug Application, or NDA, to the U.S.

Food and Drug Administration, or FDA, for vadadustat in March of 2021 for the treatment of anemia due to CKD in adult patients with CKD on dialysis, or DD-CKD, and adult patients with CKD not on dialysis, or NDD-CKD.

The Company's NDA submission was accepted for filing by the FDA in May 2021 and at the time of filing the NDA, the FDA indicated that they were not currently planning to hold an Advisory Committee meeting to discuss the application for vadadustat.

The FDA also assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022.

The Company has one commercial product, Auryxia ® (ferric citrate), which is approved by the U.S.

Food and Drug Administration, or FDA, and marketed for two indications in the United States:

the control of serum phosphorus levels in adult patients with chronic kidney disease, or CKD, on dialysis, or DD-CKD, and the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or NDD-CKD.

Ferric citrate is also approved and marketed in Japan as an oral treatment for IDA in adult patients for the improvement of hyperphosphatemia in such patients with DD-CKD and NDD-CKD under the trade name Riona (ferric citrate hydrate).

Vadadustat, the Company’s lead investigational product candidate, is an investigational oral hypoxia-inducible factor prolyl hydroxylase, or HIF-PH, inhibitor designed to mimic the physiologic effect of altitude on oxygen availability.

On March 29, 2022, the Company received a complete response letter, or CRL, from the FDA.

The CRL provided that the FDA had completed its review of the Company's new drug application, or NDA, for vadadustat for the treatment of anemia due to CKD in adult patients and had determined that it could not approve the NDA in its present form.

The Company is discussing the details of the CRL with the Company's collaboration partners.

The Company’s collaboration partner, Otsuka Pharmaceutical Co.

Ltd., submitted a Marketing Authorization Application, or MAA, for vadadustat for the treatment of anemia due to CKD in adult patients to the European Medicines Agency, or EMA, in October 2021 .

In addition, the Company has a commercial product, Auryxia ® (ferric citrate), which is currently approved by the FDA and marketed for two indications in the United States:

the control of serum phosphorus levels in DD-CKD adult patients and the treatment of iron deficiency anemia, or IDA, in NDD-CKD adult patients.

Ferric citrate is also approved and marketed in Japan as an oral treatment for IDA in adult patients for the improvement of hyperphosphatemia in adult patients with DD-CKD and NDD-CKD under the trade name Riona (ferric citrate hydrate).

Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities, and providing general and administrative support for these operations.

Ltd., or Otsuka, submitted a Marketing Authorization Application, or MAA, for vadadustat for the treatment of anemia due to CKD in adult patients with DD-CKD and NDD-CKD to the European Medicines Agency, or EMA, in October 2021 .

Vadadustat is approved in Japan as a treatment for anemia due to CKD in both DD-CKD and NDD-CKD patients under the trade name Vafseo TM , and marketed and sold in Japan by Mitsubishi Tanabe Pharma Corporation, or MTPC.

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

Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities, commercializing Auryxia, and providing general and administrative support for these operations.

The Company began recording revenue from the U.S.

sales of Auryxia and revenue from sublicensing rights to Auryxia in Japan from the Company’s Japanese partners, Japan Tobacco, Inc.

and its subsidiary Torii Pharmaceutical Co., Ltd., collectively JT and Torii, on December 12, 2018 following the consummation of a merger with Keryx Biopharmaceuticals, Inc., or Keryx, or the Merger.

Additionally, following regulatory approval of vadadustat in Japan, the Company began recognizing royalty revenues from Mitsubishi Tanabe Pharma Corporation, or MTPC, from the sale of Vafseo in August 2020.

In February 2021, the Company entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P., or the Royalty Agreement, whereby the Company sold its right to receive royalties and sales milestones under its Collaboration Agreement with MTPC, or the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information).

and its subsidiary Torii Pharmaceutical Co., Ltd., collectively JT and Torii, in December 2018.

Additionally, following regulatory approval of vadadustat in Japan, the Company began recognizing royalty revenues from MTPC from the sale of Vafseo in August 2020.

In February 2021, the Company entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P., or HCR, or the Royalty Agreement, whereby the Company sold its right to receive royalties and sales milestones under its Collaboration Agreement with MTPC, or the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information).

The Company has not generated a profit to date and may never generate profits from product sales.

Vadadustat and the Company’s other potential product candidates are subject to long development cycles, and the Company may be unsuccessful in its efforts to develop, obtain marketing approval for or market vadadustat and its other potential product candidates.

If the Company does not successfully commercialize Auryxia, vadadustat or any other potential product candidate, if approved, it may be unable to achieve profitability.

If the Company does not successfully commercialize Auryxia, vadadustat, if approved, or any other potential product candidate, it may be unable to achieve profitability.

Going Concern

The Company’s management completed its going concern assessment in accordance with Accounting Standards Codification, or ASC, 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , or ASC 205-40.

Pursuant to the requirements of ASC 205-40, the Company’s management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued.

This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued.

When substantial doubt exists under this methodology, the Company’s management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern.

The mitigating effect of the Company’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.

As of March 31, 2022, the Company had cash and cash equivalents of approximately $ 174.6 million.

The Company believes that its cash resources will be sufficient to allow the Company to fund its current operating plan through at least the next twelve months from the filing of this Quarterly Report on Form 10-Q.

If the Company receives regulatory approval of vadadustat in the U.S., the Company expects to incur significant incremental costs to its current operating plan to commercialize vadadustat, including costs of marketing, manufacturing and distribution.

The potential timely regulatory approval of vadadustat and the receipt of associated regulatory milestones is an important source of funding of the Company's cash runway.

However, the Company will require additional funding to fund its operating plan beyond the next twelve months.

There are numerous risks and uncertainties associated with research, development and commercialization activities, and actual results could vary materially as a result of a number of factors, many of which are outside of the Company's control.

There can be no assurance, however, that the current operating plan will be achieved in the time frame anticipated by the Company, or that its cash resources will fund the Company’s operating plan for the period anticipated by the Company or that additional funding will be available on terms acceptable to the Company, or at all.

The Company will require additional capital to pursue development and commercial activities related to Auryxia and vadadustat or any additional products and product candidates, including those that may be in-licensed or acquired.

The Company expects to finance future cash needs through product

revenue, public or private equity or debt transactions, payments from its collaborators, strategic transactions, or a combination of these approaches.

However, additional financing may not be available to the Company on acceptable terms, or at all.

If the Company is unable to raise capital in sufficient amounts when needed or on attractive terms, it may not be able to pursue development and commercial activities related to Auryxia and vadadustat or any additional products and product candidates, including those that may be in-licensed or acquired.

However, the Company's operating plan includes assumptions pertaining to cost avoidance measures and the reduction of overhead costs that would result from the planned amendment of certain contractual arrangements, including with certain supply and collaboration partners, and the reduction of certain infrastructure costs.

Therefore, because these cost avoidance initiatives and certain other elements of the Company's operating plan are outside of its control, including the amendment of certain contractual arrangements, including with supply and collaboration partners, and the reduction of certain infrastructure costs, there is uncertainty as to whether the Company's cash resources will be adequate to support its operations for a period through at least the next twelve months from the date of issuance of these financial statements.

In addition, on February 18, 2022, the Company and BioPharma Credit PLC, or the Collateral Agent, BPCR Limited Partnership, as a Lender, and BioPharma Credit Investments V (Master) LP, as a Lender, entered into the First Amendment and Waiver, or the First Amendment and Waiver, which amends and waives certain provisions of the Loan Agreement, dated November 11, 2019 (see Note 10).

Pursuant to the Loan Agreement, as amended, the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ending June 30, 2022 and September 30, 2022, and its future Annual Reports on Form 10-K, must not be subject to any qualification as to going concern.

If the Company does not satisfy the covenant as to going concern in any of these filings, the Company will be in default under the Loan Agreement.

If an event of default occurs and is continuing under the Loan Agreement, the Collateral Agent is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement, which the Company may not have the available cash resources to repay at such time.

There is also uncertainty as to whether or not the Company will meet its quarterly and annual debt covenants under the Loan Agreement.

These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued.

Management’s plans to alleviate the conditions that raise substantial doubt through cost avoidance measures, including amending certain contractual arrangements, and deprioritizing and cancelling certain infrastructure activities for the Company to continue as a going concern for a period of twelve months from the date the financial statements are issued.

However, the Company has concluded that the likelihood that its plan to extend its cash runway from one or more of these approaches will be successful, while reasonably possible, is less than probable.

Accordingly, the Company has concluded that substantial doubt exists about our ability to continue as a going concern for a period of at least twelve months from the date of issuance of these financial statements.

If conditions that raise substantial doubt regarding the Company's ability to continue as a going concern still exist as of the filing of the Company's Quarterly Report on Form 10-Q for the quarter ending June 30, 2022, the Company will be in default under its Loan Agreement, as amended.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business.

The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities, other than obligations under the Loan Agreement classified as current, that might result from the outcome of the uncertainties described above.

Summary of Significant Accounting Policies

4 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 nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021 or any other future period.

Interim results for the three months ended March 31, 2022 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2022 or any other future period.

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

2 unchanged sentences

The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the U.S.

Securities and Exchange Commission on February 25, 2021, or the 2020 Annual Report on Form 10-K.

The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2021 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s 2020 Annual Report on Form 10-K and are updated below as necessary.

New Accounting Pronouncements – Recently Adopted

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes.

This standard became effective for the Company on January 1, 2021.

ASU 2019-12 requires certain amendments to be applied using a modified retrospective approach, which requires a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption, while other amendments should be applied on a prospective basis.

The adoption of this standard did not have a material impact on the Company’s unaudited condensed consolidated financial statements and related disclosures.

Securities and Exchange Commission on March 1, 2022, or the 2021 Annual Report on Form 10-K.

The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements for the three months ended March 31, 2022 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s 2021 Annual Report on Form 10-K and are updated below as necessary.

New Accounting Pronouncements – Not Yet Adopted

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848):

Facilitation of the Effects of Reference Rate Reform on Financial Reporting .

The amendments provide optional guidance for a limited time to ease the potential burden in accounting for reference rate reform.

The new guidance provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met.

The amendments apply only to contracts and hedging relationships that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform.

These amendments are effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2022.

The Company is currently evaluating its contracts and the optional expedients provided by the new standard.

Use of Estimates

6 unchanged sentences

Estimates are used in the following areas, among others:

prepaid and accrued research and development expense, operating lease assets and liabilities, derivative liabilities, other non-current liabilities, including the excess purchase commitment liability, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, non-cash interest expense on the liability related to sale of future royalties, inventories, income taxes, intangible assets and goodwill.

The Company has made estimates of the impact of COVID-19 within the unaudited condensed consolidated financial statements and there may be changes to those estimates in future periods including changes to sales, payor mix, reserves and allowances, intangible assets and goodwill.

prepaid and accrued research and development expense, operating lease assets and liabilities, derivative liabilities, refund liabilities to customers, other non-current liabilities, including the excess purchase commitment liability, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, non-cash interest expense on the liability related to sale of future royalties, inventories, income taxes, intangible assets and goodwill.

Although the Company regularly assesses these estimates, actual results could differ materially from these estimates.

1 unchanged sentence

The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances.

Liability Related to Sale of Future Royalties

The Company treats the liability related to sale of future royalties, see Note 5, as a debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream.

The liability related to sale of future royalties and the debt amortization are based on the Company’s current estimates of future royalties expected to be paid over the life of the arrangement.

The Company will periodically assess the expected royalty payments.

To the extent the Company’s estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis.

Non-cash royalty revenue is reflected as royalty revenue within license, collaboration and other revenue, and non-cash amortization of debt is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss.

Product Revenue and Reserves for Variable Consideration

1 unchanged sentence

sales of Auryxia.

Total net product revenue was $ 36.8 million and $ 34.4 million for the three months ended September 30, 2021 and 2020, respectively, and $ 100.1 million and $ 94.3 million for the nine months ended September 30, 2021 and 2020, respectively.

The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2021 and 2020 (in thousands):

Total net product revenue was $ 41.4 million and $ 30.4 million for the three months ended March 31, 2022 and 2021, respectively.

The following table summarizes activity in each of the product revenue allowance and reserve categories for the three months ended March 31, 2022 and 2021 (in thousands):

and Discounts Rebates, Fees

4 unchanged sentences

Credits/payments made ( 2,465 ) ( 22,491 ) ( 1,293 ) ( 26,249 )

Balance at September 30, 2021 $ 1,119 $ 44,236 $ 536 $ 45,891

Balance at March 31, 2022 $ 1,392 $ 26,237 $ 541 $ 28,170

Balance at December 31, 2020 $ 802 $ 39,912 $ 649 $ 41,363

2 unchanged sentences

Credits/payments made ( 2,646 ) ( 29,098 ) ( 1,917 ) ( 33,661 )

Balance at September 30, 2020 $ 785 $ 41,869 $ 774 $ 43,428

Balance at March 31, 2021 $ 1,329 $ 43,216 $ 884 $ 45,429

Chargebacks, discounts and returns are recorded as a direct reduction of revenue on the unaudited condensed consolidated statement of operations with a corresponding reduction to accounts receivable on the unaudited condensed consolidated balance sheets.

Rebates, distribution-related fees, and other sales-related deductions are recorded as a reduction in revenue on the unaudited condensed consolidated statement of operations with a corresponding increase to accrued liabilities or accounts payable on the unaudited condensed consolidated balance sheets.

Accounts receivable, net related to product sales was approximately $ 22.2 million and $ 21.9 million as of September 30, 2021 and December 31, 2020, respectively.

Accounts receivable, net related to product sales was approximately $ 27.7 million and $ 24.6 million as of March 31, 2022 and December 31, 2021, respectively.

License, Collaboration and Other Significant Agreements

During the three and nine months ended September 30, 2021 and 2020, the Company recognized the following revenues from its license, collaboration and other significant agreements and had the following deferred revenue balances as of September 30, 2021:

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

2021 2020 2021 2020

During the three months ended March 31, 2022 and 2021, the Company recognized the following revenues from its license, collaboration and other significant agreements and had the following deferred revenue balances as of March 31, 2022:

Three Months Ended March 31,

License, Collaboration and Other Revenue:

(in thousands) (in thousands)

(in thousands)

MTPC Agreement $ 7,962 $ 18

5 unchanged sentences

Total License, Collaboration and Other Revenue $ 20,251 $ 21,896

September 30, 2021

Three Months Ended

March 31, 2022

Short-Term Long-Term Total

4 unchanged sentences

Otsuka International Agreement 4,248 5,973 10,221

Vifor Agreement — 4,678 4,678

Vifor Pharma Agreement — 43,296 43,296

Total $ 10,440 $ 65,356 $ 75,796

The following table presents changes in the Company’s contract assets and liabilities during the nine months ended September 30, 2021 and 2020 (in thousands):

Nine Months Ended September 30, 2021 Balance at

The following table presents changes in the Company’s contract assets and liabilities during the three months ended March 31, 2022 and 2021 (in thousands):

Three Months Ended March 31, 2022 Balance at

Period Additions Deductions Balance at End

6 unchanged sentences

Accrued expenses and other current liabilities $ — $ — $ — $ —

Nine Months Ended September 30, 2020

Three Months Ended March 31, 2021

Contract assets:

5 unchanged sentences

Accrued expenses and other current liabilities $ 10,000 $ — $ — $ 10,000

(1) Excludes accounts receivable from other services related to clinical and regulatory activities performed by the Company on behalf of MTPC that are not included in the performance obligations identified under the MTPC Agreement as of September 30, 2021 and 2020 and December 31, 2020 and 2019.

Also excludes accounts receivable related to amounts due to the Company from product sales which are included in the accompanying unaudited condensed consolidated balance sheet as of September 30, 2021 and December 31, 2020.

During the three and nine months ended September 30, 2021 and 2020, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods (in thousands):

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

(1) Excludes accounts receivable from other services related to clinical and regulatory activities performed by the Company on behalf of MTPC that are not included in the performance obligations identified under the MTPC Agreement as of March 31, 2022 and 2021 and December 31, 2021 and 2020.

During the three months ended March 31, 2022 and 2021, 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 March 31,

Revenue Recognized in the Period from:

2021 2020 2021 2020

Amounts included in deferred revenue at the beginning of the period $ 6,602 $ 5,382

2 unchanged sentences

Summary of Agreement

On December 11, 2015, the Company and MTPC entered into a collaboration agreement, or the MTPC Agreement, providing MTPC with exclusive development and commercialization rights to vadadustat in Japan and certain other Asian countries, collectively, the MTPC Territory.

On December 11, 2015, the Company and MTPC entered into the MTPC Agreement, providing MTPC with exclusive development and commercialization rights to vadadustat in Japan and certain other Asian countries, collectively, the MTPC Territory.

In addition, the Company will supply vadadustat for both clinical and commercial use in the MTPC Territory, subject to MTPC’s option to manufacture commercial drug product in the MTPC Territory.

A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2020 Annual Report on Form 10-K.

In February 2021, the Company entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P., or the Royalty Agreement, whereby the Company sold its right to receive royalties and sales milestones under the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information).

Revenue Recognition

The Company evaluated the elements of the MTPC Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, MTPC, is a customer.

The Company’s arrangement with MTPC contains the following material promises under the contract at inception:

(i) license under certain of the Company’s intellectual property to develop and commercialize vadadustat in the MTPC Territory, (ii) clinical supply of vadadustat, (iii) knowledge transfer, (iv) Phase 2 dosing study research services, and (v) rights to future know-how.

In February 2021, the Company entered into the Royalty Agreement with HCR, whereby the Company sold its right to receive royalties and sales milestones under the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information).

A more detailed description of the MTPC Agreement and the Company's evaluation of this agreement under ASC 606 can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

The Company identified two performance obligations in connection with its material promises under the MTPC Agreement as follows:

(i) License, Research and Clinical Supply Performance Obligation and (ii) Rights to Future Know-How Performance Obligation .

Factors considered in making the assessment of which material promises will be accounted for as separate performance obligations included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the good or service is highly interdependent or highly interrelated to the other elements in the arrangement, and whether there are other vendors that can provide the items.

Additionally, the MTPC Agreement does not include a general right of return.

The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price.

The Company developed a best estimate of the standalone selling price for the Rights to Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement and determined it is immaterial.

The Company developed a best estimate of the standalone selling price for the Rights to

Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement and determined it is immaterial.

As such, the Company did not develop a best estimate of standalone selling price for the License, Research and Clinical Supply Performance Obligation and allocated the entire transaction price to this performance obligation.

The deliverables associated with the License, Research and Clinical Supply Performance Obligation were satisfied as of June 30, 2018.

The transaction price at inception was comprised of:

(i) the up-front payment, (ii) the estimated cost for the Phase 2 studies, (iii) a non-substantive milestone associated with the first patient enrolled in the NDD-CKD Phase 3 study, and (iv) the cost of all clinical supply provided to MTPC for the Phase 3 studies.

No other development and no regulatory milestones were included in the transaction price at inception, as all other milestone amounts were fully constrained.

Subsequent to inception, the transaction price also included certain development and regulatory milestones, as described below.

As part of its evaluation of the constraint, the Company considers numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts.

Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to MTPC and therefore have also been excluded from the transaction price.

The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

The Company determined that the remaining consideration that may be payable to the Company subsequent to MTPC's commercial launch of Vafseo TM in the third quarter of 2020 is quarterly royalties on net sales, sales milestones, and certain regulatory milestones.

As of September 30, 2021, the transaction price was comprised of:

As of March 31, 2022, the transaction price was comprised of:

(i) the up-front payment of $ 20.0 million, (ii) the cost for the Phase 2 studies of $ 20.5 million, (iii) the cost of all clinical supply provided to MTPC for the Phase 3 studies, (iv) $ 10.0 million in development milestones received, (v) $ 25.0 million in regulatory milestones received, comprised of $ 10.0 million relating to the NDA filing in Japan and $ 15.0 million relating to regulatory approval of vadadustat in Japan, and (vi) $ 1.6 million in royalties from net sales of Vafseo.

As of September 30, 2021, all development milestones and $ 25.0 million in regulatory milestones have been achieved.

As of March 31, 2022, all development milestones and $ 25.0 million in regulatory milestones have been achieved.

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

The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

Revenue for the License, Research and Clinical Supply Performance Obligation for the MTPC Agreement is being recognized using a proportional performance method, for which all deliverables have been completed.

The Company recognized $ 0.3 million and $ 0.4 million of revenue from MTPC royalties for the three and nine months ended September 30, 2021, respectively.

The Company recognized a $ 15.0 million regulatory milestone relating to regulatory approval of vadadustat in Japan as revenue during the nine months ended September 30, 2020.

The Company recognized $ 0.3 million of revenue and immaterial revenue from MTPC royalties for the three months ended March 31, 2022 and 2021, respectively.

As noted above, in February 2021, the Company entered into the Royalty Agreement, whereby the Company sold its right to receive these royalties and sales milestones under the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information).

The revenue is classified as collaboration revenue in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss.

As of September 30, 2021, the Company recorded $ 0.2 million in accounts receivable, no deferred revenue, and no contract assets.

There were no asset or liability balances classified as long-term in the unaudited condensed consolidated balance sheet as of September 30, 2021.

The revenue is classified as license, collaboration and other revenue in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss.

As of March 31, 2022, the Company recorded $ 0.2 million in accounts receivable, no deferred revenue, and no contract assets.

There were no asset or liability balances classified as long-term in the unaudited condensed consolidated balance sheet as of March 31, 2022.

Supply of Drug Product to MTPC

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The Company does not recognize revenue under this arrangement until delivery has occurred and risk of loss passes to MTPC.

No revenues were recognized during the three and nine months ended September 30, 2021 and approximately $ 0.5 million and $ 4.5 million of revenue was recognized during the three and nine months ended September 30, 2020, respectively, for drug product that was delivered during the applicable period.

As of September 30, 2021, the Company recorded no accounts receivable, no deferred revenue, $ 3.0 million in other current liabilities and $ 0.4 million in other non-current liabilities for drug product that was subject to return by MTPC.

No revenues were recognized during each of the three months ended March 31, 2022 and 2021 for drug product that was delivered during the applicable period.

As of March 31, 2022, the Company recorded no accounts receivable, no deferred revenue, $ 1.9 million in other current liabilities and no other non-current liabilities for drug product that was subject to return by MTPC.

On July 15, 2020, the Company and its collaboration partner MTPC entered into a supply agreement, or the MTPC Supply Agreement.

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A more detailed description of this supply agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

The Company recognized $ 2.2 million and $ 6.7 million of revenue under the MTPC Supply Agreement during the three and nine months ended September 30, 2021, respectively.

During the nine months ended September 30, 2021, the Company invoiced MTPC for $ 13.4 million in payments for vadadustat drug product ordered by MTPC.

As of September 30, 2021, the Company recorded $ 4.5 million in accounts receivable, $ 4.9 million in deferred revenue, $ 16.3 million in other current liabilities and $ 5.8 million in other non-current liabilities.

The Company recognized $ 7.6 million and no revenue under the MTPC Supply Agreement during the three months ended March 31, 2022 and 2021, respectively.

As of March 31, 2022, the Company recorded $ 12.9 million in accounts receivable, no deferred revenue, $ 18.3 million in other current liabilities and $ 5.0 million in other non-current liabilities.

Collaboration and License Agreement with Otsuka Pharmaceutical Co.

Summary of Agreement

On December 18, 2016, the Company entered into a collaboration and license agreement with Otsuka, or the Otsuka U.S.

The collaboration is focused on the development and commercialization of vadadustat in the United States.

The Company is responsible for leading the development of vadadustat, for which it submitted an NDA to the FDA in March of 2021, and for which it received a CRL in March 2022.

The Company will co-commercialize vadadustat in the United States with Otsuka, subject to the approval of vadadustat by the FDA.

The Company controls and retains final decision-making authority with respect to certain matters, including U.S.

pricing strategy and manufacturing.

Under the terms of the Otsuka U.S.

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The co-exclusive license relates to activities that will be jointly conducted by the Company and Otsuka pursuant to the terms of the Otsuka U.S.

Additionally, the parties agreed not to promote, market or sell any competing product in the territory covered by the Otsuka U.S.

A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2020 Annual Report on Form 10-K.

Revenue Recognition

The Company evaluated the elements of the Otsuka U.S.

Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, Otsuka, is a customer.

The Company’s arrangement with Otsuka contains the following material promises under the contract at inception:

(i) license under certain of the Company’s intellectual property to develop, perform medical affairs activities with respect to and conduct non-promotional and commercialization activities related to vadadustat and products containing or comprising vadadustat, (ii) development services to be performed pursuant to the current global development plan, (iii) rights to future intellectual property, and (iv) joint committee services.

Additionally, the parties agreed not to promote, market or sell any competing product in the

territory covered by the Otsuka U.S.

A more detailed description of this collaboration agreement and the Company's evaluation of this agreement under ASC 606 can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

The Company has identified three performance obligations in connection with its obligations under the Otsuka U.S.

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(ii) Rights to Future Intellectual Property (Future IP Performance Obligation) and (iii) Joint Committee Services (Committee Performance Obligation).

Additionally, the Otsuka U.S.

Agreement does not include a general right of return.

A more detailed description of the performance obligations under this agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2020 Annual Report on Form 10-K.

The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price.

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(i) the best estimates of standalone selling price associated with the Future IP Performance Obligation was determined to be immaterial and (ii) the period of performance and pattern of recognition for the License Performance Obligation and the Committee Performance Obligation was determined to be similar.

The Company has concluded that a change in the key assumptions used to determine the best estimate of standalone selling price for each performance obligation would not have a significant impact on the allocation of arrangement consideration.

The transaction price at inception was comprised of:

(i) the up-front payment, (ii) the cost share payment with respect to amounts incurred by the Company through December 31, 2016, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to December 31, 2016.

No development or regulatory milestones were included in the transaction price at inception, as all milestone amounts were fully constrained.

As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts.

Any consideration related to sales-based milestones will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Otsuka and therefore have also been excluded from the transaction price.

The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

The Company determined that under ASC 606, the contract was modified in the second quarter of 2019 when the Otsuka Funding Option became effective and the Company became eligible to receive the Additional Funding (defined below) amount.

The Company determined that under ASC 606, the contract was modified in the second quarter of 2019, when the Company elected to require Otsuka to increase the aggregate percentage of current global development costs it funds under the Otsuka U.S.

Agreement and the Otsuka International Agreement, as defined below, from 52.5 % to 80 %, or the Otsuka Funding Option, and the Company became eligible to receive the Additional Funding (defined below) amount.

In connection with the modification, the Company adjusted the transaction price to include the Additional Funding amount as additional variable consideration.

The Company constrains the variable consideration to an amount for which a significant revenue reversal is not probable.

In the event that there is consideration received by Otsuka in the form of activities performed by Otsuka under the global development plan, such consideration is reflected as a reduction to the transaction price as contra revenue rather than as an expense because the associated services are not distinct from the License Performance Obligation.

The Company estimates the additional funding as a result of exercising the Otsuka Funding Option, or the Additional Funding, to total approximately $ 139.8 million or more, depending on the actual costs incurred toward the current global development plan.

The Company estimates the additional funding as a result of exercising the Otsuka Funding Option, or the Additional Funding, will total approximately $ 149.6 million or more, depending on the actual costs incurred toward the current global development plan.

The Additional Funding is fully creditable against future payments due to the Company under the arrangement, provided that future payments due to the Company may not be reduced by more than 50 % in any calendar year and any remaining creditable amount above 50 % in any calendar year will be applied to subsequent future payments until fully credited.

As of September 30, 2021, the Additional Funding was $ 106.7 million.

No amounts were allocated to the Future IP Performance Obligation because the associated best estimate of standalone selling price was determined to be immaterial.

Due to the similar performance period and recognition pattern between the License Performance Obligation and the Committee Performance Obligation, the transaction price has been allocated to the License Performance Obligation and the Committee Performance Obligation on a combined basis.

Accordingly, the Company will

recognize revenue related to the allocable arrangement consideration on a proportional performance basis as the underlying development services are performed pursuant to the current global development plan which is commensurate with the period and consistent with the pattern over which the Company’s obligations are satisfied for both the License Performance Obligation and the Committee Performance Obligation.

Effectively, the Company has treated the arrangement as if the License Performance Obligation and the Committee Performance Obligation are a single performance obligation.

As of September 30, 2021, the transaction price totaling $ 504.2 million was comprised of:

As of March 31, 2022, the Additional Funding was $ 117.4 million.

As of March 31, 2022, the transaction price totaling $ 514.4 million was comprised of:

(i) the up-front payment of $ 125.0 million, (ii) the cost share payment with respect to amounts incurred by the Company through December 31, 2016 of $ 33.8 million, and (iii) the estimate of the net cost share consideration to be received of approximately $ 355.6 million with respect to amounts incurred by the Company subsequent to December 31, 2016.

As of September 30, 2021, the Company is eligible to receive up to $ 65.0 million in regulatory milestone payments for the first HIF product to achieve the associated event and up to $ 575 million in commercial milestone payments associated with aggregate sales of licensed products.

As of March 31, 2022, the Company is eligible to receive up to $ 65.0 million in regulatory milestone payments for the first HIF product to achieve the associated event and up to $ 575 million in commercial milestone payments associated with aggregate sales of licensed products.

These future milestones are subject to reduction as a result of the Company's exercise of the Otsuka Funding Option, as described above.

As of September 30, 2021, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained.

During the three months ended September 30, 2021 and 2020, the Company recognized revenue totaling approximately $ 6.1 million and $ 16.3 million, respectively, and approximately $ 29.0 million and $ 80.7 million, during the nine months ended September 30, 2021 and 2020, respectively, with respect to the Otsuka U.S.

As of March 31, 2022, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained.

During the three months ended March 31, 2022 and 2021, the Company recognized revenue totaling approximately $ 5.6 million and $ 13.7 million, respectively, with respect to the Otsuka U.S.

The revenue is classified as collaboration revenue in the accompanying unaudited condensed consolidated statements of operations.

As of September 30, 2021, there was approximately $ 23.0 million of deferred revenue related to the Otsuka U.S.

As of March 31, 2022, there was approximately $ 22.3 million of deferred revenue related to the Otsuka U.S.

Agreement of which $ 6.2 million is classified as current and $ 16.1 million is classified as long-term in the accompanying unaudited condensed consolidated balance sheet based on the performance period of the underlying obligations.

Additionally, as of September 30, 2021, there was $ 2.4 million in accounts receivable and $ 2.4 million in prepaid expenses and other current assets in the accompanying unaudited condensed consolidated balance sheet.

Additionally, as of March 31, 2022, there was $ 9.0 million in accounts receivable and $ 2.7 million in prepaid expenses and other current assets in the accompanying unaudited condensed consolidated balance sheet.

As of December 31, 2021, there was approximately $ 2.0 million in contract liabilities (included in accounts payable) and $ 3.0 million in prepaid expenses and other current assets in the consolidated balance sheet.

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808, Collaborative Arrangements .

Additionally, the Company has determined that in the context of the medical affairs, commercialization and non-promotional activities, Otsuka does not represent a customer as contemplated by ASC 606-10-15, Revenue from Contracts with Customers – Scope and Scope Exceptions .

As a result, the activities conducted pursuant to the medical affairs, commercialization and non-promotional activities plans will be accounted for as a component of the related expense in the period incurred.

During the three months ended September 30, 2021 and 2020, the Company incurred approximately $ 3.6 million and $ 1.2 million, respectively, of costs related to the cost-sharing provisions of the Otsuka U.S.

Agreement, of which approximately $ 1.8 million and $ 0.5 million are reimbursable by Otsuka and recorded as a reduction to research and development expense during the three months ended September 30, 2021 and 2020, respectively.

During the three months ended September 30, 2021, Otsuka incurred no costs related to the cost-sharing provisions of the Otsuka U.S.

During the three months ended September 30, 2020, Otsuka incurred $ 0.5 million of costs related to the cost-sharing provisions of the Otsuka U.S.

Agreement, of which approximately $ 0.3 million were reimbursable by the Company and recorded as an increase to research and development expense during the three months ended September 30, 2020.

During the three months ended March 31, 2022 and 2021, the Company incurred approximately $ 7.6 million and $ 1.0 million, respectively, of

costs related to the cost-sharing provisions of the Otsuka U.S.

Agreement, of which approximately $ 3.8 million and $ 0.5 million are reimbursable by Otsuka and recorded as a reduction to research and development expense during the three months ended March 31, 2022 and 2021, respectively.

During the three months ended March 31, 2022, Otsuka incurred no costs related to the cost-sharing provisions of the Otsuka U.S.

During the three months ended March 31, 2021, Otsuka incurred $ 0.3 million of costs related to the cost-sharing provisions of the Otsuka U.S.

Agreement, of which approximately $ 0.2 million were reimbursable by the Company and recorded as an increase to research and development expense during the three months ended March 31, 2021.

International Collaboration and License Agreement with Otsuka Pharmaceutical Co.

Summary of Agreement

On April 25, 2017, the Company entered into a collaboration and license agreement with Otsuka, or the Otsuka International Agreement.

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Otsuka has the sole responsibility, at its own cost, for the commercialization of vadadustat in the Otsuka International Territory, subject to the approval by the relevant regulatory authorities.

A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2020 Annual Report on Form 10-K.

Revenue Recognition

The Company has accounted for the Otsuka International Agreement separately from the collaboration arrangement with Otsuka with respect to the U.S.

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The Company evaluated the Otsuka International Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, Otsuka, is a customer.

The Company’s arrangement with Otsuka related to the Otsuka International Territory contains the following material promises under the contract at inception:

(i) license under certain of the Company’s intellectual property to develop and commercialize (including the associated packaging) vadadustat and products containing or comprising vadadustat and development services to be performed pursuant to the current global development plan, (ii) rights to future intellectual property and (iii) joint committee services.

The Company has identified three performance obligations in connection with its obligations under the Otsuka International Agreement as follows:

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(ii) Rights to Future Intellectual Property (Future IP Performance Obligation) and (iii) Joint Committee Services (Committee Performance Obligation).

Factors considered in making this assessment of which material promises will be accounted for as a separate performance obligation included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the good or service is highly interdependent or highly interrelated to the other elements in the arrangement, and whether there are other vendors that can provide the items.

Additionally, the Otsuka International Agreement does not include a general right of return.

A more detailed description of the performance obligations under this agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2020 Annual Report on Form 10-K.

The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price.

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The transaction price at inception was comprised of:

(i) the up-front payment, (ii) the cost share payment with respect to amounts incurred by the Company during the quarter ended March 31, 2017, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to March 31, 2017.

No development or regulatory milestones were included in the transaction price at inception, as all milestone amounts were fully constrained.

As part of its evaluation of the constraint, the Company considered numerous factors, including whether the receipt of the milestone payment is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts.

Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Otsuka and therefore have also been excluded from the transaction price.

The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

In the event that there is consideration received by a customer in the form of activities performed by such customer under the global development plan, such consideration is reflected as a reduction to the transaction price as contra revenue rather than as an expense because the associated services are not distinct from the License Performance Obligation.

As of September 30, 2021, the transaction price totaling $ 310.4 million was comprised of:

As of March 31, 2022, the transaction price totaling $ 316.9 million was comprised of:

(i) the up-front payment of $ 73.0 million, (ii) the cost share payment with respect to amounts incurred by the Company during the quarter ended March 31, 2017 of $ 0.2 million, and (iii) an estimate of the net cost share consideration to be received with respect to amounts incurred by the Company subsequent to March 31, 2017 of $ 243.7 million.

As of September 30, 2021, the Company is eligible to receive up to $ 17.0 million in regulatory milestone payments for the licensed HIF product if the Company achieves the associated event within 12 to 24 months of the first HIF product approval.

As of March 31, 2022, the Company is eligible to receive up to $ 17.0 million in regulatory milestone payments for the licensed HIF product if the Company achieves the associated event within 12 to 24 months of the first HIF product approval.

Additionally, the Company is eligible for up to $ 525.0 million in commercial milestone payments associated with the aggregate sales of all licensed products.

As of September 30, 2021, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained.

During the three months ended September 30, 2021 and 2020, the Company recognized revenue totaling approximately $ 1.9 million and $ 7.2 million, respectively, and approximately $ 13.5 million and $ 39.4 million, respectively, during the nine months ended September 30, 2021 and 2020, with respect to the Otsuka International Agreement.

As of March 31, 2022, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained.

During the three months ended March 31, 2022 and 2021, the Company recognized revenue totaling approximately $ 5.5 million and $ 7.0 million, respectively, with respect to the Otsuka International Agreement.

The revenue is classified as collaboration revenue in the accompanying unaudited condensed consolidated statements of operations.

As of September 30, 2021, there was approximately $ 11.1 million of deferred revenue related to the Otsuka International Agreement of which $ 4.5 million is classified as current and $ 6.6 million is classified as long-term in the accompanying unaudited condensed consolidated balance sheet based on the performance period of the underlying obligations.

Additionally, as of September 30, 2021, there was $ 1.1 million in accounts receivable and $ 1.1 million in prepaid expenses and other current assets in the accompanying unaudited condensed consolidated balance sheet.

As of March 31, 2022, there was

approximately $ 10.2 million of deferred revenue related to the Otsuka International Agreement of which $ 4.2 million is classified as current and $ 6.0 million is classified as long-term in the accompanying unaudited condensed consolidated balance sheet based on the performance period of the underlying obligations.

Additionally, as of March 31, 2022, there was $ 11.3 million in accounts receivable and $ 1.2 million in prepaid expenses and other current assets in the accompanying unaudited condensed consolidated balance sheet.

As of December 31, 2021, there was approximately $ 0.9 million in contract liabilities (included in accounts payable) and $ 1.3 million in prepaid expenses and other current assets in the consolidated balance sheet.

Janssen Pharmaceutica NV Research and License Agreement

Summary of Agreement

On February 9, 2017, the Company entered into a Research and License Agreement, or the Janssen Agreement, with Janssen Pharmaceutica NV, or Janssen, a subsidiary of Johnson & Johnson, pursuant to which Janssen granted the Company an exclusive license under certain intellectual property rights to develop and commercialize worldwide certain HIF prolyl hydroxylase targeted compounds.

Under the terms of the Janssen Agreement, Janssen granted to the Company a license for a three-year research term to conduct research on the HIF compound portfolio, which research term is now expired.

During the research term, the Company could designate one or more compounds as candidates for development and commercialization.

Once a compound was designated for development and commercialization, the Company was to be solely responsible for the development and commercialization of the compound worldwide at its own cost and expense.

Under the terms of the Janssen Agreement, the Company made an upfront payment of $ 1.0 million in cash to Janssen and issued a warrant, or the Warrant, to purchase 509,611 shares of the Company’s common stock with an exercise price of $ 9.81 per share to Johnson & Johnson Innovation – JJDC, Inc., or JJDC, an affiliate of Janssen.

The Warrant is exercisable by JJDC, in whole or in part, at any time prior to February 9, 2022.

The Warrant and the shares issuable upon exercise of the Warrant will be sold and issued without registration under the Securities Act of 1933, as amended, or the Securities Act.

The Company recorded the fair value of the Warrant in the amount of $ 3.4 million to additional paid-in capital and research and development expense in March 2017.

In addition, Janssen is eligible to receive up to an aggregate of $ 16.5 million from the Company in specified development milestone payments on a product-by-product basis.

Janssen is also eligible to receive up to $ 215.0 million from the Company in specified commercial milestones as well as tiered, escalating royalties ranging from a low- to mid-single digit percentage of net sales, on a product-by-product basis, and subject to reduction upon expiration of patent rights or the launch of a generic product in the territory.

A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

In addition, Janssen could be eligible to receive up to an aggregate of $ 16.5 million from the Company in specified development milestone payments on a product-by-product basis.

Janssen could also be eligible to receive up to $ 215.0 million from the Company in specified commercial milestones as well as tiered, escalating royalties ranging from a low- to mid-single digit percentage of net sales, on a product-by-product basis, and subject to reduction upon expiration of patent rights or the launch of a generic product in the territory.

A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

Cyclerion Therapeutics License Agreement

Summary of Agreement

On June 4, 2021, the Company entered into a License Agreement, the Cyclerion Agreement, with Cyclerion Therapeutics Inc., or Cyclerion, pursuant to which Cyclerion granted the Company an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oral sGC stimulator.

Under the terms of the Cyclerion Agreement, the Company made an upfront payment of $ 3.0 million in cash to Cyclerion, which was paid during the second quarter of 2021.

Under the terms of the Cyclerion Agreement, the Company made an upfront payment of $ 3.0 million in cash to Cyclerion, which was paid during the second quarter of 2021 and recorded to research and development expense in June 2021.

Substantially all of the fair value of the assets acquired in conjunction with the Cyclerion Agreement was concentrated in the acquired license.

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In addition, Cyclerion is eligible to receive up to an aggregate of $ 222.0 million from the Company in specified development and regulatory milestone payments on a product-by-product basis.

Cyclerion will also be eligible to receive specified

commercial milestones as well as tiered royalties ranging from a low-single-digit- to mid-double-digit percentage of net sales, on a product-by-product basis, and subject to reduction upon expiration of patent rights or the launch of a generic product in the territory.

The Company recorded the upfront payment in the amount of $ 3.0 million to research and development expense in June 2021.

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 longer of the expiration of the patents licensed under the Cyclerion Agreement, the expiration of regulatory exclusivity for such product, or 10 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.

Cyclerion will also be eligible to receive specified commercial milestones as well as tiered royalties ranging from a low-single-digit- to mid-double-digit percentage of net sales, on a product-by-product basis, and subject to reduction upon expiration of patent rights or the launch of a generic product in the territory.

A more detailed description of this agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

Vifor Pharma License Agreement

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On May 12, 2017, the Company entered into a License Agreement, or the Vifor Agreement, with Vifor (International) Ltd., or Vifor Pharma, pursuant to which the Company granted Vifor Pharma an exclusive license to sell vadadustat solely to Fresenius Kidney Care Group LLC, or FKC, an affiliate of Fresenius Medical Care North America, or FMCNA, in the United States.

On April 8, 2019, the Company and Vifor Pharma entered into an Amended and Restated License Agreement, or the Vifor Amended Agreement, which amended and restated in full the Vifor Agreement.

Pursuant to the Vifor Amended Agreement, the Company granted Vifor Pharma an exclusive license to sell vadadustat to FKC and to certain third party dialysis organizations approved by the Company, or Third Party Dialysis Organizations, in the United States.

A more detailed description of this collaboration agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2020 Annual Report on Form 10-K.

On April 8, 2019, the Company and Vifor Pharma entered into an Amended and Restated License Agreement, or the Vifor First Amended Agreement, which amended and restated in full the Vifor Agreement.

On February 18, 2022, the Company and Vifor Pharma entered into a Second Amended and Restated License Agreement, or the Vifor Second Amended Agreement, which amends and restates the Vifor First Amended Agreement.

Pursuant to the Vifor Second Amended Agreement, the Company granted Vifor Pharma an exclusive license to sell vadadustat 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 to certain non-retail specialty pharmacies, or collectively, the Supply Group, in the United States, or the Territory.

Pursuant to the Vifor Second Amended Agreement, Vifor Pharma agreed that it would not sell or otherwise supply vadadustat until the FDA has granted regulatory approval for vadadustat in the DD-CKD Indication in the Territory and until Vifor Pharma has entered a supply agreement with the applicable member of the Supply Group.

Similar to the Vifor First Amended Agreement, the Vifor Second Amended Agreement is structured as a profit share arrangement between the Company and Vifor Pharma in which the Company will receive approximately 66 % of the profit, net of certain pre-specified costs.

Under the Vifor Second Amended Agreement, Vifor Pharma made an upfront payment to the Company of $ 25.0 million in lieu of the previously disclosed milestone payment of $ 25.0 million that Vifor Pharma was to pay the Company following approval of vadadustat by the FDA, as established under the Vifor First Amended Agreement.

Unless earlier terminated, the Vifor Second Amended Agreement will expire upon the later of the expiration of all patents that claim or cover vadadustat or expiration of marketing or regulatory exclusivity for vadadustat in the Territory.

Vifor Pharma may terminate the Vifor Second Amended Agreement in its entirety upon 30 months' prior written notice after the first anniversary of the receipt of regulatory approval, if approved from the FDA for vadadustat for dialysis-dependent CKD patients.

The Company may terminate the Vifor Second Amended Agreement in its entirety for convenience, following the earlier of a certain period of time elapsing or following certain specified regulatory events, and upon six months ’ prior written notice.

If the Company so terminates for convenience, subject to specified exceptions, the Company will pay a termination fee to Vifor Pharma.

In addition, either party may, subject to a cure period, terminate the Vifor Second Amended Agreement in the event of the other party’s uncured material breach or bankruptcy.

Vifor Pharma may also terminate the Vifor Second Amended Agreement upon thirty days ' notice following receipt of the CRL from the FDA for vadadustat.

Investment Agreement

In connection with the Vifor Agreement, in May 2017, the Company and Vifor Pharma entered into an investment agreement, or the Investment Agreement, pursuant to which the Company sold an aggregate of 3,571,429 shares of the Company’s common stock, or the Shares, to Vifor Pharma at a price per share of $ 14.00 for a total of $ 50.0 million.

In connection with the Vifor Agreement, in May 2017, the Company and Vifor Pharma entered into an investment agreement, or the First Investment Agreement, pursuant to which the Company sold an aggregate of 3,571,429 shares of the Company’s common stock, or the 2017 Shares, to Vifor Pharma at a price per share of $ 14.00 for a total of $ 50.0 million.

The amount representing the premium over the closing stock price of $ 12.69 on the date of the transaction, totaling $ 4.7 million, was determined by the Company to represent consideration related to the Vifor Agreement.

As the parties’ rights under the Vifor Agreement are conditioned upon (a) the approval of vadadustat for DD-CKD adult patients by the FDA;

(b) the earlier of a determination by the Centers for Medicare & Medicaid Services, or CMS, that vadadustat will be reimbursed using Medicare’s bundled reimbursement model or that vadadustat will be reimbursed using the Transitional Drug Add-On Payment Adjustment;

and (c) payment by Vifor Pharma of a $ 25.0 million milestone upon the occurrence of (a) and (b), in accordance with ASC 606, the Company has determined that the full transaction price is fully constrained.

As part of its evaluation of the constraint, the Company considered numerous factors, including clinical and regulatory risks that must be overcome in order for the parties’ rights to become effective and the probability of the $ 25.0 million milestone being achieved.

Accordingly, the $ 4.7 million continues to be recorded as deferred revenue in the accompanying unaudited condensed consolidated balance sheets.

Upon the satisfaction of the aforementioned conditions, revenue will be recognized as the Company supplies vadadustat to Vifor Pharma using a proportional performance method.

Vifor Pharma agreed to a lock-up restriction such that it agreed not to sell the Shares for a period of time following the effective date of the Investment Agreement as well as a customary standstill agreement.

In addition, the Investment Agreement contains voting agreements made by Vifor Pharma with respect to the Shares.

The Shares have not been registered pursuant to 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.

Vifor Pharma agreed to a lock-up restriction such that it agreed not to sell the 2017 Shares for a period of time following the effective date of the First Investment Agreement as well as a customary standstill agreement.

In addition, the First Investment Agreement contains voting agreements made by Vifor Pharma with respect to the 2017 Shares.

The 2017 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.

In connection with entering into the Vifor Second Amended Agreement, on February 18, 2022, the Company and Vifor Pharma entered into an investment agreement, or the Second Investment Agreement, pursuant to which the Company sold an aggregate of 4,000,000 shares of its common stock, par value $ 0.00001 per share, or the 2022 Shares, to Vifor Pharma for a total of $ 20 million on February 22, 2022.

The amount representing the premium over the grant date fair value on the date of the transaction, $ 13.6 million, was determined by the Company to represent the consideration related to the Vifor Second Amended Agreement.

Vifor Pharma has agreed to a lock-up restriction to not sell or otherwise dispose of the 2022 Shares for a period of time following the effective date of the Second Investment Agreement as well as a customary standstill agreement.

In addition, the Second Investment Agreement contains voting agreements made by Vifor Pharma with respect to the 2022 Shares.

The 2022 Shares have not been registered pursuant to 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/or Rule 506 promulgated thereunder, as the transaction does not involve any public offering within the meaning of Section 4(a)(2) of the Securities Act.

Revenue Recognition

The Company evaluated the elements of the Vifor Second Amended Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, Vifor Pharma, is a customer.

The Company’s arrangement with Vifor Pharma contains one material promise under the contract at inception, which is the non-sublicensable, non-transferrable license under certain of the Company’s intellectual property to (i) sell vadadustat solely to the Supply Group, (ii) sell vadadustat to Designated Wholesalers solely for resale to members of the Supply Group, (iii) conduct medical affairs with respect to vadadustat in the Territory in the field during the term of the Vifor Second Amended Agreement and (iv) use the Akebia Trademark solely in connection with the sale of vadadustat (the License Deliverable).

The Company has identified one performance obligation in connection with its obligations under the Vifor Second Amended Agreement, which is the License Deliverable, or License Performance Obligation.

The transaction price at inception was comprised of:

(i) the up-front payment of $ 25.0 million, (ii) the premium on paid by Vifor Pharma on the First Investment Agreement of $ 4.7 million, and (iii) the premium paid by Vifor Pharma on the Second Investment Agreement of $ 13.6 million.

Pursuant to the terms of the Vifor Second Amended Agreement, these payments from Vifor Pharma are non-refundable and non-creditable against any other amount due to the Company.

Also pursuant to the Vifor Second Amended Agreement, if the Centers for Medicare & Medicaid Services, or CMS, determines that vadadustat is excluded from the Transitional Drug Add-on Payment Adjustment, or TDAPA, the Company can terminate the Vifor Second Amended Agreement and will be required to repay the up-front payment and the premiums paid by Vifor Pharma in the First Investment Agreement and Second Investment Agreement, respectively.

The Company considered whether the transaction price was constrained as required per the guidance in ASC 606-10-32-11.

As part of its evaluation of the constraint, the Company considered numerous factors, including the CRL received from the FDA for vadadustat, the uncertainty associated with a potential future approval of vadadustat by the FDA, and if approval of vadadustat is received in the future, whether vadadustat would be included in certain reimbursement bundles by CMS, which are all outside of the Company’s control.

Vifor Pharma also agreed that it will not sell or otherwise supply vadadustat until the FDA has granted regulatory approval for vadadustat in the DD-CKD Indication.

The Company constrains the variable consideration to an amount for which a significant revenue reversal is not probable.

Therefore, the Company determined that the entire transaction price at inception was constrained under ASC 606, and the Company has recorded the transaction price to deferred revenue as of March 31, 2022.

Refund Liability to Customer

Pursuant to the Vifor Second Amended Agreement, Vifor Pharma contributed $ 40.0 million to a working capital fund established to partially fund the Company’s costs of purchasing vadadustat from its contract manufacturers, or the Working Capital Fund, which amount of funding will fluctuate, and which funding the Company will repay to Vifor over time.

The $ 40 million initial contribution to the Working Capital Fund represents 50 % of the amount of purchase orders that the Company has placed with its contract manufacturers for the supply of vadadustat for the Territory already delivered as of the effective date of the Vifor Second Amended Agreement, and to be delivered through the end of 2022.

The amount of the Working Capital Fund will be reviewed at specified intervals and is adjusted based on a number of factors including outstanding supply commitments for vadadustat for the Territory and agreed upon vadadustat inventory levels held by the Company for the Territory.

Upon termination or expiration of the Vifor Second Amended Agreement for any reason other than convenience by Vifor Pharma (including following receipt of a CRL for vadadustat), the Company will be required to refund the outstanding balance of the Working Capital Fund on the date of termination or expiration.

The Company has recorded the Working Capital Fund as a refund liability under ASC 606.

The Company has determined that the refund liability itself does not represent an obligation to transfer goods or services to Vifor Pharma in the future.

The Company has therefore determined that this refund liability is not a contract liability under ASC 606.

The Company accounted for the refund liability as a debt arrangement with zero coupon interest.

The Company imputed interest on the refund liability to the customer 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 of the Working Capital Fund.

The Company recorded an initial discount on the refund liability to the customer and a corresponding deferred gain to the refund liability to customer on the condensed consolidated balance sheet as of the date the funds were received from Vifor Pharma, which was March 18, 2022.

The discount on the note payable is being amortized to interest expense using the effective interest method over the expected term of the refund liability.

The deferred gain is being amortized to interest income on a straight-line basis over the expected term of the refund liability.

The amortization of the discount and the amortization of the deferred gain as of March 31, 2022 were not material.

Of the $ 39.9 million total refund liability, net of deferred gain and discount, the Company classified $ 16.5 million as a short-term refund liability based on management's estimate of potential amounts that could be refundable within a one-year period as a result of anticipated changes to the Company's operating plan following the CRL.

Priority Review Voucher Letter Agreement

On February 14, 2020, the Company entered into a letter agreement, or the Letter Agreement, with Vifor Pharma relating to Vifor Pharma’s agreement with a third party to purchase a Priority Review Voucher, or the PRV, issued by the FDA, subject to satisfaction of customary closing conditions, or the PRV Purchase.

A PRV entitles the holder to priority review of a New Drug Application, or NDA, or a Biologics License Application for a new drug, which reduces the target FDA review time to six months after official acceptance of the submission, and could lead to expedited approval.

A PRV entitles the holder to priority review of an NDA, or a Biologics License Application for a new drug, which reduces the target FDA review time to six months after official acceptance of the submission, and could lead to expedited approval.

Pursuant to the Letter Agreement, Akebia paid Vifor Pharma $ 10.0 million in connection with the closing of the PRV Purchase.

Vifor Pharma is obligated to retain all rights to, and maintain the validity of, the PRV until Akebia and Vifor Pharma (a) enter into a definitive agreement setting forth the financial and other terms by which Vifor Pharma will assign the PRV to Akebia for use with Akebia’s NDA for

vadadustat for the treatment of anemia due to CKD in both dialysis-dependent and non-dialysis dependent patients, or (b) make a mutual decision to sell the PRV and share the proceeds based on certain terms.

In March of 2021, the Company submitted an NDA for the treatment of anemia due to CKD in both DD-CKD and NDD-CKD adult patients.

The Company's NDA submission did not include a PRV.

In August 2021, the Company and Vifor Pharma entered into an amendment to the Letter Agreement whereby the parties agreed that Vifor Pharma would sell the PRV to a third party, and the Company and Vifor Pharma will share the proceeds from the sale based on certain terms.

During the quarter ended March 31, 2020, the $ 10.0 million payment to Vifor Pharma was recorded to research and development expense in the unaudited condensed consolidated statement of operations and as an operating cash outflow in the unaudited condensed consolidated statement of cash flows.

On August 21, 2021, the Company and Vifor Pharma executed an amendment to the Letter Agreement whereby the parties agreed that Vifor Pharma would sell the PRV to a third party, and the Company and Vifor Pharma would share the proceeds from the sale based on certain terms.

In the fourth quarter of 2021, Vifor Pharma sold the PRV to a third party, and Vifor

Pharma paid the Company $ 8.6 million in proceeds from the sale, which was recorded as contra research and development expense.

These proceeds were subsequently paid to Otsuka as reimbursement for their contribution to the purchase of the PRV, as required under a separate letter agreement executed with Otsuka.

A more detailed description of this transaction can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

License Agreement with Panion & BF Biotech, Inc.

Prior to the Merger, Keryx entered into a license agreement, or the Panion License Agreement, which was amended from time to time, with Panion & BF Biotech, Inc., or Panion, under which Keryx in-licensed the exclusive worldwide rights, excluding certain Asian-Pacific countries, or the Licensor Territory, for the development and commercialization of ferric citrate.

As a result of the merger with Keryx Biopharmaceuticals, Inc., or Keryx, or the Merger, the Company had a license agreement, which was amended from time to time, with Panion & BF Biotech, Inc., or Panion, under which Keryx, the Company's wholly owned subsidiary, was the contracting party, or the Panion License Agreement, pursuant to which Keryx in-licensed the exclusive worldwide rights, excluding certain Asian-Pacific countries, or the Licensor Territory, for the development and commercialization of ferric citrate.

On April 17, 2019, the Company and Panion entered into a second amended and restated license agreement, or the Panion Amended License Agreement, which amends and restates in full the Panion License Agreement, effective as of April 17, 2019.

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A more detailed description of this license agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

The Company recognized royalty payments due to Panion of approximately $ 3.0 million and $ 2.9 million during the three months ended September 30, 2021 and 2020, respectively, and $ 8.3 million and $ 8.2 million during the nine months ended September 30, 2021 and 2020, respectively, relating to the Company’s sales of Auryxia in the United States and JT and Torii’s sales of Riona in Japan, as the Company is required to pay a mid-single digit percentage of net sales of ferric citrate in the Company’s licensed territories to Panion under the terms of the Panion Amended License Agreement.

The Company recognized royalty payments due to Panion of approximately $ 2.5 million during each of the three months ended March 31, 2022 and 2021, relating to the Company’s sales of Auryxia in the United States and JT and Torii’s net sales of Riona in Japan, as the Company is required to pay a mid-single digit percentage of net sales of ferric citrate in the Company’s licensed territories to Panion under the terms of the Panion Amended License Agreement.

Sublicense Agreement with Japan Tobacco, Inc.

and its subsidiary, Torii Pharmaceutical Co., Ltd.

Summary of Agreement

As a result of the Merger, 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 Keryx, the Company’s wholly owned subsidiary, remains the contracting party.

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A more detailed description of this sublicense agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

Revenue Recognition

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’s arrangement with JT and Torii contains the following material promises under the contract at inception:

(i) exclusive license to develop and commercialize ferric citrate hydrate in Japan, (ii) supply of ferric citrate hydrate until JT and Torii could secure their own source, (iii) knowledge transfer, and (iv) rights to future know-how.

The Company identified two performance obligations in connection with its obligations under the JT and Torii Sublicense Agreement:

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The Company allocated the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price.

conveyed will be developed during the term of the arrangement and determined it immaterial.

As such, the Company did not develop a best estimate of standalone selling price for the License and Supply Performance Obligation and allocated the entire transaction price to this performance obligation.

Additionally, as of the consummation of the Merger, the services associated with the License and Supply Performance Obligation were completed and JT and Torii had secured their own source to manufacture ferric citrate hydrate.

As such, any initial license fees as well as any development-based milestones and manufacturing fee revenue were received and recognized prior to the Merger.

The Company determined that the remaining consideration that may be payable to the Company under the terms of the sublicense agreement are either quarterly royalties on net sales or payments due upon the achievement of sales-based milestones.

In accordance with ASC 606, the Company recognizes sales-based royalties, including milestone payments based on the level of sales, when the related sales occur as these amounts have been determined to relate predominantly to the license granted to JT and Torii and therefore are recognized at the later of when the performance obligation is satisfied, or the related sales occur.

The Company recognized license revenue of $ 1.4 million and $ 1.2 million during the three months ended September 30, 2021 and 2020, respectively, and $ 4.1 million and $ 4.0 million, respectively, during the nine months ended September 30, 2021 and 2020, respectively, related to royalties earned on net sales of Riona in Japan.

The Company recognized license revenue of $ 1.1 million and $ 1.2 million during the three months ended March 31, 2022 and 2021, respectively, related to royalties earned on net sales of Riona in Japan.

The Company records the associated mid-single digit percentage of net sales royalty expense due to Panion, the licensor of Riona, in the same period as the royalty revenue from JT and Torii is recorded.

Liability Related to Sale of Future Royalties

On February 25, 2021, the Company entered into the Royalty Agreement with HealthCare Royalty Partners IV, L.P., or HCR, pursuant to which the Company sold to HCR its right to receive royalties and sales milestones for vadadustat in Japan and certain other Asian countries, such countries, collectively, the MTPC Territory, and such payments collectively the Royalty Interest Payments, in each case, payable to the Company under the MTPC Agreement, subject to an annual maximum “cap” of $ 13.0 million, or the Annual Cap, and an aggregate maximum “cap” of $ 150.0 million, or the Aggregate Cap.

After HCR receives Royalty Interest Payments equal to the Annual Cap in a given calendar year, the Company will receive 85 % of the Royalty Interest Payments for the remainder of that year.

After HCR receives Royalty Interest Payments equal to the Aggregate Cap, or the Company pays the Aggregate Cap to HCR (net of the Royalty Interest Payments already received by HCR), the Royalty Interest Payments will revert back to the Company, and HCR would have no further right to any Royalty Interest Payments.

The Company received $ 44.8 million from HCR (net of certain transaction expenses) under the Royalty Agreement, and the Company is eligible to receive an additional $ 5.0 million in each year from 2021 through 2023 under the Royalty Agreement if specified annual sales milestones are achieved for vadadustat in the MTPC Territory, subject to the satisfaction of certain customary conditions.

On February 25, 2021, the Company entered into the Royalty Agreement with HCR, pursuant to which the Company sold to HCR its right to receive royalties and sales milestones for vadadustat in Japan and certain other Asian countries, such countries, collectively, the MTPC Territory, and such payments collectively the Royalty Interest Payments, in each case, payable to the Company under the MTPC Agreement, subject to an annual maximum “cap” of $ 13.0 million, or the Annual Cap, and an aggregate maximum “cap” of $ 150.0 million, or the Aggregate Cap.

The Company received $ 44.8 million from HCR (net of certain transaction expenses) under the Royalty Agreement.

The Company retains the right to receive all potential future regulatory milestones for vadadustat under the MTPC Agreement.

The Royalty Agreement will terminate on the earlier of the date on which HCR has received (i) the last Royalty Interest Payment or (ii) payment by the Company of an amount equal to the Aggregate Cap minus the aggregate amount of all Royalty Interest Payments actually received by HCR.

Although the Company sold its right to receive royalties and sales milestones for vadadustat in the MTPC Territory as described above, as a result of its ongoing involvement in the cash flows related to these royalties, the Company will continue to account for these royalties as revenue.

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The Company imputes interest on the unamortized portion of the liability using the effective interest method.

The annual effective interest rate as of September 30, 2021 was 19.2 % which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss.

Over the course of the Royalty Agreement, the actual interest rate will be affected by the amount and timing of royalty revenue recognized and changes in forecasted royalty revenue.

There are a number of factors that could materially affect the amount and timing of royalty payments from MTPC, none of which are within the Company's control.

The annual effective interest rate as of March 31, 2022 was 17.7 % which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss.

On a quarterly basis, the Company reassesses the effective interest rate and adjusts the rate prospectively as needed.

The following table shows the activity within the liability account for the nine months ended September 30, 2021:

September 30, 2021

A more detailed description of Royalty Agreement can be found in Note 5 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

The following table shows the activity within the liability account for the three months ended March 31, 2022:

March 31, 2022

(in thousands)

Liability related to sale of future royalties, net — beginning balance $ —

Proceeds from sale of future royalties, net 44,783

Liability related to sale of future royalties, net beginning balance at December 31, 2021 $ 53,079

MTPC royalties payable ( 329 )

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Liability related to sale of future royalties, net — ending balance $ 55,095

The Royalty Agreement requires the Company to take certain actions, including actions with respect to the Royalty Interest Payments, the MTPC Agreement, the MTPC Supply Agreement, and the Company's intellectual property.

The Royalty Agreement also contains certain representations and warranties, covenants, indemnification obligations, events of default and other provisions that are customary for a royalty monetization transaction of this nature.

In addition, the Company granted HCR a precautionary security interest in connection with the Royalty Interest Payments.

Available For Sale Securities

Cash, cash equivalents, and available for sale securities at September 30, 2021 and December 31, 2020 consisted of the following:

Amortized Cost Gross

Losses Fair Value

(in thousands)

September 30, 2021

Cash and cash equivalents $ 207,204 $ — $ — $ 207,204

Available for sale securities:

government debt securities $ — $ — $ — $ —

Total available for sale securities $ — $ — $ — $ —

Total cash, cash equivalents, and available for sale securities $ 207,204 $ — $ — $ 207,204

Amortized Cost Gross

Losses Fair Value

(in thousands)

December 31, 2020

Cash and cash equivalents $ 228,698 $ — $ — $ 228,698

Available for sale securities:

government debt securities $ 39,979 $ 13 $ — $ 39,992

Total available for sale securities $ 39,979 $ 13 $ — $ 39,992

Total cash, cash equivalents, and available for sale securities $ 268,677 $ 13 $ — $ 268,690

There were no realized gains or losses on available for sale securities for the three and nine months ended September 30, 2021 and 2020 and the Company did no t recognize any credit losses during the three and nine months ended September 30, 2021 and 2020.

Additionally, the Company did no t have any available for sale securities that were in an unrealized loss position as of September 30, 2021 and December 31, 2020.

Fair Value of Financial Instruments

The Company utilizes a portfolio management company for the valuation of the majority of its investments.

This company is an independent, third-party vendor recognized to be an industry leader with access to market information that obtains or computes fair market values from quoted market prices, pricing for similar securities, recently executed transactions, cash flow models with yield curves and other pricing models.

For valuations obtained from the pricing service, the Company performs due

diligence to understand how the valuation was calculated or derived, focusing on the valuation technique used and the nature of the inputs.

Based on the fair value hierarchy, the Company classifies its cash equivalents and available for sale securities within Level 1 or Level 2.

This is because the Company values its cash equivalents and available for sale securities using quoted market prices or alternative pricing sources and models utilizing market observable inputs.

Assets measured or disclosed at fair value on a recurring basis as of September 30, 2021 and December 31, 2020 are summarized below:

This portfolio management company is an independent, third-party vendor recognized to be an industry leader with access to market information that obtains or computes fair market values from quoted market prices, pricing for similar securities, recently executed transactions, cash flow models with yield curves and other pricing models.

For valuations obtained from the pricing service, the Company performs due diligence to understand how the valuation was calculated or derived, focusing on the valuation technique used and the nature of the inputs.

Based on the fair value hierarchy, the Company classifies its cash equivalents within Level 1 or Level 2.

This is because the Company values its cash equivalents using quoted market prices or alternative pricing sources and models utilizing market observable inputs.

Assets measured or disclosed at fair value on a recurring basis as of March 31, 2022 and December 31, 2021 are summarized below:

Fair Value Measurements Using

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(in thousands)

September 30, 2021

March 31, 2022

Cash and cash equivalents $ 174,562 $ — $ — $ 174,562

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Cash and cash equivalents $ 149,800 $ — $ — $ 149,800

government debt securities — 39,992 — 39,992

$ 149,800 $ — $ — $ 149,800

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$ — $ — $ 1,820 $ 1,820

The Company’s Loan Agreement with Pharmakon (see Note 11) contains certain provisions that change the underlying cash flows of the debt instrument, including a potential extension to the interest-only period dependent on both (a) no event of default having occurred and continuing and (b) the Company achieving certain regulatory and revenue conditions.

The Company also assessed the acceleration of the obligations under the Loan Agreement under an event of default.

The Company’s Loan Agreement with Pharmakon (see Note 10) contains certain provisions that change the underlying cash flows of the debt instrument, including a potential extension to the interest-only period dependent on both (i) no event of default having occurred and continuing and (ii) the Company achieving certain regulatory and revenue conditions.

One of the regulatory conditions was approval of vadadustat by August 2022, however, in March 2022, the Company received a CRL from the FDA stating that the FDA had determined that it could not approve the NDA for vadadustat in its present form.

Therefore, the Company is no longer eligible for the interest-only extension period and this no longer changes the underlying cash flows of the debt instrument.

The Company also assessed the acceleration of the obligations under the Loan Agreement under certain events of default.

In addition, under certain circumstances, a default interest rate will apply on all outstanding obligations during the occurrence and continuance of an event of default.

In accordance with ASC 815, the Company concluded that these features are not clearly and closely related to the host instrument, and represent a single compound derivative that is required to be re-measured at fair value on a quarterly basis.

The events of default include maintaining, on an annual basis, a minimum liquidity threshold which started in 2021, and on a quarterly basis, a minimum net sales threshold for Auryxia which started in the fourth quarter of 2020.

The Company recorded a derivative liability related to the Company’s Loan Agreement with Pharmakon of $ 1.9 million and $ 2.4 million as of September 30, 2021 and December 31, 2020, respectively.

The Company classified the derivative liability as a non-current liability on the unaudited condensed consolidated balance sheet as of September 30, 2021 and December 31, 2020.

The estimated fair value of the derivative liability on both September 30, 2021 and December 31, 2020 was determined using a scenario-based approach and discounted cash flow model that includes principal and interest payments under various scenarios involving clinical development success for vadadustat and various cash flow assumptions.

Probabilities surrounding clinical development success were derived using industry benchmarks.

The potential events of default assessed include failure to maintain, on an annual basis, a minimum liquidity threshold which started in 2021, and on a quarterly basis, a minimum net sales threshold for Auryxia which started in the fourth quarter of 2020.

The Company recorded a derivative liability related to the Company’s Loan Agreement with Pharmakon of $ 1.1 million and $ 1.8 million as of March 31, 2022 and December 31, 2021, respectively.

The Company classified the derivative liability as a non-current liability on the unaudited condensed consolidated balance sheet as of March 31, 2022 and December 31, 2021.

The estimated fair value of the derivative liability on both March 31, 2022 and December 31, 2021 was determined using a scenario-based approach and discounted cash flow model that includes principal and interest payments under various scenarios involving clinical development success for vadadustat and various cash flow assumptions.

The Company used a 0 % probability of clinical development success due to receipt of a CRL from the FDA for vadadustat.

Should the Company’s assessment of the probabilities around these scenarios change, including for changes in market conditions, there could be a change to the fair value of the derivative liability.

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Balance at March 31, 2022 $ 1,110

Change in fair value of derivative liability, recorded as other income ( 570 )

Balance at June 30, 2021 $ 1,930

Change in fair value of derivative liability, recorded as other income —

Balance at September 30, 2021 $ 1,930

The Company had no other assets or liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) at September 30, 2021 and December 31, 2020.

Investment securities are exposed to various risks such as interest rate, market and credit risks.

When the Company holds investment securities, due to the level of risk associated with certain investment securities and the level of uncertainty related to changes in the value of investment securities, the Company considers if changes in risks in the near term would result in material changes in the fair value of investments.

The Company had no other assets or liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) at March 31, 2022 and December 31, 2021.

The components of inventory are summarized as follows:

September 30, 2021 December 31, 2020

March 31, 2022 December 31, 2021

(in thousands)

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Long-term inventory, which primarily consists of raw materials and work in process, is included in other assets in the Company’s unaudited condensed consolidated balance sheets.

September 30, 2021 December 31, 2020

March 31, 2022 December 31, 2021

(in thousands)

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Total inventory $ 82,910 $ 79,059

Inventory amounts written down as a result of excess, obsolescence, scrap or other reasons and charged to cost of goods sold totaled $ 1.7 million and $ 7.1 million during the three and nine months ended September 30, 2021, respectively, and totaled $ 8.5 million and $ 18.6 million during the three and nine months ended September 30, 2020, respectively.

The decrease in inventory amounts written down for the three and nine months ended September 30, 2021 as compared to the three and nine months ended September 30, 2020 was primarily due to lower write-downs to inventory reserves related to a previously disclosed manufacturing quality issue related to Auryxia during 2020.

In addition, there were no related step-up charges during the three months ended September 30, 2021 and $ 1.4 million related step-up charges during the three months ended September 30, 2020.

Related step-up charges were $ 8.7 million during the nine months ended September 30, 2021 and $ 7.4 million during the nine months ended September 30, 2020.

Inventory amounts written down as a result of excess, obsolescence, scrap or other reasons and charged to cost of goods sold totaled $ 5.3 million and $ 5.1 million during the three months ended March 31, 2022 and 2021, respectively.

In addition, there were no related step-up charges during the three months ended March 31, 2022 and $ 8.7 million related step-up charges during the three months ended March 31, 2021.

During the three months ended March 31, 2022, the Company recorded a $ 3.2 million reduction to the excess purchase commitment liability related to Auryxia inventory previously identified as excess, reflecting Auryxia inventory that was received during the period.

If future sales of Auryxia are lower than expected, the Company may be required to write-down the value of such inventories.

Inventory write-downs and losses on purchase commitments are recorded as a component of cost of sales in the unaudited condensed consolidated statement of operations.

Inventory write-downs and losses on purchase commitments are recorded as a component of cost of goods sold in the unaudited condensed consolidated statement of operations.

Intangible Assets and Goodwill

Intangible Assets

The following table presents the Company’s intangible assets at September 30, 2021 and December 31, 2020 (in thousands):

September 30, 2021

The following table presents the Company’s intangible assets at March 31, 2022 and December 31, 2021 (in thousands):

March 31, 2022

Gross Carrying

Value Accumulated Amortization Total

Acquired intangible assets:

Intangible assets:

Developed product rights for Auryxia $ 213,603 $ ( 114,487 ) $ 99,116

Total $ 213,603 $ ( 114,487 ) $ 99,116

December 31, 2021

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Value Accumulated

Amortization ASC 842

Adjustment Total

Acquired intangible assets:

Amortization Total

Intangible assets:

Developed product rights for Auryxia $ 213,603 $ ( 105,476 ) $ 108,127

Favorable lease 545 ( 5 ) ( 540 ) —

Total $ 213,603 $ ( 105,476 ) $ 108,127

On December 12, 2018, the Company completed the Merger, whereby it acquired certain definite-lived intangible assets, including the developed product rights for Auryxia and a favorable lease.

The Company amortizes its definite-lived intangible assets acquired as part of the Merger using the straight-line method, which is considered the best estimate of economic benefit, over its estimated useful life of six years .

The Company recorded $ 9.0 million and $ 6.1 million in amortization expense related to the developed product rights for Auryxia during the three months ended September 30, 2021 and 2020, respectively, and $ 27.0 million and $ 24.3 million during the nine months ended September 30, 2021 and 2020, respectively.

Goodwill was $ 55.1 million as of September 30, 2021 and December 31, 2020.

The Company amortizes its definite-lived intangible assets using the straight-line method, which is considered the best estimate of economic benefit, over its estimated useful life of six years .

The Company recorded $ 9.0 million in amortization expense related to the developed product rights for Auryxia during each of the three months ended March 31, 2022 and 2021.

The Company's goodwill results from the acquisition of Keryx in December 2018.

Goodwill was $ 55.1 million as of March 31, 2022 and December 31, 2021.

The Company operates in one operating segment which the Company considers to be the only reporting unit.

Goodwill is evaluated for impairment at the reporting unit level on an annual basis as of October 1, and more frequently if indicators are present or changes in circumstances suggest that an impairment may exist.

There were no impairments of goodwill during the three and nine months ended September 30, 2021 or 2020.

During the first quarter of 2022, the Company evaluated business factors, including the receipt of a CRL from the FDA for vadadustat, to determine if there were events or changes in circumstance to indicate that the fair value of the reporting unit was less than its carrying value.

The Company determined that it was not more likely than not that the fair value of the reporting unit was less than its carrying value and, accordingly, determined that there was no impairment of goodwill during the three months ended March 31, 2022.

However, the future occurrence of events including, but not limited to, an adverse change in current economic and market conditions, including a significant prolonged decline in market capitalization, a significant adverse change in legal factors, unexpected adverse business conditions and an adverse action or assessment by a regulator could indicate potential impairment and trigger an interim impairment assessment of goodwill.

As a result of the significance of goodwill, the Company's results of operations and financial position in a future period could be negatively impacted should an impairment test be triggered that results in an impairment of goodwill.

Accrued Expenses

Accrued expenses as of September 30, 2021 and December 31, 2020 are as follows:

September 30, 2021 December 31, 2020

Accrued expenses as of March 31, 2022 and December 31, 2021 are as follows:

March 31, 2022 December 31, 2021

(in thousands)

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Amounts due to collaboration partners 28,019 22,654

Otsuka PRV contribution 10,000 10,000

Accrued payroll and related 7,130 15,863

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The Term Loans will mature on the fifth anniversary of the Tranche A Funding Date, or the Maturity Date.

The Company will repay the principal under the Term Loans in equal quarterly payments starting on the 33 rd-month anniversary of the applicable Funding Date or, if certain conditions are met, it will have the option to repay the principal in equal quarterly payments starting on the 48 th-month anniversary of the applicable Funding Date, or collectively the Amortization Schedule.

The Company will repay the principal under the Term Loans in equal quarterly payments starting on the 33 rd-month anniversary of the applicable Funding Date, or the Amortization Schedule.

If certain conditions are met, it would have the option to repay the principal in equal quarterly payments starting on the 48 th-month anniversary of the applicable Funding Date.

One of these conditions was approval of vadadustat;

however, the Company received a CRL from the FDA in March 2022 stating that the FDA had determined that it could not approve the NDA in its present form.

Therefore, the Company is no longer eligible for this option to delay repayment of the principal under the Loan Agreement.

Under certain circumstances, unless certain liquidity conditions are met, the Maturity Date may decrease by up to one year , and the Amortization Schedule may correspondingly commence up to one year earlier.

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The Loan Agreement contains customary representations, warranties, events of default and covenants of the Company and its subsidiaries, including maintaining, on an annual basis, a minimum liquidity threshold which started in 2021, and on a quarterly basis, a minimum net sales threshold for Auryxia which started in the fourth quarter of 2020.

On February 18, 2022, the Loan Agreement was amended, which amendment waived the provision under the Loan Agreement that required the Company to not be subject to any qualification as a going concern within the Company's 2021 Annual Report on Form 10-K.

Pursuant to the Loan Agreement, as amended, the Company's filings of Form 10-Q for fiscal quarters ending June 30, 2022 and September 30, 2022, and its future Annual Reports on Form 10-K, must not be subject to any qualification as to going concern.

If the Company does not satisfy the covenant as to going concern in any of these filings, the Company will be in default under the Loan Agreement.

There is uncertainty as to whether or not the Company will meet its future quarterly and annual debt covenants related to qualification as to going concern.

If an event of default occurs and is continuing under the Loan Agreement, the Collateral Agent is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement.

Therefore, as of March 31, 2022, the Company continued to classify the borrowings under the Loan Agreement as current.

Under certain circumstances, a default interest rate will apply on all outstanding obligations during the occurrence and continuance of an event of default.

As of September 30, 2021 and December 31, 2020, the Company determined that no events of default had occurred.

As of March 31, 2022 and December 31, 2021, the Company determined that no events of default had occurred.

The Company assessed the terms and features of the Loan Agreement in order to identify any potential embedded features that would require bifurcation or any beneficial conversion feature.

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The fair value of the derivative liability related to the Company’s Loan Agreement with Pharmakon was $ 1.9 million and $ 2.4 million as of September 30, 2021 and December 31, 2020, respectively.

The Company classified the derivative liability as a non-current liability on the unaudited condensed consolidated balance sheet as of September 30, 2021.

The Company recognized interest expense related to the Loan Agreement of $ 2.7 million and $ 2.2 million, respectively, during the three months ended September 30, 2021 and 2020, and $ 8.1 million and $ 6.6 million for the first nine months ended September 30, 2021 and 2020, respectively.

In connection with the Janssen Agreement, in February 2017, the Company issued a warrant to purchase 509,611 shares of the Company’s common stock at an exercise price of $ 9.81 per share.

The warrant was fully vested upon issuance and exercisable in whole or in part, at any time prior to February 9, 2022.

The warrant satisfied the equity classification criteria of ASC 815, and is therefore classified as an equity instrument.

The fair value at issuance of $ 3.4 million was calculated using the Black Scholes option pricing model and was charged to research and development expense as it represented consideration for a license for which the underlying intellectual property was deemed to have no alternative future use.

As of September 30, 2021, the warrant remains outstanding and expires on February 9, 2022.

The fair value of the derivative liability related to the Company’s Loan Agreement with Pharmakon was $ 1.1 million and $ 1.8 million as of March 31, 2022 and December 31, 2021, respectively.

The Company classified the derivative liability as a non-current liability on the unaudited condensed consolidated balance sheet as of March 31, 2022.

The Company recognized interest expense related to the Loan Agreement of $ 2.7 million during each of the three months ended March 31, 2022 and 2021.

Stockholders’ Equity

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

As of September 30, 2021, the authorized capital stock of the Company included 350,000,000 shares of common stock, par value $ 0.00001 per share, of which 174,551,989 and 148,074,085 shares were issued and outstanding as of September 30, 2021 and December 31, 2020, respectively;

and 25,000,000 shares of undesignated preferred stock, par value $ 0.00001 per share, of which no shares were issued and outstanding as of September 30, 2021 and December 31, 2020.

As of March 31, 2022, the authorized capital stock of the Company included 350,000,000 shares of common stock, par value $ 0.00001 per share, of which 183,386,035 and 177,000,963 shares were issued and outstanding as of March 31, 2022 and December 31, 2021, respectively;

and 25,000,000 shares of undesignated preferred stock, par value $ 0.00001 per share, of which no shares were issued and outstanding as of March 31, 2022 and December 31, 2021.

At-the-Market Facility

On November 12, 2019, the Company entered into an Amended and Restated Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co.

for the offer and sale of common stock at the then current market prices in amounts to be determined from time to time.

Also, on November 12, 2019, the Company filed a prospectus supplement pursuant to which it was able to offer and sell under the sales agreement up to $ 75.0 million of its common stock at the then current market prices from time to time.

Through December 31, 2019, the Company sold 2,684,392 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $ 16.8 million.

During the three months ended March 31, 2020, the Company sold 7,973,967 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $ 56.7 million.

On March 12, 2020, the Company filed a prospectus supplement relating to the sales agreement, pursuant to which it was able to offer and sell up to $ 65.0 million of its common stock at current market prices from time to time.

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During the three months ended March 31, 2021, the Company sold 5,224,278 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $ 15.9 million.

On February 25, 2021, the Company filed a prospectus relating to the sales agreement with its new shelf registration statement (which replaced the prior shelf registration statement and the sales agreement prospectus supplement), pursuant to which it is able to offer and sell up to $ 100.0 million of its common stock at current market prices from time to time.

During the three and nine months ended September 30, 2021 and through the date of this Quarterly Report on Form 10-Q, the Company sold 4,730,466 and 19,180,365 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $ 16.1 million and $ 67.2 million, respectively.

On February 25, 2021, the Company filed a prospectus relating to the sales agreement with its new shelf registration statement (which replaced the prior shelf registration statement and the sales agreement prospectus supplement), pursuant to which it was able to offer and sell up to $ 100.0 million of its common stock at current market prices from time to time.

Through December 31, 2021, the Company sold 21,128,065 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $ 72.4 million.

On March 1, 2022, the Company filed a prospectus relating to the sales agreement, pursuant to which it was authorized to offer and sell up to $ 25.3 million of its common stock at current market prices from time to time.

During the three months ended March 31, 2022 and through the date of this Quarterly

Report on Form 10-Q, the Company sold 404,600 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $ 0.8 million.

The Company maintains one stock incentive plan, the 2014 Incentive Plan, or the 2014 Plan, as well as the 2014 Employee Stock Purchase Plan, or the 2014 ESPP.

The 2014 Plan replaced the Company’s Amended and Restated 2008 Equity Incentive Plan, or the 2008 Plan, however, options or other awards granted under the 2008 Plan prior to the adoption of the 2014 Plan that have not been settled or forfeited remain outstanding and effective.

On June 6, 2019, the Company’s shareholders approved the

Amended and Restated 2014 Employee Stock Purchase Plan, or the ESPP.

On June 6, 2019, the Company’s stockholders approved the Amended and Restated 2014 Employee Stock Purchase Plan, or the ESPP.

The Company also maintains an inducement award program that is separate from the Company's equity plans under which inducement awards may be granted consistent with Nasdaq Listing Rule 5635(c)(4).

During the nine months ended September 30, 2021, the Company granted 1,228,200 options to purchase shares of the Company’s common stock to new hires as inducements material to such employees' entering into employment with the Company, of which 1,154,200 options remained outstanding as of September 30, 2021.

During the three months ended March 31, 2022, the Company granted 279,000 options to purchase shares of the Company’s common stock to new hires as inducements material to such employees' entering into employment with the Company, of which 279,000 options remained outstanding as of March 31, 2022.

The 2014 Plan allows for the granting of stock options, stock appreciation rights, or SARs, restricted stock, unrestricted stock, RSUs, performance awards and other awards convertible into or otherwise based on shares of the Company’s common stock.

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The Company initially reserved 1,785,000 shares of its common stock for the issuance of awards under the 2014 Plan.

The 2014 Plan provides that the number of shares reserved and available for issuance under the 2014 Plan will automatically increase annually on January 1 of each calendar year, by an amount equal to three percent ( 3 %) of the number of Akebia Shares (as defined in Note 1 of the 2020 Annual Report on Form 10-K) outstanding on a fully diluted basis as of the close of business on the immediately preceding December 31, or the 2014 Plan Evergreen Provision.

The 2014 Plan provides that the number of shares reserved and available for issuance under the 2014 Plan will automatically increase annually on January 1 of each calendar year, by an amount equal to three percent ( 3 %) of the number of the Company's outstanding shares on a fully diluted basis as of the close of business on the immediately preceding December 31, or the 2014 Plan Evergreen Provision.

The Company’s Board of Directors may act prior to January 1 of any year to provide that there will be no automatic increase in the number of Akebia Shares available for grant under the 2014 Plan for that year (or that the increase will be less than the amount that would otherwise have automatically been made).

On December 12, 2018, in connection with the consummation of the Merger, the Company assumed outstanding and unexercised options to purchase Keryx Shares (as defined in Note 1 of the 2020 Annual Report on Form 10-K), as adjusted by the Exchange Multiplier pursuant to the terms of the Merger Agreement, under the following Keryx equity plans, or the Keryx Equity Plans:

On December 12, 2018, in connection with the consummation of the Merger, the Company assumed outstanding and unexercised options to purchase Keryx's stock, as adjusted by the Exchange Multiplier pursuant to the terms of the Merger Agreement, under the following Keryx equity plans, or the Keryx Equity Plans:

the Keryx 1999 Share Option Plan, the Keryx 2004 Long-Term Incentive Plan, the Keryx 2007 Incentive Plan, the Keryx Amended and Restated 2013 Incentive Plan, and the Keryx 2018 Equity Incentive Plan, or the Keryx 2018 Plan.

1 unchanged sentence

The Company grants annual service-based stock options to employees under the 2014 Plan.

During the nine months ended September 30, 2021, the Company issued 1,997,200 options to employees.

During the three months ended March 31, 2022, the Company issued 2,833,500 options to employees.

In addition, the Company issues stock options to directors, new hires and occasionally to other employees not in connection with the annual grant process.

During the nine months ended September 30, 2021, the Company issued 200,800 options to directors under the 2014 Plan.

Options granted by the Company vest over periods of between 12 and 48 months, subject, in each case, to the individual’s continued service through the applicable vesting date.

Options vest either 100 % on the first anniversary of the grant date or in installments of (i) 25 % at the one year anniversary and (ii) 12 equal quarterly installments beginning after the one year anniversary of the grant date, subject to the individual’s continuous service with the Company.

Options 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 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 generally expire 10 years after the date of grant.

The Company also grants performance-based stock options to employees under the 2014 Plan.

The performance-based stock options granted by the Company vest in connection with the achievement of specified commercial and regulatory milestones.

The performance-based stock options also feature a time-based vesting component.

The Company issued no performance-based stock options during the three months ended March 31, 2022.

The performance-based stock options granted by the Company generally vest in connection with the achievement of specified commercial and regulatory 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 and regulatory milestones.

The Company issued 99,558 performance-based stock options during the nine months ended September 30, 2021.

The Company also grants annual service-based restricted stock units, or RSUs, to employees under the 2014 Plan.

During the nine months ended September 30, 2021, the Com pany issued 3,396,012 RSUs to employees.

In addition, the Company issued 82,200 RSUs to directors under the 2014 Plan during the nine months ended September 30, 2021.

During the three months ended March 31, 2022, the Com pany issued 2,914,308 RSUs to employees.

The Company also occasionally issues RSUs not in connection with the annual grant process to employees.

Generally, RSUs granted by the Company vest in one of the following ways:

(i) 100 % of each RSU grant vests on either the first 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) 50 % of each RSU grant vests on the first anniversary and 25 % of each RSU grant vests every six months after the one year anniversary of the grant date, subject, in each case, to the individual’s continued service through the applicable vesting date.

(i) 100 % of each RSU grant vests on the first or third anniversary of the grant date, (ii) one third of each RSU grant vests on the first, second and third anniversaries of the grant date, or (iii) 50 % of each RSU grant vests on the first anniversary and 25 % of each RSU grant vests every six months after the one year anniversary of the grant date, subject, in each case, to the individual’s continued service through the applicable vesting date.

The expense recognized for these awards is based on the grant date fair value of the Company’s common stock multiplied by the number of units granted and recognized on a straight-line basis over the vesting period.

The Company also grants performance-based restricted stock units, or PSUs, to employees under the 2014 Plan.

The PSUs granted by the Company vest in connection with the achievement of specified commercial and regulatory milestones.

The PSUs also feature a time-based vesting component.

The Company issued no PSUs during the three months ended March 31, 2022.

The PSUs granted by the Company generally vest in connection with the achievement of specified commercial and regulatory 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 and regulatory milestones.

The Company issued 37,150 PSUs during the nine months ended September 30, 2021.

The ESPP provides for the issuance of options to purchase shares of the Company’s common stock to participating employees at a discount to their fair market value.

As noted above, the Company’s stockholders approved the ESPP, which amended and restated the Company’s 2014 ESPP, on June 6, 2019.

As of September 30, 2021, the maximum aggregate number of shares of the Company’s common stock available for future issuance under the ESPP is 5,173,141 .

As of March 31, 2022, the maximum aggregate number of shares of the Company’s common stock available for future issuance under the ESPP is 4,981,995 .

Under the ESPP, each offering period is six months , at the end of which employees who elect to purchase shares of the Company’s common stock through payroll deductions made over the term of the offering.

The per-share purchase price at the end of each offering period is equal to the lesser of eighty-five percent ( 85 %) of the closing price of the Company’s common stock at the beginning or end of the offering period.

The Company issued 307,193 shares under the ESPP during the nine months ended September 30, 2021.

The Company issued 191,146 shares under the ESPP during the three months ended March 31, 2022.

Commitments and Contingencies

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In November 2020, the Company entered into a Sixth Amendment to the Cambridge Lease, or the Sixth Amendment, to extend the term of the Cambridge Lease with respect to the lab space from November 30, 2021 to January 31, 2025.

The Sixth Amendment includes two months of free rent starting in December 2020 and additional monthly lease payments of approximately $ 48,000 commencing in December 2021, and is subject to annual rent escalations, which commence in December 2022.

Additionally, as a result of the Merger, the Company has a lease for 27,300 square feet of office space in Boston, Massachusetts, or the Boston Lease, which expires in February 2023.

The total monthly lease payments under the base rent are approximately $ 136,000 and are subject to annual rent escalations.

The Sixth Amendment includes two months of free rent starting in December 2020 and additional monthly lease payments of approximately $ 48,000 , which commenced in December 2021, and is subject to annual rent escalations, which commence in December 2022.

Additionally, as a result of the Merger, the Company has a lease for 27,300 square feet of office space in Boston, Massachusetts, or the Boston Lease.

The total monthly lease payments under the initial base rent were approximately $ 136,000 and are subject to annual rent escalations.

In February 2022, the Company entered into the First Amendment to the Boston Lease, or the First Lease Amendment, to extend the term of the Boston Lease from February 2023 to July 2031.

The First Lease Amendment includes five months of free rent starting in March 2023 and monthly lease payments of $ 200,122 commencing on August 1, 2023, with an annual rent escalation of approximately 2 % commencing on August 1, 2024.

The First Lease Amendment also includes a landlord's allowance for certain leasehold improvements to the premises in an amount of up to $ 1,954,680 , provided that such allowance must be used prior to August 1, 2024.

The term of the Cambridge Lease with respect to the office space expires on September 11, 2026, with one five-year extension option available.

The term of the Boston Lease office space expires on February 28, 2023, with an extension option for one additional five-year term available.

The term of the Boston Lease office space expires on July 31, 2031, with an extension option for one additional five-year term available.

The renewal options in these real estate leases were not included in the calculation of the operating lease assets and operating lease liabilities as the renewal is not reasonably certain.

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The lease agreements do not contain residual value guarantees.

Operating lease costs were $ 1.7 million for each of the three months ended September 30, 2021 and 2020 and $ 5.0 million for each of the nine months ended September 30, 2021 and 2020.

Cash paid for amounts included in the measurement of operating lease liabilities was $ 1.8 million for each of the three months ended September 30, 2021 and 2020 and $ 5.3 million for each of the nine months ended September 30, 2021 and 2020, respectively.

Operating lease costs were $ 1.8 million and $ 1.7 million for the three months ended March 31, 2022 and 2021, respectively.

Cash paid for amounts included in the measurement of operating lease liabilities was $ 1.8 million for each of the three months ended March 31, 2022 and 2021.

In September 2019, Keryx entered into an agreement to sublease the Boston office space to Foundation Medicine, Inc., or Foundation.

1 unchanged sentence

The term of the sublease commenced on October 16, 2019, upon receipt of the required consent from the landlord for the sublease agreement, and expires on February 27, 2023.

Foundation is obligated to pay Keryx rent that approximates the rent due from Keryx to its landlord with respect to the Boston Lease.

Foundation is obligated to pay Keryx rent that approximates the rent due from Keryx to its

landlord with respect to the Boston Lease.

Sublease rental income is recorded to other income.

Keryx continues to be obligated for all payment terms pursuant to the Boston Lease, and the Company will guaranty Keryx’s obligations under the sublease.

Keryx recorded $ 0.4 million in sublease rental income from Foundation during each of the three months ended September 30, 2021 and 2020 and $ 1.3 million during each of the nine months ended September 30, 2021 and 2020.

The Company has not entered into any material short-term leases or financing leases as of September 30, 2021.

The total security deposit in connection with the Cambridge Lease is $ 1.6 million as of September 30, 2021.

Keryx recorded $ 0.5 million and $ 0.4 million in sublease rental income from Foundation during the three months ended March 31, 2022 and 2021, respectively.

The Company has not entered into any material short-term leases or financing leases as of March 31, 2022.

The total security deposit in connection with the Cambridge Lease is $ 1.6 million as of March 31, 2022.

Additionally, the Company recorded $ 1.4 million for the security deposit under the Boston Lease.

Both the Cambridge Lease and the Boston Lease have their security deposits in the form of a letter of credit, all of which are included as restricted cash in other assets in the Company’s unaudited condensed consolidated balance sheets as of September 30, 2021.

As of September 30, 2021, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter are as follows:

As of March 31, 2022, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter are as follows:

Leases Lease Payments

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In arriving at the operating lease liabilities, the Company applied incremental borrowing rates ranging from 6.65 % to 7.25 %, 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, 2021, the remaining lease terms ranged from 1.41 years to 4.95 years.

As of September 30, 2021, the following represents the difference between the remaining undiscounted minimum rental commitments under non-cancelable leases and the operating lease liabilities:

As of March 31, 2022, the remaining lease terms ranged from 4.45 years to 9.34 years.

As of March 31, 2022, the following represents the difference between the remaining undiscounted minimum rental commitments under non-cancelable leases and the operating lease liabilities:

(in thousands)

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As a result of the Merger, the Company's contractual obligations include Keryx’s commercial supply agreements with BioVectra Inc., or BioVectra, and Siegfried Evionnaz SA, or Siegfried, to supply commercial drug substance for Auryxia.

Pursuant to the Manufacture and Supply Agreement with BioVectra and the Product Manufacture and Supply and Facility Construction Agreement with BioVectra, collectively the BioVectra Agreement, the Company agreed to purchase minimum quantities of Auryxia drug substance annually at predetermined prices.

Pursuant to the Manufacture and Supply Agreement with BioVectra and the 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.

On September 4, 2020, the Company and BioVectra entered into an Amended and Restated Product Manufacture and Supply and Facility Construction Agreement, which provided for reduced minimum quantity commitments and revised the predetermined prices.

The price per kilogram decreases with an increase in quantity above the predetermined purchase quantity tiers.

In addition, the Manufacture and Supply Agreement with BioVectra and the Amended and Restated Product Manufacture and Supply and Facility Construction Agreement with BioVectra, collectively the Amended BioVectra Agreement, requires the Company to reimburse BioVectra for certain costs in connection with construction of a new facility for the manufacture and supply of Auryxia drug substance.

In addition, the Manufacture and Supply Agreement with BioVectra and the Amended and Restated Product Manufacture and Supply and Facility Construction Agreement with BioVectra, require the Company to reimburse BioVectra for certain costs in connection with construction of a new facility for the manufacture and supply of Auryxia drug substance.

These construction costs are recorded in other assets and amortized into drug substance as inventory is released to the Company from BioVectra.

The term of the Manufacture and Supply Agreement with BioVectra expires on December 31, 2022.

The term of the Amended and Restated Product Manufacture and Supply and Facility Construction Agreement expires on December 31, 2026, after which it automatically renews for successive one-year terms unless either party gives notice of its intention to terminate within a specified time prior to the end of the then-current term.

gives notice of its intention to terminate within a specified time prior to the end of the then-current term.

In addition, the Company and BioVectra each have the ability to terminate these agreements upon the occurrence of certain conditions.

As of September 30, 2021, the Company is required to reimburse BioVectra for certain costs in connection with the construction of the new facility and to purchase minimum quantities of Auryxia drug substance annually for a total cost of approximately $ 82.9 million through the end of the contract term.

As of March 31, 2022, the Company is required to reimburse BioVectra for certain costs in connection with the construction of the new facility and to purchase minimum quantities of Auryxia drug substance annually for a total cost of approximately $ 83.6 million through the end of the contract term.

Pursuant to the Siegfried Master Manufacturing Services and Supply Agreement, as amended (the most recent amendment having been executed on February 11, 2021), or the Siegfried Agreement, the Company has agreed to purchase a minimum quantity of drug substance of Auryxia at predetermined prices.

The term of the Siegfried Agreement expires on December 31, 2022, subject to our option to extend the term through December 31, 2023 by providing 12 months’ prior written notice to Siegfried.

The price per kilogram will decrease with an increase in quantity above the minimum purchase quantity.

The term of the Siegfried Agreement expires on December 31, 2022, subject to the Company's option to extend the term through December 31, 2023 by providing 12 months’ prior written notice to Siegfried.

The Siegfried Agreement provides the Company and Siegfried with certain early termination rights.

September 30, 2021, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $ 27.7 million through the year ending December 31, 2022.

In the first quarter of 2022, the Company notified Siegfried that the Company has elected not to exercise the option to extend the term of the Siegfried Agreement through December 31, 2023.

As of March 31, 2022, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $ 13.5 million through the year ending December 31, 2022.

As part of purchase accounting, the Company identified executory contracts in the commercial supply agreements between Keryx and its contract manufacturers for Auryxia, which include future firm purchase commitments.

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The Company regularly reviews its estimate of the excess purchase commitment liability including a review of assumptions of expected future demand, estimates of anticipated expiry of inventory under firm purchase commitments that are estimated to expire before they could be sold as well as any modifications to supply agreements during each reporting period.

The excess purchase commitment liability relating to these executory contracts was $ 71.2 million and $ 55.8 million as of September 30, 2021 and December 31, 2020, respectively.

During the quarter ended September 30, 2021, the Company reviewed the detailed assumptions above and recorded a $ 6.0 million reduction to the excess purchase commitments liability within cost of goods sold.

The reduction to the excess purchase commitments liability was primarily due to the settlement of all patent litigation proceedings related to Abbreviated New Drug Applications filed with respect to Auryxia, which allows for generic versions of Auryxia beginning in March 2025.

The Company recognized this non-cash gain in accordance with ASC 270 Interim Reporting, specifically ASC 270-10-45-6(c) Other Presentation Matters, which allows for recovery of losses on the same inventory in later interim periods of the same fiscal year as long as the as long as the recovery of losses does not exceed the previously recognized loss.

During the quarter ended June 30, 2021, the Company completed a routine update of its long-range plan and related estimates of expiry.

This routine update included the impact of recent activity with regards to our long-term payor contract strategy which continues to focus on contract economics and net revenue growth and resulted in a $ 30.3 million charge to cost of goods sold during the quarter ended June 30, 2021.

In addition, as of June 30, 2021, the Company also considered whether this increase was a potential indicator of impairment of the Auryxia asset group as of June 30, 2021.

As part of its assessment, the Company reviewed the Auryxia net sales and estimated future cash flows included in its long-range plan and concluded that the increase in excess purchase commitment liability was not an indicator of impairment of the Auryxia asset group as of June 30, 2021.

In addition, during the first quarter ended March 31, 2021, the Company recorded a non-cash gain to cost of goods sold of $ 9.0 million driven largely by a reduction in purchase commitments due to the amendment to the Siegfried Agreement.

The excess purchase commitment liability relating to these executory contracts was $ 72.7 million and $ 76.7 million as of March 31, 2022 and December 31, 2021, respectively.

During the quarter ended March 31, 2022, the Company reviewed the detailed assumptions above and recorded a $ 0.8 million reduction to the excess purchase commitments liability within cost of goods sold.

During the quarter ended March 31, 2022, the Company reduced the excess purchase commitment liability by $ 3.2 million for inventory received that had previously been identified as excess.

On April 9, 2019, the Company entered into a Supply Agreement with Esteve Química, S.A., or Esteve, or the Esteve Agreement.

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Pursuant to the Esteve Agreement, the Company has agreed to purchase a certain percentage of the global demand for vadadustat drug substance from Esteve.

As of September 30, 2021, the Company has committed to purchase $ 34.4 million of vadadustat drug substance from Esteve through the fourth quarter of 2022.

As of March 31, 2022, the Company has committed to purchase $ 39.0 million of vadadustat drug substance from Esteve through the second quarter of 2023.

On March 11, 2020, the Company entered into a Supply Agreement with Patheon Inc., or Patheon, or the Patheon Agreement.

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Pursuant to the Patheon Agreement, the Company has agreed to purchase a certain percentage of the global demand for vadadustat drug product from Patheon.

As of September 30, 2021, the Company had a minimum commitment with Patheon for $ 4.2 million through the third quarter of 2021.

As of March 31, 2022, the Company had a minimum commitment with Patheon for $ 3.9 million through the fourth quarter of 2022.

On April 2, 2020, the Company entered into a Supply Agreement with STA Pharmaceutical Hong Kong Limited, a subsidiary of WuXi AppTec, or WuXi STA, as amended on April 15, 2021, or the WuXi STA DS Agreement.

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Pursuant to the WuXi STA DS Agreement, the Company has agreed to purchase a certain percentage of the global demand for vadadustat drug substance from WuXi STA.

As of September 30, 2021, the Company has committed to purchase $ 44.8 million of vadadustat drug substance from WuXi STA through the end of 2022.

As of March 31, 2022, the Company has committed to purchase $ 77.9 million of vadadustat drug substance from WuXi STA through the end of 2023.

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

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Other Third-Party Contracts

Under the Company’s agreement with IQVIA to provide contract research organization services for the PRO 2 TECT and INNO 2 VATE programs, the total remaining contract costs as of September 30, 2021 were approximately $ 7.6 million, of which Otsuka reimburses a significant portion back to the Company.

Under the Company’s agreement with IQVIA to provide contract research organization services for the PRO 2 TECT and INNO 2 VATE programs, the total remaining contract costs as of March 31, 2022 were approximately $ 4.7 million, of which Otsuka reimburses a significant portion back to the Company.

Substantive performance for the committed work with IQVIA was completed in 2020 and close out activities will be performed throughout 2022.

The Company also contracts with various other organizations to conduct research and development activities with remaining contract costs to the Company of approximately $ 244.4 million at September 30, 2021.

The Company also contracts with various other organizations to conduct research and development activities with remaining contract costs to the Company of approximately $ 211.9 million at March 31, 2022.

The scope of the services under these research and development contracts can be modified and the contracts cancelled by the Company upon written notice.

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Changes in Company estimates could have a material impact on the Company’s results and financial position.

As of September 30, 2021, the Company does not have any significant legal disputes that require a loss liability to be recorded.

As of March 31, 2022, the Company does not have any significant legal disputes that require a loss liability to be recorded.

The Company continually monitors the need for a loss liability for litigation and related matters.

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

As of September 30,

As of March 31,

Warrant — 509,611

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Total 19,970,534 18,402,397

Subsequent Events

Reduction in Force

On April 4, 2022, the Board of Directors of the Company approved a reduction of the Company’s workforce by approximately 42 % across all areas of the Company ( 47 % inclusive of the closing of the majority of open positions) following the receipt of a CRL from the FDA to the Company’s NDA for vadadustat for the treatment of anemia due to CKD in adult patients.

workforce reduction will be substantially completed by the end of the second quarter of 2022.

On May 5, 2022, the Company implemented a further reduction in workforce consisting of several members of management.

This workforce reduction is expected to be substantially complete by the end of January 2023.

These actions reflect the Company’s determination to refocus its strategic priorities around its commercial product, Auryxia ® , and its development portfolio, and are steps in a cost savings plan to significantly reduce the Company’s expense profile in line with being a single commercial product company.

The Company plans to seek to effect additional measures to further reduce its operating expenses and increase revenue from Auryxia.

Affected employees in the workforce reductions were offered separation benefits, including severance payments, healthcare coverage and related benefits.

The Company expects to record restructuring charges of approximately $ 16.5 million in the aggregate primarily related to one-time termination benefits and contractual termination benefits including severance, non-cash stock-based compensation expense, healthcare and related benefits primarily in the second quarter of 2022.

The Company may incur additional costs not currently contemplated due to events associated with or resulting from the workforce reduction.

The charge that the Company expects to incur in connection with the workforce reductions is an estimate and is subject to a number of assumptions, and actual results may differ materially.

At-the-Market Facility Agreement

On April 7, 2022, the Company entered into an Open Market Sale Agreement SM , or the sales agreement, with Jefferies LLC, or Jefferies, as agent, for the offer and sale of common stock at current market prices in amounts to be determined from time to time.

Also, on April 7, 2022, the Company filed a prospectus supplement relating to the sales agreement, pursuant to which it is able to offer and sell under the sales agreement up to $ 26.0 million of its common stock at current market prices from time to time.

From the date of filing of the prospectus supplement through the date of the filing of this Quarterly Report on Form 10-Q, the Company has not sold any shares of its common stock under this program.

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