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☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Delaware

20-8756903

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

245 First Street, Cambridge, MA

02142

(Address of principal executive offices)

(Zip Code)

Securities registered pursuant to Section 12(b) of the Act:
Title of each class			Trading symbol(s)			Name of each exchange on which registered
Common Stock, par value $0.00001 per share			AKBA			The Nasdaq Global Market

Large accelerated filer			ý			Accelerated filer			☐
Non-accelerated filer			¨			Smaller reporting company			☐
						Emerging growth company			☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

			Outstanding at October 31, 2022
			183,962,083

•the potential therapeutic benefits, safety profile, and effectiveness of vadadustat; 

•that delivering value broadly to the kidney community, as well as others who may benefit from our medicines, will result in delivering value for stockholders;

•our pipeline and portfolio, including its potential, and our related research and development activities;

•the timing of or likelihood of regulatory filings and approvals, including with respect to labeling or other restrictions, the potential approval of vadadustat and our outlook related thereto, and potential indications for vadadustat;

•the timing, investment and associated activities involved in continued commercialization of Auryxia® (ferric citrate), its growth opportunities and our ability to execute thereon;

•the potential indications, demand and market opportunity, potential and acceptance of Auryxia and vadadustat, if approved, including the size of eligible patient populations; 

•the potential therapeutic applications of the hypoxia inducible factor pathway;

•our competitive position, including estimates, developments and projections relating to our competitors and their products and product candidates, and our industry; 

•our expectations, projections and estimates regarding our capital requirements, need for additional capital, financing our future cash needs, costs, expenses, revenues, capital resources, cash flows, financial performance, profitability, tax obligations, liquidity, growth, contractual obligations, the period of time our cash resources and collaboration funding will fund our current operating plan, our internal control over financial reporting and disclosure controls and procedures, and remediation of the material weakness we have identified in our internal control over financial reporting relating to our inventory process or any future deficiencies or material weaknesses in our internal controls and procedures; 

•estimates, beliefs and judgments related to the valuation of intangible assets, goodwill, contingent consideration, debt and other assets and liabilities, including our impairment analysis and our methodology and assumptions regarding fair value measurements;

•the timing of the availability and disclosure of clinical trial data and results;

•our and our collaborators’ strategy, plans and expectations with respect to the development, manufacturing, supply, commercialization, launch, marketing and sale of Auryxia and vadadustat, if approved, and the associated timing thereof; 

•the designs of our studies, and the type of information and data expected from our studies and the expected benefits thereof;

•our ability to maintain any marketing authorizations we currently hold or will obtain, including our marketing authorizations for Auryxia and our ability to complete post-marketing requirements with respect thereto;

•our ability to negotiate, secure and maintain adequate pricing, coverage and reimbursement terms and processes on a timely basis, or at all, with third-party payors for Auryxia and vadadustat, if approved;

•the timing of initiation of our clinical trials and plans to conduct preclinical studies and clinical trials in the future; 

•the timing and amounts of payments from or to our collaborators and licensees, and the anticipated arrangements and benefits under our collaboration and license agreements, including with respect to milestones and royalties; 

•our intellectual property position, including obtaining and maintaining patents, and the timing, outcome and impact of administrative, regulatory, legal and other proceedings relating to our patents and other proprietary and intellectual property rights, patent infringement suits that we have filed or may file, or other actions that we may take against companies, and the timing and resolution thereof;

•expected ongoing reliance on third parties, including with respect to the development, manufacturing, supply and commercialization of Auryxia and vadadustat, if approved;

•accounting standards and estimates, their impact, and their expected timing of completion;

•estimated periods of performance of key contracts;

•our facilities, lease commitments, and future availability of facilities;

•cybersecurity;

•insurance coverage;

•remediation of our material weakness;

•estimates with respect to our ability to operate as a going concern;

•management of personnel, including our management team, and our employees, including employee compensation, employee relations, and our ability to attract, train and retain high quality employees;

•the implementation of our business model, current operating plan, and strategic plans for our business, product candidates and technology, and business development opportunities including potential collaborations, alliances, mergers, acquisitions or licensing of assets;

AURYXIA®, AKEBIA Therapeutics®, VafseoTM and their associated logos are trademarks of Akebia and/or its affiliates. All other trademarks, trade names and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. All website addresses given in this Quarterly Report on Form 10-Q are for information only and are not intended to be an active link or to incorporate any website information into this document.

•We have incurred significant losses since our inception, and anticipate that we will continue to incur significant losses and cannot guarantee when, if ever, we will become profitable or attain positive cash flows.

•We may not be successful in our efforts to identify, acquire, in-license, discover, develop and commercialize additional products or product candidates or our decisions to prioritize the development of certain product candidates over others may not be successful, which could impair our ability to grow.

•The commercialization of RionaTM and VafseoTM in Japan and our current and potential future efforts with respect to the development and commercialization of our products and product candidates outside of the United States subject us to a variety of risks associated with international operations, which could materially adversely affect our business.

•Our stock price has been and may continue to be volatile, which could result in substantial losses for holders or future purchasers of our common stock and lawsuits against us and our officers and directors.

Part I. Financial Information
Item 1 – Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021			7
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2022 and 2021			8
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2022 and 2021			9
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021			10
Notes to Condensed Consolidated Financial Statements			12
Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations			35
Item 3 – Quantitative and Qualitative Disclosures about Market Risk			49
Item 4 – Controls and Procedures			49
Part II. Other Information			51
Item 1 – Legal Proceedings			51
Item 1A – Risk Factors			54
Item 2 – Unregistered Sales of Equity Securities and Use of Proceeds			105
Item 3 – Defaults Upon Senior Securities			105
Item 4 – Mine Safety Disclosures			105
Item 5 – Other Information			106
Item 6 – Exhibits			107
Signatures			108

			September 30, 2022						December 31, 2021
Assets
Current assets:
Cash and cash equivalents			$	144,761					$	149,800
Inventory			40,039						38,195
Accounts receivable, net			23,094						50,875
Prepaid expenses and other current assets			29,618						33,140
Total current assets			237,512						272,010
Property and equipment, net			5,622						6,754
Operating lease assets			30,337						33,852
Goodwill			55,053						55,053
Other intangible assets, net			81,095						108,127
Other assets			26,275						49,754
Total assets			$	435,894					$	525,550
Liabilities and stockholders' equity
Current liabilities:
Accounts payable			$	19,708					$	33,588
Accrued expenses and other current liabilities			87,364						104,456
Short-term deferred revenue			1,265						20,906
Current portion of refund liability to customer			13,681						—
Current portion of long-term debt			65,947						97,543
Total current liabilities			187,965						256,493
Deferred revenue, net of current portion			43,296						21,474
Operating lease liabilities, net of current portion			30,683						33,703
Derivative liability			760						1,820
Liability related to sale of future royalties, net			58,236						53,079
Refund liability to customer, net of current portion			26,788						—
Other non-current liabilities			74,313						82,525
Total liabilities			422,041						449,094
Commitments and contingencies (Note 13)
Stockholders' equity:
Preferred stock $0.00001 par value, 25,000,000 shares authorized; 0 shares issued and    outstanding at September 30, 2022 and December 31, 2021			—						—
Common stock $0.00001 par value; 350,000,000 shares authorized at September 30, 2022 and December 31, 2021; 183,951,583 and 177,000,963 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively			2						1
Additional paid-in capital			1,559,206						1,536,800
Accumulated other comprehensive loss			6						6
Accumulated deficit			(1,545,361)						(1,460,351)
Total stockholders' equity			13,853						76,456
Total liabilities and stockholders' equity			$	435,894					$	525,550

			Three Months Ended September 30,												Nine Months Ended September 30,
			2022						2021						2022						2021
Revenues:
Product revenue, net			$	42,239					$	36,753					$	127,390					$	100,120
License, collaboration and other revenue			6,725						12,003						110,032						53,853
Total revenues			48,964						48,756						237,422						153,973
Cost of goods sold:
Product			28,936						6,933						60,859						76,012
Amortization of intangibles			9,011						9,011						27,032						27,032
Total cost of goods sold			37,947						15,944						87,891						103,044
Operating expenses:
Research and development			27,350						40,471						97,210						118,296
Selling, general and administrative			30,918						46,357						108,052						129,336
License expense			743						870						2,323						2,460
Restructuring			180						—						14,711						—
Total operating expenses			59,191						87,698						222,296						250,092
Operating loss			(48,174)						(54,886)						(72,765)						(199,163)
Other income (expense):
Interest expense			(3,952)						(5,085)						(14,051)						(14,853)
Other income			1,167						427						2,712						1,854
Loss on extinguishment of debt			(906)						—						(906)						—
Net loss			$	(51,865)					$	(59,544)					$	(85,010)					$	(212,162)
Net loss per share - basic and diluted			$	(0.28)					$	(0.34)					$	(0.47)					$	(1.30)
Weighted-average number of common shares - basic and diluted			183,882,446						173,782,151						182,375,443						163,050,769
Comprehensive loss:
Net loss			$	(51,865)					$	(59,544)					$	(85,010)					$	(212,162)
Other comprehensive loss - unrealized loss on debt securities			—						—						—						(7)
Total comprehensive loss			$	(51,865)					$	(59,544)					$	(85,010)					$	(212,169)

			Common Stock
			Number of Shares						$0.00001 Par Value						Additional Paid-In Capital						Unrealized Gain/(Loss)						Accumulated Deficit						Total Stockholders' Equity
Balance at December 31, 2020			148,074,085						$	1					$	1,425,115					$	13					$	(1,177,511)					$	247,618
Issuance of common stock, net of    issuance costs			9,228,017						1						29,497						—						—						29,498
Proceeds from sale of stock under    employee stock purchase plan			154,276						—						367						—						—						367
Stock-based compensation expense			—						—						5,992						—						—						5,992
Restricted stock unit vesting			1,063,711						—						—						—						—						—
Unrealized loss			—						—						—						(4)						—						(4)
Net loss			—						—						—						—						(69,580)						(69,580)
Balance at March 31, 2021			158,520,089						$	2					$	1,460,971					$	9					$	(1,247,091)					$	213,891
Issuance of common stock, net of    issuance costs			10,446,160						—						37,266						—						—						37,266
Stock-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
Balance at December 31, 2021			177,000,963						$	1					$	1,536,800					$	6					$	(1,460,351)					$	76,456
Issuance of common stock, net of    issuance costs			4,404,600						1						7,177						—						—						7,178
Proceeds from sale of stock under    employee stock purchase plan			191,146						—						367						—						—						367
Stock-based compensation expense			—						—						4,536						—						—						4,536
Restricted stock unit vesting			1,789,326						—						—						—						—						—
Net loss			—						—						—						—						(62,421)						(62,421)
Balance at March 31, 2022			183,386,035						$	2					$	1,548,880					$	6					$	(1,522,772)					$	26,116
Stock-based compensation expense			—						—						6,841						—						—						6,841
Exercise of options			142,440						—						67						—						—						67
Restricted stock unit vesting			176,179						—						—						—						—						—
Net income			—						—						—						—						29,276						29,276
Balance at June 30, 2022			183,704,654						$	2					$	1,555,788					$	6					$	(1,493,496)					$	62,300
Share-based compensation expense			—						—						3,375						—						—						3,375
Proceeds from sale of stock under    employee stock purchase plan			144,000						—						43						—						—						43
Restricted stock unit vesting			102,929						—						—						—						—						—
Net loss			—						—						—						—						(51,865)						(51,865)
Balance at September 30, 2022			183,951,583						$	2					$	1,559,206					$	6					$	(1,545,361)					$	13,853

			Nine Months Ended
			September 30, 2022						September 30, 2021
Operating activities:
Net loss			$	(85,010)					$	(212,162)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			1,246						1,485
Amortization of intangibles			27,032						27,032
Amortization of premium/discount on investments			—						(15)
Non-cash interest expense related to sale of future royalties			6,352						6,779
Non-cash royalty revenue related to sale of future royalties			(1,195)						(425)
Non-cash collaboration revenue			(9,550)						—
Non-cash R&D expense			3,941						—
Non-cash interest expense			1,467						852
Non-cash operating lease expense			(1,818)						(1,415)
Non-cash loss on extinguishment of debt			406						—
Fair value step-up of inventory sold or written off			—						21,575
Write-down of inventory			10,002						7,126
Change in excess inventory purchase commitments			12,422						15,376
Stock-based compensation			14,808						18,099
Change in fair value of derivative liability			(1,060)						(490)
Changes in operating assets and liabilities:
Accounts receivable			27,781						(22,837)
Inventory			1,405						(35,282)
Prepaid expenses and other current assets			9,131						(25,020)
Other long-term assets			14,817						4,728
Accounts payable			(17,420)						(14,933)
Accrued expense			(22,364)						15,099
Operating lease liabilities			1,771						1,173
Deferred revenue			2,181						3,098
Other non-current liabilities			(14,820)						—
Net cash used in operating activities			(18,475)						(190,157)
Investing activities:
Purchase of equipment			(114)						(59)
Proceeds from the maturities of available for sale securities			—						40,000
Net cash (used in) provided by investing activities			(114)						39,941
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			7,122						82,799
Proceeds from the sale of stock under employee stock purchase plan			410						746
Proceeds from the exercise of stock options			67						—
Payments on debt			(33,000)						—
Net cash provided by financing activities			14,599						128,328
(Decrease) in cash, cash equivalents, and restricted cash			(3,990)						(21,888)
Cash, cash equivalents, and restricted cash at beginning of the period			151,839						231,132
Cash, cash equivalents, and restricted cash at end of the period			$	147,849					$	209,244
Non-cash financing activities
Unpaid offering costs			$	—					$	57

Akebia Therapeutics, Inc., referred to as Akebia or the Company, was incorporated in the State of Delaware in 2007. Akebia is a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease. The Company has one commercial product, Auryxia® (ferric citrate), which is approved by the U.S. Food and Drug Administration, or FDA, and marketed for two indications in the United States: the control of serum phosphorus levels in adult patients with chronic kidney disease, or CKD, on dialysis, or DD-CKD, and the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or NDD-CKD. Ferric citrate is also approved and marketed in Japan as an oral treatment for IDA in adult patients for the improvement of hyperphosphatemia in such patients with DD-CKD and NDD-CKD under the trade name Riona (ferric citrate hydrate).

Vadadustat, the Company’s lead investigational product candidate, is an investigational oral hypoxia-inducible factor prolyl hydroxylase, or HIF-PH, inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. On March 29, 2022, the Company received a complete response letter, or CRL, from the FDA. 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. In July 2022, the Company held an end of review meeting with the FDA to inform the Company's next steps with respect to the potential U.S. approval of vadadustat, if any, and in October 2022, the Company submitted a Formal Dispute Resolution Request, or FDRR, with the FDA. The FDRR focuses on the favorable balance between the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis in light of safety concerns expressed by the FDA in the CRL related to the rate of adjudicated thromboembolic events driven by vascular access thrombosis for vadadustat compared to the active comparator and the risk of drug-induced liver injury. On May 12, 2022, the Company received notice from its former collaboration partner, Otsuka Pharmaceutical Co. Ltd., or Otsuka, that Otsuka had elected to terminate the Collaboration and License Agreement dated December 18, 2016, or the Otsuka U.S. Agreement, and the Collaboration and License Agreement dated April 25, 2017, or the Otsuka International Agreement. On June 30, 2022, the Company and Otsuka entered into a Termination and Settlement Agreement, or the Termination Agreement, pursuant to which, among other things, the Company and Otsuka agreed to terminate the Otsuka U.S. Agreement and the Otsuka International Agreement as of June 30, 2022 (see Note 4 for further details). In October 2021, 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 connection with the Termination Agreement, Otsuka transferred the MAA for vadadustat with the EMA to the Company. 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 VafseoTM, and marketed and sold in Japan by Mitsubishi Tanabe Pharma Corporation, or MTPC.

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,

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.

3.Product Revenue and Reserves for Variable Consideration

			Chargebacks and Discounts						Rebates, Fees and other Deductions						Returns						Total
Balance at December 31, 2021			$	1,278					$	26,625					$	475					$	28,378
Current provisions related to sales in current year			8,592						64,322						3,692						76,606
Adjustments related to prior year sales			(248)						33						—						(215)
Credits/payments made			(8,194)						(65,611)						(3,669)						(77,474)
Balance at September 30, 2022			$	1,428					$	25,369					$	498					$	27,295
Balance at December 31, 2020			$	802					$	39,912					$	649					$	41,363
Current provisions related to sales in current year			8,911						105,432						4,866						119,209
Adjustments related to prior year sales			(1)						(1,590)						—						(1,591)
Credits/payments made			(8,593)						(99,518)						(4,979)						(113,090)
Balance at September 30, 2021			$	1,119					$	44,236					$	536					$	45,891

4.License, Collaboration and Other Significant Agreements

			Three Months Ended September 30,												Nine Months Ended September 30,
			2022						2021						2022						2021
License, Collaboration and Other Revenue:			(in thousands)												(in thousands)
MTPC Agreement			$	5,487					$	2,555					$	13,885					$	7,167
Otsuka U.S. Agreement			—						6,144						86,773						28,988
Otsuka International Agreement			—						1,860						5,503						13,532
Total Proportional Performance Revenue			$	5,487					$	10,559					$	106,161					$	49,687
JT and Torii			1,238						1,444						3,871						4,093
MTPC Other Revenue			—						—						—						73
Total License, Collaboration and Other Revenue			$	6,725					$	12,003					$	110,032					$	53,853

			September 30, 2022
			Short-Term						Long-Term						Total
Deferred Revenue:			(in thousands)
MTPC Agreement			$	1,265					$	—					$	1,265
Vifor Pharma Agreement			—						43,296						43,296
Total			$	1,265					$	43,296					$	44,561

Nine Months Ended September 30, 2022			Balance at Beginning of Period						Additions						Deductions						Balance at End of Period
Contract assets:
Accounts receivable(1)			$	19,094					$	92,612					$	(109,836)					$	1,870
Prepaid expenses and other current assets			$	4,309					$	9,550					$	(8,250)					$	5,609
Contract liabilities:
Deferred revenue			$	42,380					$	66,307					$	(64,126)					$	44,561
Accounts payable			$	3,171					$	—					$	(3,171)					$	—
Accrued expenses and other current liabilities			$	—					$	—					$	—					$	—
Nine Months Ended September 30, 2021
Contract assets:
Accounts receivable(1)			$	3,045					$	38,795					$	(20,427)					$	21,413
Prepaid expenses and other current assets			$	1,722					$	1,725					$	(5)					$	3,442
Contract liabilities:
Deferred revenue			$	40,559					$	65,890					$	(62,792)					$	43,657
Accounts payable			$	7,227					$	—					$	(7,227)					$	—
Accrued expenses and other current liabilities			$	10,000					$	—					$	—					$	10,000

			Three Months Ended September 30,												Nine Months Ended September 30,
Revenue Recognized in the Period:			2022						2021						2022						2021
Amounts included in deferred revenue at the beginning of the period			$	5,047					$	9,159					$	29,574					$	20,363
Performance obligations satisfied in previous periods			$	—					$	—					$	—					$	—

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. 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 6 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. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of the standalone selling price for the Rights to Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement and determined it is immaterial. As such, the

Under the terms of the Otsuka U.S. Agreement, the Company granted to Otsuka a co-exclusive, non-sublicensable license under certain intellectual property controlled by the Company solely to perform medical affairs activities and to conduct non-promotional and commercialization activities related to vadadustat in the United States in accordance with the associated plans. The co-exclusive license related to activities that would be jointly conducted by the Company and Otsuka pursuant to the terms of the Otsuka U.S. Agreement. 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.

Under the terms of the Otsuka International Agreement, the Company granted to Otsuka an exclusive, sublicensable license under certain intellectual property controlled by the Company to develop and commercialize vadadustat and products containing or comprising vadadustat in the Otsuka International Territory. Additionally, under the terms of this agreement, the Company was responsible for leading the development of vadadustat. Otsuka had 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 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.

Under the terms of the Cyclerion Agreement, the Company made an upfront payment of $3.0 million in cash to Cyclerion, which was paid and recorded to research and development expense in June 2021. Substantially all of the fair value of the assets acquired in conjunction with the Cyclerion Agreement was concentrated in the acquired license. As a result, the Company accounted for this transaction as an asset acquisition under ASU No. 2017-01, Business Combinations (Topic 805): Clarifying

the Definition of a Business. The upfront payment was charged to expense at acquisition, as it relates to a development stage compound with no alternative future use. In addition, Cyclerion is eligible to receive up to an aggregate of $222.0 million from the Company in specified development and regulatory milestone payments on a product-by-product basis. Cyclerion will also be eligible to receive specified commercial milestones as well as tiered royalties ranging from a low-single-digit- to mid-double-digit percentage of net sales, on a product-by-product basis, and subject to reduction upon expiration of patent rights or the launch of a generic product in the territory. A more detailed description of this agreement can be found in Note 4 of the Notes to the Consolidated Financial Statements in the 2021 Annual Report on Form 10-K.

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 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 September 30, 2022.

The Company identified two performance obligations in connection with its obligations under the JT and Torii Sublicense Agreement: (i) License and Supply Performance Obligation and (ii) Rights to Future Know-How Performance Obligation. The Company allocated the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of the standalone selling price for the Rights to Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement and determined it immaterial. As such, the Company did not develop a best estimate of standalone selling price for the License and Supply Performance Obligation and allocated the entire transaction price to this performance obligation.

The workforce reduction is expected to include total restructuring charges of approximately $14.7 million. During the three and nine months ended September 30, 2022, the Company recognized $0.2 million and $14.7 million, respectively, of restructuring charges in the condensed consolidated statement of operations. These charges included $11.4 million of one-time termination benefits and contractual termination benefits for severance, healthcare, and related benefits and $3.3 million of non-cash share-based compensation expense. The charges were recorded pursuant to ASC 712, Compensation-Nonretirement Postemployment Benefits or ASC 420, Exit or Disposal Cost Obligations, depending on the employee.

			September 30, 2022
			(in thousands)
Balance at December 31, 2021			$	—
Restructuring charges			14,711
Stock-based compensation expense			(3,253)
Severance payments and adjustments			(7,220)
Balance at September 30, 2022			$	4,238

6.Liability Related to Sale of Future Royalties

			September 30, 2022
			(in thousands)
Liability related to sale of future royalties, net beginning balance at December 31, 2021			$	53,079
MTPC royalties payable			(1,195)
Non-cash interest expense recognized			6,352
Liability related to sale of future royalties, net — ending balance			$	58,236

			Fair Value Measurements Using
			Level 1						Level 2						Level 3						Total
			(in thousands)
September 30, 2022
Assets:
Cash and cash equivalents			$	144,761					$	—					$	—					$	144,761
			$	144,761					$	—					$	—					$	144,761
Liabilities:
Derivative liability			$	—					$	—					$	760					$	760
			$	—					$	—					$	760					$	760

			Fair Value Measurements Using
			Level 1						Level 2						Level 3						Total
			(in thousands)
December 31, 2021
Assets:
Cash and cash equivalents			$	149,800					$	—					$	—					$	149,800
			$	149,800					$	—					$	—					$	149,800
Liabilities:
Derivative liability			$	—					$	—					$	1,820					$	1,820
			$	—					$	—					$	1,820					$	1,820

Balance at December 31, 2021			$	1,820
Change in fair value of derivative liability, recorded as other income			(710)
Balance at March 31, 2022			$	1,110
Change in fair value of derivative liability, recorded as other income			—
Balance at June 30, 2022			$	1,110
Change in fair value of derivative liability, recorded as other income			(350)
Balance at September 30, 2022			$	760

			September 30, 2022						December 31, 2021
			(in thousands)
Raw materials			$	397					$	1,763
Work in process			32,855						62,635
Finished goods			18,970						14,661
Total inventory			$	52,222					$	79,059

			September 30, 2022						December 31, 2021
			(in thousands)
Balance Sheet Classification:
Inventory			$	40,039					$	38,195
Other assets			12,183						40,864
Total inventory			$	52,222					$	79,059

9.Intangible Assets and Goodwill

			September 30, 2022
			Gross Carrying Value						Accumulated Amortization						Total
Intangible assets:
Developed product rights for Auryxia			$	213,603					$	(132,508)					$	81,095
Total			$	213,603					$	(132,508)					$	81,095

			December 31, 2021
			Gross Carrying Value						Accumulated Amortization						Total
Intangible assets:
Developed product rights for Auryxia			$	213,603					$	(105,476)					$	108,127
Total			$	213,603					$	(105,476)					$	108,127

			September 30, 2022						December 31, 2021
			(in thousands)
Product revenue allowances			$	25,222					$	26,624
Accrued clinical			8,652						14,036
Amounts due to collaboration partners			19,550						22,654
Accrued payroll and related			9,140						15,863
Lease liability			4,260						4,802
Royalties			2,916						3,472
Professional fees			1,725						1,899
Accrued commercial manufacturing			3,167						3,843
Accrued restructuring			4,238						—
Accrued other			8,494						11,263
Total accrued expenses			$	87,364					$	104,456

			Principal
			Payments
			(in thousands)
2022			$	—
2023			32,000
2024			35,000
Total before unamortized discount and issuance costs			67,000
Less: unamortized discount and issuance costs			(1,053)
Total term loans			$	65,947

12.Stockholders’ Equity

The Company grants annual service-based stock options to employees under the 2014 Plan. During the nine months ended September 30, 2022, the Company issued 3,233,500 options to employees under the 2014 Plan. In addition, the Company issues stock options to directors, new hires and occasionally to other employees not in connection with the annual grant process. During the nine months ended September 30, 2022, the Company issued 140,700 options to directors under the 2014 Plan. 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 Company issued 400,000 performance-based stock options under the 2014 Plan during the nine months ended September 30, 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 also grants annual service-based restricted stock units, or RSUs, to employees and directors under the 2014 Plan. The Company also occasionally issues RSUs not in connection with the annual grant process to employees and directors. During the nine months ended September 30, 2022, the Company issued 5,216,908 RSUs to employees and 95,900 RSUs to directors under the 2014 Plan. Generally, RSUs granted by the Company vest in one of the following ways: (i) 100% of each RSU grant vests on the first anniversary of the grant date, (ii) one third of each RSU grant vests on the first, second and third anniversaries of the grant date, (iii) 50% of each RSU grant vests on the first anniversary and 25% of each RSU grant vests every six months after the one year anniversary of the grant date, or (iv) one third of each RSU grant vests on the first anniversary and the remaining two thirds vests in eight substantially equal quarterly installments beginning after the one year anniversary, subject, in each case, to the individual’s continued service through the applicable vesting date. The 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 Company issued 400,000 PSUs during the nine months ended September 30, 2022. The PSUs granted by the Company generally vest in connection with the achievement of specified commercial, regulatory and corporate milestones. The PSUs also generally feature a time-based vesting component. The expense recognized for these awards is based on the grant date fair value of the Company’s common stock multiplied by the number of units granted and recognized over time based on the probability of meeting such commercial, regulatory and corporate milestones.

13.Commitments and Contingencies

The Company leases approximately 65,167 square feet of office and lab space in Cambridge, Massachusetts under a lease which was most recently amended in November 2020, collectively the Cambridge Lease. Under the Third Amendment to the Cambridge Lease, or the Third Amendment, executed in July 2016, total monthly lease payments under the initial base rent were approximately $242,000 and are subject to annual rent escalations. In addition to such annual rent escalations, base rent payments for a portion of said premises commenced on January 1, 2017 in the monthly amount of approximately $22,000. The Fourth Amendment to the Cambridge Lease, executed in May 2017, provided additional storage space to the Company and did not impact rent payments. In April 2018, the Company entered into a Fifth Amendment to the Cambridge Lease, or the Fifth Amendment, for an additional 19,805 square feet of office space on the 12th floor. Monthly lease payments for the existing 45,362 square feet of office and lab space, under the Third Amendment, remain unchanged. The new space leased by the Company was delivered in September 2018 and additional monthly lease payments of approximately $135,000 commenced in February 2019 and are subject to annual rent escalations, which commenced in September 2019. In November 2020, the Company entered into a Sixth Amendment to the Cambridge Lease, 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, which commenced in December 2021, and is subject to annual rent escalations, which commence in December 2022.

			Operating Leases						Lease Payments to be Received from Sublease						Net Operating Lease Payments
			(in thousands)
Remaining 2022			$	1,837					$	461					$	1,376
2023			6,954						307						6,647
2024			8,167						—						8,167
2025			8,293						—						8,293
2026			6,571						—						6,571
Thereafter			12,200						—						12,200
Total			$	44,022					$	768					$	43,254

			Operating Leases
			(in thousands)
Undiscounted minimum rental commitments			$	44,022
Present value adjustment using incremental borrowing rate			(8,733)
Operating lease liabilities			$	35,289

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. The WuXi STA DS Agreement includes the terms and conditions under which WuXi STA will manufacture vadadustat drug substance for commercial use. Pursuant to the WuXi STA DS Agreement, the Company provides rolling forecasts to WuXi STA on a quarterly basis, or the WuXi STA DS Forecast. The WuXi STA DS Forecast reflects the Company’s needs for vadadustat drug substance produced by WuXi STA over a certain number of quarters. The parties have agreed to a volume-based pricing structure under the WuXi STA DS Agreement. The WuXi STA DS Agreement has an initial term of four years, beginning April 2, 2020 and ending April 2, 2024. Pursuant to the WuXi STA DS Agreement, the Company has agreed to purchase a certain percentage of the global demand for vadadustat drug substance from WuXi STA. As of September 30, 2022, the Company has committed to purchase $19.2 million of vadadustat drug substance from WuXi STA through the end of 2023.

From time to time, the Company may become subject to legal proceedings and claims which arise in the ordinary course of its business. Consistent with ASC 450, Contingencies, the Company’s policy is to record a liability if a loss in a significant legal dispute is considered probable and an amount can be reasonably estimated. The Company provides disclosure when a loss in excess of any reserve is reasonably possible, and if estimable, the Company discloses the potential loss or range of possible loss. Significant judgment is required to assess the likelihood of various potential outcomes and the quantification of loss in those scenarios. The Company’s estimates change as litigation progresses and new information comes to light. Changes in Company estimates could have a material impact on the Company’s results and financial position. As of September 30, 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.

			As of September 30,
			2022						2021
Warrant			—						509,611
Outstanding stock options			11,844,609						11,593,539
Unvested restricted stock units			6,971,930						5,378,916
Total			18,816,539						17,482,066

•Auryxia® (ferric citrate) is approved and marketed in the United States for two indications: (1) the control of serum phosphorus levels in adult patients with chronic kidney disease, or CKD, on dialysis, or DD-CKD, or the Hyperphosphatemia Indication, and (2) the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or NDD-CKD, or the IDA Indication. Ferric citrate is also approved and marketed in Japan as an oral treatment the improvement of hyperphosphatemia in adult patients with CKD, including DD-CKD and NDD-CKD, and for the treatment of patients with IDA under the trade name Riona (ferric citrate hydrate). Auryxia is our only product approved for sale in the United States and it generated approximately $42.2 million and $36.8 million in revenue from U.S. product sales during the three months ended September 30, 2022 and 2021, respectively.

•Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase, or HIF-PH, inhibitor 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. The significance of the HIF pathway was recognized by the 2019 Nobel Prize and the 2016 Albert Lasker Basic Medical Research Award, which honored the three physician-scientists who discovered the HIF pathway and elucidated this primary oxygen sensing mechanism that is essential for survival.

In addition, the direct and indirect impacts of the pandemic or the response efforts to the pandemic, including among others, competition for labor and resources and increases in labor, sourcing, manufacturing and shipping costs, may cause disruptions to, closures of, or other impacts on our CMOs and other vendors in our supply chain on which we rely for the supply of our products and product candidates. For example, areas of China have recently continued to implement lockdowns for COVID-19, which could impact the global supply chain. At this time, our third party contract manufacturers continue to operate at or near normal levels. However, it is possible that the COVID-19 pandemic and response efforts may have an impact in the future on our contract manufacturers' ability to manufacture and deliver Auryxia and vadadustat (if approved in the United States and EMA and which is currently marketed under the trade name VafseoTM by MTPC in Japan), which may result in increased costs and delays, or disruptions to the manufacturing and supply of our products.

•personnel-related expenses, including salaries, benefits, recruiting fees, travel and stock-based compensation expense of our research and development personnel;

•expenses incurred under agreements with CROs and investigative sites that conduct our clinical studies;

•the cost of acquiring, developing and manufacturing clinical study materials through CMOs;

•facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies;

•costs associated with pre-launch inventory build for vadadustat in the United States and Europe, for which we received the CRL from the FDA in the United States in March 2022.

			Three Months Ended September 30,												Nine Months Ended September 30,
			2022						2021						2022						2021
			(in thousands)												(in thousands)
Vadadustat external costs			$	13,840					$	14,339					$	42,752					$	44,059
External costs for other programs			3,823						7,425						15,279						18,989
Total external research and development expenses			17,663						21,764						58,031						63,048
Headcount, consulting, facilities and other			9,687						18,707						39,179						55,248
Total research and development expenses			$	27,350					$	40,471					$	97,210					$	118,296

			Three Months Ended												Increase
			September 30, 2022						September 30, 2021						(Decrease)
			(in thousands)
Revenues:
Product revenue, net			$	42,239					$	36,753					$	5,486
License, collaboration and other revenue			6,725						12,003						(5,278)
Total revenues			48,964						48,756						208
Cost of goods sold:
Product			28,936						6,933						22,003
Amortization of intangibles			9,011						9,011						—
Total cost of goods sold			37,947						15,944						22,003
Operating expenses:
Research and development			27,350						40,471						(13,121)
Selling, general and administrative			30,918						46,357						(15,439)
License expense			743						870						(127)
Restructuring			180						—						180
Total operating expenses			59,191						87,698						(28,507)
Operating loss			(48,174)						(54,886)						6,712
Other expense, net			(2,785)						(4,658)						1,873
Loss on extinguishment of debt			(906)						—						(906)
Net loss			$	(51,865)					$	(59,544)					$	7,679