0001628280-24-044551 | 10-Q | XBRL Viewer

DERIVATIVE LIABILITIES

9 Months Ended

Sep. 30, 2024

Derivative Instruments and Hedging Activities Disclosure [Abstract]

2018 Exit Fee

In May 2018, in connection with entering into the 2018 Loan Agreement, we entered into an agreement pursuant to which we agreed to pay $1.5 million in cash (2018 Exit Fee) upon any change of control transaction in respect of the Company or if we obtain both (i) U.S. FDA approval of XPHOZAH and (ii) U.S. FDA approval of IBSRELA, which was obtained on September 12, 2019 (2018 Exit Fee Agreement). Notwithstanding the February 2022 prepayment of the 2018 Loan, our obligation to pay the 2018 Exit Fee would have expired on May 16, 2028. We concluded that the 2018 Exit Fee was a freestanding derivative which was recorded at fair value as a derivative liability included in accrued expense and other current liabilities on the condensed balance sheets.

In October 2023, we received approval from the U.S. FDA for XPHOZAH to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. This triggered our obligation to pay the 2018 Exit Fee to the 2018 Lenders, which we paid in October 2023.

2022 Exit Fee

In February 2022, in connection with entering into the 2022 Original Loans, we entered into an agreement, whereby we agreed to pay an exit fee in the amount of 2% of the 2022 Original Loan funded (2022 Exit Fee) upon (i) any change of control transaction or (ii) our achievement of net revenue from the sale of any products equal to or greater than $100.0 million, measured on a six (6) months basis (Revenue Milestone), tested monthly at the end of each month. The Term C and Term D Loans do not result in payment of an additional exit fee. Notwithstanding the prepayment or termination of the 2022 Loan, the 2022 Exit Fee will expire on February 23, 2032. We concluded that the 2022 Exit Fee is a freestanding derivative which should be accounted for at fair value on a recurring basis. The estimated fair value of the 2022 Exit Fee was recorded as a derivative liability and included in accounts payable and accrued expenses and other current liabilities on the accompanying condensed balance sheets as of September 30, 2024 and December 31, 2023, respectively. As of September 30, 2024 and December 31, 2023, the estimated fair value of the 2022 Exit Fee was $1.0 million and $0.7 million, respectively. During the three months ended June 30, 2024, we achieved the Revenue Milestone and we paid the $1.0 million 2022 Exit Fee to the Agent in October 2024.

The fair value of the derivative liability was determined using a discounted cash flow analysis and was classified as a Level 3 measurement within the fair value hierarchy since our valuation utilized significant unobservable inputs prior to June 30, 2024. Specifically, the key assumptions included in the calculation of the estimated fair value of the 2022 Exit Fee derivative liability included: (i) our estimates of both the probability and timing of achieving the Revenue Milestone and (ii) the probability and timing of funding the Term B Loan, which was dependent upon (a) approval by the U.S. FDA for our NDA for the control of serum phosphorus in adult patients with CKD on dialysis by November 30, 2023, and (b) achievement of certain product revenue milestone targets. As of September 30, 2024, uncertainty around all of the noted valuation estimates had been removed, as the Term B Loan had been funded, the U.S. FDA had approved our NDA for the control of serum phosphorus in adult patients with CKD on dialysis prior to November 30, 2023, and we had achieved the Revenue Milestone.

Changes in the fair value of recurring measurements are presented as other income, net in our condensed statements of operations and comprehensive income (loss) and were as follows for the nine months ended September 30, 2024 and 2023 (in thousands):


	2024		2023
Fair value of exit fee derivative liabilities at January 1,	$	675	$	1,656

Changes in estimated fair value:
2018 Exit Fee	—		273
2022 Exit Fee	325		126
Fair value of exit fee derivative liabilities at September 30,	$	1,000	$	2,055

ORGANIZATION AND BASIS OF PRESENTATION (Policies)

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Basis of Presentation

These condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted. These condensed financial statements have been prepared on the same basis as our most recent annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary to present fairly our financial position, results of operations, changes in stockholders’ equity, and cash flows for the interim periods presented.

The accompanying condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the entire year ending December 31, 2024, or for any other interim period or future year.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes thereto. On an ongoing basis, management evaluates its estimates, including those related to recognition of revenue, clinical trial accruals, contract manufacturing accruals, expected demand for inventory, fair value of assets and liabilities, income taxes and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could materially differ from those estimates.

Recent Accounting Pronouncements

New Accounting Pronouncements - Recently Adopted

We have adopted no new accounting pronouncements subsequent to filing our most recent Annual Report on Form 10-K.

Recent Accounting Pronouncements Not Yet Adopted

In October 2023, the Financial Accounting Standards Board (FASB) issued ASU No. 2023-06, Disclosure Improvements - Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments in this Update modify the disclosure or presentation requirements of a variety of Topics in the Codification. The amendments are in response to the U.S. Securities and Exchange Commission's (SEC) Release No. 33-10532, Disclosure Update and Simplification, in which the SEC referred certain of its disclosure requirements that overlap with, but require incremental information to, generally accepted accounting principles to the FASB for potential incorporation into the Codification. For entities subject to the SEC’s existing disclosure requirements and for entities required to file or furnish financial statements with or to the SEC in preparation for the sale of or for purposes of issuing securities that are not subject to contractual restrictions on transfer, the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. For all other entities, the amendments will be effective two years later. For all entities, if by June 30, 2027, the SEC has not removed the applicable requirement from Regulation S-X or Regulation S-K, the pending content of the related amendment will be removed from the Codification and will not become effective for any entity. Management is currently assessing the impact of this standard on the Company’s financial statements.

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures. This Update requires publicly traded entities to provide enhanced disclosures about significant segment expenses regularly reviewed by the chief operating decision maker, including public traded entities with a single reportable segment. The amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. Management is currently assessing the impact of this standard on the Company’s financial statements.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures, an amendment which modifies the measurement and recognition of credit losses for most financial assets and certain other instruments. The amendments in this Update provide more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. For public business entities, the amendments in this Update are effective for annual periods beginning after December 15, 2024. Early adoption is permitted on a prospective basis for annual financial statements that have not yet been issued or made available for issuance. Management is currently assessing the impact of this standard on the Company’s financial statements.

Fair Value Measurements

The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:


Level 1 –			Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date.

Level 2 –			Valuations based on inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 –			Valuations based on unobservable inputs for which there is little or no market data, which require us to develop our own assumptions.

Where quoted prices are available in an active market, securities are classified as Level 1. We classify money market funds as Level 1. When quoted market prices are not available for the specific security, we estimate fair value by using benchmark yields, reported trades, broker/dealer quotes and issuer spreads. We classify U.S. government-sponsored agency bonds, U.S. treasury securities, commercial paper, corporate bonds, asset-backed securities, and Yankee bonds as Level 2. In certain cases, where there is limited activity or less transparency around inputs to valuation, securities or derivative liabilities, such as the 2022 Exit Fee valuation as of December 31, 2023, as defined and discussed in Note 9. Derivative Liabilities, are classified as Level 3. The conditions for payment of the 2022 Exit Fee were met at the measurement date of June 30, 2024 and it was therefore valued at its full contractual amount of $1.0 million as of that date. The 2022 Exit Fee was included in accounts payable and accrued liabilities on the accompanying condensed balance sheets at $1.0 million and $0.7 million as of September 30, 2024 and December 31, 2023, respectively.

The carrying amounts reflected in the condensed balance sheets for accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values at both September 30, 2024 and December 31, 2023 due to their short-term nature.

Based on our procedures under the expected credit loss model, including an assessment of unrealized losses in our portfolio, we concluded that any unrealized losses on our marketable securities were not attributable to credit and, therefore, we have not recorded an allowance for credit losses for these securities as of September 30, 2024 and December 31, 2023.

Fair Value of Debt

The principal amount outstanding under our term loan facilities is subject to a variable interest rate. Therefore, we believe the carrying amount of the term loan facility approximates fair value as of September 30, 2024 and December 31, 2023. See Note 8. Borrowing for a description of the Level 2 inputs used to estimate the fair value of the liability.

The carrying value of the deferred royalty obligation related to the sale of future royalties approximates its fair value as of September 30, 2024 and December 31, 2023 and is based on our current estimates of future royalties and commercialization milestones expected to be paid to us by Kyowa Kirin Co., Ltd. (Kyowa Kirin) over the life of the agreement. See Note 7. Deferred Royalty Obligation Related to the Sale of Future Royalties for a description of the Level 3 inputs used to estimate the fair value of the liability.

LEASES - Undiscounted Cash Payment Obligations for Operating Lease Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Undiscounted cash payment obligations
Remainder of 2024	$ 1,255
2025	1,660
2026	702
2027	238
2028	124
Thereafter	21
Total undiscounted operating lease payments	4,000
Imputed interest expenses	(215)
Total operating lease liabilities	3,785	$ 6,160
Less: Current portion of operating lease liability	(2,567)	(4,435)
Operating lease liability, net of current portion	$ 1,218	$ 1,725

EQUITY INCENTIVE PLANS - Narrative (Details) $ / shares in Units, shares in Thousands, $ in Millions	9 Months Ended
	Sep. 30, 2024 USD ($) $ / shares shares
Board of directors
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Issuance of common stock for services (in shares)	41
ESPP shares issuable
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Issuance of common stock under employee stock purchase plan (in shares)	500
Purchase price (in dollars per share) \| $ / shares	$ 4.64
Proceeds from ESPP \| $	$ 2.2

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023
Operating activities
Net income (loss)	$ (43,781)	$ (37,265)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense	1,548	930
Non-cash lease expense	2,973	2,690
Stock-based compensation	27,518	9,600
Non-cash interest expense	5,420	3,093
Non-cash royalty revenue related to the sale of future royalties	(1,776)	0
Other, net	(3,577)	(1,483)
Changes in operating assets and liabilities:
Accounts receivable	(31,164)	(35,530)
Inventory	(35,671)	(19,152)
Prepaid commercial manufacturing	6,497	(3,609)
Prepaid expenses and other assets	(5,759)	(2,671)
Accounts payable	3,686	(3,123)
Accrued compensation and benefits	(1,056)	809
Operating lease liabilities	(3,388)	(2,880)
Accrued and other liabilities	19,695	6,466
Deferred revenue	4,216	1,126
Net cash used in operating activities	(54,619)	(80,999)
Investing activities
Proceeds from maturities and redemptions of investments	120,354	36,264
Purchases of investments	(96,634)	(137,644)
Purchases of property and equipment	(418)	(301)
Net cash provided by (used in) investing activities	23,302	(101,681)
Financing activities
Proceeds from 2022 Loan Agreement, net of issuance costs	49,750	0
Proceeds from issuance of common stock in at the market offering, net of issuance costs	0	119,248
Proceeds from issuance of common stock under equity incentive and stock purchase plans	7,526	1,059
Net cash provided by financing activities	57,276	120,307
Net increase (decrease) in cash and cash equivalents	25,959	(62,373)
Cash and cash equivalents at beginning of period	21,470	96,140
Cash and cash equivalents at end of period	47,429	33,767
Supplementary disclosure of cash flow information:
Cash paid for interest	6,962	2,692
Cash paid for income taxes	272	19
Supplementary disclosure of non-cash activities:
Right-of-use assets obtained in exchange for lease obligations	1,010	339
Issuance of common stock for services	$ 257	$ 337

SUBSEQUENT EVENTS	9 Months Ended
SUBSEQUENT EVENTS	Sep. 30, 2024
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	SUBSEQUENT EVENTS On October 3, 2024, we and BMR-Pacific Research Center LP (Landlord) entered into a Lease Agreement (New Fremont Lease) whereby we agreed to lease approximately 15,000 square feet on the first floor of the building located at 7999 Gateway Boulevard, Newark, California (New Fremont Premises). The initial term of the New Fremont Lease will be thirty-nine (39) months and we will have one (1) option to extend the term by sixty (60) months. The Landlord has agreed to conduct certain tenant improvements at Landlord’s expense. The initial term of the New Fremont Lease commences once the tenant improvements are completed, which is estimated to be February 10, 2025. The initial monthly base rent will equal three and 15/100 dollars ($3.15) per square foot of rentable area of the New Fremont Premises and will be subject to an annual upward adjustment of three and a half percent (3.5%) of the then-current base rent. In connection with entering into the New Fremont Lease, we and the Landlord entered into a sixth amendment (the Sixth Amendment) to our existing lease (the Existing Fremont Lease) whereby we lease certain premises at 34175 Ardenwood Boulevard in Fremont, California, which amends the expiration date of the Existing Fremont Lease to be the date that is the later of (a) March 10, 2025, and (b) the date that is the actual “Term Commencement Date” under the New Fremont Lease. On October 25, 2024, we entered into a Commercial Supply Agreement (the CSA) with Hovione Farmaciência, S.A. (Hovione Portugal) and Hovione, LLC (Hovione NJ and, together with Hovione Portugal, Hovione). The CSA contemplates that Hovione will perform spray-drying services for the Company at commercial scale, in the manner developed and validated under the existing Master Services Agreement between the parties. The CSA provides that Hovione will manufacture, and the Company will purchase, certain minimum quantities of tenapanor API beginning in 2024 from its Portugal facility and continuing through the end of the term of the CSA. The parties have agreed that Hovione will purchase, install, validate and qualify equipment at its New Jersey site so that, beginning in 2027, additional product can be supplied by Hovione NJ. The initial term of the CSA is until December 31, 2030, unless terminated earlier by one of the parties by its terms. Thereafter, the CSA will automatically renew for successive terms of two years until terminated by one of the parties. On October 29, 2024, we entered into a Fourth Amendment to Loan and Security Agreement (the Fourth Amendment), by and among Ardelyx, as borrower, SLR, as collateral agent and the lenders party thereto, which amends the SLR Loan Agreement. The Fourth Amendment, among other things, (1) provided for the immediate draw of the Term D loan in a principal amount of $50.0 million on the closing date of the Fourth Amendment and (2) provides us with the option to draw an additional $50.0 million of committed senior secured term loans by June 30, 2025 (the Term E Loan); (3) extends the Maturity Date for all term loans under the SLR Loan Agreement from March 1, 2027 to July 1, 2028; and (4) extends the interest-only period for all term loans under the SLR Agreement until the Maturity Date. The interest rate for the Term D Loan and the Term E Loan is 4.00% plus a rate equal to 0.022% plus the 1-month SOFR reference rate, subject to a SOFR floor of 4.70%. We paid a fee of $0.3 million in connection with the funding of the Term D Loan. We are also obligated to pay an additional $0.3 million on the earliest of (1) the funding date of the Term E Loan, (2) June 30, 2025, and (3) the prepayment, refinancing, substitution, or replacement of any term loan under the SLR Loan Agreement on or prior to the date immediately preceding June 30, 2025. (See Note 8. Borrowing for additional information related to borrowing).

STOCKHOLDERS’ EQUITY (Details) - USD ($) $ / shares in Units, shares in Millions	1 Months Ended		3 Months Ended	9 Months Ended		20 Months Ended
	Jan. 31, 2023	Aug. 31, 2021	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Mar. 31, 2023
Subsidiary, Sale of Stock [Line Items]
Proceeds from issuance of common stock in at the market offering, net of issuance costs				$ 0	$ 119,248,000
2021 Open Market Sales Agreement
Subsidiary, Sale of Stock [Line Items]
Commission on sale of stock per agreement (as percent)		3.00%
Total of gross proceeds			$ 150,000,000.0			$ 150,000,000.0
Weighted-average sales price per share (in dollars per share)			$ 3.35			$ 1.57
Issuance of common stock in at-the-market offerings (in shares)			15.5
Proceeds from issuance of common stock in at the market offering, net of issuance costs			$ 51,900,000
2023 Open Market Sales Agreement
Subsidiary, Sale of Stock [Line Items]
Commission on sale of stock per agreement (as percent)	3.00%
Weighted-average sales price per share (in dollars per share)				$ 4.17
Issuance of common stock in at-the-market offerings (in shares)				16.8
Proceeds from issuance of common stock in at the market offering, net of issuance costs				$ 70,000,000.0
Common stock
Subsidiary, Sale of Stock [Line Items]
Maximum aggregate offering price	$ 250,000,000.0
Common stock \| 2021 Open Market Sales Agreement
Subsidiary, Sale of Stock [Line Items]
Maximum aggregate offering price		$ 150,000,000.0
Common stock \| 2023 Open Market Sales Agreement
Subsidiary, Sale of Stock [Line Items]
Maximum aggregate offering price	$ 150,000,000.0

NET INCOME (LOSS) PER SHARE (Tables)

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

Schedule of Computation of Net Income (Loss) Per Common Share

The following table sets forth the computation of net income (loss) per common share (in thousands, except per share amounts):


	Three Months Ended September 30,				Nine Months Ended September 30,
Numerator:	2024		2023		2024		2023
Net income (loss)	$	(809)	$	6,629	$	(43,781)	$	(37,265)
Denominator:
Weighted average common shares outstanding - basic	235,911		222,782		234,516		214,977
Weighted average common shares outstanding - diluted	235,911		227,894		234,516		214,977
Net income (loss) per share of common stock - basic and diluted	$	(0.00)	$	0.03	$	(0.19)	$	(0.17)

Schedule of Anti-Dilutive Securities Not Considered in Diluted Net Loss Per Common Share Calculation

For the periods presented, the total numbers of securities that could potentially dilute net income per share in the future that were not considered in the diluted net loss per share calculations because the effect would have been anti-dilutive were as follows (in thousands):


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Options to purchase common stock	28,296	14,718	27,584	20,561

Restricted stock units	8,257	268	7,753	2,982

ESPP shares issuable	224	197	231	247
Total	36,777	15,183	35,568	23,790

SUBSEQUENT EVENTS (Details) - Subsequent event ft² in Thousands	Oct. 29, 2024 USD ($)	Oct. 25, 2024	Oct. 03, 2024 USD ($) ft² renewal_option
Subsequent Event [Line Items]
Amount of leased area (in square feet) \| ft²			15
Initial term of lease			39 months
Number of extension options \| renewal_option			1
Lease extension term			60 months
Monthly base rent per square foot			$ 3.15
Monthly base rent, annual adjustment percentage			3.50%
Supply agreement renewal term		2 years
Loan Agreement \| Term Loan D
Subsequent Event [Line Items]
Interest rate (as percent)	4.00%
Obligated payment in connection with funding	$ 300,000
Closing fee	$ 300,000
Loan Agreement \| Term Loan D \| Secured Overnight Financing Rate (SOFR)
Subsequent Event [Line Items]
Floating per annum rate (as percent)	0.022%
Loan Agreement \| Term Loan D \| Floor Rate
Subsequent Event [Line Items]
Floating per annum rate (as percent)	4.70%
Loan Agreement \| Term Loan E
Subsequent Event [Line Items]
Term loan face amount	$ 50,000,000
Amount available to draw	$ 50,000,000
Interest rate (as percent)	4.00%
Closing fee	$ 300,000
Loan Agreement \| Term Loan E \| Secured Overnight Financing Rate (SOFR)
Subsequent Event [Line Items]
Floating per annum rate (as percent)	0.022%
Loan Agreement \| Term Loan E \| Floor Rate
Subsequent Event [Line Items]
Floating per annum rate (as percent)	4.70%

EQUITY INCENTIVE PLANS

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

EQUITY INCENTIVE PLANS

Stock-based compensation expense recognized for stock options, restricted stock units (RSUs), and our employee stock purchase program (ESPP) are recorded as operating expenses in our condensed statements of operations and comprehensive income (loss), as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Selling, general and administrative	$	6,199	$	2,574	$	20,305	$	6,965
Research and development	2,934		915		7,213		2,635

Total	$	9,133	$	3,489	$	27,518	$	9,600

As of September 30, 2024, our total unrecognized stock-based compensation expense, net of estimated forfeitures, and average remaining vesting period, included the following (dollars in thousands):


	Unrecognized Compensation Expense		Average Remaining Vesting Period (Years)
Stock option grants	$	59,155	2.8
RSU grants	$	51,963	3.1
ESPP	$	394	0.4

Stock Options

A summary of our stock option activity and related information for the nine months ended September 30, 2024 is as follows (in thousands, except dollar amounts):


	Number of Shares	Weighted-Average Exercise Price per Share
Balance at December 31, 2023	22,168	$	4.20
Options granted	8,738	$	8.20
Options exercised	(2,228)	$	2.38
Options forfeited or canceled	(510)	$	5.46
Balance at September 30, 2024	28,168	$	5.57
Exercisable at September 30, 2024	14,030	$	5.49

Restricted Stock Units

A summary of our RSUs activity and related information for the nine months ended September 30, 2024 is as follows (in thousands, except dollar amounts):


	Number of RSUs	Weighted-Average Grant Date Fair Value Per Share
Non-vested restricted stock units at December 31, 2023	3,646	$	3.09
Granted	6,646	$	8.20
Vested	(1,724)	$	5.76
Forfeited	(285)	$	5.35
Non-vested restricted stock units at September 30, 2024	8,283	$	6.55

Employee Stock Purchase Plan

During the nine months ended September 30, 2024, we sold approximately 0.5 million shares of our common stock under the ESPP. The shares were purchased by employees at an average purchase price of $4.64 per share resulting in proceeds to us of approximately $2.2 million.

Issuance of Common Stock for Services

Under Our Amended and Restated Non-Employee Director Compensation Program, members of our board of directors may elect to receive shares of our stock in lieu of their cash fees. During the nine months ended September 30, 2024, we issued 41 thousand shares of our common stock to members of the board of directors in accordance with the program.

INVENTORY - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Inventory Disclosure [Abstract]
Prepaid commercial manufacturing	$ 16,700	$ 23,200
Prepaid commercial manufacturing, non-current	$ 0	$ 4,235

BORROWING

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

BORROWING

Solar Capital and Western Alliance Bank Loan Agreement

In May 2018, we entered into a loan and security agreement (as amended on October 9, 2020, March 1, 2021, May 5, 2021, and July 29, 2021) (2018 Loan Agreement) with Solar Capital Ltd. and Western Alliance Bank (collectively, the 2018 Lenders). The 2018 Loan Agreement provided for a loan facility for up to $50.0 million with a maturity date of November 1, 2022 (2018 Loan). As of the Closing Date for the 2022 Loan, as discussed below, we owed $25.0 million in principal payments from the 2018 Loan, which we repaid in full at that time.

As discussed in Note 9. Derivative Liabilities, in connection with entering into the 2018 Loan Agreement, we entered into an agreement pursuant to which we agreed to pay $1.5 million in cash upon the occurrence of certain conditions (2018 Exit Fee). Our obligations for the 2018 Exit Fee remained outstanding following the full repayment of the 2018 Loan in February 2022 until October 2023 when we received approval from the U.S. FDA for XPHOZAH to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. This triggered our obligation to pay the 2018 Exit Fee to the 2018 Lenders and we subsequently paid the 2018 Exit Fee in October 2023.

SLR Investment Corp. Loan Agreement

On February 23, 2022 (Closing Date), we entered into a loan and security agreement (2022 Loan Agreement) with SLR Investment Corp. as collateral agent (Agent or SLR), and the lenders listed in the 2022 Loan Agreement (collectively, the 2022 Lenders). The 2022 Loan Agreement was subsequently amended in August 2022 (the First Amendment), February 2023 (the Second Amendment) and October 2023 (the Third Amendment). We concluded that the First Amendment, the Second Amendment and the Third Amendment were each modifications to the 2022 Loan Agreement.

The 2022 Loan Agreement, as amended by the First Amendment and the Second Amendment, provided for a senior secured loan facility, with $27.5 million (Term A Loan) funded on the Closing Date and an additional $22.5 million which was funded upon our election in October 2023 (Term B Loan, and together with the Term A Loan, the 2022 Original Loans). The 2022 Term A Loan funds were used to repay the 2018 Loan with the 2018 Lenders.

The Third Amendment, among other things, (1) provided us with the option to draw an additional $50.0 million of committed capital by March 15, 2024 (the Term C Loan) provided we have drawn the Term B Loan; and (2) provided us with the option to draw up to an additional $50.0 million of uncommitted capital by December 31, 2026, subject to approval by the Agent’s investment committee (the Term D Loan). In February 2024, we provided the Agent with notice of our decision to draw the Term C Loan to support the commercial launch of XPHOZAH and received the proceeds of the Term C Loan in March 2024.

As discussed in Note 15. Subsequent Events, on October 29, 2024, we entered into a Fourth Amendment (the Fourth Amendment) to the 2022 Loan Agreement by and between us and the 2022 Lenders. The Fourth Amendment, among other things, (1) provided for the immediate draw of the Term D Loan in a principal amount of $50.0 million on the closing date of the Fourth Amendment and (2) provides us with the option to draw an additional $50.0 million of committed capital by June 30, 2025 (the Term E Loan and together with the Term A, B, C and D Loans, the Five 2022 Loans).

Under the Fourth Amendment, the maturity date for the Five 2022 Loans is extended from March 1, 2027 to July 1, 2028 (the Maturity Date). The interest rate for each of the Term A Loan and the Term B Loan is 7.95% plus a SOFR value equal to 0.022% plus the 1-month CME Term SOFR reference rate as published by the CME Term SOFR Administrator on the CME Term SOFR Administrator’s Website, subject to a SOFR floor of one percent. The interest rate for the Term C Loan is 4.25% plus a SOFR value equal to 0.022% plus the 1-month CME Term SOFR reference rate as published by the CME Term SOFR Administrator on the CME Term SOFR Administrator’s Website, subject to a SOFR floor of 4.7%. The interest rate for each of the Term D Loan and the Term E Loan is 4.00% plus a SOFR value equal to 0.022% plus the 1-month CME Term SOFR reference rate as published by the CME Term SOFR Administrator on the CME Term SOFR Administrator's Website, subject to a SOFR floor of 4.7%.

In addition, pursuant to the Fourth Amendment, the period under which we are permitted to make interest-only payments on the Five 2022 Loans was extended to the Maturity Date.

We paid fees of $0.2 million, upon the closing of the Term A Loan, $0.1 million on the funding date of the Term B Loan, $0.3 million on the funding date of the Term C Loan and $0.3 million on the funding date of the Term D Loan in October 2024. In addition, we will be obligated to pay 0.5% of the aggregate original principal amount of the Term E Loan commitment, which shall be due on the earliest of (1) the funding of the Term E Loan, (2) June 30, 2025, and (3) the prepayment, refinancing, substitution or replacement of any of the Five 2022 Loans on or prior to the date immediately preceding June 30, 2025.

We are obligated to pay a final fee equal to 4.95% of the aggregate original principal amount of the Five 2022 Loans, to the extent such loans are funded, upon the earliest to occur of the maturity date, the acceleration of the Five 2022 Loans, and the prepayment, refinancing, substitution, or replacement of the Five 2022 Loans.

We may voluntarily prepay all amounts outstanding under the Five 2022 Loans, subject to a prepayment premium of (i) 3% of the outstanding principal amount of the Five 2022 Loans if prepaid prior to or on October 17, 2024, (ii) 2% of the outstanding principal amount of the Five 2022 Loans if prepaid after October 17, 2024 through and including October 17, 2025, or (iii) 1% of the outstanding principal amount of the Five 2022 Loans if prepaid after October 17, 2025 and prior to the maturity date. The Five 2022 Loans are secured by substantially all of our assets, except for our intellectual property and certain other customary exclusions. Additionally, as discussed in Note 9. Derivative Liabilities, in connection with the 2022 Original Loans, we entered into an agreement whereby we agreed to pay an exit fee in the amount of 2% of the 2022 Original Loans funded (2022 Exit Fee). We paid the 2022 Exit Fee to the Lender in October 2024.

The 2022 Loan Agreement, as amended, contains customary representations and warranties and customary affirmative and negative covenants, including, among others, requirements as to financial reporting and insurance and restrictions on our ability to dispose of our business or property, to change our line of business, to liquidate or dissolve, to enter into any change in control transaction, to merge or consolidate with any other entity or to acquire all or substantially all the capital stock or property of another entity, to incur additional indebtedness, to incur liens on our property, to pay any dividends or other distributions on capital stock other than dividends payable solely in capital stock or to redeem capital stock. We have agreed to not allow our cash, cash equivalents and available-for-sale investments to be less than the eighty percent (80%) of the outstanding balance of the Five 2022 Term Loans for any period in which our net revenue from the sale of any products, calculated on a trailing six (6) month basis and tested monthly, is less than sixty percent (60%) of the outstanding balance of the Five 2022 Loans.

In addition, the 2022 Loan Agreement, as amended, contains customary events of default that entitle the Agent to cause our indebtedness under the 2022 Loan Agreement to become immediately due and payable, and to exercise remedies against us and the collateral securing the Five 2022 Term Loans, including our cash. Under the 2022 Loan Agreement, an event of default will occur if, among other things, we fail to make payments under the 2022 Loan Agreement, we breach any of our covenants under the 2022 Loan Agreement, subject to specified cure periods with respect to certain breaches, certain Lenders determine that a material adverse change has occurred, we or our assets become subject to certain legal proceedings, such as bankruptcy proceedings, we are unable to pay our debts as they become due or we default on contracts with third parties which would permit the holder of indebtedness to accelerate the maturity of such indebtedness or that could have a material adverse change on us. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 4% per annum will apply to all obligations owed under the 2022 Loan Agreement. We have classified the 2022 Original Loan balance as a non-current liability as of September 30, 2024 due to principal repayment on July 1, 2028. We have concluded that the provisions that could cause acceleration of the principal repayments are remote.

As of September 30, 2024, our future payment obligations related to the 2022 Loan, excluding interest payments and the 2022 final fee, were as follows (in thousands):


Total repayment obligations	$	104,950
Less: Unamortized discount and debt issuance costs	(944)
Less: Unaccreted value of final fee	(3,299)
Long-term debt	100,707
Less: Current portion of long-term debt	—
Long-term debt, net of current portion	$	100,707

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
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-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 470
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/470/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 835
-SubTopic 30
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482925/835-30-45-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
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-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1E
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1E

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Section 50
-Paragraph 1I
-Subparagraph (b)
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-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

+ Details

LEASES - Lease Costs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
LEASES - Lease Costs (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Lease costs
Operating lease expense	$ 1,067	$ 1,061	$ 3,204	$ 3,127
Cash paid for operating lease	$ 1,229	$ 1,119	$ 3,594	$ 3,316

BORROWING (Tables)

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

Schedule of Future Debt Payment Obligations

As of September 30, 2024, our future payment obligations related to the 2022 Loan, excluding interest payments and the 2022 final fee, were as follows (in thousands):


Total repayment obligations	$	104,950
Less: Unamortized discount and debt issuance costs	(944)
Less: Unaccreted value of final fee	(3,299)
Long-term debt	100,707
Less: Current portion of long-term debt	—
Long-term debt, net of current portion	$	100,707

INVENTORY (Tables)

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

Schedule of Current Inventory

Inventory as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Raw materials	$	25,992	$	22,920
Work in process	57,335		24,582
Finished goods	1,831		1,985
Total	$	85,158	$	49,487
Reported as:
Inventory	$	11,378	$	12,448
Inventory, non-current	73,780		37,039
Total	$	85,158	$	49,487

Schedule of Noncurrent Inventory

Inventory as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Raw materials	$	25,992	$	22,920
Work in process	57,335		24,582
Finished goods	1,831		1,985
Total	$	85,158	$	49,487
Reported as:
Inventory	$	11,378	$	12,448
Inventory, non-current	73,780		37,039
Total	$	85,158	$	49,487

FAIR VALUE MEASUREMENTS

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

FAIR VALUE MEASUREMENTS

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.

The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:


Level 1 –			Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date.

Level 2 –			Valuations based on inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 –			Valuations based on unobservable inputs for which there is little or no market data, which require us to develop our own assumptions.

The following table sets forth the fair value of our financial assets and liabilities that are measured or disclosed on a recurring basis by level within the fair value hierarchy (in thousands):


	September 30, 2024
	Total Fair Value		Level 1		Level 2		Level 3
Assets:
Money market funds	$	39,869	$	39,869	$	—	$	—
U.S. government-sponsored agency bonds	53,098		—		53,098		—
U.S. treasury securities	36,743		—		36,743		—
Commercial paper	30,792		—		30,792		—

Corporate bonds	17,408		—		17,408		—
Asset-backed securities	2,978		—		2,978		—
Yankee bonds	1,954		—		1,954		—

Total	$	182,842	$	39,869	$	142,973	$	—


	December 31, 2023
	Total Fair Value		Level 1		Level 2		Level 3
Assets:
Money market funds	$	18,641	$	18,641	$	—	$	—
U.S. government-sponsored agency bonds	102,093		—		102,093		—
Commercial paper	49,654		—		49,654		—

Asset-backed securities	8,625		—		8,625		—
U.S. treasury securities	2,457		—		2,457		—
Total	$	181,470	$	18,641	$	162,829	$	—

Liabilities:
Derivative liability for exit fees	$	675	$	—	$	—	$	675
Total	$	675	$	—	$	—	$	675

Fair Value of Debt

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

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+ Details

REVENUE - Chargebacks, Discounts and Reserve Balances (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($)
Gross-to-net sales accruals and reserves
Beginning balance	$ 8,628
Provisions	73,862
Credits/payments	(59,170)
Ending balance	23,320
Discounts and Chargebacks
Gross-to-net sales accruals and reserves
Beginning balance	478
Provisions	10,074
Credits/payments	(8,974)
Ending balance	1,578
Rebates, Wholesaler and GPO Fees
Gross-to-net sales accruals and reserves
Beginning balance	4,234
Provisions	43,398
Credits/payments	(33,925)
Ending balance	13,707
Copay and Returns
Gross-to-net sales accruals and reserves
Beginning balance	3,916
Provisions	20,390
Credits/payments	(16,271)
Ending balance	$ 8,035

NET INCOME (LOSS) PER SHARE - Computation of Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Numerator:
Net income (loss)	$ (809)	$ 6,629	$ (43,781)	$ (37,265)
Denominator:
Weighted average common shares outstanding - basic (in shares)	235,911,399	222,782,229	234,516,305	214,976,555
Weighted average common shares outstanding - diluted (in shares)	235,911,399	227,894,335	234,516,305	214,976,555
Net income (loss) per share of common stock - basic (in dollars per share)	$ 0.00	$ 0.03	$ (0.19)	$ (0.17)
Net income (loss) per share of common stock - diluted (in dollars per share)	$ 0.00	$ 0.03	$ (0.19)	$ (0.17)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

+ Details

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

+ Details

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

ORGANIZATION AND BASIS OF PRESENTATION (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($) segment	Dec. 31, 2023 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of segments \| segment	1
Cash and short-term investments	$ 190,402	$ 184,299
Accumulated deficit	$ 889,985	$ 846,204

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

REVENUE - Schedule of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Disaggregation of Revenue [Line Items]
Total revenues	$ 98,241	$ 56,391	$ 217,486	$ 90,093
Product sales
Disaggregation of Revenue [Line Items]
Total revenues	92,090	22,285	208,193	51,949
IBSRELA
Disaggregation of Revenue [Line Items]
Total revenues	40,638	22,285	104,444	51,949
XPHOZAH
Disaggregation of Revenue [Line Items]
Total revenues	51,452	0	103,749	0
Product supply revenue
Disaggregation of Revenue [Line Items]
Total revenues	5,322	2,092	7,461	5,354
Licensing revenue
Disaggregation of Revenue [Line Items]
Total revenues	20	32,014	56	32,790
Non-cash royalty revenue related to the sale of future royalties
Disaggregation of Revenue [Line Items]
Total revenues	$ 809	$ 0	$ 1,776	$ 0

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

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+ Details

REVENUE (Tables)

9 Months Ended

Sep. 30, 2024

Revenue from Contract with Customer [Abstract]

Schedule of Revenue

Total revenues during the three and nine months ended September 30, 2024 and 2023 were as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Product sales, net:
IBSRELA	$	40,638	$	22,285	$	104,444	$	51,949
XPHOZAH	51,452		—		103,749		—
Total product sales, net	92,090		22,285		208,193		51,949
Product supply revenue	5,322		2,092		7,461		5,354
Licensing revenue	20		32,014		56		32,790

Non-cash royalty revenue related to the sale of future royalties	809		—		1,776		—
Total revenues	$	98,241	$	56,391	$	217,486	$	90,093

Schedule of Revenue from Customers as a Percentage of Total Product Revenue, Net

Revenue from customers who contributed greater than 10% of our total gross product revenue during the three and nine months ended September 30, 2024 and 2023 was as follows (as a percentage of total gross product revenue):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
BioRidge Pharma, LLC	53.4	%	19.5	%	49.3	%	19.2	%
AmerisourceBergen Drug Corporation	14.0	%	21.2	%	15.1	%	21.3	%
Cardinal Health	12.6	%	22.2	%	13.8	%	22.3	%
McKesson Corporation	13.2	%	18.4	%	13.2	%	19.0	%

Schedule of Chargebacks, Discounts and Reserve Balances

The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows (in thousands):


	Discounts and Chargebacks		Rebates, Wholesaler and GPO Fees		Copay and Returns		Total
Balance as of December 31, 2023	$	478	$	4,234	$	3,916	$	8,628
Provisions	10,074		43,398		20,390		73,862
Credits/payments	(8,974)		(33,925)		(16,271)		(59,170)
Balance as of September 30, 2024	$	1,578	$	13,707	$	8,035	$	23,320

COLLABORATION AND LICENSING AGREEMENTS

9 Months Ended

Sep. 30, 2024

Collaboration and Licensing Agreements

COLLABORATION AND LICENSING AGREEMENTS

Kyowa Kirin Co., Ltd. (Kyowa Kirin)

In November 2017, we entered into an exclusive license agreement with Kyowa Kirin (2017 Kyowa Kirin Agreement), under which we granted Kyowa Kirin an exclusive license to develop and commercialize certain NHE3 inhibitors including tenapanor in Japan for the treatment of cardiorenal diseases and conditions, excluding cancer. We retained the rights to tenapanor outside of Japan, and also retained the rights to tenapanor in Japan for indications other than those stated above. Pursuant to the 2017 Kyowa Kirin Agreement, Kyowa Kirin is responsible for all costs and expenses incurred in the development and commercialization of tenapanor for all licensed indications in Japan. We are responsible for supplying the tenapanor drug substance for Kyowa Kirin’s use in development and commercialization throughout the term of the 2017 Kyowa Kirin Agreement, provided that Kyowa Kirin may exercise an option to manufacture the tenapanor drug substance under certain conditions. In October 2022, we entered into a Commercial Supply Agreement with Kyowa Kirin to further define the obligations of the parties with respect to the commercial supply of tenapanor drug substance (2022 Kyowa Kirin Supply Agreement). As detailed below under the heading Deferred Revenue we have received advanced payments from Kyowa Kirin for the manufacturing of tenapanor drug substance that will be used to satisfy Kyowa Kirin needs.

We assessed these arrangements in accordance with Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606) and related amendments (ASC 606) and concluded that the contract counterparty, Kyowa Kirin, is a customer. Under the terms of the 2017 Kyowa Kirin Agreement, we received $30.0 million in upfront license fees, which was recognized as revenue when the agreement was executed. Based on our assessment, management determined that the license and the manufacturing supply services were its material performance obligations at the inception of the 2017 Kyowa Kirin Agreement, and as such, each of the performance obligations is distinct.

We may be entitled to receive up to $55.0 million in total development and regulatory milestones, of which $35.0 million has been received and recognized as revenue as of September 30, 2024. We may also be eligible to receive approximately ¥8.5 billion for commercialization milestones, or approximately $59.8 million at the currency exchange rate on September 30, 2024, as well as reimbursement of costs plus a reasonable overhead for the supply of product and royalties on net sales throughout the term of the agreement. As discussed in Note 7. Deferred Royalty Obligation Related to the Sale of Future Royalties, the future royalties and commercial milestone payments we may receive under the 2017 Kyowa Kirin Agreement are remitted to HealthCare Royalty Partners IV, L.P. (HCR) upon receipt pursuant to a Royalty and Sales Milestone Interest Acquisition Agreement (HCR Agreement). The variable consideration related to the remaining milestone payments was fully constrained at September 30, 2024.

In April 2022, we entered into a second amendment to the 2017 Kyowa Kirin Agreement (2022 Amendment). Under the terms of the 2022 Amendment, we and Kyowa Kirin agreed to a reduction in the royalty rate payable to us by Kyowa Kirin upon net sales of tenapanor for hyperphosphatemia in Japan. The royalty rate will be reduced from the high teens to low double digits for a two-year period of time following the first commercial sale in Japan, and then to mid-single digits for the remainder of the royalty term. As discussed in Note 7. Deferred Royalty Obligation Related to the Sale of Future Royalties, the future commercial milestones and royalties we may receive under the 2017 Kyowa Kirin Agreement will be remitted to HCR pursuant to the HCR Agreement. As consideration for the reduction in the royalty rate, Kyowa Kirin agreed to pay us up to an additional $40.0 million payable in two tranches, with the first payment due following Kyowa Kirin's filing with the Japanese Ministry of Health, Labour and Welfare (MHLW) of its application for marketing approval for tenapanor and the second payment due following Kyowa Kirin’s receipt of regulatory approval to market tenapanor for hyperphosphatemia in Japan, both of which occurred as of September 30, 2023.

In October 2022, we announced that Kyowa Kirin submitted a New Drug Application (NDA) to the Japanese MHLW for tenapanor for the improvement of hyperphosphatemia in adult patients with CKD on dialysis, which resulted in payment to us from Kyowa Kirin for an aggregate of $35.0 million for milestone payments and payments under the 2022 Amendment. We received these payments during the fourth quarter of 2022 and recorded them as licensing revenue on our condensed statement of operations and comprehensive income (loss).

In September 2023, we announced that Kyowa Kirin received approval from the Japanese MHLW for the NDA for tenapanor for the improvement of hyperphosphatemia in adult patients with CKD on dialysis, which resulted in payment to us from Kyowa Kirin for an aggregate of $30.0 million for milestone payments and payments under the 2022 Amendment. We received these payments in October 2023 and recorded them as licensing revenue on our condensed statement of operations and comprehensive income (loss) when earned during the three months ended September 30, 2023. In February 2024, Kyowa Kirin announced the launch of tenapanor, marketed as PHOZEVEL®, for patients in Japan. During the three and nine months ended September 30, 2024, we recognized $0.8 million and $1.8 million, respectively, of non-cash royalty revenue related to the sale of future royalties which we remit to HCR upon receipt in accordance with the HCR Agreement.

During the three and nine months ended September 30, 2024, we recognized $5.3 million and $7.5 million, respectively, of product supply revenue pursuant to the 2017 Kyowa Kirin Agreement. During the three and nine months ended September 30, 2023, we recognized $2.1 million and $5.4 million, respectively, of product supply revenue pursuant to the 2017 Kyowa Kirin Agreement.

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma)

In December 2017, we entered into an exclusive license agreement with Fosun Pharma (Fosun Agreement) for the development, commercialization and distribution of tenapanor in China for both hyperphosphatemia and IBS-C. We assessed these arrangements in accordance with ASC 606 and concluded that the contract counterparty, Fosun Pharma, is a customer. Under the terms of the Fosun Agreement, we received $12.0 million in upfront license fees which was recognized as revenue when the agreement was executed. Based on our assessment, we determined that the license and the manufacturing supply services represented the material performance obligations at the inception of the agreement and, as such, each of the performance obligations are distinct.

We may be entitled to receive development and commercialization milestones of up to $113.0 million, of which $8.0 million has been received and recognized as revenue as of September 30, 2024, as well as reimbursement of cost plus a reasonable overhead for the supply of product and tiered royalties on net sales ranging from the mid-teens to 20%. The variable consideration related to the remaining development milestone payments was fully constrained at September 30, 2024.

In July 2023, we announced that an NDA for tenapanor had been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with CKD on hemodialysis. This acceptance triggered a $2.0 million milestone payment to us under the terms of the Fosun Agreement. We received this payment during the third quarter of 2023 and recorded it as licensing revenue on our condensed statement of operations and comprehensive income (loss) when earned during the three months ended September 30, 2023. In October 2023, we announced that the U.S. FDA had approved XPHOZAH to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. This triggered an additional $3.0 million milestone payment to us under the terms of the Fosun Agreement, which was received during the first quarter of 2024. Also, in October 2023, we announced that Fosun Pharma received approval from the Hong Kong Department of Health for the marketing application for tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C).

During the three and nine months ended September 30, 2024, we did not recognize a material amount of revenue pursuant to the Fosun Agreement. During the three and nine months ended September 30, 2023, we recognized $2.0 million of licensing revenue pursuant to the Fosun Agreement.

Knight Therapeutics, Inc. (Knight)

In March 2018, we entered into an exclusive license agreement with Knight Therapeutics, Inc., (Knight Agreement) for the development, commercialization and distribution of tenapanor in Canada for hyperphosphatemia and IBS-C. We assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Knight, is a customer. Based on our assessment, we determined that the license and the manufacturing supply services were the material performance obligations at the inception of the agreement and, as such, each of the performance obligations are distinct.

Under the terms of the Knight Agreement, we received a $2.3 million non-refundable, one-time upfront payment in March 2018 and may be eligible to receive additional development and commercialization milestone payments worth up to CAD 22.2 million, or approximately $16.4 million at the currency exchange rate on September 30, 2024, of which $0.7 million has been received and recognized as revenue as of September 30, 2024. We are also eligible to receive royalties ranging from the mid-single digits to the low twenties throughout the term of the agreement, and a transfer price for manufacturing services. The variable consideration related to the remaining development milestone payments was fully constrained at September 30, 2024.

During the three and nine months ended September 30, 2024 and 2023, we did not recognize a material amount of revenue pursuant to the Knight Agreement.

AstraZeneca AB (AstraZeneca)

In June 2015, we entered into a termination agreement with AstraZeneca (AstraZeneca Termination Agreement) pursuant to which we have agreed to pay AstraZeneca (i) future royalties at a royalty rate of 10% of net sales of tenapanor or other NHE3 products by us or our licensees, and (ii) 20% of non-royalty revenue received from a new collaboration partner should we elect to license, or otherwise provide rights to develop and commercialize tenapanor or other NHE3 products, up to a maximum of $75.0 million in aggregate for (i) and (ii). As of September 30, 2024, to date in aggregate, we have recognized $50.3 million of the $75.0 million, which has been recorded as other cost of revenue on our condensed statements of operations and comprehensive income (loss). During the three and nine months ended September 30, 2024, we recognized $10.0 million and $22.7 million, respectively, as other cost of revenue related to the AstraZeneca Termination Agreement. During the three and nine months ended September 30, 2023 we recognized $5.7 million and $8.7 million, respectively, as other cost of revenue related to the AstraZeneca Termination Agreement.

Deferred Revenue

The following tables present changes in our current and non-current deferred revenue balances during the reporting period, which are all attributable to the 2017 Kyowa Kirin Agreement (in thousands):


	2024				2023
	Current		Non-Current		Current		Non-Current
Balance at January 1,	$	7,182	$	8,644	$	4,211	$	9,025
Amounts invoiced as prepayments for product supply	2,654		8,212		1,182		4,530
Decrease for revenue recognized for product supply	(6,650)		—		(4,586)		—
Reclassify amounts to be recognized in the next twelve months	4,086		(4,086)		3,265		(3,265)
Balance at September 30,	$	7,272	$	12,770	$	4,072	$	10,290

DERIVATIVE LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2024

Derivative Instruments and Hedging Activities Disclosure [Abstract]

Schedule of Changes in Fair Value of Derivative Liability


	2024		2023
Fair value of exit fee derivative liabilities at January 1,	$	675	$	1,656

Changes in estimated fair value:
2018 Exit Fee	—		273
2022 Exit Fee	325		126
Fair value of exit fee derivative liabilities at September 30,	$	1,000	$	2,055

BORROWING - Narrative (Details) - USD ($)	Oct. 29, 2024	Feb. 23, 2022	Sep. 30, 2024	Oct. 31, 2023	May 31, 2018
Debt Instrument [Line Items]
Principal outstanding			$ 104,950,000
2018 Exit Fee
Debt Instrument [Line Items]
Agreed amount for exit fee upon occurrence of certain conditions					$ 1,500,000
2022 Exit Fee
Debt Instrument [Line Items]
Exit fee (as percent)				2.00%
2018 Term Loan \| Loan Agreement
Debt Instrument [Line Items]
Term loan face amount					$ 50,000,000.0
Principal outstanding		$ 25,000,000.0
2022 Term Loan \| Loan Agreement
Debt Instrument [Line Items]
Final fee due upon maturity, acceleration, prepayment, or termination (as percent)		4.95%
Loan agreement covenant, cash and cash equivalents as percentage of outstanding loan balance, minimum		80.00%
Loan agreement, covenant, cash and cash equivalents as percentage of outstanding loan balance, calculation period (in months)		6 months
Loan agreement covenant, net product revenue as percentage of outstanding loan balance, minimum		60.00%
Additional default interest rate (as percent)		4.00%
2022 Term Loan \| Loan Agreement \| Prior to first anniversary of closing date
Debt Instrument [Line Items]
Prepayment premium (as percent)				3.00%
2022 Term Loan \| Loan Agreement \| After first anniversary through second anniversary of closing date
Debt Instrument [Line Items]
Prepayment premium (as percent)				2.00%
2022 Term Loan \| Loan Agreement \| After second anniversary to maturity date
Debt Instrument [Line Items]
Prepayment premium (as percent)				1.00%
Term Loan A \| Loan Agreement
Debt Instrument [Line Items]
Proceeds from the sale of future royalties, net of issuance costs		$ 27,500,000
Closing fee			200,000
Term Loan A \| Loan Agreement \| Subsequent event
Debt Instrument [Line Items]
Interest rate (as percent)	7.95%
Term Loan A \| Loan Agreement \| Secured Overnight Financing Rate (SOFR) \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	0.022%
Term Loan A \| Loan Agreement \| Floor Rate \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	1.00%
Term Loan B \| Loan Agreement
Debt Instrument [Line Items]
Term loan face amount		$ 22,500,000
Future obligation upon loan funding or other events			100,000
Term Loan B \| Loan Agreement \| Subsequent event
Debt Instrument [Line Items]
Interest rate (as percent)	7.95%
Term Loan B \| Loan Agreement \| Secured Overnight Financing Rate (SOFR) \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	0.022%
Term Loan B \| Loan Agreement \| Floor Rate \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	1.00%
Term Loan C \| Loan Agreement
Debt Instrument [Line Items]
Term loan face amount				$ 50,000,000.0
Closing fee			$ 300,000
Term Loan C \| Loan Agreement \| Subsequent event
Debt Instrument [Line Items]
Interest rate (as percent)	4.25%
Term Loan C \| Loan Agreement \| Secured Overnight Financing Rate (SOFR) \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	0.022%
Term Loan C \| Loan Agreement \| Floor Rate \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	4.70%
Term Loan D \| Loan Agreement
Debt Instrument [Line Items]
Additional uncommitted capital				$ 50,000,000.0
Term Loan D \| Loan Agreement \| Subsequent event
Debt Instrument [Line Items]
Interest rate (as percent)	4.00%
Closing fee	$ 300,000
Term Loan D \| Loan Agreement \| Secured Overnight Financing Rate (SOFR) \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	0.022%
Term Loan D \| Loan Agreement \| Floor Rate \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	4.70%
Term Loan E \| Loan Agreement \| Subsequent event
Debt Instrument [Line Items]
Term loan face amount	$ 50,000,000
Proceeds from the sale of future royalties, net of issuance costs	$ 50,000,000
Interest rate (as percent)	4.00%
Closing fee	$ 300,000
Closing fee percentage	0.50%
Term Loan E \| Loan Agreement \| Secured Overnight Financing Rate (SOFR) \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	0.022%
Term Loan E \| Loan Agreement \| Floor Rate \| Subsequent event
Debt Instrument [Line Items]
Floating per annum rate (as percent)	4.70%

EQUITY INCENTIVE PLANS - Restricted Stock Units Activity (Details) - Restricted stock units shares in Thousands	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Number of RSUs
Non-vested restricted stock units, beginning balance (in shares) \| shares	3,646
Granted (in shares) \| shares	6,646
Vested (in shares) \| shares	(1,724)
Forfeited (in shares) \| shares	(285)
Non-vested restricted stock units, ending balance (in shares) \| shares	8,283
Weighted-Average Grant Date Fair Value Per Share
Non-vested restricted stock units, beginning balance (in dollars per share) \| $ / shares	$ 3.09
Granted (in dollars per share) \| $ / shares	8.20
Vested (in dollars per share) \| $ / shares	5.76
Forfeited (in dollars per share) \| $ / shares	5.35
Non-vested restricted stock units, ending balance (in dollars per share) \| $ / shares	$ 6.55

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss) Attributable to Parent	$ (809)	$ 6,629	$ (43,781)	$ (37,265)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	500,000,000	500,000,000
Common stock, shares issued (in shares)	236,890,431	232,453,190
Common stock, shares outstanding (in shares)	236,890,431	232,453,190

DERIVATIVE LIABILITIES - Changes in Fair Value of Derivative Liability (Details) - Exit Fee derivative liability - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Beginning balance	$ 675	$ 1,656
Ending balance	1,000	2,055
2018 Exit Fee
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Changes in estimated fair value	0	273
2022 Exit Fee
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Changes in estimated fair value	$ 325	$ 126

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenues:
Total revenues	$ 98,241	$ 56,391	$ 217,486	$ 90,093
Cost of goods sold:
Total cost of goods sold	15,728	7,692	32,292	12,718
Operating expenses:
Research and development	15,310	8,637	38,651	26,012
Selling, general and administrative	64,970	32,664	182,618	86,653
Total operating expenses	80,280	41,301	221,269	112,665
Income (loss) from operations	2,233	7,398	(36,075)	(35,290)
Interest expense	(3,357)	(1,107)	(9,039)	(3,210)
Non-cash interest expense related to the sale of future royalties	(1,924)	(922)	(5,202)	(2,859)
Other income, net	2,282	1,460	6,766	4,308
Income (loss) before provision for income taxes	(766)	6,829	(43,550)	(37,051)
Provision for income taxes	43	200	231	214
Net income (loss)	$ (809)	$ 6,629	$ (43,781)	$ (37,265)
Net income (loss) per share of common stock - basic (in dollars per share)	$ 0.00	$ 0.03	$ (0.19)	$ (0.17)
Net income (loss) per share of common stock - diluted (in dollars per share)	$ 0.00	$ 0.03	$ (0.19)	$ (0.17)
Shares used in computing net income (loss) per share - basic (in shares)	235,911,399	222,782,229	234,516,305	214,976,555
Shares used in computing net income (loss) per share - diluted (in shares)	235,911,399	227,894,335	234,516,305	214,976,555
Comprehensive income (loss):
Net income (loss)	$ (809)	$ 6,629	$ (43,781)	$ (37,265)
Unrealized gains (losses) on available-for-sale securities	286	9	(39)	(147)
Comprehensive income (loss)	(523)	6,638	(43,820)	(37,412)
Product sales
Revenues:
Total revenues	92,090	22,285	208,193	51,949
Cost of goods sold:
Total cost of goods sold	1,715	644	4,133	1,508
Product supply revenue
Revenues:
Total revenues	5,322	2,092	7,461	5,354
Licensing revenue
Revenues:
Total revenues	20	32,014	56	32,790
Non-cash royalty revenue related to the sale of future royalties
Revenues:
Total revenues	809	0	1,776	0
Other cost of revenue
Cost of goods sold:
Total cost of goods sold	$ 14,013	$ 7,048	$ 28,159	$ 11,210

DEFERRED ROYALTY OBLIGATION RELATED TO THE SALE OF FUTURE ROYALTIES (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended		9 Months Ended
	Jun. 30, 2022	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Oct. 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Non-cash interest expense related to the sale of future royalties		$ 1,924	$ 922	$ 5,202	$ 2,859
Proceeds from royalty payments				1,000
Healthcare royalty partners IV, L.P \| License
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Royalty payments and commercial milestone payments	$ 20,000
Revenue to be received	10,000					$ 5,000
Payment to be received	$ 5,000					$ 5,000
Transaction costs		$ 400		$ 400
Amortization, effective interest rate (as percent)				33.30%

LEASES (Tables)

9 Months Ended

Sep. 30, 2024

Leases [Abstract]

Schedule of Additional Details of Leases

The following table provides additional details of our facility leases presented in our condensed balance sheets (dollars in thousands):


Facilities	September 30, 2024			December 31, 2023
Right-of-use assets	$	3,625		$	5,589

Current portion of lease liabilities	2,567			4,435
Operating lease liability, net of current portion	1,218			1,725
Total lease liabilities	$	3,785		$	6,160

Weighted-average remaining life (years)	1.7			1.6
Weighted-average discount rate	6.6		%	6.8		%

Schedule of Lease Costs

The lease costs, which are included in operating expenses in our condensed statements of operations and comprehensive income (loss), were as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Operating lease expense	$	1,067	$	1,061	$	3,204	$	3,127
Cash paid for operating lease	$	1,229	$	1,119	$	3,594	$	3,316

Schedule of Undiscounted Cash Payment Obligations for Operating Lease Liabilities

The following table summarizes our undiscounted cash payment obligations for our operating lease liabilities as of September 30, 2024 (in thousands):


Remainder of 2024	$	1,255
2025	1,660
2026	702
2027	238
2028	124
Thereafter	21
Total undiscounted operating lease payments	4,000
Imputed interest expenses	(215)
Total operating lease liabilities	3,785
Less: Current portion of operating lease liability	(2,567)
Operating lease liability, net of current portion	$	1,218

CONTINGENCIES (Details)						4 Months Ended
CONTINGENCIES (Details)	Sep. 25, 2024 claim	Sep. 13, 2024 claim	Aug. 16, 2024 shareholder	Jul. 19, 2022 claim	Aug. 12, 2021 claim defendant	Mar. 29, 2022 claim defendant	Sep. 30, 2024 USD ($)
Contingencies [Line Items]
Contingent liabilities \| $							$ 0
Strezsak v. Ardelyx, Inc.
Contingencies [Line Items]
Number of lawsuits				2	2
Number of defendants \| defendant					2
Go v. Raab
Contingencies [Line Items]
Number of lawsuits						2
Number of defendants \| defendant						2
Yarborough v. Ardelyx, Inc.
Contingencies [Line Items]
Number of shareholders who filed \| shareholder			2
Ardelyx, Inc. Stockholder Derivative Litigation
Contingencies [Line Items]
Number of lawsuits	2	2
Contingent liabilities \| $							$ 0

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

CASH, CASH EQUIVALENTS AND INVESTMENTS - Narrative (Details) - investment	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Cash and Cash Equivalents [Abstract]
Short-term securities, contractual maturities maximum (in years)	1 year	1 year
Investment in continuous unrealized loss position for more than one year	0	0

DERIVATIVE LIABILITIES - Narrative (Details) - USD ($) $ in Millions	1 Months Ended
	Oct. 31, 2024	Feb. 28, 2022	Sep. 30, 2024	Dec. 31, 2023	Oct. 31, 2023	May 31, 2018
2018 Exit Fee
Derivative [Line Items]
Agreed amount for exit fee upon change of control or regulatory approval						$ 1.5
2022 Exit Fee
Derivative [Line Items]
Exit fee (as percent)					2.00%
Exit fee, net product revenue threshold		$ 100.0
Derivative liability			$ 1.0	$ 0.7
2022 Exit Fee \| Subsequent event
Derivative [Line Items]
Milestone payment	$ 1.0

- Definition

Fair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (bbb)(2)(i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (bbb)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

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+ Details

- Definition

Nominal or face amount used to calculate payments on the derivative liability.

+ References + Details

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2024	Oct. 25, 2024
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-36485
Entity Registrant Name	ARDELYX, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-1303944
Entity Address, Address Line One	400 Fifth Avenue
Entity Address, Address Line Two	Suite 210
Entity Address, City or Town	Waltham
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02451
City Area Code	510
Local Phone Number	745-1700
Title of 12(b) Security	Common Stock, par value $0.0001
Trading Symbol	ARDX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		236,854,270
Entity Central Index Key	0001437402
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

CONTINGENCIES	9 Months Ended
CONTINGENCIES	Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]
CONTINGENCIES	CONTINGENCIES On July 30 and August 12, 2021, two putative securities class action lawsuits were commenced in the U.S. District Court for the Northern District of California naming as defendants Ardelyx and two current officers captioned Strezsak v. Ardelyx, Inc., et al., Case No. 4:21-cv-05868-HSG, and Siegel v. Ardelyx, Inc., et al., Case No. 5:21-cv-06228-HSG (together, the "Securities Class Actions"). The complaints allege that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act"), as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to tenapanor. The plaintiffs seek damages and interest, and an award of costs, including attorneys’ fees. On July 19, 2022, the court consolidated the two putative class actions and appointed a lead plaintiff and lead counsel. The lead plaintiff filed a second amended complaint under which the plaintiffs seek to represent all persons who purchased or otherwise acquired Ardelyx securities between March 6, 2020 and July 19, 2021. Defendants filed a motion to dismiss the amended complaint on June 2, 2023. On March 22, 2024, the court granted defendants’ motion to dismiss. The court provided plaintiffs a third opportunity to amend and plaintiffs filed a third amended complaint on April 19, 2024. Defendants filed a motion to dismiss the third amended complaint on June 3, 2024. The case was dismissed with prejudice on September 12, 2024. On October 9, 2024, plaintiff appealed the District Court's dismissal of the case to the Ninth Circuit. We believe the plaintiffs' claims are without merit and we have not recorded any accrual for a contingent liability associated with these legal proceedings. On December 7, 2021 and March 29, 2022, two verified shareholders derivative lawsuits were filed in the U.S. District Court for the Northern District of California purportedly on behalf of Ardelyx against certain of Ardelyx’s executive officers and members of our board of directors, captioned Go v. Raab, et al., Case No. 4:21-cv-09455-HSG, and Morris v. Raab, et al., Case No. 4:22-cv-01988-JSC. The complaints allege that the defendants' violations of Section 14(a) of the Securities Exchange Act of 1934, as amended, breaches of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets for personally making and/or causing Ardelyx to make materially false and misleading statements regarding the Company’s business, operations and prospects. The complaint seeks contribution under Sections 10(b) and 21D of the Securities Exchange Act of 1934 from two executive officers. On January 19, and April 27, 2022, the court granted the parties’ stipulation to stay the Go and Morris actions, respectively, until resolution of the anticipated motion(s) to dismiss in the Securities Class Actions. On October 25, 2022, the parties filed a stipulation to consolidate and stay the Go and Morris actions, and on October 27, 2022, the court consolidated the Go and Morris action and stayed the consolidated action pending resolution of the anticipated motion(s) to dismiss in the Securities Class Action. The consolidated case remains stayed pending resolution of the appeal in the Securities Class Action. We believe the plaintiffs' claims are without merit and we have not recorded any accrual for a contingent liability associated with these legal proceedings. On July 17, 2024, the Company, in partnership with the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF), filed a lawsuit in the U.S. District Court for the District of Columbia against the Centers for Medicare & Medicaid Services (CMS), claiming that CMS has violated its statutory and regulatory authority under the Medicare Improvements for Patients and Providers Act (MIPPA), which established the ESRD PPS bundled payment system for dialysis services in 2008. Specifically, the lawsuit claims that CMS’s plan to move XPHOZAH, along with all oral-only drugs, into the ESRD PPS is inconsistent with MIPPA’s statutory provision, and contradicts CMS’s own regulations. XPHOZAH and other oral-only drugs, which are currently available to patients under Medicare Part D, are not administered by dialysis providers and cannot be taken during the delivery of maintenance dialysis. The Company, AAKP and NMQF are seeking relief under the Administrative Procedure Act to enjoin CMS from proceeding with its plan to include XPHOZAH in the ESRD PPS and eliminate coverage under Medicare Part D beginning on January 1, 2025. On September 17, 2024, defendants filed a Motion to Dismiss, the case, and on September 19, 2024, plaintiffs filed a Motion for Preliminary Injunction or, in the Alternative, for Expedited Summary Judgment. On August 16, 2024, a complaint was filed against the Company in the U.S. District Court of Massachusetts, captioned Yarborough v. Ardelyx, Inc., et al., No. 24-cv-12119 (D. Mass.). The complaint names the Company, Mike Raab, and Justin Renz as defendants and alleges violations of Sections 10(b) and 20(a) the Exchange Act and Rule 10b-5 promulgated thereunder, related to the Company’s announcement on July 2, 2024 that it had chosen not to file an application for Transitional Drug Add-on Payment Adjustment (TDAPA) for XPHOZAH (the "Yarborough Action"). The plaintiffs seek damages and interest, and an award of costs, including attorneys' fees. Two shareholders filed motions to be appointed lead plaintiff in the Yarborough Action on October 15, 2024. The court has not yet appointed a lead plaintiff. We believe the plaintiff's claims are without merit and we have not recorded any accrual for a contingent liability associated with these legal proceedings. On September 6 and 13, 2024, certain Ardelyx shareholders filed two verified derivative complaints purportedly on behalf of the Company in the United States District Court for the District of Massachusetts alleging violations of Sections 10(b) and/or 14(a) of the Exchange Act, breaches of fiduciary duty, unjust enrichment, waste, and aiding and abetting breaches of fiduciary duty against certain members of our board of directors and management based on substantially the same factual allegations in the Yarborough Action. The complaints seek unspecified damages and corporate governance reforms, as well as costs and attorneys' fees. On September 25, 2024, the Court consolidated the two derivative actions into the case In re Ardelyx, Inc. Stockholder Derivative Litigation, Case No. 1:24-cv-12302-LTS (D. Mass.). We believe the plaintiffs' claims are without merit and we have not recorded any accrual for a contingent liability associated with these legal proceedings. From time to time, we may be involved in legal proceedings arising in the ordinary course of business. As of September 30, 2024, there is no litigation pending that would reasonably be expected to have a material adverse effect on our results of operations and financial condition, and no contingent liabilities were accrued as of September 30, 2024.

LEASES

9 Months Ended

Sep. 30, 2024

Leases [Abstract]

LEASES

All of our leases are operating leases and each contain customary rent escalation clauses. Certain of the leases have both lease and non-lease components. We have elected to account for each separate lease component and the non-lease components associated with that lease component as a single lease component for all classes of underlying assets.

The following table provides additional details of our facility leases presented in our condensed balance sheets (dollars in thousands):


Facilities	September 30, 2024			December 31, 2023
Right-of-use assets	$	3,625		$	5,589

Current portion of lease liabilities	2,567			4,435
Operating lease liability, net of current portion	1,218			1,725
Total lease liabilities	$	3,785		$	6,160

Weighted-average remaining life (years)	1.7			1.6
Weighted-average discount rate	6.6		%	6.8		%

The lease costs, which are included in operating expenses in our condensed statements of operations and comprehensive income (loss), were as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Operating lease expense	$	1,067	$	1,061	$	3,204	$	3,127
Cash paid for operating lease	$	1,229	$	1,119	$	3,594	$	3,316

The following table summarizes our undiscounted cash payment obligations for our operating lease liabilities as of September 30, 2024 (in thousands):


Remainder of 2024	$	1,255
2025	1,660
2026	702
2027	238
2028	124
Thereafter	21
Total undiscounted operating lease payments	4,000
Imputed interest expenses	(215)
Total operating lease liabilities	3,785
Less: Current portion of operating lease liability	(2,567)
Operating lease liability, net of current portion	$	1,218

Insider Trading Arrangements

3 Months Ended

9 Months Ended

Sep. 30, 2024

Trading Arrangements, by Individual

Non-Rule 10b5-1 Arrangement Adopted

false

Rule 10b5-1 Arrangement Terminated

false

Non-Rule 10b5-1 Arrangement Terminated

false

Michael Raab [Member]

Trading Arrangements, by Individual

Material Terms of Trading Arrangement

During the three months ended September 30, 2024, our Section 16 officers and directors adopted or terminated contracts, instructions or written plans for the purchase or sale of our securities as noted below:

Name and Title of Director or Officer

Action

Date

Trading Arrangement

Total Shares Available to be Sold

Expiration Date

Rule 10b5-1*

Non-Rule 10b5-1**

Michael Raab, President and Chief Executive Officer

Adoption

September 4, 2024

500,000

January 2, 2026

*Intended to satisfy the affirmative defense conditions of Rule 10b5-1(c)

**Not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c)

Name

Michael Raab

Title

President and Chief Executive Officer

Rule 10b5-1 Arrangement Adopted

true

September 4, 2024

January 2, 2026

485 days

500,000

EQUITY INCENTIVE PLANS - Stock-Based Compensation Expense Recognized (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Stock-based Compensation [Line Items]
Stock-based compensation expense	$ 9,133	$ 3,489	$ 27,518	$ 9,600
Selling, general and administrative
Stock-based Compensation [Line Items]
Stock-based compensation expense	6,199	2,574	20,305	6,965
Research and development
Stock-based Compensation [Line Items]
Stock-based compensation expense	$ 2,934	$ 915	$ 7,213	$ 2,635

ORGANIZATION AND BASIS OF PRESENTATION	9 Months Ended
ORGANIZATION AND BASIS OF PRESENTATION	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
ORGANIZATION AND BASIS OF PRESENTATION	ORGANIZATION AND BASIS OF PRESENTATION Ardelyx, Inc. (Company, we, us or our) is a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. We developed a unique and innovative platform that enabled the discovery of new biological mechanisms and pathways to develop potent, and efficacious therapies that minimize the side effects and drug-drug interactions frequently encountered with traditional, systemically absorbed medicines. The first molecule we discovered and developed was tenapanor, a minimally absorbed, first-in-class, oral, small molecule therapy. Tenapanor, branded as IBSRELA®, is approved in the U.S. for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Tenapanor, branded as XPHOZAH®, is approved in the U.S. to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. We operate in one business segment, which is the development and commercialization of biopharmaceutical products. Basis of Presentation These condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted. These condensed financial statements have been prepared on the same basis as our most recent annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary to present fairly our financial position, results of operations, changes in stockholders’ equity, and cash flows for the interim periods presented. The accompanying condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the entire year ending December 31, 2024, or for any other interim period or future year. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes thereto. On an ongoing basis, management evaluates its estimates, including those related to recognition of revenue, clinical trial accruals, contract manufacturing accruals, expected demand for inventory, fair value of assets and liabilities, income taxes and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could materially differ from those estimates. Liquidity As of September 30, 2024, we had cash, cash equivalents and short-term investments of approximately $190.4 million. We have incurred operating losses since inception in 2007 and our accumulated deficit as of September 30, 2024 is $890.0 million. We have addressed our operating cash flow requirements through cash generated from product sales of IBSRELA and XPHOZAH, proceeds from the sale of shares of our common stock under our at-the-market offering, the receipt of milestone payments from our collaboration partners and payments from our Japanese collaboration partner under the second amendment to our License Agreement, and funds from our loan agreements with SLR Investment Corp. (SLR), as amended. We believe our available cash, cash equivalents and short-term investments as of September 30, 2024 will be sufficient to fund our planned operations for at least a period of one year from the issuance of these condensed financial statements. Summary of Significant Accounting Policies Our significant accounting policies are described in Note 2 to our audited financial statements for the fiscal year ended December 31, 2023, included in our Annual Report on Form 10-K. There have been no material changes in our significant accounting policies as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. Recent Accounting Pronouncements New Accounting Pronouncements - Recently Adopted We have adopted no new accounting pronouncements subsequent to filing our most recent Annual Report on Form 10-K. Recent Accounting Pronouncements Not Yet Adopted In October 2023, the Financial Accounting Standards Board (FASB) issued ASU No. 2023-06, Disclosure Improvements - Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments in this Update modify the disclosure or presentation requirements of a variety of Topics in the Codification. The amendments are in response to the U.S. Securities and Exchange Commission's (SEC) Release No. 33-10532, Disclosure Update and Simplification, in which the SEC referred certain of its disclosure requirements that overlap with, but require incremental information to, generally accepted accounting principles to the FASB for potential incorporation into the Codification. For entities subject to the SEC’s existing disclosure requirements and for entities required to file or furnish financial statements with or to the SEC in preparation for the sale of or for purposes of issuing securities that are not subject to contractual restrictions on transfer, the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. For all other entities, the amendments will be effective two years later. For all entities, if by June 30, 2027, the SEC has not removed the applicable requirement from Regulation S-X or Regulation S-K, the pending content of the related amendment will be removed from the Codification and will not become effective for any entity. Management is currently assessing the impact of this standard on the Company’s financial statements. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures. This Update requires publicly traded entities to provide enhanced disclosures about significant segment expenses regularly reviewed by the chief operating decision maker, including public traded entities with a single reportable segment. The amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. Management is currently assessing the impact of this standard on the Company’s financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures, an amendment which modifies the measurement and recognition of credit losses for most financial assets and certain other instruments. The amendments in this Update provide more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. For public business entities, the amendments in this Update are effective for annual periods beginning after December 15, 2024. Early adoption is permitted on a prospective basis for annual financial statements that have not yet been issued or made available for issuance. Management is currently assessing the impact of this standard on the Company’s financial statements.

BORROWING - Future Debt Payment Obligations (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Debt Disclosure [Abstract]
Total repayment obligations	$ 104,950
Less: Unamortized discount and debt issuance costs	(944)
Less: Unaccreted value of final fee	(3,299)
Long-term debt	100,707
Less: Current portion of long-term debt	0
Long-term debt	$ 100,707	$ 49,822

- Definition

Amount of unamortized debt discount (premium) and debt issuance costs.

+ References + Details

- Definition

Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

EQUITY INCENTIVE PLANS - Total Unrecognized Stock-Based Compensation Expense, Net of Estimated Forfeitures (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($)
ESPP
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized Compensation Expense	$ 394
Average Remaining Vesting Period (Years)	4 months 24 days
Stock option grants
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized Compensation Expense	$ 59,155
Average Remaining Vesting Period (Years)	2 years 9 months 18 days
RSU grants
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized Compensation Expense	$ 51,963
Average Remaining Vesting Period (Years)	3 years 1 month 6 days

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

COLLABORATION AND LICENSING AGREEMENTS - Narrative (Details) $ in Thousands, $ in Millions, ¥ in Billions	1 Months Ended			3 Months Ended		9 Months Ended			77 Months Ended
	Dec. 31, 2017 USD ($)	Nov. 30, 2017 USD ($)	Jun. 30, 2015 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2024 CAD ($)	Sep. 30, 2023 USD ($)	Mar. 31, 2024 USD ($)	Sep. 30, 2024 JPY (¥)	Oct. 31, 2023 USD ($)	Jul. 31, 2023 USD ($)	Oct. 31, 2022 USD ($)	Apr. 30, 2022 USD ($) payment_tranche	Mar. 31, 2018 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues				$ 98,241	$ 56,391	$ 217,486		$ 90,093
Licensing revenue
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues				20	32,014	56		32,790
Non-cash royalty revenue related to the sale of future royalties
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues				809	0	1,776		0
Product supply revenue
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues				5,322	2,092	7,461		5,354
2017 KKC Agreement \| Non-cash royalty revenue related to the sale of future royalties
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues				800		1,800
2017 KKC Agreement \| Product supply revenue
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues				5,300	2,100	7,500		5,400
Fosun Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues				0		0
Fosun Agreement \| Licensing revenue
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues					2,000			2,000
Knight Agreement \| Licensing revenue
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenues				0	0	0		0
KKC \| 2017 KKC Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront license fees		$ 30,000
Potential development milestones		$ 55,000
Total revenues									$ 35,000
Potential commercialization milestones				59,800		59,800				¥ 8.5
Fee receivable for reduction in royalty rate														$ 40,000
Number of payment tranches for fee receivable for reduction in royalty rate \| payment_tranche														2
KKC \| 2017 KKC Agreement \| Licensing revenue
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Proceeds from milestone payments					30,000			30,000					$ 35,000
Fosun Pharma \| Fosun Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Proceeds from milestone payments				8,000		8,000					$ 3,000	$ 2,000
Upfront payment received	$ 12,000
Potential development and commercialization milestones						$ 113,000
Threshold percentage of net sales for tiered royalties						20.00%	20.00%
Knight \| Knight Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential development milestones				700		$ 700
Non-cash royalty revenue															$ 2,300
Potential development and commercialization milestones						16,400	$ 22.2
AstraZeneca \| AZ Termination Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Percentage of royalty revenue			10.00%
Percentage of non-royalty revenue			20.00%
Maximum potential payment per agreement			$ 75,000
Aggregate cost of revenue recognized				50,300		50,300
Cost of revenue				$ 10,000	$ 5,700	$ 22,700		$ 8,700

CASH, CASH EQUIVALENTS AND INVESTMENTS - Securities Classified as Cash, Cash Equivalents and Investments (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Cash and cash equivalents:
Fair Value	$ 47,429	$ 21,470
Short-term investments:
Amortized Cost	142,788	162,605
Gross Unrealized Gains	193	280
Gross Unrealized Losses	(8)	(56)
Fair Value	142,973	162,829
Total cash equivalents and investments, Amortized Cost	190,217	184,075
Total cash equivalents and investments, Gross Unrealized Gains	193	280
Total cash equivalents and investments, Gross Unrealized Losses	(8)	(56)
Total cash, cash equivalents and investments	190,402	184,299
U.S. government-sponsored agency bonds
Short-term investments:
Amortized Cost	53,052	101,892
Gross Unrealized Gains	52	235
Gross Unrealized Losses	(6)	(34)
Fair Value	53,098	102,093
U.S. treasury securities
Short-term investments:
Amortized Cost	36,697	2,455
Gross Unrealized Gains	47	2
Gross Unrealized Losses	(1)	0
Fair Value	36,743	2,457
Commercial paper
Short-term investments:
Amortized Cost	30,738	49,630
Gross Unrealized Gains	54	41
Gross Unrealized Losses	0	(17)
Fair Value	30,792	49,654
Corporate bonds
Short-term investments:
Amortized Cost	17,371
Gross Unrealized Gains	37
Gross Unrealized Losses	0
Fair Value	17,408
Asset-backed securities
Short-term investments:
Amortized Cost	2,975	8,628
Gross Unrealized Gains	3	2
Gross Unrealized Losses	0	(5)
Fair Value	2,978	8,625
Yankee bonds
Short-term investments:
Amortized Cost	1,955
Gross Unrealized Gains	0
Gross Unrealized Losses	(1)
Fair Value	1,954
Cash
Cash and cash equivalents:
Fair Value	7,560	2,829
Money market funds
Cash and cash equivalents:
Fair Value	$ 39,869	$ 18,641

EQUITY INCENTIVE PLANS (Tables)

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Schedule of Stock-Based Compensation Expense Recognized


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Selling, general and administrative	$	6,199	$	2,574	$	20,305	$	6,965
Research and development	2,934		915		7,213		2,635

Total	$	9,133	$	3,489	$	27,518	$	9,600

Schedule of Total Unrecognized Stock-Based Compensation Expense, Net of Estimated Forfeitures

As of September 30, 2024, our total unrecognized stock-based compensation expense, net of estimated forfeitures, and average remaining vesting period, included the following (dollars in thousands):


	Unrecognized Compensation Expense		Average Remaining Vesting Period (Years)
Stock option grants	$	59,155	2.8
RSU grants	$	51,963	3.1
ESPP	$	394	0.4

Schedule of Stock Option Activity

A summary of our stock option activity and related information for the nine months ended September 30, 2024 is as follows (in thousands, except dollar amounts):


	Number of Shares	Weighted-Average Exercise Price per Share
Balance at December 31, 2023	22,168	$	4.20
Options granted	8,738	$	8.20
Options exercised	(2,228)	$	2.38
Options forfeited or canceled	(510)	$	5.46
Balance at September 30, 2024	28,168	$	5.57
Exercisable at September 30, 2024	14,030	$	5.49

Schedule of Restricted Stock Units Activity

A summary of our RSUs activity and related information for the nine months ended September 30, 2024 is as follows (in thousands, except dollar amounts):


	Number of RSUs	Weighted-Average Grant Date Fair Value Per Share
Non-vested restricted stock units at December 31, 2023	3,646	$	3.09
Granted	6,646	$	8.20
Vested	(1,724)	$	5.76
Forfeited	(285)	$	5.35
Non-vested restricted stock units at September 30, 2024	8,283	$	6.55

CONDENSED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 47,429	$ 21,470
Short-term investments	142,973	162,829
Accounts receivable	53,195	22,031
Inventory	11,378	12,448
Prepaid commercial manufacturing	16,663	18,925
Prepaid expenses and other current assets	12,460	8,408
Total current assets	284,098	246,111
Inventory, non-current	73,780	37,039
Prepaid commercial manufacturing, non-current	0	4,235
Right-of-use assets	3,625	5,589
Property and equipment, net	1,028	1,009
Other assets	5,332	3,596
Total assets	367,863	297,579
Current liabilities:
Accounts payable	15,824	11,138
Accrued compensation and benefits	11,541	12,597
Current portion of operating lease liability	2,567	4,435
Deferred revenue	7,272	7,182
Accrued expenses and other current liabilities	33,295	15,041
Total current liabilities	70,499	50,393
Operating lease liability, net of current portion	1,218	1,725
Long-term debt	100,707	49,822
Deferred revenue, non-current	12,770	8,644
Deferred royalty obligation related to the sale of future royalties	24,372	20,179
Total liabilities	209,566	130,763
Commitments and contingencies (Note 14)
Stockholders’ equity:
Common stock, $0.0001 par value; 500,000,000 shares authorized; 236,890,431 and 232,453,190 shares issued and outstanding as of September 30, 2024 and December 31, 2023	24	23
Additional paid-in capital	1,048,073	1,012,773
Accumulated deficit	(889,985)	(846,204)
Accumulated other comprehensive income	185	224
Total stockholders’ equity	158,297	166,816
Total liabilities and stockholders’ equity	$ 367,863	$ 297,579

REVENUE - Revenue from Customers as a Percentage of Total Product Revenue, Net (Details) - Gross product revenue - Customer	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
BioRidge Pharma, LLC
Disaggregation of Revenue [Line Items]
Concentration risk (as percent)	53.40%	19.50%	49.30%	19.20%
AmerisourceBergen Drug Corporation
Disaggregation of Revenue [Line Items]
Concentration risk (as percent)	14.00%	21.20%	15.10%	21.30%
Cardinal Health
Disaggregation of Revenue [Line Items]
Concentration risk (as percent)	12.60%	22.20%	13.80%	22.30%
McKesson Corporation
Disaggregation of Revenue [Line Items]
Concentration risk (as percent)	13.20%	18.40%	13.20%	19.00%

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

FAIR VALUE MEASUREMENTS - Financial Assets and Liabilities Measured on a Recurring Basis (Details) - Recurring - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Assets:
Assets, fair value	$ 182,842	$ 181,470
Liabilities:
Liabilities, fair value		675
Derivative liabilities for exit fee
Liabilities:
Liabilities, fair value		675
Level 1
Assets:
Assets, fair value	39,869	18,641
Liabilities:
Liabilities, fair value		0
Level 1 \| Derivative liabilities for exit fee
Liabilities:
Liabilities, fair value		0
Level 2
Assets:
Assets, fair value	142,973	162,829
Liabilities:
Liabilities, fair value		0
Level 2 \| Derivative liabilities for exit fee
Liabilities:
Liabilities, fair value		0
Level 3
Assets:
Assets, fair value	0	0
Liabilities:
Liabilities, fair value		675
Level 3 \| Derivative liabilities for exit fee
Liabilities:
Liabilities, fair value		675
Money market funds
Assets:
Assets, fair value	39,869	18,641
Money market funds \| Level 1
Assets:
Assets, fair value	39,869	18,641
Money market funds \| Level 2
Assets:
Assets, fair value	0	0
Money market funds \| Level 3
Assets:
Assets, fair value	0	0
U.S. government-sponsored agency bonds
Assets:
Assets, fair value	53,098	102,093
U.S. government-sponsored agency bonds \| Level 1
Assets:
Assets, fair value	0	0
U.S. government-sponsored agency bonds \| Level 2
Assets:
Assets, fair value	53,098	102,093
U.S. government-sponsored agency bonds \| Level 3
Assets:
Assets, fair value	0	0
U.S. treasury securities
Assets:
Assets, fair value	36,743	2,457
U.S. treasury securities \| Level 1
Assets:
Assets, fair value	0	0
U.S. treasury securities \| Level 2
Assets:
Assets, fair value	36,743	2,457
U.S. treasury securities \| Level 3
Assets:
Assets, fair value	0	0
Commercial paper
Assets:
Assets, fair value	30,792	49,654
Commercial paper \| Level 1
Assets:
Assets, fair value	0	0
Commercial paper \| Level 2
Assets:
Assets, fair value	30,792	49,654
Commercial paper \| Level 3
Assets:
Assets, fair value	0	0
Corporate bonds
Assets:
Assets, fair value	17,408
Corporate bonds \| Level 1
Assets:
Assets, fair value	0
Corporate bonds \| Level 2
Assets:
Assets, fair value	17,408
Corporate bonds \| Level 3
Assets:
Assets, fair value	0
Asset-backed securities
Assets:
Assets, fair value	2,978	8,625
Asset-backed securities \| Level 1
Assets:
Assets, fair value	0	0
Asset-backed securities \| Level 2
Assets:
Assets, fair value	2,978	8,625
Asset-backed securities \| Level 3
Assets:
Assets, fair value	0	$ 0
Yankee bonds
Assets:
Assets, fair value	1,954
Yankee bonds \| Level 1
Assets:
Assets, fair value	0
Yankee bonds \| Level 2
Assets:
Assets, fair value	1,954
Yankee bonds \| Level 3
Assets:
Assets, fair value	$ 0

COLLABORATION AND LICENSING AGREEMENTS - Deferred Revenue (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Current
Beginning balance	$ 7,182
Ending balance	7,272
Non-Current
Beginning balance	8,644
Ending balance	12,770
2017 KKC Agreement
Current
Beginning balance	7,182	$ 4,211
Amounts invoiced as prepayments for product supply	2,654	1,182
Decrease for revenue recognized for product supply	(6,650)	(4,586)
Reclassify amounts to be recognized in the next twelve months	4,086	3,265
Ending balance	7,272	4,072
Non-Current
Beginning balance	8,644	9,025
Amounts invoiced as prepayments for product supply	8,212	4,530
Decrease for revenue recognized for product supply	0	0
Reclassify amounts to be recognized in the next twelve months	(4,086)	(3,265)
Ending balance	$ 12,770	$ 10,290

DEFERRED ROYALTY OBLIGATION RELATED TO THE SALE OF FUTURE ROYALTIES	9 Months Ended
	Sep. 30, 2024
Advance Royalties [Abstract]
DEFERRED ROYALTY OBLIGATION RELATED TO THE SALE OF FUTURE ROYALTIES	DEFERRED ROYALTY OBLIGATION RELATED TO THE SALE OF FUTURE ROYALTIES In June 2022, we and HealthCare Royalty Partners IV, L.P. (HCR) entered into a Royalty and Sales Milestone Interest Acquisition Agreement (HCR Agreement). Under the terms of the HCR Agreement, HCR has agreed to pay us up to $20.0 million in exchange for the royalty payments and commercial milestone payments (collectively, the Royalty Interest Payments) that we may receive under our 2017 License Agreement with Kyowa Kirin based upon Kyowa Kirin's net sales of tenapanor in Japan for hyperphosphatemia. As consideration for the sale of the Royalty Interest Payments, HCR paid to us a $10.0 million upfront payment in June 2022 and a $5.0 million payment, which we received in October 2023, as a result of Kyowa Kirin's receipt of regulatory approval to market tenapanor for hyperphosphatemia in Japan. We are eligible to receive another $5.0 million payment in the event net sales by Kyowa Kirin in Japan exceed a certain annual target level by the end of 2025. The HCR Agreement is effective until terminated by the mutual agreement of the parties and contains customary representations and warranties and customary affirmative and negative covenants, including, among others, requirements as to prosecution, maintenance, defense and enforcement of certain patent rights in Japan, restrictions regarding our ability to forgive, release or reduce any Royalty Interest Payments due to us under the 2017 Kyowa Kirin Agreement, to create or incur any liens with respect to the Royalty Interest Payments, the 2017 Kyowa Kirin Agreement or certain patents, or to sell, license or transfer certain patents in the field and territory described in the 2017 Kyowa Kirin Agreement. In addition, the HCR Agreement contains customary events of default with respect to which we may incur indemnification obligations to HCR for any losses incurred by HCR and related parties as a result of the event of default, subject to a specified limitation of liability cap. Under the HCR Agreement, an event of default will occur if, among other things, any of the representations and warranties included in the HCR Agreement proves not to have been true and correct in all material respects, at the time it was made, we breach any of our covenants under the HCR Agreement, subject to specified cure periods with respect to certain breaches, we are in breach or default under the 2017 Kyowa Kirin Agreement in any manner which is likely to cause a material adverse effect on the Royalty Interest Payments, the occurrence of a termination of the 2017 Kyowa Kirin Agreement under certain circumstances or we or our assets become subject to certain legal proceedings, such as bankruptcy proceedings, or we are unable to pay our debts as they become due. The $10.0 million upfront payment from HCR received in June 2022 and the $5.0 million payment received in October 2023 have been recorded as a deferred royalty obligation related to the sale of future royalties (deferred royalty obligation) on our balance sheets. Due to our ongoing manufacturing obligations under the 2017 Kyowa Kirin Agreement, we account for the proceeds as imputed debt and therefore will recognize royalties earned under the arrangement as non-cash royalty revenue. Non-cash interest expense will be recognized over the life of the HCR Agreement using the effective interest method based on the imputed interest rate derived from estimated amounts and timing of future royalty payments to be received from Kyowa Kirin. As part of the sale, we incurred approximately $0.4 million in transaction costs, which, along with the deferred royalty obligation, are being amortized to non-cash interest expense over the estimated life of the HCR Agreement using the effective interest method. As future royalties are remitted to us by Kyowa Kirin, and subsequently from us to HCR, the balance of the deferred royalty obligation will be effectively repaid over the life of the HCR Agreement. There are a number of factors that could materially affect the fair value of the deferred royalty obligation. Such factors include, but are not limited to, the amount and timing of potential future royalty payments to be received from Kyowa Kirin under the 2017 Kyowa Kirin agreement, changing standards of care, the introduction of competing products, manufacturing or other delays, intellectual property matters, adverse events that result in governmental health authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates as the royalties remitted to HCR are made in U.S. dollars while the underlying sales of the products by Kyowa Kirin are made in Japanese yen, and other events or circumstances that could result in reduced royalty payments from Kyowa Kirin, which are not within our control, and all of which would result in a reduction of non-cash royalty revenues and the non-cash interest expense over the life of the deferred royalty obligation. We periodically assess the estimated royalty payments from Kyowa Kirin and, to the extent that the amount or timing of such payments is materially different than our original estimates, we prospectively adjust the imputed interest rate and the related amortization of the deferred royalty obligation. As of September 30, 2024, our effective interest rate used to amortize the liability is 33.3%. During the three and nine months ended September 30, 2024, we recognized $1.9 million and $5.2 million, respectively, of non-cash interest expense related to the deferred royalty obligation. During the three and nine months ended September 30, 2023, we recognized $0.9 million and $2.9 million, respectively, of non-cash interest expense related to the deferred royalty obligation. As of September 30, 2024, we have received $1.0 million royalty payments from Kyowa Kirin and the deferred royalty obligation has been reduced accordingly.

LEASES - Additional Details of Leases (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Right-of-use assets and lease liabilities
Right-of-use assets	$ 3,625	$ 5,589
Current portion of lease liabilities	2,567	4,435
Operating lease liability, net of current portion	1,218	1,725
Total operating lease liabilities	$ 3,785	$ 6,160
Additional details
Weighted-average remaining life (years)	1 year 8 months 12 days	1 year 7 months 6 days
Weighted-average discount rate	6.60%	6.80%

EQUITY INCENTIVE PLANS - Stock Options Activity (Details) - $ / shares	9 Months Ended
	Sep. 30, 2024
Number of Shares
Options outstanding balance, beginning (in shares)	22,168,000
Options granted (in shares)	8,738,000
Options exercised (in shares)	(2,228,000)
Options forfeited or canceled (in shares)	(510,000)
Options outstanding balance, ending (in shares)	28,168,000
Options exercisable (in shares)	14,030,000
Weighted-Average Exercise Price per Share
Options outstanding balance, beginning (in dollars per share)	$ 4.20
Options granted (in dollars per share)	8.20
Options exercised (in dollars per share)	2.38
Options forfeited or canceled (in dollars per share)	5.46
Options outstanding balance, ending (in dollars per share)	5.57
Options exercisable (in dollars per share)	$ 5.49

FAIR VALUE MEASUREMENTS (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Schedule of Fair Value of Financial Assets and Liabilities Measured on a Recurring Basis

The following table sets forth the fair value of our financial assets and liabilities that are measured or disclosed on a recurring basis by level within the fair value hierarchy (in thousands):


	September 30, 2024
	Total Fair Value		Level 1		Level 2		Level 3
Assets:
Money market funds	$	39,869	$	39,869	$	—	$	—
U.S. government-sponsored agency bonds	53,098		—		53,098		—
U.S. treasury securities	36,743		—		36,743		—
Commercial paper	30,792		—		30,792		—

Corporate bonds	17,408		—		17,408		—
Asset-backed securities	2,978		—		2,978		—
Yankee bonds	1,954		—		1,954		—

Total	$	182,842	$	39,869	$	142,973	$	—


	December 31, 2023
	Total Fair Value		Level 1		Level 2		Level 3
Assets:
Money market funds	$	18,641	$	18,641	$	—	$	—
U.S. government-sponsored agency bonds	102,093		—		102,093		—
Commercial paper	49,654		—		49,654		—

Asset-backed securities	8,625		—		8,625		—
U.S. treasury securities	2,457		—		2,457		—
Total	$	181,470	$	18,641	$	162,829	$	—

Liabilities:
Derivative liability for exit fees	$	675	$	—	$	—	$	675
Total	$	675	$	—	$	—	$	675

FAIR VALUE MEASUREMENTS - Narrative (Details) - USD ($)	Sep. 30, 2024	Jun. 30, 2024	Dec. 31, 2023	Sep. 30, 2023	Dec. 31, 2022
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Allowance for credit loss on available for-sale debt securities	$ 0		$ 0
Exit Fee derivative liability
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Estimated fair value	$ 1,000,000	$ 1,000,000	$ 675,000	$ 2,055,000	$ 1,656,000

INVENTORY - Schedule of Inventory (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Inventory Disclosure [Abstract]
Raw materials	$ 25,992	$ 22,920
Work in process	57,335	24,582
Finished goods	1,831	1,985
Inventory	11,378	12,448
Inventory, non-current	73,780	37,039
Total	$ 85,158	$ 49,487

CASH, CASH EQUIVALENTS AND INVESTMENTS

9 Months Ended

Sep. 30, 2024

Cash and Cash Equivalents [Abstract]

CASH, CASH EQUIVALENTS AND INVESTMENTS

Securities classified as cash, cash equivalents and short-term investments as of September 30, 2024 and December 31, 2023 are summarized below (in thousands):


	September 30, 2024
			Gross Unrealized
	Amortized Cost		Gains		Losses		Fair Value
Cash and cash equivalents:
Cash	$	7,560	$	—	$	—	$	7,560
Money market funds	39,869		—		—		39,869


Total cash and cash equivalents	47,429		—		—		47,429
Short-term investments:
U.S. government-sponsored agency bonds	$	53,052	$	52	$	(6)	$	53,098
U.S. treasury securities	36,697		47		(1)		36,743
Commercial paper	30,738		54		—		30,792
Corporate bonds	17,371		37		—		17,408
Asset-backed securities	2,975		3		—		2,978
Yankee bonds	1,955		—		(1)		1,954
Total short-term investments	142,788		193		(8)		142,973
Total cash, cash equivalents and investments	$	190,217	$	193	$	(8)	$	190,402


	December 31, 2023
			Gross Unrealized
	Amortized Cost		Gains		Losses		Fair Value
Cash and cash equivalents:
Cash	$	2,829	$	—	$	—	$	2,829
Money market funds	18,641		—		—		18,641


Total cash and cash equivalents	21,470		—		—		21,470
Short-term investments:
U.S. government-sponsored agency bonds	$	101,892	$	235	$	(34)	$	102,093
Commercial paper	49,630		41		(17)		49,654

Asset-backed securities	8,628		2		(5)		8,625
U.S. treasury securities	2,455		2		—		2,457
Total short-term investments	162,605		280		(56)		162,829


Total cash, cash equivalents and investments	$	184,075	$	280	$	(56)	$	184,299

Cash equivalents consist of money market funds with original maturities of three months or less at the time of purchase, and the carrying amount is a reasonable approximation of fair value. We invest our cash in high quality securities of financial and commercial institutions. These securities are carried at fair value, which is based on readily available market information, with unrealized gains and losses included in accumulated other comprehensive income (loss) within stockholders’ equity on our balance sheets. We use the specific identification method to determine the amount of realized gains or losses on sales of marketable securities. Realized gains or losses have not been significant and are included in other income, net, in the statement of operations and comprehensive income (loss).

All of our available-for sale securities held as of September 30, 2024 and December 31, 2023 had contractual maturities of less than one year. Our available-for-sale securities are subject to a periodic impairment review. We consider a debt security to be impaired when its fair value is less than its carrying cost, in which case we would further review the investment to determine whether it is other-than-temporarily impaired. When we evaluate an investment for other-than-temporary impairment, we review factors such as the length of time and extent to which fair value has been below cost basis, the financial condition of the issuer and any changes thereto, intent to sell, and whether it is more likely than not we will be required to sell the investment before the recovery of its cost basis. If an investment is other-than-temporarily impaired or subject to credit losses, we write it down through the statement of operations and comprehensive income (loss) to its fair value and establish that value as a new cost basis for the investment. Our unrealized losses as of September 30, 2024 and December 31, 2023 were not material. We determined that none of our available-for-sale securities were other-than-temporarily impaired as of September 30, 2024 and December 31, 2023, and no investment was in a continuous unrealized loss position for more than one year. As such, we believe that it is more likely than not that the investments will be held until maturity or a forecasted recovery of fair value.

NET INCOME (LOSS) PER SHARE - Anti Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share (Details) - shares shares in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	36,777	15,183	35,568	23,790
Options to purchase common stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	28,296	14,718	27,584	20,561
Restricted stock units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	8,257	268	7,753	2,982
ESPP shares issuable
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	224	197	231	247

CASH, CASH EQUIVALENTS AND INVESTMENTS (Tables)

9 Months Ended

Sep. 30, 2024

Cash and Cash Equivalents [Abstract]

Schedule of Securities Classified as Cash, Cash Equivalents and Investments

Securities classified as cash, cash equivalents and short-term investments as of September 30, 2024 and December 31, 2023 are summarized below (in thousands):


	September 30, 2024
			Gross Unrealized
	Amortized Cost		Gains		Losses		Fair Value
Cash and cash equivalents:
Cash	$	7,560	$	—	$	—	$	7,560
Money market funds	39,869		—		—		39,869


Total cash and cash equivalents	47,429		—		—		47,429
Short-term investments:
U.S. government-sponsored agency bonds	$	53,052	$	52	$	(6)	$	53,098
U.S. treasury securities	36,697		47		(1)		36,743
Commercial paper	30,738		54		—		30,792
Corporate bonds	17,371		37		—		17,408
Asset-backed securities	2,975		3		—		2,978
Yankee bonds	1,955		—		(1)		1,954
Total short-term investments	142,788		193		(8)		142,973
Total cash, cash equivalents and investments	$	190,217	$	193	$	(8)	$	190,402


	December 31, 2023
			Gross Unrealized
	Amortized Cost		Gains		Losses		Fair Value
Cash and cash equivalents:
Cash	$	2,829	$	—	$	—	$	2,829
Money market funds	18,641		—		—		18,641


Total cash and cash equivalents	21,470		—		—		21,470
Short-term investments:
U.S. government-sponsored agency bonds	$	101,892	$	235	$	(34)	$	102,093
Commercial paper	49,630		41		(17)		49,654

Asset-backed securities	8,628		2		(5)		8,625
U.S. treasury securities	2,455		2		—		2,457
Total short-term investments	162,605		280		(56)		162,829


Total cash, cash equivalents and investments	$	184,075	$	280	$	(56)	$	184,299

NET INCOME (LOSS) PER SHARE

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

NET INCOME (LOSS) PER SHARE

Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of common shares outstanding during the period and excludes any dilutive effects of stock-based awards and warrants. Diluted net income (loss) per common share is computed giving effect to all potential dilutive common shares, including common stock issuable upon exercise of stock options, and unvested restricted common stock and stock units. As we had net losses for the nine months ended September 30, 2024 and 2023, all potential common shares were determined to be anti-dilutive during those periods.

The following table sets forth the computation of net income (loss) per common share (in thousands, except per share amounts):


	Three Months Ended September 30,				Nine Months Ended September 30,
Numerator:	2024		2023		2024		2023
Net income (loss)	$	(809)	$	6,629	$	(43,781)	$	(37,265)
Denominator:
Weighted average common shares outstanding - basic	235,911		222,782		234,516		214,977
Weighted average common shares outstanding - diluted	235,911		227,894		234,516		214,977
Net income (loss) per share of common stock - basic and diluted	$	(0.00)	$	0.03	$	(0.19)	$	(0.17)


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Options to purchase common stock	28,296	14,718	27,584	20,561

Restricted stock units	8,257	268	7,753	2,982

ESPP shares issuable	224	197	231	247
Total	36,777	15,183	35,568	23,790

COLLABORATION AND LICENSING AGREEMENTS (Tables)

9 Months Ended

Sep. 30, 2024

Collaboration and Licensing Agreements

Schedule of Deferred Revenue Balances

The following tables present changes in our current and non-current deferred revenue balances during the reporting period, which are all attributable to the 2017 Kyowa Kirin Agreement (in thousands):


	2024				2023
	Current		Non-Current		Current		Non-Current
Balance at January 1,	$	7,182	$	8,644	$	4,211	$	9,025
Amounts invoiced as prepayments for product supply	2,654		8,212		1,182		4,530
Decrease for revenue recognized for product supply	(6,650)		—		(4,586)		—
Reclassify amounts to be recognized in the next twelve months	4,086		(4,086)		3,265		(3,265)
Balance at September 30,	$	7,272	$	12,770	$	4,072	$	10,290

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Income
Beginning balance (in shares) at Dec. 31, 2022		198,575,016
Beginning balance at Dec. 31, 2022	$ 98,329	$ 20	$ 878,500	$ (780,137)	$ (54)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock under employee stock purchase plan (in shares)		435,708
Issuance of common stock under employee stock purchase plan	808		808
Issuance of common stock for services (in shares)		86,095
Issuance of common stock for services	337		337
Issuance of common stock upon exercise of options (in shares)		127,221
Issuance of common stock upon exercise of options	251		251
Issuance of common stock upon vesting of restricted stock units (in shares)		634,351
Issuance of common stock in at-the-market offerings (in shares)		32,274,741
Issuance of common stock in at-the-market offerings	119,248	$ 3	119,245
Stock-based compensation	9,600		9,600
Unrealized gains (losses) on available-for-sale securities	(147)				(147)
Net income (loss)	(37,265)			(37,265)
Ending balance (in shares) at Sep. 30, 2023		232,133,132
Ending balance at Sep. 30, 2023	191,161	$ 23	1,008,741	(817,402)	(201)
Beginning balance (in shares) at Jun. 30, 2023		217,862,921
Beginning balance at Jun. 30, 2023	123,161	$ 22	947,380	(824,031)	(210)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock under employee stock purchase plan (in shares)		269,739
Issuance of common stock under employee stock purchase plan	670		670
Issuance of common stock upon exercise of options (in shares)		28,227
Issuance of common stock upon exercise of options	40		40
Issuance of common stock upon vesting of restricted stock units (in shares)		211,277
Issuance of common stock in at-the-market offerings (in shares)		13,760,968
Issuance of common stock in at-the-market offerings	57,163	$ 1	57,162
Stock-based compensation	3,489		3,489
Unrealized gains (losses) on available-for-sale securities	9				9
Net income (loss)	6,629			6,629
Ending balance (in shares) at Sep. 30, 2023		232,133,132
Ending balance at Sep. 30, 2023	191,161	$ 23	1,008,741	(817,402)	(201)
Beginning balance (in shares) at Dec. 31, 2023		232,453,190
Beginning balance at Dec. 31, 2023	166,816	$ 23	1,012,773	(846,204)	224
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock under employee stock purchase plan (in shares)		479,609
Issuance of common stock under employee stock purchase plan	2,227		2,227
Issuance of common stock for services (in shares)		40,549
Issuance of common stock for services	$ 257		257
Issuance of common stock upon exercise of options (in shares)	2,228,000	2,227,627
Issuance of common stock upon exercise of options	$ 5,299	$ 1	5,298
Issuance of common stock upon vesting of restricted stock units (in shares)		1,689,456
Stock-based compensation	27,518		27,518
Unrealized gains (losses) on available-for-sale securities	(39)				(39)
Net income (loss)	(43,781)			(43,781)
Ending balance (in shares) at Sep. 30, 2024		236,890,431
Ending balance at Sep. 30, 2024	158,297	$ 24	1,048,073	(889,985)	185
Beginning balance (in shares) at Jun. 30, 2024		235,401,398
Beginning balance at Jun. 30, 2024	146,990	$ 23	1,036,244	(889,176)	(101)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock under employee stock purchase plan (in shares)		226,297
Issuance of common stock under employee stock purchase plan	1,189		1,189
Issuance of common stock upon exercise of options (in shares)		663,358
Issuance of common stock upon exercise of options	1,508	$ 1	1,507
Issuance of common stock upon vesting of restricted stock units (in shares)		599,378
Stock-based compensation	9,133		9,133
Unrealized gains (losses) on available-for-sale securities	286				286
Net income (loss)	(809)			(809)
Ending balance (in shares) at Sep. 30, 2024		236,890,431
Ending balance at Sep. 30, 2024	$ 158,297	$ 24	$ 1,048,073	$ (889,985)	$ 185

INVENTORY

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

INVENTORY

Inventory as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Raw materials	$	25,992	$	22,920
Work in process	57,335		24,582
Finished goods	1,831		1,985
Total	$	85,158	$	49,487
Reported as:
Inventory	$	11,378	$	12,448
Inventory, non-current	73,780		37,039
Total	$	85,158	$	49,487

In addition to inventory, we had prepaid commercial manufacturing of $16.7 million and $23.2 million as of September 30, 2024 and December 31, 2023, respectively, which consisted of prepayments to third party contract manufacturing organizations, including prepayments of zero and $4.2 million as of September 30, 2024 and December 31, 2023 that are expected to be converted into inventory after 12 months.

STOCKHOLDERS’ EQUITY	9 Months Ended
STOCKHOLDERS’ EQUITY	Sep. 30, 2024
Stockholders' Equity Note [Abstract]
STOCKHOLDERS’ EQUITY	STOCKHOLDERS’ EQUITY At-the-Market Offering Agreements In July 2020, we filed a registration statement on Form S-3, which became effective in August 2020 (2020 Registration Statement). In August 2021, we filed a prospectus supplement under the 2020 Registration Statement for the offering, issuance and sale by us of up to a maximum aggregate offering price of $150.0 million of our common stock that may be issued and sold, from time to time, under a sales agreement (2021 Open Market Sales Agreement) we entered into with Jefferies LLC (Jefferies), pursuant to which we may, from time to time, sell up to $150.0 million in shares of our common stock through Jefferies. Pursuant to the 2021 Open Market Sales Agreement, Jefferies, as our sales agent, receives a commission of up to 3.0% of the gross sales price for shares of common stock sold under the 2021 Open Market Sales Agreement. As of March 2023, we had received the maximum gross proceeds of $150.0 million under the 2021 Open Market Sales Agreement at a weighted average share price of approximately $1.57 per share, which included 15.5 million shares of our common stock for which we received gross proceeds of $51.9 million at a weighted average share price of approximately $3.35 during the quarter ended March 31, 2023. In January 2023, we filed a registration statement on Form S-3, which became effective in January 2023 (2023 Registration Statement), containing (i) a base prospectus for the offering, issuance and sale by us of up to a maximum aggregate offering price of $250.0 million of our common stock, preferred stock, debt securities, warrants and/or units, from time to time in one or more offerings; and (ii) a prospectus supplement for the offering, issuance and sale by us of up to a maximum aggregate offering price of $150.0 million of our common stock that may be issued and sold, from time to time, under a sales agreement with Jefferies, deemed to be “at-the-market offerings” (2023 Open Market Sales Agreement). Pursuant to the 2023 Open Market Sales Agreement, Jefferies, as sales agent, may receive a commission of up to 3.0% of the gross sales price for shares of common stock sold under the 2023 Open Market Sales Agreement. During the nine months ended September 30, 2024, we completed no sales pursuant to the 2023 Open Market Sales Agreement. As of September 30, 2024, we have sold 16.8 million shares of our common stock and received gross proceeds of $70.0 million at a weighted average sales price of approximately $4.17 per share under the 2023 Open Market Sales Agreement.

- Definition

The entire disclosure for equity.

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+ Details

REVENUE

9 Months Ended

Sep. 30, 2024

Revenue from Contract with Customer [Abstract]

REVENUE

Total revenues during the three and nine months ended September 30, 2024 and 2023 were as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Product sales, net:
IBSRELA	$	40,638	$	22,285	$	104,444	$	51,949
XPHOZAH	51,452		—		103,749		—
Total product sales, net	92,090		22,285		208,193		51,949
Product supply revenue	5,322		2,092		7,461		5,354
Licensing revenue	20		32,014		56		32,790

Non-cash royalty revenue related to the sale of future royalties	809		—		1,776		—
Total revenues	$	98,241	$	56,391	$	217,486	$	90,093


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
BioRidge Pharma, LLC	53.4	%	19.5	%	49.3	%	19.2	%
AmerisourceBergen Drug Corporation	14.0	%	21.2	%	15.1	%	21.3	%
Cardinal Health	12.6	%	22.2	%	13.8	%	22.3	%
McKesson Corporation	13.2	%	18.4	%	13.2	%	19.0	%

The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows (in thousands):


	Discounts and Chargebacks		Rebates, Wholesaler and GPO Fees		Copay and Returns		Total
Balance as of December 31, 2023	$	478	$	4,234	$	3,916	$	8,628
Provisions	10,074		43,398		20,390		73,862
Credits/payments	(8,974)		(33,925)		(16,271)		(59,170)
Balance as of September 30, 2024	$	1,578	$	13,707	$	8,035	$	23,320

Adjustments to prior period provisions recorded in the current period were not material.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

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