ARDELYX, INC.
For the period ended Sep 30, 2025. Filed Oct 30, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Oct 30, 2025
ARDX$2.88-3.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-04.
0001628280-25-037464
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-10-30.
0001437402-25-000018
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 69 previous paragraphs and 72 current paragraphs.
42 unchanged; 25 reworded; 4 added; 2 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
On October 30, 2025, we announced that a development program had been initiated for RDX10531, a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas. NHE3 is an antiporter expressed on the apical surface of the small and large intestines and is responsible for absorbing the majority of ingested sodium. The Company plans to submit an IND in 2026.
Current report
The increase in non-cash royalty revenue in the three and nine months ended September 30, 2025 included approximately $3.4 million related to a commercialization milestone earned during the 2025 third quarter under the terms of the Kyowa Kirin Agreement. The payment will be remitted to HCR upon receipt in accordance with the HCR Agreement.
Current report
The decrease in other cost of revenue in the three and nine months ended September 30, 2025 primarily reflected the full recognition of the $75.0 million royalty obligation under the AstraZeneca Termination Agreement as of the 2025 second quarter, partially offset by costs related to product supply revenue.
Current report
The employee-related expenses included stock-based compensation expense, which decreased by $0.6 million in the three months ended September 30, 2025 and increased by $1.1 million in the nine months ended September 30, 2025.
Removed paragraphs (2)
Previous report
The increase in other cost of revenue in the three and six months ended June 30, 2025 primarily reflected higher product supply revenue and costs associated with that revenue.
Previous report
The increase in interest expense in the six months ended June 30, 2025 was also attributable to a full 2025 first quarter of interest expense related to the Term C Loan draw in March 2024, as compared to a partial 2024 first quarter of interest expense.
Reworded paragraphs (25)
Previous wording
As of June 30, 2025, we have fully recognized the $75.0 million royalty obligation under the AstraZeneca Termination Agreement.
Current wording
As of the 2025 second quarter, we had fully recognized the $75.0 million royalty obligation, which had been fully remitted as of September 30, 2025 under the AstraZeneca Termination Agreement.
Previous wording
The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of results to be expected for the entire year ending December 31, 2025, or for any other interim period or future year. See Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our 2024 Form 10-K to enhance the understanding of our financial metrics below.
Current wording
The results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of results to be expected for the entire year ending December 31, 2025, or for any other interim period or future year. See Part II, Item 7,
Previous wording
(a) Percent change is not meaningful.
Current wording
(a)Percent change is not meaningful.
Previous wording
The increase in IBSRELA product sales, net in the three and six months ended June 30, 2025 primarily reflected higher demand, driven by continued increase in awareness and prescriber experience, and to a lesser extent, higher net price.
Current wording
The increase in IBSRELA product sales, net in the three and nine months ended September 30, 2025 primarily reflected higher demand, driven by continued increase in awareness and prescriber experience, and to a lesser extent, higher net price.
Previous wording
The decrease in XPHOZAH product sales, net in the three and six months ended June 30, 2025 primarily reflected lower demand and lower net price, driven by the loss of XPHOZAH Medicare Part D reimbursement. As of January 1, 2025, the Centers of Medicare and Medicaid Services officially began the transition of oral only therapies, including XPHOZAH, into the End Stage Renal Disease Prospective Payment System. This decrease was partially offset by continued growth in other channels.
Current wording
The decrease in XPHOZAH product sales, net in the three and nine months ended September 30, 2025 primarily reflected lower demand and lower net price, both driven by the loss of XPHOZAH Medicare Part D reimbursement. As of January 1, 2025, the Centers for Medicare and Medicaid Services officially transitioned oral only therapies for ESRD patients on dialysis, including XPHOZAH, into the ESRD Prospective Payment System. This decrease was partially offset by continued growth in other channels.
Previous wording
The decrease in XPHOZAH product sales, net in the six months ended June 30, 2025 included the release of $3.8 million of prior periods’ estimated product returns for XPHOZAH in the 2025 first quarter.
Current wording
The decrease in XPHOZAH product sales, net in the nine months ended September 30, 2025 included the release of $3.8 million of prior periods’ estimated product returns for XPHOZAH in the 2025 first quarter.
Previous wording
Product supply revenue is primarily impacted by the timing of product supply shipments to our collaboration partners under our product supply agreements in support of non-U.S. launches. The product supply revenue was primarily attributable to Kyowa Kirin in the three and six months ended June 30, 2025 and 2024.
Current wording
Product supply revenue is primarily impacted by the timing of product supply shipments to our collaboration partners under our product supply agreements in support of non-U.S. launches. The product supply revenue was primarily attributable to Kyowa Kirin in the nine months ended September 30, 2025 and 2024.
Previous wording
Licensing revenue is primarily impacted by the timing of regulatory and commercial milestone achievements from our collaboration partners, as well as sales-based royalties received from Knight.
Current wording
Licensing revenue is primarily impacted by the timing of regulatory and commercialization milestone achievements from our collaboration partners, as well as sales-based royalties received from Knight.
Previous wording
The licensing revenue in the six months ended June 30, 2025 was primarily attributable to a $5.0 million milestone under the terms of the Fosun Agreement upon approval of an NDA for tenapanor for the control of hyperphosphatemia in adult patients with CKD undergoing hemodialysis by China’s Center for Drug Evaluation of the NMPA.
Current wording
The licensing revenue in the nine months ended September 30, 2025 was primarily attributable to a $5.0 million milestone earned during the 2025 first quarter under the terms of the Fosun Agreement, following approval of an NDA for tenapanor for the control of hyperphosphatemia in adult patients with CKD undergoing hemodialysis by China’s Center for Drug Evaluation of the NMPA.
Previous wording
The increase in non-cash royalty revenue in the three and six months ended June 30, 2025 reflected royalties from Kyowa Kirin for sales of PHOZEVEL in Japan, which was launched in February 2024.
Current wording
Non-cash royalty revenue reflects royalties and commercialization milestones from Kyowa Kirin for sales of PHOZEVEL in Japan, which was launched in February 2024.
Previous wording
The increase in GTN adjustment percentage in the three and six months ended June 30, 2025 reflected the unfavorable payor mix shifts, primarily associated with loss of XPHOZAH Medicare Part D reimbursement.
Current wording
The increase in GTN adjustment percentage in the three and nine months ended September 30, 2025 reflected the unfavorable payor mix shifts, primarily associated with loss of XPHOZAH Medicare Part D reimbursement.
Previous wording
The increase in GTN adjustment percentage in the six months ended June 30, 2025 included the favorable impact of a change in prior periods’ estimate of expected returns of XPHOZAH, which occurred in the 2025 first quarter.
Current wording
The increase in GTN adjustment percentage in the nine months ended September 30, 2025 included the favorable impact of a change in prior periods’ estimate of expected returns of XPHOZAH, which occurred in the 2025 first quarter.
Previous wording
The increase in cost of product sales in the three and six months ended June 30, 2025 reflected higher product sales. A portion of the costs of IBSRELA and XPHOZAH units recognized as revenue during the three and six months ended June 30, 2025 was expensed as research and development expenses in periods prior to the commencement of capitalization of inventory costs for each respective product. The cost associated with inventory sold but previously expensed as research and development was $1.0 million and $1.7 million for the three and six months ended June 30, 2025, and $1.2 million and $2.4 million for the three and six months ended June 30, 2024, respectively. The value of inventory on hand as of June 30, 2025 and December 31, 2024 that was previously expensed as research and development was approximately $13.4 million and $19.6 million, respectively.
Current wording
The increase in cost of product sales in the three and nine months ended September 30, 2025 reflected higher product sales. A portion of the costs of IBSRELA and XPHOZAH units recognized as revenue during the three and nine months ended September 30, 2025 was expensed as research and development expense in periods prior to the commencement of capitalization of inventory costs for each respective product. The cost associated with inventory sold but previously expensed as research and development was $0.3 million and $2.0 million for the three and nine months ended September 30, 2025, and $2.2 million and $4.6 million for the three and nine months ended September 30, 2024, respectively. The value of inventory on hand as of September 30, 2025 and December 31, 2024 that was previously expensed as research and development was approximately $12.3 million and $15.6 million, respectively.
Previous wording
The increase in other cost of revenue in the three months ended June 30, 2025 was partially offset by lower AstraZeneca royalties. Other cost of revenue related to the AstraZeneca Termination Agreement was $3.8 million and $12.7 million for the three and six months ended June 30, 2025, and $7.9 million and $12.6 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, the total $75.0 million royalty obligation has been fully recognized.
Current wording
Other cost of revenue related to the AstraZeneca Termination Agreement was zero and $12.7 million for the three and nine months ended September 30, 2025, and $10.0 million and $22.7 million for the three and nine months ended September 30, 2024, respectively.
Previous wording
The increase in R&D expenses in the three and six months ended June 30, 2025 primarily reflected the increase in employee-related expenses, driven by higher headcount to support medical engagement with scientific communities in the areas of gastroenterology and nephrology related to our marketed products, as well as higher external R&D and other expenses associated with life cycle management. These increases included incremental stock-based compensation expenses of $0.1 million and $1.7 million in the three and six months ended June 30, 2025, respectively.
Current wording
The increase in R&D expenses in the three and nine months ended September 30, 2025 primarily reflected higher external R&D and other expenses associated with life cycle management, as well as the increase in employee-related expenses, driven by higher headcount to support medical engagement with scientific communities in the areas of gastroenterology and nephrology related to our marketed products.
Previous wording
The increase in selling, general and administrative expenses in the three and six months ended June 30, 2025 primarily reflected increased commercialization and administrative costs to support net sales growth of IBSRELA and XPHOZAH. The increases consisted of spending for disease awareness initiatives, patient affordability, access support and related patient awareness, as well as increased commercial infrastructure. In addition, these increases were attributable to increased headcount, including incremental stock-based compensation expenses of $0.8 million and $3.7 million in the three and six months ended June 30, 2025, respectively.
Current wording
The increase in selling, general and administrative expenses in the three and nine months ended September 30, 2025 primarily reflected increased commercialization and administrative costs to support net sales growth of IBSRELA and XPHOZAH. The increases consisted of spending for disease awareness initiatives, patient affordability, access support and related patient awareness, as well as increased commercial infrastructure. In addition, these increases were attributable to increased headcount, including incremental stock-based compensation expenses of $4.2 million and $7.9 million in the three and nine months ended September 30, 2025, respectively.
Previous wording
The increase in interest expense in the three and six months ended June 30, 2025 primarily reflected a higher loan balance resulting from the Term D Loan draw in October 2024.
Current wording
The increase in interest expense in the three and nine months ended September 30, 2025 primarily reflected a higher outstanding loan balance resulting from the Term D Loan and the Term E Loan draws in October 2024 and June 2025, respectively.
Previous wording
The increase in non-cash interest expense related to the sale of future royalties in the three and six months ended June 30, 2025 primarily reflected the increasing outstanding balance of the deferred royalty obligation attributable to the imputed interest accrued on the outstanding balance, partially offset by royalties received from Kyowa Kirin related to the sale of PHOZEVEL, which were remitted to HCR.
Current wording
The increase in non-cash interest expense related to the sale of future royalties in the three and nine months ended September 30, 2025 primarily reflected the increasing outstanding balance of the deferred royalty obligation attributable to the imputed interest accrued on the outstanding balance, partially offset by royalties received from Kyowa Kirin related to the sale of PHOZEVEL, which were remitted to HCR.
Previous wording
Other income, net consists of interest income earned on our cash, cash equivalents and short-term investments and currency exchange gains and losses. In the three and six months ended June 30, 2024, other income, net also included the periodic revaluation of our previously outstanding 2022 Exit Fee related to our 2022 Loan Agreement that was settled in October 2024.
Current wording
Other income, net consists of interest income earned on our cash, cash equivalents and short-term investments and currency exchange gains and losses. In the three and nine months ended September 30, 2024, other income, net also included the periodic revaluation of our previously outstanding 2022 Exit Fee related to our 2022 Loan Agreement that was settled in October 2024.
Previous wording
We regularly assess our cash position and our working capital needs to execute our strategy. Our primary uses of cash to date have been to fund research and development expenditures related to our development of tenapanor and to support the commercialization of our marketed products. We have funded our operations primarily from the sale of common stock, product sales, funds from our collaboration partnerships, funds from our loan agreements with SLR, as well as sale of future royalties to HCR. We expect that we will increasingly rely on cash generated from operations to fund our operating plan while maintaining financial flexibility from our ability to source cash from future equity sales and debt financing.
Current wording
We regularly assess our cash position and our working capital needs to execute our strategy. We have historically funded our operations primarily from the sale of common stock, product sales, funds from our collaboration partnerships, funds from our loan agreements with SLR, as well as sale of future royalties to HCR. We expect that we will increasingly rely on cash generated from operations to fund our operating plan while maintaining financial flexibility from our ability to source cash from future equity sales and debt financing.
Previous wording
In January 2023, we filed a registration statement on Form S-3, which became effective in January 2023, 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. In the six months ended June 30, 2025, we completed no sales pursuant to the 2023 Open Market Sales Agreement. As of June 30, 2025, we have completed sales pursuant to the 2023 Open Market Sales Agreement, resulting in the issuance of 16.8 million shares of our common stock and receipt of gross proceeds of $70.0 million at a weighted average sales price of approximately $4.17.
Current wording
In January 2023, we filed a registration statement on Form S-3, which became effective in January 2023, 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. In the nine months ended September 30, 2025, we completed no sales pursuant to the 2023 Open Market Sales Agreement. As of September 30, 2025, we have completed sales pursuant to the 2023 Open Market Sales Agreement, resulting in the issuance of 16.8 million shares of our common stock and receipt of gross proceeds of $70.0 million at a weighted average sales price of approximately $4.17.
Previous wording
We have a loan and security agreement (as amended, the 2022 Loan Agreement) with SLR. The 2022 Loan Agreement provides a total of $300.0 million, of which $200.0 million has been drawn and outstanding as of June 30, 2025, including $50.0 million of the Term E Loan drawn during the three months ended June 30, 2025. The additional available borrowings of $100.0 million consist of the Term F Loan and the Term G Loan, each in the amount of $50.0 million. The Term F Loan and the Term G Loan may be drawn at the Company’s election by June 30, 2026 and December 20, 2026, respectively. The borrowings under the 2022 Loan Agreement bear interest at SOFR plus a spread based on our public debt rating. We classify the outstanding borrowings under the 2022 Loan Agreement as long-term based on their maturity date. See Note 9. Borrowing of our 2024 Form 10-K and Note 8. Borrowingof this Quarterly Report on Form 10-Q for further discussion.
Current wording
We have a loan and security agreement (as amended, the 2022 Loan Agreement) with SLR. The 2022 Loan Agreement provides a total of $300.0 million, of which $200.0 million has been drawn and outstanding as of September 30, 2025, including $50.0 million of the Term E Loan drawn during the 2025 second quarter. The additional available borrowings of $100.0 million consist of the Term F Loan and the Term G Loan, each in the amount of $50.0 million. The Term F Loan and the Term G Loan may be drawn at the Company’s election by June 30, 2026 and December 20, 2026, respectively. See Note 9. Borrowing of our 2024 Form 10-K and Note 8. Borrowingof this Quarterly Report on Form 10-Q for further discussion.
Previous wording
Net cash used in operating activities increased in the six months ended June 30, 2025 primarily due to higher expenses to support our commercial growth and higher disbursements for previously accrued royalties under the AstraZeneca Termination Agreement. This increase was partially offset by cash inflows from higher product sales, net and timing of collection of our accounts receivable.
Current wording
Net cash used in operating activities increased in the nine months ended September 30, 2025 primarily due to higher expenses to support our commercial growth, as well as higher disbursements for previously accrued royalties under the AstraZeneca Termination Agreement, pursuant to which the maximum royalty obligation of $75.0 million had been fully remitted as of September 30, 2025. This increase was partially offset by cash inflows from higher product sales, net and timing of collection of our accounts receivable.
Previous wording
Net cash provided by investing activities increased in the six months ended June 30, 2025 primarily due to the timing of our investment maturities and purchases.
Current wording
Net cash used in investing activities increased in the nine months ended September 30, 2025 primarily due to the timing of our investment maturities and purchases.
Previous wording
Net cash provided by financing activities decreased in the six months ended June 30, 2025 due to receipts from the Term E Loan, net of costs ($48.7 million) and the issuance of common stock under our equity incentive and stock purchase plans, which were lower than receipts from the Term C Loan, net of costs ($49.8 million) and the issuance of common stock under our equity incentive and stock purchase plans in the six months ended June 30, 2024.
Current wording
Net cash provided by financing activities decreased in the nine months ended September 30, 2025 due to receipts from the Term E Loan, net of costs ($48.7 million) and the issuance of common stock under our equity incentive and stock purchase plans, which were lower than receipts from the Term C Loan, net of costs ($49.8 million) and the issuance of common stock under our equity incentive and stock purchase plans in the nine months ended September 30, 2024.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our 2024 Form 10-K to enhance the understanding of our financial metrics below.