ARDELYX, INC.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
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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.
Jun 30, 2026 · Filed Aug 6, 2026
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 2026-03-31; filed 2026-04-30.
0001437402-26-000022
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001437402-26-000044
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 74 previous paragraphs and 79 current paragraphs.
46 unchanged; 23 reworded; 10 added; 4 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 9 previous and 9 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 (10)
Current report
Effective April 28, 2026, we entered into the Sixth Amendment to our Loan Agreement with SLR as collateral agent and the lenders party thereto, resulting in better overall terms.
Current report
On June 26, 2026, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the District Court’s dismissal of our lawsuit against CMS related to CMS reimbursement classification of XPHOZAH. We are not pursuing further litigation on this matter.
Current report
On June 29, 2026, we received $50.0 million of funding as a result of our draw down of the Term F Loan. We elected to draw down the Term F Loan for general corporate purposes and to enhance flexibility to support our ongoing strategic initiatives, in line with our capital allocation strategy.
Current report
The increase in GTN adjustment percentage in the six months ended June 30, 2026 reflected a $3.8 million favorable adjustment recognized in the 2025 first quarter, which was driven by a change in previously estimated XPHOZAH product returns.
Current report
External R&D expenses consist substantially of costs associated with our life cycle management initiatives for tenapanor, with more than half of these costs attributable to our CIC program for the three and six months ended June 30, 2026, respectively. External R&D expenses also include costs associated with early-stage, preclinical programs as well as unallocated program-specific costs, which were individually immaterial for the periods presented. We begin to track program-specific costs for early-stage, preclinical programs once they become material, which generally occurs following IND and when clinical-stage work has commenced. We do not track employee and facility-related expenses by program, as we typically use our employee and infrastructure resources across multiple R&D programs.
Current report
The increase in external R&D expenses in the three and six months ended June 30, 2026 reflected increased clinical trial activities, including Phase 3 clinical trials evaluating tenapanor in adults with CIC, as well as engagement with medical and scientific communities in the areas of gastroenterology and nephrology related to our marketed products.
Current report
The increase in employee-related expenses in the three and six months ended June 30, 2026 was primarily driven by increased headcount in connection with pipeline expansion activities as well as engagement with medical and scientific communities in the areas of gastroenterology and nephrology related to our marketed products.
Current report
Other income, net remained materially unchanged in the three and six months ended June 30, 2026 and primarily consisted of interest income earned on our cash, cash equivalents and short-term investments.
Current report
Critical Accounting Policies and Estimates
Current report
Our preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and related disclosures. We have discussed those policies and estimates that we believe are critical and require the use of significant judgment in their application in our 2025 Form 10-K. We have made no material changes to our critical accounting policies or the methodologies or assumptions that we apply under them during the six months ended June 30, 2026.
Removed paragraphs (4)
Previous report
Effective as of April 28, 2026, we entered into the Sixth Amendment with SLR as collateral agent and the lenders party thereto, resulting in a collectively reduced interest rate under all term loans, including the term loans we have the future option to draw from, and an extended maturity date for the outstanding term loans. For additional information, refer to Note 15. Subsequent Events.
Previous report
The external R&D and other expenses consist primarily of expenses associated with life cycle management initiatives for tenapanor, including our CIC program. The increase in external R&D and other expenses in the three months ended March 31, 2026 reflected increased clinical trial activities, including the initiation of the Phase 3 clinical trial evaluating tenapanor in adult CIC patients.
Previous report
The decrease in other income, net in the three months ended March 31, 2026 reflected lower income on our investments resulting from lower interest rates throughout the period, partially offset by higher investment balances.
Previous report
Effective as of April 28, 2026, we entered into the Sixth Amendment with SLR as collateral agent and the lenders party thereto, resulting in a collectively reduced interest rate under all term loans, including the term loans we have the future option to draw from, and an extended maturity date for the outstanding term loans. For additional information, refer to Note 15. Subsequent Events.
Reworded paragraphs (23)
Previous wording
We are a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs. We currently market two therapies from the active ingredient tenapanor, an NHE3 inhibitor that was discovered and developed by Ardelyx. NHE3 is an antiporter expressed on the apical surface of the small and large intestines. Tenapanor is a minimally absorbed, small molecule therapy.
Current wording
We are a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs. We currently market two therapies from the active ingredient tenapanor, an NHE3 inhibitor that was discovered and developed by Ardelyx. NHE3 is an antiporter expressed on the apical surface of the small and large intestines. Tenapanor is a minimally absorbed, small molecule therapy. In addition, we are building a pipeline which is currently focused on expanding the commercial footprint of tenapanor.
Previous wording
Tenapanor, branded as IBSRELA®, is approved in the U.S. for the treatment of adults with IBS-C. We believe that IBSRELA can bring meaningful benefit to the approximately 13 million Americans who suffer from the symptoms of IBS-C, many of whom continue to experience symptoms despite intervention with other therapies. We are seeking to further expand the IBSRELA eligible patient population to include patients with CIC, and have initiated a Phase 3 clinical trial (ACCEL) evaluating tenapanor in adult CIC patients. In January 2026, the Company dosed the first patient in ACCEL and has initiated all pre-identified sites. The Company expects to complete enrollment by the end of 2026 with topline data read out in the second half of 2027. IBSRELA is also being evaluated in multiple pediatric clinical trials which could potentially provide six months of additional patent life for tenapanor.
Current wording
Tenapanor, branded as IBSRELA®, is approved in the U.S. for the treatment of adults with IBS-C. We believe that IBSRELA can bring meaningful benefit to the approximately 13 million Americans who suffer from the symptoms of IBS-C, many of whom continue to experience symptoms despite intervention with other therapies. We are seeking to further expand the IBSRELA eligible patient population to include patients with CIC, and have initiated a Phase 3 clinical trial (ACCEL) evaluating tenapanor in adults with CIC. In January 2026, we dosed the first patient in ACCEL and have initiated all pre-identified sites. We expect to complete enrollment by the end of 2026 and to announce topline data in the second half of 2027. IBSRELA is also being evaluated in multiple pediatric clinical trials which could expand its use and potentially provide six months of additional patent life for tenapanor.
Previous wording
Tenapanor, branded as XPHOZAH®, is approved in the U.S. to reduce serum phosphorus in adults with chronic kidney disease 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 believe XPHOZAH can bring meaningful relief to adult chronic kidney disease patients on dialysis, the vast majority of whom have elevated levels of serum phosphorus and are unable to achieve target serum phosphorus levels with phosphate binders alone. Continually elevated levels of serum phosphorus can result in severe cardiovascular health complications.
Current wording
Tenapanor, branded as XPHOZAH®, is approved in the U.S. 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. We believe XPHOZAH can bring meaningful relief to adult CKD patients on dialysis, the vast majority of whom have elevated levels of serum phosphorus and are unable to achieve target serum phosphorus levels with phosphate binders alone. Continually elevated levels of serum phosphorus can result in severe cardiovascular health complications.
Previous wording
The results of operations for the three months ended March 31, 2026 are not necessarily indicative of results to be expected for the entire year ending December 31, 2026, 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 2025 Form 10-K to enhance the understanding of our financial metrics below.
Current wording
The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of results to be expected for the entire year ending December 31, 2026, 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 2025 Form 10-K to enhance the understanding of our financial metrics below.
Previous wording
The increase in IBSRELA product sales, net in the three months ended March 31, 2026 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 six months ended June 30, 2026 primarily reflected higher demand, driven by continued increase in awareness and prescriber experience, and to a lesser extent, higher net price.
Previous wording
XPHOZAH product sales, net in the three months ended March 31, 2026 remained consistent with the prior year and reflected continued growth in other non-Medicare sales channels. XPHOZAH product sales, net in the prior year included a $3.8 million favorable adjustment driven by a change in previously estimated product returns.
Current wording
The increase in XPHOZAH product sales, net in the three and six months ended June 30, 2026 primarily reflected higher demand and net price. XPHOZAH product sales, net in the six months ended June 30, 2025 included a $3.8 million favorable adjustment driven by a change in previously estimated product returns.
Previous wording
The product supply revenue was primarily attributable to Fosun Pharma and Knight in the three months ended March 31, 2026 and 2025, respectively.
Current wording
The product supply revenue was primarily attributable to Fosun Pharma in the three and six months ended June 30, 2026. In the three and six months ended June 30, 2025, the product supply revenue was primarily attributable to Kyowa Kirin.
Previous wording
The licensing revenue in the three months ended March 31, 2025 was primarily attributable to a $5.0 million milestone earned under the terms of the Fosun Agreement, following the NDA approval by China’s Center for Drug Evaluation of the NMPA for tenapanor in the control of serum phosphorus in adult patients with CKD on hemodialysis.
Current wording
The licensing revenue was primarily attributable to sales-based royalties received from Fosun Pharma in the three and six months ended June 30, 2026. The licensing revenue in the six months ended June 30, 2025 included a $5.0 million milestone earned in the 2025 first quarter under the terms of the Fosun Agreement, following the NDA approval by China’s Center for Drug Evaluation of the NMPA for tenapanor in the control of serum phosphorus in adult patients with CKD on hemodialysis.
Previous wording
The decrease in non-cash royalty revenue in the three months ended March 31, 2026 reflected lower royalties received from Kyowa Kirin for sales of PHOZEVEL in Japan.
Current wording
The decrease in non-cash royalty revenue in the three and six months ended June 30, 2026 reflected lower royalties received from Kyowa Kirin for sales of PHOZEVEL in Japan.
Previous wording
The increase in GTN adjustment percentage in the three months ended March 31, 2026 primarily reflected the prior year favorable impact of a change in previously estimated XPHOZAH product returns, an unfavorable channel mix and Medicare and Medicaid Inflation Rebate charges.
Current wording
The increase in GTN adjustment percentage in the three and six months ended June 30, 2026 primarily reflected an unfavorable channel mix as well as Medicare and Medicaid Inflation Rebate charges.
Previous wording
The increase in cost of product sales in the three months ended March 31, 2026 reflected higher product sales. A portion of the costs of IBSRELA and XPHOZAH units recognized as revenue during the three months ended March 31, 2026 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 $0.7 million for the three months ended March 31, 2026 and 2025, respectively. The value of inventory on hand as of March 31, 2026 and December 31, 2025 that was previously expensed as research and development was approximately $7.1 million and $10.9 million, respectively.
Current wording
The increase in cost of product sales in the three and six months ended June 30, 2026 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, 2026 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 $0.6 million for the three and six months ended June 30, 2026, and $1.0 million and $1.7 million for the three and six months ended June 30, 2025, respectively. The value of inventory on hand as of June 30, 2026 and December 31, 2025 that was previously expensed as research and development was approximately $8.0 million and $10.9 million, respectively.
Previous wording
The decrease in other cost of revenue in the three months ended March 31, 2026 primarily reflected the full recognition of the maximum $75.0 million royalty obligation under the AstraZeneca Termination Agreement as of the end of the 2025 second quarter, partially offset by higher costs related to capacity expansion at our CMOs. Other cost of revenue related to the AstraZeneca Termination Agreement was $8.8 million for the three months ended March 31, 2025.
Current wording
The decrease in other cost of revenue in the three and six months ended June 30, 2026 primarily reflected the full recognition of the maximum $75.0 million royalty obligation under the AstraZeneca Termination Agreement as of the end of the 2025 second quarter and lower costs associated with product supply revenue. 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, respectively.
Previous wording
The increase in selling, general and administrative expenses in the three months ended March 31, 2026 primarily reflected increased commercialization and administrative costs to support net sales growth of IBSRELA, consisting of external spending for disease awareness initiatives, patient affordability, access support and related patient awareness, as well as increased commercial infrastructure costs. The increase was also attributable to increased headcount, including an incremental stock-based compensation expense of $3.1 million.
Current wording
The increase in selling, general and administrative expenses in the three and six months ended June 30, 2026 primarily reflected increased commercialization and administrative costs to support net sales growth of IBSRELA, consisting of external spending for disease awareness initiatives, patient affordability, access support and related patient awareness, as well as increased commercial infrastructure costs. The increase was also attributable to increased headcount, including incremental stock-based compensation expenses of $3.1 million and $6.2 million in the three and six months ended June 30, 2026, respectively.
Previous wording
The increase in interest expense in the three months ended March 31, 2026 primarily reflected a higher outstanding loan balance resulting from the Term E Loan draw in June 2025.
Current wording
The increase in interest expense in the three and six months ended June 30, 2026 primarily reflected a higher outstanding loan balance resulting from the Term E Loan draw at the end of June 2025, partially offset by the reduced interest rate under the term loans resulting from the Sixth Amendment to our Loan Agreement effective at the end of April 2026.
Previous wording
The decrease in non-cash interest expense related to the sale of future royalties in the three months ended March 31, 2026 primarily reflected the imputed interest accrued on the decreasing carrying value of the deferred royalty obligation and royalties received from Kyowa Kirin for sales of PHOZEVEL in Japan which were remitted to HCR.
Current wording
The decrease in non-cash interest expense related to the sale of future royalties in the three and six months ended June 30, 2026 primarily reflected the imputed interest accrued on the decreasing carrying value of the deferred royalty obligation and royalties received from Kyowa Kirin for sales of PHOZEVEL in Japan which were remitted to HCR.
Previous wording
We regularly assess our cash position and our working capital needs to execute our strategy. We have historically funded our operations primarily from product sales, sales of our common stock, funds from our loan agreements with SLR, funds from our collaboration partnerships, as well as the sale of future royalties and commercialization milestones to HCR. We expect that we will increasingly rely on cash generated from our commercial operations to fund our operating plan while maintaining financial flexibility 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 product sales, sales of our common stock, funds from our loan agreements with SLR, funds from our collaboration partnerships, as well as the sale of future royalties and commercialization milestones to HCR. We expect that we will increasingly rely on cash generated from our commercial operations to fund our operating plan while maintaining financial flexibility to source cash from future equity sales and debt financing. Our capital allocation strategy includes (i) accelerating IBSRELA growth, (ii) investing in our current pipeline and (iii) maintaining financial strength.
Previous wording
We have a loan and security agreement (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 is outstanding as of March 31, 2026. The additional available borrowings of $100.0 million consist of the Term F and Term G Loans, each in the amount of $50.0 million. The Term F and Term G Loans may be drawn at the Company’s election by June 30, 2026 and December 20, 2026, respectively. See Note 9. Borrowing of our 2025 Form 10-K and Note 8. Borrowingof this Quarterly Report on Form 10-Q for further information on our long-term debt.
Current wording
We have a loan and security agreement with SLR (the Loan Agreement). The Loan Agreement provides a total of $300.0 million, of which $250.0 million has been drawn and is outstanding as of June 30, 2026. The additional borrowing of $50.0 million pursuant to the Term G Loan is available at our election to draw through December 20, 2026. See Note 8. Borrowingfor further information on our long-term debt.
Previous wording
Net cash used in operating activities decreased in the three months ended March 31, 2026 primarily due to the timing of our payments and inventory purchases, partially offset by the timing of cash collections from our Customers.
Current wording
Net cash used in operating activities decreased in the six months ended June 30, 2026, primarily due to the timing of our payments and inventory purchases, partially offset by the timing of cash collections from our Customers.
Previous wording
Net cash used in investing activities increased in the three months ended March 31, 2026 primarily reflected higher short-term investment purchases.
Current wording
Net cash provided by investing activities decreased in the six months ended June 30, 2026, primarily reflecting higher short-term investment purchases.
Previous wording
Cash flows from financing activities include net proceeds associated with our 2022 Loan Agreement, sales of our common stock with respect to the “at-the-market offering” programs and issuances of our common stock under our equity incentive plans.
Current wording
Cash flows from financing activities include net proceeds associated with our Loan Agreement, sales of our common stock with respect to the “at-the-market offering” programs and issuances of our common stock under our equity incentive plans.
Previous wording
Net cash provided by financing activities increased in the three months ended March 31, 2026 due to higher proceeds from the issuance of common stock under our equity incentive plans.
Current wording
Net cash provided by financing activities included the receipts of the Term F Loan and the Term E Loan in the six months ended June 30, 2026 and 2025, respectively. Net cash provided by financing activities increased in the six months ended June 30, 2026, primarily due to higher proceeds received from the issuance of common stock under our equity incentive plans.
Previous wording
As of March 31, 2026, our total future payment obligation related to the outstanding balance of the term loans, excluding interest payments, was $209.9 million, which is due on July 1, 2028. As discussed in Note 15. Subsequent Events, effective as of April 28, 2026, we entered into the Sixth Amendment with SLR as collateral agent and the lenders party thereto. See Note 9. Borrowing of our 2025 Form 10-K and Note 8. Borrowing of this Quarterly Report on Form 10-Q for further information on our long-term debt.
Current wording
As of June 30, 2026, our total future payment obligation related to the outstanding term loans, excluding interest payments, was $260.8 million, which is due on July 1, 2030. See Note 8. Borrowing for further information on our long-term debt.
Previous wording
We have entered into various operating leases for our offices. As of March 31, 2026, our total undiscounted obligation for operating leases was $5.2 million, with maturities ranging up through July 2029. See Note 9. Leases for further information on our operating leases.
Current wording
We have entered into various operating leases for our offices. As of June 30, 2026, our total undiscounted obligation for operating leases was $4.7 million, with maturities ranging up through July 2029. See Note 9. Leases for further information on our operating leases.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The licensing revenue in the three months ended March 31, 2026 was attributable to sales-based royalties received from Fosun Pharma and Knight.