ARDELYX, INC.
For the period ended Sep 30, 2026. Filed Nov 3, 2026.
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Sep 30, 2026 · Filed Nov 3, 2026
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Notes to Condensed Financial Statements
NOTE 1. NATURE OF OPERATIONS
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, a sodium/hydrogen exchanger (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.
Tenapanor, branded as IBSRELA®, is approved in the U.S. for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). We are seeking to further expand the IBSRELA eligible patient population to include patients with chronic idiopathic constipation (CIC), and have initiated a Phase 3 clinical trial evaluating tenapanor in adults with CIC.
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 are also developing a next-generation NHE3 inhibitor, RDX10531, which is currently in IND-enabling studies and has demonstrated improved solubility and potency compared to tenapanor in preclinical models. We believe that RDX10531 can have application across multiple therapeutic areas.
We operate inone business segment, which is the development and commercialization of biopharmaceutical products. Refer to Note 12. Segment Reporting for further segment reporting information.
Basis of Presentation
These condensed financial statements have been prepared in accordance with U.S. GAAP and pursuant to the requirements of the 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 normal and recurring adjustments necessary to present fairly our financial position, results of operations, changes in stockholders’ equity and cash flows for the interim periods presented.
Certain prior year amounts have been reclassified to conform to the current year presentation on the condensed statements of operations and comprehensive loss to include the “cost of product sales” and the “other cost of revenue” captions within the “cost of sales” caption. Certain prior year amounts have also been reclassified to conform to the current year presentation in Note 12. Segment Reporting. These reclassifications had no effect on the previously reported results of operations.
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 2025 Form 10-K. The results for the three and nine months ended September 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.
Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for definitions of terms used throughout the document.
Use of Estimates
The preparation of financial statements requires management to make estimates, judgments and assumptions. The most significant assumptions are estimates used in our revenue gross-to-net accruals. 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.
Concentration of Credit Risk
Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. We are exposed to credit risks in the event of default by the counterparties to the extent of the amount recorded in our condensed balance sheets. Cash, cash equivalents and short-term investments are invested through banks and other financial institutions in the U.S.
Recent Accounting Pronouncements
Recent Accounting Pronouncement Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03, Income Statement (Topic 220) -Reporting Comprehensive Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses, which requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in the financial statements. The new disclosure requirements are effective for the Company’s annual periods beginning January 1, 2027, and interim periods beginning January 1, 2028, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is in the process of evaluating the impact of this new guidance on its disclosures.
NOTE 2. CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
The following table summarizes our cash, cash equivalents and short-term investments:
| September 30, 2026 · December 31, 2025 | ||||||||
|---|---|---|---|---|---|---|---|---|
| AmortizedCost · Gross Unrealized · FairValue · AmortizedCost · Gross Unrealized · FairValue | ||||||||
| (in thousands) · Gains · Losses · Gains · Losses | ||||||||
| Cash and cash equivalents | ||||||||
| Cash | $8,040 | $— | $— | $8,040 | $18,569 | $— | $— | $18,569 |
| Money market funds | 38,277 | — | — | 38,277 | 49,430 | — | — | 49,430 |
| Total cash and cash equivalents | 46,317 | — | — | 46,317 | 67,999 | — | — | 67,999 |
| Short-term investments | ||||||||
| U.S. treasury securities | $140,138 | $— | $(265) | $139,873 | $95,052 | $105 | $— | $95,157 |
| Commercial paper | 60,573 | — | (146) | 60,427 | 46,421 | 32 | (3) | 46,450 |
| U.S. government-sponsored agency bonds | 10,477 | — | (17) | 10,460 | 27,330 | 36 | — | 27,366 |
| Corporate bonds | 23,245 | — | (55) | 23,190 | 22,557 | 25 | — | 22,582 |
| Yankee bonds | 5,071 | — | — | 5,071 | 5,132 | 3 | — | 5,135 |
| Total short-term investments | 239,504 | — | (483) | 239,021 | 196,492 | 201 | (3) | 196,690 |
| Total cash, cash equivalents and investments | $285,821 | $— | $(483) | $285,338 | $264,491 | $201 | $(3) | $264,689 |
Realized gains or losses have not been significant and are included in other income, net in our condensed statements of operations and comprehensive loss.
Unrealized losses as of September 30, 2026 and December 31, 2025 were not material. All of the short-term available-for-sale securities held as of September 30, 2026 and December 31, 2025 had contractual maturities of less than one year, andno investment was in a continuous unrealized loss position for more than one year. Therefore, we do not intend to sell the investments, and it is not likely that we will be required to sell the investments before recovery of their amortized cost basis, which may be at maturity.
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 havenot recorded an allowance for credit losses for these securities as of September 30, 2026 and December 31, 2025.
See “Cash Equivalents” and “Short-Term Investments” captions of Note 2. Summary of Significant Accounting Policies of our 2025 Form 10-K for more information on our accounting policies for cash equivalents and short-term investments.
NOTE 3. FAIR VALUE MEASUREMENTS
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 based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access 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 that are measured or disclosed on a recurring basis by level within the fair value hierarchy:
| September 30, 2026 | December 31, 2025 | |||||||
|---|---|---|---|---|---|---|---|---|
| (in thousands) | TotalFair Value | Level 1 | Level 2 | Level 3 | TotalFair Value | Level 1 | Level 2 | Level 3 |
| Assets | ||||||||
| Money market funds | $38,277 | $38,277 | $— | $— | $49,430 | $49,430 | $— | $— |
| U.S. treasury securities | 139,873 | — | 139,873 | — | 95,157 | — | 95,157 | — |
| Commercial paper | 60,427 | — | 60,427 | — | 46,450 | — | 46,450 | — |
| Corporate bonds | 23,190 | — | 23,190 | — | 22,582 | — | 22,582 | — |
| U.S. government-sponsored agency bonds | 10,460 | — | 10,460 | — | 27,366 | — | 27,366 | — |
| Yankee bonds | 5,071 | — | 5,071 | — | 5,135 | — | 5,135 | — |
| Total | $277,298 | $38,277 | $239,021 | $— | $246,120 | $49,430 | $196,690 | $— |
Fair Value of Debt
The outstanding principal under our Loan Agreement is subject to a variable interest rate based on the one-month SOFR. Therefore, we believe the carrying amount of the term loan facility approximated its fair value as of September 30, 2026 and December 31, 2025. See Note 8. Borrowing for more information.
The carrying value of the deferred royalty obligation related to the sale of future royalties approximated its fair value as of September 30, 2026 and December 31, 2025, and is based on our current estimates of future royalties and commercialization milestones expected to be received by HCR over the life of the HCR Agreement. See Note 7. Deferred Royalty Obligation Related to the Sale of Future Royalties for more information.
NOTE 4. INVENTORY
Inventory consisted of the following:
| (in thousands) | September 30, 2026 | December 31, 2025 |
|---|---|---|
| Raw materials | $24,816 | $28,009 |
| Work in process | 116,528 | 88,259 |
| Finished goods | 16,215 | 6,839 |
| Total | $157,559 | $123,107 |
| Reported as | ||
| Inventory | $24,440 | $17,735 |
| Inventory, non-current | 133,119 | 105,372 |
| Total | $157,559 | $123,107 |
Prepaid commercial manufacturing with third-party CMOs not included in inventory was $17.2 million and $14.5 million as of September 30, 2026 and December 31, 2025, respectively. There wereno prepayments expected to be converted into inventory after 12 months as of September 30, 2026 and December 31, 2025.
NOTE 5. REVENUE
Disaggregation of total revenues by nature is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Product sales, net | $125,455 | $105,515 | $336,957 | $263,406 |
| Product supply revenue | 1,380 | — | 3,710 | 6,439 |
| Licensing revenue | 216 | 25 | 363 | 5,065 |
| Non-cash royalty revenue related to the sale of future royalties | 604 | 4,789 | 1,975 | 7,195 |
| Total revenues | $127,655 | $110,329 | $343,005 | $282,105 |
Product Sales, Net
Total product sales, net was as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| ($ in thousands) | 2026 | 2025 | 2026 | 2025 |
| Product sales, net | ||||
| IBSRELA | $96,286 | $78,158 | $252,603 | $187,606 |
| XPHOZAH | 29,169 | 27,357 | 84,354 | 75,800 |
| Total product sales, net | $125,455 | $105,515 | $336,957 | $263,406 |
| Product sales, net as a percentage of total revenues | 98.3% | 95.6% | 98.2% | 93.4% |
Concentrations
Gross product sales from Customers accounting for more than 10% of total revenues were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Customers(1) | ||||
| BioRidge Pharma, LLC | 70.6% | 66.3% | 76.7% | 63.8% |
| Cencora, Inc. | 16.5% | 17.3% | 16.5% | 18.6% |
| McKesson Corporation | 15.0% | 20.7% | 15.0% | 19.7% |
| Cardinal Health, Inc. | 14.8% | 25.5% | 14.1% | 23.9% |
| Caremark, LLC | 14.4% | —% | 13.4% | —% |
(1)The total of the percentages exceeds 100% as the numerators used in the calculations represent gross product sales for each Customer, as opposed to product sales, net as presented in our condensed statements of operations and comprehensive loss.
GTN Adjustments
The activities and ending reserve balances for each significant category of GTN adjustments on product sales, net, which constitute variable consideration, were as follows:
| (in thousands) | Discounts and Chargebacks | Rebates, Wholesaler and GPO Fees | Copay Assistance and Returns | Total |
|---|---|---|---|---|
| Balance as of December 31, 2025 | $1,693 | $34,456 | $9,274 | $45,423 |
| Provisions(1) | 28,955 | 109,001 | 34,494 | 172,450 |
| Credits/payments | (27,851) | (89,119) | (35,351) | (152,321) |
| Balance as of September 30, 2026 | $2,797 | $54,338 | $8,417 | $65,552 |
(1)Adjustments to prior period provisions recorded in the current period were not material.
NOTE 6. COLLABORATION AND LICENSING AGREEMENTS
We have out-licensed the development and commercialization of tenapanor outside of the U.S. to external partners. We recognize revenue from our collaboration partnerships as licensing revenue, product supply revenue or non-cash royalty revenue related to the sale of future royalties. See Note 7. Collaboration and Licensing Agreements and “Collaboration and Licensing Revenue” caption of Note 2. Summary of Significant Accounting Policies of our 2025 Form 10-K for more information on the nature, purpose, significant rights and obligations of the parties, as well as our accounting policies for such revenue streams.
The following table summarizes total revenues by collaboration partner:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Licensing revenue | ||||
| Fosun Pharma | $216 | $— | $331 | $5,000 |
| Knight | — | 25 | 32 | 65 |
| Total licensing revenue | $216 | $25 | $363 | $5,065 |
| Product supply revenue | ||||
| Fosun Pharma | $1,380 | $— | $3,708 | $— |
| Kyowa Kirin | — | — | 2 | 6,185 |
| Knight | — | — | — | 254 |
| Total supply revenue | $1,380 | $— | $3,710 | $6,439 |
| Non-cash royalty revenue related to the sale of future royalties | ||||
| Kyowa Kirin | $604 | $4,789 | $1,975 | $7,195 |
The following table presents changes in our current deferred revenue balances by collaboration partner:
| 2026 | 2025 | |||||
|---|---|---|---|---|---|---|
| (in thousands)Current | Kyowa Kirin | Fosun Pharma | Total | Kyowa Kirin | Fosun Pharma | Total |
| Deferred revenue balance as of January 1, | $— | $1,206 | $1,206 | $10,686 | $— | $10,686 |
| Prepaid product supply | — | 7,599 | 7,599 | 227 | 301 | 528 |
| Product supply delivered | — | (3,308) | (3,308) | (4,633) | — | (4,633) |
| Reclassify amounts to be recognized in the next 12 months | — | — | — | — | — | — |
| Deferred revenue balance as of September 30, | $— | $5,497 | $5,497 | $6,280 | $301 | $6,581 |
The following table presents changes in our non-current deferred revenue balances by collaboration partner:
| 2026 | 2025 | |||||
|---|---|---|---|---|---|---|
| (in thousands)Non-current | Kyowa Kirin | Fosun Pharma | Total | Kyowa Kirin | Fosun Pharma | Total |
| Deferred revenue balance as of January 1, | $13,699 | $— | $13,699 | $7,232 | $— | $7,232 |
| Prepaid product supply | — | — | — | 6,467 | — | 6,467 |
| Product supply delivered | — | — | — | — | — | — |
| Reclassify amounts to be recognized in the next 12 months | — | — | — | — | — | — |
| Deferred revenue balance as of September 30, | $13,699 | $— | $13,699 | $13,699 | $— | $13,699 |
Significant developments and updates related to our collaboration partnerships in the nine months ended September 30, 2026 and 2025 are discussed below.
Kyowa Kirin
In the 2025 third quarter, Kyowa Kirin achieved the first commercialization milestone from sales of tenapanor in Japan, triggering a ¥500.0 million payment to us, or approximately $3.4 million at the currency exchange rate as of September 30, 2025. This milestone was recorded as non-cash royalty revenue related to the sale of future royalties in our condensed statements of operations and comprehensive loss in the 2025 third quarter. The milestone payment was subsequently remitted to HCR upon receipt. See Note 7. Deferred Royalty Obligation Related to the Sale of Future Royalties for more information regarding the HCR Agreement.
Fosun Pharma
In March 2026, Fosun Pharma reported the first commercial sales of tenapanor, marketed under the Chinese trade name Wan Ti Le, for patients with CKD on hemodialysis with hyperphosphatemia in China. Pursuant to the terms of the license and manufacturing services agreements with Fosun Pharma, we are eligible to receive 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%.
In February 2025, we announced 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. This approval triggered a $5.0 million milestone to us, which was recorded as licensing revenue in our condensed statements of operations and comprehensive loss in the 2025 first quarter.
Knight - Former Collaboration Partner
Effective as of March 13, 2026, we entered into a termination agreement with Knight, pursuant to which we and Knight agreed to mutually terminate our exclusive license agreement for the development, commercialization and distribution of tenapanor in Canada for hyperphosphatemia and IBS-C. The decision was not related to any concerns regarding the safety, efficacy or quality of the product. Sales of IBSRELA in Canada were discontinued effective March 31, 2026. The termination did not have a material effect on our operations or financial results, and we do not expect it to adversely impact our operations or financial results in the future.
AstraZeneca
As of the end of the 2025 second quarter, we fully recognized the maximum $75.0 million royalty obligation in connection with the AstraZeneca Termination Agreement. The final payment was remitted to AstraZeneca during the 2025 third quarter. We recognized royalty expense of $12.7 million as cost of sales in our condensed statements of operations and comprehensive loss for the nine months ended September 30, 2025.
NOTE 7. DEFERRED ROYALTY OBLIGATION RELATED TO THE SALE OF FUTURE ROYALTIES
We and HCR have an agreement in which HCR paid $15.0 million in exchange for royalty and commercialization milestone payments that we may receive under our Kyowa Kirin Agreement. See Note 8. Deferred Royalty Obligation Related to the Sale of Future Royalties of our 2025 Form 10-K for further discussion on the nature, purpose, significant rights and obligations of the parties, as well as our accounting policies regarding the HCR Agreement.
Payments received from HCR are recorded as a deferred royalty obligation on our condensed balance sheets, which is being amortized as non-cash interest expense over the life of the HCR Agreement using the effective interest method. The deferred royalty obligation will be effectively repaid over the life of the HCR Agreement as we remit to HCR royalties and commercialization milestones paid to us by Kyowa Kirin. We periodically assess the estimated amounts and timing of future royalties and commercialization milestone 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.
A summary of financial information related to the HCR Agreement is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Non-cash interest expense related to the sale of future royalties | $(1,502) | $(2,188) | $(4,086) | $(6,478) |
| ($ in thousands) | 2026 | 2025 |
|---|---|---|
| Deferred royalty obligation balance as of January 1, | $25,876 | $25,527 |
| Non-cash interest expense related to the sale of future royalties | 4,086 | 6,478 |
| Royalty and commercialization milestone payments remitted to HCR | (2,747) | (3,379) |
| Deferred royalty obligation balance as of September 30, | $27,215 | $28,626 |
| Effective interest rate as of September 30, | 22.8% | 31.5% |
NOTE 8. BORROWING
The following table presents our outstanding term loans under the Loan Agreement:
| (in thousands) | September 30, 2026 | December 31, 2025 |
|---|---|---|
| Principal(1) | ||
| Term A Loan | $14,371 | $27,500 |
| Term B Loan | 11,758 | 22,500 |
| Term C Loan | 41,940 | 50,000 |
| Term D Loan | 50,000 | 50,000 |
| Term E Loan | 50,000 | 50,000 |
| Term F Loan | 50,000 | — |
| Term H Loan | 31,931 | — |
| Total principal | 250,000 | 200,000 |
| Adjustments to principal value | ||
| Unamortized discount and debt issuance costs | (2,860) | (1,127) |
| Accreted value of final fee | 5,220 | 3,961 |
| Total long-term debt | 252,360 | 202,834 |
| Less: Current portion of long-term debt | — | — |
| Long-term debt, net of current portion | $252,360 | $202,834 |
(1)The outstanding term loans bear an interest rate at the sum of 4.55% plus the greater of (a) the one-month SOFR or (b)3.50%, and mature on July 1, 2030.
On April 28, 2026, we entered into an amendment to our Loan Agreement (the Sixth Amendment), by and among us, as borrower, SLR, as collateral agent and the lenders party thereto. Pursuant to the Sixth Amendment, among other things, (i) a portion of $200.0 million in outstanding principal previously allocated among the Term A through C Loans (collectively, the Revised Loans) was refinanced with a new Term H Loan; (ii) the maturity date for the Revised Loans, the Term D Loan and the Term E Loan was extended from July 1, 2028 to July 1, 2030 (the New Maturity Date), which is the maturity date for each other term loan; (iii) the interest-only payment period for the Revised Loans, the Term D Loan and the Term E Loan was extended until the New Maturity Date, which is the interest-only payment period for each other term loan; (iv) the interest rate for each term loan will have a collectively reduced interest rate, at the sum of 4.55% plus the greater of (a) the one-month SOFR reference rate or (b)3.50%; (v) we retained the option to draw the Term F and Term G Loans, each in the amount of $50.0 million, at our election by June 30, 2026 and December 20, 2026, respectively; and (vi) we amended certain negative covenants and other conditions to provide additional flexibility to us. We concluded that the Sixth Amendment was a modification to the Loan Agreement and we accounted for it accordingly.
On the closing date of the Sixth Amendment, we paid approximately $1.9 million in final fees and prepayment premium in connection with the partial repayment of the Term A through C Loans.
We are obligated to pay a final fee with respect to each of the outstanding amounts under each of the term loans, upon the earliest to occur of (i) the New Maturity Date, (ii) the acceleration of the applicable term loan or (iii) the prepayment, refinancing, substitution or replacement of the applicable term loan. This final fee is 4.95% for the Term A through E Loans,3.45% for the Term F and Term G Loans and 2.50% for the Term H Loan. The total unaccreted final fee was $5.6 million and $5.9 million as of September 30, 2026 and December 31, 2025, respectively.
We may voluntarily prepay all amounts outstanding under the Revised Loans, the Term D Loan, the Term E Loan and the Term H Loan, subject to a prepayment premium of (i)three percent of the outstanding principal amount of the applicable term loan if prepaid on or after April 28, 2026 through and including April 28, 2027, (ii)two percent of the outstanding principal amount of the applicable term loan if prepaid on or after April 29, 2027 through and including April 28, 2028 or (iii)one percent of the outstanding principal amount of the applicable term loan if prepaid after April 28, 2028 and prior to July 1, 2030.
We may voluntarily prepay all amounts outstanding under the Term F and Term G Loans, subject to a prepayment premium of (i)two percent of the outstanding principal amount of the applicable term loan if prepaid on or after July 1, 2026 through and including June 30, 2027 or (ii)one percent of the outstanding principal amount of the applicable term loan if prepaid after June 30, 2027 and prior to July 1, 2030.
The Loan Agreement contains certain covenants, including a single financial covenant that the sum of our net product revenue, calculated on a trailingsix-month basis, plus unrestricted cash and cash equivalents that are subject to a first-priority perfected lien in favor of SLR, shall be greater than or equal to 100% of the principal amount outstanding under the Loan Agreement. The outstanding term loans are secured by substantially all of our assets, except for our intellectual property and certain other customary exclusions. In addition, the Loan Agreement contains subjective clauses to accelerate the maturity of outstanding principal amount in the event that a material adverse change has occurred within our business, operations or financial condition.
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.
As of September 30, 2026, our total future payment obligation related to the outstanding term loans, excluding interest payments, was $260.8 million, which is due on July 1, 2030.
NOTE 9. LEASES
The following table provides additional details of our facility leases presented in our condensed balance sheets:
| ($ in thousands) | ||
|---|---|---|
| Facilities | September 30, 2026 | December 31, 2025 |
| Right-of-use assets | $3,692 | $4,795 |
| Current portion of lease liabilities | $1,579 | $1,479 |
| Operating lease liability, net of current portion | 2,400 | 3,641 |
| Total lease liabilities | $3,979 | $5,120 |
| Weighted-average remaining term (in years) | 2.4 | 3.1 |
| Weighted-average discount rate | 5.6% | 5.6% |
The following table presents the lease costs, which are included in our condensed statements of operations and comprehensive loss, and the supplemental cash flow information related to the leases:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Operating lease expense | $532 | $409 | $1,396 | $1,779 |
| Cash paid for operating leases | $445 | $279 | $1,333 | $1,666 |
The following table summarizes our undiscounted cash payment obligations for our operating lease liabilities as of September 30, 2026:
| (in thousands) | Operating Leases |
|---|---|
| Remainder of 2026 | $451 |
| 2027 | 1,836 |
| 2028 | 1,402 |
| 2029 | 575 |
| Thereafter | — |
| Total undiscounted operating lease payments | 4,264 |
| Imputed interest expenses | (285) |
| Total operating lease liabilities | 3,979 |
| Less: Current portion of operating lease liability | (1,579) |
| Operating lease liability, net of current portion | $2,400 |
NOTE 10. STOCKHOLDERS’ EQUITY
In November 2025, we filed an automatic shelf registration statement on Form S-3ASR, which became effective upon filing, containing (i) a base prospectus, which covers the offering, issuance and sale from time to time in one or more offerings of our common stock, preferred stock, debt securities, warrants and/or units; and (ii) a prospectus supplement for the offering, issuance and sale of up to a maximum aggregate offering price of $100.0 million of our common stock that may be issued and sold from time to time under an open market sales agreement (the Sales Agreement), deemed to be “at-the-market offerings.” Jefferies, as sales agent, may receive a commission of up tothree percent of the gross sales price for shares of our common stock sold under the Sales Agreement. As of September 30, 2026, there have beenno sales of our common stock under the Sales Agreement.
NOTE 11. EQUITY INCENTIVE PLANS
Stock-Based Compensation Expense
Stock-based compensation expense for stock options, RSUs and our ESPP included in our condensed statements of operations and comprehensive loss was as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Selling, general and administrative | $12,566 | $10,400 | $36,530 | $28,157 |
| Research and development | 2,535 | 2,342 | 8,045 | 8,360 |
| Total | $15,101 | $12,742 | $44,575 | $36,517 |
A summary of our total unrecognized stock-based compensation expense, net of estimated forfeitures, as of September 30, 2026 is as follows:
| Unrecognized Compensation Expense(in thousands) | Average Remaining Vesting Period(in years) | |
|---|---|---|
| Stock option grants | $41,453 | 2.5 |
| RSU grants | $77,234 | 2.7 |
| ESPP | $231 | 0.4 |
Stock Options
A summary of our stock option activity and related information for the nine months ended September 30, 2026 is as follows:
| Number of Shares(in thousands) | Weighted-Average Exercise Priceper Share | |
|---|---|---|
| Outstanding as of December 31, 2025 | 28,977 | $5.54 |
| Granted | 4,892 | $6.85 |
| Exercised | (2,041) | $3.26 |
| Forfeited or cancelled | (4,948) | $7.03 |
| Outstanding as of September 30, 2026 | 26,880 | $5.68 |
| Exercisable as of September 30, 2026 | 17,923 | $5.37 |
Restricted Stock Units
A summary of our RSU activity and related information for the nine months ended September 30, 2026 is as follows:
| Number of RSUs(in thousands) | Weighted-Average Grant Date Fair Valueper Share | |
|---|---|---|
| Unvested as of December 31, 2025 | 12,583 | $5.71 |
| Granted | 7,692 | $6.96 |
| Vested | (4,287) | $6.05 |
| Forfeited or cancelled | (2,694) | $6.35 |
| Unvested as of September 30, 2026 | 13,294 | $6.19 |
Employee Stock Purchase Plan
During the nine months ended September 30, 2026, we issued approximately 0.4 million shares of our common stock under the ESPP. The shares were purchased by employees at an average purchase price of $4.08 per share, resulting in proceeds to us of approximately $1.4 million.
Issuance of Common Stock for Services
During the nine months ended September 30, 2026, we issued approximately 33 thousand shares of our common stock to members of the board of directors who elected to receive stock in lieu of their cash fees under our Non-Employee Director Compensation Program.
NOTE 12. SEGMENT REPORTING
We operate in a single reportable segment. The Chief Executive Officer is our Chief Operating Decision Maker, who primarily uses aggregated net loss as reported on the condensed statements of operations and comprehensive loss to measure segment loss, supplemented by certain additional significant expense details reflected in the table below. There have been no changes in the determination of segmentation or the measurements used to determine reported segment loss discussed in our 2025 Form 10-K. See Note 17. Segment Reporting of our 2025 Form 10-K for more discussion on our segment reporting.
Detailed information regarding our single operating segment’s significant revenues, expenses and operating loss is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Revenues | ||||
| Product sales, net | $125,455 | $105,515 | $336,957 | $263,406 |
| Other revenues(1) | 2,200 | 4,814 | 6,048 | 18,699 |
| Total revenues | 127,655 | 110,329 | 343,005 | 282,105 |
| Less | ||||
| Cost of product sales(2) | 3,393 | 2,662 | 9,957 | 8,247 |
| Other cost of revenue(3) | 1,146 | 1,320 | 5,152 | 20,441 |
| Research and development(4) | 22,664 | 15,725 | 63,445 | 40,311 |
| Selling(4) | 62,961 | 55,361 | 197,305 | 170,113 |
| General and administrative(4) | 18,367 | 17,851 | 63,766 | 52,552 |
| Stock-based compensation | 15,101 | 12,742 | 44,575 | 36,517 |
| Income (loss) from operations | 4,023 | 4,668 | (41,195) | (46,076) |
| Other reconciliation items(5) | (4,760) | (5,637) | (13,868) | (15,116) |
| Net loss | $(737) | $(969) | $(55,063) | $(61,192) |
(1)Other revenues includes revenues from our collaboration partnerships, including licensing revenue, product supply revenue and non-cash royalty revenue related to the sale of future royalties.
(2)Cost of product sales includes the cost of commercial goods sold to our Customers, such as the cost of materials, third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process and indirect overhead costs.
(3)Other cost of revenue includes the cost of materials sold to our collaboration partners under product supply agreements, certain costs related to capacity expansion at current and future CMOs and payments due to AstraZeneca. As of the end of the 2025 second quarter, the maximum $75.0 million royalty obligation in connection with the AstraZeneca Termination Agreement was fully recognized.
(4)Research and development, sellingand general and administrative expenses herein do not include stock-based compensation expenses.
(5)Other reconciliation items includes interest expense, non-cash interest expense related to the sale of future royalties, provision for income taxes and other income, net.
NOTE 13. NET LOSS PER SHARE
Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period and excludes any dilutive effect of stock-based awards. Diluted net loss per common share is computed giving effect to all potential dilutive common shares, including common stock issuable upon exercise of stock options, unvested restricted stock units and ESPP shares issuable pursuant to the current purchase period. As we had net losses for the three and nine months ended September 30, 2026 and 2025, all potential common shares were determined to be anti-dilutive during those periods.
The following table sets forth the computation of net loss per common share:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands, except per share amounts) | 2026 | 2025 | 2026 | 2025 |
| Numerator | ||||
| Net loss | $(737) | $(969) | $(55,063) | $(61,192) |
| Denominator | ||||
| Weighted average common shares outstanding - basic and diluted | 250,007 | 241,908 | 247,992 | 240,166 |
| Net loss per share of common stock - basic and diluted | $(0.00) | $(0.00) | $(0.22) | $(0.25) |
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:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Options to purchase common stock | 28,845 | 30,064 | 29,423 | 29,940 |
| Restricted stock units | 14,506 | 13,536 | 15,232 | 12,510 |
| ESPP shares issuable | 225 | 157 | 201 | 174 |
| Total | 43,576 | 43,757 | 44,856 | 42,624 |
NOTE 14. COMMITMENTS AND CONTINGENCIES
On July 17, 2024, in partnership with the AAKP and the NMQF, we filed a lawsuit in the U.S. District Court for the District of Columbia against CMS, claiming that CMS has violated its statutory and regulatory authority under MIPPA, which established the ESRD PPS bundled payment system for dialysis services in 2008. Specifically, the lawsuit claims that moving 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 are not administered by dialysis providers and cannot be taken during the delivery of maintenance dialysis. On November 8, 2024, the U.S. District Court for the District of Columbia granted defendants’ Motion to Dismiss and denied plaintiffs’ Motion for Preliminary Injunction, or in the Alternative, for Expedited Summary Judgment. Following the District Court’s denial of plaintiffs’ Motion to Alter or Amend the Judgment, or in the Alternative, for an Injunction Pending Appeal, plaintiffs filed an Emergency Motion for an Administrative Stay and Injunction Pending Appeal, which was denied by the United States Court of Appeals for the District of Columbia Circuit. Appellants filed an initial brief in the appeal on February 4, 2025; Appellees filed an initial brief on March 6, 2025; and Appellants filed a reply brief on March 27, 2025. Both Appellees and Appellants filed a final brief on April 10, 2025. Oral argument in the case was heard on September 25, 2025. On June 26, 2026, the United States Court of Appeals affirmed the District Court’s dismissal. We are not pursuing further litigation on this matter.
On August 16, 2024, a complaint was filed against us in the U.S. District Court for the District of Massachusetts, captioned Yarborough v. Ardelyx, Inc., et al., No. 24-cv-12119 (D. Mass.). The complaint names the Company, Michael Raab, and Justin Renz as defendants and alleges violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder, related to our announcement on July 2, 2024 that it had chosen not to file an application for Transitional Drug Add-on Payment Adjustment for XPHOZAH (the Yarborough Action). The plaintiffs seek damages and interest, and an award of costs, including attorneys’ fees. The Court appointed Tate Wood as lead plaintiff on October 30, 2024. The lead plaintiff filed an amended complaint on January 13, 2025, in which he added Susan Rodriguez, Laura Williams and Elizabeth Grammer as additional defendants and removed Justin Renz as a defendant. The lead plaintiff purports to bring claims on behalf of all those who acquired Ardelyx common stock between February 22, 2024 and July 1, 2024. Defendants filed a motion to dismiss the amended complaint on March 14, 2025. Plaintiffs filed a response on May 13, 2025. Defendants filed a reply in support of their motion to dismiss on June 23, 2025. A hearing on the motion to dismiss was held on September 25, 2025, and on December 24, 2025, the Court granted defendants’ motion to dismiss and issued an order dismissing the case with prejudice. On January 21, 2026, Plaintiffs appealed the District Court’s decisions to the United States Court of Appeals for the First Circuit. On March 26, 2026, the Court granted the Parties’ stipulated voluntary dismissal of Plaintiffs’ appeal.
On September 6 and 13, 2024, certain Ardelyx shareholders filedtwo verified derivative complaints purportedly on behalf of the Company in the U.S. 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 thetwo derivative actions into the case In re Ardelyx, Inc. Stockholder Derivative Litigation, Case No. 1:24-cv-12302-LTS (D. Mass.). On November 7, 2024, the Court stayed the consolidated derivative action pending resolution of any and all motion(s) to dismiss in the Yarborough Action. On April 9, 2026, the Court dismissed the consolidated derivative action pursuant to the parties’ stipulation of dismissal.
On September 17, 2026, a complaint was filed against us in the U.S. District Court for the District of Massachusetts captioned Broadwater v. Ardelyx, Inc., et al., No. 26-cv-14270 (D. Mass.). The complaint names the Company, Michael Raab, Justin Renz, Susan Hohenleitner, and Eric Foster as defendants and alleges violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder (the Broadwater Action). The plaintiff purports to bring claims on behalf of all those who acquired Ardelyx common stock between January 13, 2025 and August 6, 2026. The plaintiff seeks unspecified damages, interest, costs, and fees. The deadline for shareholders to seek to be appointed lead plaintiff in this action is currently November 16, 2026. We intend to defend against the plaintiff’s allegations vigorously. At this time, we are unable to predict the ultimate outcome of the lawsuit or reasonably estimate the amount or range of any potential loss, if any.
On October 13, 2026, an Ardelyx shareholder filed a verified derivative complaint purportedly on behalf of the Company in the U.S. District Court for the District of Massachusetts, captioned Marti v. Raab, et al., No. 26-cv-14635 (D. Mass.). The complaint alleges violations of Section 14(a) of the Exchange Act, breaches of fiduciary duty, unjust enrichment, waste of corporate assets, gross mismanagement, and abuse of control, and seeks contribution under Sections 10(b) and 21D of the Exchange Act. The claims are brought against certain current and former members of our board of directors and management and are based on substantially the same factual allegations as the Broadwater Action. The complaint seeks unspecified damages, restitution, and corporate governance reforms, as well as interest, costs, and attorneys’ fees. We intend to defend against the plaintiff’s allegations vigorously. At this time, we are unable to predict the ultimate outcome of the lawsuit or reasonably estimate the amount or range of any potential loss, if any.
From time to time, we may be involved in legal proceedings arising in the ordinary course of business. As of September 30, 2026, there is no litigation pending that would reasonably be expected to have a material adverse effect on our results of operations and financial condition.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.