3 unchanged sentences
Our actual results could differ materially from those discussed in these forward-looking statements.
−Removed: Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report entitled “Risk Factors .” These forward-looking statements speak only as of the date hereof.
+Added: Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report titled “Risk Factors .” These forward-looking statements speak only as of the date hereof.
Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason.
−Removed: Unless the context requires otherwise, the terms “Ardelyx,” “we,” “us,” “our” and “the Company” refer to Ardelyx, Inc.
+Added: Unless the context requires otherwise, the terms “Ardelyx,” “Company,” “we,” “us” and “our” refer to Ardelyx, Inc.
EXECUTIVE SUMMARY AND FINANCIAL HIGHLIGHTS
−Removed: We are a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.
−Removed: We developed a unique and innovative platform that enabled the discovery of new biological mechanisms and pathways to develop potent and efficacious therapies that minimize the side effects and drug-drug interactions frequently encountered with traditional, systemically absorbed medicines.
−Removed: The first molecule we discovered and developed was tenapanor, a minimally absorbed, first-in-class, oral, small molecule therapy.
+Added: We are a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs.
+Added: We currently market two therapies from the active ingredient tenapanor, an NHE3 inhibitor that was discovered and developed by Ardelyx.
+Added: NHE3 is an antiporter expressed on the apical surface of the small and large intestines.
+Added: Tenapanor is a minimally absorbed, first-in-class, oral, small molecule therapy.
Tenapanor, branded as IBSRELA ® , is approved in the U.S.
−Removed: for the treatment of adults with IBS-C.
+Added: for the treatment of adults with irritable bowel syndrome with constipation.
+Added: 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.
+Added: We are seeking to further expand the IBSRELA eligible patient population to include patients with CIC, and have initiated a Phase 3 clinical trial evaluating tenapanor in adult CIC patients.
Tenapanor, branded as XPHOZAH ® , is approved in the U.S.
−Removed: 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.
−Removed: Table of Conten t s
+Added: 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.
+Added: 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.
+Added: Continually elevated levels of serum phosphorus can result in severe cardiovascular health complications.
+Added: In addition to commercializing IBSRELA and XPHOZAH, we are also developing a next-generation NHE3 inhibitor that we believe can have application across multiple therapeutic areas.
+Added: Refer to the Summary of Abbreviated Terms at the end of this Annual Report on Form 10-K for definitions of terms used throughout the document.
+Added: We are committed to our mission of developing and commercializing innovative medicines that address unmet patient needs.
+Added: Our principal strategy is to continue our commercial momentum with our current products while advancing and expanding a portfolio of important medicines for patients with unmet medical needs.
+Added: Our priorities include (i) driving significant IBSRELA growth, (ii) maintaining XPHOZAH commercial momentum, (iii) further advancing our pipeline and portfolio and (iv) maintaining a solid financial foundation to support our future growth.
+Added: Table of Co n t e n t s
+Added: 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.
+Added: This approval triggered a $5.0 million milestone to us under the terms of the Fosun Agreement, which was recorded as licensing revenue on our statements of operations and comprehensive loss when earned during the 2025 first quarter and was received in April 2025.
+Added: As of the end of the 2025 second quarter, we had fully recognized the maximum $75.0 million royalty obligation, which had been fully remitted as of the end of the 2025 third quarter under the AstraZeneca Termination Agreement.
+Added: On June 30, 2025, we entered into an amendment to our 2022 Loan Agreement (the Fifth Amendment), by and among the Company, as borrower, SLR, as collateral agent and the lenders party thereto.
+Added: The Fifth Amendment, among other things, (i) provided for the immediate draw of $50.0 million of the Term E Loan on the closing date of the Fifth Amendment;
+Added: and (ii) provides us with the option to draw an additional $100.0 million of committed senior secured term loans, consisting of the Term F Loan and the Term G Loan, each in the amount of $50.0 million.
+Added: 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.
+Added: In September 2025, we submitted an IND application to the FDA for IBSRELA to expand the IBSRELA eligible patient population to include patients with CIC.
+Added: In January 2026, we initiated ACCEL (ten-03-301), a Phase 3 clinical trial designed to assess the safety and efficacy of tenapanor for the treatment of CIC.
+Added: Enrollment in ACCEL is expected throughout 2026, with topline data read out in the second half of 2027.
+Added: CIC is characterized by difficult, infrequent or incomplete bowel movements, and is associated with significantly impaired quality of life, disrupted productivity and high healthcare-related costs.
+Added: CIC is estimated to affect more than 34 million Americans.
+Added: Pending the outcome of the Phase 3 clinical trial, if successful, we intend to submit a supplemental NDA to the FDA for tenapanor for the CIC indication.
+Added: In October 2025, we announced a development program for RDX10531.
+Added: We believe RDX10531 is a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas.
+Added: We are currently conducting activities to support an IND submission to the FDA for RDX10531 in the second half of 2026.
+Added: The 2023 Open Market Sales Agreement with Jefferies with respect to an “at-the-market offering” program which was established under the Company’s prior shelf registration statement on Form S-3 expired in January 2026.
+Added: In November 2025, we filed an automatic shelf registration statement on Form S-3ASR, along with a prospectus supplement relating to the offering and sale of up to $100.0 million of our common stock pursuant to the 2025 Open Market Sales Agreement with Jefferies, deemed to be “at-the-market offerings.” During the year ended December 31, 2025, we did not sell any shares under the 2023 or 2025 Open Market Sales Agreements.
+Added: On January 22, 2026, we received an Issue Notification from the USPTO indicating the issuance of U.S.
+Added: The patent relates to the formulation of tenapanor and covers the commercial formulations of IBSRELA and XPHOZAH and has an expiration date of November 26, 2042.
Below is a summary of our product sales, net by product for the years ended December 31 and total cash, cash equivalents and short-term investments as of December 31:
8 unchanged sentences
$ 264,689 $ 250,100
−Removed: IBSRELA and XPHOZAH product sales have continually grown since their respective commercial launches.
−Removed: IBSRELA net sales growth was attributed to patient demand for this first-in-class therapy as well as increased product awareness achieved through the IBSRELA field-based team.
−Removed: XPHOZAH’s commercial launch has been met with a strong response from the prescribing community and net sales continued to increase during 2024, the first full year of commercialization.
−Removed: As of January 1, 2025, we no longer receive reimbursement for XPHOZAH from Medicare Part D following the decision by the Centers of Medicare and Medicaid Services to eliminate Medicare Part D reimbursement to transition oral only therapies, including XPHOZAH, into the End Stage Renal Disease Prospective Payment System.
−Removed: Patient access to XPHOZAH remains through a prescription written by a qualifying healthcare provider through our ArdelyxAssist specialty pharmacy partner.
−Removed: Patients who do not have affordable access will be evaluated for eligibility to receive XPHOZAH fulfilled by our Ardelyx patient assistance program.
−Removed: The increase in our cash, cash equivalents and short-term investment was attributed to higher product sales, net and incremental borrowings.
−Removed: During 2024, we amended the 2022 Loan Agreement with SLR and drew an additional $100.0 million in debt as discussed in Note 9.
−Removed: We expect that we will increasingly rely on cash generated from operations to fund our operating plan.
−Removed: We believe our existing cash, cash equivalents and short-term investments, and cash generated from operations will be sufficient to satisfy our anticipated cash needs for operations for at least the next few years.
−Removed: Our access to additional capital, including our ability to source cash from future equity sales and debt financing, provides us financial flexibility to execute our principal strategy as discussed below.
−Removed: We are committed to our mission of discovering, developing and commercializing first-in-class medicines that address unmet patient needs.
−Removed: Our principal strategy is to maintain our commercial momentum with our current products while identifying additional assets that leverage our core capabilities, including clinical, developmental and regulatory expertise and commercial excellence while maintaining a solid financial foundation, to support our future growth.
−Removed: Our priorities include:
−Removed: (i) accelerating IBSRELA growth momentum;
−Removed: (ii) executing our XPHOZAH strategy to grow utilization;
−Removed: (iii) building a pipeline focused on areas of unmet patient need;
−Removed: and (iv) continuing to deliver strong commercial and financial performance.
RECENT ACCOUNTING PRONOUNCEMENTS
−Removed: A summary of recent accounting pronouncements that we have adopted or may expect to adopt is included in Note 2.
+Added: A summary of recent accounting pronouncements that we have adopted or expect to adopt is included in Note 2.
Summary of Significant Accounting Policies in the notes to our financial statements, included in Part II, Item 8, of this Annual Report on Form 10-K.
3 unchanged sentences
The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses.
−Removed: Our critical accounting policies are those that significantly affect our financial condition and results of operations and require the most difficult, subjective or complex judgments, often because of the need to make estimates about the effect of matters that are inherently uncertain.
−Removed: While we believe that our estimates, assumptions and judgments are reasonable, they are based on information available when the estimate or assumption was made.
−Removed: Actual results may differ significantly.
−Removed: Additionally, changes in our assumptions, estimates or assessments due to unforeseen events or otherwise could have a material impact on our financial position or results of operations.
−Removed: Table of Conten t s
+Added: Our critical accounting policies are those that significantly affect
+Added: Table of Co n t e n t s
+Added: our financial condition and results of operations and require the most difficult, subjective or complex judgments, often because of the need to make estimates about the effect of matters that are inherently uncertain.
+Added: While we believe that our estimates, assumptions and judgments are reasonable, they are based on information presently available.
+Added: Actual results may differ significantly from these estimates due to changes in judgments, assumptions or conditions as a result of unforeseen events or otherwise, which could have a material impact on our financial position and results of operations.
Revenue Recognition
1 unchanged sentence
Total revenues are recognized following a five-step model:
−Removed: (i) identify the customer contract;
−Removed: (ii) identify the contract’s performance obligations;
−Removed: (iii) determine the transaction price;
−Removed: (iv) allocate the transaction price to the performance obligations;
−Removed: and (v) recognize revenue when or as a performance obligation is satisfied.
+Added: (i) identify the customer contract, (ii) identify the contract’s performance obligations, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations and (v) recognize revenue when or as a performance obligation is satisfied.
Product Sales, Net
−Removed: GTN adjustments are primarily a function of sales volume, payor mix, contractual or legislative discounts and rebates.
−Removed: The transaction price for product sales, net is reduced for estimates of variable consideration related to GTN adjustments for discounts and chargebacks, rebates, wholesaler and GPO fees, copay assistance and returns.
−Removed: Except for certain wholesaler and GPO fees and discounts, which are based on contracts, these adjustments involve estimation and judgment.
−Removed: The GTN adjustments for rebates, copay assistance and chargebacks are impacted by our estimate of payor mix, which requires significant judgment.
−Removed: We consider legal interpretations of applicable laws and regulations, historical experience, current contract prices under applicable programs, unbilled claims, processing time lags and inventory levels in the distribution channel in determining our estimates.
+Added: Product revenue is recognized when Customers take control of the product, which typically occurs upon delivery to the Customers.
+Added: The transaction price for product sales is reduced for estimates of variable consideration related to (i) discounts and chargebacks, (ii) rebates, wholesaler and GPO fees, and (iii) copay assistance and returns (collectively, gross-to-net adjustments or GTN adjustments).
+Added: Except for certain wholesaler and GPO fees and discounts, which are based on contracts, our estimates of GTN adjustments involve assumptions and judgments.
+Added: Our estimates of GTN adjustments for rebates, copay assistance and chargebacks require significant assumptions and judgments, considering factors such as legal interpretations of applicable laws and regulations, historical experience, payor mix (e.g., Medicare or Medicaid), current contract prices under applicable programs, unbilled claims, processing time lags and inventory levels in the distribution channel.
Estimates are assessed each period and adjusted as required to revise information or actual experience.
1 unchanged sentence
business participates in programs with government entities, the most significant of which are the U.S.
−Removed: Department of Defense and the U.S.
−Removed: Department of Veterans Affairs, and other parties, including covered entities under the 340B program, whereby pricing on products is extended below wholesaler list price to participating entities.
−Removed: These entities purchase products through wholesalers at the lower program price and the wholesalers then charge us the difference between their acquisition cost and the lower program price.
−Removed: Accounts receivable is reduced for the estimated amount of unprocessed chargeback claims attributable to a sale (typically within a two to four week time lag).
−Removed: Our Customers may also receive prompt pay discounts for payment within a specified period, generally approximating two percent of the invoiced sales price.
+Added: Department of Defense, the U.S.
+Added: VA, and other parties, including covered entities under the 340B program, whereby pricing on products is extended below wholesale acquisition cost (lower program price) for qualified government providers when products are purchased through wholesalers.
+Added: The chargeback represents the difference between the wholesale acquisition cost and this lower program price that the wholesalers charge us.
+Added: In such sales, accounts receivable is reduced for the estimated amount of unprocessed chargeback claims (typically within a two- to four-week time lag).
+Added: Our Customers may receive prompt pay discounts for payment within a specified period, generally approximating two percent of the invoiced sales price.
Our payment terms are generally 30 to 60 days.
−Removed: We expect discounts to be earned when offered and we deduct the full amount of these discounts from product sales when revenue is recognized.
−Removed: Accounts receivable is reduced for the estimated amount of fees and cash discount at the time of sale and the discount is typically taken by the customer within contractual terms.
+Added: We expect discounts to be earned when offered and therefore deduct the full amount of these discounts from product sales when revenue is recognized.
+Added: Accordingly, accounts receivable is reduced for the estimated amount of these discounts.
Rebates, Wholesaler and GPO Fees
−Removed: business participates in state government Medicaid and Medicare programs and other qualifying Federal and state government programs requiring discounts and rebates to participating state and local government entities.
−Removed: All discounts and rebates provided through these programs are included in our Medicaid and Medicare rebate accruals.
−Removed: Medicaid rebates have also been extended to drugs used in managed Medicaid plans.
−Removed: The estimated amount of unpaid or unbilled rebates and discounts is presented as a liability.
−Removed: Settlement of Medicare and Medicaid accruals can lag for multiple quarters due to extensive time delays between recording an accrual and subsequent receipt of an invoice.
+Added: business participates in state government Medicaid and Medicare programs and other qualifying federal and state government programs requiring discounts and rebates to participating federal, state and local government entities.
+Added: For Medicaid and Medicare programs, we estimate the portion of sales attributed to such programs’ patients as rebates to be paid to the respective participating entities, which requires significant judgment.
+Added: The IRA, among other things, imposes financial penalties for price increases that outpace inflation (first due in 2023) and replaces the Medicare Part D coverage gap discount program with a new discounting program (which began in 2025).
+Added: The standard Part D benefit now comprises three phases:
+Added: the deductible phase, the initial coverage phase and the catastrophic coverage phase.
+Added: Applicable dispensed drugs will be subject to manufacturer discounts of 10% during the initial coverage phase and 20% during the catastrophic coverage phase.
+Added: Beginning in 2025, we estimate the percentage of products sold to patients in the initial coverage and catastrophic coverage phases and adjust the transaction price for such discount at the time of sale.
+Added: Under the redesigned Medicare Part D, we are a specified manufacturer whose applicable drugs for Low Income Subsidy-eligible beneficiaries under section 1860D-14(a) of the Social Security Act are subject to lower applicable discounts during the phase-in period.
+Added: Prior to 2025, we paid a 70% discount to CMS when the Medicare Part D beneficiaries were in the coverage gap.
+Added: All unpaid or unbilled discounts and rebates provided through these programs are recorded in accrued expenses and other current liabilities on the balance sheets.
+Added: Settlement of these accruals can lag for multiple quarters due to extensive time delays
+Added: Table of Co n t e n t s
+Added: between recording an accrual and subsequent receipt of an invoice.
Due to this lag, adjustments can incorporate revision of several prior quarters.
−Removed: Through December 31, 2024, we paid a 70% discount to CMS when the Medicare Part D beneficiaries were in the coverage gap.
−Removed: Beginning in 2025, as part of the Medicare Part D redesign within the IRA, there is a $2,000 cap for out-of-pocket costs for Medicare Beneficiaries and manufacturers are responsible for 10% of costs up to the cap and 20% after the cap is reached.
−Removed: Wholesaler and GPO administrative fees are a significant portion of our GTN adjustments, however, since they are based on contracts, they require inherently less estimation.
+Added: We pay wholesaler and GPO fees for distribution and related services, which are a significant portion of our GTN adjustments;
+Added: however, since they are based on contracts, they require inherently less estimation.
Copay Assistance and Returns
−Removed: Patients who have commercial insurance may receive copay assistance when product is dispensed by pharmacies to patients.
−Removed: We estimate the amount of copay assistance provided to eligible patients based on the terms of the program and redemption information provided by third-party claims processing organizations.
−Removed: We also estimate the amount of copay assistance that we will provide to patients associated with product we have sold but has not yet been dispensed to commercial patients, which requires significant estimation and judgment.
−Removed: Our estimates are recorded in accrued expenses and other current liabilities on the balance sheets.
−Removed: Table of Conten t s
−Removed: Considering the timing of our respective product launches, and limited experiences with returns, we are primarily reliant on historical sales returns of similar products, such as those within the same product line, similar therapeutic area, similar distribution model, estimated levels of inventory in the distribution channel and projected demand.
−Removed: We increasingly rely on our products’ actual returns history and other factors, including levels of our inventory in the distribution channel and estimated shelf life, to estimate our returns.
+Added: We offer financial assistance to qualified commercially-insured patients for the portion of their prescription cost that is not covered by payors.
+Added: We estimate the amount of copay assistance provided to qualified patients based on the terms of the program and redemption information provided by third-party claims processing organizations.
+Added: We also estimate the amount of copay assistance that we will provide associated with product we have sold but has not yet been dispensed to patients, which requires significant assumption and judgment.
Our estimates are recorded in accrued expenses and other current liabilities on the balance sheets.
+Added: We primarily rely on our products’ actual returns history and other factors, including levels of our inventory in the distribution channel and estimated shelf life, to estimate our products’ returns.
+Added: We also consider historical sales returns of similar products, such as those within the same product line, similar therapeutic area, similar distribution model, estimated levels of inventory in the distribution channel and projected demand.
+Added: Our estimates of products’ returns reduce accounts receivable.
Use of Information from External Sources
Information from external sources is used to estimate GTN adjustments.
−Removed: Our estimate of inventory at the wholesalers is based on the historical inventory experience, as well as our analysis of third-party information, including written and oral information obtained from certain wholesalers with respect to their inventory levels and sell-through to customers and our internal information.
+Added: Our estimate of inventory at the wholesalers is based on historical inventory experience, as well as our analysis of third-party information, including written and oral information obtained from certain wholesalers with respect to their inventory levels and sell-through to customers and our internal information.
The inventory information received from wholesalers is a product of their recordkeeping process and excludes inventory held by intermediaries to whom they sell, such as retailers and hospitals.
We also use information from external sources to identify prescription trends, patient demand and average selling prices.
−Removed: Our estimates are subject to inherent limitations of estimates that rely on third-party information, as certain third-party information was itself in the form of estimates and reflect other limitations including lags between the date as of which third-party information is generated and the date on which we receive third-party information.
+Added: Our estimates are subject to inherent limitations of relying on third-party information, as certain third-party information is itself in the form of estimates and reflects other limitations, including lags between the date third-party information is generated and the date we receive it.
RESULTS OF OPERATIONS
−Removed: Our revenue to date has been generated primarily through a combination of product sales and payments in connection with license, research and development collaborative agreements with our various collaboration partners.
−Removed: In the future, we may generate revenue from a combination of our own product sales and payments in connection with our current or future collaborative partnerships, including license fees, other upfront payments, milestone payments, royalties and payments for drug product and/or drug substance.
+Added: Our revenue to date has been generated through a combination of product sales and payments in connection with our current collaboration partnerships with various external partners.
+Added: In the future, we may generate revenue from a combination of our own product sales and payments in connection with our current or future collaboration partnerships, including license fees, other upfront payments, milestone payments, royalties and payments for drug product and/or drug substance.
We expect that any revenue we generate will fluctuate in future periods as a result of many factors as described in Part I, Item 1A, “Risk Factors,” of this Annual Report on Form 10-K.
Below is a summary of our total revenues:
−Removed: Year Ended December 31, Change
+Added: Year Ended December 31, Change 2025 vs.
+Added: 2024 Change 2024 vs.
($ in thousands)
2 unchanged sentences
Product supply revenue 15,879 11,649 6,121 4,230 36 % 5,528 90 %
−Removed: Licensing revenue 78 35,809 35,031 (35,731) (100) % 778 2 %
−Removed: Non-cash royalty revenue related to the sale of future royalties 2,692 — — 2,692 (a) — (a)
+Added: Licensing revenue 5,088 78 35,809 5,010 (a) (35,731) (100) %
+Added: Non-cash royalty revenue related to the sale of future royalties 8,545 2,692 — 5,853 217 % 2,692 (a)
Total revenues $ 407,320 $ 333,615 $ 124,456 $ 73,705 22 % $ 209,159 168 %
(a) Percent change is not meaningful.
+Added: Table of Co n t e n t s
Below is a summary of our product sales, net by product:
−Removed: Year Ended December 31,
+Added: Year Ended December 31, Change 2025 vs.
+Added: 2024 Change 2024 vs.
($ in thousands)
2 unchanged sentences
IBSRELA $ 274,207 $ 158,286 $ 80,062 $ 115,921 73 % $ 78,224 98 %
−Removed: XPHOZAH 160,910 2,464 —
+Added: XPHOZAH 103,601 160,910 2,464 (57,309) (36) % 158,446 (a)
Total product sales, net $ 377,808 $ 319,196 $ 82,526 $ 58,612 18 % $ 236,670 287 %
+Added: (a) Percent change is not meaningful.
Product sales, net:
−Removed: The increase in IBSRELA product sales, net in 2024 and 2023 was due to higher demand since its commercial launch in March 2022, reflecting continued increase in awareness and prescriber experience.
−Removed: In addition, the increase in 2024 was attributable to the completion of our field-base team expansion.
−Removed: Table of Conten t s
−Removed: The increase in XPHOZAH product sales, net in 2024 and 2023 was due to higher demand since its commercial launch in November 2023.
−Removed: As of January 1, 2025, we no longer receive reimbursement for XPHOZAH from Medicare Part D following the decision by the Centers of Medicare and Medicaid Services to eliminate Medicare Part D reimbursement to transition oral only therapies, including XPHOZAH, into the End Stage Renal Disease Prospective Payment System.
−Removed: Patient access to XPHOZAH remains through a prescription written by a qualifying healthcare provider through our ArdelyxAssist specialty pharmacy partner.
−Removed: Patients who do not have affordable access will be evaluated for eligibility to receive XPHOZAH fulfilled by our Ardelyx patient assistance program.
+Added: The increase in IBSRELA product sales, net in 2025 and 2024 primarily reflected higher demand, driven by continued increase in awareness and prescriber experience.
+Added: To a lesser extent, the increase in 2025 also reflected higher net price.
+Added: The decrease in XPHOZAH product sales, net in 2025 primarily reflected lower demand and lower net price, both driven by the loss of XPHOZAH Medicare Part D reimbursement.
+Added: On January 1, 2025, CMS officially transitioned oral only therapies for ESRD patients on dialysis, including XPHOZAH, into the ESRD Prospective Payment System.
+Added: This decrease was partially offset by continued growth in other channels.
+Added: The increase in XPHOZAH product sales, net in 2024 primarily reflected higher demand since its commercial launch in November 2023.
Product supply revenue:
−Removed: The increase in product supply revenue in 2024 and 2023 was due to product supply shipments to our collaboration partners, primarily Kyowa Kirin, under our respective commercial supply agreements in support of non-US launches.
+Added: 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 the development and commercialization of our products ex-U.S.
+Added: by our collaboration partners.
+Added: The product supply revenue was primarily attributable to Kyowa Kirin for all years presented.
Licensing revenue:
−Removed: Licensing revenue is primarily impacted by the timing of regulatory and commercial milestone achievements from our out-licensing partners, as well as sales-based royalties received from Knight.
−Removed: The 2023 licensing revenue included $30.0 million in payments received under the Kyowa Kirin Agreement, following Kyowa Kirin’s submission to the Japanese MHLW for the NDA for tenapanor in the improvement of hyperphosphatemia in adult patients with CKD on dialysis;
−Removed: and a $5.0 million payment under the Fosun Agreement, following the NDA acceptance 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 and the U.S.
−Removed: FDA approval of XPHOZAH to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
+Added: 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.
+Added: The licensing revenue in 2025 was primarily attributable to a $5.0 million milestone earned during 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.
+Added: The licensing revenue in 2023 was primarily attributable to $30.0 million in payments received under the Kyowa Kirin Agreement, following Kyowa Kirin’s submission to the Japanese MHLW for the NDA for tenapanor in the improvement of hyperphosphatemia in adult patients with CKD on dialysis;
+Added: and a $5.0 million milestone payment under the Fosun Agreement, following the NDA acceptance 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 and the FDA approval of XPHOZAH to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
Non-cash royalty revenue:
−Removed: Non-cash royalty revenue in 2024 was attributable to royalties from Kyowa Kirin for sales of PHOZEVEL in Japan since its launch in February 2024, which we remitted to HCR upon receipt in accordance with the HCR Agreement.
+Added: Non-cash royalty revenue reflects royalties and commercialization milestones from Kyowa Kirin for sales of PHOZEVEL in Japan, which was launched in February 2024.
+Added: Non-cash royalty revenue in 2025 included approximately $3.4 million related to a commercialization milestone earned during the 2025 third quarter under the terms of the Kyowa Kirin Agreement.
+Added: The payment was remitted to HCR upon receipt in accordance with the HCR Agreement.
+Added: Table of Co n t e n t s
GTN Adjustments
−Removed: We recognize product sales net of GTN adjustments that are further described in Note 6.
−Removed: Revenue and the “Critical Accounting Policies and Estimates” caption in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Reconciliation of gross product sales to product sales, net by GTN adjustment category is as follows:
−Removed: Year Ended December 31,
+Added: We recognize product sales net of GTN adjustments, as further described in Note 6.
+Added: Revenue and the “Critical Accounting Policies and Estimates” caption in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Reconciliation of gross product sales to product sales, net is as follows:
+Added: Year Ended December 31, Change 2025 vs.
+Added: 2024 Change 2024 vs.
($ in thousands)
4 unchanged sentences
GTN adjustment percentage 30.2 % 25.6 % 27.5 %
−Removed: 25.6 % 27.5 % 27.9 %
GTN adjustments are primarily a function of sales volume, payor mix, contractual or legislative discounts and rebates.
−Removed: Adjustments to provisions for product sales made in prior periods due to changes in estimates were not significant for any of the years presented.
−Removed: The decrease in GTN adjustment percentage in 2024 was primarily due to a higher percentage of sales which had a more favorable GTN rate.
−Removed: The reduction was mainly due to lower sales subjected to copay assistance and contractual chargebacks which had higher GTN adjustment percentages.
−Removed: We expect GTN adjustment percentages to increase in the future due to unfavorable payor mix shifts associated with loss of XPHOZAH Medicare Part D reimbursement beginning January 1, 2025.
−Removed: Table of Conten t s
+Added: The increase in GTN adjustment percentage in 2025 reflected the unfavorable payor mix shifts, primarily associated with loss of XPHOZAH Medicare Part D reimbursement.
+Added: The decrease in GTN adjustment percentage in 2024 was primarily due to a more favorable payor mix and lower sales subjected to copay assistance.
The activities and ending reserve balances for each significant category of GTN adjustments on product sales, net, which constitute variable consideration, were as follows:
8 unchanged sentences
Provisions (1)
+Added: 23,356 108,547 31,667 163,570
Credits/payments (23,306) (88,566) (33,563) (145,435)
Balance as of December 31, 2025 $ 1,693 $ 34,456 $ 9,274 $ 45,423
−Removed: Adjustments to prior period provisions recorded in the current period were not material.
−Removed: Below is a summary of our cost of goods sold, operating expenses, interest expense, non-cash interest expense related to the sale of future royalties and other income, net:
−Removed: Year Ended December 31, Change
+Added: (1) Provisions included approximately $4.4 million of net favorable adjustment resulting from changes in prior periods’ estimates.
+Added: Table of Co n t e n t s
+Added: Costs and Expenses
+Added: Below is a summary of our costs and operating expenses, interest expense, non-cash interest expense related to the sale of future royalties and other income, net:
+Added: Year Ended December 31, Change 2025 vs.
+Added: 2024 Change 2024 vs.
($ in thousands)
2025 2024 2023 $ % $ %
−Removed: Cost of product sales $ 6,851 $ 2,323 $ 566 $ 4,528 195 % $ 1,757 310 %
−Removed: Other cost of revenue 43,705 15,472 3,551 28,233 182 % 11,921 336 %
−Removed: Total cost of goods sold $ 50,556 $ 17,795 $ 4,117 $ 32,761 184 % $ 13,678 332 %
+Added: Cost of sales $ 39,537 $ 50,556 $ 17,795 $ (11,019) (22) % $ 32,761 184 %
Research and development 71,527 52,317 35,536 19,210 37 % 16,781 47 %
Selling, general and administrative 337,233 258,692 134,401 78,541 30 % 124,291 92 %
−Removed: Total operating expenses $ 311,009 $ 169,937 $ 111,800 $ 141,072 83 % $ 58,137 52 %
+Added: Total costs and operating expenses $ 448,297 $ 361,565 $ 187,732 $ 86,732 24 % $ 173,833 93 %
Interest expense $ (20,102) $ (13,006) $ (4,950) $ (7,096) 55 % $ (8,056) 163 %
1 unchanged sentence
Other income, net $ 8,745 $ 9,174 $ 6,630 $ (429) (5) % $ 2,544 38 %
−Removed: Cost of Goods Sold
−Removed: Cost of product sales consists of the cost of commercial goods sold to our Customers and includes 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.
−Removed: Other cost of revenue consists of the cost of materials sold to our international partners under product supply agreements, certain costs related to capacity expansion at current and future CMOs, as well as payments due to AstraZeneca based on sales of tenapanor.
−Removed: See the “AstraZeneca” caption in Note 7.
−Removed: Collaboration And Licensing Agreements for further detail.
+Added: Cost of Sales
+Added: Cost of sales consists of (i) cost of product sales and (ii) other cost of revenue.
+Added: 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.
+Added: 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, as well as payments due to AstraZeneca based on sales of tenapanor, as discussed further under the “AstraZeneca” caption in Note 7.
+Added: Collaboration and Licensing Agreements .
+Added: Below is a summary of our costs of sales:
+Added: Year Ended December 31, Change 2025 vs.
+Added: 2024 Change 2024 vs.
+Added: ($ in thousands) 2025 2024 2023 $ % $ %
Cost of product sales $ 11,185 $ 6,851 $ 2,323 $ 4,334 63 % $ 4,528 195 %
−Removed: The increase in cost of product sales in 2024 and 2023 was due to higher product sales.
−Removed: A portion of the costs of IBSRELA and XPHOZAH units recognized as revenue during the years ended December 31, 2024 and 2023 were expensed as research and development expenses in periods prior to the commencement of capitalization of inventory costs for each respective product as discussed in Note 2.
+Added: Other cost of revenue 28,352 43,705 15,472 (15,353) (35) % 28,233 182 %
+Added: Cost of sales $ 39,537 $ 50,556 $ 17,795 $ (11,019) (22) % $ 32,761 184 %
+Added: The increase in cost of product sales in 2025 and 2024 reflected higher product sales.
+Added: A portion of the costs of IBSRELA and XPHOZAH units recognized as revenue during 2025 and 2024 was expensed as research and development expense in periods prior to the commencement of capitalization of inventory costs for each respective product as discussed in Note 2.
Summary of Significant Accounting Policies.
1 unchanged sentence
The value of inventory on hand as of December 31, 2025 and 2024 that was previously expensed as research and development was approximately $10.9 million and $15.6 million, respectively.
−Removed: Table of Conten t s
−Removed: Other cost of revenue:
−Removed: The increase in other cost of revenue in 2024 and 2023 was primarily due to higher AstraZeneca royalties, driven by higher product sales, net of tenapanor.
−Removed: In 2023, AstraZeneca royalties attributed to licensing revenue had a greater impact on the obligation than royalties from product sales, net.
+Added: The decrease in other cost of revenue in 2025 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 associated with product supply revenue.
+Added: The increase in other cost of revenue in 2024 primarily reflected higher AstraZeneca royalties, driven by higher product sales, net of tenapanor, as well as higher costs associated with product supply revenue.
Other cost of revenue related to the AstraZeneca Termination Agreement was $12.7 million, $34.7 million and $12.4 million in 2025, 2024 and 2023, respectively.
−Removed: The remaining future royalty obligation to AstraZeneca was $12.1 million as of December 31, 2024.
−Removed: In addition, the increase in other cost of revenue was due to higher product supply revenue and costs associated with that revenue.
+Added: As of the end of the 2025 second quarter, the maximum $75.0 million royalty obligation under the AstraZeneca Termination Agreement had been fully recognized.
+Added: Table of Co n t e n t s
Research and Development
Research and development activities include research and early discovery, preclinical and clinical development, drug formulation and medical support to marketed products.
−Removed: External R&D expenses include research and development expenses incurred under agreements with outside consultants, third-party CROs and investigative sites where a substantial portion of our clinical studies are conducted, and with CMOs where our clinical supplies are produced;
−Removed: employee-related expenses, which include salaries, bonuses, benefits, travel and stock-based compensation;
−Removed: expenses associated with supplies and materials consumed in connection with our research operations;
−Removed: and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation and amortization expense, information technology expense and other supplies.
+Added: External R&D and other expenses include research and development expenses incurred under agreements with outside consultants, third-party CROs and investigative sites where a substantial portion of our clinical studies are conducted, and with CMOs where our clinical supplies are produced.
+Added: Employee-related expenses include salaries, bonuses, benefits, travel and stock-based compensation.
+Added: Facilities, equipment, depreciation and other expenses include supplies and materials consumed in connection with our research operations, direct and allocated expenses for rent and maintenance of facilities, depreciation and amortization expense, information technology expense and other supplies.
Below is a summary of our research and development expenses:
−Removed: Year Ended December 31, Change
+Added: Year Ended December 31, Change 2025 vs.
+Added: 2024 Change 2024 vs.
($ in thousands)
6 unchanged sentences
Total research and development expenses $ 71,527 $ 52,317 $ 35,536 $ 19,210 37 % $ 16,781 47 %
−Removed: The increase in R&D expenses in 2024, including other R&D expenses, primarily reflected increased medical engagement with scientific communities in the areas of gastroenterology and nephrology related to our marketed products.
−Removed: The increase in external R&D expenses was also attributable to clinical trial and pharmacovigilance activities.
−Removed: The increase in employee-related R&D expenses was the result of increases in headcount and personnel costs, including an increase in stock-based compensation expenses totaling $6.0 million and $0.4 million in 2024 and 2023, respectively.
−Removed: R&D expenses in 2023 remained relatively stable as compared to 2022, however, the focus of 2023 activities primarily shifted towards medical and pharmacovigilance efforts supporting our marketed products.
−Removed: Whereas, in 2022, activities focused more on clinical activities in preparation for the respective regulatory approvals.
+Added: The increase in R&D expenses in 2025 reflected higher external R&D and other expenses primarily associated with clinical trial activities.
+Added: The increase in R&D expenses was also due to increased employee-related expenses primarily driven by higher headcount to support clinical trial activities and medical engagement with scientific communities in the areas of gastroenterology and nephrology related to our marketed products.
+Added: The increase in R&D expenses in 2024 reflected increased employee-related expenses primarily driven by higher headcount to support medical engagement with scientific communities in the areas of gastroenterology and nephrology related to our marketed products and higher external R&D and other expenses attributable to clinical trial and pharmacovigilance activities.
+Added: The increases in employee-related expenses in 2025 and 2024 included incremental stock-based compensation expenses of $0.7 million and $6.0 million, respectively.
Selling, General and Administrative
−Removed: Selling, general and administrative expenses relate to sales and marketing, finance, human resources, legal and other administrative activities, including information technology investments.
+Added: Selling, general and administrative expenses relate to sales and marketing, finance, human resources, legal and other administrative activities, including information technology.
Selling, general and administrative expenses consist primarily of personnel costs, outside professional services, marketing, advertising and legal expenses, facilities costs not otherwise allocated to research and development and other general and administrative costs.
−Removed: The increase in selling, general and administrative expenses in 2024 and 2023 was primarily due to increased commercialization and administrative costs to support net sales growth of IBSRELA and XPHOZAH and to support our strategy.
−Removed: The increases consisted of external spending for disease awareness initiatives, patient affordability, access support and related patient awareness, as well as increased commercial infrastructure and increased legal fees incurred related to the Company’s lawsuit against CMS in 2024.
−Removed: The increase was also attributable to increases in headcount and related personnel costs, including an increase in stock-based compensation expense totaling $17.8 million and $2.4 million in 2024 and 2023, respectively.
−Removed: Table of Conten t s
+Added: The increase in selling, general and administrative expenses in 2025 and 2024 primarily reflected increased commercialization and administrative costs to support net sales growth of IBSRELA and XPHOZAH.
+Added: The increases consisted of external spending for disease awareness initiatives, patient affordability, access support and related patient awareness, as well as increased commercial infrastructure.
+Added: In addition, these increases were attributable to increases in headcount and related personnel costs, including incremental stock-based compensation expenses of $10.9 million and $17.8 million in 2025 and 2024, respectively.
Interest Expense
−Removed: Interest expense represents the interest associated with our loan agreements.
−Removed: The increase in interest expense in 2024 and 2023 was due to a higher loan balance resulting from the term loan draws in each respective year:
−Removed: $50.0 million for the Term D Loan in October 2024, $50.0 million for the Term C Loan in March 2024, and $22.5 million for the Term B Loan in October 2023.
+Added: Interest expense represents the interest associated with our 2022 Loan Agreement.
+Added: The increase in interest expense in 2025 and 2024 primarily reflected a higher outstanding loan balance resulting from the term loan draws in each respective year:
+Added: $50.0 million for the Term E Loan in June 2025, $50.0 million for the Term D Loan in October 2024 and $50.0 million for the Term C Loan in March 2024.
Non-Cash Interest Expense Related to the Sale of Future Royalties
−Removed: Non-cash interest expense related to the sale of future royalties represents the imputed interest expense on our deferred royalty obligation related to the sale of future royalties using the effective interest method.
−Removed: Non-cash interest expense is impacted by the outstanding balance of the deferred royalty obligation, which increases from milestone payments received from HCR under the sale of future royalties agreement and imputed interest accrued on the outstanding deferred royalty obligation, and decreases as royalties received from Kyowa Kirin related to the sale of tenapanor for cardiorenal indications in Japan are subsequently remitted to HCR.
+Added: Non-cash interest expense consists of imputed interest on the carrying value of our deferred royalty obligation, which is impacted by the imputed interest rate derived from estimated amounts and timing of future royalties and commercialization payments to be received by HCR.
+Added: The carrying value of the deferred royalty obligation increases from proceeds received from
+Added: Table of Co n t e n t s
+Added: HCR and recorded non-cash interest expense, and decreases as royalties and commercialization milestone payments received from Kyowa Kirin from sales of tenapanor in Japan are remitted to HCR.
Refer to Note 8.
Deferred Royalty Obligation Related to the Sale of Future Royalties for further detail.
−Removed: The increase in non-cash interest expense related to the sale of future royalties in 2024 and 2023 was due to the increasing outstanding balance of the deferred royalty obligation attributed to the upfront milestones received from HCR, including the $10.0 million upfront payment received in June 2022 and the $5.0 million milestone payment received in October 2023 as a result of Kyowa Kirin’s receipt of regulatory approval to market tenapanor for hyperphosphatemia in Japan in February 2024 and imputed interest accrued on the outstanding balance.
−Removed: In 2024, we began to receive royalties from Kyowa Kirin which were remitted to HCR, thereby reducing the outstanding deferred royalty obligation.
+Added: The increase in non-cash interest expense related to the sale of future royalties in 2025 and 2024 primarily reflected the imputed interest accrued on the increasing carrying value of the deferred royalty obligation, partially offset by royalties and commercialization milestones received from Kyowa Kirin related to the sale of PHOZEVEL, which were remitted to HCR.
Other Income, Net
−Removed: Other income, net consists of interest income earned on our cash, cash equivalents and short-term investments, the periodic revaluation of the exit fees related to our loan agreements, as well as currency exchange gains and losses.
−Removed: The increase in other income, net in 2024 and 2023 primarily reflected higher income on our investments, resulting from both higher interest rates and larger investment balances throughout the periods.
+Added: Other income, net consists of interest income earned on our cash, cash equivalents and short-term investments, the periodic revaluation of previously outstanding exit fees, as well as currency exchange gains and losses.
+Added: The decrease in other income, net in 2025 primarily reflected lower income on our investments resulting from lower interest rates throughout the period, partially offset by larger investment balances and higher currency exchange gains.
+Added: The increase in other income, net in 2024 primarily reflected higher income on our investments resulting from both higher interest rates and larger investment balances throughout the period.
+Added: In 2024 and 2023, other income, net included the periodic revaluations of our previously outstanding 2022 Exit Fee and 2018 Exit Fee, as discussed in Note 10.
+Added: Derivative Liabilities, which were settled in October 2024 and October 2023, respectively.
Provision for Income Taxes
6 unchanged sentences
Below is a summary of our cash, cash equivalents and short-term investments:
−Removed: December 31, Change
+Added: December 31, Change 2025 vs.
($ in thousands)
4 unchanged sentences
We regularly assess our cash position and our working capital needs to execute our strategy.
−Removed: 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.
−Removed: 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 sales of future royalties to HCR.
−Removed: 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.
−Removed: Table of Conten t s
−Removed: Under a registration statement filed in 2020, we had the ability to sell up to $150.0 million of our common stock through Jefferies, as our sales agent.
−Removed: As of March 2023, we had received the maximum gross proceeds of $150.0 million at a weighted average share price of approximately $1.57.
−Removed: 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;
−Removed: 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).
−Removed: 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.
−Removed: As of December 31, 2024, 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.
+Added: 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.
+Added: 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.
+Added: Sources of Liquidity
+Added: In January 2023, we entered into the 2023 Open Market Sales Agreement with Jefferies with respect to an “at-the-market offering” program, which was established under the Company’s shelf registration statement on Form S-3 and expired in January 2026.
+Added: Under the 2023 Open Market Sales Agreement, we sold a total of 16.8 million shares of our common stock and received gross proceeds of $70.0 million at a weighted average sales price of approximately $4.17.
+Added: During the year ended December 31, 2025, we did not sell any shares under the 2023 Open Market Sales Agreement.
+Added: 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;
+Added: 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 the 2025 Open Market Sales Agreement, deemed to be “at-the-market offerings.” Pursuant to the
+Added: Table of Co n t e n t s
+Added: 2025 Open Market Sales Agreement, Jefferies, as sales agent, may receive a commission of up to three percent of the gross sales price for shares of our common stock sold under the 2025 Open Market Sales Agreement.
+Added: As of December 31, 2025, there have been no sales of our common stock under the 2025 Open Market Sales Agreement.
We have a loan and security agreement (as amended, the 2022 Loan Agreement) with SLR.
−Removed: The 2022 Loan Agreement provides a total of $200.0 million, of which $150.0 million has been drawn as of December 31, 2024 to support our ongoing operations and the commercial launches of IBSRELA and XPHOZAH.
−Removed: The borrowings under the 2022 Loan Agreement bear interest at SOFR plus a spread based on our public debt rating.
−Removed: We classify outstanding borrowings under the 2022 Loan Agreement as long-term based on the maturity date of the loan.
−Removed: All the term loans mature on July 1, 2028.
+Added: The 2022 Loan Agreement provides a total of $300.0 million, of which $200.0 million has been drawn and is outstanding as of December 31, 2025, including $50.0 million of the Term E Loan drawn during the 2025 second quarter.
+Added: The additional available borrowings of $100.0 million consist of the Term F Loan and the Term G Loan, each in the amount of $50.0 million.
+Added: The Term F Loan and the Term G Loan may be drawn at the Company’s election by June 30, 2026 and December 20, 2026, respectively.
Borrowing for further discussion.
−Removed: We believe our available cash, cash equivalents and short-term investments as of December 31, 2024 will be sufficient to fund our planned operations for at least a period of one year from the issuance of these financial statements.
−Removed: We have based this estimate on assumptions that may prove to be wrong and we could utilize our available capital resources sooner than we currently expect.
−Removed: In particular, our operating plan may change and we may require significant additional capital to fund our operations.
−Removed: There are no assurances that our efforts to meet our operating cash flow requirements will be successful.
−Removed: If our current cash, cash equivalents and short-term investments as well as our plans to meet our operating cash flow requirements are not sufficient to fund necessary expenditures and meet our obligations following the issuance of these financial statements, our liquidity, financial condition and business prospects will be materially affected.
−Removed: Our future funding requirements will depend on many factors as described in Part I, Item 1A, “Risk Factors,” of this Annual Report on Form 10-K.
Cash Flow Activities
The following table summarizes our cash flows activities:
−Removed: Year Ended December 31, Change
+Added: Year Ended December 31, Change 2025 vs.
($ in thousands)
1 unchanged sentence
Net cash used in operating activities $ (42,483) $ (44,809) $ 2,326 (5) %
−Removed: Net cash (used in) provided by investing activities (18,318) (131,248) 18,415 112,930 (86) % (149,663) (813) %
+Added: Net cash used in investing activities (8,959) (18,318) 9,359 (51) %
Net cash provided by financing activities 54,509 106,589 (52,080) (49) %
−Removed: Net increase (decrease) in cash and cash equivalents $ 43,462 $ (74,670) $ 23,712 $ 118,132 (158) % $ (98,382) (415) %
+Added: Net increase in cash and cash equivalents
+Added: $ 3,067 $ 43,462 $ (40,395) (93) %
Cash Flows from Operating Activities
−Removed: Net cash used in operating activities decreased in 2024 compared to 2023, primarily due to cash generated from higher product sales, net, partially offset by working capital cash uses to support our commercial growth.
−Removed: Net working capital cash outflows were driven primarily by increases in customer credit and inventory purchases, which were partially offset by increases in accounts payable and accruals.
−Removed: Net cash used in operating activities increased in 2023 compared to 2022, primarily due to working capital cash uses to support our commercial launches, partially offset by cash generated from higher product sales, net from such launches.
−Removed: Net working capital cash outflows were driven primarily by increases in customer credit, upfront payments to CMOs for the commercial manufacturing of IBSRELA and XPHOZAH and increased prepaid selling and marketing spending.
−Removed: Table of Conten t s
+Added: Cash flows from operating activities represent the cash receipts and payments related to all of our activities other than investing and financing activities.
+Added: Net operating cash flow is derived by adjusting our net loss for non-cash operating items and changes in operating assets and liabilities resulting from timing differences between the cash receipts and payments and when the transactions are recognized in our result of operations.
+Added: As a result, changes in net operating cash flow reflect, among other things, the timing of (i) cash collections from our Customers and (ii) payments made in the normal course of business such as payments to suppliers, including our CMOs, CROs and government agencies.
+Added: Net cash used in operating activities in 2025 was materially unchanged compared to 2024, primarily due to the increased cash inflows generated from our product sales and timing of cash collections from our Customers exceeded the increased payments made in the normal course of business to support our commercial growth and research and development activities.
Cash Flows from Investing Activities
−Removed: Net cash used in investing activities for 2024 and 2023 was primarily impacted by the timing of our investment maturities and purchases.
−Removed: In 2023, net investment purchases were significantly higher when compared to other reported periods.
−Removed: To a lesser extent, the 2024 cash used for investing activities included property, plant and equipment purchases associated with our new leased facility and build outs of existing facilities.
+Added: Cash flows from investing activities include cash used for capital expenditures and purchases of short-term investments as well as net proceeds from asset dispositions and maturities of short-term investments.
+Added: Net cash used in investing activities in 2025 primarily reflected our short-term investment maturities and purchases.
Cash Flows from Financing Activities
−Removed: Net cash provided by financing activities decreased in 2024 compared to 2023, primarily due to $99.5 million net proceeds from the Term C Loan and Term D Loan and proceeds from the issuance of common stock under our equity incentive and stock purchase plans in 2024 which were less than $119.2 million received in 2023 from the issuance of common stock pursuant to at the market offerings.
−Removed: We have not received any proceeds under the 2021 Open Market Sales Agreement in 2024.
−Removed: Net cash provided by financing activities increased in 2023 compared to 2022, primarily due to higher net proceeds from issuance of our common stock pursuant to the at the market offerings of $47.6 million, as well as net proceeds received of $22.4 million from drawing the Term B Loan as compared to net expenditure of $6.1 million in 2022 in conjunction with entering into the 2022 Loan Agreement and repaying the principal outstanding under the 2018 Loan.
−Removed: This increase was partially offset by lower net proceeds from the sale of future royalties to HCR of $5.0 million.
−Removed: SMALLER REPORTING COMPANY AND LARGE ACCELERATED FILER STATUS
−Removed: As a non-accelerated filer, we were not required to obtain an opinion of our independent auditors with respect to our internal controls over financial reporting for the year ended December 31, 2022.
−Removed: On June 30, 2023, our public float exceeded $700.0 million and therefore since January 1, 2024, we are considered a large accelerated filer.
−Removed: This Annual Report on Form 10-K includes an opinion of Ernst & Young LLP, our independent auditors with respect to our internal control over financial reporting as of December 31, 2024 .
+Added: Cash flows from financing activities include net proceeds associated with our loan agreements, 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.
+Added: Net cash provided by financing activities in 2025 included $48.7 million received from the Term E Loan, net of costs and $5.8 million received from the issuance of our common stock under our equity incentive plans, which was lower than $99.5 million received from the Term C Loan and Term D Loan, net of costs and $8.1 million received from the issuance of our common stock under our equity incentive plans in 2024.
+Added: Table of Co n t e n t s
+Added: Funding Requirements
+Added: Based on our current operating model, we believe our available cash, cash equivalents and short-term investments as of December 31, 2025 will be sufficient to fund our planned operations for at least a period of one year from the issuance of these financial statements.
+Added: We have based this estimate on assumptions that may prove to be wrong and we could utilize our available capital resources sooner than we currently expect.
+Added: In particular, our operating plan may change and we may require significant additional capital to fund our operations.
+Added: There are no assurances that our efforts to meet our operating cash flow requirements will be successful.
+Added: If our current cash, cash equivalents and short-term investments as well as our plans to meet our operating cash flow requirements are not sufficient to fund necessary expenditures and meet our obligations following the issuance of these financial statements, our liquidity, financial condition and business prospects will be materially affected.
+Added: Our future funding requirements will depend on many factors as described in Part I, Item 1A, “Risk Factors,” of this Annual Report on Form 10-K.
+Added: Contract Obligations and Commitments
+Added: As of December 31, 2025, 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.
+Added: Borrowing for further information on our long-term debt.
+Added: We have entered into various operating leases for our offices.
+Added: As of December 31, 2025, our total undiscounted obligation for operating leases was $5.6 million, with maturities ranging up through July 2029.
+Added: Leases for further information on our operating leases.
+Added: We enter into a variety of contracts in the normal course of business.
+Added: These contracts generally allow us to terminate on notice, reschedule or adjust our requirements based on our business needs prior to the delivery of goods or performance of services.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.