Ardelyx, Inc.

Company overview

Ardelyx is a commercial-stage biopharmaceutical company focused on the development and commercialization of NHE3 inhibitors. Its core approved therapies are:

• IBSRELA (tenapanor) for irritable bowel syndrome with constipation (IBS-C) in adults. Tenapanor is minimally absorbed and acts in the gut.
• XPHOZAH (tenapanor) for hyperphosphatemia in adults with chronic kidney disease (CKD) on dialysis as add-on therapy for patients with inadequate response or intolerance to phosphate binders.

The company's growth strategy emphasizes expanding IBSRELA usage, maintaining XPHOZAH momentum, advancing the pipeline, and sustaining a solid financial base.

Products and pipeline

IBSRELA (tenapanor)

• Indication: IBS-C in adults (FDA-approved in the U.S.).
• Mechanism: First-in-class, gut-local NHE3 inhibitor.
• Status: Commercial product with ongoing commercialization efforts; competition from other IBS-C therapies and generics.

XPHOZAH (tenapanor)

• Indication: Hyperphosphatemia in CKD patients on dialysis (FDA-approved in the U.S.).
• Status: Commercial product. Coverage changes under ESRD prospective payment system and removal from Medicare Part D effective January 1, 2025 affected revenue dynamics.

CIC expansion program

• IND for IBSRELA to treat chronic idiopathic constipation (CIC) submitted September 2025.
• ACCEL (ten-03-301) Phase 3 for CIC initiated January 2026; topline data expected in second half of 2027.
• A successful outcome could support a supplemental NDA for CIC.

RDX10531

• October 2025: disclosed program for a next-generation NHE3 inhibitor.
• ACCEL enrollment for CIC is anticipated through 2026 with topline data in second half of 2027.

Collaborations and territories

• Canada: Knight holds an exclusive license for IBSRELA and hyperphosphatemia; Knight markets IBSRELA and Ardelyx supplies the product.
• Japan: Kyowa Kirin holds an exclusive license for development and commercialization; Kyowa Kirin launched PHOZEVEL in Japan for CKD hyperphosphatemia in 2024.
• China/other territories: Fosun Pharma holds an exclusive license for hyperphosphatemia and IBS-C; commercialization efforts are ongoing.
• METiS: Collaboration for a portfolio of TGR5 agonist compounds across therapeutic areas.

Manufacturing and supply

• Ardelyx relies on contract manufacturing organizations (CMOs) for API and finished product; several stages are single-source.
• The company has obligations to supply drug substance and/or finished product to partners (Knight, Fosun, Kyowa Kirin) for their territories.
• Some partners require finished drug product for development and commercialization; Ardelyx supplies API to Kyowa Kirin for Japan.

Regulation and compliance

• Active focus on U.S. and international regulatory pathways, including FDA NDA processes and Hatch-Waxman exclusivity considerations.
• Ongoing post-approval requirements may include label changes, REMS, or post-marketing studies.

Financial highlights (as of and around 12/31/2025)

• Employees: 489 full-time employees total.
  • 93 in research, development and manufacturing
  • 305 in sales and marketing
  • 91 in general and administrative
• Cash and liquidity: Cash, cash equivalents and short-term investments of $264.7 million.
• Accumulated deficit: $946.9 million as of December 31, 2025.
• Financing:
  • 2023 Open Market Sales Agreement with Jefferies: up to $100.0 million available under the 2025 ATM; $70.0 million gross raised previously (16.8 million shares at a weighted average price of $4.17); no 2025 activity under the program.
  • November 2025: automatic shelf registration (Form S-3ASR) with a base prospectus and up to $100.0 million of common stock available under the Open Market Sales Agreement.
• Debt facilities:
  • 2022 Loan Agreement with SLR: total facility up to $300.0 million.
  • Draws to date (as of 12/31/2025): $200.0 million outstanding, plus a $50.0 million Term E loan drawn in Q2 2025.
  • Optional future draws: up to $100.0 million more (two $50.0 million term loans) available through mid-2026 and end of 2026.
  • Covenants and collateral: standard financial reporting and insurance requirements, restrictions on dispositions, debt and liens; collateral includes substantially all assets (excluding IP, which is subject to a negative pledge).
  • An event of default could require repayment and could restrict operations and force scaling back commercialization and trials.

Intellectual property

• Tenapanor patents include seven issued U.S. patents and multiple international patents (Israel, Mexico, EPO, Japan, Korea, Hong Kong, Australia, Brazil, China, India, etc.).
• U.S. patent family covering composition and certain uses of tenapanor expires December 2029 without extensions. U.S. Patent No. 8,541,448 (composition of matter) was extended to August 1, 2033 via patent term adjustment and Hatch-Waxman extension; related use protection extends into 2033, with other territories having varying expiry timelines (for example, some use-related patents are predicted to expire April 2034).
• Formulation patent: U.S. Patent No. 12,539,299 issued January 22, 2026, covering tenapanor formulations and commercial IBSRELA/XPHOZAH formulations; expiration date November 26, 2042.
• General approach: protection through patents, trade secrets, and know-how across multiple jurisdictions.
• Bayh-Dole considerations: potential government rights could arise if development involved federal funding.

Manufacturing and supply risk

• Heavy reliance on CMOs with multiple single-source steps.
• Supply and pricing risks tied to third-party manufacturers and raw material sources.
• Potential for disruption from regulatory changes, geopolitical events, or supply chain constraints.

Regulatory and market context

• XPHOZAH coverage changes under ESRD PPS and removal from Medicare Part D effective January 1, 2025 created revenue uncertainty and affected growth pace.
• ACCEL timelines and potential supplemental NDA for CIC depend on trial outcomes.
• Ongoing scrutiny around pricing, reimbursement, U.S. healthcare reform measures, and international pricing dynamics may affect market performance.

Key disclosures

• The company has incurred losses every year since inception and expects continued commercialization and development expenditures.
• No dividends are expected in the near term; the company intends to reinvest in business growth.