ARDELYX, INC. Q4 FY2025 earnings call

• Mike Raab stated 2025 was an extraordinary year with the team delivering on all strategic priorities, including accelerating IBSRELA growth, executing on XPHOZAH strategy, building a pipeline and delivering strong financial performance. IBSRELA had 73% revenue growth in 2025 and 61% in Q4. • Eric Foster highlighted 2025 was an outstanding year with strong commercial execution for IBSRELA and XPHOZAH. For IBSRELA, focused on optimizing sales team, improving prescription pull - through and engaging with patients. For XPHOZAH, focused on patient access, clinical conviction and expanding reach. • Laura Williams discussed the company's pipeline, including the Phase III program to expand IBSRELA label to CIC and the next - generation NHE3 inhibitor 531. • Sue Hohenleitner reviewed financials, talked about 2026 guidance for IBSRELA and XPHOZAH, and expected OpEx increase in 2026 to support growth and pipeline advancement.

In 2025, total revenue was $407.3 million, up 22% year - over - year. IBSRELA revenue was $274.2 million, a 73% increase from 2024, contributing a significant portion. XPHOZAH revenue was $103.6 million, a 36% decrease from 2024. Research and development expenses were $71.5 million in 2025 compared to $52.3 million in 2024. Selling, general and administrative expenses were $337.2 million in 2025 versus $258.7 million in 2024. Net loss for 2025 was $61.6 million or $0.26 per share compared to $39.1 million or $0.17 per share in 2024. Ending 2025 with $264.7 million in total cash, cash equivalents and short - term investments, an increase from $250.1 million at the end of 2024.

• For 2026, IBSRELA revenues are expected to be between $410 million and $430 million. • XPHOZAH revenues are expected to be between $110 million and $120 million in 2026. • Expect overall 2026 operating expenses to increase by approximately 25% to up to $520 million. • IBSRELA is on track to deliver $1 billion in revenue in 2029 with a CAGR of 38%. • Reaffirm XPHOZAH growth expectations with $750 million before the expiration of the XPHOZAH method of use patent in 2034.

Q: Could you talk about your level of confidence on the underlying volume growth for IBSRELA to get to your $410 million to $430 million IBSRELA guidance? What's really driving that outside of big TAM? And how much of that guidance assumes improvements on the pull - through and the shift to specialty pharmacies?

A: Michael Raab and Eric Foster responded stating great confidence in reaching the guidance, driving volume through optimizing sales force, doubling field reimbursement manager team and leveraging the IBSRELA Pharmacy network.

Q: Following up on some of the prepared remarks on expenses, just could you provide any more color on the cadence of the RV and SG&A step - ups for '26? And just with those increases, how should we be thinking about the path forward or the path toward sustained cash flow positivity? And then just on the $410 million to $430 million guidance for this year and going to $1 billion for IBSRELA in '29. Do you feel your existing commercial infrastructure is sufficient for hitting that longer - term guidance? Or just how should we be thinking about incremental investments on that front?

A: Sue Hohenleitner and others responded discussing OpEx increase, investments in growth and pipeline, and that existing infrastructure is being optimized with incremental investments.

Q: Can you talk more about the 2 lower doses you're testing in the CIC trial? If I recall correctly, these dose levels weren't quite as efficacious in IBS - C. So what are your expectations for how these dose levels will perform in this trial? And is having multiple dose options part of your strategy in CIC? Or are you trying to find just one optimal dose?

A: Laura Williams responded discussing the purpose of testing lower doses and that having multiple dose options is part of the strategy in CIC.

Q: With IBSRELA offering its differentiated NHE3 inhibitor profile, what do you see being the greatest distinctions in the future for the CIC market when we think about the other GCC agonists or serotonin receptor agonist mechanisms, for instance? Really just any color on the unmet need and the differentiation there?

A: Laura Williams and Michael Raab responded discussing the fluidity between IBS - C and CIC and the differentiation of IBSRELA's mechanism.

Q: So I was curious for CIC, what will prescribers focus on most in terms of the primary and secondary endpoints in the Phase III study? And is there an efficacy bar that you're thinking about for defining a highly successful trial in CIC?

A: Michael Raab and Eric Foster responded discussing primary endpoint of durable CSBN response and secondary endpoints like quality of life.

Q: Any additional color you can provide on additional patents or other layers of protection you could -- you're thinking about building up in the future? And how are you thinking about long - term XPHOZAH growth post 2026, given potential adjustments in Medicare base rates for phosphate binders? Any additional color you can provide on that?

A: Michael Raab responded discussing ongoing IP efforts and that XPHOZAH growth is focused on non - Medicare segments.

Q: So perhaps one question for IBSRELA. So historically, you've positioned IBSRELA for later lines of treatment for IBS - C. But as you're now projecting over $400 million in revenue for this year, just wonder if there might be more leverage to reengage with payers and reexploring how frontline use can fit into the picture. And to that end, I wonder if frontline utilization, how much if at all factors into your 2029 peak revenue target?

A: Michael Raab and Eric Foster responded discussing market opportunity and that frontline utilization is not factored into the numbers.

Q: Can you talk about how the recently issued 299 patent contributes to your overall IP strategy for tenapanor? Wondering if the patent covers unexpected effects or any other features that you believe help strengthen the patent. And then I thought I heard in prepared remarks that CIC labeling could potentially bolster your ongoing efforts in IBS - C. Just wondering if you could expand on that some more, what dynamics would you expect to be at play there?

A: Michael Raab and Eric Foster responded discussing the patent's role in IP strategy and how CIC labeling can bolster IBS - C efforts.

Q: IBSRELA question. So you guide now 2029 $1 billion plus. So you consistently got $1 billion, but we previously assumed I think that would occur in 2033. So do you have any comments, any forecast, any sort of guidance as it comes to 2033, how -- what should we expect for that year? And when do you think that PPA actually may happen for IBSRELA? And the second question I'll ask is about the CIC trial. So those -- as you mentioned, those have always been interrelated indications. And so you decided to start the trial. Just curious to understand how the things changed over the past several years. So was it previously you didn't start the trial because of financial constraints? Or what are other potential reasons that sort of simulated.

A: Michael Raab responded discussing financial constraints and growth projections.

Q: Could you talk about how the CIC trial is powered? And then what proportion of patients need to be CDSM responders and that you're targeting?

A: Laura Williams responded discussing the powering of the CIC trial and the proportion of patients targeted.

Q: With the IBSRELA drug on IBS - C, I wanted to understand where is the greatest opportunity? And what is driving the market growth of double digit? And how sustainable do you think it's going to be? And on XPHOZAH, you shared that the peak opportunity being at $750 million. Can you talk about how you get to that number based on the current trends?

A: Michael Raab responded discussing IBSRELA market opportunity and XPHOZAH peak opportunity based on trends.