Ardelyx, Inc.

Good day, everyone, and welcome to the Ardellix third quarter 2025 earnings conference call. All participants are in a listen-only mode. Now I'd like to turn the call over to Caitlin Lowy, Vice President of Corporate Communications and Investor Relations. Caitlin, please go ahead.

Thank you. Good afternoon and welcome to our third quarter 2025 financial results call. During this call, we will refer to the press release issued earlier today, which is available on the investor section of the company's website at ardell.com. During this call, we will be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ significantly from those described. We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q that will be filed today and can be found on our website at ardellis.com. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our views change. Our president and CEO, Mike Robb, will begin today's call with opening remarks and an overview of the company's progress during the third quarter of 2025. Next, Chief Commercial Officer Eric Foster will provide an update on the performance of Estrella and Exposa. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the third quarter ended September 30, 2025, before we open the call to questions. With that, let me pass the call over to Mike.

Thanks, Caitlin. It's great to be here with all of you today to share our third quarter of 2025 results, another standout quarter for both Xrella and Xposa. This performance demonstrates the power of our commercial model, the momentum behind our products, the exceptional execution by our team, and the real-world impact that our differentiated therapies are having for both patients with IDSE and for those with CKD on dialysis. We generated $105.5 million in product revenue during the third quarter, representing 15% year-over-year growth, a signal of strong demand across our portfolio. In January, I outlined four key priorities for our Delux this year. One, to accelerate the Zarrello's momentum. Two, to execute on our exposure strategy. Three, to build a pipeline. And four, to continue delivering strong financial performance. Ten months later, it is clear that the team at Ardelux is delivering on these key priorities, and as a result, we're building real, sustainable momentum. I'd like to provide a bit more detail on each of these areas. Izrella continues to outperform and is the foundation of our portfolio and the main engine for Ardelux's future growth. Izrella set yet another record, generating $78.2 million during the third quarter, a 92% increase over last year. Demand growth is broad-based and demonstrates how vital this therapy is for patients. The Izrella team is doing an exceptional job expanding reach and deepening prescriber engagement and conviction. Every driver that has fueled our success remains strong, a passionate patient community, an engaged prescriber base, and a novel commercial strategy. We expect this momentum to continue through Q4 and beyond, and as a result, we are raising our guidance, and we expect to generate between $270 and $275 million in Xrella revenue this year. Xfosa also had an incredibly strong quarter, generating $27.4 million in revenue, a 9% increase compared to Q2. The Exposa team is navigating this dynamic market with determination and agility as we execute on our strategy, ensuring patient access, strengthening clinical conviction among nephroliths, and driving prescription pull-through. Exposa is a valuable component of our growth, and we expect its contribution to our business will only grow over time. Today's announcement of RDX105531, which we will refer to as 531, is the next generation NHE3 inhibitor and marks an important milestone for Ardelix as we reinvigorate our pipeline. We at Ardelix pioneered NHE3 inhibition, and with Tenapenor, we have the only approved modulator of this pathway on the market. With 531, we may be able to unlock even greater benefit for patients. Early preclinical data demonstrates that 531 is a highly potent, highly soluble molecule that could open development opportunities across a broad range of therapeutic areas. Preclinical manufacturing activities are underway in advance of a phase one study. This investment in 531 reflects thoughtful stewardship of an important internal asset and is our first new development program in more than three years. We are committed to building a broad, sustainable pipeline, capitalizing first on an internal asset, while in parallel, we explore external opportunities. As we build this pipeline, we are taking a disciplined and forward-thinking approach, identifying opportunities where our delics can win. We are going to leverage our expertise, assets, and scientific, clinical, and commercial leadership to unlock value. 531 is a reflection of that approach, and I look forward to sharing more information on our plans for this molecule as we advance through the development program. Finally, I want to highlight our financial strength. With the meaningful revenues we expect to generate in 2026 and beyond, we're extremely well-positioned to thoughtfully invest our capital in current commercial endeavors and to grow our pipeline. We are delivering on our four key priorities. We are driving meaningful impact with patients, and we are creating lasting value for shareholders. Before I hand the call over to Eric, I'd like to formally welcome Sue Holm-Leitner to Artelix as our Chief Financial Officer. She's a remarkable leader who brings deep financial and strategic expertise to Artelix, and she's already making her mark, challenging our thinking, strengthening our plans, and energizing our path forward. She's joining a highly experienced leadership team with the technical expertise, vision, and enthusiasm to lead and write the next chapter for Ardelix. With that, I'm pleased to turn the call over to Eric, who will share his perspectives on our commercial performance. Eric.