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Ardelyx, Inc.
2/19/2026
Welcome to the Ardellix Fourth Quarter 2025 Earnings Conference. All participants will be in a listen-only mode. I would now like to turn the conference over to Kaitlyn Lowy, Vice President of Corporate Communications and Investor Relations. Kaitlyn, you may begin.
Thank you. Good afternoon and welcome to our fourth quarter and full year 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 ardellis.com. Please note that we are also including a slide presentation to accompany today's remarks. You can view the material by accessing the webcast version of today's call on the investor section of ardellis.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 annual report on Form 10-K that will be filed today. It can be found on our website at ardellix.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 filed by Eric Foster, Chief Commercial Officer, who will provide an update on the performance of Isdrella and Expoza. Dr. Laura Williams, our Chief Patient Officer and Interim Chief Medical Officer, will share an update on our recently announced development program before our Chief Financial Officer, Sue Hohenleitner, reviews the company's financial performance. We will then open the call to questions. With that, let me pass the call over to Mike.
Thank you, Kaitlin, and good afternoon, everyone. It's great to be with all of you here today. 2025 was an extraordinary year for the company as a team delivered on every single one of our strategic priorities. That performance establishes a strong foundation for what we will accomplish in 2026. We will continue growing as Foz and Utrella and execute on our growth initiatives. What was accomplished over these past 12 months is remarkable. We delivered on all four of our key strategic priorities, accelerating building a pipeline focused on addressing areas of unmet patient need and delivering strong financial performance. First, Ibsrella has proven to be a critical growth engine for the company and is a powerful example of our disciplined execution and our conviction in the benefit that a first-in-class medicine can offer IBSC patients. Ibsrella is now helping tens of thousands of patients, evidenced by the incredible revenue growth of 73% compared to 2024 and 61% year-over-year growth in the fourth quarter. Second, 18 months ago we made the decision to preserve access to Xfosa for all appropriate patients as we recognize at a core foundational level that staying true to our principles and doing what's best for patients will result in doing what's best for the company. Today I can tell you that our patient first strategy is working. More patients now have access to Xfosa than ever before and we're confident in our growth expectations. An additional development from just a few weeks ago was the issuance of a new patent for the commercial formulations of Ibsrella and Exposa that expires in 2042 and is now listed in the Orange Book at the FDA. This patent is an important component of our strategy to create additional, valuable intellectual property to support Ibsrella and Exposa. Our job is to maximize the value of these franchises by building a comprehensive IP portfolio, and this patent is an important step in just doing that. Third, we launched two development programs, which along with our Observer Pediatric Program exemplify how we plan to build out our portfolio, develop and commercialize innovative medicine for patients with unmet needs that align with our long-term strategy, leverage our internal core competencies that reflect thoughtful use of our financial resources to create durable, long-term shareholder values. In the fourth quarter, we announced that our Phase III programs expand the Absrella label to include chronic idiopathic constipation, or CIC. Assuming addition of this indication, Absrella would be better aligned with real-world prescribing habits, allowing us to be more comprehensive in our messaging, serve more patients, and increase the scale and the opportunity for Absrella. As well, we announced the commencement of a development program for our next generation NHE3 inhibitor, RDX10531, which we refer to as 531. Building on our foundational expertise in NHE3 inhibition, 531 presents us with the opportunity to potentially extend our reach into new therapeutic areas. Finally, coupled with this extraordinary performance is continued disciplined cash management and execution, resulting with ending 2025 in a stronger financial position than was the case at the end of 2024. We made bold, patient-centric decisions in complex market environments, we strengthened our leadership team to pursue our growth aspirations, and we positioned Ardelex for long-term growth and value creation. We are in a great position. I'm excited about where we're going and our ability to identify and capitalize on the opportunities ahead. In 2026, we will elevate our organization to even higher levels. Our priorities haven't changed, but our expectations for them have. We're delivering on our vision for what the future of Ardelix is becoming, a consequential, patient-centric enterprise built on a broad, thoughtful portfolio of best-in-class medicines. We are focused on significantly growing Ibsrella and maintaining Ibsrella's momentum. With the guidance we shared in January, Ibsrella is clearly demonstrating its blockbuster potential and is on track to deliver a billion dollars in revenue in 2029 with significant growth thereafter. Ibsrella is a powerful engine for the company. We are determined and extremely excited about our future and the many opportunities ahead. Our confidence is high and we have the leadership, the team, the strategy, and the urgency to execute and achieve these goals. With that, I'm turning the call to Eric, Laura, and Sue to walk you through specific drivers and our outlook in more detail. Eric?
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