4/30/2026

speaker
Ross
Conference Operator

Welcome to the Ardelix First Quarter 2026 Earnings Call. All participants will be in a listen-only mode. I would now like to turn the conference over to Lisa Capparelli, Senior Vice President of Corporate Communications and Investor Relations. Lisa, you may begin.

speaker
Lisa Capparelli
Senior Vice President of Corporate Communications and Investor Relations, Ardellix

Thank you, Ross. Good afternoon, everyone, and welcome to our First Quarter 2026 Financial Results and Business Update Call. Earlier today, we issued our earnings release, which can be found on the investor section of our website at ardellix.com. Slides that accompany today's call can also be found on our website. On today's call, I'm joined by Mike Robb, President and CEO of Ardellix, who will share our Q1 progress towards our 2026 priorities. Eric Foster, Chief Commercial Officer, will provide an update on the performance of Ibsrella and Exposa. And Sue Hohenleitner, our Chief Financial Officer, will provide some key highlights from our financial results. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements. which are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our annual report on Form 10-K, our quarterly report on Form 10-Q, which was filed today, and from time to time in our other documents filed with the SEC. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligations to do so, even if our views change. I will now pass the call over to Mike. Mike?

speaker
Mike Robb
President and Chief Executive Officer, Ardellix

Thank you, Lisa. Good afternoon, everyone. It's great to be with all of you today. Before we dive in, I want to take a moment to welcome Lisa to the team. We're excited to have her on board, leading our IR efforts as our new head of investor relations. 2026 is poised to be another significant year of growth for our company, and we're already off to a great start. At Ardellix, we're building an innovative pipeline of medicines for patients with unmet medical needs. Our first quarter's performance reinforces our confidence in the strategy we've laid out and in our ability to capture the opportunities ahead to create long-term value. As we build on this momentum, our focus is on executing on our four key priorities. Accelerating the growth of the umbrella, maintaining the exposure momentum, building and expanding our pipeline, and delivering strong financial results. Starting with Ibsrella, in the first quarter, our disciplined commercial execution drove 58% year-over-year revenue growth. With more than 7 million prescriptions written for IVSE-indicated medicines last year, Ibsrella is well-positioned as a differentiated mechanism for patients who continue to experience symptoms despite treatment with a secretagogue. Our strategy continues to positively impact demand drivers, and today, Israel is helping tens of thousands of patients with IBSC, and we remain on track to deliver at least a billion dollars in annual revenue in 2029. With Exposa, our patient-first strategy continues to guide our execution with demand growing. Today, more patients have access to Exposa than ever before, and we remain committed to supporting patients irrespective of payer coverage. Next, our pipeline. As a result of our performance and execution, we are at a stage where we have the financial flexibility to further invest in our pipeline, positioning our company for durable long-term growth. Earlier this year, we initiated Excel Trial, a phase three clinical trial about evaluating mozzarella for chronic idiopathic constipation, or CIC, as part of our efforts to expand our label and to reach more patients. This trial has rapidly gained attention from clinicians and patients alike. And all pre-identified sites have been initiated in under four months and are engaged in patient recruitment activities. We remain on track to complete enrollment by year end and to announce top line data in the second half of 2027. If Excel reads positive, IBSRELA will expand treatment options for more patients. In addition, we have a strategy to expand the use of IBSRELA, which may help pediatric patients with IBSC and has potential to extend Tenapenor's patent life for an additional six months. Our ongoing pediatric program consists of several studies evaluating Azrel and patients with IBSC and functional constipation, pediatric equivalent to the adult CIC. This effort is an example of our ongoing strategy to extend Synapenor, which includes our recently announced orange booklet listed 2099 patent covering the commercial formulations of Azrel and Exfosa, building additional value for these franchises. Also included in our pipeline is our development program for our next generation NHG3 inhibitor, 531, which continues to progress through IND-enabling studies, building on our foundational experience in NHG3 inhibition. And 531 may extend our reach into other therapeutic areas, which would be driving additional value for shareholders. We're excited for this next phase of Ardelix's evolution as we execute on our pipeline and explore various external opportunities that align with our mission and core capabilities and meet our disciplined capital allocation approach. We've been growing our team at Ardelix and now have a deep bench of talent at the executive level. I'm excited with the two newest additions who have joined the executive team. Felicia Attenberg, our chief legal officer, and Dr. Rajani Dhanabahi, our chief medical officer. Felicia's broad legal training and experience as a business partner, as well as Rajani's experience in advancing innovative therapies from development to patients will be beneficial to our deluxe as we build upon our commercial foundation, invest in our pipeline, and focus on delivering meaningful outcomes for patients. I'd also like to take a moment to thank Dr. Laura Williams, our Chief Patient Officer, who's been serving the dual role of CMO and CPO while helping to guide us on this journey and has done an outstanding job advancing our clinical programs. Thank you, Laura. Finally, we remain in a position of financial strength. Our Q1 revenue performance position is to reiterate our previously communicated full year 2026 revenue guidance for Absrolla and Exfosa. We have the flexibility to allocate capital to both near-term commercial execution and investments that will expand our pipeline to drive long-term growth value for the company, our patients, and our shareholders. I'm confident in our strategy and our team's ability to deliver on our key priorities. Together, we are advancing a growing, differentiated, innovative pipeline of medicines that address unmet patient needs. And with that, I'm pleased to turn the call over to Eric to walk you through our commercial success. Eric?

Disclaimer

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