5/1/2025

speaker
Operator
Conference Moderator

Good day, everyone, and welcome to the Ardelix first quarter 2025 earnings. All participants will be in a listen-only mode. Now, I'd like to turn the conference over to Caitlin Lowey, Vice President of Corporate Communications and Investor Relations. Caitlin, you may begin.

speaker
Caitlin Lowey
Vice President of Corporate Communications and Investor Relations

Thank you. Good afternoon, and welcome to our first 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 Ardelix.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 was filed today and can be found on our website at ardellx.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 performance during the first 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 first quarter ended March 31, 2025, before we open the call to questions. With that, I'll hand the call over to Mike.

speaker
Mike Robb
President and Chief Executive Officer

Good afternoon and thank you for joining us today. We're pleased to share an outstanding start to the year at Ardellix. We've made excellent progress across all of our priorities and continue to build significant momentum while navigating a rapidly changing and dynamic marketplace. As compared to the same period last year, we generated revenue growth of 61%, totaling $74 million. This is noteworthy. Our teams are building clinical conviction for our therapies and serving more and more patients with these two important therapeutic options. We have successfully launched two products during the last three years and we're delivering on our mission. Now starting with Absrella. Absrella's exciting growth trajectory continues. We delivered one of the highest prescription demand quarters to date during the first quarter, reinforcing our confidence in Absrella as a differentiated, important, and valuable treatment for patients. Ibsrella's significant long-term potential is supported by a large and growing market and continued unmet need among patients who remain inadequately served by secretagogues. Our commercial team is effectively driving prescriber adoption by building clinical conviction among high-value targets, while our expanded field access management team is enhancing patient access and pull-through. Together, these efforts are positioning Ibsrella for sustained growth and deeper market penetration. We are on track to meet our 2025 guidance of $240 to $250 million in net sales, and we have a clear path to achieving peak annual net sales revenue of over a billion dollars. Now, turning to XFOSA. During the first quarter, XFOSA grew by 30% compared to last year, not including the one-time gross net adjustments for return reserve release. This performance reflects the clear unmet need that exists for patients, the growing role for Exposa is playing in helping patients achieve and maintain target phosphorus levels, and the remarkable momentum our team built in 2024. It is important to recognize that with the loss of Medicare Part D coverage for phosphate lowering therapies, the dialysis market is undergoing significant disruption, and it is causing increased frustration among both nephrologists and patients. Our decisions around exposure remain firmly grounded in a commitment to patient care. Amid this uncertainty, we're encouraged by early signals. Patients across both Medicare and non-Medicare segments are successfully accessing the therapy, and real-time feedback from the field reinforces exposure's clinical value. As the environment remains fluid, we are not yet providing formal revenue guidance at this time. Instead, we are closely monitoring uptake and market dynamics, and we will provide further updates as the landscape continues to evolve. Across the board, Ardellis continues to execute with resolve, discipline, and agility, and we're making progress in our strategic priorities, driving strong commercial execution for Ipsrella, navigating the access complexities and generating important commercial momentum with Exposa, building a pipeline to unlock long-term growth, and continually delivering on a strong financial performance. Our high-performing team, differentiated products, and commitment to patient-centric innovation position us to lead and grow in a rapidly evolving healthcare environment, and we remain steadfast as we build long-term value for our shareholders. Thank you for your continued support and confidence in Ardellix, and I will now hand it over to Eric to share his perspectives on our commercial performance during the first quarter. Eric?

Disclaimer

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