Ardelyx, Inc.

Good afternoon, everyone, and welcome to the RDELX fourth quarter 2022 conference call. At this time, all participants are in a listen-only mode. Should you need assistance, please say no to a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one using your telephone keypad. To withdraw your questions, you may press star and two. As a reminder, today's event is being recorded, and at this time, I'd like to turn the floor over to Caitlin Lowy, Vice President, Corporate Communications and Investor Relations. You may begin.

Thank you. Good afternoon, everyone, and welcome to our fourth quarter 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 materially from those described. We encourage you to review our risk factors in our most recent annual report on Form 10-K, filed today, which 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 and an overview of the company's progress during 2022 with a look ahead to 2023. Next, Susan Rodriguez, Chief Commercial Officer, will provide an update on the launch of Estrella as well as preparation activities to support a successful launch of Exposa if approved. Justin Renz, Chief Financial and Operations Officer, will conclude today's formal remarks with a review of the company's financial performance during the fourth quarter and full year ended December 31st, 2022. Dr. Laura Williams, Chief Medical Officer, Dr. David Rosenbaum, Chief Development Officer, and Rob Links, Chief Regulatory Affairs and Quality Assurance Officer, will join us for the question and answer period. With that, let me pass the call over to Mike.

Thank you, Kaitlin, and good afternoon, everyone. It is a great pleasure that I provide an update on our XRELA launch and the tremendous progress that we have made on our path to bring Exposa to patients on dialysis. To be clear, the progress Susan, Justin, and I will discuss today is not just about Exposa. It's about Adrella and Exposa. The last year for Ardellis captures the results of well over a decade of hard work, dedication, and tenacity on the part of the entire Ardellis team, as well as our many supporters from the patient and healthcare provider communities. In the midst of all of the challenge everyone faced during this pandemic, our continued success illustrates our ability to execute on our plans and to realize the vision of Ardellis. And most importantly, it demonstrates our profound commitment to doing the hard work of bringing novel mechanism products to patients in need. We say this often, but our mission is to develop, discover, develop, and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Many of us in biotech have similar goals and missions, but it isn't often that a company, especially a company of our size, can say that we have done that once And we are on the path to do it again with the potential to bring another important medicine to patients later this year. In March of last year, we launched our first novel therapy, Hidzarella, for patients with irritable bowel syndrome with constipation. And we're demonstrating significant quarter over quarter prescription growth in both new and refill prescriptions and bringing much needed relief to patients with IBSC. In our December update, Spherics noted that 60% of surveyed GIs reported the use of Absrella, rating their satisfaction with the treatment as either moderate or high. In addition, 32% of non-using GIs surveyed in the report, and they reported an intent to adopt Absrella within the next three months. Absrella is providing clinically meaningful benefits to patients, and Ardellis is establishing itself as a commercial company. In addition, last quarter, we experienced an overwhelmingly positive CardioRenal Advisory Committee vote supporting the benefit of Xfosa, which was then followed by the Office of New Drugs granting our appeal and instructing the CardioRenal Division to work with us on an appropriate label for Xfosa. We are moving quickly towards our NDA resubmission, and in mid-February, we held a Type A meeting with the CardioRenal Division. It was a very positive discussion, and we are really appreciative of the time and responsiveness of the FDA. We are now completing our work on the NDA for EXPOSA and are on track for resubmission early in the second quarter. As we have said before, our base case expectations are that this will be a six-month Class 2 review. We, of course, are hopeful that it could be shorter. Regardless, we are well positioned and will be ready to launch in the second half of this year if approved. As things progress, we will apprise you of the goal review date and any other updates we are able to share. In a moment, I'm going to hand the call over to Susan to walk through the commercial momentum that is building for Exrella and our go-to market planning activities for Expoza. What I want you to take away from today's call is that Exrella is growing and continues to gain important momentum. When we announced the launch of Izrella, we shared that we expected we could capture mid to high single digit share of its 5 million prescription IBSC market, which we expect would yield a peak revenue of at least $500 million. Based on what we are seeing today, there's nothing that changes that perspective. And I believe we are on our way to achieving that target. Importantly, I also want you to have confidence that the Ardelix team is mobilizing and ready to launch EXPOSE if approved. Finally, I want to reinforce a critical aspect of our business and our approach that is behind the results that we are generating. With what we continue to accomplish, we are demonstrating that Ardelix is a company with a crucial remit that spans the discovery and development of important therapeutics, and we are executing on an innovative commercial strategy that is unique and replicable. We have developed first-in-class therapies with strong clinical data demonstrating meaningful benefits for patients. We are in therapeutic areas where there is a persistent and significant unmet medical need. We are executing with Absrella in a large, established market with a concentrated set of specialist healthcare providers, and we expect our commercialization efforts for Exposa will follow a very similar dynamic. We have a long runway of strong intellectual property with no new branded agents on the horizon. And we have an innovative, disruptive commercial strategy led by a highly experienced commercial leadership team that will continue to drive results. What we have is true for our current portfolio of first-in-class agents, both Ibsrella and Exposa. We will leverage this commercial strategy as we continue to build the growth and momentum for Ibsrella. execute on our plans for successful launch of Exposon, and we will seek to expand our businesses to support the next phase of our growth. With that, I'll turn the call over to Susan. Susan?