Ardelyx, Inc.

Good afternoon and welcome to the RDELX's second quarter 2022 conference call. At this time, all participants are in a listen-only mode. There will be a question and answer session after the prepared remarks. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. As a reminder, today's call is being recorded. I would now like to turn the call over to Justin Renz, Chief Financial Officer of Ardelix. You may begin.

Thank you, and good afternoon, everyone, and welcome to our second quarter financial results call. During this call, we will refer to the press release issued earlier today, which is available in the investor section of the company's website at Ardelix.com. On the call with me today are Mike Robb, President and CEO, and Susan Rodriguez, Chief Commercial Officer with prepared remarks. Dr. Laura Williams, Chief Medical Officer, Dr. David Rosenbaum, Chief Development Officer, and Rob Blanks, Chief Regulatory Affairs and Quality Assurance Officer, will join us for the question and answer period. 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 quarterly report on Form 10-Q filed today, which can also be found on our website at ardalex.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 should change. And with that, I will pass the call over to Mike.

Thank you, Justin, and good afternoon, everyone. It is a great pleasure that I provide you an update on our progress since our last call. First, for Exrella, I'm pleased to report that we continue to make great progress in our launch, laying the foundation for growth and meaningful market penetration of this important product. During these first three months of launch, the commercial team has made significant inroads in building demand for Exrella. Physicians are enthusiastic to have a novel drug added to their treatment armamentarium and are responding favorably to the Exrella first-in-class mechanism and clinical data. Integration of Ibsrella into already established processes across GI offices is driving favorable prior authorization approval rates, thus enabling patient access for Ibsrella. Awareness and intent to prescribe Ibsrella is growing with well-coordinated scientific engagement and education, our high-impact Salesforce efforts, and broad reaching initiatives. Susan will provide more details on the momentum we are building and why we are excited about the important role that we believe Azrella will play in the treatment of IBSC. Turning briefly to Exposon. As we announced in June, we received notification from the FDA that they will convene a cardiovascular and renal advisory drug advisory committee tentatively scheduled for November 16th to gain additional insights into the clinical meaningfulness of the phosphate lowering effect observed in our phase three clinical program for Exposon. We welcome this advisory panel as it will allow the FDA to receive input from treating clinicians to get a better understanding of their perspective on the clinical meaningfulness and significance of the phosphate lowering effect observed in our clinical trials at Exposa. There is strong support within the nephrology community for Exposa bolstered by their belief in the importance of the need for novel mechanism therapies for the treatment of hyperphosphatemia. We are preparing for the adcom with a goal of demonstrating the important role Exposa can play in advancing the management of hyperphosphatemia for patients with CKD on dialysis. We are driven by our limitations and stockholders and know that execution and operational excellence is imperative to our success. We take great pride in our accomplishments across our programs, especially in such a tough market environment. We continue to exercise cash management, and we've undertaken multiple steps to bolster our balance sheet and raise non-diluted capital. In April, we announced an amendment to our license agreement with Oya Kirin, or KKC, our partner in Japan for hypophosphatemia, which may provide us up to an additional $40 million payable in two tranches in return for reduced royalties. The first tranche is expected within the second half of this year following KKC's mission of its application to market tenapenor in Japan. The second tranche is expected within the second half of 2023 following KKC's receipt of regulatory approval to market cunefenol for hyperphosphatemia in Japan. In addition, last month we announced that we had further monetized under the remaining royalties due to us from KKC, under which we may receive up to an additional $20 million. Under the agreement, we received a $10 million upfront payment And additionally, we expect to receive $5 million following KKC's receipt of regulatory approval to market Tanapinor for hyperphosphatine in Japan, and $5 million in the event net sales in Japan exceed a certain annual target level in 2025. In return, healthcare royalty partners will receive the royalty payments and commercial sales milestones that may become due us under our agreement with KKC. In summary, we see ourselves as a highly differentiated revenue-generating biopharmaceutical company. We are in the early phases of launching Ipsirella, an important advancement for the treatment of IBSC. We have an opportunity ahead of us with a November 16th advisory committee meeting to advance our formal dispute resolution process and demonstrate to the committee of the meaningfulness of Exposys phosphate reduction. We have a pipeline of two internally discovered candidates, which include RDX13 for hyperkalemia and RDX020 for metabolic acidosis. and we have a strengthening cash position. This unique position is a result of our dedicated, tenacious, and talented teams across the company. It is evidence of our vision, our science, and our belief in the drugs that we've created, coupled with persistence and a laser focus on the execution of our strategies. Now I'd like to pass the call to Susan to provide an update on the launch of the Zerola. Susan?