Ardelyx, Inc.

Good afternoon, and welcome to Ardelix's fourth quarter and year-end 2021 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. 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. Sir, you may now begin.

Thank you. Good afternoon, everyone, and welcome to our first financial results call, a practice we intend to implement going forward as we march toward becoming a commercial stage company. 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 ardalex.com. On the call with me today are Mike Robb, President and CEO, and Susan Rodriguez, Chief Commercial Officer. 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 annual report on Form 10-K, which we filed today. It also 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. With that, let me pass the call over to Mike.

Thank you, Justin, and good afternoon, everyone. It's exciting for me to kick off what will now be quarterly calls on the eve of launching our commercial product, Idsrella, in the coming weeks. What is so important to understand about Idsrella is that it represents a significant advance in innovation in for treating irritable bowel syndrome with constipation in adults. With over 5 million prescriptions written annually, there remains a significant unmet need for many of those patients. Compared to current treatment choices, Ibsrella provides a unique mechanism of action, offering physicians and patients a different option to address the debilitating impact of IBSC. Today's dynamics around the IBSC market, and particularly with Ibsrella, make it a very compelling opportunity for patients, the company, and our shareholders. This is a significant inflection point for Ardelix, and we are excited to bring our innovative product to market as a commercially focused organization. I would like to review a few key points. Number one, we see a highly favorable dynamics as we prepare for launch. The IVSC market has been cultivated and expanded over the past 10 years and is ripe for a differentiated product with a unique mechanism of action. Two, the established prescription market includes over 1.6 million IBSC patients treated with currently available therapies, with at least 35% of whom are inadequately managed and in need of effective treatment alternatives. Three, this is a highly concentrated market with 9,000 physicians responsible for approximately 50% of the over 5 million annual scripts for IBSC. This is a dynamic that is ideal for our focus, targeted, specialized sales force, all of whom have been hired, trained, and are preparing for launch. And four, based on thoughtful, well-considered assumptions of mid to high single-digit penetration in the IBSC market, we expect to achieve peak annual net revenue of over $500 million with a clear path ahead of us to achieve break-even and ultimately profitability for the product which we believe will create significant shareholder value. Susan will review our Absrella launch plans in more detail later on the call. But before that, I'd like to update you on the progress we were making at the FDA with our formal dispute resolution efforts for hyperphosphatina and hyperphosphatemia. To remind you, our initial appeal was filed with the FDA's Office of Cardiology, Hematology, Endocrinology, and Nephrology on December 2nd of 2021. Following an information request from the office on December 22nd, we submitted additional analyses on January 7th of this year. As we had anticipated, on February 4th, we received an appeal denial letter from the office. Also in February, we then filed our second appeal to the Center for Drug Evaluation and Research, Office of New Drugs. If accepted for consideration, we expect a decision on the second appeal in April of this year, and we'll keep you updated as progress is made. Meanwhile, Koya Kirin, or KKC, our partner for tenafinor in Japan, has now completed three of four planned phase three studies in adult patients on dialysis, and although we're not yet able to disclose the results of their studies, on February 7th, KKC announced positive results from one of their phase three studies and their plans to file for approval of tenapenor in Japan in the second half of 2022, with potential regulatory clearance in the second half of 2023. Tenapenor continues to offer great promise as an important and novel treatment for hyperphosphatemia for adult patients with chronic kidney disease on dialysis. The comprehensive clinical data generated for tenapenor in this indication are consistent and support its safety and efficacy as a twice-daily oral therapy. We will continue to push the FDA dispute resolution process on behalf of patients and their treating physicians whom we know deserve better therapeutic alternatives to address the challenges of managing serum phosphorus. In addition, we continue to advance our small molecule potassium secretagogue program, RDX013, as a potential treatment for hyperkalemia. We are in the process of evaluating the efficacy, safety, and pharmacodynamics of RDX13 in adult patients with hyperkalemia from our Phase II study, with the next steps to be determined based on the final analyses of these results, continued formulation development, and sufficient financial resources. We also continue to make progress with our RDX020 program, a bicarbonate exchange inhibitor, to treat metabolic acidosis, a highly prevalent comorbidity in CKD patients that is strongly correlated with disease progression and adverse outcomes. We have identified lead compounds that are potent, selective, and proprietary inhibitors of bicarbonate secretion. We continue to advance this program utilizing third-party CROs. To summarize, Ardellis is well-positioned with an approved product, launching in a large market with few competitors, a strong pipeline of internally discovered drug candidates, a talented team that will drive our success, and an anticipated revenue stream that has the potential to transform the company into a profitable entity. To that end, I believe that we are uniquely poised to weather projected near-term market volatility with much higher probability for long-term success. Now, I'd like to pass the call to Susan to share details on the launch. Susan?