Ardelyx, Inc.

Good afternoon, and welcome to the Ardellix Second Quarter 2024 Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal 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 then one on your telephone keypad. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to Caitlin Lowy, Vice President of Corporate Communications and Investor Relations at Ardellix. Please go ahead. Thank you.

Good afternoon and welcome to our second quarter 2024 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 ardellix.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 the risk factors in our most recent quarterly report on Form 10Q 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 Ross, and Chief Financial and Operations Officer, Justin Wren, will share prepared remarks before we open the call to questions. I will now hand the call over to Mike.

Thank you, Kaitlin, and good afternoon, everyone. It is great to be back together to discuss another quarter of strong performance. Across all fronts, we continue to drive exceptional progress. Izrella's growth momentum continued at a strong pace with another quarter of meaningful gains with revenue growing 25% compared to the first quarter of 2024 and nearly double compared to the second quarter of last year. This performance demonstrates the important role Izrella is playing addressing the large unmet need among patients with IBSC. Every month, we continue to see increases in new and repeat riders as well as new and refill prescriptions. Healthcare providers see their patients having positive experiences with Adrella and are expanding the number of patients and their practices for whom they prescribe. Our market access and affordability program, Ardellis Assist, provides a straightforward path for patients to access Adrella. Adrella is an important and effective treatment option that is bringing relief to more and more patients who, despite previous treatment, continue to experience the debilitating symptoms of IBSC. The potential for Israel is significant and reinforces our conviction that it can achieve at least a 10% share of the IBS prescription market and is well on the path to becoming a billion-dollar product before patent expiry. The launch of Exposa has been remarkable and makes it abundantly clear that patients have needed a different option to manage their phosphorus when binders are insufficient or not well-tolerated. Nephrologists are responding favorably to the benefit exposure is providing their patients that are increasingly integrating exposure into their therapeutic regimens. The consistent feedback from the field is that healthcare practitioners are seeing serum phosphorus improvements in their patients, many for the first time as a result of exposure. These dynamics are translating into significant growth for exposure in only the second full quarter since launch. Throughout the development and commercialization of this important therapy, we've demonstrated how vital it is for us to assume the role we have to advocate for the rights of CKD patients on dialysis. As we discussed during our call in July, we believe that moving Exposa into the Medicare bundle would severely restrict and effectively eliminate access to Exposa for all patients. To allow patients who are now and may in the future benefit from Exfosa to no longer have access to the therapy due to a misguided government payment policy is not acceptable. We believe that CMS is not acting in the best interest of patients and has instead ignored the countless voices from patient, physician, provider communities who have clearly and consistently communicated that oral-only phosphate-lowering therapies do not belong in the bundle. As we have announced in the past month, we have chosen to advocate for patient access to exposure across numerous fronts. First is the Kidney Patient Act. There is significant support for this bill across multiple stakeholder groups, and we call on Congress to act and pass this bipartisan, bicameral legislation and protect access to all phosphate-lowering therapies for all dialysis patients. We announced in mid-July that we filed a lawsuit claiming that CMS's plan to move oral-only phosphate-lowering therapies, including Exposa, into the bundle is unlawful and oversteps its statutory and regulatory authority. In addition, the complaint argues that the plan is incompatible with CMS's own regulations stating that renal dialysis services do not include those services that are not essential for the delivery of maintenance dialysis. We seek relief under the Administrative Procedure Act to enjoin CMS from proceeding with its plan to include Exposa in the bundle and thus eliminate coverage for patients under Medicare Part D beginning January 1, 2025. We are honored to be joined in this lawsuit by the American Association of Kidney Patients, the nation's largest independent kidney patient organization, and the National Minority Quality Forum, the nation's largest minority healthcare research, education, and advocacy organization. Their partnership demonstrates just how significant of an impact this policy will have on patients and how critical it is that we protect patient choice and timely access to phosphate laryngotherapies. we are still early in the process and cannot share details regarding our expectations of timing or success at this point we await confirmation that a government lawyer has been assigned to the case and then we will be able to commence discussions regarding a timeline we are hopeful that there can be some action before the end of the year on the case third With our decision not to apply for TdapA, we believe that we are able to continue making progress on our strategy to maximize patient access to Exposa. As we learn more and make decisions, we are committed to communicating to you as comprehensively as possible. I hope that what you can take away from our past actions and from our approach is that we will exhaust all options available to us to protect patient access to Exfosa and to protect our business. What should be clear from my remarks and from Justin's to come is that our business is growing and our performance during the second quarter demonstrates the strong fundamentals driving this growth. delivering on our priorities, executing our disruptive commercial and market access approach, and remaining committed to the Ardellis mission of putting patients first. Our two first-in-class medicines are bringing meaningful benefits to patients. We are well capitalized, and we are focused on our future, both in terms of our current products as well as pipeline expansion. I will now turn the call to Justin, who will walk through the details of our financial performance. Justin?