10/31/2023

speaker
Operator
Conference Call Operator

Good day and welcome to the Ardellis Third Quarter 2023 Earnings Conference Call. All participants will be in a 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 a touch-tone phone. To withdraw your question, please press star then two. Please note, this 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.

speaker
Caitlin Lowy
Vice President of Corporate Communications and Investor Relations, Ardellix

Thank you. Good morning and welcome to our third 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 ardellix.com. During this call, we'll be making forward-looking statements that are subject to risk and uncertainty. 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 10-Q that was filed today and can be found on our website at Ardell.com. Only 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 the third quarter of 2023. Susan Rodriguez, Chief Commercial Officer, will provide an update on the performance of Estrella and the launch of Exposet following its approval earlier this month. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks for the review of the company's financial performance during the quarter ended September 30, 2023, before we open the call to questions. With that, let me pass the call over to Mike.

speaker
Mike Robb
President and CEO, Ardellix

Good morning, everyone, and thank you for joining us on the call. I'm very pleased to be here once again, just a short few weeks after we celebrated the approval of Exposa. With this approval, we now have delivered on our mission to provide patients with medicines that matter for the second time. It is something I am immensely proud of. Today, Susan, Justin, and I will share details on the performance from the third quarter, as well as important updates from the first couple of weeks in the fourth quarter following the announcement of Exposa's approval. Before I hand it over to them, let me share a few of my thoughts on the third quarter and what we expect in the near future for our delits. First, Ibsrella momentum continues. Our quarter-over-quarter growth in Q3 was driven by a clear need patients have for new medicine to address the challenging and sometimes intractable symptoms experienced by patients with IBSC. Ibsrella is establishing a unique role in what has traditionally been thought to be a challenging market to penetrate. We are demonstrating that when you have a novel mechanism product with a strong safety and efficacy profile that is benefiting patients, and when you're thinking differently about marketing innovative products, that you can disrupt markets. Exposa is ready for success. As Susan discussed on our approval call, awareness, interest, and intent to adopt Exposa are high among the nephrology community. The response to our approval has been nothing short of amazing. It is also humbling as we now have the responsibility to deliver for patients. We've received words of congratulations from across the kidney community with nephrologists expressing their excitement about having this novel therapy available to prescribe for their patients. As we've shared, there is significant pent-up demand, and we expect strong uptake at launch. Our sales team is already in the field, and we expect to have exposure at our distributors shortly after the conclusion of ASN's kidney week. The new era for managing hyperphosphatemia among kidney patients is here. Finally, we are well resourced for the foreseeable future. We've carefully and thoughtfully financed the company and have a strong cash position as a result, sufficient to fund the commercialization of Exposa and support the critical ongoing investment in Adrelva. We will also begin investments in R&D in the coming quarters as we work towards the next phase of Ardelix. I will now hand it to Susan. who will share more on Exrella's performance and additional details on the launch activities for Expoza. Susan?

Disclaimer

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