2/22/2024

speaker
Conference Operator
Moderator

And welcome to the RDELX fourth quarter and full year 2023 financial results 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. Please note this event is being recorded. I would now like to turn the conference over to Kaitlyn Lowy, Vice President of Corporate Communications and Investor Relations at Ardelix. Please go ahead.

speaker
Kaitlyn Lowy
Vice President of Corporate Communications and Investor Relations

Thank you. Good afternoon and welcome to our fourth quarter and full year 2023 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 Ardelix.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 annual report on Form 10-K that was filed today. It 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 the fourth quarter of 2023 and the full year 2023. Next, Susan Rodriguez, Chief Commercial Officer, will provide an update on the performance of Estrella and Xposa. Our Chief Medical Officer, Dr. Laura Williams, will then discuss an Xposa real-world evidence study announced today. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the fourth quarter and full year ended December 31st, 2023, before we open the call to questions. With that, let me pass the call over to Mike.

speaker
Mike Robb
President and CEO

Good afternoon, everyone, and thank you for joining us on the call. I feel like I've said this every quarter, but we are really excited to be here to discuss our progress and performance. The fourth quarter was significant, as was all of 2023, as we continue our evolution as an integrated biotech company, bringing two first-in-class products to patients. Edzarella and Exposa are demonstrating favorable market response with high healthcare practitioner interest and continuously expanding adoptions. In November of last year, we launched Exposa, and the market response, both in terms of treatment uptake and direct feedback we received from the field, has validated what has always been clear to us, that physicians and patients have been waiting for a novel mechanism option to help control serum phosphorus. As you will hear from Susan, all the indicators we track early in launch point to a strong uptake. As we announced today, as part of our commitment to continually build our understanding of the clinical utility of our products, we are conducting a real-world evidence study designed to capture the impact that an exposure-based regimen can have on the treatment of hyperphosphatemia. Laura will review more details about the study during our call today. Turning to Absrella, in January, we shared our enthusiasm for our commercial progress we are making and our expectations for Absrella are high. We shared that we believe Azrella has the potential to become a billion-dollar drug. The patients are there, they need relief, and many of them continue to experience symptoms despite treatment with incumbent therapies, clearly reinforcing the need for novel treatment options like Azrella. Azrella's mechanism of action, solid clinical data, and a growing user base of positive experience is resonating, driving expanding consideration and adoption by more and more healthcare practitioners. With patients' positive experiences with Adrella, ACPs are beginning to change how they engage with and treat their IBSC patients as they are expanding their use of the therapy. In addition, the path for access is established. These are the fundamentals of our commercial strategy, and they are working. As we noted in January, we will always look to expand the opportunity and to ensure our medicines get to those patients who need it. Thus, we are thoughtfully investing in expanding our commercial reach. We are also thinking about what the future of Ardellis will look like, and we find ourselves in a unique and enviable position. We have options. With both Exposa and Adrella approved in the U.S. and doing well, we are engaging potential international partners to bring these products to patients in other global markets. In addition, with our established and proven commercial organization, we are merging as a partner of choice for development stage assets in therapeutic areas where patients continue to have unmet needs. With our successful track record of discovery, development, and regulatory approvals, we also have the opportunity to develop earlier stage assets ourselves. These activities are ongoing, and we look forward to sharing more information when appropriate. In the meantime, our top priority is to focus on sustaining the commercial momentum of Adzarella and Exposa. I will now hand the call to Susan to share an update on our commercial performance. Susan?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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