Akebia Therapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Akibia's third quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Mercedes Carrasco, Senior Director of Corporate Communications. Please go ahead.

Thank you. Thank you, and welcome to the TBA's third quarter 2022 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, November 3rd, detailing our third quarter financial results, and that release is available on the investor section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, and Dave Spellman, Chief Financial Officer. Before we begin, I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additionally, information describing these risks is included in the financial results press release that we issued on November 3rd, as well as in the risk factors and management discussion and analysis section of our most recent annual and quarterly reports filed with the SEC. The forward-looking statements on this call speak only as to the original date of this call and, except as required by law, we do not undertake any obligation to update or revise these statements. With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes, and thank you all for joining us this afternoon. Since our last update, our team has been laser-focused on work that aligns to Aqibia's three strategic pillars. First, we're working to drive Arixia revenue while managing costs. And this quarter, we're pleased to again report an increase in net revenue for Arixia over the third quarter of 2021. Second, we continue to support Vatadustat globally. I'll provide more color on the regulatory review processes for Vatadustat as a treatment for anemia due to CKD. Our third pillar is to thoughtfully invest in our pipeline. I'm pleased with the progress we've made with respect to our pipeline, particularly as it pertains to our work in the area of HIF-based science. but today I'll just say a few words about our next steps in continuing to explore Vatadustat as a treatment for acute respiratory distress syndrome. We recognize that we won't have the opportunity to invest in that pipeline and build that long-term value unless we continue to drive financial stability today. Gabe will share more specific details about the financial results, but there are two important headlines in Q3. First, As I previously noted, we continue to see a year-over-year increase in Arixia net product revenue, which is driven by an increase in net price per pill. Second, our team has and is continuing to work to bring down operating costs. We reported a decrease in operating expenses compared to Q222, as well as versus the prior year quarter. Driving Arixia revenue and managing expenses positions Aqibia to make strategic decisions about our future. As we think about potential catalysts to add value, our most immediate is clearly Vatadustat. As we reported last quarter, we regained the rights to Vatadustat from Otsuka in the United States, Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories. Akibia assumed full responsibility for the marketing authorization application, or MAA, submitted to the European Medicines Agency last October and in the United Kingdom, Switzerland, and Australia through the Access Consortium. We're excited about the value of potential approval of Vatadustat in these markets could bring to Akibia. Now based on a typical review timeline for an MAA, we're targeting a potential approval by the end of next quarter. We're eager to bring Vatadustat to patients impacted by anemia due to chronic kidney disease. Now while our team is leading the regulatory process, We do not expect to commercialize Vatadustat in Europe without a partner. Our process for identifying a partner for Europe is well underway. In the US, we recently submitted a formal dispute resolution request referred to as an FDRR with the FDA to appeal the issuance of the CRL for Vatadustat in March of 2022. The FDRR focuses on the favorable balance of the benefits and risks of Vatadustat for the treatment of anemia due to CKD in adult patients on dialysis. We've always believed that Vatadustat delivered a favorable balance of benefits and risks as a treatment for anemia due to CKD and continue to believe in the unmet need. Now, clinicians often publicly discuss the unmet need, as we heard again late last month during a cardiovascular and renal drug advisory committee meeting. And moreover, patients continue to share their experiences related to the burden of the disease. As we reported last quarter, we completed the end of review conference, which was beneficial to refine the issues for the dispute. Again, both the end of review conference and the FDRR narrowed on the dialysis patient population. And the FDRR focuses on the benefits and risks of Vatadustat in light of safety concerns expressed by the FDA in the CRL related to the rate of adjudicated thromboembolic events driven by vascular access thrombosis for Vatadustat compared to the active comparator and the risk of drug-induced liver injuries. Based on the typical FDRR process, AKIBI expects to receive response to its submission from the FDA by the end of this year. And of course, we'll share that outcome with you. It will be important for our long-term planning to have clarity on a potential path towards approval for Vatadusat in the U.S. In the meantime, we continue to explore other potential opportunities for the product that we believe could bring significant value. Recall in our last update we reported data related to Vatadustat as a treatment for ARDS. ARDS is a condition with few therapeutic options approved for intervention and a mortality rate for serious ARDS that can be over 40% according to multiple studies. We were encouraged by the data from a phase two investigator sponsored clinical study evaluating Vatadustat for the prevention and treatment of ARDS in subjects with COVID-19 and hypoxemia. Since that time, we've continued discussions on the design and timing of starting a follow-on placebo-controlled study in a broad ARDS population. We're working closely with UT Health Houston and the team that conducted the phase two study and incorporating FDA feedback on a protocol into the design. As I've said, our financial stability is critical as we invest thoughtfully in our pipeline. To that end, I'd like to compliment our team for their ongoing resilience. The team is committed to the three pillars that will drive our future. They're working to deliver near-term value through Orixia and Vatadustat, as well as create long-term value opportunities for Akibia. And with that, I'll turn to Dave to provide more details on our financial picture.