Akebia Therapeutics, Inc.

Hello and welcome to the QBIS second quarter 2022 financial results. 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 your question, you may press star then one on your telephone keypad. 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 Mercedes Carrasco, Senior Director of Corporate Communications. Please go ahead.

Thank you, and welcome to TBI's second quarter 2022 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, August 4th, detailing our second quarter financial results, and that release is available on our investor section of our website. For your convenience, a replay of today's call will also be available on our website shortly after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, Steve Burke, Chief Medical 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. Additional information describing these risks is included in the financial results press release that we issued on August 4th, 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 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. Our team has spent the quarter working to make notable progress to align with our refined strategic focus and reshape Akebia. As you all know, in May, we outlined the strategic pillars for Akebia in the wake of the unexpected CRL for Vatadustat from the FDA. We are working to first drive Arixia revenue and identify cash management opportunities with the objective to enable Akibia to manage the company with existing cash resources and ongoing cash from operations. Second, support our partners selling and seeking approval for Vatadustat globally. This includes potential EMA approval and European launch through a new partner, as well as evaluate the path for potential U.S. approval. And third, thoughtfully invest in our pipeline of internal assets and assess other strategic growth opportunities. Now let's begin with Arixia, our existing commercial product. Today, we're reporting 32% revenue growth for Arixia over the same quarter last year, and a 5% increase over the first quarter of 2022. We believe the progress on Arixia revenue growth is critical for our success moving forward. Despite challenges in the dialysis centers, our commercial team has delivered increased net revenue again this quarter. We've increased our 2022 Arixia revenue guidance to $170 to $175 million, raising both the top and bottom end of the guidance range by $5 million. In addition to revenue growth, we've taken significant steps towards reducing our cost structure. I'm equally pleased and impressed with how our team has responded to that challenge, We're working efficiently and prioritizing the most critical business initiatives that we believe will drive value. Dave will talk through specific cost management processes and savings that we've realized in Q2. Now shifting to our second pillar, advancement of Atadustat globally, we continue to believe in the potential of Atadustat as an oral treatment for patients with anemia due to chronic kidney disease. We're pleased to have successfully regained the rights to Atadustat from Otsuka in the United States, Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories. Vatadustat is currently under review by the EMA. From day one of the EMA process, we worked very closely with our former partner on the initial marketing authorization application, or MAA, and we're well positioned to assume full responsibility for the MAA. The review is proceeding on the expected timeline with a potential approval early next year. To note, Vatadustat is also under review in the United Kingdom, Switzerland, and Australia through the Access Consortium. Our team is working through the review processes in these markets, and we're excited about the value of potential approval of Vatadustat in these markets could bring to Akibia, as well as to the patients who are impacted by anemia due to chronic kidney disease. While our team is executing the regulatory process, we do not believe we would commercialize Vatadustat in Europe without a partner. To that end, we've begun a process for identifying a partner for Europe. In the U.S., last quarter we noted that we would engage with the FDA to determine a path for potential approval for Vatadustat. We completed the end of review conference with the agency, the first step in the process. We felt it was a constructive dialogue. We've not yet received minutes from the meeting, so we will not be discussing any detail from the meeting at this time. Now on to our third pillar. Earlier today, we shared data from a Phase II investigator-sponsored clinical study evaluating Vatadustat for the prevention and treatment of ARDS in subjects with COVID-19 and hypoxemia. We're extremely pleased with the study UT Health used and ran. and thank them for their leadership. We also want to thank the patients who participated in the study, as well as their families. While Vatadustat did not meet the primary endpoint in the study, we're still very excited about the data and believe that Vatadustat has the potential to impact ARDS broadly, a condition with few therapeutic options approved for intervention. To design our development plan, we plan to spend more time analyzing the full data set, but also consult additional experts and ultimately speak to the FDA. But today, we believe Vatadustat as a potential treatment for ARDS might be an important addition to our pipeline. Now, of course, this could be even more valuable now that we've re-secured full rights to Vatadustat in the U.S. and Europe. And with that, let me pass it over to Steve to provide more details on the study.