Akebia Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the KBS first quarter 2022 financial results conference call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. If you require any further assistance, please press star zero. Thank you. I would like to hand the conference over to your speaker today. Mercedes Carrasco, Director of Corporate Communications. Please go ahead, ma'am. Thank you.

Thank you, and welcome to Akebia's first quarter 2022 financial results and business updates conference call. Please note that a press release was issued earlier today, Monday, May 9th, detailing our first 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 be available on our website shortly 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. Additional information describing these risks is included in the financial results press release that we issued on May 9th, 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 any of these statements. With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes, and thank you all for joining us. Our first quarter and the weeks since have been extremely eventful for the Akibia team. Given all the moving pieces, I believe it's important to start with an outline of our strategic focus as we reshape Akibia to maximize value and deliver on our purpose. As you know, Akibi received a complete response letter, or CRL, for the company's new drug application for Vatadustat, an investigational oral hypoxia-inducible factor, prolohydroxylase inhibitor, for the treatment of anemia due to chronic kidney disease. The CRL came as a surprise and we're extremely disappointed by the outcome. Regardless, we acted quickly with the goal to both strengthen and secure the company financially, as well as begin to rechart our near-term and longer-term focus. We've organized our strategic focus into three pillars. First, maximizing Arixia performance and corporate-wide cost management. Second, supporting our global partners through Vatadustat review, approval, and launch, as well as additional geographic expansion, and evaluating options for potential U.S. approval. Third, at the appropriate time, thoughtfully investing in our pipeline by developing internal assets and evaluating other strategic growth opportunities. These efforts are intended to create shareholder value. Let me begin with our first pillar. Most critical for our success is maximizing the value of our commercial product, Arixia. Our commercial team has done a great job positioning the product to increase revenue and contribution from the brand. Our financial guidance of $165 to $170 million represents a 17% to 20% annual net revenue growth for the year. We made some important decisions in 2021 that created the opportunity to increase net price to Akibia. Those decisions are beginning to bear fruit now. In addition, we've been very deliberate in our efforts to rationalize costs with a goal to align our spending with our top strategic objectives. We believe this work will enable meaningful value creation in the near term. Again, the goal is to drive ORIXIA 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. Our recently announced reduction in force aligns with our go-forward operating model and strategic plan. Several members of our leadership team will also depart the company over the coming quarters. The planned transition time for each executive is to ensure Akebia is positioned for long-term success. We're very fortunate that we've had a focus on leadership development for a number of years. For example, While Del Falkingham, our chief commercial officer, will be leaving the company at the end of June, he's built an incredibly strong leadership team and, frankly, an incredibly strong commercial organization, which I'm confident will continue to deliver results for Akibia and our patients. For me, losing anyone is tough, but especially losing these leaders and employees who are impacted by this necessary change in direction. They have made lasting contributions to Akibia, Each has helped establish a foundation of talent and culture that will enable us to build for the future. For that work, I'm extremely grateful. Moving to our second pillar. Vatadustat is still a key value driver for Akibia. It's approved in Japan and under review in Europe and several other markets. We will continue to support our partners in their efforts to obtain regulatory approval for and sell Vatadustat outside the U.S. As you recall, our partner Otsuka filed an MAA with the European Medicines Agency for Vatadustat in October of last year. Approval in Europe, if obtained, could drive significant non-dilutive growth capital and potentially benefit thousands of patients. As I've always said, we're committed to all people impacted by kidney disease. That commitment drives our efforts to explore a path forward for Vatadustat in the U.S. as we continue to believe in its benefit as a treatment for anemia due to CKD. The next step available to us is to request an end review conference with the FDA. We're working on the documentation to support that request and expect to submit it to the FDA this quarter. Now on to our third pillar. We've been working hard to build a pipeline beyond the Rixia and Vatadustat. These efforts have become even more important now. In addition to our clinical development pipeline opportunities, We have several promising preclinical stage programs based on internal research that we're currently evaluating. We will take advantage of opportunities to advance our pipeline as appropriate. Building our pipeline and leveraging our excellent commercial organization is a key component of our strategy. We've maintained several important capabilities that we believe continue to make us an appealing partner moving forward. Furthermore, as we've shared, Vatadustat is being studied by the University of Texas Health as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome, or ARDS, in adult patients who've been hospitalized due to COVID-19. UT Health expects to read out of the data from the investigator-sponsored study later this quarter. We look forward to updating you there as appropriate. With that, let me pass it over to Dave to look more carefully at the numbers. Dave?