Akebia Therapeutics, Inc.

Good day, ladies and gentlemen. Thank you for standing by, and welcome to our KPS Fourth Quarter 2022 Financial Results Conference call. At this time, all participants are in 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 1-1 on your telephone. You will then hear an automatic message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Mercedes Carrasco, Senior Director of Corporate Communications. Please go ahead.

Thank you, and welcome to Atebia's fourth quarter and full year 2022 financial results and business updates conference call. Today, we also celebrate World Kidney Day, an opportunity to raise awareness for kidney health and recognize all those in the kidney community who share in our purpose to better the lives of people impacted by kidney disease. Joining me for today's call, we have John Butler, Chief Executive Officer, and Dave Spellman, Chief Financial Officer. A press release was issued earlier today, Thursday, March 9th, detailing our fourth quarter and full year 2022 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. 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 March 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 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. Everyone at Akebia has entered 2023 with renewed optimism. Through the past year, our team's work and the strategic decisions we've made have put us in a position to thrive as a company. We continue to engage with the kidney community and support our patients on anorexia. We've advanced the regulatory process for Vatadustat in Europe to a point where we're now approaching a potential marketing authorization. And we're excited to look ahead as we evaluate and drive potential pipeline expansion opportunities. including developing hypoxia-inducible factor prohydroxylase inhibitor compounds for potential indications of serious unmet need. We have a team that works with purpose, and I'm proud of their accomplishments, as they've delivered a company today with a strong revenue base, multiple near-term catalysts, and mid- and long-term product development opportunities. Now, let's begin with Arixiax. In 2022, we reported net product revenue growth of nearly 25% over 2021, exceeding the revenue target guidance we established mid-year. Achieving net product revenue growth, while the phosphate binder market continues to decline, is a credit to our dedicated commercial team that works hard to ensure thousands of patients have access to Arixia. Last year, we launched a new commercial model that aligns to customer objectives. We believe the model will enable our team to continue high-touch engagement with high-value individual prescribers and entities that are focused on delivering coordinated, cost-effective care for advanced CKD patients, including those receiving dialysis. Orixia net product revenue is integral to our operating plan as we continue to support the regulatory processes for Vatadustat globally and invest in our other drug research and development activities. Regarding Vatadustat, we're quickly approaching a potential milestone. In late February, the Committee for Medicinal Products for Human Use, or CHMP, of the EMA adopted a positive opinion recommending that the European Commission approve Vafcio, Vatadustat, for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. We anticipate a potential marketing authorization for Vapcio to be granted by the EC in May of this year, which would be applicable to all 30 European Union member states and affiliated countries. Beyond the EU, we also anticipate a regulatory decision for Vatadustat for access consortium countries, the UK, Switzerland, and Australia later this year. We are dedicated to delivering an oral treatment option to patients with anemia due to chronic kidney disease and continue our efforts to select a potential partner in Europe to commercialize Vafsio if approved. We don't expect to formalize a partner engagement until sometime after Vafsio receives marketing authorization, but we're deeply engaged in the process to select a partner that can maximize the potential value of Vafsio while quickly reaching appropriate patients. A Vafsio marketing authorization in Europe would mean that a DO-STAT would be approved in 31 countries as it's currently approved and marketed in Japan by MTPC for dialysis-dependent and non-dialysis-dependent adult patients. We believe in the favorable benefit-risk profile of Vatadustat, and to that end, we continue to pursue a potential path for approval in the U.S. for patients on dialysis. Last year, we submitted a formal dispute resolution request with the FDA regarding the complete response letter for Vatadustat, specifically related to adult patients on dialysis. In February of 23, we received a second interim response from the FDA, indicating that due to agency resource constraints and staffing needs, Dr. Peter Stein, the director of the Office of New Drugs, or OND, will serve as the deciding authority for the appeal. Dr. Stein has indicated he will seek internal consultation with nephrology, cardiology, and liver safety experts in the OND to complete the review. And we expect to receive a response 30 days from when Dr. Stein completes his discussions. We continue to engage with Dr. Stein and the OND, and we'll update investors on this process as appropriate. Now, Vanadu said it's also being evaluated for other indications, notably acute respiratory distress syndrome, or ARDS. Last year, we shared data from an investigator-sponsored clinical study with UT Health evaluating Vatadustat for the prevention and treatment of ARDS in patients with COVID-19 and hypoxia. Since that time, we've continued to work with UT Health to plan an adequate, well-controlled study in a broad patient population beyond COVID-related ARDS in an acute setting. And we expect that study to begin enrolling patients this year. Within our four walls, we have the expertise to innovate and develop medicines to address patients' unmet needs. Further, our commercial team continues to keep us connected to patients while also enabling a product revenue stream to fund operations and pipeline expansion. To that end, we're also actively assessing regulatory and development paths for Vatadustat in other acute treatment indications. This year, we also plan to advance preclinical development of multiple novel HIF-PHI compounds for serious disease areas with limited or no treatment options, such as acute kidney injury. Our patient focus drives us thoughtfully to invest in new programs to expand our pipeline. We're eager to do that as we look forward into 2023 and beyond. Again, we're able to do this because of the financial base we've strengthened through the past year. And to that end, I'll ask Dave to talk more about our operating plan and our financials.