Akebia Therapeutics, Inc.

Thank you for standing by. Welcome to the Akibia's first quarter 2023 financial results conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star 1-1 on your phone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. And I would now like to hand the conference over to your speaker today, Ms. Mercedes Carrasco, Senior Director of Investor and Corporate Communications. Ms. Carrasco, please go ahead.

Thank you. And welcome to Ikebia's first quarter 2023 financial results and business updates conference call. Please note that a press release was issued earlier today, Monday, May 8th, detailing our first quarter financial results and that release is available in the investor section of our website. For your convenience, a replay of today's call will 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. I'd like to remind everyone that the 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 8th, 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 of the original date of this call and except as required by law, we do not undertake any obligations 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. I want to begin today by recognizing an exciting milestone that's been years in the making. Last month, the European Commission granted marketing authorization for Vafseo, Vatadustat, approving the product as a treatment for symptomatic anemia associated with chronic kidney disease in adult patients on dialysis. The headline here is that Vataducet is now approved in 32 countries. We're extremely proud of this accomplishment and are eager to bring Vafseo to market in Europe and beyond, delivering an additional oral therapeutic option to patients on dialysis with anemia. To that end, I'll note that our priority in Europe is to quickly complete a partnership with a company that truly understands the complexity of the dialysis market across Europe and who will make Vafseo a priority for the more than 325,000 dialysis patients across Europe who are currently treated for anemia due to CKD. We're running a very active process, and we look forward to announcing our partner, then collaborating with them to support a launch of AFSEO in Europe late this year. Again, the approval was an important catalyst for Akibia, and it would not have been possible without our dedicated team. If you recall, we assumed responsibility for the marketing authorization application last summer, and we worked to remain on track for approval. I'm proud of the team's demonstrated commitment to patients and to Akibia. I'm also grateful for the patients, physicians, investigators, and site coordinators who participated in our clinical trials that led to the approval. In the U.S., our work towards a potential approval for Vatadustat continues, as we remain engaged with the Office of New Drugs, or OND, on our appeal to the Vatadustat Complete Response Letter, or CRL. Last quarter, we met with Dr. Peter Stein, Director of the Office of New Drugs, and the deciding authority on our appeal. Since that time, Dr. Stein indicated he has completed his internal discussions with experts within the OND, and we anticipate a response within the next 30 days. We continue to believe in the potential benefits Vatadustat can deliver as a treatment for anemia due to chronic kidney disease, and we believe in the overall market opportunity for that indication. In fact, last month, we announced positive top-line results from FOCUS, an alternate dosing study evaluating the efficacy and safety of Vatadustat in hemodialysis patients who were converted from a long-acting erythropoiesis stimulating agent, or ESA, to three times weekly oral Vatadustat dosing for the maintenance treatment of anemia. The data demonstrated that Vatadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA in the treatment of anemia due to chronic kidney disease in patients on hemodialysis when used three times a week at the time of dialysis and with a comparable safety profile to the current standard of care. We believe the positive top line results are important because if Vataducet is approved for this dosing schedule, a three times weekly dosing schedule aligns with in-center hemodialysis visits, ensuring patient compliance. Again, I want to extend our sincere appreciation to everyone involved in this study, as it was a significant undertaking, and we are very pleased with the results. You'll recall we're also working with UT Health evaluating Vatadustat as a treatment for acute respiratory distress syndrome, or ARDS. Since our last update, I'll confirm that we continue to work with UT Health to design and initiate an adequate, well-controlled study in a broad ARDS patient population, and we expect to enroll patients this year. As strategic business decisions and our team's adherence to our strategic focus has enabled us to live up to our purpose to better the lives of people impacted by kidney disease. We know there are many potential catalysts ahead in the near term, and we look forward to reporting on them as we continue to execute against our strategic plan. And with that, I'll ask Dave to talk more about our quarterly financials.