Akebia Therapeutics, Inc.

Good day, ladies and gentlemen, and welcome to Akibia Therapeutics' first quarter of 2021 Financial Results and Business Update conference call. As a reminder, this call is being recorded. I would now like to introduce your host for today's event, Kristen Shepard, Senior Vice President of Investor Relations with Akibia.

Thank you, and welcome to Akibia's first quarter 2021 Financial Results and Business Update conference call. Please note that the press release detailing our results for the first quarter was issued earlier this morning and 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 shortly after we conclude today's call. Joining me for today's event is John Butler, our Chief Executive Officer, and David Spellman, our Chief Financial Officer. Before we begin, I'd like to remind everyone that this call includes forward-looking statements Each forward-looking statement contained in this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information regarding these factors is described in the forward-looking statement section of the press release we issued earlier today, as well as in the risk factors and management's discussion and analysis sections of our most recent annual and quarterly reports filed with the SEC. The four 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 obligation to update or revise any of these statements. With that, I'd like to introduce our CEO, John Butler. John?

Thank you, Kristen, and thank you all for joining us today. Akiba is off to a great start in 2021, building positive momentum with solid execution on strategic priorities that set the stage for an exciting year. Most importantly, in late March, we submitted the Vatadustat new drug application to the FDA. Our comprehensive NDA submission package includes compelling data from over 8,000 patients across 36 clinical trials of Vatadustat, including our most recent global phase three program. We remain confident in both the clarity and quality of this data package. Submitting the NDA has been our highest priority since reporting our top-line results in 2020. It's a significant milestone for our company, our partner Otsuka, patients, and the entire kidney community. Although our team and our colleagues at Otsuka have extensive experience with regulatory submissions and interfacing with regulatory authorities, this is the first NDA for Akibia as a company. As an organization committed to bettering the lives of people impacted by kidney disease, we're excited to be advancing our lead product candidate and be one step closer to helping address the needs of people living with anemia due to CKD. On behalf of Akiva, I want to express our deepest appreciation to everyone involved in this program, including the physicians, investigators, site coordinators, and most importantly, the patients. We look forward to engaging with the FDA on our NDA and plan to provide an update on our submission at the end of this month. In addition to submitting the NDA, our team has also been hard at work supporting the independent Executive Steering Committee for the Vatadustat Global Phase III Program as they present and publish our Phase III data. Topline data has been presented at medical meetings, including ASN, and the methods papers for both programs have been published in peer-reviewed journals, Nephrology Dialysis and Transplantation, and the American Heart Journal. On our last call, we shared our expectation that the results manuscripts for our Phase III program would be published in a top-tier journal. We are honored that the results of both Innovate and Protect have been published in the New England Journal of Medicine. We believe acceptance and publication in the New England Journal reinforces the scientific rigor and quality of the development program, as well as the clarity of the data for the broader medical community. We're also proud as we believe these publications mark the first time that comprehensive Phase III efficacy and MACE safety results have been published in a peer-reviewed journal for a product candidate in the HIF-PHI class. The lead authors of these publications are Drs. Glenn Chertow from Stanford and Kai-Yui Eckart from Berlin, who are also the co-chairs of the Independent Executive Steering Committee for both Innovate and Protect. Doctors Chertau and Eckart and the entire committee, in collaboration with Akibia, designed the Global Phase III Program after extensive dialogue with the FDA and European regulators. This work included aligning with regulators on the details of our statistical analysis plan, the pre-specified analyses, and the non-inferiority margins. Publication of both innovate and protect efficacy and safety results in the New England Journal further demonstrates a collective commitment to transparency. And having recently submitted our NDA for Betadustat to the FDA, the timing of these publications could not have been better. Feedback and interest in these publications from key opinion leaders and the broader kidney community has been very positive. Subject to regulatory approval of Vatadustat, we believe these publications will be highly informative for physicians, patients, dialysis providers, and payers as they make important decisions about patient care, and potentially a key consideration when differentiating among HIFs in the class, as well as differentiating Vatadustat from treatment with ESAs. Of course, these are the initial results manuscripts. Given the richness of the data set we generated across the program, we anticipate additional data publications will not only inform physicians, but also have the potential to drive adoption of Vatadustat subject to FDA approval. Having successfully executed on the NDA submission and peer-reviewed publications, let's turn to the next phase of our story. The opportunity ahead of us is very clear, and our goal is for Vatadustat to become the oral standard of care for adult patients with anemia due to CKD. And, of course, my comments regarding the launch of Adadustad, its adoption and use, are all subject to its regulatory approval. We are progressing many exciting elements of our business plan towards ensuring the successful launch of Adadustad. Now, let me start with dialysis. We believe dialysis represents a potential $2 billion market opportunity in the U.S. alone. We're confident that upon approval, will have the potential to address the unmet needs of over 500,000 adult patients on dialysis in the US and rapidly establish Vatadustat as the new oral standard of care for the treatment of anemia due to CKD. We anticipate that the consistency and clarity of our dialysis data, bolstered by recent publications in the New England Journal, will play a meaningful role in helping dialysis providers develop treatment protocols which are critical to driving adoption in the dialysis market. To further strengthen Vatadustat's potential profile for in-center dialysis patients, we're conducting two studies, one led by our partner, Otsuka, to demonstrate that Vatadustat can also be dosed three times a week. We plan to have data from these studies available at launch, and assuming the data are positive, use them to support a supplemental NDA for this dosing regimen post-approval. Although the significant majority of dialysis patients are cared for in center, several factors including the COVID-19 pandemic are supporting a growing shift towards home dialysis. Based on reports from the largest dialysis providers, home dialysis appears to be the fastest growing segment of the dialysis population. These trends are exciting as we believe that as a convenient once daily oral therapeutic, Vatadustat has the potential to offer an important value proposition both to the growing number of home dialysis patients and to dialysis providers looking to better support these patients, simplify administration, and grow their home programs. In fact, data from our Innovate program showed that the results in the subgroup of patients receiving peritoneal dialysis, the largest segment of home dialysis, were similar to the overall population. We very much look forward to presenting these data at a future medical meeting and sharing where appropriate with dialysis providers. With our planned commercial launch and strategic alignments, we believe that we can support rapid adoption of Vatadustat in the dialysis market. We intend to leverage our existing nephrology-focused commercial organization with our partner Otsuka sharing in the launch costs and responsibilities. Understanding the dynamics of the dialysis industry, we strategically positioned Vatadustat for potential rapid adoption in up to 60% of the U.S. dialysis market via an exclusive distribution relationship with V4 Pharma. Adding to this is a unique reimbursement model in the U.S. dialysis market with TDAPA, an add-on payment to the bundle that's intended to encourage adoption of innovative therapies by clinicians and dialysis providers. We continue to believe that the commercial and operational advantages with this go-to-market strategy will be meaningful to both our near-term and long-term growth potential in this market. We're also continuing to advance our launch preparedness activities. These activities include ongoing cultivation of key medical expert and patient advocacy relationships, development of the Vatadustat brand, Salesforce optimization, and market access activities. We're encouraged by the growing awareness at society and medical meetings where HIF-PHI's potential in treating anemia are a focal point of both sessions and discussions. Again, there's a significant unmet need among patients with anemia due to CKD, and we see a promising opportunity in Vatadustat to advance the standard of care for patients on dialysis. I'm turning to non-dialysis. As I mentioned earlier and consistent with our prior comments, we submitted our NDA for Vatadustat pursuing a broad label for both adult patients on dialysis and adult patients not on dialysis. While we remain cautious for approval in non-dialysis, we believe we've put forward a compelling and extensive NDA data package, and we look forward to working with the FDA in the review of the efficacy and safety data. Now shifting gears to performance of our existing commercial product, Erixia. Despite the ongoing negative impact of COVID-19 on dialysis patients, We're encouraged with Arixia's performance in the first quarter. We continue to be pleased with how the market is viewing Arixia's strengths. And importantly, our team continues to do a great job supporting our customers and patients, getting our therapies to those in need. We're also proud that through our work with industry groups, including kidney care partners, we were able to assist in helping the administration prioritize vaccines for these patients who are among the most at risk for COVID. We're hopeful that as the industry continues to focus on prioritizing vaccines for dialysis patients, COVID-related hospitalizations and mortality steadily decline. In summary, we accomplished a great deal, both in the first quarter and more recently with the New England Journal of Medicine publications, setting the stage for what's shaping up to be an exciting year. Fundamental to our success is the team's ongoing execution of our strategic objectives. So I'd like to wrap up with an overview of potential catalysts we are executing on for 2021. Based on standard FDA review timelines, the FDA has a 60-day period to determine whether the NDA is complete and acceptable for review. Given this, we'd expect to provide an update on our NDA submission at the end of this month. Outside the U.S., we're working in close collaboration with Otsuka on Vatadustat's MAA submission to the European Medicines Agency, which is expected this year. We continue to explore potential development opportunities for Vatadustat and look to share more information on these efforts later this year. And where possible, any updates from UT Health regarding their ongoing investigator-sponsored study of Vatadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome, or ARDS, in adult patients who have been hospitalized due to COVID-19. With a recent $5 million grant from the Department of Defense, UT Health has expanded the study to target 400 patients and currently has over 220 patients enrolled. As I mentioned, we also continue to execute on our publication strategy. We look towards additional presentations of our phase three results and data, including oral presentations of the hematologic efficacy of Vatadustat from both Innovate and Protect at the upcoming ERA-EDTA virtual medical meeting in June. and presentation of Innovate's home dialysis data, among others, at future medical conferences and in peer-reviewed journals. Lastly, as we move closer to the potential launch of Adadustat, we'll also look to share progress on our pre-commercial activities. We are pleased to be doing all of this from a place of financial strength, with a cash runway that extends beyond the expected U.S. launch of Adadustat, assuming timely regulatory approval and the receipt of associated regulatory milestones. And as Dave will discuss, we successfully executed on some key financial as well as operational priorities during Q1, and we remain committed to both maintaining a strong balance sheet and improving our cost structure moving forward. We are excited about the future. And together with our collaborator, Otsuka, we look forward to bringing Vatadustat for the treatment of anemia due to CKD to patients globally upon approval. I'll now turn the call over to Dave, who will review our financial results.