Akebia Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the QVS third quarter 2021 financial results. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. And to ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, simply press star 0. With now, I would like to hand a conference over to our first speaker, Mercedes Carrasco. Thank you, and please go ahead.

Thank you, and welcome to Kibia's third quarter 2021 financial results and business updates conference call. Please note that a press release was issued on Thursday, November 4th, detailing our third 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 also be available on our website shortly after we conclude. Joining me for today's call, we have John Butler, our Chief Executive Officer, Dave Spellman, Chief Financial Officer, Del Falkingham, Chief Commercial Officer, as well as Dr. Stephen Burke, our Head of R&D and Chief Medical Officer, who will be available for questions. 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 November 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 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.

Thanks, Mercedes, and thanks, everyone, for joining us today. Well, today we're within five months of the PDUFA target action date for Vatadustat. Our investigational hypoxia-inducible factor, prolohydroxylase inhibitor, or HIF-PHI, currently under review by the FDA for the treatment of anemia due to chronic kidney disease in adult patients, both on dialysis and not on dialysis. As a reminder, Vatadustat is not yet approved. Any discussions or comments we'll make about the potential of Vatadustat are subject to its regulatory approval. We have a tremendous opportunity. to bring a potential first-in-class product to market, a novel oral therapeutic for people living with this disease. And approval has the potential to be a pivotal catalyst for Akibia, and importantly, a step towards delivering on our purpose to better the lives of people impacted by kidney disease. That is what motivates our team, and we're excited about the momentum we've gained as we prepare for launch. Developments over the past quarter continue to increase our confidence in a path for approval and launch success for Vatadustat, including the FDA's completion of our mid-cycle review and release of additional global phase 3 data for Vatadustat during ASN Kidney Week, which just completed this weekend. Our team has also made significant progress preparing for successful launch. including our medical team's efforts to educate physicians, payers, and dialysis organizations about anemia due to CKD and Vatadustat. We're excited about Vatadustat's potential to be the first in class HIF-PHI in the U.S. This is a much larger market opportunity than we anticipated just a few months ago. Of course, we believe Vatadustat can have a significant impact globally as well. The product was launched by our partner, MTPC, just over a year ago in Japan. We're encouraged that the HIF-PHI share of the anemia market continues to grow in Japan, along with Vafcio market share, and that more physicians in Japan have stated an intention to prescribe HIF-PHIs over erythropoiesis stimulating agents, or ESAs. We're proud to have worked closely with our collaboration partner, Otsuka, on the European marketing authorization. which was submitted last month to the European Medicines Agency. We will continue to support Otsuka as the EMA begins the review process. We continue to explore development opportunities for Vatadustat. University of Texas helps 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've been hospitalized due to COVID-19 continues to progress. With the support of their data monitoring committee, UT Health has decided to expand their study beyond the initial 400 patients, an enrollment target they've now surpassed. We look forward to updating you on this study when UT Health completes it. Right now, we are focused on preparing for a successful launch of Atadustat as a treatment for anemia due to CKD, as our PDUFA date is fast approaching. In a moment, I'll ask Del to share some details on our launch preparation. But first, let me share a few words on the market opportunity and our data. I'd like to start with the big picture opportunity. There are approximately 560,000 dialysis patients in the United States, and approximately 90% are being treated with ESAs to manage their anemia. The dialysis data from our phase three program are clear and consistent. We feel very confident that these data support an approval for this patient population. Our phase three data demonstrated that once daily dosing of Atadustat increased hemoglobin in a gradual and steady manner and minimized hemoglobin overshoots compared to darbopoietin alpha and ESA. In the MACE safety analysis, Atadustat demonstrated a hazard ratio of 0.96. with an upper bound of the confidence interval of 1.11, well below the agreed-to target of 1.25 in the U.S. and 1.3 in Europe. Our data published in the New England Journal of Medicine and additional data presented at ASN last week demonstrated no increased risk of thromboembolic events, seizures, or serious infections, and a rate of dialysis-axis thrombosis equal to that of darbopoietin. In the past, we've discussed the importance of home dialysis, which is the fastest growing segment of the market. Data on Vatadustat for treatment of anemia in patients with dialysis-dependent CKD receiving peritoneal dialysis was also presented at ASN Kidney Week. The data demonstrated the ability to titrate hemoglobin into the target range with fewer dose adjustments over time. The ability to dose Vatadustat once daily means PD patients won't have to come into dialysis centers regularly for infusions of ESA. The data presented showed that the safety profile of Vatadustat in patients with dialysis-dependent CKD receiving peritoneal dialysis was similar to what was seen in the overall dialysis program. Our data are encouraging and support the unique value proposition we believe Vatadustat offers, to both the growing number of home dialysis patients and to dialysis providers looking to better support these patients. The impact of anemia on all patients with CKD is significant. We believe in the potential of Vatadustat to help these patients. With U.S. approval, we'll have the potential to address the unmet needs of over half a million adult patients on dialysis and rapidly establish Vatadustat as the new oral standard of care for the treatment of anemia due to CKD. That represents a potential $2 billion market opportunity in the U.S. alone. We believe there are compelling data supporting a positive benefit-risk profile for the use of Vatadustat broadly in patients with CKD, including non-dialysis patients. We remain cautious about receiving a broad label for Vatadustat that would extend to non-dialysis patients with anemia due to CKD. However, we believe we've put forth a compelling and extensive data package in the NDA with respect to the non-dialysis population. We continue to be pleased with our engagement with the FDA and look forward to their decision in March. And with that, let me turn to Dell who will speak to our pre-commercialization activities.