Good day, thank you for standing by. Welcome to the Akebia Corporate Conference Call. At this time, all participants are in 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 one one on your phone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ms. Mercedes Carrasco, Senior Director, Investor and Corporate Communications. Ms. Carrasco, please go ahead. Thank you, Chris. Welcome, thank you for joining the call this morning. Today, Akebia announced that we have received a written response from the Office of New Drugs of the FDA regarding our formal dispute resolution regarding the complete response letter received in March 2022 for vadadustat. Today, we will discuss the response, next steps in the regulatory process, and provide a general business update related to vadadustat. Please note that a press release was issued earlier today, Tuesday, May 30th, detailing the response, 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. Speaking today, we have John Butler, Chief Executive Officer. Dave Spellman, Chief Financial Officer, Dr. Steven Burke, our Chief Medical Officer, and Ian Hunt, Senior Vice President of Regulatory Affairs, are also on the line and available for questions. 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 press release that we issued on May 30th, 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 thanks everyone for joining us today. It's an exciting day for Akebia. Actually, it's been an exciting week, which began last week with the approval of Vafseo in the U.K., bringing the approval count to 33 countries. By midweek, we had announced the signing of a tremendous partner in Europe with MEDICE, and now we have a clear path forward to resubmit the NDA for a potential approval of vadadustat in the U.S. This is an extremely positive step towards our purpose to better the lives of people impacted by kidney disease. While our appeal was denied, the letter from the Office of New Drugs, or OND, of the FDA outlined a straightforward path for resubmitting our NDA. As suggested in the letter, we plan to request a Type A meeting, followed by resubmission of our NDA, and ultimately, we look forward to potentially making vadadustat available for CKD patients on dialysis in the United States. The letter was a very comprehensive and thoughtful review by Dr. Stein, Director of the Office of New Drugs. Let me summarize the key points that will inform our resubmission. There are two points that we've been focused on with the FDA: vascular access thrombosis, or VAT, and drug-induced liver injury, or DILI. Let me take them one at a time. First, VAT. The complete response letter cited an increased risk of VAT driven by an imbalance in time to first event. We believe the fact that the number of occurrences of VAT is the same in the two arms and that there is no imbalance in downstream consequences of VAT are important considerations in the assessment. To clarify our position, we shared several analyses of the data to support our conclusions during the FDR process. While not dismissing the potential safety signal, the FDR response letter indicated that the extent of the increase in potential risk is not large, and in the end, it may be a reasonable conclusion that the increase in VAT events can be managed as a labeling issue. We agree with this position. Second, the issue of DILI. The CRL noted the potential for an increased risk of DILI with vadadustat. The basis of this concern is largely a single case of serious DILI seen in our phase two program and other assessments by the FDA liver safety team. The CRL raised the concern that monitoring and clinical use, if the drug was to be approved, would be less uniformly implemented when the product's commercially available than it was in the clinical trials. It's apparent from the FDR response letter that the OND did a very comprehensive review of all of the data, as well as its own analyses, and concluded that while there is a signal for DILI, it appears to be modest in intensity and potentially manageable with appropriate monitoring. The OND also acknowledged our comment that dialysis patients already undergo rigorous routine monitoring, so any monitoring in the label is likely to be implemented. During the FDR process, we provided data that showed absence of a DILI signal in the post-marketing experience in Japan, where tens of thousands of patients have received the drug over the past 2+ years. The OND noted that a robust analysis of this data would be helpful for the division to review on the resubmission of our NDA to assess the risk of DILI. The OND concluded the letter by outlining the additional analyses for VAT and DILI that we should include in the resubmission of our NDA. There was no suggestion of the need for new clinical data in the letter. The letter did suggest that we request a Type A meeting with the division to assure alignment on the resubmission. We plan to request the Type A meeting, and we'll do so as soon as possible. After the Type A meeting, we plan to move quickly to resubmit the NDA. We expect to resubmit this year. The exact timing within the year could be influenced by the Type A meeting. Given that we're submitting data that was not in the original NDA, our expectation is that our resubmission would undergo a six-month review. Upon a potential approval, we intend to have drug commercially available quickly, and after the TDAPA application process, the product would be widely available for patients. Again, we're extremely pleased that the letter has outlined the path for resubmission, and our team is already hard at work. Now let's shift to what we believe to be the commercial opportunity. First, I'd like to start with some of the unique dynamics of the commercial dialysis space. Dialysis patients are a unique patient population in the U.S. from a payment perspective. The drugs used in this population are paid for as part of a bundled payment made to the providers. That bundled payment includes the current standard of care, the ESA treatment used to manage anemia. To quantify, we estimate that approximately 88% of the nearly 550,000 patients on dialysis are treated with an ESA for anemia. In an effort to promote innovative drug use, CMS years ago passed a transitional add-on payment adjustment, or TDAPA, that vadadustat would be eligible for approximately six months after approval. This payment would cover the cost of the oral HIF, and as vadadustat would be a replacement for the ESA, provides additional incentive for providers to use vadadustat, as the ESA cost is already captured in the bundled payment. We also have a unique collaboration with CSL Vifor that provides access to up to 60% of the dialysis market through existing CSL Vifor relationships. Recall that CSL Vifor has a relationship with Fresenius Kidney Care for the procurement of therapeutic products used in their network, and vadadustat would be made available through this collaboration. We believe our unique understanding of the dialysis market, partnered with CSL Vifor, would put us in a strong position for success. Our collaboration with CSL Vifor is a profit share, where we retain approximately two-thirds of the profit from vadadustat, net of certain pre-specified costs, with CSL Vifor keeping the remaining one-third. As a reminder, last year, when we were originally preparing for launch, we were in a position where we have to further split our two-thirds profit with our former partner, Otsuka. As a result of regaining our rights in the U.S. from our former partner, our economics are double what they were last year. To summarize, if vadadustat's approved, we believe we're uniquely set up for success in 60% of the market, where we retain two-thirds of the economics within the CSL Vifor channel, and for the other 40% of the market, we would retain 100% of the economics of any sales. Beyond the straight economics, we'd like to remind you of the unique features of vadadustat in this market. Based on its being once daily, it could be ideal for use in home patients, which is the fastest-growing segment of the dialysis market. Also, assuming approval, we plan to pursue an sNDA to potentially include 3 times weekly data in our label based on the recently released positive FO2CUS study. Lastly, from a cash perspective, we're excited that we've completed the recent European partnership with MEDICE and added the upfront, as well as our internal expectations of royalties, commercial milestones, and resources for manufacturing support to our internal cash model. Importantly, we believe that today we have the right scale and ability to support a resubmission, potential approval, and launch within our current operating plan. While we may choose to incur modest additional costs to ensure a successful launch and supply chain rebuild, our prior cash guidance remains. I did want to recognize our new partner in Europe and Australia. In MEDICE, we have found a partner that has deep expertise in nephrology, and importantly, they understand the very specific country-by-country nuances of the dialysis market. We're confident that they share our commitment to Vafseo, and we both believe in its medical and commercial potential. With that, I'll open the line for questions and ask Dave Spellman, Dr. Steven Burke, and Ian Hunt to join us. Thank you. As a reminder, to ask a question, please press star one on your phone and wait for your name to be announced. To withdraw your question, please press star one again. Stand by as we compile the Q&A roster. One moment, please, for our first question. Our first question will come from Allison Bratzel of Piper Sandler. Your line is open. Hi, good morning. Congrats on the update. Thanks for taking my question. I guess just first, can you frame for us the any gating factors to resubmission, topics that need to be worked out or addressed at the upcoming Type A meeting? Just your overall confidence that FDA will find the resubmission approvable in dialysis without the generation of additional clinical data? Ally, thanks so much for the question. Framing, we've already been at work on the resubmission. You know, a lot of it is an update of the safety data, and we had, you know, studies like FO2CUS, that we'd have to add that data. Very importantly for this, the OND focused on how supportive the Japanese experience would be, towards, you know, confirming the low level of DILI risk. The fact that, you know, tens of thousands of patients have been exposed there and have not seen any DILI signal, is incredibly important. There are some analyses we'll need to do of that data. You know, we think that that's the maybe the single gating item, but it's that certainly won't take us very long. The Type A meeting, we'll have to put together a briefing book for that, where we'll ask the questions. The Type A meeting is granted in 30 days. It will happen reasonably quickly. It's possible that the division could ask for particular analyses of that data, or other, you know, VAT analyses, et cetera, that might influence, you know, the speed of the submission. We're getting ready to go as quickly as we can. I think, you know, as soon as we have, you know, that Type A meeting completed, we'll know exactly, we'll be able to give a much tighter timeline. Clearly be this year, but obviously, we'll be moving as early this year as possible. Great. That's helpful. Then just to follow up on FDA's conclusion that the increase in vascular access thrombosis can be a labeling issue. I mean, you know, just looking at the daprodustat label, it already includes a black box warning for MACE and calls out vascular access thrombosis. I mean, should it be our base case assumption that VAD's label would look materially different? That, you know, I guess maybe more broadly, that this or the DILI monitoring will be a major point of differentiation as docs and dialysis centers do implement HIF products going forward? I think that the, you know, looking at the daprodustat label and the VAT black box that already exists there, I would expect that would be similar, if not the same. You know, it's too early to say, you know, on the DILI monitoring, but again, this is not something that, you know. Given the amount of monitoring that dialysis patients already undergo, I can't imagine that there's anything in that monitoring that might be differentiating or certainly a negative. Steve, I don't know if you wanna add a comment to that. I mean, you've spent a lot of time talking to the nephrologist. Yeah, no, I agree. The monitoring should be easy to implement and won't burden the care of the patients. It's really routine. Yeah. I honestly we'll see as we go through the process, but I doubt there'll be anything that would be substantively different than what you see in the daprodustat label. Got it. Well, thanks so much, and congrats again. Thanks, Ally. Thank you. Again, to ask a question, please press star one one on your phone and wait for your name to be announced. One moment, please, for our next question. Our next question will come from Ed Arce of H.C. Wainwright & Co. Your line is open. Great. Congratulations on the path forward, and thanks for taking my questions. I wanted to ask, you know, the letter, as you noted in the release, requested specific information regarding the resubmission. I wanted to know if there was anything else mentioned in there besides vadadustat and DILI. Then separately, you know, how is this path outlined as it is in the letter, similar or different to that offered to Ardelyx? Do you see that as sort of a precedent with the OND? Thanks so much. Thanks, Ed. Thanks for the questions. As I said, it was a comprehensive letter, it did talk about, you know, a number of issues, even issues that had already been agreed upon, if you will, between the parties. Really, you know, as we've been saying, these two issues, VAT and DILI, are the ones that were the real focus and will be the focus of any, you know, these new analyses that we'll include. It was, you know, it was quite comprehensive, but we really focused on the things that matter in our resubmission. The rest, I think, there's good agreement on. You know, this is really the best outcome we could have hoped for, from this review. You know, I mean, as you've mentioned, this was a, you know, the appeal was denied, but a path forward is identified. We've always said that was the most likely outcome, which is, you know, you didn't know what that path might be. This path forward, from my perspective, is almost as good as an appeal granted. You know, they've asked for new analyses, like the Japanese data. You know, it, you know, if you're putting in new analyses, you know, you're not being considered just on the original NDA, which would be an appeal granted, right? It almost has to be, I think, an appeal denied. As I said, I can't imagine a better outcome. Comparing it to the Ardelyx process, I think all of these are unique. I think the similarities that Dr. Stein was incredibly thoughtful and balanced in the way he reviewed the information and incredibly comprehensive. You know, when you read the letter, it was clear that he had done a very detailed analysis of the data and, you know, didn't leave a stone unturned, and we appreciate that. You know, Remember, Ardelyx canakinumab ended up having an AdCom and then a Type A and a resubmission. We're not having an advisory committee meeting here. We're simply having the Type A meeting, going straight to a resubmission. Given that there's new data that's being analyzed, you know, it would call for a six-month review, and we expect that that's what we'll see. Great. Maybe just one follow-up. You mentioned earlier, the FO2CUS data would be included in that resubmission. Perhaps just talk about, you know, how that would fit, not only in the consideration with the agency, but also looking forward to your launch commercially. Yeah. The FO2CUS data will be included in the safety section of the resubmission. you know, we can't ask for the three times weekly dosing regimen in the resubmission, or it would be a fresh NDA. you know, the expectation... You have to include all the safety data that you've generated from the last time you submitted anything to the agency. They'll see that safety data, and then upon approval, we expect that we'll seek an sNDA to add the three times weekly dosing to the label. In the meantime, you know, obviously, we're very pleased with the outcome of that study and, you know, we expect we'll be submitting it to a scientific meeting and publishing it as quickly as we can and letting the market, you know, kind of understand that data. Great. Congrats again. Thanks, Ed. Thank you. To ask a question, please press star one on your phone and wait for your name to be announced. Stand by as we compile the Q&A roster. Speakers, I see no further questions in the queue. I would now like to turn the conference back to John Butler for closing remarks. Thanks, Chris. In closing, we are incredibly excited about the outcome of the FDR process. Honestly, as I said, this is really the best we could have hoped for, and our team is already hard at work on the resubmission. I do wanna thank our full team, who really has worked tirelessly on the process, who never wavered in their belief in the potential benefit of vadadustat. Again, I also wanna thank the FDA for their thoughtful review, and I look forward to speaking to you all again soon with an update. Thanks. Have a great day. This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.