Good day, thank you for standing by. Welcome to Akebia'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 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 of Investor and Corporate Communications. Ms. Carrasco, please go ahead. Thank you. Welcome to Akebia'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 David 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. 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. Thank you all for joining us. I wanna begin today by recognizing an exciting milestone that's been years in the making. Last month, the European Commission granted marketing authorization for VAFSEO, vadadustat, approving the product as a treatment for symptomatic anemia associated with chronic kidney disease in adult patients on dialysis. The headline here is that vadadustat 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 Vafseo in Europe late this year. The approval was an important catalyst for Akebia, and it would not have been possible without our dedicated team. If you recall, we assumed responsibility for the marketing authorisation 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 Akebia. 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 vadadustat continues as we remain engaged with the Office of New Drugs, or OND, on our appeal to the vadadustat 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 vadadustat 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 FO2CUS, an alternate dosing study evaluating the efficacy and safety of vadadustat in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent, or ESA, to 3x weekly oral vadadustat dosing for the maintenance treatment of anemia. The data demonstrated that vadadustat 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 3x 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 vadadustat is approved for this dosing schedule, a 3x 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 vadadustat 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. Our 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. With that, I'll ask Dave to talk more about our quarterly financials. Thank you, John. Good morning, everyone. I'd like to begin by addressing Auryxia revenue. It's important to note that we are affirming our annual net product revenue guidance of $175 million-$180 million. While last quarter we noted a significant increase in channel inventory, this quarter there was a significant move against us with a large reduction in Auryxia rev inventory at our selling partners to the tune of approximately $5 million. Auryxia net product revenue in the first quarter of 2023 was $34.8 million compared to $41.4 million in the first quarter of 2022, a 15.9% decrease. We anticipate that with current contracting dynamics, quarterly performance will be a little bit bumpy. We are realizing a higher net price per tablet, approximately 80% higher than three years ago. As a result, changes in inventories in the channel are now much more apparent. Cost of goods sold decreased versus the same period in 2022. We are now what I would call at a normal cost of goods for Auryxia, which will include the $9 million quarterly non-cash Auryxia intangible asset amortization cost through Q4 of 2024. Next, I'll review operating expenses, an area I believe that our team has performed extremely well. In the first quarter of 2023, we realized a nearly 50% reduction in operating expense versus the first quarter of 2022 and a nearly 30% reduction from the fourth quarter of 2022. Our team has been diligent in its efforts to manage, spend, and sustain a reduction in operating costs. Rather than diving into the comparisons, I believe it would be valuable to remind folks of the actions we have taken over the last 12 months while working diligently to further reduce our overhead. Some of those actions and accomplishments include reducing our headcount by more than 55% from Q1 of 2022, reducing external spend on several support functions, occupying less office space, winding down of historical clinical programs, reduction of contractors and consultants, and a reduction of our supply chain commitments to better reflect our current needs, as well as other important activities while still having several value creation activities ongoing, supporting our third strategic pillar. As for cash, with our continued execution of our plan, our cash and Auryxia revenues will allow us to fund our business for at least the next 12 months. We ended the quarter with approximately $57 million in cash on hand. Our debt position has been reduced to $51 million, a 24% reduction from the end of the year. We have significantly reduced our current liabilities. I also want to address our stock price and Nasdaq listing. As many know, we have been out of compliance with Nasdaq's minimum bid price rules for over a year. In an effort to regain compliance, earlier this year, we filed proxy materials proposing amendments to our charter, including a proposal to affect a reverse stock split of our outstanding common stock. The primary purpose for affecting the reverse stock split was to increase the per-share trading price of our common stock so as to regain compliance with the minimum bid price rule and maintain the listing of our common stock on Nasdaq. Unfortunately, the proposal did not pass. We anticipate that we will receive a delisting notice imminently. While we plan to appeal the delisting, Nasdaq is under no obligation to accept the appeal. There could be no assurance that the appeal will be successful. Per Nasdaq rules, the only way to maintain a listing upon completion of the appeal process is to trade over $1, either organically or through a reverse split, for no less than 10 consecutive business days. If our stock does not organically regain compliance during the appeal process, we currently plan to file a new proxy statement seeking approval of a reverse stock split. We appreciate that the majority of our voting shareholders supported the reverse stock split proposals at the special meeting and find value in maintaining a Nasdaq listing. In the meantime, we continue to operate our business as usual and recognize the value that could come from potential near-term catalysts. We extremely proud of our business progress over the last year since we established our new strategic pillars. I'd like to close with a recognition of all the Akebians who have got us here. With that, we'll open the line for questions. Operator? Thank you. As a reminder, to ask a question, please press star one one on your phone and wait for your name to be announced. To withdraw your question, please press star one one again. Standby 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. Thanks. Good morning, thanks for taking my questions. First, just on the vadadustat FDR process, could you just help us understand the communication you've had with FDA on that process, at least to the extent that you can? Just clarify, when did this 30-day clock start? Or just what gives you confidence you'll get an answer from Dr. Stein within 30 days? I have a couple follow-ups. Great. Thanks, Ali. We've been in regular contact. We mentioned that we had a, you know, formal Type A meeting with Dr. Stein last quarter. You know, there's been regular communication, you know, with the project manager as there normally is during an FDA review. We expect to have an answer from Dr. Stein within 30 days, but recall that it's also possible that he'll ask more questions, right, and extend it another 30 days. We don't think that's where it's gonna go, you know, we don't really have insight into, you know, what that next communication will say. While we believe that, you know, he has the information he needs to make a decision, and of course, you know, we feel strongly about where that decision should go, we don't really have any insight into what that communication's gonna be. We're looking forward to seeing that. Of course, I'm sure there'll be ongoing communication over the next 30 days as well, just that regular course of business. Got it. Just on the EU partnership, can you just help us understand what kind of partnerships could be on the table there and just how those discussions have progressed now that you have the approval on hand in Europe and any kind of clarity or visibility on timing there for a partnership? That would be helpful. Thanks. Sure, Ali. It is a very active process. Obviously, you know, as we've been saying all along, you know, having the CHMP vote was important, having the approval in hand and knowing exactly what's in the label, et cetera, you know, really has accelerated that. I guess at the end of the day, you know, you can expect a pretty typical type of a transaction would be my guess at this point. I think the important thing is, you know, the indication is in dialysis is a, you know, is a complicated market. Finding a partner who, you know, really understands that market opportunity, and again, I mean, it's a European approval, but every one of those European markets is different, and dialysis is different within each one. That expertise is really important, and we're weighing that heavily as we weigh between, you know, the options that we think we have for a partnership. You know, again, it's the kind of thing we wanna move quickly because, you know, we want to launch the product as quickly as possible, and we're anticipating that before the end of the year. You know, we wanna be very deliberate and pick the right person who's gonna maximize the value in the long term. Got it. That's helpful. Then just last one from me, just on the FO2CUS trial data, can you kind of walk us through the importance of that, the 3x weekly vadadustat dosing and maybe what venue we could expect to see full data presented or published at? Just seems you'd want to get that data out to docs pretty quickly. Thanks. Yeah, that's exactly right. I mean, as you know, dialysis is delivered 3x a week, hemodialysis in center. You know, we know that home dialysis is gonna be an important market for vadadustat. We've talked about that from the beginning. The once a day oral dosing for vada, you know, is quite important there. Hemodialysis is still a dominant way of delivering dialysis both here and in Europe. You know, having the option for dialysis providers to basically give the patient, you know, their pills while they're on dialysis just simplifies things for everyone, you know, for the dialysis providers and for the patients. You're ensuring their compliance, you know, particularly in the U.S., when you think about TDAPA and the fact that the dialysis providers are buying, you know, the vadadustat, will be buying the vadadustat, you know, if we're approved, you know, they want to ensure that the drug is being taken by the patient. We think that the 3x weekly dosing is quite important. As you referenced, we wanna try to have that data be available as quickly as possible. I know that there is a manuscript that's being worked on. You know, of course the meeting you generally will present data at would be the ASN meeting. We certainly don't know whether the data will be presented there yet, but that would be my expectation. Okay. Got it. Thank you. Thanks, Ali. Thank you. One moment please for our next question. Our next question will come from Ed Arce of H.C. Wainwright & Co. Your line is open. Hi, good morning, everyone. This is Thomas Yip asking a couple questions for Ed. Just perhaps the first question regarding the FDRR process as you alluded to, a response expected within 30 days. Just internally wondering what would you consider to be the best and worst case scenarios? Would you be open to file another round of FDRR if needed? Thomas, thanks for the question. You know, we've kind of described in the past the, you know, what the potential outcomes are for the process. I think those very much hold. The I suppose the worst case scenario is that our appeal is denied and we're referred back to the division. That would be, you know, kinda again, there probably wouldn't be a path forward for vadadustat in the U.S., with that outcome. Obviously, that's not the one we're hoping for. The clearest outcome, positive outcome, then is that the appeal is granted. Remember, this isn't an approval, right? It's an appeal process. If the appeal is granted, then we refile the NDA, and the division has either two or six months, depending on whether they make it a type 1 or 2 submission to review the product again, and then that leads to the approval. You know, with an approved, a granted appeal, I mean, your likelihood of success is extraordinarily high. The third option would be an appeal that's denied, but an identified path forward. You know, from our perspective, that is almost as good as a, an appeal granted, right? FDA is giving you, Dr. Stein, is giving you a clear path forward for approval. You know, we've talked before, maybe that's, you know, holding an AdCom, though we think that's probably unlikely. Maybe it's, you know, some other, something else he puts, forward as, you know, something that allows you to get an approval, something short of more clinical data, right? It's something, an analysis you have, a REMS program, something else that he says, you know, this will give you a path to approval. That's a very common, outcome as we've learned from, you know, these, FDR processes. Got it. Thank you so much for laying out all the scenarios. We appreciate it. Perhaps one question from us. Switching gears to Auryxia. You mentioned in the press release, beyond the loss of exclusivity that's anticipated, March 25th, 2025, what are some possibilities to keep that market going? Can you discuss? Thank you. Yeah, no, it's a great question. Thank you. Right now, the expectation in dialysis, remember where Auryxia is used, is to treat hyperphosphatemia in dialysis patients. Right now, CMS is expecting to add phosphate binders, all oral products that aren't part of the bundle already, to the bundle as of January 1, 2025. What they've said in their last rule is that they're going to have a TDAPA period for these oral products, because right now they don't have the data to know what to add to the bundle payment. If you use the calcimimetics as an example, you know, the Amgen product, they went through their TDAPA period a few years ago, and, you know, you go from being a Part D drug to a Part B drug. CMS collects all of the data on utilization of the products, and then at the end of the TDAPA period, they make a determination for the dollars per dialysis session that they'll be adding to that bundled payment. That's what we expect them to do, looking at the different binders, the utilization of each. For, you know, when you think about this from a dialysis provider's perspective, you know, there's great incentive to, you know, A, treat patients very effectively, so really focus on the treatment of hyperphosphatemia and, frankly, focus on the use of branded products within that, in order to, you know, maximize that, the value of that, of that payment that's added. 'Cause once that's added, it doesn't change. you know, CMS doesn't feel they have the ability to go back and look at that payment again. you know, for those two years, and that's the TDAPA period that's been defined by CMS at this point in time, so 2025 and 2026, there's a real motivation for them to utilize products like Auryxia and utilize the branded products. you know, we'll have to contract directly with the dialysis providers and work with them on their protocols, et cetera, so that they're utilizing the product. It's unlike a situation where, you know, you simply lose exclusivity and generics come in to dominate the market, you know, we think that there's more opportunity there. Even if we get to a situation where we didn't have TDAPA, given the nature of these phosphate binders, if you look at sevelamer, Renagel, Renvela, as an example, even though they lost their patents, the dynamics, the generic dynamics of the amount of product that has to be delivered to a patient is such that there wasn't really significant interest from generic manufacturers to bring the product to market. They had a very long tail on sevelamer. If we see something like that, either through TDAPA or through kinda the normal course, there's very significant revenue still. It'll be a declining revenue stream, to be clear, but one that will need very little sales and marketing investment. You know, significant opportunity for positive cash flow for the company. Understood. That makes sense. Thank you again for taking our questions, really looking forward to the FDR response. Are we. Thanks, Tom. Thank you. This will end the Q&A portion of the conference. I would now like to turn the conference back to John Butler for closing remarks. Thanks, Chris. Thank you all again for joining us this morning. You know, it's hard not to reflect on the progress we've made over the past year since receiving the CRL. We've negotiated an exit with Otsuka that brought $55 million in cash and secured significant global rights. We've continued to drive Auryxia, allowing us to run the company on Auryxia revenue plus our cash on hand. We've completely changed the cost structure of the company. We've worked through the FDR process with the FDA. Most importantly, to date, we took over the European filing and led vadadustat to be approved in Europe. We have what may be even more important milestones ahead in the next months. I really look forward to discussing those with you in the near future. Thanks, everyone. Have a great week. This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.