Akebia Therapeutics, Inc.

Good day, ladies and gentlemen. Thank you for standing by, and welcome to our KPS Fourth Quarter 2022 Financial Results Conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automatic message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Mercedes Carrasco, Senior Director of Corporate Communications. Please go ahead.

Thank you, and welcome to Atebia's fourth quarter and full year 2022 financial results and business updates conference call. Today, we also celebrate World Kidney Day, an opportunity to raise awareness for kidney health and recognize all those in the kidney community who share in our purpose to better the lives of people impacted by kidney disease. Joining me for today's call, we have John Butler, Chief Executive Officer, and Dave Spellman, Chief Financial Officer. A press release was issued earlier today, Thursday, March 9th, detailing our fourth quarter and full year 2022 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 after we conclude. 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. Additionally, information describing these risks is included in the financial results press release that we issued on March 9th, 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 thank you all for joining us. Everyone at Akebia has entered 2023 with renewed optimism. Through the past year, our team's work and the strategic decisions we've made have put us in a position to thrive as a company. We continue to engage with the kidney community and support our patients on anorexia. We've advanced the regulatory process for Vatadustat in Europe to a point where we're now approaching a potential marketing authorization. And we're excited to look ahead as we evaluate and drive potential pipeline expansion opportunities. including developing hypoxia-inducible factor prohydroxylase inhibitor compounds for potential indications of serious unmet need. We have a team that works with purpose, and I'm proud of their accomplishments, as they've delivered a company today with a strong revenue base, multiple near-term catalysts, and mid- and long-term product development opportunities. Now, let's begin with Arixiax. In 2022, we reported net product revenue growth of nearly 25% over 2021, exceeding the revenue target guidance we established mid-year. Achieving net product revenue growth, while the phosphate binder market continues to decline, is a credit to our dedicated commercial team that works hard to ensure thousands of patients have access to Arixia. Last year, we launched a new commercial model that aligns to customer objectives. We believe the model will enable our team to continue high-touch engagement with high-value individual prescribers and entities that are focused on delivering coordinated, cost-effective care for advanced CKD patients, including those receiving dialysis. Orixia net product revenue is integral to our operating plan as we continue to support the regulatory processes for Vatadustat globally and invest in our other drug research and development activities. Regarding Vatadustat, we're quickly approaching a potential milestone. In late February, the Committee for Medicinal Products for Human Use, or CHMP, of the EMA adopted a positive opinion recommending that the European Commission approve Vafcio, Vatadustat, for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. We anticipate a potential marketing authorization for Vapcio to be granted by the EC in May of this year, which would be applicable to all 30 European Union member states and affiliated countries. Beyond the EU, we also anticipate a regulatory decision for Vatadustat for access consortium countries, the UK, Switzerland, and Australia later this year. We are dedicated to delivering an oral treatment option to patients with anemia due to chronic kidney disease and continue our efforts to select a potential partner in Europe to commercialize Vafsio if approved. We don't expect to formalize a partner engagement until sometime after Vafsio receives marketing authorization, but we're deeply engaged in the process to select a partner that can maximize the potential value of Vafsio while quickly reaching appropriate patients. A Vafsio marketing authorization in Europe would mean that a DO-STAT would be approved in 31 countries as it's currently approved and marketed in Japan by MTPC for dialysis-dependent and non-dialysis-dependent adult patients. We believe in the favorable benefit-risk profile of Vatadustat, and to that end, we continue to pursue a potential path for approval in the U.S. for patients on dialysis. Last year, we submitted a formal dispute resolution request with the FDA regarding the complete response letter for Vatadustat, specifically related to adult patients on dialysis. In February of 23, we received a second interim response from the FDA, indicating that due to agency resource constraints and staffing needs, Dr. Peter Stein, the director of the Office of New Drugs, or OND, will serve as the deciding authority for the appeal. Dr. Stein has indicated he will seek internal consultation with nephrology, cardiology, and liver safety experts in the OND to complete the review. And we expect to receive a response 30 days from when Dr. Stein completes his discussions. We continue to engage with Dr. Stein and the OND, and we'll update investors on this process as appropriate. Now, Vanadu said it's also being evaluated for other indications, notably acute respiratory distress syndrome, or ARDS. Last year, we shared data from an investigator-sponsored clinical study with UT Health evaluating Vatadustat for the prevention and treatment of ARDS in patients with COVID-19 and hypoxia. Since that time, we've continued to work with UT Health to plan an adequate, well-controlled study in a broad patient population beyond COVID-related ARDS in an acute setting. And we expect that study to begin enrolling patients this year. Within our four walls, we have the expertise to innovate and develop medicines to address patients' unmet needs. Further, our commercial team continues to keep us connected to patients while also enabling a product revenue stream to fund operations and pipeline expansion. To that end, we're also actively assessing regulatory and development paths for Vatadustat in other acute treatment indications. This year, we also plan to advance preclinical development of multiple novel HIF-PHI compounds for serious disease areas with limited or no treatment options, such as acute kidney injury. Our patient focus drives us thoughtfully to invest in new programs to expand our pipeline. We're eager to do that as we look forward into 2023 and beyond. Again, we're able to do this because of the financial base we've strengthened through the past year. And to that end, I'll ask Dave to talk more about our operating plan and our financials.

Thank you, John, and good morning, everyone. 2022 was an important year for Akiva, and we have developed an operating plan that will enable us to further build value as we capitalize on potential upcoming catalysts in 2023. Most immediately, assuming Vatadu's debt gets approved by the EMA in May, we will have developed a second drug that will be approved in over 30 countries and has the potential to benefit thousands of patients. Beyond the European approval for Vatadustat, we could initiate our next ARDS study with UT Health in a non-COVID ARDS population, generate preclinical data for indications for Vatadustat in acute settings, secure a potential approval for Vatadustat in other countries, including the UK, Switzerland, and Australia, secure an XUS licensing deal, resolve our FDR process with the FDA, which would provide clarity to our expense profile and the potential revenue related to Vatadustat in the US. Beyond Vatadustat, broader portfolio opportunities that may be added within our operating plan include potential to leverage our infrastructure to build out our development and commercial portfolio with new external assets, and maturation of our preclinical programs with the potential for multiple INDs over the coming years. Arixia continues to perform well, which based on our guidance for 2023 will deliver net revenues in excess of $350 million over the 2022-2023 time period. Our Arixia guidance of $175 to $180 million assumes inventories return to normal levels and that we realize an increase in net price per pill, partially offset by a reduction in total units sold. We also assume that the binder market continues to have challenges. Our cost management exercise has yielded important financial strength and stability for us. We expect to have cleared the going concern analysis upon filing of our 10-K, meaning that we have cash that will provide us the resources to fund our operating plan for at least 12 months. This is the result of two main focuses of the company, which we have previously discussed in great detail, but given the significance of the event, is worth reviewing again. First and most obvious is the commercial success that led to a nearly 25% increase in year-over-year net product revenue for Orixia. Our commercial leadership team undertook a laborious process to look at each and every commercial contract and position the brand to deliver more revenue on fewer net tabs sold. Few products achieve this type of growth, let alone those that are in their eighth year on the market. Many congrats are owed to our commercial team, including our key account managers. Second, and just as important, has been the narrowing of our strategic focus, which has enabled concentrated spend on items that will support our future growth. We've exited several contracts that were not yielding the return we needed and have asked our people to do more with less, and it's stopped. certain activities in order to push more money into our R&D pipeline. In addition, we reduced our debt balance and are paying less interest expense than otherwise would have. Overall, we are managing our working capital tightly. We are not offering operating expense guidance at this time, but will continue to focus on extending our cash runway. Our focus on maximizing Arixia revenue remains both pre- and post-LOE, and we will only look to reinvest in high-value areas we can afford to pursue. We will also look for areas to potentially grow our revenues with Arixia, for example, by ensuring that we have a Tdapa strategy in place to maximize revenue during this period, as well as potentially having revenue from VataduStat first with a European partnership. On that note, as you are all aware we recently obtained a positive opinion for VATADY's debt from the CHMP and now anticipate a potential approval in May. As John mentioned, we have been actively pursuing a partnership to ensure a successful launch in a timely manner. We cannot at this time provide guidance on deal economics, but can say we are looking for a partner who will team with us to maximize the value of the asset and shares our goal of benefiting as many patients as possible within the approved indication. Finally, pivoting to NASDAQ compliance, we have filed our definitive proxy and are on track to take the appropriate steps to regain compliance with the price criteria for continued listing on NASDAQ. On today's call, we will not be going through year-over-year fluxes of the financials beyond those provided in the press release, but are happy to dive into questions. With that, we'll open the line to questions. Operator?

Thank you. Ladies and gentlemen, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please send by while we compile the Q&A roster. And our first question coming from the line of Allison Bradford with Piper Assembly. Your line is open.

Hey, good morning, guys. Thank you for taking my questions. So first, just one on the vet-adjusted appeal process. Could you just help us understand if you've had any additional communications with FDA since the interim response in late February? And just hoping you could walk us through the possible outcomes and expected kind of cadence of events there. Do you plan to communicate when the 30-day clock starts for Dr. Stein's review? And then I have a couple of follow-up questions after this.

Thanks, Ali. So we are in regular conversation with the agency, usually administrative more than anything else. And again, just to stress, we don't understand. We can't say what exactly the timing of this is going to be. It will be 30 days after he's finished his internal review. he has clearly communicated that he's looking to do that in an efficient manner. Um, you know, exactly what that means. We can't say, so I can't guide you towards, you know, when that might be, but, um, uh, it seemed clear in the letter, um, that there's not an expectation of dragging that, uh, review out, but, um, you know, I, I don't want to set an expectation, you know, that we can't, uh, meet because it takes them, uh, you know, a while longer to, uh, to complete those conversations. But there is a regular kind of administrative communication through the process. There isn't a commitment that we'll know exactly when that 30-day clock will start. So it's hard to say we will definitively tell you when it does. But as I said, we will clearly update as appropriate as we understand the process going forward without getting into that kind of You know that that day to day communication. And so I think you asked about potential outcomes and. So there's a number of potential outcomes. You know there's the outcome of an appeal being denied and just being referred back to the CRL and then back to the division to talk about what a path forward would be. And a very common one is an appeal denied, but identifying a path forward. Um, you know, this is not, uh, that would, that's similar to what happened with, uh, to Napa nor, uh, in our delicts, right? There was the appeal was denied, but, uh, there was an adcom, uh, for, for the product that ultimately, I think they're, they're very much on a path for an approval now. Um, so that's quite common where they'll deny the appeal, but give you a path that ultimately leads to, to an approval. And then there's the appeal granted, in which case you are then going to refile your NDA. And it could be a two-month review clock or a six-month review clock. That's part of the communication. But then you're kind of on the road to an approval based on a re-review of your NDA. So I think those are That's kind of the universe of what we might hear. Within that appeal denied, you know, but a path forward, you know, there's, we don't know what other kind of things might come up from there, but I think there's a limited number of things like an adcom.

Did you ask something else for that? Got it. Yes, that's it.

Did you say you had follow-up questions?

Yeah, no, and thanks. That was, that's helpful. Another question I wanted to ask about the DAPRA D-STAT approval, just hoping you could kind of share your thoughts on how that approval and also now that the FDA review documents have been published, just how does that impact your thinking about, you know, the chances for a successful appeal outcome for VETADU-STAT? And also just for a potential VETADU-STAT label, you know, just noticing that the DAPRA label is – Specifically indicated for patients on dialysis for at least four months is that is it your sense that that would reflect class labeling or is that more something?

Specific to that produce that and understanding this might be a cart before the horse question, but just interested in your thoughts Yeah, well, that's where I was going to start out Lee I mean it'd be fantastic to be having that conversation with the FDA about what the label looks like so, you know Of course, we haven't had that yet. So So, you know, don't know, you know, couldn't comment at all on what, you know, might be considered class labeling versus not. I mean, I think there's no question that the FDA approving Daprodustat, you know, approving, you know, a drug in the PHI class is a positive signal that they, you know, are willing to, you know, make products available from the class. So I think that's, there's no way to read that in a negative way from my perspective. And every product is an individual product though, right? And so, you know, how our, what our label might look like vis-a-vis there is, you know, impossible to predict what that would be. Now, like I said, I can't wait to be in those labeling discussions with the FDA. And, you know, we just do not know kind of what will come from the FDR. But, you know, we continue to have a lot of confidence in the data. You know, a European CHMP positive opinion, I think, similarly is nothing but a positive for, you know, kind of for the FDA as Dr. Stein looks at the label. You know, 31 countries have now decided. that the product's safe and effective. But we'll do everything we can on our end to move the process effectively. And again, we'll communicate it as quickly as we can.

Okay. Yeah, understood. And then maybe just a last question from me, just on the expense trajectory. I guess this came up a bit in prepared remarks, but just wondering if there's any color you can provide to help us understand that expense trajectory for both R&D and SG&A and just expectations for cash burn over the course of 23? Or is that something you'll be able to describe more once you do get that answer from FDA?

Yes, so Ali, thanks for the question. So like I said in the prepared remarks, we're not going to provide the specific guidance, but we have done a lot of work to continue to bring down R&D and SG&A, and we continue to do so even this quarter. A lot of that focus is bring it down so that we can balance the ORIXIA revenue and revenue growth with reinvesting in these pipeline opportunities. You know, I think the big thing I mentioned, you know, the expectation to clear the going concern analysis, that is our, you know, that's the strongest guidance that we can give, that we plan to be able to, you know, manage our expenses within the cash that we have and the Erixia revenue. So we're very excited about that. And I think long-term, the two things that would just factor into the burn would be success in the pipeline. And to your point, The Bata-Dustat investment in a commercial launch is not something that we've got in our plan right now. So if we are fortunate enough to be having those conversations, we would definitely be reassessing the investment plan. But again, this is where, going back to something we haven't talked about for a long time, our leverage and our commercial expertise, the model that we have right now, the focus on the dialysis center, is so the relationship in the dialysis center is so strong and the relationship with B4 to be able to partner with them on that potential launch, we don't expect that this is a major, major new investment. Leverage is going to be the name of the game there.

Yeah, it's such an important point. And I mean, when we made the change to the commercial structure, it was with the thought of we've got to do that launch in mind as well. And with the V4 partnership, I mean, that would be incredible leverage we could get out of that, out of that organization. But yeah, there is, there is investment to be made in a, in a launch, but in this case, it's not, it's a very, very small investment in people, a couple of marketing people maybe, but, and, you know, we dust off a launch plan that we had a year ago and, and, you know, I think it would be, obviously it'd be, phenomenal outcome for us. But again, as Dave said, I mean, we've built our budget without, right? We want the company to have the discipline of, you know, we want to drive to positive cash with Arixia alone and a disciplined approach to spending. And the team's done a phenomenal job of delivering on that.

And we expect to continue to deliver towards that in 2023.

Got it. Thanks so much.

Thank you.

Thank you. And our next question coming from the lineup. And RC with AC, when regular is open.

Great. Thanks for taking my questions. And congrats on all the operational progress in 2022, including the strong growth of Eryxia. First question for me, I noticed you mentioned you have signed a European license agreement with Averroa for Rixia in Europe. I'm wondering if you could just discuss what you expect there, what kind of communications we can expect going forward with that, and what's your expectations for the end of exclusivity in those markets?

And thanks for the question. So, Averro is a small European company. And, you know, again, with Arixia, we've only had the product available in the U.S. And the idea of bringing this to European patients where we think there can be a benefit, you know, has always been attractive for us. But we knew this is something we weren't going to execute on our own. you know, bringing in a partner to look at this and look at it a little bit differently. They've got to look at the market, you know, just a little bit differently. And they're working on that now and they're consulting with regulatory authorities. And, you know, we tried to put a contract in place here that created upside for us if they're successful with very, very little, you know, I don't say downside risk, but, you know, distraction for the organization. And, you know, that was quite important. So, you know, Again, we're living our purpose of bringing products to patients where there's a need, you know, but doing it in a way that, you know, really just creates potential upside for us. Remember, in Europe, you have data exclusivity timeframe, blanking on the amount of time it is, but that's what they'll be relying on. you know, rather than, you know, patent protection per se in the market. So there's an opportunity there. You know, this is a deal that, you know, obviously a royalty-based deal for us. They're taking some risk and we're taking very little, but, you know, the upside is if they're successful in the way they approach the EMA with this. So, you know, we'll see. I wouldn't say this is something that, you know, we put a significant amount of focus on as we think about, you know, building the company. But we're happy with Avro as a partner and look forward to supporting them as necessary.

Okay.

And then you also mentioned in the release that you're working on certain initiatives to extend the revenues of Orixia beyond March 2025. I wondered if you Would care to expand upon that in any way and perhaps related. I think I heard brief mention on your in your prepared remarks. Of to DAPA and wondering if there is any opportunity for you to leverage that come 2025. Thanks.

Thanks, Ed. Yeah, that's that's that's very much. I think what you know where Dave really was focused in that in that comment. I mean, there's two. There's two pieces. You know, first and foremost, there's, you know, we have this and the settlements of March of 25. But we do know that, you know, if you look at the analog of Sevelimer, you know, given a volume of drug that has to be manufactured per patient, it took quite some time before there was significant generic entry into the market. And, you know, it was It wasn't a patent cliff, it was a patent slope. And, you know, ultimately they did come in, but Sanofi at the time, who was selling the drug, had, you know, significant profitability from that. And so there's some opportunity of that. And here we have a product that's a much smaller revenue product. That was a billion-dollar product developer at the time. So, you know, is it financially attractive for a number of companies of generic manufacturers to bring the product in. That's an assessment they have to make. But what's unique to the situation we're in today is, as you said, the Tdapa process that CMS has said that the phosphate binders will go into the bundle as of January of 25, which has been the expectation. But in the last final rule, they made that clear, and they made it clear that they were going to have a two-year TdapA process. And I think a three-year TdapA process, which they did for Senocalcit, would be more appropriate. And we'll talk to them about that. But with a two-year TdapA process, it means they're collecting data for those two years to see how the dialysis providers utilize phosphate binders so they can make a decision about what dollar amount to add to the bundled payment come January of 27th. So if you think about this from a dialysis provider standpoint, there's a lot of motivation to use, you know, obviously to treat patients appropriately, but to, you know, to use products like branded products so that they're not going to end up with a bundled payment that doesn't cover their costs ultimately. So, you know, there's clearly an opportunity for us with Erixia, you know, over the course of 25 and 26, to work with them on, you know, utilizing the drug appropriately for patients, of course, but increasing, continuing to increase the utilization, and then helping with that switch over to generics beyond 2026. So, you know, there's some really, I think, some meaningful revenue opportunities there, and we're just, you know, now working with dialysis providers to see how that will be rolled out.

Okay, great.

And then one last question. I joined a bit late, so maybe you discussed this already, but I just wanted to clarify for Vatadustat in the U.S., if that process were to ultimately result in an approval, commercially, what is your plan right now?

So the focus of the FDR now is for patients, is for dialysis patients only. So that would be the expectation of, you know, what an approval would yield. And the commercial organization that we've put in place now, you know, the reorganization we did late last year, we think from a field perspective, we probably have to add a couple of marketing people, but from a field perspective, we have what we need for that launch. because of the V4 relationship, right? We have, you know, the V4 relationship that we have, you know, where they have, you know, we'll sell directly to Fresenius and the other, you know, small and medium providers who have contracts, they have contracts with, really allows us to have a much more efficient commercial focus and, you know, delivers a tremendous amount of leverage for us on our P&L if we're successful with that.

Great. Thanks so much. Thanks, Ed.

Thanks, Ed.

Thank you. Our next question coming from the line up, Robert Haslett with BTIG. Your line is open.

Yeah, thank you for taking the questions, and congrats on the progress. Looking forward to more. Just a quick question on margins for this quarter. I think you mentioned it in the call, excuse me, in the release, but COGS had a benefit. This quarter, I think there was some mention about contract termination fees. Could you go into a little bit more detail about how we should be thinking about the cost of goods and gross margin? Again, I know you're not commenting on expense guides, but just in general, thinking about the operations of Verixia and costs and gross margins and things in general. Thanks.

Yeah, thanks for the question, Bert. So as folks are aware, back in December, We 8K'd a release on the termination of a supply contract that we had, a multi-year supply contract. Between the different supply agreements that we had back then, we had been each quarter been providing updates on something that we called an excess purchase commitment. with the restructuring of the supply chain, we expect that those charges are going away and we have reversed those charges in the fourth quarter. So what you'll see going forward within that COGS line, you'll still see the amortization of intangible that is clearly in there and called out as a non-cash expense. But what you'll see now is, you know, you'll see a much more normal cost of goods line, which would be just our cost to produce and sell Arixia. And that'll be, again, we're not providing the specific numbers, but you can go back historically and look at what we've disclosed, whether it's excess purchase or inventory write-offs, take those to the side, and it'll just be a much more normal rate. And we're really, really happy about those contract terminations and reworks, because it does save us a real significant amount on the cash flow. And again, a big, big contributor to us having this cash runway that we're talking about now has been changing of those contracts. It was in excess of $70 million that we reversed for those excess purchase commitments.

Terrific. Looking forward to cleaner numbers moving forward. That's great.

I bet.

Looking at a couple of questions on Vata-Deuce debt. and in the U.S. Is Dr. Stein seeking additional data from Akiva at all? Are you interacting with him directly in any way, shape, or form?

So the focus of the letter is the internal discussions that he's having. If he requests anything from us, obviously we'll be responsive to that. Part of the FDR is that you can't actually give new data into the review, so we couldn't proactively give him anything new to look at. It's got to be all things that are included in the NDA. That's part of the rules of the FDR. I think his initial focus is certainly I don't want to speak for him, but coming up to speed, clearly from his letter, he's come up to speed a long way. I mean, he really was quite versed in the issues at hand, but wants to seek that internal guidance. So I think it's more about that. We will do everything we can to support him in that process and support a positive outcome. So having a direct communication with him on these issues is something we would be clearly welcome.

Okay, terrific. And then just thinking about, again, there's a little bit of additional data coming up, the focus study, the three times weekly data. What does this give you? What should we expect in terms of data release for that study?

Yeah, so, I mean, we do expect that we'll be presenting that data at a scientific session or in a publication to be determined. It's an important study. It is the study that we feel will be the basis for having a three times weekly dose. for Vatadustat in our label and obviously in dialysis patients, right? So even with a negative outcome in the US, we have a positive outcome in Europe and having that ability for dialysis providers to deliver the drug when the patient's on dialysis is just another option for them that can be very helpful and ensure compliance for their patients. And so it's important And I think it's important for patients, and it's important commercially, too. It's giving physicians more of an option. So that study is completing, and we do expect that that data will be presented this year.

Okay, terrific. And just one more, and I think you talked about this to some degree, but I'm sorry to kind of come back to it, but just maybe a little bit more formally. What... would a label look like in the EU for VAT adduced debt or VAT sale as we're moving forward? Just any kind of broad characterization you can do, you can provide for the potential authorization may would be helpful. Thanks.

So, obviously, you know, until we have that marketing authorization, you know, we don't want to kind of get ahead of that. But you obviously are talking about a label as you go through the CHMP. And, you know, we're very pleased from, you know, kind of at least I'm looking at it with a commercial eye. And, you know, I think it's a label that we absolutely can work with. There's nothing that's – outside of what I would expect in there and obviously focused on dialysis patients alone. But when I look at the concerns expressed by the FDA, those are all handled in a very appropriate way in the SMPC, or the anticipated SMPC. So we'll see the final when we have it, but I have no concerns from a commercial perspective based on what I've seen so far.

Terrific. And just one more. Along those lines, how would you characterize the status of interactions for folks with additional commercial parties in the EU. You said pretty clearly that obviously nothing's going to happen until formal authorization, but just love to get a sense of the temperament out there. Thanks.

Yeah, no, it's a very active process. It's, you know, getting clarity that it's dialysis versus dialysis and non-dialysis, you know, obviously was important to the process. Having the CHMP positive opinion is Very value creating for us and having an authorization creates more value for us, you know, ultimately as you get to, you know, to a deal. And, you know, creating, you know, we have an active process with multiple parties. who are interested. And, you know, seeing that process through and maintaining multiple parties usually yields the best outcome for us and for the product. And, you know, if that takes a little bit more time, that's time that's usually very, very well spent. So, you know, we're very pleased with how this process is moving forward.

Thanks for all that. Congrats on the progress. Looking forward to more. Thank you.

Thanks, Bert.

I'm showing no further questions at this time. I will now turn the call back over to Mr. John Butler for any closing remarks.

Thanks, operator, and thank you all for your attendance this morning. You know, while we celebrate Rural Kidney Day today, our commitment to patients drives us forward every day, and I hope you got a sense of our excitement from this call. I just want to really summarize very quickly a few of the exciting developments we're expecting in 2023. We're going to continue to drive revenue growth for Orixia and expect to deliver net product revenue of $175 to $180 million. We received a positive opinion from the CHMP for Vatadustat and anticipate marketing authorization in a couple of months. We expect a regulatory decision for the access consortium countries. We anticipate engaging a partner to commercialize Vatadustat in Europe. We expect a decision on the FDR process with the FDA. We anticipate that UT Health will initiate an ARDS study with Vatadustat in a broader patient population. And we look forward to talking much more about our pipeline development for Vatadustat and other novel HIF-PHI compounds as the year progresses. So it will be a very, very busy year for us, I think an exciting year for Akibia, and we look forward to updating you further on it. Thanks again for joining us. Have a great day.

Ladies and gentlemen, that's our conference for today. Thank you for your participation. You may now disconnect.

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Good day, ladies and gentlemen. Thank you for standing by, and welcome to our KPS Forward Quarter 2022 Financial Results Conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automatic message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Mercedes Carrasco, Senior Director of Corporate Communications. Please go ahead.

Thank you, and welcome to Atebia's fourth quarter and full year 2022 financial results and business updates conference call. Today, we also celebrate World Kidney Day, an opportunity to raise awareness for kidney health and recognize all those in the kidney community who share in our purpose to better the lives of people impacted by kidney disease. Joining me for today's call, we have John Butler, Chief Executive Officer, and Dave Spellman, Chief Financial Officer. A press release was issued earlier today, Thursday, March 9th, detailing our fourth quarter and full year 2022 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 after we conclude. 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. Additionally, information describing these risks is included in the financial results press release that we issued on March 9th, 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 thank you all for joining us. Everyone at Akebia has entered 2023 with renewed optimism. Through the past year, our team's work and the strategic decisions we've made have put us in a position to thrive as a company. We continue to engage with the kidney community and support our patients on anorexia. We've advanced the regulatory process for Vatadustat in Europe to a point where we're now approaching a potential marketing authorization. And we're excited to look ahead as we evaluate and drive potential pipeline expansion opportunities. including developing hypoxia-inducible factor prohydroxylase inhibitor compounds for potential indications of serious unmet need. We have a team that works with purpose, and I'm proud of their accomplishments, as they've delivered a company today with a strong revenue base, multiple near-term catalysts, and mid- and long-term product development opportunities. Now, let's begin with the Rixie app. In 2022, we reported net product revenue growth of nearly 25% over 2021, exceeding the revenue target guidance we established mid-year. Achieving net product revenue growth, while the phosphate binder market continues to decline, is a credit to our dedicated commercial team that works hard to ensure thousands of patients have access to Arixia. Last year, we launched a new commercial model that aligns to customer objectives. We believe the model will enable our team to continue high-touch engagement with high-value individual prescribers and entities that are focused on delivering coordinated, cost-effective care for advanced CKD patients, including those receiving dialysis. Orixia net product revenue is integral to our operating plan as we continue to support the regulatory processes for Vatadustat globally and invest in our other drug research and development activities. Regarding Vatadustat, we're quickly approaching a potential milestone. In late February, the Committee for Medicinal Products for Human Use, or CHMP, of the EMA adopted a positive opinion recommending that the European Commission approve Vafcio, Vatadustat, for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. We anticipate a potential marketing authorization for Vapcio to be granted by the EC in May of this year, which would be applicable to all 30 European Union member states and affiliated countries. Beyond the EU, we also anticipate a regulatory decision for Vatadustat for access consortium countries, the UK, Switzerland, and Australia later this year. We are dedicated to delivering an oral treatment option to patients with anemia due to chronic kidney disease and continue our efforts to select a potential partner in Europe to commercialize Vafsio if approved. We don't expect to formalize a partner engagement until sometime after Vafsio receives marketing authorization, but we're deeply engaged in the process to select a partner that can maximize the potential value of Vafsio while quickly reaching appropriate patients. A Vafsio marketing authorization in Europe would mean that a DO-STAT would be approved in 31 countries as it's currently approved and marketed in Japan by MTPC for dialysis-dependent and non-dialysis-dependent adult patients. We believe in the favorable benefit-risk profile of Vatadustat, and to that end, we continue to pursue a potential path for approval in the U.S. for patients on dialysis. Last year, we submitted a formal dispute resolution request with the FDA regarding the complete response letter for Vatadustat, specifically related to adult patients on dialysis. In February of 23, we received a second interim response from the FDA, indicating that due to agency resource constraints and staffing needs, Dr. Peter Stein, the director of the Office of New Drugs, or OND, will serve as the deciding authority for the appeal. Dr. Stein has indicated he will seek internal consultation with nephrology, cardiology, and liver safety experts in the OND to complete the review. And we expect to receive a response 30 days from when Dr. Stein completes his discussions. We continue to engage with Dr. Stein and the OND, and we'll update investors on this process as appropriate. Now, Vanadu said it's also being evaluated for other indications, notably acute respiratory distress syndrome, or ARDS. Last year, we shared data from an investigator-sponsored clinical study with UT Health evaluating Vatadustat for the prevention and treatment of ARDS in patients with COVID-19 and hypoxia. Since that time, we've continued to work with UT Health to plan an adequate, well-controlled study in a broad patient population beyond COVID-related ARDS in an acute setting. And we expect that study to begin enrolling patients this year. Within our four walls, we have the expertise to innovate and develop medicines to address patients' unmet needs. Further, our commercial team continues to keep us connected to patients while also enabling a product revenue stream to fund operations and pipeline expansion. To that end, we're also actively assessing regulatory and development paths for Vatadustat in other acute treatment indications. This year, we also plan to advance preclinical development of multiple novel HIF-PHI compounds for serious disease areas with limited or no treatment options, such as acute kidney injury. Our patient focus drives us thoughtfully to invest in new programs to expand our pipeline. We're eager to do that as we look forward into 2023 and beyond. Again, we're able to do this because of the financial base we've strengthened through the past year. And to that end, I'll ask Dave to talk more about our operating plan and our financials.

Thank you, John, and good morning, everyone. 2022 was an important year for Akiva, and we have developed an operating plan that will enable us to further build value as we capitalize on potential upcoming catalysts in 2023. Most immediately, assuming Vatadu's debt gets approved by the EMA in May, we will have developed a second drug that will be approved in over 30 countries and has the potential to benefit thousands of patients. Beyond the European approval for Batadustat, we could initiate our next ARDS study with UT Health in a non-COVID ARDS population, generate preclinical data for indications for Batadustat in acute settings, secure a potential approval for Batadustat in other countries, including the UK, Switzerland, and Australia, secure an XUS licensing deal, resolve our FDR process with the FDA, which would provide clarity to our expense profile and the potential revenue related to Vatadustat in the US. Beyond Vatadustat, broader portfolio opportunities that may be added within our operating plan include potential to leverage our infrastructure to build out our development and commercial portfolio with new external assets, and maturation of our preclinical programs with the potential for multiple INDs over the coming years. Arixia continues to perform well, which based on our guidance for 2023 will deliver net revenues in excess of $350 million over the 2022-2023 time period. Our Arixia guidance of $175 to $180 million assumes inventories return to normal levels and that we realize an increase in net price per pill, partially offset by a reduction in total units sold. We also assume that the binder market continues to have challenges. Our cost management exercise has yielded important financial strength and stability for us. We expect to have cleared the going concern analysis upon filing of our 10-K, meaning that we have cash that will provide us the resources to fund our operating plan for at least 12 months. This is the result of two main focuses of the company, which we have previously discussed in great detail, but given the significance of the event, is worth reviewing again. First and most obvious is the commercial success that led to a nearly 25% increase in year-over-year net product revenue for Orixia. Our commercial leadership team undertook a laborious process to look at each and every commercial contract and position the brand to deliver more revenue on fewer net tabs sold. Few products achieve this type of growth, let alone those that are in their eighth year on the market. Many congrats are owed to our commercial team, including our key account managers. Second, and just as important, has been the narrowing of our strategic focus, which has enabled concentrated spend on items that will support our future growth. We've exited several contracts that were not yielding the return we needed and have asked our people to do more with less, and it's stopped. certain activities in order to push more money into our R&D pipeline. In addition, we reduced our debt balance and are paying less interest expense than otherwise would have. Overall, we are managing our working capital tightly. We are not offering operating expense guidance at this time, but we'll continue to focus on extending our cash runway. Our focus on maximizing Arixia revenue remains both pre- and post-LOE, and we will only look to reinvest in high-value areas we can afford to pursue. We will also look for areas to potentially grow our revenues with Arixia, for example, by ensuring that we have a Tdapa strategy in place to maximize revenue during this period, as well as potentially having revenue from VataduStat first with a European partnership. On that note, as you are all aware we recently obtained a positive opinion for VATADY's debt from the CHMP and now anticipate a potential approval in May. As John mentioned, we have been actively pursuing a partnership to ensure a successful launch in a timely manner. We cannot at this time provide guidance on deal economics, but can say we are looking for a partner who will team with us to maximize the value of the asset and shares our goal of benefiting as many patients as possible within the approved indication. Finally, pivoting to NASDAQ compliance, we have filed our definitive proxy and are on track to take the appropriate steps to regain compliance with the price criteria for continued listing on NASDAQ. On today's call, we will not be going through year-over-year fluxes of the financials beyond those provided in the press release, but are happy to dive into questions. With that, we'll open the line to questions. Operator?

Thank you. Ladies and gentlemen, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please send by while we compile the Q&A roster. And our first question coming from the line of Allison Bradford with Piper Assembly. Your line is open.

Hey, good morning, guys. Thank you for taking my questions. So first, just one on the vet-adjusted appeal process. Could you just help us understand if you've had any additional communications with FDA since the interim response in late February? And just hoping you could walk us through the possible outcomes and expected kind of cadence of events there. Do you plan to communicate when the 30-day clock starts for Dr. Stein's review? And then I have a couple of follow-up questions after that.

Thanks, Ali. So, you know, we are in regular conversation with the agency, usually administrative more than anything else. And, you know, again, just to stress, we don't understand. We can't say what exactly the timing of this is going to be. You know, it will be 30 days after he's finished his internal review. he has clearly communicated that he's looking to do that in an efficient manner. Um, you know, exactly what that means. We can't say, so I can't, you know, guide you towards, you know, when that might be, but, um, uh, it seemed clear in the letter, um, that there's not an expectation of dragging that, uh, review out, but, um, you know, I, I don't want to set an expectation, you know, that we can't, uh, meet because it takes them, uh, you know, a while longer to, uh, to complete those conversations. But there is a regular kind of administrative communication through the process. There isn't a commitment that we'll know exactly when that 30-day clock will start. So it's hard to say we will definitively tell you when it does. But as I said, we will clearly update as appropriate as we understand the process going forward without getting into that kind of You know that that day to day communication. And so I think you asked about potential outcomes and. So there's a number of potential outcomes. You know there's the outcome of an appeal being denied and just being referred back to the CRL and then back to the division to talk about what a path forward would be. and a very common one is an appeal denied, but identifying a path forward. Um, you know, this is not, uh, that would, that's similar to what happened with, uh, to Napa nor, uh, in our delicts, right? There was the appeal was denied, but, uh, there was an adcom, uh, for, for the product that ultimately I think they're, they're very much on a path for an approval now. Um, so that's quite common where they'll deny the appeal, but give you a path that ultimately leads to, to an approval. And then there's the appeal granted, in which case you are then going to refile your NDA. And it could be a two-month review clock or a six-month review clock. That's part of the communication. But then you're kind of on the road to an approval based on a re-review of your NDA. So I think those are kind of the universe of what we might hear. Within that appeal denied, you know, but a path forward, you know, there's, we don't know what other kind of things might come up from there, but I think there's a limited number of things like an adcom.

Did you ask something else? Got it. Yes, that's it.

Did you say you had follow-up questions?

Yeah, no, and thanks. That was, that's helpful. Another question I wanted to ask about a the DAPRA D-STAT approval, just hoping you could kind of share your thoughts on how that approval and also now that the FDA review documents have been published, just how does that impact your thinking about, you know, the chances for a successful appeal outcome for Vatadustat? And also just for a potential Vatadustat label, you know, just noticing that the DAPRA label is specifically indicated for patients on dialysis for at least four months, is that Is it your sense that that would reflect class labeling or is that more something specific to that produce that? And understanding this might be a cart before the horse question, but just interested in your thoughts there.

Yeah, well, that's where I was going to start, Ali. I mean, it'd be fantastic to be having that conversation with the FDA about what the label looks like. So, you know, of course, we haven't had that yet. So, you know, don't know, you know, couldn't comment at all on what, you know, might be considered class labeling versus not. I mean, I think there's no question that the FDA approving DAP or DUSDAT, you know, approving, you know, a drug in the PHI class is a positive signal that they, you know, are willing to, you know, make products available from the class. So I think that's, there's no way to read that in a negative way from my perspective. Every product is an individual product though, right? And so, you know, how our what our label might look like vis-a-vis theirs, you know, impossible to predict what that would be. Now, like I said, I can't wait to be in those labeling discussions with the FDA. And, you know, we just do not know kind of what will come from the FDR, but, you know, we continue to have a lot of confidence in the data. You know, a European CHMP positive opinion I think similarly is nothing but a positive for the FDA as Dr. Stein looks at the label. 31 countries have now decided that the product's safe and effective. But we'll do everything we can on our end to move the process effectively, and again, we'll communicate it as quickly as we can.

Okay. Yeah, understood. And then maybe just a last question from me just on the expense trajectory. I guess this came up a bit in prepared remarks, but just wondering if there's any color you can provide to help us understand that expense trajectory for both R&D and SG&A and just expectations for cash burn over the course of 23. Or is that something you'll be able to describe more once you do get that answer from FDA?

Yes, so Ali, thanks for the question. So like I said in the prepared remarks, we're not going to provide the specific guidance, but we have done a lot of work to continue to bring down R&D and SG&A, and we continue to do so even this quarter. A lot of that focus is bring it down so that we can balance the ORIXIA revenue and revenue growth with reinvesting in these pipeline opportunities. You know, I think the big thing I mentioned, you know, the expectation to clear the going concern analysis, that is our, you know, that's the strongest guidance that we can give, that we plan to be able to, you know, manage our expenses within the cash that we have and the Erixia revenue. So we're very excited about that. And I think long-term, the two things that would just factor into the burn would be success in the pipeline. And to your point, The Bata-Dustat investment in a commercial launch is not something that we've got in our plan right now. So if we are fortunate enough to be having those conversations, we would definitely be reassessing the investment plan. But again, this is where, going back to something we haven't talked about for a long time, our leverage and our commercial expertise, the model that we have right now, the focus on the dialysis center, is so the relationship in the dialysis center is so strong and the relationship with B4 to be able to partner with them on that potential launch, we don't expect that this is a major, major new investment. Leverage is going to be the name of the game there.

Yeah, such an important point. And I mean, when we made the change to the commercial structure, it was with the thought of we've got to do that launch in mind as well. And with the V4 partnership, I mean, that would be incredible leverage we could get out of that, out of that organization. But yeah, there is, there is investment to be made in a, in a launch, but in this case, it's not, it's a very, very small investment in people, a couple of marketing people maybe, but, and, you know, we dust off a launch plan that we had a year ago and, and, you know, I think it would be, obviously it'd be, phenomenal outcome for us. But again, as Dave said, I mean, we've built our budget without, right? We want the company to have the discipline of, you know, we want to drive to positive cash with Arixia alone and a disciplined approach to spending. And the team's done a phenomenal job of delivering on that. And we expect to continue to deliver towards that in 2023.

Got it. Thanks so much.

Thank you.

Thank you. And our next question coming from the lineup. And RC with AC, when regular is open.

Great. Thanks for taking my questions. And congrats on all the operational progress in 2022, including the strong growth of Eryxia. First question for me, I noticed you mentioned you have signed a European license agreement with Averroa for Rixia in Europe. I'm wondering if you could just discuss what you expect there, what kind of communications we can expect going forward with that, and what's your expectations for the end of exclusivity in those markets?

And thanks for the question. So, Averro is a small European company. And, you know, again, with Arixia, we've only had the product available in the U.S. And the idea of bringing this to European patients where we think there can be a benefit, you know, has always been attractive for us. But we knew this is something we weren't going to execute on our own. you know, bringing in a partner to look at this and look at it a little bit differently. They've got to look at the market, you know, just a little bit differently. And they're working on that now, and they're consulting with regulatory authorities. And, you know, we tried to put a contract in place here that created upside for us if they're successful with very, very little, you know, I don't say downside risk, but, you know, distraction for the organization. And, you know, that was quite important. So, you know, Again, we're living our purpose of bringing products to patients where there's a need, you know, but doing it in a way that, you know, really just creates potential upside for us. Remember, in Europe, you have data exclusivity timeframe, blanking on the amount of time it is, but that's what they'll be relying on. you know, rather than, you know, patent protection per se in the market. So there's an opportunity there. You know, this is a deal that, you know, obviously a royalty-based deal for us. They're taking some risk and we're taking very little, but, you know, the upside is if they're successful in the way they approach the EMA with this. So, you know, we'll see. I wouldn't say this is something that, you know, we put a significant amount of focus on as we think about, you know, building the company. But we're happy with Adro as a partner and look forward to supporting them as necessary.

Okay.

And then you also mentioned in the release that you're working on certain initiatives to extend the revenues of Orixia beyond March 2025. I wondered if you Would care to expand upon that in any way and perhaps related. I think I heard brief mention in your prepared remarks of to DAPA and wondering if there is any opportunity for you to leverage that come 2025. Thanks.

Thanks, Ed. Yeah, that's very much I think what, you know, where Dave really was focused in that comment. I mean, there's two pieces. You know, first and foremost, there's, you know, we have this and the settlements of March of 25. But we do know that, you know, if you look at the analog of Sevelimer, you know, given the volume of drug that has to be manufactured per patient, it took quite some time before there was significant generic entry into the market. And, you know, it was It wasn't a patent cliff, it was a patent slope. And, you know, ultimately they did come in, but Sanofi at the time, who was selling the drug, had significant profitability from that. And so there's some opportunity of that. And here we have a product that's a much smaller revenue product. That was a billion-dollar product developer at the time. So, you know, is it financially attractive for a number of companies of generic manufacturers to bring the product in. That's an assessment they have to make. But what's unique to the situation we're in today is, as you said, the Tdapa process that CMS has said that the phosphate binders will go into the bundle as of January of 25, which has been the expectation. But in the last final rule, they made that clear, and they made it clear that they were going to have a two-year TdapA process. And I think a three-year TdapA process, which they did for Senocalcit, would be more appropriate. And we're talking to them about that. But with a two-year TdapA process, it means they're collecting data for those two years to see how the dialysis providers utilize phosphate binders so they can make a decision about what dollar amount to add to the bundled payment come January of 2017. So if you think about this from a dialysis provider standpoint, there's a lot of motivation to use, you know, obviously to treat patients appropriately, but to, you know, to use products like branded products so that they're not going to end up with a bundled payment that doesn't cover their costs ultimately. So, you know, there's clearly an opportunity for us with Erixia, you know, over the course of 25 and 26, to work with them on, you know, utilizing the drug appropriately for patients, of course, but increasing, continuing to increase the utilization, and then helping with that switch over to generics beyond 2026. So, you know, there's some really, I think, some meaningful revenue opportunities there, and we're just, you know, now working with dialysis providers to see how that will be rolled out.

Okay, great.

And then one last question. I joined a bit late, so maybe you discussed this already, but I just wanted to clarify for Vatadustat in the U.S., if that process were to ultimately result in an approval, commercially, what is your plan right now?

So the focus of the FDR now is for patients, is for dialysis patients only. So that would be the expectation of, you know, what an approval would yield. And the commercial organization that we've put in place now, you know, the reorganization we did late last year, we think from a field perspective, we probably have to add a couple of marketing people, but from a field perspective, we have what we need for that launch. because of the V4 relationship. The V4 relationship that we have where they will sell directly to Fresenius and the other small and medium providers who they have contracts with really allows us to have a much more efficient commercial focus and delivers a tremendous amount of leverage for us on our P&L if we're successful with that.

Great. Thanks so much.

Thanks, Ed. Thanks, Ed.

Thank you. Our next question coming from the line of Robert Haslett with BTIG. Your line is open.

Yeah, thank you for taking the questions, and congrats on the progress. Looking forward to more. Just a quick question on margins for this quarter. I think you mentioned it in the call, excuse me, in the release, but COGS had a benefit. this quarter, I think there was some mention about contract termination fees. Could you go into a little bit more detail about how we should be thinking about the cost of goods and gross margin? Again, I know you're not commenting on expense guides, but just in general, thinking about the operations of Verixia and costs and gross margins and things in general. Thanks.

Yeah, thanks for the question, Bert. So as folks are aware, back in December, We 8K'd a release on the termination of a supply contract that we had, a multiyear supply contract. Between the different supply agreements that we had back then, we had been each quarter been providing updates on something that we called an excess purchase commitment. with the restructuring of the supply chain, we expect that those charges are going away and we have reversed those charges in the fourth quarter. So what you'll see going forward within that COGS line, you'll still see the amortization of intangible that is clearly in there and called out as a non-cash expense. But what you'll see now is, you know, you'll see a much more normal cost of goods line, which would be just our cost to produce and sell Arixia. And, you know, that'll be, you know, again, we're not providing the specific numbers, but you can go back historically and look at what we've disclosed, whether it's excess purchase or inventory write-offs, take those to the side and it'll just be a much more normal rate. And, you know, we're really, really happy about those contract terminations and reworks because it does save us a real significant amount on the cashflow. And, again, a big, big contributor to us having this cash runway that we're talking about now has been changing of those contracts. It was in excess of $70 million that we reversed for those excess purchase commitments.

Terrific. Looking forward to cleaner numbers moving forward. That's great.

A couple of questions on Vata-Deuce debt.

and in the U.S. Is Dr. Stein seeking additional data from Akiva at all? Are you interacting with him directly in any way, shape, or form?

So the focus of the letter is the internal discussions that he's having. If he requests anything from us, obviously we'll be responsive to that. Part of the FDR is that you can't actually give new data into the review, so we couldn't proactively give him anything new to look at. It's got to be all things that are included in the NDA. That's part of the rules of the FDR. So, I mean, I think his initial focus is certainly I don't want to speak for him, but coming up to speed, clearly from his letter, he's come up to speed a long way. I mean, he really was quite versed in the issues at hand, but wants to seek that internal guidance. So I think it's more about that. We will do everything we can to support him in that process and support a positive outcome. So having a direct communication with him on these issues is something we would be clearly welcome.

Okay, terrific. And then just thinking about, again, there's a little bit of additional data coming up, the focus study, the three times weekly data. What does this give you? What should we expect in terms of data release for that study?

Yeah, so, I mean, we do expect that we'll be presenting that data at a scientific session or in a publication to be determined. It's an important study. It is the study that we feel will be the basis for having a three times weekly dose for Vatadustat in our label and obviously with the in-dialysis patients, right? So even with a negative outcome in the US, we have a positive outcome in Europe and having that ability for dialysis providers to deliver the drug when the patient's on dialysis is just another option for them that can be very helpful and ensure compliance for their patients. And so it's important And I think it's important for patients, and it's important commercially, too. It's giving physicians more of an option. So that study is completing, and we do expect that that data will be presented this year.

Okay, terrific. And just one more, and I think you talked about this to some degree, but I'm sorry to kind of come back to it, but just maybe a little bit more formally. What... would a label look like in the EU for VAT adduced debt or VAT sale as we're moving forward? Just any kind of broad characterization you can do, you can provide for the potential authorization may would be helpful. Thanks.

So, obviously, you know, until we have that marketing authorization, you know, we don't want to kind of get ahead of that. But you obviously are talking about a label as you go through the CHMP. And, you know, we're very pleased from, you know, kind of at least I'm looking at it with a commercial eye. And, you know, I think it's a label that we absolutely can work with. There's nothing that's – outside of what I would expect in there, and obviously focused on dialysis patients alone. But when I look at the concerns expressed by the FDA, those are all handled in a very appropriate way in the SMPC, or the anticipated SMPC. So we'll see the final when we have it, but I have no concerns from a commercial perspective based on what I've seen so far.

Terrific. And just one more. Along those lines, how would you characterize the status of interactions for folks with additional commercial parties in the EU. You said pretty clearly that obviously nothing's going to happen until formal authorization, but just love to get a sense of the temperament out there. Thanks.

Yeah, no, it's a very active process. It's, you know, getting clarity that it's dialysis versus dialysis and non-dialysis, you know, obviously was important to the process. Having the CHMP positive opinion is Very value creating for us and having an authorization creates more value for us, you know, ultimately as you get to, you know, to a deal. And, you know, creating, you know, we have an active process with multiple parties. who are interested. And, you know, seeing that process through and maintaining multiple parties usually yields the best outcome for us and for the product. And, you know, if that takes a little bit more time, that's time that's usually very, very well spent. So, you know, we're very pleased with how this process is moving forward.

Thanks for all that. Congrats on the progress. Looking forward to more. Thank you. Thanks, Bert. Thanks, Bert.

I'm showing no further questions at this time. I will now turn the call back over to Mr. John Butler for any closing remarks.

Thanks, operator, and thank you all for your attendance this morning. You know, while we celebrate Rural Kidney Day today, our commitment to patients drives us forward every day, and I hope you got a sense of our excitement from this call. I just want to really summarize very quickly a few of the exciting developments we're expecting in 2023. We're going to continue to drive revenue growth for Orixia and expect to deliver net product revenue of $175 to $180 million. We received a positive opinion from the CHMP for Vatadustat and anticipate marketing authorization in a couple of months. We expect a regulatory decision for the access consortium countries. We anticipate engaging a partner to commercialize Vatadustat in Europe. We expect a decision on the FDR process with the FDA. We anticipate that UT Health will initiate an ARDS study with Vatadustat in a broader patient population. And we look forward to talking much more about our pipeline development for Vatadustat and other novel HIF-PHI compounds as the year progresses. So it will be a very, very busy year for us, I think an exciting year for Kibia, and we look forward to updating you further on it. Thanks again for joining us. Have a great day.

Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.