Q3 2020 Akebia Therapeutics Inc Earnings Call

Good daily.

Operator: Good morning, ladies and gentlemen, and welcome to Akebia Therapeutics' third quarter fiscal 2020 financial results and business update conference call. As a reminder, this call is being recorded.

Me too.

Eric.

2020 financial results in business at the conference call.

Reminder, this call is being recorded.

Operator: I would now like to introduce your host for today's event, the Senior Vice President of Investor Relations with the team. Thank you, and welcome to Akebia's third quarter fiscal 2020 financial results and business update conference call. Please note that the press release detailing our results for the third quarter was issued earlier this morning and is available on our investor relations website. For your convenience, a replay of today's call will also be available on our website shortly after we conclude today's call. John Butler, our Chief Executive Officer, and David Spellman, our Chief Financial Officer, will be joining me on today's call. Before we begin, I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement contained in this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements.

I'd like to introduce your hopes for today to get Christian Shephard, Senior Vice President of Investor Relations with Ikea.

Thank you and welcome to keep your third quarter of fiscal 2020 Finance will result in business update conference call. Please.

Please note that the press release detailing <unk> results for the third quarter was issued earlier. This morning and is available on our Investor Relations website.

For your convenience a replay of today's call will also be available on our website. Shortly after we conclude today's call.

Joining me for today's college, John Butler, I, Chief Executive Officer, and David Spellman, Our Chief Financial Officer.

Before we begin I'd like to remind everyone that this call includes forward looking statements. Each for looking statement contained in this call is subject to risks and uncertainties that could cause actual results to differ materially from notes described in your statement.

Additional information regarding these package as described in a forward looking statements section. The press release, we issued this morning as well as in the Red scratches and management's discussion and analysis section of your most recent quarterly and annual reports filed with the SEC.

John P. Butler: Additional information regarding these factors is described in the forward-looking statements section of the press release we issued this morning, as well as in the risk factors and management discussion and analysis sections of our most recent quarterly and annual reports filed with the SEC. The forthcoming statements on this call speak only as of the original date of this call, and we do not undertake any obligation to update or revise any of these statements. With that said, I'd like to introduce our CEO, Jon Butler. Jon?

Before they can statements on this call speak only as of the original date of this call and we do not in to take any obligation to update or advise any of these statements.

With that I'd like to introduce our C E O John Butler John.

Thank you Kristin and thank you all for joining us today.

John P. Butler: Thank you, Kristen, and thank you all for joining us. We held an investor briefing webcast two short weeks ago to go over the newly presented data in detail. My comments on today's call will be mainly focused on our regulatory submission for the potential U.S. approval of Atadustat for the treatment of anemia due to CKD. I'll then turn the call over to Dave to review the financial results for the quarter, and we'll conclude with some Q&A. So with that, let's get started.

Hello, New dresser briefing webcast two short weeks ago to go over the newly presented data detail.

My comments on today's call will be mainly focus on a regulatory submission for the potential use approval gotta do set for the treatment of anemia due to C. K D.

I wouldn't turn the call over to be to review the financial results for the quarter and we will conclude with some <unk>.

So we got let's get started.

Keep it has made significant progress is here and I'm proud of our teams resilience performance.

John P. Butler: Akebia has made significant progress, and I'm proud of our team's resilience, performance, and their unwavering commitment to kidney patients and the community that we serve, especially given the challenges presented by the ongoing global COVID-19 pandemic. Our team is leading Akebia through the most dynamic period in its history.

Unwavering commitment to kidney patient and the community that we serve.

Especially given the challenges presented by the ongoing global COVID-19 pandemic.

Our team is leaving a T V. It through the most dynamic period in its history.

And importantly, we believe we're position and your T. B a deliberate strategy that we believe will build longterm value for our shareholders.

John P. Butler: And importantly, we believe we're positioning Akebia to deliver on a strategy that we believe will build long-term value for our shareholders. We recently completed our pre-NDA meeting with the FDA. Following this important milestone, we remain on track to submit to the FDA our MDA for Vatidustat as early as possible next year. A key component of this NDA is the positive data from our Global Phase III Innovate Program and Dialysis, which we first announced in May and then shared more recently at ASN Kidney. These data were clear and consistent across both efficacy and safety.

We recently completed are pretending a meeting with the F D. A.

Following this important milestone you remain on track to submit to the F. B a R. N D. A forgot to do stuff cause early as possible next year.

A key component of this N D. A is the positive data from our global for you three innovative programming dialysis, which we first announced in May and then cheered more recently.

At a S N kidney week.

John P. Butler: The data showed that Datadustat achieved both primary and key secondary efficacy, as well as the primary and key secondary safety or MACE endpoints of the Innovate program. More specifically, the data showed Vatadustat achieved and maintained patients in the target hemoglobin range while minimizing excursions above that. In addition, Bata Dusat achieved non-inferiority to DARPA POET and ALF on key secondary safety endpoints that included expanded mace, cardiovascular mace, cardiovascular mortality, and all-cause mortality. We believe these data underscore Vatadustat's potential as a new oral standard of care for treating patients with anemia due to chronic kidney disease, or CKD, on dialysis, marking a significant milestone And we believe it is an even more significant milestone for people on dialysis and their care.

John P. Butler: Based on our pre-NDA meeting, we remain confident that the Innovate results place us on a straightforward path to advance Vatidustat to potential approval for the treatment of anemia due to CKD in patients on dialysis, and we're on track to complete an NDA submission as early as possible in 2021. Upon approval, we believe we have a significant opportunity to advance our mission and help address the unmet needs of the 500,000-plus adult patients with anemia due to CKD on dialysis in the U.S., including both incident and prevalent dialysis. We believe this could translate into a potential $2 billion market opportunity in the U.S. alone.

As early as possible in 2021.

Upon approval, we believe we have a significant opportunity to advance our mission and help address the unmet needs of the 500000, plus adult patients with anemia due to CKD on dialysis in the us incur.

Including both incident and prevalent dialysis patients we.

We believe this could translate into a potential 2 billion dollar market opportunity in the us alone.

John P. Butler: We are equally excited with Vatadustat's opportunity in dialysis beyond the U.S., and we're working in close collaboration with OTSUCA to prepare a Marketing Authorization Application, or MAA, for submission to the European Medicines Agency next year, following our NDA. We look forward to leveraging our renal expertise and existing nephrology-focused commercial organization to support a strong data-do-stat launch in di We believe we are also well-positioned with our partner, Otsuka, sharing in the launch costs and responsibilities and a unique reimbursement system in the U.S. dialysis market that encourages the adoption of innovative therapies. These go-to-market strategies, coupled with the unique reimbursement structure, represent opportunities to meaningfully enhance the potential of bringing Vatidustat to patients on dialysis as quickly as possible, subject to regulatory approval.

John P. Butler: A great example of this is where our team is already supporting the commercialization of adidustat in its first major market, Japan, under the trade name Vafseo. I'd like to pause here and say how incredibly rewarding it is for all of us to see the promise of that induced path realized, where it's commercially available with a broad label to treat adult patients both on dialysis and not on dialysis. Both MTPC, our partner in Japan, and Akebia have worked hard to achieve this goal.

John P. Butler: And we look forward to future commercial success in this market and potentially others, which is a nice segue to say that I'm very pleased with the strength of our MTPC partnership, as well as our more extensive collaboration with them. I'm encouraged by the confidence and enthusiasm they continue to demonstrate in both Zadadustat and Akebia. While our highest priority in 2021 remains submitting our NDA. We're continuing to execute across many different workstreams, focused on areas such as medical affairs, scientific communications, disease state education, patient services, and manufacturing to ensure commercial readiness upon approval. Together with our partner, Roots.

Future commercial success in this market and potentially others.

Which is a nice segue to say that I'm very pleased with the strength of our MTBC partnership.

As well as our more extensive collaboration with otsuka.

Encouraged by the confidence and enthusiasm they continue to demonstrate in both reduced that and the caveat.

While our highest priority in 2021 remaining submitting our end da working.

John P. Butler: We recently launched a comprehensive campaign designed to increase awareness and education of anemia due to CKD among healthcare providers, all with the goal of improving the management of this disease for patients. Again, there is a significant unmet need among patients with anemia due to CKD. And we see a promising opportunity in VATADUSTAT to advance the standard of care for patients with diabetes. And as Dave will discuss, we're pleased to be doing all of this from a place of financial strength, with a cash runway that extends beyond the expected U.S. launch of Adidas. While our commercial team executes on pre-commercialization activities, our medical team continues to support Vatadustat's potential with a robust publication, in addition to all of the data presentations at ASN.

John P. Butler: We look forward to the publication of the full Innovate data in a prestigious peer-reviewed publication, as well as many other publications moving forward. I'd also like to touch on our non-dialysis. The Nondialysis Syndication will also be part of our NDA. A pre-NDA meeting confirmed that, as we expected, the FDA will need to review our global phase three data to determine whether it's sufficient to support approval of Addustat for the treatment of anemia due to CKD in adult patients not on dialysis. So we are being appropriately cautious in our outlook for approval in non-dialysis indications, and we suggest you are as well. Importantly, based on all of our regulatory interactions, including the pre-NDA meeting, we believe this review issue in non-dialysis will not impact the potential approvability of Atadustat for the treatment of adult patients with anemia due to CKD on dialysis.

So we are being appropriately cautious in our outlook for approval and the non dialysis indication and we suggest you are as well.

Importantly, based on all of our regulatory interactions, including the pre NDA meeting. We believe this review issue in non dialysis will not impact the potential approvability of how to do stat for the treatment of adult patients with anemia due to CKD on dialysis.

In summary, given the strength of our dialysis data, we remain confident that subject to approval by the dues that has the potential to be a new oral standard of care to help address the unmet needs of adult patients with anemia due to CKD on dialysis and that this is currently at 2 billion dollar market opportunity in the U.S.

John P. Butler: In summary, given the strength of our dialysis data, we remain confident that, subject to approval, BataDosDat has the potential to be a new oral standard of care to help address the unmet needs of adult patients with anemia due to CKD on dialysis, and that this is currently a $2 billion market opportunity in the U.S. alone. Together with our collaborator, Otsuka, we look forward to bringing this innovative therapy to patients on dialysis globally if approved. Now I'll turn the call over to our CFO, Dave Spellman, who I think many of you know. He joined Akebia back in July and brings with him an extensive background in commercial companies. We are very excited to have him on board. Dave?

Hello.

Together with our collaborator Otsuka, we look forward to bringing this innovative therapy to patients on dialysis globally if approved.

Now I'll turn the call over to our CFO, Dave Spelman, who I think many of you know.

David A. Spellman: Thank you, John, and good morning, everyone. After completing my first full quarter as Akebia's Chief Financial Officer, I would just like to say how inspiring it has been to be part of a company, and more so, a tightly knit community of really talented people pursuing a deeply held mission to better the lives of people impacted by kidney disease. I'm excited to be here.

David A. Spellman: And I'm looking forward to speaking with all of you as we continue to advance both Akebia and our Vatidustat development program. With that, I'll jump right into the quarter's results. Total revenue for the third quarter of 2020 was $60 million, compared to $92 million for the third quarter of 2019.

David A. Spellman: The decline versus the prior period was driven by lower collaborative revenue, consistent with the company advancing the BataDustat development program and completing both the Innovate and Protect studies. As you may know, 80% of our Phase III Vatidustat development costs are reimbursed by our collaborator, Otsuka, and these corresponding payments are recorded as collaborative revenue. So as these costs decline... So will the corresponding payment.

David A. Spellman: Also, a note that's subject to the terms of our collaboration agreements with Otsuka. Akebia has the potential to receive development and regulatory milestone payments from Otuka upon approval of Vatidustat in both the U.S. and in Europe. As John mentioned, the third quarter marked the first commercial availability of Vatadustat under the trade name Vaseo in Japan.

Has the potential to receive development and regulatory milestone payments from otsuka upon approval of that is that in both the U S and in Europe.

As John mentioned in the third quarter marked the first commercial availability of valid is that under the trade name that Seo and Japan.

I'm pleased to report that since launching in late August we recorded $373000 and royalty revenue related to the sale of Seo by Mitsubishi Tanabe are.

David A. Spellman: I'm pleased to report that since launching in late August, we recorded $373,000 in royalty revenue related to the sale of SAO by Mitsubishi Tanabe, our collaboration partner in Japan. We're pleased with this early commercial performance and continue to believe that Japan represents a meaningful growth opportunity for Vatidu. In terms of Akebia's commercial performance, net product revenue for Erixia, Ferric Citrate, increased 14.6% to $34.4 million for the third quarter of 2020, compared with $30.0 million for the third quarter of 2019. While this is encouraging performance, we remain cautious in our planning for Erixia revenue due to the fundamental impact that CMS's non-coverage decision continues to have on our business, as well as uncertainty from COVID-19. Cost of goods sold associated with the manufacture of Orexia was $30.3 million for the three months ended September 30, 2020, and it includes the impact of $9.9 million in non-cash inventory write-downs largely related to a previously disclosed manufacturing quality issue with Erixia.

A collaboration partner in Japan, where pleased with this early commercial performance and continue to believe that Japan represents a meaningful growth opportunity for <unk>.

In terms of a television commercial performance.

<unk> product revenue for <unk>, Eric citrate increased 14.6% to $34.4 million for the third quarter of 2020, compared with 30.0 million for the third quarter of 2019.

While this is encouraging performance, we remain cautious and are planning for a rexene revenue due to the fundamental impact that CMS is non coverage decision continues to have on our business as well as uncertainty from COVID-19.

Cost of goods sold associated with the manufacturer of Auryxia was $33 million for the three months ended September 30th 2020 and includes the impact of $9.9 million in non-cash inventory write downs largely related to a previously disclosed manufacturing quality issue with auryxia.

Move into a research and development expenses.

David A. Spellman: Moving to our Research and Development expenses, R&D expenses were $46.9 million for the third quarter of 2020 compared to $74.5 million for the third quarter of 2019. As I just mentioned, the decline here was primarily driven by a decrease in costs consistent with the company completing the Innovate and Protect study. Selling general and administrative expenses were $40.2 million for the third quarter of 2020, compared to $34.2 million for the third quarter of 2019.

R&D expenses were 46.9 million for the third quarter of 2020 compared to 74.5 million for the third quarter of 2019 as.

As I just mentioned decline here was primarily driven by a decrease in cost consistent with the company completing the innovate and protect studies.

Selling general and administrative expenses were 40.2 million for the third quarter of 2020.

Care to 34.2 million for the third quarter of 2019 the.

The increase was primarily a result of higher professional service fees related to some of the pre commercial activities currently underway to support Vatted used that's introduction in the U S subject to approval.

We expect to continue to focus our investments and.

David A. Spellman: The increase was primarily a result of higher professional service fees related to some of the pre-commercial activities currently underway to support Vatidustat's introduction in the U.S., subject to approval. We expect to continue to focus our investment in our potential market opportunity with FATADUSTAT in patients on dialysis, where we see significant potential to help patients and drive future growth. For our bottom line, the company reported a net loss of $60 million for the third quarter of 2020 as compared to a net loss of $54.6 million for the third quarter of 2019.

And our potential market opportunity with that abuse that in patients on dialysis, where we see significant potential to help patients and drive future growth.

For our bottom line the company reported a net loss of $60 million for the third quarter of 2020 as compared to a net loss of $54.6 million for the third quarter of 2019.

Turning to our capital position, we ended the third quarter of 2020, and a strong financial position with cash cash equivalents and available for sale securities of $269.3 million.

David A. Spellman: Turning to our capital position, we ended the third quarter of 2020 in a strong financial position with cash equivalents and available for sale securities of $269.3 million. We expect our cash resources to fund our current operating plan beyond the expected U.S. launch of Vatadustat, assuming regulatory approval. And lastly, we ended the quarter with approximately 143 million shares outstanding.

Operator: With that, we'll open the line for questions. Operator? Thank you. Ladies and gentlemen, as a reminder to ask a question, you will need to press star then 1 on your telephone. To withdraw your question, press the pound.

Allison Marie Bratzel: Again, that's star number one to ask the question. Our first question comes from the line of Chris Raymond with Piper Sandler. Hi, this is Allie Bratzel on for Chris this morning.

Allison Marie Bratzel: Thanks for taking the questions. So just first, on the regional PROTECT MACE analysis, I think we had been expecting the PROTECT data cuts would all be pre-specified. And it's our understanding that for the regional MACE analysis presented at ASN, rescaling age from a dichotomous to a continuous variable increased the power, but that change wasn't actually pre-specified in the stat plan.

John P. Butler: So just hoping you could talk about how you get comfort that FDA will accept the non-pre-specified analysis. And then also, from your prepared remarks, it sounds like FDA is mainly interested in global rather than regional MACE analysis and pre-dialysis. So maybe just help us out. Do we hear that right?

John P. Butler: And could you expand on that? Sure, Ali, thanks for the question. So when it comes to the continuous ages, continuous variable analysis, it's important to recognize that age was a pre-specified part of the model. And now the SAP had dichotomous looking at kind of old versus young, if you want, you want to call over 65 old.

John P. Butler: And now using the continuous ages, the continuous variable is a tool to give you more specificity. So it is actually the way it's normally run. If you look at it as a continuous as a dichotomous variable, you have a hazard ratio of 1.06 and a top end at 1.29, not meaningfully different.

John P. Butler: This is safety data, and ultimately, what you're demonstrating there is that you're not increasing cardiovascular risk. Now, I want to make sure that you're interpreting correctly what I said. We have confidence in this analysis and what we're going to put in front of the FDA on non-dialysis. But we absolutely recognize that we missed the primary safety endpoint. And, you know, given that, there's clearly significant risk.

And we think it's just best for you all to.

To approach it that way as well.

What I really think thats, an important message today to to to.

To deliver is that the dialysis data and based on our pre NDA meeting and frankly every regulatory interaction that weve had they look at that as a separate population with a separate risk benefit and given the data that we presented in innovate we feel very confident in our platform.

John P. Butler: And we think it's just best for you all to approach it that way as well. What I really think is an important message today to deliver is that the dialysis data, and based on our pre-MDA meeting, and frankly, every regulatory interaction that we've had, they look at that as a separate population with a separate risk benefit. And given the data that we presented at Innovate, we feel very confident in our path forward for dialysis. Okay, thanks. And maybe just one more question. Now that you've had the pre-NDA meeting with FDA, what are your thoughts on the chances for an ADCOM for vatostat changing, and just maybe, in your view, is this at all dependent on or even related to the approval decision for roxodistat in dialysis and pre-dialysis next month? Yeah, I mean, I really can't comment on Roxaduce.

Board for dialysis.

Okay, Thanks, and maybe just one more question.

Now that you've had the the pre NDA meeting with the FDA heavier.

John P. Butler: I think we're all going to know what happens there in six weeks or so. Honestly, the pre-NDA meeting was a very constructive, productive meeting that really simply kind of confirmed everything that we had been working towards already. So we are preparing for an adcom. Frankly, we'd welcome an adcom.

John P. Butler: You know, we think that, you know, describing the benefit that patients would get from treatment with Vataduce, that non-dialysis, we think, would be important. But that's, of course, up to the FDA. But I don't think it has changed our view at all.

John P. Butler: We've always been preparing for an adcom. Okay, thank you. Thanks, Allie. Thank you. Our next question comes from the line of Defe Yang with Mizuho. Your line is open. Hi, good morning everyone. This is Alex on 4D-FE.

Unknown Attendee: Thank you for taking the question. I'm wondering if you still plan on filing for regulatory approval early next year using the Priority Review Voucher for Vataduce. Secondly, uh... I'm wondering if you could give us a sense of how quickly you would expect to be able to apply for TDAP, following potential.

For the question so.

So we still have the option to use the P. R V.

Of course, that's not our decision alone that's.

Our partner before and we have to agree on that so those discussions are are ongoing. So we haven't made any determination yet as to whether or not we'll use that.

As far as T Dapper goes at.

John P. Butler: Sure, thanks for the question. So, um, we still have the option to use the PRV. And, of course, that's not our decision alone.

The.

Basically the process is your file once you have your approval and it takes it kind of depending on when the approval comes theirs.

John P. Butler: That's, you know, our partner before, and we have to agree on that. So those discussions are ongoing. So we haven't made any determination yet as to whether or not we'll use that. As far as TDAPA goes, the, you know, basically the process is you file once you have your approval, and it takes, you know, kind of depending on when the approval comes. There's a, you know, they do these kind of once a quarter, I think, is when they give you the HCPCS code that you need to be part of TDAPA.

Do these kind of once a quarter I think is when they they grant the hick picks code that you need to be part of TDAP us. So, we'll we'll be able to get a little more granular on that as we get closer to knowing exactly.

John P. Butler: So, you know, we'll be able to get a little more granular on that as we get closer to knowing exactly when approval will be. But there's a clear process for how you go about getting that code you need to be part of TDAPA. It doesn't happen instantaneously on approval, you know; there will be some months of, depending on when you get it, when you get your approval, some months of delay. Great. Thank you. Thank you. Our next question comes from the line of 8R. Wainwright.

John P. Butler: Your line is open. Hi, good morning, everyone. This is Thomas Yip asking a couple of questions for Ed. First, a couple of questions about Validusdebt for use with NDAs, one in dialysis patients and one in non-dialysis patients. Do you expect to file them together, perhaps in the first half or second half of 2021? And following on from the question on the PRV, if they are indeed filed separately, how does the PRV come into play?

John P. Butler: Thanks for the question. So very important to know this is one NDA. The one NDA will include both the dialysis and non-dialysis population as part of the new drug application. And, you know, FDA can determine that the drug is approved for both populations or just for one.

They use the pov or not along with our partner.

It'll be determined on the one NDA and let me point, we're planning on filings as early as we can next year.

We haven't gotten beyond that this idea of of force the first or second half.

John P. Butler: So that kind of makes your second question moot. I mean, whether we decide to use the PRV or not, along with our partner, it'll be determined in the one NDA. And let me point out, we're planning on filing this as early as we can next year. We haven't guided beyond that, this idea of the first or second half. We're going to move as quickly as we can to get that done, so I don't think you should look too far ahead with that filing.

We're going to move as quickly as we can to get that done so.

And I don't think you should look too far out.

<unk>.

To to that filing.

Okay. Thanks for your clarification on this through and and then following on on.

On the preamp a meeting.

That the S. A request ended up I should know analysis for the amount that was this population and.

What else is needed before you got something about the N B a.

I don't think we're any specific additional analysis there will be additional analyses that are part of the NDA and it's.

John P. Butler: Okay. Thanks for the clarification and explanation. And then, following the pre-NDA meeting, did the FDA request any additional analysis for the non-dialysis population, and if not, what else is needed before you can submit the NDA? I don't think there were any specific additional analyses.

Obviously, the what they receive as the briefing book for the pre NDA meeting versus the the NDA is is dramatically different so.

John P. Butler: There will be additional analyses that are part of the NDA. I mean, obviously, the briefing book for the pre-NDA meeting versus the NDA is dramatically different. So, you know, we're still analyzing the data. We're still, you know, doing analyses. And if those support the NDA, then we'll include those. Okay, I got it. And then one final question. First, congratulations on the launch with Mitsubishi in Japan. So we see that there's 0.4 million in royalty revenue from Mitsubishi already, and that was launched in August. So it's about a month of sales.

And we're still analyzing the data we're still doing analyses and if those support the.

The NDA then then we'll include those.

Okay got it and then one one final question first congratulations on the launch witness Mitsubishi in Japan. So we see that there is point 4 million or artwork the revenue from Mister Fisher, you're ready that would launch.

In August so it's about a month of sales so how should we look <unk> royalty revenue.

And fourthquarter 2020.

David A. Spellman: If so, how should we look at the sales of royalty revenue in the fourth quarter of 2020? Yeah, thanks for the question. So, yeah, it is about a month, four or five weeks of sales that are in that royalty calculation. There is some pull through and selling, but as you would expect with any launch, there is some inventory built.

Yeah. Thanks for the question. So yes. It is about a month for five weeks of sales that are in that royalty calculation areas and pull through and selling but as you would expect with any launch there is some inventory bill.

We're not guiding to the fourth quarter amount, but hopefully that gives you a little bit of direction.

Okay got it characterize our partner is pleased with the absolutely with the launch so we are as well.

David A. Spellman: We're not guiding to the fourth quarter amount, but hopefully, that gives you a little bit of direction. I think I would characterize our partner as pleased with the launch, so we are as well. Okay, completely understood. Once again, congratulations on the launch in Japan. Thank you for taking our questions, and we look forward to a very eventful 2021 for the business.

Okay completely understood and once again congrats congratulations on the launch in Japan. Thank you for taking my questions and we look forward to very eventful 20th 21 for that.

We do as well thank you.

Thank you.

Reminded ladies and gentlemen to ask the question you would need to press started in one on your phone.

Our next question comes from Atlanta Bird Paisley would be T. I D. You line is open yeah. Thanks. Thanks for taking the question My most of mine had been addressed but uhm just one.

John P. Butler: As a reminder, ladies and gentlemen, to ask a question, you will need to press star then 1 on your phone.

John P. Butler: Our next question comes from the line of Bert Hazlett with DTIG. Yeah, thanks. Thanks for taking the question. Most of mine have been addressed.

One that's just slightly different than what was just asked and your interactions would that be a regarding the non dialysis population were there any other specific requirements that you got the sense would be necessary.

John P. Butler: But just one, one that's just slightly different than what was just asked. In your interactions with FDA regarding the non-dialysis population, were there any other specific requirements that you sensed would be necessary? No, Bert, as I said, it was pretty much, you know, constructive. And, you know, we got clarification on, you know, some, a lot of technical things also. But there was no, You know, there's like small things, but nothing that would be, you know, the significant other analysis that they said we needed to do.

No bird.

As I said I mean, it was pretty much.

And it was it was constructive and.

We got clarification on some a lot of technical things also but there was no.

You know there was like small things, but nothing that would be.

Significant other analysis or they said we needed to do I mean, they they.

I mean I feel like they were.

John P. Butler: I mean, they, I mean, I feel like they understood what we were presenting to them and understood that we were going to be submitting all of it together, and they were going to review all of it together. Anyway, so there was nothing kind of that came out of that that was a surprise or a big change in the way we were approaching things. It's very much as we had been communicating with you before. Okay, thanks. And you've spoken just one other time about partnerships. You've spoken a couple of different times about V4 and Otsuka and Mitsubishi. Can you just, in general, characterize the interactions you're having with your partners in this current environment?

Understood.

What we were presented to them and understood that that we were going to be submitting all of it together and they were going to review all of it together.

Anyways.

So there was nothing kind of that came out of that that was.

A surprise or a big.

Change for the way we were approaching thinks it's very much as we had been communicating to you before.

Okay. Thanks, and you've spoken just one other on partnerships you've spoken a couple of different times about of before and.

Ah Cougar and Mitsubishi.

In general characterize the.

The interactions you are having with your partner.

In this in this current environment.

Sure Bird. Thanks for the question I mean, we are incredibly pleased.

John P. Butler: Thanks. Sure, Bert, thanks for the question. I mean, we are incredibly pleased with the partners that we've chosen. I'll point to Otsuka most directly since we have the most interaction with them, obviously. We're working side by side with them on the NDA. I mean, we are leading the NDA, they'll be leading the MAA, but we are kind of in lockstep from a strategic standpoint. Obviously, Otsuka representatives were on the pre-NDA call with us as well. Our strategy is aligned, and they've just been great to work with throughout. But as I say, Mitsubishi V4 we obviously have fewer kinds of day-to-day interactions with, but they've been great through the process.

With the partner does that we've chosen.

Point towards sukkah, most directly since the we have the most interaction with them obviously.

They are we are working side by side with them on the NDA I mean, we are leading the NDA they'll be leading the MAA.

But we are kind of block step from a strategy standpoint, obviously otsuka representatives were on the pre NDA call with us as well.

Our strategy is aligned and.

They have just been great to work with throughout.

As I say mid.

Mitsubishi before we have obviously fewer kind of day to day interactions with.

But it's been great through the.

Through the process.

John P. Butler: Okay, thank you. Thanks, Burke. Thank you. Our next question comes from the line of Chad. Hello, everyone. This is Gilan from Chad.

Okay. Thank you.

Thanks Birch.

Thank you. Our next question comes from the line of Cat necessarily need them May company.

Okay.

Hello, everyone. This is go on for chat and thank you for taking our question.

Unknown Attendee: And thank you for taking our question. Although I feel you might have kind of addressed this already. So, with the FDA feedback, is there any indication that the FDA would be looking at additional studies and non-dialysis that they would ask you to do? I mean, there are no previous studies performed against ESA, not this large. It's valid.

Uhm.

Although I feel you might've kind of address this already so with it yesterday a feedback is there any indication the FDA would be looking at at additional studies and non dialysis that that that would ask you to do I mean, there's no previous studies performed again USA.

Not be slot not not this large so.

John P. Butler: Well, I'm not sure I understood the question exactly, but I will say that there was no indication, nor did I expect there to be, in a pre-NDA meeting, that any additional studies would be necessary. But again, that would be extraordinarily unusual for a pre-NDA meeting. But I'm not sure I understood the characterization of that comparison question. It's just because the active control in your study is different than, let's say, you know, studies done on Roxas-Eustat and non-dialysis defense. Yeah, maybe the FDA is looking at this differently. That's kind of what I was alluding to.

It's a valid.

Kind of direction.

Well I'm not sure I understood exactly the question, but I will say that there was no indication nor what I expect there to be.

And a pre NDA meeting that any additional studies would be necessary.

But again I mean that would be extraordinarily unusual for pre NVA meeting.

But I'm not sure I understood that characterization of.

Of that comparison question.

It's just because.

The active control in your study.

A different than but let's say that'd be stinker rocks at this that then and on Dallas with dependent.

Yeah, maybe the Fda's looking at this differently.

What I was alluding to.

John P. Butler: Yeah. Well, again, I mean, the program we did, we did with the guidance of the FDA. This is what they asked for, and this is what we're giving them. And I think, you know, from the results, why they want that direct comparison. So, you know, again, we'll see how things roll out here. But, you know, again, we're certainly comfortable with the program that we did.

Yeah, well again I mean, we.

The program, we did we did with the guidance of the FDA.

What they ask for and what we're giving them and I think you see from the results why they want that direct comparisons so again.

We'll see.

How things how things rollout here, but.

Again, we were.

Certainly comfortable with the program that we've done and.

John P. Butler: And, you know, we are cautious about our ability to have an approval in non-dialysis. But we, you know, are pleased with the package that we've been able to put together based on the data. Alright, thank you for answering our questions and good luck with everyone. This is Aldo.

We are we are cautious about our ability to have an approval and non dialysis and but we were pleased with the package that we're able to put together based on the data.

Alright, uhm well, thank you for for answering my questions and good luck with all.

John P. Butler: Thank you. Thank you very much. Thank you. Our next question comes from the line of Ken and McKay with RBC Capital Markets. Hey guys, thanks for taking our questions. This is Vikram on behalf of Canon.

Maybe I'll be all thank you milestones.

Thanks very much.

Thank you.

Our next question comes from my line of Kennedy K with RBC capital market.

Okay.

You guys. Thanks for taking a a question this is <unk>.

We had a couple of questions. So first on the Anson presentation for protected study, we're just trying to better understand the U S forces X U S differences in cardiovascular.

Unknown Attendee: We had a couple of questions. So first, in the ASN presentation for the PROTECT study, we're just trying to better understand the US versus non-US differences in cardiovascular events, and it's, other than just the treatment hemoglobin range of 10 to 11 versus 10 to 12, is there anything else that stood out to you from the data, or did you see any correlation between the patients who achieved a higher hemoglobin outside of that range and they had higher cardiovascular events? I guess we're just trying to better understand what could be driving this difference between U.S. and ex-U.S. patients. It's a great question.

Events and it's.

Other than just the treatment hemoglobin range of tend to 11 worst is 10 to 12 is there anything else that came out to you from the data or.

Did you see any go relation between now the Bichons, which achieved a higher haemoglobin outside of that range and they had higher cardiovascular events.

I guess, we're just trying to better understand what could be driving this difference between you as an X U S patients.

But it's a great question and again I mean, the geographic analysis was Prespecified analysis and that's one of the reasons why it was a prespecified analysis, because there is a different hemoglobin target in the U S versus the rest of the world and so the data.

John P. Butler: And again, I mean that the geographic analysis was a pre-specified analysis. And that's one of the reasons why it was a pre-specified analysis, because there's a different hemoglobin target in the US versus the rest of the world. And, you know, so the data kind of showed the data, right? I mean, the difference in MACE was driven by ex-US patients who were, you know, treated to a target range of 10 to 12. That's why we performed the post hoc analysis that looked at patients who actually achieved the hemoglobin level during the primary efficacy endpoint of under 11 versus over 11. And you saw that same effect. If they were managed to a lower hemoglobin range, you know, within 10 to 11, there was no increased cardiovascular risk. All of the increased cardiovascular risk showed up when you treated patients to higher hemoglobin.

Kind of show the data right I mean, the the difference and mace was driven by.

X U S patients who were.

Treat it to a target range of 10 to 12, that's why we performed the post hoc analysis that looked at patients who actually achieved the hemoglobin level during the primary efficacy endpoint.

Of under 11 versus over 11, and you saw that same effect. If they were managed to to a lower hemoglobin range.

Within 10 to 11 they had.

There was there was no increased cardiovascular risk all of the increased cardiovascular risk showed up when you treated patients to wire hemoglobin. So.

John P. Butler: So, you know, it really does lead us to the conclusion that, you know, if you treat patients to a hemoglobin target of 10 to 11, which is the target in the US, you don't increase cardiovascular risk. And that's the argument that we've put, and we will put in front of the FDA with the NDA. Okay, super helpful. And just to follow up on that, I think I'm looking at the curves in the U.S., the pre-specified sub-curve analysis, just in the U.S. There's a split happening between the curves for VDATA stat and the control arm around it. Week 120.

It really does lead us to the to the conclusion that it is that if you treat patients to a hemoglobin target at 10 to 11, which is the target in the U S. You don't increase the cardiovascular risk and that's the the the.

<unk> that we've we've put we will put in front of the FCA with the MTA.

Okay Super helpful and just to follow up on that I think I'm looking at the cars in the U S. B specified some analysis just in the U S. There's a split happening between the Greens or would that would that would be that and the control arm.

Around week 120.

Unknown Attendee: So could you comment on maybe why the curves are splitting at that point, or is there anything you saw that could be driving that? No, I mean, the important thing is that they come back together again, that they don't maintain a split. And that's why you look at the overall MACE, you know, there's clearly no increased cardiovascular risk there. I mean, that's not something unusual to see where there's a non, we're non-inferior. Got it. I was just thinking in terms of the duration of exposure of the drug could be maybe driving the cardiovascular events or that, correct me if I'm wrong, if something like that is happening.

So could you comment on maybe why that because there's bleeding at that point or anything.

Anything you saw that could be driving that.

No I mean, it's.

The important thing is that they come back together again.

They don't maintain a split and that's why you look at the overall mace, there's clearly no increased cardiovascular risk there.

I mean, that's not something unusual to see where there is a non non inferior.

Got it I was just thinking in terms of duration of exposure off the <unk> could be maybe driving the cardiovascular events or not.

John P. Butler: No, it's not. I mean, you wouldn't see it come back together again then if that was the case. I think what you start to see is that the ends start to get smaller. And so, you know, you start to see that separation. But, you know, the fact that they come back together when the ends are even smaller kind of demonstrates it. And that's, you know, all of the statistics demonstrate that there's not an increased cardiovascular risk in that population.

Correct me, if I'm wrong or something like that is happening.

No. It's not I mean, you wouldn't see it come back together again if.

If that was the case I think what you start to see is that the ends start to get smaller and so you start to see that right separation, but the fact that they.

And they come back together when they ends or even smaller is is.

Kind of demonstrates isn't that's all of the statistics demonstrate that there is not an increased cardiovascular risk in that population.

Okay got it. Thank you so much and congrats on the progress and thank you so much again.

John P. Butler: Okay, I got it. Thank you so much, and congrats on the progress. Thank you so much. Thank you; I appreciate it. Thank you. I'm showing no further questions in the queue now. I would now like to turn the call back over to Mr. John Butler for closing remarks. Thank you, Tawanda, and thanks to everyone for joining us this morning. We look forward to continuing to update you on Akebia's progress. Thanks. Have a good day. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. BF-WATCH TV 2021, The Bulletproof Executive 2013,

Thank you I appreciate it.

Thank you.

I'm showing no further questions in the queue now.

Now like to turn the call back over to Mister job, but no for closing remarks.

Thank you to wander and thanks to everyone for joining us. This morning, we look forward to continuing to update on <unk> progress.

Thanks have a good day.

Ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.

[music] [noise].