Q2 2021 Akebia Therapeutics Inc Earnings Call
[music].
Good day, ladies and gentlemen, and welcome to the key get Therapeutics second quarter of 2 day.
'twenty, 1 financial results and business update conference call of the.
A reminder, this call is being recorded I would now like to introduce your host for today's event Kristen Sheppard.
Senior Vice President of Investor Relations with Ikea.
Thank you and welcome.
<unk> second quarter, 2021 financial results and business update conference call.
Please note that the press release detailing our results for the second quarter was issued earlier. This morning and is available on the investors section of our website.
Ear convenience the replay of today's call will alter the available on our website. Shortly after we conclude.
Joining me for today's events of John Butler, Our Chief Executive Officer, David Spellman, Our Chief Financial Officer, Dr. Steven Burke of Chief Medical Officer, and dealt Buckingham, our Chief commercial officer.
And large peer reviewed studies have demonstrated the increased cardiovascular risk associated with Esa use in both dialysis and non dialysis patients.
Physicians and key opinion leaders associate that risk with the speed of hemoglobin increase and hemoglobin overshoots above their target level.
These concerns were raised recently and the context of the Fda's review of another company's <unk> PHA products under development.
And their newly disclosed adverse event data.
While we will not speculate on the outcome for their company or their data. We believe there are differentiating and important aspects of the global phase III data from <unk> and our program.
As the value that NDA is actively under review at the FDA.
Limit my comments to our public data, which Fortunately there is an abundance of and it's published and 1 of the most reputable journals and the world.
Our team has done a great job executing on our publication plants.
First our global Phase III clinical data showed that once daily dosing of that <unk> increased hemoglobin and a gradual and steady manner.
Data also showed that <unk> minimized hemoglobin, overshoots compared to debacle and alpha and Esa.
We have been highlighting this treatment goal and the design of our studies for a number of years.
And it's encouraging to see this approach validated and the phase III results across both our dialysis and non dialysis programs.
I'd also like to remind you that our entire global phase III program, including the starting dose used in both dialysis and non dialysis programs.
And as designed after extensive dialogue with both the FDA and European regulators.
This was a very significant undertaking and we're very pleased that and enabled us to align with regulators on the details of our statistical analysis plan, the pre specified analyses and the non inferiority margins.
We're also grateful to have the support of the chairs of the independent executive steering committee for both innovate and protect doctors turtle and effort and the entire committee who have continued to ensure the ongoing quality of our program as well as an objective independent and voice and data analysis and publication.
Having the results of our global Phase III program published and the New England Journal of Medicine was tremendous validation of all of this work.
We believe these publications not only reinforce the scientific rigor and quality of our program, but also speak to the clarity of the data for the broader medical community.
This is 1 more tangible example of <unk> commitment to transparency.
Feedback and interest and these publications from key opinion leaders and the broader kidney community continues to be very positive.
We believe these publications will be highly informative for physicians and patients dialysis providers and payers as they make important decisions about patient care and potentially a key consideration when differentiating among hips and the class as well as differentiating that reduced that from treatment with Esa.
Importantly, as seen in and New England Journal publications, and our global Phase III data showed no significant safety signal on adverse events, including thromboembolic events seizures and infections.
More specifically the data show that these events were very similar from that of <unk> as compared to Darva potent alpha in the dialysis and non dialysis programs.
We've provided the links to these journal publications and today's press release and of course. They are also available on our website.
I encourage you to read these papers and the supplementary data as well as we believe they will provide a very clear understanding of that and <unk> and our program.
And of course, we have Dr. Burke, our chief Medical officer on the call today to answer any questions you have about the journal publications.
Without a <unk> date set for March and progressing on our path to commercialization and are highly focused on prelaunch activities to ensure that we are well positioned for successful U S launch in 2022 subject to regulatory approval.
More recently with the exciting potential from that or do start to now be first to market.
We've been expanding our planning to include a broader market opportunity and dialysis than originally anticipated.
We believe dialysis represents a large and growing potential $2 billion market opportunity and the U S alone.
We believe we have a clear path ahead of us and dialysis and were confident that upon U S approval, we will have the potential to address the unmet needs of over half a million adult patients on dialysis and rapidly established that and use that as the new oral standard of care and the treatment of anemia due to <unk>.
We anticipate that the consistency and clarity of our dialysis data bolstered by recent publication and the New England Journal will play a meaningful role and helping develop treatment protocols within dialysis providers, which are critical to driving adoption and the dialysis market.
We're also conducting 2 studies 1 led by our partner Otsuka to show that <unk> can also be dosed 3 times a week.
Assuming the data are positive we expect to use this data to support a supplemental NDA for this dosing regimen and post approval.
Although the significant majority of dialysis patients are cared for and center several factors, including the COVID-19 pandemic are supporting a growing shift towards home dialysis.
Based on reports from the largest dialysis providers on dialysis appears to be the fastest growing segment of the dialysis population.
CMS is also creating payment models to encourage this move to home treatment.
These trends are exciting as we believe that as a convenient once daily oral therapeutics that abuse that has the potential to offer an important value proposition book to the growing number of home dialysis patients and to dialysis providers looking to better support these patients simplify administration and grow their home programs.
With our planned commercial launch and strategic alignment, we believe that we can enable broad market access for patients and support rapid adoption of that of <unk> in the dialysis market.
As a potential first to market product our go to market strategy now has a broad focus.
Our plans include leveraging our exclusive distribution relationship with before pharma to access Fresenius medical care and certain independent dialysis providers, which include up to 60% of the U S dialysis patients. Additionally.
Additionally, we plan to leverage our direct and nephrology focused sales force to facilitate adoption of davita and other strategically important dialysis providers.
Accounts for the remaining 40% of patients with our partner Otsuka sharing and the launch costs and responsibilities.
Adding to this is a unique reimbursement model in the U S dialysis market with teed up and add on payment to the bundle that is intended to encourage adoption of innovative therapies by clinicians and dialysis providers.
Although there is limited market experience with the TDAP a process our understanding of the process suggests it may take approximately 6 months from the regulatory approval to TDAP a designation.
Now, it's teed up payments will continue for 2 years following TDAP a designation.
And we believe that the timing of TDAP, a designation will be important to the rate of adoption.
Again as a potential first in class product. We now believe that abuse that has a broader market opportunity and dialysis than originally anticipated and we believe we created a go to market strategy to support both our near term and long term growth potential and this market.
Now turning to non dialysis and.
Assistant with our prior comments, while we remain cautious for approval and non dialysis. We believe we have put forward a compelling and extensive NDA data package and we look forward to continuing to work with the FDA on their review of the efficacy and safety data.
We believe the patient need for a safe and effective oral treatment for anemia due to <unk> is clear across both the dialysis and non dialysis populations.
Now shifting gears to performance of our existing commercial product auryxia.
We're encouraged with Auryxia as performance from the second quarter.
We continue to be pleased with how the market is viewing auryxia strengths and importantly, the team continues to do a great job supporting our customers and patients getting our therapies to those in need.
We're hopeful that as the industry continues to focus on prioritizing vaccines for dialysis patients COVID-19 related hospitalizations and mortality will continue to decline.
We continue to expect Auryxia to deliver annual revenue growth for 2021.
And again, we're excited to leverage this outstanding team with the expected launch of <unk> next year.
And.
Finally, I'd like to share with you a number of potential catalysts that we're focused on for 2021 and beyond.
As our largest potential market. The U S remains our highest priority provided <unk> with a <unk> target action date of March 29.2022.
We're also continuing to collaborate with our partner Otsuka and expect to file that at least at MAA submission to the European Medicines Agency later this year.
We continue to explore potential development opportunities from <unk> and look to share more information on these efforts later this year.
As we've discussed previously UT health is engaged and an ongoing investigator sponsored study of <unk> as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome or rds in adult patients who have been hospitalized due to COVID-19.
They currently have over 300 patients enrolled in this 400 patient study and when possible we will share an update on the study.
We look towards additional presentations of our phase III results and data, including multiple abstracts expected at ASN and at future medical conferences and in peer reviewed journals.
Lastly, as we move closer to the potential launch of that and <unk> will also look to share progress on our pre commercial activities.
So to briefly summarize this is a busy and exciting time at Acadia, we remain confident in <unk> potential as a first in class treatment for anemia due to <unk> and we look forward to continuing to engage with the FDA and the review of our NDA.
I'll now turn the call over to Dave who will review our financial results.
Dave.
Thank you John and good morning, everyone.
As John mentioned, having laid the groundwork for potential approval for ADESA and pre commercial launch preparations for that it is that.
We believe we are well positioned with our existing commercial footprint and together with our partners. Our team is fully engaged and the work to ensure appropriate commercial drug supply at the time of launch subject to approval.
Turning to our financial results for the quarter starting with revenue.
Total revenue was $52.9 million and the second quarter of 2021 compared to $90.1 million for the second quarter of 2020 <unk>.
Reflecting lower collaboration revenue consistent with successfully completed our global phase III clinical development program for value set.
In terms of the caveats commercial performance net product revenue for Auryxia increased 7.4% to $33 million for the second quarter of 2021, compared with $30.7 million for the second quarter of 2020.
We're encouraged by this growth, which we believe is a great illustration of our commercial team's execution and this ongoing COVID-19 environment.
We believe this performance also highlights our ixia as favorable product profile and the critical nature of this therapy.
Looking ahead, we believe the team's focus and execution on our marketing sales and payer strategy will continue to drive net product revenue growth.
Turning to expenses, we continue to prioritize investments to support both that it is that and topline growth.
We're also continuing to focus on improving costs and advancing our pipeline of development opportunities.
Cost of goods sold was $52.5 million for the second quarter of 2021 compared to $174.6 million for the second quarter of 2020.
Current year includes a 30 million noncash charge for excess purchase commitments consistent with continued execution of our long term care contract strategy, which remains focused on contract economics and net product revenue growth.
Cost of goods sold from the prior year period included the impact of a noncash impairment charge of $115.5 million related to the Auryxia and tangible asset and addition to other charges noted on our press release for that period.
Research and development expenses were $37.2 million for the second quarter of 2021 compared to $52.8 million for the second quarter of 2020.
The spending reduction was primarily driven by a decrease and costs consistent with completing the innovate and protect global phase III clinical programs.
We expect that R&D expenses will remain significant as we continue to support ongoing planned clinical work as well as the cost of our supply chain and inventory build ahead of the expected approval of that of this debt.
For clarity and you would like.
To remind you that consistent with the terms of our collaboration agreements for regions, including the U S Europe, Japan, and others that do step supply chain costs associated with our partners respectively.
Selling general and administrative expenses increased to $41.7 million for the second quarter of 2021 compared to 35.5 million from the second quarter of 2020.
The increase compared to the prior year period was due primarily to higher marketing expenses as we prepare for a potential launch of about it is that subject to approval.
And as our commercial team is already in place, we expect only a modest increase and SG&A for the remainder of 2021 to support these efforts indirect sales growth.
For our bottom line net loss was $83 million for the second quarter of 2021 compared to $175.8 million for the second quarter of 2020.
The improvement and net loss compared to the prior year period was due primarily to the non recurrence of the 1 time impairment charge and the prior year quarter as well as lower operating expenses, partially offset by lower collaboration revenue for the second quarter of 2021.
Turning to our capital position.
We ended the second quarter with $247 million and cash cash equivalents and available for sales securities.
Our Q2 cash balance includes the impact of $37.3 million and net proceeds from sales of stock under our ATM and the second quarter.
We also received $16.1 million and net proceeds from sales under the ATM subsequent to the quarter and through July 16th.
We believe that our cash resources will be sufficient to fund our current operating plan through at least the next 12 months. Additionally, we believe our cash runway will extend beyond that period, assuming timely regulatory approval of that and these debt and the receipt of associated regulatory milestones.
With respect to future milestone payments to <unk> I'll remind you that subject to the terms of our collaboration agreements with Otsuka and <unk> has the right to receive milestone payments from otsuka upon the approval of that these debt and U S and Europe.
Given the tiered nature of these milestones.
Does that succeeds and be in the first half BHI to market and the U S. The U S regulatory milestones from Otsuka are estimated to be $15 million and $50 million for dialysis and non dialysis indications respectively.
Additionally, there are significant sales and commercial milestones.
As a part of our existing R&D funding arrangement with otsuka up to 50% of these milestones may be used to offset accumulated R&D pre funding, which today stands at $100 million.
In addition, consistent with the terms of our license agreement with before and <unk> has the right to receive a $25 million milestone payment upon U S approval of <unk> and its inclusion and the prospective payment system or to tapper whichever is first.
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 then 1 on your telephone.
Withdraw your question press the pound key.
And Thats Star 1 to ask a question. Please standby, while we compile the Q&A roster.
Our first question comes from the line of Chris Raymond with Piper Sandler Your line is open.
Hi.
Kelly, Brad on for Chris and good morning.
A couple of questions from us and that it is Scott.
Kind of based on the rocks and he's got outcome. So first.
Could you talk to how the outcome on the rocks on panel and you guys are thinking on the likelihood that that afternoon, and we'll convene a panel for pro rata for you Scott.
Okay.
And just on the population used for those and I think that Mace analysis could you just confirm that.
Analyses were shown on and on study basis, rather than and on treatment basis, I guess that was on <unk>.
And that's playing on that but anything on articles, but it was an area of debate during the rock Satcom. So wanted to verify and then last question just on dosing and.
So you saw a slower rise in hemoglobin per.
Thank you, Scott and assays and innovate and protect.
And that does seem to validate the dosing scheme and.
I'm just curious.
And just hoping you could talk to your confidence and in fact, the rate QD dosing protocol that will be acceptable to regulators and maybe related to that.
And kind of how does that discussion at the FDA and by the FDA of dotcom.
On rock city, stats dosing and and the rapid increase in hemoglobin, maybe change your view on your probability of the 3 times weekly regimens and that you're exploring with Scott.
Thanks.
Good morning, Alex Thanks for the questions that was kind of a long list. So hopefully I jotted them all down and we.
We can get to the market happy to answer them all.
Your first question was.
And about the likelihood of a panel for <unk> now.
And again, we the last communication, we had around the panel with the FDA as we've.
And previously as I said not to expect the panel.
And I don't think its worth speculating, whether its more likely or less likely at this point, but as we said back then and even before the rocks do stockpile.
We're planning for 1 and then we're preparing for 1 so.
If we learn from FDA that day.
And wed like to hold the panel will be ready for that.
But we haven't heard any update on that.
Your second question was around the population for the analysis was is and on treatment are on study analysis.
And I'm going to ask Dr book, 2 to comment on that Steve Yes.
As outlined in the New England Journal of Medicine publications, It was and intent to treat analysis and the safety population. So if a patient was randomized to receive the dose of study medication. We followed those patients until the very end of the global study completion date and we.
Each time, we announced the closure on the study and asked the sites to bring the patients back and further end of treatment and end of study visit so and so.
Pure and.
The intent to treat.
Alright, and I think that's 1 of the strengths of the.
The way, we designed the studies and again did that and consultation with the regulators, but it was a true make study where.
Because you had an active control you are able to continue to follow.
The patients.
And I think your third question revolved around the dosing regimen and the gradual dose and.
Again.
And I'll pass it to Steve.
For that the dosing regimen was designed in collaboration with the FDA, including the starting dose and it was designed to have and gradual.
And a sustained increase in hemoglobin, while minimizing hemoglobin overshoots rapid rise in hemoglobin.
And this has described and new England Journal and Medicine.
And again, we've said.
We've been saying this for for years now but.
We did have this discussion with the FDA before if you recall, our starting dose and the phase II studies was 450 milligrams a day and in consultation with the agency and really focus on that concern about too rapid a rise in hemoglobin.
And we again and consultation went to a 300 milligram starting dose for both dialysis and non dialysis and I think importantly, the results speak for themselves.
See that gradual rise youll see fewer overshoots and so from that perspective.
This is why we have so much confidence and the data the efficacy data and both dialysis and non dialysis is very clear physicians aren't in a rush to get hemoglobin.
Elevated higher doing this over time, avoiding those overshoots and keeping them on a range long term, that's what they're looking for.
And again that avoiding Overshoots I think we heard is something that the FDA is really concerned about and we feel quite good about.
How we designed the program and maybe more importantly, the data.
And that the program generated.
So your third question revolves around <unk> and <unk>.
That is our <unk> studies, and modify and focus our ongoing modifies fully enrolled focus is.
<unk> is enrolling now.
We have.
I think most importantly, obviously when we see that data we will give you an answer as to.
The viability of that 3 times weekly dose again, we saw on phase II and a small phase II that we were able to do that but that's those are ongoing.
We know we have.
Safe and effective once daily dose and dialysis and that's the that's the dose that we will be launching with it.
Assuming.
Regulatory approval and again the data is so clear.
That that works I don't know, Steve and if there's anything you want to add on the TRW.
John.
Okay did we cover all of your questions Ali.
Yes. Thank you.
Thank you.
Thank you.
Our next question comes from the line of Bert Hazlett with <unk>. Your line is open.
Yes, thanks, congratulations on all the progress.
With regard to the could you put a little more meat on the bone with regard to home dialysis and the <unk> process.
Kind of the efforts that you're considering.
Longer term with home dialysis, and then maybe more near term with DARPA.
And kind of what the gating items are and then secondly could you also talk a little bit more about your commercial sales force infrastructure.
<unk>.
Approval. Thanks, so much.
Great. Thanks for the question so.
Of course home dialysis and <unk> are both dialysis issues, but they're so they're related but not.
Exactly the same.
And I'm going to turn to Dell too.
To ask maybe start on home dialysis.
Yeah, absolutely thanks for the question.
We feel like we're in a real position of strength as you think about home dialysis.
Clearly our data is under review with the FDA. So we're not sure exactly what our final label is going to look like but when you think about the clarity of our phase III data.
When you look at the things that John just talked about relative to.
And the gradual steady rise hemoglobin, overshoots, and I think that and thinking about the dosing.
It really does.
Align very well with the home dialysis population and this is a population that is growing at about 15% a year right now it's the fastest growing segment of the market.
And we feel like that and use that is really well positioned upon approval to drive rapid adoption there through the dialysis organizations.
I think to speak to your second question I, just wanted to emphasize something on the on the home.
Dell said it exactly right I mean, this is a growing population.
And center is still the largest population, but you look at all of the initiatives that are coming out.
And today they are all focused on giving patients more choice and getting patients out of the center to home and I think the Covid pandemic is the clearest example of why that matters.
The mortality rate and the dialysis population as we've talked about before was small studies at 20% to 30% having all these people and center is.
Is a challenge and cms's even putting.
Different payment programs. This ESR day treatment choice Mtc program, which is encouraging.
Mandatory program.
And that encourages dialysis providers to move patients to the home setting and.
So this is going to continue to be a fast growing segment to be sure. We think about just that has applicability and will be used in both.
Home and and center, but home is just such a clear opportunity for a once daily dose <unk> is another really important opportunity for us so.
This is.
Not a lot of people have gone through it and non have gone through the <unk> process. So we think we understand it but we'll learn more as we go but.
Do you want to talk about that yes.
Yes sure.
Our understanding of the rule is that the rule is is it seems very clear and.
Are we believe that that at least that will be eligible for <unk> coverage.
Coverage period will be 2 years once approved and.
And essentially our understanding is it based on the quarterly coding system will apply and as soon as possible after approval.
And at that point and time there'll be some time in between we think it could be about 6 months before.
Before we receive.
<unk> reimbursement and we think that will be.
Key and patient adoption as we launch and and really looking at the revenue ramp for the product.
And I think our commercial infrastructure is really setup.
To help us launch quickly.
And right now we have a commercial team that is about 142 people. The majority of those are field based employees.
And supporting Auryxia today, and this is a really experienced nephrology sales force and.
And they have a strong reputation with nephrologist and the Doe community and when you look at our promotion with Auryxia in dialysis patients with Hyperpotassemia. The overlap is so strong with where it will be when we launched that and new stat that we feel like we really have the right commercial leverage to launch.
Well and to launch quickly.
The only the only thing I'll kind of emphasized on the sheet appetite Dell thanks for for that is.
Again, we're going to see exactly how this comes down we will launch.
And right after approval as quickly as we can.
And we will go through the TDAP a process as quickly as we cash remember its very important for the dialysis providers at that point when they have access to the drug after approval to start working on their protocols they need to have those protocols in order to really.
Convert.
All of those patients so the timing actually works quite well I think we just wanted to emphasize.
On that.
That process, because as Dell said, it really will influence the speed of the ramp.
Having that TDAP a reimbursement so that's.
Just wanted to make sure we're really clear about that does that help.
Yes that does.
A quick follow up if I could actually just ship.
As regard to manufacturing and CMC.
Are any of those issues gating items with regard to the progress of the NDA just a quick 1.
No gating items for it seemed obviously all of that was part of our.
Our NDA and comp.
Confident we'll have multiple drug product drug substance manufacturers are as our plan was that was included in R&D day. So we feel.
Fine about.
About that.
Terrific. Thanks, so much.
Thank you.
Our next question comes from the line of Alethia Young with Cantor Fitzgerald. Your line is open.
Hi, Thanks for taking my questions and congrats on the progress this is neena on for Alethia.
And we were wondering if you could just share some differences and and market dynamics for dialysis and non dialysis and <unk>.
And the U S and Europe.
And.
And so he could.
Share how much more investment is needed for the dialysis launch if approved in 2022 and since.
And since you already have a sales force broadly and please thanks.
Thank you for the question so.
I'll handle the market dynamics kind of and in a general sense.
So the U S market is.
The dialysis and non dialysis markets are quite different from a reimbursement perspective treatment perspective.
And we've talked a lot about that the non dialysis patients are generally not treated.
DSA is because of the safety concerns the difficulty of acquiring the product. The fact that it's injectable, whereas dialysis patients are routinely treated within ESI. So as we think about the dialysis market. The U S. It's a market, where we take share and in the non dialysis market, it's where we are.
<unk>.
And growing.
And the size of the market opportunity.
Europe vis vis the U S. I mean, it's a little.
Little bit smaller dialysis market and.
And it's hard to talk about Europe, because every country in Europe is quite different.
And.
The UK is very large very few dialysis centers were in Germany. There is hundreds of very small dialysis centers.
The other differences that non dialysis patients are more frequently treated with.
And with Esa in in Europe, so that the level of concern around safety.
Never been as high and the.
And the European market for the non dialysis population and the access has been good there is also more.
Biosimilar products available and the European market.
Japan is.
And of dialysis patients and they are treated these are healthy more healthy patients because theres no transplants culturally not.
And it kind of acceptable and Japan, so healthy patients stay on dialysis outcomes as usual are quite good and they stay on.
Longer I think similarly.
And we're looking at growing the non dialysis market.
In Japan.
And I missed anything there.
I think you covered it all and I think it was.
Yes.
And I missed the second and last question.
Investment and the U S.
Dale do you want to absolutely.
And as we said, we really feel like with our existing commercial infrastructure, we're really in a position of strength here to launch that in new staff and we're excited about the opportunity that lies ahead, we feel like we have the right experience and our sales organization and when you think about what we're going to need.
2 to add value stack to the bag, so to speak and support the portfolio.
We really think the investment is going to be very incremental from where it is today.
We collaborate closely with <unk> and we will work together with them too.
Create the deployment that maximizes value stats launch, but we really feel like overall, we have coming at it from a position of strength and won't need a whole lot more.
Thanks, Phil.
Thank you.
Thank you.
Thank you.
Our next question comes from the line of David Lebowitz with Morgan Stanley.
Line is open.
Hi, This is avatar Jones on for Dave. This morning, a few questions from Us first.
Have you received questions from FDA on the causality of mace events and if so how do you plan to address those.
Secondly, suicide from rapid hemoglobin rise.
Ross as panel they hypothesize that the mace events could be related to non specific.
Inhibition can you comment on that and do stats in that regard.
And then lastly.
Can you offer any updates on the progress of Auryxia and litigation and coverage. Thank you.
Great. Thank you for the.
For the comments so we are.
And the discussions with the FDA now and kind of the normal review process.
Won't speak to the nature of them because they're basically they look broadly it's a very very robust package and.
Again, we have confidence and the data and so we feel confident and being able to answer any other questions that FDA raises.
On the.
And <unk>.
So commenting on the panel or the fact that they brought up this idea that there may be non specific hip.
And kind of off target effects.
<unk>.
It's really important to look at the data that's the.
And that's what kind of where.
I think FDA will.
Always land is what does the data tell us and.
We are very confident and the safety profile that we've generated with <unk>.
Don't know if that.
That data was driven because we have the right dosing regimen or because of the differences and the products. We have the data to support the safety and efficacy.
That is <unk> and we believe that's what matters and we've always recognized the complexity of the <unk> pathway and back before any of US who are in the room here today were with the company and we selected that are due status product for development based on the characteristics that we're going to give it.
The most kind of preference for increasing IPOH and managing and.
EMEA, so we're really quite confident and the product and we're quite confident on the product because of the data that we've generated.
And then the third question was around Auryxia litigation and that is ongoing.
And as soon as we have any.
Further updates beyond that we will we will update you.
Excellent. Thank you thank.
Thank you.
Thank you. Our next question comes from the line of.
Lisa Yang with Mizuho Securities.
Hi. Thank you this is Dan Clark on for <unk>.
First question from Us.
And the feedback from the Nephrologist community changed following the outcome of your competitor we'd be curious to know anything you've heard regarding data versus sales and better versus other oral hits from that thank you.
So.
It's obviously.
Early and this is a long process of communication, but.
We are very.
<unk> by the conversations we Havent nephrologist.
And remember the difference.
<unk> brings to the table here as a nephrologist can go directly to the New England Journal of Medicine, and review the data and full and.
And.
That makes a huge difference the credibility of that.
Of that publication and again I mean, we don't talk about it I think maybe we don't talk about it enough.
Lead authors on each of those papers and New England Journal, where the co chairs of our independent steering committee for innovate and protect so the analyses and the New England Journal.
The abstracts that show up at the scientific meetings and the analysis of the data and general.
From the beginning I've been overseen and done in collaboration with this independent steering committee and that I think brings great credibility.
2 the data to the process and at the end of the day allows us very significant.
Differentiation I don't know, if Steve or Dell Dale do you want to.
Yes, I think.
Certainly recent market events.
Create perceptions and some confusion and they're in the marketplace and we certainly hear and hear that from Nephrologist, but I think as the potential first in class product here, we have a lot of work to do moving forward and ensuring that we are differentiating value stat from other <unk> as well.
As ensuring that people are really clear on the unmet need which we believe is still very substantial and nephrology and to understand that as well.
That might have been the most important thing that came out of.
And the AD com was that our of open discussion, where you heard from from patients both dialysis and non dialysis patients about the need and I think.
And I know the FDA heard that as well and sees the need here also so we're encouraged by by our position.
Great. Thank you just another quick 1 from us.
Have your <unk>.
<unk> plans materially change I understand you mentioned is a larger opportunity out there now following the outcome have you made changes to your commercialization plans following that.
So yes.
And in fairness the opportunity is still the same the markets are the same we just have the opportunity first and and Dell and his team are pretty excited about that.
Yes, we're really excited about it I think the opportunity to be first and to be a leader in the marketplace gives us the opportunity as mentioned to really differentiate ourselves from the other products as well as the Esa and to really help build that unmet need in the marketplace as John talked about.
And when you say when you look at our overall commercialization plan.
I don't think it's materially changed and the customers that we're working with in the marketplace.
We're engaging with Auryxia today, and how we plan to engage with that and the status on approval.
But we certainly recognize the opportunity to be the market leader as the first product to market potentially and we're really excited about it.
And our relationship with before is still has a lot of power for US also as we said thats, what really moves the needle quickly for us and the dialysis community. So yes. It is.
And it's an exciting time and really the opportunity to potentially be first to market is kind of a game changer for us.
Thank you.
Thank you.
Thank you.
Our next question comes from the line of Eric Joseph from Jpmorgan. Your line is open.
Hi, good morning, Thanks for taking my questions.
Assuming approval and both the non dialysis and dialysis setting can you just unpack a little bit more how the reimbursement and economic strength.
And it.
Between the 2 segments and what that could mean for <unk>.
Net pricing was good abuse and misuse.
And then perhaps separately is key data.
And <unk> eligibility eligibility something that applies and the non dialysis study. Thanks.
Eric Thanks, so much for the questions. They are 2 very different markets and different from a reimbursement standpoint, and I'll ask delta to walk through that.
So I think starting with the.
At the highest level when you look at the dialysis opportunity.
It's really contract driven at the dialysis organization level.
And the <unk> payment, which we believe they were eligible for.
Is is intended to drive use of new and innovative products at launch and we think the rules clear here and that will be covered for the patients that are part of the PPS bundle.
In addition to that.
There are other payment groups, but still that drive largely through the dialysis contract. So that's if you look at the dialysis business. If you move over and look at the <unk> population, it's going to be and more typical contracting with payers and pbms for coverage of the product.
And we anticipate given the unmet need and the space that we will be able to obtain coverage for our product and drive coverage and get access and reimbursement.
That will be important.
Moving forward and and obviously.
And that's the key focus for us right now.
Yeah, Yeah, and again I mean as.
As we said upfront I always want to make sure we were telling people that we remain cautious on the NCD.
The indication given the miss on mace, but overall, but as I also said, we still feel quite confident and the data that we've submitted and we will be ready to launch and both.
And both areas.
And you had a second question.
Was there and how that was it showed up and eligibility.
Yes, it could have a eligibility would not apply to the non dialysis operating right right.
Got it okay. That's very helpful. Thanks for taking the question.
Thanks, Eric.
Thank you.
Our next question comes from the line of Ed Arce with H C. Wainwright. Your line is open.
Great. Thanks for taking my questions.
3 for me first.
On that line of discussion around differentiation here, we talked.
About the adverse events that were highlighted at the recent ad com.
I'm wondering if.
There is any.
Quantitative.
Data around.
B.
IPOH Overshoots.
And given the focus on the rapid rise there if there is any.
Data, specifically that you can point to either and the new England journal or is that something that perhaps you could.
Book to Bill, we could look to core.
ASM.
Potential follow on publication.
Analysis.
1 second.
And given the.
And the recent CRM on.
Not the norm.
And hypercholesterolemia and just wondering.
Your.
<unk> from.
Clinicians on the impact on the overall space, there and and.
And and potentially the impact to Auryxia is growth.
Going forward.
And then finally a.
A question on the regulatory milestones and I know.
We went over this and the prepared remarks, but I missed some of the numbers. So if you could repeat that that'd be that'd be helpful. Thank you so much.
And thanks, so much for your questions.
First on the <unk>.
We haven't published the data on <unk>, which is what we said is that.
There was clearly fewer overshoots with value stack versus that of a poet and that's.
And that certainly could be the basis for a publication later and we do think it will be an important differentiator. So I think youre right.
To bring that up and that is on mentioned and the new England Journal.
Yes, yes, sorry, Chris and yes, it's mentioned that data just doesn't company and it's a company at this point so.
That would certainly be and interesting publication on its own.
And then your second question was on the <unk>.
<unk> and the impact.
On that.
As a purpose driven company that is focused on patient care anything that actually can help patients achieve a lower.
Hydro lower phosphorus level and managed by professional team and I think it would be welcome so from that perspective, I guess, it's disappointing.
And we never really looked at it and as a competitor per se because we really thought that that would be there'd be utilization of the products together, but I don't think we've seen much impact other than that.
We believe Auryxia has.
And Rick Shea Auryxia has growth potential and that will grow this year Dale do you want to add comments on that.
I think there is a tremendous amount of room for improvement and patient outcomes and so certainly from an impact perspective and the space.
But as John said, we believe that Auryxia is an important part of that equation and improving outcomes and as a foundational treatment for hopper hyperpotassemia and it has been for more than 6 years, and we have a lot of real world efficacy and safety data that supports that.
And so from our point of view it hasn't really changed our view of what we hope to accomplish with Auryxia and we're going to continue to execute against our commercial plans to drive net revenue growth moving forward.
Thanks, Dale and.
David I think it was skewed so.
And I can clarify the regulatory milestones, so and the U S for a first half approved and dialysis the milestone would be $15 million.
And if we are the first half approved and non dialysis that would be $50 billion.
Great. Thanks, so much appreciate it.
Thanks, Pat Thanks, Ed.
Thank you.
Ladies and gentlemen that concludes our Q&A session I would now like to turn the call back over to Mr. Butler for closing remarks.
Thanks, Wanda and thanks to everyone, who joined us for the call today as I mentioned this is a very exciting time.
<unk>.
The potential to be first in class.
And really energizing the company and we look forward to continuing to update you on our progress as we move through the year.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
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