Q3 2021 Akebia Therapeutics Inc Earnings Call
Good day, and thank you for standing by welcome today.
Third quarter 2021 financial results.
At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session and to ask a question. During the session you will need to press star one on your telephone.
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With now I would like to hand, the conference over to your first speaker Mercedes <unk>. Thank you and please go ahead.
Thank you and welcome to <unk> third quarter 2021 financial results and business update conference call. Please note that our press release was issued on Thursday November 4th detailing our third quarter financial results and that release is available on the investors section of our website for your convenience a replay.
<unk> of todays call will also be available on our website. Shortly after we conclude.
For today's call, we have John Butler, our Chief Executive Officer, Dave Spellman, <unk>, Chief Financial Officer, they'll coughing him Chief commercial officer, as well as Dr. Steven Burke, our head of R&D, and Chief Medical Officer, who will be available for questions before.
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 additional information describing these risks is included in the financial results press release that we issued on November 4th as well as in the risk factors and manage.
<unk> discussion and analysis section of our most recent annual and quarterly reports filed with the SEC. The forward looking statements on this call speak only as of the original date of this call 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.
Thanks, everyone for joining us today.
Well today, we're within five months of the <unk> target action date for <unk>.
Our investigational hypoxia inducible factor prolyl hydroxylase inhibitor or <unk> currently under review by the FDA for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and not on dialysis.
As a reminder, that as you said is not yet approved any discussions or comments, we will make about the potential of that are used that are subject to its regulatory approval.
We have a tremendous opportunity to bring a potential first in class product to market a novel oral therapeutic for people living with this disease.
And approval has the potential to be a pivotal catalyst for <unk> and importantly, a step towards delivering on our purpose to better the lives of people impacted by kidney disease.
That is what motivates our team.
And we're excited about the momentum we've gained as we prepare for launch.
Developments over the past quarter continued to increase our confidence in a path for approval and launch success for <unk>, including the Fda's completion of our mid cycle review and release of additional global Phase III data for <unk> during ASN kidney week, which just completed this weekend.
Our team has also made significant progress preparing for successful launch, including our medical teams efforts to educate physicians payers and dialysis organizations about anemia due to <unk> <unk>.
We're excited about that or do such potential to be the first in class <unk> <unk> in the U S. This is a much larger market opportunity than we anticipated just a few months ago.
Of course, we believe that <unk> can have a significant impact globally as well.
The product was launched by our partner MTBC just over a year ago in Japan. We are encouraged that the hip PHA share of the anemia market continues to grow in Japan.
Along with <unk> market share and that more physicians in Japan have stated an intention to prescribe <unk> over erythropoiesis stimulating agents or Esa.
We're proud to have worked closely with our collaboration partner Otsuka on the European marketing authorization, which was submitted last month to the European Medicines Agency, we will continue to support Otsuka as the EMA begins the review process.
We continue to explore development opportunities for <unk>.
University of Texas helps ongoing investigator sponsored study of <unk> as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome or <unk> in adult patients who have been hospitalized due to COVID-19 continues to progress.
With the support of their data monitoring Committee UT health has decided to expand their study beyond the initial 400 patients and enrollment target they have now surpassed.
We look forward to updating you on this study when Ut help completes it.
Right now we are focused on preparing for a successful launch of <unk> as a treatment for anemia due to <unk> as our <unk> date is fast approaching.
In a moment I'll ask Darrell to share some details on our launch preparation for.
First let me share a few words on the market opportunity and our data.
I'd like to start with the big picture opportunity there.
There are approximately 560000 dialysis patients in the United States and approximately 90% are being treated with Esa is to manage their anemia.
The dialysis data from our phase III program are clear and consistent we feel very confident that these data support an approval for this patient population.
Our phase III data demonstrated that once daily dosing of <unk> debt increased hemoglobin in a gradual and steady manner and minimize hemoglobin overshoots compared to double to Darva poet and Alpha and Esa.
In the Mace safety analysis that reduced that demonstrated the hazard ratio of zero point 96, with an upper bound of the confidence interval of 111, well below the agreed to target of one to five in the U S and one three in Europe.
Our data published in the New England Journal of Medicine, and additional data presented at ASN last week, demonstrating no increased risk of thromboembolic events seizures or serious infections and a rate of dialysis access thrombosis equal to that of <unk>.
In the past we've discussed the importance of home dialysis, which is the fastest growing segment of the market.
Data on <unk> for treatment of anemia in patients with dialysis dependent <unk>, receiving peritoneal dialysis was also presented at ASN kidney week.
The data demonstrated the ability to titrate hemoglobin into the target range with fewer dose adjustments over time.
The ability to dose of <unk> once daily means PD patients won't have to come into dialysis centers regularly for infusions of BSA.
The data presented showed that the safety profile of <unk> in patients with dialysis dependent <unk>, receiving peritoneal dialysis with similar to what was seen in the overall dialysis program.
Our data are encouraging and support the unique value proposition. We believe that <unk> offers to both the growing number of home dialysis patients and to dialysis providers looking to better support these patients.
The impact of anemia on all patients with <unk> is significant.
We believe in the potential of that to do that to help these patients.
With U S approval, we'll have the potential to address the unmet needs of over half a million adult patients on dialysis and rapidly established that reduce that as the new oral standard of care for the treatment of anemia due to <unk> <unk>.
That represents a potential $2 billion market opportunity in the U S alone.
We believe there are compelling data supporting a positive benefit risk profile for the use of <unk> broadly in patients with <unk>, including non dialysis patients. We remain cautious about receiving a broad label for <unk> that would extend to non dialysis patients with anemia due to <unk>. However, we believe.
We put forth a compelling an extensive data package in the NDA with respect to the non dialysis population. We continue to be pleased with our engagement with the FDA and look forward to their decision in March.
And with that let me turn to Dell, who will speak to our pre commercialization activities.
Thank you John.
We are deep in commercial preparedness activities and I am pleased to share that picture of what we believe launch will look like if that stat is approved.
Today, we will focus on the opportunity within dialysis.
Although it is important to note that we are planning in parallel for the opportunity in non dialysis as well.
Our overall objective is to prepare for a successful launch that maximizes the value stack commercial opportunity.
Our team is energized by the potential to be first to market.
As John highlighted with a U S approval, we will have the opportunity to address the unmet needs of over half a million adult patients on dialysis.
And we will seek to rapidly establish that would use that as the new oral standard of care for the treatment of anemia due to <unk>.
That represents a potential $2 billion market opportunity in the U S alone.
Our cross functional team with support from our partner Optica has developed a robust launch plan.
We are investing in pre commercialization activities.
Aimed at addressing the unmet needs of patients on dialysis with anemia due to <unk>.
Differentiating value stat from the current standard of care and.
And providing broad access for all appropriate patients if that is that is approved.
Specifically.
As we look to secure rapid adoption for <unk> that.
Our distribution relationship with <unk> pharma will be critical.
The agreement facilitates access to Fresenius medical care and certain other dialysis providers, which together treat up to 60% of U S dialysis patients.
Additionally, <unk> already has a strong presence in the kidney community and our nephrology focused sales force is well positioned to engage with davita.
And other strategically important dialysis providers when appropriate to access the remaining 40% of U S style assist patients.
We believe that rapid adoption is also likely in the U S. Due to a reimbursement model unique to the dialysis market referred to as <unk>.
This is an add on payment to the bundle that is intended to encourage adoption of innovative therapies by clinicians and dialysis providers.
Our team is preparing for reimbursement for <unk> under <unk>.
Which we anticipate will take approximately six months from regulatory approval to official <unk> designation and will extend for two years from the date of designation.
Our leadership position in the kidney space has been established with Auryxia, our current commercial product we.
Have an experienced team that knows the payers healthcare providers and patients.
Our field team possesses deep insights related to the unmet needs of the <unk> community and.
And this information has been beneficial in informing our value stat launch plans.
As well as our view of what we believe to be a highly attractive commercial opportunity.
Our commercial team is on the ready to support a second product.
And as a key component to a successful U S launch.
With that I want to recognize our team as they remain dedicated to kidney patients who have been disproportionately impacted by the COVID-19 pandemic.
Revenue for Auryxia continues to grow.
We are encouraged with how the market views auryxia strengths and applaud the commitment and tenacity of our team to find new ways to connect with customers and support patients.
We continue to expect Auryxia to deliver annual revenue growth for 2021, and again believe this is an important foundation to support the successful launch of that I'd use that if approved.
Now I'll turn the call over to Dave to discuss our financial results.
Thank you Dale and good morning, everyone.
As Jonathan mentioned, having laid the groundwork for potential approval, we're advancing prelaunch preparations for value set.
We believe we are well positioned with our existing commercial footprint and working 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 $48 8 million.
Third quarter of 2021 compared to $60 million for the third quarter of 2020, reflecting lower collaboration revenues since we successfully completed our global phase III clinical development program for <unk> and are currently engaged in closeout activities with respect to the program.
It is worth noting explicitly here that our collaboration revenue is directly tied to work performed on Nevada, New start program collaboration revenue is reduced because bad debt related expenses have tapered.
For Auryxia net product revenue increased 7% to $36 8 million for the third quarter of 2021, compared with $34 4 million for the third quarter of 2020.
<unk> team is very proud of the performance. This is a challenging market, where COVID-19 has caused increased mortality and the patients. We serve the growth is reflective of a higher net revenue per pill than previously realized over the last three years. It includes some one time true ups that reflects what we believe is our current payer mix.
Turning to expenses <unk> all had some time to review our expenses, but a few items that are worth noting.
We have prioritized our spend with expenses to build our supply chain and to invest in value creation initiatives, including work on our three times a week studies for <unk> and continued his face research where.
We're able to cost effectively prioritize the spend because of our already existing commercial footprint, thereby avoiding more significant supply chain build out costs.
Most other biotechs without a commercial product would occur.
As a reminder, consistent with the terms of our collaboration agreements certain values that supply chain costs are shared across our partnerships.
From a bottom line net loss was $59 $5 million for the third quarter of 2021 compared to $60 million for the third quarter of 2020.
Regarding our capital position, we ended the third quarter with $207 2 million in cash cash.
Equivalents and available for sale Securities.
Our third quarter cash balance includes net proceeds of $16 1 million from sales of common stock under the Companys at the market offering program. During the third quarter of 2021, which was previously disclosed for clarity there were no sales on the ATM between the filing of the second and third quarter 10 Qs.
We believe that our cash resources will be sufficient to fund our current operating plan through at least the next 12 months, commenting beyond that would require guidance on bad <unk> launch revenues, which were not prepared to provide at this time.
On our last call, we provided clarification on future milestone payments to <unk>, which are worth repeating.
Subject to the terms of our collaboration agreements with Otsuka.
<unk> has the right to receive milestone payments from otsuka upon the approval of <unk> in the U S and Europe, given the tiered nature of these milestones if that succeeds in being the first if PEGI to be approved in the U S.
The U S regulatory milestones from Otsuka are estimated to be up to $65 million.
Additionally, there are significant potential sales milestones.
As a part of our existing R&D funding arrangement with otsuka up to 50% of these milestones may be used to offset our accumulated R&D pre funding, which today stands at $100 million.
Given that our partner Otsuka has now filed the MAA in Europe, we should point out that we are eligible to receive up to $17 million and regulatory regulatory milestones assuming no delays in the MAA review process.
In addition, consistent with the terms of our license agreement with before <unk> has the right to receive $25 million in milestone payments upon U S approval of <unk> and its inclusion in the prospective payment system or to dapper whichever is first.
With that we'll open the lines for questions operator.
Thank you at this time I would like to take any questions you might have for us today and as a reminder to ask a question you will need to press Star then the number one on your telephone keypad. Once again. Please press star one to ask a question, we'll pause for a moment to compile the kidney list.
This is the only tigger humam.
Our first question comes from the line of Chris Raymond from Piper Sandler. Your line is open. Please go ahead.
Hi, Good morning. This is Alex <unk> on for Chris. This morning, Thanks for taking the question.
So I guess just coming off the ASN meeting and some of the additional VSAT analyses presented there.
What kind of feedback are you getting from the nephrology community on that profile, maybe especially as it relates to comparisons to the deputy Stat data set presented this weekend.
I guess any color or characterizing of that feedback and how docs are viewing differentiation among kits.
Would be really helpful.
Sure Ali Thanks, so much for for the question obviously.
Obviously, the that produce that data was just presented this weekend. So I think it's early it will.
Be very immediate kind of feedback and I think as the new England Journal papers are out there and people digest them, we'll learn more I think generally speaking.
There was also a presentation at the ASN meeting from Sferics, Jennifer Robinson presented on <unk>.
Physicians reactions to half and their expectations around that.
And.
I was really encouraged to see that.
I think it was almost 60% of physicians said, they were probably or extremely likely to prescribe <unk> and fully 85%.
Kind of fill into the expectation of prescribing.
At some point, so I think that.
Concerns.
We're.
Kind of felt.
<unk> the <unk> data are starting to people are seeing that there's differences between the products.
There is a path forward.
Again, I think the that reduce that data really only serves to confirm that the issues seen with rocks do set we're not a class effect.
And that these products can be used safely.
Quite frankly, I think that produce that data for our part.
US more confidence in our approval certainly in dialysis, but with the non dialysis data.
But they saw as well Steve.
Steve did you want to make any other comments about that no I agree I think people are taking comfort in the Def reduced that data and it supports our hypothesis that you can use these drugs safely.
We target to hemoglobin.
Right I mean thats the number of the <unk> studies, they had a hemoglobin.
<unk> target of 10% to 11.
Across all of the patients in our and remember our non dialysis.
The data that we've put forth to the FDA is that the U S population, where we did target of 10% to 11.
You see a data set that looks extraordinarily like.
The overall data set for that reduced that we're 10 to 11 was targeted so once again I think that supports our our contention and while.
Obviously, we've only seen.
What's been presented on <unk> and dialysis our own data.
Incredibly strong there and I think that.
This only confirms what we've seen and it gives us that much more encouraging path forward.
And then when you think about the data we presented at that I referenced in my remarks.
Those issues around imbalanced in thromboembolic events seizures and serious infections that were really the center of the concern at the AD Com, we presented the data now some of the New England Journal papers, but now we presented that more discretely.
They just we just don't see that so that gives us great confidence across the board.
Got it thanks guys.
Thanks Ali.
Our next question comes from the line of Alicia Yap from Cantor Fitzgerald. Your line is open. Please go ahead.
Hey, guys. Thanks for taking my questions, maybe a couple for me.
Yes.
I feel like one of your competitors recently sudden passing the days effect that they may have a conference I'm sorry, a panel.
Maybe thats conjecture on their part I just wanted to kind of get your perspective, any kind of updated commentary you heard on year end it sounds like you're reiterating your confidence not everyone.
And then a little bit more.
On that I guess.
With their trial.
Kind of hitting a non dialysis does that change the kind of the calculus as you think about non dialysis, even though I mean, I know what the valuation is optionality, but I just wanted to comment.
Your perspective on that and then as it relates to dialysis.
<unk>.
Now the collaboration theme.
Well it kind of continuing to lock in that potential share even if there was another competitor enter the market. Thanks.
Sure. So on the first question on the panel.
I know that at this point, we are the only.
<unk> that's in front of the FDA so.
<unk>.
While we are preparing for a panel and certainly open to one.
The FDA has not given us any indication that we'll have a path. So we've we've said that we expected one and it would be ready for one but.
I think the message from FDA has continued to be that.
At this time.
They don't expect a panel, which always allows them the opportunity to change their minds. So we'll just.
Wait and see as the review progresses.
But the.
So as I referenced in answer to the last question of non dialysis actually the debt reduced that data really encourage us encourages us around our own.
The path forward. This is as I mentioned.
What we've been saying is when you target of hemoglobin of 10 to 11, which is the target in the U S which.
Which we had for U S patients in our studies recall outside the U S. We targeted 10% to 12 and patients were generally manage to a higher hemoglobin level in the U S. We had a hazard ratio. If you looked at U S patients using ages continuous variable.
Had a hazard ratio of just over one one.
One or two I think we're hoping to one.
With an upper bound at one to two so.
Clearly not showing an increased cardiovascular risks.
That result for for that reduced that really was confirmed basically in their overall.
Population where there.
Where they hit their primary endpoints so for us it really gives us that much more confidence that is FDA looks at this class broadly that there isn't an elevated cardiovascular risk and importantly, again fca's recognizing southern ought to do step penalty recognize that.
There is an unmet need here.
Patients need treatment options and Thats, what goes to this benefit risk that benefit of treating patients with the <unk> outweighs the risk, particularly when you go back and look at the things that are really focused on in the rocks, a panel, which were thromboembolic events seizures and serious infections, where we simply didn't see.
Any difference there. So we will see as I said, we're engaged with the FDA, it's ongoing we're <unk>.
<unk> bye.
Their level of engagement.
But.
We will continue to we look forward to March 29th I guess it is what it comes down to.
And then with dialysis.
Yes.
As I said, we had been planning to be second of three and that was the rationale for for the <unk> deal now.
Now we are planning to be first of two and that rationale doesn't change and we think it's very important to have before to.
To have access to those fresenius patients that Mcdonald's is anything you want to add.
To that we think that's an important.
I mean opportunity for US yes, no absolutely we're excited about the market opportunity for that to do just that in dialysis and I think the.
The access that before gives us to FMC and certain other dialysis providers.
It does enable us to be the exclusive hip hip in 60% of the U S dialysis patients. So we do think that is.
A real opportunity for us at launch and we're excited about it and.
<unk> you.
You mentioned non dialysis being kind of Optionality and I certainly wouldn't disagree with you there we've talked about being cautious, though we're very confident in our data.
I think when you look at valuation today.
Dialysis isn't reflected right and this is an approval in dialysis is not reflected in this is a $2 billion opportunity that we get.
To be in first four.
For a year or more depending on on filing dates so.
We think this is.
A phenomenal opportunity for us.
Great. Thank you for all the color.
Thank you.
Our next question comes from the line of Eric Joseph from Jpmorgan. Your line is open. Please go ahead.
Hi, good morning, Thanks for taking the questions I just wanted to follow up on some of the commentary regarding pre commercial activities.
Specifically.
Yes, how are you.
Do you anticipate any expansion of the sales of our MSL teams to support.
<unk> and dialysis over what Youre currently sites.
So I'll start with Auryxia.
And sort of what personnel support do you expect otsuka in the U S.
And then.
Yes, there is the optionality of non dialysis I guess.
And our support expansion or launched in the non dialysis segment, how should we be about sales force sizing.
As well.
I'm sorry, Eric that last part of your second question there.
Feed it out.
Sorry.
And if you are a proven non dialysis, obviously, you're thinking about salesforce of MSL sizing to support non dialysis.
The contribution from <unk> versus Otsuka.
Great.
One of the.
The benefits of having our commercial organization already in place we have got to do separately to get great leverage from that organization.
Darryl do you want to.
Google Detailer absolutely.
So as you know we have an experienced nephrology focused field team that.
Really established a strong reputation in the kidney market with a rich.
And we think that this is a really a key point of leverage.
As we move towards the potential launch of <unk>, certainly being first to market is an exciting opportunity and as we've looked at the field force sizing and our current MSL and sales footprint.
We really feel like we largely have the team here at Acadia.
The launch in dialysis.
And even if you look at the opportunity in non dialysis, if we receive approval in both indications.
We still believe that the field resources needed are going to be incremental and this is where our partnership with otsuka would come in we can leverage their existing commercial.
Commercial and medical footprint as well to make sure. What we have we have what we need to support the share of voice in the marketplace. So this is one where we really feel like we're in a great position today, and and we won't need to add a lot of infrastructure moving forward.
To create a successful launch.
Otsuka has just been a great partner.
That's one of the things we're working on Bill, particularly is working on the detail around that the who does what in the launch but.
Our sales force is focused on dialysis and the Otsuka Salesforce is focused outside of dialysis.
We're in a great position that if we get that.
Expanded.
<unk> population.
That we have access to those resources without having to.
To build a larger team at all so it really is a great position to be in and I think as we kind of finalize some of those discussions with otsuka.
Around the detail, we will be able to update you as we.
We get closer to launch.
Great. That's very helpful. Just a follow up if I could.
Respect to the milestones that you outlined.
In your prepared remarks, the $65 million in the U S is that.
Consider approval in both dialysis and non dialysis is there.
Okay.
Are certain milestone Eric.
Prior to the individual segments.
Yeah, Eric It's a good question. So we had previously disclosed that $15 million of that is attached to dialysis and 50 is attached to non dialysis and those are based on being first to market.
Yes.
Okay, great. Thanks for taking my questions.
Thanks, Eric.
Our next question comes from the line of Serge Belanger from Needham <unk> Company. Your line is open. Please go ahead.
Hi, good morning, Thanks for taking my questions.
First one on the commercial prep for that.
Pat.
Assuming you get approval in late March.
Maybe talk about your readiness for launch in terms of product supply.
So that was the key.
Reimbursement aspect what is a six month process, how does that play into the launch timing.
And then secondly on the rich.
Maybe just talk about what has been driving our recent growth.
Given the recent settlement, where generics does that change your.
Your outlook for the product could we see additional investments now that you have clarity on the IP runway.
Yeah.
Thanks, so much thanks for the questions.
It's nice to welcome you to the call.
So from a supply perspective, we have two API in two drug product suppliers.
For launch so we made the decision to build redundancy into our supply chain early on and so we are very comfortable that we'll have.
Adequate supply.
Available at launch.
A very successful fast uptake within the dialysis.
Market.
<unk> do you want to talk about kind of the <unk> process and the like.
Yes, as you as you mentioned we expect.
At regulatory approval too.
To apply for TDAP.
<unk> said, we expect the process to take approximately six months.
But we will we plan to launch in dialysis as soon as possible after regulatory approval. So we don't anticipate waiting until the TDAP a period starts.
When you think about the opportunity to be first to market.
We want to be out there focusing on educating on the unmet patient need and the clinical data for that is that and ensuring that we have all the operational details in place.
So that one's dialysis providers begin to ramp will be certainly ready to go there.
Obviously, given that <unk> was created to encourage adoption of new therapies. We believe the timing of TDAP or will be important as you think about our rate of adoption of that at <unk> and dialysis or or said another way, we think that the revenue ramp for <unk> that will certainly be linked to that is to TDAP a timing. So so.
That's our plan for <unk> and dialysis.
As far as as a Ric Sia goes.
As I think most companies are experiencing it's been a challenging market.
Overall phosphate binder market is down.
And really significantly due to the disproportionate mortality in this space and.
So that's been really difficult and then certainly access to health care providers continues to be a challenge, but I think our team has really demonstrated.
Some strong resilience and has.
Adapted a hybrid approach to engagement, where we're focusing more on multichannel and non personal promotion.
But overall I think we're really proud of the job. The team has done this year given the market dynamics.
We expect the market to continue to be challenging.
But we certainly believe we can continue to grow Auryxia net revenue moving forward.
And I think the settlement.
The final <unk> settlement, which pushes out.
It gives us confidence in.
The market opportunity up till three of 25.
It's just a great opportunities for us to continue to grow the product in and just because.
There is the ability for generics to enter the market.
2025 doesn't mean, we don't think we can continue to have important business with auryxia.
Particularly given that phosphate binders could be moving into the bundled payment system. The PPS payment in 2025 that creates an opportunity for us long term and having multiple products as part of that.
<unk>.
Gives us great opportunities as well so.
Great to have confidence that no one's entering before then but we think that the area under the curve for quite a while.
Contribute significantly from a cash perspective.
And just to clarify one thing.
Just for clarity the supply that we have in place.
Is comfortable for us with quick uptake in dialysis, but if we get both dialysis and non dialysis. We are still in a comfortable position. We do expect it to take the non dialysis ramp will be slower than dialysis, but.
We've made sure we'll be in a supply positioned to support.
Any speed of launch in both pay.
Patient populations.
Thank you.
Thanks.
Yeah.
Our next question comes from the line of David Lebowitz of Morgan Stanley. Your line is open. Please go ahead.
Hi, This is avatar Jones on for David This morning, a couple questions from US. The first is how should we look at SG&A expenses over the next 12 months in the context of a potential new launch and secondly can you provide any color on developments for Medicare part D reimbursement of <unk>.
<unk>.
And potential timelines for resolution there. Thank you.
Dave you want to handle the <unk>, yes, I think so for SG&A.
<unk>.
Talked about a few times, we're very proud of the infrastructure that we've built and I think that in terms of the team that we need to build to support.
A successful <unk> launch team is largely in place and that from an expense perspective.
Really just be looking at some shared expenses that we would have with otsuka to build the <unk> brand.
But largely from a personnel perspective.
<unk> is in place.
And I think your second question was on the Medicare part D coverage for <unk>.
I assume that was focused on the Ida indication where.
We didnt have coverage for or don't have coverage for auryxia.
You might have seen a few weeks ago.
Put out an announcement that we did.
Dismissed the lawsuit.
Again, CMS, where we were seeking coverage for the Ida indication.
As a a very difficult decision for us to make.
<unk>.
We know that patients have a need to access this drug and.
It's incredibly unfortunate that.
CMS disagrees.
The product should be covered now it's covered for dialysis patients for Hypophosphatasia. So that's which is by far the larger market opportunity for us. So so we continue to grow in that space, but.
We spent so much time and resources on the lawsuit.
Didn't get the preliminary injunction, we made the very difficult decision that.
We were going to.
To walk away from that but we're not walking away from those patients or working to get coverage for for Ida and.
We're looking more on the legislative side, where we've been engaging with members of Congress and we have.
Recently had legislation.
Reduced.
To provide coverage for it obviously there is still a lot of work to do to get to an answer for that so we're not walking away from the opportunity.
And then Delon his and his team are working on ways to optimize access.
For the Hypophosphatasia population and continuing to grow that.
Population Ida.
It was a small much smaller part of the the.
The Orix Auryxia revenue and and it stayed that way, even though private pay patients can access the product for Adi.
We expect that until we find a legislative fix.
That it'll stay that but.
Bill referenced earlier, we have the opportunity to continue to grow and Hypophosphatasia.
For some time and Thats, where our focus is.
Understood. Thank you.
Our next question comes from the line of Ed RSA from H C. Wainwright and company. Your line is open. Please go ahead.
Thanks, Thanks for taking my questions a couple for me firstly.
On.
The commentary around your sales footprint being largely in place right now and even just.
Incremental.
<unk>.
Investment would be necessary as non dialysis were approved.
Wondering.
In that regard how many if you could remind us how many reps and nsls and other sort of ancillary support staff.
In the overall sales and marketing teams do you have today.
And perhaps also discuss.
The areas of training and readiness activities that.
Would be going on ahead of the approval.
And then secondly.
I think there was a comment early on in the prepared remarks.
<unk>.
The overall.
Anemia market is much larger than expected, even just a few months ago.
I'm wondering if you could clarify that what have you discovered and what exactly do you see now thanks so much.
Okay. Thanks, so much for your questions I'll take the second question and I'll pass it to Dell for the first the <unk>.
$2 billion market opportunity is still the size of the market opportunity, but a few months ago, we were expecting to be the second product to the market.
And the opportunity to be the first product to the market.
And.
Have that opportunity to introduce the first in class hip BHI.
Is an opportunity where unexpected I haven't been expecting for the last eight years, we've been expecting it to be that's how we've been planning.
First to market with we think at least a year.
So have a head start over a second entrant.
Is a really great opportunity for us and a much larger opportunity than we had been considering and delta and you can talk about the footprint.
Training readiness.
Absolutely.
So currently we have a commercial team of 140 people and all of those.
About 110 field based employees, so our sales and our access teams.
The medical team, which reports into Steve is has about 13 MSL.
Yes.
A small management team so.
That's the group that right now is working with Auryxia, and we will be able to support.
The launch of that to do that certainly in dialysis and largely in non dialysis as well as we mentioned if there are any incremental resources that we need to launch in non dialysis, that's where we're working out the details of that with our.
With our partner Optica, and it's great to have that that partnership in place to be able to do that as.
As far as readiness materials.
<unk> activities I should say.
The team is really.
Working across the different functions to make sure that we will be ready at our <unk> date to launch in full.
Certainly from a marketing and a sales training perspective, our market access team has started to have pre label and our actions and certainly our medical affairs team is talking about education around this space. So we certainly feel like we're in full.
Pre commercialization and prelaunch activities.
We'll be ready to go at at approval.
The full team.
Yes.
Before we have an approval the commercial seems very limited in what they can do but the medical affairs team.
The idea of educating nephrologists on hip.
The mechanism.
<unk> of anemia management those are incredibly important as we run up towards towards launch of course, if if physicians are interested in learning about that or do start date of the medical team Ken can educate them on that as well and it's critically important, particularly given the datasets of three different.
<unk> that are out there clarifying those differences.
<unk> is really going to be critical for launch success.
Great. Thanks, so much.
Thanks, Ed.
Our next question comes from the line of Bert Hazlett from <unk>. Your line is open. Please go ahead.
Yes, thanks, and congrats on all the progress apologies. If this has been addressed a little bit I've been jumping around calls. This morning, it's been a busy morning, but just with regard to the.
So a good application in Europe first.
First of all do you have any sense of timing in terms of the.
The application itself.
<unk> process in Europe.
And then secondly.
Do you expect them to.
Be addressing the same types of issues with regard to dialysis and non dialysis data in patients.
That will be discussed in.
In the U S.
Thanks.
Thanks, so much for the questions. So.
So the application was submitted and has been validated generally the timing is a 12 month review for Europe. So that's the assumption that we're working on.
Maybe talk about the reimbursement or is it different in different countries, but yes.
Yes, absolutely.
I think that the.
The reimbursement structures are quite different in Europe and.
And because of the regional differences in treatment and patient characteristics.
Really looking at Europe, more on a country by country basis.
Certainly we would expect.
The larger countries too.
To be the most important for launch and some of them to be the earliest to reimburse it reimbursed.
Typically U K and Germany are on the earlier side of European launches.
With France, and Italy, and Spain to follow sometime after but.
There'll be there'll be an individual by by country process one.
Once we receive approval. So we'll certainly update you more as we learn more.
And from an initiative standpoint, obviously, we haven't really.
Who will be leading the discussions with EMA. So we don't know exactly where their focus will be but.
I certainly have an expectation that.
That they will they will look at some of the same issues I mean, I think it's important to note that <unk> was approved and labeled in Europe with the challenges that they've had they've labeled around those so.
When I think about our data package.
Kind of in its totality I think we feel very confident in.
Certainly in dialysis again, and maybe more than.
Also we have confidence in the non dialysis data and in Europe as well, so but again very very early days there.
Terrific. Thank you very much.
Thanks Bert.
And there are no further questions at this time Jon Please continue.
Thanks Mara this is a busy and exciting time at <unk>.
At least thats approved in Japan, the MAA MAA has been submitted to the EMA and we use that is late in its FDA review process with the <unk> date set for March 29th of next year.
Our focus remains on preparing to bring to market a novel oral therapeutic for people living with anemia due to chronic kidney disease, we remain confident in <unk> potential as a first in class treatment for anemia due to <unk> in dialysis patients and we look forward to engaging and continuing to engage with the FDA and the review of our NDA.
And we look forward to updating you on our progress.
Have a great day.
This concludes today's conference call. Thank you all for participating you may now disconnect have a great day.
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