Good day, and thank you for standing by. Welcome to the Akebia’s Third Quarter 2021 Financial Results [Operator Instructions]. I would now like to hand the conference over to your first speaker Mercedes Carrasco. Thank you, and please go ahead..

Thank you, and welcome to Akebia’s third quarter 2021 financial results and business update conference call. Please note that a press release was issued on Thursday, November 4, detailing our third quarter financial results and that release is available on the Investors section of our Web site.

For your convenience, a replay of today’s call will also be available on our Web site shortly after we conclude. Joining me for today’s call we have John Butler, our Chief Executive Officer; Dave Spellman, Chief Financial Officer; Dell Faulkingham, Chief Commercial Officer as well as Dr.

Steven Burke, our Head of R&D and Chief Medical Officer, who’ll be available for question. Before we begin, I would 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 management’s discussion and analysis sections 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 would like to introduce our CEO, John Butler..

Thanks Mercedes. Thanks everyone for joining us today. Well, we’re within five months of the PDUFA target action date for vadadustat.

Our investigational hypoxia inducible factor, prolyl hydroxylase inhibitor, or HIF-PHI currently under review by the FDA for the treatment of anemia due to chronic kidney disease in adult patients, both on dialysis and not on dialysis. As a reminder, vadadustat is not yet approved.

Any discussions or comments we will make about the potential of vadadustat 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.

An approval has the potential to be a pivotal catalyst for Akebia and importantly, a step towards delivering on that purpose to better the lives of people impacted by kidney disease. That is what motivates our team and we are excited about the momentum we have gained as we prepare for launch.

Developments over the past quarter continue to increase our confidence and a path for approval and launch success for vadadustat, including the FDA's completion of our mid cycle review and release of additional global Phase 3 data for vadadustat 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 CKD and vadadustat. We are excited about vadadustat's potential to be the first-in-class HIF-PHIs in the US.

This is a much larger market opportunity than we anticipated just a few months ago. Of course, we believe vadadustat can have a significant impact globally as well. The product was launched by our partner MTPC just over a year ago in Japan.

We are encouraged that the HIF-PHI share of the anemia market continues to grow in Japan, along with VASFSEO market share. And that more physicians in Japan have stated an intention to prescribe HIF-PHIs over erythropoiesis-stimulating agents or ESAs.

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 vadadustat.

University of Texas Health's ongoing investigator sponsored study of vadadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome or ARDS 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, an enrollment targets they've now surpassed. We look forward to updating you on this study when UT Health completes it.

Right now, we are focused on preparing for a successful launch of vadadustat as a treatment for anemia due to CKD as our PDUFA date is fast approaching. In a moment, I'll ask Dell to share some details on our launch preparation. But 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 are approximately 560,000 dialysis patients in the United States, and approximately 90% are being treated with ESAs to manage their anemia. The dialysis data from our Phase 3 program are clear and consistent. We feel very confident that these data support an approval for this patient population.

Our Phase 3 data demonstrated that, once daily dosing of vadadustat increased hemoglobin in a gradual and steady manner and minimized hemoglobin overshoots compared to darbepoetin alfa and ESA.

In a MACE safety analysis, vadadustat demonstrated a hazard ratio of 0.96 with an upper bound of the confidence interval of 1.11, well below the agreed to target of 1.25 in the US and 1.3 in Europe.

Our data published in the new England Journal of Medicine and additional data presented at ASN last week demonstrated no increased risk of thromboembolic events, seizures or serious infections, and a rate of dialysis access thrombosis equal to that of darbepoetin.

In the past, we've discussed the importance of home dialysis, which is the fastest growing segment of the market. Data on vadadustat for treatment of anemia in patients with dialysis dependent CKD 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 vadadustat once daily means PD patients won't have to come into dialysis centers regularly for infusions of ESA.

The data presented showed that the safety profile of vadadustat in patients with dialysis dependent CKD receiving peritoneal dialysis was similar to what was seen in the overall dialysis program.

Our data are encouraging and support the unique value proposition we believe vadadustat 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 CKD is significant. We believe in the potential of vadadustat to help these patients.

With US approval, we'll have the potential to address the unmet needs of over half of million adult patients on dialysis and rapidly establish vadadustat as the new oral standard of care for the treatment of anemia due to CKD. That represents a potential $2 billion market opportunity in the US alone.

We believe there are compelling data supporting a positive benefit risk profile for the use of vadadustat broadly in patients with CKD, including non-dialysis patients. We remain cautious about receiving a broad label for vadadustat that would extend to non dialysis patients with anemia due to CKD.

However, we believe we put forward a compelling and 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'm pleased to share the picture of what we believe launch will look like if vadadustat is approved. Today, we'll focus on the opportunity within dialysis, although, it's 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 vadadustat commercial opportunity. Our team is energized by the potential to be first to market. As John highlighted, with the US approval we will have the opportunity to address the unmet needs of over of half a million adult patients on dialysis.

And we will seek to rapidly establish vadadustat as the new oral standard of care for the treatment of anemia due to CKD. That represents a potential $2 billion market opportunity in the US alone. Our cross-functional team with support from our partner Otsuka 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 CKD, differentiating vadadustat from the current standard of care and providing broad access for all appropriate patients if vadadustat approved.

Specifically, as we look to secure rapid adoption for vadadustat our distribution relationship with Vifor Pharma will be critical. The agreement facilitates access to Fresenius Medical Care and certain other dialysis providers, which together treat up to 60% of US dialysis patients.

Additionally, Akebia 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 US dialysis patients.

We believe that rapid adoption is also likely in the US due to a reimbursement model unique to the dialysis market referred to as TDAPA. 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 vadadustat under TDAPA, which we anticipate will take approximately six months from regulatory approval to official TDAPA 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 CKD community and this information has been beneficial in informing our vadadustat 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 is a key component to a successful US 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’s 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 vadadustat if approved. Now, I'll turn the call over to Dave to discuss our financial results..

Thank you, Dell and good morning, everyone. As John and Dell mentioned, having laid the groundwork for potential approval, we’re advancing pre-launch preparations for vadadustat. 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 $40.8 million for the 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 3 clinical development program for vadadustat and are currently engaged in close out activities with respect to the program.

It is worthnoting explicitly here that our collaboration revenue is directly tied to work performed on the vadadustat program. Collaboration revenue is reduced because vadadustat 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. The Akebia team is very proud of the performance, this is a challenging market where COVID has caused increased mortality in the patients we serve.

The growth is reflective of a higher net revenue per pill than previously realized over the last three years and include some one-time true-ups that reflects what we believe is our current payer mix. Turning to expenses. You've 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 3 times a week studies for vadadustat and continue to have Phase 3 research.

We're able to cost effectively prioritize this spend because of our already existing commercial footprint, thereby, avoiding more significant supply chain build out costs than most other biotechs without a commercial products would incur.

As a reminder, consistent with the terms of our collaboration agreements, certain vadadustat supply chain costs are shared across our partnerships. For our 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 company's aftermarket 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 for at least the next 12 months. Commenting beyond that would require guidance on vadadustat launch revenues, which we are not prepared to provide at this time.

On our last call, we provided clarification on future milestone payments to Akebia, which are worth repeating.

Subject to the terms of our collaboration agreements with Otsuka, Akebia has the right to receive milestone payments from Otsuka on approval of vadadustat in the US and Europe, given the tiered nature of these milestones, if vadadustat succeeds in being the HIF-PHIs to be approved in the US.

The US regulatory milestones for 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 maybe used to offset our accumulated R&D pre-funding, which today stands at $100 million.

Given that our partner has Otsuka now filed their MAA in Europe, we should point out that we are eligible to receive up to $17 million in regular milestones, assuming no delays in the MAA review process.

In addition, consistent with the terms of our license agreement with Vifor, Akebia has the right to receive $25 million in milestone payments upon US approval of vadadustat and its inclusion in the perspective payment system or TDAPA whichever is first. With that, we will open the line for questions.

Operator?.

[Operator Instructions] Our first question comes from the line of Chris Raymond with Piper Sandler. .

This is Alli Bratzel on for Chris this morning. Thanks for taking the question. So I guess just coming off the ASN meeting and some of the additional vadadustat analysis 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 vadadustat data set presented this weekend.

I guess any color or characterizing about feedback and how docs are viewing differentiation among kids would be really helpful?.

Obviously, the vadadustat data was just presented this weekend. So I think it's 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 Spherix, Jennifer Robinson presented on physicians reactions to HIF 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 are extremely likely to prescribe HIF and fully 85% kind of fill into the expectation of prescribing at some point.

So I think the concerns that were kind of felt around the roxadustat data are starting to -- people are seeing that there's differences between the products and there's a path forward.

And again, I think the daprodustat data really only serves to confirm that the issues seen with roxadustat were not a class effect and that in these products can be used safely. Quite frankly, I think the daprodustat for our part gives us more confidence in our approval, certainly in dialysis, but with the non dialysis data that they saw as well.

Steve, did you want to make any other comments about that?.

No, I agree. I think people are taking comfort in the daprodustat data and it supports our hypothesis that you can use these drugs safely if you appropriately target the hemoglobin..

I mean, that's the -- remember the daprodustat studies, they had a hemoglobin target of 10 to 11 across all of the patients in our -- and remember our non dialysis, the data that we've put forward to the FDA is that the US population where we did target a 10 to 11, you see a dataset that looks extraordinarily like the overall data set for daprodustat where 10 to 11 was targeted.

So once again, I think that supports our contention. And while obviously we've only seen what's been presented on dapro and dialysis our own data is incredibly strong there. And I think that this only kind of confirms what we've seen and gives us that much more encouraging path forward.

And then when you think about the data we presented that I referenced in my remarks, there was issues around imbalance in thromboembolic events, seizures and serious infections that were really the center of the concern at the AdCom. We presented the data now some in New England Journal papers but now we presented that more discreetly.

We just don't see that, so that gives us great confidence across the board..

Our next question comes from the line of Alethia Young from Cantor Fitzgerald..

Maybe a couple from me. One, I feel like one of your competitors kind of recently said in past that they suspect that they may have a panel, but maybe that's conjecture on their part. I just wanted to kind of get your perspective and any kind of update, commentary you heard on your end. It sounds like you reiterate your confidence not having one.

And then a little bit more on dapa, I guess, with their trial, kind of hitting in non-dialysis. Does that change the kind of the calculus as you think about non dialysis even though, I mean, I know what the evaluation with optionality, but just want to kind of to get your perspective on that.

And then as it relates to dialysis, I guess, the question is, now the Vifor collaboration seems to kind of continue to lock in that potential share even if there was another competitor out of the market? Thanks..

So on the first question on the panel. I know that, at this point, we are the only HIF PHI that’s in front of the FDA. So 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 have said that we've expected one and we'll 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 mind. So we'll just kind of wait and see as the review progresses.

So as I’ve referenced in answer to the last question, on non-dialysis, actually daprodustat data really encourages us around our own path forward. This is, as I mentioned, what we've been saying is when you target a hemoglobin of 10 to 11, which is the target in the US, which we had for US patients in our studies.

Recall outside the US we targeted 10 to 12 and patients were generally managed to a higher hemoglobin level. In the US we had a hazard ratio, if you looked at us patients using ages continuous variable, you had a hazard ratio of just over 1, 1.01 and 1.02, I think, with an upper bound at 1.22.

So clearly not showing an increased cardiovascular risks that result for daprodustat really was kind of confirmed basically in their overall population where they hit their primary end point. So for us, it really gives us that much more confidence that as FDA looked at this class broadly that, there isn't an elevated cardiovascular risk.

And importantly, again, FDA is recognizing -- saw the roxadustat panel. They recognize that there is an unmet need here that patients need treatment options.

And that's what goes to this benefit risk, the benefit of treating patients with the vadadustat outweighs the risks, particularly when you go back and look at the things that it really focused on in the roxa panel, which were thromboembolic events, seizures and serious infections where we simply didn't see any difference there. So we'll see.

As I said, we are engaged with the FDA. It's ongoing. We're pleased by their level of engagement. But we'll continue to -- we look forward to March 29th, I guess, is what it comes down to. And then with dialysis, yes, as I said, we had been planning to be seconds of three and that was the rationale for the Vifor deal.

Now we're planning to be first of two and that rationale doesn't change. And we think it's very important to have Vifor to have access to those Fresenius patients. I don't know, Dell, is there anything you want to add to that? We think that's an important opportunity for us..

We're excited about the market opportunity for vadadustat and dialysis. And I think the access that Vifor gives us to FMC and certain other dialysis providers does enable us to be the exclusive HIF in 60% of the US dialysis patients. So we do think that's a real opportunity for us at launch and we are excited about it..

And Alethia as you mentioned non-dialysis being kind of optionality and I certainly wouldn't disagree with you there. We've talked about being cautious, so we are very confident in our data. I think when you look at valuation today, dialysis isn't reflected.

And this is prevalent dialysis is not reflected, and this is a $2 billion opportunity that we get to be in first for a year or more depending on filing date. So we think this is a phenomenal opportunity for us..

Our next question comes from the line of Eric Joseph from JP Morgan..

I just wanted to follow-up on some of the commentary regarding commercial activities. Specifically how you anticipate any extension to sales or MSL teams to support vadadustat in dialysis over what you're currently sites for with Auryxia and sort of personnel support do you expect coming from Otsuka in the US.

And then, yes, as the optionality in non dialysis, I think, support expansion or launch in non-dialysis, so I think how should we [Technical Difficulty] there?.

Eric, that last part of your second question there faded out..

If you are approved in non-dialysis, how should we be thinking about sales force and MSL sizing to support non-dialysis and sort of the contribution from Akebia versus Otsuka?.

That's one of the benefits of having a commercial organization already in place. As we have vadadustat we’re going to get great leverage from that organization.

But Dell, do you want to to give a little detail there?.

So as you know, we have an experienced nephrology focused field team that's really established a strong reputation in the kidney market with Auryxia. And we think that this is a really a key point of leverage as we move towards the potential launch of vadadustat. Certainly, being first to market is an exciting opportunity.

And as we've looked at the field for sizing and our current MSL and sales footprint, we really feel like we've largely have the team here at Akebia to 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 and medical footprints 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 we won't need to add a lot of infrastructure moving forward to create a successful launch..

Also has just been a great partner. And that's one of the things we're working on, Dells, particularly is working on the detail around who does what in the launch. But our sales force is focused on dialysis and the Otsuka sales force is focused outside of dialysis.

So we're in a great position that if we get that expanded patient population that we have access to those resources without having 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'll be able to update you as we get closer to launch..

Just a follow-up if I could. With respect to the milestones that you outlined in your prepared remarks, the 65 million in the US.

Is that considered approval in both dialysis and non dialysis? Is there a certain milestone amounts tied to individual segments?.

So we have previously disclosed that 15 million of that is attached to dialysis and 50 million is attached to a non dialysis, and those are based on being the first HIF to market..

Our next question comes from the line of Serge Belanger from Needham and Company..

First one on the commercial prep for vadadustat, assuming you get approval in late March. Maybe talk about your readiness for launch in terms of product supply.

And since TDAPA is the key reimbursement aspect, what is a six months process, how does that play into the launch timing? And then secondly on Auryxia, maybe just talk about what has been driving recent growth? And given the recent settlement with generics, does that change your outlook for the product? Could we see additional investments now that you have clarity on the IP runway?.

So from a supply perspective, we have two API and 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 for a very successful fast uptake within the dialysis market.

Dell, do you want to talk about kind of TDAPA process and the like?.

As you mentioned, we expect at regulatory approval to apply for TDAPA. As you said, we expect the process to take approximately six months. But we plan to launch in dialysis as soon as possible after regulatory approval. So we don't anticipate waiting until the TDAPA 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 needs and the clinical data for vadadustat and ensuring that we have all the operational details in place. So that once dialysis providers begin to ramp, we will be certainly ready to go there.

Obviously, given that TDAPA was created to encourage adoption of new therapies, we believe the timing of TDAPA will be important as you think about our rate of adoption of vadadustat in dialysis or said another way, we think that the revenue ramp for vadadustat will certainly be linked to TDAPA timing. So that's our plan for vadadustat in dialysis.

As far as Auryxia goes, as I think most companies are experiencing, it's been a challenging market. The 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 healthcare 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 are focusing more on multi-channel and non-personal promotion. But overall, I think we are 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 end of settlement, which pushes out -- give us confidence in the market opportunity up till 3 of 25, it's just a great opportunity for us to continue to grow the product.

And just because there is the ability for generics to enter the market in 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 payments system, the PPS payment in 2025 that creates an opportunity for us long term and having multiple products as part of that bundle, gives us great opportunities as well.

So it's great to have confidence that no one is entering before then. But we think the area under the curve for quite a while will 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 have both dialysis and non-dialysis, we are still in a comfortable position. We do expected to the non-dialysis ramp will be slower than dialysis. But we've made sure we will be in a supply position to support any speed of launch in both patient populations..

Our next question comes from the line of David Lebowitz from Morgan Stanley..

This is Avatar Jones on for David this morning. A couple of 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 Auryxia and potential time lines for resolution there?.

Dave, do you want to handle?.

Yes, I think. So, for SG&A, like we've 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 vadadustat launch, I think the team is largely in place and that, from an expense perspective, you'd really just be looking at some shared expenses that we would have with Otsuka to build the vadadustat brand.

But largely, from a personnel perspective, the team is in place..

And I think your second question was on the Medicare Part D coverage for Auryxia, and I assume that was focused on the IDA indication where we didn't have coverage for or don't have coverage for Auryxia.

And you might have seen a few weeks ago, we put out an announcement that we did dismiss the lawsuit against CMS where we were seeking coverage for the IDA indication. This was a very difficult decision for us to make.

We know that patients have a need to access this drug, and it's incredibly unfortunate that CMS disagrees that the product should be covered. Now, it's covered for dialysis patients for hyperphosphatemia, so that's -- which is by far the larger market opportunity for us, so we continue to grow in that space.

But we spent so much time and resources on the lawsuit. We didn't get the preliminary injunction; we made the very difficult decision that we were going to walk away from that. But we're not walking away from those patients or working to get coverage 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 introduced to provide coverage for it. Obviously, there's 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, Dell and his team are working on ways to optimize access for the hyperphosphatemia population and continuing to grow that population. IDA was a small, much smaller part of the Auryxia revenue, and it's stayed that way, even though private-pay patients can access the product for IDA.

We expect that, until we find a legislative fix that it will stay [indiscernible]. But as Dell referenced earlier, we have the opportunity to continue to grow in hyperphosphatemia for some time, and that's where our focus is..

Our next question comes from the line of Ed Arce from H.C. Wainwright & Company..

A couple for me.

Firstly, on the commentary around your sales footprint being largely in place right now and even just incremental investment would be necessary if non-dialysis were approved, wondering in that regard how many -- if you could remind us, how many reps and MSLs 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 that 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?.

Ed, thanks so much for your questions. I'll take the second question, and then I'll pass it to Dell for the first. The $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 HIF-PHI is an opportunity we're unexpected -- I haven't been expecting for the last 8 years. We've been expecting to be second.

That's how we've been planning. First to market with, we think at least a year or so of 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 Dell, maybe you can talk about the footprint and training readiness..

So currently, we have a commercial team of 140 people, and of those, we have about 110 field-based employees, so our sales and our access teams. The medical team, which reports into Steve, is -- has about 13 MSLs, plus a small management team.

So that's the group that right now is working with Auryxia and will be able to support the launch of vadadustat, 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 partner, Otsuka, and it's great to have that partnership in place to be able to do that.

As far as readiness materials or readiness activities, I should say, the team is really working across the different functions to make sure that we'll be ready at our PDUFA date to launch in full. Certainly, from a marketing and a sales training perspective, our market access team has started to have pre-label interactions.

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 approval with the full team..

I mean, before we have an approval, the commercial team is very limited in what they can do. But the medical affairs team, the idea of educating nephrologists on HIF, the mechanism, the challenges of anemia management, those are incredibly important as we run up towards launch.

Of course, if physicians are interested in learning about that vadadustat data, the medical team can educate them on that as well. And it's critically important, particularly given the data sets of three different products that are out there. Clarifying those differences is really going to be critical for launch success..

Our next question comes from the line of Bert Hazlett from BTIG..

Congrats on all the progress. Apologies if this has been addressed a little bit. Have been jumping around calls this morning. It's been a busy morning.

But just with regard to the PDUFA application in Europe, first of all, do you give any sense of timing in terms of the -- not only the application itself, but the reimbursement 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 and patients that we discussed in the US?.

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. Dell, do you want to maybe talk about the reimbursement? I mean, it differs in different countries, but --.

I think that the reimbursement structures are quite different in Europe, 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 to be the most important for launch, and some of them to be the earliest to reimburse.

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 an individual by-country process, once we receive approval, so we'll certainly update you more as we learn more..

And from an issue standpoint, obviously, we haven't really -- or Otsuka will be leading the discussions with the MA, so we don't know exactly where their focus will be. But I certainly have an expectation that they'll look at some of the same issues. I mean, I think it's important to note that roxadustat 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 -- or also, we have confidence in the non-dialysis data in Europe as well. But again, very, very early days there..

And there are no further questions at this time. John, please continue..

Thanks, Myra. This is a busy and exciting time at Akebia. Vadadustat is approved in Japan. The MAA has been submitted to the EMA, and vadadustat is late in its FDA review process, with a PDUFA date set for March 29 of next year.

Our focus remains on comparing to bring to market a novel oral therapeutic for people living with anemia due to chronic kidney disease.

We remain confident in vadadustat's potential as a first-in-class treatment for anemia due to CKD in dialysis patients, and we look forward to engaging -- continuing to engage with the FDA in 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..