Earnings Call Transcript - AKBA Q3 2021

Operator, Operator

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

Mercedes Carrasco, Corporate Secretary

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 website. For your convenience, a replay of today’s call will also be available on our website 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 questions. 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.

John Butler, CEO

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, is 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 in 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 a 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 U.S. 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’s 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 target 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 target of 1.25 in the U.S. 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 U.S. approval, we'll have the potential to address the unmet needs of over half a 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 U.S. 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.

Dell Faulkingham, CRO

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 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 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 U.S. 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 is 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 U.S. 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 U.S. dialysis 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 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 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’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, we 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.

Dave Spellman, CFO

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 closeout activities concerning the program. It is worth noting 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 this 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 includes some one-time true-ups that reflect 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 three 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 biotech firms without 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 upon approval of vadadustat in the U.S. and Europe; given the tiered nature of these milestones, if vadadustat succeeds in being the HIF-PHIs to be approved in the U.S., the U.S. 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 may be used to offset our accumulated R&D pre-funding, which today stands at $100 million. Given that our partner, 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 U.S. approval of vadadustat and its inclusion in the prospective payment system or TDAPA, whichever is first. With that, we will open the line for questions. Operator?

Operator, Operator

Our first question comes from Chris Raymond with Piper Sandler.

Alli Bratzel, Analyst

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?

John Butler, CEO

The vadadustat data was recently presented, providing immediate feedback. During the ASN meeting, there was a presentation from Spherix where Jennifer Robinson discussed physicians' responses to HIF and their expectations. I was encouraged by the fact that nearly 60% of physicians indicated they were likely to prescribe HIF, with 85% indicating they plan to prescribe it at some point. Concerns about the roxadustat data are diminishing as people recognize the differences between the products and the potential for moving forward. Additionally, the daprodustat data supports that the issues related to roxadustat do not apply to the entire class of products, indicating that these products can be safely used. I believe daprodustat enhances our confidence in our approval, especially for dialysis, but also in regard to the non-dialysis data presented. Steve, did you want to add anything further on that?

Steven Burke, Chief Medical Officer

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.

John Butler, CEO

The daprodustat studies aimed for a hemoglobin target of 10 to 11 for all patients, and our non-dialysis data submitted to the FDA follows a similar trend. This reinforces our position. Although we've only observed the findings on dapro and dialysis so far, our data is extremely robust. This further validates what we have observed and provides a more optimistic outlook moving forward. Additionally, considering the data we presented, there were concerns regarding imbalances in thromboembolic events, seizures, and severe infections highlighted at the Advisory Committee meeting. We have now shared some of that data in publications, and we do not observe those issues, which gives us significant confidence overall.

Operator, Operator

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

Alethia Young, Analyst

Maybe a couple from me. One, I feel like one of your competitors kind of recently said in the 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 or 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 calculus as you think about non-dialysis even though, I mean, I know what the evaluation with optionality, but just want to kind of 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.

John Butler, CEO

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 the 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 U.S., which we had for U.S. patients in our studies. Recall outside the U.S. we targeted 10 to 12, and patients were generally managed to a higher hemoglobin level. Therefore, for us, it really gives us that much more confidence that as the FDA looks at this class broadly, there isn't an elevated cardiovascular risk. And importantly, again, the FDA is recognizing the unmet need here that patients need treatment options. And that's consistent with this benefit-risk balance, the benefit of treating patients with vadadustat outweighs the risks, particularly when you look at the issues 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. 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 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 second 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. 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.

Dell Faulkingham, CRO

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 U.S. dialysis patients. So we do think that's a real opportunity for us at launch, and we are excited about it.

John Butler, CEO

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 a $2 billion opportunity that we get to be in first for a year or more, depending on the filing date. So we think this is a phenomenal opportunity for us.

Operator, Operator

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

Eric Joseph, Analyst

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 U.S. And then, yes, as the optionality in non-dialysis, I think, support expansion or launch in non-dialysis, so I think how should we think about there?

John Butler, CEO

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

Eric Joseph, Analyst

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?

John Butler, CEO

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 give a little detail there?

Dell Faulkingham, CRO

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 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 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 ensure that 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.

John Butler, CEO

Also has just been a great partner. And that's one of the things we're working on, 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 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.

Eric Joseph, Analyst

Just a follow-up if I could. With respect to the milestones that you outlined in your prepared remarks, the $65 million in the U.S. Is that considered approval in both dialysis and non-dialysis? Is there a certain milestone amounts tied to individual segments?

John Butler, CEO

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.

Operator, Operator

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

Serge Belanger, Analyst

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-month 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?

John Butler, CEO

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?

Dell Faulkingham, CRO

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 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.

John Butler, CEO

The conclusion of the settlement gives us confidence in the market opportunity until 2025, providing us with a great chance to continue growing the product. Although generics may enter the market in 2025, we believe there is still potential for significant business with Auryxia, especially as phosphate binders could be integrated into the bundled payments system in 2025. This creates a long-term opportunity for us, and having multiple products included in that bundle enhances our prospects as well. It’s reassuring that no competitors will enter before then. We anticipate that the area under the curve will significantly contribute to our cash flow for an extended period. For clarity, our supply position is secure, allowing for quick adoption in dialysis, and we are also well-prepared to support both dialysis and non-dialysis markets. While we expect the growth in the non-dialysis segment to be gradual compared to dialysis, we have ensured we are ready to meet demand no matter the launch pace across both patient groups.

Operator, Operator

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

Avatar Jones, Analyst

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 timelines for resolution there?

John Butler, CEO

Dave, do you want to handle?

Dave Spellman, CFO

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.

John Butler, CEO

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. 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, 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, and 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 at 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 continue growing 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 limited. 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.

Operator, Operator

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

Ed Arce, Analyst

I have a couple of questions. Firstly, regarding your sales footprint being mostly established at this point, could you remind us how many representatives, medical science liaisons, and other support staff are currently part of your overall sales and marketing teams? Additionally, could you discuss the training and readiness activities that will take place before approval? Secondly, I recall a comment in the prepared remarks that the overall anemia market is significantly larger than what was anticipated just a few months ago. Can you elaborate on this? What insights have you gained, and what is your current perspective?

John Butler, CEO

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 market and have that opportunity to introduce the first-in-class HIF-PHI is an opportunity we weren't expecting. I haven't been expecting for the last 8 years. We've been expected to be second. 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.

Dell Faulkingham, CRO

So currently, we have a commercial team of 140 people, and of those, we have about 110 field-based employees, so our sales and access teams. The medical team, which reports into Steve, 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 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 pre-launch activities. We'll be ready to go at approval with the full team.

John Butler, CEO

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, and 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.

Operator, Operator

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

Bert Hazlett, Analyst

Congratulations on all the progress. I apologize if this has been mentioned already; I've been switching between calls this morning and it's been quite hectic. Regarding the PDUFA application in Europe, could you share any updates on the timing for both the application and the reimbursement process there? Additionally, do you anticipate that they will be dealing with similar issues concerning dialysis and non-dialysis data and patients as we discussed in the U.S.?

John Butler, CEO

The application was submitted and has been validated. Generally, the timing is a 12-month review for Europe, so that's the assumption we're working with. Dell, do you want to discuss the reimbursement? It varies from country to country.

Dell Faulkingham, CRO

I think that the reimbursement structures are quite different in Europe, and because of the regional differences in treatment and patient characteristics, we're 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, the 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.

John Butler, CEO

From an issue standpoint, we don't know exactly where Otsuka will focus in the discussions with the MA. However, I expect they'll consider some of the same issues. It's important to note that roxadustat was approved in Europe, and they have labeled it based on the challenges they faced. Looking at our data package as a whole, we feel very confident, especially concerning dialysis, and we also have confidence in the non-dialysis data in Europe. Nevertheless, it's still very early in the process.

Operator, Operator

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

John Butler, CEO

Thanks. This is a busy and exciting time at Akebia. Vadadustat has been approved in Japan. The Marketing Authorization Application has been submitted to the European Medicines Agency, and vadadustat is currently undergoing its FDA review process, with a Prescription Drug User Fee Act date set for March 29 of next year. Our focus is on getting ready to introduce a novel oral treatment for individuals suffering from anemia related to chronic kidney disease. We are optimistic about vadadustat's potential as a first-in-class option for anemia in dialysis patients, and we look forward to continuing our discussions with the FDA as they review our New Drug Application. We will keep you updated on our progress. Have a great day.

Operator, Operator

This concludes today's conference call. Thank you all for participating. You may now disconnect. Have a great day.