Welcome to Akebia's 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. To ask a question during the session, you will need to press star one on your telephone. If you require any further assistance, simply press star zero. Now, I would like to hand the conference over to your first speaker, Mercedes Carrasco. Thank you, and please go ahead.
Thank you. Welcome to Akebia's third quarter 2021 financial results and business updates 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 investor 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 K. Burke, our Head of R&D and Chief Medical Officer, who will be available for questions. 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 Management 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 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'll 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 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 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 III 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 team's efforts to educate physicians, payers, and dialysis organizations about anemia due to CKD and vadadustat. We're excited about vadadustat's potential to be the first in class HIF-PHI 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're encouraged that the HIF-PHI share of the anemia market continues to grow in Japan, along with Vafseo 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've been hospitalized due to COVID-19 continues to progress.
With the support of their data monitoring committee, UTHealth 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 UTHealth 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 Del to share some details on our launch preparation. 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 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 vadadustat increased hemoglobin in a gradual and steady manner and minimized hemoglobin overshoots compared to darbepoetin alfa and ESA. In the 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 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've put forth 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.
With that, let me turn to Dell Faulkingham, 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 a U.S. approval, we will have the opportunity to address the unmet needs of over 500,000 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, 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 in 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 is $48.8 million for the third quarter of 2021, compared to $60 million for the third quarter of 2020, reflecting lower collaboration revenue since we successfully completed our global phase III clinical development program for vadadustat 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 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 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 continued HIF-based 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 product 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 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 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 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 the approval of vadadustat in the U.S. and Europe.
Given the tiered nature of these milestones, if vadadustat succeeds in being the first HIF-PHI 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 their MAA in Europe, we should point out that we are eligible to receive up to $17 million in regulatory 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'll open the line to questions. Operator?
Thank you. At this time, we would like to take any questions you might have for us today. 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 Q&A list. This will only take a few moments. 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 Allison Bratzel for Chris this morning. Thanks for taking the question. So I guess just coming off the ASN meeting and some of the additional vadadustat data analyses presented there, what kind of feedback are you getting from the nephrology community on vadadustat's profile, maybe especially as it relates to comparisons to the daprodustat dataset presented this weekend? I guess any color or characterizing of that feedback and how docs are viewing differentiation among HIF would be really helpful.
Sure, Allison. Thanks so much for the question. Obviously the daprodustat data was just presented this weekend, so I think it's early. It'll be very immediate kind of feedback. I think, you know, as the New England Journal papers are out there and people digest them, we'll learn more. You know, I think generally speaking, you know, there was also a presentation at the ASN meeting from Spherix. Jennifer Robinson presented on physicians' reactions to HIF and their expectations around that. You know, I was really encouraged to see that I think it was almost 60% of physicians said they were probably or extremely likely to prescribe HIF and fully 85%, you know, kind of fell into the expectation of prescribing at some point.
You know, 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 that there's a path forward. You know, again, I think the daprodustat data really only serves to confirm that the issues seen with roxadustat were not a class effect and that these products can be used safely. Quite frankly, I think the daprodustat data for our part gives us more confidence in our approval, certainly in dialysis, but you know, 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.
Right. I mean, that's the. Remember, the daprodustat studies, they had a hemoglobin target of 10-11 across all of the patients. In our non-dialysis, you know, the data that we've put forth to the FDA is that the U.S. population, where we did target a 10-11, you see a data set that looks extraordinarily like the overall data set for daprodustat where 10-11 was targeted. Once again, I think that supports our contention. You know, while obviously we've only seen, you know, what's been presented on daprodustat in dialysis, our own data is incredibly strong there.
I think that, you know, this only kind of confirms what we've seen and, you know, gives us that much more encouraging path forward. Then when you think about the data we presented that I referenced in my remarks, those 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 was in the New England Journal papers, but now we presented that more discretely. We just don't see that. You know, that gives us great confidence across the board.
Got it. Thanks, guys.
Thanks, Alisson.
Our next question comes from the line of Alethia Young from Cantor Fitzgerald. Your line is open. Please go ahead.
Hey, guys. Thanks for taking my questions. Maybe a couple from me. One, I feel like one of your competitors kinda recently said in passing that they suspect that they may have a conference. I'm sorry, a panel, but you know, maybe that's conjecture on their part. I just wanted to kinda get your perspective and any kind of update commentary you heard on your end. It sounds like you reiterate your confidence in not having one. Then, a little bit more on Dapa. I guess, you know, with their trial, you know, 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 the valuation is optionality, but just wanted to kinda get your perspective on that.
As it relates to dialysis, I guess, the question is, you know, is now the Vifor collaboration will it kinda continue to lock in that potential share even if there was another competitor to enter the market? Thanks.
Sure. On the first question on the panel, you know, I know that at this point, we're the only HIF-PHI that's in front of the FDA. You know, while we are preparing for a panel and certainly open to one, you know, the FDA has not given us any indication that we'll have a panel. You know, we've said that we've expected one and we'd be ready for one, but I think the message from FDA has continued to be that you know, at this time, they don't expect a panel, which always allows them the opportunity to change their mind.
You know, we'll just kinda wait and see as the review progresses. As referenced in answer to the last question, a non-dialysis, actually, the daprodustat data really encourages us around our own path forward. You know, this is, you know, as I mentioned, you know, what we've been saying is when you target a hemoglobin of 10-11, 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 10-12, and patients were generally managed to a higher hemoglobin level. In the U.S., we had a hazard ratio.
If you looked at U.S. patients using age as a continuous variable, you had a hazard ratio of just over one, 1.01 or 1.02, I think 1.01, with an upper bound at 1.22. You know, clearly not showing an increased cardiovascular risk. That result for daprodustat really was confirmed basically in their overall population where they hit their primary endpoint. You know, for us, it really gives us that much more confidence that, you know, as FDA looks at this class broadly, that there isn't an elevated cardiovascular risk. Importantly, again, FDA is recognizing. You saw the roxadustat panel. They recognize that there is an unmet need here. That patients need treatment options. That's what goes to this benefit risk.
The benefit of treating patients with the vadadustat outweighs the risk, particularly when you go back and look at the things that it really focused on in the roxadustat panel, which were thromboembolic events, seizures, and serious infections where we simply didn't see any difference there. You know, we'll see. As I said, we're engaged with the FDA. It's ongoing. We're pleased by their level of engagement, but you know, we'll look forward to March 29, I guess is what it comes down to. With dialysis, yes, I mean, as I said, we had been planning to be second of three, and you know, that was the rationale for the Vifor deal. You know, now we're planning to be first of two, and that rationale doesn't change.
You know, we think it's very important to have Vifor to have access to those Fresenius patients. I don't know, Dell, if there's anything you wanna add to that. We think that's an important, you know, opportunity for us.
Yeah, no, absolutely. We're excited about the market opportunity for vadadustat in dialysis. I think the access that Vifor gives us to FMC and certain other dialysis providers does, you know, enable us to be the exclusive HIF in 60% of the U.S. dialysis patients. We do think that's a real opportunity for us at launch, and we're excited about it.
Alethia, as you. You know, you mentioned non-dialysis being, you know, kinda optionality, and I certainly wouldn't disagree with you there. You know, 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? This is, you know, approval in dialysis is not reflected. This is a $2 billion opportunity that we get, you know, to be in first for a year or more, depending on filing dates. You know, 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 JP Morgan. 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, you know, how you anticipate any expansion of the sales or MSL teams to support vadadustat in dialysis over what you're currently sized for with Auryxia, and sort of what personnel support do you expect coming from Otsuka in the U.S.? You know, yes, there's the optionality in non-dialysis. I guess, you know, in order to kinda support expansion or launch in the non-dialysis setting, how should we think about sales force sizing there as well?
I'm sorry, Eric, that last part of your second question there, faded out.
Sorry. 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?
Great. That's one of the benefits of having a commercial organization already in place, is we add vadadustat, we're gonna get great leverage from that organization. Dell, do you wanna give a little detail there?
Absolutely. So, you know, as you know, we have an experienced nephrology-focused field team that's really established a strong reputation in the kidney market with Auryxia. 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. 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 Akebia to launch in dialysis. 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. You know, this is where our partnership with Otsuka would come in.
We can leverage their existing commercial and medical footprints as well to make sure we have what we need to support the share of voice in the marketplace. 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.
Yeah. Otsuka has just been a great partner and, you know, that's one of the things we're working on. Dell particularly is working on the detail around the who does what in the launch. You know, our sales force is focused on dialysis and, you know, the Otsuka sales force is focused outside of dialysis. You know, we're in a great position that if we get that expanded patient population that we have access to those resources without having to to build a larger team at all. It really is a great position to be in. You know, 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.
Thanks. That's very helpful. Just to 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? Are certain milestones-
Yeah, Eric.
Amounts tied to individual segments? Thank you.
Yeah, Eric, it's a good question. We had previously disclosed that $15 million of that is attached to dialysis and $50 million is attached to non-dialysis, and those are based on being the first HIF to market.
Okay, great. Thanks for taking the questions, guys.
Thanks, Eric.
Our next question comes from the line of Serge Belanger from Needham & Company. Your line is open. Please go ahead.
Hi, good morning, team. Thanks for taking my questions. 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 a key reimbursement aspect, what is a six-month process, how does that play into the launch timing? Secondly, on the 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? Thanks.
Serge, thanks so much. Thanks for the questions. It's nice to welcome you to the call. From a supply perspective, we have two API and two drug product suppliers for launch. You know, we've made the decision to build redundancy into our supply chain early on. 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 wanna talk about kind of the TDAPA process and the like?
Yeah. As you mentioned, we expect, you know, at regulatory approval to apply for TDAPA. As you said, we expect the process to take approximately six months. We plan to launch in dialysis as soon as possible after regulatory approval. We don't anticipate waiting until the TDAPA period starts. You know, when you think about the opportunity to be first to market, we wanna 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'll be certainly ready to go there.
You know, 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. Said another way, we think that the revenue ramp for vadadustat will certainly be linked to that is to, TDAPA timing. That's our plan for vadadustat in dialysis. You know, as far as Auryxia goes, you know, as I think most companies are experiencing, it's been a challenging market. The overall phosphate binder market is down, and really is significantly due to the disproportionate mortality in this space. You know, that's been really difficult. Certainly access to healthcare providers continues to be a challenge.
I think our team has really demonstrated, you know, some strong resilience and has adapted a hybrid approach to engagement where we're focusing more on multi-channel and non-personal promotion. Overall, I think we're really proud of the job the team has done this year given the market dynamics. You know, we expect the market to continue to be challenging, but we certainly believe we can continue to grow Auryxia net revenue moving forward.
I think the settlement, you know, the final end of settlement, which pushes out, you know, kind of gives us confidence in, you know, the market opportunity up till Q3 2025. You know, it is just a great opportunity for us to continue to grow the product. Just because, you know, that there is the ability for generics to enter the market in 2025, does not mean we do not 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 bundle gives us great, you know, opportunities as well.
It's great to have confidence that no one's entering before then, but you know, we think the area under the curve for quite a while will contribute significantly from a cash perspective. Just to clarify one thing I said, 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're still in a comfortable position. We do expect the non-dialysis ramp will be slower than dialysis. You know, we've made sure we'll be in a supply position to support any speed of launch in both patient populations.
Thank you.
Thanks, Serge.
Our next question comes from the line of David Lebowitz from 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? Secondly, can you provide any color on developments for Medicare Part D reimbursement of Auryxia and potential timelines for resolution there? Thank you.
Dave, you wanna handle that question?
Yeah. I think so for SG&A, you know, like we've talked about a few times, we're you know, very proud of the infrastructure that we've built. 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. 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. Largely, from a personnel perspective, the team is in place.
I think your second question was on the Medicare Part D coverage for Auryxia. 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. You know, we know that patients have a need to access this drug and you know, it's incredibly unfortunate that CMS disagrees that the product should be covered. Now it's covered for dialysis patients for hyperphosphatemia. That's you know, which is by far the larger market opportunity for us.
We continue to grow in that space. You know, we'd spent so much time and resources on the lawsuit. We didn't get the preliminary injunction. We made the very difficult decision that you know, we were going to walk away from that. We're not walking away from those patients or working to get coverage for IDA. You know, 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. We're not walking away from the opportunity.
Dell and his team are, you know, 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. You know, we expect that until we find a legislative fix that it'll stay that. As Dell referenced earlier, we have the opportunity to continue to grow in hyperphosphatemia for some time, and that's where our focus is.
Understood. Thank you.
Our next question comes from the line of Ed Arce from H.C. Wainwright & Co. 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 investment would be necessary if non-dialysis were approved. Wondering in that regard, 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 you know the areas of training and readiness activities that would be going on ahead of the approval.
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? Thanks so much.
Ed, thanks so much for your questions. I'll take the second question, and I'll pass it to Dell for the first. You know, the $2 billion market opportunity is still the size of the market opportunity. A few months ago, we were expecting to be the second product to the market. The opportunity to be the first product to the market, you know, 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 eight years. You know, 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. Dell, maybe you can talk about the footprint and training readiness.
Absolutely. 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, has about 13 MSLs, plus a small management team. That's the group that right now is working with Auryxia, and we'll 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. It's great to have that partnership in place to be able to do that.
As far as readiness activities, I should say, the team is really, you know, working across the different functions to make sure that we'll be ready at our PDUFA date to launch in full. You know, certainly from a marketing and a sales training perspective, our market access team has started to have pre-label interactions. Certainly our medical affairs team is talking about education around the space. 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.
Yeah, I mean, if before we have an approval, the commercial team is very limited in what they can do. The medical affairs team, you know, the idea of educating nephrologists on HIF, the mechanism, the challenges of anemia management, now those are incredibly important, as we run up towards launch. Of course, if physicians are interested in learning about vadadustat data, the medical team can educate them on that as well. You know, it's critically important, particularly given the data sets of three different products that are out there. You know, clarifying those differences is really gonna be critical for launch success.
Great. Thanks so much.
Thanks, Ed.
Our next question comes from the line of Bert Hazlett from BTIG. Your line is open. Please go ahead.
Yes, thanks. 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. Just with regard to the EMA application in Europe, first of all, do you have any sense of timing in terms of not only the application itself, but the reimbursement process in Europe? 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 we discussed in the U.S.? Thanks.
Bert, thanks so much for the question. The application, you know, was submitted and it's been validated. Generally, the timing is a 12-month review for Europe. That's the assumption that we're working on. Dell, you wanna maybe talk about the reimbursement? I mean, it differs in different countries, but.
Yeah, absolutely. You know, 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 you know, the larger countries to be the most important for launch and some of them to be the earliest to reimburse. You know, typically, U.K. and Germany are on the earlier side of European launches, with France and Italy and Spain to follow sometime after. There'll be an individual by country process once we receive approval. We'll certainly update you more as we learn more.
From an issue standpoint, obviously we haven't really or Otsuka will be leading the discussions with the EMA. You know, we don't know exactly where their focus will be, but you know, I certainly have an expectation that you know they will 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, you know, with the challenges that they've had, they've labeled around those. You know, when I think about our data package kind of in its totality, I think we you know we feel very confident in certainly in dialysis again, and maybe more than you know or also we have confidence in the non-dialysis data in Europe as well.
Again, very early days there.
Terrific. Thank you very much.
Thanks, Bert.
There are no further questions at this time. John, please continue.
Thanks, Myra. This is a busy and exciting time at Akebia. Now vadadustat's approved in Japan, the MAA has been submitted to the EMA, and vadadustat is late in its FDA review process with the PDUFA date set for March 29 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 vadadustat's potential as a first in class treatment for anemia due to CKD in dialysis patients, and we look forward to engaging and 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.