Akebia Therapeutics Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 9, 2024

There are 6 speakers on the call.

Operator

Hello, and welcome to Akebia's First Quarter 20 24 Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer Please be advised that today's conference is being recorded. It is now my pleasure to introduce Senior Director, Investor Relations, Mercedes Carrasco.

Speaker 1

Thank you, and welcome to Akebia's Q1 2024 Financial Results and Business Update Conference Call. Please note that a press release was issued earlier today, Thursday, May 9, detailing our Q1 financial results, and that release is available on the Investors section of our website. For our convenience, a replay of today's call will be available on our website after we conclude. Joining me for the call today, we have John Butler, Chief Executive Officer and Principal Financial Officer and Nick Grund, Chief Commercial Officer. I'd like to remind everyone that this call includes forward looking statements.

Speaker 1

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 May 9th 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 to 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.

Speaker 2

Thanks, Mercedes, and thanks everyone for joining us today. This is our first quarterly call since the approval of Appseo in late March. Though only about 6 weeks ago, I'm extremely encouraged by our early progress. I'm excited by the reaction of the dialysis market, prescribers, dialysis providers and patient groups as well as the excitement from the folks at Akebia to get this product into the hands of patients. We celebrated the milestone and win for the kidney community for a moment then immediately kicked into high gear to initiate our launch.

Speaker 2

On our VAPZIO approval call, I outlined 3 things we have to execute effectively to drive a successful launch and ensure long term growth of Apsio in dialysis. 1st, drive demand from prescribers 2nd, contract effectively with dialysis providers and 3rd, demonstrate potential additional benefits of VASIO for dialysis patients and the folks who serve them. Nick will go into more detail, but I'll share that our commercial and medical affairs teams have already engaged with thousands of physicians. I'm extremely encouraged by the physicians' interest and enthusiasm, particularly when I speak to investigators who have experience using the product. We believe the VASIO label supports widespread adoption and that's how we're presenting the product to the market.

Speaker 2

We've developed our launch strategy and tactics that best position VASIO to potentially become a new oral standard of care for dialysis patients with anemia due to chronic kidney disease. As I speak to potential VASIO prescribers, besides describing their clear interest in using the product for their dialysis patients, they ask me to please not give up on working towards an approval for non dialysis patients. We will not give up on this patient population. The FDA in the vadadustat CRL suggested we return and discuss appropriate subpopulations where the benefit risk is positive. Now this may include conducting a new clinical trial to supplement the data we already have in the patient population we plan to discuss.

Speaker 2

One potential subgroup we're exploring are CKD patients with anemia not on dialysis with a GFR below 15. We believe these patients would benefit from treatment with VASIO. Over 70% of these patients are not treated today and they routinely have a higher mortality rate than patients who had their anemia controlled before dialysis. And they continue to have a higher mortality rate 12 months after starting dialysis. A once a day oral option may be ideal for this patient population.

Speaker 2

We plan to engage the FDA this year to discuss a path forward for these patients. And it's critical that we take this population into account as we determine our WACC pricing for VASIO. We are carefully considering pricing and we'll announce the WACC by next month. So now let me ask Nick to give us more detail on launch execution.

Speaker 3

Thanks, John, and good morning to those of you joining us on the call. I'm pleased to report that the experienced Akebia commercial and medical affairs organizations have been extremely active in the field engaging with prescribers to build demand for VASIO and with dialysis prescribers to effectively contract as we prepare for product availability and TDAPA reimbursement in January. It is apparent that excitement and advocacy around the HIF class is strong. A clear unmet medical need exists with nephrologists reporting that 1 third of the dialysis patients with anemia due to CKD have hemoglobin levels that are below the target range. This is despite the availability of ESAs.

Speaker 3

Further, Akebia sponsored market research found 85% of physicians are familiar with the HIF class and of those who are extremely familiar, 85% have a very positive impression. This is despite the low early adoption of the other approved HIF. I believe this is a very solid foundation to build upon with strong differentiating messages specific to VASIO. Additional research suggests that nephrologists envision broad utilization of a HIF product with over 75% of nephrologists stating that they are comfortable prescribing a HIF in any dialysis setting. In fact, research suggests a HIF will be the preferred treatment versus ESAs for almost 1 third of nephrologists.

Speaker 3

These metrics are very encouraging. Even prior to approval, we had started to ramp up for launch. The first step was the expansion of our field based medical and commercial teams, which grew we grew 55% from 2023. We are excited to have expanded the teams now so that we have an 8 month runway to continue to build advocacy and demand for VASIO. In the 1st 6 weeks since approval Akebia's key account managers have been actively engaging with approximately 4,500 calls to our key target prescribers with many of those calls including VASIO messaging.

Speaker 3

John will talk more about this later, but I will quickly note that the VASIO approval has facilitated improved access to Auryxia prescribers. The efforts in the field team have been further supported by digital tactics. Vassio messages appeared in almost 26,000 times in paid search. And we have had over 240,000 targeted brand impressions. We are also proud to have had sponsorship presence at 3 key meetings since approval.

Speaker 3

The American Nephrology Nurses Association, the Renal Physicians Association and the Renal Healthcare Association meetings, which allowed for scientific exchange sessions and in-depth discussions with key customers. In parallel, Akebia's medical affairs team continues to work with our publication steering committee to ensure timely and continued publication of relevant vadadustat data for clinical and scientific community. To date, the primary results for both INNOVATE and PROTECT global Phase 3 clinical programs have been published in the New England Journal of Medicine in 2 separate manuscripts. Data on several additional important analysis in subgroups have been published including peritoneal dialysis subgroup, erythropoietic effects of vadadustat, overall adverse event profile of vadadustat from the pooled Phase 3 clinical program, etcetera. These publications were helpful in driving the high degree of HIF awareness that we are reporting from the field.

Speaker 3

As of the Q1, the medical affairs team continues to publish key data and analysis at scientific meetings such as the 2024 Annual Dialysis Conference where the cardiovascular safety of vadadustat in patients new to dialysis with CKD related anemia and the safety and efficacy of vadadustat in the treatment of anemia patients with CKD in the U. S. Region were presented. Beyond driving prescriber awareness, advocacy and demand, contracting with dialysis organizations is critical. Through that process, we will finalize our WACC price.

Speaker 3

As a reminder, we anticipate pricing VASIO at a premium. As you likely know, medications for dialysis patients are contracted through dialysis organizations and those contracts include both an off invoice discount and a volume based discount opportunity, meaning that when volume goes up, net price will come down. Engagement with dialysis organizations has been productive. Commercial discussions have been initiated with large dialysis organizations and ongoing contract development meetings are planned. Auryxia in the high likelihood phosphate binders will be in the bundle has allowed for us to begin dialogue with dialysis organization where we aligned around contract structure and critical components of implementation applicable across the portfolio.

Speaker 3

With both products available, we have a unique offering to help patients in dialysis organizations achieve their goals. I look forward to updating you as we finalize these agreements over the next several months. Turning now to TDAPA. We will submit our application by June. And as a reminder, that the application is only accepted once a quarter.

Speaker 3

After a 6 month TDAPA application process anticipated to be completed in January 2025, we expect the product would be reimbursed and widely available and accessible to patients with rapid adoption. As you can see, our entire organization is working on every aspect of reaching our prospective prescribers, securing access for patients through key channels and laying groundwork for future growth. Our partners are hard at work too. Medici plans to launch VASIO in Germany and Austria as early as June 1st. They also have launches planned in Netherlands, Switzerland, Sweden, Norway and Finland by end of the year.

Speaker 3

While we reiterate that a U. S. Launch of VASIO represents the primary commercial opportunity for Akebia and the potential to target an approximately $1,000,000,000 U. S. Market.

Speaker 3

We're also pleased that patients through Europe will soon have access to the product. Now let me pass it to John to cover additional opportunities and next steps.

Speaker 2

Thanks Nick. Nick covered prescriber demand and the contracting progress. The 3rd strategic imperative is to continue to collaborate on clinical studies to fill gaps in our data, potentially to expand our label and separately to allow large dialysis providers to gain experience utilizing VASIO in their own patients. We're in discussions with key investigators and dialysis providers on a collaborative study that we believe will generate significant data. We hope that these data will lead to valuable publications to support further physician education as well as provide doctors with increased comfort in utilizing VASIO, potentially enabling continued growth and utilization even after TDAPA concludes.

Speaker 2

Again, we believe the VASIO label supports wide spread adoption in dialysis patients. Our team has been working diligently to prepare the groundwork for potential VASIO label expansion to permit for more flexible utilization of the product in both new to dialysis patients and in alternative dosing regimens. As I mentioned earlier, we also believe VAPZIO could benefit CKD patients who are not on dialysis and we plan to explore label expansion to those patients as well. This is the most significant potential value driver for Akebia after the launch in dialysis. Now I'll switch gears to our financial results.

Speaker 2

But before I review the financials, I'll mention that we have an active search for CFO that's going well. I'd like to thank our finance team and our Chief Accounting Officer, Richard Malabray for the effort and attention they've put in since our year end close to ensure the quarter close process was seamless while I serve as Principal Financial Officer. As we've previously reported, I can reiterate that we are well financed to execute on our VAP SEAL launch. We also previously strengthened our balance sheet with proceeds from our at the market or ATM sales agreement. Our cash and cash equivalents as of March 31, 2024 were approximately $42,000,000 In addition, in Q2, we drew down the additional $8,000,000 available to us upon approval of VASIO under the BlackRock debt facility.

Speaker 2

We expect that our cash on hand as well as revenue generated by Auryxia and now VASIO starting in January will fund planned operations for at least 2 years. We've kept tight control of our spending in the Q1 and are managing the business for stable year over year spending in 2024. The team is demonstrating good financial discipline while investing appropriately for a successful launch. You'll notice we also announced that we amended our working capital agreement with Vifor to simplify the payback as a royalty. This does not fundamentally change the timing of the payback of that cash, but it greatly simplifies the operational aspects of managing our supply chain.

Speaker 2

Total revenues were $32,600,000 for the Q1 of 2024 compared to $40,000,000 for the Q1 of 2023. Net product revenues were $31,000,000 for the Q1 of 2024 compared to $34,700,000 for the Q1 of 2023. The decrease versus last year is largely a volume decrease as a result of our contracting strategy as we exited the final large Part D payer contract. We remain confident that we can achieve net product revenue growth in 2024 versus 2023. We believe our Auryxia outreach is actually enhanced by the VAPTIO launch as prescribers are eager to discuss a new product.

Speaker 2

And recall that there's a 96% overlap between Auryxia and VAPSIO target prescribers. Also, CMS has released guidance on incorporating phosphate binders into the dialysis bundle. Dialysis organizations are now contracting with an eye towards the binders going into the bundle in 2025 as Nick mentioned. One other note on Auryxia. In April, Akebia's licensee, Avarola submitted a marketing authorization application to the European Medicines Agency for ferric citrate coordination complex.

Speaker 2

And if approved, AVERO will make the product available to patients throughout the EU. I want to congratulate AVERO on the submission and will be available to support launch efforts in the coming years. Cost of goods sold were $11,600,000 for the Q1 of 2024 compared to $20,200,000 for the Q1 of 2023. Akebia continues to carry a non cash intangible amortization charge of $9,000,000 per quarter through the Q4 of this year. Research and development expenses were $9,700,000 for the Q1 of 2024 compared to $19,700,000 for the Q1 of 2023.

Speaker 2

Now we will continue to progress a number of new programs in 2024, including the collaborative study I mentioned earlier, as well as preclinical development of HIF based molecules in our pipeline, but we do not expect a step up over 23 expenses. SG and A expenses were $25,400,000 for the Q1 of 2024 compared to $25,100,000 for the Q1 of 2023. Again, we're tightly controlling spend and do not expect a significant uptick as we launch VASIO. Net loss was $18,000,000 for the Q1 of 2024 compared to a net loss of $26,900,000 for the Q1 of 2023. Before opening the line for questions, I know that Ali Bratzel from Piper could not make the call this morning, but she sent Mercedes a couple of questions and maybe we can start with those.

Speaker 2

Mercedes?

Speaker 1

Sure. Thanks, John. The first question, please walk us through the Vifor license agreement and amendment and how we should think about modeling the impact?

Speaker 2

Sure. So just to remind everyone, back in 2022 as part of an amendment to the Vifor agreement, Vifor provided $40,000,000 of working capital or working capital fund to finance the product purchases for VAPSIO in advance of launch. And in the agreement, we had basically a payback that would go on over time where ultimately the $40,000,000 would be returned to them. It was a very complicated as POs are approved, more money is added or money is refunded. And POs have to be agreed upon and it really complicated the management of our supply chain.

Speaker 2

But it was wonderful to have that $40,000,000 in cash to help finance the purchases of our product. So we really wanted to look to simplify that arrangement. So previously, the way we would model it out is that $40,000,000 would be a hit to our cost of goods over time. And as I said, that would decrease over the life of the product, ultimately being paid back fully. So we really tried to model that as closely as we could in a royalty relationship.

Speaker 2

So basically, there will be no payments, no royalty payments till July 1 next year. And then it's an 8% royalty for the first or for under $100,000,000 in revenue and the dollars over $100,000,000 is a 14% revenue over time. And then there's 3 makeup periods at the end of 2026, 2027 and 2028. That's $10,000,000 if they haven't received that in royalty, dollars 20,000,000 and then $40,000,000 at the end of 20 18. So that will come in, now would be in your models as a royalty obligation.

Speaker 2

And again, as I said, it really is somewhat quite close to the way we expected that money to be paid back over time previously.

Speaker 1

Thank you. Next, you've indicated cash and cash resources to fund operations for at least 2 years. What are the underlying assumptions to that projection?

Speaker 2

Yes. So it's very simple actually. We have we finished our ATM back in the Q1, then we drew the $8,000,000 on the BlackRock note and that's kind of current cash. And we think about current cash plus sales of Auryxia and VAPSIO and that again will last us at least 24 months. As we think about Auryxia, we recognize that there is LOE in March of next year, but with the phosphate binders going into the bundle, we do think there's an opportunity for the product to not have the kind of patent cliff you usually describe to a small molecule.

Speaker 2

But I think we've been appropriately cautious in our cash planning around the way that the revenues will progress for Auryxia. We think that there's real opportunity for the product, but we wanted to be cautious as we planned. And then on the VASIO launch, obviously, we're looking at sales starting in the Q1 of next year. And during that PDAPA period, we've talked about the opportunity for rapid adoption. Again, I think even if we are more conservative in our launch projections, we're very comfortable with the cash projection of at least 24 months of cash runway.

Speaker 2

Of course, if that launch goes even better, that's even that's an even longer runway. Okay. So now Andrew, maybe we can open the line for questions.

Operator

Absolutely. And our first question comes from the line of Ed Arce with H. C. Wainwright.

Speaker 4

Hello, can you hear me?

Speaker 2

Yes, we can. Hey, Ed.

Speaker 4

Great. Hi, John, Nick, congrats on the approval once again. And it looks like you're really gearing up for preparations starting for sales in January. A few questions for me. First, on the pricing.

Speaker 4

You mentioned that the WACC would be disclosed next month and that, of course, given the value offered here that this would be priced at a premium. I'm wondering if you could go into a little bit more detail around some of the criteria that you've evaluated or are evaluating as you come to a final determination on the pricing. In particular, the consideration of when the product comes off the TDAPA designation. That's 1. 2 is the collaborative study.

Speaker 4

I was wondering if you could give a little more detail as to what the objectives are there and timelines to the extent that you could share that? And then finally, third question is around Avero in the EU. I'm hoping you could provide us the economics of that partnership there and also when the loss of exclusivity would be under that agreement? Thanks so much.

Speaker 2

Great. So we'll start with pricing and I'll ask Nick to give some color on the work that we're doing. We've talked about announcing WACC pricing next month and it's really important to kind of the difference between WACC pricing and what our net pricing in the market will be. And again, I'll ask Nick to spend a little bit of time on it. But WACC pricing kind of really gives you the starting point for pricing and that TDAPR reimbursement.

Speaker 2

But all of these sales will be contracted sales. And as we said on the earnings call sorry, on the approval call, while not guiding on price because this really will be contract dependent, when I look at your model and the other analysts covering the company, the range of net pricing is certainly within reasonable expectations of where that will land. And all of you kind of bring net pricing down post TDAPA and that's exactly what will happen. We expect that it will become get closer to ESA pricing. But as we think about WACC, we also really have to think about the MDD population.

Speaker 2

And with the IRA, you're only allowed to price once and you have to think about the entire lifecycle of the product. And as I mentioned, there are patient populations that we're considering, but we're still drilling down if you will on kind of what patient population to go and talk to the FDA about and that affects the size of the population and therefore and the value we'll bring and will be part of pricing. But then understanding the economics and dialysis is part of it as well. So Nick maybe talk a little bit about that? Yes.

Speaker 3

No, it's a great question, Ed, and I could go on for weeks on pricing. But if I just think about the major components is first, what's the value of the product, right? Really simply, we believe this is an innovative product. We have physician support of that through our market research where just about 90% of folks believe the hip class is an advanced or major advance versus existing ESA therapy. And so their perceived value as well as what I'll call the real valuable to tangible value we see in the label and with the product.

Speaker 3

As you noted in my script, 30% of patients are missing target range on their hemoglobin. And that's despite decades of uses with ESAs. The second piece around value I think about is the frequency of overshoots and undershoots, how hard it is for dialysis organizations and physicians to manage hemoglobin within a relatively tight range. All that value goes into the product and the value of the price. 2nd, I think about differentiation versus the existing if in the marketplace today.

Speaker 3

We spent a lot of time talking about their label and the risk it poses for

Speaker 4

people with

Speaker 3

a history of heart failure. 40% of that population has a history of heart failure. And therefore differentiation versus the other hip is high. John mentioned the future value of NDD that's in our thinking as well or non dialysis. But then again, when we think about TDAPA and why it was set up, it was set up to support innovative products and support the utilization of those innovative products outside of the bundled rate.

Speaker 3

And therefore, making sure that the economic support that usage within the dialysis organizations is critically important. Our conversations with dialysis organizations, they understand the innovative value. They also understand the economic incentives associated with it as well. And we've been in good conversations driving towards conclusion here in the late summer, early fall.

Speaker 2

Thanks, Nick. So your second question was on the collaborative study. Now this is definitely still in process, but this is kind of outlined in the script. I mean, we're there are always data gaps. The way I like to think about it is, it took 20 years for dialysis providers, physicians to understand how to use ESAs effectively in dialysis.

Speaker 2

So there's always a need to generate new data. I look at the TDAPA products that have been introduced And one of the places I think that they've missed the mark is that they haven't continued to support the product to generate new data. And we think beyond TDAPA and think about long term adoption. Price may have to come down post TDAPA. That's the reality of the market, but the market will continue to grow and we'll continue to want to penetrate further.

Speaker 2

And as we said, we have a desire to be an oral standard of care. To do that, you have to continue to generate data. So I'll refrain from giving specifics around endpoints, etcetera, in the study. But basically what you want to do is demonstrate that these are things outcomes that are significant advantages for patients, but also provide either cost savings or benefit to the dialysis providers as well. Beyond that, I mean, it's also an opportunity for a lot of physicians to have an opportunity to use the drug in their dialysis clinics.

Speaker 2

And that kind of for dialysis providers to see the drug in their patient populations. I referenced that and I've had the opportunity to speak to a number of investigators in other studies. And when they've used the drug, they've seen the benefit, they've seen how easy it is for them to use, fewer dose titrations, etcetera. And any bigger study gives more physicians the opportunity to see the benefits of using the product while generating really important data that we can publish and can help grow the product through its lifecycle. So stay tuned.

Speaker 2

I think we're quite close to being able to talk more about that study, but it's one we're quite excited about. And then the third question was on AVEROA and Auryxia in Europe. This was very much an opportunistic deal. We really had concerns about pricing in Europe and the ability to make a business. AVERO has approached it in a really creative strategic manner, have worked very, very hard on introducing or getting the product to MAA.

Speaker 2

The agreement calls for mid single digit to low double digit royalties and the expectation for AbiRoa, which we don't know how likely this will be, but they do hope to get regulatory exclusivity because of the way they're approaching the indication and that would yield them, I think it's in Europe 12 years of exclusivity on market exclusivity. But that's not a sure thing yet. But the way this contract was structured was very opportunistic for us and we're really quite happy with the progress our partners made.

Speaker 4

Fantastic. That's helpful. Thank you.

Speaker 2

Thanks, Ed.

Operator

Thank you. One moment please for our next question. And our next question comes from the line of Julian Harrison with BTIG.

Speaker 5

Hi, good morning. Congrats on the progress and thank you for taking my questions. First, can you remind us of the segments of the dialysis dependent CKD market where you expect VAPTIO to have the strongest use case? And with Auryxia now entering the bundle in 2025, I'm wondering if you could talk more about how maybe your long term outlook for Auryxia revenue has changed?

Speaker 2

Julian, thanks so much for the question. So I'm going to ask Nick to talk about segmentation. Of course, as I said, our positioning is that this product is appropriate and labeled for any patient who's been on dialysis at least 3 months. But clearly, whenever we introduce a new product, there are areas where physicians will want to use the product first and maybe you can outline that.

Speaker 3

Yes. And then just to reiterate, in talking to dialysis organizations as well as physicians, they don't pigeonhole it to any particular modality of dialysis that whether that be in center or home, though many, their first inclination is home patients make sense. You don't have to bring them into the facility for additional, injections. They think they'll be well managed in the home. Many patients who are at home, who unfortunately may have to stick themselves with a needle would enjoy the ease of use as well as the less pain associated with an oral dosing.

Speaker 3

And so that's a real advantage in a real population that we think will be one of the faster growing in the initial launch. The second And the size of that? That's about 80,000 patients and so sizable. The second patient population is the high dose ESA patients. Those are folks that are not well controlled on an ESA.

Speaker 3

They're requiring higher and higher doses. We heard from several dialysis organization that it represents roughly 15% to 30% of their total population and one dialysis organization went as far as said 20 percent of our patients on high dose represent 50% of our ESA cost. So not only do you see a benefit in driving down high doses of ESAs that have been linked to mortality rates, you see the opportunity for economic advantages within the dialysis organizations around spending as we don't see the same dose response needs with Vazio. And so those 2 very quickly go to mind. But others have also suggested that they would love to take all of the ESA management out of the dialysis organization.

Speaker 3

And so I do believe it will be a stepwise fashion about anchoring back to what John said is the broad use in dialysis patients and becoming the next standard of care, which requires us to be able to address all patient needs.

Speaker 2

And that's one of the reasons for the desire to continue to generate more clinical And as we said, we plan on talking to the FDA ultimately about adding the 3 times weekly dosing to the label. So we've heard with the FOCUS data that was presented last year that many dialysis providers will make that choice on their own. I am encouraged to hear about the folks who really just want to take anemia management out of the dialysis center completely and the once a day oral nature of product makes a lot of sense. Again, I'll ask for Nick's comments on Auryxia revenue and maybe on more specifics around the binders and the bundle. I'll have to say, Julian, I mean that was has been our expectation.

Speaker 2

This is where we're going to land. I know and there's still the potential for legislation to delay that. But given that CMS has now put out guidance, I think it's less and less likely that there's going to be any delay and we've been readying ourselves for this for some time.

Speaker 3

Yes. When I think about boundaries in the bundle, it is one where the TDAPA profile around creating incentives around innovative products also applies to branded products that are existing in the marketplace as they go into the bundled environment. When I think about that, I imagine dialysis organizations in our conversations, they're going to want to put further controls around their formularies, around that and therefore making sure we're out there engaging with them around the value of Auryxia is extremely important. Auryxia is a very, very good binder in the eyes of the physician and they really want to use it moving forward. I believe it will allow us to contract for predictability around volume in the face of potential generic competition.

Speaker 3

We haven't necessarily built that into our cash flow models as we've talked about it. But if you can imagine folks having Auryxia on formulary with open access, certainly in the Medicare fee for service patients will be that first population that we'll see usage in. But on open formulary position with Auryxia compared to where we are today will be an enhancement to physicians access to the product. And all that underpins how we think about the opportunity binders going into the bundle may present for Auryxia.

Speaker 5

Very helpful. Thank you very much.

Operator

Thank you. Now I'm showing no further questions. So with that, I'll hand the call back over to CEO, John Butler for any closing remarks.

Speaker 2

Thanks, Andrew. And I just want to make one correction. I referenced 12 years of exclusivity and my crack team already got back to me and said it's 10 years exclusivity in Europe. So thank you. Thanks for that.

Speaker 2

But a very nice opportunity for our partner and for Akebia. So I do want to thank everyone for joining us this morning. Our organization is excited, focused and executing on the opportunities ahead of us. Since our last earnings report, we've received approval for VAPZIO. We're engaging thousands of potential prescribers.

Speaker 2

We've had contracting discussions for both of our products with almost all significant dialysis providers. We'll submit our application for TDAPA reimbursement in June. We're finalizing plans for a significant collaborative research study with Vassia. We've simplified our working capital fund repayment with Vifor CSL. We're preparing to engage FDA on a path for the new dialysis and the pre dialysis patient populations.

Speaker 2

We're supporting one partner for a launch of VAPCEA in Europe this quarter and a second on a potential launch of Auryxia in Europe next year. And we're doing all of this from a position of financial strength. I look forward to continuing to update you on our progress.

Speaker 5

Have a great day.

Operator

Ladies and gentlemen, thank you for participating. This does conclude today's program and you may now disconnect.

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Earnings Conference Call
Akebia Therapeutics Q1 2024
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