Akebia Therapeutics at Jefferies Conference: Strategic Growth Insights

On Thursday, 05 June 2025, Akebia Therapeutics (NASDAQ:AKBA) presented at the Jefferies Global Healthcare Conference 2025, highlighting strategic moves in the anemia treatment market. The company reported a robust launch of its new therapy, Vafzio, and shared insights into its financial health and future plans. While facing challenges from generic competition, Akebia remains optimistic about its market position and growth prospects.

Key Takeaways

• Vafzio’s successful launch with strong prescriber engagement and positive payer mix.
• Auryxia maintains sales despite generic competition, supported by contracted access.
• Akebia ended Q1 with $113 million in cash, financing its path to profitability.
• Plans for a Phase 3 trial for Vafzio in non-dialysis dependent patients.
• Focus on data generation and market expansion post-TDAPA for Vafzio.

Financial Results

• Vafzio:

- Launched with 640 physicians prescribing, averaging over 12 prescriptions each in Q1.

- Positive payer mix with 40% coverage from fee-for-service Medicare and up to 20% from Medicare Advantage Plans.

• Auryxia:

- Achieved Q1 revenues of $44 million, consistent with Q4, showing year-over-year growth.

• Cash Position:

- Concluded Q1 with $113 million in cash, ensuring funding through profitability.

• Pricing:

- Vafzio’s price post-TDAPA is expected to be approximately $2,500 per year.

• Market Opportunity:

- Dialysis-dependent segment valued at about $1 billion in the U.S.

- Non-dialysis dependent segment presents a multi-billion dollar opportunity.

Operational Updates

• Vafzio:

- Broad prescribing across various patient types, with 12% of prescriptions for home patients.

- Collaboration with MDOs, IDOs, and STOs, with a pilot program anticipated in the second half of the year.

• VOICE Study:

- Aims to demonstrate a 10% reduction in hospitalization and mortality, with 75% of 2,200 patients enrolled.

• NDD Program:

- Plans to meet with the FDA and initiate a Phase 3 trial in the second half of the year.

• Pipeline:

- Advancing AKI program into Phase 1 and developing HIF-based technology for ROP.

Future Outlook

• Vafzio:

- Emphasis on pricing, data generation, and expanded access post-TDAPA.

• NDD:

- Addressing significant unmet needs with a robust data package for potential labeling expansion.

• Auryxia:

- Conservative modeling in light of generic competition, with potential upside from delayed generic entry.

• Pipeline:

- Early-stage programs in AKI and ROP poised for development.

• Financials:

- Well-positioned financially, with operational expenses covering the Phase 3 NDD trial.

Q&A Highlights

• The success of Vafzio’s launch attributed to strategic access, pricing, and a differentiated clinical profile.
• Vafzio’s gentle rise in hemoglobin noted as a key differentiator from competitors.
• Management anticipates typical generic erosion once a second generic enters the Auryxia market.

Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - Jefferies Global Healthcare Conference 2025:

Roger Song, Senior Analyst, Jefferies: Welcome to Jefferies twenty twenty five global healthcare conference. My name is Roger Song, one of the senior analysts cover Simica Biotech in The US. It’s my pleasure to have the fireside chat with our first of the day company, Akebia Therapeutics. We have our CFO, CBO, Eric, and then Chief Commercial Officer, Nick here with us. Welcome gentlemen.

Great. Thanks, Roger. Awesome. All right. Let’s just kick this off and then we know VavCO just had a great first quarter, full quarter launch and then maybe just give us some tidbits and highlights for the first quarter sales, any surprise to you, how you get the traction and then we get the conversation going?

Nick, Chief Commercial Officer, Akebia Therapeutics: Yes, we are very pleased with the launch of Vafsio and how it’s going into the first quarter. We measure ourselves on a couple of different measures. First, we look for prescriber depth and we look for prescriber reach. In that reach category is how many physicians are prescribing. And in Q1, in the first quarter, we had six forty physicians prescribing the product, which is very, very broad reach.

Most of those physicians were S. Renal Care, but we have seen prescribing at other IDOs and STOs, the small and the medium sized dialysis organizations. The second is depth. Typically, you go through a launch, people go through stages of trial to adoption.

We had over 12 prescriptions per physician in the first quarter, which is very, very high for our launch. The surprising thing, if anything about that is, we’ve always talked about patient populations for which we thought the product was going to be used, whether it be the high dose ESA patient, whether it be the home patient, those are the profiles that we most heard that physicians wanted to use the product in. But in the first quarter, we saw broad prescribing across all different patient types, which means physicians are seeing the value not only for those initial patients, but beyond the patients they had originally identified to use the product in. So if that’s the only surprise we have throughout the whole launch, that would be great.

Roger Song, Senior Analyst, Jefferies: Excellent. Great. Thanks for that. Exciting to see this very successful launch. It’s not easy to do this in the renal business for the particularly for the dialysis dependent patient.

So, drill down a little bit, you mentioned the breadth and the depths of the user, which is very pleased to see. Maybe I know it’s early, but you don’t have the steady state of numbers, but if you can throw us some number in terms of the breakdown between this high ESA home use versus others and then also in terms of the payer mix, I know your initial focus is fee for service, but also seems you are getting some traction in the Medicare Advantage as well.

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah, we don’t quite have all of the data yet at this time to say which patients are high dose versus other versus home. We do know that we see the home patients at about twelve percent of our prescriptions are home patients, which is in line with the percentage of the population, which are home patients within the dialysis community. When we look at the payer mix, we’re actually very encouraged. What we originally thought was we would be most available to fee for service Medicare patients. That’s about forty percent of the population.

When you think of see the prescribing and the plans that are covering today, we have seen coverage with Medicare Advantage Plans. That represents another forty percent of the patient population. They’re a little slower to come on. It requires a negotiation between the dialysis organization and the Medicare Advantage Plan. But in the first quarter, we saw an additional up to twenty percent coverage of patients through those Medicare Advantage Plans.

So very encouraged to see that so early on in the launch.

Roger Song, Senior Analyst, Jefferies: Wow, that speaks to the profile of last year and then the demand and unmet need in this population. Okay. And how about the DO, the size? I know you are trying to get those larger one, but also you start with some small, mid one.

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah, and so today we’re working with the MDOs, IDOs and STOs, in other words, the small and the medium dialysis organizations. A vast majority of prescriptions in Q1 with U. S. Renal Care. That being said, we have been working with the large dialysis organizations.

For example, one large dialysis organization is doing going to do a pilot in the second half of the year and the third quarter. What they mean by a pilot is it could be between 5,200 clinics. Now to put that into perspective, 200 clinics would make them the fifth largest dialysis organization in The U. S. So just the pilot alone has significant breadth to it.

In that pilot, they usually train their physicians, and it’s an operational pilot. They’re not trying to prove safety or efficacy. What they’re trying to do is really make sure a physician can order it, and it goes through their electronic medical record. They get reimbursed for it. The patient gets that prescription in the home or in clinic, and then they’re allowed to get refills.

So those are typically shorter pilots. An operational pilot is typically two to three months long. And this large dialysis organization is indicated after that. They’ll make it available broadly to their physician base. With the other large dialysis organization, they’re a little bit further behind.

We’re working together to work through the protocol process with them. But we expect that’ll end in a good place, but later on likely into 2026.

Roger Song, Senior Analyst, Jefferies: Yeah. It makes sense for those large deal to do some kind of pilot operation because it’s just too big to roll out right away across all the other clinics. I mean, then you mentioned this 50 to 200, that’s not considered as small anymore, right? So it’s not real pilot pilot. That’s right.

Right? Okay. Got it. So initial launch is very encouraging, right? So obviously you have for the dynamic is you have a two year TDAPA outside of the bundle and then later on.

But let’s just focus on the initial kind of TDAPA period. So how you think about the next stage of the growth look like and then how you think about ramp up going to look like.

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah, and just to take a step back, TDAPA is transitional drug add on payment adjustment, which is a mechanism that CMS put in place to allow for innovative therapies to be created and launched into a space that has a bundled environment. And it allows for an additional payment or reimbursement outside of the bundled rates. In dialysis, dialysis organizations receive $274 per treatment for each patient that’s treated. This would sit outside of that bundle. They would still receive the $2.74 and then additionally they would get Vafsio reimbursement.

When we think about that two year period, the economics in there are certainly one that that help the DO cover the cost of innovation. After the TDAPA period, we spoke about this in in several places, we’re going to be lowering the price to to be approximately the ESA price, which is $2,500 a year on average. But remember, 2,500 a year times five hundred thousand patients who are anemic is a billion dollar marketplace. And so post TDAPA, we’re going to be being competitive on price. The second thing, which is actually more important is the clinical profile of the product.

As we continue to invest in studies to create data to support the product, we’ll hopefully see decreased hospitalization mortality through the voice trial. And so that’s the second piece. The third piece is expanding the pie with access to only Medicare fee for service and some Medicare advantage. Post TDAPA, all patients have access. So the pie gets bigger, the data gets bigger, and hopefully the market share continues to grow.

Roger Song, Senior Analyst, Jefferies: Got it. Yep. All right. Good. And then maybe just remind us in terms of the DO, the breakdown between the small, mid, large and then I think you said that, right now it’s mostly coming from the relatively mid to large and small mid, a little bit large, but what’s the next two years and then the trajectory look like?

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah, so great question. So we really, this small to medium size, we use the word small to medium size. It’s 150,000 patients. So it’s significant. So today we have plenty of room to grow in the second quarter and beyond with just the small to medium sized dialysis organizations.

But as we approach the second half of the year, the large dialysis organization is kicking off the pie, it becomes another catalyst to grow. We have to remember is the current physician base of those writers that we have today, 50% of them also write in the large dialysis organizations. So their experience should allow us faster penetration than you might normally see in that LDO who’s running the pilot and beyond. And then the other LDO, 26 we’ll see where that ends up. But beyond TDAPA, we talked about pricing, data generation and having access to the full population.

Roger Song, Senior Analyst, Jefferies: Yep. Yep. That’s great. So, I think in the next two years, the pricing is not the issue because it outside the bundle and then you just keep this momentum going, right, based on the profile operation and then people get, if they start to use and they like it and then they’re going to keep the patient on treatment because CKD patient is chronic disease and if you like the experience, that’s good, you have the initial kind of the experience to get there. And then after the Tadapa, post Tadapa period, so the key thing is pricing and then also expand this whole pie and then hopefully you can keep the market share and even grow from there.

Nick, Chief Commercial Officer, Akebia Therapeutics: Well, the other important part frankly is NDD. I mean, when you think about the non dialysis patient population to really become standard of care, there’s a significant unmet medical need in the non dialysis population. Now I’m out with physicians often with our sales representatives. Not only are they excited about dialysis, but every single one of them says when can we use it in non dialysis patients or that pre dialysis patient population. And so when we think about that, it also aligns with what we’ve heard from the FDA, where there’s a significant unmet medical need in non dialysis for an oral therapy.

And if you look at the landscape of products that are being developed, we’re the only oral therapy being developed for that patient population. And so super excited for growth drivers on NDD. I don’t know Eric, if you have anything?

Eric, CFO/CBO, Akebia Therapeutics: Yeah, and I’d just add from a market opportunity perspective, the NDD opportunity is very significant. So Nick had mentioned earlier that within the dialysis dependent segment, it’s about a billion dollar opportunity in The U. S. You know, there’s approximately 500,000 patients, and that billion dollars is derived from the current standard of care cost, you know, that Nick mentioned. But when we look to NDD from a patient population standpoint in The U.

S, again, it’s about 500,000 patients. But this is outside of the bundle payment scheme. So you’d be looking at your more typical mix of commercial and Part D pricing where the pricing you’d expect would be, you know, a multiple of what we see in dialysis dependent. And so, you know, therefore NDD is a multi billion dollar market opportunity. Yep.

Roger Song, Senior Analyst, Jefferies: That’s right. So we will ask a couple more question about MDD in a moment. And then for the and you mentioned the and Nick, mentioned the voice trial and then maybe just remind us the status of that and then how based on your market research or the device from your investigator and then how does TIW going to change the patent prescribing pattern and then how this will drive the market share?

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah, so I’ll start and then I’ll turn it over to Eric is when we think about the VOICE study, it’s designed to demonstrate a ten percent reduction in hospitalization and mortality. That’s massive importance. If we’re able to achieve that, if you think about hospitalization, the average dialysis patient is hospitalized just about two times a year. The average cost of each hospitalization is $60,000 And often times, the dialysis organizations are on the hook for some part of that. And so showing a ten percent reduction in hospitalization is so meaningful from an economic perspective.

Second, it keeps the patient in the chair. So they receive the $274 if they’re sitting in the chair. If they’re in the hospital, they don’t receive that bundled payment. And lastly, patients being in the hospital is bad for patients. Keeping patients out of the hospital is the primary goal for it.

The second part of your question was TIW. Frankly, we’re already seeing TIW today in some clinics. We have a paper that we’ve published that we did a study in alternative dosing forms. One of them being TIW. And so that study is available for physicians.

We make it available as part of their protocol development process when we share all of our data with them. And so some folks have decided to move in that direction already. So the voice study being TIW, I think adds to that data package. Package. But frankly, think we’ll see people deciding to move there on their own with the existing body of evidence that we have for TIW.

Roger Song, Senior Analyst, Jefferies: Got it.

Eric, CFO/CBO, Akebia Therapeutics: Yeah, yeah. And I just add, when we think about long term adoption of and making it the standard of care in anemia management, we believe that generating incremental data that show the benefits, whether they be economic or clinical, is very helpful to that end. So the VOICE trial, it’s collaborative trial with US Renal Care. Doctor. Block is doing an incredible job from an enrollment perspective.

We announced on our Q1 call that we were seventy five percent through enrollment of 2,200 patients. We’ve made progress since then. So we look forward to completing enrollment soon this year.

Roger Song, Senior Analyst, Jefferies: Excellent. Maybe just add a little bit the granularity here. In terms of the dose, the average dose use for patient for the DD CKD because now your voice is every, you know, three times a week versus right now it’s every day. But I think, you know, based on the discussion we had before is, you know, the neutral, the pricing, the per patient cost is neutral impact. So tell us a little bit more about why.

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah. And so typically when a patient receives the product in the home, they have issues like compliance, do they take their medicines. Unfortunately, dialysis patients have a significant pill burden, and so we can expect somewhere in that kind of 60 to 70 percent compliance rate adjusting for that, because compliance if taken in center, TIW is typically better. Adjusting for compliance rate, you see just about equal dosing between those two patient populations net net.

Roger Song, Senior Analyst, Jefferies: Yeah, got it. Okay, great. All right. And then coming back to the NDD population, that’s absolutely in a multi billion, you know, multiple compared to the DD population. So, you, I think you’re having some discussion with the FDA, maybe the first question is any change with the new FDA kind of the new dynamic there and then tell us a little bit more about the recent interaction and also where you are to start the Phase three, I believe it’s by the end of the year?

Eric, CFO/CBO, Akebia Therapeutics: Yes. So, yes, as you mentioned, we’re engaging with FDA. We plan to meet with them later this year and plan to initiate this phase three trial in the second half of this year. And this would be a US based trial. So yeah, we’ll provide updates as those engagements continue.

Roger Song, Senior Analyst, Jefferies: Is the primary endpoint that design and what’s the current thinking versus the anything you get the preliminary feedback from the FDA?

Eric, CFO/CBO, Akebia Therapeutics: Yeah. So we’re looking at this as a cardiovascular outcomes trial, looking at from a patient perspective about fifteen hundred patients compared to the standard of care.

Roger Song, Senior Analyst, Jefferies: Okay, got it. Okay. And then you had that trial before in the NDD population and then seems to have the more benefit in The U. S. Population.

That’s why you want to focus for your Phase three for this time. And then any other evidence to suggest why this is could be the successful Phase three?

Nick, Chief Commercial Officer, Akebia Therapeutics: Yes, it’s a really important question because we think we’re going to be going to the FDA with a really compelling data package. Remember, we’ve had almost one hundred thousand patients non dialysis taking the therapy in Japan. That data will be part of the submission. We had the PROTECT trial, which you referenced. We just had a publication in Jason, which is a Journal of American Society of Nephrology, that demonstrated that in The U.

S. Cohort of the PROTECT trial, there was no difference in safety or efficacy versus the standard of care. We’ll have more than two years of dialysis use and the safety profile there, and then we’ll have this study. And so that data package is very, very robust when we go to the FDA. And not that anything tells us what the FDA is going to do, but we believe it gives us a decent shot at approval.

Roger Song, Senior Analyst, Jefferies: Basically this the new label label expansion for the NDD will combine the whole package as you just mentioned and then you think this is a robust package for the potential labeling expansion.

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah. I mean the FDA was very clear. There’s a high unmet medical need in that population for an oral therapy. And so they’re looking, we believe, to work with us to approve a product. Remember, in that population, only twenty eight percent of patients with anemia are getting the therapy.

And there’s a lot of data out there that talks to that if a patient moves from non dialysis onto dialysis, and they are anemic, they have worse outcomes. And so there is a desire to treat this patient population by physicians, certainly by us, and we believe the FDA recognizes the unmet medical need.

Roger Song, Senior Analyst, Jefferies: Got it. Okay, great. One question when I, you know, do the diligence about AKBLA is very interesting. We look at look through as well we do competitive landscape. So since you are the only one at least for the novel mechanism and then novel therapy and then HIF inhibitor.

So maybe first of all, so why you are the only one right now is launching The US, I believe we have passed, we have maybe successful phase three, but didn’t get approval and then they even get approval, but they withdrew. So tell us about what’s special about this market and why you are the only one in town to launch in this?

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah. It’s a really great question as As you know, obviously the prior launch was GSK. I never like to focus on perhaps what they did wrong. I love to focus on what we’re doing right. And so it starts with access.

We went out early and we created a pricing strategy that allowed us to get nearly 100% of patient service by a dialysis organization under contract. That’s a great step. As far as we know, that’s the only time within the TDAPA period that’s ever happened. So before launch, we had secured 100% of those contracts. Now you still have to go through the protocol process with those dialysis organizations, but it starts with contracting.

The second piece is is getting our team out there early with the TDAPA rules where you apply for TDAPA. And in our case, nine months later we receive TDAPA. We had nine months to create awareness and talk about the benefits of the product in the marketplace. So folks were ready to go or physicians are ready to prescribe early on. And then as we look at what we’ve done initially, we continue to grow the body of evidence.

You know, our label is a broad label. The clinical differences between Vasio and the GSK product are meaningful. They had a warning and precaution against using the product in patients with a history of heart failure. Forty percent of dialysis have a history of heart failure. We don’t have that warning and precaution in our labels.

There are differences. No two HIFs are created equal, and we believe our clinical profile is better suited for the marketplace.

Roger Song, Senior Analyst, Jefferies: Excellent. That’s great. It’s a good or bad, right? So, on one side, you don’t have a competition as the new therapy. On the other side, the people are with, know, put it for the investor side, you know, we don’t have validation for this market, how likely you’re gonna add the normal mechanism, novel therapy gonna capture in this market because it’s well established in the market.

So that’s a Okay. That’s dynamic we understood. Maybe just take a step back on the molecular level, you say something the label is differentiated or advantage compared to GSK and then what drove that for Vavsio to get that type of label and then you think the molecular is better than the other inhibitor?

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah. And you’re asking the commercial, have very scientific question, right? And so, but we can

Roger Song, Senior Analyst, Jefferies: There’s no other distinction.

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah, there are no the HIFs aren’t created equal. Our molecule is very different from whether it be GSK’s molecule or even roxadustat that was the product that didn’t get approved. We’ve seen that where our product has a more gentle rise in hemoglobin than those other products done, probably due to the characteristics of the model. Am I going to be able to tell you what those characteristics are? Probably not.

Roger Song, Senior Analyst, Jefferies: Yeah, no. That’s a, you know, as you talk with physician, a lot of people they also don’t care about how, why it’s different, but at least you have some rationale. Okay, the label is the result and then I tell you a little bit about why the mechanism it can drive this result. I think the gentle rise of the hemoglobin is one of them, Okay, good. And then, so maybe just looking ahead, we try to and also look down the road what the other things potentially can emerge in.

So in your knowledge and then what’s in the pipeline for this population both DD and NDD and anything really you will keep eye on this.

Eric, CFO/CBO, Akebia Therapeutics: Is this with respect to Vafsio that can landscape? Yes.

Roger Song, Senior Analyst, Jefferies: Vafsio competitor for DD and NDD CKD and anything in the pipeline emerging?

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah, we don’t see anything out there in a competitive landscape standpoint in terms of a competitor early for whether it’s dialysis or non dialysis. Obviously the market is currently a majority of ESAs or erythropoietin stimulating agents. We don’t see anything beyond what the current therapies are. Okay,

Roger Song, Senior Analyst, Jefferies: got it. And then the advantage you compare to the ESA and then other current standard of care is really the product profile try to be a more gentle rise and then the benefit of the label.

Nick, Chief Commercial Officer, Akebia Therapeutics: Well, it’s really the mechanism of action. When we think about a HIF PHI, what you’re really doing is trying to help the body’s normal physiological process start to work again. Whereas with an ESA, you’re really putting in synthetic ESA or ethropotent into the system. You’re not helping the body do what it’s meant to do. And so we believe that mechanism of action is one of the things that physicians are very interested in understanding versus an ESA.

So one of the compelling data points is mechanism of action.

Roger Song, Senior Analyst, Jefferies: Got it. Okay, great. Maybe we can move on to you have another product and then maybe some of that early pipeline. So for Aurexia, so you have a pretty strong 1Q sales, so it’s a bit better than our model. And then tell us what drove that and then also when the stand this generic is coming and then what should we expect in the coming quarter and then year?

Eric, CFO/CBO, Akebia Therapeutics: Yeah, you’re right. Ryxia did have a fairly strong Q1 about 44,000,000 in revenues, which was comparable with Q4. We typically see a drop off from Q4 to Q1 and it was actually up for the quarter on a year over year basis. As you recall, Auryxia lost IP exclusivity towards the March. There is an authorized generic.

However, there’s yet no incremental generic entry into the field thus far. Although, you know, we do expect that it will eventually happen. You know, in terms of that performance that you referenced, there was a move to put phosphate binders into the bundle this year at the beginning of twenty twenty five, which altered the distribution channels. We’re actually contracting directly with the DOs now versus with the distributors before. So I think those dynamics may have come into play in Q1 as well.

Don’t know, Nick, if you want to expound on that a

Nick, Chief Commercial Officer, Akebia Therapeutics: little bit. Yes. I mean, we do a little bit of a chest pound around having one hundred percent of dialysis patients contracted on Vasio. That’s also true for Auryxia. And so having broad use in Auryxia is one part of physicians like the profile of Auryxia clinically, but they also have access and reimbursement for a product broadly.

So they can actually write it broadly. You know, as we move forward with the AG, just to add to Eric’s comments, is we provide them a limited quantity of the product. It’s not enough product to utilize for the whole market. In other words, until a second generic comes on play, there’s always a significant value in the brand.

Roger Song, Senior Analyst, Jefferies: Okay. Yeah. Okay. So that’s interesting. So maybe how should and then my second part of the question is that how should we expect for Ruxia in the coming quarter?

And then because you say you eliminated the supply, would you be able to tell us what’s the quantification of that?

Eric, CFO/CBO, Akebia Therapeutics: Yeah, I mean I would say as you’re thinking about it in your modeling, I’ll tell you how we think about it. So we model fairly conservatively on Auryxia going forward. That said, the longer there is a delay in incremental generic competition, that’s upside for us from a cash perspective.

Nick, Chief Commercial Officer, Akebia Therapeutics: Yeah. And then when that second generic comes on, it’ll be your typical generic erosion curve. And so again, every day I check my email that nobody has been approved is the day that I do this wipe the sweat off my brow because Auryxia continues to add value for the company. Yes.

Roger Song, Senior Analyst, Jefferies: I think we model conservatively and then just that’s the upside case every day you don’t have another generic. AG seems to be limited supply in any way, right? You see limited and how should we think about the limitation? Yes, we

Nick, Chief Commercial Officer, Akebia Therapeutics: haven’t guided on that at all, know, and it varies from quarter to quarter.

Roger Song, Senior Analyst, Jefferies: Alright. Good. We have a couple more minutes. You have a couple early pipeline, which is absolutely not in anybody’s model or anybody’s radar, but seems a big market when I look at those mechanism and the market opportunity. So tell us a little bit more and then maybe we will talk more in the future.

Eric, CFO/CBO, Akebia Therapeutics: Yeah. No, thanks for bringing that up. And today is no different. We often find ourselves spending so much time on the near term opportunities in front of us that there is not as much time to talk about the pipeline. But that doesn’t mean that we’re, you know, not super excited about it.

We really think there’s a lot of promise beyond NDD, which we talked about already. And just to note, you know, a couple of those programs. One is an AKI, acute kidney injury. We are planning to advance that into the clinic this year, so in phase one. You know, it’s a large market opportunity.

You know, really excited as well about our program in ROP, retinopathy of prematurity. This is a rare disease, you know, as the name implies. This is outside renal, so this is an ocular disease. But it’s one in which we feel that our HIF based technology could be very well suited to address. And so there’s a lot of passion, you know, for that indication as well within the company.

Roger Song, Senior Analyst, Jefferies: Okay. Maybe tell us about the cash financial position and then you have top line revenue and then also you have a couple of things in the development. So how should we think about the cash runway and position?

Eric, CFO/CBO, Akebia Therapeutics: Yes. We feel really good about our financial position. So we ended Q1 with $113,000,000 in cash on the balance sheet. We’ve talked today about the revenue dynamics. So with Afzio off to a nice start.

We’ve talked about Auryxia as well. From an expense perspective, I think we’ve shown that we can manage expenses quite prudently when we talk about our cash runway guidance. So we are financed to profitability. We take into account this pipeline activity that we’ve talked about today. One

Nick, Chief Commercial Officer, Akebia Therapeutics: thing

Eric, CFO/CBO, Akebia Therapeutics: I would just add that from a financial perspective, I think benefited us with the launch is that we did not need to incur a sales force scale up ahead of the Vasio launch. So, the Auryxia sales force was in place. The call point overlap between Auryxia and Vasio is 90% plus. So, that was really a great benefit to us as well financially.

Roger Song, Senior Analyst, Jefferies: That’s And then clarify your OpEx, the new finance for profitability, but also you have a large Phase three MDD trial upcoming. So, is that also in the

Eric, CFO/CBO, Akebia Therapeutics: That is included in that guidance, yes.

Roger Song, Senior Analyst, Jefferies: Excellent, great. All right, I think our time’s up and then thank you for being with us with this early morning and then thank you everyone for listening.

Eric, CFO/CBO, Akebia Therapeutics: Great, thanks for us.

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