Akebia Therapeutics Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: The Q2 launch of vadadustat (Vasceo) generated over $13 million in sales—a 55% sequential increase—with prescribing access set to expand from 40,000 to 75,000 dialysis patients in Q3 and to 275,000 after DaVita’s Q4 pilot.
  • Positive Sentiment: The VOICE outcomes trial fully enrolled 2,100 patients in seven months, on track for late-2026 completion and early-2027 data, and the VOCAL study with an RBC substudy is underway to demonstrate clinical differentiation.
  • Positive Sentiment: Akebia plans to initiate the VALOR Phase III trial by year-end in non-dialysis CKD anemia patients, using an active ESA comparator per FDA feedback to pursue a potential market up to 4–5x larger than dialysis.
  • Positive Sentiment: Net product revenues rose to $60.5 million in Q2 2025 (up from $41.2 million YoY), driving a net income of $0.2 million versus a prior-year loss, and ending cash of $137.3 million supports continued R&D and launch efforts.
  • Neutral Sentiment: Auryxia sales reached $47.2 million this quarter—its highest level to date—benefiting from improved bundle reimbursement, though future performance may face uncertainty pending additional generic entrants.
AI Generated. May Contain Errors.
Earnings Conference Call
Akebia Therapeutics Q2 2025
00:00 / 00:00

There are 6 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the Akebia Second Quarter twenty twenty five Financial Results. At this time, all participants are in a listen only mode. After the speakers' presentation, we'll open up for questions. Please be advised that today's call is being recorded.

Operator

I would now like to hand the conference over to your speaker, Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.

Speaker 1

Thank you, and welcome to Akebia's Second Quarter twenty twenty five Financial Results and Business Update Conference Call. Please note that a press release was issued earlier today, Thursday, August 7, detailing our second quarter twenty twenty five financial results, and that release is available on the Investors section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer Nick Grund, Chief Commercial Officer and Eric Ostranski, Chief Financial and Chief Business 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 August 7, 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. With that, I'd like to introduce our CEO, John Butler.

Speaker 2

Thanks, Mercedes, and thanks to everyone for joining us this morning. Since Vaseo vadadustat's approval and even prior, I've spoken about our goal to make Vaseo a standard of care for patients with anemia due to chronic kidney disease. From my perspective, this endeavor has three parts. First, successfully launch Vaxio in dialysis during the TDAPA period. Second, continued growth in dialysis post TDAPA, potentially supported by the data, creating additional areas of differentiation.

Speaker 2

And third, approval and launch of Vaxio to treat anemia of CKD in patients who are not on dialysis. That's the journey we're on, and I'm proud to report the progress we've made in each area during the second quarter and to date in Q3. I continue to be incredibly pleased with the progress of our launch. We generated over $13,000,000 in vascular revenue in Q2, with approximately $12,000,000 in demand sales, a 55% increase over Q1. In Q2, US Renal Care continued to represent the vast majority of our revenue.

Speaker 2

We appreciate their foresight partnership and ongoing commitment to delivering innovative therapies to patients. But we have to broaden that access to achieve our goals. While we're pleased with the first two quarters of launch, we really only had access to about 40,000 dialysis patients during those months through USRC and other smaller dialysis organizations that operationalized the protocol to easily enable prescribing. In Q2, we had expected to have broader access at the other two midsized dialysis providers, DCI and IRC, the fourth and fifth largest dialysis provider. Today, I'm pleased to report that both are now completing their processes to make Vaxio available.

Speaker 2

As of September, we expect that physicians of these dialysis organizations will be able to write a prescription for Bacio without restriction, bringing the total patients with access to over 75,000. We believe this will enable a significant step up in growth. Even more significant from a volume and patient access perspective, DaVita, one of the largest dialysis providers, is completing preparations for its operational pilot for Basia. They've placed an initial order and expect patients to receive the drug starting in the August. Upon the successful completion of the pilot, we expect to increase patient access by more than six fold from 40,000 patients in Q1 and Q2 to at least 275,000 patients later in Q4.

Speaker 2

Nick will give you more color on all of this launch progress and metrics. The second focus to drive Vastiode to become standard of care is to enhance the environment for growth post TDAPA. I'm very pleased to report the VOICE trial being conducted in collaboration with USRC has been fully enrolled as of late June. Over 2,100 patients enrolled in only seven months. I believe this clearly speaks to investigators' interest in the potential benefits Vastio may bring their patients, and a desire to prove that dosing when administered during dialysis may be beneficial as well.

Speaker 2

The timing of enrollment completion is important, as it means the study will complete in late twenty twenty six, with data available in early 'twenty seven, shortly after the end of TDAPO. A voice is an outcomes trial looking at all cause mortality and all cause hospitalization. While its primary endpoint is non inferiority, it's powered to demonstrate potential superiority for vadadustat for all cause hospitalization. We believe any data demonstrating a positive clinical outcome will be critical in establishing Vaseo as the standard of care. We're also pleased to have initiated VOCAL, a study looking at dosing of Vapsoe three times a week, being performed in 18 DaVita dialysis facilities.

Speaker 2

This study will enroll about three fifty patients. An important and exciting substudy will look at characteristics of red blood cells in patients treated with Vasya. Now previous studies have shown that other HIF PHIs can improve the lifespan of red blood cell. I believe showing a potential positive impact on red blood cell characteristics, size, lifespan, oxygen carrying capacity with FAFCIO in a dialysis population can demonstrate the tangible differences a more physiologic approach to treating anemia can yield. The third area of focus is securing an indication for non dialysis patients in the vascular label.

Speaker 2

Recall that while the stage four and five non dialysis population with anemia is roughly the same size as dialysis, about five hundred and fifty thousand patients, it doesn't have the same pricing complexity that dialysis has in a post TDAPA setting, making it potentially four to five times larger than the $1,000,000,000 addressable market size of the dialysis market. We've continued to work to move this initiative forward. We completed a Type D meeting with the FDA in May. The meeting addressed a single focused written question to the agency related to the comparator arm for the VALORZ trial in MDD CKD. Based on FDA written feedback, we're now planning for an active ESA comparator.

Speaker 2

We believe this design will simplify the pooling of data with our prior Phase III US PROTECT program. We recently submitted a Type C meeting request to further discuss the study design, statistical analysis, and pooling strategy, and we're working to initiate VALOR by the end of the year. The team at Akebia believes strongly that patients not on dialysis would benefit from access to Vaseo, and we're working hard toward their goal to gain alignment with the FDA and be in a position to enroll the trial quickly. With the launch of Vazio and continued strong performance of Auryxia, we had over $60,000,000 in net product revenue in Q2, the highest level in the history of the company. In a moment, Eric will talk to you about our strong second quarter financial results and solid financial position.

Speaker 2

But first, let me turn it over to Nick to give more color on the Vaxio launch and what we're learning in the field. Thanks, John. Good morning, folks. As we work to build a new standard of care in treating CKD anemia in dialysis patients, we are taking a comprehensive and long term view on how to establish a successful brand in a large category. To this end, we are rapidly advancing efforts across multiple work streams, which include building patient access, broadening physician prescribing, and continuing physician education.

Speaker 2

We are making great progress on all fronts. Let me begin with some updates on prescription volumes. During the launch, we are focusing on breadth, the number of physicians prescribing, and depth, the amount they are prescribing. We are very pleased to have seven twenty five prescribers write within quarter two, up from approximately six forty in the first quarter. The prescribers are now writing an average of 13.3 prescriptions each, which is also an increase from 12 prescriptions we reported in the first quarter.

Speaker 2

The breadth and depth of prescriptions are growing, but there is still more to do. I also want to touch on refills and average doses of Vazio over time. Refills represented greater than 80% of prescriptions in quarter two, and the average dose of those refills is up 28% of the starting dose. We believe this reflects that physicians are getting comfortable treating patients at an optimal therapeutic dose, and as a result, each of our prescriptions becomes more valuable. Upon market availability, we had expected the frequency and intensity of dialysis patient care would have resulted in a higher than typical adherence rate for Basia.

Speaker 2

As we have now been out in the field since January, we have observed adherence rates consistent with the industry at seventy percent to eighty percent. As we saw in our clinical trials, some patients, especially those on higher doses of ESAs, experience a hemoglobin drop on transitioning to three hundred mg starting dose of FAFSA. This is a departure from the experience with today's standard of care, and anemia managers are conditioned to react as quickly as possible to a hemoglobin drop. In some cases anemia managers did not attempt to titrate or the protocol and patients were moved back to their prior ESAs. I am proud of how quickly the Akebia team and our partners reacted to improve adherence.

Speaker 2

We quickly revamped and highlighted our messaging focusing on dosing and titration. We worked with existing customers to adjust protocols, and we educated dialysis organizations who were developing protocols to consider this in their protocol design. We believe our messages on improving adherence are getting out there and taking effect. Our focus ahead is to accelerate growth by increasing utilization of additional DOs by enabling nephrologists with access to right prescriptions. I would like to spend a minute providing more detail on our progress.

Speaker 2

As we have discussed previously, we have commercial contracts in place with all key dialysis organizations and group purchasing organizations covering nearly one hundred percent of dialysis patients. That was step one. We are also supporting dialysis organizations in the creation and operationalization of vascular treatment protocols. I will refer to this as prescribing access. As John mentioned, we are prescribing access to over 40,000 dialysis patients in the first half of the year, resulting in most of our orders since launch coming from USRC.

Speaker 2

Within the next month, we will have prescribing access to over 75,000 dialysis patients, an increase of over 85%, which includes DCI, IRC, and many independent and small dialysis organizations. Momentum around protocol development and implementation is picking up further in the third quarter as the DaVita physician will begin prescribing Vasquez as part of its operational patent at more than 100 dialysis clinics. With large complex systems, it always makes sense to do a test run to ensure that's exactly what DaVita is doing. Activity around the pilot has already begun, as the need to notify the selected pilot sites, ordered product in July to support early pilot prescribing, and began training this down. The pilot is expected to conclude within approximately three months, which we believe will increase total prescribing access for Vasco to over 275,000 dialysis patients and enable the opportunity for a significant uptake in ordering in the fourth quarter of the year within DaVita.

Speaker 2

One additional important note on patient access. In discussions with dialysis organizations with protocols in place and a review of claims data, we've confirmed that a significant number of Medicare Advantage plans are covering Bastion. As a reminder, patients covered by Medicare fee for service represent thirty five to forty percent of dialysis patients, and Medicare Advantage, another thirty five to forty percent of patients. Therefore, depending on the dialysis organization, the addressable patient population for could be doubled and potentially up to eighty percent of all dialysis patients having reimbursement for Vasture. Looking at the totality of our efforts, we're happy with the progress on growing breadth and depth of prescribing, increasing patient access, and physician education.

Speaker 2

We have increased demand 50 to five percent quarter over quarter. We expect to meaningfully increase prescribing access from approximately 40,000 patients to over 75,000 patients in the third quarter. And we are on track to access DaVita, which we expect to lead to prescribing access to over 275,000 dialysis patients in quarter four. We're still in early stages of our goal to build a new standard of care, but we believe we are on track to make our goal a reality. Let me now turn it over to Derek.

Speaker 2

Thanks, Nick. We're happy to report another strong quarter driven by the top line performance of both Zafceo and Auryxia. I will now provide an overview of our results as compared to the second quarter of last year. Total revenues, which are comprised primarily of net product revenues and also include license, collaboration, and other revenues, were $62,500,000 this quarter as compared to $43,600,000 in Q2 of last year, representing an increase of $18,900,000 Of these amounts, net product revenues increased to $60,500,000 this quarter from $41,200,000 in Q2 of last year. This was driven by sales of Adafcio, which as mentioned, were $13,300,000 in the quarter, as well as by an increase in Auryxia sales, which were $47,200,000 this quarter as compared to $41,200,000 in Q2 of last year.

Speaker 2

As a reminder, Auryxia lost IPX exclusivity in March, and there is an authorized generic for Auryxia on the market, though no generics have been approved by the FDA at this time. We are pleased with this quarter's strong Auryxia results, though caution future Auryxia sales levels are challenging to predict due to the uncertainty around the timing of potential additional generic competition. Cost of goods sold decreased to $9,900,000 this quarter as compared to $17,000,000 in Q2 of last year. The key driver of this cost reduction is that we are no longer reporting a $9,000,000 quarterly non cash amortization charge related to the acquired development product rights for Arrhythmia, which is now fully emphasized. Also of note, Zafia sales in the quarter were derived from prelaunch inventory, which does not include the full cost of manufacturing, as a portion of those inventory related costs were previously expensed to R D prior to Zapsio's FDA approval.

Speaker 2

R and D expenses increased to $11,000,000 this quarter from $7,600,000 in Q2 of last year, driven by increased clinical trial activities related to VAPSSAY as well as our other programs. SG and A expenses decreased slightly to $26,600,000 this quarter from $26,900,000 in Q2 last year. Turning to the bottom line, we generated $247,000 of net income this quarter as compared to a net loss of $8,600,000 in Q2 of last year. This quarter's net income was driven by the increase in revenues, which was partially offset by $5,400,000 in interest expense related to the D4 settlement royalty liability, as well as $7,000,000 in non cash expense related to the change in fair value of our warrant liability, which was driven by the increase in our stock price in Q2 over the prior quarter. We ended Q2 with $137,300,000 in cash and cash equivalents.

Speaker 2

We believe our existing cash resources and the cash we expect to generate from product royalty supply and license revenues are sufficient to fund our current operating plans and profitability, including to pursue label expansion for Vaseo and advance our other pipeline programs. In closing, our Q2 financials reflect increased uptake of Vaseo, continued resilience of the Auryxia revenue stream, and careful attention to operating expenses, which resulted in our strengthened financial position. As John and Mick mentioned, the team is dedicating significant energy towards continuing to expand both the breadth and depth of Vapsteo utilization, And we look forward to discussing the results of these efforts on our next earnings call. With that, we welcome questions.

Operator

Thank you. As a reminder, to ask a question, you will need to press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Please stand by while we'll apply the q and a roster. One moment for our first question.

Operator

Our first question will come from the line of Roger Song from Jefferies. Your line is open.

Speaker 3

Hey guys, good morning. Congrats for the quarter and thank you for taking our question. You give us a lot of the good numbers here. Just want to get a sense of some of the key metrics here. So first is the patient segment.

Speaker 3

So in terms of the home use and the high ESA, what do you see this quarter and how this changed over last quarter? And then also, how do you forward looking when you have more larger DO coming online, including DaVita in 4Q, you see the patient segment will change. Similarly for the payer, you say the Medicare Advantage seems to be a significant amount of the patient and can you quantify compared to the fee for service? And I have a follow-up. Thank you.

Speaker 2

Nick, I think that's for you. Yeah, and so when I think about the patient segmentation, a great question, and you know, where USRC, who is a vast majority of our prescriptions, their protocol is broad. They're allowing QD use for both in center patients and home patients, and we see usage that very much similar to the market segmentation between PE and home patients being about 12% of the total scripts and the remainder being for in center patients. The second part of that is how do we see that moving forward when we add on DaVita and others in the third and fourth quarter. When we look at all of the protocols that they're putting in place, whether it be an IRC, DCI or DaVita, they're all broad protocols that allow for both in center and home use.

Speaker 2

When physicians think about patients top of mind that will benefit from Vasio, they go to two important segments first. They go to the home patient where it makes really, really good sense to use an oral therapy for those patients to avoid injections as well as consistent visits to the dialysis unit. And they also think about higher dose ESA patients who have a higher increased mortality in cardiovascular risk associated with those higher doses of ESAs. And so we expect to have continued broad uses. It may tip a little bit higher towards the PD section or the home section, but expect consistency moving forward given those broad protocols.

Speaker 2

The second part of your question was on market access and Medicare Advantage. To date, we're seeing about twenty percent of total prescriptions being filled in the Medicare Advantage segment of the population, where 80% is Medicare fee for service. But as we look going forward in our discussions with again IRC and ECI and DaVita, they have all indicated to have significant Medicare Advantage contracts already in place that will support Vacio through additional TDAPA coverage. And so that's a great sign. That means that those populations are growing over our initial expectations of fee for service, and they're growing at a faster rate.

Speaker 2

We always thought they would add Medicare Advantage plans over time. It's happened much earlier than we could have anticipated. I think even with US Renal, where they started with mostly a focus on fee for service, as that Medicare Advantage coverage has grown, they've kind of pushed those patient names out to dialysis centers as well, right? So we, this is the, there's still growth to be had clearly within US renal. That's correct.

Speaker 2

You know, when I think about US renal, over eighty percent of US renal care physicians are brining, which is an important metric, especially when new coverage becomes available. When that new coverage becomes available, those physicians have the opportunity to treat Vafsio to a broader population that is in need of Vafsio that previously didn't have coverage. So we're looking forward to continued access increases and look forward to driving deeper penetration within all accounts.

Speaker 3

Excellent, thank you for the detail. Just a quick one. And then what's the current average dose strength for your prescription? Because you see I know you see a higher dose level in the recent trend. Thank you.

Speaker 2

Yeah, Nick, I think that's you again. Yeah, and so as I referred to in my script, we're seeing refill scripts being at about a 28 increase over the three hundred milligram starting dose, which is great. Know, we saw in our INNO2VATE trial, clinical trial that folks got to approximately an average of four twenty milligrams per script, and so that would be a 40% increase or at a 25% increase or 28% increase to date. So we see as people progress through their prescriptions from first prescription to second prescription, third prescription, those doses continue to titrate on. As you recall, our label has people titrating up at one hundred and fifty milligrams after four weeks, and every four weeks thereafter.

Speaker 2

Therefore, it's going to take the second or third refill to get them to the appropriate dose in some cases. And I think when you mentioned the adherence changes, what some providers are doing is actually allowing a titration at week two, which you saw in the MODIFY trial as well. So the one thing to be aware of, as you bring on new dialysis providers and they bring on more new patients, so we see this step up in patients, you may actually see a bit of a step down in dose because you have more patients at that starting dose. That's exactly what we would hope to see, but as they stay on the drug, they'll titrate to that average dose. And that's obviously, as you can see, an important component of that growth in the quarter.

Speaker 3

Got it. Makes sense. Congrats again.

Speaker 2

Thanks, Roger.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Julien Harrison from BTIG. Your line is open.

Speaker 4

Hi, good morning. Congrats on the quarter and thank you for taking my questions. On the operationalized protocol you're expecting from DaVita, is that expected to be implemented in earlier or late fourth quarter? Are you able to provide any granularity there? And when we start to think about the other large dialysis organization of comparable size to DaVita, should we also expect that corresponding protocol to be preceded by a pilot study as well?

Speaker 2

Yeah, great question, Julian. Thanks for it. So the DaVita operational pilot is they are preparing for it now. They ordered the product, they're training at the sites. And we expect in the next couple of weeks, think it's the eighteenth of the month is when they expect to go live with it.

Speaker 2

So, and then that pilot will last three months. So, up to three months, obviously, it could go sooner. But I think the expectation should be around the November is when they basically open that up to the entire the V2 network. So, you know, and as you mentioned, the other large providers, Fresenius, of course, and we continue to talk to Fresenius, present them clinical data, etcetera. We have not been able to progress yet.

Speaker 2

I think as the data comes on and all these other providers come on, it becomes more and more difficult for them to keep access from their physicians and patients for this innovative product. My expectation, and correct me if I'm wrong, is they would probably do

Operator

a

Speaker 2

similar kind of operational pilot before they gate broad access.

Speaker 4

Excellent. That's very helpful. And then a follow-up, if I may. On non dialysis dependent CKD, it sounds like you're very close to finalizing the Phase III trial design for VALOR. Are you able to give us an approximate sense for how soon this label expansion opportunity could come online for VAPSCO?

Speaker 4

What does the timeline look like after that study starts around year end?

Speaker 2

So the timeline is going to be driven significantly by how quickly we can enroll this study. Right? I mean, it's an outcome study. We still expect, again, all of these details are somewhat to be determined, but the numbers we've been giving in the past, about a 1,500 patient trial, now with an active comparator versus Vastio or vadadustat, and doing it strictly in The US with US patients. So we can do that pooling of VALOR with The US PROTECT data to enhance the comfort that there isn't an increased MACE risk, which of course we didn't see in US patients with PROTECT.

Speaker 2

It's really all about how quickly can enroll and you know, giving a sense of that before we know what the final protocol looks like. I mean, this is one of the activities that we're doing to prepare is working on feasibility, you know, how many sites, how many patients per site, and that will help us to better inform you. But I don't want to get ahead of that data yet. But obviously, our goal would be to enroll as quickly as possible.

Speaker 4

Excellent. That makes a lot of sense. Thank you, and congrats again.

Speaker 2

Thanks so much, Julian.

Operator

Thank you. One moment for our next question. Our next question will come from the line of Mazi Ali Mohamed from Leerink Partners. Your line is open.

Speaker 5

Thanks for taking our question. This is Mazi on for Ruan Ruiz. So Auryxia revenues actually grew year from year. So I guess one question is, with the only one authorized generic currently in the market, what's your outlook for competitive dynamics over the remainder of 2025? And I guess, how are you thinking about positioning for additional generic entrants in the future?

Speaker 2

Izzy, thanks for the question. Nick, maybe you can talk about the market dynamics and why we're seeing that growth. Yeah, and the market dynamics, think it's great news for Auryxia. It's really built on the back of Auryxia's a ten year old product, and physicians are very comfortable with the clinical profile and the benefits of Auryxia as we've been kind of working with physicians for the last ten years. When we think about Auryxia pre bundle, the market of the access for Auryxia was actually extremely limited in prior years.

Speaker 2

Physicians often had to do a prior auth, in some cases they had to do a medical exception, and they didn't want to really do the work consistently for their patients. Now that the bundle has been implemented, access for IRTCE is actually at one of its greatest points in its history. And so physicians who are very comfortable using the product, understand its benefits in patients are taking the opportunity with that increased access to put more patients on Euryxia, which is great news for Euryxia. And so when we think about that trend continuing, maybe for the AG pieces, I'll pass it over to Eric or back to John to go into that piece. Well, mean, I think, you said, we have one AG on the market.

Speaker 2

We know exactly how much product we're supplying to the ATRIS, and how long that agreement really only goes through this year. So we really need to see what happens with FDA. We've always said to be very careful about how we think about the long term with Auryxia, but ultimately we believe that a product will be approved. We've been saying for years that the slope of that curve post generic availability isn't necessarily that patent cliff that you always see. If you use the Valimer as an example, it years before the generics took the lion's share of the market because of the volume that you have to manufacture here.

Speaker 2

But we look at it in a very conservative way. Maybe I'll pass that to Eric to talk a little more. Yeah, no, I totally agree with John. You know, from an internal perspective, you know, due to the reasons you alluded to in script as well as my comments, you know, new generic competition, you know, could come up at any time. So we budget conservatively, you know, the longer we go without that incremental generic competition is really just upside to our internal.

Speaker 2

Yeah, and when we talk about our kind of the cash runway, etcetera, being able to finance our pipeline, it's using a very conservative view of where Auryxia lands over time. So we're four months post when we had originally planned to have generics available. So we are pleased every day to continue to be able to deliver the product to the patient.

Speaker 5

Thanks for the added color. Congrats on the quarter.

Speaker 2

Thanks, Lee. Appreciate it.

Operator

Thank you. I'm showing no further questions at this time. I would now like to turn it back over to John Butler for closing remarks.

Speaker 2

Thanks, Victor, and thanks, everyone, for joining us this morning. We're focused on our goal of making Vaxio a standard of care for treating anemia due to CKD. We're making important progress across all components of that strategy. Our launch is accelerating, we're executing the studies in dialysis patients to continue to build evidence of potential benefits. And we're planning to initiate our MDD study VALOR this year.

Speaker 2

Our revenue performance and cash balance allow us to execute this strategy and advance our early pipeline from a position of financial strength. We look forward to continuing to update you on our progress. Have a great day.

Operator

Thank you for your participation This in today's does conclude the program. You may now disconnect. Everyone have a great day.

Powered by Quartr