Akebia Therapeutics (AKBA) Q2 2026 earnings call transcript

Ladies and gentlemen, thank you for standing by. This is Roy, and I will be your conference operator today. At this time, I would like to welcome everyone to the Akebia Therapeutics and Part of 2026 Financial Results. All lines have been placed on you to prevent any background noise. After the speech, there will be a question and answer session. If you would like to ask a question during this time, please press star followed by the number one on your telephone keypad. If you would like to withdraw a question, please press star again.

I would now like to turn the conference over to Mercedes Casco. Please go ahead. Thank you, and welcome to Akebia's second quarter 2026 financial results and business updates conference call. Please note that a press release was issued earlier today, Wednesday, August 5th, detailing our second quarter 2026 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 today, we have John Butler, Chief Executive Officer, Dr. Stephen Burke, our Chief Medical Officer, Nick Grund, our Chief Commercial Officer, and Eric Ostrowski, Chief Financial and Chief Business Officer. I'd like to remind everyone that this call includes forward-looking statements.

Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual risk 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 5th, 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. Thanks, Mercedes, and thanks to everyone for joining us this afternoon. As you know, we've been focused on two critical areas of our business that we believe will deliver both important therapeutic advances for patients and value to shareholders. Those are advancing our kidney disease pipeline and making Vafcio standard of care for the treatment of anemia due to CKD in dialysis patients.

We've had incredibly important advances in both areas since we last spoke to you. Today, I'll start with research and development. I believe our pipeline is underappreciated, and clinical advancement of our rare disease pipeline specifically provides the greatest opportunity to build value. Earlier this week, we announced that we initiated the Phase II basket trial to evaluate Ibribifus, previously known as AKB097 and ADX097 in IGA nephropathy, lupus nephritis, and C3 glomerulopathy. We believe Ibribifus, a next-generation complement inhibitor, could be truly differentiated in the rare kidney disease space, in these indications and others.

Beyond this initial basket study, we're doing the work to prepare for a Phase II study in anko-associated vasculitis and expect to start that study next year.

Our other rare kidney asset, Prolisaguat, continues to enroll in its Phase II study in FSGS. As with Ebre, we believe there are multiple indications where Proli can play an important therapeutic role. And again, we believe the mechanism of PRAWLI will allow it to occupy a unique competitive position in these rare diseases that each have significant unmet need.

Our third kidney disease clinical candidate is AKB9090, which was in a Phase I study in Healthy Volunteers. 9090 continues to move successfully through the SAD-MAD study, and we expect to report data early next year. Following that data readout, our plan is that next year our development team's efforts and our dollars will be focused on every Mprawley, where we believe the largest opportunity to drive near-term value exists.

Dr. Stephen Burke, our chief medical officer, is currently attending GlomCon Hawaii, where medical professionals around the world have met to discuss treatments for glomerular disease. That's the reason we're having our call this afternoon rather than a normal morning timing. I'll now ask Steve to share a few remarks on EBRI and PROLE. Steve?

Thank you, John. We've built upon our team's commitment to patients and expertise in kidney disease to advance several programs into the clinic in 2026. We believe our mid-stage pipeline products, EBRIBA FUSP and PROLISIGWAT, have the potential to deliver differentiated and targeted approaches to severe diseases with high unmet need. As John mentioned, we just initiated a Phase II basket trial for EBRI. The goal of this trial is to evaluate the safety and efficacy of EBRI in patients suffering from diseases marked by complement activation in the kidney glomeruli, namely IJ nephropathy, lupus nephritis, and C3 glomerulopathy.

These rare kidney diseases affect thousands of patients, and while there are therapies available, each requires lifelong treatment. The currently available treatments include complement inhibitors, which suppress the complement system in the blood, and many require frequent administration. Importantly, they generally have a boxed warning for significant infection risk, and this profile creates concern for long-term use. In nonclinical studies completed by Q32-Bio, EBRI was shown to be targeted specifically to the sites of complement activation.

In patients with complement-media glomerular diseases, we believe EBRI should localize to the affected glomeruli, which have significant deposits of C3D, while avoiding complement inhibition in the blood. We highlighted this during our R&D day in April and expect the findings from nonclinical and phase one studies to be published in medical journals. During our R&D presentation, Dr. Jonathan Barrett, Mayor Professor of Renal Medicine from the University of Leicester, shared that he believed a COMPL inhibitor with this profile could be used long-term and in combination with B-cell directed therapies such as APRIL and APRIL-BAF inhibitors without the associated potential of systemic complement inhibitors.

The recently initiated Phase II basket trial is expected to enroll up to 30 patients and will evaluate a once-weekly subcutaneous dose of EBRI for 26 weeks in the main study, followed by a long-term extension study for responders. In the Phase I study of every unhealthy volunteer, as again conducted by Q32Bio, this same dose achieved exposures necessary to provide tissue-specific complement inhibition without inhibiting the complement system in the blood.

The primary endpoint of the Phase II study is the incidence of adverse events and secondary endpoints, including the change in proteinuria and kidney function. In addition, the trial will measure EBRI pharmacokinetics and complement biomarkers in the blood and urine to detect if EBRI reduces complement activity in the kidney tissue while avoiding inhibition of the complement system in the blood.

The Phase II basket trial is open-label, and we expect to report initial data in 2027. With regards to our Phase II study of PROLI in patients with FSGS, enrollment activities are ongoing. FSGS is characterized by focal and segmental scarring in the glomeruli. Prolly is a small molecule that is designed to stimulate the soluble guanylate cyclase enzyme and has been shown in animal models of kidney disease to inhibit glomerulus scarring and preserve kidney function. There are about 40,000 patients currently diagnosed with FSGS in the U. S. This trial will enroll up to 60 patients with primary or genetic FSGS in a randomized, double-blind, placebo-controlled trial.

The primary endpoint is change in urine protein creatinine ratio, or UPCR, from baseline to week 24, and the secondary endpoint is partial remission of proteinuria, defined as a 40% UPCR reduction in the UPCR less than 1.5 grams per gram. And a Phase II study of diabetic kidney disease conducted by Cyclarion proudly demonstrated rapid and sustained reduction in proteinuria as measured by urine albumin creatinine ratio, or UACR. We look forward to providing further updates on these studies, and now I will turn it back over to John.

Thanks, Steve. Now let's turn our attention to Vafsio and our efforts to make this important product standard of care. We had a very positive surprise this quarter when Dr Jeff Block of US Renal Care completed the planned interim analysis of the primary endpoint in the VOICS trial and found the statistical result significantly exceeded the pre stopping criteria Vapcio demonstrated a statistically significant and clinically meaningful reduction in the primary composite endpoint of all mortality and hospitalization with the result driven by a 10 reduction in hospitalization USRC kidney research stopped the trial after a recommendation from the Independent Data Monitoring Committee and Trial Steering Committee.

And for reference, the voice trial enrolled 2,116 patients. Results of the planned interim analysis as of June 1st demonstrated that the trial met the predefined stopping criteria with a win odds of 1.16 and a p-value of 0.0016, establishing non-inferiority and superiority of the primary composite endpoint. We've always had confidence in the clinical differentiation of Vafcio and the potential for a positive outcome of the study, but we were extremely pleased that we had this result earlier than expected. The result is consistent with the post-hoc analysis of the Phase III Innovate program published earlier this year in the Journal of the American Society of Nephrology. When you look at both voice and the Innovate analysis, you see that Vafcio demonstrated a consistent result, whether dosing the product daily or three times weekly, and whether comparing Vafcio to a long-acting or a short-acting ESA.

It's also important to note that no head-to-head study of ESAs has ever demonstrated a significant benefit in hospitalization. We believe the data will make a huge difference for patients for years to come.

As I've said many times, our goal is to make VASIO standard of care for dialysis patients. Frankly, the voice data gives me greater confidence that we will achieve that goal. I'm especially encouraged by the increased interest we're seeing from the dialysis providers since we made the announcement. Now, at the same time, we currently have only shared data through a press release. Dr. Block is working with our support to present these data at a medical conference and have it published in a peer-reviewed journal as quickly as possible. While the tangible impact of this provider interest could take some time, we believe these data help competitively position and differentiate Vafsio moving forward. In the meantime, I'm pleased to report that we had our first quarter with over 10,000 patients and $20 million in revenue.

Here's Nick to provide more insight into the quarter.

Nick? Thanks, John, and good afternoon, folks. We're pleased to report significant sequential quarterly revenue growth, as well as several adoption metrics, and an important milestone with more than 10,500 patients active on Vasio. So, Basio net product revenue increased to $21.3 million in quarter two of 2026, a 34% increase over the previous quarter, representing a continuation of robust growth.

The total patients on therapy in quarter two represents an approximate 41% increase compared with quarter one. Also, once again this quarter, we had the highest number of new patient starts in a quarter since the first quarter of launch, demonstrating strong momentum. The diversification of our prescriber base continues to grow. Today, approximately a third of our prescribers are in DOs outside of USRC. Additionally, a vast majority of patients are being treated under DO-implemented observed dosing protocols, which is very much in line with our expectations. The mid-sized dialysis organizations, USRC, IRC, and DCI, drove the most significant portion of patient growth, and we believe that all three still have significant room to grow moving forward.

Another common feature of these three customers is the significant level of support in Vafsio that their leadership is demonstrating. Driving prescribing within DaVita is our highest priority, as it represents our most significant growth opportunity from a single dialysis organization. In quarter two, we continue to see additional new prescribers and patients on VASIO at DaVita. As is the case with our midsize dialysis organization customers, while it is important to educate prescribers and caregivers on VASIO, an inflection point comes with top-down support. To that end, I'm encouraged by the continued high level of interaction between the teams from Akebia and DaVita, bolstered in the past month by DaVita's interest in learning more about the recent voice trial results.

While I don't expect to see a meaningful increase in the DaVita adoption curve in quarter three, there is a heightened level of senior clinical team engagement regarding detailed operational implementation that we have not seen historically. We believe this bodes well for more impactful growth at the end of the year and sets us up well for 2027. At this stage of the launch, and to best support dialysis organizations' engagement overall, in quarter two, we implemented a more targeted, streamlined, and agile commercial strategy that prioritizes a greater focus on large group practices and strategic partners.

The goal is to increase the efficiency and effectiveness of our commercial field team, while at the same time, taking advantage of the broad awareness and breadth of patient access created previously. Our team continues efforts to drive VASIO prescribing and grow. We understand how important it is for our commercial and medical affairs teams to work closely to engage with dialysis organizations and care decision makers, and support prescribers as they continue to get more experience with VASIO to increase depth of prescribing as well. And now I'll turn it to Eric to go through the financials.

Thanks, Nick. Total revenues were $49.1 million in Q2-26 compared to $62.5 million in Q2-25. This decrease was due to lower Eryxia revenues, which were partially offset by higher VASCO.

Turning to the components of total revenues, VASCO net product revenues were $21.3 million in Q2-26 compared to $13.3 million in Q2-25, representing a 60% year-over-year increase. As we've previously discussed, we note that upon the expected end of Vapstio's Tadapa period on December 31, 2026, we plan to price Vapstio within the price range of ESAs, which is significantly lower than Vapstio's current price.

As a result, while we expect Vapstio unit sales volumes to increase in 2027 as compared to 2026, we expect 2027 revenues to decrease compared to 2026 due to this lower planned price. Eryxia net product revenues were $25.5 million in Q2-26 compared to $47.2 million in Q2-25. We continue to expect Eryxia revenues to decrease in Q2-26 due to generic competition and pricing.

License, collaboration, and other revenues increased to $2.4 million in Q2-26 compared to $2 million in Q2-25. Cost of goods sold was $10.4 million in Q2-26 compared to $9.9 million in Q2-25. Of note, Vapstio-related COGS in both periods was derived from prelaunch inventory, which does not include the full cost of manufacturing, and a portion of those inventory-related expenses were recorded as R&D expenses in a period incurred prior to Vapstio's U. S. approval. R&D expenses were $14.1 million in Q2-26, compared to $11 million in Q2-25. This increase was driven by activities related to our Phase II clinical trials for holistic-wide and abriva folks, as well as higher headcount-related costs.

SU&A expenses were $28.2 million in Q2-26, compared to $26.6 million in Q2-25, driven by higher commercialization-related activities. Net loss was $8.9 million in Q2-26 compared to net income of $0.2 million in Q2-25. The change to a net loss this quarter was the result of lower revenues and higher expenses, including a $1.9 million expense related to the commercial reorganization mentioned by Nick, which is aimed at increasing the efficiency and effectiveness of our commercial life. Cash and cash equivalents as of June 30, 2026 were approximately $155.5 million compared to $162.6 million as of March 31, 2026. We believe our existing cash resources and the cash we expect to generate from product, royalty, supply, and license revenues, along with our plan to refinance our senior secured term loan disability, will enable us to fund our current operating plan for at least two years.

With that, we will now open the line for questions.

Operator? Thank you. We will now be opening a question and answer session. If you'd like to ask a question, press star then the number one on your telephone keypad. To withdraw your question, please press star one again. Thank you.

Yeah, Matt, great question. Thanks. So really, with the new patients, what we're seeing is a couple of different things. One, the number of clinics that are starting patients is continuing to expand, right? So it's not just within a certain clinic. The number of prescribers continues to grow. It grew 17% this quarter versus quarter one. So people are starting to try Vapcio outside of what we'll call an existing physician base. You know, so certainly that generates a bunch of new patients. In addition, frankly, restarts are going really well. As you recall, we had QD patients that fell off therapy in 2025. As they've rolled through these observed dosing protocols, we've seen just about a 25% of those discontinued patients actually come back on therapy, which is also helping the growth rate as well.

And so a couple different factors in there, but most of the growth is coming through the new patients, new clinics, and new providers.

Do you have another question, Matt?

Nick, do you want to take the adherence question?

Yeah, so when it comes to adherence, when we talk about this first refill item, you know, we've seen real good consistency there. About 89% of those patients who receive a prescription for Vapso get the refill for the next period, which is really strong.

You know, after that, it really tapers down towards what I'll call normal churn in the dialysis patient population. The second part of your question was, why do people discontinue? No therapy I know of actually works in every patient, and so you may have some folks that get hospitalized during that period, go back on tween ESA, come back into the clinic, and then they'll work to put them back on Vasio. So you've got folks that just don't tolerate it. Maybe there's some GI issues associated with it. But at this point, I think we've done a nice job in moving to an adherence rate on first refill. That is where we want it to be. Yeah, I mean, that's where when we launched the product and you had this QD dosing, and particularly the anemia managers saw people's hemoglobins drop as we told them it would.

They just weren't used to not controlling that, and we really believed that that was the main reason for that first refill kind of drop in adherence, and I think the data supports that that really was the case. And so, beyond that, it really is the kind of what you normally see in a dialysis population.

So, and then I think, Anna, your second question was around the timeline to get data to the dialysis provider. So, you know, this is clearly an ongoing effort. And, you know, as I said, I think it's important to note that it's not been presented and it's not published. But, you know, this is a relatively small community, right? And we know that Jeff Block is incredibly excited about this data as we are, and I know he is talking to dialysis providers, his peers, and other dialysis providers, independent of our conversations. But I know Steve and his team have also been having those conversations. And, you know, there are places where, I mean, like U. S. Renal ran the study.

So, you know, they've been our, you know, strongest supporter, and I think that will only continue to increase. IRC and DCI also, you know, certainly IRC, incredibly excited about the clinical benefit. This only really increases that excitement. And, you know, the way we look at it, between those three providers, you've got about 66,000 patients in total, you know, most of whom, or at least 80% of whom are on an ESA today, and we've got just over 10,000 patients treated. So, huge amount of room to grow there. And, you know, again, I mean, the conversations that have been had at the clinical level at DaVita, certainly, and as Nick mentioned, I mean, now the conversation is much more operational in nature, and that really, to me, bodes well.

You know, again, it is sort of, it's a very large organization that we've learned takes a lot of work to move, but there seems to be some real momentum there. So we're encouraged by that. And, you know, we don't mention Fresenius a lot, but, you know, we believe that this is the kind of data that will be meaningful for them as well. And those conversations are starting, and I think they'll be much more interested in seeing it published.

Thank you. Your next question comes from Roger Song with Jeffries. Please go ahead.

So I'll take the first part, and then I'll turn it over to Steve. So, you know, we really do – enrollment's progressing. You know, it is a competitive space, which we knew. We're, you know, the team is continuing to drive more patients on, feel good about, you know, adding more sites, et cetera. We really look forward to saying this is when we expect to see that six-month data. We don't want to make that, you know, kind of put that stake in the ground until we're really confident that we're going to have those 60 patients fully enrolled in the study. But we are making progress on it. So I think what you're referring to is you look at the first quarter, Tavir just announced their very early data in SGS for that first approved product last night, and it is 40,000 patients, a very heterogeneous disease where multiple products will make a real difference for patients in this market.

So this is a massive commercial opportunity and a massive opportunity for patients as well. So it's worth kind of driving this forward as quickly as we can.

I'll let Steve comment on the opportunity for combination therapy or polypharmacy. Yeah, I mean, Steve, so for FSGS, you know, we will be able to treat patients who have persistent proteinuria, despite being on ACE and ARBs or endothelin antagonists. So I'm actually delighted to see the uptake of sparsentan, and there's plenty of patients who will benefit. Our drug may work well with sparsentan as well. It's something we'll need to determine in future clinical trials. In terms of Every, there is a real desire to have treatments that are safe and effective and work quickly. So complement-mediated diseases, the complement being activated is damaging the kidney cells, and if you use a complement inhibitor, generally you get a very rapid response to stop the kidney damage and clearly could be used with other therapies.

There been a lot of you know exciting data about April and April BAP inhibitors and I think those are going to be very good products in the long term They directed at suppressing the B cells that are making autoantibodies and there no reason these drugs couldn be used together I think this is one of the things that Dr. Barrett had highlighted, that those drugs are quite, you know, profoundly immunosuppressive in terms of B cells and, you know, affect your ability to respond to new infectious agents. And so I think there is a lot of interest in having a complement inhibitor that is highly effective but inherently safer because it doesn't suppress the complement system in the blood.

So I think time will tell, but I think there's clear opportunity for combination use. I hope that answered your question.

Thank you.

Hey, Steve, go back to FSGS and Prolly for a moment. I think one of the things I've heard you talk about with other folks is the difference in mechanism, the unique mechanism of Prawley and how it is quite different from the way sparsenton works and why that might actually be a benefit.

Sure. Sparsenton works by blocking the endotensin receptor and the endothelin receptor. Blocking endothelin is good because endothelin is a vasoconstrictor. It's injurious to podocytes, which are those critical cells in the glomeruli that are the barrier to protein spilling into the urine. And it's also anti-inflammatory and anti-fibrotic. Prolisiguat is hitting a completely different pathway, the soluble guanylate cyclase pathway, which leads to increases in cyclic GMP. Proli is a dilator. It's also protecting the podocyte and has anti-inflammatory and anti-fibrotic properties. So they're doing very similar things just from modulation of a different pathway. There's no reason they shouldn't work well together.

Great. Thank you, Steve. And thanks, Nabil.

Next question, operator? Yeah. Again, if you would like to ask a question, please press star 1 on your telephone keypad.

Thanks, Andrew. So I'll just comment quickly on DaVita. I mean, again, DaVita put the TIW protocol in place, and that was an important step. You know, we're seeing growth, but Nick mentioned this in his remarks. I mean, it's really that top-down advocacy that has made the difference at U. S. renal IRC DCI. And, you know, those levels of discussions we're seeing now really suggest that, you know, we're making progress there. Honestly, those conversations were happening before voice because of the innovate data, I believe. You know, this idea that, you know, this product can make a difference versus ESAs on hospitalization, I would say it's become more urgent is the wrong word, but, you know, kind of it's been a more robust conversation with the voice data.

Nick, I think you have more to add on the Davida side.

You can take the other questions as well. Yeah, and so, you know, Devita, we recently got some market research that was fielded at the beginning of June from a company called Cyrix, and what that shows is, from Devita physicians in particular, all-time highs in terms of their awareness of VASIO, all-time high with a likelihood to recommend, and also an all-time high in their preference to use VASIO instead of an ESA to improve efficacy. And so, you know, there is this pent-up desire to use Vafsio within DaVita. We've just got to help the process and help the leadership help the process from the top down to be able to allow them more rapid adoption of Vafsio.

The other questions, you know, the first question I think was utilization outside of USRC. You know, roughly, you know, a third of physicians now prescribing VASIO are non-USRC physicians. And so that kind of speaks to the diversification. You know, USRC has been kind of going gangbusters since the beginning. IRC and DCI really started at the beginning of 2026. And so they're a little bit smaller, but together they make up just about the size of USRC, and they're demonstrating very, very strong growth as well. And so, you know, just, and I think John pointed out earlier, there's so much more room to grow in those organizations. When you think about 10,000 patients, and John had, you know, 66,000 patients or 60,000 patients between the three of them, there's a ton of growth still yet to be had, which is also encouraging.

Yeah, I mean, we're all focused on the Vita, you know, with 200,000 patients that, you know, that can make a huge difference and, you know, turn those percentages on their gear.

We really are encouraged by what we're seeing there. The hard thing is to really pinpoint exact timing of, you know, when that happens. But, you know, when you get that kind of support, it takes a long time to get it, but once you get it, it sticks around also. And I think that's really important as we think about the long term here. And again, I mean, you know, we don't talk, as I said, we don't talk a lot about Fresenius, but, you know, I believe this clinical data from voice, when this is published and presented, this will make a difference. You know, those physicians who treat patients of Fresenius want to give their patient the best care as well.

So, you know, there's tremendous room for us to grow. So even in a world where we have to take this price decrease, which we will for the end of Tdapa, we recognize that. But this is still an extremely significant market that we think will have the standard of care product in.

And Julian, you also asked about protocol changes since voice. You know, there's been a lot of dialogue between all DOs. Dr. Block has been pretty active in talking about his voice results, which is encouraging. The only protocol change I'll note is DaVita, in the very beginning of June, did roll out village-wide their three-times weekly observed dosing protocol. I think that's really going to be helpful in physicians overcoming some of the compliance concerns they may have had prescribing the product at home. I think that some of the conversations that Steve's team is having with them now is looking at that versus what was in voice. And, you know, when you start hearing them get very, very specific about how do we – what do we do when this happens or that happens, that gives you a lot of encouragement.

They're not asking those questions to pass the time, right? They're really looking to do something. We just have to see when. So, you know, stay tuned.

That concludes with our question and answer session. I would now like to turn the call over to John Butler for closing your remarks.

Thanks, operator, and thanks to all of you for joining us this afternoon. We are really encouraged by the Vafcio growth trajectory through the first half of the year, and as we've been saying, the reaction we're seeing from dialysis providers to the announcement of the voice data. We believe in the long-term prospects for Vafcio and believe it can contribute significantly to Akebia's success.

At the same time, I do ask that you consider the opportunity that advancement of our pipeline, specifically Ebre and Prolly, represents for us. Notably, the opportunity to potentially bring important products to compete in rare disease markets worth many billions of dollars in expected total value. We are eager to update you on the progress of our trials, and we plan to share data as quickly as we can. Have a great day, everybody.

Goodbye.

Ladies and gentlemen, this concludes today's call. You may now disconnect.