Earnings Call Transcript - AKBA Q1 2026

Operator, Operator

Good day, and thank you for standing by. Welcome to Akebia's First Quarter 2026 Financial Results Conference Call. The operator will now provide instructions. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Mercedes Carrasco. Please go ahead.

Mercedes Carrasco, Head of Investor Relations

Thank you, and welcome to Akebia's First Quarter 2026 Financial Results and Business Update Conference Call. Please note that a press release was issued earlier today, Thursday, May 7, detailing our first 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 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 Erik Ostrowski, Chief Financial and Chief Business Officer. Dr. Steven Burke, our Chief Medical Officer, will also be available during Q&A. I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on May 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.

John Butler, Chief Executive Officer

Thanks, Mercedes, and thanks to all of you for joining us this morning. We are very pleased and excited by the start to 2026. I want to focus on three key areas that we feel we need to execute on to create near- and long-term value for patients and shareholders. First, we have to drive the near-term launch performance of Vafseo. Second, continue to build the clinical evidence to make Vafseo standard of care for patients on dialysis; and third, execute on our impressive kidney disease-focused clinical development pipeline. We've made important progress across each of these areas. Starting with the Vafseo launch, revenues were nearly $16 million in Q1, representing our highest quarter of Vafseo net product revenue to date and demonstrating the growth we expected over Q4 2025. We're pleased with the progress we're seeing within and across dialysis organizations as we expand the breadth and depth of prescribing and continue to educate the nephrology community on the benefits of Vafseo. We believe this growth is being driven by dialysis organizations that have chosen to implement an observed dosing protocol. Nick is going to expand on that important point and provide more detail on the quarter and trends we're seeing in 2026. Now we continue to work to take advantage of the TDAPA opportunity for the balance of 2026. Of course, we're already planning for the beginning of 2027 when Vafseo will enter the dialysis bundle. The ESA market today for patients on dialysis is estimated to be approximately $1 billion. This is the market we're competing in, where we continue to work to become standard of care. This leads to the second area of focus—building clinical evidence. And that body of evidence supporting the potential benefits of Vafseo continues to grow. The post-hoc hierarchical composite endpoint analysis from our Phase III INNOVATE program in dialysis was recently published in the Journal of the American Society of Nephrology. The analysis demonstrated that patients treated with Vafseo in the INNOVATE trial experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator. Earlier in Q1, at the Annual Dialysis Conference, we presented an economic analysis on the cost of hospitalizations for patients treated with Vadadustat versus darbepoetin. That analysis showed that patients in the INNOVATE trial treated with Vadadustat had 7.7% fewer hospitalization events annually, a 16% reduction in hospitalization days and, based on Medicare cost data, a 14.8% lower annual hospitalization cost. We believe these data further support the potential benefits of managing anemia with Vafseo and provide critical data to providers and prescribers making care decisions. We continue to share these important data with the medical and scientific community as we gear up for results from the VOCAL study expected by year-end. VOCAL is being conducted at DaVita clinics to evaluate Vafseo dosed three times weekly, and it contains a substudy of red blood cell characteristics, which we believe will further differentiate Vafseo's clinical profile versus ESAs. VOCAL top-line data will be followed by results from the VOICE trial being run by U.S. Renal Care, evaluating Vafseo versus standard of care on a hierarchical composite endpoint of all-cause mortality and hospitalization rates. Top-line data from VOICE are expected in early 2027; if positive, it would further support the findings of the recently published win statistics analysis. Both VOICE and VOCAL utilize a three-times-weekly dosing regimen. Alliance organizations are systematically electing to move to an observed dosing protocol. We believe that shift is improving adherence and could lead to greater utilization over time. Now shifting from Vafseo to our third area of focus. Our R&D organization has been highly productive in advancing our kidney disease pipeline, which we believe will be an additional and important value driver for the company going forward. Strategically, this initiative is a natural extension for us as it leverages our expertise in kidney disease drug development, broadens our presence within the kidney community and aligns to our purpose to better the lives of people impacted by kidney disease. In April, we hosted an R&D Day to review our pipeline with the investor community, and we were joined by leading medical experts, Dr. Jim Tumlin, Michael Holers and Jonathan Barratt. During that event, we reviewed the preclinical data in focal segmental glomerulosclerosis or FSGS models and prior clinical data in diabetic kidney disease for praliciguat, our soluble guanylate cyclase stimulator. This is an indication that has received increased attention as there's now an approved treatment specifically for FSGS. We view this as a positive development for patients and the field. And we believe praliciguat could deliver a differentiated approach via a unique mechanism of action in this heterogeneous disease. Enrollment in our Phase II study is ongoing. We're targeting up to approximately 60 patients who are already on maximally tolerated background dose of ACE inhibitors or ARBs. The study will evaluate change from baseline in UPCR at 24 weeks as the primary endpoint. AKB-097, whose generic name is Abribafisp or Abri, is our tissue-targeted anti-C3D complement inhibitor. We believe this product candidate could have comparable efficacy to the most efficacious currently approved complement inhibitors in a well-characterized pathway. Initial data suggest that Abri quickly leaves the bloodstream, directly targeting the tissue of complement activation, in this case, the kidney. We believe this could avoid the increased infection risk you see with current products. We also believe this will allow Abri to be delivered at a lower dose in a more convenient dosing regimen. As Dr. Barratt articulated during our R&D Day presentation, Abri is a second-generation complement inhibitor. We believe these characteristics support the potential for Abri to be a uniquely differentiated product in the market. We expect to initiate a Phase II open-label basket trial in the second half of this year, evaluating Abri in IgA nephropathy, lupus nephritis and C3 glomerulopathy. These indications represent a substantial market opportunity. And of course, we're evaluating additional indications to investigate as well. As part of the basket study, we'll be evaluating safety, tolerability, pharmacokinetics, pharmacodynamics and effects on disease-relevant biomarkers such as proteinuria and kidney function. Importantly, we expect the study to be designed to be able to demonstrate the efficacy and tissue-targeting profile of Abri. As a reminder, as the basket study is open-label, we expect to begin reporting initial data in 2027. Lastly, this quarter, we were pleased to announce the initiation of a Phase I study of AKB-9090, our internally developed HIF-PH inhibitor product candidate with an expected initial indication for the prevention of acute kidney injury associated with cardiac surgery. This randomized double-blind, placebo-controlled SAD/MAD study is designed to evaluate safety, tolerability and pharmacodynamics in up to 70 healthy adult participants. Top-line data from this program are expected in early 2027. Overall, we've had a strong start to the year, and we're making meaningful progress on both the commercial execution of Vafseo and the advancement of a pipeline that we believe can support long-term growth. Now let me turn it over to Nick for more granularity on the Vafseo launch.

Nicholas Grund, Chief Commercial Officer

Thanks, John. Good morning, folks. Like John, I am encouraged by the growth potential for Vafseo in 2026, which we believe is supported by our first quarter trends. While we ended 2025 with approximately 290,000 patients with prescribing access, the start of 2026 was when prescribing access translated to more widespread prescribing and more patients on therapy. I'll recap the quarterly results first and then explain what I believe is driving growth. With the move to observed dosing protocols across multiple additional dialysis providers, we are no longer receiving as much detailed data as we have in the past, but I believe we can still provide a very good sense of Vafseo utilization and growth. Q1 brought a significant increase in the number of prescribers writing and patients on Vafseo. Approximately 1,025 prescribers wrote a prescription for Vafseo, which was approximately 28% higher than the number of prescribers in Q4 2025. Importantly, approximately 30% of those prescribers were from dialysis organizations other than USRC. Dialysis organizations' inventory remained relatively flat from Q4 2025 to Q1 2026. As you know, we reported Vafseo inventory destocking in the fourth quarter of 2025 as a result of dialysis organizations transitioning to observed dosing protocols and the related shift in distribution from shipping bottles to patients' homes to stocking bottles at dialysis centers. From a patient perspective, we note a 60% increase in the number of patients on Vafseo at the end of Q1 2026 over the number of patients at the end of Q4 2025 to nearly 7,500 patients. The number of new patient starts in quarter 1 was the highest in any quarter since the initial quarter of launch. The majority of new patients began in March, so Q1 revenue reflects at most only one month of treatment for these patients. We believe increases in number of prescribers writing and number of patients on Vafseo are important indicators that adoption is broadening as more organizations implement Vafseo treatment protocols that allow for greater access. Finally, I want to spend some time on adherence and particularly the transition that dialysis organizations are making toward an observed dosing protocol. By the end of the quarter, USRC had observed dosing protocols available in nearly all of their clinics as did IRC and DCI. In quarter 1, approximately two-thirds of all Vafseo patients were being treated three times weekly, which we expect to continue to grow in coming quarters due to these protocol decisions. First refill adherence rates through the end of March were approximately 86% for patients treated under an observed dosing protocol. We believe this will reinforce the dialysis organizations' decisions to provide access to Vafseo using observed dosing. Because of this expanded access, we anticipate the greatest opportunity for Vafseo revenue growth will be among dialysis organizations that have implemented observed dosing and expect nearly all in-center patients across dialysis organizations to be on an observed dosing protocol by the end of the year. We are clearly seeing more patients start at DaVita, though more slowly than at other dialysis organizations that have ramped up, and that remains our largest potential growth opportunity from a single dialysis organization. We believe DaVita will implement an observed dosing protocol in the second half of the year. To summarize, we are seeing encouraging signs in the underlying commercial indicators that matter most, including broader prescriber engagement, improved adherence in observed dosing patients and increased prescribing at dialysis organizations beyond USRC, which all lead to a significant increase in patients on Vafseo therapy. As prescribers continue to gain real-world experience with Vafseo and we generate and disseminate more data, we expect to further grow the breadth and depth of prescribing. Let me now turn it over to Erik.

Erik Ostrowski, Chief Financial and Chief Business Officer

Thanks, Nick. We're pleased to deliver Vafseo revenue growth this quarter as we continue our pursuit to make Vafseo standard of care for the treatment of anemia in dialysis patients with CKD. I'll now provide an overview of our Q1 2026 financial results as compared to the prior year. Total revenues, which are comprised of net product revenues and license and collaboration revenues, were $53.5 million in Q1 2026 compared to $57.3 million in Q1 2025. This decrease was driven by lower Auryxia revenues, which was partially offset by higher Vafseo revenues. Of these amounts, Vafseo net product revenues were $15.8 million in Q1 2026 compared to $12 million in Q1 2025, representing a 32% increase with an even larger increase in underlying demand as evidenced by the strong Q1 patient growth Nick described as well as by the fact that Q1 2025 revenues reflected initial customer inventory build. Auryxia net product revenues were $36.2 million in Q1 2026 compared to $43.8 million in Q1 2025, which was driven by lower Auryxia pricing. Looking forward, we note that in addition to the authorized generic for Auryxia that has been on the market for the past year, an additional generic form of Auryxia has entered the market. This increased generic competition is consistent with our expectations and prior guidance. Accordingly, as we've previously communicated, we expect Auryxia revenues to decrease in 2026 as compared to 2025. Lastly, license collaboration and other revenues were $1.6 million in Q1 2026 compared to $1.5 million in Q1 2025. Turning to expenses. Cost of goods sold was $12.3 million in Q1 2026 compared to $7.6 million in Q1 2025. This increase was primarily due to an increase in inventory write-downs, including as a result of excess and obsolescence and scrap, primarily related to Auryxia during Q1 2026. Of note, Vafseo-related COGS in both periods was derived from prelaunch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as R&D expenses in the period incurred prior to Vafseo's U.S. approval. R&D expenses were $14.8 million in Q1 2026 compared to $9.8 million in Q1 2025. The increase in expenses was driven by increased clinical trial activities related to praliciguat, which we are evaluating in FSGS and AKB-9090, which we are evaluating for the prevention of cardiac surgery-related acute kidney injury, as well as higher headcount-related costs. SG&A expense was $30.4 million in Q1 2026 compared to $25.7 million in Q1 2025. This increase was driven by higher headcount-related costs. Net loss was $9.1 million in Q1 2026 compared to net income of $6.1 million in Q1 2025. The change to a net loss in Q1 2026 resulted from lower Auryxia revenues along with higher expenses this quarter as compared to Q1 2025. Cash and cash equivalents as of March 31, 2026, were $162.6 million compared to $184.8 million as of December 31, 2025. The decrease in cash was driven by the net loss for the quarter, along with an increase in working capital. We expect our existing cash resources and cash from operations will be sufficient to fund our current operating plan for at least two years. With that, we welcome questions.

Operator, Operator

Our first question is from the line of Julian Harrison with BTIG.

Julian Harrison, Analyst (BTIG)

Congrats on the progress. First, I'm wondering if you could talk more about the prominent increase of patients on Vafseo in March. Did you see follow-through of that trend into April? And was there maybe a specific dialysis provider or providers accounting for most of that uptake? And then second, is Filspari's recent approval relevant at all to your enrollment efforts in FSGS? Can you maybe walk us through how you're thinking about enrollment dynamics going forward for your Phase II trial?

John Butler, Chief Executive Officer

Sure. Nick, do you want to take the first question?

Nicholas Grund, Chief Commercial Officer

Yes. Thanks, Julian, for the question. The increase in patients nearly 60% quarter-over-quarter really was across all of our dialysis organizations, the major ones. USRC continued to have increases as they've really moved to the observed dosing protocol in all of their clinics, which is what we've indicated in previous calls has allowed them to start adding new patients on without the complications of a lower adherence rate that we saw in the once-daily dosing scheme for in-center patients. In addition, we've seen some restarts at USRC, which I think is an important characteristic. Patients that previously were on once-daily dosing fell off perhaps for compliance reasons. Now in a three-times-weekly, or observed dosing regimen, they're restarting on therapy with Vafseo, which is really important. IRC and DCI, once they got their dosing protocols in place in Q4, showed very aggressive and accelerated adoption of the product within their physician base. That advocacy that we're seeing at IRC and DCI is strong. DaVita also had significant growth in the period. They're lagging a bit behind the others. They're still under a once-daily dosing protocol. But we believe in the second half of the year we'll see them moving to an observed dosing protocol as well. So really great growth across a number of our dialysis organizations. We point to diversification, so the diversification away from USRC is an important measure to see how adoption is progressing at other dialysis organizations.

John Butler, Chief Executive Officer

It's good to see we have significant room still to grow at USRC, DCI and IRC, where we have great momentum. We all know that DaVita needs to increase. As Nick said, it's growing for sure. That observed dosing protocol is going to make all the difference in the world. Stay tuned. We're really pleased with the growth that we're seeing in the USRC, DCI and IRC clinics and expect to see significant growth from them as the year progresses. On the FSGS trial, yes, we think it's really a positive thing for patients. From a regulatory perspective, we see that the FDA is supportive of bringing new products for this patient population. Steve and I were down at an investigator meeting a few weeks ago, and I was incredibly pleased by how excited the physicians were about the opportunity for praliciguat and its unique mechanism of action. We're pleased with the progress we're making. There are multiple products in development there, so it is a competitive space, but we're very pleased that investigators are as excited as they are about praliciguat, and we think that enrollment will progress. Is there anything you want to add, Steve?

Steven Burke, Chief Medical Officer

No, I'd just echo what you said, which is the bigger issue in conducting clinical trials is competing with other sponsors for patients. So I don't think the Filspari approval is going to have a significant impact on enrollment. We haven't heard that it's having a significant impact. I don't anticipate it will, because it's only slightly better than angiotensin receptor blockers or ACE inhibitors, and the majority of patients are still not going to respond to that drug. It will likely become a background therapy similar to ACE inhibitors and ARBs.

John Butler, Chief Executive Officer

Thanks, Julian. Steve is not here in the room with us because he's down at the NKF Spring Clinical Meeting, so I'm sure he's getting more feedback on our pipeline as well. Sorry, Lauren.

Operator, Operator

Our next question comes from the line of Roger Song with Jefferies.

Nabil (on for Roger Song), Analyst (Jefferies)

This is Nabil on for Roger. So great to hear about the step-up in patients and prescribers. Regarding the first refill adherence at 86%, how should we think about that level as dosing scales more broadly across dialysis organizations? And then I have a follow-up.

John Butler, Chief Executive Officer

Nick, do you want to take that one?

Nicholas Grund, Chief Commercial Officer

Yes. In previous quarters, when we talked about first refill, the sample size was still relatively small. Now we're getting to the point where there is a sample size and penetration of observed dosing where we see a significant number of patients utilizing protocols that have an observed dosing regimen. I feel pretty confident that 86% is going to stick around there. It may move a couple of points in one direction or another, but there's no reason for us to believe at this point that it shouldn't apply as other dialysis organizations bring it on. Every dialysis organization has a slightly different protocol—whether it be starting at 900 milligrams daily, how often they titrate up, whether they're coming from Mircera or whether they're coming from Epogen. But we've seen this consistent number here, bouncing around between roughly 85 and 90% for the last couple of quarters. Right now, we're really confident that that's how you should think about it moving forward.

Jiale Song, Analyst (Jefferies)

Great. As we think about Vafseo throughout the remainder of 2026, should we expect the growth to be more linear from here or more back-half weighted as the protocol adoption matures?

John Butler, Chief Executive Officer

I don't know that we can guide that granularly. With roughly 7,500 patients on the drug, there's lots of room to grow. We see great momentum at USRC. I'm particularly excited to see so many of the patients who went off the drug last year because of adherence issues being put back on. With adherence rates remaining high, how quickly that will accelerate is a factor. These are all things that will influence the trajectory. There's tremendous room to grow. There are about 66,000 patients just between USRC, DCI and IRC. Not all of them have TDAPA reimbursement, but the access is quite good, so there's a large pool to grow into. The question is how quickly DaVita moves. DaVita has taken the strategy of allowing physicians to make the choice, whereas the others have a more top-down approach. That creates a more traditional adoption curve for DaVita, which is harder to predict exactly. We know that pool is much bigger and we need to tap into it. I don't think we can say it's going to be strictly linear or that there will be a hockey-stick at year-end. Once DaVita goes to a three-times-weekly protocol and as we publish and disseminate more data—like the JASN analysis paper—those are the kinds of data that can change the shape of the curve. Exactly how quickly that happens is to be determined, but we are pleased with the current momentum in the market.

Operator, Operator

Our next question comes from the line of Matthew Caulfield with H.C. Wainwright & Co.

Matthew Caulfield, Analyst (H.C. Wainwright)

For praliciguat development in FSGS, what do you view as the most clinically relevant change for the 24-week UPCR primary endpoint? Is there a certain delta that will be the most clinically relevant there in addition to preserving the podocyte health and just the overall reduced proteinuria?

John Butler, Chief Executive Officer

Sure. Steve, do you want to take that question?

Steven Burke, Chief Medical Officer

Sure. I think we would like to see something that's on par with what we've seen with sparsentan. So something around a 20% improvement in the change in UPCR—about 20% over what's achievable with ACE inhibitors and ARBs. I think the critical thing will be the proportion of patients who end up with a UPCR less than 0.7 grams per gram because that's the approvable endpoint now for FSGS. That will be the key metric that will drive our decision to go into Phase III or not.

John Butler, Chief Executive Officer

I think that's the bar—the sparsentan bar for approval. The PARASOL findings are encouraging because they give clarity from the FDA around the threshold for approval. Given the heterogeneity of the disease and the uniqueness of our mechanism, we think there's room for praliciguat. There are about 60,000 FSGS patients in the U.S. The approval of sparsentan is great for patients, but there's significant room for new entrants. Hitting that clinical threshold will be critical for us. Thanks for the question, Matthew.

Operator, Operator

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

John Butler, Chief Executive Officer

Thank you, Lauren, and thanks again to all of you for joining us this morning. We look forward to continuing to update you on the progress we're making in the launch of Vafseo, building the evidence to support Vafseo's long-term growth and the continued advancement of our robust kidney-focused pipeline. Have a great day, everybody.

Operator, Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.