Q4 2025 Akebia Therapeutics Inc Earnings Call

February 26, 2026

Operator: Good day, and thank you for standing by. Welcome to the Akebia's Q4 2025 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would like to hand the conference over to your first speaker today, Mercedes Carrasco, Senior Director, IR & Corporate Communications. Please go ahead.

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1-1 on your telephone.

Speaker #1: You will then hear an automated message: 'Device on, your hand is raised.' To withdraw your question, please press star one-one again. Please be advised that today's conference is being recorded.

Speaker #1: I would like to hand the conference over to your first speaker today, Mercedes Carrasco, Senior Director of IR. Please go ahead.

Speaker #2: Thank you. And welcome to Akebia's fourth quarter and full year 2025 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, February 26th, detailing our fourth quarter and full year 2025 financial results, and that release is available on the investor section of our website.

Mercedes Carrasco: Thank you. Welcome to Akebia's Q4 and full year 2025 Financial Results and Business Updates Conference Call. Please note that a press release was issued earlier today, Thursday, 26 February, detailing our Q4 and full year 2025 financial results. That release is available on the investor 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 C. Burke, our Chief Medical Officer and Head of Research and Development, is available for Q&A, dialing in from the Annual Dialysis Conference in Kansas City today, where Akebia will present data on Vafseo this weekend. I'd like to remind everyone that this call includes forward-looking statements.

Speaker #2: 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.

Speaker #2: Nick Grund, Chief Commercial Officer. And Erik Ostrowski, Chief Financial and Chief Business Officer. Dr. Stephen Burke, our Chief Medical Officer and Head of Research and Development, is available for Q&A, dialing in from the annual dialysis conference in Kansas City today, where Akebia will present data on Vassio this weekend.

Speaker #2: 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.

Mercedes Carrasco: 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 26 February, as well as in the Risk Factors and Management Discussion and Analysis section of our most recent annual report filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

Speaker #2: Additional information describing these risks is included in the financial results press release that we issued on February 26th, as well in the risk factors and management discussion and analysis section of our most recent annual report filed with the SEC.

Speaker #2: With that, I'd like to introduce our CEO, John Butler.

Speaker #3: Thanks, Mercedes, and thanks to all of you for joining us this morning. 2025 was an important year for Akebia. Marked by the commercial launch of Vassio, Vattedustat, our oral HIF pH inhibitor for the treatment of anemia due to chronic kidney disease for patients on dialysis.

John Butler: Thanks, Mercedes, thanks to all of you for joining us this morning. 2025 was an important year for Akebia, marked by the commercial launch of Vafseo, vadadustat, our oral HIF-PH inhibitor for the treatment of anemia due to chronic kidney disease for patients on dialysis. Vafseo, along with our phosphate binder, Auryxia, generated $227 million in net product revenue in 2025, during which time we also progressed multiple post-marketing clinical trials and advanced and enhanced our growing pipeline. Let's start with Vafseo. 2025 got off to a very fast start before a number of challenges flattened demand in the second half of the year. We addressed those challenges head-on, and we believe today we're starting to see the demand growth that we've expected.

Speaker #3: Vassio, along with our phosphate binder orixia, generated 227 million dollars in net product revenue in 2025, during which time we also progressed multiple post-marketing clinical trials and advanced and enhanced our growing pipeline.

Speaker #3: Let's start with Vassio. 2025 got off to a very fast start. Before a number of challenges flattened demand in the second half of the year.

Speaker #3: We addressed those challenges head-on, and we believe today we're starting to see the demand growth that we've expected. Most importantly, the body of evidence is growing.

John Butler: Most importantly, the body of evidence is growing that supports the potential for Vafseo to become standard of care in what is a billion-dollar US market opportunity after the TDAPA period ends, when we expect Vafseo will be priced roughly in parity with ESA pricing. While we didn't see the growth we expected in the second half of 2025, we built real excitement for Vafseo. Today, just over a year into the launch, more than 1,000 prescribers at 24 different dialysis organizations have written a prescription for Vafseo, and 290,000 patients have access to Vafseo in dialysis clinics with a protocol in place. I'm particularly encouraged by the shifting dynamics we began to see in Q4 that are continuing in Q1, that suggest greater breadth of prescribers as well as improving adherence rates.

Speaker #3: That supports the potential for Vassio to become standard of care in what is a billion-dollar US market opportunity after the TDAPA period ends, when we expect Vassio will be priced roughly in parity with ESA pricing.

Speaker #3: While we didn't see the growth we expected in the second half of 2025, we built real excitement for Vassio. Today, just over a year into the launch, more than 1,000 prescribers at 24 different dialysis organizations have written a prescription for Vassio.

Speaker #3: And 290,000 patients have access to Vafseo in dialysis clinics with a protocol in place. I'm particularly encouraged by the shifting dynamics we began to see in Q4 that are continuing in Q1, that suggest greater breadth of prescribers as well as improving adherence rates.

Speaker #3: Nick will provide more detail on these very encouraging trends in his remarks. Now, a key element of our strategy to have Vafseo become standard of care includes continuing to generate data supporting the benefits of managing anemia with a more physiologic approach compared to ESAs.

John Butler: Nick will provide more detail on these very encouraging trends in his remarks. A key element of our strategy to have Vafseo become standard of care includes continuing to generate data supporting the benefits of managing anemia with a more physiologic approach compared to ESAs. At the ASN meeting in November, we presented a post hoc hierarchical composite endpoint analysis of prospectively collected outcomes of death and hospitalization from our phase 3 INNO2VATE program in dialysis. This analysis demonstrated that patients treated with Vafseo experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator. This coming weekend at the ADC in Kansas City, we're presenting a cost comparison of Vafseo versus Darbepoetin based on INNO2VATE data.

Speaker #3: At the ASN meeting in November, we presented a post-hoc hierarchical composite endpoint analysis of prospectively collected outcomes of death and hospitalization from our Phase III Innovate program in dialysis.

Speaker #3: This analysis demonstrated that patients treated with Vassio experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator. This coming weekend, at the ADC in Kansas City, we're presenting a cost comparison of Vassio versus darbepoetin based on Innovate data.

Speaker #3: In this analysis, Vassio showed a 7.7% lower annual hospitalization rate; 16% reduction in hospitalization days; and based on Medicare cost data, approximately 15% lower Medicare hospitalization costs for patients treated with Vassio versus darbepoetin.

John Butler: In this analysis, Vafseo showed a 7.7% lower annual hospitalization rate, 16% reduction in hospitalization days, and based on Medicare cost data, approximately 15% lower Medicare hospitalization costs for patients treated with Vafseo versus Darbepoetin. Reduced hospitalization translated into a cost savings of about $3,700 per patient per year, meaning a savings of almost $2 billion per year if all eligible patients were treated with Vafseo. These results are meaningful for dialysis providers, Medicare, and other payers, and most importantly, for patients. Now, late this year, we'll have the results from the VOCAL study that we're conducting at DaVita Clinics. That's evaluating Vafseo dosed three times weekly. The trial also contains a sub-study of red blood cell characteristics, which we believe could make a compelling argument for Vafseo.

Speaker #3: Reduced hospitalization translated into a cost savings of about 3,700 dollars per patient per year. Meaning a savings of almost 2 billion dollars per year if all eligible patients were treated with Vassio.

Speaker #3: These results are meaningful for dialysis providers, Medicare and other payers, and most importantly, for patients. Late this year, we'll have the results from the vocal study that we're conducting at DaVita Clinics, that's evaluating Vassio dose three times weekly.

Speaker #3: The trial also contains a sub-study of red blood cell characteristics, which we believe could make a compelling argument for Vassio. Fundamentally, when you manage hemoglobin levels with a more physiologic approach, you get a more physiologic and potentially better functioning red blood cell.

John Butler: Fundamentally, when you manage hemoglobin levels with a more physiologic approach, you get a more physiologic and potentially better functioning red blood cell. The VOCAL data will be followed by results from the VOICE trial being run by USRC, evaluating Vafseo versus standard of care on a hierarchical composite of all-cause mortality and hospitalization rates. Data expected in early 2027. In my experience, in order to make a drug standard of care, particularly with nephrologists, you have to continue to deliver data that demonstrates the benefit of the product for their patients versus current treatment. Now, in addition to the launch of Vafseo in 2025, we introduced our rare kidney disease pipeline, which we believe will be an additional and important value driver for the company going forward.

Speaker #3: The vocal data will be followed by results from the voice trial being run by USRC, evaluating Vassio versus standard of care on a hierarchical composite of all-cause mortality and hospitalization rates.

Speaker #3: Data expected in early 2027. In my experience, in order to make a drug standard of care, particularly with nephrologists, you have to continue to deliver data that demonstrates the benefit of the product for their patients versus current treatment.

Speaker #3: Now, in addition to the launch of Vassio in 2025, we introduced our rare kidney disease pipeline, which we believe will be an additional and important value driver for the company going forward.

Speaker #3: 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 disease community, and fits squarely within our corporate mission.

John Butler: 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 disease community, and fits squarely within our corporate mission. We will host an R&D day for investors on 2 April to discuss our mid-stage assets in detail, namely praliciguat and AKB-097, as well as introduce our early HIF-PHI, AKB-9090. Now, praliciguat is an oral, once-daily, soluble guanylate cyclase stimulator being evaluated in a Phase II clinical trial of focal segmental glomerulosclerosis, or FSGS. We expect to enroll up to approximately 60 patients in this trial, which will evaluate change from baseline in urine protein to creatinine ratio, or UPCR, at 24 weeks as the primary endpoint.

Speaker #3: We will host an R&D day for investors on April 2nd to discuss our mid-stage assets in detail. Namely, Prolisaguat and AKB097, as well as introduce our early HIF PHI AKB9090.

Speaker #3: Prolisaguat is an oral, once-daily soluble guanylate cyclase stimulator, being evaluated in a Phase II clinical trial of focal segmental glomerulosclerosis, or FSGS. We expect to enroll up to approximately 60 patients in this trial.

Speaker #3: Which will evaluate change from baseline in urine protein to creatinine ratio, or UPCR, at 24 weeks as the primary endpoint. Both the extensive preclinical work in FSGS disease models as well as previous clinical results from Prolisaguat in diabetic kidney disease give us confidence in the potential for the therapy to impact FSGS.

John Butler: Both the extensive preclinical work in FSGS disease models, as well as previous clinical results for praliciguat in diabetic kidney disease, give us confidence in the potential for the therapy to impact FSGS. AKB-097 is our tissue-targeted complement inhibitor that we acquired late last year. We believe this product candidate could have comparable efficacy to the most efficacious, currently approved products in a well-characterized pathway. While the tissue targeting allows for the potential to, first, avoid the box warning for infection risk, and second, to deliver the drug in a more convenient dosing regimen. We believe this has best-in-class potential. We plan to initiate a Phase II open label basket trial in the second half of this year. We will be looking at initial indications of IgA nephropathy, lupus nephritis, and C3 glomerulopathy. These diseases represent a multibillion-dollar market opportunity in areas of high unmet need.

Speaker #3: AKB-097 is our tissue-targeted complement inhibitor that we acquired late last year. We believe this product candidate could have comparable efficacy to the most efficacious currently approved products in a well-characterized pathway.

Speaker #3: While the tissue targeting allows for the potential to first avoid the box warning for infection risk and second to deliver the drug in a more convenient dosing regimen.

Speaker #3: We believe this has best-in-class potential. We plan to initiate a Phase II open-label basket trial in the second half of this year. We will be looking at initial indications of IgA nephropathy, lupus nephritis, and C3 glomerulopathy.

Speaker #3: These diseases represent a multibillion-dollar market opportunity in areas of high unmet need. 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.

John Butler: 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. As this is an open label basket study, we expect to begin to report initial data in 2027. Lastly, we plan to initiate a phase I study in healthy volunteers of AKB-9090 in the first half of 2026, with top-line results later this year. Our initial target disease area for 9090 is acute kidney injury associated with cardiac surgery. Our research and development team is working hard to deliver these important catalysts as quickly as possible. Of course, all of this work will be built on the success of Vafseo. Now, let me turn it over to Nick to give more granularity on the launch.

Speaker #3: As this is an open-label basket study, we expect to begin to report initial data in 2027. And lastly, we plan to initiate a Phase I study in healthy volunteers of AKB9090 in the first half of 2026 with top-line results later this year.

Speaker #3: Our initial target disease area for 9090 is acute kidney injury associated with cardiac surgery. Our research and development team is working hard to deliver these important catalysts as quickly as possible.

Speaker #3: But of course, all of this work will be built on the success of Vassio. Now, let me turn it over to Nick to give more granularity on the launch.

Speaker #4: Thanks, John. Good morning, folks. Like John, I am encouraged by the growth potential for Vassio in 2026, which is supported by early Q1 data.

Nick Grund: Thanks, John. Good morning, folks. Like John, I am encouraged by the growth potential for Vafseo in 2026, which is supported by early Q1 data. First, let me recap the Q4 2025. During the quarter, approximately 800 prescribers wrote a prescription for Vafseo, and each prescriber, on average, wrote approximately 10.3 prescriptions. Of note, 128 of those were new prescribers. During Q4, we were pleased to see our customer base expand and the number of new starts at dialysis organizations outside of USRC, specifically at DaVita and IRC, increased over Q3. Approximately 25% of new patients came from dialysis organizations other than USRC during the Q4.

Speaker #4: But first, let me recap the quarter four 2025. During the quarter, approximately 800 prescribers wrote a prescription for Vassio, and each prescriber, on average, wrote approximately 10.3 prescriptions.

Speaker #4: Of note, 128 of those were new prescribers. During quarter four, we were pleased to see our customer base expand and the number of new starts at dialysis organizations outside of USRC, specifically at DaVita and IRC, increased over Q3.

Speaker #4: Approximately 25% of new patients came from dialysis organizations other than USRC during the fourth quarter. That said, Vassio demand in quarter four was slightly down versus quarter three, as we reported 6.2 million dollars in Vassio net product revenue on about 11 million dollars in demand.

Nick Grund: That said, Vafseo demand in Q4 was slightly down versus Q3, as we reported $6.2 million in Vafseo net product revenue on about $11 million in demand. We believe the slight decrease in demand, specifically in Q4, was primarily a result of a lower number of patient starts at dialysis organizations deciding to transition to an observed in-center dosing protocol, and thereby waiting until the observed dosing protocol was available. USRC, for example, began to transition in November in approximately 25% of clinics. By the end of Q1, we expect the vast majority of USRC in-center patients to be receiving Vafseo three times a week while receiving dialysis, utilizing USRC's observed dosing protocol.

Speaker #4: We believe the slight decrease in demand specifically in quarter four was primarily a result of a lower number of patient starts at dialysis organizations deciding to transition to an observed in-center dosing protocol and thereby waiting until the observed dosing protocol was available.

Speaker #4: USRC, for example, began to transition in November in approximately 25% of clinics, by the end of Q1, we expect a vast majority of USRC in-center patients to be receiving Vassio three times a week while receiving dialysis utilizing USRC's observed dosing protocol.

Speaker #4: Of note, USRC's decision to transition to an in-center observed dosing protocol did result in a reduction in their inventory as they shifted from shipping a bottle to a patient's home to stocking bottles at their centers.

Nick Grund: Of note, USRC's decision to transition to an in-center observed dosing protocol did result in a reduction in their inventory, as they shifted from shipping a bottle to a patient's home to stocking bottles at their centers. The distribution change resulted in a one-time inventory drawdown impact of about $4.8 million in Q4 2025. Now let's turn to 2026. We begin the year on an optimistic note, as we are already building momentum. At present, 290,000 patients have prescribing access, as DCI has implemented a Vafseo protocol. With the almost fivefold increase in prescriber access since the end of Q3 2025, and our field teams actively calling on physicians with expanded access, we are seeing an expansion of brand awareness and a comfort prescribing Vafseo within the nephrology community.

Speaker #4: The distribution change resulted in a one-time inventory drawdown impact of about 4.8 million dollars in the fourth quarter of 2025. Now let's turn to 2026.

Speaker #4: We begin the year on an optimistic note as we are already building momentum. At present, 290,000 patients have prescribing access as DCI has implemented a Vassio protocol.

Speaker #4: With the almost fivefold increase in prescriber access since the end of Q3 2025, and our field team's actively calling on physicians with expanded access, we are seeing an expansion of brand awareness and a comfort prescribing Vafseo within the nephrology community.

Speaker #4: Additional commercial trends give us confidence in quarter one and the year ahead. First, we saw improved adherence from the beginning of 2025 through the end of the year and continuing into 2026.

Nick Grund: Additional commercial trends give us confidence in Q1 and the year ahead. First, we saw improved adherence from the beginning of 2025 through the end of the year and continuing into 2026. More importantly, the percentage of patients who got an initial refill rose from approximately 75% for all daily dosing patients in the first 9 months of 2025 to approximately 91% among the small subset of patients who are on observed dosing regimen. Looking at early patient data from January, we've continued to see an improvement in first refill adherence, with approximately 87% among the now larger subset of patients on an observed dosing regimen. We're encouraged by this improvement and will continue to monitor adherence rates in 2026 as centers implement their observed dosing protocols.

Speaker #4: More importantly, the percentage of patients who got an initial refill rose from approximately 75% for all daily dosing patients in the first nine months of 2025 to approximately 91% among the small subset of patients who were on observed dosing regimen.

Speaker #4: Looking at early patient data from January, we've continued to see an improvement in first refill adherence, with approximately 87% among the now larger subset of patients on an observed dosing regimen.

Speaker #4: We're encouraged by this improvement and will continue to monitor adherence rates in 2026 as centers implement their observed dosing protocols. Second, we're also seeing a nice pickup in utilization in broader adoption from IRC, the fourth largest dialysis center.

Nick Grund: Second, we are also seeing a nice pickup in utilization and broader adoption from USRC, the fourth largest dialysis center, after USRC made Vafseo available in late August and implemented an observed dosing protocol late in Q4. In addition, Dialysis Clinic, Inc. has started to put patients on therapy. We also see the number of prescribers within DaVita starting to increase, with some physicians trialing Vafseo in their patients. This has led to a higher percentage of new patients being from non-USRC clinics than in 2025. The investment dialysis organizations continue to make in Vafseo, taking the time and effort to integrate the therapy into protocols and care plans, make me believe that providers and prescribers understand the clinical benefit Vafseo can deliver and are committed to using it long term.

Speaker #4: After IRC made Vassio available in late August and implemented an observed dosing protocol late in quarter four. In addition, DCI has started to put patients on therapy.

Speaker #4: We also see the number of prescribers within DaVita starting to increase, with some physicians trialing Vassio in their patients. This has led to a higher percentage of new patients being from non-USRC clinics than in 2025.

Speaker #4: The investment dialysis organizations continue to make in Vassio taking the time and effort to integrate the therapy and into protocols and care plans make me believe that providers and providers prescribers understand the clinical benefit Vassio can deliver and are committed to using it long-term.

Speaker #4: As prescribers continue to gain real-world experience as they transition patients onto Vassio, I expect the momentum to continue to build. Our dedicated sales team is focused on increasing the breadth and depth of prescribing a critical step to becoming standard of care for patients on dialysis.

Nick Grund: As prescribers continue to gain real-world experience as they transition patients onto Vafseo, I expect the momentum to continue to build. Our dedicated sales team is focused on increasing the breadth and depth of prescribing, a critical step to becoming standard of care for patients on dialysis. Let me now turn it over to Eric.

Speaker #4: Let me now turn it over to Eric.

Speaker #5: Thanks, Nick. As John mentioned, we saw a strong top-line performance in calendar year '25 as net product revenues increased nearly 50% over calendar year '24, driven by the US introduction of Vassio and increased sales of Orixia.

Erik Ostrowski: Thanks, Nick. As John mentioned, we saw a strong top-line performance in calendar year 2025, as net product revenues increased nearly 50% over calendar year 2024, driven by the US introduction of Vafseo and increased sales of Auryxia. Our continued careful expense management in 2025 allowed us to both invest in R&D initiatives we believe can generate significant shareholder value and maintain our solid financial position. We are excited for a strong 2026 and executing on our plans to grow Vafseo revenues and advance our pipeline, including our mid-stage rare kidney disease programs. I'll now provide an overview of our Q4 2025 and calendar year 2025 financial results as compared to the prior year.

Speaker #5: Our continued careful expense management in 2025 allowed us to both invest in R&D initiatives we believe can generate significant shareholder value and maintain our solid financial position.

Speaker #5: We are excited for a strong 2026 and executing on our plans to grow Vassio revenues and advance our pipeline, including our mid-stage rare kidney disease programs.

Speaker #5: I'll now provide an overview of our Q4 '25 and calendar year '25 financial results, as compared to the prior year. Total revenues were $57.6 million in Q4 '25 compared to $46.5 million in Q4 '24, and $236.2 million in calendar year '25 compared to $160.2 million in calendar year '24.

Erik Ostrowski: Total revenues were $57.6 million in Q4 2025, compared to $46.5 million in Q4 2024, and $236.2 million in calendar year 2025, compared to $160.2 million in calendar year 2024. These increases were driven by sales of Vafseo and an increase in Auryxia sales. Vafseo net product revenues were $6.2 million in Q4 2025 and $45.8 million in calendar year 2025. As Nick mentioned, Q4 Vafseo sales were negatively impacted by the inventory drawdown at USRC. Auryxia net product revenues were $48.1 million in Q4 2025, compared to $44.4 million in Q4 2024, and $181.5 million in calendar year 2025, compared to $152.2 million in calendar year 2024.

Speaker #5: These increases were driven by sales of Vassio and an increase in Orixia sales. Vassio net product revenues were $6.2 million in Q4 '25 and $45.8 million in calendar year '25.

Speaker #5: As Nick mentioned, Q4 Vassio sales were negatively impacted by the inventory drawdown in USRC. Orixia net product revenues were $48.1 million in Q4 '25 compared to $44.4 million in Q4 '24, and $181.5 million in calendar year '25 compared to $152.2 million in calendar year '24.

Speaker #5: We note that we anticipate generic competition for Orixia to expand this year beyond the current authorized generic competition, and therefore expect Orixia revenues to decrease in 2026 as compared to 2025 Orixia revenues.

Erik Ostrowski: We note that we anticipate generic competition for Auryxia to expand this year beyond the current authorized generic competition, and therefore expect Auryxia revenues to decrease in 2026 as compared to 2025 Auryxia revenue. Turning to expenses, cost of goods sold was $12.5 million in Q4 2025, compared to $20.4 million in Q4 2024, and $39.5 million in calendar year 2025, compared to $63.2 million in calendar year 2024. COGS in both periods was driven by higher Auryxia sales volumes in 2025 and was impacted by the elimination in 2025 of a quarterly $9 million non-cash intangible amortization charge we incurred through Q4 of 2024.

Speaker #5: Turning to expenses, cost of goods sold was $12.5 million in Q4 '25 compared to $20.4 million in Q4 '24, and $39.5 million in calendar year '25 compared to $63.2 million in calendar year '24.

Speaker #5: COGS in both periods was driven by higher Orixia sales volumes in 2025 and was impacted by the elimination in 2025 of a quarterly $9 million non-cash and tangible amortization charge being incurred through Q4 of 2024.

Speaker #5: In addition, COGS for calendar year '24 included a $12.3 million benefit due to our ability to sell inventory previously written down as excess inventory.

Erik Ostrowski: In addition, COGS for calendar year 2024 included a $12.3 million benefit due to our ability to sell inventory previously written down as excess inventory. Of note, Vafseo-related COGS in both periods of 2025 was derived from pre-launch inventory, which does not include the full cost of manufacturing, as a portion of those inventory-related expenses were reported as R&D expenses in the period incurred prior to Vafseo's approval in the US. R&D expenses were $26.6 million in Q4 2025, compared to $11.8 million in Q4 2024, and $62.4 million in calendar year 2025, compared to $37.7 million in calendar year 2024.

Speaker #5: Of note, Vassio-related COGS in both periods of 2025 was derived from pre-launch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were reported as R&D expenses in the period incurred prior to Vassio's approval in the US.

Speaker #5: R&D expenses were $26.6 million in Q4 '25 compared to $11.8 million in Q4 '24, and $62.4 million in calendar year '25 compared to $37.7 million in calendar year '24.

Speaker #5: The increase in expenses in both periods was driven by increased clinical trial-related activities for Vassio and our other product candidates, higher headcount-related costs, as well as by a $12.8 million charge incurred during Q4 '25 related to acquired in-process R&D costs associated with the acquisition of AKB097.

Erik Ostrowski: The increase in expenses in both periods was driven by increased clinical trial-related activities for Vafseo and our other product candidates, higher headcount-related costs, as well as by a $12.8 million charge incurred during Q4 2025 related to acquired in-process R&D costs associated with the acquisition of AKB-097. SG&A expenses were $26.1 million in Q4 2025, compared to $27.7 million in Q4 2024, and $107.5 million in calendar year 2025, compared to $106.5 million in calendar year 2024. Net loss in Q4 2025 decreased to $12.2 million, as compared to a net loss of $22.8 million in Q4 2024.

Speaker #5: SG&A expenses were $26.1 million in Q4 '25 compared to $27.7 million in Q4 '24, and $107.5 million in calendar year '25 compared to $106.5 million in calendar year '24.

Speaker #5: Net loss in Q4 '25 decreased to $12.2 million as compared to a net loss of $22.8 million in Q4 '24. Net loss for the year also decreased to $5.3 million in calendar year '25 as compared to a net loss of $69.4 million in calendar year '24.

Erik Ostrowski: Net loss for the year also decreased to $5.3 million in calendar year 2025, as compared to a net loss of $69.4 million in calendar year 2024. The decrease in net loss in both periods was driven by the increase in net product revenues, which was partially offset by higher expenses. Turning to the balance sheet, cash and cash equivalents as of 31 December 2025, were $184.8 million, as compared to $51.9 million as of 31 December 2024. We believe our existing cash resources and cash from operations will be sufficient to fund our current operating plan for at least the next two years. With that, we welcome questions.

Speaker #5: The decrease in net loss in both periods was driven by the increase in net product revenues, which was partially offset by higher expenses. Turning to the balance sheet, cash and cash equivalences of December 31, 2025, were $184.8 million as compared to $51.9 million as of December 31, 2024.

Speaker #5: We believe our existing cash resources, in cash from operations, will be sufficient to fund our current operating plans for at least the next two years.

Speaker #5: With that, we welcome questions.

Speaker #6: Thank you. At this time, we'll conduct the question-and-answer session. As a reminder to ask the question, you'll need to first start one one on your telephone and wait for your name to be announced.

Operator: Thank you. At this time, we'll conduct a question-and-answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Julian Harrison of BTIG. Your line is now open.

Speaker #6: To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. And our first question comes from a line of Julian Harrison of BTIG.

Speaker #6: Your line is now open.

Speaker #7: Hi. Good morning. Thank you for taking the questions. I have a few, and I'll just go one by one here. First, can you talk more about your expectations for a sequential Vassio growth in 2026?

Julian Harrison: Hi, good morning. Thank you for taking the questions. I have a few, and I'll just go one by one here. First, can you talk more about your expectations for sequential Vafseo growth in 2026? Wondering also how we should be thinking about that in relation to your inventory-adjusted demand in Q4 2025. Second, to what extent do you expect data from the VOICE study to potentially accelerate uptake next year across dialysis providers? Then finally, I'm curious how operationalized the Vafseo access at DaVita currently is. Are the VOCAL data a big gaining step there, or do you expect broad commercial uptake at DaVita before the VOCAL data are reported?

Speaker #7: Wondering also how we should be thinking about that in relation to your inventory-adjusted demand in the fourth quarter of 2025. Second, to what extent do you expect data from the voice study to potentially accelerate uptake next year across dialysis providers?

Speaker #7: And then finally, I'm curious how operationalized the Vassio access at DaVita currently is, are the vocal data a big getting step there, or do you expect broad commercial uptake at DaVita before the vocal data are reported?

Speaker #6: Great. That's a great list, Julian. Thanks. So expectations for growth first in Vassio. So we're not guiding for revenue. So I'll start with that.

John Butler: Great. That's a great list, Julian. Thanks. Expectations for growth first in Vafseo. We're not guiding for revenue, so I'll start with that. I mean, I think it's, you know, again, when you're in a launch, particularly in this dialysis market, as we saw last year, you know, we certainly, I certainly expected A, that dialysis providers would latch on to the opportunities around TDAPA more quickly. You know, we certainly didn't anticipate the issues we had with adherence, but, you know, we're certainly dealing with those, as I said, you know, very much head-on. I think the way to think about it is, kind of forget the inventory fluctuations. You know, we give you the demand number, you know, and really think about that, right?

Speaker #6: I mean, I think it's, again, when you're in a launch, particularly in this dialysis market, as we saw last year, we certainly I certainly expected A, that dialysis providers would latch on to the opportunities around Tdappa more quickly and we certainly didn't anticipate the issues we had with adherence.

Speaker #6: But we're certainly dealing with those, as I said, very much head-on. But I think the way to think about it is to kind of forget the inventory fluctuations.

Speaker #6: We give you the demand number, and really think about that, right? I mean, demand basically has been flat, right? We had $12 million in the third quarter, $11 million in the fourth quarter, and it was actually 12 in the second quarter as well, right?

John Butler: I mean, demand basically has been flat. We had $12 million in Q3, $11 million in Q4, and it was actually $12 million in Q2 as well, right? You know, we absolutely expect and are seeing growth from that level. You know, exactly how quickly that will increase, I think, some people are kind of looking for this sort of magical hockey stick. You know, when I think about launches that I've been a part of in this market, that didn't have the complexity of the dialysis provider in between, I mean, I go way back in time to sevelamer, you know, Renagel launch.

Speaker #6: So we absolutely expect and are seeing growth from that level. Exactly how quickly that will increase, I think similar kind of looking for this sort of magical hockey stick and when I think about launches that I've been a part of in this market that didn't have the complexity of the dialysis provider in between, I mean, I go way back in time to Savellam or Renagel launch.

John Butler: We did $20 million in the first year, $55 million in the second year, $130 or something in the third year. Ultimately, it was a $1.3 billion product, right? Nephrologists don't adopt products like oncologists, right? You know, you definitely have a more measured growth. I think that's what we're seeing here as well. Particularly, I think as you look at DaVita, where, you know, DaVita's made the product available, but aren't, you know, sending out lists to physicians of patients that have reimbursement. They're leaving it to the physician to make the decision. That's fine. That's on our field teams to sell and educate physicians about the benefits. You know, it's things like the data from VOICE.

Speaker #6: We did $20 million in the first year, $55 million in the second year, $130 or something in the third year. Ultimately, it was $1.3 billion product, right?

Speaker #6: But nephrologists don't adopt products like oncologists, right? And you definitely have a more measured growth. And I think that's what we're seeing here as well.

Speaker #6: Particularly, I think as you look at DaVita, where DaVita's made the product available, but aren't sending out lists to physicians of patients that have reimbursement.

Speaker #6: They're leaving it to the physician to make the decision. That's fine. That's on our field teams to sell and educate physicians about the benefits.

Speaker #6: And it's things like the data from voice. So you look at the data from the ASN meeting last year, super important data, right? We'll make a huge impact.

John Butler: You look at the data from the ASN meeting last year, it's super important data, right? Will make a huge impact, but it's not published yet, right? It's been submitted for publication. It's just been presented at ASN. Our medical affairs folks can't educate physicians with that data until there's a reprint, you know, in publication, peer-reviewed, which we expect is going to happen this year. You know, then the same thing will be the case with the cost analysis that's being presented this weekend. You have to get those things published, and I think you'll see the same with VOICE and VOCAL as well. As these things are published, available, and our sales and medical affairs folks can use them, these are the things that influence utilization in physicians.

Speaker #6: But it's not published yet, right? So it's been submitted for publication. It's just been presented at ASN. Our medical affairs folks can't educate physicians with that data until there's a reprint in publication peer-reviewed which we expect is going to happen this year.

Speaker #6: But then the same thing will be the case with the cost analysis that's being presented this weekend. We have to get those things published.

Speaker #6: And I think you'll see the same with voice and vocal as well. As these things are published available and our sales and medical affairs folks can use them, these are the things that influence utilization and physicians.

Speaker #6: And I've never been more confident that the data that we're generating supports that managing anemia with a HIF/PHI and the only one that's available is Vassio is going to be standard of care for this patient population.

John Butler: I've never been more confident that the data that we're generating supports that managing anemia with a HIF-PHI, and the only one that's available is Vafseo, is going to be standard of care for this patient population. It really is just a question of how quickly that happens. You know, we're seeing growth now, we're confident in that growth, but, you know, we're not in a place where we want to guide around that. We want to see it continue to move in the direction that it's moving now. Maybe, Nick, you can talk more about operationalizing at DaVita?

Speaker #6: It really is just a question of how quickly that happens. And we're seeing growth now. We're confident in that growth. But we're not in a place where we want to guide around that.

Speaker #6: We want to see it continue to move in the direction that it's moving now. And maybe Nick, you can talk more about operationalizing at DaVita?

Speaker #8: Yeah. And so certainly, DaVita made the product widely available throughout their "village" in late Q4. And as they've started to focus on educating their physicians, they're really starting with the home dialysis population.

Erik Ostrowski: Yeah, certainly DaVita made the product widely available throughout their "village" in late Q4. As they've started to focus on educating their physicians, they're really starting with the home dialysis population.

Speaker #8: That population within DaVita is greater than 30,000 patients. So just about the size of USRC. And so that's a great step. It really fits with.

Nick Grund: That population with DaVita is greater than 30,000 patients. Just about the size of USRC. That's a great step. It really fits with-

John Butler: USRC in total?

Nick Grund: In total, yeah.

Speaker #8: In total. Yeah. It really fits well within the profile of Vassio. So super excited about that. Second, they're also really contemplating and observed dosing protocol.

John Butler: Yeah.

Nick Grund: It really fits well within the profile of Vafseo. Super excited about that. Second, they're also, you know, really contemplating an observed dosing protocol, which will certainly, hopefully, handle some of the adherence challenges that we've seen in the past. You know, DaVita is not going to, as John suggested, send out lists and compel physicians to try it. It's our field teams, whether that be medical, educating them about Vafseo or sales, selling Vafseo, that are really going to help physicians try and then increase usage, and then ultimately adopt Vafseo as a standard of care. When we think about that process, you know, DaVita is a fairly big organization. You know, getting them to try it, and we're very encouraged.

Speaker #8: Which will certainly hopefully handle some of the adherence challenges that we've seen in the past. And so but DaVita is not going to, as John suggested, send out lists and compel physicians to try it.

Speaker #8: It's our field teams whether that be medical, educating them about Vassio or sales, selling Vassio. That are really going to help physicians try and then increase usage and then ultimately adopt Vassio as a standard of care.

Speaker #8: And so when we think about that process, DaVita is a fairly big organization. Getting them to try it. And we're very encouraged. We in the quarter four, we saw a number of DaVita physicians starting to utilize Vassio.

Nick Grund: You know, we, in Q4, we saw a number of DaVita physicians starting to utilize Vafseo, and that's continued into Q1. As John suggested, we're not gonna see this hockey stick inflection. It is gonna be steady growth month-over-month, quarter-over-quarter, as we start to penetrate deeper in terms of breadth and depth.

Speaker #8: And that's continued into quarter one. And so as John suggested, we're not going to see this hockey stick inflection. It is going to be steady growth month over month, quarter over quarter.

Speaker #8: As we start to penetrate deeper in terms of breadth and depth.

Speaker #6: I mean, it definitely depends how you define a hockey stick, right? Three-quarters of flat sales? It will be you will have growth. So that's you can call that a hockey stick.

John Butler: I mean, it definitely depends on how you define a hockey stick, right? Three quarters of flat sales, you will have growth. you know, that's-

Nick Grund: You can call that a hockey stick. We do expect that to continue to grow. It really is about what's the slope of that curve, right? You know, again, I think as I said, one of the things that surprised me most was that it didn't happen faster because of the economic benefits of using the drug during TDAPA. At the end of the day, it was always about the clinical benefit, and that's, you know, what we're showing now. You know, Nick talked about the observed dosing protocols that are being put in place. We really do think by the end of the year, most patients who are being treated in center are gonna be treated with that observed dosing.

Speaker #6: We do expect that to continue to grow. It really is about what's the slope of that curve, right? And again, I think as I said, one of the things that surprised me most was that it didn't happen faster because of the economic benefits of using the drug during Tdapa.

Speaker #6: But at the end of the day, it was always about the clinical benefit. And that's what we're showing now. And Nick talked about the observed dosing.

Speaker #6: Protocols that are being put in place. We really do think by the end of the year, most patients who are being treated in-center are going to be treated with that observed dosing.

Speaker #6: And that observed dosing means they get it three times a week when they're sitting in the chair. That helps greatly with compliance. And the anecdotes that we're hearing from physicians that have begun utilizing three times weekly dosing are and more importantly, maybe the anemia managers that are managing those patients on a daily basis.

Nick Grund: That observed dosing means they get it three times a week when they're sitting in the chair. That helps greatly with compliance. You know, the anecdotes that we're hearing from physicians that have begun utilizing three times weekly dosing are. More importantly, maybe the anemia managers that are managing those patients on a daily basis, they're really very, very positive. You know, we're really excited that DaVita is moving forward with that as well. If they focus on the first part of the year on their home population, that will be fantastic for us from a growth perspective. Hopefully, that helps, Julian.

Speaker #6: They're really very, very positive. So we're really excited that DaVita's moving forward with that as well. And if they focus in the first part of the year on their home population, that will be fantastic.

Speaker #6: For us from a growth perspective. Hopefully, that helps, Julian.

Speaker #9: Excellent. This is very helpful all around. Thank you very much.

Julian Harrison: Excellent. This is very helpful all around. Thank you very much.

Speaker #1: Thank you. One moment for our next question. Our next question comes from the line of Roger Song of Jefferies and line is now open.

[Analyst] (Jefferies): Thank you. One moment for our next question. Our next question comes from the line of Roger Song of Jefferies. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Roger Song of Jefferies. Your line is now open.

Speaker #10: Hey, good morning, team. Congrats on the progress, and thanks for taking our question. This is Nabeel on for Roger. It's encouraging to hear about the improvement in the first refill adherence.

Nabil: Hey, good morning, team. Congrats on the progress. Thanks for taking our question. This is Nabil on for Roger. It's encouraging to hear about the improvement in the first refill adherence. I was curious if you'd comment on how second and third refill rates are trending, and then any other comments just on the anemia manager education. I have a second one.

Nabeel Arsh: Hey, good morning, team. Congrats on the progress. Thanks for taking our question. This is Nabil on for Roger. It's encouraging to hear about the improvement in the first refill adherence. I was curious if you'd comment on how second and third refill rates are trending, and then any other comments just on the anemia manager education. I have a second one.

Speaker #10: I was curious if you could comment on how second and third refill rates are trending, and then any other comments just on the anemia manager education?

Speaker #10: And then I have a second one.

Speaker #6: Nick, do you want to take that one? Yeah. And so super. Let's kind of repeat the first refill because I think it is significant.

John Butler: Nick, do you want to take that one?

Nick Grund: you know, let's just kinda repeat the first refill because I think it is significant. Historically, we've seen roughly a 75% adherence on the first refill. A patient receives an initial prescription, that first refill is the next prescription. that moving from 75% to 91% in the Q4 in that small subset of patients, was really an important, I'll call it, bellwether for what we're gonna see moving on. We were waiting for the bigger subset in Q1, and specifically in January, to say, Okay, now is it, is it really coming to fruition in a larger patient population? It is. We're seeing, you know, this 87% first refill, rate.

Speaker #6: So historically, we've seen roughly a 75% adherence on the first refill. So patient receives an initial prescription. That first refill is the next prescription.

Speaker #6: And so that moving from 75% to 91% in the fourth quarter in that small subset of patients was really an important I'll call it bellwether for what we're going to see moving on.

Speaker #6: We were waiting for the bigger subset in quarter one and specifically in January to say, "Okay, now is it really coming to fruition in a larger patient population?" And it is.

Speaker #6: We're seeing this 87% first refill rate. As they moved into the second prescription, I think your question is a really good one. We've seen significant continuation of that adherence rate.

Nick Grund: As they moved into the second prescription, I think your question is a really good one, we've seen, you know, significant continuation of that adherence rate. You know, you have to remember, these patients have significant comorbidities, comortality, they receive transplants. There's an always an underlying, let's call it, 2% to 4% discontinuation rate in that population.

Speaker #6: And so you have to remember these patients have significant comorbidities, comortality. They receive transplants. There's an always an underlying let's call it 2 to 4 percent discontinuation rate in that population.

John Butler: Every month.

Speaker #6: Every single month. And so we've seen this continuation of this high 80, 90 percent adherence rate even through the second prescription is starting to lead towards some positive trends for annual adherence rates.

Nick Grund: ... every single month. We've seen this continuation of this high 80%, 90% adherence rate, even through the second prescription, is starting to lead towards some positive trends for annual adherence rates.

John Butler: You know, the other thing you're gonna see, as the clinical data continues to build, you know, even if a patient, you know, like one of the main reasons that a patient would go off is if they feel like they have some GI tolerability issues. We know those are transient, right? What we've seen from physicians who really believe in the clinical benefit, they talk to the patient and say, I understand you're dealing with this, but we put you on this medicine for a reason. You know, we really believe this is gonna benefit you. I want you to try to work through it, and, you know, it will go away. It does.

Speaker #6: And the other thing you're going to see as the clinical data continues to build, even if a patient one of the main reasons that a patient would go off is if they feel like they have some GI tolerability issues.

Speaker #6: But we know those are transient, right? And what we've seen from physicians who really believe in the clinical benefits, they talk to the patient, say, "I understand you're dealing with it, but we put you on this.

Speaker #6: Medicine for a reason. We really believe this is going to benefit you. I want you to try to work through it." And it will go away.

Speaker #6: And it does. And then there's other physicians or nurse managers who aren't as sold on the drug. Maybe it's a way to say it or don't have the same level of education on the product benefits.

John Butler: There's other physicians or nurse managers who aren't as, you know, as sold on the drug, maybe it's a way to say it, or don't have the same level of education on the product benefits, and they'll acquiesce and take the patient off, right? Yeah, Nick, you wanna add something?

Speaker #6: And they'll acquiesce and take the patient off, right? So yeah, Nick, do you want to add something?

Nick Grund: Yeah. The only thing I'd probably add is, by people moving from daily dosing to observed therapy, in the clinic, what we've seen is a number of restarts, patients coming back in. That means that physicians are saying, Hey, that patient who may not have been compliant the first time around, by being able to give it to them in the chair, we now can go back to that patient because we believe in the value that Vafseo might bring. By being able to dose it in the clinic three times a week, has allowed them to offset that compliance challenge and really provide Vafseo for that patient.

Speaker #10: Yeah. The only thing I'd probably add is and by people moving from daily dosing to observed therapy in the clinic, what we've seen is a number of restarts, patients.

Speaker #10: Patients coming back in. That means that physicians are saying, "Hey, that patient who may not have been compliant the first time around, by being able to give it to them in the chair, we now can go back to that patient because we believe in the value that Vassi might bring."

Speaker #10: And by being able to dose it in the clinic three times a week, has allowed them to offset that compliance challenge and really provide Vassi for that patient."

Speaker #6: Nabeel, you had a second question. I'm sorry. I didn't write it down. I can't remember what it is.

John Butler: Nabil, you had a second question. I'm sorry, I didn't write it down. I can't remember what it is.

Speaker #9: Oh, good. Yeah. Thank you so much for those updates and that color. Just on the 90/90 asset, again, congrats on the progress here. Just curious how that's if you can comment a little bit more on how that's mechanistically differentiated from prior SPHs and then any other thoughts there.

Nabil: All good, yeah. Thank you so much for those updates and that color. Just on the AKB-9090 asset, again, congrats on the progress here. If you can comment a little bit more on how that's mechanistically differentiated from prior HIF-PHs, and then, any other thoughts there? Thank you.

Nabeel Arsh: All good, yeah. Thank you so much for those updates and that color. Just on the AKB-9090 asset, again, congrats on the progress here. If you can comment a little bit more on how that's mechanistically differentiated from prior HIF-PHs, and then, any other thoughts there? Thank you.

Speaker #9: Thank you.

John Butler: On 90/90. Steve, are you on?

Speaker #6: On 90/90, Steve, are you on? Can you use that one?

Steven C. Burke: Yeah.

Steven Burke: Yeah.

John Butler: Take that one?

Speaker #10: Yeah. The molecule has a different pharmacokinetics and a slightly different profile. Vatadistat tends to preferentially target the liver. That's where the erythropoietin is made.

Steven C. Burke: The, you know, the molecule has a different, you know, pharmacokinetics and a slightly different profile. Vadadustat tends to preferentially target the liver. That's where the erythropoietin is made, whereas 90/90, because of its structural differences, has more widespread tissue penetration, so it gets into the lung and the kidney. In our non-clinical models of ischemia-reperfusion injury, 9090 is clearly the best compound that we had for that indication, whereas vadadustat probably would not work in that indication. It's all about the structure and the PK.

Steven Burke: The, you know, the molecule has a different, you know, pharmacokinetics and a slightly different profile. Vadadustat tends to preferentially target the liver. That's where the erythropoietin is made, whereas 90/90, because of its structural differences, has more widespread tissue penetration, so it gets into the lung and the kidney. In our non-clinical models of ischemia-reperfusion injury, 9090 is clearly the best compound that we had for that indication, whereas vadadustat probably would not work in that indication. It's all about the structure and the PK.

Speaker #10: Whereas 90/90, because of its structural differences, has more widespread tissue penetration so it gets into the lung and the kidney. And in our non-clinical models of ischemia reperfusion injury 9090 was clearly the best compound that we had for that indication.

Speaker #10: Whereas Vatadistat probably would not work in that indication. So it's all about the structure and the PK.

Speaker #9: Thank you. Very helpful. That's all from me.

Nabil: Thank you. Very helpful. That's all for me.

Nabeel Arsh: Thank you. Very helpful. That's all for me.

John Butler: Nabil, I think your other question was around anemia manager education, and I think it may be important to point out, you know, we definitely recognize how significant that is. You know, a lot of that education has to be done through the medical affairs folks, our MSLs. You know, we made the decision earlier this year to expand our medical affairs group so that we have more folks' feet on the ground, if you will, doing that education. You know, so much of this data that's coming out really needs to be delivered, whether it's to a physician, KOL or an anemia manager through the medical function rather than the sales function.

Speaker #6: And Nabeel, I think your other question was around anemia manager education. And I think it may be important to point out we definitely have recognized how significant that is.

Speaker #6: And a lot of that education has to be done through the medical affairs folks, our MSLs. And we made the decision earlier this year to expand our medical affairs group so that we have more folks' feet on the ground, if you will, doing that education.

Speaker #6: So much of this data that's coming out really needs to be delivered, whether it's to a physician, KME, or an anemia manager through the medical function rather than the sales function.

John Butler: You know, we're still finalizing the last couple of positions there, but, you know, those folks have kind of hit the ground running and, you know, are really ramping up our education. Nick, you want to add something?

Speaker #6: So we're still finalizing the last couple of positions there. But those folks have kind of hit the ground running and are really ramping up our education.

Speaker #6: Nick, do you want to add something?

Speaker #10: And it's great to see that the dialysis organizations are actually participating in that education, right? So USSC, we've had great advocacy from Dr. Dietrich and Dr. Block all along.

Nick Grund: You know, it's great to see that the dialysis organizations are actually participating in that education, right? You know, USRC, we've had great advocacy from Dr. Dietrich and Dr. Block all along, and they've been educating proactively. Within DaVita, they have a centralized anemia management model, so those folks aren't necessarily in the clinic, and they've been educating their centralized anemia managers themselves, which also is a great step for getting folks comfortable with Vafseo.

Speaker #10: And they've been educating proactively. Within DaVita, they have a centralized anemia management model so those folks aren't necessarily in the clinic. And they've been educating their centralized anemia managers themselves, which also is a great step for getting folks comfortable with Vassi.

Nabil: Thank you.

Nabeel Arsh: Thank you.

Speaker #9: Thank you.

Speaker #2: Thank you.

[Analyst] (Jefferies): Thank you.

Nabeel Arsh: Thank you.

John Butler: Thanks, Nabil.

Speaker #6: Thanks, Nabeel.

Speaker #2: Thank you. One moment for our next question. In our next question, clinical line of Rhona Ruiz of Lyrinc Partners, your line is now open.

[Analyst] (Jefferies): Thank you. One moment for our next question. Our next question comes from the line of Rona Ruiz of Leerink Partners. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Rona Ruiz of Leerink Partners. Your line is now open.

[Analyst] (Leerink Partners): Hi, this is Michael, on for Rona Ruiz at Leerink Partners. Thank you for taking our question. For VOCAL study, can you give us a sense of what success looks like? Is this primarily about demonstrating TIW non-inferiority versus ESAs, or are you powering for superiority on any endpoints? Also, how important is the RBC sub study in differentiating Vafseo's mechanism? Thank you.

Michael Schmidt: Hi, this is Michael, on for Rona Ruiz at Leerink Partners. Thank you for taking our question. For VOCAL study, can you give us a sense of what success looks like? Is this primarily about demonstrating TIW non-inferiority versus ESAs, or are you powering for superiority on any endpoints? Also, how important is the RBC sub study in differentiating Vafseo's mechanism? Thank you.

Speaker #11: Hi. This is Michael on for Rhona Ruiz at Lyrinc Partners. Thank you for taking our question. For vocal study, can you give us a sense of what success looks like?

Speaker #11: Is this primarily about demonstrating TIW non-inferiority? Versus ESAs, or are you powering for superiority on any endpoints? And also, how important is the RBC sub-study in differentiating Vassi's mechanism?

Speaker #11: Thank you.

John Butler: Steve, do you want to take that one?

Speaker #6: Steve, do you want to take that one?

Speaker #10: Sure. Yeah. No, you're right about the study. It's 350 patients. DaVita felt it was important for them to do the study in their own units.

Steven C. Burke: Sure. Yeah, you're right about the study. It's 350 patients. DaVita felt it was important for them to do the study in their own units, you know, partly to operationalize it, but also establish that the drug is as safe and effective as the ESAs, Mircera, that they're using today. I suspect we'll see superiority on some of the hemoglobin-related safety endpoints, which we saw in the FO2CUS study, so less rapid rises, less high hemoglobins, and less need for dose adjustments. It's not, you know, that's all pre-specified, but it's not like it's a primary endpoint. The primary endpoint is non-inferiority for hemoglobin control, which makes sense because you're targeting people to a range of hemoglobin between 10.

Steven Burke: Sure. Yeah, you're right about the study. It's 350 patients. DaVita felt it was important for them to do the study in their own units, you know, partly to operationalize it, but also establish that the drug is as safe and effective as the ESAs, Mircera, that they're using today. I suspect we'll see superiority on some of the hemoglobin-related safety endpoints, which we saw in the FO2CUS study, so less rapid rises, less high hemoglobins, and less need for dose adjustments. It's not, you know, that's all pre-specified, but it's not like it's a primary endpoint. The primary endpoint is non-inferiority for hemoglobin control, which makes sense because you're targeting people to a range of hemoglobin between 10.

Speaker #10: Partly to operationalize it, but also establish that the drug is as safe and effective as the ESAs, Mercera, that they're using today. I suspect we'll see superiority on some of the hemoglobin-related safety endpoints, which we saw in the focus study.

Speaker #10: So less rapid rises, less high hemoglobins, and less need for dose adjustments. But it's not that's all pre-specified, but it's not like it's a primary endpoint.

Speaker #10: The primary endpoint is non-inferiority. For hemoglobin control, which makes sense because you're targeting people. To a range of hemoglobin between 10. I do think the red blood cell study will be interesting and important because I think there may be some people who aren't really as close to this don't understand how different Vassi is from ESAs.

Steven C. Burke: I do think the red blood cell study will be interesting and important because, I think there may be some... You know, people who aren't really as close to this don't understand how different Vafseo is from ESAs. ESAs, you're basically giving a recombinant human EPO. It binds to receptor on cells in the bone marrow and helps them differentiate into red blood cells. Vafseo does so many more things, and we already know that the red blood cells that are made under the influence of Vafseo are different. They're bigger, they have more hemoglobin, they have a more uniform distribution of widths. This additional information, I think, will build on what we know to be true today, that the red blood cells really are different.

Steven Burke: I do think the red blood cell study will be interesting and important because, I think there may be some... You know, people who aren't really as close to this don't understand how different Vafseo is from ESAs. ESAs, you're basically giving a recombinant human EPO. It binds to receptor on cells in the bone marrow and helps them differentiate into red blood cells. Vafseo does so many more things, and we already know that the red blood cells that are made under the influence of Vafseo are different. They're bigger, they have more hemoglobin, they have a more uniform distribution of widths. This additional information, I think, will build on what we know to be true today, that the red blood cells really are different.

Speaker #10: Where ESAs, you're basically giving a recombinant human EPO. It binds to receptor on cells in the bone marrow and helps them differentiate into red blood cells.

Speaker #10: But Vassi does so many more things. And we already know that the red blood cells that are made under the influence of Vassi are different.

Speaker #10: They're bigger. They have more hemoglobin. They have a more uniform distribution of widths. So this additional information, I think, will build on what we know to be true today, that the red blood cells really are different.

Speaker #10: So, I think it gives physicians a reason to believe that Vassi is different. And then, when we have data around things like death and hospitalization, it makes more sense to them.

Steven C. Burke: I think it gives physicians a reason to believe that Vafseo is different, and then when we have data around things like, you know, death and hospitalization, it makes more sense to them. There's a mechanism by which they can understand these clinical benefits.

Steven Burke: I think it gives physicians a reason to believe that Vafseo is different, and then when we have data around things like, you know, death and hospitalization, it makes more sense to them. There's a mechanism by which they can understand these clinical benefits.

Speaker #10: There's a mechanism by which they can understand these clinical benefits.

[Analyst] (Leerink Partners): Oh, got it. Thank you. Another question, if you, if I may. Have you reactivated the IND for AKB-097 yet? Are there any changes you made to the protocol from Q32 that was previously aligned with FDA?

Michael Schmidt: Oh, got it. Thank you. Another question, if you, if I may. Have you reactivated the IND for AKB-097 yet? Are there any changes you made to the protocol from Q32 that was previously aligned with FDA?

Speaker #9: Oh, got it. Thank you. Another question, if I may. Have you reactivated the IND for AKB097 yet? And are there any changes you made to the protocol from Q32 that was previously aligned with FDA?

Speaker #10: That's a great question. We have been reworking the protocol just to make it simpler. But fundamentally, it's the same protocol that FDA agreed to with Q32.

Steven C. Burke: That's a great question. We have been reworking the protocol just to make it simpler, but fundamentally, it's the same protocol that FDA agreed to with Q32. We're just trying to make it less operationally complex so that it's easier to recruit and easier to run. We won't activate that IND until we resubmit the protocol that we're very close to finalizing. I hope that answered your question.

Steven Burke: That's a great question. We have been reworking the protocol just to make it simpler, but fundamentally, it's the same protocol that FDA agreed to with Q32. We're just trying to make it less operationally complex so that it's easier to recruit and easier to run. We won't activate that IND until we resubmit the protocol that we're very close to finalizing. I hope that answered your question.

Speaker #10: We're just trying to make it less operationally complex so that it's easier to recruit and easier to run. And we won't activate that IND until we resubmit the protocol that we're very close to finalizing.

Speaker #10: So I hope that answered your question.

Speaker #9: Yep. Thank

[Analyst] (Leerink Partners): Yep. Thank you.

Michael Schmidt: Yep. Thank you.

Speaker #2: Thank you. One moment for our next question. Our next question, clinical line of Alison Pretzel of Piper Sandler. Your line is now open.

[Analyst] (Jefferies): Thank you. One moment for our next question.

Operator: Thank you. One moment for our next question.

Operator: Our next question comes the line of Allison Bratzel of Piper Sandler. Your line is now open.

[Analyst] (Piper Sandler): Hi, this is Ashley on for Ali Bratzel of Piper Sandler. Just 1 question from us, because you guys did a great job of answering our other questions. Just on the R&D Day on 2 April, when you're discussing your pipeline, can you help frame some expectations for investors? You know, what should investors look forward to? You know, what level of detail are you planning to provide? Any color there would be super helpful. Thank you.

Ashley Aloupis: Hi, this is Ashley on for Ali Bratzel of Piper Sandler. Just 1 question from us, because you guys did a great job of answering our other questions. Just on the R&D Day on 2 April, when you're discussing your pipeline, can you help frame some expectations for investors? You know, what should investors look forward to? You know, what level of detail are you planning to provide? Any color there would be super helpful. Thank you.

Speaker #12: Hi. This is Ashley on for Allie Bratzel of Piper Sandler. Just one question from us because you guys did a great job of answering our other questions.

Speaker #12: But just on the R&D day on April 2nd, when you're discussing your pipeline, can you help frame some expectations for investors? What should investors look forward to?

Speaker #12: What level of detail are you planning to provide? Any color there would be super helpful. Thank you.

John Butler: Sure, Ashley. Obviously, we're still bringing together the agenda for that. As I said, I mean, we really will focus, you know, there's so much that we could talk about. That's kind of the exciting thing for the company right now. You know, there's so many areas we can go, but I think, you know, we really want to focus on praliciguat and AKB-097. You know, we think it's important that you hear from people other than Akebia employees. I mean, you'll hear from Akebia employees, but we really want to bring in KOLs to talk about...

Speaker #6: Sure, Ashley. So obviously, we're still bringing together the agenda for that. As I said, I mean, we really will focus there's so much that we could talk about.

Speaker #6: That's kind of the exciting thing for the company right now. There's so many areas we can go. But I think we really want to focus on Prolisaglut and 097.

Speaker #6: And we think it's important that you hear from other people other than Akebia employees. I mean, you'll hear from Akebia employees. But we really want to bring in KMEs to talk about when we think about the process we went through to make the decision to enlicense 097, Steve always kind of says when Eric brought this forward, it was like, "Oh, another complement inhibitor?

John Butler: You know, when we think about the process we went through to make the decision to in-license AKB-097, you know, Steven C. Burke always, you know, kind of says, well, you know, when Erik Ostrowski brought this forward, it was like, Oh, another complement inhibitor. Do we really need this? It was really talking to KMEs, you know, one of whom, you know, we expect you'll be able to hear at the R&D Day, that, you know, this concept of a next-generation complement inhibitor, really, I think those are the words that were used. So hearing the excitement around that product from people other than Akebia employees, I think is important. It'll give us the opportunity.

Speaker #6: Do we really need this?" And it was really talking to KMEs one of whom we expect you'll be able to hear at the R&D day that this concept of a next-generation complement inhibitor really I think those are the words that were used.

Speaker #6: And so hearing the excitement around that product from people other than Akebia employees I think is important. And it'll give us the opportunity we haven't had the opportunity to kind of go into depth on the data that underlies the decisions we made, the data the preclinical data on Prolisaglut, for instance, that gave us confidence in moving forward in FSGS.

John Butler: We haven't had the opportunity to kind of go into depth on, you know, the data that underlies the decisions we made, the data, the preclinical data on praliciguat, for instance, that gave us confidence in moving forward in FSGS. You know, it was exciting to get a question on AKB-9090 on this call. You know, this is, you know, the first product we're putting in the clinic from our own discovery efforts, small but mighty discovery efforts at Akebia, and kind of introducing that product and answering questions like Nabil asked about, you know, what differentiates it from vadadustat. We think it'll be a very robust day.

Speaker #6: And then I was exciting to get a question on 9090. On this call. But this is the first product we're putting in the clinic from our own discovery efforts.

Speaker #6: Small but mighty discovery efforts that Akebia and kind of introducing that product and answering questions like the Nebulask about what differentiates it from Vetadusat.

Speaker #6: So we think it'll be a very robust day. I mean, it's kind of a thing you can spend six hours on, but we'll do it in a much more streamlined fashion.

John Butler: I mean, it's kind of thing you can spend 6 hours on, but we'll do it in a much more streamlined fashion. I think it will. You know, right now, we just introduced this rare kidney pipeline in December, and I don't think people really have had the opportunity to focus on it, because quite rightly, they're focusing on the Vafseo launch. You know, we're really happy with how the Vafseo launch is going. We think that will continue to, you know, to deliver for the company and be the financial driver for, you know, continuing to build a pipeline.

Speaker #6: But I think it will, right now. We just introduced this rare kidney pipeline in December, and I don't think people really have had the opportunity to focus on it because, quite rightly, they're focusing on the Vafshi launch.

Speaker #6: We're really happy with how the Vassi launch is going. We think that will continue to deliver for the company and be the financial driver for continuing to build the pipeline.

Speaker #6: But now people will be able to really understand what we've got and why we're so excited about not just the rare kidney pipeline, but our capabilities in expanding that HIF pipeline as well.

John Butler: Now people will be able to really understand, you know, what we've got and why we're so excited about, not just the rare kidney pipeline, but our capabilities in expanding that HIF pipeline as well.

Speaker #12: Great. I really appreciate it.

[Analyst] (Piper Sandler): Great. I really appreciate it.

Ashley Aloupis: Great. I really appreciate it.

Speaker #6: Thanks, Ashley. Good to talk to you.

John Butler: Thanks, Ashley. Good to talk to you.

Speaker #2: Thank you. I'm showing no further questions at this time. I'll now turn it back to John Butler for closing remarks.

Operator: Thank you. I'm showing no further questions at this time. I'll now turn it back to John Butler for closing remarks.

Speaker #6: Great. Thank you, Marvin. I do want to take a moment again to outline the catalyst-rich next 12 months that we have at Akebia. In addition to watching our progress towards standard of care for Vassi and the billion-dollar dialysis market, we'll see Vassi top-line data from Vocal in Q4 and Voice in Q1 of '27.

John Butler: Great. Thank you, Marvin. I do want to take a moment again to outline the catalyst-rich next 12 months that we have at Akebia. In addition to watching our progress towards standard of care for Vafseo in the billion-dollar dialysis market, we'll see Vafseo top-line data from VOCAL in Q4 and VOICE in Q1 of 2027. We'll initiate the AKB-097 basket study in the second half and expect to see the first data in 2027, and we'll begin and complete the phase 1 study of AKB-9090 during the course of this year, as well as continuing to enroll the praliciguat phase 2 in FSGS. We are very excited about the present and future for Akebia. We're eager to share more about our pipeline programs at our R&D Day on 2 April, and I look forward to speaking to you then.

Speaker #6: We'll initiate the 097 basket study in the second half and expect to see the first data in 2027. And we'll begin and complete the phase one study of AKB9090 during the course of this year.

Speaker #6: As well as continuing to enroll the Prolisaglut phase two in FSGS. We are very excited about the present and future for Akebia. We're eager to share more about our pipeline programs at our R&D day on April 2nd.

Speaker #6: And I look forward to speaking to you then. Have a great day.

John Butler: Have a great day.

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

Q4 2025 Akebia Therapeutics Inc Earnings Call

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