Q2 2026 Akebia Therapeutics Inc Earnings Call

August 5, 2026

Speaker #1: gentlemen, thank you for standing by. This is Roy, and I will be your conference operator today. At this time, I would like to welcome everyone to the Akebia Second Part of 2026 Financial Results.

Speaker #1: All lines have been placed on mute to prevent any background noise. After the speakers' requests, there will be a question-and-answer session. If you would like to ask questions during this time, please press star followed by the number 1 on your telephone keypad.

Speaker #1: ahead.

Mercedes Carrasco: Welcome to Akebia's Q2 2026 financial results and business updates conference call. Please note that a press release was issued earlier today, Wednesday, 05 August 2026, detailing our Q2 2026 financial results, that release is available on the investor section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me today, we have John Butler, Chief Executive Officer, Dr. Steven K. Burke, our Chief Medical Officer, Nick Grund, our Chief Commercial Officer, and Erik Ostrowski, Chief Financial and Chief Business Officer. I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements.

Speaker #2: call. Please note that a press release was issued earlier today, Wednesday, August 5, detailing our second quarter 2026 financial results, and that release is available on the investor section of our website.

Speaker #2: For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me today we have John Butler, Chief Executive Officer, Dr. Stephen Burke, our Chief Medical Officer, Nick Grund, our Chief Commercial Officer, and Erik Ostrowski, Chief Financial and Chief Business Officer.

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 risks.

Speaker #2: Results to differ materially, from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on August 5.

Mercedes Carrasco: Additional information describing these risks is included in the financial results press release that we issued on 05 August 2026, as well as in the Risk Factors and Management Discussion and Analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

Speaker #2: 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.

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

Speaker #3: Thanks, Mercedes, and thanks to everyone for joining us this afternoon. As you know, we've been focused on two critical areas of our business that we believe will deliver both important therapeutic advances for patients and value to shareholders.

John Butler: Thanks, Mercedes, and thanks to everyone for joining us this afternoon. As you know, we've been focused on two critical areas of our business that we believe will deliver both important therapeutic advances for patients and value to shareholders. Those are advancing our kidney disease pipeline and making Vafseo standard of care for the treatment of anemia due to CKD in dialysis patients. We've had incredibly important advances in both areas since we last spoke to you. Today, I'll start with research and development. I believe our pipeline is underappreciated, and clinical advancement of our rare disease pipeline specifically provides the greatest opportunity to build value. Earlier this week, we announced that we initiated the phase II basket trial to evaluate ebribafusp, previously known as AKB-097 and ADX-097, in IgA nephropathy, lupus nephritis, and C3 glomerulopathy.

Speaker #3: Those are advancing our kidney disease pipeline and making Vasio standard of care for the treatment of anemia due to CKD in dialysis patients. We've had incredibly important advances in both areas since we last spoke to you.

Speaker #3: Today, I'll start with research and development. I believe our pipeline is underappreciated. And clinical advancement of our rare disease pipeline, specifically, provides the greatest opportunity to build value.

Speaker #3: Earlier this week, we announced that we initiated the Phase 2 basket trial to evaluate Abrevifus, previously known as AKB-097 and ADX-097, in IgA nephropathy, lupus nephritis, and C3 glomerulopathy.

Speaker #3: We believe Abrevifus a next-generation complement inhibitor could be truly differentiated in the rare kidney disease space, in these indications and others. Beyond this initial basket study, we're doing the work to prepare for a phase two study in ANCA-associated vasculitis, and expect to start that study next year.

John Butler: We believe ebribafusp, a next-generation complement inhibitor, could be truly differentiated in the rare kidney disease space in these indications and others. Beyond this initial basket study, we're doing the work to prepare for a phase II study in ANCA-associated vasculitis and expect to start that study next year. Our other rare kidney asset, praliciguat, continues to enroll in its phase II study in FSGS. As with ebri, we believe there are multiple indications where proli can play an important therapeutic role. Again, we believe the mechanism of proli will allow it to occupy a unique competitive position in these rare diseases that each have significant unmet need. Our third kidney disease clinical candidate is AKB-9090, which is in a phase I study in healthy volunteers. 9090 continues to move successfully through the SAD/MAD study, we expect to report data early next year.

Speaker #3: Our other rare kidney asset, Prolisaguat, continues to enroll in its phase two study in FSGS. As with Ebri, we believe there are multiple indications where Proli can play an important therapeutic role.

Speaker #3: And again, we believe the mechanism of Proli will allow it to occupy a unique competitive position in these rare diseases that each have significant unmet need.

Speaker #3: Our third kidney disease clinical candidate is AKB9090, which was in a phase one study in healthy volunteers. 9090 continues to move successfully through the SADMAD study, and we expect to report data early next year.

Speaker #3: Following that data readout, our plan is that next year our development team's efforts and our dollars will be focused on Ebri and Proli, where we believe the largest opportunity to drive near-term value exists.

John Butler: Following that data readout, our plan is that next year our development team's efforts and our dollars will be focused on ebri and proli, where we believe the largest opportunity to drive near-term value exists. Dr. Steven K. Burke, our Chief Medical Officer, is currently attending GlomCon Hawaii, where medical professionals around the world have met to discuss treatments for glomerular disease. That's the reason we're having our call this afternoon rather than our normal morning timing. I'll now ask Steve to share a few remarks on ebri and proli. Steve?

Speaker #3: Dr. Stephen Burke, our Chief Medical Officer, is currently attending Lom Con, Hawaii, where medical professionals around the world have met to discuss treatments for glomerular disease.

Speaker #3: That's the reason we're having our call this afternoon, rather than a normal morning timing. I'll now ask Steve to share a few remarks on Ebri and Proli.

Speaker #3: Steve?

Speaker #4: Thank you, John. We've built upon our team's commitment to patients and expertise in kidney disease to advance several programs into the clinic in 2026.

Steven K. Burke: Thank you, John. We've built upon our team's commitment to patients and expertise in kidney disease to advance several programs into the clinic in 2026. We believe our mid-stage pipeline products, ebribafusp and praliciguat, have the potential to deliver differentiated and targeted approaches to severe diseases with high unmet need. As John mentioned, we just initiated a phase II basket trial for ebri. The goal of this trial is to evaluate the safety and efficacy of ebri in patients suffering from diseases marked by complement activation in the kidney glomeruli, namely IgA nephropathy, lupus nephritis, and C3 glomerulopathy. These rare kidney diseases affect thousands of patients, while there are therapies available, each requires lifelong treatment. The currently available treatments include complement inhibitors, which suppress the complement system in the blood, many require frequent administration.

Steven Burke: Thank you, John. We've built upon our team's commitment to patients and expertise in kidney disease to advance several programs into the clinic in 2026. We believe our mid-stage pipeline products, ebribafusp and praliciguat, have the potential to deliver differentiated and targeted approaches to severe diseases with high unmet need. As John mentioned, we just initiated a phase II basket trial for ebri. The goal of this trial is to evaluate the safety and efficacy of ebri in patients suffering from diseases marked by complement activation in the kidney glomeruli, namely IgA nephropathy, lupus nephritis, and C3 glomerulopathy. These rare kidney diseases affect thousands of patients, while there are therapies available, each requires lifelong treatment. The currently available treatments include complement inhibitors, which suppress the complement system in the blood, many require frequent administration.

Speaker #4: We believe our mid-stage pipeline products, Abrevifus and Prolisaguat, have the potential to deliver differentiated and targeted approaches to severe diseases with high unmet need.

Speaker #4: As John mentioned, we just initiated a phase 2 basket trial for Ebri. The goal of this trial is to evaluate the safety and efficacy of Ebri in patients suffering from diseases marked by complement activation in the kidney glomeruli, namely IgA nephropathy, lupus nephritis, and C3 glomerulopathy.

Speaker #4: These rare kidney diseases affect thousands of patients, and while there are therapies available, each requires lifelong treatment. The currently available treatments include complement inhibitors, which suppress the complement system in the blood, and many require frequent administration.

Speaker #4: Importantly, they generally have a boxed warning for significant infection risk. And this profile creates concern for long-term use. In non-clinical studies completed by Q32 Bio, Ebri was shown to be targeted specifically to the sites of complement activation.

Steven K. Burke: Importantly, they generally have a boxed warning for significant infection risk, and this profile creates concern for long-term use. In non-clinical studies completed by Q32 Bio, ebri was shown to be targeted specifically to the sites of complement activation. In patients with complement-mediated glomerular diseases, we believe ebri should localize to the affected glomeruli, which have significant deposits of C3d, while avoiding complement inhibition in the blood. We highlighted this during our R&D Day in April and expect the findings from non-clinical and phase I studies to be published in medical journals. During our R&D presentation, Dr. Jonathan Barratt, Mayer Professor of Renal Medicine from the University of Leicester, shared that he believed a complement inhibitor with this profile could be used long term and in combination with B-cell-directed therapies such as APRIL and APRIL-BAFF inhibitors without the associated potential of systemic complement inhibition.

Steven Burke: Importantly, they generally have a boxed warning for significant infection risk, and this profile creates concern for long-term use. In non-clinical studies completed by Q32 Bio, ebri was shown to be targeted specifically to the sites of complement activation. In patients with complement-mediated glomerular diseases, we believe ebri should localize to the affected glomeruli, which have significant deposits of C3d, while avoiding complement inhibition in the blood. We highlighted this during our R&D Day in April and expect the findings from non-clinical and phase I studies to be published in medical journals. During our R&D presentation, Dr. Jonathan Barratt, Mayer Professor of Renal Medicine from the University of Leicester, shared that he believed a complement inhibitor with this profile could be used long term and in combination with B-cell-directed therapies such as APRIL and APRIL-BAFF inhibitors without the associated potential of systemic complement inhibition.

Speaker #4: In patients with complement-mediated glomerular diseases, we believe Ebri should localize to the affected glomeruli, which have significant deposits of C3D, while avoiding complement inhibition in the blood.

Speaker #4: We highlighted this during our R&D day in April, and expect the findings from non-clinical and phase one studies to be published in medical journals.

Speaker #4: During our R&D presentation, Dr. Jonathan Barrett, Mayor Professor of Renal Medicine from the University of Leicester, shared that he believed a complement inhibitor with this profile could be used long term in combination with B-cell-directed therapies, such as APRIL and APRIL-BAFF inhibitors, without the associated potential of systemic complement inhibition.

Speaker #4: The recently initiated Phase 2 basket trial is expected to enroll up to 30 patients and will evaluate a once-weekly subcutaneous dose of Ebri for 26 weeks in the main study, followed by a long-term extension study for responders.

Steven K. Burke: The recently initiated phase II basket trial is expected to enroll up to 30 patients and will evaluate a once-weekly subcutaneous dose of ebri for 26 weeks in the main study, followed by a long-term extension study for responders. In the phase I study of ebri in healthy volunteers, again conducted by Q32 Bio, this same dose achieved exposures necessary to provide tissue-specific complement inhibition without inhibiting the complement system in the blood. The primary endpoint of the phase II study is the incidence of adverse events and secondary endpoints, including the change in proteinuria and kidney function. In addition, the trial will measure ebri pharmacokinetics and complement biomarkers in the blood and urine to detect if ebri reduces complement activity in the kidney tissue while avoiding inhibition of the complement system in the blood.

Steven Burke: The recently initiated phase II basket trial is expected to enroll up to 30 patients and will evaluate a once-weekly subcutaneous dose of ebri for 26 weeks in the main study, followed by a long-term extension study for responders. In the phase I study of ebri in healthy volunteers, again conducted by Q32 Bio, this same dose achieved exposures necessary to provide tissue-specific complement inhibition without inhibiting the complement system in the blood. The primary endpoint of the phase II study is the incidence of adverse events and secondary endpoints, including the change in proteinuria and kidney function. In addition, the trial will measure ebri pharmacokinetics and complement biomarkers in the blood and urine to detect if ebri reduces complement activity in the kidney tissue while avoiding inhibition of the complement system in the blood.

Speaker #4: In the phase one study of Ebri in healthy volunteers, again conducted by Q32 Bio, this same dose achieved exposures necessary to provide tissue-specific complement inhibition without inhibiting the complement system in the blood.

Speaker #4: The primary endpoint of the phase two study is the incidence of adverse events and secondary endpoints, including the change in proteinuria and kidney function.

Speaker #4: In addition, the trial will measure Ebri pharmacokinetics and complement biomarkers in the blood and urine to detect if Ebri reduces complement activity in the kidney tissue while avoiding inhibition of the complement system in the blood.

Speaker #4: The phase two basket trial is open label, and we expect to report initial data in 2027. With regards to our phase two study of Proli in patients with FSGS, enrollment activities are ongoing.

Steven K. Burke: The phase II basket trial is open label, and we expect to report initial data in 2027. With regards to our phase II study of Proli in patients with FSGS, enrollment activities are ongoing. FSGS is characterized by focal and segmental scarring in the glomeruli. Proli is a small molecule that is designed to stimulate the soluble guanylate cyclase enzyme and has been shown in animal models of kidney disease to inhibit glomerular scarring and preserve kidney function. There are about 40,000 patients currently diagnosed with FSGS in the US. This trial will enroll up to 60 patients with primary or genetic FSGS in a randomized, double-blind, placebo-controlled trial. The primary endpoint is change in urine protein creatinine ratio, or UPCR, from baseline to week 24, and the secondary endpoint is partial remission of proteinuria, defined as a 40% UPCR reduction and a UPCR less than 1.5 grams per gram.

Steven Burke: The phase II basket trial is open label, and we expect to report initial data in 2027. With regards to our phase II study of Proli in patients with FSGS, enrollment activities are ongoing. FSGS is characterized by focal and segmental scarring in the glomeruli. Proli is a small molecule that is designed to stimulate the soluble guanylate cyclase enzyme and has been shown in animal models of kidney disease to inhibit glomerular scarring and preserve kidney function. There are about 40,000 patients currently diagnosed with FSGS in the US. This trial will enroll up to 60 patients with primary or genetic FSGS in a randomized, double-blind, placebo-controlled trial. The primary endpoint is change in urine protein creatinine ratio, or UPCR, from baseline to week 24, and the secondary endpoint is partial remission of proteinuria, defined as a 40% UPCR reduction and a UPCR less than 1.5 grams per gram.

Speaker #4: FSGS is characterized by focal and segmental scarring in the glomeruli. Proli is a small molecule that is designed to stimulate the soluble guanolate cyclase enzyme and has been shown in animal models of kidney disease to inhibit glomerular scarring and preserve kidney function.

Speaker #4: There are about 40,000 patients currently diagnosed with FSGS in the U.S. This trial will enroll up to 60 patients with primary or genetic FSGS in a randomized, double-blind, placebo-controlled trial.

Speaker #4: The primary endpoint is change in urine protein-creatinine ratio, or UPCR, from baseline to week 24. The secondary endpoint is partial remission of proteinuria, defined as a 40% UPCR reduction and a UPCR less than 1.5 grams per gram.

Speaker #4: In a phase two study of diabetic kidney disease conducted by Cyclarion, Proli demonstrated rapid and sustained reduction in proteinuria as measured by urine albumin-creatinine ratio or UACR.

Steven K. Burke: In a phase II study of diabetic kidney disease conducted by Cyclerion, Proli demonstrated rapid and sustained reduction in proteinuria as measured by urine albumin creatinine ratio, or UACR. We look forward to providing further updates on these studies. Now I will turn it back over to John.

Steven Burke: In a phase II study of diabetic kidney disease conducted by Cyclerion, Proli demonstrated rapid and sustained reduction in proteinuria as measured by urine albumin creatinine ratio, or UACR. We look forward to providing further updates on these studies. Now I will turn it back over to John.

Speaker #4: We look forward to providing further updates on these studies, and now I'll turn it back over to John.

Speaker #3: Thanks, Steve. Now let's turn our attention to VAFSIO and our efforts to make this important product standard of care. We had a very positive surprise this quarter when Dr. Jeff Block of US Renal Care completed the planned interim analysis of the primary endpoint in the voice trial and found the statistical result significantly exceeded the prespecified stopping criteria.

John Butler: Thanks, Steve. Now let's turn our attention to Vafseo and our efforts to make this important product standard of care. We had a very positive surprise this quarter when Dr. Jeff Block of U.S. Renal Care completed the planned interim analysis of the primary endpoint in the VOICE trial and found the statistical result significantly exceeded the pre-specified stopping criteria. Vafseo demonstrated a statistically significant and clinically meaningful reduction in the primary composite endpoint of all-cause mortality and hospitalization, with the result driven by a 10% reduction in hospitalization. USRC Kidney Research stopped the trial after a recommendation from the independent data monitoring committee and trial steering committee. For reference, the VOICE trial enrolled 2,116 patients.

Speaker #3: VAFSIO demonstrated a statistically significant and clinically meaningful reduction in the primary composite endpoint of all-cause mortality and hospitalization. With the result driven by a 10% reduction in hospitalization.

Speaker #3: USRC Kidney Research stopped the trial after a recommendation from the independent data monitoring committee and the trial steering committee. And for reference, the VOICE trial enrolled 2,116 patients.

Speaker #3: Results of the planned interim analysis as of June 1st demonstrated that the trial met the predefined stopping criteria, with a win odds of 1.16 and a p-value of 0.0016, establishing noninferiority and superiority of the primary composite endpoint.

John Butler: Results of the planned interim analysis as of 1 June demonstrated that the trial met the predefined stopping criteria with a win odds of 1.16 and a P value of 0.0016, establishing non-inferiority and superiority of the primary composite endpoint. We've always had confidence in the clinical differentiation of Vafseo and the potential for a positive outcome of the study, but we were extremely pleased that we had this result earlier than expected. The result is consistent with the post-hoc analysis of the phase III INNO2VATE program, published earlier this year in the Journal of the American Society of Nephrology. When you look at both VOICE and the INNO2VATE analysis, you see that Vafseo demonstrated a consistent result whether dosing the product daily or three times weekly, and whether comparing Vafseo to a long-acting or a short-acting ESA.

Speaker #3: We've always had confidence in the clinical differentiation of VAFSIO and the potential for a positive outcome of the study, but we were extremely pleased that we had this result earlier than expected.

Speaker #3: The result is consistent with the post-hoc analysis of the Phase 3 INNOVATE program, published earlier this year in the Journal of the American Society of Nephrology.

Speaker #3: When you look at both voice and the INNOVATE analysis, you see that VAFSIO demonstrated a consistent result, whether dosing the product daily or three times weekly.

Speaker #3: And whether comparing Vafseo to a long-acting or a short-acting ESA, it's also important to note that no head-to-head study of ESAs has ever demonstrated a significant benefit in hospitalization.

John Butler: It's also important to note that no head-to-head study of ESAs has ever demonstrated a significant benefit in hospitalization. We believe these data will make a huge difference for patients for years to come. As I've said many times, our goal is to make Vafseo standard of care for dialysis patients. Frankly, the VOICE data gives me greater confidence that we will achieve that goal. I'm especially encouraged by the increased interest we're seeing from the dialysis providers since we made the announcement. Now, at the same time, we currently have only shared data through a press release. Dr. Block is working with our support to present these data at a medical conference and have it published in a peer-reviewed journal as quickly as possible. While the tangible impact of this provider interest could take some time, we believe these data help competitively position and differentiate Vafseo moving forward.

Speaker #3: We believe the data will make a huge difference for patients for years to come. As I've said many times, our goal is to make Vafseo the standard of care for dialysis patients.

Speaker #3: Frankly, the voice data gives me greater confidence that we will achieve that goal. I'm especially encouraged by the increased interest we're seeing from the dialysis providers since we made the announcement.

Speaker #3: Now, at the same time, we have currently only shared data through a press release. Dr. Block is working with our support to present these data at a medical conference and have it published in a peer-reviewed journal as quickly as possible.

Speaker #3: While the tangible impact of this provider interest could take some time, we believe these data help competitively position and differentiate Vafseo moving forward. In the meantime, I'm pleased to report that we had our first quarter with over 10,000 patients and $20 million in revenue.

John Butler: In the meantime, I'm pleased to report that we had our Q1 with over 10,000 patients and $20 million in revenue. Here's Nick to provide more insight into the quarter. Nick?

Speaker #3: Here's Nick to provide more insight into the quarter. Nick?

Speaker #5: Thanks, John. And good afternoon, folks. We're pleased to report significant sequential quarterly revenue growth, as well as several adoption metrics and an important milestone with more than 10,500 patients active on VAFSIO.

Nicholas Grund: Thanks, John. Good afternoon, folks. We are pleased to report significant sequential quarterly revenue growth, as well as several adoption metrics and an important milestone with more than 10,500 patients active on Vafseo. Vafseo net product revenue increased to $21.3 million in Q2 2026, a 34% increase over the previous quarter, representing a continuation of robust growth. The total patients on therapy in Q2 represents an approximate 41% increase compared with Q1. Also, once again this quarter, we had the highest number of new patient starts in a quarter since the Q1 of launch, demonstrating strong momentum. The diversification of our prescriber base continues to grow. Today, approximately a third of our prescribers are in DOs outside of U.S. Renal Care. Additionally, a vast majority of patients are being treated under DO-implemented observed dosing protocols, which is very much in line with our expectations.

Speaker #5: VAFSIO net product revenue increased to 21.3 million in quarter two of 2026, a 34% increase over the previous quarter. Representing a continuation of robust growth.

Speaker #5: The total patients on therapy in Q2 represent an approximate 41% increase compared with Q1. Also, once again this quarter, we had the highest number of new patient starts in a quarter since the first quarter of launch, demonstrating strong momentum.

Speaker #5: The diversification of our prescriber base continues to grow. Today, approximately a third of our prescribers are DOs outside of USRC. Additionally, a vast majority of patients are being treated under DO-implemented observed dosing protocols, which is very much in line with our expectations.

Speaker #5: The midsize dialysis organizations—USRC, IRC, and DCI—drove the most significant portion of patient growth, and we believe that all three still have significant room to grow.

Steven K. Burke: The mid-size dialysis organizations, U.S. Renal Care, Innovative Renal Care, and Dialysis Clinic, Inc., drove the most significant portion of patient growth. We believe that all three still have significant room to grow moving forward. Another common feature of these three customers is the significant level of support in Vafseo that their leadership is demonstrating. Driving prescribing within DaVita Inc. is our highest priority, as it represents our most significant growth opportunity from a single dialysis organization. In Q2, we continue to see additional new prescribers and patients on Vafseo at DaVita Inc.. As is the case with our mid-size dialysis organization customers, while it is important to educate prescribers and caregivers on Vafseo, an inflection point comes with top-down support.

Nicholas Grund: The mid-size dialysis organizations, U.S. Renal Care, Innovative Renal Care, and Dialysis Clinic, Inc., drove the most significant portion of patient growth. We believe that all three still have significant room to grow moving forward. Another common feature of these three customers is the significant level of support in Vafseo that their leadership is demonstrating. Driving prescribing within DaVita Inc. is our highest priority, as it represents our most significant growth opportunity from a single dialysis organization. In Q2, we continue to see additional new prescribers and patients on Vafseo at DaVita Inc.. As is the case with our mid-size dialysis organization customers, while it is important to educate prescribers and caregivers on Vafseo, an inflection point comes with top-down support.

Speaker #5: Moving forward, another common feature of these three customers is the significant level of support in VAFSIO that their leadership is demonstrating. Driving prescribing within DaVita is our highest priority, as it represents our most significant growth opportunity from a single dialysis organization.

Speaker #5: In quarter two, we continue to see additional new prescribers and patients on VAFSIO at DaVita. As is the case with our midsize dialysis organization customers, while it is important to educate prescribers and caregivers on VAFSIO and inflection point comes with top-down support.

Speaker #5: To that end, I'm encouraged by the continued high level of interaction between the teams from Akebia and DaVita. Bolstered in the past month by DaVita's interest in learning more about the recent voice trial result.

Nicholas Grund: To that end, I am encouraged by the continued high level of interaction between the teams from Akebia Therapeutics, Inc. and DaVita Inc., bolstered in the past month by DaVita Inc.'s interest in learning more about the recent VOICE trial results. While I do not expect to see a meaningful increase in the DaVita Inc. adoption curve in Q3, there is a heightened level of senior clinical team engagement regarding detailed operational implementation that we have not seen historically. We believe this bodes well for more impactful growth at the end of the year and sets us up well for 2027. At this stage of the launch, to best support dialysis organizations' engagement overall, in Q2, we implemented a more targeted, streamlined, and agile commercial strategy that prioritizes a greater focus on large group practices and strategic partners.

Speaker #5: While I don't expect to see a meaningful increase in the DaVita adoption curve in Q3, there is a heightened level of senior clinical team engagement regarding detailed operational implementation that we have not seen historically.

Speaker #5: We believe this bodes well for more impactful growth at the end of the year and sets us up well for 2027. At this stage of the launch, and to best support dialysis organizations' engagement overall, in Q2 we implemented a more targeted, streamlined, and agile commercial strategy that prioritizes a greater focus on large group practices and strategic partners.

Speaker #5: The goal is to increase the efficiency and effectiveness of our commercial field team, while at the same time taking advantage of the broad awareness and breadth of patient access created previously.

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

Speaker #5: Our team continues efforts to drive VAFSIO prescribing and growth. We understand how important it is for our commercial and medical affairs teams to work closely to engage with dialysis organizations and care decision-makers.

Speaker #5: And support prescribers as they continue to get more experience with VAFSIO to increase depth of prescribing as well. And now I'll turn it to Erik to go through the financials.

Speaker #3: Thanks, Nick. Total revenues were 49.1 million dollars in Q2, '26, compared to 62.5 million dollars in Q2, '25. This decrease was due to lower elixir revenues, which were partially offset by higher VAFSIO.

Erik Ostrowski: Thanks, Nick. Total revenues were $49.1 million in Q2 2026 compared to $62.5 million in Q2 2025. This decrease was due to lower AURYXIA revenues, which were partially offset by higher Vafseo. Turning to the components of total revenues, Vafseo net product revenues were $21.3 million in Q2 2026 compared to $13.3 million in Q2 2025, representing a 60% year-over-year increase. As we've previously discussed, we note that upon the expected end of Vafseo's TDAPA period on 31 December 2026, we plan to price Vafseo within the price range of ESAs, which is significantly lower than Vafseo's current price. As a result, while we expect Vafseo unit sales volumes to increase in 2027 as compared to 2026, we expect 2027 revenues to decrease compared to 2026 due to this lower planned price. AURYXIA net product revenues were $25.5 million in Q2 2026 compared to $47.2 million in Q2 2025.

Speaker #3: Turning to the components of total revenues, VAFSIO net product revenues were $21.3 million in Q2 '26, compared to $13.3 million in Q2 '25, representing a 60% year-over-year increase.

Speaker #3: As we've previously discussed, we note that upon the expected end of Vafseo's TDAPA period on December 31, 2026, we plan to price Vafseo within the price range of ESAs, which is significantly lower than Vafseo's current price.

Speaker #3: As a result, while we expect VAFSIO unit sales volumes to increase in 2027 as compared to 2026, we expect 2027 revenues to decrease compared to 2026 due to this lower planned price.

Speaker #3: Eryxia net product revenues were 25.5 million dollars in Q2, '26, compared to 47.2 million dollars in Q2, '25. We continue to expect Eryxia revenues to decrease in '26 due to generic competition and price pressure.

Erik Ostrowski: We continue to expect AURYXIA revenues to decrease in 2026 due to generic competition and price reduction. License, collaboration, and other revenues increased to $2.4 million in Q2 2026 compared to $2 million in Q2 2025. Cost of goods sold was $10.4 million in Q2 2026 compared to $9.9 million in Q2 2025. Of note, Vafseo-related COGS in both periods was derived from pre-launch 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 US approval. R&D expenses were $14.1 million in Q2 2026 compared to $11 million in Q2 2025. This increase was driven by activities related to our phase II clinical trials for praliciguat and ebribafusp, as well as higher headcount-related costs.

Speaker #3: Licensed collaboration and other revenues increased to 2.4 million dollars in Q2, '26, compared to 2 million dollars in Q2, '25. Cost of goods sold was 10.4 million dollars in Q2, '26, compared to 9.9 million dollars in Q2, '25.

Speaker #3: Of note, VAFSIO related COGS in both periods was derived from pre-launch 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 VAFSIO's US approval.

Speaker #3: R&D expenses were 14.1 million dollars in Q2, '26, compared to 11 million dollars in Q2, '25. This increase was driven by activities related to our phase two clinical trials for holistic wide and debris buffers.

Speaker #3: As well as higher headcount related costs. SU net expenses were 28.2 million dollars in Q2, '26, compared to 26.6 million dollars in Q2, '25, driven by higher commercialization related activities.

Erik Ostrowski: SG&A expenses were $28.2 million in Q2 2026 compared to $26.6 million in Q2 2025, driven by higher commercialization-related activity. Net loss was $8.9 million in Q2 2026 compared to net income of $0.2 million in Q2 2025. The change to a net loss this quarter was the result of lower revenues and higher expenses, including a $1.9 million expense related to the commercial reorganization mentioned by Nick, which is aimed at increasing the efficiency and effectiveness of our commercial efforts. Cash and cash equivalents as of 30 June 2026 were approximately $155.5 million compared to $162.6 million as of 31 March 2026. We believe our existing cash resources and the cash we expect to generate from product, royalty, supply, and license revenues, along with our plan to refinance our senior secured term loan facility, will enable us to fund our current operating plans for at least two years.

Speaker #3: Net loss was $8.9 million in Q2 '26, compared to net income of $0.2 million in Q2 '25. The change to a net loss this quarter was the result of lower revenues and higher expenses, including a $1.9 million expense related to the commercial reorganization mentioned by Nick, which is aimed at increasing the efficiency and effectiveness of our commercial efforts.

Speaker #3: Cash and cash equivalents of the June 30, 2026, were approximately 155.5 million dollars, compared to 162.6 million dollars as of March 31, 2026. We believe our existing cash resources and the cash we expect to generate from product royalty supply and license revenues along with our plan to refinance our senior secured term loan facility will enable us to fund our current operating plan for at least two years.

Speaker #3: With that, we will now open the line for questions. Operator?

Erik Ostrowski: With that, we will now open the line for questions. Operator?

Speaker #5: Thank you. We will now be opening question and answer session. If you'd like to ask a question, press start then the number one on your telephone keypad.

Operator 2: Thank you. We will now be opening the question and answer session. If you'd like to ask a question, press star then 1 on your telephone keypad. To withdraw your question, please press star 1 again. Thank you. Your first question comes from Matthew Caulfield with H.C. Wainwright. Please go ahead.

Operator: Thank you. We will now be opening the question and answer session. If you'd like to ask a question, press star then 1 on your telephone keypad. To withdraw your question, please press star 1 again. Thank you. Your first question comes from Matthew Caulfield with H.C. Wainwright. Please go ahead.

Speaker #5: To withdraw your question, please press Start once again. Thank you. Your first question comes from Matthew Caulfield with H.C. Wainwright. Please go ahead.

Speaker #6: Hi, thank you guys, and really great to see the progress across the platform. So regarding the VAFSIO penetration into the dialysis organizations, obviously you've discussed the in-center dosing protocol being an important part of that in terms of adherence and growth.

Matthew Caulfield: Hi. Thank you, guys, really great to see the progress across the platform. Regarding the Vafseo penetration into the dialysis organizations, obviously you've discussed the in-center dosing protocol being an important part of that, in terms of adherence and growth. Do you think the near-term growth in the coming quarters is more a factor of new patients getting onto therapy or simply broadening the in-center protocol across those current Vafseo patients? Guess I'm just getting at kind of the best ways to think about the near-term growth drivers overall. Thanks.

Speaker #6: Do you think the near-term growth in the coming quarters is more a factor of new patients getting onto therapy, or simply broadening the in-center protocol across those current VAFSIO patients?

Speaker #6: Get some just getting at kind of the best ways to think about the near-term growth drivers overall. Thanks.

Speaker #1: Nick, you want to take that?

John Butler: Nick, you want to take that?

Speaker #2: Yeah. Matt, great question. Thanks. So really, well, the new patients what we're seeing is a couple of different things. One, the number of clinics that are starting patients is continuing to expand, right?

Nicholas Grund: Yeah, Matt, great question. Thanks. Really with the new patients, what we're seeing is a couple different things. One, the number of clinics that are starting patients is continuing to expand, right? It's not just within a certain clinic. The number of prescribers continues to grow. It grew 17% this quarter versus Q1. People are starting to try product, try Vafseo, outside of, we'll call it, existing physician base. Certainly that generates a bunch of new patients. In addition, frankly, restarts are going really well. As you recall, we had QD patients that fell off therapy in 2025. As they've rolled through these observed dosing protocols, we've seen just about 25% of those discontinued patients actually come back on therapy, which is also helping the growth rate as well.

Speaker #2: So it's not just within a certain clinic. The number of prescribers continues to grow. It grew 17% this quarter versus quarter one. So people are starting to try product try VAFSIO outside of, we'll call it, existing physician base.

Speaker #2: So certainly, that generates a bunch of new patients. In addition, frankly, restarts are going really well. As you recall, we had QD patients that fell off therapy in 2025 as they've rolled through these observed dosing protocols.

Speaker #2: We've seen just about a 25% of those discontinued patients actually come back on therapy. Which is also helping the growth rate as well. And so a couple of different factors in there.

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

Speaker #2: But most of the growth is coming through the new patients new clinics and new providers.

Speaker #6: Got it. Thank you. I appreciate that.

Matthew Caulfield: Got it. Thank you. I appreciate that.

John Butler: Just about every metric, or every metric of growth is increasing quarter-on-quarter. We're really seeing that trend of prescribing and patients increase. It's great to see the restarts as well. We're really very encouraged by that. Obviously, we hope the VOICE data only continues to accelerate that. Do you have another question, Matt?

Speaker #1: Just about every just about every metric or every metric of growth is increasing. Quarter on quarter. So we're really seeing that threat of prescribing and patients increase.

Speaker #1: It's great to see the restarts as well. We're really, really very encouraged by that. And obviously we hope the voice data only continues to accelerate that.

Speaker #1: Do you have another question, Matt?

Speaker #6: Absolutely. Thank you. No, that's it. I appreciate it.

Matthew Caulfield: Absolutely. Thank you. No, that's it. I appreciate it.

Speaker #1: Thank you.

John Butler: Thank you.

Speaker #5: Your next question comes from Rowana Ruiz with Ligarink. Please go ahead.

Operator 2: Your next question comes from Roanna Ruiz with Leerink. Please go ahead.

Operator: Your next question comes from Roanna Ruiz with Leerink. Please go ahead.

Speaker #4: Hi, this is Anna on for Rowana. Thanks so much for taking our question. Two questions from us. Just wondering if you could better characterize the persistence rates, such as 90- and 180-day persistence rates, rather than just first refill adherence.

[Analyst] (Leerink): Hi, this is Anna on for Roanna. Thanks so much for taking our question. Two questions from us. Just wondering if you could better characterize the persistence rates, such as 90 and 80 day persistence rates, rather than just first refill adherence, and give any color on maybe the principal reasons for discontinuation now that you have the three times a week dosing. The second, just wondering what the timeline is for getting VOICE data in front of the medical organizations and how much you might expect that to move these net new prescriber additions beyond the good growth you've seen so far. Thanks so much.

Speaker #4: And can you give any color on maybe the principal reasons for discontinuation now that you have the three-times-a-week dosing? And second, just wondering what the timeline is for getting VOICE data in front of the medical organizations, and how much you might expect that to move these net new prescriber additions beyond the good growth you've seen so far.

Speaker #4: Thanks so much.

Speaker #1: Great. Nick, you want to take the adherence question?

John Butler: Great. Nick, you want to take the adherence question?

Speaker #2: Yeah. So when it comes to adherence, when we talk about this first refill item, we've seen really good consistency there. About 89% of those patients who receive a prescription for VAFSIO get the refill for the next period.

Nicholas Grund: Yeah. When it comes to adherence, where we talk about this first refill item, we've seen real good consistency there. About 89% of those patients who receive a prescription for Vafseo get the refill for the next period, which is really strong. After that, it really tapers down towards what I'll call normal churn in the dialysis patient population. The second part of your question was why do people discontinue? No therapy I know of actually works in every patient. You may have some folks that get hospitalized during that period, go back onto an ESA, come back into the clinic, and then they'll work to put them back on Vafseo. You got folks that just don't tolerate it. Maybe there's some GI issues associated with it.

Speaker #2: Which is really strong. After that, it really tapers down towards what I'll call normal churn in the dialysis patient population. The second part of your question was why do people discontinue?

Speaker #2: Not any no therapy I know of actually works in every patient. And so you may have some folks that get hospitalized during that period, go back on 20, say, come back into the clinic, and then they'll work to put them back on VAFSIO.

Speaker #2: You've got folks that just don't tolerate it—maybe there are some GI issues associated with it. But at this point, I think we've done a nice job in moving to an adherence rate on first refill that is where we want it to be.

Nicholas Grund: At this point, I think we've done a nice job in moving to an adherence rate on first refill that is where we want it to be.

Speaker #1: Yeah. I mean, that's where when we launched the product and you had this QD dosing, and particularly the anemia managers saw people's hemoglobins drop as we told them it would, they just weren't used to not controlling that.

John Butler: Yeah, that's where when we launched the product and you had this QD dosing, particularly the anemia managers saw people's hemoglobins drop as we told them it would. They just weren't used to not controlling that. We really believe that that was the main reason for that first refill drop in adherence. I think the data supports that that really was the case. Beyond that, it really is what you normally see in a dialysis population. Then I think, Anna, your second question was around the timeline to get that data to the dialysis provider. This is clearly an ongoing effort. As I said, I think it's important to note that it's not been presented and it's not published, but this is a relatively small community, right?

Speaker #1: And we really believe that that was the main reason for that first refill kind of drop in adherence. And I think the data supports that that really was the case.

Speaker #1: And so beyond that, it really is what you normally see in a dialysis population. So, and then I think, Anna, your second question was around the timeline to get data to the dialysis providers.

Speaker #1: So this is clearly an ongoing effort. As I said, I think it's important to note that it's not been presented and it's not published, but this is a relatively small community, right?

Speaker #1: And we know that Jeff Block is incredibly excited about this data as we are. And I know he is talking to dialysis providers, his peers, at other dialysis providers independent of our conversations.

John Butler: We know that Jeff Block is incredibly excited about this data as we are, and I know he is talking to dialysis providers, his peers at other dialysis providers, independent of our conversations. I know Steve and his team have also been having those conversations. And there are places where, like U.S. Renal ran the study, so they've been our strongest supporter, and I think that will only continue to increase. IRC and DCI also. Certainly, IRC, incredibly excited about the clinical benefit. This only really increases that excitement. The way we look at it, between those three providers, you've got about 66,000 patients in total. Most of whom, or at least 80% of whom are on an ESA today, and we've got just over 10,000 patients treated. Huge amount of room to grow there.

Speaker #1: But I know Steve and his team have also been having those conversations. And there are places where, I mean, like US Renal ran the study.

Speaker #1: So they've been our strongest supporter. And I think that will only continue to increase. IRC and DCI also certainly IRC. Incredibly excited about the clinical benefit.

Speaker #1: This only really increases that excitement. And the way we look at it, between those three providers, you've got about 66,000 patients in total. Most of whom, or at least 80% of whom are on an ESA today.

Speaker #1: And we've got just over 10,000 patients treated. So huge amount of room to grow. There. And again, I mean, the conversations that have been had at the clinical level at DaVita certainly, and as Nick mentioned, I mean, now the conversations are much more operational in nature.

John Butler: Again, the conversations that have been had at the clinical level at DaVita, certainly, and as Nick mentioned, now the conversations are much more operational in nature. That really, to me, bodes well. Again, it's a very large organization that we've learned takes a lot of work to move, but there seems to be some real momentum there. We're encouraged by that. Conor, we don't mention Fresenius a lot, but we believe that this is the kind of data that will be meaningful for them as well, and those conversations are starting, and I think they'll be much more interested in seeing it published.

Speaker #1: And that really, to me, bodes well. Again, it's a very large organization. We've learned it takes a lot of work to move.

Speaker #1: But there seems to be some real momentum there. So we're encouraged by that. And we don't mention Fresenius a lot, but we believe that this is the kind of data that will be meaningful for them as well.

Speaker #1: And those conversations are starting, and I think they'll be much more interested in seeing it published.

Speaker #4: Great. Thank you so much.

[Analyst] (Leerink): Great. Thank you so much.

Speaker #1: Thank you.

John Butler: Thank you.

Speaker #5: Your next question comes from Roger Song with Jefferies. Please go ahead.

Operator 2: Your next question comes from Roger Song with Jefferies. Please go ahead.

Operator: Your next question comes from Roger Song with Jefferies. Please go ahead.

Speaker #6: Hey, team. This is Nabil on for Roger. Thanks for the updates. Congrats on the progress. Maybe you could comment a little bit more on the pipeline.

[Analyst] (Deutsche Bank): Hey, team, this is Nabil on for Roger. Thanks for the updates. Congrats on the progress. Maybe if you could comment a little bit more on the pipeline on Prali, if any thoughts on how enrollment is progressing, any color there as well. How do we see with recent developments in that space, I guess following on Ebara, with recent developments on that space, how do you see potential combination use? Thank you.

[Analyst] (Jefferies): Hey, team, this is Nabil on for Roger. Thanks for the updates. Congrats on the progress. Maybe if you could comment a little bit more on the pipeline on Prali, if any thoughts on how enrollment is progressing, any color there as well. How do we see with recent developments in that space, I guess following on Ebara, with recent developments on that space, how do you see potential combination use? Thank you.

Speaker #6: Probably, any thoughts on how enrollment is progressing? Any color there as well? And how do we see things with recent developments in that space?

Speaker #6: I guess, following on EBRA with recent developments in that space, how do you see potential combination use? Thank you.

Speaker #1: So I'll take the first part, and then I'll turn it over to Steve. So, enrollment is really progressing. It is a competitive space, which we knew.

John Butler: I'll take the first part, then I'll turn it over to Steve. Enrollment's progressing. It is a competitive space, which we knew. The team is continuing to drive more patients on, feel good about adding more sites, et cetera. We really look forward to saying this is when we expect to see that 6-month data. We don't want to put that stake in the ground until we're really confident that we're going to have those 60 patients fully enrolled in the study. We are making progress on it. I think what you're referring to is, you look at that, the Q1, Travere just announced their very early data in FSGS for that 1st approved product last night, it is 40,000 patients, a very heterogeneous disease where multiple products will make a real difference for patients in this market.

Speaker #1: We're the team is continuing to drive more patients on, feel good about adding more sites. Et cetera. We really look forward to seeing this is when we expect to see that six-month data.

Speaker #1: We don't want to make that kind of put that stake in the ground until we're really confident that we're going to have those 60 patients fully enrolled in the study.

Speaker #1: But we are making progress on it. And I think what you're referring to is you look at the first quarter, Trevier just announced their very early data in FSGS for that first approved product last night.

Speaker #1: And it is 40,000 patients, a very heterogeneous disease where multiple products will make a real difference for patients in this market. So this is some massive commercial opportunity and a massive opportunity for patients as well.

John Butler: This is a massive commercial opportunity and a massive opportunity for patients as well. It's worth driving this forward as quickly as we can. I'll let Steve comment on the opportunity for combination therapy or polypharmacy.

Speaker #1: So, it's worth kind of driving this forward as quickly as we can. I'll let Steve comment on the opportunity for combination therapy, or probably pharmacy.

Speaker #2: Yeah. I mean, Steve, so for FSGS, we will be able to treat patients who have persistent proteinuria despite being on ACE and ARBs or endothelin antagonists.

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

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

Speaker #2: So I'm actually delighted to see the uptake of Sparsentan. And there's plenty of patients who will benefit. Our drug may work well with Sparsentan as well.

Speaker #2: That's something we'll need to determine in future clinical trials. In terms of every there is a real desire to have treatments that are safe and effective and work quickly.

Speaker #2: So, complement-mediated diseases involve the complements being activated and damaging the kidney cells. And if you use a complement inhibitor, generally you get a very rapid response.

Speaker #2: To stop the kidney damage. And clearly, it could be used with other therapies. There's been a lot of exciting data about APRIL and APRIL bath inhibitors.

Steven K. Burke: There has been a lot of exciting data about APRIL and APRIL-BAFF inhibitors, and I think those are going to be very good products in the long term. They are directed at suppressing the B cells that are making autoantibodies, and there is no reason these drugs couldn't be used together. I think this is one of the things that Dr. Barratt had highlighted, that those drugs are quite profoundly immunosuppressive in terms of B cells and affect your ability to respond to new infectious agents. I think there is a lot of interest in having a complement inhibitor that is highly effective, but inherently safer because it doesn't suppress the complement system in the blood. I think time will tell, but I think there is clear opportunity for combination use. I hope that answered your question.

Steven Burke: There has been a lot of exciting data about APRIL and APRIL-BAFF inhibitors, and I think those are going to be very good products in the long term. They are directed at suppressing the B cells that are making autoantibodies, and there is no reason these drugs couldn't be used together. I think this is one of the things that Dr. Barratt had highlighted, that those drugs are quite profoundly immunosuppressive in terms of B cells and affect your ability to respond to new infectious agents. I think there is a lot of interest in having a complement inhibitor that is highly effective, but inherently safer because it doesn't suppress the complement system in the blood. I think time will tell, but I think there is clear opportunity for combination use. I hope that answered your question.

Speaker #2: And I think those are going to be very good products in the long term. They're directed at suppressing the B cells that are making autoantibodies.

Speaker #2: And there's no reason these drugs couldn't be used together. I think this is one of the things that Dr. Barrett had highlighted—that those drugs are quite profoundly immunosuppressive in terms of B cells, and affect your ability to respond to new infectious agents.

Speaker #2: So I think there is a lot of interest in having a complement inhibitor that is highly effective but inherently safer because it doesn't suppress the complement system in the blood.

Speaker #2: So I think time will tell, but I think there's clear opportunity for combination use. I hope that answered your question.

Speaker #6: Thank you.

[Analyst] (Deutsche Bank): Thank you.

[Analyst] (Jefferies): Thank you.

Speaker #1: Hey, Steve. Go back to FSGS and probably for a moment. I think one of the things you've I've heard you talk about with other folks is the difference in mechanism.

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

Speaker #1: The unique mechanism of probably and how it is quite different from the way Sparsentan works and why that might actually be a benefit.

Speaker #2: Sure. Yeah. Sparsentan works by blocking the angiotensin receptor and the endothelin receptor. Blocking endothelin is good because endothelin is a vasoconstrictor. It's injurious to podocytes.

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

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

Speaker #2: Which are those critical cells in the glomeruli that are the barrier to protein spilling into the urine? And it's also anti-inflammatory and anti-fibrotic. Prolisaguat is hitting a completely different pathway.

Speaker #2: The soluble guanylate cyclase pathway, which leads to increases in cyclic GMP, probably is a vasodilator. It also protects the podocyte and has anti-inflammatory and antifibrotic properties.

Speaker #2: So they're doing very similar things just from modulation of a different pathway. There's no reason they shouldn't work well together.

Speaker #1: Great. Thank you, Steve. And thanks, Nabil. Next question, operator.

John Butler: Great. Thank you, Steve. Thanks, Nabil. Next question, operator.

[Analyst] (Jefferies): Great. Thank you, Steve.

John Butler: Thanks, Nabil. Next question, operator.

Operator 2: Again, if you would like to ask a question, please press star one on your telephone keypad. Your next question comes from Julian Harrison with BTIG. Please go ahead.

Operator: Again, if you would like to ask a question, please press star one on your telephone keypad. Your next question comes from Julian Harrison with BTIG. Please go ahead.

Speaker #6: Yeah. Again, if you would like to ask a question, please press star one on your telephone keypad. Your next question comes from Julianne Harrison with BTIG.

Speaker #6: Please go ahead.

Speaker #7: Hi. This is Andrew Casson on for Julianne Harrison. Congratulations on the results and progress this quarter. And thanks for taking our questions. Just a few from us here.

Andrew Tsai: Hi, this is Andrew Tsai on for Julian Harrison. Congratulations on the results and progress this quarter, thanks for taking our questions. Just a few from us here. First, you touched on some of the key factors driving Vafseo revenue growth. How much of the growth was driven by ex-USRC uptake? Next, have any dialysis providers changed or accelerated their protocol decision since the VOICE results were shared a little more than a month ago, or has the feedback been more on an individual physician level thus far? Finally, on DaVita, I know this has been alluded to a bit, but is there any more color on the progress at DaVita that could be provided?

[Analyst] (Jefferies): Hi, this is Andrew Tsai on for Julian Harrison. Congratulations on the results and progress this quarter, thanks for taking our questions. Just a few from us here. First, you touched on some of the key factors driving Vafseo revenue growth. How much of the growth was driven by ex-USRC uptake? Next, have any dialysis providers changed or accelerated their protocol decision since the VOICE results were shared a little more than a month ago, or has the feedback been more on an individual physician level thus far? Finally, on DaVita, I know this has been alluded to a bit, but is there any more color on the progress at DaVita that could be provided?

Speaker #7: So first, you touched on some of the key factors driving vascular revenue growth. How much are the growth was driven by ex-USRC uptake? And then next, have any dialysis providers changed or accelerated their protocol decisions since the voice results were shared a little more than a month ago?

Speaker #7: Or is the feedback been more on an individual physician level thus far? And finally, on DaVita, I know this has been alluded to a bit, but is there any more color on the progress at DaVita that could be provided?

Speaker #7: And is there a future step-up in uptake we should be thinking about regarding DaVita in terms of timing specifically? And if so, could you maybe give us a little bit more of a sense of when?

Andrew Tsai: Is there a future step-up in uptake we should be thinking about regarding DaVita in terms of timing specifically, if so, could you maybe give us a little bit more of a sense of when? Thanks for taking our questions and congrats again.

[Analyst] (Jefferies): Is there a future step-up in uptake we should be thinking about regarding DaVita in terms of timing specifically, if so, could you maybe give us a little bit more of a sense of when? Thanks for taking our questions and congrats again.

Speaker #7: Thanks for taking our questions and congrats again.

Speaker #1: Thanks, Andrew. So I'll just comment quickly on DaVita. I mean, again, DaVita put the TAW protocol in place and that was an important step.

John Butler: Thanks, Andrew. I'll just comment quickly on DaVita. Again, DaVita put the TIW protocol in place, and that was an important step. We're seeing growth, but Nick mentioned this in his remarks. It's really that top-down advocacy that has made the difference at U.S. Renal Care, IRC, DCI. Those levels of discussions we're seeing now really suggest that we're making progress there. Honestly, those conversations were happening before VOICE because of the INNO2VATE data, I believe. This idea that this product can make a difference versus ESAs on hospitalization. I would say it's become more, urgent is the wrong word, but it's been a more robust conversation with the VOICE data. Nick, I think you have more to add on the DaVita side. You can take the other questions as well.

Speaker #1: We're seeing growth, but Nick mentioned this in his remarks. I mean, it's really that top-down advocacy that has made the difference at US Renal, IRC, DCI.

Speaker #1: And those levels of discussions we're seeing now really suggest that we're making progress there. Honestly, those conversations were happening before. Voice because of the Innovate data, I believe.

Speaker #1: This idea that this product can make a difference versus ESAs on hospitalization. I would say it's become more urgent is the wrong word, but kind of it's been a more robust conversation.

Speaker #1: With the voice data. Nick, I think you have more to add on the DaVita side. Maybe take the other questions as well.

Speaker #3: Yeah. And so DaVita, we recently got some market research that was fielded at the beginning of June from a company called Spherix. And what that shows is from DaVita physicians in particular, all-time highs in terms of their awareness of vascular, all-time high with a likelihood to recommend, and also an all-time high in their preference to use vascular instead of an ESA.

Nicholas Grund: Yeah. DaVita, we recently got some market research that was fielded at the beginning of June from a company called Spherix Global Insights. What that shows is from DaVita physicians in particular, all-time highs in terms of their awareness of Vafseo, all-time high with a likelihood to recommend, and also an all-time high in their preference to use Vafseo instead of an ESA to improve efficacy. There is this pent-up desire to use Vafseo within DaVita. We've just got to help the process and help the leadership help the process from the top down to be able to allow them more rapid adoption of Vafseo. The other questions, the first question I think was utilization outside of U.S. Renal Care. Roughly a third of physicians now prescribing Vafseo are non-U.S. Renal Care physicians. That speaks to the diversification. U.S. Renal Care has been going gangbusters since the beginning.

Speaker #3: To improve efficacy. And so there is this pent-up desire to use vascular within DaVita we've just got to help the process and help the leadership help the process from the top down to be able to allow them more rapid adoption of vascular.

Speaker #3: The other questions, the first question I think was utilization outside of USRC. Roughly, a third of physicians now prescribing vascular are non-USRC physicians. And so that kind of speaks to the diversification.

Speaker #3: USRC has been kind of going gangbusters since the beginning. IRC and DCI really started at the beginning of 2026. And so they're a little bit smaller, but together they make up just about the size of USRC.

Nicholas Grund: IRC and DCI really started at the beginning of 2026. They're a little bit smaller, but together they make up just about the size of U.S. Renal Care, and they're demonstrating very strong growth as well. I think John pointed out earlier, there's so much more room to grow in those organizations. When you think about 10,000 patients and John had 66,000 patients or 60,000 patients between the three of them, there's a ton of growth still yet to be had, which is also encouraging.

Speaker #3: And they're demonstrating very, very strong growth as well. And so just and I think John pointed out earlier, there's so much more room to grow in those organizations.

Speaker #3: When you think about 10,000 patients and John had 66,000 patients or 60,000 patients between the three of them, there's a ton of growth still yet to be had, which is also encouraging.

Speaker #1: Yeah. I mean, we're all focused on DaVita. With 200,000 patients, that can make a huge difference. And turn those percentages on their gear. We really are encouraged by what we're seeing there.

John Butler: Yeah. We're all focused on DaVita. With 200,000 patients, that can make a huge difference and turn those percentages on their ear. We really are encouraged by what we're seeing there. The hard thing is to really pinpoint exact timing of when that happens. When you get that kind of support, takes a long time to get it, but once you get it sticks around also. I think that's really important as we think about the long term here. Again, as I said, we don't talk a lot about Fresenius Medical Care, but I believe this clinical data from VOICE, when this is published and presented, this will make a difference. Those physicians who treat patients at Fresenius Medical Care want to give their patient the best care as well.

Speaker #1: The hard thing is to really pinpoint the exact timing of when that happens. But when you get that kind of support, it takes a long time to get it.

Speaker #1: But once you get it, it sticks around also. And I think that's really important as we think about the long-term here. And again, I mean, we don't talk as I said, we don't talk a lot about Fresenius, but I believe this clinical data from voice, when this is published and presented, this will make a difference.

Speaker #1: Those physicians who treat patients of Fresenius want to give their patient the best care as well. So there's tremendous room for us to grow.

John Butler: There's tremendous room for us to grow, even in a world where we have to take this price decrease, which we will for the end of TDAPA. We recognize that. This is still an extremely significant market that we think will have the standard of care product in.

Speaker #1: Even in a world where we have to take this price decrease—which we will for Tdap, the end of Tdapa—we recognize that. But this is still an extremely significant market that we think will have the standard-of-care product in.

Speaker #2: And Julian, you also asked about protocol changes. Since VOICE, there's been a lot of dialogue between all DOs. Dr. Block has been pretty active in talking about his VOICE results.

Nicholas Grund: Julian, you also asked about protocol changes since VOICE. There's been a lot of dialogue between all DOs. Dr. Block has been pretty active in talking about his VOICE results, which is encouraging. The only protocol change I'll note is DaVita, in the very beginning of June, did roll out village-wide their 3-times-weekly or observed dosing protocol. I think that's really going to be helpful in physicians overcoming some of the compliance concerns they may have had prescribing the product at home.

Speaker #2: Which is encouraging. The only protocol change I'll note is DaVita in the very beginning of June did roll out village-wide their three times weekly or observed dosing protocol.

Speaker #2: And I think that's really going to be helpful in physicians overcoming some of the compliance concerns they may have had prescribing the product at home.

Speaker #1: And I think that's some of the conversations that Steve's team is having with them now is looking at that versus what was in voice and when you start hearing them get very, very specific about how do we what do we do when this happens or that happens?

John Butler: I think that's some of the conversations that Steve's team is having with them now is looking at that versus what was in VOICE and when you start hearing them get very specific about What do we do when this happens or that happens? That gives you a lot of encouragement. They're not asking those questions to pass the time, right? They're really looking to do something. We just have to see when. Stay tuned.

Speaker #1: That gives you a lot of encouragement. And then not asking those questions to pass the time, right? They're really looking to do something. We just have to see when.

Speaker #1: So stay tuned.

Speaker #7: Thank you very much.

Andrew Tsai: Thank you very much.

[Analyst] (Jefferies): Thank you very much.

Speaker #1: Thanks, Andrew.

John Butler: Thanks, Andrew.

Speaker #5: That concludes with our question and answer session. I would now like to turn the call over to John Butler for closing your remarks.

Operator 2: That concludes with our question and answer session. I would now like to turn the call over to John Butler for closing remarks.

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

Speaker #1: Thanks, operator. And thanks to all of you for joining us this afternoon. And we are really encouraged by the vascular growth trajectory through the first half of the year.

John Butler: Thanks, operator, thanks to all of you for joining us this afternoon. We are really encouraged by the Vafseo growth trajectory through the H1 of the year. And as we've been saying, the reaction we're seeing from dialysis providers to the announcement of the VOICE data. We believe in the long-term prospects for Vafseo and believe it can contribute significantly to Akebia's success. At the same time, I do ask that you consider the opportunity that advancement of our pipeline, specifically ebri and prali, represents for us. Notably, the opportunity to potentially bring important products to compete in rare disease markets worth many billions of dollars in expected total value. We are eager to update you on the progress of our trials, and we plan to share data as quickly as we can. Have a great day, everybody.

Speaker #1: And as we've been saying, the reaction we're seeing from dialysis providers to the announcement of the voice data we believe in the long-term prospects for vascular and believe it can contribute significantly to Akebia's success.

Speaker #1: At the same time, I do ask that you consider the opportunity that advancement of our pipeline, specifically Evry and probably represent for us. Notably, the opportunity to potentially bring important products to compete in rare disease markets worth many billions of dollars in expected total value.

Speaker #1: We are eager to update you on the progress of our trials and we plan to share data as quickly as we can. Have a great day, everybody.

Speaker #4: Goodbye.

Mercedes Carrasco: Goodbye.

Operator 2: Ladies and gentlemen, this concludes today's call. You may now disconnect.

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

Q2 2026 Akebia Therapeutics Inc Earnings Call

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