Cuộc gọi báo cáo kết quả kinh doanh quý 3 năm 2026 của Akebia (AKBA): Nhu cầu Vafseo, định giá và quá trình chuyển đổi TDAPA

Kết quả kinh doanh quý 3/2026 của Akebia Therapeutics (NASDAQ: AKBA) ghi nhận lượng bệnh nhân sử dụng Vafseo gia tăng nhưng doanh thu báo cáo lại giảm do các phòng khám lọc máu cắt giảm lượng hàng tồn kho. Tổng doanh thu sụt giảm do Auryxia đối mặt với sự cạnh tranh từ thuốc generic, trong khi ban lãnh đạo tập trung vào quá trình chuyển đổi của Vafseo sau khi cơ chế hoàn trả TDAPA kết thúc vào tháng 1/2027.

Điểm nhấn chính

• Tổng doanh thu giảm từ 58,8 triệu USD trong quý 3/2025 xuống còn 36,9 triệu USD, chủ yếu phản ánh doanh số sụt giảm của Auryxia.
• Doanh thu sản phẩm thuần của Vafseo tăng 3% so với cùng kỳ năm trước lên 14,8 triệu USD, bất chấp số lượng bệnh nhân điều trị tăng trưởng khoảng 140%. Ban lãnh đạo cho rằng sự chênh lệch này bắt nguồn từ việc giải phóng hàng tồn kho do liều dùng trung bình thấp hơn và số buổi lọc máu ít hơn dự kiến.
• Ban lãnh đạo ước tính nhu cầu thực tế của người dùng cuối đối với Vafseo đạt từ 19 triệu đến 20 triệu USD trong quý 3, so với doanh thu báo cáo là 14,8 triệu USD và nhu cầu ước tính từ 17 triệu đến 18 triệu USD trong quý 2.
• Khoảng 11.500 bệnh nhân đang điều trị bằng Vafseo, chiếm khoảng 20% số bệnh nhân thiếu máu được điều trị bởi U.S. Renal Care, Dialysis Clinic Inc. và Innovative Renal Care. Khoảng 25% bệnh nhân từng ngừng điều trị đã bắt đầu sử dụng lại.
• Thử nghiệm VOICE ghi nhận tỷ lệ nhập viện khi dùng vadadustat thấp hơn 10% so với nhóm thuốc ESA, và không có sự khác biệt đáng kể về tỷ lệ tử vong. Nghiên cứu trên 2.116 bệnh nhân đã đáp ứng tiêu chí dừng định trước với tỷ số thắng (win odds) là 1,16 và giá trị p bằng 0,0016.
• Tiền và các khoản tương đương tiền đạt 159,3 triệu USD vào cuối quý. Akebia cho biết các nguồn lực hiện có, dòng doanh thu dự kiến và kế hoạch tái cấp vốn cho khoản vay có kỳ hạn sẽ đủ để tài trợ cho kế hoạch hoạt động hiện tại trong ít nhất hai năm.

Dữ liệu tài chính cốt lõi

Hoạt động kinh doanh và vận hành

Nhu cầu Vafseo vượt tốc độ tăng trưởng doanh thu báo cáo

Ban lãnh đạo cho biết khách hàng lớn nhất của công ty ban đầu giả định liều Vafseo trung bình là 900 miligam cho mỗi đợt lọc máu, trong khi mức sử dụng thực tế trung bình chỉ khoảng 810 miligam. Bệnh nhân cũng chỉ tham gia khoảng 10,5 đến 11 buổi lọc máu mỗi tháng, thấp hơn kỳ vọng của các nhà cung cấp dịch vụ là khoảng 12 buổi.

Do Vafseo được sử dụng dưới sự giám sát trực tiếp tại một số phòng khám, các buổi lọc máu bị bỏ lỡ đã làm giảm lượng thuốc tiêu thụ. Liều dùng thấp hơn cùng tỷ lệ tham gia điều trị giảm đã dẫn đến tình trạng dư thừa hàng tồn kho tại các phòng khám và làm giảm lượng mua hàng của khách hàng trong quý 3. Ban lãnh đạo ước tính các phòng khám đã giải phóng khoảng 4 triệu đến 5 triệu USD hàng tồn kho trong quý này.

Dự kiến hàng tồn kho sẽ tiếp tục giảm trước thời điểm cơ chế TDAPA của Vafseo hết hiệu lực vào ngày 1 tháng 1 năm 2027, do các nhà cung cấp tránh tích trữ sản phẩm được mua ở mức giá cao hơn trước khi hết hạn.

Chiến lược hậu TDAPA tập trung vào việc mở rộng khả năng tiếp cận và định giá tương đương ESA

Sau khi TDAPA hết hạn, Vafseo sẽ trở thành một phần trong gói thanh toán trọn gói cho dịch vụ lọc máu và sẽ không còn được thanh toán riêng. Ban lãnh đạo cho biết điều này sẽ mở rộng khả năng tiếp cận ra ngoài nhóm bệnh nhân đủ điều kiện theo TDAPA tới gần như toàn bộ bệnh nhân đủ điều kiện lâm sàng.

Akebia kỳ vọng chi phí điều trị trung bình hàng năm của Vafseo sẽ dao động từ 1.000 đến 1.500 USD, phản ánh việc giá thuốc ESA giảm, liều dùng trung bình thấp hơn, số buổi lọc máu thực tế và chính sách định giá theo khối lượng. Ban lãnh đạo cho biết việc điều trị cho ít nhất 200.000 đến 250.000 bệnh nhân có thể mang lại doanh thu đỉnh điểm lên tới hàng trăm triệu USD nếu Vafseo trở thành tiêu chuẩn chăm sóc y tế.

Theo Akebia, DaVita đã ký hợp đồng hậu TDAPA kéo dài đến hết năm 2027 và đã đề nghị gia hạn thêm nhiều năm. Ban lãnh đạo dự kiến việc triển khai sẽ bắt đầu chậm rãi trong quý 4/2026, sau đó mở rộng đáng kể hơn vào đầu năm 2027. Fresenius cũng bày tỏ sự quan tâm đến dữ liệu từ thử nghiệm VOICE, dù ban lãnh đạo dự kiến quá trình triển khai tại đây sẽ mất nhiều thời gian hơn.

Bằng chứng lâm sàng hỗ trợ cho tiềm năng thương mại hóa

Trong thử nghiệm VOICE, tỷ lệ biến cố bất lợi nghiêm trọng được điều chỉnh theo thời gian phơi nhiễm là 121,5 trên 100 năm-bệnh nhân đối với vadadustat, so với 134,2 đối với nhóm thuốc ESA. Vadadustat cũng cho thấy khả năng kiểm soát hemoglobin ổn định hơn và ít xuất hiện các đợt tăng vọt nồng độ hemoglobin trong một tiêu chí đánh giá thăm dò.

Phân tích kinh tế cập nhật của nghiên cứu INNO2VATE được trình bày tại ASN cho thấy Vafseo có thể giúp giảm chi phí nhập viện hàng năm khoảng 6.200 USD cho mỗi bệnh nhân so với nhóm thuốc ESA. Theo các giả định của phân tích, việc điều trị cho tất cả bệnh nhân lọc máu bị thiếu máu đủ điều kiện có thể giúp giảm hơn 600.000 ngày nằm viện.

Akebia cũng công bố kết quả sơ bộ tích cực từ thử nghiệm VOCAL. Nghiên cứu tại các phòng khám của DaVita cho thấy vadadustat dùng ba lần mỗi tuần có hiệu quả duy trì hemoglobin không thua kém liệu pháp ESA. Các phân tích sâu hơn sẽ đánh giá độ ổn định của hemoglobin, truyền máu, điều trị cứu nguy và các đặc tính của hồng cầu.

Danh mục thuốc điều trị bệnh thận hiếm đạt tiến triển

Akebia đang tuyển chọn bệnh nhân cho các nghiên cứu Giai đoạn II về praliciguat trong điều trị xơ cứng cầu thận khu trú từng đoạn, và ebribafusp trong một thử nghiệm giỏ (basket trial) đối với bệnh cầu thận C3, bệnh thận IgA và viêm thận lupus. Dữ liệu ban đầu về ebribafusp dự kiến sẽ có vào năm 2027.

Thử nghiệm ebribafusp sẽ chủ yếu đánh giá mức giảm tỷ lệ protein/creatinine trong nước tiểu, khả năng ổn định chức năng thận và các dấu ấn sinh học bổ thể. Akebia đặt mục tiêu chứng minh hoạt tính tại thận mà không ức chế toàn thân con đường bổ thể thay thế, điều mà ban lãnh đạo xem là yếu tố khác biệt tiềm năng về độ an toàn.

Triển vọng từ ban lãnh đạo

• Ban lãnh đạo dự kiến số lượng bệnh nhân sử dụng Vafseo sẽ tiếp tục tăng trong quý 4/2026, dẫn đầu chủ yếu bởi U.S. Renal Care, Innovative Renal Care và Dialysis Clinic Inc.
• Doanh thu báo cáo quý 4 có thể vẫn chịu ảnh hưởng từ chiến lược quản lý hàng tồn kho thận trọng của khách hàng trước thời điểm TDAPA hết hạn.
• DaVita dự kiến sẽ bắt đầu triển khai ở quy mô hạn chế trong quý 4, trước khi mở rộng đáng kể hơn vào đầu năm 2027.
• Doanh thu từ Auryxia dự kiến sẽ tiếp tục sụt giảm so với năm 2025 do sự cạnh tranh của thuốc generic và áp lực về giá.
• Dữ liệu ban đầu từ thử nghiệm giỏ Giai đoạn II của ebribafusp dự kiến sẽ có vào năm 2027. Akebia không cung cấp thời gian cập nhật đối với dữ liệu của praliciguat.

Rủi ro và các trọng tâm cần theo dõi

• Doanh thu của Vafseo có thể tiếp tục phân kỳ so với mức tăng trưởng bệnh nhân khi các nhà cung cấp điều chỉnh lượng hàng tồn kho cho phù hợp với liều dùng thực tế, số buổi lọc máu và thời điểm kết thúc cơ chế hoàn trả TDAPA.
• Giá thuốc ESA sụt giảm đang gây áp lực lên giá của Vafseo sau khi kết thúc TDAPA, đồng thời khối lượng tiêu thụ lớn hơn cũng được dự báo sẽ làm giảm giá bán trung bình.
• Tỷ lệ tiếp nhận thuốc từ các tổ chức lọc máu lớn đang chậm hơn so với kỳ vọng của ban lãnh đạo. DaVita đang tiến hành một cách thận trọng, trong khi Fresenius có thể cần nhiều thời gian hơn do những thay đổi về mặt tổ chức.
• Việc chuyển đổi bệnh nhân từ nhóm ESA sang Vafseo đòi hỏi hoạt động đào tạo lâm sàng và triển khai vận hành trên toàn bộ các trung tâm lọc máu.
• Auryxia tiếp tục đối mặt với sự cạnh tranh từ thuốc generic và áp lực định giá.
• Triển vọng tài chính kéo dài hai năm mà Akebia đưa ra đã bao gồm cả kế hoạch tái cấp vốn cho hợp đồng tín dụng vay có bảo đảm ưu tiên kỳ hạn.

Điểm nhấn phiên hỏi đáp với chuyên gia phân tích

Mức độ tiếp nhận của các tổ chức lọc máu lớn: Ban lãnh đạo đánh giá yêu cầu gia hạn hợp đồng nhiều năm của DaVita là một tín hiệu tích cực nhưng không định lượng quy mô triển khai theo kế hoạch. Khoảng một phần ba số bác sĩ điều trị bệnh nhân tại các tổ chức lọc máu quy mô vừa cũng làm việc tại DaVita, và tỷ lệ trùng lặp này lên tới hơn 50% nếu tính cả Fresenius, điều có thể giúp lan tỏa kinh nghiệm sử dụng Vafseo giữa các nhà cung cấp.

Thử nghiệm VOCAL và chiến lược liều lượng: Akebia vẫn đang phân tích dữ liệu từ VOCAL và sẽ xem xét cách các phát hiện này có thể định hình chiến lược pháp lý cho phác đồ dùng thuốc ba lần một tuần. Hiện công ty chưa đưa ra mốc thời gian liên quan đến việc cập nhật nhãn thuốc.

Sự khác biệt của Ebribafusp: Công ty đang hướng tới mục tiêu giảm protein niệu và ổn định chức năng thận mà không gây ức chế toàn thân con đường thay thế. Ebribafusp hiện được tiêm dưới da mỗi tuần một lần, mặc dù ban lãnh đạo cho biết tần suất dùng thuốc thưa hơn có thể sẽ được đánh giá.

Hiệu quả kinh tế từ việc giảm nhập viện: Ban lãnh đạo cho biết tỷ lệ nhập viện thấp hơn có thể mang lại lợi ích cho các tổ chức lọc máu theo các hợp đồng chăm sóc dựa trên giá trị. Tuy nhiên, các quyết định mua hàng vẫn rất nhạy cảm với chi phí mua sắm thuốc ban đầu.

Toàn văn biên bản cuộc gọi công bố kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

[Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to your first speaker today, Mercedes Carrasco, Senior Director, IR. May we begin?

Mercedes Carrasco

Thank you and welcome to Akebia's third quarter 2026 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, November 5th, detailing our third quarter 2026 financial results. And 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 for today's call, John Butler, Chief Executive Officer, and Erik Ostrowski, Chief Financial and Chief Business Officer. Dr. Steven Burke, our Chief Medical Officer, and Nicholas Grund, Chief Commercial Officer, are also available for questions. I'd like to remind everyone that this call includes forward-looking statements.

Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on November 5th, as well as in the Risk Factors and Management's Discussion and Analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

John Butler

Thanks, Mercedes. Good morning, everyone, and thank you for joining us today. Late last month, Akebia joined our peers at ASN Kidney Week in Denver. I left the event with 2 important takeaways. First, I heard tremendous excitement about the VOICE trial data that Dr. Block of U.S. Renal Care presented. We believe the data, which demonstrated a clear and compelling hospitalization outcomes benefit for vadadustat versus an ESA, dosing a regimen that most dialysis providers have chosen to implement, will have dialysis organizations thinking differently about Vafseo, and over time has the potential to drive Vafseo to become standard of care. Second, the spotlight continues to shine on rare kidney disease therapeutic product development, and we're excited about the potential to show meaningful differentiation with our mid-stage pipeline assets across multiple rare kidney indications.

We believe this would represent significant value for our shareholders. Now with this backdrop, let me walk through Q3, starting with our commercial business. We're pleased with the pace at which we're adding patients from the mid-sized dialysis providers, including USRC, DCI, and IRC. Last quarter, the number of patients on Vafseo increased to about 11,500 patients on therapy, representing about 20% of patients treated for anemia within these 3 dialysis organizations. Also important, 25% of patients that had previously discontinued therapy have restarted. Even with this progress, I believe we have significant room to continue driving growth even within the mid-sized dialysis providers, but obviously and especially at the large dialysis organizations. Vafseo net product revenues were $14.8 million for the quarter.

This is only a 3% increase versus the third quarter of last year, despite approximately 140% growth in the number of patients on therapy. There are a few somewhat related factors at play, but it was predominantly a drawdown of inventory based on a lower dose and dialysis compliance rate. If you recall, we told you that we're no longer getting data on average dose at providers who moved to TIW dosing. When our largest customer looked at their utilization, they adjusted their purchases based on the average dose they were seeing versus what they expected. Our customer made their inventory assumptions expecting an average dose of 900 milligrams per dialysis treatment, but the average was about 810 milligrams. Even more impactful, patients have been less compliant with their dialysis sessions than expected. If a patient doesn't show up for dialysis, the patient doesn't receive a Vafseo dose if the unit is using observed dosing. These 2 factors combined meant that there was more inventory in their clinics at the end of last quarter, which impacted their purchases this quarter.

So to make it very clear, when we use the updated dose and compliance data with the number of patients on therapy, end-user demand was between $17 million and $18 million for Q2 and between $19 million and $20 million for Q3. Another takeaway from my conversations at ASN is that while dialysis providers have protocols in place, as individual physicians start using Vafseo in greater numbers, they're using their own strategies to utilize the product and bring patients into or keep patients in the hemoglobin target range. This shouldn't be surprising. It took 20 years for physicians to figure out how to dose ESAs. It's gratifying to see prescribers recognize the benefits of Vafseo for their patients, though it would be easier for us if their approaches were a little more consistent. Our focus is to continue to drive more patients onto therapy and support physicians as they look for the best outcomes for their patients. Beyond the reduction in inventory based on dose and dialysis compliance, as we approach Vafseo's January 1, 2027 TDAPA expiration, expect a continued reduction in inventory levels. No provider wants drug on the shelf that they bought at a higher price when it no longer gets to bill for that price.

Now, we're working proactively to manage this dynamic. To be clear, for Q4, we expect to see continued growth in patients on therapy. That's the most important metric for the long-term growth of the product. On January 1st, we begin our post-TDAPA launch. On that day, Vafseo access will expand beyond the TDAPA-only patients to nearly all clinically eligible patients. Treatment with Vafseo will be reimbursed as part of the dialysis bundle payment, and dialysis organizations will no longer be able to bill separately when they use the product. As we've always said, post-TDAPA, we will price Vafseo to remain competitive with ESA pricing to ensure providers can access an innovative treatment for patients, even within the economic confines of a bundled payment system.

So what does this mean for pricing in 2027 and beyond? Now while we're still working on some of our post-TDAPA contracts, we know ESA price has decreased over time and now incorporating a somewhat lower dose and dialysis compliance, we expect the average annual cost of therapy to fall somewhere between $1,000 and $1,500. Certainly not the price you would normally expect for a product bringing the level of innovation that Vafseo brings, but these are the dynamics of the dialysis market. If we can make Vafseo standard of care, which means ultimately treating at least 200,000 to 250,000 patients, that would mean a potential multi-hundred-million-dollar peak revenue.

So how are we going to get there? As I said, in Q4, even though we expect our customers to be conservative with inventory, we expect to continue to see an increase in patients. We expect Q4 patient growth will be driven primarily by our current mid-sized dialysis providers, USRC, IRC, and DCI. We share our shareholders' desire to see DaVita and Fresenius begin contributing to our revenue. And while we have a post-TDAPA contract with DaVita through 2027, at their request, we're working on a multi-year extension of that contract. And they've outlined their plans to begin rolling out the product slowly, which we expect to start this quarter, and in a much more significant way early next year.

It's clearly been frustrating for us that adoption among the large dialysis providers has not progressed more quickly. But in the end, it's clinical evidence that changes the way prescribers think about patient care. Let me give you a few highlights from the VOICE data presented by Dr. Block at ASN. The trial enrolled 2,116 patients and 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 due to reduction in hospitalizations. The data demonstrated that hospitalizations were 10% lower in patients treated with vadadustat versus ESAs, without a significant difference in mortality rates.

Exposure-adjusted serious adverse events were lower with vadadustat, with 121.5 events per 100 patient-years, compared to 134.2 events per 100 patient-years for patients treated with ESAs. Given that SAEs generally drive hospitalization, this is not a surprising finding. As we've seen in the past, vadadustat showed more stable hemoglobin control versus ESAs. In an exploratory endpoint, the data showed the odds of high hemoglobin excursions were reduced in patients treated with vadadustat compared to ESAs, while there was no overall difference in low excursions. There has never been an outcome study performed before INNO2VATE that compared treatments for patients with anemia due to CKD that demonstrated an outcomes difference. And recall, like the VOICE primary endpoint, the post hoc win statistics analysis of our INNO2VATE study also demonstrated a statistically significant lower risk of dying or being hospitalized for patients receiving vadadustat versus ESAs. Now the health economic analysis of the VOICE hospitalization benefit will be completed, but we presented an updated economic analysis from INNO2VATE at ASN. This analysis suggested that treatment with Vafseo resulted in a $6,200 lower annual cost of hospitalization per patient compared with ESA.

And based on the assumptions used in the analysis, if all eligible dialysis patients with anemia were treated with Vafseo, it could result in more than 600,000 fewer hospital days versus ESA treatment. We have seen and know that adoption in nephrology, particularly dialysis, moves slowly. But this is the data that gives me the confidence to believe that Vafseo will ultimately become standard of care. This morning we announced positive top-line results from the VOCAL study, which we conducted at DaVita clinics. One more study demonstrating vadadustat dosed TIW is non-inferior to ESA in maintaining hemoglobin. We look forward to continuing the analysis of VOCAL to see what further differentiation we may be able to uncover.

Now, ASN was also a great meeting when considering our rare kidney disease pipeline. A significant part of the meeting agenda was dedicated to advances in treating rare kidney diseases. We presented preclinical data that informed our confidence in praliciguat for FSGS, as well as posters on our Phase II trial designs for both ebribafusp and praliciguat. Additionally, Dr. Jim Tumlin presented to a full house in an exhibitor spotlight, focusing on both Prali and Ebri. I was pleased with the interest in both programs from the interactions the team had with investigators and potential investigators. As you know, both programs are enrolling their Phase II trials, Prali in FSGS, and Ebri in a basket trial in C3G, IgAN, and lupus nephritis, with initial data from the Ebri trial expected in 2027.

We're excited about the opportunity for both products, but particularly with Ebri, our tissue-targeted next-generation complement inhibitor. While data will obviously help define our strategy and development priorities, we believe a differentiated approach will allow for strong positioning with the potential for similar efficacy, a potentially better safety profile, and potentially less frequent dosing regimen versus current products in diseases like C3G. We believe there's tremendous value in our pipeline that is underappreciated or ignored in Akebia's value today. Now let me turn it over to Erik to review our third quarter financial results.

John Butler

Thanks, John. Total revenues decreased to $36.9 million in Q3 '26 from $58.8 million in Q3 '25. Turning to the components of these amounts, Vafseo net product revenues increased to $14.8 million in Q3 '26 as compared to $14.3 million in Q3 '25. And Auryxia net product revenues decreased to $20 million in Q3 '26 compared to $42.5 million in Q3 '25. We continue to expect Auryxia revenues to decrease as compared to 2025 due to generic competition and pricing pressure. License, collaboration, and other revenues increased slightly to $2.1 million in Q3 '26 as compared to $2 million in Q3 '25.

Turning to expenses, cost of goods sold was $6.4 million in Q3 '26 compared to $9.4 million in Q3 '25, driven by lower product revenues. R&D expenses increased to $16.2 million in Q3 '26 from $14.9 million in Q3 '25, driven by increased clinical trial activities related to our Phase II trials evaluating Ebri and praliciguat. SG&A expenses decreased to $23.5 million in Q3 '26 from $29.1 million in Q3 '25, driven by lower marketing and headcount-related expenses.

We generated a net loss of $14.4 million in Q3 '26 versus net income of $0.5 million in Q3 '25, driven by this quarter's lower revenues, which was partially offset by lower operating expenses, which included a $1.3 million restructuring charge incurred this quarter. Turning to the balance sheet, we remain in a strong financial position with $159.3 million in cash and cash equivalents at the end of the quarter, which includes $6.6 million in ATM proceeds raised early in the quarter. This compares to cash and cash equivalents of $155.5 million as of June 30, 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 allow us to continue to invest in the future and enable us to fund our current operating plan for at least the next 2 years. With that, we will now open the line for questions.

Operator

[Operator Instructions] Our first question will come from the line of Julian Harrison of BTIG.

Phần hỏi đáp

Andrew Kassin

Hi, this is Andrew on for Julian. I know you talked a little bit about the status of DaVita and the uptake of Vafseo, but is there any more color you can provide on the potential ramp we could expect at the end of this year and in 2027? And then one on the pipeline, just any updates specifically on the enrollment in the praliciguat trial along with the Ebri trial? Thank you.

John Butler

Thanks, Andrew. So as I mentioned, I mean, we think it's a really positive sign that while DaVita has a post-TDAPA contract for '27, that they requested that we extend that contract out a number of years. To me, that suggests that they're expecting this product to be meaningful in their clinics. And, again, talking to folks from DaVita at the ASN meeting, it really is the VOICE data, that outcomes data, that is really driving that interest. And they've kind of outlined how they see it rolling out. I think their preference is that those kinds of conversations stay confidential. I don't know, Nick, if you want to add any color on our conversations there?

John Butler

Yes, I mean, they've been really constructive conversations around the extension of their contract. My opinion is you wouldn't want to do that unless you were going to make a larger step into Vafseo utilization, locking up that price. ESA-like pricing for a longer period of time allows you to do that because it creates certainty. So that's been, I think, a positive signal overall when we think about their role. And, again, we don't want to talk about anything specific, but their interest in VOICE, and now with VOCAL coming through, remember VOCAL was USRC versus Mircera, whereas VOCAL was Vafseo versus Epogen. This gives them another piece of data for what that conversion may look like within their DaVita population, because they are a Mircera shop overall. And so I take the contract extension as positive. And, you know, certainly having plans for a rollout that they're sharing with us, I think, is positive as well.

John Butler

And I mean, we've talked about the frustration, right? I mean, there's no question we're frustrated that things haven't moved faster. I think the word to use around DaVita is deliberate. They are very deliberate in the way they approach things. And the challenge of that for a company like DaVita is it takes them a long time to get going. The other side of that coin, we hope and count on is that once they start going, they can influence things very quickly in their units, and it becomes very sticky. And our job is to make sure that they have a very good experience as they convert people to Vafseo in their units. And your second question, Andrew, was around enrollment in our rare kidney trials.

And we haven't given any updates on timing for praliciguat. You know, we are, again, we don't want to do that until we feel really confident in getting the trial enrolled. I mean, I think when you look at other trials in FSGS, I think we would suggest that we're enrolling the trial at the same sort of pace. So that's what we would expect, but it's a competitive space and we want to make sure we know exactly when we're going to have the data before we make that announcement. You know, Ebri, of course, is a basket trial, open label. We're super excited about what Ebri can deliver. And we know we'll be able to deliver data sooner out of that trial. But it's early days there, right? But I will say again, seeing the sessions at ASN and having conversations with these kind of KOLs there, the differentiation that we can potentially bring with Ebri really is exciting to the community, and I think it can be a very, very meaningful product.

Andrew Kassin

Thank you for that, really helpful color.

John Butler

Thanks, Andrew.

Operator

And our next question will be coming from the line of Roger Song of Jefferies.

Nabeel Nissar

Hey, good morning. This is Nabeel on for Roger. So, on the VOCAL data, you mentioned some additional data that you're expecting. What could we look at beyond the hemoglobin non-inferiority? What other data could we be expecting here, dose intensity, dose adjustment frequency in VOCAL compared to VOICE? And then with all of this data, do you think we have enough evidence to pursue TIW on the label? Thank you.

John Butler

Thanks, Nabeel. So, you know, VOCAL, we've just presented top-line data. So as you can appreciate, I'm sure, there's many other analyses to be done, including thinking about how that would inform regulatory strategy around TIW. Steve, maybe some of the other kind of the omics and things, talk about that a little bit.

Steven Burke

Sure. This is Steve Burke, CMO. We have endpoints related to measures of hemoglobin stability, so high and low hemoglobin excursion, the need for red blood cell transfusion, rescue therapies. So we don't have that data yet. We also have some exploratory work going around red blood cell phenotyping. So are red blood cells made under the influence of Vafseo substantially different than those made under the influence of ESAs, which would make sense if there would be, given the different mechanism of action. So, we're waiting on data around that, proteomics, metabolomics, lipidomics on the red blood cells. So that could be quite interesting.

John Butler

Thanks, Steve. Nabeel, did that capture what you were looking for on Vafseo?

Nabeel Nissar

Yeah, no, that's very helpful. And then as we're thinking about DaVita also, you've mentioned previously, is there a number on the overlap of nephrologists that are at some of the mid-DSOs, and then how many of those overlap at DaVita? Again, you mentioned the adoption in this specialty is a little bit more gradual, but these are real differentiators, so curious also on the overlap.

John Butler

Totally agree. You have 20% in the midsize and virtually nothing in the large. The patients aren't different, right? But that's an important question. I'm sure Nick has a sense of that.

John Butler

Yes, when you think about DaVita and how they interact with large group practices around the U.S., they typically are partnering with large group practices in terms of rounding at their clinics, et cetera. And that large group practice also does that with USRC, they do that with IRC, and they do that with Fresenius. And so those physicians who are in those midsize organizations are getting experience with Vafseo. The overlap with DaVita in particular is typically around a third. If you add in Fresenius, it's over 50% overlap in those rounding physicians. And so certainly we hear from physicians who are using the product at USRC or IRC, some frustration about not being able to use it in other places, which bodes well, but importantly, they are getting the experience, so when they do have access to it, we're hoping that has a positive influence around how they treat patients with Vafseo going forward.

John Butler

And I think you made an important point that I didn't really make in the opening remarks, or maybe it probably wasn't as clear as it could be. In the TDAPA world today, there's always a prior auth, if you will, for does the patient have TDAPA reimbursement. Post-TDAPA, while the price is obviously very significantly lower, that exclusion no longer applies, right? I mean, every patient will be able to get it. So even in places where the physicians want to get it but the hoops are too many to jump through, hopefully there are fewer hoops and they can move more quickly. We really count on DaVita kind of driving this at a number of centers, but that doesn't mean that physicians can't access it at other centers. And we would hope that we could start to see an increase. And Nick also referenced Fresenius.

I didn't say anything about that. We met with the Fresenius team, multiple people met with the Fresenius team at ASN as well. I would say they are compelled by the VOICE data also. I don't want to give the impression that we're not doing everything we can to drive business at Fresenius also. And being in dialysis for a number of years, you know that it's kind of dominoes falling. I think as we get DaVita moving more quickly, Fresenius will have to move as well. Our frustration is that we feel like we've been saying that to you for a number of quarters, and we're anxious to see this move also. We feel much more convinced that there's a real desire to move at this point, but in a very deliberate way.

Nabeel Nissar

Thank you for the color. It's very clear clinicians are appreciating the data and look forward to seeing the upcoming quarters. I guess maybe one small question on those missed dialysis sessions, mentioning just kind of the lower compliance. Do we have any data on any impact on hemoglobin control or are those patients more likely to have need for ESA rescue or any thoughts there? And that's my last question. Thank you.

John Butler

We don't really have data on that. If you look at the USRDS data, it suggests that there are generally 13 dialysis sessions in a month if a patient showed up for every session. And the average is about 10.8. We've seen just slightly less than that. I think the expectation, I think most providers feel like they do better and that patients are there more like 12 times. And again, that could be a hospitalization that they're not there for, or they just simply miss it or the like. But it's not 12. It is closer to somewhere between 10.5 and 11. Now if you think about it, Nabeel, if you show up 10 to 11 times and you get your Vafseo every time, you're still talking about 80% plus compliance. That is generally better than what patients have when you send the product home with them. And we usually model something like two-thirds, that they take about two-thirds of their pill. You're still getting more dosing in TIW, with TIW dosing, but it's just less than the expectation, and that drove that inventory shift.

Nabeel Nissar

Great. Thank you for the clarity. Thank you for taking my questions.

John Butler

Thanks so much, Nabeel. I appreciate it.

Operator

And our next question will be coming from the line of Matthew Caufield of H.C. Wainwright & Company.

Matthew Caufield

Hi, John and team. In terms of the noted slower than expected uptake from the major DSOs, specifically, what do you see as the greatest barriers to broader utilization from the large DOs during post-TDAPA into 2027?

John Butler

So, again, I mean, I think if you look at them separately, DaVita is now looking at the product much more seriously and putting a very clear process in place. I think that it's incumbent upon us to make sure that we kind of help educate physicians, do what we can to make sure their experience is a good one. It's different switching someone from Mircera to Vafseo than switching someone from Epogen to Mircera, right? I mean, that has complexity to it. This has more.

So, having seen that, and the great thing about kind of where we are today is DaVita is going to learn a lot from what was experienced at USRC, IRC, and DCI. Dr. Jeff Block is an amazing advocate for this product because he believes in the outcomes benefit for patients. We know that there was a medical directors meeting that they have every year at ASN, where all the medical directors across the dialysis providers meet and Jeff presented the VOICE data to them and took their questions. So I think them understanding, so you understand the benefit, but then you've got to operationalize it. And making sure that operational process goes well is important.

I kind of referenced what we're hearing from USRC, IRC, and DCI is that physicians are doing different things, which is fine, but at the end of the day, you just want to make sure that they're having a good experience. We're feeling confident about DaVita, but again, it's not overnight. They're going to go in a deliberate way through the organization to get an experience level with that. Fresenius is going to take longer, right? They are clearly interested in the data. They got the potential benefit here for their patients, but they are a different organization. They have a relatively new CMO there, they have a brand new CEO there. Organizationally, they're in a little more flux than a place like DaVita. So we're continuing to work there. We have very good relationships with the folks at Fresenius, but I certainly don't want to leave the impression that we're ignoring Fresenius. We are not. We do believe that you don't get the standard of care until they start to move as well. We just know that they're going to take longer to move.

Matthew Caufield

Understood. I appreciate it. Thank you for the color.

John Butler

Thanks, Matt.

Operator

Our next question will be coming from the line of Allison Bradsell of Piper Sandler.

Unknown Speaker

Hi there, this is Peter on for Allison. You recently dosed the first patient in your Phase II basket trial in rare kidney diseases with initial data next year. What initial data can we expect and what findings will be most important in determining the next steps for the program?

Steven Burke

Sure. Hi, it's Steve Burke again. We're principally looking at decrease in urine protein-to-creatinine ratio. We're also measuring complement biomarkers in the blood and urine. We hope to show a substantial reduction in urine protein and do so without an inhibition of the complement system in the blood. And that's a very important differentiator for us versus other complement inhibitors.

John Butler

Yes, let me just kind of underline that. You're going to be looking for impact on proteinuria, and impact on what's the lab test, the alternative pathway in the blood, right? We're impacting the disease at the site, the kidney, without impacting the alternative pathway in the blood. It's pretty straightforward, and hopefully will be quite clear.

Unknown Speaker

Thank you.

Operator

And our next question will be coming from the line of Ed Arce of WestPark Capital.

Antonio Arce

A couple from me. So first on the quarterly results, I think you mentioned it earlier in some of your prepared remarks, but I think I missed it. Just the amount of the underlying growth in the quarter given the discontinuity between the sales and underlying growth. Secondly, you've talked about the potential for Fresenius, but I was curious about the VOCAL results and how you see that fitting in the near term, the impact of those results specifically with CMOs at the various dialysis organizations and ultimately payers and how they would view that data. And then finally, if I could, the reduction in the price that you mentioned, just wanted to get a better sense on the 2 drivers of the lower average dose and the lower compliance. I know you mentioned some of that before, but just wanted to get a better sense for what the changes were relative to what you thought previously. Thanks so much.

John Butler

Thanks, Ed, and welcome back to the call. It's good to have you back. So on the quarterly result, as I mentioned in my remarks, the third quarter underlying demand, patient demand, was somewhere between $19 million and $20 million. So if you think about it, we did just about $15 million in revenue. You took out somewhere between $4 million and $5 million of inventory from the clinics. And we did $21 million-ish last quarter, and it was between $17 million and $18 million demand last quarter. So you can see that was just a shift of inventory from 1 quarter to the next.

Now, the VOCAL results, again, we only have top-line results. I think Steve referenced earlier in his answering the question. There's a lot of really interesting science that I think will make for some interesting additional data. What we always try to do is like, what are the differences? Why is managing anemia with a HIF different than managing anemia with an ESA? And we've shown this outcomes difference. Now, you kind of want to continue to show why, why are you seeing an outcomes difference, because there are these differences in the way that a HIF drug behaves versus an ESA. I think we're in a totality of the data situation, right? And when you're looking at DaVita, it's the outcomes data that's driving them, but they look at every piece of data. And this is just another consistent study where we demonstrated that the drug is able to manage hemoglobin effectively. And you have all these other kind of interesting analyses that may yield some further differentiation. I mean, data has been published that shows differences in lifespan and size of red blood cells. I mean, there's already differences that have been demonstrated in managing with a HIF, but you just want to continue to build that evidence base for why it's a good thing and why it's not a fluke that in 2 studies we've seen this difference in outcome.

Now you mentioned payers. For better or worse, payers aren't really an important market for us to consider because Vafseo is now part of the dialysis bundle. So it is up to the dialysis provider to decide what product and the physicians of course to decide what product they're going to use. The payers don't have much of a say, even when you're outside of Medicare in commercial or Medicaid, these are still generally paid on a bundled rate so payers don't really have much of a say or care much what folks use. And then the reduction in price. I mean, we had seen that ESA prices were starting to drop. I think that's the bigger driver than anything else. Nick, maybe you want to comment on that?

John Butler

Yes, let me start with Epogen. Epogen has been putting pricing pressure into the market over the last, let me call it 18 months. So their prices were coming down. But frankly, DaVita is Mircera, Fresenius is Mircera, IRC is Mircera, and where Epogen is really predominant is within USRC. But frankly, the advocacy within USRC for Vafseo and it being in its TDAPA period, we were somewhat immune to that Epogen pricing decrease. That price continues to drop as they continue to try and gain share through pricing, because at some price point, LDOs view all ESAs as interchangeable. And so you look at that interchangeability, and recently, Mircera has started to reduce their price, and that has a bigger impact. And so when we say we're ESA-like pricing, the DOs are all really good at their jobs and listening to us, and as Mircera comes down, they're also putting pressure on Vafseo price. The other thing that's going on is, as we've kind of said all along, as volume increases, prices come down. And that's what we're seeing here, certainly, this current year.

The important part about all this kind of pricing pieces is in an environment where you're priced similarly and you have data like Vafseo that shows a clear differentiation in hospitalization, which has a large economic impact for the DOs, that becomes a really interesting data point as they think about which products they want to put on protocol and want to really encourage their physician base to use.

John Butler

Yes, I mean, they have this opportunity with these value-based care contracts that reducing hospitalization could yield a huge benefit for them. But the purchasing people just care about the price of acquisition, right? And this is a dialysis, it's just a different market, right? You don't have the same kind of leverage in contracting you do in other markets. And we kind of referenced that the dose was about 10% lower than average. You incorporate that in. It's a little bit more than that when you look at dialysis compliance. But between those, you're probably talking somewhere between a 25% and 30% reduction. And then the Epogen price reduction kind of leads us into that $1,000 to $1,500 price range that we think it's just easier for you all to understand that's where the market is today.

Antonio Arce

Great. Thank you both, John and Nick. Thanks for that. That's helpful, appreciate it.

Steven Burke

Thanks, Ed. Again, welcome back.

Operator

And our next question will come from the line of Roanna Ruiz of Leerink.

Unknown Speaker

Hi, guys. Good morning. This is Anna on for Roanna. Just to dig a little deeper into Ebri, just curious what differences are you looking for in the metrics you mentioned earlier to potentially differentiate between the basket of indications that you're studying? Thanks.

Steven Burke

Sure. Just to reiterate, maybe a little background. Ebri is a fusion protein that recognizes C3d on the surface of cells, and on the back end there are 2 factor H moieties, which are negative regulatory elements in the complement system. So what it's doing is targeting the factor H to the sites of complement activation, and will have a potential to have superior complement inhibition, but without inhibiting the complement system systemically, specifically, as John mentioned, via the alternative pathway, which is measured by a lab assay. So we're looking for excellent reduction in proteinuria across all the conditions. So C3G, that's very important. IgAN, very important. Lupus is a little more complicated because you need to show reduction of proteinuria and stabilization of kidney function, so the estimated GFR. But in all cases, it's reduction of proteinuria, stabilization of the kidney function, without inhibiting the alternative pathway in the blood, because inhibiting that pathway puts you at risk for serious bacterial infections. And so there's a boxed warning for most products and you need to vaccinate the patients. If you can't vaccinate them soon enough, you have to put them on prophylactic antibiotics. So that's the major point of differentiation. Right now we're giving the drug once a week subcutaneously. That may be the frequency going forward, or it could be less frequent. We need to do more work in that regard. So I hope that answers your question.

Unknown Speaker

Yes, super helpful. Thank you.

John Butler

Thanks, Anna.

Operator

I would now like to turn the conference back to John Butler for closing remarks.

John Butler

Thanks, Operator, and thanks all of you for your questions and for joining today. The past few months have provided many opportunities to speak directly with providers, prescribers, trialists, and patient advocates at ASN Kidney Week and other meetings and events. I always walk away feeling optimistic and encouraged that so many people share our commitment to improve the lives of people impacted by kidney disease. A standout among them is Nick Grund. Nick joined Akebia to guide the Vafseo launch and has worked tirelessly to get Vafseo to patients. He navigated the complex TDAPA landscape, built out a sales organization, and prepared the team for our post-TDAPA launch. While he's resigned his position as Chief Commercial Officer, we're fortunate to have Nick on board in a consulting capacity as we work to finalize Vafseo contract extensions into next year and seek to increase adoption, especially at the large dialysis organizations. I want to personally thank him for his dedication to Akebia and our patients. We remain committed to our goal to make Vafseo a standard of care and to advance our kidney disease pipeline. I look forward to updating you all on that progress. Thanks, everyone. Have a great day.

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