Summary of Akebia Therapeutics Conference Call Company Overview - **Company**: Akebia Therapeutics - **Key Product**: Vafsio, an oral HIF for treating anemia due to chronic kidney disease (CKD) in dialysis patients Core Points and Arguments 1. **Launch Performance**: - Vafsio generated $12 million in revenue in Q1 and $13.3 million in Q2, reflecting a 55% growth quarter-over-quarter [6][9] - Initial access to approximately 40,000 out of 550,000 dialysis patients in the U.S. [7] 2. **Market Expansion Plans**: - Anticipation of expanding prescribing access to additional dialysis providers, potentially increasing access to 275,000 patients by November [8][9] - Focus on making Vafsio the standard of care for anemia management in dialysis patients [12][48] 3. **Market Opportunity**: - The anemia of CKD market is primarily in the dialysis population, with 500,000 out of 550,000 patients on ESA treatments [11] - Non-dialysis market presents a significant opportunity, with a potential market size comparable to dialysis, but with a higher average price per patient post-TDAPA [38] 4. **Clinical Differentiation**: - Vafsio shows a favorable safety profile with no increased risk of major adverse cardiovascular events (MACE) compared to ESAs [20][21] - Fewer hemoglobin excursions and reduced dose titrations required with Vafsio, enhancing convenience for physicians [22][24] 5. **Patient Compliance**: - Oral administration of Vafsio improves patient compliance compared to injectable ESAs, particularly in home dialysis patients [25][26] 6. **Regulatory and Reimbursement Landscape**: - TDAPA (Transitional Drug Add-on Payment Adjustment) allows for reimbursement outside the bundled payment for dialysis for two years, facilitating the adoption of Vafsio [41][42] - Post-TDAPA, Vafsio will become part of the bundled payment, necessitating a strategic pricing approach to maintain market share [44][46] 7. **Future Studies and Trials**: - Plans to initiate a new study in the non-dialysis population, with a target enrollment of 1,500 patients [40][56] - Ongoing studies (VOICE and VOCAL) to explore alternative dosing regimens [27][60] 8. **Auryxia Update**: - Auryxia, a phosphate binder, lost exclusivity in March but continues to generate revenue without significant marketing efforts [49][50] Additional Important Insights - The dialysis market is valued at approximately $1 billion in the U.S., with significant potential for Vafsio to capture market share [38][45] - The company is focused on aligning with the FDA for future studies to ensure a clear path for product development and market entry [57][60] - The ongoing lack of generic approvals for Auryxia is viewed positively for cash flow, contributing to the company's financial stability [51][52]

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $62.5 million, up from $43.6 million in Q2 2024, representing an increase of $18.9 million [24] - Net product revenues increased to $60.5 million in Q2 2025 from $41.2 million in Q2 2024, driven by sales of Vaseo and Auryxia [24] - The company generated a net income of $247,000 in Q2 2025 compared to a net loss of $8.6 million in Q2 2024 [26] Business Line Data and Key Metrics Changes - Vaseo generated over $13 million in revenue in Q2 2025, with demand sales increasing by 55% over Q1 [5] - Auryxia sales were $47.2 million in Q2 2025, up from $41.2 million in Q2 2024 [24] - Cost of goods sold decreased to $9.9 million in Q2 2025 from $17 million in Q2 2024, primarily due to the elimination of a non-cash amortization charge [25] Market Data and Key Metrics Changes - The company expects to increase patient access from approximately 40,000 to over 75,000 dialysis patients in Q3 2025, with potential access to 275,000 patients by Q4 2025 [7][23] - Medicare Advantage plans are covering about 20% of total prescriptions, with expectations for growth as more contracts are established [33] Company Strategy and Development Direction - The company aims to establish Vaseo as the standard of care for treating anemia due to chronic kidney disease, focusing on expanding access and enhancing physician education [4][14] - Plans include launching the VALOR trial for non-dialysis patients by the end of 2025, which could significantly expand the addressable market [12][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing launch of Vaseo and the potential for significant growth as more dialysis providers come online [7][23] - The company is optimistic about the resilience of Auryxia's revenue stream despite the presence of an authorized generic [52] Other Important Information - The company ended Q2 2025 with $137.3 million in cash and cash equivalents, indicating a strong financial position to support ongoing operations and growth initiatives [26][27] Q&A Session Summary Question: Insights on patient segments and Medicare Advantage - Management noted that approximately 12% of prescriptions are for home patients, with expectations for continued broad use as more dialysis organizations implement protocols [31][32] - Currently, 20% of prescriptions are filled in the Medicare Advantage segment, with growth anticipated as more contracts are established [33] Question: Average dose strength for prescriptions - The average refill dose is approximately 28% higher than the initial 300 mg starting dose, reflecting increased physician comfort with dosing [36][37] Question: Timeline for DaVita's operational pilot - DaVita's operational pilot is expected to go live around mid-August, with broad access anticipated by November [42][43] Question: Outlook for Auryxia amid generic competition - Management highlighted that Auryxia's growth is supported by increased access post-bundle implementation, and they remain cautious about future generic competition [51][52]

Summary of Akebia Therapeutics (AKBA) FY Conference Call Company Overview - Akebia Therapeutics is a fully integrated biotech company founded in February 2007, focused on improving the lives of patients with chronic kidney disease (CKD) [2][3] - The company has two commercial products: Auryxia and Vassio [5][6] Core Products Auryxia - Auryxia is a phosphate binder used for controlling serum phosphorus in dialysis patients and treating iron deficiency anemia in non-dialysis adult patients [5][6] - The product lost exclusivity in March 2025, leading to the launch of an authorized generic [35][36] - Despite the competition, Auryxia has maintained strong clinical demand due to its clinical profile and economic value proposition [36][37] Vassio - Vassio is an oral HIF PH inhibitor launched in January 2025, indicated for treating anemia due to CKD in adult patients on dialysis [6][12] - It stimulates the body's natural production of erythropoietin, offering a novel mechanism of action compared to traditional erythropoiesis-stimulating agents (ESAs) [8][9] - Approximately 25% of patients on ESAs struggle to meet hemoglobin targets, highlighting a significant unmet need in the market [9][10] Market Dynamics - The dialysis market is characterized by a slow adoption process, with small to mid-sized dialysis organizations adopting new therapies before larger organizations [24][26] - The TDAPA (Transitional Drug Add-On Payment Adjustment) mechanism incentivizes dialysis organizations to adopt innovative therapies like Vassio [28][30] - Vassio's pricing post-TDAPA is set at approximately $2,500 per year, which is significantly lower than the initial starting dose price of $15,500, making it a billion-dollar market opportunity [30][31] Launch Progress and Adoption - In the first quarter post-launch, over 640 physicians prescribed Vassio, averaging 12 prescriptions per physician [18][21] - The company anticipates that larger dialysis organizations will begin to adopt Vassio more significantly in the second half of the year [26][34] - A pilot program with a large dialysis organization is expected to start in Q3 2025, testing operational systems for Vassio [31][34] Future Opportunities - The non-dialysis (NDD) market represents a significant opportunity, with a potential market size four to five times greater than dialysis [46][48] - The company plans to initiate a phase three study for NDD in the second half of the year, following FDA feedback on the protocol [48][49] Key Catalysts - Near-term catalysts include successful pilot program execution, full enrollment in the voice study aimed at reducing hospitalization and mortality, and progress on NDD studies [57][61] - The company is focused on Vassio as the primary growth driver, with plans to leverage its clinical differentiation and real-world physician experience to establish it as the standard of care [40][41] Underappreciated Aspects - Akebia has a pipeline of early-stage HIF assets, including studies for acute kidney injury and retinopathy of prematurity, which are significant unmet needs [62][63] - While investor focus is primarily on Vassio, the company aims to highlight its broader pipeline once Vassio demonstrates continued success [63]

Vafseo Launch and Market Opportunity - Vafseo (vadadustat) has launched as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis[8] - The U S market opportunity for Vafseo in the dialysis patient population is approximately $1 billion[8] - Akebia is pursuing label expansion of Vafseo for the late-stage non-dialysis CKD population, representing a multi-billion-dollar U S market opportunity[8] - Contracts are secured covering nearly 100% of U S dialysis patients for Vafseo[12, 20] Clinical and Patient Considerations - Current standard of care for dialysis patients (ESAs) has remained unchanged for 30 years, with nearly 25% of patients falling below target hemoglobin levels[13] - Approximately 20% of patients on dialysis are ESA hyporesponders, leading to higher hospitalization and mortality rates[13] - Market research indicates that over 2 out of 3 nephrologists identify an unmet need for anemia treatment in CKD, particularly for oral options and ESA-resistant patients[14] VOICE Trial and Label Expansion - The VOICE trial, with over 650 subjects enrolled as of January 10, 2025, is designed to demonstrate non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalization[23, 24] - A Phase 3 clinical trial for Vafseo in late-stage CKD patients not on dialysis is planned to begin in mid-2025[8, 46] Non-Dialysis Market - In patients with pre-hemodialysis Hb <9 0 g/dL (n=4855), 73 4% did not receive ESA pre-HD[26] - The U S non-dialysis market opportunity for anemia treatment is approximately $1 billion, driven by predominantly private and unbundled government payment structures[40, 41] HIF-based Pipeline - Akebia is advancing a HIF-based pipeline targeting high unmet needs, including ROP (rare disease) with a ~$1 5B+ U S market opportunity and ~30K patients[50]

Vafseo Launch and Market Opportunity - Vafseo (vadadustat) has launched as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis[8] - The U S market opportunity for Vafseo in the dialysis patient population is approximately $1 billion[8] - Akebia is pursuing label expansion of Vafseo for the late-stage non-dialysis CKD population, representing a multi-billion-dollar U S market opportunity[8] - Contracts are secured covering nearly 100% of U S dialysis patients for Vafseo[12, 20] Clinical and Patient Considerations - Current standard of care for dialysis patients (ESAs) has remained unchanged for 30 years, with nearly 25% of patients falling below target hemoglobin levels[13] - Approximately 20% of patients on dialysis are ESA hyporesponders, leading to higher hospitalization and mortality rates[13] - Market research indicates that over 2 out of 3 nephrologists identify an unmet need for anemia treatment in CKD, particularly for oral options and ESA-resistant patients[14] Vafseo Advantages and Ongoing Trials - Vafseo is an oral HIF-PH inhibitor with the potential to become standard of care, offering a unique mechanism of action and convenient oral dosing[15] - The VOICE trial, with a target enrollment of ~2,200 patients, is underway to demonstrate Vafseo's non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalization[24] Non-Dialysis Market and Future Plans - In patients with pre-hemodialysis Hb <9 0 g/dL (n=4855), 73 4% did not receive ESA pre-HD[26] - A Phase 3 clinical trial is planned to begin in mid-2025 for Vafseo in patients with late-stage CKD anemia not on dialysis, targeting ~1,500 U S subjects[8, 46] Pipeline and Financial Outlook - Akebia expects its existing cash resources and cash from operations to be sufficient to fund its current operating plan for at least two years[8] - Akebia is advancing a HIF-based pipeline targeting high unmet needs, including ROP (~$1 5B+ U S market opportunity), ARDS (~$2B U S market opportunity), and CS associated AKI (~$1 5B+ U S market opportunity)[50]

Summary of Akebia Therapeutics (AKBA) 2025 Conference Call Company Overview - **Company**: Akebia Therapeutics (AKBA) - **Product**: Vafsio, a treatment for anemia in dialysis patients - **Conference Date**: June 05, 2025 Key Points Product Launch and Sales Performance - **Successful Launch**: Vafsio had a strong first quarter launch with 640 physicians prescribing the product, indicating broad reach [2][4] - **Prescribing Depth**: Average of over 12 prescriptions per physician in Q1, indicating high adoption [4] - **Patient Population**: Broad prescribing across various patient types, not limited to initially identified profiles [4] Market Dynamics - **Payer Mix**: - 40% of prescriptions are from fee-for-service Medicare patients - 40% coverage from Medicare Advantage Plans, with an additional 20% coverage seen in Q1 [7][8] - **Home Patients**: Approximately 12% of prescriptions are for home patients, aligning with the dialysis community's demographics [7] Growth Strategy - **Transitional Drug Add-On Payment Adjustment (TDAPA)**: - Provides additional reimbursement outside the bundled payment system for dialysis treatments [17] - Expected to help cover costs of innovation during the two-year TDAPA period [18] - **Post-TDAPA Pricing**: Anticipated to be competitive at approximately $2,500 per year, targeting a billion-dollar market with 500,000 anemic patients [18][19] Clinical Trials and Data Generation - **VOICE Trial**: Aims to demonstrate a 10% reduction in hospitalization and mortality, crucial for economic viability [27] - **Enrollment Status**: 75% enrollment of 2,200 patients completed, with expectations to finish soon [32] Non-Dialysis Dependent (NDD) Market Opportunity - **Significant Unmet Need**: NDD population represents a multi-billion dollar market opportunity, with approximately 500,000 patients in the U.S. [25][23] - **FDA Engagement**: Plans to initiate a Phase 3 trial for NDD in the second half of the year, focusing on cardiovascular outcomes [38][40] Competitive Landscape - **Unique Position**: Akebia is the only company with a novel HIF inhibitor therapy in the U.S. market, differentiating itself from previous competitors [46][50] - **Clinical Profile**: Vafsio has a broader label without the heart failure warning present in previous products, enhancing its marketability [50] Financial Position - **Cash Reserves**: Ended Q1 with $113 million in cash, indicating a strong financial position to support ongoing operations and trials [72] - **Expense Management**: Efficient management of expenses, with a focus on reaching profitability while supporting pipeline activities [73][75] Pipeline and Future Opportunities - **Emerging Programs**: Plans to advance programs for acute kidney injury (AKI) and retinopathy of prematurity (ROP) into clinical trials [70][71] Additional Insights - **Market Dynamics**: The transition from traditional erythropoietin-stimulating agents (ESAs) to HIF inhibitors represents a significant shift in treatment paradigms for anemia management in chronic kidney disease [58] - **Physician Engagement**: Continuous engagement with physicians to highlight the benefits of Vafsio and its mechanism of action is crucial for adoption [58][59] This summary encapsulates the key insights and strategic directions discussed during the Akebia Therapeutics conference call, highlighting the company's growth potential and market positioning.

Financial Data and Key Metrics Changes - The first quarter marked the initial launch of Vafsio in the U.S. for anemia in CKD patients receiving dialysis, with nearly 640 physicians having prescribed the product by the end of the quarter [8][9] - Average prescriptions per prescriber were about 12, indicating a transition from trial to adoption [9] Business Line Data and Key Metrics Changes - Vafsio is positioned as a hypoxia-inducible factor prolyl hydroxylase inhibitor, with a focus on becoming the standard of care for all chronic kidney disease patients, including those not on dialysis [4][5] - Auryxia, another commercial product, is a phosphate binder that has positively impacted patients [3] Market Data and Key Metrics Changes - The dialysis market is significant, with 150,000 patients in small and medium providers, and all five top dialysis providers, representing approximately 85% of treatment, have ordered the product [11][12] - The non-dialysis market for CKD anemia is equally substantial, with over 550,000 anemic patients in stages four and five, presenting a larger revenue opportunity compared to dialysis [55][56] Company Strategy and Development Direction - The company aims to expand its pipeline within kidney disease and explore applications of HIF technology beyond the kidney space [5][6] - The strategy includes engaging with the FDA for a path forward to make Vafsio available for non-dialysis patients [5][60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch of Vafsio, highlighting the enthusiasm from nephrologists and the potential for broader adoption [7][19] - The company anticipates significant growth in Q4 as pilot programs expand, with expectations for increased prescriber engagement [46][48] Other Important Information - The TDAPA program allows for reimbursement outside the bundled payment system, facilitating the launch of Vafsio [36][38] - The company plans to initiate a Phase III trial for Vafsio in non-dialysis patients by the end of the year [60][61] Q&A Session Summary Question: How is the launch of Vafsio progressing? - The launch is progressing well, with nearly 640 physicians prescribing the product and an average of 12 prescriptions per prescriber [8][9] Question: What is the strategy for engaging with dialysis organizations? - The strategy involves creating contracts and protocols to ensure positive economics for dialysis organizations, which are financially liable for treatment costs [25][31] Question: What are the market opportunities for Vafsio? - The non-dialysis market presents a significant opportunity, with over 550,000 anemic patients in stages four and five, potentially yielding higher revenue compared to the dialysis market [55][56] Question: What are the timelines for upcoming trials? - The pilot for larger dialysis organizations is expected to start in Q3, with broader usage anticipated in Q4 [44][46]

Financial Data and Key Metrics Changes - Total revenues increased to $57.3 million in Q1 2025 from $32.6 million in Q1 2024, primarily driven by net product revenues which rose to $55.8 million from $31 million [22][25] - Net income for Q1 2025 was $6.1 million compared to a net loss of $18 million in Q1 2024, reflecting strong revenue growth [25][26] - Cost of goods sold decreased to $7.6 million in Q1 2025 from $11.6 million in Q1 2024, attributed to the full amortization of a non-cash charge related to Auryxia [23][24] Business Line Data and Key Metrics Changes - Vafcio generated $12 million in net product revenues in Q1 2025, exceeding guidance of $10 million to $11 million [6][22] - Auryxia net product revenues increased to $43.8 million in Q1 2025 from $31 million in Q1 2024, despite losing IP exclusivity [22][23] Market Data and Key Metrics Changes - The top five dialysis organizations have ordered Vafcio, with revenues primarily coming from small to mid-sized dialysis organizations treating approximately 150,000 patients [8][14] - The VOICE study is progressing towards full enrollment, with about 75% of the target 2,200 subjects enrolled [10] Company Strategy and Development Direction - The company aims to expand the use of Vafcio in both dialysis and non-dialysis patient populations, with plans to initiate a Phase III VALOR trial in the second half of 2025 [10][11] - The focus remains on increasing the breadth and depth of prescribing among current customers while unlocking new customers [21][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong early performance of Vafcio, highlighting the importance of prescriber education and patient retention [6][21] - The company is confident in its financial position and ability to achieve profitability based on its current operating plan [26][27] Other Important Information - The company ended Q1 2025 with $113.4 million in cash and cash equivalents, bolstered by a public offering that raised over $46 million [26] - The company has at least 12 months of Vafcio inventory on hand in the U.S. and does not expect significant tariff-related impacts [24] Q&A Session Summary Question: Update on timelines for adding Vafcio to protocols at large dialysis organizations - Management indicated that a large pilot is planned to operationalize protocols, with training expected to take about a month, followed by a pilot duration of two to three months [29][31][34] Question: Shift from Auryxia prescriptions to authorized generic - Management noted that the impact of the authorized generic has been minimal in Q1 2025, with expectations that it will not significantly affect business in Q2 [46][48][49] Question: Net price dynamics as large dialysis providers come on board - Management acknowledged that net prices may decrease as volumes increase, but there will be variability in pricing due to the competitive environment [53][55] Question: Demand drivers for Vafcio and reimbursement trends - Management highlighted that demand is driven by clinical efficacy and economic incentives, with positive trends in Medicare Advantage coverage [70][72][78] Question: Inventory stocking trends with large dialysis organizations - Management expects initial stocking for pilots but does not anticipate significant issues with inventory levels due to efficient distribution networks [84][88] Question: Market landscape for label expansion opportunities - Management expressed excitement about the non-dialysis market, which is comparable in size to the dialysis market, and emphasized the potential for significant revenue growth [90][92][94]

Financial Data and Key Metrics Changes - Total revenues increased to $57.3 million in Q1 2025 from $32.6 million in Q1 2024, driven by net product revenues of $55.8 million compared to $31 million in the prior year [22][25] - Net income for Q1 2025 was $6.1 million, a significant improvement from a net loss of $18 million in Q1 2024 [25] - Cost of goods sold decreased to $7.6 million in Q1 2025 from $11.6 million in Q1 2024, attributed to the absence of a non-cash amortization charge related to Auryxia [23][24] Business Line Data and Key Metrics Changes - Vafcio generated $12 million in net product revenues in Q1 2025, exceeding guidance of $10 million to $11 million [6][22] - Auryxia net product revenues increased to $43.8 million in Q1 2025 from $31 million in Q1 2024, despite the entry of an authorized generic [22][23] Market Data and Key Metrics Changes - The top five dialysis organizations have ordered Vafcio, with revenues primarily coming from small to mid-sized dialysis organizations treating approximately 150,000 patients collectively [7][14] - The VOICE study is progressing towards full enrollment, with about 75% of the target 2,200 subjects enrolled [9] Company Strategy and Development Direction - The company aims to expand the use of Vafcio in both dialysis and non-dialysis patient populations, with plans to initiate a Phase III VALOR trial in the second half of 2025 [10][11] - The focus remains on increasing the breadth and depth of prescribing among current customers while unlocking new customers [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong early performance of Vafcio, highlighting the importance of prescriber education and patient retention [6][7] - The company is confident in its financial position and believes it is financed to achieve profitability based on its current operating plan [25][26] Other Important Information - The company has at least 12 months of Vafcio inventory on hand in the U.S. and does not expect significant tariff-related impacts [24] - The average compliance rate in dialysis is expected to be around 65%, which will influence refill rates over time [60] Q&A Session Summary Question: Update on timelines for adding Vafcio to protocols at large dialysis organizations - Management indicated that a large pilot is planned to operationalize protocols, with training expected to take about a month before broader rollout [29][31][34] Question: Shift from Auryxia prescriptions to authorized generic - Management noted that the impact of the authorized generic has been minimal in Q1 2025, with expectations of maintaining significant revenue until more generics are approved [47][50] Question: Net price dynamics as large dialysis providers come on board - Management acknowledged the competitive environment and indicated that net price per patient is expected to decrease as volumes increase, with some lumpiness in pricing [55][57] Question: Demand drivers for Vafcio and reimbursement trends - Management highlighted that demand is driven by clinical value and economic incentives, with positive trends in Medicare Advantage coverage [70][78] Question: Inventory stocking trends with large dialysis organizations - Management expects initial stocking for pilots but does not anticipate significant issues with inventory levels due to efficient distribution networks [84][86] Question: Market landscape for label expansion opportunities - Management expressed excitement about the non-dialysis market, estimating a significant patient population and potential revenue opportunities [90][92]

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were $46.5 million, down from $56.2 million in Q4 2023, and for the full year 2024, revenues were $160.2 million compared to $194.6 million in 2023 [38] - Net product revenues from Auryxia were $44.4 million in Q4 2024, down from $53.2 million in Q4 2023, and for the full year, they were $152.2 million compared to $170.3 million in 2023 [38] - The net loss for Q4 2024 was $22.8 million, compared to a net income of $0.6 million in Q4 2023, and the full year net loss was $69.4 million compared to $51.9 million in 2023 [41][42] Business Line Data and Key Metrics Changes - The launch of Vafseo is in its early stages, with expected net product revenue of $10 million to $11 million for Q1 2025, which is ahead of analyst estimates [10][21] - Auryxia's revenues decreased primarily due to a reduction in volume, partially offset by price increases and execution of contracting strategies [38] Market Data and Key Metrics Changes - The demand for Vafseo is strong, with over 500 physicians prescribing it by the end of February, averaging about eight prescriptions each [33][76] - Approximately 15% of prescriptions in February were written for payers other than Medicare fee-for-service, indicating early Medicare Advantage coverage [36][86] Company Strategy and Development Direction - The company aims to make Vafseo the standard-of-care for patients with anemia due to chronic kidney disease, focusing on both dialysis and non-dialysis patient populations [10][17] - The strategy includes securing contracts with dialysis organizations and building prescriber demand, with a focus on small to medium dialysis organizations initially [12][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early traction of Vafseo and the potential for it to become a standard treatment option [10][38] - The company is preparing for a Phase 3 clinical trial (VALOR) for non-dialysis patients, with plans to initiate the study in the second half of the year [18][96] Other Important Information - The company raised $18.4 million in net proceeds from sales under its ATM facility and drew down $9.3 million from its BlackRock Credit Agreement, strengthening its financial position [44] - Cash and cash equivalents as of December 31, 2024, were $51.9 million, expected to be sufficient to fund operations for at least two years [43] Q&A Session Summary Question: Does Q1 Vafseo revenue include any stocking or inventory build? - Management confirmed that there will be a little bit of inventory included in the revenue guidance, with inventory expected to stay in the two to four week range [48] Question: What are the dose frequency trends for in-center dialysis patients? - Most patients are currently on a daily dosing protocol, with some smaller centers starting protocols with less frequent dosing [49] Question: How is protocolization gaining uptake at large-scale dialysis organizations? - Management noted that operationalizing protocols takes time, and while some larger organizations have written protocols, implementation is slower than desired [52] Question: Can you expand on the recent backlog in Auryxia? - The backlog was for all phosphate binders and Vafseo due to the transition to specialty pharmacies, which initially lacked capacity [60] Question: What is the timing for the VALOR study regulatory interaction? - The focus is on study design, and management is looking to initiate discussions with the FDA to expedite the process [68][96]