Group 1 - Akebia Therapeutics (AKBA) is outperforming the Medical sector with a year-to-date return of approximately 104.2%, while the sector has returned an average of -5.7% [4] - The Zacks Consensus Estimate for AKBA's full-year earnings has increased by 65.4% in the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [4] - Akebia Therapeutics holds a Zacks Rank of 1 (Strong Buy), suggesting it has characteristics that may lead to outperformance in the market over the next one to three months [3] Group 2 - Akebia Therapeutics is part of the Medical - Drugs industry, which consists of 155 companies and currently ranks 96 in the Zacks Industry Rank, with an average gain of 4.1% this year [6] - Another Medical stock, ResMed (RMD), has returned 10.2% year-to-date and has a Zacks Rank of 2 (Buy), with a consensus EPS estimate increase of 1.4% over the past three months [5] - The Medical - Products industry, which includes ResMed, has 84 stocks and is ranked 166, with an average return of 4.8% since the beginning of the year [6]

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]

Group 1 - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease [1][3] - The company will have its Chief Commercial Officer, Nik Grund, participate in a Fireside Chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on July 14 at 10:00 AM EDT [1] - A webcast of the presentation will be available in the "Investors" section of Akebia's website following the conference [2] Group 2 - Akebia Therapeutics was founded in 2007 and is headquartered in Cambridge, Massachusetts [3] - The company aims to be fully integrated in the biopharmaceutical sector, specifically targeting kidney disease [3]

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.

Core Insights - Akebia Therapeutics has published significant data regarding Vafseo (vadadustat) in the Journal of the American Society of Nephrology, focusing on its safety and efficacy in treating anemia related to chronic kidney disease (CKD) [1][2][4] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company dedicated to improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5] - The company aims to advance the understanding and treatment of kidney diseases through high-impact research [4] Product Information - Vafseo (vadadustat) is a once-daily oral medication approved by the U.S. FDA in March 2024 for treating anemia due to CKD in adults on dialysis for at least three months, and it has been available in the U.S. since January 2025 [3][6] - Vafseo functions as a hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulating the production of erythropoietin to manage anemia [6] Clinical Trial Insights - The global phase 3 clinical trials for vadadustat were open-label, randomized, and noninferiority trials comparing its safety and efficacy to darbepoetin alfa in adult patients with CKD-related anemia [2] - In the U.S. patient subgroup with dialysis-dependent CKD, the safety and efficacy of vadadustat were found to be similar to darbepoetin alfa, while in non-dialysis-dependent CKD patients, vadadustat showed a higher risk for major adverse cardiovascular events (MACE) outside the U.S. [2] Research Publication - The analyses published in JASN reflect the importance of geographic-specific data in understanding treatment outcomes for CKD-related anemia, highlighting how regional differences can affect clinical trial results [4]

Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [3]. Upcoming Events - Akebia Executive Management will participate in a Fireside Chat at the Jefferies Global Healthcare Conference on June 5, 2025, at 8:45 AM EDT [1]. - The Jefferies Global Healthcare Conference is scheduled to take place from June 3-5, 2025, in New York City [2]. Investor Relations - A webcast of the presentation will be available in the "Investors" section of Akebia's website following the conference [1].

Core Insights - Akebia Therapeutics, Inc. will present clinical data on Vadadustat at the 62nd European Renal Association Congress from June 4-7, 2025, in Vienna, both virtually and live [1] Company Overview - Akebia Therapeutics is a biopharmaceutical company founded in 2007, headquartered in Cambridge, Massachusetts, focused on improving the lives of individuals affected by kidney disease [2] - The company is fully integrated and aims to address the needs of patients with chronic kidney disease (CKD) [2] Presentation Highlights - Dr. Glenn Chertow will present a win-ratio analysis of the cardiovascular safety of Vadadustat in patients with CKD-related anemia undergoing dialysis on June 6 at 8:15 am CEST [2] - An e-poster will discuss the combination of Vadadustat with Ferric Citrate, highlighting its protective effects against inflammation-induced anemia and anemia caused by chronic kidney disease [2] - Insights from a Japanese database study on the real-world use of HIF-PH inhibitors and erythropoiesis-stimulating agents (ESAs) in non-dialysis-dependent CKD with anemia will also be presented [2]

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]