Summary of Akebia Therapeutics FY Conference Call Company Overview - **Company**: Akebia Therapeutics (NasdaqCM:AKBA) - **Focus**: Kidney disease treatment - **Products**: - **Auryxia**: A mature phosphate binder, past patent expiry - **Vafseo**: A hypoxia-inducible factor prolyl hydroxylase inhibitor approved for treating anemia in chronic kidney disease (CKD) patients on dialysis, launched at the beginning of the year [2][3] Financial Performance - **Recent Revenue**: Reported $14.3 million in revenue for the quarter, which was below expectations despite positive underlying metrics [5] - **Market Access**: Initially had access to about 40,000 patients, which has now grown to approximately 260,000 patients due to expanded access through major dialysis providers [6] Market Dynamics - **Dialysis Providers**: - **U.S. Renal Care**: Strong clinical advocacy, significant part of revenue base - **DaVita**: Expanded access from 100 to over 4,000 dialysis centers, indicating a successful pilot program [6][14] - **Fresenius**: More challenging engagement, but potential for significant patient access if they broaden availability [20] Clinical Insights - **Patient Management**: Emphasis on educating healthcare providers about the unique dosing and administration of Vafseo compared to traditional treatments [10][12] - **Clinical Data**: Recent data presented at ASN showed a 1% decrease in mortality and an 8% lower hospitalization rate for Vafseo compared to traditional treatments [19][23] Regulatory and Reimbursement Landscape - **TDAPA**: Transitional Drug Add-on Payment Adjustment allows billing for Vafseo outside the dialysis bundle for two years, providing a higher price point and facilitating access [25][26] - **Market Size**: The anemia treatment market in dialysis is estimated at $1 billion, with potential for Vafseo to capture a significant share if it becomes standard of care [26][29] Future Outlook - **Clinical Trials**: Ongoing studies (VOICE and VOCAL) aim to provide further evidence of Vafseo's efficacy and differentiate it from existing treatments [31][32] - **Pipeline Development**: Plans to explore additional indications for HIF-PHI, including acute kidney injury and retinopathy of prematurity [38][39] Financial Position - **Cash Reserves**: Ended the quarter with $166 million, indicating a solid balance sheet and guidance towards profitability [42]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $58.8 million, up from $37.4 million in Q3 2024, representing an increase of over $21 million [20] - Net product revenues increased to $56.8 million from $35.6 million year-over-year, driven by Vafseo sales of $14.3 million and Auryxia sales of $42.5 million, up from $35.6 million [20] - The company generated a net income of approximately $540,000 in Q3 2025, compared to a net loss of $20 million in Q3 2024 [24] Business Line Data and Key Metrics Changes - Vafseo generated $14.3 million in revenue this quarter, while Auryxia sales increased to $42.5 million [20] - The average dose of Vafseo refills increased by 5% compared to the previous quarter and 32% above the starting dose, indicating physicians are becoming more comfortable with optimal dosing [13] Market Data and Key Metrics Changes - The number of accessible patients for Vafseo increased from 40,000 at the beginning of the year to over 260,000 by the end of Q3 2025, with significant contributions from the DaVita pilot and other dialysis providers [17][19] - Over 85% of prescriptions written for Vafseo were refills, indicating a growing acceptance among prescribers [13] Company Strategy and Development Direction - The company aims to make Vafseo the standard of care for treating anemia in dialysis patients, supported by positive clinical data and strong prescriber interest [4][11] - The strategy includes addressing operational challenges and enhancing adherence through better education and support for prescribers [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming operational issues and increasing prescribing access, with expectations of significant growth in patient access by early 2026 [19][63] - The management highlighted the importance of ongoing data generation to support Vafseo's clinical differentiation and long-term growth [8][9] Other Important Information - The company is preparing for the results of the VOICE and VOCALE studies, which are expected to be important data catalysts for Vafseo [9] - Auryxia's future sales levels are uncertain due to potential generic competition, but the company continues to perform well in the market [21] Q&A Session Summary Question: What strategies could be used to overcome operational challenges for Vafseo? - The company is focusing on improving messaging around titration strategies and working closely with anemia managers to enhance adherence [26][27] Question: What has been the physician feedback regarding Vafseo's impact on hospitalization outcomes? - Physicians expressed excitement about the data presented, indicating that Vafseo could significantly change care for patients [34][35] Question: What are the greatest hurdles for expanding Vafseo in medium dialysis organizations? - The main hurdles include navigating operational processes at dialysis providers and ensuring adherence among patients [40][42]

Core Viewpoint - The drug and biotech sector is experiencing a recovery driven by a landmark drug-pricing deal between Pfizer and the Trump administration, which includes tariff exemptions and price cuts, alongside increased M&A activity in the sector [1]. Group 1: Industry Overview - The Zacks Medical-Drugs industry consists of small to medium-sized drug companies that primarily focus on developing medicines, often relying on collaborations with larger firms for revenue [3]. - The industry is currently ranked 68 in the Zacks Industry Rank, placing it in the top 28% of 243 Zacks industries, indicating strong prospects for growth [9]. Group 2: Market Performance - The Zacks Medical-Drugs industry has seen a year-to-date stock increase of 6.2%, outperforming the Zacks Medical sector, which decreased by 0.2%, but underperforming the S&P 500, which rose by 12.2% [11]. - The industry is trading at a trailing 12-month price-to-sales ratio of 2.37, lower than the S&P 500's 5.82 and the Zacks Medical sector's 2.45 [13]. Group 3: Key Trends and Innovations - There is a strong focus on innovation in areas such as rare diseases, next-generation oncology treatments, obesity, immunology, and neuroscience, which are attracting investor interest [5]. - Investment in technology and personalized medicine is crucial for smaller companies to adapt to the evolving healthcare landscape [7]. Group 4: Company Highlights - **Ironwood Pharmaceuticals**: The company is advancing its key pipeline candidate, apraglutide, for treating short bowel syndrome, with a stock increase of 115.5% in the past three months [16][17]. - **Pyxis Oncology**: The company is progressing with its lead candidate, micvotabart pelidotin, for treating head and neck cancer, with a stock increase of 197.4% in the past three months [20][21]. - **Plus Therapeutics**: Focused on targeted radiotherapeutics for CNS cancers, the company has seen its stock rise by 113.6% in the past three months [24][26]. - **Cardiol Therapeutics**: Developing CardiolRx for heart disease, the company has experienced an 18.6% decline in stock over the past three months [29][31]. - **Akebia Therapeutics**: The company launched Vafseo for anemia due to chronic kidney disease, but its stock has declined by 28.3% in the past three months [33][34].

Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on developing therapies for kidney disease, with its primary product being Auryxia, which treats iron deficiency anemia in chronic kidney disease patients [1] Financial Performance - Akebia's Return on Invested Capital (ROIC) is 0.34%, while its Weighted Average Cost of Capital (WACC) is 10.46%, resulting in a ROIC to WACC ratio of 0.033, indicating inefficiencies in capital utilization [2][6] - Ardelyx, Inc. has a ROIC of -10.63% and a WACC of 7.62%, leading to a ROIC to WACC ratio of -1.395, which, despite being negative, is the highest among its peers [3] - FibroGen, Inc. and Karyopharm Therapeutics Inc. show concerning figures with ROICs of -122.23% and -1634.05%, respectively, and WACCs of 7.40% and 16.28%, resulting in ROIC to WACC ratios of -16.521 and -100.389 [4] - Calithera Biosciences, Inc. and Aldeyra Therapeutics, Inc. also face difficulties, with ROICs of -184.41% and -75.25%, and WACCs of 3.17% and 7.59%, leading to ROIC to WACC ratios of -58.23 and -9.913 [5][6]

Core Insights - Akebia Therapeutics is a leading commercial stage company focused on kidney disease with two commercial products [3] - Auryxia, a phosphate binder, generated $47 million in revenues in Q2 despite losing IP exclusivity in March [3] - Vafseo, launched in January, targets anemia due to chronic kidney disease in adult dialysis patients, representing a $1 billion market opportunity in the U.S. [4] Product Overview - Auryxia has been on the market for several years and continues to perform well despite recent challenges [3] - Vafseo is positioned for label expansion into the late-stage non-dialysis CKD population, which is expected to be a multibillion-dollar opportunity [4]

Financial Data and Key Metrics Changes - The company ended Q2 with $137 million in cash and believes it is financed to profitability [5][79] - Auryxia generated $47 million in revenues in Q2, while Vafsio generated $13.3 million in its launch quarter [3][11] Business Line Data and Key Metrics Changes - Auryxia, a phosphate binder, has seen stable performance despite losing IP exclusivity in March [3][78] - Vafsio, launched in January, is positioned as a treatment for anemia due to chronic kidney disease (CKD) and is expected to capture a significant market share [4][10] Market Data and Key Metrics Changes - The U.S. market for anemia treatment in CKD is estimated to be a billion-dollar opportunity, with potential expansion into the non-dialysis CKD population representing a multibillion-dollar market [4][18] - There are approximately 550,000 dialysis patients with anemia in the U.S., with segments underserved by current treatments [25][27] Company Strategy and Development Direction - The company aims to establish Vafsio as the new standard of care for anemia due to CKD, focusing on expanding prescribing access and generating clinical data to support its efficacy [5][14] - Plans to initiate a Phase III trial for Vafsio in the non-dialysis segment by the end of the year [19][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential of Vafsio, citing strong physician interest and advocacy [30][31] - The company is focused on generating data from the VOICE study to demonstrate the benefits of Vafsio, particularly in reducing hospitalization rates [61][64] Other Important Information - The company has secured contracts covering nearly 100% of U.S. dialysis patients, which is crucial for the successful launch of Vafsio [10][46] - The Transitional Drug Add-On Payment Adjustment (TDAPA) program will provide additional financial incentives for dialysis organizations to adopt Vafsio [53][56] Q&A Session Summary Question: What is the opportunity in treating anemia associated with dialysis? - The dialysis market for anemia is stable, with around 550,000 patients, and has been growing at 2% to 4% prior to COVID [25][26] Question: What is the safety profile of Vafsio? - Vafsio works by stimulating the body's natural production of erythropoietin, leading to more consistent treatment outcomes compared to ESAs [28][29] Question: How has the commercial launch progressed? - The company has seen strong advocacy from physicians, with over 80% of US Renal Care physicians prescribing Vafsio [31][32] Question: What is the process for moving a drug into a new dialysis organization? - The process involves contracting, protocol development, and operationalizing the protocol within the organization [46][48] Question: What does TDAPA mean for Vafsio? - TDAPA provides additional payments to incentivize dialysis organizations to adopt innovative therapies like Vafsio [53][54] Question: What are the financial projections for the company? - The company is in a strong financial position, projecting revenues from its products while managing expenses effectively [79]

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]