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 Insights - Teradyne Inc reported better-than-expected third-quarter results, with earnings of 85 cents per share, surpassing the analyst consensus estimate of 79 cents per share [1] - The company's quarterly sales reached $769.210 million, exceeding the analyst consensus estimate of $743.776 million [1] - Following the announcement, Teradyne shares rose 20.7% to $174.50 in pre-market trading [2] Company Performance - Teradyne's strong earnings and sales figures indicate robust operational performance and effective management strategies [1] - The positive forecast for the current quarter suggests continued growth potential for the company [1] Market Reactions - The significant increase in Teradyne's share price reflects investor confidence following the strong quarterly results [2] - Other companies in the market also experienced notable movements, with some gaining substantial percentages in pre-market trading [5]

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].

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 - 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 sales decline was primarily due to a reduction in volume, partially offset by price increases and effective 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 for Vafseo were written for payers other than Medicare fee-for-service, indicating early success in 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-sized 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 2025 [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 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 TIW dosing [49] Question: How is protocolization gaining uptake at large-scale dialysis organizations? - Management noted that operationalizing protocols is taking longer than expected, but there is a desire from physicians to write prescriptions [52][53] 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, but it has subsided significantly [61] Question: What is the timing for the VALOR study regulatory interaction? - The focus is on study design, and management is looking to initiate the VALOR study as quickly as possible [66][68] Question: What are the launch metrics planned for disclosure? - Over 500 physicians have prescribed Vafseo, with an average of eight prescriptions per prescriber, indicating good breadth and depth of prescribing [76] Question: What is the current gross to net outlook? - Management did not provide specific gross to net figures but indicated that the average prescriptions are for the starting dose, with discounts expected to grow as volumes increase [90][91]

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]