[Executive Summary and Business Highlights](index=1&type=section&id=1.%20Executive%20Summary%20and%20Business%20Highlights) Akebia Therapeutics reported strong Q2 2025 financial results, driven by continued growth of Vafseo, with total net product revenues reaching $60.5 million [Second Quarter 2025 Overview](index=1&type=section&id=1.1.%20Second%20Quarter%202025%20Overview) Akebia Therapeutics reported strong Q2 2025 financial results, driven by continued growth of Vafseo, with total net product revenues reaching $60.5 million - Vafseo Q2 2025 net product revenues increased to **$13.3 million**[1](index=1&type=chunk) - Total Q2 2025 net product revenues increased to **$60.5 million**[1](index=1&type=chunk) - DaVita physicians are expected to begin treating patients with Vafseo in August 2025 as part of an operational pilot[1](index=1&type=chunk) - Patient enrollment completed in VOICE, a collaborative clinical trial of Vafseo[1](index=1&type=chunk) [Vafseo U.S. Commercial Updates](index=1&type=section&id=1.2.%20Vafseo%20U.S.%20Commercial%20Updates) Vafseo's U.S. launch gained momentum in Q2 2025, marked by a significant increase in prescription demand and expanded patient access - Vafseo net product revenue in Q2 2025 totaled **$13.3 million**[3](index=3&type=chunk) - Prescription demand grew by approximately **55%** over Q1 2025[3](index=3&type=chunk) - More than **725 prescribers** wrote a prescription for Vafseo in Q2, with an average of more than **13 prescriptions per prescriber**[3](index=3&type=chunk) - By the end of Q3, dialysis organizations are expected to enable Vafseo prescribing access to more than **75,000 patients**, an increase from about **40,000 patients** at the end of Q2[3](index=3&type=chunk) - DaVita is expected to enable prescribing Vafseo to patients in an operational pilot this month, having placed an order to supply over **100 clinics**[3](index=3&type=chunk) [Additional Key Business Updates](index=2&type=section&id=1.3.%20Additional%20Key%20Business%20Updates) Akebia made significant strides in its clinical development programs for Vafseo, completing enrollment for the VOICE trial and initiating the VOCAL trial [Clinical Development Programs](index=2&type=section&id=1.3.1.%20Clinical%20Development%20Programs) Akebia advanced its clinical pipeline by completing enrollment for the VOICE trial, initiating the VOCAL trial, and planning the VALOR Phase 3 trial for vadadustat by year-end - U.S. Renal Care (USRC) completed enrollment of **2,116 patients** in VOICE, a collaborative clinical trial of Vafseo, with top-line data expected in early 2027[6](index=6&type=chunk) - Akebia initiated the VOCAL trial to evaluate three times per week (TIW) dosing of vadadustat in approximately **350 patients** across **18 DaVita hemodialysis clinics**[6](index=6&type=chunk) - Akebia is working towards initiating VALOR, a Phase 3 clinical trial for vadadustat in late-stage CKD patients not on dialysis, by the end of this year[6](index=6&type=chunk) [Auryxia Performance](index=2&type=section&id=1.3.2.%20Auryxia%20Performance) Auryxia generated **$47.2 million** in net product revenue in Q2 2025, maintaining market presence with only one authorized generic despite loss of exclusivity - Auryxia® (ferric citrate) net product revenue in Q2 2025 totaled **$47.2 million**[6](index=6&type=chunk) - Despite loss of exclusivity on March 20, 2025, no Abbreviated New Drug Application has been approved for Auryxia to date, and there is only one authorized generic[6](index=6&type=chunk) [Financial Performance](index=2&type=section&id=2.%20Financial%20Performance) Akebia's Q2 2025 financial performance showed significant revenue growth and a shift to net income, supported by improved cash and working capital positions [Consolidated Statements of Operations](index=2&type=section&id=2.1.%20Consolidated%20Statements%20of%20Operations) Akebia reported a significant increase in total revenues for Q2 2025, reaching **$62.5 million**, primarily driven by Vafseo sales and an increase in Auryxia sales Three Months Ended June 30, (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------------------- | :------ | :------ | :----------- | | **Revenues** | | | | | Product revenue, net | $60,461 | $41,209 | +46.7% | | License, collaboration and other revenue | $2,011 | $2,439 | -17.6% | | **Total revenues** | **$62,472** | **$43,648** | **+43.1%** | | **Cost of Goods Sold** | | | | | Cost of product and other revenue | $9,919 | $8,036 | +23.4% | | Amortization of intangible asset | $— | $9,011 | -100.0% | | **Total cost of goods sold** | **$9,919** | **$17,047** | **-41.8%** | | **Operating Expenses** | | | | | Research and development | $11,013 | $7,647 | +44.0% | | Selling, general and administrative | $26,555 | $26,917 | -1.3% | | License | $896 | $762 | +17.6% | | **Total operating expenses** | **$38,464** | **$35,326** | **+8.9%** | | Income (loss) from operations | $14,089 | $(8,725) | N/A | | Other expense, net | $(6,862) | $(2,188) | +213.6% | | Change in fair value of warrant liability | $(6,980) | $2,331 | N/A | | **Net income (loss)** | **$247** | **$(8,582)** | **N/A** | | Net income (loss) per share - basic | $0.00 | $(0.04) | N/A | | Net income (loss) per share - diluted | $0.00 | $(0.04) | N/A | | Weighted-average common shares - basic | 262,565,500 | 209,705,397 | +25.2% | | Weighted-average common shares - diluted | 271,104,020 | 209,705,397 | +29.3% | - Net income was **$0.2 million** in Q2 2025, compared to a net loss of **$8.6 million** in Q2 2024, driven by increased net product revenues, partially offset by **$7.0 million** in non-cash expense related to warrant liability and **$5.4 million** in non-cash interest expense related to settlement royalty liability[13](index=13&type=chunk) [Selected Balance Sheet Data](index=3&type=section&id=2.2.%20Selected%20Balance%20Sheet%20Data) Akebia significantly improved its cash position and working capital as of June 30, 2025, compared to December 31, 2024, reflecting a stronger financial standing Selected Balance Sheet Data (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :---------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $137,308 | $51,870 | +164.7% | | Working capital | $115,940 | $32,917 | +252.2% | | Total assets | $345,595 | $220,670 | +56.6% | | Total stockholders' equity (deficit) | $29,224 | $(49,185) | N/A | - Cash and cash equivalents as of June 30, 2025, were approximately **$137.3 million**[13](index=13&type=chunk) - Akebia believes it is financed to achieve profitability based on its current operating plan, which includes pursuing label expansion for Vafseo and advancing other existing programs[13](index=13&type=chunk) [Product Information: Vafseo® (vadadustat) tablets](index=3&type=section&id=3.%20Product%20Information%3A%20Vafseo%C2%AE%20%28vadadustat%29%20tablets) This section provides detailed information on Vafseo (vadadustat) tablets, including its description, approved indications, and critical safety information [Product Description and Indication](index=3&type=section&id=3.1.%20Product%20Description%20and%20Indication) Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in **37 countries** for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months - Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor[10](index=10&type=chunk) - VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months[11](index=11&type=chunk) - Vafseo is approved for use in **37 countries**[10](index=10&type=chunk) [Important Safety Information](index=3&type=section&id=3.2.%20Important%20Safety%20Information) Vafseo carries a Boxed Warning due to increased risks of thrombotic vascular events, including death, MI, stroke, and VTE [Boxed Warning and Limitations of Use](index=3&type=section&id=3.2.1.%20Boxed%20Warning%20and%20Limitations%20of%20Use) Vafseo carries a Boxed Warning for increased risks of thrombotic vascular events and is not indicated for immediate anemia correction or in non-dialysis CKD patients - WARNING: VAFSEO increases the risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access[15](index=15&type=chunk) - VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being[14](index=14&type=chunk) - VAFSEO is not indicated as a substitute for red blood cell transfusions in patients requiring immediate correction of anemia, nor in patients with anemia due to CKD not on dialysis[14](index=14&type=chunk) [Contraindications and Warnings & Precautions](index=4&type=section&id=3.2.2.%20Contraindications%20and%20Warnings%20%26%20Precautions) Vafseo is contraindicated in patients with hypersensitivity or uncontrolled hypertension, with warnings for thrombotic events, hepatotoxicity, hypertension, seizures, and GI erosion - Contraindications include known hypersensitivity to VAFSEO or any of its components, and uncontrolled hypertension[21](index=21&type=chunk) - Warnings and Precautions include increased risk of death, MI, stroke, VTE, and thrombosis of vascular access (especially with rapid Hb rise or levels >**11 g/dL**)[17](index=17&type=chunk) - Other warnings include Hepatotoxicity, Hypertension, Seizures, and Gastrointestinal (GI) Erosion[18](index=18&type=chunk)[19](index=19&type=chunk)[20](index=20&type=chunk)[22](index=22&type=chunk) - VAFSEO is not recommended in patients with cirrhosis or active, acute liver disease, or in patients with active malignancies[18](index=18&type=chunk)[24](index=24&type=chunk) [Adverse Reactions, Drug Interactions, and Specific Populations](index=6&type=section&id=3.2.3.%20Adverse%20Reactions%2C%20Drug%20Interactions%2C%20and%20Specific%20Populations) Common adverse reactions include hypertension and diarrhea, with specific drug interaction guidelines for iron supplements and statins, and precautions for pregnant, breastfeeding, and hepatically impaired patients - The most common adverse reactions (occurring at ≥ **10%**) were hypertension and diarrhea[25](index=25&type=chunk) - Drug interactions require specific administration timing for iron supplements/phosphate binders and monitoring for BCRP substrates and statins (limiting simvastatin to **20 mg** and rosuvastatin to **5 mg**)[27](index=27&type=chunk) - Use in specific populations: May cause fetal harm in pregnancy, breastfeeding not recommended until two days after the final dose, and not recommended in patients with hepatic impairment (cirrhosis or active, acute liver disease)[27](index=27&type=chunk) [Corporate Information](index=3&type=section&id=4.%20Corporate%20Information) This section provides an overview of Akebia Therapeutics, details of its Q2 2025 earnings conference call, and important disclaimers regarding forward-looking statements and trademarks [About Akebia Therapeutics](index=3&type=section&id=4.1.%20About%20Akebia%20Therapeutics) Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company dedicated to improving the lives of people impacted by kidney disease, headquartered in Cambridge, Massachusetts - Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease[9](index=9&type=chunk) - Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts[9](index=9&type=chunk) [Conference Call Details](index=3&type=section&id=4.2.%20Conference%20Call%20Details) Akebia hosted a conference call on Thursday, August 7, 2025, at **8:00 a.m. ET** to discuss its second quarter 2025 earnings, with access available via registration link and a live webcast on the company's investor relations website - Akebia hosted a conference call on Thursday, August 7 at **8:00 a.m. Eastern Time** to discuss second quarter 2025 earnings[7](index=7&type=chunk) - A live webcast of the conference call was available via the 'Investors' section of Akebia's website at: https://ir.akebia.com/[8](index=8&type=chunk) [Forward-Looking Statements](index=6&type=section&id=4.3.%20Forward-Looking%20Statements) The report contains forward-looking statements regarding Akebia's strategy, plans, and expectations for Vafseo's launch, clinical trials, and financial performance, which are subject to various risks and uncertainties that could cause actual results to differ materially - Statements in this press release regarding Akebia's strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements[26](index=26&type=chunk) - Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including those identified in Akebia's SEC filings[29](index=29&type=chunk) [Trademarks and Contact](index=7&type=section&id=4.4.%20Trademarks%20and%20Contact) The document includes information on Akebia's registered trademarks and contact details for investor inquiries - Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates[30](index=30&type=chunk) - Contact information for Mercedes Carrasco (mcarrasco@akebia.com) is provided for Akebia Therapeutics[31](index=31&type=chunk)

Core Insights - Akebia Therapeutics has initiated a post-marketing study, the VOCAL trial, to evaluate the efficacy and safety of Vafseo (vadadustat) in patients with anemia due to chronic kidney disease (CKD) undergoing hemodialysis [1][2] - The trial aims to compare the three times per week dosing of Vafseo against standard erythropoiesis-stimulating agents (ESA) [1][2] - Vafseo was approved by the FDA in March 2024 and became available in the U.S. in January 2025 for treating anemia in adults on dialysis for at least three months [4] Study Design and Objectives - The VOCAL trial will enroll approximately 350 patients across 18 DaVita hemodialysis clinics, utilizing a 1:1 randomization method [2] - The study duration will be up to 33 weeks, including screening, treatment, and safety follow-up [2] - Primary endpoint is the change in hemoglobin levels, with secondary endpoints including serious adverse events, target hemoglobin range, and RBC transfusion rates compared to ESA treatment [2] Sub-Study and Research Focus - A sub-study will involve around 28 patients from three clinics, focusing on the impact of Vafseo on red blood cell (RBC) quality [3] - The sub-study aims to analyze RBC phenotypes, including deformability and resistance to oxidative stress, in collaboration with Vitalant Research Institute [3] Company Overview - Akebia Therapeutics is a biopharmaceutical company dedicated to improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5] - Vafseo is a once-daily oral medication that stimulates endogenous erythropoietin production to manage anemia [6] Regulatory and Safety Information - Vafseo is indicated for treating anemia due to CKD in adults on dialysis for at least three months, but it has not been shown to improve quality of life or fatigue [7] - The drug carries warnings for increased risks of death, myocardial infarction, stroke, and thrombotic events [8][10]

Company Performance - Akebia Therapeutics (AKBA) has returned 94% year-to-date, significantly outperforming the average return of -7.8% for the Medical sector [4] - The Zacks Consensus Estimate for AKBA's full-year earnings has increased by 34.4% over the past three months, indicating a stronger analyst sentiment and improving earnings outlook [4] - Akebia Therapeutics holds a Zacks Rank of 1 (Strong Buy), suggesting it has the characteristics to outperform the market in the near term [3] Industry Comparison - Akebia Therapeutics is part of the Medical - Drugs industry, which consists of 154 individual stocks and currently ranks 90 in the Zacks Industry Rank [6] - The Medical - Drugs industry has gained an average of 3.6% year-to-date, indicating that AKBA is performing better than its industry peers [6] - In contrast, Alignment Healthcare (ALHC), another outperforming stock in the Medical sector, belongs to the Medical Services industry, which has returned -7.7% year-to-date and ranks 85 [6]

About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release. Akebia Therapeutics Contact Mercedes Carrasco mcarrasco@akebia.com Akebia to Host Conference Call on August 7, 2025, at 8:00 a.m. EDT CAMBRIDGE, Mass. ...

Core Viewpoint - Akebia Therapeutics (AKBA) has been upgraded to a Zacks Rank 1 (Strong Buy) due to a positive trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system tracks the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts for the current and following years, indicating a company's earnings outlook [1][2]. - A strong correlation exists between changes in earnings estimates and near-term stock price movements, influenced by institutional investors who adjust their valuations based on these estimates [4][6]. Recent Developments for Akebia Therapeutics - Akebia Therapeutics has seen a 65.4% increase in the Zacks Consensus Estimate over the past three months, with expected earnings of -$0.05 per share for the fiscal year ending December 2025, unchanged from the previous year [8]. - The upgrade to Zacks Rank 1 places Akebia in the top 5% of Zacks-covered stocks, suggesting potential for higher stock prices in the near term due to improved earnings outlook [10]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7][9]. - The system maintains a balanced distribution of "buy" and "sell" ratings, ensuring that only the top 20% of stocks are considered for superior earnings estimate revisions [9][10].

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]