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]

Akebia Therapeutics (AKBA) Q2 2025 Earnings Call August 07, 2025 08:00 AM ET Speaker0Good day and thank you for standing by. Welcome to the Akebia Second Quarter twenty twenty five Financial Results. At this time, all participants are in a listen only mode. After the speakers' presentation, we'll open up for questions. Please be advised that today's call is being recorded.I would now like to hand the conference over to your speaker, Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________to__________ Commission File Number 001-36352 AKEBIA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisd ...

Exhibit 99.1 Akebia Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Highlights Continued Vafseo® (vadadustat) growth with Q2 2025 net product revenues increasing to $13.3 million; Total Q2 2025 net product revenues increased to $60.5 million DaVita physicians are expected to begin treating patients with Vafseo in August 2025 as part of an operational pilot at 100+ DaVita dialysis clinics Patient enrollment completed in VOICE, a collaborative clinical trial of Vafseo conducted ...

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Is Akebia Therapeutics (AKBA) one of those stocks right now? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Akebia Therapeutics is one of 983 individual stocks in the Medical sector. Collectively, these companies sit at #7 in the Zacks Sector Rank. The Zacks Sector Rank considers 16 different sector g ...

Akebia Therapeutics (AKBA) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Si ...

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]