Akebia Therapeutics (NasdaqCM:AKBA) 2025 Conference November 17, 2025 07:00 AM ET Company ParticipantsJohn Butler - CEOErik Ostrowski - Chief Financial and Chief Business OfficerConference Call ParticipantsRoger Song - Senior AnalystRoger SongOkay. Welcome, everyone, to Jefferies London Healthcare Conference 2025. My name is Roger Song, one of the senior analysts covering MedCap in the U.S. It's my pleasure to have the fireside chat with our next company, Akebia. Welcome, John and Eric.John ButlerRoger, tha ...

Core Viewpoint - Akebia Therapeutics (AKBA) is experiencing significant selling pressure, having declined 39.9% over the past four weeks, but is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a momentum oscillator that indicates whether a stock is oversold, with readings below 30 typically signaling this condition [2]. - AKBA's current RSI reading is 24.46, suggesting that the heavy selling may be exhausting, indicating a potential bounce back towards equilibrium in supply and demand [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that earnings estimates for AKBA have increased by 100% over the last 30 days, which usually correlates with price appreciation in the near term [7]. - AKBA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [8].

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]

Financial Performance - Total revenues for Q3 2025 reached $58.766 million, a 56.8% increase from $37.428 million in Q3 2024[21] - Product revenue, net for Q3 2025 was $56.789 million, up 59.5% from $35.592 million in Q3 2024[21] - Net income for Q3 2025 was $540 thousand, compared to a net loss of $20.039 million in Q3 2024[21] - The company reported a total operating income of $4.449 million for Q3 2025, reversing from an operating loss of $12.505 million in Q3 2024[21] - Net income for the nine months ended September 30, 2025, was $6,899,000, compared to a net loss of $46,606,000 for the same period in 2024[26] - Total product revenues for the three months ended September 30, 2025, were $56.789 million, a 59.5% increase from $35.592 million in the same period of 2024[168] - For the nine months ended September 30, 2025, total product revenues reached $173.041 million, up 60.5% from $107.810 million in the same period of 2024[168] Assets and Cash Position - Total assets increased to $364.152 million as of September 30, 2025, up from $220.670 million at December 31, 2024[18] - Cash and cash equivalents rose to $166.444 million, significantly higher than $51.870 million at the end of 2024[18] - Cash, cash equivalents, and restricted cash at the end of the period were $168,139,000, up from $35,693,000 at the end of September 2024[26] - As of September 30, 2025, the Company had cash and cash equivalents of approximately $166.4 million, an increase from $51.9 million as of December 31, 2024[47] Expenses - Research and development expenses for Q3 2025 were $14.944 million, a 76.5% increase from $8.487 million in Q3 2024[21] - Selling, general and administrative expenses increased to $29.094 million in Q3 2025, compared to $26.516 million in Q3 2024[21] - Stock-based compensation expense for the nine months ended September 30, 2025, was $8,084,000, compared to $6,078,000 for the same period in 2024[26] - Non-cash interest expense for the nine months ended September 30, 2025, was $17,056,000, compared to $7,475,000 for the same period in 2024[26] Equity and Shares - Weighted average shares of common stock outstanding increased to 264,786,432 in Q3 2025 from 210,348,459 in Q3 2024[21] - Total stockholders' equity increased to $41,592,000 by September 30, 2025, from a deficit of $50,402,000 at the end of the previous quarter[24] - The company issued 34,437,364 shares of common stock, raising $64,907,000 net of issuance costs during the nine months ended September 30, 2025[24] Inventory and Receivables - Total inventories as of September 30, 2025, amounted to $58.5 million, up from $51.2 million as of December 31, 2024[66] - Accounts receivable related to product sales increased to approximately $63.2 million as of September 30, 2025, compared to $32.4 million as of December 31, 2024[173] - The balance of product revenue allowances and reserves totaled $66.263 million as of September 30, 2025, reflecting adjustments and credits made during the period[172] Debt and Liabilities - Total accrued expenses and other current liabilities increased to $106.4 million as of September 30, 2025, compared to $63.5 million as of December 31, 2024[74] - The Company entered into a BlackRock Credit Agreement providing for a senior secured term loan facility of up to $55.0 million, with Tranche A funded at $37.0 million on January 29, 2024[79] - The BlackRock Term Loan Facility has an interest rate of 11.00% as of September 30, 2025, with interest expense recognized of $2.1 million and $6.2 million for the three and nine months ended September 30, 2025, respectively[83] - The total liability related to the sale of future royalties was $52.7 million as of September 30, 2025, with a current portion of $2.1 million and a long-term portion of $50.6 million[127] Product Development and Market Position - Vafseo® (vadadustat) was approved in the U.S. in March 2024 and entered the market in January 2025 for treating anemia due to chronic kidney disease[31] - Auryxia lost exclusivity in the U.S. in March 2025, impacting its market position[31] - The company continues to explore additional development opportunities to expand its pipeline and portfolio of novel therapeutics[33] Agreements and Collaborations - Under the Medice License Agreement, the Company received an up-front payment of $10 million and is eligible for additional milestone payments up to $100 million[180][182] - The Company entered into a supply agreement with Medice on September 13, 2024, to supply Vafseo drug product, but did not recognize any revenue under this agreement during the three and nine months ended September 30, 2025 or 2024[191] - Under the MTPC Agreement, the transaction price includes an up-front payment of $20.0 million, $20.5 million for Phase 2 studies, $10.0 million in development milestones, $25.0 million in regulatory milestones, and $8.2 million in royalties from net sales of Vafseo[195] Future Outlook and Risks - The Company expects to finance future cash needs through product and license revenues, collaboration, and other revenue sources[34] - The Company may seek to sell public or private equity or enter into new debt transactions to address future cash needs[34] - The Company relies on a small number of manufacturers for active pharmaceutical ingredients, which poses a risk to its supply chain[55] - The Company is currently evaluating new accounting standards that may impact its financial statements in the future[56][57][58][59][60]

Revenue Performance - Vafseo® (vadadustat) Q3 2025 net product revenues reached $14.3 million, contributing to total net product revenues of $56.8 million for the quarter[1] - Total revenues increased to $58.8 million in Q3 2025, up from $37.4 million in Q3 2024, driven by Vafseo and Auryxia® sales[6] - Auryxia net product revenues were $42.5 million in Q3 2025, compared to $35.6 million in Q3 2024, despite the loss of exclusivity on March 20, 2025[6] - Product revenue for Q3 2025 reached $56.789 million, a 59.5% increase from $35.592 million in Q3 2024[33] - Total revenues for Q3 2025 were $58.766 million, up 56.8% from $37.428 million in Q3 2024[33] Expenses - Research and development expenses increased to $14.9 million in Q3 2025, up from $8.5 million in Q3 2024, primarily due to increased clinical trial activities[6] - Selling, general and administrative expenses rose to $29.1 million in Q3 2025, compared to $26.5 million in Q3 2024, largely due to higher marketing costs[6] - Operating expenses for Q3 2025 totaled $44.934 million, an increase of 25.6% compared to $35.772 million in Q3 2024[33] - Research and development expenses for Q3 2025 were $14.944 million, an increase from $8.487 million in Q3 2024[33] Net Income and Financial Position - Net income was $0.5 million in Q3 2025, a significant improvement from a net loss of $20.0 million in Q3 2024[6] - Net income for Q3 2025 was $540,000, a significant improvement from a net loss of $20.039 million in Q3 2024[33] - Cash and cash equivalents as of September 30, 2025, were approximately $166.4 million, positioning the company to achieve profitability based on its current operating plan[7] - Cash and cash equivalents as of September 30, 2025, were $166.444 million, compared to $51.870 million at the end of 2024[35] - Working capital increased to $124.957 million as of September 30, 2025, from $32.917 million at the end of 2024[35] - Total assets as of September 30, 2025, were $364.152 million, up from $220.670 million at the end of 2024[35] - Total stockholders' equity improved to $41.592 million as of September 30, 2025, compared to a deficit of $49.185 million at the end of 2024[35] Clinical Trials and Operations - The operational pilot of Vafseo at DaVita is expected to complete in November 2025, with access for 275,000 patients anticipated by year-end[2] - Akebia does not plan to initiate the VALOR clinical trial and does not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients[5] Prescription Metrics - The average number of prescriptions written per prescriber was approximately 12.7, with over 85% of prescriptions in Q3 being refill prescriptions[3] Fair Value Changes - The company reported a change in fair value of warrant liability of $1.464 million in Q3 2025, compared to a loss of $856,000 in Q3 2024[33]

Core Insights - Akebia Therapeutics reported a significant increase in net product revenues for Vafseo, reaching $14.3 million in Q3 2025, contributing to total net product revenues of $56.8 million for the quarter [1][12] - The company aims to make Vafseo the standard of care for treating anemia in dialysis patients, with expectations to quadruple prescribing access by year-end [2][4] - A recent post-hoc analysis presented at ASN Kidney Week indicated that patients receiving vadadustat had statistically more favorable outcomes in terms of all-cause mortality and hospitalization compared to those receiving erythropoiesis-stimulating agents (ESAs) [1][6] Financial Results - Total revenues increased to $58.8 million in Q3 2025 from $37.4 million in Q3 2024, driven by Vafseo and Auryxia sales [12] - Auryxia net product revenues were $42.5 million in Q3 2025, up from $35.6 million in Q3 2024, despite the loss of exclusivity in March 2025 [12] - The company reported a net income of $0.5 million in Q3 2025, a significant improvement from a net loss of $20.0 million in Q3 2024 [12][32] Operational Highlights - An operational pilot of Vafseo at DaVita is expected to complete in Q4 2025, with access anticipated for 275,000 patients by year-end [1][6] - The number of prescribers for Vafseo reached approximately 725 in Q3 2025, with an average of 12.7 prescriptions written per prescriber [6] - The average dose of refills for Vafseo increased by 5% over Q2 2025, indicating growing acceptance among healthcare providers [6] Regulatory Update - Akebia did not achieve alignment with the FDA on its proposed path for a Phase 3 clinical trial in non-dialysis patients and does not plan to initiate the VALOR clinical trial [4][29]

Core Viewpoint - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on therapies for kidney disease, facing competition in the industry [1] Financial Performance - Akebia is set to release its quarterly earnings on November 10, 2025, with Wall Street estimating earnings per share at -$0.02 and projected revenue of approximately $58.2 million [2] - The company has a negative price-to-earnings (P/E) ratio of -14.47, while the price-to-sales ratio is about 2.62, indicating investors are paying $2.62 for every dollar of sales [3] - The enterprise value to sales ratio is approximately 2.20, reflecting the company's valuation relative to its revenue [3] Cash Flow and Financial Ratios - The enterprise value to operating cash flow ratio is significantly negative at around -186.85, indicating challenges in generating cash flow from operations [4] - The earnings yield is negative at approximately -6.91%, further highlighting financial difficulties for Akebia [4] - The debt-to-equity ratio stands at 1.83, suggesting a relatively high level of debt compared to equity, while the current ratio is approximately 1.98, indicating a reasonable level of short-term financial health [5]

CAMBRIDGE, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the presentation of a post-hoc win odds analysis of all-cause mortality and hospitalization from the Phase 3 INNO2VATE trials of vadadustat at the American Society of Nephrology Kidney Week 2025 (ASN Kidney Week). The presentation entitled, “Win-Odds Analysis of Deaths and Hospitalization in Patie ...

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