Akebia Therapeutics(AKBA) - 2025 Q2 - Quarterly Results

Executive Summary and Business Highlights 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 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] - Total Q2 2025 net product revenues increased to $60.5 million[1] - DaVita physicians are expected to begin treating patients with Vafseo in August 2025 as part of an operational pilot[1] - Patient enrollment completed in VOICE, a collaborative clinical trial of Vafseo[1] Vafseo U.S. Commercial Updates 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] - Prescription demand grew by approximately 55% over Q1 2025[3] - More than 725 prescribers wrote a prescription for Vafseo in Q2, with an average of more than 13 prescriptions per prescriber[3] - 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] - 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] Additional Key Business Updates 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 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] - 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] - 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] Auryxia Performance 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] - 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] Financial Performance 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 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] Selected Balance Sheet Data 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] - 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] Product Information: Vafseo® (vadadustat) tablets This section provides detailed information on Vafseo (vadadustat) tablets, including its description, approved indications, and critical safety information Product Description and Indication 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] - 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] - Vafseo is approved for use in 37 countries[10] Important Safety Information 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 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] - VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being[14] - 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] Contraindications and Warnings & Precautions 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] - 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] - Other warnings include Hepatotoxicity, Hypertension, Seizures, and Gastrointestinal (GI) Erosion[18][19][20][22] - VAFSEO is not recommended in patients with cirrhosis or active, acute liver disease, or in patients with active malignancies[18][24] Adverse Reactions, Drug Interactions, and Specific Populations 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] - 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] - 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] Corporate Information 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 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] - Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts[9] Conference Call Details 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] - 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 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] - 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] Trademarks and Contact 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] - Contact information for Mercedes Carrasco (mcarrasco@akebia.com) is provided for Akebia Therapeutics[31]