Akebia Therapeutics(AKBA) - 2025 Q2 - Quarterly Report

PART I—FINANCIAL INFORMATION This section presents Akebia Therapeutics, Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis for the quarter ended June 30, 2025 Item 1. Financial Statements (Unaudited) This section presents Akebia Therapeutics, Inc.'s unaudited condensed consolidated financial statements for the quarter ended June 30, 2025, including balance sheets, statements of operations and comprehensive income (loss), stockholders' equity (deficit), and cash flows, along with detailed notes explaining significant accounting policies, financial instruments, inventories, intangible assets, indebtedness, leases, commitments, and revenue recognition Condensed Consolidated Balance Sheets The Condensed Consolidated Balance Sheets show a significant increase in total assets and a shift from a stockholders' deficit to positive equity as of June 30, 2025, compared to December 31, 2024, driven primarily by an increase in cash and cash equivalents and accounts receivable Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Total Assets | $345,595 | $220,670 | | Total Liabilities | $316,371 | $269,855 | | Total Stockholders' Equity (Deficit) | $29,224 | $(49,185) | - Cash and cash equivalents increased significantly from $51.87 million at December 31, 2024, to $137.31 million at June 30, 2025[17] - Accounts receivable, net, rose from $34.37 million to $72.81 million during the same period[17] Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) The Condensed Consolidated Statements of Operations show a significant improvement in financial performance, moving from a net loss in Q2 2024 and H1 2024 to net income in Q2 2025 and H1 2025, primarily driven by increased product revenue and the absence of intangible asset amortization Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Revenues | $62,472 | $43,648 | $119,808 | $76,255 | | Total Cost of Goods Sold | $9,919 | $17,047 | $17,544 | $28,651 | | Income (Loss) from Operations | $14,089 | $(8,725) | $27,603 | $(23,660) | | Net Income (Loss) | $247 | $(8,582) | $6,359 | $(26,567) | | Basic EPS | $0.00 | $(0.04) | $0.03 | $(0.13) | | Diluted EPS | $0.00 | $(0.04) | $0.02 | $(0.13) | - Total revenues increased by 43% for the three months ended June 30, 2025, and by 57% for the six months ended June 30, 2025, compared to the respective periods in 2024[20] - Amortization of intangible asset decreased by 100% for both the three and six months ended June 30, 2025, as the asset was fully amortized by December 31, 2024[20] Condensed Consolidated Statements of Stockholders' Equity (Deficit) The Condensed Consolidated Statements of Stockholders' Equity (Deficit) reflect a significant improvement in equity from a deficit of $(49.19) million at December 31, 2024, to a positive equity of $29.22 million at June 30, 2025, primarily due to net income and proceeds from common stock issuances Condensed Consolidated Statements of Stockholders' Equity (Deficit) (in thousands) | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Total Stockholders' Equity (Deficit) | $(49,185) | $29,224 | | Additional Paid-In Capital | $1,629,167 | $1,701,217 | | Accumulated Deficit | $(1,678,360) | $(1,672,001) | - Issuance of common stock, net of issuance costs, contributed $64.91 million and $1.54 million during the six months ended March 31, 2025, and the three months ended June 30, 2025, respectively[23] - Net income of $6.11 million for the period ending March 31, 2025, and $0.25 million for the period ending June 30, 2025, also contributed to the increase in equity[23] Condensed Consolidated Statements of Cash Flows The Condensed Consolidated Statements of Cash Flows show a significant increase in cash, cash equivalents, and restricted cash, primarily driven by net cash provided by financing activities, including debt issuance and common stock sales, and a positive shift in operating activities Condensed Consolidated Statements of Cash Flows (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Net cash provided by (used in) operating activities | $8,758 | $(29,498) | | Net cash provided by (used in) investing activities | $28 | $(29) | | Net cash provided by financing activities | $76,662 | $26,115 | | Increase (decrease) in cash, cash equivalents and restricted cash | $85,448 | $(3,412) | | Cash, cash equivalents and restricted cash — end of period | $138,998 | $41,167 | - Operating activities generated $8.76 million in cash for the six months ended June 30, 2025, a substantial improvement from a $29.50 million usage in the prior year[26] - Financing activities provided $76.66 million in cash, primarily from $10.0 million in debt issuance and $66.45 million from common stock sales[26] Notes to the Unaudited Condensed Consolidated Financial Statements The notes provide detailed explanations of the company's financial position and performance, covering significant accounting policies, product information, fair value measurements, inventory valuation, intangible assets, debt agreements, lease commitments, revenue recognition, capital stock, stock-based compensation, net income per share calculations, segment information, and subsequent events 1. Nature of Business Akebia Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovative therapeutics, with two FDA-approved products: Vafseo (vadadustat) for anemia due to CKD in dialysis patients (launched Jan 2025) and Auryxia (ferric citrate) for hyperphosphatemia and IDA in CKD patients (lost exclusivity in March 2025). The company's cash resources are believed to be sufficient for at least 12 months, but future funding may be required - Vafseo (vadadustat) was approved in the U.S. in March 2024 for anemia due to CKD in adult dialysis patients and entered the U.S. market in January 2025[31] - Auryxia (ferric citrate) is marketed for controlling serum phosphorus in DD-CKD and treating IDA in NDD-CKD, and lost U.S. exclusivity in March 2025[31] - As of June 30, 2025, the Company had $137.3 million in cash and cash equivalents, expected to fund operations for at least 12 months[34] 2. Summary of Significant Accounting Policies The company's financial statements are prepared in accordance with GAAP, utilizing estimates and assumptions for various accounts. There have been no material changes to significant accounting policies since December 31, 2024. Key estimates include accrued expenses, revenue reserves, and long-term assets. The company also detailed its cash, cash equivalents, restricted cash, and credit risk management, and noted recent accounting pronouncements not yet adopted, including ASU 2023-09 (Income Tax Disclosures) and ASU 2024-03 (Expense Disclosures) - The company's allowance for credit losses increased from $1.2 million at December 31, 2024, to $2.2 million at June 30, 2025[50][54] - ASU 2023-09 (Income Taxes) is effective for fiscal years beginning after December 15, 2024, and is not expected to materially affect consolidated financial statements[56] - ASU 2024-03 (Expense Disclosures) is effective for fiscal years beginning after December 15, 2026, and requires new tabular disclosures for cost and expense categories[57] 3. Fair Value of Financial Instruments The company measures certain assets and liabilities at fair value, primarily classifying money market funds (cash equivalents) as Level 1 and warrant liability as Level 2, reflecting valuation based on observable inputs like the Black-Scholes option pricing model Fair Value of Financial Instruments (in thousands) | Item (in thousands) | June 30, 2025 Total Fair Value | December 31, 2024 Total Fair Value | | :------------------ | :----------------------------- | :----------------------------- | | Cash equivalents: Money market funds | $117,868 | N/A | | Long-term liability: Warrant liability | $14,199 | $5,176 | - Money market funds are classified as Level 1, valued using quoted market prices in active markets[61] - Warrant liability is classified as Level 2, valued using the Black-Scholes option pricing model with observable inputs[62] 4. Inventories Total inventories increased to $58.57 million at June 30, 2025, from $51.20 million at December 31, 2024, with a notable increase in long-term work-in-process. Inventory write-downs for excess or obsolescence were significantly lower in 2025 compared to 2024 Inventories (in thousands) | Inventory Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Current Inventories: | | | | Work-in-process | $14,202 | $12,031 | | Finished goods | $2,506 | $4,212 | | Total Current Inventories | $16,708 | $16,243 | | Long-term Inventories: | | | | Raw materials | $381 | $381 | | Work-in-process | $41,481 | $34,572 | | Total Long-term Inventories | $41,862 | $34,953 | | Total Inventories | $58,570 | $51,196 | - Inventory written down for excess/obsolescence was $0.1 million for the six months ended June 30, 2025, down from $1.1 million in the same period of 2024[63] 5. Intangible Asset and Goodwill The intangible asset related to Auryxia's developed product rights was fully amortized by December 31, 2024, resulting in no amortization expense in 2025, compared to $18.0 million in the first six months of 2024. Goodwill from the Keryx merger remains at $59.0 million with no impairment identified - Amortization expense for Auryxia's intangible asset was $0 for the three and six months ended June 30, 2025, compared to $9.0 million and $18.0 million for the same periods in 2024, respectively[64] - Goodwill from the Keryx merger remains at $59.0 million as of June 30, 2025, with no impairment identified to date[65] 6. Additional Balance Sheet Detail Prepaid expenses and other current assets decreased to $7.83 million at June 30, 2025, mainly due to the reclassification of prepaid manufacturing. Other long-term assets increased to $44.19 million, driven by long-term inventories. Accrued expenses and other current liabilities significantly increased to $91.62 million, primarily due to higher product rebates and current portions of settlement royalties and Working Capital Fund liability Additional Balance Sheet Detail (in thousands) | Description (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------- | :------------ | :---------------- | | Prepaid expenses and other current assets | $7,832 | $11,350 | | Other long-term assets | $44,193 | $37,377 | | Accrued expenses and other current liabilities | $91,615 | $63,460 | - Product rebates within accrued expenses increased from $6.07 million to $33.75 million[71] - Current portion of settlement royalties increased from $5.92 million to $14.66 million[71] 7. Indebtedness Akebia entered into a $55.0 million BlackRock Credit Agreement, with the final $10.0 million tranche funded in February 2025, extending maturity to January 2028. The facility accrues interest at a floating rate (11.08% as of June 30, 2025) and is secured by company assets. Warrants were issued to the lender, with a fair value of $14.2 million at June 30, 2025. Previous Pharmakon Term Loans were extinguished in January 2024 - The BlackRock Credit Agreement provides a $55.0 million senior secured term loan facility, with the final $10.0 million Tranche C funded on February 3, 2025[72][73][74] - The loan matures on January 29, 2028, with interest-only payments until December 31, 2026, at a floating annual rate (11.08% as of June 30, 2025)[75][76][80] - Warrants to purchase 4,230,769 shares of common stock were issued to the lender, with a fair value of $14.2 million as of June 30, 2025[84][85][86] 8. Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties Akebia terminated its Vifor License Agreement, resulting in a $63.39 million settlement royalties liability (effective interest rate 37.0%) and a $40.57 million Working Capital Fund liability (15.0% imputed interest), both to be repaid via tiered royalties on Vafseo net sales. The liability related to the sale of future royalties to HCR for Vafseo in Japan remains at $53.23 million, with a 0% effective interest rate as of June 30, 2025 - The Vifor License Agreement was terminated on July 10, 2024, leading to a reclassification of $43.3 million received from CSL Vifor as debt[104][107] Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties (in thousands) | Liability (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Total Settlement Royalties Liability | $63,389 | $52,621 | | Total Working Capital Fund Liability | $40,572 | $40,287 | | Total Liability Related to Sale of Future Royalties | $53,234 | $54,105 | - The annual effective interest rate for the settlement royalties liability was 37.0% as of June 30, 2025, and for the Working Capital Fund liability was 15.0%. The effective interest rate for the sale of future royalties was 0%[107][112][117] 9. Leases Akebia leases office, storage, and lab space in Cambridge, Massachusetts, under a non-cancelable operating lease expiring September 11, 2026. Operating lease costs were $1.2 million for Q2 2025 and $2.5 million for H1 2025. Future lease commitments total $6.53 million - The Cambridge Lease for office, storage, and lab space expires on September 11, 2026[122] - Operating lease costs were $1.2 million for the three months ended June 30, 2025, and $2.5 million for the six months ended June 30, 2025[124] Operating Lease Commitments (in thousands) | Year | Operating Lease Commitments (in thousands) | | :--- | :--------------------------------------- | | 2025 | $2,915 | | 2026 | $3,613 | | Total | $6,528 | 10. Commitments and Contingencies Akebia has various manufacturing and purchase commitments, including $16.9 million for Auryxia drug substance through 2026 with Siegfried, and $7.6 million for Vafseo drug substance from Esteve through 2025. The company also has license agreements with Panion (royalties on Auryxia/Riona sales) and Cyclerion (milestones and tiered royalties for praliciguat, with $0.5 million payment due by Sep 2025). Litigation and indemnification obligations are also noted - Required to purchase $16.9 million of Auryxia drug substance from Siegfried through 2026[127] - Committed to purchase $7.6 million of Vafseo drug substance from Esteve through 2025[136] - Panion is eligible for mid-single digit royalties on ferric citrate sales; Akebia incurred $5.7 million in royalties to Panion for the six months ended June 30, 2025[142][143] - Cyclerion is eligible for up to $198.5 million in development/regulatory milestones and tiered royalties for praliciguat, with a $0.5 million payment due by September 30, 2025[146][147][148][151] 11. Product Revenue and Reserves for Variable Consideration Product revenue significantly increased to $60.46 million for Q2 2025 and $116.25 million for H1 2025, driven by Vafseo's U.S. market entry in January 2025 and increased Auryxia sales. Product revenue allowances and reserves, including rebates and returns, totaled $52.02 million at June 30, 2025 Product Revenue (in thousands) | Product (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Vafseo | $13,279 | $0 | $25,313 | $0 | | Auryxia | $47,183 | $41,209 | $90,939 | $72,218 | | Total Product Revenues | $60,461 | $41,209 | $116,252 | $72,218 | - Vafseo's U.S. market entry in January 2025 generated $13.28 million in Q2 2025 and $25.31 million in H1 2025[156] Reserve Category (in thousands) | Reserve Category (in thousands) | Balance at December 31, 2024 | Balance at June 30, 2025 | | :------------------------------ | :--------------------------- | :----------------------- | | Rebates, Fees and Discounts | $1,436 | $348 | | Chargebacks and Other Deductions | $15,726 | $45,168 | | Product Returns | $6,442 | $6,505 | | Total | $23,604 | $52,021 | 12. License, Collaboration and Other Revenue License, collaboration, and other revenue decreased to $2.01 million for Q2 2025 and $3.56 million for H1 2025, primarily due to lower revenue from the MTPC supply agreement. Revenue sources include Medice (Vafseo in EEA/UK/Switzerland/Australia), MTPC (Vafseo in Japan), and JT/Torii (Riona in Japan). The Medice license agreement's $10.0 million upfront payment was recognized in 2023 License, Collaboration and Other Revenue (in thousands) | Entity | Description | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :----- | :---------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Medice | Vafseo in EU | $16 | $0 | $24 | $0 | | MTPC | Vafseo in Japan | $502 | $1,169 | $870 | $1,581 | | JT and Torii | Riona in Japan | $1,493 | $1,270 | $2,662 | $2,456 | | Total | | $2,011 | $2,439 | $3,556 | $4,037 | - The decrease in revenue was primarily due to lower revenue from the MTPC supply agreement[165] - The $10.0 million upfront payment from the Medice License Agreement was recognized as revenue in 2023[175] 13. Capital Stock As of June 30, 2025, Akebia had 263,041,832 common shares outstanding. The company raised $18.4 million net from ATM offerings and $48.1 million net from a public offering in H1 2025. Warrants to purchase 4,230,769 common shares were issued in connection with the BlackRock Credit Agreement, with 1,408,588 shares issued via cashless exercise in July 2025 - 263,041,832 common shares were issued and outstanding as of June 30, 2025[196] - Net proceeds from ATM offerings were $18.4 million for the six months ended June 30, 2025[198] - A public offering in March 2025 generated $46.5 million net, with an additional $1.6 million net from the partial exercise of an option in April 2025[199][200] - Warrants to purchase 4,230,769 shares of common stock were issued in connection with the BlackRock Credit Agreement[203][206] - On July 21, 2025, 1,408,588 shares were issued via cashless exercise of warrants[207] 14. Stock-Based Compensation and Benefit Plan Stock-based compensation expense increased to $2.68 million for Q2 2025 and $4.86 million for H1 2025. The company granted 4,009,600 stock options and 4,414,300 RSUs in H1 2025. As of June 30, 2025, $13.5 million in unrecognized stock option costs and $11.3 million in unrecognized RSU costs remain Stock-Based Compensation (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total stock-based compensation | $2,676 | $2,072 | $4,863 | $4,432 | - 4,009,600 stock options were granted to employees and directors during the six months ended June 30, 2025[210] - 4,414,300 RSUs were granted during the six months ended June 30, 2025[226] - Unrecognized compensation costs for stock options totaled $13.5 million, with a weighted average recognition period of 2.89 years[219] - Unrecognized compensation costs for RSUs totaled $11.3 million, with a weighted average recognition period of 2.08 years[226] 15. Net Income (Loss) Per Share Basic and diluted net income per share were $0.00 for Q2 2025 and $0.03/$0.02 for H1 2025, a significant improvement from losses in 2024. Potentially dilutive securities were included in 2025 calculations due to net income, but excluded in 2024 due to anti-dilutive effects from net losses Net Income (Loss) Per Share (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) | $247 | $(8,582) | $6,359 | $(26,567) | | Basic EPS | $0.00 | $(0.04) | $0.03 | $(0.13) | | Diluted EPS | $0.00 | $(0.04) | $0.02 | $(0.13) | - Dilutive securities (options, RSUs, warrants, ESPP) were included in 2025 EPS calculations due to net income, but excluded in 2024 due to anti-dilutive effects from net losses[231] 16. Segment Information Akebia operates as a single operating segment focused on developing and commercializing innovative therapeutics primarily in the U.S. The Chief Operating Decision Maker (CODM) reviews consolidated financial information, including income from operations and net income, to assess performance and allocate resources - The company operates as one operating segment, consistent with the CODM's review of consolidated financial information[232][233] Segment Information (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | $62,472 | $43,648 | $119,808 | $76,255 | | Income (loss) from operations | $14,089 | $(8,725) | $27,603 | $(23,660) | | Net income (loss) | $247 | $(8,582) | $6,359 | $(26,567) | 17. Subsequent Events On July 21, 2025, the Warrant Holder exercised an option to purchase 2,115,384 shares of common stock on a cashless basis, resulting in the issuance of 1,408,588 shares on July 23, 2025 - On July 21, 2025, 2,115,384 shares of common stock were purchased via cashless exercise of warrants[240] - As a result, 1,408,588 shares were issued to the Warrant Holder on July 23, 2025[240] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Akebia's financial condition and results of operations, highlighting the company's transition to profitability driven by Vafseo's U.S. launch and Auryxia sales, while also discussing factors affecting performance, recent financing activities, liquidity, and critical accounting estimates Business Overview Akebia Therapeutics is a fully integrated biopharmaceutical company focused on kidney disease, with two commercial products: Vafseo (vadadustat) for anemia due to CKD in dialysis patients (U.S. launch Jan 2025) and Auryxia (ferric citrate) for hyperphosphatemia and IDA in CKD patients (lost U.S. exclusivity March 2025). The company is pursuing label expansion for Vafseo in non-dialysis patients and has a pipeline of HIF-based molecules and praliciguat for other unmet needs - Vafseo (vadadustat) was approved by the FDA in March 2024 for anemia due to CKD in adult dialysis patients and launched in the U.S. in January 2025, targeting a $1 billion market opportunity[247] - Akebia is pursuing label expansion for Vafseo for CKD non-dialysis dependent patients, aiming to initiate a Phase 3 cardiovascular outcome study (VALOR) by the end of 2025[248] - Auryxia (ferric citrate) is marketed in the U.S. for DD-CKD and NDD-CKD, but lost U.S. exclusivity in March 2025, with potential for slower revenue decline due to ESRD bundle dynamics[250][251] - The company's pipeline includes two additional HIF molecules (AKB-9090 for CS-AKI/ARDS and AKB-10108 for ROP) and praliciguat for kidney disease indications[254][255] Factors Affecting Our Performance and Results of Operations Akebia's performance is influenced by product revenue from Auryxia and Vafseo, which is subject to variables like discounts, rebates, and the impact of Auryxia's loss of exclusivity. License and collaboration revenue from partners like Medice and MTPC also contribute. Cost of goods sold includes manufacturing costs and royalties, with R&D expenses focused on Vafseo development and pipeline expansion. SG&A covers commercial and administrative costs, while other income/expense includes interest and changes in warrant liability fair value - Product revenue is generated from U.S. sales of Auryxia and Vafseo, influenced by discounts, rebates, and product returns[257] - Auryxia lost U.S. exclusivity in March 2025, with an authorized generic version now being sold, impacting future Auryxia revenues[258] - License, collaboration, and other revenue includes license fees, royalties, and product supply revenue from partners like Medice, MTPC, JT, and Torii[259] - R&D expenses primarily cover Vafseo development, pipeline expansion (HIF-based molecules, praliciguat), and preclinical/clinical activities, totaling $1.7 billion since inception through June 30, 2025[264][266] - SG&A expenses include personnel, marketing, professional fees, and general corporate costs[271] Recent Events Akebia completed a public offering of common stock in March 2025, raising $46.5 million net, with an additional $1.6 million from an option exercise in April 2025. The company also drew the final $10.0 million tranche of the BlackRock Credit Agreement in February 2025, issuing additional warrants. ATM offerings in H1 2025 generated $18.4 million net - A public offering of 25,000,000 shares in March 2025 generated $46.5 million net proceeds, with an additional $1.6 million from 850,000 shares sold in April 2025[275][276] - The final $10.0 million tranche of the BlackRock Credit Agreement was drawn on February 3, 2025, providing $9.3 million net proceeds after costs[277][278][279] - Additional warrants to purchase 1,153,846 shares of common stock were issued to the Warrant Holder in connection with the Tranche C drawdown[280] - ATM offerings generated $18.4 million net proceeds from the sale of 9,437,364 shares during the six months ended June 30, 2025[283] Results of Operations Akebia's results of operations show a significant turnaround, with net income in Q2 and H1 2025 compared to net losses in 2024. This improvement is primarily driven by substantial increases in product revenue from Vafseo's U.S. launch and Auryxia sales, coupled with the cessation of intangible asset amortization. R&D expenses increased due to Vafseo clinical trials, while SG&A remained relatively stable Comparison of the Three Months Ended June 30, 2025 and 2024 For Q2 2025, Akebia reported net income of $0.25 million, a significant improvement from a net loss of $8.58 million in Q2 2024. Total revenues increased by 43% to $62.47 million, driven by Vafseo's U.S. market entry ($13.28 million) and increased Auryxia sales ($47.18 million). Cost of goods sold decreased by 42% due to the absence of intangible asset amortization, despite an increase in cost of product and other revenue. R&D expenses rose by 44% due to increased clinical trial activities Comparison of the Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | Q2 2025 | Q2 2024 | Change ($) | Change (%) | | :-------------------- | :------ | :------ | :--------- | :--------- | | Total Revenues | $62,472 | $43,648 | $18,824 | 43% | | Product Revenue, Net | $60,461 | $41,209 | $19,252 | 47% | | Vafseo Revenue | $13,279 | $0 | $13,279 | N/A | | Auryxia Revenue | $47,183 | $41,209 | $5,974 | 14% | | Total Cost of Goods Sold | $9,919 | $17,047 | $(7,128) | (42)% | | Amortization of Intangible Asset | $0 | $9,011 | $(9,011) | (100)% | | R&D Expenses | $11,013 | $7,647 | $3,366 | 44% | | Net Income (Loss) | $247 | $(8,582) | $8,829 | (103)% | - The increase in product revenue was primarily due to Vafseo's U.S. market entry in January 2025 and increased sales volumes of Auryxia[286] - Cost of product and other revenue increased due to a $4.9 million benefit in Q2 2024 from selling previously written-down inventory, partially offset by a $2.1 million charge related to firm purchase commitment liability in Q2 2024[291] Comparison of the Six Months Ended June 30, 2025 and 2024 For H1 2025, Akebia achieved net income of $6.36 million, a substantial improvement from a net loss of $26.57 million in H1 2024. Total revenues surged by 57% to $119.81 million, driven by Vafseo's U.S. launch ($25.31 million) and increased Auryxia sales ($90.94 million). Total cost of goods sold decreased by 39% due to the full amortization of intangible assets. R&D expenses increased by 19% due to Vafseo clinical trials and other programs Comparison of the Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | H1 2025 | H1 2024 | Change ($) | Change (%) | | :-------------------- | :------ | :------ | :--------- | :--------- | | Total Revenues | $119,808 | $76,255 | $43,553 | 57% | | Product Revenue, Net | $116,252 | $72,218 | $44,034 | 61% | | Vafseo Revenue | $25,313 | $0 | $25,313 | N/A | | Auryxia Revenue | $90,939 | $72,218 | $18,721 | 26% | | Total Cost of Goods Sold | $17,544 | $28,651 | $(11,107) | (39)% | | Amortization of Intangible Asset | $0 | $18,021 | $(18,021) | (100)% | | R&D Expenses | $20,767 | $17,379 | $3,388 | 19% | | Net Income (Loss) | $6,359 | $(26,567) | $32,926 | (124)% | - The increase in product revenue was primarily due to Vafseo's U.S. market entry in January 2025 and an increase in sales volumes of Auryxia[303] - Cost of product and other revenue increased due to an $8.6 million benefit in H1 2024 from selling previously written-down inventory, partially offset by a $2.1 million charge related to firm purchase commitment liability in H1 2024[308] Liquidity and Capital Resources Akebia's cash and cash equivalents stood at $137.3 million as of June 30, 2025, with total equity funding of $929.2 million since inception. The company believes current resources and expected revenues are sufficient for its operating plan, but acknowledges potential future financing needs due to Auryxia's loss of exclusivity and ongoing R&D. Major contractual obligations include the BlackRock Term Loans ($55.0 million), settlement royalties ($63.39 million), Working Capital Fund liability ($40.57 million), and future royalty sales liability ($53.23 million) - As of June 30, 2025, cash and cash equivalents were $137.3 million, with restricted cash of $1.7 million[317] - Since inception, Akebia has raised approximately $929.2 million net from equity sales[318] - The BlackRock Credit Agreement provides a $55.0 million term loan facility, maturing January 29, 2028, with interest-only payments until December 31, 2026[324][325] - Liability related to settlement royalties totaled $63.39 million as of June 30, 2025, with an annual effective interest rate of 37.0%[334] - Working Capital Fund liability was $40.57 million as of June 30, 2025, with an imputed interest rate of 15.0%[338] - Liability related to sale of future royalties was $53.23 million as of June 30, 2025, with a 0% effective interest rate[342] Cash Flows Akebia's cash flows for the six months ended June 30, 2025, show a significant increase in cash, cash equivalents, and restricted cash by $85.45 million, primarily driven by $76.66 million from financing activities (debt and stock sales) and a positive shift in operating activities to $8.76 million provided Cash Flows (in thousands) | Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------- | :----------------------------- | :----------------------------- | | Operating activities | $8,758 | $(29,498) | | Investing activities | $28 | $(29) | | Financing activities | $76,662 | $26,115 | | Increase (decrease) in cash, cash equivalents and restricted cash | $85,448 | $(3,412) | - Net cash provided by operating activities was $8.8 million for H1 2025, a positive change from $29.5 million used in H1 2024[359][360] - Net cash provided by financing activities was $76.7 million for H1 2025, mainly from $10.0 million in debt issuance and $66.4 million from common stock sales[364] Recent Accounting Pronouncements For a discussion of recent accounting pronouncements, refer to Note 2, Summary of Significant Accounting Policies, in the Notes to the unaudited condensed consolidated financial statements - Refer to Note 2 for details on recent accounting pronouncements[366] Critical Accounting Estimates and Significant Judgments Management's discussion of critical accounting estimates and significant judgments, including those related to accrued expenses, revenue reserves, inventories, and long-term assets, remains consistent with the 2024 Form 10-K, with no material changes in methodologies during H1 2025 - No material changes to methodologies for critical accounting estimates were reported during the six months ended June 30, 2025[368] - Key estimates include accrued expenses, revenue reserves, inventories, and long-term assets[367] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Akebia Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - Akebia is a smaller reporting company and is not required to provide market risk disclosures[369] Item 4. Controls and Procedures Akebia's disclosure controls and procedures were deemed ineffective as of June 30, 2025, due to a material weakness in internal control over financial reporting related to inventory accounting. Remediation efforts are ongoing, focusing on improving the precision of review controls for sales forecasts used in inventory evaluations Management's Evaluation of Disclosure Controls and Procedures Akebia's disclosure controls and procedures were not effective as of June 30, 2025, due to a previously identified material weakness in internal control over financial reporting related to the completeness, accuracy, and reasonableness of the product sales forecast used for inventory evaluations - Disclosure controls and procedures were not effective as of June 30, 2025[371] - A material weakness was identified in internal control over financial reporting related to the precision of controls for evaluating product sales forecasts used in inventory accounting[372] Remediation Efforts of the Material Weakness — Inventories Akebia is actively remediating the material weakness in inventory accounting by increasing the precision of review controls for sales forecasts. The company acknowledges that the material weakness will persist until these controls operate effectively for a sufficient period - Remediation efforts include increasing the precision of review controls for sales forecasts used in inventory evaluations[374] - The material weakness will continue to exist until controls operate effectively and are tested[375] Changes in Internal Control over Financial Reporting No changes in internal control over financial reporting materially affected or are reasonably likely to materially affect the company's internal control during the reporting period, except for the ongoing remediation efforts for the identified material weakness - No material changes in internal control over financial reporting occurred during the period, apart from ongoing remediation efforts[376] PART II—OTHER INFORMATION This section details Akebia Therapeutics, Inc.'s legal proceedings, comprehensive risk factors, unregistered equity sales, and other disclosures for the reporting period Item 1. Legal Proceedings Akebia is involved in ongoing legal proceedings, including opposition proceedings against its Indian patent for vadadustat and a European patent for vadadustat's dosing regimen, with responses submitted to the respective patent offices Opposition Proceedings Against Akebia Akebia is defending its Indian Patent No. 287720 for vadadustat's composition of matter and its European Patent No. 3007695 for vadadustat's once-daily dosing regimen against opposition filings by Dr. Reddy's Laboratories Limited and Sandoz AG, respectively - Dr. Reddy's Laboratories Limited filed an opposition to Akebia's Indian Patent No. 287720 (vadadustat composition of matter) in September 2018, with amended claims published May 9, 2025[378] - Sandoz AG filed an opposition against Akebia's European Patent No. 3007695 (vadadustat once daily dosing regimen) on November 6, 2024, to which Akebia submitted a reply on March 18, 2025[379] Item 1A. Risk Factors Akebia faces numerous risks, including financial challenges like sustained losses and the need for additional capital, commercialization hurdles for Auryxia (post-exclusivity) and Vafseo (market acceptance, reimbursement), and extensive product development risks. Regulatory complexities, reliance on third parties, intellectual property challenges, and operational management issues also pose significant threats to its business, financial condition, and stock price Risks Related to our Financial Position, Need for Additional Capital and Growth Strategy Akebia has a history of significant losses and an accumulated deficit of $1.7 billion, despite recent net income. Future profitability is uncertain, dependent on Vafseo's commercial success, Auryxia's post-exclusivity performance, and managing substantial R&D and operating expenses. The company may require significant additional financing, which could dilute stockholders, restrict operations, or necessitate relinquishing product rights. Strategic transactions and resource allocation decisions also carry risks, potentially impairing growth if new products or candidates are not successfully identified or integrated - Akebia has incurred net losses since inception, with an accumulated deficit of $1.7 billion as of June 30, 2025, despite recent net income[381] - Vafseo's U.S. approval was for a narrower indication (dialysis patients only) and delayed, impacting commercialization and requiring significant additional resources[383] - Auryxia lost U.S. exclusivity in March 2025, and its future revenue depends on maintaining dialysis contracts, generic competition, and pricing[385] - The company may require substantial additional financing, which could lead to stockholder dilution, operational restrictions, or the need to relinquish product rights[398][402][403] - Failure to identify, acquire, or successfully develop additional products or product candidates could impair long-term growth[404][406] Risks Related to our Financial Arrangements Akebia's financial condition is significantly impacted by its BlackRock Credit Agreement, which includes $55.0 million in term loans secured by company assets, with covenants requiring minimum cash balances or revenue. Non-compliance could lead to accelerated repayment and adverse effects. Additionally, the Royalty Interest Acquisition Agreement with HCR for Vafseo royalties in Japan contains covenants, and any violation could materially harm financial condition - The BlackRock Credit Agreement provides a $55.0 million senior secured term loan facility, maturing January 29, 2028[415] - Financial covenants require maintaining a minimum cash balance of $15.0 million or trailing twelve-month revenue of $150.0 million[416] - Failure to comply with covenants could result in acceleration of debt and enforcement of security interests, materially harming the business[416][419] - The Royalty Agreement with HCR for Vafseo royalties in Japan has an annual cap of $13.0 million and an aggregate cap of $150.0 million, with covenants that, if violated, could materially adversely affect financial condition[421] Risks Related to Commercialization Akebia's commercial success hinges on Auryxia and Vafseo, facing challenges from Auryxia's loss of exclusivity and generic competition, and Vafseo's limited U.S. indication and market acceptance within dialysis networks. Reimbursement policies, competition from existing and new therapies, and the ability to maintain sales and marketing capabilities are critical. International operations for Riona and Vafseo also expose the company to foreign regulatory, economic, and currency risks - Auryxia's loss of U.S. exclusivity in March 2025 and generic competition will adversely affect revenue, despite an authorized generic version[423][425] - Vafseo's U.S. approval is limited to dialysis patients, potentially affecting market acceptance and revenue if not adopted by large dialysis organizations[422][426] - Market acceptance and sales of products depend on adequate coverage and reimbursement from third-party payors, including dialysis organizations, and can be impacted by pricing pressures and formulary decisions[429][438][446][447] - Akebia faces substantial competition from existing and new drugs for hyperphosphatemia (e.g., Renagel, Velphoro, XPHOZAH) and anemia (e.g., Epogen, Aranesp, roxadustat)[452][454][455][459][460][462] - International commercialization efforts for Riona (Japan) and Vafseo (Europe, Japan) are subject to risks including political instability, changing reimbursement policies, and foreign currency fluctuations[466][468] Risks Related to Product Development Drug development is a lengthy, expensive, and uncertain process with high failure rates. Akebia faces risks in completing clinical trials for Vafseo label expansion and other candidates, including potential delays, negative results, or safety concerns (e.g., Vafseo's MACE and liver injury risks). Enrollment challenges, evolving regulatory requirements (like EU CTR and U.S. DAP guidance), and the acceptance of foreign clinical data further complicate development, potentially leading to increased costs, delayed approvals, or market limitations - Clinical drug development is lengthy, expensive, and uncertain, with high risk of failure at any stage[471] - Vafseo's U.S. approval was delayed and limited to dialysis patients due to FDA safety concerns regarding MACE in non-dialysis patients and drug-induced liver injury[487][499] - Akebia is pursuing label expansion for Vafseo in NDD-CKD patients, requiring additional Phase 3 studies (VALOR) with uncertain outcomes and timing[472][500] - Difficulties in patient enrollment for clinical trials, particularly for pediatric studies (e.g., Auryxia's Hyperphosphatemia Indication), can cause delays and increased costs[476][477][478] - Evolving regulatory landscapes, such as the EU Clinical Trials Regulation (CTR) and U.S. diversity action plan (DAP) guidance, introduce complexities and potential delays for global clinical trials[483][484] Risks Related to Governmental Regulation and Compliance Akebia operates under complex regulatory schemes, including strict post-marketing requirements for Auryxia and Vafseo (e.g., pediatric studies, REMS), and faces risks of penalties for non-compliance. The company is exposed to fraud and abuse laws (Anti-Kickback, False Claims), off-label promotion restrictions, and evolving data privacy regulations (GDPR, CCPA). Disruptions at government agencies (FDA staffing cuts, shutdowns) and healthcare reform initiatives (IRA, drug price negotiations) could hinder approvals, increase costs, and impact product pricing and reimbursement - Auryxia and Vafseo are subject to extensive post-marketing regulatory requirements, including post-approval pediatric studies, with potential penalties for non-compliance (e.g., Auryxia's delayed Hyperphosphatemia Indication study)[515] - The company is exposed to federal and state anti-kickback, false claims, and off-label promotion laws, with violations potentially leading to significant civil/criminal penalties and exclusion from healthcare programs[523][524][528][529] - Disruptions at the FDA (e.g., personnel losses, budget cuts, executive orders) could delay guidance, review, and approval of product candidates[533][534][535][536] - Compliance with evolving data privacy laws (GDPR, CCPA, state health data laws) is costly and complex, with potential for significant fines and litigation for non-compliance[542][546][547][548][550][552] - Healthcare reform measures, including the Inflation Reduction Act (IRA) and Medicare drug price negotiations, could increase costs, reduce reimbursement, and impact product pricing for Auryxia and Vafseo[568][569][571][573] Risks Related to our Reliance on Third Parties Akebia heavily relies on third-party collaborations for development and commercialization of Auryxia, Riona, and Vafseo, and on single-source manufacturers and distributors for product supply. Failure of these partners to perform, comply with regulations, or meet deadlines could severely harm the business, leading to supply disruptions, increased costs, and inability to capitalize on market potential. Geopolitical tensions, particularly with China, Europe, and Canada, also pose risks to the supply chain and manufacturing relationships - Akebia depends on collaborations with JT/Torii (Riona in Japan), Averoa (ferric citrate in Europe), and an AG Partner (authorized generic Auryxia) for commercialization[595] - Collaborations for Vafseo include MTPC (Japan/Asia) and Medice (EEA/UK/Switzerland/Australia)[596] - Reliance on single-source third-party manufacturers (e.g., Siegfried for Auryxia, Patheon/WuXi STA for Vafseo) and distributors creates significant supply chain risks[606][608] - Failure of third-party manufacturers or distributors to comply with cGMP, meet quality standards, or perform as agreed could lead to supply interruptions, increased costs, and regulatory sanctions[608][609][613][615] - Geopolitical tensions and trade policies, especially with China, Europe, and Canada, could disrupt supply chains and increase manufacturing costs, particularly with reliance on Chinese CDMOs like WuXi STA[630][631][632] Risks Related to our Intellectual Property Akebia's commercial success relies on robust intellectual property protection, but faces risks from the high cost and uncertainty of obtaining and defending patents globally. Challenges include competitors designing around patents, patent expiration before commercialization, and the difficulty of enforcing rights in certain jurisdictions. The market entry of generics, particularly for Auryxia post-exclusivity, and ongoing litigation (e.g., FibroGen disputes) pose significant threats to sales and financial performance. Additionally, the company is vulnerable to claims of wrongful use or disclosure of third-party confidential information by employees or contractors - Obtaining and defending patent protection globally is expensive and uncertain, with risks of patents being challenged, invalidated, or designed around by competitors[633][635][636][638][639] - The market entry of generic versions of Auryxia following its loss of exclusivity in March 2025 will negatively impact net product revenue[657][660] - Akebia is involved in opposition proceedings against its Indian and European patents for vadadustat, which could be costly and divert resources[669] - The company settled patent disputes with FibroGen and Astellas in the EU, UK, and Japan regarding Vafseo, but may face future challenges outside this territory[664] - Akebia is exposed to claims that employees or contractors have wrongfully used or disclosed third-party confidential information, potentially leading to litigation and loss of intellectual property rights[671][672] Risks Related to our Business and Managing Growth Akebia's ability to grow and commercialize products is highly dependent on attracting and retaining skilled personnel, especially senior management, in a competitive industry. The company faces challenges in managing operational growth, including complex partnerships and supply obligations. A material weakness in internal control over financial reporting related to inventory accounting requires ongoing remediation. Additionally, the company is exposed to product liability lawsuits, which could result in substantial liabilities and commercialization limits, and security breaches of IT systems pose risks to data integrity and intellectual property - Recruiting and retaining qualified senior management and personnel is critical, with past workforce reductions highlighting this risk[673][674] - Managing growth, including complex collaborations and supply obligations for products like Vafseo and ferric citrate, presents operational difficulties[676][677][678] - A material weakness in internal control over financial reporting as of December 31, 2024, related to inventory accounting, could impact financial reporting accuracy and fraud prevention[680][682] - Product liability lawsuits from clinical and commercial use of Auryxia and Vafseo pose an inherent risk, potentially leading to substantial liabilities and commercialization limits[704][706] - Security breaches and unauthorized use of IT systems could damage clinical trials, impact regulatory filings, compromise intellectual property, and lead to significant fines[685][686][687][690] Risks Related to our Common Stock Akebia's stock price is highly volatile due to various factors, including clinical trial results, regulatory developments, and market competition, potentially leading to substantial losses for investors and increased litigation risk. Failure to meet Nasdaq listing requirements could result in delisting. The issuance or sale of additional common stock, including from large stockholders or future offerings, could dilute existing ownership and depress the stock price. Furthermore, provisions in organizational documents and Delaware law may have anti-takeover effects, and the absence of cash dividends means capital appreciation is the sole source of stockholder gain - Akebia's stock price is volatile, influenced by clinical trial results, regulatory developments, and market competition, leading to potential investor losses and litigation[717][718] - Failure to comply with Nasdaq's continued listing requirements (e.g., minimum bid price) could result in delisting, negatively impacting stock price and capital access[720] - Sales of substantial amounts of common stock by large stockholders (BlackRock, Vanguard, CSL Vifor) or through future offerings could dilute existing ownership and depress the market price[721][722][723][724][725][726] - Organizational documents and Delaware law contain anti-takeover provisions that could discourage acquisitions or make it difficult for stockholders to change management[728][730] - Akebia does not anticipate paying cash dividends, making capital appreciation the sole source of gain for stockholders[731] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds During the quarter ended June 30, 2025, Akebia Therapeutics, Inc. did not have any unregistered sales of equity securities, other than those previously disclosed in its Current Reports on Form 8-K - No unregistered sales of equity securities occurred during Q2 2025, beyond those previously reported in Form 8-K filings[733] Item 3. Defaults Upon Senior Securities This item is not applicable to Akebia Therapeutics, Inc. for the reporting period - This item is not applicable[734] Item 4. Mine Safety Disclosures This item is not applicable to Akebia Therapeutics, Inc. for the reporting period - This item is not applicable[734] Item 5. Other Information This section confirms that none of Akebia's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 Rule 10b5-1—Director and Officer Trading Arrangements No directors or officers of Akebia Therapeutics, Inc. adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025 - No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q2 2025[737] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including organizational documents, the 2023 Stock Incentive Plan, certifications from executive officers, and Inline XBRL documents - Exhibits include the Ninth Amended and Restated Certificate of Incorporation, Second Amended and Restated Bylaws, and the 2023 Stock Incentive Plan[739] - Certifications from the Principal Executive Officer and Principal Financial Officer (Rule 13a-14(a) and 13a-14(b)) are filed[739] - Inline XBRL documents (Instance, Schema, Calculation, Definition, Labels, Presentation Linkbase) and the Cover Page Interactive Data File are included[739] Signatures The report is duly signed on August 7, 2025, by John P. Butler (President and CEO), Erik J. Ostrowski (SVP, CFO, CBO, and Treasurer), and Richard C. Malabre (SVP, Chief Accounting Officer), certifying its submission on behalf of Akebia Therapeutics, Inc - The report was signed on August 7, 2025, by John P. Butler (President and CEO), Erik J. Ostrowski (SVP, CFO, CBO, and Treasurer), and Richard C. Malabre (SVP, Chief Accounting Officer)[743]