Akebia Therapeutics(AKBA) - 2025 Q3 - Quarterly Report

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]