Eton Pharmaceuticals(US:ETON)2025-11-06 21:28Financial Performance - Total net revenues for the three months ended September 30, 2025, were $22,459,000, a 117.5% increase from $10,324,000 in the same period of 2024[12] - Product sales and royalties, net, reached $22,459,000 for the three months ended September 30, 2025, compared to $9,824,000 for the same period in 2024, reflecting a 128.5% increase[12] - Gross profit for the nine months ended September 30, 2025, was $29,640,000, up from $16,935,000 in the same period of 2024, representing a 75.0% increase[12] - For the nine months ended September 30, 2025, total revenues reached $58,669 with a gross profit of $29,640, compared to $27,364 and a gross profit of $16,935 in the same period of 2024, driven by increased sales of INCRELEX® and additional revenues from ALKINDI SPRINKLE® and GALZIN®[149] - Licensing revenue for the nine months ended September 30, 2025 was $3,286, a substantial increase from $500 in the same period of 2024, primarily due to $1,786 from out-licensing INCRELEX® rights outside the U.S.[150] - In the three months ended September 30, 2025, the Company reported total revenues of $22,459, generating a gross profit of $7,855, compared to total revenues of $10,324 and a gross profit of $6,302 in the same period of 2024, reflecting a significant increase in product sales and royalties[148] Cash and Assets - Cash and cash equivalents increased to $37,121,000 as of September 30, 2025, from $14,936,000 at the end of 2024, marking a 148.1% increase[10] - Total assets grew to $104,510,000 as of September 30, 2025, compared to $76,123,000 at the end of 2024, indicating a 37.3% increase[10] - As of September 30, 2025, the Company had total assets of $104.5 million, cash and cash equivalents of $37.1 million, and working capital of $27.8 million, indicating a solid liquidity position[153] Liabilities and Debt - Total liabilities increased to $81,384,000 as of September 30, 2025, from $51,695,000 at the end of 2024, representing a 57.4% increase[10] - The company’s existing debt obligations contain covenants that limit its ability to pay dividends or make distributions to stockholders[24] - The amended SWK Credit Agreement expanded the credit facility to $30,000, with a maturity date of December 17, 2027, and an annual interest rate of SOFR plus 6.75%[90] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $5,985,000, an increase from $4,126,000 in the same period of 2024, reflecting a 45.0% rise[12] - Research and Development expenses for the three months ended September 30, 2025 were $1,112, up from $505 in the same period of 2024, and for the nine months ended September 30, 2025, R&D expenses totaled $5,985 compared to $4,126 in 2024, largely due to a $2,155 NDA filing fee for ET-600[151] Stock and Compensation - Total stock-based compensation expense for the nine months ended September 30, 2025, was $4,388, up from $2,383 in the same period of 2024, indicating a 83.9% increase[102] - The Company recorded stock-based compensation related to RSUs of $611 for the nine months ended September 30, 2025, compared to $171 for the same period in 2024, reflecting a 257.3% increase[109] - The Company issued 108,451 shares of common stock from stock option exercises at a weighted average exercise price of $3.63 per share during the nine months ended September 30, 2025, with an intrinsic value of $1,167[108] Net Loss and Earnings - The company reported a net loss of $1,927,000 for the three months ended September 30, 2025, compared to a net income of $627,000 in the same period of 2024[12] - GAAP net loss for the three months ended September 30, 2025, was $(1,927) thousand, compared to a net income of $627 thousand for the same period in 2024[157] - Non-GAAP net income for the nine months ended September 30, 2025, was $5,418 thousand, compared to $197 thousand for the same period in 2024[157] Tax and Regulatory - The effective tax rate for the three months ended September 30, 2025, was 1.4%, compared to an effective tax rate of (25.1%) for the same period in 2024[117] - The Company has a full valuation allowance recorded on its net deferred tax assets, impacting its effective tax rate[119] Operational Highlights - The company has eight commercial rare disease products and five additional product candidates in late-stage development, indicating ongoing expansion in its product pipeline[23] - The Company entered into a licensing agreement with AMMTeK to acquire U.S. rights to Amglidia, with potential payments totaling up to $1,850, including a 14% royalty on net sales[138] - The Company acquired GALZIN® for $7,000 and INCRELEX® for $22,500, with additional payments for product inventory and royalties of 10% and $2,500 on anniversaries, respectively[139][140] Internal Controls and Compliance - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of September 30, 2025, despite a delinquent filing incident[183] - There have been no changes in internal controls over financial reporting that materially affected the company during the quarter ended September 30, 2025[184] - The company maintains disclosure controls designed to ensure timely decision-making and compliance with SEC rules[180]