
Financial Performance - Total net revenues for the three months ended March 31, 2025, were $17,282,000, a significant increase of 117.9% compared to $7,966,000 for the same period in 2024[11] - Gross profit for the three months ended March 31, 2025, was $9,861,000, compared to $5,007,000 for the same period in 2024, reflecting a gross margin improvement[11] - The net loss for the three months ended March 31, 2025, was $1,572,000, compared to a net loss of $811,000 for the same period in 2024, resulting in a net loss per share of $0.06[11] - Adjusted EBITDA for the three months ended March 31, 2025, was $3,675, a significant increase from $482 in the same period of 2024[158] - Non-GAAP net income for the three months ended March 31, 2025, was $2,395, compared to $244 in the same period of 2024, reflecting improved operational performance[158] Cash and Assets - Cash and cash equivalents increased to $17,420,000 as of March 31, 2025, from $14,936,000 at the beginning of the period[21] - Total current assets increased to $49,960,000 as of March 31, 2025, compared to $41,021,000 as of December 31, 2024[9] - As of March 31, 2025, total assets were $84.0 million, with cash and cash equivalents of $17.4 million and working capital of $24.6 million[153] Liabilities and Expenses - Total liabilities increased to $59,582,000 as of March 31, 2025, compared to $51,695,000 as of December 31, 2024, reflecting increased operational costs[9] - Research and development expenses for the three months ended March 31, 2025, were $1,161,000, up from $651,000 in the same period of 2024, indicating increased investment in product development[11] - General and administrative expenses rose to $9,170 for the three months ended March 31, 2025, from $5,156 in the same period of 2024, attributed to increased advertising, product development, and headcount[151] Revenue Sources - For the three months ended March 31, 2025, AnovoRx product sales represented 90.8% of net product revenues, down from 97.7% in the same period of 2024[32] - Product sales and royalties, net, increased by $6,030 to $13,996 for the three months ended March 31, 2025, driven by higher sales of INCRELEX®, ALKINDI SPRINKLE®, and Carglumic Acid[148] - Licensing revenue for the three months ended March 31, 2025, was $3,286, compared to zero in the same period of 2024, due to out-licensing of INCRELEX® rights and a development milestone recognition[149] Stock and Compensation - The total stock-based compensation expense for the three months ended March 31, 2025, was $1,200,000, an increase from $821,000 in the same period of 2024[102] - Stock-based compensation related to Restricted Stock Units (RSUs) was $190,000 for the three months ended March 31, 2025, compared to $60,000 in 2024[108] - The Company recorded an expense of $81,000 related to the Employee Stock Purchase Plan (ESPP) for the three months ended March 31, 2025[111] Product Development and Pipeline - The company has seven commercial rare disease products and six additional product candidates in late-stage development, indicating ongoing expansion in its product pipeline[20] - The Company expects to submit an NDA for ET-600 to the FDA, with a potential approval and launch in Q1 2026[143] Risk and Compliance - The Company relies on a small number of suppliers for key chemicals and products, which poses a risk of significant interruption in the manufacturing process[53] - The Company operates in a dynamic environment with various risks that could materially affect its financial condition and results[193] - There have been no changes in internal control over financial reporting that materially affected the Company during the reporting period[189] Tax and Interest - The income tax expense for the three months ended March 31, 2025, was $74,000, while there was no income tax expense in the same period of 2024[116] - The effective tax rate for the three months ended March 31, 2025, was (4.9%), compared to 0.0% for the same period in 2024[117] - The Company recorded interest expense of $1,163 for the three months ended March 31, 2025, compared to $238 for the same period in 2024[92]