Axonics(US:AXNX)2019-05-08 20:31Financial Performance - Net revenue for the quarter was $1,077,000, with a gross profit of $529,000[16] - The net loss for the quarter was $13,117,000, compared to a net loss of $6,604,000 in the same quarter last year[16] - The company reported a comprehensive loss of $13,127,000 for the quarter, compared to a comprehensive loss of $6,605,000 in the prior year[16] - The company incurred a net loss of $13.1 million for the three months ended March 31, 2019, compared to a net loss of $6.6 million in the same period of 2018[141] - Net revenue for the three months ended March 31, 2019, was $1.1 million, derived from sales of r-SNM Systems in Europe and Canada, with no revenue recorded in the same period of 2018[133] Operating Expenses - Total operating expenses increased to $14,148,000, up from $6,526,000 in the previous year, primarily due to higher research and development and sales and marketing costs[16] - Research and development expenses were $4,219,000, slightly down from $4,543,000 year-over-year[16] - General and administrative expenses increased by $2.6 million, or 179.8%, to $4.0 million, primarily due to higher personnel and legal costs[136] - Sales and marketing expenses surged by $5.4 million, or 978.7%, to $5.9 million, driven by increased personnel costs in anticipation of the r-SNM System's commercial launch[137] Cash and Liquidity - Cash and cash equivalents at the end of the period were $89,334,000, down from $98,306,000 at the beginning of the year[23] - The company experienced a net cash used in operating activities of $13,055,000, compared to $6,618,000 in the previous year[23] - As of March 31, 2019, the company had available cash, cash equivalents, and short-term investments of approximately $144.2 million[111] - Net cash used in operating activities was $13.1 million for the three months ended March 31, 2019, primarily due to the net loss and a decrease in net operating assets[146] Debt and Financing - The company has a term loan agreement with Silicon Valley Bank for up to $20.0 million, with $10.0 million currently outstanding from the first tranche[74] - The company has drawn $20.0 million in three tranches of term loans under the Loan Agreement with Silicon Valley Bank, maturing on December 1, 2021[150] - Outstanding principal balances under the Term Loan bear interest at the prime rate plus 1.75%, with monthly interest payments required through December 31, 2019[151] - The Loan Agreement contains covenants that limit the company's ability to engage in certain transactions, including paying cash dividends and incurring additional indebtedness[154] Inventory and Assets - As of March 31, 2019, the company had $0.6 million in finished goods inventory, $0.4 million in work-in-process inventory, and $4.1 million in raw materials inventory[51] - The company has capitalized inventory produced for commercial sale, with costs associated with developmental products charged to research and development expenses[46] - The company’s total property and equipment, net, was $2.887 million as of March 31, 2019, compared to $2.784 million as of December 31, 2018[66] Market and Product Development - The Company has obtained marketing approvals for the r-SNM System in Europe, Canada, and Australia for conditions including overactive bladder, urinary retention, and fecal incontinence[25] - The proprietary rechargeable SNM system is designed to be 60% smaller than existing technology and has a lifespan of approximately 15 years[99] - The global SNM market was estimated at $650 million in 2018, with the Company aiming to disrupt this market[99] - The company plans to continue making investments in research and development for its next-generation r-SNM System and support future regulatory submissions[106] Employment and Sales Strategy - The company plans to hire approximately 100 sales professionals, regional sales managers, and clinical support specialists in anticipation of the commercial launch of its r-SNM System in the United States[105] - The company expects to generate revenue from product sales if its r-SNM System is approved in the United States, with a focus on increasing patient and physician awareness[105] Legal and Compliance - The company is currently not a party to any legal proceedings that would have a material adverse effect on its results of operations or financial position[165] - There were no changes in internal control over financial reporting during the three months ended March 31, 2019, that materially affected the internal control[163]