Tivic Health Systems(TIVC) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue net of returns totaled $0.8 million compared to $1.2 million a year ago, a decline primarily due to a 41% decrease in unit sales associated with reductions in overall marketing spend [59] - Cost of sales decreased 12% to $0.8 million from $0.9 million in the prior year, with an inventory reserve of $354,000 in 2024 compared to $32,000 in 2023 [60] - Net loss for the year decreased to $5.7 million from $8.2 million for 2023 [63] - Cash and cash equivalents at December 31, 2024, totaled $2 million compared with $3.4 million at December 31, 2023 [64] Business Line Data and Key Metrics Changes - Gross profit was $2,000 compared with $287,000 for the prior year, primarily due to the inventory reserves recorded in 2024 [62] - Total operating expenses were $5.7 million compared to $8.5 million for 2023, with plans to increase research and development investments in the Vagus nerve platform and clinical applications [63] Company Strategy and Development Direction - The company has acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate, Intellimod, which is positioned to fill a critical gap in treatments for acute radiation syndrome [7][15] - The strategic transformation aims to build a biopharmaceutical capacity within the company, combining biologic and bioelectronic medicine to focus on immune dysrhythmias [9][11] - The company is developing a noninvasive cervical stimulation device for vagus nerve activation, targeting conditions caused by overactive immune systems [36][40] Management's Comments on Operating Environment and Future Outlook - Management views 2025 as a year of growth and progress, focusing on achieving key milestones associated with Intellimod commercialization and advancing VNS programs [68] - The company has reshaped itself into a diversified therapeutics organization, moving from a single product company to a robust immunotherapy pipeline [56][57] Other Important Information - The company received approval for a compliance plan from NASDAQ and traded above a dollar for ten consecutive days, expecting to be in compliance with continued listing requirements [54] - An equity line of credit in the amount of $25 million has been closed, providing flexible funding for development stages [55] Q&A Session Summary Question: What are the key milestones for Intellimod commercialization? - Management highlighted the importance of moving into manufacturing validation and filing a biologics license application with the FDA, with potential marketing opportunities within about two years [27][28] Question: How does the company plan to address the decline in revenue? - The company is exploring new opportunities to increase cash flow generated by the ClearUp business and has deployed a new e-commerce web infrastructure to improve user experience [61][62]