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] - Gross profit was $2,000 compared with$287,000 for the prior year, primarily due to $354,000 in inventory reserves recorded in 2024 compared to$32,000 in 2023 [62] - 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 - Cost of sales decreased 12% to $0.8 million from$0.9 million in the prior year, primarily due to a 41% decrease in unit sales [60] - 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 vagus nerve stimulation device to treat conditions related to overactive immune systems, aiming to replace surgical approaches with noninvasive methods [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 the Intellimod commercialization and advancing VNS programs [68] - The company has reshaped itself into a diversified therapeutics organization, with a robust immunotherapy pipeline and a focus on cost-effectiveness compared to traditional therapies [50][51] Other Important Information - The company received approval for a compliance plan from NASDAQ and has 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 [26][27] Question: How does the company plan to address the challenges of drug development? - The company emphasized the lower capital intensity of advancing the Intellimod program compared to developing a drug from scratch, leveraging prior investments and existing clinical data [24][52]