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Tandem Diabetes Care(TNDM) - 2023 Q4 - Annual Report

Financial Performance - The company reported significant operating losses since inception, raising concerns about achieving sustained profitability[17] - The company has incurred significant operating losses since inception and cannot assure sustained profitability[17] - The company has incurred a significant amount of indebtedness, which may restrict financial flexibility and operational capabilities[25] - The company's operating results may fluctuate significantly from quarter to quarter[21] - The price of the company's common stock may continue to fluctuate significantly, impacting investor confidence[25] Revenue Dependence - A substantial portion of revenue is generated from insulin pump products, making the company vulnerable to factors negatively impacting these sales[17] - A significant portion of revenue relies on insulin pump product sales, and any negative factors affecting these sales may adversely impact financial results[17] - Retaining a high percentage of the customer base is crucial for maintaining and growing revenue[17] Competition and Market Risks - The company faces competition from alternative products and technologies that could render its offerings less desirable[17] - Competing products and technological developments may render the company's products obsolete or less desirable[17] Supply Chain and Operational Risks - The company relies on independent distributors for sales and marketing, which poses risks if the network cannot be maintained or expanded[17] - The company is dependent on a limited number of third-party suppliers, and any disruption could harm operations[21] - The company depends on a limited number of third-party suppliers for certain components, and loss of these suppliers could harm business operations[21] Regulatory and Compliance Risks - Regulatory compliance is critical, as failure to meet requirements could significantly impact business operations[25] - Compliance with extensive governmental regulations is critical, as failure to do so could negatively impact the business[25] Financial Needs and Market Exposure - Future financing needs may arise, and failure to secure additional funds could hinder strategic objectives[21] - The company operates in a global market, making it susceptible to fluctuations in foreign currency exchange rates[21]