
Sales Performance - In 2024, syringes accounted for 68.5% of total sales, EasyPoint® products for 27.1%, and other products for 4.5%[105] - Domestic sales represented 88.9% of revenues in 2024, with a 15.1% decrease in domestic revenues primarily due to lower average selling prices and a 4.3% decrease in domestic unit sales[124] - International revenues decreased by 59.1% in 2024, largely due to fewer international vaccination-related sales, contributing to an overall revenue decline of 24.2%[124] Financial Performance - Gross profit margins fell from 20.9% in 2023 to (3.1)% in 2024, driven by decreased revenues and increased costs associated with tariffs and domestic production[127] - The loss from operations was $21.1 million in 2024, compared to a loss of $11.5 million in 2023, primarily due to lower gross profit[128] - The company held $40.3 million in debt and equity securities as of December 31, 2024, representing 25.1% of total assets[115] Operational Changes - The company plans to convert existing equipment to produce 0.5 mL syringes domestically, with commercial quantities expected in the second half of 2025[107] - The company expects to spend approximately $1 million to convert domestic equipment to increase production capacity, with completion targeted for the second quarter of 2025[139] - An estimated $3.8 million increase in annual compensation and benefits expense is anticipated due to hiring additional manufacturing personnel to mitigate tariff impacts[106] Customer Rebates and Estimates - As of December 31, 2024, the estimated total potential future credits to be issued for unclaimed prior purchases is $2.1 million[140] - The company relies on historical trends and assumptions for estimating customer rebates, including redemption rates and inventory turnover[140] - There is an inherent risk that the estimates and underlying assumptions may not reflect actual future results, potentially impacting future financial outcomes[140] - The company does not expect significant changes to the current inputs and assumptions used in rebate estimate calculations[140] - The establishment of a liability for future claims of rebates requires understanding of sales distribution channels and product categories[140] - The company examines historical results of estimates against actual results to refine future assumptions[140] - The estimates for customer rebates are based on past experience and expectations of economic factors[140] - The company has sufficient historical data to establish reserves for contractual obligations related to rebates[140] - Adjustments to reserves may have a material impact on future results if estimates or assumptions are incorrect[140] Market Risk - The disclosures about market risk are not applicable to smaller reporting companies[141] Tariff Expenses - Tariff expenses amounted to approximately $1.6 million from September to December 2024, with an additional $951,000 incurred from January 1 to March 21, 2025[106][126]