Technology and Innovation - SteraMist utilizes a patented Binary Ionization Technology (BIT) to deliver a 7.8% hydrogen peroxide-based fog, achieving a 6-log (99.9999%) kill rate of pathogens[16][17][18]. - The technology has been registered with the EPA since June 2015 and is the first EPA Registered Solution + Equipment combination for hospital-healthcare disinfection[26][27]. - The company has achieved a 99.9999% kill rate on all challenged pathogens with its SteraMist iHP technology, surpassing many competitors that offer only 99.9% to 99.99% efficacy[71]. - The SteraMist Integrated System (SIS) lineup provides versatile options for integrated enclosure decontamination, with SIS-SA stocked in inventory and SIS-Pharm made-to-order[98]. - The SteraMist Hybrid system integrates CES's stainless-steel applicators with the ENV generator, designed for precise fogging control and compliance with industry standards[96]. - The SteraMist equipment is designed to be user-friendly, requiring no preconditioning of spaces before treatment, which streamlines the disinfection process[76]. - The SteraMist Transport unit can treat a variety of vehicle sizes with an application time of only 20 minutes per 1,000 cubic feet, currently in a soft launch phase[86]. - The NV+ solution, designed for smaller areas, features a 36-minute injection time for spaces up to 1,800 cubic feet and is set to debut in April 2024[87]. Market Opportunities and Growth - The life sciences sector is experiencing growth due to global demographic trends and regulatory requirements, with increasing demand for automated decontamination solutions[31][42]. - The global pharmaceutical market is projected to grow steadily, with emerging markets driving demand for consistent and fast decontamination solutions[42][43]. - The food safety sector presents significant growth opportunities, with TOMI's technology demonstrating effectiveness in sanitizing the food supply[50][51]. - Compliance with food safety regulations is critical for businesses to protect public health and maintain consumer trust, with strict sanitation standards enforced by regulatory agencies[52]. - TOMI aims to penetrate the healthcare market by forming strategic partnerships and promoting the integration of SteraMist as a solution to manual cleaning practices[48]. - The company is expanding its presence in the food safety market, engaging with various industries including coffee, desserts, and agribusinesses to integrate iHP SteraMist into their sanitization protocols[214]. Financial Performance - The company generated a net loss of approximately $4.5 million and $3.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $54.3 million as of December 31, 2024[124]. - The company reported a net loss of approximately $4.477 million for the year ended December 31, 2024, compared to a net loss of $3.403 million for 2023, raising concerns about its ability to continue as a going concern[130]. - Cash used in operations was approximately $1.44 million in 2024, down from $3.599 million in 2023, highlighting a potential improvement in operational efficiency[130]. - The company has an accumulated deficit of $54.3 million as of December 31, 2024, which poses a significant financial challenge[130]. - Research and development expenses for the years ended December 31, 2024 and 2023, were approximately $291,000 and $492,000, respectively, indicating a decrease in investment[117]. Strategic Partnerships and Collaborations - The company secured significant agreements and new partnerships to enhance the distribution of the SteraMist brand globally[201]. - In 2024, the company contracted with six different partners across regions including Malaysia, India, Canada, Korea, and the United Kingdom[202]. - The partnerships span focused industries such as pharmaceuticals, vivarium, emergency services, and general disinfection and cleaning[202]. - A strategic partnership with EMAQ was formed in Q2 2024, with EMAQ investing over $1,000,000 in SteraMist iHP equipment to enhance market presence in the western United States[204]. - The partnership with PBSC and other OEMs aims to enhance turnkey solutions and create additional revenue streams for the company[211]. Challenges and Risks - The company does not have long-term customer contracts, making future revenue uncertain and exposing it to competitive price pressures[127]. - The BIT technology for Hospital-Healthcare disinfection has not yet achieved broad market acceptance, which could delay sales growth[129]. - The company relies on third-party manufacturers for its SteraMist® products, increasing risks related to supply chain disruptions and compliance with regulatory requirements[139]. - The company faces various international business risks, including currency fluctuations and compliance with export control laws, which could adversely affect its operations[131]. - The decontamination and environmental infectious disease control industry is highly competitive, with significant competitors having greater resources and established products[151]. - The company faces risks related to product liability claims, which could adversely affect its financial condition and operations[161]. Operational Developments - The company is committed to expanding its marketing and educational campaigns to drive adoption of the SteraMist iHP product line across various industries[58]. - The company is focused on ongoing projects and validations for its Custom Engineered System (CES), which involves longer lead times for installation and commissioning[90]. - The company is actively pursuing options to raise capital, including issuing convertible notes, but there is no assurance of success in these efforts[130]. - The company is in the process of developing remediation plans to address identified material weaknesses in internal controls over financial reporting[169]. - The company has hired additional sales personnel, but their productivity levels are yet to be realized, which may impact revenue growth[126]. Future Outlook - In 2024, the company anticipates a positive material impact from installations of CES permanent decontamination rooms, expecting increased utilization of BIT Solution to contribute to overall growth[91]. - The company plans to continue investing in research and development, focusing on new sanitizing robotic devices and backpack units[154]. - The company aims to be a global leader in disinfection and decontamination products, continuing to expand research and development and forming strategic business alliances[114]. - The company is expanding operations internationally, facing challenges in enforcing intellectual property rights in foreign jurisdictions[149]. - The company is committed to onboarding additional service providers to support the SteraMist iHP disinfection technology across various industries[205].
TOMI Environmental Solutions(TOMZ) - 2024 Q4 - Annual Report