Financial Health and Obligations - The company has accumulated a net loss of $67.2 million from January 5, 2007, through December 31, 2024, raising doubts about its ability to continue as a going concern [109]. - The company is required to make additional annual payments of approximately $2.5 million for a total of $7.5 million through 2026 following the acquisition of Wisconsin Fertility Institute [118]. - The company has incurred substantial indebtedness, including secured obligations, which may affect its ability to service its debt in the future [110]. - The company does not expect its current cash position to be sufficient to fund operations and service debt obligations for the next 12 months [111]. - The company may need to raise additional funding, which may not be available on acceptable terms, potentially forcing it to limit or terminate operations [113]. - The capital markets have been unpredictable for unprofitable companies, making it difficult for the company to secure financing on attractive terms [114]. Regulatory and Compliance Risks - The company is subject to significant domestic and international governmental regulations that could adversely affect its business operations [124]. - The company is subject to risks associated with healthcare fraud, waste, and abuse laws, which could impact its financial results and operations [126]. - The company is subject to HIPAA regulations, and failure to comply could materially harm its business, including penalties for breaches of protected health information [132]. - Compliance with FDA regulations is critical, as failure to obtain necessary clearances could delay product commercialization and impact revenue [162][164]. - The EU's new MDR regulations may increase costs and complexity in obtaining necessary approvals for medical devices, affecting market entry timelines [173][174]. - Regulatory compliance is critical, as failure to maintain it could result in sanctions, including refusal to approve new drug applications [281]. Market and Competitive Landscape - Economic downturns could negatively affect the company's sales and profitability, particularly in the fertility treatment market [145]. - The fertility business faces significant competition, with new ART services potentially rendering existing technologies obsolete, impacting market share and growth rates [152]. - The company may experience challenges due to consolidation among healthcare facilities, potentially limiting its market access [141]. - The company faces significant competition from larger pharmaceutical and biotechnology companies, which may have more resources and experience in clinical trials and regulatory approvals [236][239]. Operational Challenges - The company may face challenges in integrating and managing the operations of Wisconsin Fertility Institute, which could impact expected benefits from the acquisition [116]. - The company relies on key personnel, and the loss of executive management could adversely affect its operations and revenues [135]. - The company requires additional qualified personnel to expand its fertility business, which may be challenging to attract and retain [161]. - The management team has limited experience in managing fertility clinics, which could affect operational success [156]. - The company faces risks related to cybersecurity breaches, which could disrupt operations and lead to financial and reputational damage [148]. Product Development and Clinical Trials - The acquisition of NAYA Therapeutics presents risks due to its limited operating history and lack of approved products for commercial sale [115]. - The success of the company's therapeutics business relies on the timely completion of clinical trials and obtaining regulatory approvals, which are uncertain [184]. - The regulatory approval process for the company's product candidates is complex and may result in delays or unexpected costs, impacting the ability to generate revenue [182]. - Clinical trials are lengthy and expensive, with uncertain outcomes that may delay or prevent marketing approval [215]. - The company anticipates seeking initial regulatory approvals in the United States and the European Union, but has not yet obtained any approvals for its product candidates [185]. - The company may not be able to manufacture its product candidates in sufficient quantities or quality, impacting clinical trial outcomes [227]. Intellectual Property and Strategic Partnerships - The company relies on a combination of patents, trade secret protection, and confidentiality agreements to protect its proprietary technologies and product candidates [294]. - The patent prosecution process is expensive and time-consuming, and the company may not be able to file all necessary patent applications at a reasonable cost [296]. - The company is party to several intellectual property license agreements, which impose various obligations, including milestone payments and royalties [301]. - NAYA Therapeutics depends on intellectual property licensed from third parties, and failure to comply with license agreements could result in significant rights loss [306]. - The company has the right to bring actions against third parties for infringing on the patents it has exclusively licensed, subject to specified conditions [307].
INVO BioScience(INVO) - 2024 Q4 - Annual Report