Financial Performance and Capital Resources - The company incurred losses of €14.0 million, €17.8 million, and €17.1 million ($20.9 million) for the years ended December 31, 2018, 2019, and 2020 respectively[83]. - As of December 31, 2020, the company had capital resources of €18.7 million ($22.9 million) and received approximately €13.49 million ($16.35 million) in net proceeds from its U.S. initial public offering[86]. - The company anticipates that losses will continue to increase as it develops drug candidates and conducts clinical trials[83]. - The company expects existing capital resources will be sufficient to fund planned operating expenses for the next 12 months, but may need to seek additional funds sooner due to various factors[87]. - Future capital requirements will depend on the scope and costs of research and development, regulatory approvals, and commercialization activities[88]. - The company has a history of losses and requires substantial additional financing to achieve its goals[84]. Regulatory and Clinical Development Risks - The ongoing COVID-19 pandemic has adversely affected the company's operations and may impact future clinical trials and supply chain[75]. - The company is in the early stages of development and faces risks related to obtaining regulatory approval for drug candidates[36]. - The company relies on third parties for raw materials and conducting preclinical studies and clinical trials, which poses additional risks[41]. - The company has incurred significant expenses related to preclinical and clinical programs, impacting its financial condition[83]. - The company has no products approved for sale, with its lead drug candidate Sarconeos (BIO101) in clinical development and Macuneos (BIO201) in preclinical phase[111]. - The company may face challenges in meeting the expectations of analysts or investors, which could lead to a decline in stock price[100]. - The company faces significant delays in obtaining regulatory approvals for its drug candidates due to various factors, including the impact of COVID-19 on clinical trials and regulatory processes[114]. - The company is experiencing challenges in recruiting and retaining principal investigators and site staff for clinical trials, which may adversely affect clinical trial operations[113]. - The FDA and EMA may delay, limit, or deny approval of drug candidates for reasons such as safety and efficacy concerns, disagreements on trial protocols, or insufficient data from modified studies[119]. - The company may incur unplanned costs and delays in obtaining marketing approval if additional clinical trials or testing are required beyond current plans[129]. - The ongoing COVID-19 pandemic has led to limitations in clinical trial operations, including patient enrollment and data collection, which could impact the acceptability of data for regulatory review[128]. - The company is subject to extensive regulations by the FDA, EMA, and other foreign authorities, which differ by country and can significantly affect the ability to market investigational drug candidates[116]. - The company may face challenges in demonstrating that the clinical benefits of drug candidates outweigh any safety risks, which is critical for regulatory approval[119]. - The potential for approval policies or regulations to change significantly could render the company's clinical data insufficient for approval[119]. - The company is at risk of delays in clinical trials due to factors such as disagreements with regulatory authorities, recruitment challenges, and compliance with trial protocols[125]. - The company acknowledges that success in preclinical studies does not guarantee success in later-phase clinical trials, highlighting the uncertainty in drug development[123]. - Patient enrollment in clinical trials may face delays due to various factors, including eligibility criteria and proximity to trial sites, potentially impacting trial completion and costs[136]. - Competition for patient enrollment from other clinical trials in the same therapeutic areas may reduce the number and types of patients available for the company's trials[137]. - Undesirable side effects from drug candidates could lead to regulatory delays or prevent approval, affecting the commercial profile of the products[139]. Supply Chain and Manufacturing Risks - The company relies on a single supplier for the plant material required for Sarconeos (BIO101) and Macuneos (BIO201), which poses risks to production and regulatory approval if supply is disrupted[154][156]. - The contract manufacturing partner, Patheon, is critical for compliance with regulatory requirements, and any issues with their facilities could significantly impact the company's ability to develop and market drug candidates[158]. - The company has not entered into long-term supply agreements with its suppliers, which could affect the ability to secure necessary materials for clinical trials and commercial production[152][157]. - Regulatory authorities may impose additional restrictions or require risk evaluation strategies if undesirable side effects are identified post-approval, impacting market acceptance and revenue[145][146]. - The commercial success of drug candidates will depend on physician and patient adoption, influenced by factors such as safety, efficacy, and reimbursement availability[148][149]. - The company is evaluating alternative methods for producing key ingredients to optimize the supply chain and support projected commercial needs[154][156]. - Any disruption in third-party manufacturing or supply chains could materially impact the company's ability to progress preclinical and clinical programs[159]. - The company relies on third-party manufacturers for drug candidate production, which may require significant capacity increases and regulatory approvals[160]. Human Resources and Organizational Challenges - The company currently has 25 full-time employees, with 20 engaged in research and development activities[184]. - The company lacks a marketing or sales organization, which is critical for the commercialization of drug candidates[182]. - There are significant risks associated with building a sales organization, including hiring and retaining qualified personnel[182]. - The company may need to collaborate with third parties for sales and distribution, which could impact commercialization success[182]. - The company faces intense competition for qualified personnel in the biotechnology and pharmaceuticals field[187]. Legal and Compliance Risks - Product liability lawsuits could result in substantial liabilities and limit commercialization efforts[188]. - The company currently carries product liability insurance for clinical trials, but coverage may not be sufficient for future claims[192]. - Significant disruptions in information technology systems could adversely affect business operations and financial condition[198]. - The company must comply with GDPR regulations regarding data protection and breach notifications, which involve substantial costs[202]. - Misconduct by employees or contractors could adversely affect the company's results of operations[207]. - The company faces risks related to employee misconduct and regulatory compliance, which could lead to significant penalties and reputational harm[208]. - Compliance with environmental laws and regulations is costly and may restrict the company's business operations[209]. - The company is subject to numerous environmental, health, and safety laws, which could impact its research and development efforts[210]. - The company cannot eliminate the risk of contamination from hazardous materials, which could disrupt operations and lead to costly liabilities[211]. - The company may be held liable for contamination costs at its facilities, which could exceed its resources[211]. - The company does not carry specific biological or hazardous waste insurance, increasing its financial risk in case of contamination[213]. Intellectual Property Risks - The company's ability to protect its proprietary rights is uncertain, impacting its competitive position in the market[214]. - Legal actions to enforce intellectual property rights can be expensive and may divert management resources[219]. - The patent positions of biotechnology companies are complex and uncertain, which could negatively affect the company's patent rights[221]. - Ongoing patent opposition proceedings could lead to the cancellation of key patents, impacting the company's competitive edge[221].
Biophytis(BPTS) - 2020 Q4 - Annual Report