Assertio (US:ASRT)2023-03-07 16:00Financial Reporting and Estimates - The preparation of financial statements requires management to make estimates and assumptions that could lead to material differences in actual results [180]. Drug Development Risks - The development of drug candidates is inherently difficult and uncertain, with significant risks of delays and failures in clinical trials [182]. - Regulatory approval processes are expensive and time-consuming, and delays could impair the ability to commercialize future products [189]. - The company relies on third-party organizations for clinical trials, which may affect the timing and success of obtaining regulatory approvals [185]. - Any significant delays in the governmental approval process could adversely impact the company's financial condition and results of operations [184]. - The company may need to perform additional clinical studies to support changes from approved products, which could further delay commercialization [191]. - The entry of generic competitors could significantly affect the market success of the company's products [193]. Market and Stock Performance - The trading price of the company's common stock has historically been volatile, influenced by various external factors [191]. - The company is currently in compliance with the Nasdaq's Bid Price Rule, which requires a minimum bid price of at least $1.00 per share [198]. - A failure to comply with the Bid Price Rule in the future could lead to delisting from the Nasdaq Capital Market, adversely affecting market liquidity and stock price [199]. - The company has previously required a grace period and implemented a one-for-four reverse stock split to maintain compliance with Nasdaq listing standards [198]. - The company is classified as a "smaller reporting company," which allows it to take advantage of reduced disclosure requirements, potentially making its stock less attractive to investors [200]. Corporate Governance and Shareholder Relations - The company may face significant costs and management distractions from potential proxy contests initiated by activist shareholders [201]. - The company is subject to risks related to unsolicited takeover attempts, which could disrupt business operations and financial results [202]. - The company may encounter difficulties in obtaining shareholder approval for significant corporate actions due to its retail investor base [199]. Legal and Financial Obligations - Legal and regulatory developments, including litigation and investigations, could impact the company's operations and financial performance [195]. - The company must generate sufficient cash flow to fund operations and meet its debt obligations [195]. - Variations in revenues from commercialization agreements and other contract revenues could affect financial metrics and projections [195].