TELA Bio(US:TELA)2021-03-25 20:03Financial Performance and Risks - The company has incurred significant operating losses since inception and expects to continue incurring losses in the future[17] - Revenue is highly dependent on the commercial success of the OviTex product line, which has generated substantially all of the company's revenue to date[17] - The company may require substantial additional capital to finance planned operations, which may not be available on acceptable terms[17] - The COVID-19 pandemic has negatively impacted certain aspects of the business, potentially leading to material adverse effects on operations and financial condition[16] - The trading price of the company's common stock has been and could continue to be highly volatile, reflecting market uncertainties[22] Manufacturing and Supply Chain Risks - The company relies on Aroa as the exclusive manufacturer and supplier of its products, which poses risks related to production capacity and quality[17] Market Acceptance and Regulatory Challenges - The commercial success of the company's products will largely depend on achieving significant market acceptance[17] - The company faces risks related to achieving and maintaining adequate levels of coverage or reimbursement for its products, which could hinder commercial success[17] - Regulatory developments may delay or prevent the necessary approvals for future products, impacting the company's growth[22] - The company has limited data regarding the safety and efficacy of its products, which may affect future clinical trial results[22] Company Classification and Accounting Standards - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of certain reporting exemptions[537] - The company has elected to opt out of the extended transition period for complying with new or revised accounting standards[537] - This election is irrevocable, meaning the company will not be subject to the same accounting standards as other public companies[537]