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New words:
administered, aimed, appointed, appointment, arose, Buch, budget, caption, caution, cessation, chapter, clarify, compromise, Cynthia, debtor, deferral, delisted, describeid, DIP, disorderly, Docket, earliest, ELGXQ, erosion, executory, fashion, frame, impossible, incorrect, Joint, jointly, lack, mitigating, modification, morale, Northern, OTC, pendency, petition, Pink, Pinto, pursuit, quantify, quoted, recovery, rejection, remitted, resell, retail, SBA, strength, subscriber, symbol, urge, variance, viability, viable, vii
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accrual, command, couple, declaration, decreasing, discontinue, exchanged, foreclosure, formulating, functional, funding, insolvent, intercompany, Mahboob, meaningfully, preexisting, proceed, proposal, purpose, rationalizing, refinanced, remeasured, reserved, scheduled, Servicing, Simultaneously, streamlining, unrealized, Vaseem
Financial report summary
?Risks
- All of our revenue is generated from a limited number of products, and any decline in the sales of these products, including as a result of negative perceptions regarding our financial stability, or any material departure in expected revenues from our products as against forecasts, will negatively impact our business.
- If we fail to develop and retain our direct sales force, our business could suffer.
- We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are better able to develop and market products that are safer, more effective, less costly, easier to use, or otherwise more attractive than the products that we may develop, our business will be adversely impacted.
- If third party payors do not provide reimbursement for the use of our products, our revenue may be negatively impacted.
- We are currently engaging in certain operational restructuring efforts which we may be unsuccessful in executing and, even if successful, may lead to undesirable outcomes.
- Our success depends on the growth in the number of AAA patients treated with endovascular devices and the general support for EVAR and EVAS technologies in the medical community.
- Our success depends on convincing physicians to use, and continue to use, our products in more endovascular AAA procedures and to assist us in development of new products.
- If we or our third party suppliers fail to comply with extensive FDA regulations relating to the manufacturing of our products or any component part, or otherwise encounter manufacturing problems, this could harm our reputation, we may be subject to fines, injunctions and penalties, and our ability to commercially distribute and sell our products may be harmed.
- Our international operations involve operating risks, which could adversely impact our net sales, results of operations and financial condition.
- Our international operations expose us and our distributors to risks inherent in operating in foreign jurisdictions.
- We depend on our officers and other skilled personnel to operate our business effectively. If we are not able to retain our current employees or recruit additional qualified personnel, our business will suffer and our future revenue and profitability will be impaired.
- If we are unable to provide meaningful equity incentives to our key employees, it could adversely affect our ability to retain these key employees, which in turn could affect our ability to implement our business strategies.
- The actions and omissions of our third party distributors may subject us to revenue, compliance and other risk.
- If clinical trials of our current or future products do not produce the results necessary to support regulatory clearance or approval in the United States or elsewhere, we will be unable to commercialize these products.
- We depend on a significant number of third party suppliers, including single sourced suppliers that supply numerous components for our product lines, and any disruption in the supply of such materials could impair our ability to manufacture our products or meet customer demand for our products in a timely and cost effective manner.
- If we are unable to protect our intellectual property, our business may be negatively affected.
- The medical device industry is subject to extensive patent litigation, and if our products or processes infringe upon the intellectual property of third parties, or if we are involved in a claim that our products or processes infringe upon the intellectual property of third parties, the sale of our products may be challenged and we may have to defend costly and time-consuming legal proceedings.
- We may face product liability claims that could result in costly litigation and significant liabilities.
- We are currently involved in litigation, and may face future claims, that could adversely affect our business and financial condition, divert management’s attention from our business, and subject us to significant liabilities.
- If our facilities or systems are damaged or destroyed, we may experience delays that could negatively impact our revenue or have other adverse effects.
- Any failure to maintain the security of our information technology systems, or the loss, theft, misuse, or unauthorized disclosure of confidential or sensitive information, could interrupt our business processes or systems, damage our relationships with customers, suppliers or employees, and expose us to litigation or regulatory proceedings, any of which could materially adversely affect our business, financial condition or results of operations.
- We may never realize the expected benefits of our business combination transactions.
- We are subject to credit risk from our accounts receivable related to our product sales, which include sales within countries that are currently experiencing economic turmoil.
- Consolidation in the healthcare industry could have an adverse effect on our revenue and results of operations.
- We have a history of operating losses and may be required to obtain additional funds to pursue our business strategy.
- Changes in the credit environment and covenant restrictions under our financing arrangements may adversely affect our business and financial condition.
- Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our debt.
- We have limited resources to invest in research and development and to grow our business and may need to raise additional funds in the future for these activities.
- The expense and potential unavailability of insurance coverage for our company may have an adverse effect on our financial position and results of operations.
- Healthcare policy changes, including recent federal legislation to reform the United States healthcare system, may have a material adverse effect on us.
- Our future success depends on our ability to develop, receive regulatory clearance or approval for, and introduce new products or product enhancements that will be accepted by the market in a timely manner.
- Our business is subject to extensive governmental regulation that makes it expensive and time consuming for us to introduce new or improved products.
- The potential off-label promotion and subsequent off-label use of our products may harm our reputation in the marketplace and result in government investigations and/or penalties.
- We are required to comply with MDR requirements and must report certain malfunctions, deaths, and serious injuries associated with our products to regulatory agencies, which can result in voluntary corrective actions or agency enforcement actions.
- We are subject to federal, state and foreign healthcare fraud and abuse, transparency and other laws and regulations governing financial dealings with customers, physicians and payors, and a finding of failure to comply with such laws and regulations could have a material adverse effect on our business.
- We may be subject to privacy and security laws and regulations that protect personal health information and other types of personal information, and a finding of failure to comply with such laws and regulations could have a material adverse effect on our business
- We have certain contractual obligations pursuant to which we may be obligated to issue a significant number of additional shares of our common stock, which would result in a substantial amount of dilution to our existing stockholders.
- The price of our common stock has declined significantly and may continue to fluctuate in future periods.
- Trading in our stock over the past 24 months has been limited, which may increase the volatility of the trading price of our stock.
- Our operating results may fluctuate significantly from quarter to quarter.
- We may not achieve the projections set forth in our financial guidance, or certain other anticipated goals and objectives that we announce publicly from time to time, which could have a material adverse effect on our business and cause the market price of our shares to decline.
- Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent a change of control, even if an acquisition would be beneficial to our stockholders, which could reduce our stock price and prevent our stockholders from replacing or removing our current management.
- Our board of directors is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval.
- We may be at increased risk of securities class action litigation.
- If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud, which could cause investors to lose confidence in our reported financial information and have a negative impact on the trading price of our common stock.
- We do not intend to pay cash dividends.
- United States federal income tax reform could adversely affect us and our stockholders.
- If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline.
Management Discussion
- In December 2019, a novel strain of coronavirus, which causes COVID-19, was identified. Due to the rapid and global spread of the virus, on March 11, 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. To slow the proliferation of COVID-19, governments have implemented extraordinary measures, which include the mandatory closure of businesses, restrictions on travel and gatherings, and quarantine and physical distancing requirements. In addition, in March 2020, the U.S. Surgeon General and the American College of Surgeons issued guidance advising that elective surgical procedures be curtailed or deferred and hospitals in the U.S. and globally have, to varying degrees, suspended elective surgeries. While certain abdominal aortic aneurysm procedures treating larger-diameter or ruptured aneurysms are deemed essential and certain surgeries, like in cases of trauma, cannot be delayed, we are seeing a significant reduction in procedural volumes as hospital systems and/or patients elect to defer abdominal aortic aneurysm procedures with smaller-diameter, less-severe aneurysms. As a result of these measures, we have experienced substantial reductions in procedural volumes and anticipate this trend will continue during the pandemic. In addition, restrictions on the ability to travel as well as the temporary closures of our facilities and the facilities of our suppliers has adversely affected our business. Further, due to the travel restrictions and physical distancing requirements, the Company has been limited in its ability to train and educate surgeons on the Company’s surgical techniques and products, which may impact its ability to scale demand once healthcare services return to normal. These restrictions have also impacted the Company’s manufacturing capabilities and distribution and warehousing operations as it reduces capacity and implements policies to prioritize the health and safety of employees and contractors.