AXDX Accelerate Diagnostics, Inc.

Risks

• We have limited revenues from our products and no assurance of future revenues.
• Until we received FDA approval to market the Accelerate Pheno system, we were a development-stage company and therefore incurred significant losses in prior years. While we are in the early years of commercializing the Accelerate Pheno system, we may continue to incur losses. We cannot be certain that we will achieve or sustain profitability.
• Our future profitability and continued existence are dependent in large part upon the successful commercialization of the Accelerate Pheno system and further development and commercialization of associated test kits and complimentary products.
• If we are not successful in the development of product improvements and additional test kits and commercialization of the Accelerate Pheno system, such failure could lead to impairment of certain of our intellectual property and may result in our ceasing operations.
• We have limited experience in marketing and selling the Accelerate Pheno system.
• Our future product candidates have not obtained marketing authorization from the FDA, and they may never obtain such marketing authorization or other regulatory clearance.
• If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline.
• We may not be able to enhance the capabilities of our current and new products to keep pace with our industry’s rapidly changing technology and customer requirements.
• We are developing additional uses for the Accelerate Pheno system. Any failure or delay in launching new applications may compromise our ability to achieve our growth objectives.
• The failure of the Accelerate Pheno system or any future diagnostic products to perform as expected could significantly impair our reputation and the public image of our products, and we may be subject to legal claims arising from any defects or errors.
• If treatment guidelines for bacterial infections change, or the standard of care evolves, we may need to redesign and seek new marketing authorization from the FDA for our product candidates.
• We may not be able to correctly estimate or control our future operating expenses, which could lead to cash shortfalls.
• Breaches of our information technology systems could have a material adverse effect on our operations and potentially result in liability, depending on the type of breach and information compromised.
• Failure to comply with a variety of U.S. and international privacy laws to which we are subject could harm the Company.
• We are dependent on our key employees. If we are unable to recruit, train and retain qualified personnel, we may not achieve our goals.
• Our industry is highly competitive, and we may not be successful in competing with our competitors. We currently face competition from new and established competitors and expect to face competition from others in the future, including those with new products, technologies or techniques.
• We generate a portion of our future revenue internationally and are subject to various risks relating to our international activities which could adversely affect our operating results.
• Our employees, independent contractors, principal investigators, consultants, commercial partners, vendors and other agents may engage in misconduct or other improper activities, including non-compliance with legal standards and requirements.
• We may be unable to successfully manage our growth.
• We may in the future be subject to shareholder lawsuits, including purported class actions, which is expensive and could divert the attention of management away from our business. In addition, any adverse result of such litigation could negatively impact our financial condition or results of operations.
• Current macroeconomic conditions and the uncertain economic outlook may remain challenging for the foreseeable future.
• Compliance with public company corporate governance and reporting is complex and expensive.
• Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at similar rates, if at all.
• Changes in, interpretations of, or enforcement trends related to tax rules and regulations may adversely affect our effective income tax rates or operating margins and we may be required to pay additional tax assessments.
• We are exposed to risks associated with long-lived assets that may become impaired and result in an impairment charge.
• We may not be successful in our currently pending or future patent applications, and even if such applications are successful, we cannot guarantee that the resulting patents will sufficiently protect our products and proprietary technology.
• We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive and time consuming.
• We could face claims that our proprietary technologies infringe on the intellectual property rights of others.
• We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
• We have a single research and development facility and we may be unable to continue to conduct our research and development activities if we lose this facility. If our facility or our equipment were damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business could be materially harmed.
• We use hazardous materials in some of our research, development and manufacturing processes and face the accompanying risks and regulations governing environmental safety.
• Disruptions in the supply of raw materials, consumable goods or other key product components, or issues associated with their quality from our single source suppliers, could result in a significant disruption in sales and profitability.
• We have made and intend to make significant additional investments in research and development, but there is no guarantee that any of these investments will ultimately result in a commercial product that will generate revenues.
• Legislative and Administrative Action May Have an Adverse Effect on Our Company
• We and our suppliers, contract manufacturers and customers are subject to various governmental laws and regulations, and we may incur significant expenses to comply with, and experience delays in our product commercialization as a result of, these laws and regulations.
• Maintaining adequate sales of our product may depend on the availability of adequate reimbursement to our customers from third-party payers, including government programs such as Medicare and Medicaid, private insurance plans, and managed care programs.
• We may be adversely affected by healthcare policy changes, including additional healthcare reform and changes in managed healthcare.
• The regulatory processes applicable to our products and operations are expensive, time-consuming, and uncertain and may prevent us from obtaining required approvals for the commercialization of our products.
• Modifications to our products, if cleared or approved, may require new 510(k) clearances or pre-market approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.
• We rely on third parties to conduct studies of our products that may be required by the FDA or other regulatory authorities, and those third parties may not perform satisfactorily.
• A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products that leads to corrective actions, could have a significant adverse impact on us.
• Our stock price has been volatile and may continue to be volatile and traded on low volumes.
• The short interest in our common stock is high, which may lead to further volatility in our stock price.
• The ownership of our common stock is highly concentrated.
• Future sales of shares of our common stock may depress the price of our shares and be dilutive to our existing stockholders.
• We may require additional capital in the future, and you may incur dilution to your stock holdings.
• Negative reports issued by securities analysts, and the election by securities analysts not to cover us, may have a negative impact on the market price of our common stock.
• We do not anticipate paying any cash dividends on our capital stock in the foreseeable future.
• Provisions in our certificate of incorporation and bylaws and Delaware law may delay or prevent acquisition of our Company, which could adversely affect the value of our common stock.
• We have indebtedness in the form of convertible senior notes.
• Servicing our debt will require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our debt.
• To the extent we choose to deliver shares upon conversion of the Notes, the ownership interests of existing stockholders will be diluted and our stock price may be adversely impacted.
• The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and operating results.
• The accounting method for convertible debt securities that may be settled in cash, such as the Notes, could have a material effect on our reported financial results.
• The prepaid forward we entered into in connection with the Notes offering may affect the value of our common stock and may result in unexpected market activity in our common stock.
• We are subject to counterparty risk with respect to the prepaid forward. We will be subject to the risk that the forward counterparty might default under the prepaid forward.