Bruker Cellular Analysis (CELL) Financial Report Summaries

Risks

• Risks related to our operating history, business and strategy
• Our success depends on the success of our Berkeley Lights Platform and market acceptance of functional cell biology. Our Berkeley Lights Platform and functional cell biology may not achieve or maintain significant commercial market acceptance.
• Historically, our revenue has been primarily generated from direct platform sales, largely driven by our Beacon, which requires a substantial sales cycle and is prone to quarterly fluctuations in revenue.
• It may be difficult for us to successfully implement our strategies for growth.
• We may not successfully implement our strategy to provide customers access to our platform and functional cell biology through alternative non-direct capital sales channels, including our subscription, partnering and services offerings.
• Our revenue under our customer sales engagements, program and service agreements and strategic partnerships and services for any particular period can be difficult to forecast.
• We may face risks in connection with past, existing and future collaborations with respect to the development, manufacture and commercialization of our products and workflows.
• If we cannot maintain our current relationships with customers, fail to sustain recurring sources of revenue with our existing customers, or if we fail to enter into new relationships, our future operating results would be adversely affected as a general matter.
• Our limited operating history make it difficult to evaluate our future prospects and the risks and challenges we may encounter.
• Our operating results have fluctuated significantly in the past and may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.
• Repair or replacement costs due to warranties we provide on our products and consumables could have a material adverse effect on our business, financial condition and results of operations.
• We generally recognize revenue from extended warranty and service contracts over the contract term, and changes in sales of such contracts may not be immediately reflected in our operating results.
• We must develop new products and workflows, adapt to rigid and significant technological change and respond to introductions of new products by competitors to remain competitive, but we may be unable to develop or commercialize products and workflows successfully or at all.
• The Berkeley Lights Platform is comprised of OptoSelect chips and reagent kits, advanced automation systems and advanced application and workflow software, which may contain undetected errors or defects and may not meet the expectations of our customers, which means our business, financial condition, results of operations and prospects could suffer.
• If we are unable to support demand for the Berkeley Lights Platform, and for our future product offerings, including ensuring that we have adequate capacity to meet increased demand, or if we are unable to successfully manage our anticipated growth, our business could suffer.
• Our future capital needs are uncertain and we may need to raise additional capital to fund our existing operations, improve our platform or develop and commercialize new products, workflows, consumables and reagent kits, or expand our operations.
• The sizes of the markets and forecasts of market growth for our Berkeley Lights Platform and other of our key performance indicators are based on a number of complex assumptions and estimates, and may be inaccurate.
• The life sciences technology market is highly competitive, and if we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue, or achieve and sustain profitability.
• We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.
• We depend on our information technology systems, and any material disruptions of these systems could harm our business.
• We have limited experience in marketing and sales, and if we are unable to expand our marketing and sales organization to adequately address our customers’ needs, our business may be adversely affected.
• We may acquire businesses or form joint ventures or make investments in other companies or technologies that could negatively affect our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
• The failure to complete our acquisition of IsoPlexis may adversely affect our business and our stock price.
• Our loan and security agreement contains covenants, which restrict our operating activities, and we may be required to repay the outstanding indebtedness in an event of default, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
• Our products could become subject to more onerous regulation by the FDA or other regulatory agencies in the future, which could increase our costs and delay or prevent commercialization of our products, thereby materially and adversely affecting our business, financial condition, results of operations and prospects.
• Due to the significant resources required to enable access in new markets, we must make strategic and operational decisions to prioritize certain markets, technology offerings or partnerships. We may expend our resources to access markets, develop technologies or form certain partnerships that do not yield meaningful revenue or we may fail to capitalize on markets, technologies or partnerships that may be more profitable or with a greater potential for success.
• If we were to be sued for product liability, we could face substantial liabilities that exceed our resources.
• If our Emeryville, California operating facility becomes damaged or inoperable or we are required to vacate our existing facility, our ability to conduct and pursue our research and development efforts may be jeopardized.
• Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
• Public health crises such as the current COVID-19 pandemic or similar infectious disease outbreaks have impacted and may continue to cause impacts in our business.
• Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
• We are currently subject to, and may in the future become subject to additional, U.S., state and foreign laws and regulations imposing obligations on how we collect, store and process personal information. Our actual or perceived failure to comply with such obligations could harm our business. Ensuring compliance with such laws could also impair our efforts to maintain and expand our customer base, and thereby decrease our revenue.
• International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
• We are subject to anti-bribery, anti-corruption, anti-money laundering, economic sanctions, and export control laws, and non-compliance with such laws could adversely affect our business, financial condition, and results of operations and prospects.
• We and our third-party manufacturing partners have limited experience in producing our systems and certain parts and components for our systems, and if we are unable to manufacture our systems in high-quality commercial quantities successfully and consistently to meet demand, our growth will be limited.
• Manufacturing delays related to quality control could negatively impact our ability to bring our systems to market, harm our reputation and decrease our revenue. Any defects, errors or recalls could be expensive and generate negative publicity, which could impair our ability to market our systems and further affect our results of operations.
• We use biological and hazardous materials that require considerable expertise and expense for handling, storage and disposal and may result in claims against us.
• Our manufacturing operations and those of our key third-party manufacturers are dependent upon third-party suppliers, including single-source suppliers, making us vulnerable to supply shortages and price fluctuations, which could harm our business.
• We forecast sales to determine requirements for components and materials used in our systems, and if our forecasts are incorrect, we may experience delays in shipments or increased inventory costs.
• Shipping is a critical part of our business and any changes in our shipping arrangements or damages or losses sustained during shipping could adversely affect our business, financial condition, results of operations and prospects.
• If we are unable to obtain and maintain sufficient intellectual property protection for our technology, including the Berkeley Lights Platform, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired.
• Claims by AbCellera and the University of British Columbia that we infringe their intellectual property rights may adversely affect our business, financial condition, results of operations and prospects.
• Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
• Issued patents covering our products could be found invalid or unenforceable if challenged.
• We rely on in-licenses from third parties. If we lose these rights, our business may be materially adversely affected, our ability to develop improvements to our existing systems, workflows, consumables and reagent kits and to develop new systems, workflows, consumables and reagent kits may be negatively and substantially impacted, and if disputes arise, we may be subjected to future litigation as well as the potential loss of or limitations on our ability to develop and commercialize products and technology covered by these license agreements.
• If we cannot acquire or license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.
• We may not be able to protect our intellectual property rights throughout the world.
• If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed.
• We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
• We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest thereby harming our competitive position.
• We may be subject to claims challenging the inventorship of our patents and other intellectual property.
• We are currently and in the future may be involved in litigation related to intellectual property, which could be time-intensive and costly and may adversely affect our business, financial condition, results of operations and prospects.
• Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
• We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.
• Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
• Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
• Our use of open-source software could compromise our ability to offer our services and subject us to possible litigation.
• The market price of our common stock has been volatile and may continue to fluctuate substantially, which could result in a substantial loss for purchasers of our common stock.
• Our directors, officers and principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders.
• Provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.
• Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
• Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be our stockholder’s sole source of gain.
• Tax legislative or regulatory initiatives, new interpretations or developments concerning existing tax laws, or challenges to our tax positions could adversely affect our results of operations and financial condition.
• Our actual operating results may differ significantly from any operating guidance we may provide.
• Securities analysts may not publish favorable research or reports about our business or may publish no information at all, which could cause our stock price or trading volume to decline.
• If we experience material weaknesses in the future or otherwise fail to implement and maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations which may adversely affect investor confidence in us and, as a result, the value of our common stock.
• We incur significant costs as a result of operating as a public company and our management is required to devote substantial time to the new compliance initiative.
• Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
• Misconduct, non-compliance with laws, regulations, contractual arrangements and internal policies and unauthorized actions taken purportedly on our behalf by our employees, consultants, distributors, agents and vendors or third-parties exposes us to risk.
• Disasters and other business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.