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• The COVID-19 pandemic has significantly affected our business operations.
−Removed: • Our financial results and revenue growth rates have varied significantly from quarter-to-quarter and year-to-year, and may not be consistent with market expectations.
+Added: • Our financial results and revenue growth rates have varied significantly from quarter-to-quarter and year-to-year, and may not be consistent with expectations.
• We have incurred losses since inception, and we may continue to incur substantial losses for the foreseeable future.
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• Disruption of our manufacturing facilities or other operations, or in the operations of our customers or business partners, could result in cancellation of orders, delays in deliveries or other business activities, or loss of customers.
−Removed: • Any disruption or delay in the shipping or off-loading of our products may have an adverse effect on our financial condition and results of operations.
• We rely on single and sole source suppliers for some of the components and materials used in our products.
+Added: • Any disruption or delay in the shipping or off-loading of our products may have an adverse effect on our financial condition and results of operations.
+Added: • We may not be able to convert our orders in backlog into revenue.
• Our business operations depend upon the continuing efforts of our management team and other key employees.
−Removed: • Security breaches, loss of data, cyberattacks, and other IT failures could adversely affect our business.
−Removed: • To use our analytical systems, customers typically need to purchase specialized reagents.
• Our distribution capabilities and direct sales, field support, and marketing forces must be sufficient to meet our customers’ needs.
+Added: • To use our analytical systems, customers typically need to purchase specialized reagents.
+Added: • Security breaches, loss of data, cyberattacks, and other IT failures could adversely affect our business.
Risks Related to Quality and the Regulatory Environment
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RISKS RELATED TO OUR BUSINESS, INDUSTRY, AND STRATEGY
−Removed: The global COVID-19 pandemic has significantly affected our business operations and could adversely impact our financial position and cash flows to an extent that is unknown and difficult to predict.
−Removed: The pandemic and international public health emergency caused by SARS-CoV-2, the novel strain of coronavirus that causes the disease commonly known as COVID-19, has spread throughout all the countries in which we and our customers, suppliers, and other business partners operate, causing significant disruption and volatility in global financial markets and raising the prospect of an extended global recession.
−Removed: Public health problems resulting from COVID-19 and precautionary measures instituted by governments and businesses to mitigate its spread, including travel restrictions and quarantines, could continue to contribute to a general slowdown in the global economy, cause increasingly adverse impacts on our customers, suppliers, and other business partners, and further disrupt our operations.
+Added: The global COVID-19 pandemic has significantly affected our business operations and could continue to adversely impact our financial position and cash flows to an extent that is unknown and difficult to predict.
+Added: The pandemic and international public health emergency caused by SARS-CoV-2, the novel strain of coronavirus that causes the disease commonly known as COVID-19, has adversely affected all the countries in which we and our customers, suppliers, and other business partners operate, disrupting supply chains, causing significant volatility in global financial markets, and raising the prospect of an extended global recession.
+Added: Public health problems resulting from COVID-19 and precautionary measures instituted by governments and businesses to mitigate its spread and resurgence, including travel restrictions and quarantines, could continue to contribute to a general slowdown in the global economy, cause increasingly adverse impacts on our customers, suppliers, and other business partners, and further disrupt our operations.
Changes in our operations as a result of the COVID-19 pandemic have resulted in inefficiencies and delays, including in sales and product development efforts, and additional costs related to business continuity initiatives that cannot be fully mitigated through succession planning, employees working remotely, or teleconferencing technologies.
−Removed: The COVID-19 pandemic and related governmental reactions have had, and may continue to have, a negative impact on our business, liquidity, results of operations, and stock price due to the occurrence of some or all of the following events or circumstances among others:
+Added: The COVID-19 pandemic and related governmental and societal reactions have had, and may continue to have, a negative impact on our business, liquidity, results of operations, and stock price due to the occurrence of some or all of the following events or circumstances among others:
• reduced demand for some of our products and services due to the impact of COVID-19 on our customers, including in the global academic research community;
+Added: • the negative impact of ongoing travel restrictions and social distancing policies on our sales operations, marketing efforts, and customer field support;
• diminished business productivity due to inefficiencies in employees working from home or increasing physical distancing and other pandemic response protocols in our production facilities;
+Added: • increased voluntary turnover, together with impaired ability to hire and effectively train new personnel due to labor shortages, travel restrictions, and physical distancing protocols;
• increased susceptibility to the risk of information technology security breaches and other disruptions due to increased volumes of remote access to our information systems from our employees working at home;
−Removed: • the negative impact of travel restrictions and social distancing policies on our sales operations, marketing efforts, and customer field support;
−Removed: • impaired ability to hire and effectively train new personnel due to travel restrictions and physical distancing protocols;
• increased operating costs if one of our facilities were to experience a COVID-19 outbreak;
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In addition to its negative impact on some aspects of our business, the COVID-19 pandemic has been a source of opportunity for our diagnostics business, opening up external funding sources to support innovation and product development and resulting in increased revenues due to sales of our Advanta Dx SARS-CoV-2 RT-PCR test and related sales of our microfluidics instruments.
−Removed: However, as vaccines and alternative testing options for the coronavirus have become available and the perceived threat of the pandemic has receded, the demand for our COVID-19 testing products has slowed, resulting in a corresponding decline in COVID-19 revenue.
−Removed: As a result of these trends, we have lowered our revenue expectations for 2021.
−Removed: If our revenues decline more than expected, we may be required implement cost control initiatives as the year progresses, and may be required to raise additional financing to support our investment priorities.
−Removed: Additional details concerning these risks are
−Removed: provided in the risk factors below, including under “ Our efficiency and cost-savings initiatives could be disruptive to our operations and adversely affect our results of operations and financial condition ,” and “ Our future capital needs are uncertain and we may need to raise additional funds in the future, which may cause dilution to stockholders or may be upon terms that are not favorable to us.
−Removed: The extent to which the COVID-19 pandemic will continue to impact our business and financial results will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the continued spread of the coronavirus;
+Added: However, as vaccines and alternative testing options for the coronavirus have become available and the perceived threat of the pandemic has receded, the demand for our COVID-19 testing products has slowed, resulting in a corresponding decline in related revenue.
+Added: As a result of these trends, we have lowered our revenue expectations for COVID-19 testing products in 2021.
+Added: In the third quarter of 2021, factors such as supply chain constraints, China trade restrictions, and the ongoing slowdown in the Asia-Pacific region caused our overall revenues to decline more than expected.
+Added: As a result, we are considering the implementation of various cost control initiatives, and we may be required to draw on our $15.0 million revolving senior credit facility (Revolving Credit Facility) or raise additional financing to support our investment priorities.
+Added: Additional details concerning these risks are provided in the risk factors below, including under “ Our efficiency and cost-savings initiatives could be disruptive to our operations and adversely affect our results of operations and financial condition ,” and “ Our future capital needs are uncertain and we may need to raise additional funds in the future, which may cause dilution to stockholders or may be upon terms that are not favorable to us.
+Added: The extent to which the COVID-19 pandemic will continue to impact our business and financial results will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the continued spread and resurgences of the coronavirus;
the emergence of new strains of the disease, such as the Delta variant;
the availability, efficacy, and acceptance of COVID-19 vaccines;
−Removed: the duration of the public health emergency;
−Removed: and actions taken in the United States and elsewhere to contain the virus and prevent new outbreaks, such as social distancing and quarantines, business closures or business disruptions.
−Removed: Because the severity, magnitude, and duration of the COVID-19 pandemic and its economic consequences are uncertain and rapidly changing, we are unable to predict the impact of COVID-19 on our operations, our financial performance, and our ability to successfully execute our business strategies and initiatives.
+Added: the scope and duration of the public health emergency;
+Added: and COVID-19 mitigation measures such as travel bans and restrictions, social distancing, quarantines, and business shutdowns and closures.
+Added: Because the severity, magnitude, and duration of the COVID-19 pandemic and its economic consequences are uncertain, we are unable to predict the impact of COVID-19 on our operations, our financial performance, and our ability to successfully execute our business strategies and initiatives.
The ultimate impact of the COVID-19 pandemic on our operations and financial performance depends on many factors that are not within our control, including, but not limited, to:
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global economic conditions and levels of economic growth;
−Removed: and the pace of recovery when the COVID-19 pandemic subsides.
+Added: labor and materials shortages;
+Added: supply chain difficulties, including disruption of logistics, shipping, and other distribution operations;
+Added: and the pace of recovery when the threat of COVID-19 subsides.
As the COVID-19 pandemic continues to affect our operating and financial results, it may also have the effect of heightening many of the other risks described in our other risk factors below.
COVID-19 may also affect our operating and financial results in a manner that is not presently known to us or that we currently do not expect to present significant risks to our operations or financial results, particularly if the pandemic and its associated impacts reoccur in the coming months.
−Removed: Our financial results and revenue growth rates have varied significantly from quarter-to-quarter and year-to-year due to a number of factors, and a significant variance in our operating results or rates of growth from market expectations, if any, could lead to substantial volatility in our stock price.
+Added: Our financial results and revenue growth rates have varied significantly from quarter-to-quarter and year-to-year due to a number of factors, and a significant variance in our operating results or rates of growth from our financial guidance or market expectations, if any, could lead to substantial volatility in our stock price.
Our revenue, results of operations, and revenue growth rates have varied in the past and may continue to vary significantly from quarter-to-quarter or year-to-year.
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• fluctuations in demand for our products;
−Removed: changes in customer budget cycles and capital spending;
+Added: • changes in customer budget cycles, capital spending, and the availability of VAT and import tax exemptions;
• seasonal variations in customer operations;
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• our ability to design, manufacture, market, sell, and deliver products to our customers in a timely and cost-effective manner;
+Added: • our ability to timely obtain adequate quantities of the materials or components used in our products, which in certain cases are purchased through sole and single source suppliers;
+Added: • staffing shortages, lack of skilled labor, increased turnover, and competitive job markets;
• fluctuations or reductions in revenue from sales of legacy instruments that may have contributed significant revenue in prior periods;
• quality control or yield problems in our manufacturing operations;
−Removed: • our ability to timely obtain adequate quantities of the materials or components used in our products, which in certain cases are purchased through sole and single source suppliers;
• new product introductions and enhancements by us and our competitors;
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• our complex, variable and, at times, lengthy sales cycle;
+Added: • trade restrictions and government protectionism;
• global economic conditions;
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We have incurred significant losses in each fiscal year since our inception, including net losses of $53.0 million, $64.8 million and $59.0 million during the years 2020, 2019, and 2018, respectively.
−Removed: As of June 30, 2021, we had an accumulated deficit of $712.7 million.
+Added: As of September 30, 2021, we had an accumulated deficit of $726.6 million.
These losses have resulted principally from costs incurred in our research and development programs, and from our manufacturing costs and selling, general, and administrative expenses.
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are our principal competitors for our Imaging Mass Cytometry™ market share.
−Removed: While the aforementioned principal competitors are the largest and most prevalent in their representative technology areas, the combined markets in which we compete have an additional 10 to 20 smaller competitors with competing approaches and technologies that we routinely face in selling situations.
+Added: While the aforementioned principal competitors are the largest
+Added: and most prevalent in their representative technology areas, the combined markets in which we compete have an additional 10 to 20 smaller competitors with competing approaches and technologies that we routinely face in selling situations.
Competitors may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards, or customer requirements.
In light of these advantages, even if our technology is more effective than the product or service offerings of our competitors, current or potential customers might accept competitive products and services in lieu of purchasing our technology.
−Removed: We anticipate that we will continue to face increased competition in the future as existing companies and competitors develop new or improved products and as new companies enter the market with new
−Removed: technologies.
+Added: We anticipate that we will continue to face increased competition in the future as existing companies and competitors develop new or improved products and as new companies enter the market with new technologies.
Increased competition is likely to result in pricing pressures, which could reduce our profit margins and increase our sales and marketing expenses.
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Most of our potential customers already use expensive research systems in their laboratories and may be reluctant to replace those systems.
−Removed: Market acceptance of our systems will depend on many factors, including our ability to convince potential customers that our systems are an attractive alternative to existing technologies.
+Added: Market acceptance of our systems will depend on many factors, including our ability to
+Added: convince potential customers that our systems are an attractive alternative to existing technologies.
Compared to some competing technologies, our technology is relatively new, and most potential customers have limited knowledge of, or experience with, our products.
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Even if we successfully implement some or all of these planned improvements, we cannot guarantee that our current and potential customers will find our enhanced systems to be an attractive alternative to existing technologies, including our current products.
+Added: Our efficiency and cost-savings initiatives could be disruptive to our operations and adversely affect our results of operations and financial condition.
+Added: From time to time, we have implemented efficiency and cost-savings initiatives intended to stabilize our business operations.
+Added: These efficiency initiatives have included targeted workforce reductions, optimizing our facilities, and reducing excess space.
+Added: In 2020, in response to the uncertainty arising from the COVID-19 pandemic, we initiated a range of additional actions aimed at temporarily reducing our operating expenses and preserving liquidity, including implementing temporary enterprise-wide salary reductions of 20% for employees at or above the ‘director’ level and 10% for all others, temporarily reducing our board members’ cash retainers by 20%, and constraining hiring.
+Added: Although we discontinued our hiring constraints and pandemic-related pay reductions in 2020, we are currently reviewing other possible actions to preserve liquidity and optimize our organization.
+Added: For example, we may need to decrease or defer capital expenditures and development activities or implement further operating expense reduction measures.
+Added: The implementation of these and other efficiency and cost-savings initiatives could impair our ability to invest in developing, marketing and selling new and existing products, be disruptive to our operations, make it difficult to attract or retain employees, result in higher than anticipated charges, divert the attention of management, result in a loss of accumulated knowledge, impact our customer and supplier relationships, and otherwise adversely affect our results of operations and financial condition.
+Added: If we seek to implement a company-wide enterprise resource planning (ERP) system, such implementation could adversely affect our business and results of operations or the effectiveness of internal control over financial reporting.
+Added: We are considering implementing a company-wide ERP system to handle the business and financial processes within our operations and corporate functions.
+Added: ERP implementations are complex and time-consuming projects that involve substantial expenditures on system software and implementation activities that can continue for several years.
+Added: ERP implementations also
+Added: require transformation of business and financial processes in order to reap the benefits of the ERP system.
+Added: If we decide to implement a company-wide ERP system, our business and results of operations could be adversely affected if we experience operating problems and/or cost overruns during the ERP implementation process, or if the ERP system and the associated process changes do not give rise to the benefits that we expect.
+Added: If we do not effectively implement the ERP system as planned or if the system does not operate as intended, our business, results of operations, and internal controls over financial reporting could be adversely affected.
Our business growth strategy involves the potential for significant acquisitions, and our operating results and prospects could be harmed if we are unable to integrate future acquisitions successfully.
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If we finance acquisitions by issuing equity or convertible debt securities, our existing stockholders will likely experience dilution, and if we finance future acquisitions with debt funding, we will incur interest expense and may have to comply with financial covenants and secure that debt obligation with our assets.
−Removed: Our efficiency and cost-savings initiatives could be disruptive to our operations and adversely affect our results of operations and financial condition.
−Removed: From time to time, we have implemented efficiency and cost-savings initiatives intended to stabilize our business operations.
−Removed: These efficiency initiatives have included targeted workforce reductions, optimizing our facilities, and reducing excess space.
−Removed: In 2020, in response to the uncertainty arising from the COVID-19 pandemic, we initiated a range of additional actions aimed at temporarily reducing our operating expenses and preserving liquidity.
−Removed: These actions included implementing temporary enterprise-wide salary reductions of 20% for employees at or above the ‘director’ level and 10% for all others, temporarily reducing our board members’ cash retainers by 20%, and constraining hiring.
−Removed: Although we have discontinued our hiring constraints and pandemic-related pay reductions, actions such as these may be required in the future to preserve liquidity and optimize our organization.
−Removed: For example, we may need to decrease or defer capital expenditures and development activities or implement further operating expense reduction measures.
−Removed: The implementation of further efficiency and cost-savings initiatives could impair our ability to invest in developing, marketing and selling new and existing products, be disruptive to our operations, make it difficult to attract or retain employees, result in higher than anticipated charges, divert the attention of management, result in a loss of accumulated knowledge, impact our customer and supplier relationships, and otherwise adversely affect our results of operations and financial condition.
−Removed: If we seek to implement a company-wide enterprise resource planning (ERP) system, such implementation could adversely affect our business and results of operations or the effectiveness of internal control over financial reporting.
−Removed: We have considered implementing a company-wide ERP system to handle the business and financial processes within our operations and corporate functions.
−Removed: ERP implementations are complex and time-consuming projects that involve substantial expenditures on system software and implementation activities that can continue for several years.
−Removed: ERP implementations also require transformation of business and financial processes in order to reap the benefits of the ERP system.
−Removed: If we decide to implement a company-wide ERP system, our business and results of operations could be adversely affected if we experience operating problems and/or cost overruns during the ERP implementation process, or if the ERP system and the associated process changes do not give rise to the benefits that we expect.
−Removed: If we do not effectively implement the ERP system as planned or if the system does not operate as intended, our business, results of operations, and internal controls over financial reporting could be adversely affected.
RISKS RELATED TO OPERATIONS AND RELIANCE ON THIRD PARTIES
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Furthermore, developing an IFC for a new application may require developing a specific production process for that type of IFC.
−Removed: While all of our IFCs are produced using the same basic processes, significant variations may be required to ensure adequate yield of any particular type of IFC.
+Added: While all of our IFCs are produced using the same basic processes, significant variations may be required to ensure
+Added: adequate yield of any particular type of IFC.
Developing such a process can be time consuming, and any unexpected difficulty in doing so can delay the introduction of a product.
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Our success will depend upon their demand for and use of our products.
−Removed: Accordingly, the spending policies and practices of these customers—which have been impacted by the COVID-19 pandemic and may additionally be impacted by other factors—could have a significant effect on the demand for our technology.
−Removed: These policies may be based on a wide variety of factors, including concerns regarding any future federal government budget sequestrations, the availability of resources to make purchases, the spending priorities among various types of equipment, policies regarding spending during recessionary periods, and changes in the political climate.
+Added: Accordingly, the spending policies and practices of these customers—which have been impacted by the COVID-19 pandemic and may additionally be impacted by other factors—have had and will continue to have a significant effect on the demand for our technology.
+Added: These policies may be based on a wide variety of factors, including concerns regarding any future federal government budget sequestrations, the availability of resources to make purchases, the spending priorities among various types of equipment, policies regarding spending during recessionary periods, tariffs and trade restrictions, and changes in the political climate.
In addition, academic, governmental, and other research institutions that fund research and development activities may be subject to stringent budgetary constraints that could result in spending reductions, reduced allocations, or budget cutbacks, which could jeopardize the ability of these customers to purchase our products.
−Removed: Our operating results may fluctuate substantially due to reductions and delays in research and development expenditures by our customers.
+Added: Our operating results have fluctuated and may continue to fluctuate substantially due to reductions and delays in research and development expenditures by our customers.
For example, reductions in operating expenditures by global academic research facilities because of the COVID-19 pandemic have resulted in lower than expected sales of our mass cytometry instruments.
−Removed: Similar reductions and delays in customer spending may result from other factors that are not within our control, such as:
+Added: Additionally, the imposition of tariffs and unavailability of VAT and import tax exemptions have adversely affected the sales of our products in China.
+Added: Similar reductions and delays in customer spending have resulted and may continue to result from other factors that are not within our control, such as:
• changes in economic conditions;
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• changes in government programs that provide funding to research institutions and companies;
+Added: • macroeconomic conditions and the political climate;
+Added: • governmental protectionism, the escalation of tariffs and other trade barriers;
+Added: • availability of tax permits and incentives, including VAT and import tax exemptions;
• changes in the regulatory environment affecting life science and plant and animal research companies engaged in research and commercial activities;
+Added: • changes in our customers’ research priorities;
• differences in budget cycles across various geographies and industries;
+Added: • personnel shortages among our customers;
• market-driven pressures on companies to consolidate operations and reduce costs;
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• other factors affecting research and development spending.
−Removed: Any decrease in our customers’ budgets or expenditures, or in the size, scope, or frequency of capital or operating expenditures, could materially and adversely affect our operations or financial condition.
+Added: Any decrease in our customers’ budgets or expenditures or in the size, scope, or frequency of capital or operating expenditures, as well as any increase in local tariffs could materially and adversely affect our operations or financial condition.
If one or more of our manufacturing facilities become unavailable or inoperable, we will be unable to continue manufacturing our instruments, IFCs, assays and/or reagents and, as a result, our business will be harmed until we are able to secure a new facility.
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Our facilities and the equipment we use to manufacture our instruments, IFCs, assays, and reagents would be costly to replace and could require substantial lead times to repair or replace.
−Removed: Our facilities may be harmed or rendered inoperable by natural or man-made disasters, which may render it difficult or impossible for us to manufacture our products for some period of time.
+Added: Our facilities may be harmed or rendered inoperable by
+Added: natural or man-made disasters, which may render it difficult or impossible for us to manufacture our products for some period of time.
If any of our facilities become unavailable to us, we cannot provide assurances that we will be able to secure a new manufacturing facility on acceptable terms, if at all.
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We have significant manufacturing operations in Singapore and Canada and operations in the United States.
−Removed: In addition, our business is international in nature, with our sales, service and administrative personnel and our customers located in
−Removed: numerous countries throughout the world.
+Added: In addition, our business is international in nature, with our sales, service and administrative personnel and our customers located in numerous countries throughout the world.
Operations at our manufacturing facilities and our subcontractors, as well as our other operations and those of our customers, are subject to disruption for a variety of reasons, including work stoppages, acts of war, terrorism, public health crises (including the ongoing COVID-19 pandemic), fire, earthquake, volcanic eruptions, energy shortages, flooding, or other natural disasters.
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We cannot provide any assurance that alternate means of conducting our operations (whether through alternate production capacity or service providers or otherwise) would be available if a major disruption were to occur or that, if such alternate means were available, they could be obtained on favorable terms.
−Removed: Any disruption or delay in the shipping or off-loading of our products, whether domestically or internationally, may have an adverse effect on our financial condition and results of operations.
−Removed: We rely on shipping providers to deliver products to our customers globally.
−Removed: Labor, tariff, or World Trade Organization-related disputes, piracy, physical damage to shipping facilities or equipment caused by severe weather or terrorist incidents, congestion at shipping facilities, complications related to public health crises (including the ongoing COVID-19 pandemic), inadequate equipment to load, dock, and offload our products, energy-related tie-ups, or other factors could disrupt or delay shipping or off-loading of our products domestically and internationally.
−Removed: Such disruptions or delays may have an adverse effect on our financial condition and results of operations.
We rely on a limited number of third-party suppliers for some of the components and materials used in our products, and the loss of any of these suppliers, or delays or problems in the supply of components and materials could harm our business.
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• we may not be able to obtain adequate supply or services in a timely manner or on commercially reasonable terms.
−Removed: We have in the past experienced quality control and supply problems with some of our suppliers, such as manufacturing errors, and may again experience problems in the future.
+Added: In connection with the global supply chain disruptions following the onset of the COVID-19 pandemic, we have been experiencing problems with some of our suppliers.
+Added: In the third quarter of 2021, shortages of certain components caused a backlog and we were unable to fulfill all of the demand for our products during the quarter.
+Added: We have in the past experienced supply issues, as well as quality control problems such as manufacturing errors, with some of our suppliers, and may again experience problems in the future.
We may not be able to quickly establish additional or replacement suppliers, particularly for our single source components, or assembly service providers.
−Removed: Any interruption or delay in the supply of components or materials or assembly of our instruments, or our inability to obtain components, materials, or assembly services from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders or switch to competitive products.
+Added: Any continued or future interruption or delay in the supply of components or materials or assembly of our instruments, or our inability to obtain components, materials, or assembly services from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders or switch to competitive products, which would harm our business.
+Added: We may not be able to convert our orders in backlog into revenue.
+Added: Our backlog represents product orders from our customers that we have confirmed but have not been able to fulfill, and, accordingly, for which we have not yet recognized revenue.
+Added: We may not receive revenue from these orders, and any order backlog we report may not be indicative of our future revenue.
+Added: Many events can cause an order to be delayed or not completed at all, some of which may be out of our control, including the potential impacts from the COVID-19 pandemic and our suppliers not being able to provide us with products or components.
+Added: If we delay fulfilling customer orders or if customers reconsider their orders, those customers may seek to cancel or modify their orders with us.
+Added: Customers may otherwise seek to cancel or delay their orders even if we are prepared to fulfill them.
+Added: If our orders in backlog do not result in sales, our operating results may suffer.
+Added: Any disruption or delay in the shipping or off-loading of our products, whether domestically or internationally, may have an adverse effect on our financial condition and results of operations.
+Added: We rely on shipping providers to deliver products to our customers globally.
+Added: Labor, tariff, or World Trade Organization-related disputes, piracy, physical damage to shipping facilities or equipment caused by severe weather or terrorist incidents, congestion at shipping facilities, complications related to public health crises (including the ongoing COVID-19 pandemic), inadequate equipment to load, dock, and offload our products, energy-related tie-ups, or other factors could disrupt or delay shipping or off-loading of our products domestically and internationally.
+Added: Such disruptions or delays may have an adverse effect on our financial condition and results of operations.
Our business operations depend upon the continuing efforts of our management team and other skilled and experienced personnel, and if we are unable to retain them or to recruit and train new key executives, scientists, and technical support personnel, we may be unable to achieve our goals.
Our success depends largely on the skills, experience, and performance of our management team and scientific and technical support personnel.
−Removed: The loss of the services of any key member of our management team or our scientific or technical support staff might significantly delay or prevent the development of our products or achievement of other business objectives by diverting management’s attention to transition matters and identification of suitable replacements, if any, and could have a
−Removed: material adverse effect on our business.
+Added: The loss of the services of certain members of our management team or our scientific or technical support staff might significantly delay or prevent the development of our products or achievement of other business objectives by diverting management’s attention to transition matters and identification of suitable replacements, and staffing shortages could also negatively impact our ability to expand and scale functions that are needed to support the development of our products and the growth of our business.
Our research and product development efforts could also be delayed or curtailed if we are unable to attract, train, and retain highly skilled employees, particularly, senior scientists and engineers.
−Removed: For example, as part of our cost reduction program to manage the impact of the COVID-19 pandemic, we implemented temporary enterprise-wide salary reductions and delayed implementation of 2020 merit-based salary increases.
−Removed: Although all salaries have been restored as of the date of this filing, any reinstatement of salary reductions or any other failure to maintain competitive levels of compensation may negatively impact our ability to retain the personnel necessary to achieve our goals.
−Removed: We do not maintain fixed term employment contracts or significant key person life insurance with any of our employees.
+Added: Competition for qualified senior management and key employees in our industry is intense.
+Added: We have experienced increased turnover at all levels since the start of the COVID-19 pandemic and general labor shortages in various areas of our business, all of which could have a material adverse impact on our business.
+Added: We may need to increase employee wages and benefits in order to attract and retain the personnel necessary to achieve our goals, and our business, operations, and financial results may suffer if we are unable to do so.
+Added: We do not maintain significant key person life insurance with any of our employees and all our employees, including our management team, may terminate employment without notice and without cause or good reason.
Additionally, to expand our research and product development efforts, we need to retain and recruit scientists skilled in areas such as molecular and cellular biology, assay development, and manufacturing.
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Because of the complex and technical nature of our systems and the dynamic market in which we compete, any failure to attract and retain a sufficient number of qualified employees could materially harm our ability to develop and commercialize our technology.
+Added: If we are unable to expand our direct sales, field support, and marketing forces or distribution capabilities to adequately address our customers’ needs, our business will be adversely affected.
+Added: We may not be able to market, sell, and, distribute our products effectively enough to support our planned growth.
+Added: We sell our products primarily through our own sales force and through distributors in certain territories.
+Added: Our future sales will depend in large part on our ability to continue to increase the scope of our marketing efforts and develop and substantially expand our direct sales force and field application specialist and service engineer teams.
+Added: Our products are technically complex and used for highly specialized applications.
+Added: As a result, we believe it is necessary to continue to develop a direct sales force that includes people with specific scientific backgrounds and expertise, and a marketing group with technical sophistication.
+Added: In the past year, we have experienced significant changes and increased turnover in our sales and marketing organizations, and we face considerable challenges in recruiting and training qualified replacements.
+Added: Our future success will depend largely on our ability to recruit, retain, and motivate the skilled sales and marketing force necessary to support our business activities, and any failure to maintain competitive levels of compensation will negatively impact our ability to so.
+Added: Because competition for such employees is intense, we can provide no assurance that we will be able to retain them on favorable or commercially reasonable terms, if at all.
+Added: Failure to attract and retain our current personnel or to build an efficient and effective sales and marketing force would negatively impact sales of our products and reduce our revenue and profitability.
+Added: In addition, we may continue to enlist one or more sales representatives and distributors to assist with sales, distribution, and customer support globally or in certain regions of the world.
+Added: If we do seek to enter into such arrangements, we may not be successful in attracting desirable sales representatives and distributors, or we may not be able to enter into such arrangements on favorable terms.
+Added: If our sales and marketing efforts, or those of any third-party sales representatives and distributors, are not successful, our technologies and products may not gain market acceptance, which would materially and adversely impact our business operations.
+Added: To use our products—our Biomark, EP1, Helios/CyTOF 2, and Hyperion systems in particular—customers typically need to purchase specialized reagents.
+Added: Any interruption in the availability of these reagents for use in our products could limit our ability to market our products.
+Added: Our products, our Biomark, EP1, Helios, and Hyperion systems in particular, must be used in conjunction with one or more reagents designed to produce or facilitate the particular biological or chemical reaction desired by the user.
+Added: Many of these reagents are highly specialized and available to the user only from a single supplier or a limited number of suppliers.
+Added: Although we sell reagents for use with certain of our products, our customers may purchase these reagents directly from third-party suppliers, and we have no control over the supply of those materials.
+Added: In addition, our products are designed to work with these reagents as they are currently formulated.
+Added: We have no control over the formulation of reagents sold by third-party suppliers, and the performance of our products might be adversely affected if the formulation of these reagents is changed.
+Added: If one or more of these reagents were to become unavailable or were reformulated, our ability to market and sell our products could be materially and adversely affected.
+Added: In addition, the use of a reagent for a particular process may be covered by one or more patents relating to the reagent itself, the use of the reagent for the particular process, the performance of that process, or the equipment required to perform the process.
+Added: Typically, reagent suppliers, who are either the patent holders or their authorized licensees, sell the reagents along with a license or covenant not to sue with respect to such patents.
+Added: The license accompanying the sale of a reagent often purports to restrict the purposes for which the reagent may be used.
+Added: If a patent holder or authorized licensee were to assert against us or our customers that the license or covenant relating to a reagent precluded its use with our systems, our ability to sell and market our products could be materially and adversely affected.
+Added: For example, our Biomark system involves real-time quantitative polymerase chain reaction (qPCR) technology.
+Added: Leading suppliers of reagents for real-time qPCR reactions include Life Technologies Corporation (now part of Thermo) and Roche Diagnostics Corporation, who are our direct competitors, and their licensees.
+Added: These real-time qPCR reagents are typically sold pursuant to limited licenses or covenants not to sue with respect to patents held by these companies.
+Added: We do not have any contractual supply agreements for these real-time qPCR reagents, and we cannot assure you that these reagents will continue to be available to our customers for use with our systems, or that these patent holders will not seek to enforce their patents against us, our customers, or suppliers.
Security breaches, loss of data, cyberattacks, and other information technology failures could disrupt our operations, damage our reputation, and adversely affect our business, operations, and financial results.
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Immediately following the attack, actions were taken to recover the compromised systems and we were able to restore their operation without significant loss of business data within weeks.
−Removed: Based on the nature of the attack and its impact on our systems, we do not believe confidential data was lost or disclosed.
−Removed: If, however, confidential data were determined to have been released in the course of any event, it is possible that we could be the subject of actions by governmental authorities or claims from persons alleging they suffered damages from such a release.
+Added: Based on the nature of the attack and its impact on our systems, we believe no confidential data was lost or disclosed.
+Added: If, however, confidential data were determined to have been released in the course of any future event, it is possible that we could be the subject of actions by governmental authorities or claims from persons alleging they suffered damages from such a release.
We believe our mitigation measures and expanded information security program have reduced, but cannot eliminate, the risk of a similar attack, and we anticipate additional work and expense in the future as we continuously improve our security processes and initiatives in response to ever-changing information security challenges.
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As a result, we may have increased cyber security and data security risks, due to increased use of home wi-fi networks and virtual private networks, as well as increased disbursement of physical machines.
−Removed: While we have implemented security controls, updated our policies, and
−Removed: augmented our information security training program to reduce the risk of cyberattacks and security breaches, there is no guarantee that these measures will be adequate to safeguard all systems with the increased number of employees working remotely.
−Removed: To use our products—our Biomark, EP1, Helios/CyTOF 2, and Hyperion systems in particular—customers typically need to purchase specialized reagents.
−Removed: Any interruption in the availability of these reagents for use in our products could limit our ability to market our products.
−Removed: Our products, our Biomark, EP1, Helios, and Hyperion systems in particular, must be used in conjunction with one or more reagents designed to produce or facilitate the particular biological or chemical reaction desired by the user.
−Removed: Many of these reagents are highly specialized and available to the user only from a single supplier or a limited number of suppliers.
−Removed: Although we sell reagents for use with certain of our products, our customers may purchase these reagents directly from third-party suppliers, and we have no control over the supply of those materials.
−Removed: In addition, our products are designed to work with these reagents as they are currently formulated.
−Removed: We have no control over the formulation of reagents sold by third-party suppliers, and the performance of our products might be adversely affected if the formulation of these reagents is changed.
−Removed: If one or more of these reagents were to become unavailable or were reformulated, our ability to market and sell our products could be materially and adversely affected.
−Removed: In addition, the use of a reagent for a particular process may be covered by one or more patents relating to the reagent itself, the use of the reagent for the particular process, the performance of that process, or the equipment required to perform the process.
−Removed: Typically, reagent suppliers, who are either the patent holders or their authorized licensees, sell the reagents along with a license or covenant not to sue with respect to such patents.
−Removed: The license accompanying the sale of a reagent often purports to restrict the purposes for which the reagent may be used.
−Removed: If a patent holder or authorized licensee were to assert against us or our customers that the license or covenant relating to a reagent precluded its use with our systems, our ability to sell and market our products could be materially and adversely affected.
−Removed: For example, our Biomark system involves real-time quantitative polymerase chain reaction (qPCR) technology.
−Removed: Leading suppliers of reagents for real-time qPCR reactions include Life Technologies Corporation (now part of Thermo) and Roche Diagnostics Corporation, who are our direct competitors, and their licensees.
−Removed: These real-time qPCR reagents are typically sold pursuant to limited licenses or covenants not to sue with respect to patents held by these companies.
−Removed: We do not have any contractual supply agreements for these real-time qPCR reagents, and we cannot assure you that these reagents will continue to be available to our customers for use with our systems, or that these patent holders will not seek to enforce their patents against us, our customers, or suppliers.
−Removed: If we are unable to expand our direct sales, field support, and marketing forces or distribution capabilities to adequately address our customers’ needs, our business may be adversely affected.
−Removed: We may not be able to market, sell, and, distribute our products effectively enough to support our planned growth.
−Removed: We sell our products primarily through our own sales force and through distributors in certain territories.
−Removed: Our future sales will depend in large part on our ability to continue to increase the scope of our marketing efforts and develop and substantially expand our direct sales force and field application specialist and service engineer teams.
−Removed: Our products are technically complex and used for highly specialized applications.
−Removed: As a result, we believe it is necessary to continue to develop a direct sales force that includes people with specific scientific backgrounds and expertise, and a marketing group with technical sophistication.
−Removed: We have experienced significant changes in our sales organization.
−Removed: In addition, as part of our cost reduction program to manage the impact of the COVID-19 pandemic, we implemented temporary enterprise-wide salary reductions, including with respect to our sales and marketing employees.
−Removed: Although all salaries have been restored to prior levels as of the date of this filing, any reinstatement of salary reductions or any other failure to maintain competitive levels of compensation may negatively impact our ability to maintain the skilled sales and marketing force necessary to support our business activities.
−Removed: As a result, our future success will depend largely on our ability to retain and motivate such personnel.
−Removed: Because competition for such employees is intense, we can provide no assurance that we will be able to retain them on favorable or commercially reasonable terms, if at all.
−Removed: Failure to attract and retain our current personnel or to build an efficient and effective sales and marketing force would negatively impact sales of our products and reduce our revenue and profitability.
−Removed: In addition, we may continue to enlist one or more sales representatives and distributors to assist with sales, distribution, and customer support globally or in certain regions of the world.
−Removed: If we do seek to enter into such arrangements, we may not be successful in attracting desirable sales representatives and distributors, or we may not be able to enter into such arrangements on favorable terms.
−Removed: If our sales and marketing efforts, or those of any third-party sales representatives and distributors, are not successful, our technologies and products may not gain market acceptance, which would materially and adversely impact our business operations.
+Added: While we have implemented security controls, updated our policies, and augmented our information security training program to reduce the risk of cyberattacks and security breaches, there is no guarantee that these measures will be adequate to safeguard all systems with the increased number of employees working remotely.
RISKS RELATED TO QUALITY AND THE REGULATORY ENVIRONMENT
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EUAs issued by the FDA will specify the scope of authorization and conditions of authorization, including limitations on distribution and conditions related to product advertising and promotion.
−Removed: Once granted, an EUA is effective until the declaration that circumstances exist justifying the authorization of the emergency use is terminated under Section 564(b)(2) of the FD&C Act or the EUA is revoked under Section 564(g) of the FD&C Act, after which the product must be cleared or
−Removed: approved by the FDA under a traditional pathway as defined by the FDA and we must comply with the FDA quality system regulations in order to remain on the market or to continue commercialization of the product.
+Added: Once granted, an EUA is effective until the declaration that circumstances exist justifying the authorization of the emergency use is terminated under Section 564(b)(2) of the FD&C Act or the EUA is revoked under Section 564(g) of the FD&C Act, after which the product must be cleared or approved by the FDA under a traditional pathway as defined by the FDA and we must comply with the FDA quality system regulations in order to remain on the market or to continue commercialization of the product.
In August 2020, the FDA granted EUA for our Advanta Dx SARS-CoV-2 RT-PCR Assay for qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens from individuals suspected by their healthcare providers of having COVID-19, with the use of the assay limited to CLIA high complexity laboratories.
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There is significant competition among RADx projects, which are evaluated by experts on a rolling basis.
−Removed: Projects with the most potential for success are advanced to the next stage.
There is no certainty that we can meet all the milestones in our NIH Contract on a timely basis, if at all.
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In addition, we could suffer serious reputational harm if allegations of impropriety were made against us, which could cause our stock price to decrease.
−Removed: To the extent we elect to label and promote any of our non-EUA products as medical devices, we would be required to obtain prior approval or clearance by the FDA or comparable foreign regulatory authority, which could take significant time and expense and could fail to result in a marketing authorization for the intended uses we believe are commercially attractive.
+Added: To the extent we elect to label and promote any of our non-EUA products as medical devices, we would be required to obtain prior approval or clearance by the FDA or comparable foreign regulatory authority, which could take significant time and expense and could fail to result in a marketing authorization for the intended uses we believe are commercially
Obtaining marketing authorization in one jurisdiction does not mean that we will be successful in obtaining marketing authorization in other jurisdictions where we conduct business.
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As a result, the time required to obtain clearances or approvals outside the United States may differ from that required to obtain FDA clearance or approval and we may not be able to obtain foreign regulatory approvals on a timely basis or at all.
−Removed: In Europe, we need to comply with the In Vitro Diagnostic Directive
−Removed: 98/79/EC and transition to the In Vitro Diagnostic Regulation 2017/746, which became effective May 26, 2017, with an application date of May 26, 2022.
+Added: In Europe, we need to comply with the In Vitro Diagnostic Directive 98/79/EC and transition to the In Vitro Diagnostic Regulation 2017/746, which became effective May 26, 2017, with an application date of May 26, 2022.
This will increase the difficulty of regulatory approvals in Europe in the future.
In addition, the FDA regulates exports of medical devices.
−Removed: Failure to comply with these regulatory requirements or obtain and maintain required approvals, clearances and certifications could impair our ability to commercialize our products for diagnostic use outside of the United States.
+Added: Failure to comply with these regulatory requirements or obtain and maintain
+Added: required approvals, clearances and certifications could impair our ability to commercialize our products for diagnostic use outside of the United States.
In February 2021, we announced a supply and distribution agreement to market our CyTOF technology, panels, and reagents to clinical labs in China.
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Following this HHS announcement, the FDA announced in October 2020 that it will no longer review EUA requests for COVID-19 LDTs at this time and will continue to prioritize review of EUA requests for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput tests that are widely distributed.
−Removed: While these actions by HHS and the FDA are expected to reduce the regulatory burden on clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that develop LDTs, it is unclear how this action as well as legislation and
−Removed: executive orders by the Biden administration and state governments and FDA regulation will impact the industry, including our business and that of our customers.
−Removed: In an FDA FAQ updated on January 13, 2021, FDA indicated that it is reviewing EUA requests from laboratories that offer COVID-19 diagnostic tests and appears to take a different position from the HHS rescission policy.
+Added: While these actions by HHS and the FDA are expected to reduce the regulatory burden on clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that develop LDTs, it is unclear how this action as well as legislation and executive orders by the Biden administration and state governments and FDA regulation will impact the industry, including our business and that of our customers.
+Added: In an FDA FAQ updated on January 13, 2021, FDA indicated that it is reviewing EUA requests from laboratories that offer COVID-19 diagnostic tests and appears to take a different position from the HHS
+Added: rescission policy.
HHS’s policy and the FDA’s position with respect to LDTs in the short term and in general in the long-term may change, especially as the leadership at FDA changes under the Biden administration.
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During the years 2020, 2019, and 2018, approximately 54%, 63%, and 57% respectively, of our product and service revenue was generated from sales to customers located outside of the United States.
−Removed: We believe that a significant percentage of our future revenue will continue to come from international sources as we expand our international operations and develop
−Removed: opportunities in other countries.
+Added: We believe that a significant percentage of our future revenue will continue to come from international sources as we expand our international operations and develop opportunities in other countries.
Engaging in international business inherently involves a number of difficulties and risks, including:
−Removed: • required compliance with existing and changing foreign regulatory requirements and laws that are or may be applicable to our business in the future, such as the European Union’s General Data Protection Regulation and other data privacy requirements, labor and employment regulations, anticompetition regulations, the U.K.
+Added: • required compliance with existing and changing foreign regulatory requirements and laws that are or may be applicable to our business in the future, such as the European Union’s General Data Protection Regulation, the California Consumer Privacy Act, and other data privacy requirements, labor and employment regulations, anticompetition regulations, the U.K.
Bribery Act of 2010 and other anticorruption laws, and the RoHS and WEEE directives and REACH regulation, which regulate the use and importation of certain hazardous substances in, and require the collection, reuse, and recycling of waste from, products we manufacture;
6 unchanged sentences
• changes in social, economic, and political conditions or in laws, regulations and policies governing foreign trade, manufacturing, development, and investment both domestically as well as in the other countries and jurisdictions in which we operate and into which we sell our products, including as a result of the separation of the United Kingdom from the European Union (Brexit);
−Removed: • business interruptions resulting from global sociopolitical events, including war and terrorism, public health crises (including the ongoing COVID-19 pandemic), and natural disasters including earthquakes, typhoons, floods and fires;
+Added: • business interruptions and travel restrictions resulting from global sociopolitical events, including war and terrorism, public health crises (including the ongoing COVID-19 pandemic), and natural disasters including earthquakes, typhoons, floods and fires;
• potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements, and other trade barriers;
1 unchanged sentence
• difficulties protecting or procuring intellectual property rights.
−Removed: If one or more of these risks occurs, it could require us to dedicate significant resources to remedy, and if we are unsuccessful in finding a solution, our financial results will suffer.
+Added: Since the beginning of the COVID-19 pandemic, travel restrictions have caused significant slowdowns in China, Japan, and other parts of the Asia-Pacific region.
+Added: These slowdowns, in addition to shipment delays in China due to a lack of VAT and import tax exemptions for our products, have caused our financial results to suffer.
+Added: If these situations continue, or if other risks occur, we could be forced to dedicate significant resources to their resolution, and if we are unsuccessful in finding a solution, our financial condition and results will suffer.
Adverse conditions in the global economy and disruption of financial markets may significantly harm our revenue, profitability, and results of operations.
Adverse economic conditions in the U.S.
−Removed: and international markets, including the worldwide economic disruption related to the COVID-19 pandemic, have negatively affected our revenues and operating results and may continue to do so.
+Added: and international markets, including the worldwide economic disruption related to the COVID-19 pandemic and related slowdowns in China, Japan, and elsewhere in the Asia-Pacific region, have negatively affected our revenues and operating results and may continue to do so.
Even before the current public health crisis took hold, the global credit and financial markets had been experiencing volatility and disruptions, including diminished liquidity and credit availability, increased concerns about inflation and deflation, and the downgrade of U.S.
debt and exposure risks on other sovereign debts, decreased consumer confidence, lower economic growth, volatile energy costs, increased unemployment rates, and uncertainty about economic stability.
−Removed: Geopolitical events including the COVID-19 pandemic, the United States government’s adoption and expansion of trade restrictions, and the United Kingdom’s withdrawal from the European Union have caused significant economic, market, political and regulatory uncertainty in some of our markets.
+Added: Geopolitical events including the COVID-19 pandemic, the adoption and expansion of trade restrictions by the United States and China, and the United Kingdom’s withdrawal from the European Union have caused significant economic, market, political and regulatory uncertainty in some of our markets.
Volatility and disruption of financial markets could limit our customers’ ability to obtain adequate financing or credit to purchase and pay for our products in a timely manner or to maintain operations, which could result in a decrease in sales volume that could harm our results of operations.
8 unchanged sentences
dollar relative to foreign currencies could decrease demand for our products and adversely impact our financial performance.
−Removed: For example, if the value of the U.S.
+Added: example, if the value of the U.S.
dollar increases relative to foreign currencies, our products could become more costly to the international consumer and therefore less competitive in international markets, or if the value of the U.S.
dollar decreases relative to the Singapore dollar or the Canadian dollar, it would become more costly in U.S.
−Removed: dollars for us to manufacture our
−Removed: products in Singapore and/or in Canada.
+Added: dollars for us to manufacture our products in Singapore and/or in Canada.
Additionally, our expenses are generally denominated in the currencies of the countries in which our operations are located, which is primarily in the United States, with a portion of expenses incurred in Singapore and Canada where a significant portion of our manufacturing operations are located.
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Our future capital needs are uncertain and we may need to raise additional funds in the future, which may cause dilution to stockholders or may be upon terms that are not favorable to us.
−Removed: We believe that our existing cash, cash equiv alents, and investments, along with funding available under our $10.0 million term loan facility and $15.0 million revolving senior credit facility (collectively, Credit Facility) will be sufficient to meet our anticipated cash requirements for at least the next 18 months.
+Added: We believe that our existing cash, cash equiv alents, and investments, along with funding available under our Revolving Credit Facility, will be sufficient to meet our anticipated cash requirements for at least the next 12 months.
However, we have continued to experience losses and, if that trend continues, we may need to seek additional sources of financing.
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During the third quarter of 2020, we sold approximately 2.5 million shares of our common stock pursuant to the Sale Agreement, for aggregate gross proceeds of $20.9 million.
−Removed: Our net proceeds were approximately $20.1 million, after deducting related expenses, including commissions of approximately $0.6 million and issuance costs of approximately $0.2 million.
−Removed: If we raise additional funds by issuing equity securities, either under the ATM
−Removed: program or otherwise, our stockholders will experience dilution.
+Added: Our net proceeds were approximately $20.1 million, after deducting related expenses, including commissions of approximately $0.6 million and
+Added: issuance costs of approximately $0.2 million.
+Added: If we raise additional funds by issuing equity securities, either under the ATM program or otherwise, our stockholders will experience dilution.
Debt financing in addition to the Credit Facility, if available, may involve covenants restricting our operations or our ability to incur additional debt.
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We make estimates and assumptions in valuing such intangible assets that affect our condensed consolidated financial statements.
−Removed: As of June 30, 2021, we had approximately $142.6 million of goodwill and net intangible assets, including approximately $106.5 million of goodwill and $35.7 million of net intangible assets.
+Added: As of September 30, 2021, we had approximately $138.8 million of goodwill and net intangible assets, including approximately $106.4 million of goodwill and $32.4 million of net intangible assets.
These assets represent a significant portion of the assets recorded on our condensed consolidated balance sheet and relate primarily to our acquisition of DVS Sciences, Inc.
11 unchanged sentences
The Credit Facility contains customary affirmative and negative covenants which, unless waived by the bank, limit our ability to, among other things, incur additional indebtedness, grant liens, make investments, repurchase stock, pay dividends, transfer assets, enter into affiliate transactions, undergo a change of control, or engage in merger and acquisition activity, including merging or consolidating with a third party.
−Removed: If we fail to comply with the covenants and our other obligations under the Credit Facility, the lenders would be able to
−Removed: accelerate the required repayment of amounts due under the Credit Facility and, if they are not repaid, could foreclose upon the assets securing our obligations under the Credit Facility.
+Added: Additionally, we are required to maintain a minimum Adjusted Quick Ratio (as defined) of at least 1.25 to 1.00.
+Added: If we fail to
+Added: comply with the covenants and our other obligations under the Credit Facility, the lenders would be able to accelerate the required repayment of amounts due under the Credit Facility and, if they are not repaid, could foreclose upon the assets securing our obligations under the Credit Facility.
Our ability to use net operating loss carryforwards to offset future taxable income for U.S.
8 unchanged sentences
Adoption of a tax benefit preservation plan could make it more difficult for a third party to acquire, or could discourage a third party from acquiring, us or a large block of our common stock.
−Removed: We are subject to risks related to taxation in multiple jurisdictions and if taxing authorities disagree with our interpretations of existing tax laws or regulations, our effective income tax rate could be adversely affected and we could have additional tax liability.
+Added: We are subject to risks related to taxation in multiple jurisdictions and our effective income tax rate could be adversely affected and we could have additional tax liability if existing tax laws or regulations change or if taxing authorities disagree with our interpretations of tax laws or regulations.
We are subject to income taxes in both the United States and certain foreign jurisdictions.
13 unchanged sentences
We have significant outstanding convertible debt.
−Removed: As of June 30, 2021, we had outstanding $0.6 million aggregate principal amount of our 2.75% Senior Convertible Notes due 2034 (2014 Notes) and $55.0 million aggregate principal amount of our 5.25% convertible senior notes due 2024 (2019 Notes).
−Removed: The 2014 Notes will mature on February 1, 2034, unless earlier
−Removed: converted, redeemed, or repurchased in accordance with the terms of the 2014 Notes.
+Added: As of September 30, 2021, we had outstanding $0.6 million aggregate principal amount of our 2.75% Senior Convertible Notes due 2034 (2014 Notes) and $55.0 million aggregate principal amount
+Added: of our 5.25% convertible senior notes due 2024 (2019 Notes).
+Added: The 2014 Notes will mature on February 1, 2034, unless earlier converted, redeemed, or repurchased in accordance with the terms of the 2014 Notes.
Pursuant to the terms of the indenture governing the 2014 Notes (2014 Notes Indenture), holders of the 2014 Notes may require us to repurchase all or a portion of the 2014 Notes at a repurchase price in cash equal to 100% of the principal amount of such 2014 Notes plus accrued and unpaid interest thereon, on each of February 6, 2024 and February 6, 2029.
139 unchanged sentences
• manufacturing disruptions that could occur if we are unable to successfully expand our production in our current or an alternative facility;
+Added: • supply chain disruptions;
• any future sales of our common stock or other securities in connection with raising additional capital or otherwise;
48 unchanged sentences
Any conversion of some or all of the 2014 Notes or 2019 Notes will dilute the ownership interests of our existing stockholders.
−Removed: Any sales in the public market of our common stock issuable upon such conversion could also adversely affect
−Removed: prevailing market prices of our common stock.
+Added: Any sales in the public market of our common stock issuable upon such conversion could also adversely affect prevailing market prices of our common stock.
In addition, holders of the 2014 Notes or 2019 Notes may hedge their position in such Convertible Notes by entering into short positions with respect to the underlying common stock.
4 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.