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In addition, you should consider the interrelationship and compounding effects of two or more risks occurring simultaneously.
−Removed: Also, the impacts of the COVID-19 pandemic may exacerbate the risks described below as well as risks and uncertainties not presently known to us.
Summary Risk Factors
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Risks related to our business and industry:
+Added: • Fluctuations in our operating results due to a variety of factors;
+Added: • Our ability to generate sufficient revenue, to become free cash flow positive and to achieve and maintain profitability;
+Added: • Our ability to generate revenue from recently introduced products;
• Our dependency on research and development spending by research institutions;
−Removed: • The COVID-19 pandemic and its impact on our customers and suppliers as well as on our operations, including supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages;
−Removed: • Our ability to generate sufficient revenue to achieve and maintain profitability;
• Our ability to compete effectively;
−Removed: • The ability of suppliers to meet our needs and the needs of our customers;
−Removed: • Fluctuations in our operating results due to a variety of factors;
−Removed: • Our products are specialized, complex and difficult to manufacture and we could experience production problems;
• Our ability and the ability of our partners to ship and manufacture products to the necessary specifications and quantities, and within necessary timeframes, to meet demand;
−Removed: • Our dependency on revenue generated from the sale of our Chromium solutions;
−Removed: • Our ability to effectively manage product transitions and forecast customer demand, including for our Chromium X Series;
+Added: • The ability of suppliers to meet our needs and the needs of our customers;
+Added: • Our products are specialized, complex and difficult to manufacture and we could experience production problems, including in sourcing raw materials and undetected errors and defects in our solutions;
• Our ability to increase penetration into our existing markets;
• Our ability to develop new products and enhance the capabilities of our existing products;
+Added: • Our dependency on revenue generated from the sale of our Chromium solutions;
+Added: • Our ability to effectively manage product transitions and forecast customer demand, including for our Chromium X Series;
• The success of our products in achieving and sustaining scientific acceptance;
−Removed: • Our ability to manage growth and anticipated growth;
−Removed: • The impact of seasonal fluctuations in our revenue and results of operations.
+Added: • Doing business internationally, including in China;
+Added: • The COVID-19 pandemic and its impact on our customers and suppliers as well as on our operations, including supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages.
Risks related to our regulatory environment and taxation:
−Removed: • Ethical, legal, privacy and social concerns or governmental restrictions surrounding the use of the genomic and multi-omic information and gene editing;
• Our products could become subject to more onerous government regulation;
• Enhanced trade tariffs, import restrictions, export restrictions, Chinese regulations or other trade barriers;
+Added: • Changes in tax laws or regulations that are applied adversely to us or our customers;
+Added: • Ethical, legal, privacy and social concerns or governmental restrictions surrounding the use of the genomic and multi-omic information and gene editing.
Risks related to our intellectual property, information technology and data security:
• Our success will depend on our ability to obtain, maintain and protect our intellectual property rights;
−Removed: • Our solutions contain third-party open source software components.
+Added: • Our dependence on certain intellectual property rights that are licensed to us.
Risks related to litigation and our intellectual property:
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• The multi-class structure of our common stock;
−Removed: • The requirement of our bylaws that the State of Delaware is the exclusive forum for disputes between us and our shareholders.
+Added: • The requirement of our bylaws that the State of Delaware is the exclusive forum for substantially all disputes between us and our shareholders.
+Added: General risks:
+Added: • Our ability to meet our publicly announced guidance or other expectations about our business;
+Added: • The volatility of the market price of our Class A common stock.
The summary risk factors described above should be read together with the text of the full risk factors below in this section entitled “ Risk Factors ” and the other information set forth in this Annual Report on Form 10-K, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC.
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Risks related to our business and industry
−Removed: Our business currently depends significantly on research and development spending by research institutions and the ability of researchers to access and fully utilize labs and conduct research, a reduction in which could limit demand for our products and materially and adversely affect our business and operating results.
−Removed: In the near term, we expect that a large portion of our revenue will continue to be derived from sales of Chromium and Visium products, including our instruments and consumables, to research institutions.
−Removed: As a result, the demand for our products will depend upon purchasing patterns of these customers, the ability of such customers to adequately staff, access and utilize labs and conduct research in light of the COVID-19 pandemic, the research and development budgets of these customers and the ability of such customers to receive funding for research, all of which are impacted by factors beyond our control, such as:
−Removed: • reductions in or other difficulties relating to staffing, capacity, slowdowns or shutdowns of laboratories or other institutions as well as other impacts stemming from the COVID-19 pandemic, such as reduced or delayed spending on instruments or consumables due to reductions in or other difficulties relating to staffing, capacity, slowdowns or shutdowns of laboratories or other institutions in which our instruments and solutions are used;
−Removed: • our inability or the inability of our customers to source products or necessary equipment, components and materials used in our products or in conjunction with our products because of issues with suppliers or distribution networks stemming from the COVID-19 pandemic, including supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages;
−Removed: • changes in our customers' research priorities, including those caused by the COVID-19 pandemic;
+Added: Our operating results have in the past fluctuated significantly and may continue to fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
+Added: Our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results.
+Added: These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to:
+Added: • the level of demand for our products, which may vary significantly and result in excess capacity expenses, our ability to accurately forecast such demand and our ability to increase penetration in our existing markets and expand into new markets;
+Added: • general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors;
+Added: • the success of our recently introduced products and new versions of existing products, and our ability to generate revenue for such products, and the introduction of other new products or product enhancements by us or others in our industry;
+Added: • risks related to our business in China, including potential impacts of COVID-19, competition or other factors;
+Added: • changes in governmental funding of life sciences research and development or other changes that impact budgets, budget cycles or seasonal or other spending patterns of our customers;
+Added: • changes in product mix, particularly from newly introduced products with lower gross margins;
+Added: • the volume and mix of our instrument and consumable sales or changes in the manufacturing or sales costs related to our instruments and consumables;
+Added: • differences in purchasing patterns across our customer base, including potential differences in consumables spending between early adopters of our solutions and more recent customers and variances in rates of increase of consumables spending following new instrument purchases, some of which may be compounded by impacts of the COVID-19 pandemic;
+Added: • the timing of our price increases;
+Added: • our ability and the ability of our partners to successfully manufacture our instruments and consumables in necessary quantities at necessary quality, including due to the impacts of supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages;
+Added: • shortages, delays, production problems, distribution and quality issues with the materials we purchase for manufacturing, which could impact our ability to manufacture and ship our instruments, consumables and related components;
+Added: • our inability or the inability of our customers to source our products or necessary equipment, components and materials used in our products or in conjunction with our products because of issues with suppliers, including supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages;
+Added: • the timing and amount of expenditures that we may incur to acquire, develop or commercialize additional products and technologies or for other purposes;
+Added: • our dependence and the dependence of our customers on single source and sole source suppliers for some of the equipment, components and materials used in our products or in conjunction with our products;
+Added: • the effects of inflation on us or our customers, manufacturers and suppliers, including increases in the cost of labor and materials;
+Added: • our ability to successfully integrate personnel, technology and other assets that we acquire into our company;
+Added: • difficulties encountered by our commercial carriers in delivering our instruments or consumables, whether as a result of external factors such as weather, customs or import processes, transportation bottlenecks, port lockdowns or slowdowns or fuel shortages or internal issues such as labor disputes or difficulties hiring and retaining adequate staffing;
+Added: • higher than anticipated warranty costs;
+Added: • the timing and amount of expenditures (including success fees) related to litigation, as well as the outcomes of and related rulings in the litigation and administrative proceedings which may vary substantially from quarter to quarter;
+Added: • the outcome of any current or future litigation or governmental investigations involving us or other third parties;
+Added: • changes in customer payment timing trends including potential increases in the days sales outstanding (DSO);
+Added: • future accounting pronouncements or changes in our accounting policies;
+Added: • expenses related to our facilities and real estate portfolio, including construction projects;
+Added: • disruptions in customers’ on-going experiments or interruptions in the ability of our customers to complete research projects, including as a result of the COVID-19 pandemic;
+Added: • reductions in or other difficulties relating to staffing, capacity, shutdowns or slowdowns of laboratories and other institutions, such as reduced or delayed spending on instruments or consumables due to reductions in or other difficulties relating to staffing, capacity, shutdowns or slowdowns of laboratories and other institutions in which our instruments and solutions are used;
+Added: • the impacts of geopolitical issues, infectious disease, epidemics or pandemics such as COVID-19 outbreaks and resurgences on our business operations and on the business operations of our customers, manufacturers and suppliers;
+Added: • the other factors described in this “ Risk Factors ” section.
+Added: The cumulative effects of the factors discussed above could result in large fluctuations and unpredictability in our quarterly and annual operating results.
+Added: As a result, comparing our operating results on a period-to-period basis may not be meaningful.
+Added: Investors should not rely on our past results as an indication of our future performance.
+Added: This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period.
+Added: If our revenue or operating results fall below the expectations of analysts or investors or below any guidance we may provide, or if the guidance we provide is below the expectations of analysts or investors, the price of our Class A common stock could decline substantially.
+Added: Such a stock price decline could occur even when we have met or exceeded any previously publicly stated guidance we may provide.
+Added: Our business currently depends significantly on research and development spending by research institutions, a reduction in which could limit demand for our products and materially and adversely affect our business and operating results.
+Added: In the near term, we expect that a large portion of our revenue will continue to be derived from sales of Chromium, Visium and Xenium products, including our instruments and consumables, to research institutions.
+Added: As a result, the demand for our products will depend upon purchasing patterns of these customers, the ability of such customers to adequately staff, access and utilize labs and conduct research, the research and development budgets of these customers and the ability of such customers to receive funding for research, all of which are impacted by factors beyond our control, such as:
• decreases in funding of research and development;
−Removed: • changes in, availability of or interruptions to funding or other incentives for our customers, including VAT and import tax exemptions available or potentially available to certain of our customers in China, including administrative or other delays in funding or incentive award processes, changes in the amount of funds or other incentives allocated to different areas of research, changes that have the effect of increasing the length of the funding or incentive award process or the impact of the COVID-19 pandemic on our customers and potential customers and their sources of funding or other incentives;
−Removed: • macroeconomic conditions and the political climate;
−Removed: • scientists’ and customers’ opinions of the utility of new products or services;
+Added: • changes in our customers' research priorities;
+Added: • macroeconomic conditions;
+Added: • scientists’ and customers’ opinions of the utility of recently introduced products or services;
+Added: • competitor product offerings or pricing;
+Added: • risks related to our business in China, including potential impacts from COVID-19, local competitors or other factors:
+Added: • changes in, availability of or interruptions to funding or other incentives for our customers, including VAT and import tax exemptions available or potentially available to certain of our customers in China, including administrative or other delays in funding or incentive award processes, changes in the amount of funds or other incentives allocated to different areas of research, changes that have the effect of increasing the length of the funding or incentive award process, or the impact of the COVID-19 pandemic or a resurgence of COVID-19 on our customers and potential customers and their sources of funding or other incentives;
+Added: • our inability or the inability of our customers to source products or necessary equipment, components and materials used in our products or in conjunction with our products because of issues with suppliers or distribution networks, including those that may arise from a resurgence of COVID-19, including supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages;
• citation of new products or services in published research;
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• differences in budgetary cycles;
−Removed: • competitor product offerings or pricing;
• market-driven pressures to consolidate operations and reduce costs;
+Added: • reductions in or other difficulties relating to staffing, capacity, slowdowns or shutdowns of laboratories or other institutions in which our solutions are used, including those that may arise from a resurgence of COVID-19, including reduced or
+Added: delayed spending on instruments or consumables due to reductions in or other difficulties relating to staffing, capacity, slowdowns or shutdowns of laboratories or other institutions in which our solutions are used;
• market acceptance of relatively new technologies, such as ours.
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Additionally, the research of our customers often requires long uninterrupted studies performed on a consistent basis over time.
−Removed: Reductions in or other difficulties relating to staffing, capacity, lab slowdowns or shutdowns or interruptions in the ability of our customers to complete research projects, including reductions in staffing, capacity, slowdowns or shutdowns or interruptions stemming from the COVID-19 pandemic, could be particularly damaging to these studies, our customers and our business.
−Removed: The impacts and potential impacts of the COVID-19 pandemic continue to create significant uncertainty for our business, financial condition and results of operations.
−Removed: The extent of the impacts of the COVID-19 pandemic on our business and financial results will continue to depend on numerous evolving factors that we are not able to accurately predict and which will vary by market, including the duration and scope of the pandemic, supply chain disruptions, logistics, shipping and other distribution disruptions, operations disruptions, labor shortages, resurgences, local, state, national and global vaccination efforts, global economic conditions during and after the pandemic, governmental actions that have been taken, or may be taken in the future, in response to the pandemic, and changes in customer behaviors in response to the pandemic, some of which may be more than just temporary.
−Removed: Our global operations expose us to risks associated with the COVID-19 pandemic, which has continued to result in challenging operating environments.
−Removed: COVID-19 continues to affect all of the countries and territories in which our products are developed, made, manufactured, distributed or sold.
−Removed: COVID-19 mitigation measures, including travel bans and restrictions, quarantines, curfews, shelter in place and safer-at-home orders, business shutdowns, slowdowns and closures, have impacted and continue to impact us, our employees, customers, contract manufacturers, distributors, partners, suppliers and other third parties with whom we do business.
−Removed: The countries and territories in which our products are developed, made, manufactured, distributed or sold are in varying stages of restrictions, re-opening and closing to address the COVID-19 pandemic.
−Removed: Certain jurisdictions have begun re-opening only to return to restrictions in the face of increases in new COVID-19 cases.
−Removed: There remains considerable uncertainty regarding how the effects of the pandemic, including supply chain disruptions, logistics, shipping and other distribution disruptions, labor shortages and current and future health and safety measures implemented in response to the pandemic, will impact our business, including whether they will result in further changes in demand for our products, further increases in operating costs (whether as a result of labor shortages, changes or disruptions to supply chains or logistics, shipping and other distribution operations or increases in employee costs, operating costs or otherwise), further impact our ability to perform research and development, manufacturing, and shipping
−Removed: of our products and other necessary equipment, components and materials, how they will further impact our supply chain and the availability of our products or equipment, components and materials used in conjunction with our products and whether they will result in further reduced availability of air or other commercial transport, port closures or border restrictions or cause other disruptions to logistics, shipping or other distribution operations, each or all of which can impact our ability to make, manufacture, distribute and sell our products.
−Removed: To date, we have incurred increased costs as a result of COVID-19, including increased expenses related to supply chain disruptions, logistics, shipping and other distribution disruptions, labor shortages and implementation of additional measures to ensure the health and safety of our workforce.
−Removed: In addition, measures that impact our ability to access and utilize our facilities may continue to impact the availability of our employees, some of whom are not able to perform their job functions remotely.
−Removed: If a significant percentage of our or our partners’ workforce is unable to work, including because of illness, facility closures, quarantine, curfews, shelter in place orders, travel restrictions, social distancing requirements or other governmental restrictions or voluntarily adopted practices, our operations will be negatively impacted.
−Removed: Any sustained interruption in our, our partners’ or other third parties' operations, research and development, labor force, distribution network or supply chain or any significant continuous shortage of products, equipment, components or materials or other supplies as a result of the COVID-19 pandemic or otherwise, including as a result of increased demand for certain products, could materially impair our ability to develop, make, manufacture, distribute or sell our products.
−Removed: If the operations of our suppliers or our customers' suppliers are impacted by supply chain disruptions, logistics, shipping and other distribution disruptions or labor shortages, we may not be able to source the necessary equipment, components and materials to build or distribute our products in sufficient quantities to meet demand or our customers may not be able to source the equipment, components and materials they need to use our products.
−Removed: • demand for COVID-19 testing and research has impacted, and may continue to impact, our ability and our customers' ability to utilize facilities and source equipment, components and materials used in our products or in conjunction with our products that are also needed for COVID-19 testing and research;
−Removed: • shortages of non-10x sequencing consumables has impacted, and may continue to impact, the workflows of our customers and their ability to complete their experiments;
−Removed: • the storage and distribution of COVID-19 vaccines has impacted, and may continue to impact, the availability of cold storage for our consumables and other components and materials used by us and our customers in connection with our products;
−Removed: • plastic component shortages, including of pipette tips utilized by our customers to complete their experiments, have impacted, and may continue to impact, the availability of plastic components used by us and our customers in connection with our products;
−Removed: • competition for shipping and air transport has impacted, and may continue to impact, our ability to timely deliver products to our customers;
−Removed: • shortages of certain chemicals, oils and beads utilized in our microfluidic chips has impacted, and may continue to impact, our ability to carry a buffer of inventory to safeguard against continuous significant shortages of such materials;
−Removed: • semiconductor chip shortages have impacted, and may continue to impact, the availability of semiconductor chips utilized in our instruments and in the manufacture of certain of our products;
−Removed: • energy shortages and other issues have impacted, and may continue to impact, factory production of upstream components utilized by us or our suppliers;
−Removed: • natural gas shortages have impacted, and may continue to impact, the availability of dry ice utilized in the storage and distribution of our products.
−Removed: The risk that we will not be able to source the necessary equipment, components and materials to manufacture our products has led us to carry higher inventory.
−Removed: Additionally, the risk that we, our suppliers, our customers or other third parties may not be able to source the equipment, components and materials needed to manufacture or use our products may require that we redesign and/or requalify, or attempt to redesign and/or requalify, certain of our products in order to facilitate our customers' experiments, and such attempts to redesign and/or requalify may not be successful.
−Removed: Compliance with governmental or other measures imposed in response to COVID-19 has caused and will continue to cause us to incur additional costs, and any inability to comply with such measures can subject us to restrictions on our business activities, fines and other penalties, any of which can adversely affect our business.
−Removed: In addition, while much of our workforce had returned to our offices and resumed onsite work, resurgences of COVID-19 resulted in a return to remote work for our employees.
−Removed: Having our employees working remotely amplified certain risks to our business and may do so again.
−Removed: For example, the increase in remote work has increased demand on our information technology resources and systems, increased phishing and other malicious activity
−Removed: as cybercriminals try to exploit the uncertainty surrounding the COVID-19 pandemic and led to an increase in the number of points of potential exposure, such as laptops and mobile devices, to be secured.
−Removed: Any failure to effectively manage these risks, including to timely identify and appropriately respond to any security incidents, may adversely affect our business.
−Removed: Public concern regarding the risk of contracting COVID-19 has and may impact demand from customers.
−Removed: The ongoing economic impacts and health concerns associated with the pandemic may continue to affect customer behaviors and resurgences of COVID-19 could amplify such impacts.
−Removed: In addition, changes in customer purchasing patterns may increase demand for our products in one quarter, resulting in decreased customer demand for our products in subsequent quarters.
−Removed: Spikes in customer demand for our products may make it harder for us to distribute our products in a timely manner.
−Removed: In addition, some researchers who would be running experiments using our platforms have instead shifted their resources to COVID-19 experimentation.
−Removed: Furthermore, our growth strategies include capital intensive initiatives, such as significant investments in research and development and the acquisition or licensing of core technologies and associated intellectual property.
−Removed: The continued economic uncertainty associated with the COVID-19 pandemic has resulted in volatility in the global capital and credit markets which could impair our ability to access these markets on terms commercially acceptable to us, or at all, and execute our growth strategies.
−Removed: While we have developed and implemented and continue to develop and implement health and safety protocols, business continuity plans and crisis management protocols in an effort to try to mitigate the negative impact of COVID-19 on our employees and our business, there can be no assurance that we will be successful in our efforts or that such efforts may not have detrimental unintended consequences, and as a result, our business, financial condition and results of operations and the price of our Class A common stock may be materially and adversely affected.
+Added: Reductions in or other difficulties relating to staffing, capacity, lab slowdowns or shutdowns or interruptions in the ability of our customers to complete research projects, including reductions in staffing, capacity, slowdowns or shutdowns or interrupt ions stemming from a resurgence of COVID-19, could be particularly damaging to these studies, our customers and our business.
+Added: Our industry is highly competitive.
+Added: If we fail to compete effectively, our business and operating results will suffer.
+Added: We face significant competition.
+Added: We currently compete with both established and early-stage companies that have introduced products for, among other things, genomics analysis, single cell analysis, spatial analysis and in situ analysis.
+Added: There are additional companies, including both early stage and established, that have indicated that they are designing, manufacturing and marketing products to compete with us or that they intend to do so in the future.
+Added: Some of these companies may have substantially greater financial and other resources than we do, including larger research and development staff or larger, more established marketing, distribution, service and sales organizations.
+Added: In addition, they may have greater name recognition than we do.
+Added: Other competitors are in the process of developing novel technologies for the life sciences market which may lead to products that rival or replace our products.
+Added: We expect new competitors to emerge and the intensity of competition to increase.
+Added: We also face competition from researchers developing their own solutions.
+Added: The area in which we compete involves rapid innovation and some of our customers have in the past, and more may in the future, elect to create their own platform or assays rather than rely on a third-party supplier such as ourselves.
+Added: This is particularly true for the largest research centers and labs who are continually testing and trying new technologies, whether from a third-party vendor or developed internally.
+Added: We also compete for the resources our customers allocate for purchasing a wide range of products used to analyze biological systems, some of which are additive to or complementary with our own but not directly competitive.
+Added: Our products may not compete favorably or be successful in the face of increasing competition from products and technologies introduced by our existing competitors, companies entering our markets or developed by our customers internally.
+Added: In addition, our competitors may have or will in the future develop products or technologies that currently or in the future will enable them to produce competitive products with greater capabilities or at lower costs than ours or that are able to run comparable experiments at a lower total experiment cost.
+Added: Any failure to compete effectively could materially and adversely affect our business, financial condition and operating results.
+Added: We may be unable to consistently manufacture our instruments and consumables to the necessary specifications or in quantities necessary to meet demand at an acceptable cost or at an acceptable performance level.
+Added: Our products are integrated solutions with many different components that work together.
+Added: As such, a quality defect in a single component can compromise the performance of the entire solution.
+Added: Certain of our consumables are manufactured at our
+Added: Pleasanton, California and Singapore facilities using complex processes, sophisticated equipment and strict adherence to specifications and quality systems procedures.
+Added: Our Chromium and Visium CytAssist instruments are manufactured by our third-party manufacturers at their facilities.
+Added: In order to successfully generate revenue from our products, we need to manufacture products that meet our specifications before we allow them to be shipped and to supply our customers with products that meet their expectations for quality and functionality in accordance with established specifications.
+Added: In order to ensure we are able to meet these expectations, our Pleasanton, California manufacturing facilities, as well as the facilities of our third-party manufacturers, have obtained International Organization for Standardization (“ISO”) quality management certifications and employ other quality control measures.
+Added: On occasion, our customers have experienced quality control and manufacturing defects and may again in the future.
+Added: For example, a manufacturing defect in certain of our legacy Chromium Controllers resulted in an unacceptable level of LCD screen failures and we launched a free replacement program in 2018 to allow customers to replace affected LCD screens as a result.
+Added: In addition, in the first half of 2023 we plan to move certain of our operations currently located in leased facilities in Pleasanton to a newly constructed facility located in Pleasanton which we own.
+Added: We may experience operational delays or difficulties as a result of transitioning operations to our new facility, including if our equipment and materials are harmed or rendered inoperable as a result of the move, which could adversely affect our business, financial condition and results of operations.
+Added: Additionally, as we continue to grow and introduce new products, and as our products incorporate increasingly sophisticated technology, it will be increasingly difficult to ensure our products are produced in the necessary quantities without sacrificing quality and in the necessary timeframes.
+Added: There is no assurance that we or our third-party manufacturers will be able to continue to manufacture our products so that they consistently achieve the product specifications, quality and volumes that meet our requirements or our customers' expectations.
+Added: Certain of the raw materials we use and certain of our consumables have a shelf life, after which their performance is not ensured.
+Added: Expiring raw materials could increase our operational costs and cause delays in manufacturing adequate volumes of our products within the timeframes required.
+Added: Shipments of defective instruments or consumables to customers may result in recalls and warranty replacements, which would increase our costs, and depending upon current inventory levels and the availability and lead time for additional inventory, could lead to availability issues.
+Added: Any future design issues, unforeseen manufacturing problems, such as contamination of our third-party manufacturer's facilities, equipment malfunctions, aging components, quality issues with components and materials sourced from third-party suppliers, or failures to strictly follow procedures or meet specifications, may have a material adverse effect on our brand, business, financial condition and operating results and could result in us or our third-party manufacturers losing ISO quality management certifications.
+Added: If we or our third-party manufacturers fail to manufacture products without defects that meet our specifications or maintain ISO quality management certifications, our customers might choose not to purchase products from us.
+Added: Furthermore, we or our third-party manufacturers may not be able to increase manufacturing to meet anticipated demand or may experience downtime.
+Added: In addition, as we increase manufacturing capacity, we will also need to make corresponding improvements to other operational functions, such as our customer service and billing systems, compliance programs and our internal quality assurance programs.
+Added: We will also need additional equipment, manufacturing and warehouse space and trained personnel to process higher volumes of products.
+Added: We cannot assure you that any increases in scale, related improvements and quality assurance will be successfully implemented or that equipment, manufacturing and warehouse space and appropriate personnel will be available.
+Added: As we develop additional products, we may need to bring new equipment online, implement new systems, technology, controls and procedures and hire personnel with different qualifications.
+Added: Our ability to increase our manufacturing capacity at our Pleasanton, California and Singapore locations is complicated by the use of our proprietary equipment that is not readily available from third-party manufacturers.
+Added: The risk of manufacturing defects or quality control issues is generally higher for new products, whether produced by us or a third-party manufacturer, products that are transitioned from one manufacturer to another, particularly if manufacturing is transitioned or initiated with a manufacturer we have not worked with in the past, and products that are transferred from one manufacturing facility to another.
+Added: Our current product roadmap calls for the introduction of new instruments and consumables, which may require that we utilize manufacturers with which we have little or no prior manufacturing experience and the risk of manufacturing defects or quality control issues could increase as a result.
+Added: The expansion of our manufacturing capabilities could increase the risk of manufacturing defects or quality control issues in the consumables we manufacture.
+Added: We and our third-party manufacturers may not be able to launch new products on time, transition manufacturing of existing products to new manufacturers, transition our manufacturing capabilities to a new location or transition manufacturing of any additional consumables in-house without manufacturing def ects.
+Added: An inability to manufacture products and components that consistently meet specifications, in necessary quantities and at commercially acceptable costs will have a negative impac t and may have a material adverse effect on our business, financial condition and results of operations.
We and our customers are dependent on single source and sole source suppliers for some of the equipment, components and materials used in our products and in conjunction with our products and the loss of any of these suppliers could harm our business.
−Removed: The ability of suppliers to meet our needs and the needs of our customers could be reduced or eliminated by the impacts of the COVID-19 pandemic or other factors.
We do not have long-term contracts with our suppliers for the significant majority of the services, equipment, materials and components we use for the manufacture and delivery of our products.
−Removed: We also rely on single suppliers for all of our requirements for certain equipment, materials or components.
+Added: We also rely on single suppliers for certain equipment, materials and components.
In many cases we do not have long term contracts with these suppliers, and even in the cases where we do, the contracts include significant qualifications that would make it extremely difficult for us to force the supplier to provide us with their services, equipment, materials or components should they choose not to do so.
We are therefore subject to the risk that these third-party suppliers will not be able or willing to continue to provide us with equipment, materials and components that meet our needs, specifications, quality standards and delivery schedules.
−Removed: Factors that could impact our suppliers’ willingness and ability to continue to provide us with the required equipment, materials and components include shortages, alternative priorities, logistics, shipping or other distribution difficulties, disruption at or affecting our suppliers’ facilities, such as difficulties hiring and retaining adequate staffing, work stoppages or natural disasters, infectious disease, epidemics or pandemics including COVID-19, outbreaks and resurgences, adverse weather or other conditions that affect their supply, the financial condition of our suppliers, deterioration in our relationships with these suppliers or the decision by such suppliers to introduce products that compete directly with our solutions.
+Added: Factors that could impact our suppliers’ willingness and ability to continue to provide us with the required equipment, materials and components include shortages, alternative priorities, logistics, shipping or other distribution difficulties, disruption at or affecting our suppliers’ facilities, such as difficulties hiring and retaining adequate staffing, work stoppages or natural disasters, infectious disease, epidemics or pandemics such as COVID-19 outbreaks and resurgences, adverse weather or other conditions that affect their supply, the financial condition of our suppliers, deterioration in our relationships with these suppliers or the decision by such suppliers to introduce products that compete directly with our solutions.
If we are not able to obtain equipment, materials and components that meet our needs, specifications, quality standards and delivery schedule on satisfactory terms, our business will be harmed.
−Removed: Any increase in equipment, material and component costs or decrease in availability could reduce our sales and harm our gross margins.
+Added: Any increase in equipment, material and component costs or decrease in availability could reduce our sales, harm our gross margins or prevent us from timely delivering our products to our customers.
For example, we depend on a limited number of suppliers for enzymes and amplification mixes used in our consumables.
−Removed: In some cases, these manufacturers are the sole source of certain types of enzymes and reagents.
+Added: In some cases, these manufacturers are the sole source of certain necessary enzymes and reagents.
We do not have long-term contracts with most of these sole source suppliers.
−Removed: Lead times for some of these components can be several months or more and in the past have been, and in the future could be again, exacerbated due to the COVID-19 pandemic, supply chain disruptions, labor shortages or other factors.
+Added: Lead times for some of these components can be several months or more and in the past have been, and in the future could be again, extended due to a resurgence of the COVID-19 pandemic, supply chain disruptions, labor shortages or other factors.
In the event that demand increases, a manufacturing ‘lot’ does not meet our specifications or we fail to forecast and place purchase orders sufficiently in advance, this could result in a material shortage.
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We have not qualified secondary sources for all equipment, materials or components that we source through a single supplier and qualification of a secondary supplier may not prevent future supply issues.
−Removed: Labor shortages, logistics, shipping or other
−Removed: distribution operations difficulties or disruption in the supply of equipment, materials or components could impair our ability to sell our products and meet customer demand, and also could delay the launch of new products, any of which could harm our business and results of operations.
+Added: Labor shortages, logistics, shipping or other distribution operations difficulties or disruption in the supply of equipment, materials or components could impair our ability to sell our products and meet customer demand, and also could delay the launch of new products, any of which could harm our business and results of operations.
If we were to have to change suppliers, the new supplier may not be able to provide us equipment, materials or components in a timely manner and in adequate quantities that are consistent with our quality standards and on satisfactory pricing terms.
In addition, alternative sources of supply may not be available for equipment or materials.
−Removed: While we have taken steps to mitigate potential supply chain and transportation infrastructure system issues which may result from the COVID-19 pandemic, the impacts of the COVID-19 pandemic, supply chain disruptions, logistics, shipping and other distribution disruptions, labor shortages or other factors may exacerbate the risks described in this risk factor and could cause certain of our suppliers to reduce their ability to meet our or our customers' needs, be unable to operate temporarily or even go out of business permanently.
+Added: While we have taken steps to mitigate potential supply chain and transportation infrastructure system issues, including those which may result from a resurgence of COVID-19, the impact of supply chain disruptions, logistics, shipping and other distribution disruptions, labor shortages or other factors may exacerbate the risks described in this risk factor and could cause certain of our suppliers to reduce their ability to meet our or our customers' needs, be unable to operate temporarily or even go out of business permanently.
The realization of any of these risks could prevent us from producing, selling or delivering our products, reduce our sales and harm our gross margins or permanently cause a change in one or more of our products that may not be accepted by our customers or cause us to eliminate that product altogether.
In addition, our suppliers or customers may face difficulties in procuring or delivering, or in some cases may be unable to procure or deliver, the equipment, materials or components from their own suppliers necessary to supply us with products, equipment, components or materials or conduct experiments using our solutions.
−Removed: • demand for COVID-19 testing and research has impacted, and may continue to impact, our ability and our customers' ability to source equipment, components and materials used in our products or in conjunction with our products that are also needed for COVID-19 testing and research;
−Removed: • shortages of non-10x sequencing consumables has impacted, and may continue to impact, the workflows of our customers and their ability to complete their experiments;
−Removed: • the storage and distribution of COVID-19 vaccinations has impacted, and may continue to impact, the availability of cold storage for components and materials used by us and our customers in connection with our products;
−Removed: • plastic component shortages, including of pipette tips utilized by our customers to complete their experiments, have impacted, and may continue to impact, the availability of plastic components used by us and our customers in connection with our products;
−Removed: • competition for shipping and air transport has impacted, and may continue to impact, our ability to timely deliver products to our customers;
−Removed: • shortages of certain chemicals, oils and beads utilized in our microfluidic chips has impacted, and may continue to impact, our ability to carry a buffer of inventory to safeguard against continuous significant shortages of such materials;
−Removed: • semiconductor chip shortages have impacted, and may continue to impact, the availability of semiconductor chips utilized in our instruments and in the manufacture of certain of our products;
−Removed: • energy shortages and other issues have impacted, and may continue to impact, factory production of upstream components utilized by us or our suppliers.
−Removed: We rely exclusively on commercial carriers to transport our products, including perishable consumables, to our customers in a timely and cost-efficient manner and if these delivery services are disrupted, our business will be harmed.
−Removed: Our business depends on our ability to quickly and reliably deliver our products and in particular, our consumables, to our customers.
−Removed: The majority of our consumables are perishable and must be kept below certain temperatures.
−Removed: As such, we ship our refrigerated consumables on dry ice and only ship such consumables on certain days of the week to reach customers on a timely basis.
−Removed: Disruptions in the delivery of our products, whether due to hiring difficulties or labor disruptions, fuel shortages, dry ice shortages, bad weather, natural disasters, infectious disease, conflict, war, civil unrest, epidemics or pandemics including COVID-19, outbreaks and resurgences, terrorist acts or threats or for other reasons could result in delivery delays or our customers receiving consumables that are not fit for usage, and if used, could result in inaccurate results or ruined experiments.
−Removed: While we work with customers to replace any consumables that are impacted by delivery disruptions, our reputation and our business may be adversely impacted even if we replace perished consumables free of charge.
−Removed: In addition, if we are unable to continue to obtain expedited delivery services on commercially reasonable terms, our operating results may be adversely affected.
−Removed: In addition, both shipping and air transport has recently been negatively impacted in terms of speed and capacity.
−Removed: Should our commercial carriers encounter difficulties in delivering our instruments or consumables to customers, including due to impacts stemming from the COVID-19 pandemic, it could adversely impact our ability to deliver our products to our customers, or to recognize revenue for those products and accordingly adversely affect our financial results for that period and such impact could be particularly acute at the end of any financial quarter.
−Removed: Our operating results have in the past fluctuated significantly and may continue to fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
−Removed: Our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results.
−Removed: These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to:
−Removed: • reductions in or other difficulties relating to staffing, capacity, shutdowns or slowdowns of laboratories and other institutions as well as other impacts stemming from the COVID-19 pandemic or other factors, such as reduced or delayed spending on instruments or consumables due to reductions in or other difficulties relating to staffing, capacity, shutdowns or slowdowns of laboratories and other institutions in which our instruments and solutions are used;
−Removed: • our inability or the inability of our customers to source our products or necessary equipment, components and materials used in our products or in conjunction with our products because of issues with suppliers stemming from the COVID-19 pandemic, including supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages;
−Removed: • disruptions in customers’ on-going experiments or interruptions in the ability of our customers to complete research projects as a result of the COVID-19 pandemic;
−Removed: • differences in purchasing patterns across our customer base, including potential differences in consumables spending between early adopters of our solutions and more recent customers and variances in rates of increase of consumables spending following new instrument purchases, some of which may be compounded by impacts of the COVID-19 pandemic;
−Removed: • our dependence and the dependence of our customers on single source and sole source suppliers for some of the equipment, components and materials used in our products or in conjunction with our products;
−Removed: • shortages, delays, production problems, distribution and quality issues with the materials we purchase for manufacturing, which could impact our ability to manufacture and ship our instruments, consumables and related components;
−Removed: • the level of demand for our products, which may vary significantly and result in excess capacity expenses, our ability to accurately forecast such demand and our ability to increase penetration in our existing markets and expand into new markets;
−Removed: • the effects of inflation on us or our customers, manufacturers and suppliers, including increases in the cost of labor and materials;
−Removed: • our ability to successfully integrate new personnel, technology and other assets that we acquire into our company;
−Removed: • the timing and amount of expenditures (including success fees) related to litigation, as well as the outcomes of and related rulings in the litigation and administrative proceedings which may vary substantially from quarter to quarter;
−Removed: • our ability and the ability of our partners to successfully manufacture our instruments and consumables in necessary quantities at necessary quality, including due to the impacts of supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages;
−Removed: • the timing and cost of, and level of investment in, research and development and commercialization activities relating to our products, which may change from time to time;
−Removed: • the volume and mix of our instrument and consumable sales or changes in the manufacturing or sales costs related to our instruments and consumables;
−Removed: • the success of our recently introduced products and new versions of existing products and the introduction of other new products or product enhancements by us or others in our industry;
−Removed: • the timing and amount of expenditures that we may incur to acquire, develop or commercialize additional products and technologies or for other purposes;
−Removed: • changes in governmental funding of life sciences research and development or other changes that impact budgets, budget cycles or seasonal or other spending patterns of our customers;
−Removed: • future accounting pronouncements or changes in our accounting policies;
−Removed: • the outcome of any current or future litigation or governmental investigations involving us or other third parties;
−Removed: • difficulties encountered by our commercial carriers in delivering our instruments or consumables, whether as a result of external factors such as weather, customs or import processes, transportation bottlenecks, port lockdowns or slowdowns or fuel shortages or internal issues such as labor disputes or difficulties hiring and retaining adequate staffing;
−Removed: • general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors;
−Removed: • higher than anticipated warranty costs;
−Removed: • expenses related to our facilities and real estate portfolio, including construction projects;
−Removed: • the impacts of infectious disease, epidemics, pandemics, outbreaks and resurgences, including the effects of the COVID-19 pandemic, on our business operations and on the business operations of our customers, manufacturers and suppliers;
−Removed: • the other factors described in this “ Risk Factors ” section.
−Removed: The cumulative effects of the factors discussed above could result in large fluctuations and unpredictability in our quarterly and annual operating results.
−Removed: As a result, comparing our operating results on a period-to-period basis may not be meaningful.
−Removed: Investors should not rely on our past results as an indication of our future performance.
−Removed: This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period.
−Removed: If our revenue or operating results fall below the expectations of analysts or investors or below any guidance we may provide, or if the guidance we provide is below the expectations of analysts or investors, the price of our Class A common stock could decline substantially.
−Removed: Such a stock price decline could occur even when we have met or exceeded any previously publicly stated guidance we may provide.
+Added: • competition for shipping and air transport in the past impacted, and in the future may impact, our ability to timely deliver products to our customers;
+Added: • energy shortages and other issues in the past impacted, and in the future may impact, factory production of upstream components utilized by us or our suppliers;
+Added: • shortages of non-10x sequencing consumables in the past impacted, and in the future may impact, the workflows of our customers and their ability to complete their experiments;
+Added: • the storage and distribution of COVID-19 vaccinations in the past impacted, and in the future may impact, the availability of cold storage for components and materials used by us and our customers in connection with our products;
+Added: • plastic component shortages, including of pipette tips utilized by our customers to complete their experiments, in the past impacted, and in the future may impact, the availability of plastic components used by us and our customers in connection with our products;
+Added: • shortages of certain chemicals, oils and beads utilized in our microfluidic chips in the past impacted, and in the future may impact, our ability to carry a buffer of inventory to safeguard against continuous significant shortages of such materials;
+Added: • semiconductor chip shortages in the past impacted, and in the future may impact, the availability of semiconductor chips utilized in our instruments and in the manufacture of certain of our products.
Our instruments, consumables and related components are specialized, complex and difficult to manufacture.
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We may have quality variations, supply issues, backorders, delays, shortages or production difficulties of needed components and may require components that are difficult to obtain or manufacture in necessary quantities and at necessary quality, in a timely manner or in accordance with regulatory requirements.
−Removed: Such issues, issues with our manufacturing processes or the manufacturing processes of our third-party manufacturers, shipping issues, inaccurate demand forecasts or other production issues (including issues stemming from the COVID-19 pandemic) could result in our inability to supply our products to our customers, backorders, insufficient inventory, excess inventory, shipping delays, product deficiencies or other operational failures.
−Removed: For example, the COVID-19 pandemic has disrupted air, sea and other travel in the United States and globally.
−Removed: Such disruptions could reduce or eliminate our ability to receive components or supply our customers.
−Removed: If we cannot supply our products to our customers in a timely manner, our customers may delay or cancel their orders.
−Removed: Furthermore, even if we have inventory, if we do not have adequate inventory of products in the geographic regions in which they are ordered, we may not be able to deliver products to our customers in a timely manner and customers may delay or cancel their orders.
−Removed: Many other factors could cause production or shipping delays or interruptions, including difficulties in transporting materials, equipment, raw material or other shortages, raw material failures, equipment malfunctions, facility contamination, labor problems, natural disasters, infectious disease, conflict, war, civil unrest, epidemics or pandemics including COVID-19, outbreaks and resurgences, disruption in utility services, terrorist activities or circumstances beyond our control.
+Added: Such issues, issues with our manufacturing processes or the manufacturing processes of our third-party manufacturers, shipping issues, inaccurate demand forecasts or other production issues could result in our inability to produce our products in sufficient volumes to meet demand, supply our products to our customers, backorders, insufficient inventory, excess inventory, shipping delays, product deficiencies or other operational failures.
+Added: For example, in the past the COVID-19 pandemic disrupted air, sea and other travel in the United States and globally.
+Added: Similar disruptions in the future could reduce or eliminate our ability to receive components or supply our customers.
+Added: Many other factors could cause production or shipping delays or interruptions, including difficulties in transporting materials, equipment, raw material or other shortages, raw material failures, spoilage, equipment malfunctions, facility contamination, labor problems, natural disasters, infectious disease, conflict, war, civil unrest, epidemics or pandem ics such as COVID-19 o utbreaks and resurgences, disruption in utility services, terrorist activities or circumstances beyond our control.
Additionally, we and our third-party manufacturers may encounter problems in hiring and retaining the experienced specialized personnel needed to develop and operate our manufacturing processes or the manufacturing processes of our third-party manufacturers, which could result in backorders, shortages, delays in our production or difficulties in maintaining compliance with applicable regulatory requirements.
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We use a broad range of materials and supplies, including metals, chemicals and electronic components, in our products.
−Removed: A significant disruption in the supply of materials, including disruptions stemming from the COVID-19 pandemic, could decrease
−Removed: production and shipping levels, materially increase our operating costs and materially adversely affect our profit margins.
−Removed: Shortages of materials or interruptions in production and transportation systems, labor strikes, work stoppages, infectious disease, epidemics or pandemics including COVID-19, outbreaks and resurgences, conflict, war, civil unrest, acts of terrorism or other interruptions to or difficulties in the employment of labor or transportation that adversely impact equipment, materials and components we require for the production of our products, may adversely affect our ability to maintain production of our products and generate revenue.
+Added: A significant disruption in the supply of materials could decrease production and shipping levels, materially increase our operating costs and materially adversely affect our profit margins.
+Added: Shortages of materials or interruptions in production and transportation systems, labor strikes, work stoppages, infectious disease, epidemics or pandemics such as COVID-19 outbreaks and resurgences, geopolitical issues, conflict, war, civil unrest, acts of terrorism or other interruptions to or difficulties in the employment of labor or transportation that adversely impact equipment, materials and components we require for the production of our products, may adversely affect our ability to maintain production of our products and generate revenue.
In addition, a significant prolonged increase in inflation could negatively impact the cost of materials and components.
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If we were to experience a significant disruption in the supply of, or prolonged shortage of, critical components from any of our suppliers and could not procure the components from other sources, we would be unable to manufacture our products and to ship such products to our customers in a timely fashion, which would adversely affect our sales, margins and customer relations.
−Removed: We may be unable to consistently manufacture our instruments and consumables to the necessary specifications or in quantities necessary to meet demand at an acceptable cost or at an acceptable performance level.
−Removed: Our products are integrated solutions with many different components that work together.
−Removed: As such, a quality defect in a single component can compromise the performance of the entire solution.
−Removed: Certain of our consumables are manufactured at our Pleasanton, California and Singapore facilities using complex processes, sophisticated equipment and strict adherence to specifications and quality systems procedures.
−Removed: In many cases, the consumables we manufacture are bundled with products or components that we source from third parties and assemble, package and perform quality assurance testing at our Pleasanton facilities.
−Removed: Our Chromium instruments are manufactured by our third-party manufacturers at their facilities.
−Removed: In order to successfully generate revenue from our products, we need to manufacture products that meet our specifications before we allow them to be shipped and to supply our customers with products that meet their expectations for quality and functionality in accordance with established specifications.
−Removed: In order to ensure we are able to meet these expectations, our Pleasanton, California manufacturing facilities, as well as the facilities of our third-party manufacturers, have obtained International Organization for Standardization (“ISO”) quality management certifications and employ other quality control measures.
−Removed: While customer complaints regarding defects in our products and consumables have historically been low, our customers have experienced quality control and manufacturing defects in the past.
−Removed: For example, a manufacturing defect in certain of our Chromium Controllers resulted in an unacceptable level of LCD screen failures and we launched a free replacement program in 2018 to allow customers to replace affected LCD screens as a result.
−Removed: As we continue to grow and introduce new products, and as our products incorporate increasingly sophisticated technology, it will be increasingly difficult to ensure our products are produced in the necessary quantities without sacrificing quality.
−Removed: There is no assurance that we or our third-party manufacturers will be able to continue to manufacture our products so that they consistently achieve the product specifications and quality that meet our requirements or our customers' expectations.
−Removed: Certain of our consumables are subjected to a shelf life, after which their performance is not ensured.
−Removed: Shipment of consumables that effectively expire early or prior to use by our customers due to delivery delays, or shipment of defective instruments or consumables to customers, may result in recalls and warranty replacements, which would increase our costs, and depending upon current inventory levels and the availability and lead time for additional inventory, could lead to availability issues.
−Removed: Any future design issues, unforeseen manufacturing problems, such as contamination of our or their facilities, equipment malfunctions, aging components, quality issues with components and materials sourced from third-party suppliers, or failures to strictly follow procedures or meet specifications, may have a material adverse effect on our brand, business, financial condition and operating results and could result in us or our third-party manufacturers losing ISO quality management certifications.
−Removed: If we or our third-party manufacturers fail to manufacture products without defects that meet our specifications or maintain ISO quality management certifications, our customers might choose not to purchase products from us.
−Removed: Furthermore, we or our third-party manufacturers may not be able to increase manufacturing to meet anticipated demand or may experience downtime.
−Removed: In addition, as we increase manufacturing capacity, we will also need to make corresponding improvements to other operational functions, such as our customer service and billing systems, compliance programs and our internal quality assurance programs.
−Removed: We will also need additional equipment, manufacturing and warehouse space and trained personnel to process higher volumes of products.
−Removed: We cannot assure you that any increases in scale, related improvements and quality assurance will be successfully implemented or that equipment, manufacturing and warehouse space and appropriate personnel will be available.
−Removed: As we develop additional products, we may need to bring new equipment online, implement new systems, technology, controls and procedures and hire personnel with different qualifications.
−Removed: Our ability to increase our manufacturing capacity at our Pleasanton, California and Singapore locations is complicated by the use of our proprietary equipment that is not readily available from third-party manufacturers.
−Removed: The risk of manufacturing defects or quality control issues is generally higher for new products, whether produced by us or a third-party manufacturer, products that are transitioned from one manufacturer to another, particularly if manufacturing is transitioned or initiated with a manufacturer we have not worked with in the past, and products that are transferred from one manufacturing facility to another.
−Removed: Our current product roadmap calls for the introduction of new instruments and consumables, which may require that we utilize manufacturers with which we have little or no prior manufacturing experience and the risk of manufacturing defects or quality control issues could increase as a result.
−Removed: The expansion of our manufacturing capabilities could increase the risk of manufacturing defects or quality control issues in the consumables we manufacture.
−Removed: We and our third-party manufacturers may not be able to launch new products on time, transition manufacturing of existing products to new manufacturers, transition our manufacturing capabilities to a new location or transition manufacturing of any additional consumables in-house without manufacturing defects.
−Removed: Additionally, impacts stemming from the COVID-19 pandemic, including supply chain disruptions, logistics, shipping and other distribution disruptions, labor shortages and issues relating to the health and safety of our manufacturing staff or on the global supply chain and transportation infrastructure, may limit our ability to manufacture products and components that meet specifications, in necessary quantities and at commercially acceptable costs and deliver them in commercially acceptable timeframes to our customers.
−Removed: An inability to manufacture products and components that consistently meet specifications, in necessary quantities and at commercially acceptable costs will have a negative impact and may have a material adverse effect on our business, financial condition and results of operations.
−Removed: Our industry is highly competitive.
−Removed: If we fail to compete effectively, our business and operating results will suffer.
−Removed: We face significant competition.
−Removed: We currently compete with both established and early-stage companies that design, manufacture and market instruments, consumables and software for, among other applications, genomics, single cell analysis, spatial analysis, in situ analysis and immunology.
−Removed: We believe our competitors include Becton, Dickinson and Company and Nanostring Technologies, Inc., each of which has products that compete to varying degrees with some but not all of our product solutions, as well as a number of other emerging and established companies.
−Removed: Many of these companies have introduced products or announced plans to introduce products that compete with our single cell, spatial and future in situ platforms.
−Removed: Some of our current competitors may enjoy a number of competitive advantages over us, including:
−Removed: • greater name and brand recognition;
−Removed: • greater financial and human resources;
−Removed: • broader product lines;
−Removed: • larger sales forces and more established distributor networks;
−Removed: • substantial intellectual property portfolios;
−Removed: • larger and more established customer bases and relationships;
−Removed: • better established, larger scale and lower cost manufacturing capabilities.
−Removed: We also face competition from researchers developing their own solutions.
−Removed: The area in which we compete involves rapid innovation and some of our customers have in the past, and more may in the future, elect to create their own platform or assays rather than rely on a third-party supplier such as ourselves.
−Removed: This is particularly true for the largest research centers and labs who are continually testing and trying new technologies, whether from a third-party vendor or developed internally.
−Removed: We also compete for the resources our customers allocate for purchasing a wide range of products used to analyze biological systems, some of which are additive to or complementary with our own but not directly competitive.
−Removed: Our products may not compete favorably or be successful in the face of increasing competition from products and technologies introduced by our existing competitors, companies entering our markets or developed by our customers internally.
−Removed: In addition, our competitors may have or will in the future develop products or technologies that currently or in the future will enable them to produce competitive products with greater capabilities or at lower costs than ours or that are able to run comparable experiments at a lower total experiment cost.
−Removed: Any failure to compete effectively could materially and adversely affect our business, financial condition and operating results.
−Removed: We are significantly dependent upon revenue generated from the sale of our Chromium solutions, and in particular our Single Cell Gene Expression solutions.
−Removed: We currently generate substantially all of our revenue from the sale of our Chromium instruments, which we refer to as “instruments,” and our proprietary microfluidic chips, slides, reagents and other consumables for both our Visium and Chromium solutions, which we refer to as “consumables.” In particular, we are dependent upon revenue generated from sales of our Single Cell Gene Expression consumables.
−Removed: There can be no assurance that we will be able to design future products, particularly non-Chromium product lines, that will meet the expectations of our customers or that our future products will become commercially successful.
−Removed: As technologies change in the future for research equipment in general and in genomics solutions specifically, we will be expected to upgrade or adapt our products in order to keep up with the latest technology.
−Removed: To date we have limited experience simultaneously designing, testing, manufacturing and selling non-Chromium products and there can be no assurance we will be able to do so.
−Removed: Our sales expectations are based in part on the assumption that sales of our instruments will increase workflows for our future customers and their associated purchases of our consumables.
−Removed: If sales of our instruments fail to materialize so will the related consumable sales and associated revenue.
−Removed: Our sales expectations are based in part on the continued success of our existing solutions and the future success of new products we launch.
−Removed: If our new products fail to achieve sufficient market acceptance or sales of our existing products decrease, our consumables revenue could be materially and adversely impacted.
−Removed: Our failure to effectively manage product transitions or accurately forecast customer demand could result in excess or obsolete inventory and resulting charges.
−Removed: Because the market for our products is characterized by rapid technological advances, we frequently introduce new products with improved ease-of-use, improved performance or additional features and functionality.
−Removed: At times, we pre-announce products and services, in some cases before such products and services have been fully developed or tested, and risk failing to meet expectations when and if such products and services become available.
−Removed: The risks associated with the introduction of new products include the difficulties of predicting customer demand and effectively managing inventory levels to ensure adequate supply of the new product and avoiding excess supply of the legacy product.
−Removed: In addition, the COVID-19 pandemic, supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages have made it more difficult to predict customer demand and effectively manage inventory levels for our instruments and consumables and the risk that we will not be able to source the necessary equipment, components and materials to manufacture our products has led us to carry higher inventory.
−Removed: Further, differences in purchasing patterns across our customer base, including potential differences in consumables spending between early adopters of our solutions and more recent customers and variances in rates of increase of consumables spending following new instrument purchases, some of which may be compounded by impacts of the COVID-19 pandemic, could negatively impact our ability to accurately forecast demand.
−Removed: We may strategically enter into non-cancelable commitments with vendors to purchase materials for our products in advance of demand to take advantage of favorable pricing, address concerns about the availability of future supplies or build safety stock to help ensure customer shipments are not delayed should we experience higher than anticipated demand for materials with long lead times.
−Removed: During periods of decreased demand, which have occurred and which we expect to continue to occur as a result of the COVID-19 pandemic, these non-cancelable commitments could prevent our related costs from decreasing in proportion to decreases in demand.
−Removed: Our future success is dependent upon our ability to increase penetration in our existing markets and to maintain and increase the effectiveness of our commercial organization.
+Added: We rely exclusively on commercial carriers to transport our products, including perishable consumables, to our customers in a timely and cost-efficient manner and if delivery of our products is disrupted, our business will be harmed.
+Added: Our business depends on our ability to quickly and reliably deliver our products and in particular, our consumables, to our customers.
+Added: The majority of our consumables are perishable and must be kept below certain temperatures.
+Added: As such, we ship our refrigerated consumables on dry ice and only ship such consumables on certain days of the week to reach customers on a timely basis.
+Added: Disruptions in the delivery of our products, whether due to hiring difficulties or labor disruptions, fuel shortages, dry ice shortages, bad weather, natural disasters, infectious disease, conflict, war, civil unrest, epidemics or pandemics such as COVID-19 outbreaks and resurgences, terrorist acts or threats or for other reasons could result in delivery delays or our customers receiving consumables that are not fit for usage, and if used, could result in inaccurate results or ruined experiments.
+Added: For example, certain of our customers were negatively impacted by a process breakdown in our logistics cold-chain that resulted in product spoilage which delayed purchases by affected customers, negatively impacting our revenue in 2022.
+Added: While we work with customers to replace any consumables impacted by delivery disruptions, our reputation and our business may be adversely impacted if customers receive consumables that are not fit for usage.
+Added: In addition, if we are unable to continue to obtain delivery services on commercially reasonable terms, our operating results may be adversely affected.
+Added: In addition, in the past both shipping and air transport have been negatively impacted in terms of speed and capacity.
+Added: If we cannot supply our products to our customers in a timely manner, our customers may delay or cancel their orders.
+Added: Furthermore, even if we have inventory, if we do not have adequate inventory of products in the geographic regions in which they are ordered, we may not be able to deliver products to our customers in a timely manner and customers may delay or cancel their orders.
+Added: Should we or our commercial carriers encounter difficulties in delivering our instruments or consumables to customers , including due to impacts stemming from the COVID-19 pandemic, it could adversely impact our ability to recognize revenue for those products and accordingly adversely affect our financial results for that period and such impact could be particularly acute at the end of any financial quarter.
+Added: Our future success is dependent upon our ab ility to increase penetration in our existing customer segments and to maintain and increase the effectiveness of our commercial organization.
Our customer base includes academic, government, biopharmaceutical, biotechnology and other institutions.
−Removed: Our success will depend upon our ability to increase our market penetration among these customers and to expand our market by developing and marketing new products and new applications for existing products.
+Added: Our success will depend upon our ability to increase our penetration among these customers and to expand our opportunity by developing and marketing new products and new applications for existing products.
We regularly introduce new versions of existing products, and our future success will partially depend on our ability to commercialize these products.
−Removed: As we continue to scale our business, we may find that certain of our products, certain customers or certain markets, including the biopharmaceutical market, may require a dedicated sales force or sales personnel with different experience than those we currently employ in our commercial organization.
+Added: As we continue to scale our business, we may find that certain of our products, certain customers or certain segments, including biopharmaceutical or translational segments, may require a dedicated sales force or sales personnel with different experience than those we currently employ in our commercial organization.
Identifying, recruiting and training additional qualified personnel would require significant time, expense and attention.
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Any failure to increase penetration in our existing markets would adversely affect our ability to improve our operating results.
−Removed: Additionally, potential impacts of the COVID-19 pandemic on hiring and on the health and safety of our employees, customers and partners could decrease the effectiveness of our commercial organization and adversely affect our business and operating results.
−Removed: Additionally, while some on-site and other in-person sales and marketing and customer service activities previously restricted or eliminated due to COVID-19 have resumed, our commercial organization’s ability to participate in on-site or other
−Removed: in-person sales and marketing or customer service activities, including participation in trade shows and other in-person events, or on-site installation of our products, has been and continues to be restricted due to the impacts of the COVID-19 pandemic and such activities may be further restricted or eliminated in the future, including due to outbreaks or resurgences.
−Removed: The effectiveness of our commercial organization may be decreased and our business and operating results may be materially and adversely affected as a result.
We may not be able to develop new products, enhance the capabilities of our existing products to keep pace with rapidly changing technology and customer requirements or successfully manage the transition to new product offerings, any of which could have a material adverse effect on our business and operating results.
Our success depends on our ability to develop new products and applications for our technology while improving the performance and cost-effectiveness of our existing products, in each case in ways that address current and anticipated customer requirements.
−Removed: Such success is dependent upon several factors, including feasibility, competition among potential new products for Company resources, functionality, competitive pricing and integration with existing and emerging technologies.
−Removed: The development timelines of certain new products may be delayed due to prioritization of other new products, including our forthcoming Xenium platform.
+Added: Such success is dependent upon several factors, including feasibility, competition among our products for Company resources, functionality, competitive pricing and integration with existing and emerging technologies.
+Added: The development timelines of certain new products may be delayed due to prioritization of other new products.
New technologies, techniques or products could emerge that might offer better combinations of price and performance or better address customer requirements as compared to our current or future products.
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Due to the significant lead time involved in bringing a new product to market, we are required to make a number of assumptions and estimates regarding the commercial feasibility of a new product, including assumptions and estimates regarding the biological analytes that researchers will want to measure, the appropriate method of measuring such analytes, how researchers intend to use the resulting data and the scope and type of data that will be most useful to researchers.
−Removed: As a result, it is possible that we may introduce a new product that uses technologies or methods of analysis that have been displaced by the time of launch, addresses a market that no longer exists or is smaller than previously thought, targets biological analytes or produces data that provides less utility to researchers than previously thought or otherwise is not competitive at the time of launch.
−Removed: We anticipate that we will 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.
+Added: As a result, it is possible that we may introduce a new product that uses technologies or methods of analysis that
+Added: have been displaced by the time of launch, competes with one or more of our other products, addresses an opportunity that no longer exists or is smaller than anticipated, targets biological analytes or produces data that provides less utility to researchers than anticipated or otherwise is not competitive at the time of launch.
+Added: We face significant competition from both established and early-stage companies.
Our ability to mitigate downward pressure on our selling prices will be dependent upon our ability to maintain or increase the value we offer to researchers.
The expenses or losses associated with unsuccessful product development or launch activities, or a lack of market acceptance of our new products, could adversely affect our business, financial condition or results of operations.
−Removed: Because our solutions are used with other products, such as sequencers, to conduct an experiment, we also expect to face competition from these complementary products, either directly or indirectly, as researchers and labs look to reduce the total cost of any given experiment.
−Removed: For example, if a sequencer manufacturer were successful in vertically integrating their product to provide functionality equivalent to our instruments, they would likely be able to deliver a solution that is capable of running comparable experiments with a total experiment cost that would be significantly less than the cost of running such experiments using our products together with third-party sequencers.
−Removed: Conversely, if genome sequencing falls out of favor as a preferred approach for genomic research, whether through the development of alternative solutions or real or perceived problems with sequencing itself or if our products are not compatible with sequencers used by our customers or potential customers, the utility of our products could be significantly impacted.
+Added: Because our solutions are used with other products, including third-party sequencers in the case of our Chromium and Visium solutions, to conduct an experiment, we also expect to face competition from these complementary products, either directly or indirectly, as researchers and labs look to reduce the total cost of any given experiment.
+Added: For example, if a third-party sequencer manufacturer were successful in vertically integrating their product to provide functionality equivalent to our instruments, they potentially could be able to deliver a solution that is capable of running comparable experiments with a total experiment cost that would be less than the cost of running such experiments using our products together with third-party sequencers.
+Added: Conversely, if genome sequencing falls out of favor as a preferred approach for genomic research, whether through the development of alternative solutions or real or perceived problems with sequencing itself or if our products are not compatible with third-party sequencers used by our customers or potential customers, the utility of our products which are used in conjunction with third-party sequencers could be significantly impacted.
It is critical to our success that we anticipate changes such as these in technology and customer requirements and successfully introduce new, enhanced and competitive technologies to meet our customers’ and prospective customers’ needs on a timely and cost-effective basis.
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Our ability to attract new customers and increase revenue from existing customers also depends on our ability to deliver any enhanced or new solutions to our customers in a format where they can be easily and consistently deployed by most or all users without significant customer service or training.
−Removed: If our customers believe that deploying our enhanced or new solutions would be overly time-consuming, confusing or technically challenging, or require significant training or retraining, then our ability to grow
−Removed: our business would be substantially harmed.
+Added: If our customers believe that deploying our enhanced or new solutions would be overly time-consuming, confusing or technically challenging, or require significant training or retraining, then our ability to grow our business would be substantially harmed.
We need to create and deliver a repeatable, user-friendly, prescriptive approach to deployment that allows users of all kinds to effectively and easily deploy our solutions, and if we fail to do so, our business and results of operations would be harmed.
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Such developments may involve external suppliers and service providers, making the management of development projects complex and subject to risks and uncertainties regarding timing, timely delivery of required components or services and satisfactory technical performance of such components or assembled products.
−Removed: We expect that impacts stemming from the COVID-19 pandemic will delay the development of certain of our new life science products as well as new versions of existing products.
−Removed: If we do not achieve the required technical specifications or successfully manage new product development processes, or if development work is not performed according to schedule, including because of delays in our research and development programs stemming from the COVID-19 pandemic, then such new technologies or products may be adversely impacted and our business and operating results may be harmed.
+Added: Undetected errors or defects in our solutions could harm our reputation and decrease market acceptance of our solutions.
+Added: Our instruments and consumables, as well as the software that accompanies them, may contain undetected errors or defects due to design, manufacturing, delivery or other issues.
+Added: Disruptions or other performance problems with our products or software may adversely impact our customers’ research or business, harm our reputation and result in reduced revenue or increased costs associated with product repairs or replacements.
+Added: If that occurs, we may also incur significant costs, the attention of our key personnel could be diverted or other significant customer relations problems may arise.
+Added: We may also be subject to warranty claims or breach of contract for damages related to errors or defects in our solutions.
+Added: We are significantly dependent upon revenue generated from the sale of our Chromium solutions, and in particular our Single Cell Gene Expression solutions.
+Added: We currently generate our revenue from the sale of our instruments and our proprietary microfluidic chips, slides, reagents and other consumables for our Chromium, Visium and Xenium platforms, which we refer to as “consumables.” Historically we have
+Added: been dependent upon revenue generated from sales of our Chromium solutions, particularly our Single Cell Gene Expression consumables.
+Added: There can be no assurance that we will be able to design future products, particularly non-Chromium solutions, that will meet the expectations of our customers or that our future products will become commercially successful.
+Added: Our sales expectations are based in part on the continued success of our existing solutions and the future success of new products we launch.
+Added: If our new products fail to achieve sufficient market acceptance or sales of our existing products decrease, our consumables revenue could be materially and adversely impacted.
+Added: Our failure to effectively manage product transitions or accurately forecast customer demand could result in excess or obsolete inventory and resulting charges.
+Added: Because the market for our products is characterized by rapid technological advances, we frequently introduce new products with improved ease-of-use, improved performance or additional features and functionality.
+Added: At times, we pre-announce products and services, in some cases before such products and services have been fully developed or tested, and risk failing to meet expectations when and if such products and services become available.
+Added: The risks associated with the introduction of new products include the difficulties of predicting customer demand and effectively managing inventory levels to ensure adequate supply of the new product and avoiding excess supply of the legacy product, including legacy versions of our instruments which are supplanted by new versions.
+Added: In addition, in the past supply chain disruptions, logistics, shipping and other distribution disruptions and labor shortages have made it more difficult to predict customer demand and effectively manage inventory levels for our instruments and consumables and at times the risk that we will not be able to source the necessary equipment, components and materials to manufacture our products led us, and may again lead us, to carry higher inventory.
+Added: Further, differences in purchasing patterns across our customer base, including potential differences in consumables spending between early adopters of our solutions and more recent customers and variances in rates of increase of consumables spending following new instrument purchases, could negatively impact our ability to accurately forecast demand.
+Added: We may strategically enter into non-cancelable commitments with vendors to purchase materials for our products in advance of demand to take advantage of favorable pricing, address concerns about the availability of future supplies or build safety stock to help ensure customer shipments are not dela yed should we experience higher than anticipated demand for materials with long lead times.
+Added: During periods of decreased demand, which in the past have occurred and which may occur again, these non-cancelable commitments could prevent our related costs from decreasing in proportion to decreases in demand.
If our existing and new products fail to achieve and sustain sufficient scientific acceptance, we will not generate expected revenue and our prospects may be harmed.
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If too few researchers describe the use of our products, too many researchers shift to a competing product and publish research outlining their use of that product or too many researchers negatively describe the use or usability of our products in publications, it may drive existing and potential customers away from our products, which could harm our operating results.
−Removed: Additionally, the ability of researchers to conduct research or publish in peer-reviewed journal publications has been and will continue to be impacted by the COVID-19 pandemic.
−Removed: For example, we believe COVID-19 has limited and may continue to limit the ability of the research community to connect, collaborate, attend conferences and share best practices.
−Removed: Further, even though many of our customers are using our instruments and consumables to research and understand COVID-19 and such efforts may result in peer-reviewed journal publications which describe the use of our products, the COVID-19 pandemic may result in life sciences journals prioritizing research related to COVID-19 in lieu of research relating to other fields, such as oncology, where our instruments and consumables have regularly been mentioned.
−Removed: Any decrease in the frequency at which our instruments and consumables are mentioned in peer reviewed journals, even if only temporarily due to COVID-19, may negatively impact our prospects.
If we do not sustain or successfully manage our growth and anticipated growth, our business and prospects will be harmed.
−Removed: We have experienced rapid growth in recent periods.
−Removed: This growth and our anticipated growth will place significant strains on our management, operational and manufacturing systems and processes, financial systems and internal controls and other aspects of our business.
+Added: We have historically experienced rapid growth and future growth will place significant strains on our management, operational and manufacturing systems and processes, financial systems and internal controls and other aspects of our business.
For example, we consummated two acquisitions each in 2018 and 2020 and one more in January 2021, and we intend to continue to make investments that meet management’s criteria to expand or add key technologies that we believe will facilitate the commercialization of new products in the future.
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Further development and commercialization of our current and future products are key elements of our growth strategy.
−Removed: Developing and launching new products and innovating and improving our existing products have required us to hire and retain additional scientific, sales and marketing, software, manufacturing, distribution and quality assurance personnel.
+Added: Developing and launching new products and innovating and improving our existing products
+Added: have required us to hire and retain additional scientific, sales and marketing, software, manufacturing, distribution and quality assurance personnel.
As a result, we have experienced rapid headcount growth from 110 employees as of December 31, 2015 to 1,243 employees as of December 31, 2022.
As we have grown, our employees have become more geographically dispersed.
−Removed: We currently serve thousands of researchers in many countries and plan to continue to expand to new non-United States jurisdictions as part of our growth strategy which will lead to increased dispersion of our employees.
−Removed: As a public company, our management and other personnel must devote a substantial amount of time towards maintaining compliance with these requirements.
−Removed: We may face challenges integrating, developing and motivating our rapidly growing and increasingly dispersed employee base, including as a result of certain of our employees working from home.
−Removed: In addition, certain members of our management have not previously
−Removed: worked together for an extended period of time, do not have experience managing a public company or do not have experience managing a global business, which may affect how they manage our growth.
−Removed: To effectively manage our growth, we must continue to improve our operational and manufacturing systems and processes, our financial systems and internal controls and other aspects of our business and continue to effectively expand, train and manage our personnel.
−Removed: As our organization continues to grow, and we are required to implement more complex organizational management structures, we may find it increasingly difficult to maintain the benefits of our corporate culture, including our ability to quickly develop and launch new and innovative products, which difficulties may be exacerbated by the impacts of the COVID-19 pandemic.
+Added: We may face challenges integrating, developing and motivating our rapidly growing and increasingly dispersed employee base, including as a result of certain of our employees working remotely.
+Added: In addition, certain members of our management have not previously worked together for an extended period of time, do not have experience managing a public company or do not have experience managing a global business, which may affect how they manage our growth.
+Added: To effectively manage our growth, we must continue to improve our operational and manufacturing systems and processes, our financ ial systems and internal controls and other aspects of our business and continue to effectively expand, train and manage our personnel.
+Added: As our organization continues to grow, and we are required to implement more complex organizational management structures, we may find it increasingly difficult to maintain the benefits of our corporate culture, including our ability to quickly develop and launch new and innovative products.
If we do not successfully manage our anticipated growth, our business, results of operations and growth prospects will be harmed.
−Removed: Our limited operating history and rapid revenue growth make it difficult to evaluate our future prospects and the risks and challenges we may encounter.
−Removed: We launched our first product in mid-2015 and have experienced significant revenue growth in recent periods.
−Removed: In addition, we operate in highly competitive markets characterized by rapid technological advances and our business has, and we expect it to continue, to evolve over time to remain competitive.
−Removed: Our limited operating history, evolving business and rapid growth make it difficult to evaluate our future prospects and the risks and challenges we may encounter and may increase the risk that we will not continue to grow at or near historical rates.
−Removed: If we fail to address the risks and difficulties that we face, including those described elsewhere in this “ Risk Factors ” section, our business, financial condition and results of operations could be adversely affected.
−Removed: We have encountered in the past, and will encounter in the future, risks and uncertainties frequently experienced by growing companies with limited operating histories in rapidly changing industries.
−Removed: If our assumptions regarding these risks and uncertainties, which we use to plan and operate our business, are incorrect or change, or if we do not address these risks successfully, our results of operations could differ materially from our expectations and our business, financial condition and results of operations could be materially and adversely affected.
The size of the market for our solutions may be smaller than estimated and new opportunities may not develop as quickly as we expect, or at all, limiting our ability to successfully sell our solutions.
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If demand for our current and future solutions are smaller than estimated or do not develop as we expect, our growth may be limited and our business, financial condition and operational results may be adversely affected.
−Removed: Additionally, impacts stemming from the COVID-19 pandemic have and may continue to limit demand for our solutions for the foreseeable future.
We depend on our key personnel and other highly qualified personnel, and if we are unable to recruit, train, retain and ensure the health and safety of our personnel, we may not achieve our goals.
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Saxonov, our Chief Executive Officer and one of our co-founders, and Dr.
−Removed: Hindson, our Chief Scientific Officer, President and one of our co-founders, are critical to our vision, strategic direction, culture and products.
+Added: Hindson, our Chief Scientific Officer, President and one of our co-
+Added: founders, are critical to our vision, strategic direction, culture and products.
Competition for qualified personnel is intense, particularly in the San Francisco Bay Area.
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New hires also require significant training and, in most cases, take significant time before they achieve full productivity.
−Removed: Our failure to successfully integrate these key personnel into our business could adversely affect our business.
−Removed: Additionally, some of our employees are working from home due to the COVID-19 pandemic and additional employees may return to remote work in the future.
−Removed: Because of the challenges of working from home, including collaborating with and managing employees, it may take significant time before our teams can achieve full productivity again, if at all, and it may take significantly longer for new hires to achieve full productivity, if at all.
−Removed: Our continued growth depends, in part, on attracting, retaining and motivating highly trained sales personnel with the necessary scientific background and ability to understand our systems at a technical level to effectively identify and sell to potential new customers.
−Removed: In addition, the continued development of complementary software tools, such as our analysis tools and visualization software, requires us to compete for highly trained software engineers in the San Francisco Bay Area and for highly trained customer service personnel globally.
−Removed: We also compete for computational biologists and qualified scientific personnel with other life sciences companies, academic institutions and research institutions.
+Added: Our failure to successfully integrate our personnel into our business could adversely affect our business.
+Added: Additionally, some of our employees work remotely and because of the challenges of working remotely, including collaborating with and managing employees, it may take significant time before our teams can achieve full productivity, if at all, and it may take significantly longer for new hires to achieve full productivity, if at all.
+Added: We do not maintain key person life insurance for an y of our employees.
+Added: Additionally, we have not entered into fixed term contracts with almost any of our employees and as a result, almost any of our employees could leave our company with little or no prior notice which could harm our business.
Many of our scientific personnel are qualified foreign nationals whose ability to live and work in the United States is contingent upon the continued availability of appropriate visas.
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As a result, changes to United States immigration policies could restrain the flow of technical and professional talent into the United States and may inhibit our ability to hire qualified personnel.
−Removed: The typical immigration and visa procedures of the United States have been impacted by COVID-19 and may be further impacted in the future, and our current or future employees may be negatively affected by delays, disruptions or changes in United States immigration policies.
+Added: Additionally, our current or future employees may be negatively affected by delays, disruptions or changes in United States immigration policies.
Past United States administrations have made restricting immigration and reforming the work visa process a priority and these efforts may adversely affect our ability to find qualified personnel.
−Removed: We do not maintain key person life insurance for any of our employees nor have we entered into fixed term contracts with almost any of our employees.
−Removed: As a result, almost any of our employees could leave our company with little or no prior notice and would be free to work for a competitor.
−Removed: Because of the complex and technical nature of our products and the dynamic market in which we compete, any failure to attract, train, retain and motivate qualified personnel could materially harm our operating results and growth prospects.
−Removed: Additionally, while we are committed to maintaining a safe workplace and to support our personnel through the COVID-19 pandemic, the health and safety of our personnel may be impacted by COVID-19 and our operating results and growth prospects could be materially harmed as a result.
−Removed: Further, we may face civil liability if any of our employees contracts COVID-19 while performing his or her job or is otherwise negatively impacted by the COVID-19 pandemic.
−Removed: Our management uses certain key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions and such metrics may not accurately reflect all of the aspects of our business needed to make such evaluations and decisions, in particular as our business continues to grow.
−Removed: In addition to our consolidated financial results, our management regularly reviews a number of operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions.
−Removed: We believe that these metrics are representative of our current business;
−Removed: however, these metrics may not accurately reflect all aspects of our business and we anticipate that these metrics may change or may be substituted for additional or different metrics as our business grows and as we introduce new products.
−Removed: With the emerging complexity of our product offerings, we believe pull-through per instrument is less relevant today than in past periods given the expanding breadth of our portfolio, and as such, is not representative of trends in our business.
−Removed: For example, some of our customers are purchasing Chromium X Series instruments to replace previously purchased Chromium Controllers.
−Removed: Additionally, certain of our solutions do
−Removed: not require a Chromium instrument, such as our Visium solution, and forthcoming solutions, such as our Xenium platform which is expected to utilize a separate family of 10x Genomics' instruments and not rely on a Chromium instrument for its workflow.
−Removed: Our consumables pull-through is also impacted by additional factors including expanding utilization by our existing customers, the rate of new customer acquisition, the ramp of utilization by new customers and the overall mix of “halo” users and their ordering patterns.
−Removed: As our business, product lines and customer composition have become more complex since adopting this key business metric, we believe that this metric represents an oversimplification of these different drivers and can obscure underlying trends in the business.
−Removed: Cumulative instruments sold and pull-through per instrument do not accurately reflect information relating to customers who purchase consumables but do not own an instrument.
−Removed: If our management fails to review other relevant information or change or substitute the key business metrics they review as our business grows and we introduce new products, their ability to accurately formulate financial projections and make strategic decisions may be compromised and our business, financial results and future growth prospects may be adversely impacted.
−Removed: The COVID-19 pandemic may impact historical trends and the comparability of certain of the key business metrics over time.
−Removed: For example, the COVID-19 pandemic may cause a general decrease in the rate of growth of our instrument sales.
+Added: Our continued growth depends, in part, on attracting, retaining and motivating highly trained sales personnel with the necessary scientific background and ability to understand our systems at a technical level to effectively identify and sell to potential new customers.
+Added: In addition, the continued development of complementary software tools, such as our analysis tools and visualization software, requires us to compete for highly trained software engineers in the San Francisco Bay Area and for highly trained customer service personnel globally.
+Added: We also compete for computational biologists and qualified scientific personnel with other life sciences companies, academic institutions and research institutions.
+Added: This competition affects both our ability to retain key employees and hire new ones.
+Added: In August 2022 we conducted a reduction in force in order to decrease costs and maintain a streamlined organization to support the business.
+Added: In order to be successful and build our framework for future growth, we must continue to execute and deliver on our initiatives with fewer employees and losses of intellectual capital.
+Added: We must also attract, retain, train and motivate key employees including highly qualified management, scientific, manufacturing, sales, marketing and other personnel who are critical to our business.
+Added: Additionally, we compete with both companies that may have greater financial resources than we do and early stage companies that promise short-term growth opportunities.
+Added: We may not be able to attract, retain, train or motivate qualified employees in the future and our inability to do so could materially harm our operating results and growth prospects.
If our facilities or our third-party manufacturers’ facilities become unavailable or inoperable, our research and development programs could be adversely impacted and manufacturing of our instruments and consumables could be interrupted.
−Removed: The manufacturing process for our Chromium Controller and Chromium X Series instruments takes place at our third-party manufacturer’s facilities in Singapore and the manufacturing process for our Chromium Connect instrument takes place at our third-party manufacturer’s facilities in Nevada.
+Added: The manufacturing process for our instruments takes place at our third-party manufacturers' facilities.
The majority of our consumables are manufactured at our facilities in Pleasanton, California and Singapore using proprietary equipment.
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Our Pleasanton facilities also house the majority of our research and development and quality assurance teams.
−Removed: Our Chromium Connect is manufactured by our partner at their facility.
+Added: Our Chromium and Visium CytAssist instruments are manufactured by our partners at their facilities.
The facilities and the equipment we and our third-party manufacturers use to manufacture our instruments and consumables and that we use in our research and development programs would be costly to replace and could require substantial lead times to repair or replace.
Our facilities in Pleasanton and Singapore are vulnerable to natural disasters and catastrophic events.
−Removed: For example, our Pleasanton facilities are located near earthquake fault zones and are vulnerable to damage from earthquakes.
−Removed: Our facilities are vulnerable to other types of disasters, including fires, floods, infectious disease, epidemics or pandemics including COVID-19, outbreaks and resurgences, power loss, conflict, war, civil unrest, communications failures and similar events.
+Added: For example, our Pleasanton facilities are located near earthquake fault zones and are vulnerable to damage from earthquak es.
+Added: Our facilities are vulnerable to other types of disasters, including fires, floods, infectious disease, epidemics or pandemics such as COVID-19 outbreaks and resurgences, power loss, conflict, war, civil unrest, communications failures and similar events.
If any disaster or catastrophic event were to occur, our ability to operate our business would be seriously, or potentially completely, impaired.
−Removed: If our facilities or any of our third-party manufacturers’ facilities become unavailable or understaffed for any reason, including due to the impacts of the COVID-19 pandemic, we cannot provide assurances that we will be able to secure alternative manufacturing facilities with the necessary capabilities and equipment on acceptable terms, if at all.
−Removed: Further, while we are an essential business that can continue operations under current governmental shelter-in-place measures meant to combat the COVID-19 pandemic, there is no guarantee that we will be able to continue operations at our Pleasanton facilities or other facilities while shelter-in-place or other COVID-19-related measures remain in place or if new shelter-in-place or other COVID-19-related measures are implemented in the future.
−Removed: Additionally, potential impacts of the COVID-19 pandemic on hiring or on the health and safety of our manufacturing staff could decrease the effectiveness of our manufacturing operations and adversely affect our business and operating results.
+Added: If our facilities or any of our third-party manufacturers’ facilities become unavailable or understaffed for any reason, including due to the resurgence of COVID-19, we cannot provide assurances that we will be able to secure alternative manufacturing facilities with the necessary capabilities and equipment on acceptable terms, if at all.
+Added: Further, while we are an essential business that continued operations under previously required governmental shelter-in-place measures meant to combat the COVID-19 pandemic, there is no guarantee that we will be able to continue operations at our Pleasanton facilities or other facilities if new shelter-in-place or other restrictive measures are implemented in the future.
+Added: Additionally, potential issues with our ability to hire staff or the health and safety of our manufacturing staff, including as a result of a resurgence of COVID-19, could decrease the effectiveness of our
+Added: manufacturing operations and adversely affect our business and operating results.
We may encounter particular difficulties in replacing or counterbalancing any unavailability of our Pleasanton staff or facilities given the specialized skills of our team and the specialized equipment housed within our facilities.
−Removed: The inability to manufacture our instruments and/or consumables, combined with our limited inventory of manufactured instruments and consumables, may result in the loss of customers or harm our reputation, and we may be unable to reestablish relationships with those customers in the future.
+Added: The inability to manufacture our instruments and/or consumables, combined with potential limited inventory of manufactured instruments and consumables, may result in the loss of customers or harm our reputation, and we may be un able to reestablish relationships with those customers in the future.
Because certain of our consumables and the raw materials we use to manufacture consumables at our Pleasanton facilities are perishable and must be kept in temperature controlled storage, the loss of power to our facilities, mechanical or other issues with our storage facilities or other events that impact our temperature controlled storage could result in the loss of some or all of such consumables and raw materials and we may not be able to replace them without disruption to our customers or at all.
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If our products become unavailable during the planning process, researchers may use alternative products.
−Removed: If our research and development programs were disrupted by a disaster or catastrophe, including the COVID-19 pandemic, the launch of new products and the timing of improvements to existing products could be significantly delayed and could adversely
−Removed: impact our ability to compete with other available products and solutions.
+Added: If our research and development programs were disrupted by a disaster or catastrophe or for other reasons, the launch of new products and the timing of improvements to existing products could be significantly delayed and could adversely impact our ability to compete with other available products and solutions.
If our or our third-party manufacturers’ capabilities are impaired, we may not be able to manufacture and ship our products in a timely manner, which would adversely impact our business.
Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.
+Added: Our limited operating history and rapid revenue growth make it difficult to evaluat e our future prospects and the risks and challenges we may encounter.
+Added: We launched our first product in mid-2015 and have historically experienced rapid revenue growth.
+Added: In addition, we operate in highly competitive markets characterized by rapid technological advances and our business has, and we expect it to continue, to evolve over time to remain competitive.
+Added: Our limited operating history, evolving business and rapid growth make it difficult to evaluate our future prospects and the risks and challenges we may encounter and may increase the risk that we will not continue to grow at or near historical rates.
+Added: If we fail to address the risks and difficulties that we face, including those described elsewhere in this “ Risk Factors ” section, our business, financial condition and results of operations could be adversely affected.
+Added: We have encountered in the past, and will encounter in the future, risks and uncertainties frequently experienced by growing companies with limited operating histories in rapidly changing industries.
+Added: If our assumptions regarding these risks and uncertainties, which we use to plan and operate our business, are incorrect or change, or if we do not address these risks successfully, our results of operations could differ materially from our expectations and our business, financial condition and results of operations could be materially and adversely affected.
Costs, delays or other factors related to our facilities and real estate portfolio could adversely impact our business.
−Removed: We plan to expand our facilities in Pleasanton, California and in other locations where we operate or may operate in the future.
−Removed: For example, we are currently engaged in a project to construct new facilities on land we own located in Pleasanton, California.
+Added: We may expand our facilities in Pleasanton, California and in other locations where we operate or may operate in the future.
+Added: For example, we are currently completing construction of a new facility on land we own located in Pleasanton, California.
We believe that maintaining our existing facilities and opening new facilities is necessary to maintain and expand our operations.
−Removed: Our ability to maintain our existing facilities, build out new or existing facilities and open new operating facilities depends on our ability to identify attractive locations, negotiate leases or real estate purchase agreements and other agreements on acceptable terms, identify and obtain adequate utility and water sources and comply with environmental regulations, zoning laws and other similar factors.
−Removed: We may not have the level of cash flow or financing necessary to support our expansion strategy.
−Removed: Additionally, our proposed facilities projects may increase demands on our operational, financial, managerial and administrative resources.
−Removed: Costs, delays or other factors related to our facilities and real estate portfolio, including our project to construct new facilities on land we own located in Pleasanton, California or any failure to adequately maintain our current facilities, may adversely impact our business results and financial condition.
−Removed: Undetected errors or defects in our solutions could harm our reputation and decrease market acceptance of our solutions.
−Removed: Our instruments and consumables, as well as the software that accompanies them, may contain undetected errors or defects when first introduced or as new versions are released.
−Removed: Disruptions or other performance problems with our products or software may adversely impact our customers’ research or business, harm our reputation and result in reduced revenue or increased costs associated with product repairs or replacements.
−Removed: If that occurs, we may also incur significant costs, the attention of our key personnel could be diverted or other significant customer relations problems may arise.
−Removed: We may also be subject to warranty claims or breach of contract for damages related to errors or defects in our solutions.
−Removed: We have incurred significant losses since inception, we expect to incur losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability.
−Removed: We have incurred significant losses since we were formed in 2012 and expect to incur losses in the future.
−Removed: We incurred net losses of $58.2 million and $542.7 million for the years ended December 31, 2021 and 2020, respectively.
−Removed: As of December 31, 2021, we had an accumulated deficit of $863.3 million.
−Removed: We expect that our losses will continue in the near term as we continue to invest significantly in research and development and the commercialization of both new products and improved versions of existing products.
−Removed: We also expect that our operating expenses will continue to increase as we grow our business.
−Removed: To date, we have financed our operations principally from the sale of convertible preferred stock, stock option exercises and purchases under our 2019 Employee Stock Purchase Plan, the sale of Class A common stock in our IPO and our September 2020 follow-on offering, revenue from sales of our products and the incurrence of indebtedness.
−Removed: There can be no assurance that our revenue and gross profit will increase sufficiently such that our net losses decline, or we attain profitability, in the future.
−Removed: Further, our limited operating history and rapid revenue growth over the last several years make it difficult to effectively plan for and model future growth and operating expenses.
−Removed: Our ability to achieve or sustain profitability is based on numerous factors, many of which are beyond our control, including general economic, industry and market conditions, customer purchasing decisions, impacts stemming from the COVID-19 pandemic, the impact of market acceptance of our products, future product development, our market penetration and margins and current and future litigation.
−Removed: Additionally, inflationary pressure could adversely impact our financial results.
−Removed: Our operating costs have increased, and may continue to increase, due to the recent growth in inflation.
−Removed: We may not fully offset these cost increases by raising prices for our instruments and consumables, which could result in downward pressure on our margins.
−Removed: Further, our clients may choose to reduce their business with us if we increase our pricing.
−Removed: We may never be able to generate sufficient revenue to achieve or sustain profitability and our recent and historical growth should not be considered indicative of our future performance.
−Removed: Our failure to achieve or maintain growth or profitability could negatively impact the value of our Class A common stock.
+Added: Our ability to maintain our existing facilities, build out new or existing facilities and open new operating facilities depends on our ability to identify attractive locations, negotiate leases, subleases, real estate purchase agreements or other agreements on acceptable terms, identify and obtain adequate utility and water sources and comply with environmental regulations, zoning laws and other similar factors.
+Added: We may not maintain the level of cash flow or access financing opportunities necessary to support our real estate strategy.
+Added: Our facilities projects may increase demands on our operational, financial, managerial and administrative resources.
+Added: We may also decide to reduce our real estate portfolio but be unable to do so.
+Added: Our real estate leases, which generally obligate us for long periods, subject us to potential financial risk.
+Added: For example, our real estate strategy may commit us to leases or other agreements or arrangements requiring us to incur costs for facilities we later determine are unnecessary for our business.
+Added: While we have the right to terminate or sublease some of our leases under specified conditions, we may not be able to terminate or sublease certain of our leases if or when we would like to do so.
+Added: If we decide or are required to permanently vacate facilities we lease, we are typically required to continue to perform obligations under the applicable leases, which generally include, among other obligations, paying rent and certain expenses for the balance of the lease term, and the performance of any of these obligations may be significant.
+Added: When we assign leases or sublease to third parties, or if we vacate facilities we lease, we can
+Added: remain liable on the lease obligations for the balance of the term and we could be contingently liable if the assignee does not perform their obligations to us or third parties.
+Added: Additionally, if we may decide to sublease certain of our facilities to third parties, we may be unable to find suitable sublease arrangements for leased facilities that we do not wish to occupy ourselves.
+Added: Costs, delays or other factors related to our facilities and real estate portfolio ensuing from these and other risks related to our real estate portfolio may adversely impact our business results and financial condition.
If we fail to offer high-quality customer service, our business and reputation could suffer.
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Additionally, we believe our customer service team has a positive influence on recurring consumables revenue.
−Removed: exceptional customer experience requires significant time and resources from our customer service team.
−Removed: Potential impacts of the COVID-19 pandemic on the health and safety of our customer service organization could reduce or eliminate our ability to provide an exceptional customer experience.
−Removed: Additionally, our ability to provide on-site, in-person customer service (including on-site installation of our instruments) has and may continue to be restricted or eliminated due to the impacts of the COVID-19 pandemic.
−Removed: Therefore, failure to scale our customer service organization adequately or impacts on our ability to provide an exceptional customer experience may adversely impact our business results and financial condition.
+Added: Providing an exceptional customer experience requires significant time and resources from our customer service team, and failure to manage our customer service organization adequately or impacts on our ability to provide an exceptional customer experience may adversely impact our business results and financial condition.
Customers utilize our service teams and online content for help with a variety of topics, including how to use our products efficiently, how to integrate our products into existing workflows, how to determine which of our other products may be needed for a given experiment and how to resolve technical, analysis and operational issues if and when they arise.
−Removed: As we introduce new products such as our Chromium X Series, Chromium Connect, Single Cell Multiome ATAC+Gene Expression solution, Targeted Gene Expression solution, Visium Spatial Proteomics solution, Visium Spatial Gene Expression for FFPE solution and forthcoming Xenium platform and enhance existing products, we expect utilization of our customer service teams to increase.
+Added: As we introduce new products and e nhance existing products, we expect utilization of our customer service teams to increase.
In particular, the introduction of new or improved products that utilize different workflows or variations on existing workflows may require additional customer service efforts to ensure customers use such products correctly and efficiently.
−Removed: While we have developed significant resources for remote training, including an extensive library of online videos, we may need to rely more on these resources for future customer training or we may experience increased expenses to enhance our online and remote solutions, particularly due to the impacts of the COVID-19 pandemic.
+Added: While we have developed significant resources for remote training, including an extensive library of online videos, we may need to rely more on these resources for future customer training or we may experience increased expe nses to enhance our online and remote solutions.
If our customers do not adopt these resources, we may be required to increase the staffing of our customer service team, which would increase our costs.
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If these third-party distributors do not provide a high-quality customer experience, our business operations and reputation may suffer.
+Added: Our management uses certain key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions and such metrics may not accurately reflect all of the aspects of our business needed to make such evaluations and decisions, in particular as our business continues to grow.
+Added: In addition to our consolidated financial results, our management regularly reviews a number of operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions.
+Added: We believe that these metrics are representative of our current business;
+Added: however, these metrics may not accurately reflect all aspects of our business and we anticipate that these metrics may change or may be substituted for additional or different metrics as our business grows and as we introduce new products.
+Added: If our management fails to review other relevant information or change or substitute the key business metrics they review as our business grows and we introduce new products, their ability to accurately formulate financial projections and make strategic decisions may be compromised and our business, financial results and future growth prospects may be adversely impacted.
+Added: We have incurred significant losses since inception, we expect to incur losses in the future and we may not be able to generate sufficient revenue to achieve and maintain positive free cash flow or profitability.
+Added: We have incurred significant losses since we were formed in 2012 and expect to incur losses in the future.
+Added: We incurred net losses of $166.0 million and $58.2 million for the years ended December 31, 2022 and 2021, respectively.
+Added: As of December 31, 2022, we
+Added: had an accumulated deficit of $1.0 billion.
+Added: We expect that our losses will continue in the near term as we continue to invest significantly in research and development and the commercialization of both new products and improved versions of existing products.
+Added: We also expect that our operating expenses will continue to increase as we grow our business.
+Added: To date, we have financed our operations principally from the sale of convertible preferred stock, stock option exercises and purchases under our 2019 Employee Stock Purchase Plan, the sale of Class A common stock in our initial public offering ("IPO") and our September 2020 follow-on offering, revenue from sales of our products and the incurrence of indebtedness.
+Added: There can be no assurance that our revenue and gross profit will increase sufficiently such that our net losses decline, or we become free cash flow positive or attain profitability, in the future.
+Added: Further, our limited operating history and rapid revenue growth over the last several years make it difficult to effectively plan for and model future growth and operating expenses.
+Added: Our ability to achieve or sustain profitability is based on numerous factors, many of which are beyond our control, including general economic, industry and market conditions, customer purchasing decisions, the impact of market acceptance of our products, future product development, our market penetration and margins and current and future litigation.
+Added: Additionally, inflationary pressures could adversely impact our financial results.
+Added: Our operating costs have increased, and may continue to increase, due to the recent growth in inflation.
+Added: We may not fully offset these cost increases by raising prices for our instruments and consumables, which could result in downward pressure on our margins.
+Added: Further, our clients may choose to reduce their business with us if we increase our pricing.
+Added: Additionally, changes in our product mix may negatively affect our gross margins.
+Added: We may never be able to generate sufficient revenue to achieve or sustain positive free cash flow or profitability and our recent and historical growth should not be considered indicative of our future performance.
+Added: Our failure to achieve or maintain growth, positive free cash flow or profitability could negatively impact the value of our Class A common stock.
Investments and acquisitions could disrupt our business, cause dilution to our stockholders and otherwise harm our business.
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Our previous acquisitions and any future transactions could be material to our financial condition and operating results and expose us to many risks, including:
−Removed: • difficulties integrating acquired personnel, technologies and operations into our existing business;
−Removed: • diversion of management time and focus from operating our business;
• increases in our expenses and reductions in our cash available for operations and other uses;
+Added: • difficulties integrating acquired personnel, technologies and operations into our existing business;
• failure to realize anticipated benefits or synergies from such a transaction;
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• unanticipated liabilities related to acquired real estate or companies, including liabilities related to acquired intellectual property or litigation relating thereto;
+Added: • diversion of management time and focus from operating our business;
• possible write-offs or impairment charges relating to acquired businesses;
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Foreign acquisitions, such as our acquisitions of Spatial Transcriptomics Holdings AB, CartaNA AB and Tetramer Shop involve unique risks in addition to those mentioned above, including those related to integration of operations across different cultures and languages, currency risks and the particular economic, political and regulatory risks associated with specific countries.
−Removed: Even if we identify a strategic transaction that we wish to pursue, we may be prohibited from consummating such transaction due to the terms of future indebtedness we may incur.
+Added: Even if we identify a strategic transaction that we wish to pursue, we may be prohibited from consummating such transaction due to the terms of future indebtedness we may incur or due to circumstances outside our control.
Future investments, acquisitions or dispositions could result in potentially dilutive issuances of our equity securities, the incurrence of debt, contingent liabilities or amortization expenses or write-offs of goodwill, any of which could harm our financial condition.
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Similarly, our biopharmaceutical customers typically have calendar year fiscal years which also result in a disproportionate amount of their purchasing activity occurring during our fourth quarter.
+Added: Our international customers also have different purchasing patterns due to procurement or budgeting cycles, holidays or other factors which may result in a disproportionate amount of their purchasing activity occurring in specific periods.
These factors have contributed, and may contribute in the future, to substantial fluctuations in our quarterly operating results.
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Other fluctuations, including spikes in customer demand for our products in demand for our products, may make it harder for us to distribute our products in a timely manner.
−Removed: Additionally, impacts of the COVID-19 pandemic could cause unpredictable temporary or permanent fluctuations in seasonal or cyclical variations as in the second quarter of 2020 in which widespread shutdowns caused a significant decrease in our revenue.
Our reliance on distributors for sales of our products in certain geographies outside of the United States could limit or prevent us from selling our products and impact our revenue.
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As such, our distributors may not commit the necessary resources to market our products to the level of our expectations or may choose to favor marketing the products of our competitors.
−Removed: Further, the ability of our distributors to sell and distribute our products has been and may continue to be impacted by the COVID-19 pandemic.
+Added: Further, the ability of our distributors to sell and distribute our products in the past has been, and in the future may be, impacted by the COVID-19 pandemic.
If current or future distributors do not or are unable to perform adequately or if we are unable to enter into effective arrangements with distributors in particular geographic areas, our revenues could be significantly impacted.
Additionally, our business, financial condition and results of operations could be materially and adversely affected if we are unsuccessful in selling directly to customers who previously purchased our products from third-party distributors.
+Added: Uncertain economic or social conditions may adversely impact demand for our products or cause our customers, vendors and suppliers to suffer financial hardship, which could adversely impact our business.
+Added: Our business could be negatively impacted by reduced demand for our products related to one or more significant local, regional or global economic or social disruptions.
+Added: These disruptions have included and may in the future include a slow-down, recession or inflationary pressures in the general economy, reduced market growth rates, tighter credit markets for us, our suppliers, vendors or customers, a significant shift in government policies, significant social unrest, or the deterioration of economic relations between countries or regions.
+Added: Additionally, these and other economic conditions may cause our suppliers, distributors, contractors or other third-party suppliers or manufacturers to suffer financial or operational difficulties that they cannot overcome, resulting in their inability to provide us with the materials and services we need, in which case our business and results of operations could be adversely affected.
+Added: Inflationary pressures, and changes in foreign currency exchange rates, interest rates and market value of our investments, including marketable securities, could have a significant effect on results.
+Added: We, our suppliers and our customers are exposed to inflationary pressure and a variety of market risks, including the effects of increases in energy and raw material prices, foreign currency exchange rates and interest rates.
+Added: Such risks are inherently unpredictable and difficult to mitigate.
+Added: As a result, significant increases in energy and raw material prices, foreign currency exchange rates or interest rates as well as increased material, freight, logistics, and similar costs could have an adverse effect on our financial condition or results of operations.
+Added: For example, interest rates have increased significantly as central banks in developed countries attempt to subdue inflation while government deficits and debt remain at high levels in many global markets.
+Added: Higher government deficits and debt, tighter monetary policy and potentially higher interest rates may drive a higher cost of capital for our business.
Doing business internationally creates operational and financial risks for our business.
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Conducting operations on an international scale requires close coordination of activities across multiple jurisdictions and time zones.
−Removed: If we fail to coordinate and manage these activities
−Removed: effectively, our business, financial condition or results of operations could be materially and adversely affected and failure to comply with laws and regulations applicable to business operations in foreign jurisdictions may also subject us to significant liabilities and other penalties.
+Added: If we fail to coordinate and manage these activities effectively, our business, financial condition or results of operations could be materially and adversely affected and failure to comply with laws and regulations applicable to business operations in foreign jurisdictions may also subject us to significant liabilities and other penalties.
International operations entail a variety of other risks, including, without limitation:
+Added: • currency fluctuations ;
+Added: • potentially longer sales cycles and more time required to engage and educate customers on the benefits of our products outside of the United States;
• United States and foreign government trade restrictions, including those which may impose restrictions on the importation, exportation, re-exportation, sale, shipment or other transfer of programming, technology, components and/or services to foreign persons or entities;
+Added: • reduced protection for intellectual property rights in some countries and practical difficulties of enforcing intellectual property or other legal rights abroad;
• changes in diplomatic and trade relationships, including new tariffs, trade protection measures, import or export licensing requirements, trade embargoes and other trade barriers;
• tariffs or other restrictions imposed by the United States on goods from other countries and tariffs or other restrictions imposed by other countries on United States goods, or increases in existing tariffs;
−Removed: • deterioration of political relations between the United States and China, Russia, the United Kingdom, the European Union, Canada or other nations or political organizations, which could have a material adverse effect on our sales and operations in these countries;
+Added: • deterioration of political relations between the United States and China, the United States and Russia or other nations or political organizations, which could have a material adverse effect on our sales and operations in these countries;
• challenges in staffing and managing foreign operations;
−Removed: • potentially longer sales cycles and more time required to engage and educate customers on the benefits of our products outside of the United States;
• the potential need for localized software, documentation and post-sales support;
−Removed: • reduced protection for intellectual property rights in some countries and practical difficulties of enforcing intellectual property and contract rights abroad;
−Removed: • complexities associated with managing a third-party contract manufacturer located outside of the United States;
+Added: • complexities associated with managing third-party contract manufacturers and suppliers located outside of the United States;
• changes in social, political and economic 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 into which we sell our products, including as a result of the United Kingdom’s exit from the European Union;
−Removed: • difficulties in obtaining export licenses or in overcoming other trade barriers and restrictions resulting in delivery delays or our inability to sell our products in certain countries;
−Removed: • natural disasters, infectious diseases, conflict, war, civil unrest, epidemics or pandemics including COVID-19, outbreaks, resurgences or major catastrophic events;
+Added: • difficulties in obtaining export licenses or in overcoming other trade barriers and restrictions resulting in delivery delays or our inability to manufacture or sell our products in certain countries;
+Added: • natural disasters, infectious diseases, conflict, geopolitical turmoil, war, civil unrest, epidemics or pandemics such as COVID-19 outbreaks or resurgences or major catastrophic events;
• increased financial accounting and reporting burdens and complexities;
−Removed: • significant taxes or other burdens of complying with a variety of foreign laws, including laws relating to privacy and data protection such as the GDPR and the California Consumer Privacy Act (the “CCPA”).
+Added: • higher levels of credit risk and payment fraud and longer payment cycles associated with, and increased difficulty of payment collections from certain international customers;
+Added: • significant taxes or other burdens of complying with a variety of foreign laws, including laws relating to privacy and data protection such as the GDPR.
In conducting our international operations, we are subject to United States laws relating to our international activities, such as the Foreign Corrupt Practices Act of 1977, as well as foreign laws relating to our activities in other countries, such as the United Kingdom Bribery Act of 2010.
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Department of Commerce, the United Nations Security Council and other relevant sanctions authorities.
−Removed: These laws generally prohibit, unless authorized by the relevant authority or otherwise exempt from the regulations, the conduct of business with persons, countries, regions, and governments that are targeted by “sanctions,” including but not limited to persons listed on the United States Department of Commerce’s List of Denied Persons and the United States Department of Treasury’s Specially Designated Nationals and Blocked Persons List, and the areas subject to trade embargoes by the United States (currently, Cuba, Iran, Syria, North Korea, and the Crimea region of Ukraine).
+Added: These laws generally prohibit, unless authorized by the relevant authority or otherwise exempt from the regulations, the conduct of business with persons, countries, regions, and governments that are targeted by “sanctions,”
+Added: including but not limited to persons listed on the United States Department of Commerce’s List of Denied Persons and the United States Department of Treasury’s Specially Designated Nationals and Blocked Persons List, and the areas subject to trade embargoes by the United States (currently, Cuba, Iran, Syria, North Korea, and the Crimea region of Ukraine).
Our global operations expose us to the risk of violating, or being accused of violating, these laws and regulations.
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These risks have become increasingly prevalent as we have expanded our sales into countries that are generally recognized as having a higher risk of corruption and sanctions risks.
−Removed: For instance, we conduct significant sales in Russia annually.
−Removed: In response to escalating tensions along the Russia-Ukraine border, the U.S.
−Removed: government has stated it is considering imposing enhanced export controls on certain products and sanctions on certain industry sectors and parties in Russia.
−Removed: The governments of other jurisdictions
−Removed: in which we operate, such as the European Union, may also implement sanctions or other restrictive measures against Russia.
−Removed: These potential sanctions and export controls, as well as any responses from Russia, could adversely impact our operations and negatively impact our business in the region.
+Added: For instance, we continue to sell our products through a distributor to research institutions in Russia.
+Added: As a result of the crisis in Ukraine both the United States and the European Union have implemented sanctions against certain Russian individuals and entities.
+Added: Our business in Russia could expose us to risks that could adversely affect our business, financial condition, results of operations, cash flows or the market price of our securities, including tariffs, economic sanctions and import-export restrictions.
+Added: Current geopolitical instability in Russia and Ukraine and related sanctions, including by the U.S.
+Added: government, against certain companies and individuals may hinder our ability to conduct business with potential or existing distributors, end-users and vendors in these countries.
+Added: While we believe that existing sanctions currently do not preclude us from conducting business with our current end-users, distributors or vendors in Russia, the sanctions may be expanded in the future to restrict us from engaging with them or our supplier agreements or purchase orders, due to the Ukraine crisis, may include terms and conditions that require that we limit or refrain from conducting business in Russia.
+Added: Violations of complex foreign and United States laws and regulations could result in fines and penalties, criminal sanctions against us, our officers or our employees, prohibitions on the conduct of our business and on our ability to offer our products and services in one or more countries, and could also materially affect our brand, our international growth efforts, our ability to attract and retain employees, our business and our operating results.
+Added: Even if we implement policies or procedures designed to ensure compliance with these laws and regulations, there can be no assurance that our distribution partners, our employees, contractors or agents will not violate our policies and subject us to potential claims or penalties.
+Added: Our business in China subjects us to unique operational, competitive and regulatory risks.
+Added: Our ability to sell our products in China may be impacted by evolving laws and regulations in the U.S.
+Added: In addition, increased local competition, trade tensions between the United States and China or weakening economic conditions in China, among other factors, may result in reduced sales, decreased market share, or lower margins for our products in China.
+Added: In addition, impacts stemming from COVID-19, including the public health and policy response to COVID-19 in China, may continue to present risks to our business in China.
+Added: Certain risks and uncertainties of doing business in China are solely within the control of the Chinese government, and Chinese law regulates the scope of our investments and business conducted within China.
+Added: The Chinese government may adopt new regulations that may impact entities operating in China, potentially with little advance notice.
+Added: In order to maintain access to the Chinese market, we may be required to comply with significant technical and other regulatory requirements, at times with short notice.
+Added: These actions may increase the cost of doing business in China or limit how we may do business in China, which could materially and adversely affect our business.
+Added: We are subject to risks associated with COVID-19.
+Added: Our global sales and operations expose us to risks associated wi th the COVID-19 pandemic.
+Added: Impacts from COVID-19 may adversely affect our operations, supply chains, distribution systems and customer demand, including as a result of impacts associated with preventative and precautionary measures that we, other businesses and governments have taken and may take in the future.
+Added: Some of the risks we have experienced and/or may experience in the future as a result of impacts from COVID-19 include:
+Added: • a decline in sales activities and customer orders or cancellations of existing orders, depending on the severity and duration of any future COVID-19 outbreaks and the extent of mitigation and containment measures that may be undertaken by governments and businesses;
+Added: • supply chain disruptions may result in the lack of raw materials or component shortages, delay in the release of new products or deliveries of products or compressed margins due to an increase in material costs.
+Added: Due to these impacts and measures, we may experience significant and unpredictable reductions in demand for our products and our customers may
+Added: postpone or cancel their orders.
+Added: In addition, our customers' suppliers may not be able to supply products that meet our or our customers' needs due to supply chain disruptions;
+Added: • the effectiveness of our sales teams may be negatively impacted by the lack of or reduction in travel resulting in their reduced ability to engage with decision-makers;
+Added: • the unanticipated loss or unavailability of key employees due to the COVID-19 outbreaks could harm our ability to operate or execute our business strategy.
+Added: We may not be successful in finding and integrating suitable successors in the event of key employee loss or unavailability;
+Added: • remote working, which we, similar to many other companies, implemented in response to the initial outbreak of COVID-19, and which continues to some extent even as COVID-19 outbreaks generally subside, could cause challenges for the effective operation of our internal controls, increase the risk of a security breach of our information technology systems, create data accessibility issues, challenge our ability to innovate and develop new products and improve existing solutions and increase the risk for communication disruptions;
+Added: • in addition to travel restrictions, though countries in general have re-opened their borders to U.S.
+Added: travelers, in the future, countries may again impose or expand travel restrictions and impose or resume prolonged quarantines if there is a resurgence of COVID-19 cases, which would significantly impact our ability to support our business operations and customers in those locations and the ability of our employees to access their places of work to produce products, or significantly hamper our products from moving through the supply chain.
+Added: As a result, given the uncertainty of the evolving nature of the virus, COVID-19 outbreaks may continue and may negatively affect our revenue growth, and it is uncertain how materially COVID-19 will affect our global operations if we experience any one or a combination of these impacts over an extended period of time.
+Added: Any of these impacts could have an adverse effect on our business, financial condition and results of operations.
+Added: In addition, our ability to raise capital in the future may also be negatively affected.
+Added: Public concern regarding the risk of contracting COVID-19 may impact demand from customers.
+Added: Economic impacts and health concerns associated with the pandemic may continue to affect customer behaviors and resurgences of COVID-19 could amplify such impacts.
+Added: In addition, changes in customer purchasing patterns could increase demand for our products in one quarter, resulting in decreased customer demand for our products in subsequent quarters.
+Added: Spikes in customer demand for our products may make it harder for us to distribute our products in a timely manner.
+Added: Furthermore, our growth strategies include capital intensive initiatives, such as significant investments in research and development and the acquisition or licensing of core technologies and associated intellectual property.
+Added: The current economic environment has resulted in volatility in the global capital and credit markets which could impair our ability to access these markets on terms commercially acceptable to us, or at all, and execute our growth strategies and resurgences of COVID-19 could compound this risk.
+Added: Our results of operations could be materially adversely affected by fluctuations in foreign currency exchange rates.
Historically, most of our revenue has been denominated in U.S.
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As our operations in countries outside of the United States grow, our results of operations and cash flows will become increasingly subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future.
−Removed: For example, if the value of the U.S.
−Removed: dollar increases relative to foreign currencies, in the absence of a corresponding change in local currency prices, our revenue could be adversely affected as we convert revenue from local currencies to U.S.
During periods of economic crises, such as fallout from the COVID-19 pandemic, foreign currencies may be devalued significantly against the U.S.
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dollars, but report our results of operations in U.S.
−Removed: dollars, we also face remeasurement exposure to fluctuations in currency exchange rates, which could hinder our ability to predict our future results and earnings and could materially impact our results of operations.
+Added: dollars, we also face remeasurement exposure to fluctuations in currency exchange rates, which could hinder our ability to predict our future results and earnings and could materially impact revenue and our results of operations.
We do not currently maintain a program to hedge foreign currency exposures.
−Removed: Violations of complex foreign and United States laws and regulations could result in fines and penalties, criminal sanctions against us, our officers or our employees, prohibitions on the conduct of our business and on our ability to offer our products and services in one or more countries, and could also materially affect our brand, our international growth efforts, our ability to attract and retain employees, our business and our operating results.
−Removed: Even if we implement policies or procedures designed to ensure compliance with these laws and regulations, there can be no assurance that our distribution partners, our employees, contractors or agents will not violate our policies and subject us to potential claims or penalties.
−Removed: The United Kingdom’s withdrawal from the European Union may have a negative effect on global economic conditions, financial markets and our business.
−Removed: Following the United Kingdom’s departure from the European Union ("EU") on January 31, 2020, and the end of the “transition period” on December 31, 2020, the EU and the United Kingdom have entered into a trade and cooperation agreement ("TCA") which governs certain aspects of their future relationship, including ensuring tariff-free trade for certain goods and services.
−Removed: The TCA provides details on how some aspects of the United Kingdom’s and EU’s relationship will operate going forward, however there are still many uncertainties.
−Removed: The uncertainty concerning the United Kingdom’s legal, political and economic relationship with the EU since Brexit may be a source of instability in the international markets, create significant currency fluctuations, and/or otherwise adversely affect trading agreements or similar cross-border co-operation arrangements (whether economic, tax, fiscal, legal, regulatory or otherwise).
−Removed: These developments have had, and may continue to have, a significant adverse effect on global economic conditions and the stability of global financial markets, and could significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets.
−Removed: The illegal distribution and sale by third parties of counterfeit or unfit versions of our products or stolen products could have a negative impact on our reputation and business.
−Removed: Third parties might illegally distribute and sell counterfeit or unfit versions of our products, which do not meet our rigorous manufacturing, distribution and quality standards.
−Removed: As we expand our business internationally, we expect to encounter counterfeit versions of our products, particularly our consumables.
−Removed: A researcher who receives and uses counterfeit consumables could obtain erroneous results, experience failed experiments or potentially damage his or her instrument.
−Removed: Our reputation and business could suffer harm as a result of counterfeit products sold under our brand name.
−Removed: In addition, inventory that is stolen from warehouses, plants or while in-transit, and that is subsequently improperly stored and sold through unauthorized channels, could adversely impact our customers’ experiments, our reputation and our business.
−Removed: The investment of marketable securities is subject to risks which may cause losses and affect the liquidity of these investments.
−Removed: From time to time, we have and may invest portions of excess cash and cash equivalents in marketable securities.
−Removed: We have and may invest in liquid, investment-grade marketable securities such as corporate bonds, commercial paper, asset-backed securities, U.S.
−Removed: treasury securities, money market funds, and other cash equivalents.
−Removed: We currently, and expect to continue, to follow an established investment policy and set of guidelines to monitor and help mitigate our exposure to liquidity and credit risks which set forth credit quality standards and limit our exposure to any one issuer as well as our maximum exposure to various asset classes.
−Removed: However, these investments are subject to general credit, liquidity, market and interest rate risks.
−Removed: We may realize losses in
−Removed: the fair value of these investments, which could include a complete loss of these investments, which would have a negative effect on our consolidated financial statements.
−Removed: In addition, should our investments cease paying or reduce the amount of interest paid to us, our interest income would decrease.
−Removed: Indebtedness may impair our financial and operating flexibility.
−Removed: We may incur indebtedness in the future including, for example, in connection with the expansion of our headquarters in Pleasanton.
−Removed: The debt instruments governing such indebtedness could contain restrictive provisions.
−Removed: If we incur debt, a portion of our cash flows will be needed to satisfy our debt service obligations.
−Removed: In the event that additional financing is required, we may not be able to raise it on terms acceptable to us or at all.
−Removed: As a result, we would be more vulnerable to general adverse economic, industry and capital markets conditions in addition to the risks associated with indebtedness described in this risk factor.
+Added: Due to our exposure to currencies other than U.S.
+Added: dollars, an increase in the value of certain currencies against the U.S.
+Added: dollar could increase our costs by increasing labor and other costs that are denominated in local currency.
+Added: There can be no assurance that any future hedging activities which are designed to partially offset this impact, will be successful.
+Added: In addition, our currency hedging activities, if any, in the future, could themselves be subject to risk.
+Added: These could include risks related to counterparty performance under future hedging contracts and risks related to currency fluctuations.
If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.
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Any failure to maintain effective disclosure controls and internal control over financial reporting could materially and adversely affect our business, results of operations and financial condition and could cause a decline in the trading price of our Class A common stock.
+Added: The continuing impact of "Brexit" may have a negative effect on our business.
+Added: Following a national referendum and subsequent legislation, the United Kingdom formally withdrew from the European Union, commonly referred to as “Brexit,” and ratified a trade and cooperation agreement governing its future relationship with the European Union.
+Added: Among other things, the agreement, which became effective in 2021, addresses trade, economic arrangements, law enforcement, judicial cooperation and governance.
+Added: Because the agreement merely sets forth a framework in many respects that requires complex additional bilateral negotiations between the United Kingdom and the European Union, significant uncertainty remains about how the precise terms of the relationship between the parties will differ from the terms before withdrawal.
+Added: Brexit has had, and may continue to have, a significant adverse effect on global economic conditions and the stability of global financial markets, and could significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets.
+Added: The illegal distribution and sale by third parties of counterfeit or unfit versions of our products or stolen products could have a negative impact on our reputation and business.
+Added: Third parties might illegally distribute and sell counterfeit or unfit versions of our products, which do not meet our rigorous manufacturing, distribution and quality standards.
+Added: As we expand our business internationally, we expect to encounter counterfeit versions of our products, particularly our consumables.
+Added: A researcher who receives and uses counterfeit consumables could obtain erroneous results, experience failed experiments or potentially damage his or her instrument.
+Added: Our reputation and business could suffer harm as a result of counterfeit products sold under our brand name.
+Added: In addition, inventory that is stolen from warehouses, plants or while in-transit, and that is subsequently improperly stored and sold through unauthorized channels, could adversely impact our customers’ experiments, our reputation and our business.
+Added: The investment of marketable securities is subject to risks which may cause losses and affect the liquidity of these investments.
+Added: From time to time, we have and may invest portions of excess cash and cash equivalents in marketable securities.
+Added: We have and may invest in liquid, investment-grade marketable securities such as corporate bonds, commercial paper, asset-backed securities, U.S.
+Added: treasury securities, money market funds, and other cash equivalents.
+Added: We currently, and expect to continue, to follow an established investment policy and set of guidelines to monitor and help mitigate our exposure to liquidity and credit risks which set forth credit quality standards and limit our exposure to any one issuer as well as our maximum exposure to various asset classes.
+Added: However, these investments are subject to general credit, liquidity, market and interest rate risks.
+Added: We may realize losses in the fair value of these investments, which could include a complete loss of these investments, which would have a negative effect on our consolidated financial statements.
+Added: In addition, should our investments cease paying or reduce the amount of interest paid to us, our interest income would decrease.
+Added: Indebtedness may impair our financial and operating flexibility.
+Added: We may incur indebtedness in the future.
+Added: The debt instruments governing such indebtedness could contain restrictive provisions.
+Added: If we incur debt, a portion of our cash flows will be needed to satisfy our debt service obligations.
+Added: In the event that additional financing is required, we may not be able to raise it on terms acceptable to us or at all.
+Added: As a result, we would be more vulnerable to general adverse economic, industry and capital markets conditions in addition to the risks associated with indebtedness described in this risk factor.
Risks related to our regulatory environment and taxation
−Removed: Ethical, legal, privacy and social concerns or governmental restrictions surrounding the use of the genomic and multi-omic information and gene editing could reduce demand for our products.
−Removed: While we do not make gene sequencing or gene editing products, our products are used to better understand genomic information that could further gene editing endeavors.
−Removed: For example, our single cell gene expression solutions allow users to examine cells that have been genetically perturbed using clustered regularly interspaced short palindromic repeats (“CRISPR”) gene editing technology.
−Removed: Advances in genome editing or gene therapy, such as CRISPR Cas9 technology have been subject to negative publicity and increased regulatory scrutiny, in part due to the underlying ethical, legal, privacy and social concerns regarding the use or potential misuse of such technology.
−Removed: Governmental authorities could, for safety, social or other purposes, call for limits on or regulation of technologies and products used in the genome editing or gene therapy fields.
−Removed: Such concerns or governmental restrictions could limit the use of our products.
−Removed: Because the science and technology of genome editing or gene therapy is incredibly complex, any regulations or restrictions placed on such technology or aimed at curtailing its usage could, intentionally or inadvertently, limit or restrict the usage of our products.
−Removed: Any such restrictions or any reduction in usage of our products as a result of concerns regarding the usage of genome editing technology could have a material adverse effect on our business, financial condition and results of operations.
Our products could become subject to more onerous regulation by the U.S.
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A product labeled RUO but which is actually intended for clinical diagnostic use may be viewed by the FDA as adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (“FDC Act”), and subject to FDA enforcement action.
−Removed: In the European Union (“EU”), under Directive 98/79/EC (“EU IVDD”), RUO products which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation used in diagnostic procedures.
−Removed: More importantly, Regulation (EU) 2017/746 (“EU IVDR”) expressly provides that products intended for RUO are excluded from the scope of the regulation.
+Added: In the European Union (“EU”), under Regulation (EU) No 2017/746 (“EU IVDR”), RUO products which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation used in diagnostic procedures.
+Added: More importantly, the EU IVDR expressly provides that products intended for RUO are excluded from the scope of the Regulation.
A material intended for RUO, without any medical purpose or objective, is therefore not considered as an in vitro diagnostic medical device (“IVD”) and is not subject to compliance with IVD requirements.
−Removed: However, depending on the type of RUO products in question, requirements to market some products may be tighten under the EU IVDR such as for laboratory developed tests.
+Added: However, depending on the type of RUO products in question, requirements to market some products may be tighter under the EU IVDR such as for laboratory developed tests.
Depending on the product in question, other regulations may be applicable to the RUO products.
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The FDA and foreign authorities could disagree with our assessment that our products are properly marketed as RUOs, or could conclude that products labeled as RUO are actually intended for clinical diagnostic use, and could take enforcement action against us, including requiring us to stop distribution of our products until we are in compliance with applicable regulations, which would reduce our revenue, increase our costs and adversely affect our business, prospects, results of operations and financial condition.
−Removed: In the event that the FDA or foreign authorities requires us to obtain marketing authorization or certification of our RUO products in the future, there can be no assurance that these authorities will grant any clearance, approval or certification requested by us in a timely manner, or at all.
+Added: In the event that the FDA or foreign authorities requires us to obtain marketing authorization or certification of our RUO products in the
+Added: future, there can be no assurance that these authorities will grant any clearance, approval or certification requested by us in a timely manner, or at all.
We may also in the future decide to develop products that are intended for clinical or diagnostic uses.
1 unchanged sentence
In the EU, there is currently no premarket government review of medical devices (including IVDs).
−Removed: However, the EU requires that all IVDs placed on the market in the EU must meet the essential requirements of the EU IVDD including the requirement that an IVD must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.
−Removed: Compliance with the essential requirements of the IVDD is a prerequisite for European conformity marking (“CE mark”) without which IVDs cannot be marketed or sold in the EU.
−Removed: The EU regulatory landscape concerning IVDs is evolving.
−Removed: On April 5, 2017 the EU IVDR was adopted to establish a modernized and more robust EU legislative framework, with the aim of ensuring better protection of public health and patient safety.
+Added: However, the EU requires that all IVDs placed on the market in the EU must meet general and safety requirements of the EU IVDR including the requirement that an IVD must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose.
+Added: IVDs must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and – where applicable – other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.
+Added: Compliance with general and safety requirements of the EU IVDR is a prerequisite for European conformity marking (“CE mark”) without which IVDs cannot be marketed or sold in the EU.
+Added: The EU regulatory landscape concerning IVDs recently evolved.
+Added: On May 26, 2022, the EU IVDR became applicable, and repealed and replaced the EU IVDD.
Unlike the EU IVDD, the EU IVDR is directly applicable in all EU member states without the need for member states to implement into national law.
This aims at reducing the risk of discrepancies in interpretation across the different European markets.
−Removed: The EU IVDR will fully apply on May 26, 2022 but there will be a tiered system extending the grace period for many devices (depending
−Removed: on their risk classification) before they have to be fully compliant with the regulation.
−Removed: Once applicable, the EU IVDR may impose increased compliance obligations for us if we decide to market products for clinical or diagnostic uses and impact our development plans.
+Added: The EU IVDR may impose increased compliance obligations for us if we decide to market products for clinical or diagnostic uses and impact our development plans.
In addition, the process of obtaining approval or clearance from the FDA or certification from notified bodies in the EU or approved bodies in the United Kingdom for new products, or with respect to enhancements or modifications to existing products, could take a significant period of time, require the expenditure of substantial resources, involve rigorous pre-clinical and clinical testing, require changes to products or result in limitations on the indicated uses of products.
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and Chinese markets.
−Removed: Therefore, it is possible further tariffs may be imposed that could cover imports of the export or sale of our instruments and/or consumables, or our business may be adversely impacted by retaliatory trade measures taken by China or other countries, which could materially harm our business, financial condition and results of operations.
+Added: Therefore, it is possible further tariffs may be imposed that could cover imports of the export or sale of our instruments and/or consumables, or our business may be adversely impacted by retaliatory trade measures taken by China or other countries, which could materially
+Added: harm our business, financial condition and results of operations.
The nature of the dispute between the United States and China is evolving and additional products such as ours could become subject to tariffs, which could adversely affect the marketability of our products and our results of operations.
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Any such changes could directly and adversely impact our financial results and results of operations.
−Removed: Additionally, in November 2018, the United States Commerce Department’s Bureau of Industry and Security released an advance notice of proposed rulemaking to control the export of emerging technologies.
−Removed: This notice included “[b]iotechnology, including nanobiology;
−Removed: synthetic biology;
−Removed: genomic and genetic engineering;
−Removed: or neurotech” as possible areas of increased export controls.
−Removed: Therefore, it is possible that our ability to export our products may be restricted in the future.
+Added: In recent years, the United States government has a renewed focus on export control matters.
+Added: For example, the Export Control Reform Act of 2018 and regulatory guidance thereunder have imposed additional controls and may result in the imposition of further additional controls, on the export of certain “emerging and foundational technologies.” Our current and future products may be subject to these heightened regulations, which could increase our compliance costs.
The imposition of new, or changes in existing, tariffs, trade restrictions, trade barriers, export controls or retaliatory trade measures taken by other countries could adversely impact our business, financial condition and results of operations.
+Added: Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
+Added: New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could affect the tax treatment of our domestic and foreign earnings.
+Added: Any new taxes could adversely affect our domestic and international business operations and our business and financial performance.
+Added: Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us.
+Added: For example, the Tax Cuts and Jobs Act of 2017 (the "TCJA") requires U.S.
+Added: research and experimental expenditures to be capitalized and amortized ratably over a five-year period.
+Added: Any such expenditures attributable to research conducted outside the United States must be capitalized and amortized over a 15-year period.
+Added: The TCJA also imposes limitations on the deductibility of interest and the use of NOL carryforwards, among other significant changes to corporate taxation of business activities outside the United States.
+Added: In addition, the Inflation Reduction Act of 2022 recently became law and imposes a minimum tax on certain corporations with book income of at least $1 billion, subject to certain adjustments, and a 1% excise tax on certain stock buybacks and similar corporate actions.
+Added: Finally, the Organization for Economic Co-Operation and Development has released guidance and blueprints covering various topics, including a global minimum effective tax rate on certain corporate groups known as “Pillar Two," and rules governing transfer pricing, country-by-country reporting, and definitional changes to permanent establishment that could ultimately impact our tax liabilities as those guidance and blueprints are potentially implemented in various jurisdictions.
Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
11 unchanged sentences
As a result, our net operating losses generated through November 1, 2013 may be subject to limitation under Section 382 of the Code.
−Removed: The amount of pre-change loss carryforwards which may be subject to this limitation is $4.8 million.
−Removed: In addition, certain attributes are subject to annual limitations as a result of our acquisition of ReadCoor, which constitutes an ownership change.
−Removed: Such limitations may result in expiration of a portion of the carryforwards before utilization.
+Added: In addition, certain attributes attributable to ReadCoor are subject to annual limitations as a result of our acquisition of ReadCoor, which constituted an ownership change of ReadCoor.
+Added: Such limitations may result in expiration of a portion of our net operating loss carryforwards or other tax attributes before utilization.
Our ability to use net operating loss carryforwards, research and development credit carryforwards and other tax attributes to reduce future taxable income and liabilities may be further limited as a result of future changes in stock ownership.
−Removed: As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards or other pre-change tax attributes to offset United States federal and state taxable income may still be subject to limitations, which could potentially result in increased future tax liability to us.
+Added: As a result, if we earn net taxable income, our
+Added: ability to use our pre-change net operating loss carryforwards or other pre-change tax attributes to offset United States federal and state taxable income may still be subject to limitations, which could potentially result in increased future tax liability to us.
We are subject to risks related to taxation in multiple jurisdictions.
4 unchanged sentences
If material, payment of such additional amounts upon final adjudication of any disputes could have a material impact on our results of operations and financial position.
−Removed: Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
−Removed: New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could affect the tax treatment of our domestic and foreign earnings.
−Removed: Any new taxes could adversely affect our domestic and international business operations and our business and financial performance.
−Removed: Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us.
−Removed: For example, the Tax Cuts and Jobs Act of 2017 (the “TCJA”) significantly revised the Code.
−Removed: This federal income tax law contains significant changes to corporate taxation.
−Removed: In April 2020, recent interpretations of a German law relating to withholding taxes on intellectual property rights emerged.
−Removed: We have completed our evaluation of the overall impact of this recent interpretation of German law and our evaluation of the overall impact of TCJA on our effective tax rate and balance sheet through December 31, 2021 and have reflected the amounts in our financial statements for the quarter ended December 31, 2021.
−Removed: On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was signed into law.
−Removed: The CARES Act includes provisions relating to net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property.
−Removed: These provisions are not expected to have a material impact on the Company’s consolidated financial statements.
+Added: Ethical, legal, privacy and social concerns or governmental restrictions surrounding the use of the genomic and multi-omic information and gene editing could reduce demand for our products.
+Added: While we do not make gene sequencing or gene editing products, our products are used to better understand genomic information that could further gene editing endeavors.
+Added: For example, our Chromium Single Cell Gene Expression solution allows users to examine cells that have been genetically perturbed using clustered regularly interspaced short palindromic repeats (“CRISPR”) gene editing technology.
+Added: Advances in genome editing or gene therapy, such as CRISPR Cas9 technology have been subject to negative publicity and increased regulatory scrutiny, in part due to the underlying ethical, legal, privacy and social concerns regarding the use or potential misuse of such technology.
+Added: Governmental authorities could, for safety, social or other purposes, call for limits on or regulation of technologies and products used in the genome editing or gene therapy fields.
+Added: Such concerns or governmental restrictions could limit the use of our products.
+Added: Because the science and technology of genome editing or gene therapy is incredibly complex, any regulations or restrictions placed on such technology or aimed at curtailing its usage could, intentionally or inadvertently, limit or restrict the usage of our products.
+Added: Any such restrictions or any reduction in usage of our products as a result of concerns regarding the usage of genome editing technology could have a material adverse effect on our business, financial condition and results of operations.
Risks related to our intellectual property, information technology and data security
8 unchanged sentences
The intellectual property laws and other statutory and contractual arrangements in the United States and other jurisdictions we depend upon may not provide sufficient protection in the future to prevent the infringement, use, violation or misappropriation of our patents, trademarks, data, technology and other intellectual property rights by others, and may not provide an adequate remedy if our intellectual property rights are infringed, misappropriated or otherwise violated by others.
−Removed: We rely in part on our portfolio of issued and pending patent applications in the United States and other countries to protect our intellectual property and competitive position.
−Removed: However, it is also possible that we may fail to identify patentable aspects of inventions made in the course of our development, manufacture and commercialization activities before it is too late to obtain patent protection on them.
+Added: We rely in part on our portfolio of issued patents and pending patent applications in the United States and other countries to protect our intellectual property and competitive position.
+Added: However, it is also possible that we may fail to identify patentable aspects of inventions made in the course of the development, manufacture and commercialization activities conducted by or on behalf of us before it is too late to obtain patent protection on such inventions.
If we fail to timely file for patent protection in any jurisdiction, we may be precluded from doing so at a later date.
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Therefore, these patents and patent applications may not be prosecuted, maintained and/or enforced in a manner consistent with the best interests of our business.
−Removed: While we generally apply for patents in those countries where we intend to make, have made, use, import, offer to sell or sell patented products, we may not accurately predict all of the countries where patent protection will ultimately be desirable.
+Added: While we generally apply for patents in those countries where we intend to make, have made, use, import, offer for sale or sell our products, we may not accurately predict all of the countries where patent protection will ultimately be desirable.
Furthermore, the issuance of a patent does not give us the right to practice the patented invention.
−Removed: Third parties may have blocking patents that could prevent us from manufacturing and/or commercializing our own products or services, or otherwise practicing our own technology.
+Added: Third parties may have blocking patents that could prevent us from importing, manufacturing and/or commercializing our own products or services, or otherwise practicing our own technology.
Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.
The patent positions of companies, including our patent position, may involve complex legal and factual questions that have been the subject of much litigation in recent years, and, therefore, the scope of any patent claims that we have or may obtain cannot be predicted with certainty.
−Removed: Accordingly, we cannot provide any assurances about which of our patent applications will issue, the breadth of any resulting patent, whether any of the issued patents will be found to be infringed, invalid or unenforceable or will be threatened or challenged by third parties, that any of our issued patents have, or that any of our currently pending or future patent applications that mature into issued patents will include, claims with a scope sufficient to protect our products and services.
+Added: Accordingly, we cannot provide any assurances about which of our patent applications will issue, the breadth of any resulting patent, whether any of the issued patents will be found to be infringed, invalid or unenforceable or will be threatened or challenged by third parties, that any of our issued patents have, or that any of our currently pending or future patent applications that mature into issued patents will include, claims with a scope sufficient to protect our products, services or technology.
Our pending and future patent applications may not result in the issuance of patents or, if issued, may not issue in a form that will be advantageous to us.
The coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance.
−Removed: We cannot offer any assurances that the breadth of our granted patents will be sufficient to stop a competitor from developing, manufacturing and commercializing a product or technologies in a non-infringing manner that would be competitive with one or more of our products or technologies, or otherwise provide us with any competitive advantage.
−Removed: Furthermore, any successful challenge to these patents or any other patents owned by or licensed to us after patent
−Removed: issuance could deprive us of rights necessary for our commercial success.
+Added: We cannot offer any assurances that the breadth of our issued patents will be sufficient to stop a competitor from developing, manufacturing and commercializing a product or technologies in a non-infringing manner that would be competitive with one or more of our products or technologies, or otherwise provide us with any competitive advantage.
+Added: Furthermore, any successful challenge to these patents or any other patents owned by or licensed to us after patent issuance could deprive us of rights necessary for our commercial success.
Further, there can be no assurance that we will have adequate resources to enforce our patents.
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The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:
+Added: • others will not develop, manufacture and/or commercialize similar or alternative products or technologies that do not infringe our patents;
+Added: • any patents issued to us will provide a basis for an exclusive market for our commercially viable products or technologies will provide us with any competitive advantages or will not be challenged by third parties;
+Added: • any of our challenged patents will be found to ultimately be valid and enforceable;
• any of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our products or services;
3 unchanged sentences
• we were the first to file patent applications for these inventions;
−Removed: • others will not develop, manufacture and/or commercialize similar or alternative products or technologies that do not infringe our patents;
−Removed: • any of our challenged patents will be found to ultimately be valid and enforceable;
−Removed: • any patents issued to us will provide a basis for an exclusive market for our commercially viable products or technologies will provide us with any competitive advantages or will not be challenged by third parties;
• we will develop additional proprietary technologies or products that are separately patentable;
• our commercial activities or products will not infringe upon the patents of others.
−Removed: We are subject to certain manufacturing restrictions related to licensed intellectual property rights that were developed with the financial assistance of United States government grants.
−Removed: Under the Bayh-Dole Act, the federal government retains a “nonexclusive, nontransferable, irrevocable, paid-up license” in inventions produced with its financial assistance (“Government Funded Inventions”) for its own benefit.
−Removed: The Bayh-Dole Act provides federal agencies with march-in rights (“March-In Rights”), which allows a government agency, in specified circumstances, to require the patent owner or successors in title to the patent directed to such Government Funded Inventions (“Patent Owner”) to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants,” which if exercised, would allow such government agency to require such Patent Owner to grant a non-exclusive, partially exclusive or exclusive license in any field of use to a third-party designated by such agency.
−Removed: The Bayh-Dole Act also provides that the Patent Owner manufacture products embodying the respective Government Funded Inventions domestically in accordance with certain requirements.
−Removed: If this domestic manufacturing requirement is not met, the government agency that funded the relevant grant is entitled to exercise March-In Rights.
−Removed: We are subject to the Bayh-Dole Act with respect to certain licensed technologies that were developed with United States government grants.
−Removed: Such licensed technologies are used, for example, in a substantial majority of our consumables.
−Removed: Further, we cannot be sure that if we acquired intellectual property rights in the future it will be free from government rights or regulations pursuant to the Bayh-Dole Act.
−Removed: If we own, co-own or license in technology that is critical to our business that is developed in whole or in part with federal funds subject to the Bayh-Dole Act, our ability to enforce or otherwise exploit patents covering such technology may be adversely affected.
−Removed: Further, the exercise of March-In rights, the requirement that we grant additional licenses to third parties, or the termination of our license of the relevant technologies could materially adversely affect our business, operations and financial condition.
−Removed: The restrictions of the Bayh-Dole Act may also limit our ability to manufacture our products in geographies where it may be more economically favorable to do so which could limit our ability to respond to competitive developments or otherwise adversely affect our results of operations.
−Removed: Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
−Removed: Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
−Removed: Patent and Trademark Office, or USPTO, and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.
−Removed: In addition, periodic maintenance fees, renewal fees, annuity fees and various other government fees on issued patents often must be paid to the USPTO and foreign patent agencies over the lifetime of the patent and/or applications and any patent rights we may obtain in the future.
−Removed: While an unintentional lapse of a patent or patent application can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
−Removed: Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
−Removed: If we fail to maintain the patents and patent applications covering our products or services, we may not be able to stop a competitor from marketing products or services that are the same as or similar to our products or services, which would have a material adverse effect on our business, financial condition and results of operations.
If we cannot successfully enforce our intellectual property rights, the commercial value of our products and technologies will be adversely affected and our competitive position may be harmed.
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Mechanisms for such challenges include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).
−Removed: In a patent or other intellectual property infringement proceeding, a court
−Removed: may decide that a patent or other intellectual property right of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims or other intellectual property narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents or other intellectual property do not cover the technology in question.
+Added: In a patent or other intellectual property infringement proceeding, a court may decide that a patent or other intellectual property right of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims or other intellectual property narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents or other intellectual property do not cover the technology in question.
Furthermore, even if our patents or other intellectual property rights are found to be valid and infringed, a court may refuse to grant injunctive relief against the infringer and instead grant us monetary damages and/or ongoing royalties.
Such monetary compensation may be insufficient to adequately offset the damage to our business caused by the infringer’s competition in the market.
−Removed: An adverse result in any litigation or administrative proceeding could put one or more of our patents or other intellectual property rights at risk of being invalidated or interpreted narrowly, which could adversely affect our competitive business position, financial condition and results of operations.
+Added: An adverse result in any litigation or administrative proceeding could put one or more of our patents or other intellectual property rights at risk of being
+Added: invalidated or interpreted narrowly, which could adversely affect our competitive business position, financial condition and results of operations.
Moreover, even if we are successful in any litigation, we may incur significant expense in connection with such proceedings, and the amount of any monetary damages may be inadequate to compensate us for damage as a result of the infringement and the proceedings.
−Removed: If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be harmed.
−Removed: Our trademarks could be challenged, invalidated, infringed, and circumvented by third parties, and our trademarks could also be diluted, declared generic or found to be infringing on other marks.
−Removed: If any of the foregoing occurs, we could be forced to re-brand our products or technologies, resulting in loss of brand recognition and requiring us to devote resources to advertising and marketing new brands, and suffer other competitive harm.
−Removed: Third parties may also adopt trademarks similar to ours, which could harm our brand identity and lead to market confusion.
−Removed: Further, there can be no assurance that competitors will not infringe our trademarks or that we will have adequate resources to enforce our trademarks.
−Removed: At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion.
−Removed: Certain of our current or future trademarks may become so well known by the public that their use becomes generic and they lose trademark protection.
−Removed: Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively.
−Removed: Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, operating results and prospects.
−Removed: We rely on our trademarks, trade names and brand names, such as our 10X, 10X GENOMICS, CHROMIUM, VISIUM and XENIUM marks, to distinguish our products and technologies from the products and technologies of our competitors, and have registered or applied to register many of these trademarks in the United States and certain countries outside the United States, however, we have not yet registered all of our trademarks in all of our current and potential markets.
−Removed: There can be no assurance that our trademark applications will be approved for registration.
−Removed: During trademark registration proceedings, we may receive rejections.
−Removed: Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections.
−Removed: In addition, in proceedings before the USPTO and comparable agencies in many foreign jurisdictions, third parties may also oppose our trademark applications and may seek to cancel trademark registrations or otherwise challenge our use of the trademarks.
−Removed: Opposition or cancellation proceedings may be filed against our trademark filings in these agencies, and such filings may not survive such proceedings.
−Removed: While we may be able to continue the use of our trademarks in the event registration is not available, particularly in the United States, where trademark rights are acquired based on use and not registration, third parties may be able to enjoin the continued use of our trademarks if such parties are able to successfully claim infringement in court.
−Removed: In addition, opposition or cancellation proceedings may be filed against our trademark applications and registrations and our trademarks may not survive such proceedings.
−Removed: If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would.
−Removed: Our trademarks or trade names may be infringed, circumvented, declared generic or determined to be violating or infringing on other marks.
−Removed: Changes in patent law could diminish the value of our patents in general, thereby impairing our ability to protect our current and future products or technologies, and could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our current or future patents.
−Removed: Our ability to obtain patents and the breadth of any patents obtained is uncertain in part because, to date, some legal principles remain unresolved, and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States and other countries.
−Removed: Changes in either patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property rights or narrow the scope of our patent protection, which in turn could diminish the commercial value of our products and services.
−Removed: Patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement and defense of our patents and applications.
−Removed: Furthermore, the U.S.
−Removed: Supreme Court and the U.S.
−Removed: Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States
−Removed: are interpreted.
−Removed: The United States Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
−Removed: In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.
−Removed: Depending on actions by the United States Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we own or that we might obtain or license in the future.
−Removed: An inability to obtain, enforce, and defend patents covering our proprietary technologies would materially and adversely affect our business prospects and financial condition.
−Removed: For example, various courts, including the U.S.
−Removed: Supreme Court, have rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to the life sciences.
−Removed: Specifically, these decisions stand for the proposition that patent claims that recite laws of nature (for example, the relationships between gene expression levels and the likelihood of risk of recurrence of cancer) are not themselves patentable unless those patent claims have sufficient additional features that provide practical assurance that the processes are genuine inventive applications of those laws rather than patent drafting efforts designed to monopolize the law of nature itself.
−Removed: What constitutes a “sufficient” additional feature is uncertain.
−Removed: Furthermore, in view of these decisions, in December 2014 the USPTO, published revised guidelines for patent examiners to apply when examining process claims for patent eligibility.
−Removed: This guidance was updated by the USPTO in July 2015 and additional illustrative examples provided in May 2016.
−Removed: The USPTO provided additional guidance on examination procedures pertaining to subject matter eligibility in April 2018 and June 2018.
−Removed: The guidance indicates that claims directed to a law of nature, a natural phenomenon or an abstract idea that do not meet the eligibility requirements should be rejected as non-statutory, patent ineligible subject matter;
−Removed: however, method of treatment claims that practically apply natural relationships should be considered patent eligible.
−Removed: We cannot assure you that our patent portfolio will not be negatively impacted by the current uncertain state of the law, new court rulings or changes in guidance or procedures issued by the USPTO.
−Removed: From time to time, the U.S.
−Removed: Supreme Court, other federal courts, the U.S.
−Removed: Congress or the USPTO may change the standards of patentability and validity of patents within the life sciences and any such changes could have a negative impact on our business.
−Removed: Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted.
−Removed: Changes in patent laws and regulations in other countries or jurisdictions, changes in the governmental bodies that enforce them, or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we own or may obtain in the future.
−Removed: Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States.
−Removed: In addition, any protection afforded by foreign patents may be more limited than that provided under U.S.
−Removed: patent and intellectual property laws.
−Removed: We may encounter significant problems in enforcing and defending our intellectual property both in the United States and abroad.
−Removed: For example, if the issuance in a given country of a patent covering an invention is not followed by the issuance in other countries of patents covering the same invention, or if any judicial interpretation of the validity, enforceability or scope of the claims or the written description or enablement in a patent issued in one country is not similar to the interpretation given to the corresponding patent issued in other countries, our ability to protect our intellectual property rights in those countries may be limited.
−Removed: Changes in either patent laws or in interpretations of patent laws in the United States and other countries may materially diminish the value of our intellectual property rights or narrow the scope of our patent protection.
−Removed: We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by U.S.
−Removed: and foreign legislative bodies.
−Removed: Those changes may materially affect our patents or patent applications and our ability to obtain additional patent protection in the future.
−Removed: Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.
−Removed: The legal systems in certain countries may also favor state-sponsored or companies headquartered in particular jurisdictions over our first-in-time patents and other intellectual property protection.
−Removed: We are aware of incidents where such entities have stolen the intellectual property of domestic companies in order to create competing products and we believe we may face such circumstances ourselves in the future.
−Removed: For example, through its “Annual Special 301 Report on Intellectual Property,” the Office of the United States Trade Representative (“USTR”) has been reporting on the adequacy and effectiveness of intellectual property protection in a number of foreign countries that are U.S.
−Removed: trading partners and their protection and enforcement of intellectual property rights.
−Removed: A number of countries in which both we and our distributors operate have been identified in the reports as being on the Priority Watch List.
−Removed: Placement of a country on the Priority Watch List indicates that particular problems exist in that country with respect to intellectual property protection, enforcement, or market access for persons relying on intellectual property rights.
−Removed: Countries placed on the Priority Watch List are the focus of increased bilateral attention concerning the specific problem areas.
−Removed: It is possible that we will not be able to enforce our intellectual property rights against third parties that misappropriate our proprietary technology in those countries.
−Removed: We depend on certain intellectual property rights that are licensed to us.
−Removed: We may be unsuccessful in licensing or acquiring intellectual property rights from third parties that may be necessary to develop, manufacture and/or commercialize our current and/or future products or technologies.
−Removed: Various proprietary technologies that are used in a substantial majority of our consumables are protected by intellectual property rights that we in-license from third parties.
−Removed: Our rights to use such intellectual property rights in our business are subject to the continuation of and our compliance with the terms of the license agreements between us and each of our licensors.
−Removed: A third party may hold intellectual property rights, including patent rights, that are important or necessary to the development, manufacture and/or commercialization of our current and/or future products or technologies, in which case we would be need to acquire or obtain a license to such intellectual property rights from such third party.
−Removed: A third party that perceives us to be a competitor may be unwilling to assign or license its intellectual property rights to us.
−Removed: In addition, the licensing or acquisition of third-party intellectual property rights is a competitive area, and other companies may also pursue similar strategies to license or acquire such third party’s intellectual property rights.
−Removed: Some of these companies may be established and may have a competitive advantage over us due to their size, capital resources and greater development, manufacturing and commercialization capabilities.
−Removed: We also may be unable to license or acquire third party intellectual property rights on commercially reasonable terms that would allow us to make an appropriate return on our investment, or we may be unable to obtain any such license or acquisition at all.
−Removed: If we are unable to successfully obtain rights to necessary third-party intellectual property rights, we may not be able to develop, manufacture or commercialize our current and/or future products or technologies, which could have a material adverse effect on our business, financial condition and results of operations.
−Removed: We may be subject to claims that we or our employees have misappropriated the intellectual property rights of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors.
−Removed: We may be subject to claims that our employees or consultants have wrongfully used for our benefit or disclosed to us confidential information of third parties.
−Removed: Many of our employees and consultants were previously employed at or engaged by other medical device companies, including our competitors or potential competitors.
−Removed: Some of these employees and consultants may have executed confidential information non-disclosure and inventions assignment agreements and non-competition agreements in connection with such previous employment or engagements.
−Removed: Although we try to ensure that our employees and consultants do not use the intellectual property rights, proprietary information, know-how or trade secrets of others in their work for us, we may be subject to claims that we or these individuals have, inadvertently or otherwise, misappropriated the intellectual property rights or disclosed the alleged trade secrets or other proprietary information, of these former employers or customers.
−Removed: To the extent that our employees or consultants use intellectual property rights or proprietary information owned by others in their work for us, disputes may arise as to the rights in any related or resulting know-how and inventions.
−Removed: Litigation may be necessary to defend against these claims.
−Removed: There is no guarantee of success in defending these claims, and even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees.
We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property rights.
7 unchanged sentences
Additionally, we may be subject to claims from third parties challenging ownership interest in or inventorship of intellectual property rights we regard as our own, based on claims that our agreements with employees or consultants obligating them to assign their intellectual property rights to us are ineffective or in conflict with prior or competing contractual obligations to assign inventions and intellectual property rights to another employer, to a former employer, or to another person or entity.
−Removed: may be necessary to defend against such claims, and it may be necessary or we may desire to obtain a license to such third party’s intellectual property rights to settle any such claim;
+Added: Litigation may be necessary to defend against such claims, and it may be necessary or we may desire to obtain a license to such third party’s intellectual property rights to settle any such claim;
however, there can be no assurance that we would be able to obtain such license on commercially reasonable terms, if at all.
5 unchanged sentences
A loss of key personnel or their work product could hamper or prevent our ability to develop, manufacture and/or commercialize our products or services, which could materially and adversely affect our business, financial condition and results of operations.
+Added: We depend on certain intellectual property rights that are licensed to us.
+Added: We may be unsuccessful in licensing or acquiring intellectual property rights from third parties that may be necessary to develop, manufacture and/or commercialize our current and/or future products or technologies.
+Added: Various proprietary technologies that are used in a substantial majority of our consumables are protected by intellectual property rights that we in-license from third parties.
+Added: Our rights to use such intellectual property rights in our business are subject to the continuation of and our compliance with the terms of the license agreements between us and each of our licensors.
+Added: A third party may hold intellectual property rights, including patent rights, that are important or necessary to the development, manufacture and/or commercialization of our current and/or future products or technologies, in which case we would need to acquire or obtain a license to such intellectual property rights from such third party.
+Added: A third party that perceives us to be a competitor may be unwilling to assign or license its intellectual property rights to us.
+Added: In addition, the licensing or acquisition of third-party intellectual property rights is a competitive area, and other companies may also pursue similar strategies to license or acquire such third party’s intellectual property rights.
+Added: Some of these companies may be established and may have a competitive advantage over us due to their size, capital resources and greater development, manufacturing and commercialization capabilities.
+Added: We also may be unable to license or acquire third party intellectual property rights on commercially reasonable terms that would
+Added: allow us to make an appropriate return on our investment, or we may be unable to obtain any such license or acquisition at all.
+Added: If we are unable to successfully obtain rights to necessary third-party intellectual property rights, we may not be able to develop, manufacture or commercialize our current and/or future products or technologies, which could have a material adverse effect on our business, financial condition and results of operations.
If we fail to execute invention assignment agreements with our employees and contractors involved in the development of intellectual property rights or are unable to protect the confidentiality of our trade secrets, the value of our products and technologies and our business and competitive position could be harmed.
23 unchanged sentences
Further, we may not be able to obtain adequate remedies for any breach.
−Removed: While we use commonly accepted security measures, trade secret violations are often a matter of state law in the United States, and the criteria for protection of trade secrets can vary among different jurisdictions.
+Added: While we use commonly accepted security measures, trade secret violations are often a matter of state law in the United States, and the criteria for protection of trade
+Added: secrets can vary among different jurisdictions.
If the steps we have taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret.
1 unchanged sentence
If any of our intellectual property rights or confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, it could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.
+Added: We may be subject to claims that we or our employees have misappropriated the intellectual property rights of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors.
+Added: We may be subject to claims that our employees or consultants have wrongfully used for our benefit or disclosed to us confidential information of third parties.
+Added: Many of our employees and consultants were previously employed at or engaged by other medical device companies, including our competitors or potential competitors.
+Added: Some of these employees and consultants may have executed confidential information non-disclosure and inventions assignment agreements and non-competition agreements in connection with such previous employment or engagements.
+Added: Although we try to ensure that our employees and consultants do not use the intellectual property rights, proprietary information, know-how or trade secrets of others in their work for us, we may be subject to claims that we or these individuals have, inadvertently or otherwise, misappropriated the intellectual property rights or disclosed the alleged trade secrets or other proprietary information, of these former employers or customers.
+Added: To the extent that our employees or consultants use intellectual property rights or proprietary information owned by others in their work for us, disputes may arise as to the rights in any related or resulting know-how and inventions.
+Added: Litigation may be necessary to defend against these claims.
+Added: There is no guarantee of success in defending these claims, and even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees.
+Added: Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
+Added: Patent and Trademark Office, or USPTO, and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.
+Added: In addition, periodic maintenance fees, renewal fees, annuity fees and various other government fees on issued patents often must be paid to the USPTO and foreign patent agencies over the lifetime of the patent and/or applications and any patent rights we may obtain in the future.
+Added: While an unintentional lapse of a patent or patent application can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
+Added: Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
+Added: If we fail to maintain the patents and patent applications covering our products or services, we may not be able to stop a competitor from marketing products or services that are the same as or similar to our products or services, which would have a material adverse effect on our business, financial condition and results of operations.
+Added: Changes in patent law could diminish the value of our patents in general, thereby impairing our ability to protect our current and future products or technologies, and could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our current or future patents.
+Added: Our ability to obtain patents and the breadth of any patents obtained is uncertain in part because, to date, some legal principles remain unresolved, and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States and other countries.
+Added: Changes in either patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property rights or narrow the scope of our patent protection, which in turn could diminish the commercial value of our products and services.
+Added: Patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement and defense of our patents and applications.
+Added: Furthermore, the U.S.
+Added: Supreme Court and the U.S.
+Added: Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States are interpreted.
+Added: The United States Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
+Added: In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.
+Added: Depending on actions by the United States Congress, the
+Added: federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we own or that we might obtain or license in the future.
+Added: An inability to obtain, enforce, and defend patents covering our proprietary technologies would materially and adversely affect our business prospects and financial condition.
+Added: For example, various courts, including the U.S.
+Added: Supreme Court, have rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to the life sciences.
+Added: Specifically, these decisions stand for the proposition that patent claims that recite laws of nature (for example, the relationships between gene expression levels and the likelihood of risk of recurrence of cancer) are not themselves patentable unless those patent claims have sufficient additional features that provide practical assurance that the processes are genuine inventive applications of those laws rather than patent drafting efforts designed to monopolize the law of nature itself.
+Added: What constitutes a “sufficient” additional feature is uncertain.
+Added: Furthermore, in view of these decisions, in December 2014 the USPTO, published revised guidelines for patent examiners to apply when examining process claims for patent eligibility.
+Added: This guidance was updated by the USPTO in July 2015 and additional illustrative examples provided in May 2016.
+Added: The USPTO provided additional guidance on examination procedures pertaining to subject matter eligibility in April 2018 and June 2018.
+Added: The guidance indicates that claims directed to a law of nature, a natural phenomenon or an abstract idea that do not meet the eligibility requirements should be rejected as non-statutory, patent ineligible subject matter;
+Added: however, method of treatment claims that practically apply natural relationships should be considered patent eligible.
+Added: We cannot assure you that our patent portfolio will not be negatively impacted by the current uncertain state of the law, new court rulings or changes in guidance or procedures issued by the USPTO.
+Added: From time to time, the U.S.
+Added: Supreme Court, other federal courts, the U.S.
+Added: Congress or the USPTO may change the standards of patentability and validity of patents within the life sciences and any such changes could have a negative impact on our business.
+Added: Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted.
+Added: Changes in patent laws and regulations in other countries or jurisdictions, changes in the governmental bodies that enforce them, or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we own or may obtain in the future.
+Added: Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States.
+Added: In addition, any protection afforded by foreign patents may be more limited than that provided under U.S.
+Added: patent and intellectual property laws.
+Added: We may encounter significant problems in enforcing and defending our intellectual property both in the United States and abroad.
+Added: For example, if the issuance in a given country of a patent covering an invention is not followed by the issuance in other countries of patents covering the same invention, or if any judicial interpretation of the validity, enforceability or scope of the claims or the written description or enablement in a patent issued in one country is not similar to the interpretation given to the corresponding patent issued in other countries, our ability to protect our intellectual property rights in those countries may be limited.
+Added: Changes in either patent laws or in interpretations of patent laws in the United States and other countries may materially diminish the value of our intellectual property rights or narrow the scope of our patent protection.
+Added: We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by U.S.
+Added: and foreign legislative bodies.
+Added: Those changes may materially affect our patents or patent applications and our ability to obtain additional patent protection in the future.
+Added: Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.
+Added: The legal systems in certain countries may also favor state-sponsored or companies headquartered in particular jurisdictions over our first-in-time patents and other intellectual property protection.
+Added: We are aware of incidents where such entities have stolen the intellectual property of domestic companies in order to create competing products and we believe we may face such circumstances ourselves in the future.
+Added: For example, through its “Annual Special 301 Report on Intellectual Property,” the Office of the United States Trade Representative (“USTR”) has been reporting on the adequacy and effectiveness of intellectual property protection in a number of foreign countries that are U.S.
+Added: trading partners and their protection and enforcement of intellectual property rights.
+Added: A number of countries in which both we and our distributors operate have been identified in the reports as being on the Priority Watch List.
+Added: Placement of a country on the Priority Watch List indicates that particular problems exist in that country with respect to intellectual property protection, enforcement, or market access for persons relying on intellectual property rights.
+Added: Countries placed on the Priority Watch List are the focus of increased bilateral attention concerning the specific problem areas.
+Added: It is possible that we will not be able to enforce our intellectual property rights against third parties that misappropriate our proprietary technology in those countries.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage.
−Removed: • we, or current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future;
−Removed: • we, or current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
• others may independently develop, manufacture and commercialize technologies or products that are similar to, or are alternatives or duplicates of any of our technologies or products without infringing, misappropriating or otherwise violating our intellectual property rights;
−Removed: • it is possible that our pending patent applications or those that we may own in the future will not lead to issued patents;
• issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;
+Added: • it is possible that our pending patent applications or those that we may own in the future will not lead to issued patents;
• our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop, manufacture and commercialize competitive products or technologies for sale in our major commercial markets;
+Added: • we, or current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future;
+Added: • we, or current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
• we may not develop additional proprietary technologies that are patentable;
1 unchanged sentence
• we may choose not to seek patent protection for some of our proprietary technology to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such trade secrets or know-how.
+Added: If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be harmed.
+Added: Our trademarks could be challenged, invalidated, infringed, and circumvented by third parties, and our trademarks could also be diluted, declared generic or found to be infringing on other marks.
+Added: If any of the foregoing occurs, we could be forced to re-brand our products or technologies, resulting in loss of brand recognition and requiring us to devote resources to advertising and marketing new brands, and suffer other competitive harm.
+Added: Third parties may also adopt trademarks similar to ours, which could harm our brand identity and lead to market confusion.
+Added: Further, there can be no assurance that competitors will not infringe our trademarks or that we will have adequate resources to enforce our trademarks.
+Added: At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion.
+Added: Certain of our current or future trademarks may become so well known by the public that their use becomes generic and they lose trademark protection.
+Added: Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively.
+Added: Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, operating results and prospects.
+Added: We rely on our trademarks, trade names and brand names, such as our 10X, 10X GENOMICS, CHROMIUM, VISIUM and XENIUM marks, to distinguish our products and technologies from the products and technologies of our competitors, and have registered or applied to register many of these trademarks in the United States and certain countries outside the United States, however, we have not yet registered all of our trademarks in all of our current and potential markets.
+Added: There can be no assurance that our trademark applications will be approved for registration.
+Added: During trademark registration proceedings, we may receive rejections.
+Added: Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections.
+Added: In addition, in proceedings before the USPTO and comparable agencies in many foreign jurisdictions, third parties may also oppose our trademark applications and may seek to cancel trademark registrations or otherwise challenge our use of the trademarks.
+Added: Opposition or cancellation proceedings may be filed against our trademark filings in these agencies, and such filings may not survive such proceedings.
+Added: While we may be able to continue the use of our trademarks in the event registration is not available, particularly in the United States, where trademark rights are acquired based on use and not registration, third parties may be able to enjoin the continued use of our trademarks if such parties are able to successfully claim infringement in court.
+Added: In addition, opposition or cancellation proceedings may be filed against our trademark applications and registrations and our trademarks may not survive such proceedings.
+Added: If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would.
+Added: Our trademarks or trade names may be infringed, circumvented, declared generic or determined to be violating or infringing on other marks.
Our solutions contain third-party open source software components and failure to comply with the terms of the underlying open source software licenses could restrict our ability to sell our products.
6 unchanged sentences
We may be subject to suits by third parties claiming ownership of what we believe to be open source software, or claiming non-compliance with the applicable open source licensing terms.
−Removed: Use of open source software may
−Removed: also present additional security risks because the public availability of such software may make it easier for hackers and other third parties to compromise or attempt to compromise our technology platform and systems.
+Added: Use of open source software may also present additional security risks because the public availability of such software may make it easier for hackers and other third parties to compromise or attempt to compromise our technology platform and systems.
Although we typically review our use of open source software to avoid subjecting our solutions to conditions we do not intend, the terms of many open source software licenses have not been interpreted by United States courts, and there is a risk that these licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to commercialize our solutions.
7 unchanged sentences
Our business, including our ability to operate and expand internationally, could be adversely affected if legislation or regulations are adopted, interpreted or implemented in a manner that is inconsistent with our current business practices and that require changes to these practices.
−Removed: The global data protection landscape is rapidly evolving and new laws and regulations are likely to be enacted and violations of existing and new laws and regulations may subject companies to significant penalties and fines, government investigations and/or enforcement actions, private litigation and other claims.
−Removed: For example, the GDPR imposes stringent requirements for processing personal data of individuals within the European Economic Area ("EEA").
−Removed: The GDPR is likely to increase compliance burdens on us, including by mandating potentially burdensome documentation requirements and granting certain rights to individuals to control how we collect, use, disclose, retain and leverage information about them or how we obtain consent from them.
−Removed: The processing of sensitive personal data, such as physical health condition, may impose heightened compliance burdens under the GDPR and is a topic of active interest among foreign regulators.
+Added: The global data protection landscape is rapidly evolving and new laws and regulations are constantly being enacted such as China's "Personal Information Protection Law" and Singapore's "Personal Data Protection Act," and violations of existing and new laws and regulations may subject companies to significant penalties and fines, government investigations and/or enforcement actions, private litigation and other claims.
+Added: Our operations abroad may also be subject to increased scrutiny or attention from data protection authorities.
+Added: For example, in Europe, the European Union General Data Protection Regulation (“GDPR”) went into effect in May 2018 and imposes stringent requirements for processing personal data of individuals within the European Economic Area ("EEA").
+Added: The processing of sensitive personal data, such as physical health conditions, may impose heightened compliance burdens under the GDPR and is a topic of active interest among foreign regulators.
In addition, the GDPR provides for breach reporting requirements, more robust regulatory enforcement and greater penalties for noncompliance than previous data protection laws, including fines of up to €20 million or 4% of a noncompliant company’s global annual revenue for the preceding financial year, whichever is greater.
−Removed: Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States;
−Removed: in July 2020, the Court of Justice of the European Union (“CJEU”) limited how organizations could lawfully transfer personal data from the EU/EEA to the United States by invalidating the Privacy Shield for purposes of international transfers and imposing further restrictions on the use of standard contractual clauses (“SCCs”).
−Removed: The European Commission issued revised SCCs on June 4, 2021 to account for the decision of the CJEU and recommendations made by the European Data Protection Board.
−Removed: The revised SCCs must be used for relevant new data transfers from September 27, 2021;
−Removed: existing standard contractual clauses arrangements must be migrated to the revised clauses by December 27, 2022.
−Removed: The new SCCs apply only to the transfer of personal data outside of the EEA and not the United Kingdom;
−Removed: the UK’s Information Commissioner’s Office launched a public consultation on its draft revised data transfers mechanisms in August 2021 and laid its proposal before the UK Parliament, with the UK SCCs expected to come into force in March 2022, with a two-year grace period.
−Removed: There is some uncertainty around whether the revised clauses can be used for all types of data transfers, particularly whether they can be relied on for data transfers to non-EEA entities subject to the GDPR.
+Added: Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries outside the EEA that have not been found to provide adequate protection to such personal data, including the United States;
+Added: in July 2020, the Court of Justice of the European Union (“CJEU”) limited how organizations could lawfully transfer personal data from the EU/EEA to the United States by invalidating the EU/U.S.
+Added: Privacy Shield for purposes of international transfers and imposing further restrictions on the use of standard contractual clauses (“SCCs”).
+Added: In March 2022, the US and EU announced a new regulatory regime intended to replace the invalidated regulations;
+Added: however, this new EU-US Data Privacy Framework has not been implemented beyond an executive order signed by President Biden on October
+Added: 7, 2022 on Enhancing Safeguards for United States Signals Intelligence Activities.
+Added: European court and regulatory decisions subsequent to the CJEU decision of July 16, 2020 have taken a restrictive approach to international data transfers.
As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.
−Removed: Since the beginning of 2021, after the end of the transition period following the UK’s departure from the EU, we are also subject to the UK data protection regime, which imposes separate but similar obligations to those under the GDPR and comparable penalties, including fines of up to £17.5 million or 4% of a noncompliant company’s global annual revenue for the preceding financial year, whichever is greater.
−Removed: Other foreign jurisdictions, such as China and Russia, are increasingly implementing or
−Removed: developing their own privacy regimes with complex and onerous compliance obligations and robust regulatory enforcement powers.
+Added: Since the beginning of 2021, we have also been subject to the UK data protection regime, which imposes separate but similar obligations to those under the GDPR and comparable penalties, including fines of up to £17.5 million or 4% of a noncompliant company’s global annual revenue for the preceding financial year, whichever is greater.
+Added: Other foreign jurisdictions, such as China and Russia, are increasingly implementing or developing their own privacy regimes with complex and onerous compliance obligations and robust regulatory enforcement powers.
As we continue to expand into other foreign countries and jurisdictions, we may be subject to additional laws and regulations that may affect how we conduct business.
−Removed: In the United States, California enacted the CCPA, which came into effect on January 1, 2020 and limits and imposes requirements on how we may collect and use personal information and provides for civil penalties for violations and a private right of action for data breaches.
−Removed: In addition, in November 2020, the California Privacy Rights Act (the "CPRA") passed in California.
−Removed: The CPRA modifies and expands the CCPA and established a new California Privacy Protection Agency.
−Removed: While the CPRA extended the current CCPA exemption of employment and business-to-business data until January 1, 2023, it also established January 1, 2023 as the new compliance date for most of the other substantive provisions that companies doing business in California must be prepared to meet.
+Added: In the United States, California enacted the California Consumer Privacy Act of 2018, as amended (the "CCPA"), which came into effect on January 1, 2020 and limits and imposes requirements on how we may collect and use personal information and provides for civil penalties for violations and a private right of action for data breaches.
+Added: Further, the California Privacy Rights Act (the "CPRA"), generally went into effect in January 2023 and, modifies and expands the CCPA and established a new California Privacy Protection Agency.
In addition to applying to businesses that buy and sell personal information the CPRA applies to businesses that buy, sell or share personal information and sets forth a new category of "sensitive personal information" that includes, genetic data;
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There is still a significant amount of uncertainty with respect to the CPRA's three-year compliance roll-out and the impact it will have on us and others in our industry, however, we expect to incur increased compliance costs and may be subject to increased potential liability in the event we fail to comply.
−Removed: Similar privacy and data protection laws have also been proposed in other states and at the federal level.
+Added: Similar laws have passed in Virginia, Colorado, Connecticut and Utah, and have been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the United States.
+Added: The enactment of such laws could have potentially conflicting requirements that would make compliance challenging.
Furthermore, the Federal Trade Commission (“FTC”) and many state Attorneys General continue to enforce federal and state consumer protection laws against companies for online collection, use, dissemination and security practices that appear to be unfair or deceptive.
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We operate some of these systems but we also rely on third-party providers for a range of software, products and services that are critical to our operations and business.
−Removed: Both our and our third-party providers’ information technology systems are vulnerable to disruption due to breakdown, malicious intrusion, computer viruses, worms, ransomware or other disruptive events including but not limited to natural disasters and catastrophes.
+Added: Both our and our third-party providers’ information technology systems are vulnerable to attack, damage or disruption due to breakdown, malicious intrusion, computer viruses, worms, malware (e.g.
+Added: ransomware) or other disruptive events, including but not limited to, natural disasters and catastrophes.
In addition, malicious code (such as viruses, worms and ransomware), bugs or vulnerabilities in our code, employee theft or misuse, human error, social engineering and phishing scams, denial-of-service attacks and sophisticated nation-state and nation-state supported attacks (including advanced persistent threat intrusions), are all increasingly common threats to companies like us.
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In addition, in the ordinary course of business, we and certain of our third-party providers collect, store, and process sensitive and confidential information including personal data.
−Removed: An attack or security incident that exposes personal data, or sensitive or confidential information to unauthorized persons could lead to the loss of trade
−Removed: secrets or other intellectual property, or could lead to the exposure of personal data of our employees, customers and others, any of which could have a material adverse effect on our business, reputation, financial condition and results of operations.
−Removed: Concerns regarding data privacy and security may cause some of our customers to stop using our solutions.
+Added: An attack or security incident that exposes personal data, or sensitive or confidential information to unauthorized persons could lead to the loss of trade secrets or other intellectual property, or could lead to the exposure of personal data of our employees, customers and others, any of which could have a material adverse effect on our business, reputation, financial condition and results of operations.
+Added: Concerns regarding data privacy and security may cause some of our customers to stop using our platform for Cloud Services or other product solutions.
This discontinuance in use could substantially harm our business, operating results and growth prospects.
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We have not always been able in the past and may be unable in the future to anticipate or prevent techniques used to obtain unauthorized access or to compromise our systems because the techniques used change frequently and are generally not detected until after an incident has occurred.
+Added: We may also face increased cybersecurity risks due to our reliance on internet technology when our employees are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities.
Cyberattacks and other malicious internet-based activity continue to increase and cloud-based platform providers of services have been and are expected to continue to be targeted and threat actors are increasingly utilizing tools and techniques designed to evade controls, to avoid detection and even to obfuscate or remove forensic evidence.
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Further, defending a suit, regardless of its merit, could be costly, divert management attention and harm our reputation.
+Added: Threats involving the misuse or access of our network, systems, and information by our current or former employees, contractors, vendors, or partners, whether intentional or unintentional, also pose a risk to the security of our network, systems, information and data.
+Added: For example, we are subject to the risk that employees may inadvertently share confidential information with unintended third parties, or that departing employees may take, or create their own information based on, our confidential information upon leaving the company.
+Added: In addition, any such insiders may be the victims of social engineering attacks that enable third parties to access our network, systems, and information using an authorized person’s credentials.
+Added: We and our network, systems, and information are also vulnerable to malicious acts by insiders, including leaking, modifying, or deleting confidential information, or performing other acts that could materially interfere with our operations and business.
+Added: While we provide regular training to our employees regarding cybersecurity threats and best practices, we cannot ensure that such training or other efforts will prevent unauthorized access to or sabotage of our network, systems, and information.
+Added: While we implement security measures designed to reduce these risks, there is no guarantee these measures will be adequate to safeguard all systems and networks.
+Added: Any failure to maintain performance, reliability, security and availability of our systems and networks may result in accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our data, including personal or proprietary information.
We rely on on-premise, co-located and third-party data centers and platforms to host our website and other online services, as well as for research and development purposes and any interruptions of service or failures may impair and harm our business.
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The visualization of such data can also be computationally intensive.
−Removed: As we iterate and improve our products and as the related technologies advance, our continued growth may require an ability to provide our
−Removed: customers with direct access to a high-performance computing system and/or alternative means of obtaining our software.
+Added: As we iterate and improve our products and as the related technologies advance, our continued growth may require an ability to provide our customers with direct access to a high-performance computing system and/or alternative means of obtaining our software.
As a result, we expect our reliance on internal and third-party data centers to increase in the future.
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and damages to our reputation because of any such incident.
+Added: We are subject to certain manufacturing restrictions related to licensed intellectual property rights that were developed with the financial assistance of United States government grants.
+Added: Under the Bayh-Dole Act, the federal government retains a “nonexclusive, nontransferable, irrevocable, paid-up license” in inventions produced with its financial assistance (“Government Funded Inventions”) for its own benefit.
+Added: The Bayh-Dole Act provides federal agencies with march-in rights (“March-In Rights”), which allows a government agency, in specified circumstances, to require the patent owner or successors in title to the patent directed to such Government Funded Inventions (“Patent Owner”) to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants,” which if exercised, would allow such government agency to require such Patent Owner to grant a non-exclusive, partially exclusive or exclusive license in any field of use to a third-party designated by such agency.
+Added: The Bayh-Dole Act also provides that the Patent Owner manufacture products embodying the respective Government Funded Inventions domestically in accordance with certain requirements.
+Added: If this domestic manufacturing requirement is not met, the government agency that funded the relevant grant is entitled to exercise March-In Rights.
+Added: We are subject to the Bayh-Dole Act with respect to certain licensed technologies that were developed with United States government grants.
+Added: Such licensed technologies are used, for example, in a substantial majority of our consumables.
+Added: Further, we cannot be sure that if we acquired intellectual property rights in the future it will be free from government rights or regulations pursuant to the Bayh-Dole Act.
+Added: If we own, co-own or license in technology that is critical to our business that is developed in whole or in part with federal funds subject to the Bayh-Dole Act, our ability to enforce or otherwise exploit patents covering such technology may be adversely affected.
+Added: Further, the exercise of March-In rights, the requirement that we grant additional licenses to third parties, or the
+Added: termination of our license of the relevant technologies could materially adversely affect our business, operations and financial condition.
+Added: The restrictions of the Bayh-Dole Act may also limit our ability to manufacture our products in geographies where it may be more economically favorable to do so which could limit our ability to respond to competitive developments or otherwise adversely affect our results of operations.
+Added: Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Risks related to litigation and our intellectual property
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Ultimately, if we are unable to obtain such licenses or make any necessary changes to our products or services, we could be forced to cease some aspect of our business operations, which could harm our business significantly.
−Removed: A finding of infringement, or an unfavorable interference or derivation proceedings outcome could prevent us from developing, manufacturing and/or commercializing our products or technologies, or force us to cease some or all of our business operations, which could materially harm our business.
+Added: A finding of infringement, or an unfavorable interference or derivation proceedings outcome could prevent us from developing, manufacturing and/or commercializing our products or technologies, or force us to cease some or all of our business operations,
+Added: which could materially harm our business.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business, financial condition, results of operations and prospects.
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• stop developing, making, selling or using products or technologies that allegedly infringe, misappropriate or otherwise violate the asserted intellectual property right;
−Removed: • lose the opportunity to license our intellectual property rights to others or to collect royalty payments based upon successful protection and assertion of our intellectual property rights against others;
−Removed: • incur significant legal expenses;
• pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing, misappropriating or otherwise violating;
−Removed: • pay the attorney’s fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing, misappropriating or otherwise violating;
• redesign those products, services or technologies that contain the allegedly infringing intellectual property, which could be costly, disruptive and infeasible;
and attempt to obtain a license to the relevant intellectual property rights from third parties, which may not be available on commercially reasonable terms or at all, or from third parties who may attempt to license rights that they do not have;
+Added: • lose the opportunity to license our intellectual property rights to others or to collect royalty payments based upon successful protection and assertion of our intellectual property rights against others;
+Added: • incur significant legal expenses;
+Added: • pay the attorney’s fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing, misappropriating or otherwise violating.
Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.
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With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel, and the patent examiner were unaware during prosecution.
−Removed: If a third party were to prevail on a legal assertion of invalidity and/or unenforceability, we may lose at least
−Removed: part, and perhaps all, of the patent protection on our products or technologies.
+Added: If a third party were to prevail on a legal assertion of invalidity and/or unenforceability, we may lose at least part, and perhaps all, of the patent protection on our products or technologies.
Such a loss of patent protection would have a material adverse impact on our business, financial condition, results of operations, and prospects.
Because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation.
−Removed: There could also be public announcements of the results of hearing, motions, or other interim developments.
+Added: There could also be public
+Added: announcements of the results of hearing, motions, or other interim developments.
If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock.
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District Court for the District of Delaware alleging that Nanostring's GeoMx Digital Spatial Profiler and associated instruments and reagents infringe U.S.
−Removed: 10,472,669, 10,662,467, 10,961,566, 10,983,113, and 10,996,219.
+Added: 10,472,669, 10,662,467, 10,961,566, 10,983,113 and 10,996,219 (the "GeoMx Action").
On May 19, 2021, we filed an amended complaint additionally alleging that the GeoMx products infringe U.S.
11,001,878 and 11,008,607.
−Removed: On July 1, 2021, Nanostring filed a motion to dismiss.
−Removed: On November 17, 2021, the Court held a hearing and dismissed without prejudice our claims for pre-suit indirect infringement and willful infringement.
+Added: On May 4, 2022, we filed an amended complaint in the GeoMx Action additionally alleging that the GeoMx products infringe U.S.
+Added: 11,293,917 and withdrawing our claim of infringement of U.S.
+Added: Nanostring filed its answer to the GeoMx Action on May 18, 2022.
Discovery is in progress.
−Removed: A Markman hearing is scheduled for October 2022 and trial is scheduled for June 2023.
−Removed: In addition to the litigation against Nanostring discussed above, we may in the future be a party to other litigation or legal proceedings to protect, enforce or defend our patents or other intellectual property, which, if resolved adversely to us, could invalidate or render unenforceable our intellectual property or generally preclude us from restraining, enjoining or otherwise seeking to exclude competitors from commercializing products using technology developed or used by us.
+Added: A Markman hearing is scheduled for February 2023 and trial is scheduled for November 2023.
+Added: On February 28, 2022, we filed a second suit against Nanostring in the U.S.
+Added: District Court for the District of Delaware alleging that Nanostring's CosMx Spatial Molecular Imager and associated instruments, reagents and services infringe U.S.
+Added: 10,227,639 and 11,021,737 (the "CosMx Action").
+Added: On May 12, 2022, we filed an amended complaint in the CosMx Action additionally alleging that the CosMx products infringe U.S.
+Added: 11,293,051, 11,293,052 and 11,293,054.
+Added: Nanostring filed its answer to the CosMx Action on May 26, 2022.
+Added: Discovery is in progress.
+Added: A Markman hearing is scheduled for July 2023 and trial is scheduled for June 2024.
+Added: On August 16, 2022, Nanostring filed a counterclaim in the CosMx Action alleging that our Visium products infringe U.S.
+Added: We filed our answer to Nanostring's counterclaim in the CosMx Action on August 30, 2022.
+Added: On November 23, 2022, we moved to sever claims relating to NanoString’s assertion of U.S.
+Added: 11,377,689 and consolidate those claims with the patent case NanoString filed against us on October 20, 2022 (discussed below).
+Added: On January 24, 2023, the Court granted our motion.
+Added: On October 20, 2022, Nanostring filed suit against us in the U.S.
+Added: District Court for the District of Delaware alleging that our Visium products infringe U.S.
+Added: 11,473,142, a continuation of U.S.
+Added: 11,377,689 (the "Nanostring Action").
+Added: On January 24, 2023, the Court severed Nanostring’s claims with respect to U.S.
+Added: 11,377,689 from the CosMx Action and consolidated those claims with this action.
+Added: Discovery is in progress;
+Added: no case schedule has been set.
+Added: We believe Nanostring's claim in the Nanostring Action is meritless and we intend to vigorously defend ourselves.
+Added: On March 9, 2022, we filed suit in the Munich Regional Court in Germany alleging that Nanostring's CosMx Spatial Molecular Imager and associated instruments, reagents and services infringe EP Patent No.
+Added: 2794928B1 (the "928 Patent") (the "Germany CosMx Action").
+Added: Nanostring filed its statement of defense to the Germany CosMx Action on August 26, 2022.
+Added: A hearing on infringement is scheduled for March 2023 and a decision is expected around May 2023.
+Added: On July 29, 2022, Nanostring filed a nullity action with the German Federal Patent Court challenging the validity of the 928 Patent.
+Added: On February 10, 2023, the Federal Patent Court issued a preliminary opinion upholding the validity of certain claims of the 928 Patent directed to in situ analysis.
+Added: A hearing on validity is scheduled before the Federal Patent Court in May 2024 and a decision is expected around the end of 2024.
+Added: In May 2022, we filed suit against Vizgen, Inc.
+Added: ("Vizgen") in the U.S.
+Added: District Court for the District of Delaware alleging that Vizgen’s MERSCOPE Platform and workflow and Vizgen’s Lab Services program, including associated instruments and reagents, infringe U.S.
+Added: 11,021,737, 11,293,051, 11,293,052, 11,293,054 and 11,299,767.
+Added: On July 25, 2022, Vizgen filed a motion to dismiss our claims for willful and indirect infringement, which the Court denied on September 19, 2022.
+Added: Discovery is in progress.
+Added: A Markman hearing is scheduled for July 2023 and trial is scheduled for July 2024.
+Added: On August 30, 2022, Vizgen filed its answer and counterclaims alleging that our Xenium product infringes U.S.
+Added: Vizgen also filed counterclaims alleging that we tortiously interfered with Vizgen's contractual and business relationship with Harvard and that we engaged in unfair practices under Massachusetts state law.
+Added: On October 27, 2022, we filed a partial answer and motion to dismiss the infringement counterclaim and the tort counterclaims.
+Added: On February 2, 2023, our motion to dismiss was denied.
+Added: We believe Vizgen’s claims are meritless and intend to vigorously defend ourselves.
+Added: On August 24, 2022, we filed suit against Parse Biosciences, Inc.
+Added: ("Parse") in the U.S.
+Added: District Court for the District of Delaware alleging that Parse’s Evercode Whole Transcriptomics and ATAC-seq products infringe U.S.
+Added: 10,155,981, 10,697,013, 10,240,197, 10,150,995, 10,619,207, and 10,738,357.
+Added: On October 17, 2022, Parse filed a motion to dismiss alleging that the asserted claims are directed to patent ineligible subject matter.
+Added: The Court held a hearing on the motion to dismiss on November 22, 2022, and supplemental briefing was submitted on December 15, 2022.
+Added: A ruling on the motion to dismiss is expected around March 2023.
+Added: Discovery has not yet commenced and no case schedule has been set.
+Added: In addition to the litigation discussed above, we may in the future be a party to other litigation or legal proceedings to protect, enforce or defend our patents or other intellectual property, which, if resolved adversely to us, could invalidate or render unenforceable our intellectual property or generally preclude us from restraining, enjoining or otherwise seeking to exclude competitors from commercializing products using technology developed or used by us.
For example, our patents and any patents which we in-license may be challenged, narrowed, invalidated or circumvented.
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If we fail to successfully defend such claims, in addition to paying monetary damages, we may be subject to injunctive relief and lose valuable intellectual property rights.
−Removed: A loss of key research personnel work product could hamper or prevent our
−Removed: ability to commercialize certain potential products, which could severely harm our business.
+Added: A loss of key research personnel work product could hamper or prevent our ability to commercialize certain potential products, which could severely harm our business.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
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We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights protection and contractual restrictions to protect our proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage.
−Removed: Worldwide we own or exclusively license 465 issued or allowed patents and 837 pending patent applications as of December 31, 2021.
+Added: Worldwide we own or exclusively license over 700 issued or allowed patents and more than 1,050 pending patent applications as of December 31, 2022.
We also license additional patents on a non-exclusive and/or territory restricted basis.
We continue to file new patent applications to attempt to obtain further legal protection of the full range of our technologies.
−Removed: If we fail to protect our intellectual property, third parties may be able to compete more effectively against us and we may incur substantial litigation costs in our attempts to recover or restrict the use of our intellectual property.
+Added: If we fail to protect our intellectual property, third parties may be able to
+Added: compete more effectively against us and we may incur substantial litigation costs in our attempts to recover or restrict the use of our intellectual property.
It is our general policy not to out-license our patents but to protect our sole right to own and practice our patents.
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The laws of some countries do not protect intellectual property rights to the same extent as the laws of the United States and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions.
−Removed: The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the infringement of our patents.
+Added: The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the
+Added: infringement of our patents.
The legal systems in certain countries may also favor state-sponsored or companies headquartered in particular jurisdictions over our first-in-time patents and other intellectual property protection.
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Transfers between our co-founders are permitted transfers and will not result in conversion of the shares of Class B common stock that are transferred.
−Removed: The conversion of Class B common stock to Class A common stock has had, and will continue to have, the effect, over time, of increasing the relative voting power of those individual holders of Class B common stock who retain their shares in the long term.
−Removed: To date, such conversions have had the effect of increasing the relative voting power of our co-founders and certain of our directors and will continue to have such an effect if our co-founders and such directors retain their shares in the long term.
−Removed: We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices, including maintaining an effective system of internal controls over financial reporting.
−Removed: We ceased to be an "emerging growth company" and are now required to comply with certain provisions of SOX and are no longer permitted to take advantage of reduced disclosure requirements applicable to emerging growth companies.
−Removed: We have incurred and will continue to incur significant legal, accounting and other expenses that we did not incur as a private company and we expect these expenses to increase because we are no longer eligible to take advantage of the reduced disclosure requirements and other benefits available to emerging growth companies.
−Removed: The Dodd-Frank Wall Street Reform and Consumer Protection Act, SOX, the listing requirements of Nasdaq and other applicable federal and Delaware rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
−Removed: These requirements will increase our legal and financial compliance costs and will make some activities more time-consuming and costly.
−Removed: Moreover, since we ceased to be an “emerging growth company” on January 1, 2021, we may no longer take advantage of certain exemptions from various reporting requirements that are applicable to public companies.
−Removed: This increase in reporting requirements will further increase our compliance burden.
−Removed: Our management and other personnel are required to devote a substantial amount of time to these compliance initiatives.
−Removed: Moreover, these rules and regulations have increased our legal and financial compliance costs and have made some activities more time-consuming and costly.
−Removed: We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements.
−Removed: The impact of these requirements also could make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.
−Removed: Moreover, these rules and regulations often are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.
−Removed: This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
−Removed: The rules and regulations applicable to us as a public company and recent trends in the insurance market have made it more expensive for us to obtain director and officer liability insurance.
−Removed: We have currently obtained only director and officer liability coverage (commonly referred to as “Side A” coverage).
−Removed: This means that while our directors and officers have direct insurance
−Removed: coverage for acts which the company is not legally required or permitted to indemnify them, the company itself does not have coverage for amounts incurred in defending, among other things, stockholder derivative or securities class action lawsuits or in the event of certain investigative actions, for amounts it must pay as a result of such suits or amounts it must pay to indemnify our directors or officers.
−Removed: We are in essence self-insuring for these costs.
−Removed: Any costs incurred in connection with such litigation could have a material adverse effect on our business, financial condition and results of operations.
−Removed: In September 2018, California enacted a law ("Senate Bill 826") that requires publicly held companies headquartered in California to have at least one female director by the end of 2019 and at least three by the end of 2021, depending on the size of the board.
−Removed: In September 2020, California enacted a law ("Assembly Bill 979") that requires publicly held companies headquartered in California to have at least one director from an underrepresented community, as defined in the law, by the end of 2021 and at least three by the end of 2022, depending on the size of the board.
−Removed: A director from an “underrepresented community” means a director who self-identifies as Black, African American, Hispanic, Latino, Asian, Pacific Islander, Native American, Native Hawaiian, Alaska Native, gay, lesbian, bisexual or transgender.
−Removed: In addition, in August 2021, the SEC announced that it had approved Nasdaq’s proposed rule change to advance board diversity and enhance transparency of board diversity statistics through new listing requirements.
−Removed: Under these new listing rules, Nasdaq-listed companies are required, subject to certain exceptions, to annually disclose diversity statistics regarding their directors’ voluntary self-identified characteristics and include on their boards of directors at least two “Diverse” directors or publicly disclose why their boards do not include such “Diverse” directors.
−Removed: Under the phase-in period for these new listing rules, for companies listed on the Nasdaq Global Select Market, this disclosure requirement regarding the existence of at least one “Diverse” director applies starting on the later of August 7, 2023, or the date that the company files its proxy statement for its annual shareholder meeting during 2023, and regarding the existence of at least two “Diverse” directors applies starting on the later of August 6, 2025, or the date that the company files its proxy statement for its annual shareholder meeting during 2025.
−Removed: Under the proposed rule, a “Diverse” director is someone who self-identifies either as (i) female, (ii) Black or African American, Hispanic or Latinx, Asian, Native American or Alaska Native, Native Hawaiian or Pacific Islander, or two or more races or ethnicities, or (iii) lesbian, gay, bisexual, transgender or a member of the queer community.
−Removed: Our board of directors currently includes two female directors, and three directors from an “underrepresented community.” We are currently in compliance with Assembly Bill 979 but, while we are actively seeking a new director, we are not currently in compliance with Senate Bill 826.
−Removed: An initial violation of either law can result in a fine from the California Secretary of State in the amount of $100,000, with each subsequent violation resulting in a fine of $300,000.
−Removed: In addition, if our current or future female or other “Diverse” directors no longer serve on our board of directors prior to the applicable dates under the phase-in period for the new Nasdaq listing rules, we could be out of compliance with the new Nasdaq listing rules.
−Removed: We cannot assure that we can recruit, attract and/or retain qualified members of the board and meet gender and diversity requirements under California law or Nasdaq listing rules, which may expose us to financial penalties and adversely affect our reputation.
+Added: The conversion of Class B common stock to Class A common stock has had, and is expected to continue to have, the effect, over time, of increasing the relative voting power of those individual holders of Class B common stock who retain their shares in the long term.
+Added: To date, such conversions have had the effect of increasing the relative voting power of our co-founders and certain of our directors and is expected to continue to have such an effect if our co-founders and such directors retain their shares in the long term.
Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Class A common stock.
14 unchanged sentences
These anti-takeover defenses could discourage, delay or prevent a transaction involving a change in control of our company.
−Removed: These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors of their choosing and to cause us to take other corporate actions they desire, any of which, under certain circumstances, could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our Class A common stock.
+Added: These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors of their
+Added: choosing and to cause us to take other corporate actions they desire, any of which, under certain circumstances, could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our Class A common stock.
Our amended and restated bylaws designate a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers or employees.
6 unchanged sentences
General risk factors
−Removed: 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.
−Removed: The trading market of our common stock is influenced to some extent by the research and reports that industry or financial analysts publish about us and our business.
−Removed: We do not control these analysts.
−Removed: We may be slow to attract research coverage and the analysts who publish information about our common stock may have had relatively little experience with us or our industry, which could affect their ability to accurately forecast our results and could make it more likely that we fail to meet their estimates.
−Removed: If any of the analysts who cover us provide inaccurate or unfavorable research or issue an adverse opinion regarding our stock price, our stock price could decline.
−Removed: If one or more of these analysts cease coverage of us or fail to publish reports covering us regularly, we could lose visibility in the market, which in turn could cause our stock price or trading volume to decline.
−Removed: If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
−Removed: The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes.
−Removed: We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent from other sources.
−Removed: If our assumptions change or if actual circumstances differ from our assumptions, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
−Removed: If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our Class A common stock.
−Removed: The preparation of financial statements in conformity with generally accepted accounting principles in the United States (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes.
−Removed: We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent from other sources.
−Removed: If our assumptions underlying our estimates and judgements relating to our critical accounting policies change or if actual circumstances differ from our assumptions, estimates or judgements, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our Class A common stock.
+Added: We may fail to meet our publicly announced guidance or other expectations about our business, which could cause our stock price to decline.
+Added: In the past we have provided, and in the future we may provide, guidance and other expectations regarding our expected financial and business performance.
+Added: Correctly identifying key factors affecting business conditions and predicting future events is inherently an uncertain process, and our guidance or the other expectations we set may not ultimately be accurate and has in the past been inaccurate in certain respects.
+Added: For example, in February 2022 we announced our expectations regarding full year 2022 revenue, which we revised in August 2022 to reflect lower expected revenue for full year 2022.
+Added: In August 2022, we announced our goal to be free cash flow positive by the end of 2023.
+Added: We may not be able to achieve this goal if we do not generate sufficient revenue or achieve our gross margin targets, if we acquire businesses or technologies, if our spending is higher than anticipated or due to many other factors.
+Added: If our guidance varies from actual results or if we fail to meet other expectations regarding our business, including our previously announced objective to become free cash flow positive by the end of 2023, the market value of our common stock could decline significantly.
The market price of our Class A common stock may be volatile, which could result in substantial losses for investors.
2 unchanged sentences
• the timing of our launch of future products and degree to which the launch and commercialization thereof meets the expectations of securities analysts and investors;
−Removed: • the outcomes of and related rulings in the litigation and administrative proceedings in which we are currently or may in the future become involved;
• changes in the structure or funding of research at academic and research laboratories and institutions, including changes that would affect their ability to purchase our instruments or consumables;
1 unchanged sentence
• announcements about new research programs or products of our competitors;
−Removed: • developments or disputes concerning patent applications, issued patents or other proprietary rights;
−Removed: • the recruitment or departure of key personnel;
−Removed: • litigation and governmental investigations involving us, our industry or both;
−Removed: • regulatory or legal developments in the United States and other countries;
+Added: • general economic, industry and market conditions;
• volatility and variations in market conditions in the life sciences sector generally, or the genomics sector specifically;
+Added: • whether our financial results meet our publicly announced expectations or the expectations of securities analysts or investors;
+Added: • actual or anticipated changes in our estimates as to our financial results or development timelines, variations in our financial results or those of companies that are perceived to be similar to us or changes in estimates or recommendations by securities analysts, if any, that cover our Class A common stock or companies that are perceived to be similar to us;
• investor perceptions of us or our industry;
• the level of expenses related to any of our research and development programs or products;
−Removed: • actual or anticipated changes in our estimates as to our financial results or development timelines, variations in our financial results or those of companies that are perceived to be similar to us or changes in estimates or recommendations by securities analysts, if any, that cover our Class A common stock or companies that are perceived to be similar to us;
−Removed: • whether our financial results meet the expectations of securities analysts or investors;
+Added: • litigation and governmental investigations involving us, our industry or both;
+Added: • the outcomes of and related rulings in the litigation and administrative proceedings in which we are currently or may in the future become involved;
+Added: • developments or disputes concerning patent applications, issued patents or other proprietary rights;
+Added: • the recruitment or departure of key personnel;
+Added: • regulatory or legal developments in the United States and other countries;
• the announcement or expectation of additional financing efforts;
2 unchanged sentences
• sales of our Class A common stock or Class B common stock by us, our insiders or other stockholders;
−Removed: • general economic, industry and market conditions;
−Removed: • natural disasters, infectious diseases, conflict, war, civil unrest, epidemics or pandemics including COVID-19, outbreaks, resurgences or major catastrophic events;
+Added: • natural disasters, infectious diseases, conflict, war, civil unrest, epidemics or pandemics such as COVID-19 outbreaks or resurgences or major catastrophic events;
• the other factors described in this “ Risk Factors ” section.
9 unchanged sentences
Any costs incurred in connection with such litigation could have a material adverse effect on our business, financial condition and results of operations.
+Added: 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.
+Added: The trading market of our common stock is influenced to some extent by the research and reports that industry or financial analysts publish about us and our business.
+Added: We do not control these analysts.
+Added: The analysts who publish information about our common stock may have had relatively little experience with us or our industry, which could affect their ability to accurately forecast our results and could make it more likely that we fail to meet their estimates.
+Added: If any of the analysts who cover us provide inaccurate or unfavorable research or issue an adverse opinion regarding our stock price, our stock price could decline.
+Added: If one or more of these analysts cease coverage of us or fail to publish reports covering us regularly, we could lose visibility in the market, which in turn could cause our stock price or trading volume to decline.
+Added: If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
+Added: For example, the market price of our common stock declined after our financial results for the quarter ended June 30, 2022 fell short of the expectations of securities analysts and investors.
+Added: The preparation of financial statements in conformity with generally accepted accounting principles in the United States ("GAAP") requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes.
+Added: We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent from other sources.
+Added: If our assumptions change or if actual circumstances differ from our assumptions, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
+Added: If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our Class A common stock.
+Added: The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes.
+Added: We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent from other sources.
+Added: If our assumptions underlying our estimates and judgements relating to our critical accounting policies change or if actual circumstances differ from our assumptions, estimates or judgements, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our Class A common stock.
+Added: We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives and corporate governance practices, including maintaining an effective system of internal controls over financial reporting.
+Added: We have incurred and will continue to incur significant legal, accounting and other expenses because the Dodd-Frank Wall Street Reform and Consumer Protection Act, SOX, the listing requirements of Nasdaq and other applicable federal and Delaware rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
+Added: Our management and other personnel are required to devote a substantial amount of time to these compliance initiatives.
+Added: Moreover, these rules and regulations have increased our legal and financial compliance costs and have made some activities more time-consuming and costly.
+Added: We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements.
+Added: The impact of these requirements also could make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.
+Added: Moreover, these rules and regulations often are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.
+Added: This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
+Added: The rules and regulations applicable to us as a public company and recent trends in the insurance market have made it more expensive for us to obtain director and officer liability insurance.
+Added: We have currently obtained only director and officer liability coverage (commonly referred to as “Side A” coverage).
+Added: This means that while our directors and officers have direct insurance coverage for acts which the company is not legally required or permitted to indemnify them, the company itself does not have coverage for amounts incurred in defending, among other things, stockholder derivative or securities class action lawsuits or in the event of certain investigative actions, for amounts it must pay as a result of such suits or amounts it must pay to indemnify our directors or officers.
+Added: We are in essence self-insuring for these costs.
+Added: Any costs incurred in connection with such litigation could have a material adverse effect on our business, financial condition and results of operations.
+Added: In August 2021, the SEC announced that it had approved Nasdaq’s proposed rule change to advance board diversity and enhance transparency of board diversity statistics through new listing requirements.
+Added: Under these new listing rules, Nasdaq-listed companies are required, subject to certain exceptions, to annually disclose diversity statistics regarding their directors’ voluntary self-identified characteristics and include on their boards of directors at least two “Diverse” directors or publicly disclose why their boards do not include such “Diverse” directors.
+Added: Under the phase-in period for these new listing rules, for companies listed on the Nasdaq Global Select Market, this disclosure requirement regarding the existence of at least one “Diverse” director applies starting on the later of August 7, 2023, or the date that the company files its proxy statement for its annual shareholder meeting during 2023, and regarding the existence of at least two “Diverse” directors applies starting on the later of August 6, 2025, or the
+Added: date that the company files its proxy statement for its annual shareholder meeting during 2025.
+Added: Under the proposed rule, a “Diverse” director is someone who self-identifies either as (i) female, (ii) Black or African American, Hispanic or Latinx, Asian, Native American or Alaska Native, Native Hawaiian or Pacific Islander, or two or more races or ethnicities, or (iii) lesbian, gay, bisexual, transgender or a member of the queer community.
+Added: Our board of directors currently includes two female directors, and three directors from an “underrepresented community.” However, if our current or future female or other “Diverse” directors no longer serve on our board of directors prior to the applicable dates under the phase-in period for the new Nasdaq listing rules, we could be out of compliance with the new Nasdaq listing rules.
+Added: We cannot assure that we can recruit, attract and/or retain qualified members of the board and meet gender and diversity requirements under Nasdaq listing rules, which may expose us to financial penalties and adversely affect our reputation.
Unresolved Staff Comments.
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.