We have incurred losses since we were formed and expect to incur losses in the future. We cannot be certain that we will achieve or sustain profitability.
Our future capital needs are uncertain and we may need to raise additional funds in the future.
Provisions of our existing and any future debt instruments may restrict our ability to pursue our business strategies.
Our financial results may vary significantly from quarter to quarter which may adversely affect our stock price.
If we do not achieve, sustain or successfully manage our anticipated growth, our business and growth prospects will be harmed.
Our future success is dependent upon our ability to expand our customer base and introduce new applications and products.
The life sciences research market is highly competitive. If we fail to compete effectively, our business and operating results will suffer.
New product development involves a lengthy and complex process, and we may be unable to commercialize on a timely basis, or at all, any of the products we develop.
New market opportunities may not develop as quickly as we expect, limiting our ability to successfully market and sell our products.
We face risks related to health epidemics and other outbreaks, such as COVID-19, which could significantly disrupt our operations and could have a material adverse impact on us.
Our sales cycle is lengthy and variable, which makes it difficult for us to forecast revenue and other operating results.
Our reliance on distributors for sales of our products outside of the United States could limit or prevent us from selling our products and impact our revenue.
Adverse events or perceptions affecting the financial services industry could adversely affect our operating results, liquidity, financial condition and prospects.
The value of our investments is subject to significant capital markets risk related to changes in interest rates and credit spreads as well as other investment risks, which may adversely affect our business, financial condition, operating results and prospects.
We may not be able to develop new products, enhance the capabilities of our systems 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.
We are dependent on third-party manufacturers, service providers and single source suppliers for some of the components and materials used in our products, and the loss of any of these suppliers, or difficulties or delays in securing components or materials, could harm our business.
We may experience manufacturing problems or delays that could limit our growth or adversely affect our operating results.
If our greater Seattle area facilities become unavailable or inoperable, we will be unable to continue our research and development, manufacturing our consumables or processing sales orders, and our business will be harmed.
We expect to generate a substantial portion of our revenue internationally and are subject to various risks relating to our international activities, which could adversely affect our operating results.
We could be subject to additional income tax liabilities.
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.
Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
Acquisitions or joint ventures could disrupt our business, cause dilution to our stockholders and otherwise harm our business.
We may fail to achieve the expected cost savings and related benefits from our reduction in workforce initiated in October 2023.
If we are unable to recruit, train and retain key personnel, we may not achieve our goals.
Undetected errors or defects in our products could harm our reputation, decrease market acceptance of our products or expose us to product liability claims.
We face risks related to handling of hazardous materials and other regulations governing environmental safety.
If we experience a significant disruption in our information technology systems or breaches of data security, our business could be adversely affected.
Any interruptions or delays in services from third parties, including cloud computing platform providers, and other software and hardware vendors, or from our inability to adequately plan for and manage service interruptions or infrastructure capacity requirements, could impair the delivery of our services and harm our business.
Significant United Kingdom or European developments stemming from the United Kingdom’s withdrawal from the European Union could have a material adverse effect on us.
We intend to seek strategic collaborations and partnerships and other transactions, which may result in the use of a significant amount of our management resources or significant costs, and we may not be able to fully realize the potential benefit of such transactions.
If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, our stock price and trading volume could decline.
Our “Research Use Only” products for the research life sciences market could become subject to more stringent regulatory requirements as medical devices by the FDA or other regulatory agencies in the future which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results of operations.
For medical devices that we manufacture for third parties, we are subject to ongoing and extensive regulatory requirements, and our failure to comply with these requirements could substantially harm our business.
We may be subject, directly or indirectly, to healthcare fraud and abuse laws and other laws applicable to our commercial practices, as well as laws and regulations relating to privacy and data protection. If we or our agents and contractors are unable to comply, or have not complied, with such laws and regulations, we could face substantial penalties.
Involvement in lawsuits to protect or enforce our patent and proprietary rights, to determine the scope, coverage and validity of others’ proprietary rights, or to defend against third-party claims of intellectual property infringement, could be time-intensive and costly and may adversely impact our business or stock price.
If we are unable to protect our intellectual property effectively, our business would be harmed.
We depend on certain technologies that are licensed to us. We do not control these technologies and any loss of our rights to them could prevent us from selling our products.
We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our employees’ former employers.
Our products 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.
We use third-party software that may be difficult to replace or cause errors or failures of our products that could lead to lost customers or harm to our reputation.
The price of our common stock may be volatile, and you could lose all or part of your investment.
Servicing our Secured Notes and our Convertible Notes may require a significant amount of cash, and we may not have sufficient cash flow or the ability to raise the funds necessary to satisfy our obligations under the Secured Notes and
Convertible Notes, and our current and future indebtedness may limit our operating flexibility or otherwise affect our business.
We may not be able to maintain our listing on the Nasdaq Global Market, or the Nasdaq, or trading on the Nasdaq may otherwise be halted or suspended, which may make it more difficult for investors to sell shares of our common stock and consequently may negatively impact the price of our common stock.
Future sales of our common stock in the public market could cause our stock price to fall.
We have broad discretion over the use of the proceeds from our March 2020 Convertible Notes offering and October 2020 underwritten public offering and may apply the proceeds to uses that do not improve our operating results or the value of your securities.
Exercise of the 2023 Warrants and transactions relating to our Convertible Notes may dilute the ownership interest of existing stockholders, or may otherwise depress the price of our common stock.
Anti-takeover provisions in our charter documents and under Delaware or Washington law could make an acquisition of us difficult, limit attempts by our stockholders to replace or remove our current management and limit our stock price.
Complying with the laws and regulations affecting public companies increases our costs and the demands on management and could harm our operating results.
Our product revenue is derived from sales of our spatial biology and nCounter instruments and related consumables. There may be fluctuations in sales mix between instruments and consumables from period to period. Service revenue consists of fees associated with service contracts and from our TAP. Our customer base is primarily comprised of academic institutions, government laboratories, biopharmaceutical companies, and clinical laboratories.
Instrument revenue during the three and nine month periods ended September 30, 2023 increased as compared to the same periods in 2022, primarily as a result of increased shipments of our spatial biology systems, primarily of our CosMx systems. The increase was partially offset by lower instrument shipments for our nCounter platform, which is in a more mature phase of its product life cycle.
Consumables revenue currently includes sales of consumables for our spatial biology systems and for nCounter, and sales of Prosigna in vitro diagnostic kits to our partner Veracyte. Consumables revenue increased for the three and nine month periods ended September 30, 2023 as compared to the same periods in 2022. The increase in consumables revenue for the three and nine month periods ended September 30, 2023 was driven primarily by higher spatial biology consumables sales, as our installed base of spatial biology instruments increased as compared to the same periods in 2022.
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