Risk Factors Update Summary
- The company's ability to compete effectively against current and future competitors could impact its market adoption and sales.
- Development of new products and workflows involves a high degree of risk and may not gain market acceptance.
- Revenue from strategic partnerships and services engagements is expected to decline in the near term.
- The company's employee count decreased from 293 to 285, with a decrease in research and development employees from 111 to 76.
- The company may need to raise additional capital to fund its operations and infrastructure growth.
- The company entered into an amended and restated loan and security agreement, refinancing the outstanding term loan of $20.0 million. This change might result in improved loan terms and reduced interest payments.
- AbCellera and UBC filed lawsuits in the United States District Court seeking invalidity and unenforceability of asserted patents. This change might result in potential savings on royalties or damages.
- Revenue decreased 8% to $78.6 million in 2022 compared to $85.4 million in 2021.
- Risks associated with collaborations and partnerships, including termination, changes in focus, and disagreements.
- The concentration of ownership decreased from 40% to 35% of outstanding common stock.
- The company's accumulated deficit increased from $263.6 million to $361.6 million as of December 31, 2022.
- The company now manufactures many of its commercially released reagent kits in-house, reducing reliance on third-party contract manufacturers.
- The company's expansion internationally may lead to engagement with additional third parties, increasing the risk of liability for corrupt activities. This change might result in legal penalties and reputational harm.
- The company's pursuit of acquisitions may result in significant expenses and integration challenges.
- The company has expanded its focus from "finding biology that cures disease" to "enabling the ongoing revolution in biological sciences." This change might result in a broader range of applications and opportunities for the company.
- The company has recently expanded into the gene therapy and agricultural biology markets, in addition to its focus on antibody therapeutics and cell line development. This change indicates potential growth and diversification in the company's product offerings.
- Revenue growth has been fluctuating, with significant fluctuations in recent periods.
- The enforceability of choice of forum provisions in the Certificate of Incorporation has been challenged in legal proceedings.
- The completion of the acquisition of IsoPlexis is subject to customary closing conditions and may impact the company's business and stock price.
- Revenue from top five customers decreased from 52% in 2021 to 44% in 2022.
- The company is subject to economic and trade sanctions regulations, which could impact business operations and increase compliance costs. This change may result in reduced sales and increased compliance expenses.
- The company's future debt financing may involve additional covenants and restrictions on its operations.
- The company's net losses increased from $71.7 million to $98.0 million for the year ended December 31, 2022.
- The number of owned U.S. patents increased from 50 to 63, pending U.S. patent applications decreased from 9 to 6, and pending PCT applications increased from 286 to 404.
- The company's dependence on information technology systems and potential disruptions could harm its business.
- The company filed petitions for Inter Partes Review (IPR) challenging the validity of asserted claims. This change might result in a potential reduction in legal risks and costs.
- The company formed strategic collaborations with Thermo Fisher Scientific and Bayer CropScience to accelerate and expand product development. This change might result in increased revenue and market opportunities.
- The number of owned trademarks decreased from 110 to 85 in the U.S. and from 52 to 34 internationally, inclusive of Madrid Protocol applications.
- The company has entered into a definitive agreement to acquire IsoPlexis in an all-stock transaction with an estimated purchase price of $57.8 million. This acquisition could provide synergistic opportunities and contribute to the company's strategic plan.
- The company's ability to achieve and maintain significant commercial market acceptance of its Berkeley
- The company's rapid growth and geographic expansion may pose challenges in managing its employees and operations.
- The company's reliance on third-party manufacturers and suppliers poses risks of supply shortages, price fluctuations, and quality issues. This change could lead to delays in production and harm the company's business operations.
- Limited operating history and rapid revenue growth make it difficult to evaluate future prospects.
- The court granted the company's motion to stay the consolidated lawsuits pending the outcome of the IPR proceedings. This change might result in a delay in the resolution of the lawsuits.
- The company faces risks related to epidemics, infectious disease outbreaks, or public health crises that could significantly disrupt operations. This change highlights the potential impact on business continuity and financial performance.
- Tax legislative or regulatory initiatives could adversely affect the company's results of operations and financial condition.
- The company filed a complaint in the United States District Court seeking a declaratory judgment of non-infringement and invalidity of challenged claims. This change might result in potential savings on damages or royalties.
- The company's ability to use net operating loss carryforwards and other tax attributes may be limited.
- The company's dependence on single-source suppliers for critical components increases the risk of supply interruptions and delays in production. This change may limit the company's ability to manufacture products and negatively impact its financial condition.
- The company's Berkeley Lights Platform combines digital functional cell biology and technology, allowing for deep phenotypic and genotypic profiling of single cells. This change highlights the unique capabilities of the platform and its potential impact on cell-based product development.
- The company collects and stores sensitive data, including personally identifiable information, which poses risks of unauthorized access, data corruption, and legal claims. This change emphasizes the importance of data security and potential liabilities.
- The company's status as a public company incurs additional costs and may adversely affect its business and financial condition.
- The company may face uncertainties and increased costs surrounding the prosecution of intellectual property due to changes in patent laws and interpretations. This change might result in potential delays and increased expenses in obtaining and enforcing patents.
- The company's intellectual property rights may be challenged, leading to uncertainties and potential litigation. This change could result in the loss of patent protection and harm the company's business prospects.
- The company aims to generate positive operating cash flow by early 2025 and prioritize R&D return on investment. This change indicates a shift towards profitability and disciplined expense management.
- The company is subject to evolving compliance requirements and operational challenges when doing business internationally, including privacy regulations, tax laws, and economic sanctions. This change highlights potential risks and resource allocation.
- Changes in worldwide or regional economic conditions and government policies could adversely impact the company's business.
- The proposed rule by the FTC to ban non-compete obligations in the United States may impact the company's ability to protect trade secrets. This change might increase the risk of trade secrets becoming known to competitors.
- The company plans to build a world-class leadership team and evaluate merger and acquisition opportunities to accelerate profitable growth. This change suggests a focus on strategic expansion and leveraging the company's current cost structure.
- The company is subject to anti-bribery and anti-corruption laws, such as the FCPA and PRC anti-bribery laws. Non-compliance with these laws could adversely affect the company's financial condition and operations.
- The company is facing patent infringement allegations from AbCellera, which could result in legal proceedings and potential damages. This change may impact the company's financial condition and reputation.
- The company's business model is focused on driving the adoption of the Berkeley Lights Platform and maximizing its use across customers' product development processes. This change emphasizes the company's commitment to providing an end-to-end solution for cell-based products.
- Misconduct or fraudulent acts by employees, consultants, distributors, and commercial partners expose the company to risk and potential legal or regulatory sanctions.
- The company's use of open-source software may expose it to claims challenging compliance with open-source license terms. This change might result in potential legal disputes and limitations on software usage.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1689657&owner=exclude
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