What the changes say
- The DNA data-storage spinout reduces diversification, while Twist retains only equity, royalties and milestone upside from Atlas.
- AI now presents both a potential substitute for some gene synthesis demand and new compliance, privacy and liability risks.
- Tariffs, geopolitical tensions and halted federal research grants could raise costs, disrupt supply chains and weaken industry demand.
- The filing emphasizes dependence on synthetic DNA, critical suppliers, manufacturing scale-up, cybersecurity and evolving biosecurity and FDA rules.
What changed since the prior 10-K
New
- NewRisks Related to Our Business
Substantially all of our revenue generated to date is from our synthetic DNA products. Our financial results are dependent on strengthening our synthetic biology and NGS product groups while diversifying into other developing sectors
Twist remains heavily dependent on synthetic DNA revenue to fund R&D, collaborations and expansion into new synthetic biology and NGS markets.
- NewRisks Related to Our Business
If we, or our partners or suppliers, experience a significant disruption in, or breach in security of, information technology systems or other cybersecurity incidents, our business could be adversely affected
Disruptions or breaches in Twist’s centralized systems and e-commerce platform could interrupt orders, shipments, financial records and revenue.
- NewRisks Related to Our Business
As we continue to grow our business, we will need to implement new systems and software successfully, otherwise our business and our financial condition and results of operations could be adversely affected
Growth requires costly upgrades to operational and IT systems, with implementation failures potentially disrupting operations and delaying efficiency benefits.
- NewRisks Related to Our Business
AI capabilities may indicate that it could be a significant disruptor in the synthetic biology industry. For example, AI may reduce customer demand for certain types of gene synthesis
AI could disrupt synthetic biology and reduce customer demand for certain gene-synthesis products as competitors develop superior or cheaper technologies.
- NewRisks Related to Our Business
Issues relating to the use of AI and machine learning and compliance with evolving regulations and industry standards could adversely affect our business and operating results
Improper workplace AI use could create bias, privacy, legal, regulatory and reputational liabilities as AI rules and standards evolve.
- NewRisks Related to Our Business
Adverse global economic conditions and U.S. policy changes could have a negative effect on our business, financial condition and results of operations
Tariffs, trade restrictions, geopolitical tensions and reduced federal research grants could increase costs, disrupt supply chains and weaken demand or innovation.
- NewRisks Related to Our Business
the raw materials or component parts we use could result in decreased revenue or could impair our ability to maintain or expand our business
Higher raw-material prices or shortages could squeeze margins, force price increases customers may reject, or limit production capacity.
- NewRisks Related to Our Business
We may not achieve the anticipated benefits from the spin out of our DNA data storage application
The Atlas DNA-data-storage spinout may fail to deliver expected milestones, royalties or strategic benefits while reducing Twist’s diversification and consuming transition resources.
- NewRisks Related to Our Business
The FSAP involves rules administered by the CDC and the APHIS that regulate possession, use and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products
Noncompliance with CDC or APHIS rules governing biological select agents and toxins could trigger penalties, operating restrictions or reputational damage.
- NewRisks Related to Our Business
A violation of data privacy or data protection laws could adversely harm our operating results and financial condition, damage our reputation or otherwise materially harm our business
Global privacy and data-protection requirements, including restrictions on cross-border transfers and emerging AI-related rules, create significant compliance challenges.
- NewRisks Related to Our Business
Our products could in the future be subject to additional regulation by the FDA or other domestic and international regulatory agencies, which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results of operations
Customers’ clinical use of Twist’s research-use-only IVD products could expose the business to additional FDA or international regulatory requirements.
- NewRisks Related to Our Business
We may not be able to scale our manufacturing capacity to meet future demand, which could harm our business
Twist may misjudge future demand or face technical and cost hurdles when expanding complex manufacturing equipment and production capacity.
- NewRisks Related to Our Business
We may require additional financing to achieve our goals, and such additional financing may not be available acceptable terms, or at all, which could have an adverse effect on our business
- NewRisks relating to owning our common stock
Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us
Dropped
- DroppedRisks related to our business
We may require additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product manufacturing and development and other operations
- DroppedRisks related to our business
affected. Cyberattacks and security vulnerabilities could lead to reduced revenue, increased costs, liability claims, or harm to our reputation or competitive position
Additional financing may be unavailable or unfavorable, forcing delays, reductions or termination of manufacturing, development and other operations.
- DroppedRisks related to our business
Issues relating to the use of artificial intelligence and machine learning could adversely affect our business and operating results
- DroppedRisks related to our business
If we are unable to expand into adjacent addressable markets, our business may be materially and adversely affected
- DroppedRisks related to our business
If we are unable to expand our DNA synthesis manufacturing capacity, we could lose revenue and our business could be harmed
Cyberattacks and security vulnerabilities could reduce revenue, increase costs, trigger liability claims or damage reputation and competitive position.
- DroppedRisks related to our business
for early-stage companies that do not have significant off-setting revenues and which are making significant investments in the commercialization and marketing of their products
- DroppedRisks related to our business
Any damage to our reputation or brand may materially and adversely affect our business, financial condition and results of operations
- DroppedRisks related to our business
additional regulatory controls including enforcement action, administrative and judicial sanctions, all of which could adversely affect our business, financial condition, or results of operations. See "Business-Government regulation-FDA"
Workplace AI and machine-learning use could create legal, regulatory and reputational risks.
- DroppedRisks related to our business
Our inability to collect on our accounts receivable by a significant number of customers may have an adverse effect on our business, financial condition and results of operations
Failure to expand into pharmaceutical biologics drug discovery and DNA data storage could limit revenue growth and addressable markets.
- DroppedRisks related to our intellectual property
prevent these other companies or institutions from continuing to license intellectual property that we may need to operate our business
- DroppedRisks relating to owning our common stock
Our amended and restated certificate of incorporation and amended and restated bylaws provide that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law
- DroppedRisks relating to owning our common stock
Evolving expectations around corporate responsibility practices, specifically related to environmental, social and governance (“ESG”) matters, may expose us to reputational and other risks
Reworded
- 78% rewrittenRisks Related to Our Business
Our revenue, results of operations, cash flows and reputation in the marketplace may suffer upon the loss of a limited number of large customers
Adds that customers may reduce purchases during the transition from product development to commercial production.
- 65% rewrittenRisks Related to Our Business
We generally do not have long-term contracts with our customers requiring them to purchase any specified quantities from us
Adds dependence on one single-source supplier for a critical DNA-synthesis component.
- 62% rewrittenRisks Related to Our Business
Because we are subject to existing and potential additional governmental regulation, the markets for our products may be narrowed
No substantive change; it continues to address export controls, genetic-engineering restrictions and evolving regulation narrowing markets.
- 61% rewrittenRisks Related to Our Business
The enactment of legislation implementing changes in taxation of international business activities, the adoption of other corporate tax reform policies, or changes in tax legislation or policies could impact our future financial position and results of operations
Replaces detailed Tax Cuts and Jobs Act history with the July 2025 OBBBA, including immediate domestic R&D expensing and permanent tax provisions.
- 50% rewrittenRisks Related to Our Business
We have incurred net losses in every period to date, and we may continue to experience losses as we develop our business and may never achieve profitability
Removes the prior loss figures and DNA-data-storage industry reference, while adding technology investment to the path toward profitability.
Was: We have incurred net losses in every period to date, and we expect to continue to incur significant losses as we develop our business and may never achieve profitability
- 46% rewrittenRisks Related to Our Business
We are substantially dependent on the success of our synthetic DNA products
Adds that DNA synthesis is particularly capital-intensive for early-stage companies without offsetting revenue and investing in commercialization and marketing.
- 43% rewrittenRisks Related to Our Business
We must continue to secure and maintain sufficient and stable supplies of raw materials. Any shortage of raw materials or materials necessary for our production capabilities may adversely affect our business
No substantive change; the risk remains shortages, supplier capacity, specifications, quality, pricing and unfavorable supply terms.
- 39% rewrittenRisks Related to Our Business
We may engage in strategic transactions, including acquisitions, collaborations, or investments in other companies or technologies, that could disrupt our business, cause dilution to our stockholders, reduce our financial resources, or prove not to be successful
No substantive change; it still covers acquisitions and other strategic transactions potentially failing, harming competition or being viewed negatively.
- 38% rewrittenRisks Related to Our Business
We operate in a highly competitive industry and if we are not able to compete effectively, our business and operating results will likely be harmed
- 35% rewrittenRisks related to our intellectual property
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
- 34% rewrittenRisks Related to Our Business
Rapidly changing technology and extensive competition in synthetic biology could make the products we are developing and producing obsolete or non-competitive unless we continue to develop and manufacture new and improved products and pursue new market opportunities
- 33% rewrittenRisks Related to Our Business
We use biological and hazardous materials that require considerable expertise and expense for handling, storage and disposal and may result in claims against us
- 28% rewrittenRisks related to our intellectual property
Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain
- 25% rewrittenRisks Related to Our Business
If we are unable to attract new customers and retain and grow sales from our existing customers, our business will be materially and adversely affected
- 25% rewrittenRisks relating to owning our common stock
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline
- 22% rewrittenRisks Related to Our Business
We may encounter difficulties in managing our growth, and these difficulties could impair our profitability
- 21% rewrittenRisks Related to Our Business
Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations
- 21% rewrittenRisks relating to owning our common stock
Our actual operating results may differ significantly from our guidance
All 59 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business
- 01We have incurred net losses in every period to date, and we may continue to experience losses as we develop our business and may never achieve profitability50% rewritten
- 02If we are unable to maintain adequate revenue growth or do not successfully manage such growth, our business and growth prospects will be harmed
- 03We may encounter difficulties in managing our growth, and these difficulties could impair our profitability22% rewritten
- 04The continued success of our business relies heavily on our disruptive technologies and products and our position in the market as a leading provider or synthetic DNA using a silicon chip
- 05We are substantially dependent on the success of our synthetic DNA products46% rewritten
- 06Substantially all of our revenue generated to date is from our synthetic DNA products. Our financial results are dependent on strengthening our synthetic biology and NGS product groups while diversifying into other developing sectorsnew
- 07We operate in a highly competitive industry and if we are not able to compete effectively, our business and operating results will likely be harmed38% rewritten
- 08If we are unable to attract new customers and retain and grow sales from our existing customers, our business will be materially and adversely affected25% rewritten
- 09Our revenue, results of operations, cash flows and reputation in the marketplace may suffer upon the loss of a limited number of large customers78% rewritten
- 10If we, or our partners or suppliers, experience a significant disruption in, or breach in security of, information technology systems or other cybersecurity incidents, our business could be adversely affectednew
- 11As we continue to grow our business, we will need to implement new systems and software successfully, otherwise our business and our financial condition and results of operations could be adversely affectednew
- 12Rapidly changing technology and extensive competition in synthetic biology could make the products we are developing and producing obsolete or non-competitive unless we continue to develop and manufacture new and improved products and pursue new market opportunities34% rewritten
- 13AI capabilities may indicate that it could be a significant disruptor in the synthetic biology industry. For example, AI may reduce customer demand for certain types of gene synthesisnew
- 14Issues relating to the use of AI and machine learning and compliance with evolving regulations and industry standards could adversely affect our business and operating resultsnew
- 15Adverse global economic conditions and U.S. policy changes could have a negative effect on our business, financial condition and results of operationsnew
- 16A significant portion of our sales depends on customers’ budgets that may be subject to significant and unexpected variation, including seasonality
- 17We generally do not have long-term contracts with our customers requiring them to purchase any specified quantities from us65% rewritten
- 18The loss of this component provided by this supplier could require us to change the design of our manufacturing process based on the functions, limitations, features and specifications of the replacement components
- 19We must continue to secure and maintain sufficient and stable supplies of raw materials. Any shortage of raw materials or materials necessary for our production capabilities may adversely affect our business43% rewritten
- 20the raw materials or component parts we use could result in decreased revenue or could impair our ability to maintain or expand our businessnew
- 21We may be unable to successfully recruit and maintain adequate sales, marketing and other support personnel in order to increase our market share and expand our customer base
- 22We may engage in strategic transactions, including acquisitions, collaborations, or investments in other companies or technologies, that could disrupt our business, cause dilution to our stockholders, reduce our financial resources, or prove not to be successful39% rewritten
- 23We may not achieve the anticipated benefits from the spin out of our DNA data storage applicationnew
- 24We may be subject to significant pricing pressures and if we are unable to pass on any cost increase to our customers, our business, financial position and results of operations could be adversely affected
- 25We use biological and hazardous materials that require considerable expertise and expense for handling, storage and disposal and may result in claims against us33% rewritten
- 26The FSAP involves rules administered by the CDC and the APHIS that regulate possession, use and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant productsnew
- 27Third parties may use our products in ways that could damage our reputation
- 28A violation of data privacy or data protection laws could adversely harm our operating results and financial condition, damage our reputation or otherwise materially harm our businessnew
- 29Because we are subject to existing and potential additional governmental regulation, the markets for our products may be narrowed62% rewritten
- 30Our products could in the future be subject to additional regulation by the FDA or other domestic and international regulatory agencies, which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results of operationsnew
- 31Certain of our potential customers may require that we become certified under the Clinical Laboratory Improvement Amendments of 1988
- 32Natural disasters, public health crises, political crises, severe weather events, and other catastrophic events or other events outside of our control may damage our facilities or the facilities of third parties on which we depend and could impact our ability to sell products
- 33We may not be able to scale our manufacturing capacity to meet future demand, which could harm our businessnew
- 34Delivery of our products could be delayed or disrupted by factors beyond our control, and we could lose customers as a result
- 35We may require additional financing to achieve our goals, and such additional financing may not be available acceptable terms, or at all, which could have an adverse effect on our businessnew
- 36We could engage in exporting or related activity that contravenes international trade restraints, or regulatory authorities could promulgate more far-reaching international trade restraints, which could give rise to one or more of substantial legal liability, impediments to our business and reputational damage
- 37Doing business internationally creates operational and financial risks for our business
- 38Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations21% rewritten
- 39The enactment of legislation implementing changes in taxation of international business activities, the adoption of other corporate tax reform policies, or changes in tax legislation or policies could impact our future financial position and results of operations61% rewritten
- 40Ethical, legal and social concerns surrounding the use of genetic information could reduce demand for our technology
Risks related to being a public company
- 41If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired, which would adversely affect our business
- 42The requirements of being a public company may strain our resources and require a substantial amount of management’s attention
Risks related to our intellectual property
- 43Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain28% rewritten
- 44If we are unable to obtain, maintain and enforce intellectual property protection, others may be able to make, use, or sell products and technologies substantially the same as ours, which could adversely affect our ability to compete in the market
- 45We may not be able to protect our intellectual property rights throughout the world
- 46If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected
- 47assert their patents and other proprietary rights against us as a means of slowing our entry into such markets or as a means to extract substantial license and royalty payments from us
- 48We may not be successful in obtaining or maintaining necessary rights to our products and technologies through acquisitions and in-licenses, and our intellectual property agreements with third parties may involve unfavorable terms or be subject to disagreements over contract interpretation
- 49We have not yet registered some of our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business
- 50We 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 products35% rewritten
Risks relating to owning our common stock
- 51We have never paid dividends on our capital stock and we do not intend to pay dividends for the foreseeable future. Consequently, any gains from an investment in our common stock will likely depend on whether the price of our common stock increases
- 52Our charter documents and Delaware law could prevent a takeover that stockholders consider favorable and could also reduce the market price of our stock
- 53The market price of our common stock could be subject to wide fluctuations in response to, among other things, the factors described in this “Risk Factors” section or otherwise, and other factors beyond our control, such as fluctuations in the valuations of companies perceived by investors to be comparable to us
- 54Our quarterly and annual operating results and cash flows have fluctuated in the past and might continue to fluctuate, causing the value of our common stock to decline substantially
- 55If securities or industry analysts do not publish research or reports about our business or publish negative reports about our business, our share price and trading volume could decline
- 56Our actual operating results may differ significantly from our guidance21% rewritten
- 57We have in the past and may in the future be subject to short selling strategies that may drive down the market price of our common stock
- 58Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline25% rewritten
- 59Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to usnew
Other Twist Bioscience 10-Ks
- 2024 10-K risk factors
57 risks. Profitability depends on scaling synthetic DNA sales while funding manufacturing expansion and adjacent markets.
Filed Nov 18, 2024
About this page
Item 1A of the 10-K on EDGAR was split into its risk factors and, where the company's previous 10-K is on file, each heading was matched to last year's and the text compared word for word. The headings are the filing's own. The one-line readings and the overview were written by a language model from the text of the new, dropped, and rewritten risks; they refer to risks by position and cannot misquote a heading.