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What changed in Twist Bioscience Corp's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Twist Bioscience Corp's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+396 added−465 removedSource: 10-K (2025-11-17) vs 10-K (2024-11-18)

Top changes in Twist Bioscience Corp's 2025 10-K

396 paragraphs added · 465 removed · 310 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

75 edited+11 added−56 removed57 unchanged
Biggest changeIn the antibody discovery market, we compete with contract research organizations including Curia, GenScript, and Genovac (formerly part of Aldevron, LLC), and antibody discovery biotechnology companies, such as Fair Journey/Iontas, Adimab, Distributed Bio (owned by Charles River), Ablexis, Specifica, OmniAb and AbCellera Biologics Inc.
Biggest changeIn the antibody discovery market, we compete with contract research organizations including Curia Global, Inc., GenScript Biotech Corporation, and Genovac (formerly part of Aldevron, LLC), and antibody discovery biotechnology companies, such as FairJourney Biologics S.A/IONTAS Limited, Adimab, LLC, Distributed Bio (owned by Charles River Laboratories International, Inc.), Ablexis, LLC, Specifica Inc., OmniAb, Inc., Alloy Therapeutics, Inc. and AbCellera Biologics Inc. 9 Table of Contents Corporate Responsibility We are at the forefront of the bioeconomy revolution, and our products are increasingly being used to empower our customers, which consist of diagnostic, therapeutic and healthcare companies, agricultural biotech companies, chemical companies, academic institutions and government entities, around the world to address large societal challenges.
If the FDA or other regulatory authorities assert that any of our RUO products are subject to regulatory clearance or approval, our business, financial condition, or results of operations could be adversely affected. Some of our customers may use our products in their own laboratory-developed tests, or LDTs.
If the FDA or other regulatory authorities assert that any of our RUO products are subject to regulatory clearance or approval, our business, financial condition, or results of operations could be adversely affected. Some of our customers may use our products in their own laboratory-developed tests ("LDTs").
The registered entities primarily consist of academic, federal and non-federal government, commercial, and private facilities that conduct research studies or diagnostic activities. We are not a registered entity under FSAP and it is our policy generally not to produce or otherwise work with any biological material that is subject to FSAP license requirements.
The registered entities primarily consist of academic, federal and non-federal government, commercial, and private facilities that conduct research studies or diagnostic activities. We are not a registered entity under the FSAP and it is our policy generally not to produce or otherwise work with any biological material that is subject to the FSAP license requirements.
To the extent that we may possess, use, or transfer any material considered a select agent or toxin under FSAP prospectively, we would seek to register with FSAP and obtain all necessary permits for possession, transfer, importation, or any other regulated activity.
To the extent that we may possess, use, or transfer any material considered a select agent or toxin under the FSAP prospectively, we would seek to register with the FSAP and obtain all necessary permits for possession, transfer, importation, or any other regulated activity.
The pooling process has been fully automated through a mixture of custom proprietary and over-the-counter liquid handling equipment. We have the capacity to make many millions of high-quality oligos per day that can be used to make genes and gene fragments of various lengths, oligo pools of various sizes, DNA libraries and NGS tools products.
The pooling process has been fully automated through a mixture of custom proprietary and over-the-counter liquid handling equipment. We have the capacity to make many millions of high-quality oligos per day that can be used to make genes and gene fragments of various lengths, multiplex gene fragments, oligo pools of various sizes, DNA libraries and NGS tools products.
We offer a wide range of products intended for "Research Use Only" (RUO) as well as a limited catalog of NGS tools that have been CE-marked pursuant to, and regulated by, the In Vitro Diagnostic Device Regulation (EU) 2017/746, or IVDR, and sold as in-vitro diagnostic medical devices (IVDs) in the European market.
We offer a wide range of products intended for "Research Use Only" ("RUO") as well as a limited catalog of NGS tools that have been CE-marked pursuant to, and regulated by, the In Vitro Diagnostic Device Regulation (EU) 2017/746 (the "IVDR"), and sold as in-vitro diagnostic medical devices ("IVDs") in the European market.
Our oligo pools are also used for high-throughput reporter assays that are used to study cell signaling pathways, gene regulation, and the structure of cell regulatory elements. For these applications, we provide customers with accurate and uniform synthetic oligos to precisely match their required designs.
Our oligo pools are also used for high-throughput reporter assays to study cell signaling pathways, gene regulation and the structure of cell regulatory elements. For these applications, we provide customers with accurate and uniform synthetic oligos to precisely match their required designs.
In addition to NGS tools for DNA workflows, we offer full RNA sequencing workflows. Synthetic controls Leveraging our DNA synthesis platform, we offer positive synthetic controls that provide quality control measures for a wide range of applications from assay development to routine testing of samples with both next-generation sequencing (NGS) and reverse transcription polymerase chain reaction (RT-PCR) assays.
In addition to NGS tools for DNA workflows, we offer full RNA sequencing workflows. Synthetic Controls Leveraging our DNA synthesis platform, we offer positive synthetic controls that provide quality control measures for a wide range of applications from assay development to routine testing of samples with both NGS and reverse transcription polymerase chain reaction (RT-PCR) assays.
Item 1. Business At Twist Bioscience Corporation, we work in service of our customers who are changing the world for the better. In fields such as health care, food/agriculture, industrial chemicals/materials, academic research and data storage, by using our products, our customers are developing ways to better lives and improve the sustainability of the planet.
Item 1. Business At Twist Bioscience Corporation, we work in service of our customers who are changing the world for the better. In fields such as health care, food/agriculture, industrial chemicals/materials and academic research, by using our products, our customers are developing ways to better lives and improve the sustainability of the planet.
According to the FDA, including the RUO labeling statement will not necessarily render the device exempt from FDA premarket clearance, approval, or other regulatory requirements if the totality of circumstances surrounding the distribution of the product indicate that the manufacturer intended its IVDs for diagnostic use.
According to the FDA, including the RUO labeling statement will not necessarily render the device exempt from FDA premarket clearance, approval, or other regulatory requirements if the totality of circumstances surrounding the distribution of the product indicate that the manufacturer intended its RUO products for diagnostic use.
Customers (biotech, pharma, industrial chemical, agricultural companies as well as academic labs) order our synthetic genes to conduct a wide range of research, including product development for therapeutics, diagnostics, chemicals/materials, food/agriculture, data storage as well as a multitude of emerging applications within academic research.
Customers (biotech, pharma, industrial chemical, agricultural companies as well as academic labs) order our synthetic genes to conduct a wide range of research, including product development for therapeutics, diagnostics, chemicals/materials, food/agriculture as well as a multitude of emerging applications within academic research.
However, if we expand our portfolio of IVDs , we may be subject to a variety of specialized regulatory requirements, including those set forth by the U.S. Food and Drug Administration, or the FDA in the United States and the IVDR in the European Union.
However, if we expand our portfolio of IVDs , we may be subject to a variety of specialized regulatory requirements, including those set forth by the U.S. Food and Drug Administration (the "FDA") in the United States and the IVDR in the European Union ("EU").
All of our work supports our mission to provide synthetic DNA and DNA products to improve health and sustainability. Full results from our Corporate Responsibility efforts, including our 2024 Corporate Responsibility Report can be found here: https://www.twistbioscience.com/company/corporate-responsibility.
All of our work supports our mission to provide synthetic DNA and DNA products to improve health and sustainability. Full results from our Corporate Responsibility efforts, including our 2025 Corporate Responsibility Report can be found here: https://www.twistbioscience.com/company/corporate-responsibility.
As NGS technology improves and the cost of sequencing declines, new emerging markets that were once considered impractical, such as population-scale sequencing, liquid biopsy (a test that detects multiple types of cancer from a single blood sample), minimal residual disease testing and single cell sequencing, have become major areas of interest and investment.
As NGS technology improves and the cost of sequencing declines, new emerging markets that were once considered impractical, such as therapy selection, population-scale sequencing, liquid biopsy (a test that detects multiple types of cancer from a single blood sample), minimal residual disease ("MRD") testing and single cell sequencing, have become major areas of interest and investment.
Our RUO 12 Table of Contents products are sold and promoted for non-diagnostic and non-clinical purposes to academic institutions, life sciences and research laboratories, and biopharmaceutical and biotechnology companies who then integrate our products into their workflows for further commercialization. These products serve as vital research tools, enabling our customers to develop a diverse spectrum of commercial products.
Our RUO products are sold and promoted for non-diagnostic and non-clinical purposes to academic institutions, life sciences and research laboratories, and biopharmaceutical and biotechnology companies who then integrate our products into their workflows for further commercialization. These products serve as vital research tools, enabling our customers to develop a diverse spectrum of commercial products.
Export controls Some sequences and synthetic controls we produce may be subject to licensing requirements for export outside of the United States under the U.S. Export Administration Regulations (EAR). Given the evolving nature of our industry, legislative bodies or regulatory authorities may adopt additional regulation or expand existing regulation to include our service.
Export Controls Some sequences and synthetic controls we produce may be subject to licensing requirements for export outside of the United States under the U.S. Export Administration Regulations. Given the evolving nature of our industry, legislative bodies or regulatory authorities may adopt additional regulation or expand existing regulation to include our products.
Oligonucleotide, or Oligo pools Oligo pools, or high diversity collections of oligonucleotides, are utilized in many applications, including targeted NGS, CRISPR gene editing, mutagenesis experiments, DNA origami (the nanoscale folding of DNA to create two- and three-dimensional shapes at the nanoscale), DNA computing and data storage in DNA, among others.
Oligonucleotide, or Oligo Pools Oligo pools, or high diversity collections of oligonucleotides, are utilized in many applications, including targeted NGS, CRISPR gene editing, mutagenesis experiments, DNA origami (the nanoscale folding of DNA to create two- and three-dimensional shapes at the nanoscale), among others.
Our guiding principles set the tone for how we work together, provide a framework for giving feedback and increase the power of our brand. Service is at the core of our business and our interactions with one another. We relentlessly focus on exceeding internal and external customer needs. Employee population As of September 30, 2024, we had 923 employees.
Our guiding principles set the tone for how we work together, provide a framework for giving feedback and increase the power of our brand. Service is at the core of our business and our interactions with one another. We relentlessly focus on exceeding internal and external customer needs. Employee Population As of September 30, 2025, we had 979 employees.
For example, we launched a limited line of IVDs that are CE-marked and IVDR compliant to support our European customers who are in the in vitro diagnostic medical device market. FDA Pursuant to its authority under the Federal Food, Drug, and Cosmetic Act, or the FDC Act, the FDA has jurisdiction over medical devices.
For example, we launched a limited line of IVDs that are CE-marked and IVDR compliant to support our European customers who are in the in vitro diagnostic medical device market. 11 Table of Contents FDA Pursuant to its authority under the Federal Food, Drug, and Cosmetic Act (the "FDC Act"), the FDA has jurisdiction over medical devices.
For synthetic genes, we have built a highly scalable gene production process with what we believe is industry-leading capacity to address the growing demand of scalable, high-quality, affordable synthetic genes. As of September 30, 2024, we employed 357 people in our manufacturing and operations team. In addition to synthetic genes, we manufacture oligo pools.
For synthetic genes, we have built a highly scalable gene production process with what we believe is industry-leading capacity to address the growing demand of scalable, high-quality, affordable synthetic genes. As of September 30, 2025, we employed 412 people in our manufacturing and operations team. In addition to synthetic genes, we manufacture oligo pools.
NGS has transformed many markets in recent years by changing the landscape of diagnosing disease and disorders and offers a path to prevent or treat disease. Some of the markets impacted by NGS include oncology, reproductive health, food/agriculture, consumer genomics, infectious disease research and drug discovery.
NGS has transformed many markets in recent years by changing the landscape of diagnosing disease and disorders and offers a path to prevent or treat disease. Some of the markets impacted by NGS include cancer diagnosis and care, reproductive health, food/agriculture, consumer genomics, infectious disease research and drug discovery.
In fiscal year 2024, we expanded our Express product portfolio to include many other products offered including Multiplexed Gene Fragments on a fast turnaround timeline. Our ability to provide this rapid turnaround for products at scale differentiates us from our competitors.
In fiscal year 2024, we expanded our Express product portfolio to include many other products including Multiplexed Gene Fragments and IgG proteins on a fast turnaround timeline. Our ability to provide this rapid turnaround for products at scale differentiates us from our competitors.
Implementing a QMS for medical devices is crucial for ensuring patient safety, regulatory compliance, and the overall effectiveness and reliability of medical devices in the market. The international standard ISO 13485 is widely recognized and provides a framework for developing and maintaining a QMS specific to the medical device industry.
Implementing a QMS for medical devices is crucial for ensuring patient safety, regulatory compliance, and the overall effectiveness and reliability of medical devices in the market. The international standard International Organization for Standardization (“ISO”) 13485 is widely recognized and provides a framework for developing and maintaining a QMS specific to the medical device industry.
As such, we may be subject to certain regulatory requirements, directly or indirectly, and maintain a robust quality management system to ensure compliance. Furthermore, if we expand our own portfolio of IVDs, we anticipate further engagement with regulatory bodies such as the FDA.
As such, we may be subject to certain regulatory requirements, directly or indirectly, and maintain a robust QMS to ensure compliance. Furthermore, if we expand our own portfolio of IVDs, we anticipate further engagement with regulatory bodies such as the FDA.
Background We currently generate revenue through our synthetic biology and NGS tools product lines as well as biopharma services for antibody discovery, optimization and development. In addition, we are leveraging our platform to expand our portfolio to include other products and address additional market opportunities, including vertical market opportunities in digital data storage.
Background We currently generate revenue through our synthetic biology and NGS tools product lines as well as biopharma services for antibody discovery, optimization and development. In addition, we are leveraging our platform to expand our portfolio to include other products and services to address additional market opportunities.
FSAP requirements govern possession, use, and transfer of select agents and toxins consisting of biological materials that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. The FSAP currently lists approximately 68 select agents and toxins.
FSAP requirements govern possession, use, and transfer of select agents and toxins consisting of biological materials that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. 12 Table of Contents The FSAP currently lists approximately 63 select agents and toxins.
As of September 30, 2024, we employed 236 employees and dedicated commercial consultants in sales, marketing and customer support. Research and development We are engaged in ongoing research and development efforts focused on enhancements to existing products and the development of new products.
As of September 30, 2025, we employed 278 employees and 5 dedicated commercial consultants in sales, marketing and customer support. Research and Development We are engaged in ongoing research and development efforts focused on enhancements to existing products and the development of new products.
Additionally, we compete with both large and emerging providers in the life sciences tools and diagnostics industries focused on sample preparation for NGS such as Thermo Fisher Scientific Inc., Illumina, Inc., Integrated DNA Technologies, Inc., Roche, New England Biolabs and Agilent.
Additionally, we compete with both large and emerging providers in the life sciences tools and diagnostics industries focused on sample preparation for NGS such as Thermo Fisher Scientific Inc., Illumina, Inc., Integrated DNA Technologies, Inc., Roche Holding AG, New England Bioloabs, Inc., Watchmaker Genomics, Inc. and Agilent Technologies, Inc.
The information on our website, including, without limitation, in the 2024 Corporate Responsibility Report, should not be deemed incorporated by reference into this annual report or otherwise “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
The information on our website, including, without limitation, in the 2025 Corporate Responsibility Report, should not be deemed incorporated by reference into this annual report or otherwise “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section.
We believe our products enable a broad range of applications that may ultimately improve health and the sustainability of the planet across multiple industries, including: • healthcare for the identification, prevention, diagnosis and treatment of disease (antibody discovery and optimization technology); • chemicals/materials for cost-effective and sustainable production of new and existing specialty chemicals and materials, such as spider silk, nylon, rubber, fragrances, food flavors and food additives; • food/agriculture for more effective and sustainable crop production; • academic research for a broad range of education and discovery applications; and • technology for potential use as an alternative long-term data storage medium.
We believe our products and services enable a broad range of applications that may ultimately improve health and the sustainability of the planet across multiple industries, including: • healthcare for the identification, prevention, diagnosis and treatment of disease (antibody discovery and optimization technology); • chemicals/materials for cost-effective and sustainable production of new and existing specialty chemicals and materials, such as spider silk, nylon, rubber, fragrances, food flavors and food additives; • food/agriculture for more effective and sustainable crop production; and • academic research for a broad range of education and discovery applications.
Human Capital 9 Table of Contents Our employees are a key factor in our ability to serve our customers. The ability to hire and retain highly skilled professionals remains key to our success in the marketplace.
Human Capital Our employees are a key factor in our ability to serve our customers. The ability to hire and retain highly skilled professionals remains key to our success in the marketplace.
In addition to these owned and exclusively licensed patents and pending patent applications, we also license patents on a non-exclusive and/or territory restricted basis. Our intellectual property portfolio includes important patents and patent applications directed to DNA synthesis, next generation sequencing, antibody libraries, and DNA data storage.
In addition to these owned and exclusively licensed patents and pending patent applications, we also license patents on a non-exclusive and/or territory restricted basis. Our intellectual property portfolio includes important patents and patent applications directed to DNA synthesis, NGS and antibody libraries.
We believe Twist Bioscience is uniquely positioned to help accelerate their efforts and the faster our customers succeed, the better for all of us. We have developed a disruptive DNA synthesis platform to industrialize the engineering of biology that provides DNA for a wide range of uses and markets.
We believe Twist Bioscience is uniquely positioned to help accelerate their efforts and the faster our customers succeed, the better for all of us. We have developed a disruptive DNA synthesis platform to industrialize the engineering of biology.
FSAP 14 Table of Contents The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) administer requirements of the Federal Select Agent Program, or FSAP.
Federal Select Agent Program The Centers for Disease Control and Prevention (the "CDC") and the Animal and Plant Health Inspection Service (the "APHIS") administer requirements of the Federal Select Agent Program ("FSAP").
As of September 30, 2024, we employed 182 people in our research and development team. Patents and other intellectual property rights Worldwide, we own or exclusively in-license over 150 issued or allowed patents and more than 250 pending patent applications as of September 30, 2024.
As of September 30, 2025, we employed 91 people in our research and development team. Patents and Other Intellectual Property Rights Worldwide, we own or exclusively in-license over 200 issued or allowed patents and more than 250 pending patent applications as of September 30, 2025.
We have applied our unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next generation sequencing, or NGS, sample preparation, and antibody libraries for drug discovery and development, all designed to enable our customers to conduct research more efficiently and effectively.
We have applied our unique technology to manufacture a broad range of products, including synthetic genes, tools for next generation sequencing ("NGS"), sample preparation, and both products and services for drug discovery and development, all designed to enable our customers to conduct research more efficiently and effectively.
We partner with community colleges and Hispanic Serving Institutions to build our brand within diverse communities as a source of diverse, high-quality candidates for every role with the goal of identifying the best possible candidate to fill open positions within the Company.
We partner with community colleges to build our brand as a source of high-quality candidates for every role with the goal of identifying the best possible candidate to fill open positions within the Company.
We certified our QMS to the ISO 9001:2015 (Quality Management Systems—Requirements) standard and ISO 13485:2016 standard (Medical devices—Quality management systems—Requirements for regulatory purposes). ISO is a global network of national standards with over 18,000 standards for nearly every aspect of technology and business. ISO has standard bodies in 163 countries.
We certified our QMS to ISO 13485:2016 standard (Medical 8 Table of Contents devices—Quality management systems—Requirements for regulatory purposes). ISO is a global network of national standards with over 21,000 standards for nearly every aspect of technology and business. ISO has standard bodies in 163 countries.
Our growth strategy Our objective is to be the leading provider of synthetic DNA and DNA-based products worldwide and to leverage our platform to build a leadership position in other life sciences markets in which we have a competitive advantage.
Our Growth Strategy Our objective is to be the leading provider of synthetic DNA and related solution worldwide, including RNA and proteins, and to leverage our platform to build a leadership position in other life sciences markets in which we have a competitive advantage.
IVDs are a category of medical devices that include reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
In addition, the FDA regulates the import and export of medical devices. Medical Device Regulation in General IVDs are a category of medical devices that include reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
EU Regulation In the European Union (EU), the new In Vitro Diagnostic Device Regulation (EU) 2017/746, or IVDR, imposes stricter requirements for the marketing and sale of applicable medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance.
EU Regulation In the EU, the new IVDR imposes stricter requirements for the marketing and sale of applicable medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance.
Currently, we are pursuing research and development projects with respect to the following: • process development for highest quality oligos; • develop proprietary enzymes to optimize SynBio and NGS products and workflows; • silicon process and enzymatic chemistry development for our data storage initiative; • evaluate and implement AI applications to potentially optimize services for our customers; 7 Table of Contents • expansion of our product offerings for oligo, gene, synthetic controls, NGS library preparation and target enrichment, and DNA Libraries products; • continuous process improvements across the business to facilitate speed, efficiency and automation; and, • develop new products including mRNA and proteins.
Currently, we are pursuing research and development projects with respect to the following: • process development for highest quality oligos; • develop proprietary enzymes to optimize SynBio and NGS products and workflows; 7 Table of Contents • evaluate and implement AI applications to potentially optimize services for our customers; • expansion of our product offerings for oligo, gene, synthetic controls, NGS library preparation and target enrichment, and DNA Libraries products; • continuous process improvements across the business to facilitate speed, efficiency and automation; • develop new products including mRNA and proteins; and • expand capabilities for antibody and protein production to support multiple formats and provide a wide array of characterization assays.
Of these employees, 182 were primarily engaged in research and development activities; 236 were primarily engaged in marketing, sales and customer support; 148 were primarily engaged in general and administrative activities; and 357 were primarily engaged in operations and manufacturing, dedicated to manufacturing our synthetic genes, oligo pools, NGS tools and DNA libraries.
Of these employees, 91 were primarily engaged in research and development activities; 278 were primarily engaged in marketing, sales and customer support; 198 were primarily engaged in general and administrative activities; and 412 were primarily engaged in operations and manufacturing, dedicated to manufacturing our synthetic genes, oligo pools, NGS tools, antibody proteins and DNA libraries.
For example, we have been recently evaluated by an external third party who has determined that we have processes in place to support compliance with current Good Manufacturing Practices (cGMP) and to support the required regulatory requirements as future regulations are updated by the FDA.
For example, we have been recently evaluated by an external third party who has determined that we have processes in place to support compliance with current Good Manufacturing Practices and to support the required regulatory requirements as future regulations are updated by the FDA. Currently, our QMS adheres to ISO 13485:2016 to ensure the quality and reliability of our products.
Supply chain We have historically purchased many of the components and raw materials used in our products from numerous suppliers worldwide. For reasons of quality assurance, sole source availability or cost effectiveness, certain components and raw materials used in the manufacture of our products are available only from one supplier.
For reasons of quality assurance, sole source availability or cost effectiveness, certain components and raw materials used in the manufacture of our products are available only from one supplier.
Changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time, and we may be unable to obtain or maintain comparable regulatory approval or clearance of our service, if required. These regulations and restrictions may materially and adversely affect our business, financial condition, and results of operations.
Changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time, and we may be unable to obtain or maintain comparable regulatory approval or clearance of our products, if required.
In fiscal year 2024, we served approximately 3,562 customers and reported $313.0 million in revenue, including $169.0 million in revenue from the healthcare sector, $83.5 million in revenue from the chemicals/materials sector, $58.5 million in revenue from the academic research sector and $2.1 million in revenue from the food/agriculture sector. 3 Table of Contents Our Markets Synthetic Biology Our synthetic biology products serve life sciences researchers across a variety of healthcare applications including drug discovery, disease detection, enzyme engineering, gene editing and basic academic research.
In fiscal year 2025, we served more than 3,800 customers and reported $376.6 million in revenue, including $215.1 million in revenue from the healthcare sector, $93.2 million in revenue from the chemicals/materials sector, $65.9 million in revenue from the academic research sector and $2.4 million in revenue from the food/agriculture sector. 3 Table of Contents Our Markets Synthetic Biology Our synthetic biology products serve life sciences researchers across a variety of healthcare applications including drug discovery, disease detection, enzyme engineering, gene editing and basic academic research.
We sell our products to a global customer base of approximately 3,562 customers across a broad range of industries.
We sell our products and services to a global customer base of more than 3,800, customers across a broad range of industries.
Our products work on multiple sequencing platforms as we are sequencer agnostic. In particular, we are focused on addressing the demand for better sample preparation products that improve sequencing workflow, increase sequencing accuracy, and reduce downstream sequencing costs. Using our silicon-based DNA synthesis platform, we are able to synthesize exact 5 Table of Contents sequences of interest.
NGS Tools Building from our DNA synthesis platform, we have developed products to enable NGS. Our products work on multiple sequencing platforms as we are sequencer agnostic. In particular, we are focused on addressing the demand for better sample preparation products that improve sequencing workflow, increase sequencing accuracy, and reduce downstream sequencing costs.
Leveraging our silicon-based synthesis platform, we provide customers with a high throughput IgG capability, removing this bottleneck from the antibody discovery process. We offer standard and Express turnaround times in both CHO and HEK293 cell lines. NGS tools Building from our DNA synthesis platform, we have developed products to enable next-generation sequencing.
Leveraging our silicon-based synthesis platform, we provide customers with a high throughput IgG capability, removing this bottleneck from the 5 Table of Contents antibody discovery process. We offer standard and Express turnaround times in both CHO and HEK293 cell lines as well as a wide variety of antibody characterization assays.
We intend to accomplish this objective by executing on the following: • maintain and expand our position as the provider of choice for high-quality, affordable synthetic DNA, RNA and proteins to customers across multiple industries; • become a leading supplier of NGS sample preparation products; • conduct biopharma services for our current customers and future partners; • continue to develop commercial solution for storing digital data in DNA; and • expand our global presence.
We intend to accomplish this objective by executing on the following: • maintain and expand our position as the provider of choice for high-quality, affordable synthetic DNA, RNA and proteins to customers across multiple industries; • expand antibody and protein production as well as expand array of characterization assays to support customers conducting therapeutics discovery projects; • become a leading supplier of NGS sample preparation products for a wide range of applications including liquid biopsy tests, MRD, agricultural genomics and population genomics; • conduct biopharma services for our current customers and future partners; and • expand our global presence.
Our NGS target enrichment and library preparation products are used in a more comprehensive workflow for next generation sequencing for research purposes only. In the future, we may develop this larger workflow as an in vitro diagnostic, for which we will obtain prior authorization from FDA or other applicable regulatory authorities before commercialization.
In the future, we may develop this larger workflow as an in vitro diagnostic, for which we will obtain prior authorization from FDA or other applicable regulatory authorities before commercialization.
Currently, our quality management system adheres to ISO 13485:2016 to ensure the quality and reliability of our products. RUO is a term applicable to our target enrichment products for the next-generation sequencing (NGS) market and is applied to kits sold to this market segment. It is intended to restrict use of the kits to non-in vitro diagnostic purposes.
RUO is a term applicable to our target enrichment products for the NGS market and is applied to kits sold to this market segment. It is intended to restrict use of the kits to non-in vitro diagnostic purposes. Our NGS target enrichment and library preparation products are used in a more comprehensive workflow for NGS for research purposes only.
Some of our partners include Bayer, Boehringer Ingelheim GmbH, Takeda Pharmaceutical Company Limited, Adicet Bio, Ono Pharmaceutical Ltd., Kyowa Kirin, Invetx, Inc., Astellas Pharma Inc. and Neogene Therapeutics, Inc.
Through these partnerships, we had 1182 completed programs and 84 active programs with 82 of the programs including milestones and/or royalties as of September 30, 2025. Some of our partners include Bayer, Boehringer Ingelheim GmbH, Takeda Pharmaceutical Company Limited, Adicet Bio, Ono Pharmaceutical Ltd., Kyowa Kirin, Invetx, Inc., Astellas Pharma Inc. and Neogene Therapeutics, Inc.
The ability of the Twist DNA synthesis platform to precisely manufacture target enrichment probes at large scale has dramatically increased the types of projects that can now be addressed using NGS technologies.
The ability of the Twist DNA synthesis platform to precisely manufacture target enrichment probes at large scale has dramatically increased the types of projects that can now be addressed using NGS technologies. In addition to target enrichment, we offer innovative and application-specific library preparation with Twist-developed enzymes, buffers, beads, unique dual indexes ("UDIs"), unique molecular identifiers ("UMIs"), adapters and more.
As part of our efforts, all employees and managers complete workplace harassment and sexual harassment training that includes details on how to report any violation of these policies.
As part of our efforts, all employees and managers complete workplace harassment and sexual harassment training that includes details on how to report any violation of these policies. Employee Communications and Engagement We employ a variety of tools to facilitate open and direct communication including open forums with executives, employee surveys and engagement through focus groups, forums and committees.
While synthetic DNA has been produced for more than 40 years, the complexities of biology and the production constraints inherent in legacy processes have historically limited the applications and market opportunities for DNA synthesis. Next-Generation Sequencing Our NGS tools play an integral role in the way our customers prepare their patient samples to be sequenced.
While synthetic DNA has been produced for more than 40 years, the complexities of biology and the production constraints inherent in legacy processes have historically limited the applications and market opportunities for DNA synthesis. Synthetic DNA is the fundamental building block that allows researchers to engineer biology.
Our current offering consists of two primary product lines, synthetic biology tools and NGS tools, that address different needs of our customers across a variety of applications. In addition to DNA, we now offer RNA and protein products. Synthetic Biology Products Synthetic genes and gene fragments Synthetic genes are manufactured strands of DNA.
Our current offering consists of two primary product lines, synthetic biology tools and NGS tools, that address different needs of our customers across a variety of applications as well as a biopharma service offering.
We face competition from a broad range of providers of synthetic biology products such as GenScript Biotech Corporation, DNA Script, Inc., GENEWIZ (owned by Azenta), Integrated DNA Technologies, Inc. (owned by Danaher Corporation), DNA 2.0 Inc. d/b/a/ ATUM, GeneArt (owned by Thermo Fisher Scientific Inc.), Eurofins Genomics LLC, Promega Corporation, OriGene Technologies, Inc., Blue Heron Biotech, LLC, Elegen and others.
(owned by Danaher Corporation), DNA 2.0 Inc. d/b/a/ ATUM, GeneArt (owned by Thermo Fisher Scientific Inc.), Eurofins Genomics LLC, OriGene Technologies, Inc., Eurofins Genomics Blue Heron, Elegen Corporation, Ansa Biotechnologies, Inc., Telesis Bio, Inc. and others.
Our platform stems from extensive analyses and improvements to the existing gene synthesis and assembly workflows.
Our Platform We developed the Twist Bioscience DNA synthesis platform to address the limitations of throughput, scalability, and cost inherent in legacy DNA synthesis methods. Our platform stems from extensive analyses and improvements to the existing gene synthesis and assembly workflows.
We invest in our next generation of leaders through a six-month leadership program and individualized coaching for mid-level managers. In addition, we offer tuition reimbursement aimed at growth and career development. We have made a significant investment in an online learning platform with on-demand, video-based content.
We invest in our next generation of leaders through a six-month leadership program and individualized coaching for mid-level managers. In addition, we offer tuition reimbursement aimed at growth and career development. Compensation and Benefits, Health and Wellness We strive to provide pay, comprehensive benefits and services that help meet the varying needs of our employees.
In addition, customers use our NGS tools for population genetics research and biomarker discovery, translational research, microbiology and applied markets research. Our customers are primarily diagnostic companies and hospitals, research institutions, agricultural biotechnology companies, and consumer genetics companies conducting diagnostic tests for a wide range of applications.
Our customers are primarily diagnostic companies and hospitals, research institutions, agricultural biotechnology companies, and consumer genetics companies conducting diagnostic tests for a wide range of applications. We offer a wide variety of NGS tools for our customers including library preparation kits, human exome kits, fixed and custom panels as well as Alliance panels.
Partnerships with leading companies We believe we have several avenues available to monetize our antibody discovery program. In general, partnerships for our antibody development platform require us to provide rapid, on-demand (high affinity) antibodies based on one or more targets provided by the customer.
Partnerships for our antibody development platforms require us to provide rapid, high quality, fit for purpose antibodies based on one or more targets and functional criterion provided to us by the customer.
Synthetic DNA is the fundamental building block that allows researchers to engineer biology. Synthetic DNA is a foundational product enabling the entire bioeconomy, with synthetic biology alone expected to have a $2-4 trillion global impact by 2030-2040.
Synthetic DNA is a foundational product enabling the entire bioeconomy, with synthetic biology alone expected to have a $2-4 trillion global impact by 2030-2040. The National Security Commission on Emerging Biotechnology recognized synthetic DNA as a critical choke point in many supply chains, making broad access important for many industries.
Our biopharma services group offers the “discovery trifecta” – in vivo, in vitro and in silico antibody discovery all under one roof. We provide comprehensive discovery services for our partners that results in improved diversity, improved screening, ultra fast lead selection and engineering, which can mean a faster path in the race to the clinic.
We provide comprehensive discovery services for our partners including library generation, screening, developability assays and antibody expression and characterization that result in ultra fast lead selection and engineering, which can mean a faster path in the race to the clinic. Partnerships with Leading Companies We have several avenues available to monetize our antibody discovery programs.
In the target enrichment process, our synthetic DNA probes bind to the sequence of interest within the sample, acting like a magnet to isolate and physically extract the targeted segment of DNA. Our NGS products are primarily used within diagnostic tests for various indications including rare disease, SARS-CoV-2 and cancer through liquid biopsy and minimal residual disease (MRD).
Using our silicon-based DNA synthesis platform, we are able to synthesize exact sequences of interest. In the target enrichment process, our synthetic DNA probes bind to the sequence of interest within the sample, acting like a magnet to isolate and physically extract the targeted segment of DNA.
In addition, the speed of our DNA synthesis platform enables customers to quickly deploy NGS technologies to applications where the time to answer is critical. Our Platform We developed the Twist Bioscience DNA synthesis platform to address the limitations of throughput, scalability, and cost inherent in legacy DNA synthesis methods.
Our platform has unlocked new applications, improved data quality, and dramatically expanded the types of scientific questions that can be answered using NGS. In addition, the speed of our DNA synthesis platform enables customers to quickly deploy NGS technologies to applications where the time to answer is critical.
Overall, Twist’s process to synthesize DNA significantly reduces the quantity of chemicals used, overproduced product and waste, for a more sustainable production process. Government regulation Twist Bioscience is a leading provider of synthetic DNA products, serving customers across research, development, and commercial applications.
We are working to engage with the local community organizations to provide volunteer opportunities for our employees. Government Regulation Twist Bioscience is a leading provider of synthetic DNA products, serving customers across research, development and commercial applications.
The FDA has historically taken the position that LDTs are considered to be IVDs, but has generally exercised enforcement discretion.
The FDA has historically taken the position that LDTs are considered to be IVDs but has generally exercised enforcement discretion. However, the FDA recently attempted to regulate virtually all LDTs as medical devices by publishing a final rule that would have phased out the policy of enforcement discretion it historically applied to LDTs (the “LDT Final Rule”).
Based on a recent survey conducted in February 2024 where 91% of our employees responded: • 89% of employees understand Twist’s mission • 86% understand how they contribute to the mission of the Company • 88% understand how their goals contribute to Twist We hold All Employee meetings twice per month as well as a monthly managers meeting for all people managers.
We endeavor to further refine our employee programs through our employee engagement survey as well as follow up quarterly pulse surveys. Our most recent survey was conducted in September 2025 where 90% of our employees responded. We hold All Employee meetings twice per month as well as a monthly managers meeting for all people managers.
Recertification is required every three years and we have been successfully recertified since obtaining our original ISO certification. 8 Table of Contents In 2020, our QMS for manufacturing our NGS Target Enrichment Panels in our South San Francisco, and subsequently in 2023 our Wilsonville manufacturing facilities was certified to ISO 13485:2016.
In 2020, our QMS for manufacturing NGS Target Enrichment Panels at our South San Francisco facility was certified to ISO 13485:2016, followed by certification of our Wilsonville manufacturing facility in 2023. Supply Chain We have historically purchased many of the components and raw materials used in our products from numerous suppliers worldwide.
ISO Surveillance Audits are carried out twice within a three-year period by the registrar (certification body) to ensure we maintain our system in compliance with ISO standards.
ISO surveillance audits are carried out annually by the registrar (certification body) to ensure we maintain our system in compliance with ISO standards and to demonstrate the continuous improvement of our QMS. Recertification is required every three years, and we have been successfully recertified since obtaining our original ISO certification. Our latest successful surveillance audit took place in September 2025.
Our libraries are explicitly developed for a specific area of the genome or tailored to a specific disease, with antibody compounds evenly represented across all desired areas of the genome. Biopharma Services Modern therapeutic targets are increasing in complexity and traditional, single modality platforms are no longer sufficient on their own.
Drug and Target Discovery Services and Solutions Biopharma Services Modern therapeutic targets are increasing in complexity and traditional, single modality platforms are no longer sufficient on their own. Our biopharma services group offers the “discovery trifecta” – in vivo, in vitro and in silico antibody discovery all under one roof.
The course equips leaders and employees with the tools they need to identify and address unwelcome conduct in non-adversarial, respectful terms. Employee health and safety We remain steadfast in our commitment to promote the health and safety of our employees and have implemented a robust Injury and Illness Prevention Program (IIPP).
Our total rewards package includes above-market pay; fully covered healthcare benefits for employees, with family member healthcare benefits covered at 90%; onsite services; and other benefits. 10 Table of Contents Employee Health and Safety We remain steadfast in our commitment to promote the health and safety of our employees and have implemented a robust Injury and Illness Prevention Program (IIPP).
In addition, many of our partnerships include success-based milestones for key clinical, regulatory and commercial achievements and/or royalties on any product sales resulting from our collaboration. To date, we have generated antibody leads to multiple biological targets and these antibody leads are in various stages of early discovery and development.
To date, we have generated antibody leads to multiple biological targets and these antibody leads are in various stages of early discovery and development. 6 Table of Contents As of September 30, 2025, we had signed 442 revenue-generating partnerships.
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Leveraging our same platform, we have expanded our footprint beyond DNA synthesis to manufacture synthetic RNA as well as antibody proteins to disrupt and innovate within larger market opportunities, in addition to discovery partnerships for biologic drugs and developing completely new applications for synthetic DNA, such as digital data storage.
Added
Building from this platform, we deliver products and services for a wide range of uses and markets.
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The National Security Commission on Emerging Biotechnology recognized synthetic DNA as a critical choke point in many supply chains, making broad access important for many industries. Researchers at a wide range of institutions design synthetic DNA to regulate the production of proteins and other molecules to achieve a specific functional purpose.
Added
In addition to synthetic DNA, we offer RNA products and proteins to fuel discoveries through the design-build-test-learn cycle. Next-Generation Sequencing Our NGS tools play an integral role in the way our customers prepare their patient samples to be sequenced.
Removed
In addition to target enrichment, we have expanded our offerings to include innovative library preparation with Twist-developed enzymes, buffers, beads, unique dual indexes (UDIs), unique molecular identifiers (UMIs), adapters and more. Our platform has unlocked new applications, improved data quality, and dramatically expanded the types of scientific questions that can be answered using NGS.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThese risks are discussed more fully in the section titled “Risk factors.” These risks and uncertainties include, but are not limited to, the following: • 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; • 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; • If we are unable to maintain adequate revenue growth or do not successfully manage such growth, our business and growth prospects will be harmed; 15 Table of Contents • 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; • The continued success of our business relies heavily on our disruptive technologies and products and our position in the market as a leading provider of synthetic DNA using a silicon chip; • If we are unable to expand our DNA synthesis manufacturing capacity, we could lose revenue and our business could be harmed. • We depend on one single-source supplier for a critical component for our DNA synthesis process.
Biggest changeThese risks are discussed more fully in the section titled “Risk Factors.” These risks and uncertainties include, but are not limited to, the following: • 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; • If we are unable to maintain adequate revenue growth or do not successfully manage such growth, our business and growth prospects will be harmed; • The 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; • We are substantially dependent on the success of our synthetic DNA products; 13 Table of Contents • 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; • 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; • Our revenue, results of operations, cash flows and reputation in the marketplace may suffer upon the loss of a limited number of large customers; • 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; • 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; • 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; • We depend on one single-source supplier for a critical component for our DNA synthesis process.
As we move into new markets and applications for our products and processes, incumbent participants in such 34 Table of Contents markets may assert 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.
As we move into new markets and applications for our products and processes, incumbent participants in such markets may 34 Table of Contents assert 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.
As a public company, we are required to comply with Section 404 of the Sarbanes Oxley Act of 2002 (“SOX”), which requires, among other things, that companies maintain disclosure controls and procedures to ensure timely disclosure of material information, and that management review the effectiveness of those controls on a quarterly basis and that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting in this Annual Report on Form 10-K, among other additional requirements.
As a public company, we are required to comply with Section 404 of the Sarbanes Oxley Act of 2002 (“SOX”), which requires, among other things, that companies maintain disclosure controls and procedures to ensure timely disclosure of material information, and that management review the effectiveness of those controls on a quarterly basis and that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting in this Form 10-K, among other additional requirements.
In addition, as permitted by Section 145 of the DGCL, our amended and restated bylaws and our indemnification agreements that we have entered into with our directors and officers provide that: • we will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law, which provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful; • we may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law; • we are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification; • we will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification; • the rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons; and 41 Table of Contents • we may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.
In addition, as permitted by Section 145 of the DGCL, our amended and restated bylaws and our indemnification agreements that we have entered into with our directors and officers provide that: • we will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law, which provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the company and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful; • we may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law; • we are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification; • we will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification; 41 Table of Contents • the rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons; and • we may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.
In addition to other risk factors listed in this section, some of the important factors that may cause fluctuations in our quarterly and annual operating results are further described in “Risk factors—Risks relating to owning our stock.” In addition, a significant portion of our operating expense is relatively fixed in nature, and planned expenditures are based in part on expectations regarding future revenue.
In addition to other risk factors listed in this section, some of the important factors that may cause fluctuations in our quarterly and annual operating results are further described in “Risk Factors—Risks relating to owning our common stock.” In addition, a significant portion of our operating expense is relatively fixed in nature, and planned expenditures are based in part on expectations regarding future revenue.
Our future success depends upon the continuing services of members of our senior management team and scientific and engineering personnel. We are highly dependent on Dr. Emily Leproust, our Chief Executive Officer, who is employed “at will,” meaning we or she may terminate the employment relationship at any time.
Our future success depends upon the continuing services of members of our senior management team and scientific and engineering personnel. We are highly dependent on Dr. Emily Leproust, our Chief Executive Officer ("CEO"), who is employed “at will,” meaning we or she may terminate the employment relationship at any time.
The requirements of being a public company may strain our resources and require a substantial amount of management’s attention. As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, Nasdaq listing requirements and other applicable securities rules and regulations.
The requirements of being a public company may strain our resources and require a substantial amount of management’s attention. As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, Nasdaq listing requirements and other applicable securities rules and regulations.
In general, under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change net operating loss carryforwards, or NOLs, to offset future taxable income.
In general, under Section 382 of the Internal Revenue Code of 1986, as amended (the "Code"), a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change net operating loss carryforwards ("NOLs"), to offset future taxable income.
As we expand our development and commercialization activities outside of the United States, we will be subject to an increased risk of inadvertently conducting activities in a manner that violates the U.S. Foreign Corrupt Practices Act and similar laws.
As we expand our development and commercialization activities outside of the United States, we will be subject to an increased risk of inadvertently conducting activities in a manner that violates the U.S. Foreign Corrupt Practices Act (the "FCPA") and similar laws.
These provisions include: • providing for a classified board of directors with staggered, three-year terms; • authorizing our board of directors to issue preferred stock with voting or other rights or preferences that could discourage a takeover attempt or delay changes in control; • prohibiting cumulative voting in the election of directors; • providing that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; • prohibiting the adoption, amendment or repeal of our amended and restated bylaws or the repeal of the provisions of our amended and restated certificate of incorporation regarding the election and removal of directors without the required approval of at least 66.67% of the shares entitled to vote at an election of directors; • prohibiting stockholder action by written consent; • limiting the persons who may call special meetings of stockholders; and • requiring advance notification of stockholder nominations and proposals.
These provisions include: • providing for a classified board of directors with staggered, three-year terms; • authorizing our board of directors to issue preferred stock with voting or other rights or preferences that could discourage a takeover attempt or delay changes in control; • prohibiting cumulative voting in the election of directors; • providing that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; • prohibiting the adoption, amendment or repeal of our amended and restated bylaws or the repeal of the provisions of our amended and restated certificate of incorporation regarding the election and removal of directors without the required approval of at least 66.67% of the shares entitled to vote at an election of directors; • prohibiting stockholder action by written consent; • limiting the persons who may call special meetings of stockholders; and 37 Table of Contents • requiring advance notification of stockholder nominations and proposals.
Cybersecurity incidents, including phishing attacks and attempts to misappropriate or compromise confidential or proprietary information or sabotage enterprise IT systems are becoming increasingly frequent.
Cybersecurity incidents, including phishing attacks and attempts to misappropriate or compromise confidential or proprietary information or sabotage enterprise IT systems are becoming increasingly frequent and sophisticated.
Their research and development budgets are based on a wide variety of factors, including factors beyond our control, such as: • the allocation of available resources to make purchases; • funding from government sources; • funding from research grants; • changes in government programs that provide funding to research institutions and companies; • the spending priorities among various types of research equipment; • policies regarding capital expenditures during recessionary periods; • political climate or macroeconomic conditions, including economic downturns or market uncertainty or reduced spending in response to emergency public health situations; • inability to raise sufficient funds in the capital markets; • changes in the regulatory environment; • healthcare legislative reform measures, • differences in budgetary cycles; • inflationary pressures; and • market acceptance of relatively new technologies, such as ours.
Their research and development budgets are based on a wide variety of factors, including factors beyond our control, such as: • the allocation of available resources to make purchases; • funding from government sources; • funding from research grants; • changes in government programs that provide funding to research institutions and companies; 20 Table of Contents • the spending priorities among various types of research equipment; • policies regarding capital expenditures during recessionary periods; • political climate or macroeconomic conditions, including government shutdowns, economic downturns or market uncertainty or reduced spending in response to emergency public health situations; • inability to raise sufficient funds in the capital markets; • changes in the regulatory environment; • healthcare legislative reform measures, • differences in budgetary cycles; • inflationary pressures; and • market acceptance of relatively new technologies, such as ours.
Such concerns or governmental restrictions could limit the use of our DNA synthesis products, which could have a material adverse effect on our business, financial condition and results of operations. In addition, public perception about the safety and environmental hazards of, and ethical concerns over, genetically engineered products and processes could influence public acceptance of our technologies, products and processes.
Such concerns or governmental restrictions could limit the use of our products, which could have a material adverse effect on our business, financial condition and results of operations. In addition, public perception about the safety and environmental hazards of, and ethical concerns over, genetically engineered products and processes could influence public acceptance of our technologies, products and processes.
With respect to our Wilsonville facility, if regulatory, manufacturing, or other problems require us to discontinue production at the facility, we will not be able to manufacture our synthetic genes, oligo pools or selected NGS products or create our DNA libraries, which would adversely impact our business.
With respect to our Wilsonville facility, if regulatory, manufacturing, or other problems require us to discontinue production at the facility, we may not be able to manufacture our synthetic genes, oligo pools or selected NGS products or create our DNA libraries, which would adversely impact our business.
If adequate funds are not available to us on a timely basis, we may be required to: • delay, limit, reduce or terminate our manufacturing, research and development activities; or • delay, limit, reduce or terminate our establishment of marketing and sales capabilities or other activities that may be necessary to generate revenue and achieve profitability.
If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce or terminate our manufacturing, research and development activities, marketing and sales capabilities or other activities that may be necessary to generate revenue and achieve profitability.
To perform sales, marketing, distribution and customer support successfully, we will face a number of risks, including that: • we may not be able to attract, retain and manage the sales, marketing and service workforce necessary to publicize and gain broader market acceptance of our technology; • the time and cost of establishing a specialized sales, marketing and service force for a particular product or service, which may be difficult to justify in light of the revenue generated; • our field sales personnel may not be able to access our customers’ premises which could delay the adoption and ordering of our products; and • our sales, marketing and service force may be unable to initiate and execute successful commercialization activities with respect to new products or markets we may seek to enter.
To perform sales, marketing, distribution and customer support successfully, we will face a number of risks, including that: • we may not be able to attract, retain and manage the sales, marketing and service workforce necessary to publicize and gain broader market acceptance of our technology; • the time and cost of establishing a specialized sales, marketing and service force for a particular product or service, which may be difficult to justify in light of the revenue generated; • our field sales personnel may not be able to access our customers’ premises which could delay the adoption and ordering of our products; and 23 Table of Contents • our sales, marketing and service employees may be unable to initiate and execute successful commercialization activities with respect to new products or markets we may seek to enter.
For example, we currently generate a significant amount of our NGS tool revenues from sales related to liquid biopsy applications that are undergoing clinical studies and/or subject to coverage and reimbursement determinations by government and private payors.
For example, we currently generate a significant amount of our NGS tool revenues from sales related to liquid biopsy applications, including MRD, that are undergoing clinical studies and/or subject to coverage and reimbursement determinations by government and private payors.
Our continued growth could require significant capital expenditures and might divert financial resources from other projects such as the development of new products and services, including the development and commercialization of additional products in the synthetic biology, biologic drug and data storage industries.
Our continued growth could require significant capital expenditures and might divert financial resources from other projects such as the development of new products and services, including the development and commercialization of additional products in the synthetic biology and biologic drug industries.
Although we have a reserve of supplies and alternative suppliers exist, the loss of this supplier or its failure to supply us with the necessary component on a timely basis could cause delays in the future capacity of our DNA synthesis process and adversely affect our business; • We depend on the continuing efforts of our senior management team and other key personnel.
Although we have a reserve of supplies and alternative suppliers exist, the loss of this supplier or its failure to supply us with the necessary component on a timely basis could cause delays in the future capacity of our DNA synthesis process and adversely affect our business; • We depend on the continuing efforts of our senior management team and other key personnel, including our scientific and engineering personnel.
If these liquid biopsy applications are proven to have less clinical value than anticipated and/or fail to receive adequate coverage and reimbursement determinations, it could have a material negative impact on our sales and revenues.
If these liquid biopsy applications, including MRD, are proven to have less clinical value than anticipated and/or fail to receive adequate coverage and reimbursement determinations, it could have a material negative impact on our sales and revenues.
However, improper use, including algorithmic biases, ethical considerations, data privacy issues, and potential regulatory non-compliance, could result in reputational damage, legal liabilities, and financial losses. The rapidly evolving regulatory landscape surrounding AI also poses a risk, as new laws and regulations could impose additional compliance burdens, resulting in increased operational costs.
However, improper use, including algorithmic biases, ethical considerations, data privacy issues, and potential regulatory non-compliance, could result in reputational damage, legal liabilities, and financial losses. The rapidly evolving regulatory landscape surrounding AI also poses risks, as new laws and regulations could impose additional compliance burdens, resulting in increased operational costs.
Some of our current competitors, as well as many of our 26 Table of Contents potential competitors, have significant name recognition, substantial intellectual property portfolios, longer operating histories, greater resources to invest in new technologies, substantial experience in new product development and manufacturing capabilities and more established distribution channels to deliver products to customers than we do.
Some of our current competitors, as well as many of our potential competitors, have significant name recognition, substantial intellectual property portfolios, longer operating histories, greater resources to invest in new technologies, substantial experience in new product development and manufacturing capabilities and more established distribution channels to deliver products to customers than we do.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business, put our 33 Table of Contents own patents at risk of being invalidated or interpreted narrowly, put our patent applications at risk of not being issued, and provoke third parties to assert claims against us.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business, put our own patents at risk of being invalidated or interpreted narrowly, put our patent applications at risk of not being issued, and provoke third parties to assert claims against us.
Legal action could be initiated against the owners of the intellectual property that we license. Even if we are not a party to these legal actions, an adverse outcome could harm our business because it might 36 Table of Contents prevent these other companies or institutions from continuing to license intellectual property that we may need to operate our business.
Legal action could be initiated against the owners of the intellectual property that we license. Even if we are not a party to these legal actions, an adverse outcome could harm our business because it might prevent these other companies or institutions from continuing to license intellectual property that we may need to operate our business.
The DNA synthesis business is very capital intensive, particularly 22 Table of Contents 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. Substantially all of our revenue generated to date is from our synthetic DNA products.
The DNA synthesis business is very capital intensive, particularly 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. Substantially all of our revenue generated to date is from our synthetic DNA products.
Accordingly, although there can be no 25 Table of Contents assurance that we will undertake or successfully complete any collaborations, any transactions that we do complete may be subject to the foregoing or other risks and have a material and adverse effect on our business, financial condition, results of operations and prospects.
Accordingly, although there can be no assurance that we will undertake or successfully complete any collaborations, any transactions that we do complete may be subject to the foregoing or other risks and have a material and adverse effect on our business, financial condition, results of operations and prospects.
If any disaster were to occur, our ability to operate our business at any of our facilities could be seriously, or potentially completely, impaired. In addition, the nature of our activities could cause significant delays in our research programs and commercial activities and make it difficult for us to recover from a disaster.
If any disaster were to occur, our ability to operate our business at any of our facilities could be seriously, or potentially completely, impaired. In addition, the nature of our 27 Table of Contents activities could cause significant delays in our research programs and commercial activities and make it difficult for us to recover from a disaster.
Stockholder activism, the current political environment, and the current high level of government intervention and regulatory reform may lead to 31 Table of Contents substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact, in ways we cannot currently anticipate, the manner in which we operate our business.
Stockholder activism, the current political environment, and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact, in ways we cannot currently anticipate, the manner in which we operate our business.
Further, while the impact that AI may have on the synthetic biology industry is still uncertain, recent advances in 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.
Further, while the impact that AI may have on the synthetic biology industry is still uncertain, recent advances in 19 Table of Contents 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.
If we are required or agree to defend or indemnify any of these third parties in connection with any infringement claims, we could incur significant costs and expenses that could adversely affect our business, operating results, or financial condition.
If we are required or agree to defend or indemnify any of these third parties in 35 Table of Contents connection with any infringement claims, we could incur significant costs and expenses that could adversely affect our business, operating results, or financial condition.
Additionally, some actors are using artificial intelligence (“AI”) technology to launch more automated, targeted and coordinated attacks. Our, or our partners’ or suppliers’ information technology systems also may experience interruptions, delays or cessations of service or produce errors in connection with system integration, software upgrades or system migration work that takes place from time to time.
Additionally, some actors are using AI technology to launch more automated, targeted and coordinated attacks. Our, or our partners’ or suppliers’ information technology systems also may experience interruptions, delays or cessations of service or produce errors in connection with system integration, software upgrades or system migration work that takes place from time to time.
Moreover, we have no control over the timing and volume of purchases by these customers and potential customers, and as 21 Table of Contents a result, revenue from these sources may vary significantly due to factors that can be difficult to forecast.
Moreover, we have no control over the timing and volume of purchases by these customers and potential customers, and as a result, revenue from these sources may vary significantly due to factors that can be difficult to forecast.
For example, as previously disclosed in our annual reports on Form 10-K for the fiscal years ended September 30, 2020, 2021, 2022 and 2023 we had at least one material weakness in our internal control over financial reporting as of the end of each of these fiscal years.
For example, as previously disclosed in our annual reports on Form 10-K for the fiscal years ended September 30, 2020, 2021, 2022 and 2023 we had at least one material weakness in our internal control over financial reporting as of the end of each of these fiscal years, each of which has been remediated.
Patent terms may be shortened or lengthened by, for example, terminal disclaimers, patent term adjustments, supplemental protection certificates, and patent term extensions. Although extensions may be available, 32 Table of Contents the life of a patent, and the protection it affords, is limited.
Patent terms may be shortened or lengthened by, for example, terminal disclaimers, patent term adjustments, supplemental protection certificates, and patent term extensions. Although extensions may be available, the life of a patent, and the protection it affords, is limited.
Factors that could cause the market price of our common stock to fluctuate significantly include: • actual or anticipated fluctuations in our financial condition and operating results, including fluctuations in our quarterly and annual results; • announcements of technological innovations by us or our competitors; • overall conditions in our industry and the markets in which we operate; • addition or loss of significant customers, or other developments with respect to significant customers; • changes in laws or regulations applicable to our products; • actual or anticipated changes in our growth rate relative to our competitors; • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; • additions or departures of key personnel; • operational impacts resulting from a reduction in force; • competition from existing products or new products that may emerge; • issuance of new or updated research or reports by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain intellectual property protection for our technologies; • announcement or expectation of additional financing efforts; • sales of our common stock by us or our stockholders; • the addition or removal of our stock to or from a stock index fund; • share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; • the expiration of contractual lock-up agreements with our executive officers, directors and stockholders, which we may enter into in the future from time to time; • general economic and market conditions, including economic downturns or uncertainty in financial markets; and • other factors beyond our control, such as terrorism, war, natural disasters and pandemics.
Factors that could cause the market price of our common stock to fluctuate significantly include: • actual or anticipated fluctuations in our financial condition and operating results, including fluctuations in our quarterly and annual results; • announcements of technological innovations by us or our competitors; • overall conditions in our industry and the markets in which we operate; • addition or loss of significant customers, or other developments with respect to significant customers; • changes in laws or regulations applicable to our products; • actual or anticipated changes in our growth rate relative to our competitors; • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; • additions or departures of key personnel; • operational impacts resulting from a reduction in force; • competition from existing products or new products that may emerge; • issuance of new or updated research or reports by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain intellectual property protection for our technologies; • announcement or expectation of additional financing efforts; • sales of our common stock by us or our stockholders; • the addition or removal of our stock to or from a stock index fund; • share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; • the expiration of contractual lock-up agreements with our executive officers, directors and stockholders, which we may enter into in the future from time to time; • trade and national security disputes, particularly with China, including the effect of sanctions, tariffs and other trade restrictions that may affect supply chain or sales opportunities in the United States, China and Europe; • general economic and market conditions, including economic downturns or uncertainty in financial markets; and • other factors beyond our control, such as terrorism, war, natural disasters and pandemics.
During our fiscal years ended September 30, 2024, 2023 and 2022, 40%, 40% and 41%, respectively, of our revenue was generated from customers located outside of the United States. In connection with our growth strategy, we intend to further expand in international markets.
During our fiscal years ended September 30, 2025, 2024 and 2023, 42%, 40% and 40%, respectively, of our revenue was generated from customers located outside of the United States. In connection with our growth strategy, we intend to further expand in international markets.
In 2024, we received ISO 27001:2022 certification, the most advanced information security standard published by the International Organization for Standardization (ISO), the world’s largest developer of voluntary international standards, and the International Electrotechnical Commission.
In 2024, we received ISO 27001:2022 certification, the most advanced information security standard published by the ISO, the world’s largest developer of voluntary international standards, and the International Electrotechnical Commission.
In addition, shortages of raw materials or component parts or an increase in the cost of the raw materials or component parts we use could result in decreased revenue or could impair our ability to maintain or expand our business.
In addition, shortages of raw materials or component parts or an increase in the cost of 22 Table of Contents the raw materials or component parts we use could result in decreased revenue or could impair our ability to maintain or expand our business.
Our future capital requirements depend on many factors, including: • the number and characteristics of any additional products or manufacturing processes we develop or acquire to serve new or existing markets; • the scope, progress, results and costs of researching and developing future products or improvements to existing products or manufacturing processes, including increasing our manufacturing capabilities; • the cost of manufacturing our DNA synthesis equipment and tools, our NGS sample preparation kits, and any future products we successfully commercialize; • our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements; • the costs of expanding our sales and marketing capabilities in the United States and in other geographies; • any lawsuits related to our products or commenced against us or any regulatory actions or proceedings commenced; • the expenses needed to attract and retain skilled personnel; • the costs associated with being a public company; 17 Table of Contents • the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and • the timing, receipt and amount of sales of, or royalties on, any future approved products, if any.
Our future capital requirements depend on many factors, including: • the number and characteristics of any additional products or manufacturing processes we develop or acquire to serve new or existing markets; • the scope, progress, results and costs of researching and developing future products or improvements to existing products or manufacturing processes, including increasing our manufacturing capabilities; • the cost of manufacturing our DNA synthesis equipment and tools, our NGS sample preparation kits, and any future products we successfully commercialize; • our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements; 28 Table of Contents • the costs of acquiring or investing in complementary businesses or assets; • the costs of expanding our sales, marketing and manufacturing capabilities in the United States and in other geographies; • any lawsuits related to our products or commenced against us or any regulatory actions or proceedings commenced; • the expenses needed to attract and retain skilled personnel; • the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and • the timing, receipt and amount of sales of, or royalties on, any future approved products, if any.
If that occurs, we may be subject to civil or criminal penalties which could have a material adverse effect on our business, financial condition, results of operations and growth prospects. We are subject to the U.S.
If that occurs, we may be subject to civil or criminal penalties which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
This guidance is not prepared with a view toward compliance with published guidelines of the American Institute of Certified Public Accountants (AICPA) regarding projections or the SEC regarding forward-looking statements, and neither our independent registered public accounting firm nor any other independent expert or outside party compiles or examines the projections.
This guidance is not prepared with a view toward compliance with published guidelines of the American Institute of Certified Public Accountants regarding projections, and neither our independent registered public accounting firm nor any other independent expert or outside party compiles or examines the projections.
Risk factors The following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other statements in this Annual Report on Form 10-K.
Risk Factors The following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other statements in this Form 10-K.
In addition, we do not have “key person” life insurance policies covering members of our management team or other key personnel except Dr. Leproust.
In addition, we do not have “key person” life insurance policies covering members of our management team or other key personnel.
Item 1A. Risk factors Risk Factor Summary Investing in our common stock involves a high degree of risk. You should carefully consider all information in the Annual Report on Form 10-K and in subsequent reports we file with SEC prior to investing in our common stock.
Item 1A. Risk Factors Risk Factor Summary Investing in our common stock involves a high degree of risk. You should carefully consider all information in this Form 10-K and in subsequent reports we file with SEC prior to investing in our common stock.
To do this, we aim to attract new and existing buyers of synthetic DNA and NGS tool kits, convert makers of synthetic DNA into buyers of synthetic DNA, monetize our antibody discovery platform by entering into partnerships and achieve widespread market acceptance by delivering both our current product offerings and new products and technologies at low cost, with high-quality, reliable turnaround times and throughput, superior e-commerce services and effective technical support.
To do this, we aim to attract new and existing buyers of synthetic DNA and NGS tool kits, convert makers of synthetic DNA into buyers of synthetic DNA, monetize our antibody discovery platform by entering into partnerships, expand the market opportunities available for our product portfolio and achieve widespread market acceptance by delivering both our current product offerings and new products and technologies at affordable cost, with high-quality, reliable turnaround times and throughput, superior e-commerce services and effective technical support.
Many of these employees could leave our Company with little or no prior notice and would be free to work for a competitor.
Our employees could leave our Company with little or no prior notice and would be free to work for a competitor.
While AI and machine learning presents opportunities for enhanced productivity and innovation, it also introduces inherent risks, including legal and regulatory, that could adversely impact our business and reputation. Proper use of AI and machine learning can lead to improved decision-making, cost reduction, and competitive 20 Table of Contents advantage.
While AI and machine learning presents opportunities for enhanced productivity and innovation, it also introduces inherent risks, including legal and regulatory compliance risks and potential liability, that could adversely impact our business and reputation. Proper use of AI and machine learning can lead to improved decision-making, cost reduction, and competitive advantage.
Foreign Corrupt Practices Act, or the FCPA, which prohibits corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity.
We are subject to the FCPA, which prohibits corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity.
We, our suppliers, third-party service providers and customers are vulnerable to damage from natural disasters, including fire, floods or monsoons, power loss, communications failures, public health crises, such as pandemics and epidemics, political crises, such as 29 Table of Contents terrorism, war, political instability or other conflict and similar events.
We, our suppliers, third-party service providers and customers are vulnerable to damage from natural disasters, including fire, floods or monsoons, power loss, communications failures, public health crises, such as pandemics and epidemics, political crises, such as terrorism, war, political instability or other conflicts and similar events.
Certain countries in Europe and developing countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.
Certain countries in Europe and developing countries, including China and India, have 33 Table of Contents compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.
In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Moreover, collaboration arrangements are complex and time-consuming to negotiate, document, implement and maintain. We may not be successful in our efforts to establish and implement collaborations or other alternative arrangements should we so choose to enter into such arrangements.
In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Moreover, collaboration arrangements are complex and time-consuming to negotiate, document, implement and maintain. We may not be successful in our efforts to establish and implement collaborations or other alternative arrangements.
Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the success of our existing products and the development and commercialization of additional products in the synthetic biology, biologic drug and data storage industries as well as leveraging our investment in our manufacturing facility in Wilsonville, Oregon.
Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the success of our existing products and the development and commercialization of additional products in the synthetic biology and biologic drug industries as well as leveraging our investment in our manufacturing facility in Wilsonville, Oregon, and investing in technology to support our growth.
In addition, there is extensive competition in the synthetic biology industry, and our future success will depend on our ability to maintain a competitive position with respect to technological advances. Technological development by others may result in our technologies, as well as products developed using our technologies, becoming obsolete.
In addition, there is extensive competition in our end markets, and our future success will depend on our ability to maintain a competitive position with respect to technological advances. Technological development by others may result in our technologies, as well as products developed using our technologies, becoming obsolete.
Our products could in the future be subject to additional regulation by the U.S. Food and Drug Administration 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. The FDA regulates medical devices, including in vitro diagnostics, or IVDs.
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. The FDA regulates medical devices, including IVDs.
Thus, these patents and patent applications are not written by us or our attorneys, and we did not have control over the drafting and prosecution.
Thus, these patents and patent applications are not written by us or 36 Table of Contents our attorneys, and we did not have control over the drafting and prosecution.
Although management has since remediated these material weaknesses and concluded that our internal control over financial reporting was effective as of September 30, 2024, weaknesses in our internal control over financial reporting could again be discovered in the future.
Although management has concluded that our internal control over financial reporting was effective as of September 30, 2024 and September 30, 2025, weaknesses in our internal control over financial reporting could again be discovered in the future.
Even if profitability is achieved, we may not be able to sustain profitability. We incurred net losses of $208.7 million, $204.6 million and $217.9 million for the years ended September 30, 2024, 2023 and 2022, respectively. As of September 30, 2024, we had an accumulated deficit of $1,241.9 million.
Even if profitability is achieved, we may not be able to sustain profitability. We incurred net losses of $77.7 million, $208.7 million and $204.6 million for the years ended September 30, 2025, 2024 and 2023, respectively. As of September 30, 2025, we had an accumulated deficit of $1,319.6 million.
Our IVD products are not intended for clinical or diagnostic use, and we market and label them as RUO. Our customers, however, may use our products in their own laboratory-developed tests, or LDTs. The FDA has historically taken the position that LDTs are considered to be IVDs, but has generally exercised enforcement discretion.
Our RUO IVD products sold in the United States are not intended for clinical or diagnostic use, and we market and label them as RUO. Our customers, however, may use our products in their own assay workflows. The FDA has historically taken the position that LDTs are considered to be IVDs, but has generally exercised enforcement discretion.
This includes attacks which could materially disrupt our systems and operations, supply 19 Table of Contents chain, and ability to produce, sell and distribute our products and services.
This includes attacks which could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products and services.
Any shortage of raw materials or materials necessary for our production capabilities may adversely affect our business. 23 Table of Contents Although historically we have not experienced price increases due to unexpected shortages in raw materials or other materials and other unanticipated events, there is no assurance that our supply of raw materials or other materials will not be significantly adversely affected in the future, which may in turn adversely affect our business, prospects, financial condition and results of operation.
Although historically we have not experienced price increases due to unexpected shortages in raw materials or other materials and other unanticipated events, there is no assurance that our supply of raw materials or other materials will not be significantly adversely affected in the future, which may in turn adversely affect our business, prospects, financial condition and results of operation.
Additionally, we compete with both large and emerging providers in the life sciences tools and diagnostics industries focused on sample preparation for NGS such as Thermo Fisher Scientific Inc., Illumina, Inc., Integrated DNA Technologies, Inc., Roche, New England Bioloabs and Agilent.
Additionally, we compete with both large and emerging 16 Table of Contents providers in the life sciences tools and diagnostics industries focused on sample preparation for NGS such as Thermo Fisher Scientific Inc., Illumina, Inc., Integrated DNA Technologies, Inc., Roche Holding AG, New England Bioloabs, Inc., Watchmaker Genomics, Inc. and Agilent Technologies, Inc.
See "Business-Government regulation-FDA" . In the future, certain of our products or related applications could be subject to additional FDA regulation. Even where a product is not subject to FDA clearance or approval requirements or deemed exempt, the FDA may impose restrictions as to the types of customers to which we can market and sell our products.
While the LDT Final Rule was unsuccessful, in the future, certain of our products or related applications could be subject to additional FDA regulation. Even where a product is not subject to FDA clearance or approval requirements or deemed exempt, the FDA may impose restrictions as to the types of customers to which we can market and sell our products.
To date, we have invested a substantial portion of our efforts and financial resources towards the research and development and commercialization of our synthetic DNA products.
We are substantially dependent on the success of our synthetic DNA products. To date, we have invested a substantial portion of our efforts and financial resources towards the research and development and commercialization of our synthetic DNA products.
(owned by Danaher Corporation), DNA 2.0 Inc. d/b/a/ ATUM, GeneArt (owned by Thermo Fisher Scientific Inc.), Eurofins Genomics LLC, Promega Corporation, OriGene Technologies, Inc., Blue Heron Biotech, LLC, Elegen and others.
(owned by Danaher Corporation), DNA 2.0 Inc. d/b/a/ ATUM, GeneArt (owned by Thermo Fisher Scientific Inc.), Eurofins Genomics LLC, OriGene Technologies, Inc., Eurofins Genomics Blue Heron, Elegen Corporation, Ansa Biotechnologies, Inc., Telesis Bio, Inc. and others.
In addition, many countries are beginning to implement legislation and other guidance to align their international tax rules with the Organization for Economic Co-operation and Development’s Base Erosion and Profit Shifting recommendations and action plan that aim to standardize and modernize global corporate tax policy, including changes to cross-border tax, transfer-pricing documentation rules, and nexus-based tax incentive practices.
In addition, many countries have enacted or plan to enact legislation and other guidance to align their international tax rules with the Organization for Economic Co-operation and Development’s Base Erosion and Profit Shifting recommendations and action plan that aim to standardize and modernize global corporate tax policy, including changes to cross-border tax, transfer-pricing documentation rules, and nexus-based tax 30 Table of Contents incentive practices.
Neither we nor our supplier may successfully complete any required increase to existing manufacturing capacity in a timely manner, or at all. We must continue to secure and maintain sufficient and stable supplies of raw materials.
Neither we nor our supplier may successfully complete any required increase to existing manufacturing capacity in a timely manner, or at all. 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.
Risks related to our business 16 Table of Contents 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. We have incurred net losses each year since inception and have generated limited revenue from product sales to date.
Risks 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. We have incurred net losses each year since inception and have generated limited revenue from product sales to date.
Our ability to manage our operations and costs, including research and development, costs of components, manufacturing, sales and marketing, requires us to continue to enhance our operational, financial and management controls, reporting systems and procedures and to attract and retain sufficient numbers of talented employees.
Our ability to manage our operations and costs, including research and development, costs of components, manufacturing, sales and marketing, requires us to continue to invest in and improve our technology systems and processes and take other actions to enhance our operational, financial and management controls, reporting systems and procedures and to attract and retain sufficient numbers of talented employees.
Our products may be used to create DNA sequences of humans, agricultural crops and other living organisms. Our products could be used in a variety of applications, which may have underlying ethical, legal and social concerns. Governmental authorities could, for safety, social or other purposes, impose limits on or implement regulation of the use of gene synthesis.
Our products could be used in a variety of applications, which may have underlying ethical, legal and social concerns. Governmental authorities could, for safety, social or other purposes, impose limits on or implement regulation of the use of gene synthesis.
Issues relating to the use of artificial intelligence and machine learning could adversely affect our business and operating results. In our ongoing efforts to innovate and optimize operational efficiency, we have integrated AI and machine learning into various aspects of our workplace.
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. In our ongoing efforts to innovate and optimize operational efficiency, we have integrated AI and machine learning into various aspects of our workplace.
Our technology and the production process for our DNA synthesis equipment and tools are complex, involving specialized parts, and we may encounter unexpected difficulties in the manufacture, improvement or increasing the capacity of our DNA synthesis equipment and tools, and addressing these difficulties may cause us to divert our time and resources from our other product offerings.
Our technology and the production process for our equipment and tools are complex. We may encounter unexpected difficulties in manufacturing, improving or increasing the capacity of our equipment and tools, and addressing these difficulties may cause us to divert our time and resources from our other product offerings.
In addition, the provisions of Section 203 of the Delaware General Corporate Law, or the DGCL, govern us. These provisions may prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock, from merging or combining with us for a certain period of time without the consent of our board of directors.
These provisions may prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock, from merging or combining with us for a certain period of time without the consent of our board of directors.
Companies that are subject to unfavorable allegations, even if untrue, may have to expend a significant amount of resources to investigate such allegations and/or defend themselves, including shareholder suits against the company that may be prompted by such allegations.
Accordingly, the opinions they express may be based on distortions, omissions or fabrications. Companies that are subject to unfavorable allegations, even if untrue, may have to expend a significant amount of resources to investigate such allegations and/or defend themselves, including shareholder suits against the company that may be prompted by such allegations.
We manage our website and e-commerce platform internally and as a result any compromise of our security or misappropriation of proprietary information could have a material adverse effect on our business, financial condition and results of operations.
In addition, we currently generate a growing portion of our revenue through sales on our e-commerce platform. We manage our website and e-commerce platform internally and as a result any compromise of our security or misappropriation of proprietary information could have a material adverse effect on our business, financial condition and results of operations.
Our customers may buy less of our products depending on their own technological developments, the clinical efficacy and commercial success of the applications for which they use our products, end-user demand for our products and internal budget cycles.
Our customers may buy less of our products depending on their own technological developments, the clinical efficacy and commercial success of the applications for which they use our products, end-user demand for our products and internal budget cycles. Customers may also buy less of our products during the transition period from product development to commercial production.
In the antibody discovery market, we compete with contract research organizations including Curia, GenScript, and Genovac (formerly part of Aldevron, LLC), and antibody discovery biotechnology companies, such as Fair Journey/Iontas, Adimab, Distributed Bio (owned by Charles River), Ablexis, Specifica, OmniAb and AbCellera Biologics Inc.
In the antibody discovery market, we compete with contract research organizations including Curia Global, Inc., GenScript Biotech Corporation, and Genovac (formerly part of Aldevron, LLC), and antibody discovery biotechnology companies, such as FairJourney Biologics S.A/IONTAS Limited, Adimab, LLC, Distributed Bio (owned by Charles River Laboratories International, Inc.), Ablexis, LLC, Specifica Inc., OmniAb, Inc., Alloy Therapeutics, Inc. and AbCellera Biologics Inc.
These broad market fluctuations, as well as general economic, systemic, political and market conditions, such as recessions, interest rate changes or international currency fluctuations, may negatively affect the market price of our common stock.
These fluctuations often have been unrelated or disproportionate to the operating performance of those companies. These broad market fluctuations, as well as general economic, systemic, political and market conditions, such as recessions, interest rate changes or international currency fluctuations, may negatively affect the market price of our common stock.
Although we are not currently subject to the Clinical Laboratory Improvement Amendment of 1988, or CLIA, we may in the future be required by certain customers to obtain a CLIA certification.
Certain of our potential customers may require that we become certified under the Clinical Laboratory Improvement Amendments of 1988. Although we are not currently subject to the Clinical Laboratory Improvement Amendment of 1988 ("CLIA"), we may in the future be required by certain customers to obtain a CLIA certification.
These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.
These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management. In addition, the provisions of Section 203 of the Delaware General Corporate Law (the "DGCL"), govern us.
In these countries, the patent owner may have limited remedies, which could materially diminish the value of any patents. We cannot be certain that the steps we have taken will prevent unauthorized use or unauthorized reverse engineering of our technology. In addition, competitors may be able to design alternative methods or devices that avoid infringement of our patents.
In these countries, the patent owner may have limited remedies, which could materially diminish the value of any patents. 32 Table of Contents We cannot be certain that the steps we have taken will prevent unauthorized use or unauthorized reverse engineering of our technology.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeManagement’s Role in Assessing and Managing Materials Risks from Cybersecurity Threats Under the IRP, cybersecurity incidents are escalated based on a defined incident severity to management as appropriate. Management, including the CIO, is involved in assessing and managing our cybersecurity risks. Our CIO has 13 years of experience managing information technology in complex environments.
Biggest changeBased on its nature and severity, the Board would be informed of an incident by our executive team. 43 Table of Contents Management’s Role in Assessing and Managing Materials Risks from Cybersecurity Threats Under the IRP, cybersecurity incidents are escalated based on a defined incident severity to management as appropriate.
Our Chief Information Officer (“CIO”) together with our Senior Director of IT Infrastructure, Security and Compliance and other members of the Information and Business Technology (“IBT”) Security team, are responsible for establishing and implementing cybersecurity policies and procedures, which includes developing and updating our Security Incident Response Policy (“IRP”), managing incident response, and overseeing any policy exceptions and potential compensating controls.
Our Chief Information Officer (“CIO”) together with our Senior Director of IT Infrastructure, Security and Compliance and other members of the Information and Business Technology (“IBT”) Security team, are responsible for establishing and implementing cybersecurity policies and procedures, which includes developing and updating our Security Incident Response Policy (“IRP”), managing incident response, and overseeing any policy exceptions and potential compensating controls. 42 Table of Contents Our cybersecurity program is based on the ISO 27001 security controls.
When cybersecurity incidents are identified, our practice is to respond to and address them utilizing incident classifications and escalation protocols, in accordance with applicable governmental regulations and other legal requirements. 42 Table of Contents We have an IRP to prepare for and respond to cybersecurity incidents.
When cybersecurity incidents are identified, our practice is to respond to and address them utilizing incident classifications and escalation protocols, in accordance with applicable governmental regulations and other legal requirements. We have an IRP to prepare for and respond to cybersecurity incidents. The process is tested in annual tabletop exercises to help identify strengths and areas for improvement.
For additional information regarding these risks, please refer to Item 1A, “Risk Factors,” “If we, or our partners or suppliers, experience a significant disruption in, or breach in security of, information technology systems, or fail to implement new systems and software successfully, our business could be adversely affected.
For additional information regarding these risks, please refer to Item 1A, “Risk Factors — 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” in this Form 10-K.
Third-Party Service Provider Risk Management We have a process in place to oversee and identify risks from cybersecurity threats associated with our use of key third-party service providers during the course of engagement. The company maintains a formal risk management program to identify, assess, monitor and mitigate risks associated with third-party relationships, including cybersecurity risks.
We refine and mature our cybersecurity roadmap and strategy based on findings and their risk standing. Third-Party Service Provider Risk Management We have a process in place to oversee and identify risks from cybersecurity threats associated with our use of key third-party service providers during the course of engagement.
Depending on the nature and severity of an incident, this process provides for escalating notification to our executive team, to evaluate the overall impact and appropriate or required external notifications. Based on its nature and severity, the Board would be informed of an incident by our executive team.
We have procedures led by our CIO which govern our assessment, response and notification of internal and external parties upon the occurrence of a cybersecurity incident. Depending on the nature and severity of an incident, this process provides for escalating notification to our executive team, to evaluate the overall impact and appropriate or required external notifications.
Our vendor security assessment process evaluates key vendors and, where appropriate, assesses vendor’s controls for IT security, privacy, business continuity, and other third-party risks. Following an evaluation, the company determines and prioritizes risks based on their potential impact, which help inform the appropriate level of additional due diligence and ongoing compliance monitoring.
Following an evaluation, the company determines and prioritizes risks based on their potential impact, which help inform the appropriate level of additional due diligence and ongoing compliance monitoring.
The process is tested in annual tabletop exercises to help identify strengths and areas for improvement. Engagement of Third Party Advisors We engage third party advisors, including assessors, cybersecurity consultants, and auditors to assess, validate, and enhance our cybersecurity program. We benefit from engaging third parties to provide specialized skills, knowledge, tools, and resources.
Engagement of Third Party Advisors We engage third party advisors, including assessors, cybersecurity consultants, and auditors to assess, validate, and enhance our cybersecurity program. We benefit from engaging third parties to provide specialized skills, knowledge, tools, and resources. These third parties also help reduce costs, increase efficiency, improve quality, mitigate risks, and review cybersecurity strategy, trends, and threat landscape.
We also provide annual, mandatory cybersecurity training for employees to equip our workforce with the knowledge to identify and respond to cybersecurity threats, such as phishing attempts. Our process for assessing, identifying, and managing material risks from cybersecurity threats is integrated into our overall enterprise risk management process.
Our process for assessing, identifying, and managing material risks from cybersecurity threats is integrated into our overall enterprise risk management process.
Cyberattacks and security vulnerabilities could lead to reduced revenue, increased costs, liability claims, or harm to our reputation or competitive position” in this Annual Report on Form 10-K. Cybersecurity Governance Board Oversight of Risks from Cybersecurity Threats The Board oversees management’s processes for identifying and mitigating risks, including cybersecurity risks, to help align our risk exposure with our strategic objectives.
Cybersecurity Governance Board Oversight of Risks from Cybersecurity Threats The Board oversees management’s processes for identifying and mitigating risks, including cybersecurity risks, to help align our risk exposure with our strategic objectives. Our CIO regularly briefs the Board on cybersecurity matters.
As noted above, the company’s IRP includes standard processes for escalating significant cybersecurity incidents to management, including the CIO, who then informs the Board based on the nature and severity of the incident. The company’s incident response team also coordinates with external legal advisors, cybersecurity forensic firms, communication specialists, and other outside advisors and experts, as appropriate.
The company’s incident response team also coordinates with external legal advisors, cybersecurity forensic firms, communication specialists, and other outside advisors and experts, as appropriate.
Our cybersecurity program is based on the International Organization for Standardization (“ISO”) 27001 security controls. We maintain an ISO 27001:2022 certification and we undergo routine audits by an independent, certified accreditation body to maintain this certification.
We maintain an ISO 27001:2022 certification and we undergo routine audits by an independent, certified accreditation body to maintain this certification. We also provide annual, mandatory cybersecurity training for employees to equip our workforce with the knowledge to identify and respond to cybersecurity threats, such as phishing attempts.
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These third parties also help reduce costs, increase efficiency, improve quality, mitigate risks, and review cybersecurity strategy, trends, and threat landscape. We refine and mature our cybersecurity roadmap and strategy based on findings and their risk standing.
Added
The company maintains a formal risk management program to identify, assess, monitor and mitigate risks associated with third-party relationships, including cybersecurity risks. Our vendor security assessment process evaluates key vendors and, where appropriate, assesses vendor’s controls for IT security, privacy, business continuity, and other third-party risks.
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Our CIO regularly briefs the Board on cybersecurity matters. We have procedures led by our CIO which govern our assessment, response and notification of internal and external parties upon the occurrence of a cybersecurity incident.
Added
Management, including the CIO, is involved in assessing and managing our cybersecurity risks. Our CIO has 14 years of experience managing information technology in complex environments. As noted above, the company’s IRP includes standard processes for escalating significant cybersecurity incidents to management, including the CIO, who then informs the Board based on the nature and severity of the incident.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeProperties Our principal facilities are described below: 43 Table of Contents Principal Facilities Approximate Square Footage Lease Expiration Use Owned or Leased Wilsonville, OR 211,995 2044 General & Administration and Manufacturing Leased South San Francisco, CA 91,791 2028 General & Administration, R&D and Manufacturing Leased Brisbane, CA 24,786 2026 Warehouse facility Leased Quincy, MA 38,853 2032 General & Administration, R&D and Manufacturing Leased Guangzhou, China 9,956 2026 General & Administration, Sales & Marketing and Supply Chain activities Leased Carlsbad, CA 8,772 2026 Sales & Marketing Leased Singapore 1,353 2025 Sales & Marketing Leased The Company believes its existing facilities are in good operating condition and are suitable for the conduct of its business.
Biggest changeProperties Our principal facilities are described below: Principal Facilities Approximate Square Footage Lease Expiration Use Owned or Leased Wilsonville, OR 211,995 2044 General & Administration and Manufacturing Leased South San Francisco, CA 91,791 2028 General & Administration, R&D and Manufacturing Leased Brisbane, CA 24,786 2026 Warehouse facility Leased Quincy, MA 38,853 2032 General & Administration, R&D and Manufacturing Leased Guangzhou, China 9,956 2026 General & Administration, Sales & Marketing and Supply Chain activities Leased Carlsbad, CA 8,772 2026 Sales & Marketing Leased Singapore 1,353 2028 Sales & Marketing Leased The Company believes its existing facilities are in good operating condition and are suitable for the conduct of its business.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal proceedings For a description of material pending legal proceedings, see Note 9 “Commitments and Contingencies - Legal Proceedings” of the Notes to Condensed Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K, which is incorporated herein by reference.
Biggest changeItem 3. Legal Proceedings For a description of material pending legal proceedings, see Note 10 “Commitments and Contingencies - Legal Proceedings” of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Form 10-K, which is incorporated herein by reference.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe returns shown on the graph below are based on historical results and are not necessarily indicative of future performance, and we do not make or endorse any predictions as to future returns. 44 Table of Contents * $100.00 invested on October 1, 2019 in stock or index, including reinvestment of dividends. 9/30/2019 9/30/2020 9/30/2021 9/30/2022 9/30/2023 9/30/2024 Twist Bioscience Corporation $ 100.00 $ 318.13 $ 447.95 $ 147.57 $ 84.84 $ 189.20 Nasdaq Composite Index $ 100.00 $ 140.96 $ 183.61 $ 135.41 $ 170.76 $ 236.74 Nasdaq Biotechnology Index $ 100.00 $ 136.90 $ 164.57 $ 123.00 $ 130.12 $ 158.21 Holders of Record As of November 13, 2024, there were approximately 50 holders of record of our common stock.
Biggest changeThe returns shown on the graph below are based on historical results and are not necessarily indicative of future performance, and we do not make or endorse any predictions as to future returns. * $100.00 invested on September 30, 2020 in stock or index, including reinvestment of dividends.
An investment of $100 is assumed to have been made in our common stock and each index on September 30, 2019 and its performance is presented as of the end of each our fiscal years through September 30, 2024.
An investment of $100 is assumed to have been made in our common stock and each index on September 30, 2020 and its performance is presented as of the end of each our fiscal years through September 30, 2025.
Any future determination to declare cash dividends will be made at the discretion of our board of directors, subject to applicable laws, and will depend on our financial condition, results of operations, capital requirements, general business conditions and other factors that our board of directors may deem relevant. 45 Table of Contents Sales of unregistered securities None.
Any future determination to declare cash dividends will be made at the discretion of our board of directors, subject to applicable laws, and will depend on our financial condition, results of operations, capital requirements, general business conditions and other factors that our board of directors may deem relevant. Sales of Unregistered Securities None. Issuer Purchases of Equity Securities None.
Item 5. Market for registrant’s common equity, related stockholder matters and issuer purchases of equity securities Market information for common stock Our common stock began trading on The Nasdaq Global Market under the symbol “TWST” on October 31, 2018 in connection with the initial public offering of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information for Common Stock Our common stock is traded on The Nasdaq Global Market under the symbol “TWST”.
Removed
Prior to that date, there was no public market for our common stock.
Added
September 30, 2020 2021 2022 2023 2024 2025 Twist Bioscience Corporation $ 100.00 $ 140.81 $ 46.39 $ 26.67 $ 59.47 $ 37.04 Nasdaq Composite Index $ 100.00 $ 130.26 $ 96.06 $ 121.14 $ 167.95 $ 210.64 Nasdaq Biotechnology Index $ 100.00 $ 120.21 $ 89.85 $ 95.05 $ 115.57 $ 119.26 45 Table of Contents Holders of Record As of November 13, 2025, there were approximately 34 holders of record of our common stock.
Removed
Issuer Purchases of Equity Securities None. Item 6. [Reserved] 46 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeYear ended September 30, (in thousands, except percentages) 2024 % 2023 % 2022 % Americas $ 193,884 62% $ 151,263 62% $ 122,473 61% EMEA 92,567 30% 71,389 29% 62,078 30% APAC 26,523 8% 22,457 9% 19,014 9% Total revenues $ 312,974 100% $ 245,109 100% $ 203,565 100% Revenues by products The table below sets forth revenues by products: Year ended September 30, (in thousands, except percentages) 2024 % 2023 % 2022 % Synthetic genes $ 92,679 30% $ 73,541 30% $ 61,509 30% Oligo pools 16,906 5% 14,489 6% 12,424 6% DNA libraries 13,933 4% 10,201 4% 6,149 3% Antibody discovery 20,328 7% 23,172 9% 24,171 12% NGS tools 169,128 54% 123,706 51% 99,312 49% Total revenues $ 312,974 100% $ 245,109 100% $ 203,565 100% 49 Table of Contents Revenues by industry The table below sets forth revenues by industry: Year ended September 30, (in thousands, except percentages) 2024 % 2023 % 2022 % Industrial chemicals/materials $ 83,472 26% $ 59,321 24% $ 57,940 29% Academic research 58,452 19% 45,847 19% 37,097 18% Healthcare 168,959 54% 137,148 56% 106,363 52% Food/agriculture 2,091 1% 2,793 1% 2,165 1% Total revenues $ 312,974 100% $ 245,109 100% $ 203,565 100% Revenues increased 28% to $313.0 million in the year ended September 30, 2024, as compared to $245.1 million in the year ended September 30, 2023.
Biggest changeYear ended September 30, (in thousands, except percentages) 2025 % 2024 % Americas $ 225,580 60% $ 193,884 62% EMEA 124,240 33% 92,567 30% APAC 26,752 7% 26,523 8% Total revenues $ 376,572 100% $ 312,974 100% Revenues by Products The table below sets forth revenues by products: Year ended September 30, (in thousands, except percentages) 2025 % 2024 % Synthetic genes $ 113,602 30% $ 92,679 30% Oligo pools 20,230 6% 16,906 5% DNA libraries 11,184 3% 13,933 4% Antibody discovery 23,452 6% 20,328 7% NGS tools 208,104 55% 169,128 54% Total revenues $ 376,572 100% $ 312,974 100% 49 Table of Contents Revenues by Industry The table below sets forth revenues by industry: Year ended September 30, (in thousands, except percentages) 2025 % 2024 % Industrial chemicals/materials $ 93,246 25% $ 83,472 26% Academic research 65,861 17% 58,452 19% Healthcare 215,092 57% 168,959 54% Food/agriculture 2,373 1% 2,091 1% Total revenues $ 376,572 100% $ 312,974 100% Revenues increased 20% to $376.6 million for the year ended September 30, 2025, as compared to $313.0 million for the year ended September 30, 2024.
We have combined our silicon-based DNA writing technology with proprietary software, scalable commercial infrastructure and an e-commerce platform to create an integrated technology platform that enables us to achieve high levels of quality, precision, automation, and manufacturing throughput at a significantly lower cost than our competitors We have applied our unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next generation sequencing, or NGS, sample preparation, and antibody libraries for drug discovery and development, all designed to enable our customers to conduct research more efficiently and effectively.
We have combined our silicon-based DNA writing technology with proprietary software, scalable commercial infrastructure and an e-commerce platform to create an integrated technology platform that enables us to achieve high levels of quality, precision, automation, and manufacturing throughput at a significantly lower cost than our competitors We have applied our unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next generation sequencing ("NGS"), sample preparation, and antibody libraries for drug discovery and development, all designed to enable our customers to conduct research more efficiently and effectively.
Valuation of long-lived assets We recorded impairment charges totaling $44.9 million related to property and equipment and finite-lived intangible assets which are included in “Impairment of long-lived assets” on our condensed consolidated statements of operations and comprehensive loss for the year ended September 30, 2024.
Valuation of Long-lived Assets We recorded impairment charges totaling $44.9 million related to property and equipment and finite-lived intangible assets which are included in “Impairment of long-lived assets” on our consolidated statements of operations and comprehensive loss for the year ended September 30, 2024.
General and administrative expenses are incurred for executive, finance and accounting, legal and human resources functions and consist of personnel costs, audit and legal expenses, consulting costs, depreciation, insurance costs, travel expenses, rent, IT, maintenance and facility costs. Personnel costs consist of salaries, employee benefit costs, bonuses, commissions and stock-based compensation expenses.
General and administrative expenses are incurred for executive, finance and accounting, legal and human resources functions and consist of personnel costs, audit and legal expenses, consulting costs, depreciation, insurance costs, travel expenses, rent, IT, maintenance and facility costs. Personnel costs consist of salaries, employee benefit costs, bonuses, commissions and stock-based compensation expense.
Cost of revenues Cost of revenues reflects the aggregate cost incurred in the production and delivery of our products and consists of production materials, personnel costs, cost of expensed equipment and consumables, laboratory supplies, consulting costs, depreciation, production overhead costs, information technology (“IT”), maintenance and facility costs. Personnel costs consist of salaries, employee benefit costs, bonuses, and stock-based compensation expenses.
Cost of Revenues Cost of revenues reflects the aggregate cost incurred in the production and delivery of our products and consists of production materials, personnel costs, cost of expensed equipment and consumables, laboratory supplies, consulting costs, depreciation, production overhead costs, information technology (“IT”), maintenance and facility costs. Personnel costs consist of salaries, employee benefit costs, bonuses, and stock-based compensation expense.
Investing activities In fiscal year 2024, our net cash used in the investing activities was $3.1 million primarily as a result of the net result of purchases and maturity of investments of $2.0 million and purchases of laboratory property, equipment and computers of $5.1 million.
In fiscal year 2024, our net cash used in the investing activities was $3.1 million primarily as a result of the net result of purchases and maturity of investments of $2.0 million and purchases of property and equipment of $5.1 million.
However, we anticipate these will change or may be substituted for additional or different metrics as our business grows. Product shipments including synthetic genes We believe that the number of genes shipped serves as a direct indicator of our operational efficiency and market demand. This metric is crucial for assessing our performance in meeting customer demand and generating revenues.
However, we anticipate these will change or may be substituted for additional or different metrics as our business grows. Number of Genes Shipped We believe that the number of genes shipped serves as a direct indicator of our operational efficiency and market demand. This metric is crucial for assessing our performance in meeting customer demand and generating revenues.
The last day of our fiscal year is September 30, and we refer to our fiscal year ended September 30, 2022 as fiscal year 2022 or 2022, September 30, 2023 as fiscal year 2023 or 2023 and our fiscal year ended September 30, 2024 as fiscal year 2024 or 2024.
The last day of our fiscal year is September 30, and we refer to our fiscal year ended September 30, 2023 as fiscal year 2023 or 2023, September 30, 2024 as fiscal year 2024 or 2024 and our fiscal year ended September 30, 2025 as fiscal year 2025 or 2025.
We measure stock-based compensation expense for restricted stock and stock options granted to non-employee consultants on the date of grant and recognize the corresponding compensation expense of those awards over the period in which the related services are received. We adjust for actual forfeitures as they occur.
We measure stock-based compensation expense for restricted stock and stock options granted to non-employee consultants on the date of grant and recognize the corresponding compensation expense of those awards over the period in which the related services are received. We adjust for actual forfeitures as they occur. We grant performance-based restricted stock units (PRSUs) to employees.
We believe our products enable a broad range of applications that may ultimately improve health and the sustainability of the planet across multiple industries including healthcare, chemicals/materials, food/agriculture, academic research, and technology. We sell our synthetic DNA and synthetic DNA-based products to a customer base of approximately 3,562 customers annually across a broad range of industries.
We believe our products enable a broad range of applications that may ultimately improve health and the sustainability of the planet across multiple industries including healthcare, chemicals/materials, food/agriculture, academic research, and technology. We sell our synthetic DNA and synthetic DNA-based products to a customer base of more than 3,800 customers annually across a broad range of industries.
We recognize revenue for synthetic biology tools, NGS tools, and DNA libraries when control of the products is transferred to the customer and at a transaction price that is determined based on the agreed upon rates in the applicable order or master supply agreement applied to the quantity of synthetic DNA that was manufactured and shipped to the customer.
We recognize revenue for synthetic biology tools, NGS tools, and DNA libraries when control of the products is transferred to the customer and at a transaction price that is determined based on the agreed upon rates in the applicable order or master supply agreement.
Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the success of our existing products and the development and commercialization of additional products in the synthetic biology, biologic drug and data storage industries as well as leveraging our investment in our manufacturing facility in Wilsonville, Oregon.
Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the success of our existing products and the development and commercialization of additional products in the 47 Table of Contents synthetic biology and biologic drug industries as well as leveraging our investment in our manufacturing facility in Wilsonville, Oregon.
Financing activities Net cash provided by financing activities was $6.9 million in fiscal year 2024, which consisted of $3.8 million from proceeds from issuance of shares under the 2018 ESPP and $7.1 million from the exercise of stock options, offset by $4.0 million in repurchases of common stock for income tax withholdings.
Net cash provided by financing activities was $6.9 million in fiscal year 2024, which consisted of $7.1 million from the exercise of stock options and $3.8 million from proceeds from issuance of shares under our employee stock purchase plan, offset by $4.0 million in repurchases of common stock for income tax withholdings.
The change in operating assets and liabilities was mainly due to increases in accounts receivable of $4.3 million, prepaid and other current assets of $4.2 million and accrued expenses of $2.6 million, offset by decreases in inventory of $7.2 million, other non-current assets of $1.4 million, accounts payable of $2.5 million, accrued compensation of $1.1 million and other liabilities $0.1 million.
The change in operating assets and liabilities was mainly due to increases in accounts receivable of $22.4 million, inventory of $4.2 million, prepaid and other current assets of $3.7 million, and other non-current assets of $1.6 million, offset by increases in accounts payable, accrued expenses, and accrued compensation of $12.7 million and other liabilities $6.6 million.
Operating capital requirements Our primary uses of capital are, and we expect will continue to be for the near future, compensation and related expenses, manufacturing costs, laboratory and related supplies, legal and other regulatory expenses, and general overhead costs and the capital expenditures. We had $1.6 million in commitments for capital expenditures as of September 30, 2024.
Operating Capital Requirements Our primary uses of capital are, and we expect will continue to be for the near future, compensation and related expenses, manufacturing costs, laboratory and related supplies, legal and other regulatory expenses, and general overhead costs and the capital expenditures. We had $17.5 million in commitments for capital expenditures as of September 30, 2025.
Shipments of number of genes in years ended September 30, 2024, 2023 and 2022 were as follows: Year ended September 30, (in thousands) 2024 2023 2022 Number of genes shipped 772 634 558 Number of customers We believe that the number of customers who have purchased from us since inception is representative of our ability to drive adoption of our products.
Shipments of number of genes in years ended September 30, 2025 and 2024 were as follows: Year ended September 30, (in thousands) 2025 2024 Number of genes shipped 938 772 Number of Customers We believe that the number of customers who have purchased from us since inception is representative of our ability to drive adoption of our products.
Recently issued accounting pronouncements For a description of accounting changes and recent accounting pronouncements, including the expected dates of adoption and estimated effects, if any, on our consolidated financial statements, see Note 2, “Summary of Significant Accounting Policies” in the Notes to Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K.
Recently Issued Accounting Pronouncements For a description of accounting changes and recent accounting pronouncements, including the expected dates of adoption and estimated effects, if any, on our consolidated financial statements, see Note 2, “Summary of Significant Accounting Policies” in the notes to consolidated financial statements included elsewhere in this Form 10-K.
Other income (expense) was $2.7 million in fiscal year 2024, as compared to $0.7 million in fiscal year 2023, mainly due to fiscal year 2024 impairment losses on an equity investment.
Other income (expense) was $0.9 million in fiscal year 2025, as compared to $2.7 million in fiscal year 2024, mainly due to impairment losses on an equity investment recognized in fiscal year 2024.
These estimates and assumptions include, among others, the level and timing of revenues, operating expenses, working capital and discount rates, we believe to be consistent with the inherent risks associated with the Biopharma asset group, which was approximately 14%.
Calculating the fair value of an asset group involves making certain estimates and assumptions. These estimates and assumptions include, among others, the level and timing of revenues, operating expenses, working capital and discount rates, we believe to be consistent with the inherent risks associated with the Biopharma asset group, which was approximately 14%.
Since our inception, we have incurred significant operating losses and have accumulated a net deficit of $1,241.9 million.
Since our inception, we have incurred significant operating losses and have accumulated a net deficit of $1,319.6 million.
Interest and other income (expense), net 52 Table of Contents Other income (expense), net consists of realized foreign exchange gains and losses, loss on disposal of property and equipment and impairment of equity investments.
Interest and Other Income (Expense), Net Other income (expense), net, consists of realized foreign exchange gains and losses, loss on disposal of property and equipment, impairment of equity investments, and sub-lease income.
Leveraging our same technology, we have expanded our footprint beyond DNA synthesis to manufacture synthetic RNA as well as antibody proteins to disrupt and innovate within larger market opportunities, in addition to discovery partnerships for biologic drugs and developing completely new applications for synthetic DNA, such as digital data storage.
Leveraging our same technology, we have expanded our footprint beyond DNA synthesis to manufacture synthetic RNA as well as antibody proteins to disrupt and innovate within larger market opportunities, in addition to discovery partnerships for biologic drugs.
We generated revenues of $313.0 million in the year ended September 30, 2024, $245.1 million in the year ended September 30, 2023 and $203.6 million in the year ended September 30, 2022, while incurring net losses of $208.7 million, $204.6 million and $217.9 million in the years ended September 30, 2024, 2023 and 2022, respectively.
We generated revenues of $376.6 million, $313.0 million, and $245.1 million in the years ended September 30, 2025, September 30, 2024, and September 30, 2023, respectively, while incurring net losses of $77.7 million, $208.7 million and $204.6 million in the years ended September 30, 2025, 2024 and 2023, respectively.
The number of our genes shipped in the year ended September 30, 2024, increased to approximately 772,000 genes, compared to approximately 634,000 genes in the year ended September 30, 2023, an increase of 22%.
The number of our genes shipped for the year ended September 30, 2025 increased to approximately 938,000 genes, compared to approximately 772,000 genes for the year ended September 30, 2024, an increase of 22%.
We review our estimate of the transaction price and progress toward completion based on the best information available to recognize the cumulative progress toward completion as of the end of each reporting period and make revisions to such estimates as necessary. Also, these research and development agreements may include license payments.
We review our estimate of the transaction price and progress toward completion based on the best information available to recognize the cumulative progress toward completion as of the end of each reporting period and make revisions to such estimates as necessary.
Key business metrics We regularly review the following key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions. We believe that the following metrics are representative of our current business.
See “Results of Operations” below for discussion of our results for the periods presented. Key Business Metrics We regularly review the following key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions. We believe that the following metrics are representative of our current business.
Our sales are primarily subject to Ex Works (as defined in Incoterms 2010) delivery terms and revenue, other than Biopharma revenue, is recorded at the point in time when products are picked up by the customer’s freight forwarder, as we have determined that this is the point in time that product control transfers to the customer.
Our sales are primarily subject to Ex Works delivery terms and is recorded at the point in time when products are picked up by the customer’s freight forwarder, as we have determined that this is the point in time that product control transfers to the customer. Shipping and handling are considered fulfillment costs and included in revenue.
After consideration of the impairment charge recorded in the current quarter, the remaining carrying amount of long-lived assets within the Biopharma asset group is approximately $11.6 million, which primarily comprises of operating lease right-of-use assets.
After consideration of the impairment charge recorded during the year ended September 30, 2024, the remaining carrying amount of long-lived assets within the Biopharma asset group was approximately $11.6 million, which primarily comprises of operating lease right-of-use assets.
Year ended September 30, Change (in thousands, except percentages) 2024 2023 2022 2024-2023 2023-2022 Revenues $ 312,974 $ 245,109 $ 203,565 $ 67,865 28% $ 41,544 20% Revenues by geography We have one reportable segment from the manufacturing of synthetic DNA products. The following table shows our revenues by geography, based on our customers’ shipping addresses.
Year ended September 30, (in thousands, except percentages) 2025 2024 Change % Revenues $ 376,572 $ 312,974 $ 63,598 20% Revenues by Geography We have one reportable segment from the manufacturing of synthetic DNA products. The following table shows our revenues by geography, based on our customers’ shipping addresses.
We concluded that the carrying value of the 57 Table of Contents asset group was not recoverable as it exceeded the future undiscounted cash flows the assets are expected to generate from the use and eventual disposition of the asset group.
We concluded that the carrying value of the asset group was not recoverable as it exceeded the future undiscounted cash flows the assets are expected to generate from the use and eventual disposition of the asset group. To measure the impairment loss, we estimated the fair value of the Biopharma asset group by applying a discounted cash flow method.
Percentage of revenue from repeat customers We believe that the percentage of revenue that we generate from both new and repeat customers is an indicator of our ability to drive adoption of our products amongst existing customers while also generating a robust pipeline of new customers.
In 2025 and 2024, the number of customers who purchased products from us were more than 3,800 and 3,550 customers, respectively. 48 Table of Contents Percentage of Revenue from Repeat Customers We believe that the percentage of revenue that we generate from both new and repeat customers is an indicator of our ability to drive adoption of our products amongst existing customers while also generating a robust pipeline of new customers.
The transaction price for each agreement is determined based on the amount of consideration we expect to be entitled to for satisfying all performance obligations within the agreement.
At the inception of the agreement, we assess whether each obligation represents a separate performance obligation or whether such obligations should be combined as a single performance obligation. The transaction price for each agreement is determined based on the amount of consideration we expect to be entitled to for satisfying all performance obligations within the agreement.
We believe the following critical accounting policies require that we make significant judgments and estimates in preparing our consolidated financial statements. 55 Table of Contents Revenue recognition Our revenue is generated through the sale of synthetic biology tools, such as synthetic genes, or clonal genes and fragments, oligonucleotide pools, or oligo pools, NGS tools, DNA libraries, and biopharma services for antibody discovery, optimization and development ("Biopharma") .
Revenue Recognition Our revenue is generated through the sale of synthetic biology tools, such as synthetic genes, or clonal genes and fragments, oligonucleotide pools, or oligo pools, NGS tools, DNA libraries, and biopharma services for antibody discovery, optimization and development ("Biopharma").
We have granted performance-based stock units (PSUs) and performance stock options (PSOs) to executive officers and senior level employees. We value PSUs using a grant date fair value equal to the closing share price of our common stock on the date of grant and the probability of the achievement of the performance condition.
We value PRSUs using a grant date fair value equal to the closing share price of our common stock on the date of grant and the probability of the achievement of the performance conditions.
We test goodwill for impairment in our fourth quarter each year, or more frequently if indicators of an impairment exist. Evaluating goodwill for impairment involves the determination of the fair value of our reporting unit in which goodwill is recorded using a qualitative or quantitative analysis.
Evaluating goodwill for impairment involves the determination of the fair value of our reporting unit in which goodwill is recorded using a qualitative or quantitative analysis. If the fair value of the reporting unit exceeds its carrying value, goodwill is considered not impaired.
We have an unconditional option to bypass the qualitative assessment in any period and proceed directly to performing the first step of the goodwill impairment test. For 2024, we elected to proceed directly to the step-one assessment which indicated that the fair value of our reporting unit substantially exceeded the carrying value.
If the carrying value of the reporting unit exceeds its fair value, we would record an impairment loss up to the difference between the carrying value and implied fair value. We have an unconditional option to bypass the qualitative assessment in any period and proceed directly to performing the first step of the goodwill impairment test.
Cash flows The following table summarizes our sources and uses of cash and cash equivalents: Year ended September 30, (in thousands) 2024 2023 2022 Net cash used in operating activities $ (64,094) $ (142,474) $ (124,385) Net cash provided by (used in) investing activities (3,071) 50,612 (232,930) Net cash provided by financing activities 6,890 911 270,534 Operating activities Net cash used in operating activities was $64.1 million in fiscal year 2024 and consisted primarily of a net loss of $208.7 million adjusted for non-cash items including depreciation and amortization expenses of $31.4 million, stock-based compensation expense of $50.9 million, impairment of long-lived assets of $44.9 million, non-cash lease expense of $0.9 million, and a change in operating assets and liabilities of $15.4 million.
Net cash used in operating activities was $64.1 million in fiscal year 2024 and consisted primarily of a net loss of $208.7 million adjusted for non-cash items including depreciation and amortization expenses of $31.4 million, stock-based compensation expense of $50.9 million, impairment of long-lived assets of $44.9 million, non-cash lease expense of $0.9 million, and a change in operating assets and liabilities of $15.4 million.
Critical accounting policies and estimates The discussion and analysis of our financial condition and results of operations are based upon our audited consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States.
For more information, please see Part II, Item 9B and Note 19, Subsequent Events of the notes to our consolidated financial statements included elsewhere in this Form 10-K. 54 Table of Contents Critical Accounting Policies and Estimates The discussion and analysis of our financial condition and results of operations are based upon our audited consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States.
We expense our research and development expenses in the period in which they are incurred.
Personnel costs consist of salaries, employee benefit costs, bonuses, and stock-based compensation expense. We expense our research and development expenses in the period in which they are incurred.
Year ended September 30, Change (in thousands, except percentages) 2024 2023 2022 2024-2023 2023-2022 Research and development $ 90,852 $ 106,894 $ 120,307 $ (16,042) (15)% $ (13,413) (11)% Research and development expenses decreased 15% to $90.9 million for the year ended September 30, 2024, as compared to the $106.9 million for the year ended September 30, 2023.
Year ended September 30, (in thousands, except percentages) 2025 2024 Change % Research and development $ 80,285 $ 90,852 $ (10,567) (12)% Research and development expenses decreased 12% to $80.3 million for the year ended September 30, 2025, as compared to $90.9 million for the year ended September 30, 2024.
Net cash provided by financing activities was $0.9 million in fiscal year 2023, which consisted of $3.9 million from proceeds from issuance of shares under the 2018 ESPP and $1.4 million from the exercise of stock options, offset by $4.4 million in repurchases of common stock for income tax withholdings.
Financing Activities Net cash provided by financing activities was $28.5 million in fiscal year 2025, which consisted of $15.0 million from XOMA for the sale of future revenue, $9.3 million from the exercise of stock options, and $4.2 million from proceeds from issuance of shares under our employee stock purchase plan.
We define a customer as a unique "Bill To" account where a single customer may have many "Ship To" locations and may have many unique points of contact within a single "Bill To" customer. In 2024, 2023 and 2022 the number of customers who purchased products from us were approximately 3,562, 3,450 and 3,300 customers, respectively.
We define a customer as a unique "Bill To" account where a single customer may have many "Ship To" locations and may have many unique points of contact within a single "Bill To" customer.
Year ended September 30, Change (in thousands, except percentages) 2024 2023 2022 2024-2023 2023-2022 Selling, general and administrative $ 218,398 $ 189,738 $ 212,949 $ 28,660 15% $ (23,211) (11)% 51 Table of Contents Total selling, general and administrative expenses increased 15% to $218.4 million for the year ended September 30, 2024, as compared to $189.7 million for the year ended September 30, 2023.
Year ended September 30, (in thousands, except percentages) 2025 2024 Change % Selling, general and administrative $ 246,976 $ 218,398 $ 28,578 13% Selling, general and administrative expenses increased 13% to $247.0 million for the year ended September 30, 2025, as compared to $218.4 million for the year ended September 30, 2024.
Further, the increase is attributable to increases in outside service costs of $1.1 million, facilities costs of $2.3 million, marketing costs of $3.4 million, IT services costs of $2.9 million and depreciation and amortization expense of $0.9 million.
The increase is primarily due to increases in stock-based compensation expense of $12.7 million, personnel costs of $6.8 million, IT services costs of $4.0 million, marketing costs of $1.5 million and other outside service costs of $3.1 million.
In fiscal year 2023, our net cash used in the investing activities was $50.6 million primarily as a result of the net result of purchases and maturity of investments of $78.4 million and purchases of laboratory property, equipment and computers of $27.8 million.
Investing Activities In fiscal year 2025, our net cash used in the investing activities was $24.8 million primarily as a result of purchases of property and equipment of $28.0 million, offset by the proceeds from the sale of our data storage business of $2.5 million, and the net result of purchases and maturity of investments of $0.7 million.
This is a critical part of our strategy to address our large markets and diverse customer base, as well as drive commercial productivity, enhance the customer experience, and promote loyalty. We currently generate revenue through our synthetic biology and NGS tools product lines as well as biopharma services for antibody discovery, optimization and development.
We currently generate revenue through our synthetic biology and NGS tools product lines as well as biopharma services for antibody discovery, optimization and development.
The amount of taxes collected from customers and payable to governmental entities is included on the balance sheet as part of “Accrued expenses and other current liabilities.” Stock-based compensation We have granted stock-based awards, consisting of restricted stock and stock options, to our employees, certain non-employee consultants and certain members of our board of directors.
Stock-based Compensation We have granted stock-based awards, consisting of restricted stock and stock options, to our employees, certain non-employee consultants and certain members of our board of directors.
Year ended September 30, Change (in thousands, except percentages) 2024 2023 2022 2024-2023 2023-2022 Cost of revenues $ 179,625 $ 155,380 $ 119,330 $ 24,245 16% $ 36,050 30% Gross profit $ 133,349 $ 89,729 $ 84,235 $ 43,620 49% $ 5,494 7% Gross margin 42.6 % 36.6 % 41.4 % 6% (5)% Cost of revenues increased 16% to $179.6 million in the year ended September 30, 2024, as compared to $155.4 million in the year ended September 30, 2023.
Year ended September 30, (in thousands, except percentages) 2025 2024 Change % Cost of revenues $ 185,570 $ 179,625 $ 5,945 3% Gross profit $ 191,002 $ 133,349 $ 57,653 43% Gross margin 50.7 % 42.6 % 8.1% Cost of revenues increased 3% to $185.6 million for the year ended September 30, 2025, as compared to $179.6 million for the year ended September 30, 2024.
We recorded income tax benefit of $10.4 million in 2022 mainly as a result of the business acquisition of Abveris. 53 Table of Contents Liquidity and capital resources Sources of liquidity To date, we have financed our operations principally through public equity raises, private placements of our convertible preferred stock, borrowings from credit facilities and revenue from our commercial operations.
Income Tax Expense Year ended September 30, (in thousands, except percentages) 2025 2024 Change % Income tax expense $ (719) $ (560) $ (159) 28 % For the years ended September 30, 2025 and 2024, we recognized income tax provisions of $0.7 million and $0.6 million, respectively, mainly attributable to our foreign operations. 52 Table of Contents Liquidity and Capital Resources To date, we have financed our operations principally through public equity raises, private placements of our convertible preferred stock, borrowings from credit facilities and revenue from our commercial operations.
The change in operating assets and liabilities was mainly due to decreases in accounts receivable of $8.4 million, inventory of $8.0 million, prepaid and other current assets of $0.4 million, other non-current assets of $0.4 million, accounts payable of $11.8 million and other liabilities $2.3 million, offset by increases in accrued expenses of $4.4 million and accrued compensation of $7.9 million. 54 Table of Contents Net cash used in operating activities was $142.5 million in fiscal year 2023 and consisted primarily of a net loss of $204.6 million adjusted for non-cash items including depreciation and amortization expenses of $29.3 million, stock-based compensation expense of $30.3 million, impairment of property and equipment and other assets of $6.8 million, non-cash lease expense of $2.6 million, change in fair value of contingent consideration and holdbacks of $5.9 million and a change in operating assets and liabilities of $1.0 million.
The change in operating assets and liabilities was mainly due to decreases in accounts receivable of $8.4 million, inventory of $8.0 million, prepaid and other current assets of $0.4 million, other non-current assets of $0.4 million, accounts payable of $11.8 million and other liabilities $2.3 million, offset by increases in accrued expenses of $4.4 million and accrued compensation of $7.9 million.
The following table lists the value of orders received during the periods indicated: Year ended September 30, (in thousands) 2024 2023 2022 Order value $ 344,200 $ 263,887 $ 226,435 Results of operations Comparison of the years ended September 30, 2024, 2023 and 2022 Revenues We generate revenue from sales of synthetic genes, oligo pools, NGS tools, DNA libraries and antibody discovery services.
Year ended September 30, 2025 2024 Revenue from repeat customers 99 % 98 % Results of Operations Comparison of the Years Ended September 30, 2025 and 2024 Revenues We generate revenue from the sales of synthetic biology tools, such as synthetic genes, oligo pools, NGS tools, DNA libraries and biopharma services for antibody discovery, optimization and development.
The increase in revenue primarily reflects growth in NGS tools revenue of $45.4 million and growth in synthetic genes revenue of $19.1 million, including the Express Genes offering, which is primarily attributable to increase in revenues from our customers in the healthcare, industrial chemicals/materials and academic research industries and an increase in the number of customers.
These improvements in revenues from NGS tools and synthetic gene are largely due to higher sales to our customers in the healthcare, industrial chemicals/materials and academic research industries, as well as an increase in the number of customers.
The decrease is primarily due to a decrease in personnel costs of $9.3 million, including stock-based compensation expense of $2.7 million due to the reduction of headcount related to the 2023 restructuring plan. The remaining decrease is attributable to decreases in outside services costs of $2.2 million, depreciation expenses of $1.0 million and lab supplies costs of $6.1 million.
This reduction is primarily attributed to lower personnel costs of $4.9 million and a decrease in stock-based compensation expense of $2.2 million, both driven by the sale of DNA digital data storage business. The remaining decrease is attributable to a reduction in outside services costs of $1.1 million and a reduction of depreciation and amortization of $1.8 million.
The increase is primarily attributable to an increase in material costs of $19.0 million, due to higher sales volume, and an increase in depreciation and amortization expense of $3.2 million primarily due to the capital investment to increase manufacturing capacity in prior years. The remaining increase is attributable to an increase in lab supplies and facilities costs of $1.4 million.
The increase is primarily attributable to an increase in material costs of $9.4 million, due to higher sales volume and an increase in stock-based compensation expense of $3.0 million. These cost increases were partially offset by decreases in depreciation and amortization of $4.6 million and a decrease in outside service costs of $2.2 million.
Impairment of long-lived assets Year ended September 30, Change (in thousands, except percentages) 2024 2023 2022 2024-2023 2023-2022 Impairment of long-lived assets $ 44,930 $ 6,785 $ — $ 38,145 562 % $ 6,785 100 % We recognized impairment of intangible assets and property and equipment of $44.9 million related to the Biopharma asset group during the year ended September 30, 2024 (see discussion in critical accounting policies and estimates — impairment of long-lived assets below), as compared to impairment of property and equipment of $6.8 million during the year ended September 30, 2023, related to write-off of lab equipment and leasehold improvements for decommissioned labs and computer software.
Impairment of Long-lived Assets Year ended September 30, (in thousands, except percentages) 2025 2024 Change % Impairment of long-lived assets $ — $ 44,930 $ (44,930) (100) % We recognized an impairment of intangible assets and property and equipment of $44.9 million related to the Biopharma asset group during the year ended September 30, 2024. 51 Table of Contents Gain on Sale of Business Year ended September 30, (in thousands, except percentages) 2025 2024 Change % Gain on sale of business $ 48,847 $ — $ 48,847 100% We recognized a gain on the sale of business of $48.8 million related to the sale of our DNA digital data storage business during the year ended September 30, 2025.
Contractual obligations and other commitments As of September 30, 2024, our operating lease obligation was $85.0 million related to various operating lease arrangements for facilities. See Note 8, Leases, of the Notes to the Consolidated Financial Statements for further discussion relating to these lease obligations.
Off-balance Sheet Arrangements We do not have any off-balance sheet arrangements other than our indemnification agreements as described in Note 10 of the consolidated financial statements included elsewhere in this Form 10-K. Contractual Obligations and Other Commitments As of September 30, 2025, our operating lease obligation was $75.6 million related to various operating lease arrangements for facilities.
Year ended September 30, Change (in thousands, except percentages) 2024 2023 2022 2024-2023 2023-2022 Interest income $ 15,344 $ 14,365 $ 3,062 $ 979 7 % $ 11,303 369 % Interest expense (29) (5) (80) (24) 480 % 75 (94) % Other income (expense) (2,650) (667) (1,087) (1,983) 297% 420 (39) % Total interest, and other income (expense), net $ 12,665 $ 13,693 $ 1,895 $ (1,028) 784 % $ 11,798 237 % Interest income increased 7%, to $15.3 million in the year ended September 30, 2024, as compared to $14.4 million for the year ended September 30, 2023, resulting from our cash and cash equivalents and short-term investments balance.
Year ended September 30, (in thousands, except percentages) 2025 2024 Change % Interest income $ 11,364 $ 15,344 $ (3,980) (26) % Other income (expense), net (903) (2,679) 1,776 (66)% Total interest, and other income (expense), net $ 10,461 $ 12,665 $ (2,204) (17) % Interest income decreased 26%, to $11.4 million in the year ended September 30, 2025, as compared to $15.3 million for the year ended September 30, 2024, due to lower cash equivalents and short-term investments balances and lower interest rates.
As of September 30, 2024, we had a balance of $226.3 million of cash and cash equivalents and $50.1 million in short-term investments. Capital resources Our primary cash needs are for operating expenses, working capital and capital expenditures to support the growth in our business.
Our primary cash needs are for operating expenses, working capital and capital expenditures to support the growth in our business. We believe that our existing cash, cash equivalents, restricted cash and short-term investments and anticipated cash flows from operations, will be sufficient to meet our anticipated cash requirements for more than 12 months from the date of this Form 10-K.
Gross margin increased 600 basis points to 42.6% for the year ended 50 Table of Contents September 30, 2024 as compared to 36.6% for the year ended September 30, 2023 mainly due to increase in revenue and the fixed costs being spread over larger revenue base resulting in an increase in gross margin.
Gross margin increased 8.1% to 50.7% for the year ended September 30, 2025, as compared to 42.6% for the year ended September 30, 2024, mainly due to an increase in revenue, holding fixed manufacturing costs relatively flat, and driving additional cost savings through continuous process improvement initiatives. 50 Table of Contents Research and Development Expenses Research and development expenses consist primarily of costs incurred for the development of our products, which include personnel costs, laboratory equipment and supplies, consulting costs, depreciation, rent, IT, maintenance and facility costs.
A discussion of our research and development expenses for the year ended September 30, 2022 as compared to the year ended September 30, 2021 can be found on page 55 of our 2023 Annual Report. Selling, general and administrative expenses Selling expenses consist of personnel costs, customer service expenses, direct marketing expenses, educational and promotional expense, market research and analysis.
The decrease in depreciation and amortization is mainly due to impairment of Biopharma assets in 2024 and the sale of DNA digital data storage business in the current year. Selling, General and Administrative Expenses Selling expenses consist of personnel costs, customer service expenses, direct marketing expenses, educational and promotional expense, market research and analysis.
We did not grant any options during the years ended September 30, 2024 and 2023. Goodwill Determining when to test for impairment, the reporting unit, the assets and liabilities of the reporting unit, and the fair value of the reporting unit requires significant judgment and involves the use of significant estimates and assumptions.
We did not grant any options during the years ended September 30, 2025 and 2024. 55 Table of Contents Goodwill We test goodwill for impairment in our fourth quarter each year, or more frequently if indicators of an impairment exist.
Removed
Highlights from fiscal year 2024 compared with fiscal year 2023 include: • Revenue growth of 28% to $313.0 million from $245.1 million, primarily due to order growth in NGS tools and synthetic genes; • Gross margin increased to 42.6% from 36.6%; • Net cash used in operating activities for the year ended September 30, 2024 decreased to $64.1 million from $142.5 million for the year ended September 30, 2023. 47 Table of Contents Financial highlights The following table summarizes certain selected historical financial results: Year ended September 30, (in thousands) 2024 2023 2022 Revenues $ 312,974 $ 245,109 $ 203,565 Gross margin 42.6 % 36.6 % 41.4 % Loss from operations $ (220,831) $ (217,159) $ (234,776) Net loss attributable to common stockholders $ (208,726) $ (204,618) $ (217,863) Net cash used in operating activities $ (64,094) $ (142,474) $ (124,385) Net loss per share attributable to common stockholders—basic and diluted $ (3.60) $ (3.60) $ (4.04) See “Results of Operations” below for discussion of our results for the periods presented.
Added
Additional information related to the comparison of our results of operations and liquidity and capital resources between the years 2024 and 2023 is included in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of our Annual Report on Form 10-K for the fiscal year ended September 30, 2024 filed with U.S. Securities and Exchange Commission.
Removed
Year ended September 30, 2024 2023 2022 Number of customers 3,562 3,450 3,300 Revenue from repeat customers 99 % 98 % 98 % Value of orders received We believe that the value of orders we receive is a leading indicator of our ability to generate revenue in subsequent quarters, although there can be no assurance orders will translate into revenue.
Added
This is a critical part of our strategy to address our large markets and diverse customer base, as well as drive commercial productivity, enhance the customer experience, and promote loyalty. As we have moved further up the value chain from fragments to genes to preps to proteins and beyond, the strategic connection between our SynBio and Biopharma products tightens.
Removed
We define an order as a contract with a 48 Table of Contents customer or purchase order from a customer, which outlines the promised goods at an agreed upon-price.
Added
More customers now leverage both products and services to accelerate discovery and identify breakthrough therapeutics. This growing convergence highlights the power of our integrated platform and reinforces Twist’s unique position to serve the full spectrum of innovation in discovery.
Removed
In some cases, we receive a blanket purchase order from our customers, which includes pricing, payment and other terms and conditions, with quantities defined at the time each customer subsequently issues periodic releases against the blanket purchase order. We regularly assess trends relating to the value of orders we receive, including with respect to our customer concentration.
Added
We sold our DNA data storage business to Atlas Data Storage, Inc. ("Atlas"), a newly formed company, that will focus solely on DNA data storage technology and commercialization, with $155.0 million in seed financing round from third-party investors.
Removed
Orders may never convert into actual revenue and the timing of delivery of our orders and recognition of revenue, if any, may vary based on the nature of the order, and there can be no assurance that orders will result in recognized revenue.
Added
The purpose of the transaction was to unlock value by accelerating data storage technology development and allowing each company to focus strategically on its unique products, customers and investors.
Removed
Revenues increased from $203.6 million to $245.1 million in the year ended September 30, 2023, which was an increase of $41.5 million, or 20%, as compared to the same period in 2022.
Added
Under the terms of the contribution agreement executed with Atlas, we assigned and licensed our DNA data storage technology to Atlas in exchange of receiving a minority ownership interest upon close, an upfront cash payment and a secured promissory note.
Removed
The increase in revenue was primarily due to the increase in revenue from NGS tools, which grew from $99.3 million in 2022 to $123.7 million in 2023, an increase in revenue from synthetic genes, which grew from $61.5 million in 2022 to $73.5 million and an increase in revenue from DNA libraries revenue, which grew from $6.1 million in 2022 to $10.2 million.
Added
We retained an ownership stake in Atlas and may participate in the upside of DNA data storage through future technology and commercial milestone payments, and a revenue share through royalties on future sales of Atlas’ products and services.
Removed
The growth in NGS tools revenue is primarily attributable to an increase in revenue from our top customers and the adoption of our product by a larger customers base. Our synthetic genes revenue grew mainly from our top customers and growth in the healthcare and academic research industries as well as an improved turnaround time.
Added
Financial highlights from fiscal year 2025 compared with fiscal year 2024 include: • Revenue growth of 20% to $376.6 million from $313.0 million, primarily due to growth in NGS tools and synthetic genes; • Gross margin increased to 50.7% from 42.6%, mainly due to increase in revenues and holding fixed manufacturing costs relatively flat and driving additional cost savings through continuous process improvement initiatives; • Loss from operations decreased to $(136.3) million from $(220.8) million primarily due to an increase in both revenues and gross profit for the year ended September 30, 2025, and impairment of long-lived assets recognized in the year ended September 30, 2024.
Removed
In the year ended September 30, 2023, we shipped approximately 634,000 genes compared to approximately 558,000 genes in the year ended September 30, 2022, an increase of 14%. Changes in our synthetic gene pricing, while favorable, had a minimal impact on our results of operations period-over-period.
Added
Additional contributing factors were a decrease in research and development expenses offset by an increase in selling, general and administrative expenses for the year ended September 30, 2025; • Net cash used in operating activities for the year ended September 30, 2025 decreased to $47.6 million from $64.1 million for the year ended September 30, 2024; and • Gain on the sale of DNA digital data storage business of $48.8 million.
Removed
Our DNA libraries revenue grew year over year as a result of increased customers, mainly in the healthcare and academic research industries.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 7A. Quantitative and qualitative disclosures about market risk Interest rate sensitivity We are exposed to market risk related to changes in interest rates. We had cash, cash equivalents and marketable securities of $276.4 million as of September 30, 2024, which consisted primarily of money market funds and marketable securities, largely composed of investment grade, short term fixed income securities.
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk Interest Rate Sensitivity We are exposed to market risk related to changes in interest rates. We had cash, cash equivalents and marketable securities of $232.4 million as of September 30, 2025, which consisted primarily of money market funds and marketable securities, largely composed of investment grade, short term fixed income securities.
We regularly review our exposure and may, as part of this review, make changes to it. 58 Table of Contents
We regularly review our exposure and may, as part of this review, make changes to it. 57 Table of Contents

Other TWST 10-K year-over-year comparisons