What changed in this filing

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Item 1. Business

2022-11-25 compared with 2021-11-24 · 87 added, 72 removed, 94 unchanged (63% of the section changed)

We are a leading global provid er of life science sample exploration and management solutions for the life sciences market.

We support our customers from research to clinical development with our sample management, automated storage, and genomic services expertise to help our customers bring impactful therapies to market faster.

We understand the importance of sample integrity and offer a broad portfolio of products and services spanning across the life cycle of samples from procurement and sourcing, automated storage platforms, genomic services and a broad range of consumables, informatics and data software, and sample management solutions.

Our expertise and leadership positions enable us to be a trusted partner to pharmaceutical, biotechnology, and life sciences research institutions globally.

In total, our life sciences business employs approximately 2,900 full-time employees, part-time employees and contingent workers worldwide and have sales in more than 80 countries.

We are a leading global provid er of life sciences sample exploration and management solutions for the life sciences market.

We entered the life sciences market in 2011, leveraging our in-house capabilities of precision automation and cryogenics capabilities that we were then applying in the semiconductor market.

These led us to provide solutions for automated ultra-cold storage.

Since then, we have expanded our life sciences offerings both organically and through a series of acquisitions.

We now support our customers from research to clinical development with our sample management, automated storage, and genomic services expertise to help our customers bring impactful therapies to market faster.

We understand the importance of sample integrity and offer a broad portfolio of products and services supporting customers at every stage of the life cycle of samples, including procurement and sourcing, automated storage systems, genomic services and a multitude of sample consumables, informatics and data software, and sample repository solutions.

Our expertise, global footprint, and leadership positions enable us to be a trusted global partner to pharmaceutical, biotechnology, and life sciences research institutions.

In total, we employ approximately 3,200 full-time employees, part-time employees, and contingent workers worldwide and have sales in more than 100 countries.

We are headquartered in Chelmsford, Massachusetts and have operations in North America, Asia, and Europe.

Since our founding in 1978, we have been a leading automation provider and partner to the global semiconductor manufacturing industry.

In the fourth quarter of fiscal year 2021, we entered into a definitive agreement to sell our

semiconductor automation business, to Thomas H.

Lee Partners, L.P., or THL, for approximately $3.0 billion in cash subject to customary adjustments.

The semiconductor automation results are classified as discontinued operations, and, unless otherwise noted, the description of our business in this report relates solely to our continuing operations.

We anticipate the closing of the transaction in the first half of the calendar year 2022 upon satisfaction of customary closing conditions and regulatory approvals.

In the fourth quarter of fiscal year 2021, we announced that our remaining business, which consists of our reportable segments, Life Sciences Products and Life Sciences Services will be rebranded under a single, unified brand, Azenta Life Sciences, or Azenta, during the first half of fiscal year 2022.

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Our life sciences portfolio includes products and services that we acquired over time to bring together a comprehensive capability to serve our customers’ needs.

We continue to develop our products and services offerings through the expertise of our research and development resources.

We believe our acquisition, investment, and integration approach has allowed us to accelerate our internal development and significantly accelerate our time to market.

Our Company was founded in 1978 and became a leading automation provider and partner to the global semiconductor manufacturing industry.

In the fourth quarter of fiscal year 2021, we entered into a definitive agreement

to sell our semiconductor automation business, to Thomas H.

Lee Partners, L.P., or THL, and completed the sale on February 1, 2022 for $2.9 billion in cash.

The semiconductor automation results are classified as discontinued operations, and, unless otherwise noted, the description of our business in this Form 10-K relates solely to our continuing operations.

In connection with the planned divesture of the semiconductor automation business and our continued focus on our life sciences businesses, we changed our corporate name from “Brooks Automation, Inc.” to “Azenta, Inc.” and our common stock started to trade on the Nasdaq Global Select Market under the symbol “AZTA” on December 1, 2021.

Our portfolio includes products and services offerings developed by us internally as well as many offerings we have added through multiple acquisitions designed to bring together a comprehensive capability to serve our customers’ needs in the sample-based services arena.

We continue to develop new products and services offerings and enhance existing and acquired offerings through the expertise of our research and development resources.

We believe our acquisition, investment, and integration approach has allowed us to accelerate internal development and significantly accelerate time to market.

For further information on our acquisitions, please refer to Note 4, “Acquisitions” to our Consolidated Financial Statements included under Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.

Life Sciences Market

Our life sciences businesses serve a broad range of end markets within the life sciences industry to address a confluence of life sciences trends, such as technology, information management and new sophisticated tools and applications.

Our businesses serve a broad range of end markets within the life sciences industry in the pursuit of a growing list of scientific possibilities for advancing the development of therapies to improve people’s lives and cure diseases.

With the advent of biologics and personalized medicine, biological samples have become critical assets to the success of drug and therapy pipelines, and the proper management and protection of these samples has gained increased importance to our customers.

We believe this trend has created a sizable market opportunity for Brooks to provide comprehensive sample management and genomic solutions.

We believe this trend has created a sizable market opportunity for Azenta to provide comprehensive sample management and genomic solutions.

Since the successful mapping of the full human genome at the turn of this century, the market for genomic services has grown in support of research in biologic drug development, personalized medicine and cell/gene therapy.

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Other companies and institutions have fewer or no in-house options and make use of outsourced capabilities as their primary solution.

We participate in this market as a value-added laboratory services provider, offering high quality genetic testing services with fast turnaround time.

We have more than 8,700 customers globally and we address only a fraction of the industry.

We serve top customers in the pharmaceutical and biotechnology industry, the most advanced research hospitals performing clinical research and therapy development, as well as some of the newest and leading-edge start-ups in the biotech space.

We also serve academic and government institutions.

We believe that the sample-based services and products business will continue to demonstrate a growth trajectory and we do not observe cyclical characteristics in demand for these offerings.

Our business is comprised of two reportable segments, our Life Sciences Products segment and our Life Sciences Services segment.

We participate in this market as a value-added laboratory services provider, offering high quality genetic testing services with fast turnaround times.

We have more than 12,000 customers globally and believe we are well positioned to expand our customer base.

We serve top pharmaceutical and biotechnology companies, the most advanced research hospitals performing clinical research and therapy development, as well as some of the newest and leading-edge start-ups in the biotech space.

In addition, we also serve academic and government institutions.

We believe that the sample-based services and products businesses will continue to demonstrate a growth trajectory and we do not observe cyclical demand for these offerings.

Our business is comprised of two reportable segments:

Life Sciences Products and Life Sciences Services.

For further information on our reportable and operating segments, please refer to Note 18, “Segment and Geographic Information” to our Consolidated Financial Statements included under Item 8, “Financial Statements and Supplementary Data” of this Form 10- K.

Life Sciences Products

Our Life Sciences Products business is a leading provider of automated ultra-cold storage solutions for biological and chemical compound samples.

Our Life Sciences Products business is a leading provider of automated cold storage solutions for biological and chemical compound samples.

Our storage systems provide reliable automation and sample inventory management at temperatures down to -190°C and can store anywhere from one to millions of samples.

Our sample management

solutions include consumable vials and tubes, polymerase chain reaction (PCR) plates, instruments for supporting workflow, and informatics, all of which focus on providing customers with the highest level of sample quality, security, availability, intelligence and integrity throughout the lifecycle of samples providing customers with complete end-to-end “cold-chain of custody” capabilities.

Our sample management solutions include consumable vials and tubes, polymerase chain reaction, or PCR, plates, instruments for supporting

workflows, and informatics.

This portfolio provides customers with the highest level of sample quality, security, availability, intelligence, and integrity throughout the lifecycle of samples providing customers with complete end-to-end “cold-chain of custody” capabilities.

On July 1, 2022, we acquired Barkey Holding GmbH and its subsidiaries, or Barkey, a leading provider of controlled rate thawing devices for customers in the medical, biotech and pharmaceutical industries, headquartered in Leopoldshöhe, Germany.

Life Sciences Products Offerings

The principal offerings of the Life Sciences Products segment include the following:

Automated ultra-cold storage systems – provides stand-alone systems that store up to 20 million samples in temperature ranges from ambient temperatures to -80°C and cryogenic storage with temperatures at -190°.

Automated cold storage solutions – includes stand-alone systems that store over 20 million samples in temperature ranges from ambient to -80°C to cryogenic storage at -190°C.

Our systems provide high throughput capability and optimized storage of multi-format tubes and plates while maintaining consistent temperature profiles across stored samples.

We also provide a portfolio of service products designed to optimize productivity of our storage systems offerings.

We also offer a portfolio of service products designed to optimize productivity of our storage systems offerings.

Consumables and instruments - includes a complete range of consumables, including multiple formats of racks, tubes, caps, plates and foils, which are used for storage and handling of samples in ambient and ultra-cold storage environments.

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Our offerings include a range of products aimed at the genomic sample preparation and services market for PCR and sequencing, imaging, plate sealing, liquid handling, and sample processing.

Controlled rate thawing devices – includes a range of products for automated thawing of plasma, blood and stem cells as well as on cell and gene therapy, or CGT, applications.

Our products are used for controlled rate thawing of cryopreserved samples and therapies, and are used in R&D, clinical trials, good manufacturing practices and in the hospital setting.

Our Barkey plasmatherm product is the only automated cell thawing device approved by the U.S.

Food and Drug Administration, or FDA, as a medical device for use in patient care.

Life Sciences Services

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We process millions of samples every year, each containing valuable information that must be preserved with the sample.

Through our genomic services we provide a broad capability to customers for sequencing and synthesis of genes.

Our genomic services provide a broad capability to customers for sequencing and synthesis of genes.

Our sample management services include off-site storage services, transport services, laboratory services, and interactive informatics solutions.

We also provide expert-level consultation services to our clients throughout their experimental design and implementation.

Our services also include short- and long-term sample storage and management of the “cold chain of custody” from collection, to storage, to retrieving the sample which ultimately may go back into the customer’s research workflow.

We also offer expert-level consultation services to our clients throughout their experimental design and implementation.

Life Sciences Services Offerings

The principal offerings of the Life Sciences Services segment include the following:

Genomic Services - provides gene sequencing and gene synthesis services, enabling the fast-expanding research of gene-based healthcare discoveries and therapies.

Genomic Services - offers gene sequencing and gene synthesis services, enabling the fast-expanding research of gene-based healthcare discoveries and therapies.

These service offerings include Next Generation sequencing, or NGS, Sanger sequencing, gene synthesis, bioinformatics, and good laboratory practices, or GLP, regulatory services.

The sequencing services are available with both standard and custom services for extraction, library preparation, sequencing, and bioinformatics, supported by Ph.D.-level project managers providing consultations, updates, and post-delivery assistance.

The gene synthesis offerings provide production of a wide range of sequence lengths and structural complexity, DNA cloning, gene fragment synthesis, and oligo synthesis.

The gene synthesis offerings provide production of a wide range of sequence lengths and structural complexity, DNA cloning, gene fragment synthesis, oligo synthesis, and plasmid purification.

Sample Repository Solutions - includes a complete range of services consisting of on-site and off-site sample storage, cold chain logistics, sample transport and collection relocation, bio-processing solutions (inclusive of sample preparation, and genomic and cell culture analysis), disaster recovery and business continuity, biospecimen procurement services, as well as project management and consulting.

Informatics - provides sample intelligence software solutions.

Our informatics suite supports laboratory workflow scheduling for life science tools and instrument work cells, sample inventory and logistics, environmental and temperature monitoring, clinical trial and consent management, and planning, data management, virtualization, and

visualization of sample collections.

Our Informatics solutions provides sample intelligence software

solutions, and support laboratory workflow scheduling for life science tools and instrument work cells, sample inventory and logistics, environmental and temperature monitoring, clinical trial and consent management, and planning, data management, virtualization, and visualization of sample collections.

We offer enhanced on-site and off-site management of biological sample inventories and integration solutions to our customers for their increasingly distributed workflow.

We believe the combination of our broad sample-based offerings, including genomic analysis, sample management solutions, automated storage systems, informatic solutions and sample sourcing and procurement services has enabled us to better serve our customers with an integrated and comprehensive portfolio.

Acquisition completed after fiscal year end

On October 3, 2022, we acquired B Medical Systems S.á.r.l and its subsidiaries, or B Medical, a market leader in temperature-controlled storage and transportation solutions that enables the delivery of life-saving treatments to more than 150 countries worldwide.

The acquisition complements our cold chain capabilities, adding differentiated solutions for reliable and traceable transport of temperature-sensitive specimens.

Sales, Marketing and Customer Support

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We supplement the sale of consumables and instruments with distributors that reach a broad range of customers.

In regions with emerging life science industries such as China, India and the Middle East, we leverage local distributors to assist with the sales process for store systems.

Our larger automated store systems sales process may take months to complete and may involve a team from sales, marketing, and engineering.

Sales of genomic services are generally generated with on-line orders from the customer lab and delivered via a courier service, with the simplest of sequencing requests completed in less than 24 hours and more complex synthesis tasks within weeks.

In regions with emerging life science industries such as China, India, and the Middle East, we leverage local distributors to assist with the sales process for automated stores.

Our larger automated store systems sales process may take months to complete and involve a team from sales, marketing, and engineering.

Sales of genomic services are generally generated with on-line orders from the customer laboratory and delivered via a courier service, with the simplest of sequencing requests completed in less than 24 hours and more complex synthesis tasks within weeks.

We utilize a worldwide partner network of clinical sites and biobanks for the collection capability of our biospecimen procurement business.

We typically provide product warranties for a period of one to two years depending on the product type.

Our marketing activities include participation in trade shows, seminars, participation in industry forums, creation and distribution of sales literature and white papers, publication of press releases and articles in business and industry publications.

We maintain sales and service centers in Asia, Europe, the Middle East and North America to enhance our customers’ support and communication.

Given the breadth of the sample management solutions and genomic services offered by our Life Sciences Products and Life Sciences Services segments, we believe we have a unique portfolio of products and services that we provide to our customers.

Our marketing activities include participation in trade shows, seminars, and industry forums, creation and distribution of sales literature, webinars, and white papers, and publication of press releases and articles in business and industry publications.

We maintain sales and service centers in Asia, Europe, the Middle East, and North America to enhance support of and communication with customers.

Each of the business lines within the two segments, however, has unique competitors in their area of offerings.

In the Life Sciences Products segment, our main competitors include Hamilton Company and Liconic AG for automation systems and Thermo Fisher Scientific for consumables and services, In the Life Sciences Services segment, our main competitors include Laboratory Corporation of America Holdings and Thermo Fisher Scientific Inc.

for storage services, and BGI Genomics Co., Ltd.,, Eurofins, Scientific S.E., Genscript Biotech Corporation, Integrated DNA Technologies, Inc., Novogene Co., Ltd.

and Twist Bioscience Corporation for genomic services.

In the Life Sciences Products segment, our main competitors include Hamilton Company and Liconic AG for automation systems and Thermo Fisher Scientific for consumables and services.

In the Life Sciences Services segment, our main competitors include Laboratory Corporation of America Holdings and Thermo Fisher Scientific Inc.

for storage services, and BGI Genomics Co., Ltd., Eurofins, Scientific S.E., GenScript Biotech Corporation, Integrated DNA Technologies, Inc., Novogene Co., Ltd., and Twist Bioscience Corporation for genomic services.

Research and Development

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Within our Life Sciences Products segment, we have developed and continue to develop automated biological sample storage solutions for operating in ultra-low temperature environments.

We have a complete line up of automated stores from ambient temperatures to -190°C.

Our BioStore’s ™ unique design allows controlled temperature storage down to -80°C with the industry’s highest throughput of sample retrieval.

We have a complete line up of automated

stores from ambient temperatures to -190°C.

Our BioStore ™ has a unique design, which allows controlled temperature storage down to -80°C with the industry’s highest throughput of sample retrieval.

Our BioStore portfolio offers improved data management and sample security for vaccines and biologics stored at -80°C.

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We invest in R&D services to develop protocols and efficiencies in our own laboratories and to provide proprietary offerings to our customers.

As an example, in our genomic services business we launched a portfolio of new services, targeting analysis of adeno-associated virus, a common vector used in cell and gene therapy.

We will continue to focus on developing processes and technologies that can streamline sample to data workflow.

As an example, in our genomic services business, we enriched our portfolio by adding regulated services targeting analysis of adeno-associated virus, a common vector used in cell and gene therapy.

Furthermore, we continue to add value to drug discovery and development research by expanding our portfolio to include proteomics solutions.

We will continue to focus on developing processes and technologies that can streamline sample to data workflows.

Manufacturing and Service

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We implement quality assurance procedures that include standard design practices, reliability testing and analysis, supplier and component selection procedures, vendor controls, manufacturing process controls, and service processes that ensure high-quality performance of our products.

Our major manufacturing facilities are in Manchester, United Kingdom and Chelmsford, Massachusetts.

Our major manufacturing facilities are in Manchester and Wotton, United Kingdom and Billerica, Massachusetts.

Our manufacturing operations are designed to provide high quality, optimal cost, differentiated products to our customers in short lead times through responsive and flexible processes and sourcing strategies.

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Our patents will expire at various dates through 2039.

Environmental Matters

We are subject to federal, state, local environmental laws and regulations, and the environmental laws and regulations of the foreign national and local jurisdictions in which we have manufacturing facilities.

We believe we are in compliance in all material respects with such laws and regulations.

Compliance with foreign, federal, state, and local laws and regulations has not had, and is not expected to have, an adverse effect on our capital expenditures, competitive position, financial condition or results of operations.

Environmental Matters and Government Regulations

Environmental Regulations

We are subject to various laws and governmental regulations concerning environmental matters and employee safety and health in the United States and other countries.

Federal environmental legislation in the United States that affects us includes the Resource Conservation and Recovery Act, the Clean Air Act, the Clean Water Act, the Safe Drinking Water Act, and the Comprehensive Environmental Response Compensation and Liability Act.

We are also subject to regulation by the Occupational Safety and Health Administration, or OSHA, concerning employee safety and health matters.

The United States Environmental Protection Agency, or EPA, OSHA, and other federal agencies have the authority to promulgate regulations that have an effect on our operations.

In addition to these federal laws and regulations, various states have been delegated certain authority under the federal statutes and have authority over these matters under state laws.

Many state and local governments have adopted environmental and employee safety and health laws and regulations, some of which are similar to federal requirements.

Other Laws and Regulations

Our operations are also subject to other government regulations.

While most of our products are not regulated, our recent acquisitions of Barkey and B Medical include certain products that are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act.

Our businesses also include export and import activities, we are subject to pertinent laws enforced by the U.S.

Departments of Commerce, State and Treasury.

In addition, our logistics activities must comply with the rules and regulations of the Department of Transportation, the Federal Aviation Administration, and similar foreign agencies.

We believe we are in compliance in all material respects with all applicable environmental, employee health and safety and other government regulations, and such compliance has not had, and is not expected to have, an adverse effect on our capital expenditures, competitive position, financial condition, or results of operations.

Human Capital

As of September 30, 2021, we employed approximately 2,800 people which includes full-time and part-time employees, in addition, we utilized the services of 80 contingent associates, primarily in the United States.

As of September 30, 2022, we employed approximately 3,100 people which includes full-time and part-time employees.

In addition, we utilized the services of 100 contingent associates, primarily in the United States.

None of our employees are covered by collective bargaining agreements.

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Our goal is to develop cultural competency by seeking knowledge, increasing awareness, developing sensitivity, modeling respect and promoting inclusion and unity.

Approximately 48% of our employees are

gender diverse, and 41% of our U.S.-based employees identify as being racially diverse.

Additional detail on our gender and racial diversity can be found on our website in our ESG governance reports.

Approximately 48% of our employees are gender diverse, and 41% of our U.S.-based employees identify as being racially diverse.

Additional detail on our gender and racial diversity can be found on our website in our environmental, social, and governance, or ESG, governance reports.

Employee Engagement .

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Employee Health and Safety.

Compliance with environmental, health and safety (“EH&S”) laws and regulations underlies the basis of the EH&S programs we have in place.

Compliance with environmental, health and safety, or EH&S, laws and regulations underlies the basis of the EH&S programs we have in place.

As we continue to monitor the impact of the COVID-19 pandemic, we have implemented and will continue to implement measures to ensure the safety of our employees.

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Purpose and Core Values .

Our Company Purpose is to advance science and technology to enable a healthier and more connected world for everyone, everywhere.

Our Company Purpose is to enable life sciences organizations around the world to bring impactful and breakthrough therapies to market – faster.

We are committed to making sure that every team member understands our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value, and Integrity.

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Our Standards of Conduct also outline what is expected of our employees and ensure we continue to foster a culture of high integrity.

We adhere to the governance requirements established by federal and state law, the Securities and Exchange Commission (“SEC”), and the Nasdaq Global Select Market, and we strive to establish appropriate risk management methods and control procedures to adequately manage, monitor, and control the major risks we may face day to day.

Semiconductor Automation Business

As noted above, in the fourth quarter of fiscal year 2021, we entered into a definitive agreement to sell our semiconductor automation business to THL.

We anticipate the sale closing in the first half of fiscal year 2022 upon satisfaction of customary closing conditions and regulatory approvals.

Our semiconductor automation business is a leading automation provider and partner to the global semiconductor manufacturing industry.

We provide advanced, high precision, high throughput robots, vacuum automation systems, contamination control systems, and reticle storage solutions to the global semiconductor capital equipment industry.

We sell our semiconductor products and services both to OEMs and directly to global semiconductor chip manufacturers.

In the third quarter of fiscal year 2021, we acquired collaborative robots and automation subsystems developer Precise Automation, Inc., a leading developer of collaborative robots and automation subsystems headquartered in Fremont, California.

At the completion of the sale, we will no longer serve the semiconductor market.

We adhere to the governance requirements established by federal and state law, the Securities and Exchange Commission, or SEC, and the Nasdaq Global Select Market, and we strive to establish appropriate risk management methods and control procedures to adequately manage, monitor, and control the major risks we may face day to day.

Available Information

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Our SEC filings are available to the public over the internet at the SEC’s website at http://www.sec.gov.

We also maintain a website at www.brooks.com, through which you can access our SEC filings.

We also maintain a website at www.azenta.com, through which you can access our SEC filings.

The information found on our website is not part of this or any other report we file with or furnish to the SEC.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business