What changed in this filing

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Item 1. Business

2020-12-18 compared with 2019-12-19 · 79 added, 39 removed, 378 unchanged (24% of the section changed)

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("we", "Agilent" or the "company"), incorporated in Delaware in May 1999, is a global leader in life sciences, diagnostics and applied chemical markets, providing application focused solutions that include instruments, software, services and consumables for the entire laboratory workflow.

For fiscal year ended October 31, 2019 , we have three business segments comprised of the life sciences and applied markets business, diagnostics and genomics business and the Agilent CrossLab business.

For fiscal year ended October 31, 2020, we have three business segments comprised of the life sciences and applied markets business, the diagnostics and genomics business and the Agilent CrossLab business.

Our life sciences and applied markets business provides application-focused solutions that include instruments and software that enable customers to identify, quantify and analyze the physical and biological properties of substances and products, as well as enable customers in the clinical and life sciences research areas to interrogate samples at the molecular and cellular level.

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The Chemical & Energy Market.

The natural gas and petroleum refining markets use our products to measure and control the quality of their finished products and to verify the environmental safety of their operations.

Petroleum refiners use our measurement solutions to analyze crude oil composition, perform raw material analysis, verify and improve refining processes and ensure the overall quality of gasoline, fuels, lubricants and other products.

Our solutions are also used in the development, manufacturing and quality control of fine chemicals and other industrial applications such as materials analysis.

Our products and solutions are used throughout the chemicals sector in the development, manufacturing, and quality control of commodity chemicals, specialty and agrochemicals, and fine chemicals.

Chemical market customers use our products to determine chemical composition, perform impurity analysis, qualify raw materials, conduct materials characterization, and verify and ensure the environmental safety of operations and employees.

The natural gas and petroleum exploration and refining markets use our products to analyze crude oil composition, perform intermediate material analysis, verify and improve refining processes and ensure the overall quality of gasoline, fuels, lubricants and other products.

The Environmental & Forensics Market.

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The Agilent LC portfolio is modular in construction and can be configured as analytical and preparative systems.

These systems can be stepwise upgraded to highly sophisticated, automated workflow solutions such as method development, multi‑method/walk-up, high-capacity/high-throughput or multi‑dimensional LC and can be extended to application‑based analyzers e.g.

for bio-molecular separations, chiral analysis or size exclusion chromatography.

As a leader in liquid chromatography, we continue to expand our application space with new HPLC columns, new services and diagnostics offerings and ongoing instrument and software product enhancements.

Gas Chromatography

Agilent is the world's leading provider of gas chromatographs, both laboratory and portable models.

GC's are used to separate any gas, liquid or solid that can be vaporized and then detect the molecules present to determine their identity and quantity.

Agilent is the world's leading provider of gas chromatographs ("GC"), both laboratory and portable models.

GCs are used to separate any gas, liquid or solid that can be vaporized and then detect the molecules present to determine their identity and quantity.

Agilent provides custom or standard analyzers configured for specific chemical analysis applications, such as detailed speciation of a complex hydrocarbon stream, calculation of gas calorific values in the field, or analysis of a new bio-fuel formulation.

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Agilent's LCMS portfolio includes instruments built around four main analyzer types - single quadrupole, triple quadrupole, time-of-flight ("TOF") and quadrupole time-of-flight ("QTOF").

Agilent's GC/MS portfolio includes instruments built around three main analyzer types - single quadrupole, triple quadrupole, and quadrupole time-of-flight ("QTOF").

We significantly expanded our mass spectrometry portfolio in recent years with a focus on improving performance, sensitivity, and ease of use.

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Within the diagnostics and genomics business, we focus primarily on the diagnostics and clinical market.

A significant part of our clinical diagnostic customers are in pathology labs throughout the world.

Our high-quality, automated pathology tissue staining platforms and solutions are used most heavily by the large labs located in hospitals, medical centers, and reference labs.

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Our CoverStainer and Artisan based product families target primary cancer diagnostics through hematoxylin and eosin staining as well as special stains for additional insights and detection of potentially carcinogenic tissue.

Dako Omnis and Autostainer based IHC solution and Instant Quality Fluorescence In Situ Hybridization ("IQFISH") technologies provide advanced tumor typing through investigation of protein and gene expression.

Dako Omnis and Autostainer based IHC solution and Instant Quality Fluorescence In Situ Hybridization ("IQFISH") technologies provide advanced tumor typing through

investigation of protein and gene expression.

These products also include companion diagnostic tests that are used to help identify patients most likely to benefit from a specific targeted therapy.

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PCR and qPCR Instrumentation and Molecular Biology Reagents

Polymerase chain ceaction ("PCR") is a standard laboratory method used to amplify the amount of genetic material of a given sample to enable further interrogation.

Polymerase chain reaction ("PCR") is a standard laboratory method used to amplify the amount of genetic material of a given sample to enable further interrogation.

Quantitative PCR ("qPCR") or real time PCR is also a standard method used in genomic research facilities to measure the amount of a specific nucleic acid sequence within a sample.

There are several applications for qPCR, among the most common are identifying the expression level of a specific gene, or calculating the amount of a specific pathogen present in a sample.

There are several applications for qPCR;

among the most common are identifying the expression level of a specific gene or calculating the amount of a specific pathogen present in a sample.

Agilent offers a complete portfolio of PCR & qPCR instruments, as well as specialty enzymes for amplifying difficult sample types.

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Our nucleic acid solutions business is a contract manufacturing and development services business with equipment and expertise focused on mid to large scale production of synthesized oligonucleotide APIs under pharmaceutical GMP conditions for an emerging class of drugs that utilize oligonucleotide molecules for disease therapy.

These drugs have advanced from single strand DNA molecules to complex, highly modified molecules including antisense, aptamers, double-stranded RNA, and RNA mixtures.

These drugs have advanced from

single strand DNA molecules to complex, highly modified molecules including antisense, aptamers, double-stranded RNA, and RNA mixtures.

These advancements in the technology have greatly improved the efficacy of delivery and stability of the oligos in-vivo.

Our nucleic acid solutions business offers industry leading experience to efficiently advance our customer’s oligo drug candidates from clinical trials to commercial launch with a common goal of patient health and safety.

Our nucleic acid solutions business offers industry leading experience to efficiently advance our customers' oligo drug candidates from clinical trials to commercial launch with a common goal of patient health and safety.

Automated Electrophoresis and Microfluidics

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Our FDA registered sites include California, Colorado, Texas and Denmark.

We utilize just-in-time manufacturing and so typically do not maintain a high level of inventory.

Diagnostics and Genomics Competition

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Our principal competitors in the diagnostics and genomics arena include:

Roche Ventana

Medical Systems, Inc., a member of the Roche Group, Leica Biosystems, Inc., a division of Danaher Corporation, Abbott Laboratories, Ilumina, Inc.

Roche Ventana Medical Systems, Inc., a member of the Roche Group, Leica Biosystems, Inc., a division of Danaher Corporation, Abbott Laboratories, Illumina, Inc.

and Affymetrix, Inc., a division of Thermo Fisher Scientific Inc.

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The Chemical & Energy Market.

The natural gas and petroleum refining markets use our services and consumable products to support their quality control and environmental safety reviews.

Petroleum refiners use our services and consumable products to support their analysis of crude oil composition and raw materials, as well as help improve their refining processes and improve the quality of their products.

Our services and consumable products are also used in the development, manufacturing and quality control of fine chemicals and other industrial applications, such as material analysis.

Our services, software, technical support, and consumables are used throughout the chemicals sector in the development, manufacturing, and quality control of commodity chemicals, specialty and agrochemicals, and fine chemicals.

Chemical market customers use our services, software, technical support, and consumables to maintain, optimize, and enable higher productivity and profitability for labs, and support quality control and compliance with environmental and safety regulations.

The natural gas and petroleum exploration and refining markets use our services, software, technical support, and consumables to support quality control, environmental safety reviews, analysis of crude oil composition, and improve their refining processes and quality of products.

The Environmental & Forensics Market.

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Our support services include maintenance, troubleshooting, repair and training for all of our chemical and bioanalytical instrumentation hardware and software products.

With advances in digital and virtual support technologies, many of those services can be offered remotely.

Special service bundles have also been designed to meet the specific application needs of various industries.

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Our active reseller program augments our ability to provide more complete solutions to our customers.

We utilize telesales to enhance the transactional sales model of our products.

All channels are supported by technical product and application specialists to meet our customer’s specific requirements.

We deliver our support services to customers in a variety of ways, including on-site assistance with repair or exchange of returned products, telephone support and self-diagnostic services provided over the Internet.

We also offer special industry-focused service bundles that are designed to meet the specific needs of hydrocarbon processing, environmental, pharmaceutical and

biopharmaceutical customers to keep instruments fully operational and compliant with the respective industry requirements.

A substantial portion of consumable sales are processed by our digital commerce infrastructure.

All channels are supported by technical product and application specialists to meet our customers' specific requirements.

We deliver our support services to customers in a variety of ways, including on-site assistance with repair or exchange of returned products, as well as a growing number of remote service delivery options.

In addition to the traditional telephone support and on-site service, our teams remotely engage customers through various digital tools and omni-channel platforms.

We also offer special industry-focused service bundles that are designed to meet the specific needs of hydrocarbon processing, environmental, pharmaceutical and biopharmaceutical customers to keep instruments fully operational and compliant with the respective industry requirements.

Our products typically come with standard warranties, and extended warranties are available for additional cost.

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At the cross-roads of the organization, the Research Labs are able to identify and enable synergies across Agilent's businesses to create competitive differentiation and compelling customer value.

The technical staff have advanced degrees that cover a wide range of scientific and engineering fields, including molecular and cell biology, chemistry, physics, pathology, mathematics, software and informatics, artificial intelligence, deep and machine learning, image processing, nano/microfabrication, fluidics, and business.

Global Infrastructure Organization

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Generally, these organizations are managed from Santa Clara, California, with operations and services provided worldwide.

As of the end of October 2019 , our global infrastructure organization employed approximately 2,600 people worldwide.

As of October 31, 2020, our global infrastructure organization employed approximately 2,600 people worldwide.

Agilent Order Fulfillment Organizations

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In general, OFS employees are dedicated to specific businesses and the associated costs are directly allocated to those businesses.

The following discussions of Research and Development, Backlog, Intellectual Property, Materials, Environmental and Acquisition and Disposal of Material Assets include information common to each of our businesses.

The following discussions of Research and Development, Backlog, Intellectual Property, Materials, Environmental, Regulatory Affairs and Human Capital Management include information common to each of our businesses.

Research and Development

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This policy covers specified active, inactive and divested locations.

Regulatory Affairs

A number of our products and services are subject to regulation by the FDA and certain similar foreign regulatory agencies.

These regulations govern a wide variety of product and service related activities, from quality management, design and development to labeling, manufacturing, promotion, sales and distribution.

If we fail to comply with FDA and other applicable regulatory requirements or are perceived to potentially have failed to comply, we may face, among other things, warning letters;

adverse publicity;

investigations or notices of non-compliance, fines, injunctions, and civil penalties;

import or export restrictions;

partial suspensions or total shutdown of production facilities or the imposition of operating restrictions;

increased difficulty in obtaining required FDA clearances or approvals or foreign equivalents;

seizures or recalls of our products or those of our customers;

or the inability to sell our products.

In Europe, the European Union is going to enforce new requirements, known as the EU In Vitro Diagnostic Regulation (the “EU IVDR”), which imposes stricter requirements for the marketing and sale of in vitro diagnostics in the European Union.

These new regulations are more stringent in a variety of areas, including clinical requirements, quality systems and post-market surveillance activities.

We will have until May 2022 to meet the new EU IVDR requirements.

We are subject to laws and regulations governing government contracts, and failure to address these laws and regulations or comply with government contracts could harm our business by leading to a reduction in revenue associated with these customers.

We have agreements relating to the sale of our products to government entities and, as a result, we are subject to various statutes and regulations that apply to companies doing business with the government.

We are also subject to investigation for compliance with the regulations governing government contracts.

A failure to comply with these regulations could result in suspension of these contracts, criminal, civil and administrative penalties or debarment.

We are also subject to various significant international, federal, state and local regulations in the areas of health and safety, packaging, product content, employment, labor and immigration, import/export controls, trade restrictions and anti-

Violations of these laws and regulations could result in fines and penalties, criminal sanctions, restrictions on our business conduct and on our ability to offer our products in one or more countries, and could also materially affect our brand, our ability to attract and retain employees, our international operations, our business and our operating results.

In addition, as a global organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal, sensitive and/or patient health data in the course of our business.

The EU's General Data Protection Regulation ("GDPR"), which became effective in May 2018, applies to all of our activities related to products and services that we offer to EU customers and workers.

The GDPR established new requirements regarding the handling of personal data and includes significant penalties for non-compliance (including possible fines of up to 4 percent of total company revenue).

Other governmental authorities around the world have passed or are considering similar types of legislative and regulatory proposals concerning data protection.

Each of these privacy, security and data protection laws and regulations could impose significant limitations and increase our cost of providing our products and services where we process end user personal data and could harm our results of operations and expose us to significant fines, penalties and other damages.

While we believe we are in compliance in all material respects with such laws and regulations, any noncompliance could result in substantial fines or otherwise restrict our ability to operate and thereby have an adverse effect on our financial condition.

To date, none has had a material impact on our operations.

Human Capital Management

As of October 31, 2020, we employed approximately 16,400 persons, of whom approximately 5,600 were employed in the United States and approximately 10,800 were employed outside of the United States.

We also leverage temporary workers to provide flexibility for our business and manufacturing needs.

We believe that our future success largely depends upon our continued ability to attract and retain highly skilled employees.

We provide our employees with competitive salaries and bonuses, opportunities for equity ownership, development programs that enable continued learning and growth and a robust employment package that promotes well-being across all aspects of their lives, including health care, retirement planning and paid time off.

As part of our promotion and retention efforts, we also invest in ongoing leadership development through programs such as our Emerging Leader Program, our Managing at Agilent programs and our experienced managers’ Accelerate program.

In addition, we regularly conduct an employee survey to gauge employee engagement and identify areas of focus.

As a global company, much of our success is rooted in the diversity of our teams and our commitment to inclusion.

We value diversity at all levels and continue to focus on extending our diversity and inclusion initiatives across our entire workforce, from working with managers to develop strategies for building diverse teams to promoting the advancement of leaders from different backgrounds.

Information about our Executive Officers

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Hansen, Deloitte Consulting and NVE.

Mark Doak , 64, has served as our Senior Vice President, Agilent and President, Agilent CrossLab Group since September 2014.

From August 2008 to September 2014, Mr.

Doak served as our Vice President and General Manager of the Services and Support Division.

Prior to that, he held several senior management positions across functions in marketing, quality and services.

Rodney Gonsalves, 55, has served as our Vice President, Corporate Controllership and Chief Accounting Officer since May 2015.

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Before joining Agilent, Mr.

Gonsalves held a variety of positions in finance with Hewlett- Packard Co.

Grau, 60, has served as our Senior Vice President, Human Resources since August 2014.

Gonsalves held a variety of positions in finance with Hewlett-Packard Company.

Grau, 61, has served as our Senior Vice President, Human Resources and Global Communications since November 2018.

From August 2014 to October 2018 he served as Senior Vice President, Human Resources.

From May 2012 to August 2014 Mr.

Grau served as Vice President, Worldwide Human Resources.

Prior to that, he served as Vice President, Compensation, Benefits and HR Services from May 2006 to May 2012.

Prior to that, he served as Vice President,

Compensation, Benefits and HR Services from May 2006 to May 2012.

Grau had previously served in various capacities for Agilent and Hewlett-Packard Company.

Padraig McDonnell , 49, has served as our Senior Vice President, Agilent and President, Agilent CrossLab Group since May 2020.

From November 2016 to April 2020, Mr.

McDonnell served as our Vice President and General Manager of the Chemistries and Supplies Division.

Prior to that, he served as our Vice President and General Manager of EMEAI Laboratory Solutions Sales.

McDonnell has previously held a variety of positions with Agilent and Hewlett-Packard Company.

McMahon, 52, has served as our Senior Vice President since August 2018 and Chief Financial Officer since September 2018.

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Prior to that he served as Vice President and General Manager of the Genomics Solutions unit from January 2013 to October 2013.

Before joining Agilent, he served in various capacities at Dako A/S, a Danish diagnostics company,

including as Corporate Vice President of R&D, Vice President, System Development, R&D, Vice President, Strategic Marketing and Vice President, Global Sales Operations.

Before joining Agilent, he served in various capacities at Dako A/S, a Danish diagnostics company, including as Corporate Vice President of R&D, Vice President, System Development, R&D, Vice President, Strategic Marketing and Vice President, Global Sales Operations.

Prior to Dako, Mr.

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Therefore, we file periodic reports, proxy statements and other information with the Securities and Exchange Commission (“SEC”).

The SEC maintains an Internet site (http://www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically.

The SEC maintains an Internet site (https://www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically.

Our financial and other information can be accessed at our Investor Relations website.

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We make available, free of charge, copies of our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after filing such material electronically or otherwise furnishing it to the SEC.

Our Amended and Restated Bylaws, Corporate Governance Standards, the charters of our Audit and Finance Committee, our Compensation Committee, our Executive Committee and our Nominating/Corporate Governance Committee, as well as our Standards of Business Conduct (including code of ethics provisions that apply to our principal executive officer, principal financial officer, principal accounting officer and senior financial officers) are available on our website at www.investor.agilent.com under “Corporate Governance”.

Standards of Business Conduct (including code of ethics provisions that apply to our principal executive officer, principal financial officer, principal accounting officer and senior financial officers) are available on our website at www.investor.agilent.com under “Corporate Governance”.

These items are also available in print to any stockholder in the United States and Canada who requests them by calling (877) 942-4200.

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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