What changed in this filing

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Item 1A. Risk Factors

2026-02-24 compared with 2025-02-25 · 92 added, 58 removed, 157 unchanged (49% of the section changed)

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changes in regulatory conditions;

warranty and recall claims and other litigation and customer reactions thereto;

increased competition, seasonal consumer shopping patterns, and changes in the retail industry for products such as consumer electronics, warranty and recall claims and other litigation and customer reactions thereto;

possible adverse results of pending or future litigation or infringement claims;

changes in tax laws;

import and export duty and tariff rates in or with the countries with which we conduct business, including those recently adopted and potential new tariffs;

import and export duty and tariff rates in or with the countries with which we conduct business;

negative impact of any governmental investigations and associated litigation, including securities litigation relating to the conduct of our business;

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The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law or the rules of the NASDAQ Global Select Market.

Accordingly, any forward-looking statement should be read in conjunction with the additional information about risks and uncertainties identified under the heading “Risk Factors” in the Company’s latest Form 10-K and Form 10-Q filed with the SEC, which risks and uncertainties include supply chain constraints that have affected, are affecting, and will continue to affect, general economic and industry conditions, customers, suppliers, and the regulatory environment in which the Company operates.

Forward-looking information includes content supplied by S&P Global Mobility Light Vehicle Production Forecast of January 16, 2025 (http://www.gentex.com/forecast-disclaimer).

Accordingly, any forward-looking statement should be read in conjunction with the additional

information about risks and uncertainties identified under the heading “Risk Factors” in the Company’s latest Form 10-K and Form 10-Q filed with the SEC, which risks and uncertainties include tariffs and supply chain constraints that have affected, are affecting, and will continue to affect, general economic and industry conditions, customers, suppliers, and the regulatory environment in which the Company operates.

Includes content supplied by S&P Global Mobility Light Vehicle Production Forecast of January 14, 2026 (http://www.gentex.com/forecast-disclaimer).

T he following risk factors, together with all other information provided in this Annual Report on Form 10-K should be carefully considered.

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The automotive industry has always been cyclical and highly impacted by levels of economic activity.

part and material shortages (especially electronics components), automotive and Tier 1 supplier plant shutdowns, customer and supplier financial issues, commodity raw material cost increases, supply constraints, consumer vehicle preference shifts (where we have a lower penetration rate and lower content per vehicle), and supply chain stresses.

The current economic environment, including tariffs and inflation, continues to be uncertain, and continues to cause financial and production stresses evidenced by volatile automotive production levels, volatility with customer orders, supplier part and material shortages (especially electronics components), automotive and Tier 1 supplier plant shutdowns, customer and supplier financial issues, commodity raw material cost increases, supply constraints, consumer vehicle preference shifts (where we have a lower penetration rate and lower content per vehicle), and supply chain stresses.

When automotive customers (including their Tier 1 suppliers) and suppliers experience significant plant shutdowns, work stoppages, strikes, part shortages, etc., it disrupts our shipments to these customers, which adversely affects our business, financial condition, and/or results of operations.

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Key Customers.

We have a number of large customers, including three automotive customers which each account for 10% or more of our annual net sales in 2024 (including direct sales to OEM customers and sales through their Tier 1 suppliers):

We have a number of large customers, including three automotive customers which each account for 10% or more of our annual consolidated net sales in 2025 (including direct sales to OEM customers and sales through their Tier 1 suppliers):

Toyota Motor Company, Volkswagen Group, and General Motors.

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Pricing Pressures.

We continue to experience ongoing pricing pressures from our automotive customers and competitors, which have affected, and which will continue to affect our profit margins to the extent that we are unable to offset the pricing pressures with price adjustments, engineering and purchasing cost reductions, productivity improvements, increases in unit shipments of mirrors and electronics with advanced features, and/or new or advanced technologies, each of which pose ongoing challenges, which continue to adversely impact our business, financial condition, and/or results of operations.

We continue to experience ongoing pricing pressures from our customers and competitors, which have affected, and which will continue to affect our profit margins to the extent that we are unable to offset these pricing pressures with price adjustments, engineering and purchasing cost reductions, productivity improvements, increases in product shipments, and/or introduction of new products and new and advanced technologies, each of which pose ongoing challenges, which continue to adversely impact our business, financial condition, and/or results of operations.

Raw Materials and Other Product Component Costs.

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Business Combinations.

Acquisitions of businesses, technologies, and assets are playing a role in our future growth.

We continue pursuing selected acquisitions of, and investments in, businesses, technologies, and other assets as a component of our growth strategy.

We cannot be certain that we will be able to identify attractive acquisition targets, have resources available for, or obtain financing for, acquisitions on satisfactory terms, successfully acquire identified targets, or manage timing of acquisitions with our businesses.

Additionally, we are not always successful in integrating acquired businesses into our existing operations, achieving projected synergies, and/or maximizing the value of acquired technologies and businesses.

Additionally, we may not always be successful in integrating acquired businesses into our existing operations, achieving projected synergies, and/or maximizing the value of acquired technologies and businesses.

Competition for acquisition opportunities in the various industries in which we operate already exists and may increase, thereby increasing our costs of making acquisitions or causing us to refrain from making further acquisitions.

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These and other acquisition-related factors negatively and adversely impact our business, financial condition, and/or results of operations.

Impairment of Goodwill and Intangible Assets.

We evaluate the recoverability of recorded goodwill and other intangible asset amounts annually, or when evidence of potential impairment exists.

The annual impairment test is based on several factors requiring judgment.

We have experienced impairment charges in the past (refer to Note 1 , Summary of Significant A ccounting and Reporting Policies ) of the Consolidated Financial Statements ).

Additional future impairment may result from, among other things, deterioration in the performance of our business or product

lines, adverse market conditions and changes in the competitive landscape, and a variety of other circumstances.

The amount of any impairment is recorded as a charge to our Consolidated Statement of Income.

We may never realize the full value of our goodwill and intangible assets, and determinations requiring impairment charges have had and will continue to have an adverse effect on our financial condition and results of operations.

The geopolitical environment between the Unites States and other jurisdictions, most significantly China, continues to cause uncertainty, especially in light of recently imposed tariffs, tariffs threatened to be imposed, and those already existing.

Previously enacted tariffs have increased the Company's input costs and challenge the Company's competitive position in foreign markets.

The continuance of these tariffs and/or escalation of disputes in the geopolitical environment interferes with automotive supply chains and have a continued negative impact on the Company’s business, financial condition, and/or results of operations, especially since the Company primarily manufactures and ships from one location.

For example, the United States has imposed, proposed, and/or threatened tariffs on a broad range of foreign-sourced products and materials including tariffs on products imported from China, Mexico, and Canada.

In response, certain trading partners of the United States, including China, have imposed, proposed, and/or threatened retaliatory tariffs and other measures on goods manufactured in the United States.

Previously enacted tariffs have increased the Company's input costs and challenged the Company's competitive position in foreign markets, especially in China.

The continuance of these tariffs and/or escalation of disputes in the geopolitical environment interferes with supply chains and have had and will continue to have a negative impact on the Company’s business, financial condition, and/or results of operations, especially since the Company primarily manufactures and ships from the United States.

We cannot predict what further action may be taken with respect to tariffs or trade relations between the U.S.

and other governments, and any further changes in U.S.

or international trade policy could have a further adverse impact on our business.

or international trade policy could have a further adverse impact on our business, financial condition, and results of operations.

Technology Investments.

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These investments are subject to risks related to the businesses in which we invest, which may be different than the risks inherent in our own business.

These investments could become impaired or have realized

or unrealized losses in future periods, which could have an adverse effect on our financial condition and results of operations.

Some of these investments have, and could in the future become impaired or have realized or unrealized losses in future periods, which has had and will continue to have an adverse effect on our financial condition and results of operations.

We recognize that Magna Mirrors, our main competitor, has considerably more resources available to it, and presents a formidable competitive threat.

Additionally, other companies have demonstrated products that are competitive to our FDM ® system and other products.

Additionally, other companies have demonstrated products that are competitive to our FDM ® system and other products, especially in the China market.

We acknowledge that dimming device (e.g., electrochromic) technology is the subject of research and development efforts by numerous third parties.

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The Company believes that combining video displays with mirrors provides a more robust product by addressing all driving conditions in a single solution that can be controlled by the driver.

The Company has been in production with the Company's FDM ® since 2015 and has, in the ordinary course of business, been awarded programs with sixteen (16) OEM customers.

The Company is currently shipping production FDM ® to all sixteen of these customers.

The Company's CMS solution uses three cameras to provide a comprehensive view of the sides and rear of the vehicle while still providing the traditional safety of interior and exterior mirrors, that still function when cameras are obstructed, or not functioning.

The Company has previously announced that the Company continues to develop in the areas of imager performance, camera dynamic range, lens design, image processing from the camera to the display, and camera lens cleaning.

The Company acknowledges that as such technology evolves over time, such as cameras replacing mirrors and/or autonomous driving, there will be increased competition.

Biometrics Market.

A component of the Company's growth strategy includes expansion of our biometric technology and solutions into commercial markets.

Although the use of biometric readers on popular consumer products, such as smartphones, has increased interest in biometrics as a means of authenticating and/or identifying individuals, commercial markets for biometrics technology are still developing and evolving.

Biometrics-based solutions compete with more traditional security methods including keys, cards, personal identification numbers, fingerprints, and security personnel.

Acceptance of biometrics as an alternative to such traditional methods depends upon a number of factors, including:

the cost, performance and reliability of our products and services and the products and services offered by our competitors;

customers’ perceptions regarding the benefits of biometrics solutions;

public perceptions regarding the intrusiveness of these solutions and the manner in which organizations use the biometric information collected;

public perceptions regarding the confidentiality of private information;

proposed or enacted

legislation related to privacy of information;

customers’ satisfaction with biometrics solutions;

and marketing efforts and publicity regarding biometrics solutions.

A considerable number of established companies have developed or are developing and marketing software and hardware for biometrics products and applications, including facial recognition, fingerprint biometrics, and other iris authentication competitors that currently compete with, or will compete directly with, our biometric authentication solutions.

We expect that additional competitors will enter the biometrics market and become significant long-term competitors, and that as a result, competition will increase.

Companies competing with us may introduce solutions that are competitively priced, have increased performance or functionality or incorporate technological advances we have not yet developed or implemented.

There is no assurance the Company will be successful in this area.

Supply Chain Disruptions.

As a result of just-in-time supply chains within our business and the automotive industry, disruptions in our supply chain have occurred, are occurring, and may continue to occur due to the industry-wide parts shortages, labor shortages, and other global supply chain constraints.

We have and continue to take a number of steps to mitigate the current supply chain challenges, which include strategies involving the additional procurement of available raw materials to prepare for assembling finished goods more quickly when supply constraints ease for certain common components.

These inventory strategies further introduce obsolescence risk that impacts our business, financial conditions, and/or results of operations.

As our customers' forecasted demand changes, inventory becomes obsolete and write-offs or write-downs of our inventory are exacerbated.

As a result of just-in-time supply chains within our business and the automotive industry, disruptions in our supply chain have occurred, are occurring, and may continue to occur due to industry-wide parts shortages, labor shortages, and other global supply chain constraints.

We have and continue to take a number of steps to mitigate supply chain challenges, which include strategies involving the additional procurement of available raw materials to prepare for assembling finished goods more quickly when supply constraints ease for certain common components.

These inventory strategies further introduce obsolescence risk that impacts our business, financial condition, and/or results of operations.

Moreover, as our customers' forecasted demand changes, our inventory may become obsolete and write-offs or write-downs of our inventory may be exacerbated.

Disruptions can also occur due to natural disasters, pandemics, work stoppages, strikes, bankruptcy, etc.

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Our financial performance has been impacted by the mix of products we sell, and to which customers, during a given period.

The automotive industry is subject to rapid technological change, vigorous competition, short product life cycles and cyclical, ever-changing consumer demand patterns.

The industries we operate in are subject to rapid technological change, vigorous competition, short product life cycles and cyclical, ever-changing consumer demand patterns.

When our customers are adversely affected by these factors, we are similarly affected to the extent that our customers reduce the volume of orders for our products or certain of our products.

As a result of such changes and circumstances impacting our customers, our sales mix shifts, which has either favorable or unfavorable impact on revenue and would include shifts in regional growth, in OEM sales demand, as well as in consumer demand related to vehicle segment purchases, and content penetration.

A decrease in consumer demand for specific types of vehicles where we have traditionally provided higher value content has a significant effect on our business, financial condition, and/or results of operations.

As a result of such changes and circumstances impacting our customers, our sales mix shifts, which has either favorable or unfavorable impact on revenue and would include shifts in regional growth and in sales demand, as well as in consumer demand.

For example, within the automotive industry, where a decrease in consumer demand for specific types of vehicles where we have traditionally provided higher value content has occurred, that would have a significant effect on our business, financial condition, and/or results of operations.

Our forward guidance and estimates assume a certain geographic sales mix as well as a product sales mix.

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Intellectual Property.

We believe that our patents and trade secrets provide us with a competitive advantage in automotive rearview mirrors, variable dimmable devices, certain electronics, and fire protection technologies, although no single patent is necessarily required for the success of our products.

We believe that our patents and trade secrets provide us with some competitive advantage in automotive rearview mirrors, variable dimmable devices, certain electronics, fire protection technologies, and biometric technologies, though no single patent is necessarily required for the success of our products.

The loss of any significant combination of patents and trade secrets regarding our products could adversely affect our business, financial condition, and/or results of operations.

Lack of intellectual property protection in a number of countries, including China, represents a current and ongoing risk for the Company.

Lack of IP protection in a number of countries, including China, represents a current and ongoing risk for the Company.

New Technology and Product Development.

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Intellectual Property Litigation and Infringement Claims.

A successful claim of patent or other intellectual property infringement and damages against us could affect business, financial condition, and/or results of operations.

If a person or company claims that our products infringed their intellectual property rights, any resulting litigation would be costly, time consuming, and would divert the attention of management and key personnel from other business issues.

The complexity of the technology involved in our business and the uncertainty of intellectual property litigation significantly increases these risks and makes such risk part of our ongoing business.

To that end, we periodically obtain intellectual property rights, in the ordinary course of business, to strengthen our intellectual property portfolio and minimize potential risks of infringement.

The increasing tendency of patents granted to others on combinations of known technology is a potential threat to our Company.

Any of these adverse consequences could potentially have an effect on our business, financial condition and/or results of operations.

Certain automakers and Tier 1 customers from time to time may consider the sale of certain business segments or bankruptcy or other changes as a result of financial stress.

Should one or more of our larger customers (including sales through their Tier 1 suppliers) declare bankruptcy or sell their business, it could adversely affect the collection of receivables, our business, financial condition, and/or results of operations.

The products we sell are continually changing as a result of improved technology.

Although we and our suppliers attempt to avoid infringing known proprietary rights of third parties in our products, we may be subject to legal proceedings and claims for alleged infringement of a third party’s patents, trade secrets, trademarks, or copyrights.

A successful claim of patent or other IP infringement and damages against us could affect our business, financial condition, and/or results of operations.

If a person or company claims that our products infringed their IP rights, any resulting litigation would be costly, time consuming, and would divert the attention of management and key personnel from other business issues.

The complexity of the technology involved in our business and the uncertainty of IP litigation significantly increases these risks and makes

such risk part of our ongoing business.

To that end, we periodically obtain IP rights, in the ordinary course of business, to strengthen our IP portfolio and minimize potential risks of infringement.

The increasing tendency of patents granted to others on combinations of known technology and claims for royalties are threats to our Company.

Any of these adverse consequences could potentially have a negative impact on our business, financial condition and/or results of operations.

The Company has trade accounts receivable balances due from customers to whom sales are made in the ordinary course of business.

From time to time, the Company also makes loans in the ordinary course of business to certain of its technology investees.

Certain automakers, Tier 1 customers, large retail and commercial customers of the Company, and the Company's technology investees from time to time may consider the sale of certain business segments, bankruptcy, or other changes as a result of financial stress in the existing economic environment.

Should one or more of our larger customers (including sales through their Tier 1 suppliers), our investees to whom we have provided loans, or others to whom the Company has extended credit, declare bankruptcy, become insolvent, and/or sell their business, it would adversely affect the collection of receivables, our business, financial condition, and/or results of operations.

The current economic environment continues to cause increased financial pressures and production stresses on our customers, which could impact the timeliness of customer payments and ultimately the collectability of receivables.

Our allowance for doubtful accounts primarily relates to financially distressed automotive mirror and electronics customers.

We continue to work with these financially distressed customers in collecting past due balances.

Refer to Note 1 of the Consolidated Financial Statements .

Our allowance for credit losses applicable to trade accounts receivable primarily relate to financially distressed automotive mirror and electronics customers.

We continue to work with financially distressed customers in collecting past due balances.

Our allowance for credit losses applicable to loans receivable reflect the Company's estimate of expected credit losses over the contractual life of the loans, considering historical loss experience, current conditions, and reasonable and supportable forecasts.

Refer to Note 1 , Summary of Significant Accounting and R eporting Policies of the Consolidated Financial Statements .

Business Disruptions.

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One of our manufacturing facilities is located in Holland, Michigan, which is approximately three miles from our other primary manufacturing facilities in Zeeland, Michigan.

Should a catastrophic event occur, our ability to manufacture product, complete existing orders and provide other services could be severely impacted for an undetermined period of time.

Should a natural disaster or other catastrophic event occur, our ability to manufacture product, complete existing orders and provide other services could be severely impacted for an undetermined period of time.

We have purchased business interruption insurance to address some of these risks.

Our inability to conduct normal business operations for a period of time may have an adverse impact on our business, financial condition, and/or results of operations.

IT Infrastructure and Cybersecurity .

Any failure of our information technology ("IT") infrastructure adversely impacts our business, financial condition, and/or results of operations.

We rely upon the capacity, reliability and security of our information technology infrastructure and our ability to expand and continually update this infrastructure in response to the changing needs of our business.

Information Technology ("IT) Infrastructure and Cybersecurity .

Any failure of our IT infrastructure adversely impacts our business, financial condition, and/or results of operations.

We rely upon the capacity, reliability and security of our IT infrastructure and our ability to expand and continually update this infrastructure in response to the changing needs of our business.

For example, we have implemented enterprise resource planning and other IT systems in certain aspects of our business over a period of several years and continue to update and further implement new systems going forward.

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We, and certain of our third-party vendors, receive and store personal information in connection with our human resources operations and other aspects of our business.

Despite our implementation of security measures, our IT systems, like all IT systems, are vulnerable to damages from computer

viruses, natural disasters, unauthorized access, cyber-attack and other similar disruptions.

Any such system failure, accident or security breach results in disruptions to our operations.

A material network breach in the security of our IT systems could include the theft of our intellectual property, trade secrets or customer information.

To the extent that any disruptions or security breach results in a loss or damage to our data, or an inappropriate disclosure of confidential or customer information, it could cause significant damage to our reputation, affect our relationships with our customers, lead to claims against the Company and ultimately harm our business, reputation, financial condition, and/or results of operations.

Despite our implementation of security measures, our IT systems, like all IT systems, are vulnerable to damages from computer viruses, natural disasters, unauthorized access, cyber-attack, and other similar disruptions.

System failures, accidents or security breaches result in disruptions to our operations.

A material network breach in the security of our IT systems could include the theft of our IP, trade secrets or customer information.

To the extent that any disruptions or security breaches result in a loss or damage to our data, or an inappropriate disclosure of confidential or customer information, it could cause significant damage to our reputation, affect our relationships with our customers, lead to claims against the Company and ultimately harm our business, reputation, financial condition, and/or results of operations.

In addition, we incur significant costs to protect against damage caused by these disruptions or security breaches.

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As a result, in 2012 the SEC adopted annual disclosure and reporting requirements for those companies who use conflict minerals mined from the DRC and adjoining countries in their products.

These requirements necessitate due diligence efforts, and the Company has disclosed its findings annually to the SEC on Form SD around May 30 each year since 2012.

These requirements necessitate due diligence efforts, and the Company has disclosed its findings annually to the SEC on Form SD around May 30 of each year since 2012.

As there are only a limited number of suppliers offering "conflict free" minerals necessary for our products, the Company cannot always be absolutely certain that we will be able to obtain necessary conflict minerals from such suppliers in sufficient quantities or at competitive prices.

Also, the Company may face reputational challenges if we determine that certain of our products contain minerals not determined to be conflict free or if the Company is unable to sufficiently verify the origins for all conflict minerals used in the Company's products through the procedures the Company has implemented.

Also, the Company may face reputational challenges if we determine that certain of our products contain minerals not determined to be conflict free (not withstanding Company efforts to ensure they are) or if the Company is unable to sufficiently verify the origins for all conflict minerals used in the Company's products through the procedures the Company has implemented.

The Company, along with many governments, regulators, investors, employees, customers and other stakeholders, are increasingly focused on environmental, social, and governance considerations relating to our business, including greenhouse gas emissions, human and civil rights and diversity, equity and inclusion.

New laws and regulations in these areas have been proposed and may be adopted by varying levels of government, and the criteria used by regulators and other relevant stakeholders to evaluate practices, capabilities and performance are changing rapidly, which in each case could require us to undertake costly initiatives or operational changes.

Non-compliance with emerging rules or standards or a failure to address regulator, stakeholder and societal expectations may result in potential cost increases, litigation, fines, penalties, production and sales restrictions, brand or reputational damage, loss of customers, suppliers and commercial partners, failure to retain and attract talent, lower valuation and higher investor activism activities.

In addition, we may make statements about our goals and initiatives in this regard through periodic financial and non-financial reports, information provided on our website, press statements and other communications.

Managing these considerations and implementing these goals and initiatives involves risks and uncertainties, including increased costs, requires investments and often depends on third-party performance or data that is outside our control.

We cannot guarantee that we will achieve any such goals and initiatives we may announce, satisfy all stakeholder expectations, or that the benefits of implementing or achieving these goals and initiatives will not surpass their projected costs.

Any failure, or perceived failure, to achieve such goals and initiatives, as well as to manage risks attendant thereto, adhere to public statements, comply with federal, state or international laws and regulations or meet evolving and varied stakeholder expectations and standards could result in legal and regulatory proceedings against us and materially adversely affect our business, financial condition or results of operations.

Antitakeover Provisions.

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• Changes in investors’ or analysts’ perceptions of the risks and conditions of our business and in particular our primary industry;

• Intellectual property litigation and infringement claims or other litigation;

• IP litigation and infringement claims or other litigation;

• The size of the public float of our common stock;

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and other foreign jurisdictions.

Changes in tax rates, adoption of new tax laws or other additional tax policies, the expiration of existing tax benefits, and other proposals to reform United States and foreign tax laws could adversely affect the Company's operating results, cash flows, and financial condition.

Changes in tax rates, adoption of new tax laws or other additional tax policies, the expiration of existing tax benefits, and other proposals to reform United States and foreign tax laws can adversely affect the Company's operating results, cash

flows, and financial condition.

The Company’s domestic and international tax liabilities are dependent upon the location of earnings among these different jurisdictions.

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Failure to ensure that we have the leadership capacity with the necessary skill sets and experience and a skilled workforce could impede our ability to deliver our growth objectives and execute our strategic plan.

Organizational and reporting changes within management could result in, and low unemployment has contributed to, increased turnover.

Organizational and reporting changes within management could result in, and relatively low unemployment (especially where our manufacturing operations are located) has contributed to, increased turnover.

Turnover, inability to attract and retain key employees, including managers, or government mandated remote work have had, and may continue to have a negative effect on our business, financial condition and/or results of operations.

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• Tariffs (as discussed herein), quotas, customs, and other import or export restrictions and other trade barriers;

• Natural disasters, political crises, and public health crises (e.g.

pandemics), which have caused, are causing, and will likely continue to cause downtime and closures at both supplier and customer facilities;

• Natural disasters, political crises, and public health crises (e.g., pandemics), which have caused, are causing, and will likely continue to cause downtime and closures at both supplier and customer facilities;

• Expropriation and nationalization;

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legal systems;

• Reduced intellectual property protection;

• Reduced IP protection;

• Withholding and other taxes on remittances and other payments by subsidiaries;

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• General economic conditions continue to be of concern in many of the regions in which we do business, given that our primary industry is greatly impacted by overall general economic conditions.

Any continued adverse worldwide economic conditions, currency exchange rates, trade war, war or significant terrorist acts, could each affect worldwide automotive sales and production levels, thereby impacting the Company;

Any continued adverse worldwide economic conditions, currency exchange rates, trade wars (including tariffs and counter-tariff measures), war or significant terrorist acts, each affect worldwide automotive sales and production levels, thereby impacting the Company;

• Climate change;

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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 1A. Risk Factors