Item 1A. Risk Factors
Item
1A. Risk Factors
In
evaluating our Company, careful consideration should be given to the following risk factors, in addition to the other information included
in this Annual Report on Form 10-K. Each of these risk factors could adversely affect our business, operating results and/or financial
condition, as well as adversely affect the value of an investment in our common stock. In addition to the following disclosures, please
refer to the other information contained in this report, including our consolidated financial statements and the related notes.
Risks
Related to our Business
A
large percentage of our net sales have been made to a small number of customers, and the loss of a major customer, if not replaced, would
adversely affect us.
One
customer accounted for at 27.7% of net sales for the year ended December 31, 2024, and two customers, individually, accounted for 25.7%
and 10.3%, respectively, of net sales for the year ended December 31, 2023. The loss of a substantial portion of net sales to our largest
customers could have a material adverse effect on us.
We
are dependent on suppliers for components and raw materials and may experience shortages, extended lead times, cost premiums and shipment
delays that would adversely affect our customers and us.
We
purchase raw materials, commodities and components for use in our production process. Increased costs of these materials could have
an adverse effect on our production costs if we are unable to pass along price increases or reduce the other cost of goods produced
through cost improvement initiatives. Fuel and energy cost increases could also adversely affect our freight and operating costs.
Due to customer specifications and requirements, we are dependent on suppliers to provide critical electronic and other components
and materials for our operations that could result in shortages of some of the components needed for production. Component shortages
may result in an inability to deliver products on time or at all, expedited freight, overtime premiums and increased component
costs. In addition to the financial impact on operations from lost net sales and increased cost, there could potentially be harm to
our customer relationships. To reduce the effects of supply chain disruption for our customers, we purchase and hold raw material
and finished goods inventory, which results in a reduction of cash available. If we are unable to sell such inventory or sell such
inventory within a reasonable timeframe, it may adversely affect our operations and financial results.
6
Our
customers cancel orders, change order quantity, timing and specifications that if not managed would have an adverse effect on the timing
of net sales and inventory carrying costs.
We
face, through the normal course of business, customer cancellations and rescheduled orders and are not always successful in
recovering the costs of such cancellations or rescheduling. With every new product or substantial redesign of a product, we utilize
our new product introduction process. Such process is intended to improve the manufacturability, compliance with customer
specifications and quality standards relating to the product but may result in delays in commencement of production impacting the
timing of net sales. In addition, excess and obsolete inventory losses as a result of customer order changes, cancellations, product
changes and contract termination could have an adverse effect on our operations. We record inventory at the lower of cost or net
realizable value in accordance with generally accepted accounting principles in the United States of America (“U.S.
GAAP”) for exposures related to the estimated impact from these possibilities.
We
depend heavily on our people and may from time to time have difficulty attracting and retaining skilled employees and the cost of labor
may continue to increase.
Our
operations depend upon the continued contributions of our key management, marketing, technical, financial, accounting, product development
engineers, salespeople and operations personnel. We also believe that our continued success will depend upon our ability to attract,
retain and develop highly skilled managerial and technical resources and direct labor resources within our highly competitive industries.
Not being able to attract or retain these employees could have a material adverse effect on net sales and earnings. In addition, the
cost of attracting and retaining direct and indirect labor may continue to increase, which will increase our operating costs and may
reduce our profitability.
Our
engineering net sales depend on our ability to deliver quality value-added engineering services required by our customers.
The
markets for our engineering services are characterized by rapidly changing technology and evolving process development. The
continued success of our business to generate engineering net sales will depend upon our ability to hire and retain qualified
engineering personnel and maintain and enhance our technological leadership. Although we believe that we currently can provide the
value-added engineering services that are required by our customers, there is no certainty that we will develop the capabilities
required by our customers in the future. The emergence of new technology, industry standards or customer requirements may render the
engineering services we currently provide obsolete or uncompetitive. The acquisition and implementation of new engineering
knowledge, technical skills and related equipment may require significant expense that could adversely affect our operating results,
as could our failure to anticipate and adapt to our customers’ changing technological requirements.
We
operate in highly competitive industries, and we depend on continuing outsourcing by Original Equipment Manufacturers (“OEM”).
We
compete against many companies that engineer and manufacture complex electromedical and electromechanical medical
device, medical imaging, aerospace and defense, and industrial products. The larger global competitors have more resources and greater
economies of scale and have more geographically diversified international operations. We also compete with OEM operations that are continually
evaluating manufacturing products internally against the advantages of outsourcing or delaying their decision to outsource. We may also
be at a competitive disadvantage with respect to price when compared to manufacturers with excess capacity, lower cost structures and
availability of lower cost labor.
7
Competitive
factors in our targeted markets are believed to be product and service pricing, quality, the ability to meet delivery schedules,
customer service, value-added engineering, technology solutions and geographic location. We also expect that our competitors will
continue to improve the performance of their current products or services, to reduce their current products or service sales prices
and improve services that may be offered. Any of these could cause a decline in net sales, loss of market share, or lower profit
margin.
The
availability of excess manufacturing capacity of our competitors also creates competitive pressure on price and winning new business.
We must continue to provide a quality product, be responsive and flexible to customers’ requirements, and deliver to customers’
expectations. Our lack of execution could have an adverse effect on our results of operations and financial condition.
The
manufacture and sale of products carries potential risk for product liability claims and warranty claims .
We
generally are required to represent and warrant to our customers that the goods and services we deliver are free from defects in material
and workmanship generally for one year. Certain customers require longer warranty periods. If a product liability claim results in our
being liable, it could have a material adverse effect on our business and financial position. We have insurance coverage for product
liability claims, but there can be no assurances that the amount of coverage will be adequate or that insurance proceeds will be available
for a particular claim. Our insurance may not cover claims for non-conformance or defective products that are not product liability claims
from customers.
The
Company is majority owned by one group of shareholders, and those shareholders may be able to take actions that do not reflect the will
or best interests of other shareholders.
Curtis
Squire, Inc. and the Kunin family, collectively as a group, own a majority of our common stock. As a result, our majority shareholder
group will have the ability to elect all of the members of our Board of Directors and thereby control our policies and operations, including
the appointment of management, future issuances of our common stock or other securities, the payment of dividends, if any, on our common
stock, the incurrence or modification of debt by us, amendments to our articles of incorporation, as amended and amended and restated
bylaws and the entering into of extraordinary transactions, and their interests may not in all cases be aligned with interests of other
shareholders.
In
addition, the majority shareholder group may have an interest in pursuing transactions that, in its judgment, could enhance its investment,
even though such transactions might be inconsistent with your investment objectives.
As
a majority owned or controlled company, NASDAQ does not require the Company to comply with certain corporate governance rules including
that we are not required to have a majority of independent directors on the board, an independent compensation committee, or an independent
nominating and corporate governance committee. The Company is required to have an audit committee comprised of independent directors.
Having fewer independent directors or fewer independent members of the Compensation and Talent Committee or the Nominating and Corporate
Governance Committee may result in increased influence of the majority ownership group over business operations.
Operating
in foreign countries exposes our operations to risks that could adversely affect our operating results.
We
operate manufacturing facilities in Mexico and China. Our operations in those countries are subject to risks that could adversely
impact our financial results and costs, such as economic or political volatility, foreign legal and regulatory requirements, international
trade relations factors (such as tariffs, trade sanctions, duties, export controls and other trade restrictions), protection of our
and our customers’ intellectual property and proprietary technology in certain countries, potentially burdensome taxes, crime,
employee turnover, staffing, managing personnel in diverse culture, labor instability, transportation delays, and foreign currency
fluctuations. Legal and regulatory requirements in Mexico and China are continually changing which may and has affected our ability
to predict timing and/or whether we will receive applicable tax refunds such as VAT tax refunds. The changing regulatory environment
may impact negatively the timing and recognition of such net sales and/or whether we ultimately collect cash from these net sales.
8
We
face risks arising from the restructuring of our operations .
In
recent years, we have undertaken initiatives to restructure our business operations with the intention of improving utilization and realizing
cost savings. These initiatives have included reducing the size of our workforce, changing the number and location of our production
facilities in an effort to align our capacity and infrastructure with current and anticipated customer demand. The process of restructuring
entails, among other activities, moving production between facilities, transferring programs from higher cost geographies to lower cost
geographies, closing facilities, reducing size of our workforce, realigning our business processes and reorganizing our management.
Restructurings
could adversely affect us, including a decrease in employee morale, delays encountered in finalizing the scope of, and implementing,
the restructurings, failure to achieve targeted cost savings, and failure to meet operational targets and customer requirements due to
the restructuring process. These risks are further complicated by our extensive international operations, which subject us to different
legal and regulatory requirements that govern the extent and speed of our ability to reduce our manufacturing capacity and workforce.
We
have and may be required to take additional restructuring charges in the future to align our operations and cost structures with global
economic conditions, market demands, cost competitiveness, and our geographic footprint as it relates to our customers’ production
requirements or following divestitures. We may consolidate or divest certain manufacturing facilities or transfer certain of our operations
to other geographies. If we are required to take additional restructuring charges in the future, our operating results, financial condition,
and cash flows could be adversely impacted.
Risks
Related to our Assets
We
are dependent on our information technology systems for order, inventory and production management, financial reporting, communications
and other functions. If our information systems fail or experience major interruptions due to physical damage or loss of power on our
business and our financial results could be adversely affected.
We
rely on our information technology systems to effectively manage our operational and financial functions. Our computer systems, web sites,
telecommunications, and data networks are vulnerable to damage or interruption from power loss, natural disasters and other sources of
physical damage or disruption to the equipment which maintains, stores and hosts our information technology systems. We have taken steps
to protect and create redundancies for the equipment that facilitates the use of our management information systems, but these steps
may not be adequate to ensure that our operations are not disrupted by events within and outside of our control.
9
Disruptions
to our information systems, including security breaches, losses of data or outages, cyber attacks and other security issues, have and
could in the future adversely affect our operations and/or financial results.
We
rely on information systems, some of which are managed by third parties, to store, process and transmit confidential information, including
financial reporting, inventory management, procurement, invoicing and electronic communications, belonging to our customers, our suppliers,
our employees and/or us. We monitor and mitigate our exposure to cybersecurity issues and modify our systems when warranted and we have
implemented certain business continuity items, including leveraging our multiple sites for redundancies, as well as backup and restore
methods inclusive of off-site, secure hosted and cloud based third-party providers. Nevertheless, these systems are vulnerable to, and
at times have suffered from, among other things, damage from power loss or natural disasters, computer system and network failures, loss
of telecommunication services, physical and electronic loss of data, terrorist attacks, computer viruses, cyberattacks and security breaches,
ranging from uncoordinated individual attempts to gain unauthorized access to our information technology systems to sophisticated and targeted measures.
These include data theft, malware, phishing, ransomware attacks, or other cybersecurity threats or incidents. The increased use of mobile
technologies and the internet of things can heighten these and other operational risks. If we, or the third parties who own and operate
certain of our information systems, are unable to prevent such breaches, losses of data and outages, our operations could be disrupted.
Also, the time and funds spent on monitoring and mitigating our exposure and responding to breaches, including the training of employees,
the purchase of protective technologies and the hiring of additional employees and consultants to assist in these efforts could adversely
affect our financial results. The increasing sophistication of cyberattacks requires us to continually evaluate the threat landscape
and new technologies and processes intended to detect and prevent these attacks. There can be no assurance that the security measures
and systems configurations we choose to implement will be sufficient to protect the data we manage. Any theft or misuse of information
resulting from a security breach could result in, among other things, loss of significant and/or sensitive information, litigation by
affected parties, financial obligations resulting from such theft or misuse, higher insurance premiums, governmental investigations,
negative reactions from current and potential future customers (including potential negative financial ramifications under certain customer
contract provisions) and negative publicity and any of these could adversely affect our financial results.
In
addition, we must comply with increasingly complex regulations intended to protect business and personal data in the U.S. and globally.
In many cases, these laws apply not only to third-party transactions, but also restrict transfers of personal information among the Company
and its international subsidiaries. Several jurisdictions have passed laws in this area, and additional jurisdictions are considering
imposing additional restrictions or have laws that are pending. These laws continue to develop and may be inconsistent from jurisdiction
to jurisdiction. Complying with emerging and changing requirements causes the Company to incur substantial costs and has required and
may in the future require the Company to change its business practices. Compliance with these regulations can be costly and any failure
to comply could result in legal and reputational risks as well as penalties, fines and damages that could adversely affect our financial
results.
We
are investing in new technologies which are inherently risky .
We have made investments in research and development
(“R&D”) of new technologies that we believe if successful will strengthen our relationships with customers. Our intent
is that the Company own intellectual property arising from R&D activities. To the extent that those investment efforts are unsuccessful,
our competitive position may be harmed, and we may not realize a return on our investments.
To compete more successfully, we believe it is advantageous to maintain an effective R&D program to develop new
products and manufacturing processes that will benefit our customers. Our R&D efforts are currently funded through investment of capital
generated from operations, and we incurred R&D expenses of approximately $1.2 million in each of the years ended December 31, 2024
and 2023. We are focusing our R&D efforts across several key areas, including development of fiber optic technologies for a wide range
of applications like active optical cables, expanded beam technology and physical contact cables.
10
We
do not expect all our R&D investments to be successful. Some of our efforts to develop and market new products and technologies fail
or fall short of our expectations, or will not be well-received by customers, who may adopt competing technologies.
Our
investments in new products and technologies are inherently risky and are a departure from historical business operations .
Developing
Company owned technology and products is different than our historical manufacturing business. While we believe that this is an important
step to further cultivate relationships with customers and partners, the Company has not historically developed its own technologies
or products; rather, it has historically developed and manufactured products designed by our customers.
Development
of new products and technologies may expose us to potential product liability risks that are inherent in the design, manufacture and
marketing of those products. As a result, we face an inherent risk of damage to our reputation if one or more of our products or technologies
are, or are alleged to be, defective. Although we carry product liability insurance, we may be exposed to product liability and warranty
claims in the event that our products actually or allegedly fail to perform as expected or the use of our products results, or is alleged
to result, in bodily injury and/or property damage. Product liability, warranty and recall costs may have a material adverse effect on
our business, financial condition and results of operations.
Financial
Risks
If
we fail to comply with the covenants contained in our credit agreement, we may be unable to secure additional financing and repayment
obligations on our outstanding indebtedness may be accelerated.
Our
credit agreement contains financial and operating covenants with which we must comply. Effective as of February 29, 2024, we entered
into a new credit agreement with Bank of America (the “Revolver”.) Our Revolver contains financial and operating
covenants with which we must comply. Our compliance with these covenants is dependent on our financial results, which are subject to
fluctuation as described elsewhere in these risk factors. We were not in compliance with financial covenants related to the maximum
operating expense contributions to our Mexican operations in the first and second quarters of 2024. We received a waiver of the
Mexican operating expenses event of default from the bank in August 2024. On March 27 , 2025, we amended the Revolver
agreement to waive the leverage ratio and minimum charge coverage ratio events of default as of December 31, 2024 and March 31, 2025
and to further defer the Company’s compliance with these ratios until the third quarter of 2025, and reset compliance
thresholds for our covenant ratios for 2025. We have included the Amendment
No. 1 to Credit Agreement, Waiver, and Consent as an exhibit to this filing and any description of that document contained in this
risk factor is only a summary and is qualified by its entirety by the Amendment No. 1 to Credit Agreement, Waiver, and Consent.
If we fail to comply with the covenants in the future or if our lender does not agree to waive any future non-compliance, we may be
unable to borrow funds and any outstanding indebtedness could become immediately due and payable, which could materially harm our
business.
Our
exposure to financially troubled customers, start-up businesses or suppliers may adversely affect our financial results.
We
provide manufacturing services to companies and industries that have in the past, and may in the future, experience financial
difficulty. Also, we provide services and products to new and high growth companies. If our customers experience financial
difficulty or lack of funding for operations, we could have difficulty recovering amounts owed to us from these customers, or demand
for our services or products from these customers could decline. Additionally, if our suppliers experience financial difficulty, we
could have difficulty sourcing supply necessary to fulfill production requirements and meet scheduled shipments. If one or more of
our customers were to become insolvent or otherwise were unable to pay for the services provided by us on a timely basis, or at all,
our operating results and financial condition could be adversely affected. Such adverse effects could include one or more of the
following: an increase in expenses for expected accounts receivable credit losses and inventory write-offs, a reduction in net
sales, and an increase in our working capital requirements due to higher inventory levels and in days our accounts receivables are
outstanding.
11
Changes
in foreign currency translation rates could adversely impact our net sales and earnings.
Changes
in foreign currency exchange rates will impact our reported net sales and earnings. Substantially all our net sales are transacted in
U. S. Dollars. A majority of our manufacturing and cost structure is based in the United States and transacted in U.S. Dollars. We have
exposures to local currencies for certain net sales in China denominated in Chinese Yuan, value added tax receivables denominated in
the Mexican Peso, as well as certain costs incurred at our facilities in China and Mexico that are denominated in their respective local
currencies. Significant fluctuations in foreign exchange rates between the U.S. dollar
and foreign currencies may adversely affect our results of operations.
Our
Mexico facility operates as a maquiladora, and its financial records are kept in Mexican Pesos. As the function currency of the
maquiladora is the U. S. Dollar, we translate the Mexican Pesos financial records into U. S. Dollars and record a currency
translation gain or loss in the statement of operations. These translation gains or losses may be material to the financial results
of the Company. For the years ended December 31, 2024 and 2023, we recorded translation losses of $137 thousand and $54 thousand,
respectively. The majority of these losses were related to the translation of value added tax receivables denominated in Mexican
Pesos.
We
do not expect to pay dividends for the foreseeable future, and we may never pay dividends; investors must rely on stock appreciation
for any return on investment in our common stock.
We
currently intend to retain any future earnings to support the development and expansion of our business and do not anticipate paying
cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of our Board of Directors after
taking into account various factors, including but not limited to, our financial condition, operating results, cash needs, growth plans,
and the terms of any credit agreements that we may be a party to at the time. In addition, our ability to pay dividends on our common
stock may be limited by state law. Accordingly, investors must rely on sales of their common stock after price appreciation, which may
never occur, as the only way to realize certain returns on their investment. As a result, investors must rely on stock appreciation and
a liquid trading market for any return on investment in our common stock.
We
expect volatility in the price of our common stock, which may subject us to securities litigation.
The
market for our common stock may be characterized by significant price volatility when compared to other issuers, and we expect that our
share price will be more volatile than other issuers for the indefinite future. In the past, plaintiffs have often initiated securities
class action litigation against companies following periods of volatility in the market price of their securities. We may in the future
be the target of similar litigation. Securities litigation could result in substantial costs and liabilities and could divert management’s
attention and resources.
If
we fail to maintain effective systems of internal control over financial reporting and disclosure controls and procedures, we may not
be able to accurately report our financial results or prevent fraud.
Effective
internal control over financial reporting and disclosure controls and procedures are necessary for us to provide reliable financial reports
and effectively prevent fraud and operate successfully as a public company. Any failure to develop or maintain effective internal control
over financial reporting and disclosure controls and procedures could harm our reputation or operating results or cause us to fail to
meet our reporting obligations. As we expand our business operations both within the United States and internationally, we will need
to maintain effective internal controls over financial reporting and disclosure controls and procedures.
12
Our
services involve other inventory risk.
Our
production services primarily provide that we purchase some, or all, of the required materials and components based on customer forecasts
or orders. Although, in general, our contracts with our customers obligate our customers to ultimately purchase inventory ordered to
support their forecasts or orders, we generally finance these purchases initially. In addition, suppliers may require us to purchase
materials and components in minimum order quantities that may exceed customer requirements. A customer’s cancellation, delay or
reduction of forecasts or orders can also result in excess inventory or additional expense to us. Engineering changes by a customer or
a product’s end-of-life may result in obsolete materials or components. While we attempt to cancel, return or otherwise mitigate
excess and obsolete inventory, as well as require customers to reimburse us for these items and/or price our services to address related
risks, we may not actually be reimbursed timely or in full, be able to collect on these obligations or adequately reflect such risks
in our pricing. In addition to increasing inventory in certain instances to support new program ramps, we may also increase inventory
if we experience component shortages or longer lead-times for certain components in order to maintain a high level of customer service.
In such situations, we may procure components earlier, which leads to an increase in inventory in the short term and may lead to increased
excess or obsolete inventory in the future. Excess or obsolete inventory, the need to acquire increasing amounts of inventory due to
shortages, customer demand or otherwise, or other failures to manage our working capital, could adversely affect our operating results,
including our return on invested capital.
In
addition, we provide managed inventory programs for some of our customers under which we hold and manage finished goods or work-in-process
inventories. These managed inventory programs may result in higher inventory levels, further reduce our inventory turns and increase
our financial exposure with such customers. In addition, our inventory may be held at a customer’s facility or warehouse, or elsewhere
in a location outside of our control, which may increase the risk of loss. Even though our customers generally have contractual obligations
to purchase such inventories from us, we remain subject to customers’ credit risks as well as the risk of potential customer default
and the need to enforce those obligations.
Market
Risks
The
economic conditions around the world could adversely affect demand for our products and services and the financial health of our customers.
Demand
for our products and services depends upon worldwide economic conditions, including but not limited to overall economic growth rates,
construction, tariffs, taxes, consumer spending and confidence, financing availability, employment rates, interest rates, inflation,
defense spending levels, global politics and conflict, and the profits, capital spending, and liquidity of industrial companies.
13
An
economic downturn or financial market turmoil may depress demand for our products and/or services in all major geographies and markets.
If customers are unable to purchase our products or services because of unavailable credit or unfavorable credit terms, depressed end-user
demand, or are simply unwilling to purchase our products or services, our net sales and earnings will be adversely affected. Also, we
are subject to the risk that our customers will have financial difficulties, which could harm their ability to satisfy their obligation
to pay accounts receivable. Further, an economic downturn may affect our ability to satisfy the financial covenants in our
financing arrangements.
Pandemics
or disease outbreaks could adversely affect our operations, supply chains, financial condition and results of operations.
Outbreaks
of epidemic, pandemic, or contagious diseases, such as, historically, the COVID-19 virus, Ebola virus, Middle East Respiratory Syndrome,
Severe Acute Respiratory Syndrome, or the H1N1 virus, could cause a disruption to our business. Business disruptions could include temporary
closures of our facilities or the facilities of our suppliers, reduced demand from customers, unavailability or restricted availability
of our material portions of our workforce, raw materials or components necessary to manufacture our products, or disruptions or restrictions
on our ability to travel or to distribute our products. Any disruption of our operations, our suppliers or our customers would likely
impact our net sales and operating results. In addition, a significant outbreak of epidemic, pandemic, or contagious diseases in the
human population could result in a widespread health crisis that could adversely affect the economies and financial markets of many countries,
resulting in an economic downturn that could affect demand for our products and services. Any of these events could negatively impact
our net sales and have a material adverse effect on our business, financial condition, results of operations, or cash flows.
Legal
and Regulatory Risks
We
are subject to extensive government regulations and industry standards and the terms of complex contracts; a failure to comply with current
and future regulations and standards, or the terms of our contractual arrangements, could have an adverse effect on our business, customer
relationships, reputation and profitability.
We
are subject to extensive government regulation and industry standards relating to the products we manufacture as well as how we conduct
our business, including regulations and standards relating to labor and employment practices, workplace health and safety, the environment,
sourcing and import/export practices, the market sectors we support, privacy and data protection, the regulations that apply to government
contracts, and many other facets of our operations. The regulatory climate in the U.S. and other countries has become increasingly complex
and fragmented, and regulatory activity has increased in recent periods. Failure or noncompliance with such regulations or standards
could have an adverse effect on our reputation, customer relationships, profitability and results of operations. In addition, we regularly
enter into a large number of complex contractual arrangements as well as operate pursuant to the terms of a significant number of ongoing
intricate contractual arrangements. Our failure or our customers’ failure to comply with the terms of such arrangements could expose
us to claims or other demands and could have an adverse effect on our reputation, customer relationships, profitability and results of
operations.
We
may not meet regulatory quality standards applicable to our manufacturing and quality processes which could have an adverse effect on
our business .
We
are registered with the FDA and are subject to periodic inspection by the FDA for compliance with its Quality Management System Regulation/Medical
Device Good Manufacturing Practices requirements, which require manufacturers of medical devices to adhere to certain regulations, including
testing, quality control and documentation procedures.
Also,
our US facilities are ITAR compliant which is required for our manufacturing of defense related products. Compliance with applicable
regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections and product field monitoring.
If any inspection reveals noncompliance with these regulations, it could adversely affect our operations.
Our
international operations are, and will continue to be, subject to risks relating to changes in foreign legal and regulatory requirements.
It
can be costly and time-consuming for the Company and our customers to obtain and maintain regulatory approvals and certifications to
operate in these markets. Product approvals subject to regulations might not be granted for new medical devices on a timely basis, if
at all. Proposed new regulations or changes to regulations could result in the need to incur significant additional costs to comply.
Failure of the Company or any of its customers operating in these markets to effectively respond to changes to applicable laws and regulations
or comply with existing and future laws and regulations may have a negative effect on the Company’s business, financial condition,
results of operations and cash flows.
14
Complying
with securities laws, tax laws, accounting policies and regulations, and subsequent changes, may be costly for us and adversely affect
our financial statements.
New
or changing laws, regulations, policy and standards relating to corporate governance and public disclosure, including SEC and Nasdaq
regulations, domestic or international tax legislation and the implementation of significant changes in U.S. GAAP, present
challenges due to complexities, assumptions and judgements required to implement. We apply judgments based on our understanding,
interpretation and analysis of the relevant facts, circumstances, historical experience and valuations, as appropriate. As a result,
actual amounts could differ from those estimated at the time the financial statements are issued. In addition, implementation may
change the financial accounting or reporting standards that govern the preparation of our financial statements or authoritative
entities could reverse their previous interpretations or positions on how various financial accounting or reporting standards should
be applied. These changes may be difficult to predict and implement and could materially or otherwise impact how we prepare and
report our estimates, uncertainties, financial statements, operating results and financial condition. Our efforts to comply with
evolving laws, regulations, accounting policies and standards have resulted in, and are likely to continue to result in, increased
general and administrative expenses and management time and attention from net sales-generating activities to compliance activities
and may have an adverse effect on our financial statements, including cash flows.
Anti-Corruption
and Trade Laws - We may incur costs and suffer damages if our employees, agents, or suppliers violate anti-bribery, anti-corruption or
trade laws and regulations.
Laws
and regulations related to bribery, corruption and trade, and enforcement thereof, are increasing in frequency, complexity and severity
on a global basis. The continued geographic expansion of our business into China and Mexico increases our exposure to, and cost of complying
with, these laws and regulations. If our internal controls and compliance program do not adequately prevent or deter our employees, agents,
suppliers and other third parties with whom we do business from violating anti-corruption laws, we may incur defense costs, fines, penalties,
reputational damage and business disruptions.
Non-compliance
with environmental laws may result in restrictions and could adversely affect operations.
Our
operations are regulated under a number of federal, state, and foreign environmental and safety laws and regulations that govern the
discharge of hazardous materials into the air and water, as well as the handling, storage, and disposal of such materials. These laws
and regulations include the Clean Air Act; the Clean Water Act; the Resource Conservation and Recovery Act; and the Comprehensive Environmental
Response, Compensation, and Liability Act; as well as similar federal, state and foreign laws. Compliance with these environmental laws
is a major consideration for us due to our manufacturing processes and materials. It is possible we may be subject to potential financial
liability for costs associated with the investigation and remediation at our sites; this may have an adverse effect on operations. We
have not incurred significant costs related to compliance with environmental laws and regulations and we believe that our operations
comply with all applicable environmental laws.
Environmental
laws could also become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with
violation. We operate in environmentally sensitive locations and are subject to potentially conflicting and changing regulatory agendas
of political, business, and environmental groups. Changes or restrictions on discharge limits; emissions levels; or material storage,
handling, or disposal might require a high level of unplanned capital investment or relocation. It is possible that environmental compliance
costs and penalties from new or existing regulations may harm our business, financial condition, and results of operations.
15
Global
climate change and related regulations could negatively affect the Company.
Changes
in environmental and climate change laws or regulations, including laws relating to Green House Gas (“GHG”) emissions, could
lead to new or additional investment in the Company’s facilities and could increase environmental compliance expenditures. Changes
in climate change concerns including GHG emissions, and the regulation of such concerns including climate-related disclosures, could
subject the Company to additional costs and restrictions, including increased energy and raw material costs and other compliance requirements
which could negatively impact the Company’s reputation, business, capital expenditures, results of operations and financial position.
Natural
disasters, such as tornadoes and earthquakes, and possible future changes in climate could negatively impact our business and supply
chain. Our properties may be exposed to rare catastrophic weather events, such as severe storms and/or floods. If the frequency of extreme
weather events increases due to climate change, our exposure to these events could increase.
If
we use hazardous materials in a manner that causes contamination or injury, we could be liable for resulting damages.
We
are subject to Federal, State, and local laws, rules and regulations governing the use, discharge, storage, handling, and disposal of
biological material, chemicals, and waste. We cannot eliminate the risk of accidental contamination or injury to employees or third parties
from the use, storage, handling, or disposal of these materials. In the event of contamination or injury, we could be held liable for
any resulting damages, remediation costs, and any related penalties or fines. This liability could exceed our resources or any applicable
insurance coverage we may have. The cost of compliance with these laws and regulations may become significant, and our failure to comply
may result in substantial fines or other consequences, and either could have a significant impact on our operating results.
If
we are not able to comply with Department of Defense cybersecurity requirements, our net sales from defense contractors could be
reduced.
In
2019, the U.S. Department of Defense announced the development of Cybersecurity Maturity Model Certification (“CMMC”) as
a framework to assess and enhance the cybersecurity posture of the Defense Industrial Base (“DIB”), particularly as it relates
to controlled unclassified information within the supply chain. CMMC is designed to ensure that contractors providing services to the
U.S. Department of Defense have implemented cybersecurity controls and processes to adequately protect information that resides on DIB
systems and networks. We are working to comply with CMMC requirements with the intention of seeking CMMC level 2 compliance in 2025.
If we are unsuccessful in our efforts to timely comply with CMMC requirements, our ability to maintain contracts with customers that
are defense contractors and resulting net sales may be impacted negatively.