Item
1a. Risk Factors.
Investing
in our common stock is highly speculative and involves a significant degree of risk. Before you invest in our securities, you should
give careful consideration to the following risk factors, in addition to the other information included in this Annual Report on Form
10-K, including our financial statements and related notes, before deciding whether to invest in our securities. The occurrence of any
of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition,
results of operations or prospects. In that case, the trading price of our common stock could decline, and you may lose all or part of
your investment.
Risks
Related to Our Business and Operations
The
Company operates through SteriLumen and MunnWorks and its only material assets are its equity interests in those subsidiaries. As a result,
our only current source of revenue is distributions from our subsidiaries and SteriLumen has incurred losses since its inception and
we anticipate it will continue to incur significant losses for the foreseeable future and revenue from MunnWorks may not be sufficient
to offset those loses.
The
Company is a holding company for SteriLumen and MunnWorks and has no material assets other than its equity interests in those subsidiaries.
Therefore, the only current revenue source is future distributions from its subsidiaries. SteriLumen is an early-stage designer and marketer
of disinfection systems with limited operating history spanning from December 2016. We expect negative cash flows from SteriLumen’s
operations for the foreseeable future which may not be off-set by cash flows from MunnWorks. Our utilization of cash has been and will
continue to be highly dependent on SteriLumen’s product development programs and cash flow from MunnWorks’ operations. Our
cash expenses will be highly dependent on the product development programs that SteriLumen chooses to pursue, the progress of these product
development programs, the results of SteriLumen’s validation/marketing studies, the terms and conditions of SteriLumen’s
contracts with service providers and manufacturing contractors, and the terms of recruitment of facilities in our validation/marketing
studies. In addition, the continuation of SteriLumen’s validation/marketing studies, and quite possibly its entire business, will
depend on results of upcoming clinical data analyses and our financial resources at the time. Failure to raise capital as and when needed,
on favorable terms or at all, would have a negative impact on our financial condition and SteriLumen’s ability to develop its product
candidates.
SteriLumen
has devoted substantially all of its financial resources to develop its product candidates. SteriLumen has financed its operations primarily
through the contributions of its founders. The amount of SteriLumen’s future net losses will depend, in part, on the development
of adequate distribution channels for the Disinfecting System, the demand for the Disinfecting System, the rate of its future expenditures
and our ability to obtain funding through the issuance of our securities, strategic collaborations or grants. Disinfection product development
is a highly speculative undertaking and involves a substantial degree of risk. SteriLumen successfully completed the prototype phase
of testing and development for the Disinfecting System, but has not yet commenced pivotal testing in health care facility settings. Even
if SteriLumen obtains positive results from such testing, its future revenue will depend upon its ability to achieve sufficient market
acceptance, pricing, the performance of its independent sales representatives and its manufacturing and distribution suppliers.
We
expect SteriLumen to continue to incur significant losses until it is able to commercialize the Disinfecting System, which it may not
be successful in achieving. We anticipate that SteriLumen’s expenses will increase substantially if and as SteriLumen:
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continues
the research and development of the Disinfecting System and other disinfecting products; |
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expands
the scope of its testing for the Disinfecting System and other disinfecting products; |
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establishes
a sales, marketing, and distribution infrastructure to commercialize its product candidates; |
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seeks
to maintain, protect, and expand its intellectual property portfolio; |
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seeks
to attract and retain skilled personnel; and |
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creates
additional infrastructure to support its product candidate development and planned future commercialization efforts. |
Furthermore,
any additional fundraising efforts may divert our management from our subsidiaries’ day-to-day activities, which may adversely
affect our ability to develop and commercialize their product candidates. In addition, we cannot guarantee that future financing will
be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect
the holdings or the rights of holders of our securities and the issuance of additional securities, whether equity or debt, by us, or
the possibility of such issuance, may cause the market price of our shares to decline. The incurrence of indebtedness could result in
increased fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations on our ability
to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions
that could adversely affect our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative
partners or otherwise at an earlier stage than otherwise would be desirable, and we may be required to relinquish rights to some of our
technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on
our business, operating results, and prospects. Even if we believe that we have sufficient funds for our current or future operating
plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.
If
we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our
research or development programs or the commercialization of any product candidates or be unable to expand our operations or otherwise
capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of
operations.
The
pandemic caused by the spread of the Coronavirus could have an adverse impact on our financial condition and results of operations and
other aspects of our business.
In
December 2019, a novel strain of Coronavirus was reported to have surfaced in Wuhan, China. The virus has since spread to over 150 countries
and every state in the United States. On January 30, 2020, the World Health Organization declared the outbreak of Coronavirus a “Public
Health Emergency of International Concern”. On March 11, 2020, the World Health Organization declared the outbreak a pandemic,
and on March 13, 2020, the United States declared a national emergency.
The
spread of the virus in many countries continues to adversely impact global economic activity and has contributed to significant volatility
and negative pressure in financial markets and supply chains. The pandemic has had, and could have a significantly greater, material
adverse effect on the U.S. economy where we conduct a majority of our business. The pandemic has resulted, and may continue to result
for an extended period, in significant disruption of global financial markets, which may reduce our ability to access capital in the
future, which could negatively affect our liquidity.
Most
states and cities have reacted by instituting quarantines, restrictions on travel, “stay at home” and “social distancing”
rules and restrictions on the types of businesses that may continue to operate, as well as guidance in response to the pandemic and the
need to contain it.
We
have taken steps to take care of our employees, including providing the ability for employees to work remotely and implementing strategies
to support appropriate social distancing techniques for those employees who are not able to work remotely. We have also taken precautions
with regard to employee, facility, and office hygiene as well as implementing significant travel restrictions. We are also assessing
our business continuity plans for all business units in the context of the pandemic. This is a rapidly evolving situation, and we will
continue to monitor and mitigate developments affecting our workforce, our suppliers, our customers, and the public at large to the extent
we are able to do so. We have and will continue to carefully review all rules, regulations, and orders and responding accordingly. We
are dependent upon suppliers to provide us with all of the raw materials for products that we manufacture and sell and we currently manufacture
the majority of our products in China. The pandemic has impacted and may continue to impact suppliers of materials and the manufacturing
locations for our products. As a result, we have faced and may continue to face delays or difficulty manufacturing certain products,
which could negatively affect our business and financial results. Even if we are able to find alternate sources for materials and manufacturing,
they may cost more, which could adversely impact our profitability and financial condition.
If
the current pace of the pandemic cannot be slowed and the spread of the virus is not contained, our business operations could be further
delayed or interrupted. We expect that government and health authorities may announce new or extend existing restrictions, which could
require us to make further adjustments to our operations in order to comply with any such restrictions. We may also experience limitations
in employee resources. In addition, our operations could be disrupted if any of our employees were suspected of having the virus, which
could require quarantine of some or all such employees or closure of our facilities for disinfection. The duration of any business disruption
cannot be reasonably estimated at this time but may materially affect our ability to operate our business and result in additional costs.
Although
it is difficult to predict the effect and ultimate impact of the Coronavirus outbreak on our business, it is likely that the impact of
Coronavirus will adversely affect our results of operations, financial condition and cash flows in fiscal year 2022.
We
are vulnerable to continued global economic uncertainty and volatility in financial markets.
Our
business is highly sensitive to changes in general economic conditions as a seller of goods and services. Financial markets inside the
United States and internationally have experienced extreme disruption in recent times, including, among other things, extreme volatility
in security prices, severely diminished liquidity and credit availability, and declining valuations of investments. We believe these
disruptions are likely to have an ongoing adverse effect on the world economy. A continuing economic downturn and financial market disruptions
could have a material adverse effect on our business, financial condition, and results of operations, including by:
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reducing
demand for our products and services, increasing order cancellations and resulting in longer sales cycles and slower adoption of
new technologies; |
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increasing
the difficulty of collecting accounts receivable and the risk of excess and obsolete inventories; |
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increasing
price competition in our served markets; and |
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resulting
in supply interruptions, which could disrupt our ability to produce our products. |
We
could need to raise additional capital in the future, and if we are unable to secure adequate funds on terms acceptable to us, we could
be unable to execute our business plan.
To
remain competitive, we must continue to make significant investments in the development of our products, the expansion of our sales and
marketing activities, and the expansion of our operating and management infrastructure as we increase sales domestically and internationally.
If cash generated from our operations is insufficient to fund such growth, we could be required to raise additional funds through the
issuance of equity or debt securities in the public or private markets, or through a collaborative arrangement or sale of assets. Additional
financing opportunities may not be available to us, or if available, may not be on favorable terms. The availability of financing opportunities
will depend, in part, on market conditions, and the outlook for our business. Any future issuance of equity securities or securities
convertible into equity securities could result in substantial dilution to our stockholders, and the securities issued in such a financing
could have rights, preferences or privileges senior to those of our Common Stock. In addition, if we raise additional funds through debt
financing, we could be subject to debt covenants that place limitations on our operations. We could not be able to raise additional capital
on reasonable terms, or at all, or we could use capital more rapidly than anticipated. If we cannot raise the required capital when needed,
we may not be able to satisfy the demands of existing and prospective customers, we could lose revenue and market share and we may have
to curtail our capital expenditures.
The
following factors, among others, could affect our ability to obtain additional financing on favorable terms, or at all:
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our
results of operations; |
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general
economic conditions and conditions in the sanitation and disinfection industries and performance of sanitation devices as opposed
to sanitation and disinfection substances; |
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the
perception of our business in the capital markets; |
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making
capital improvements to improve our infrastructure; |
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hiring
qualified management and key employees; |
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responding
to competitive pressures; |
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complying
with regulatory requirements, if any; |
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our
ratio of debt to equity; |
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our
financial condition; |
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our
business prospects; and |
If
we are unable to obtain sufficient capital in the future, we could have to curtail our capital expenditures. Any curtailment of our capital
expenditures could result in a reduction in net revenue, reduced quality of our products, increased manufacturing costs for our products,
harm to our reputation, or reduced manufacturing efficiencies and could have a material adverse effect on our business, financial condition,
and results of operations.
Raising
additional capital may cause dilution to our existing stockholders and restrict our operations or require us to relinquish certain intellectual
property rights.
We
may seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships and
alliances, licensing arrangements, and grants. To the extent that we raise additional capital through the sale of equity or convertible
debt securities, the ownership interest of our existing stockholders may be diluted, and the terms may include liquidation or other preferences
that adversely affect the rights of our stockholders. Debt and receivables financings may be coupled with an equity component, such as
warrants to purchase shares, which could also result in dilution of our existing stockholders’ ownership. The incurrence of indebtedness
would result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our
ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions
that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances
and licensing arrangements with third parties, we may have to relinquish valuable rights to our or our subsidiaries’ products or
grant licenses on terms that are not favorable to us. A failure to obtain adequate funds may cause us to curtail certain operational
activities, including research and development, validation/marketing studies, sales and marketing, and manufacturing operations, in order
to reduce costs and sustain the business, and would have a material adverse effect on our business and financial condition.
Our
success depends, in part, on our relationships with, and the efforts of, third-party manufacturers, distributors, and other third parties
that perform various tasks for us. If these third parties do not successfully carry out their contractual duties or meet expected, we
may not be able to commercialize our product candidates and our business could be substantially harmed.
While
we internally manufacture all of MunnWorks’ products that are manufactured domestically, currently approximately 75% of MunnWorks’
products and all of SteriLumen’s products are manufactured overseas in China by third party manufacturers. We do not currently
have the infrastructure or capability internally to manufacture all of the components of our products and systems, and we lack the resources
and the capability to manufacture and distribute the Disinfecting System on a commercial scale. We plan to rely on third parties for
such operations. There are a limited number of manufacturers who have the ability to produce our products, and there may be a need to
identify alternate manufacturers to prevent a possible disruption of our manufacturing and distribution process. Switching manufacturers
or distributors, if necessary, may involve substantial costs and is likely to result in a delay in our desired commercial timelines,
which could harm our business and results of operations.
Our
suppliers may not supply us with a sufficient amount or adequate quality of materials, which could have a material adverse effect on
our business, financial condition, and results of operations.
Our
business depends on our ability to obtain timely deliveries of materials, components, and subassemblies of acceptable quality and in
acceptable quantities from third-party suppliers. We generally purchase components and subassemblies from a limited group of suppliers
through purchase orders, rather than written supply contracts. Consequently, many of our suppliers have no obligation to continue to
supply us on a long-term basis. In addition, our suppliers manufacture products for a range of customers, and fluctuations in demand
for the products those suppliers manufacture for others could affect their ability to deliver components for us in a timely manner. Moreover,
our suppliers could encounter financial hardships, be acquired, or experience other business events unrelated to our demand for components,
which could inhibit or prevent their ability to fulfill our orders and satisfy our requirements.
If
any of our suppliers cease to provide us with sufficient quantities of our components in a timely manner or on terms acceptable to us,
or ceases to manufacture components of acceptable quality, we could incur manufacturing delays and sales disruptions while we locate
and engage alternative qualified suppliers, and we might be unable to engage acceptable alternative suppliers on favorable terms. In
addition, we could need to reengineer our components, which could significantly delay production. Any interruption or delay in the supply
of components or materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely
manner, could impair our ability to meet the demand of our customers and cause them to cancel orders or switch to competitive procedures.
We are continually in the process of identifying and qualifying alternate source suppliers for our key components. There can be no assurance,
however, that we will successfully identify and qualify an alternate source supplier for any of our key components or that we could enter
into an agreement with any such alternate source supplier on terms acceptable to us, or at all.
Our
reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them
or that our trade secrets will be misappropriated or disclosed.
Because
we rely on third parties to develop and manufacture our products, we must, at times, share trade secrets with them. We seek to protect
our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative
research agreements, consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior
to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use
or disclose our confidential information, such as trade secrets. Despite the contractual provisions employed when working with third
parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by
our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.
Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade
secrets or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business.
We
may engage in future acquisitions or strategic transactions which may require us to seek additional financing or financial commitments,
increase our expenses and/or present significant distractions to our management.
We
may make acquisitions in the future. In the event we engage in an acquisition or strategic transaction, we may need to acquire additional
financing (particularly, if the acquired entity is not cash flow positive or does not have significant cash on hand). Obtaining financing
through the issuance or sale of additional equity and/or debt securities, if possible, may not be at favorable terms and may result in
additional dilution to our current stockholders. Any future acquisition by us or one of our subsidiaries may require us to incur non-recurring
or other charges, may increase our near and long-term expenditures, and may pose significant integration challenges or disrupt our management
or business, which could adversely affect our operations and financial results. For example, an acquisition or strategic transaction
such as the acquisition may entail numerous operational and financial risks, including the risks outlined above and additionally:
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exposure
to unknown liabilities; |
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disruption
of our business and diversion of our management’s time and attention in order to develop acquired products or technologies
higher than expected acquisition and integration costs; |
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write-downs
of assets or goodwill or impairment charges; |
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increased
amortization expenses; |
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difficulty
and cost in combining the operations and personnel of any acquired businesses with our operations and personnel; |
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impairment
of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and |
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inability
to retain key employees of any acquired businesses. |
Accordingly,
although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and
any transactions that we do complete could have a material adverse effect on our business, results of operations, financial condition
and prospects.
Recent
U.S. tax legislation may materially affect our financial condition, results of operations and cash flows.
The
recently enacted Tax Cuts and Jobs Act (the “Tax Act”) has significantly changed the U.S. federal income taxation of U.S.
businesses, including by reducing the U.S. corporate income tax rate, limiting interest deductions, permitting immediate expensing of
certain capital expenditures, modifying or repealing many business deductions and credits.
The
Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) modifies certain provisions of the Tax Act, including
increasing the amount of interest expense that may be deducted.
The
Tax Act as modified by the CARES Act is unclear in many respects and could be subject to potential amendments and technical corrections,
as well as interpretations and implementing regulations by the Treasury and IRS, any of which could lessen or increase certain adverse
impacts of the legislation. In addition, it is unclear how these U.S. federal income tax changes will affect state and local taxation,
which often uses federal taxable income as a starting point for computing state and local tax liabilities. Our analysis and interpretation
of this legislation is preliminary and ongoing and there may be material adverse effects resulting from the legislation that we have
not yet identified. While some of the changes made by the tax legislation may adversely affect us, other changes may be beneficial. We
continue to work with our tax advisors and auditors to determine the full impact that the recent tax legislation as a whole will have
on us. We urge our investors to consult with their legal and tax advisors with respect to such legislation and its potential effect on
an investment in our common stock.
Our
operating results are affected by many factors and may fluctuate significantly on a quarterly basis.
Our
operating results may vary substantially from quarter to quarter and may be greater or less than those achieved in the immediately preceding
period or in the comparable period of the prior year. Factors that may cause quarterly results to vary include, but are not limited to,
the following:
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the
number of new product introductions by our subsidiaries; |
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losses
related to inventory write-offs; |
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marketing
exclusivity, if any, which may be obtained on certain new products; |
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the
level of competition in the marketplace for certain products; |
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our
subsidiaries’ ability to create demand in the marketplace for their products; |
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availability
of raw materials and finished products from suppliers; |
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our
subsidiaries’ ability to contract manufacturers to make their products; |
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Our
dependence on a small number of products for a significant portion of net revenue or income; |
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price
erosion and customer consolidation; and |
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uncertainty
of future import tariffs. |
The
profitability of our subsidiaries’ product sales is also dependent upon the prices they are able to charge for their products,
the costs to purchase products from third parties, and their ability to manufacture their products in a cost-effective manner. If their
revenues decline or do not grow as anticipated, they may not be able to reduce their operating expenses to offset such declines. Failure
to achieve anticipated levels of revenues could, therefore, significantly harm our operating results for a particular fiscal period.
We
could be subject to significant warranty obligations if our products are defective, which could have a material adverse effect on our
business, financial condition, and results of operations.
In
manufacturing our products, we depend upon third parties for the supply of various components. Many of these components require a significant
degree of technical expertise to design and produce. If we fail to adequately design, or if our suppliers fail to produce components
to specification, or if the suppliers, or we, use defective materials or workmanship in the manufacturing process, the reliability and
performance of our products will be compromised. Our products could contain defects that cannot be repaired easily and inexpensively
that can result some or all of the following:
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loss
of customer orders and delay in order fulfillment; |
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damage
to our brand reputation; |
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increased
cost of our warranty program due to product repair or replacement; |
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inability
to attract new customers; |
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diversion
of resources from our manufacturing and engineering and development departments into our service department; and |
We
are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity
and data leakage risks.
Significant
disruptions to our information technology systems or breaches of information security could adversely affect our business. In the ordinary
course of business, we collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure
manner to maintain the confidentiality and integrity of such information. We have also outsourced significant elements of our information
technology infrastructure; as a result, we manage independent vendor relationships with third parties who are responsible for maintaining
significant elements of our information technology systems and infrastructure and who may or could have access to our confidential information.
The size and complexity of our information technology systems, and those of our third-party vendors, make such systems potentially vulnerable
to service interruptions and security breaches from inadvertent or intentional actions by our employees, partners or vendors. These systems
are also vulnerable to attacks by malicious third parties and may be susceptible to intentional or accidental physical damage to the
infrastructure maintained by us or by third parties. Maintaining the secrecy of confidential, proprietary, and/or trade secret information
is important to our competitive business position. While we have taken steps to protect such information and have invested in systems
and infrastructures to do so, there can be no guarantee that our efforts will prevent service interruptions or security breaches in our
systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect our business
operations or result in the loss, dissemination, or misuse of critical or sensitive information. A breach our security measures or the
accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information,
or other confidential information, whether as a result of theft, hacking, fraud, trickery or other forms of deception, or for any other
cause, could enable others to produce competing products, use our proprietary technology or information, and/or adversely affect our
business position. Further, any such interruption, security breach, loss or disclosure of confidential information could result in financial,
legal, business, and reputational harm to us and could have a material adverse effect on our business, financial position, results of
operations and/or cash flow.
Product
liability claims against us could be costly and could harm our reputation.
The
sale of our products involves the risk of product liability claims against us. Claims could exceed our product liability insurance coverage
limits. Our insurance policies are subject to various standard coverage exclusions, including damage to the product itself, losses from
recall of our product, and losses covered by other forms of insurance such as workers compensation. We cannot be certain that we will
be able to successfully defend any claims against us, nor can we be certain that our insurance will cover all liabilities resulting from
such claims. In addition, we cannot provide assurance that we will be able to obtain such insurance in the future on terms acceptable
to us, or at all. Regardless of merit or eventual outcome, any product liability claim brought against us could result in harm to our
reputation, decreased demand for our products, costs related to litigation, product recalls, loss of revenue, an increase in our product
liability insurance rates, or the inability to secure coverage in the future, and could have a material adverse effect on our business
by reducing cash collections from customers and limiting our ability to meet our operating cash flow requirements.
Litigation
against us could be costly and time-consuming to defend and could materially and adversely affect our business, financial condition,
and results of operations.
We
are from time to time involved in various claims, litigation matters and regulatory proceedings incidental to our business, including
claims for damages arising out of the use of our products or services and claims relating to intellectual property matters, employment
matters, commercial disputes, competition, sales and trading practices, environmental matters, personal injury, and insurance coverage.
Some of these lawsuits include claims for punitive as well as compensatory damages. The defense of these lawsuits could divert our management’s
attention, and we could incur significant expenses in defending these lawsuits. In addition, we could be required to pay damage awards
or settlements or become subject to unfavorable equitable remedies. Moreover, any insurance or indemnification rights that we could have
may be insufficient or unavailable to protect us against potential loss exposures.
If
we lose our key management personnel, or are unable to attract or retain qualified personnel, it could adversely affect our ability to
execute our growth strategy.
Our
success is dependent, in part, upon our ability to hire and retain management, engineers, marketing and sales personnel, and technical,
research and other personnel who are in high demand and are often subject to competing employment opportunities. Our success will depend
on our ability to retain our current personnel and to attract and retain qualified like personnel in the future. Competition for senior
management, engineers, marketing and sales personnel, and other specialized technicians is intense and we may not be able to retain our
personnel. If we lose the services of any executive officers or key employees, our ability to achieve our business objectives could be
harmed or delayed, which could have a material adverse effect on our daily operations, operating cash flows, results of operations, and
ultimately share price. In general, our officers could terminate their employment at any time without notice for any reason.
Climate
change initiatives could materially and adversely affect our business, financial condition, and results of operations.
Both
domestic and international legislation to address climate change by reducing greenhouse gas emissions and establishing a price on carbon
could create increases in energy costs and price volatility. Considerable international attention is now focused on development of an
international policy framework to address climate change. Proposed and existing legislative efforts to control or limit greenhouse gas
emissions could increase the cost of raw materials derived from sources that generate greenhouse gas emissions. If our suppliers are
unable to obtain energy at a reasonable cost in the future, the cost of our raw materials could be negatively impacted which could result
in increased manufacturing costs.
Our
failure to maintain effective internal controls over financial reporting could have an adverse impact on us.
We
are required to establish and maintain appropriate internal controls over financial reporting. Failure to establish those controls, or
any failure of those controls once established, could adversely impact our public disclosures regarding our business, financial condition
or results of operations. In addition, management’s assessment of internal controls over financial reporting may identify weaknesses
and conditions that need to be addressed in our internal controls over financial reporting or other matters that may raise concerns for
investors. Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reporting,
disclosure of management’s assessment of our internal controls over financial reporting or disclosure of our public accounting
firm’s attestation to or report on management’s assessment of our internal controls over financial reporting may have an
adverse impact on the price of our common stock.
A
control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of
the control system are met. In addition, the design of a control system must reflect the fact that there are resource constraints and
the benefit of controls must be relative to their costs. Because of the inherent limitations in all control systems, no system of controls
can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. These inherent
limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error
or mistake. Further, controls can be circumvented by individual acts of some persons, by collusion of two or more persons, or by management
override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of
future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Over time, a control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may
deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may
not be detected.
At
present, we believe that we have effective internal controls in place. However, our management, including our Chief Executive Officer,
cannot guarantee that our internal controls and disclosure controls that we have in place will prevent all possible errors, mistakes
or all fraud.
Our
financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information, which, as a
public company, could materially harm our stock price.
We
require significant financial resources to maintain our public reporting status. We cannot assure you we will be able to maintain adequate
resources to ensure that we will not have any future material weakness in our system of internal controls. The effectiveness of our controls
and procedures may in the future be limited by a variety of factors including:
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faulty
human judgment and simple errors, omissions or mistakes; |
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fraudulent
action of an individual or collusion of two or more people; |
|
• |
inappropriate
management override of procedures; and |
|
• |
the
possibility that any enhancements to controls and procedures may still not be adequate to assure timely and accurate financial information. |
Our
internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles
in the United States of America. Our internal control over financial reporting includes those policies and procedures that (i) pertain
to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets
of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements
in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in
accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention
or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect
on the financial statements.
Despite
these controls, because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives.
Furthermore, smaller reporting companies like us face additional limitations. Smaller reporting companies employ fewer individuals and
can find it difficult to employ resources for complicated transactions and effective risk management. Additionally, smaller reporting
companies tend to utilize general accounting software packages that lack a rigorous set of software controls.
If
we fail to have effective controls and procedures for financial reporting in place, we could be unable to provide timely and accurate
financial information and be subject to investigation by the Securities and Exchange Commission and civil or criminal sanctions.
We
are an “emerging growth company” under the JOBS Act of 2012 and we cannot be certain if the reduced disclosure requirements
applicable to emerging growth companies will make our common stock less attractive to investors.
We
are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”),
and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that
are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation
requirements of section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic
reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and
shareholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock
less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may
be a less active trading market for our common stock and our stock price may be more volatile.
In
addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended
transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933 (the “Securities Act”) for complying with
new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting
standards until those standards would otherwise apply to private companies. We are choosing to take advantage of the extended transition
period for complying with new or revised accounting standards.
We
will remain an “emerging growth company” until December 31, 2025, the last day of the fiscal year following the fifth anniversary
of August 31, 2020, the date of the first sale of our Common Stock pursuant to an effective registration statement under the Securities
Act, although we will lose that status sooner if our revenues exceed $1.07 billion, if we issue more than $1 billion in non-convertible
debt in a three year period, or if the market value of our Common Stock that is held by non-affiliates exceeds $700 million as of the
last day of our most recently completed second fiscal quarter.
Our
status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need
it.
Because
of the exemptions from various reporting requirements provided to us as an “emerging growth company” and because we will
have an extended transition period for complying with new or revised financial accounting standards, we may be less attractive to investors
and it may be difficult for us to raise additional capital as and when we need it. Investors may be unable to compare our business with
other companies in our industry if they believe that our financial accounting is not as transparent as other companies in our industry.
If we are unable to raise additional capital as and when we need it, our financial condition and results of operations may be materially
and adversely affected.
There
may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may
materially harm our company. If we fail to remediate a material weakness, or if we experience material weaknesses in the future
or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately or timely report
our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of
our common stock and Warrants.
Prior
to the completion of our initial public offering in August 2020, we had been a private company with limited accounting personnel to adequately
execute our accounting processes and limited supervisory resources with which to address our internal control over financial reporting.
As a newly public company, we have designed a control environment as required of public companies under the rules and regulations
of the SEC.
Proper
systems of internal controls over financial accounting and disclosure controls and procedures are critical to the operation of a public
company. We may be unable to effectively establish such systems, especially in light of the fact that we expect to operate as a publicly
reporting company. This would leave us without the ability to reliably assimilate and compile financial information about our company
and significantly impair our ability to prevent error and detect fraud, all of which would have a negative impact on our company from
many perspectives.
Moreover,
we do not expect that disclosure controls or internal control over financial reporting, even if established, will prevent all errors
and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that
the control system’s objectives will be met. Further, the design of a control system must reflect the fact that there are resource
constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.
Failure of our control systems to prevent error or fraud could materially adversely impact us.
Geopolitical
conditions, including trade disputes and direct or indirect acts of war or terrorism, could have an adverse effect on our operations
and financial results.
Recently,
Russia initiated significant military action against Ukraine. In response, the U.S. and certain other countries imposed significant sanctions
and export controls against Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business,
and financial organizations, and the U.S. and certain other countries could impose further sanctions, trade restrictions, and other retaliatory
actions should the conflict continue or worsen. It is not possible to predict the broader consequences of the conflict, including related
geopolitical tensions, and the measures and retaliatory actions taken by the U.S. and other countries in respect thereof as well as any
counter measures or retaliatory actions by Russia or Belarus in response, including, for example, potential cyberattacks or the disruption
of energy exports, is likely to cause regional instability, geopolitical shifts, and could materially adversely affect regional economies
and the global economy. The situation remains uncertain, and while it is difficult to predict the impact of any of the foregoing, the
conflict and actions taken in response to the conflict could increase our costs, disrupt our supply chain, reduce our sales and earnings,
impair our ability to raise additional capital when needed on acceptable terms, if at all, or otherwise adversely affect our business,
financial condition, and results of operations.
If
we sustain a cyber-attack or suffer privacy or data security breaches that disrupt our information systems or operations, or result in
the dissemination of sensitive personal or confidential information, we could suffer increased costs, exposure to significant liability,
reputational harm, loss of business, and other serious negative consequences.
Our
information technology systems and safety control systems are subject to a growing number of threats from computer programmers, hackers,
and other adversaries that may be able to penetrate our network security and misappropriate our confidential information or that of third
parties, create system disruptions, or cause damage, security issues, or shutdowns. They also may be able to develop and deploy viruses,
worms, and other malicious software programs that attack our systems or otherwise exploit security vulnerabilities. Because the techniques
used to circumvent, gain access to, or sabotage security systems, can be highly sophisticated and change frequently, they often are not
recognized until launched against a target, and may originate from less regulated and remote areas around the world. We may be unable
to anticipate these techniques or implement adequate preventive measures, resulting in potential data loss and damage to our systems.
Our systems are also subject to compromise from internal threats such as improper action by employees, including malicious insiders,
or by vendors, counterparties, and other third parties with otherwise legitimate access to our systems. Our policies, employee training
(including phishing prevention training), procedures, and technical safeguards may not prevent all improper access to our network or
proprietary or confidential information by employees, vendors, counterparties, or other third parties. Our facilities may also be vulnerable
to security incidents or security attacks, acts of vandalism or theft, misplaced or lost data, human errors, or other similar events
that could negatively affect our systems, and our and our members’, data. Additionally, our third-party service providers who process
information on our behalf may cause security breaches for which we are responsible.
Moreover,
we face the ongoing challenge of managing access controls in a complex environment. The process of enhancing our protective measures
can itself create a risk of systems disruptions and security issues. Given the breadth of our operations and the increasing sophistication
of cyber-attacks, a particular incident could occur and persist for an extended period of time before being detected. The extent of a
particular cyber-attack and the steps that we may need to take to investigate the attack may take a significant amount of time before
such an investigation could be completed and full and reliable information about the incident is known. During such time, the extent
of any harm or how best to remediate it might not be known, which could further increase the risks, costs, and consequences of a data
security incident. In addition, our systems must be routinely updated, patched, and upgraded to protect against known vulnerabilities.
The volume of new software vulnerabilities has increased substantially, as has the importance of patches and other remedial measures.
In addition to remediating newly identified vulnerabilities, previously identified vulnerabilities must also be updated. We are at risk
that cyber-attackers exploit these known vulnerabilities before they have been addressed. The complexity of our systems and platforms,
the increased frequency at which vendors are issuing security patches to their products, our need to test patches, and, in some instances,
coordinate with third-parties before they can be deployed, all could further increase our risks.
Any
compromise or perceived compromise of the security of our systems or the systems of one or more of our vendors or service providers could
damage our reputation and brand, cause the termination of relationships with our members, result in disruption or interruption to our
business operations, marketing partners and carriers, reduce demand for our services, and subject us to significant liability and expense,
which would harm our business, operating results, and financial condition.
Risks
Related to SteriLumen’s Business
Certain
ResInnova testing limitations.
Our
claims on the effectiveness of the Disinfecting System against certain pathogens are supported by the analysis of the Disinfecting System
performed in ResInnova’s laboratory. The environment in ResInnova’s laboratory is controlled and does not account for all
real-world variables, which may impact the effectiveness of ultraviolet light in killing microorganisms. Such variables include humidity,
air temperature, and the presence of organic soils that differ from those used in the laboratory tests. If any one of these un-accounted
for variables proves to be significant in the evaluation of the effectiveness of the Disinfecting System, the laboratory results obtained
by ResInnova could be significantly more favorable than the results experienced by our customers. Furthermore, in accordance with CDC
guidelines only laboratories with a biosafety level 3 or 4 may test against SARS-CoV-2, the virus that causes COVID-19. ResInnova is
a biosafety level 2 laboratory and cannot test against SARS-CoV-2 and therefore in its place tested against OC43, which, according to
ResInnova is a common surrogate for SARS-CoV-2 as both are of the Beta genre of coronaviruses. If the results from testing the Disinfecting
System against OC43 are different from the results that would have occurred from testing against SARS-CoV-2, ResInnova’s testing
results could be materially more favorable than the results experienced by our customers with respect to SARS-CoV-2. If the Disinfecting
System is not effective against SARS-CoV-2, this could have a material adverse effect on the Company’s, which would have a material
adverse effect on our business prospects and financial condition.
The
complete and final assembly of the Disinfecting System has not yet received safety certification from a nationally recognized testing
laboratory.
All
of the component parts of the Disinfecting System have been certified by ETL. The ETL listings for ETL Listing numbers: SLR-1 = E519669
for the ribbon unit and SLD-1 = E519957 for the drain unit is new for such a UVC device for the UL and due to incomplete standards
does not guarantee successful deployment and installation at scale in the US. If we are unable or significantly delayed in obtaining
confidence for installations within the marketplace with above certifications, our business and financial prospects will be materially
adversely affected.
In
accordance with an August 24, 1993 Interpretation Letter from OSHA, all electrical equipment must be accepted, certified, labeled, listed,
or otherwise determined that such equipment is safe by a NRTL or by another Federal agency or by a State, municipal, or other local authority
responsible for enforcing occupational safety provisions of the National Electric Safety Code.
If
SteriLumen is unable to develop a successful marketing approach, our business will suffer.
If
SteriLumen fails to develop a successful marketing approach or to manage its growth effectively, our business and financial results will
be materially harmed. Healthcare facilities operate in a highly regulated and dynamic market with changing regulations, codes, standards
and guidelines and as a result are very loyal to vendors they trust. Achieving market acceptance will require extensive customer education
and product validation. Some of the ways in which SteriLumen intends on achieving market acceptance is through working with professional
trade organizations, having articles published in industry trade publications, conducting validation/marketing studies at well-known
hospitals and lab testing. However, there is no assurance that SteriLumen will be successful in organizing these efforts or if the results
from them will be positive. SteriLumen has sought and may also seek in the future to expand its business through complementary or strategic
acquisitions of other businesses, products or assets such as its recent acquisition of the Airocide product line, or through joint ventures,
strategic partnerships or other arrangements with established and trusted disinfection companies. Any such acquisitions, joint ventures
or other business combinations may involve significant integration challenges, operational complexities and time consumption and require
substantial resources and effort. It may also disrupt SteriLumen’s ongoing businesses, which may adversely affect its relationships
with customers, employees and others with whom it has business or other dealings. Further, if SteriLumen is unable to realize synergies
or other benefits expected to result from any acquisitions, joint ventures or other business combinations, or to generate additional
revenue to offset any unanticipated inability to realize these expected synergies or benefits, its growth and ability to compete may
be impaired, which would require it and us to focus additional resources on the integration of operations rather than other profitable
areas of its business, and may otherwise cause a material adverse effect on our business, results of operations and financial condition.
However, failure to acquire or partner with established and trusted disinfection companies would prevent SteriLumen’s products
from being part of a bundle of disinfection products that could be sold all at once, which could have a material adverse effect on the
financial results of our business.
The
air purification market is fragmented and competitive and we may not be able to compete successfully with our existing competitors or
new entrants into the markets we serve.
The
air purification market is fragmented and competitive. SteriLumen’s competition varies by product line, customer classification
and geographic market. The principal competitive factors in our industry are quality of product, pricing, service and delivery capabilities
and availability of product. We will compete with many local, regional and national air purification distributors and dealers. In addition,
some air purification suppliers might sell and distribute their products directly to our customers, and the volume of such direct sales
could increase in the future. Additionally, distributors of products similar to those distributed by us may elect to sell and distribute
to our customers in the future or enter into exclusive supplier arrangements with other distributors. Some of our competitors have greater
financial resources and may be able to withstand sales or price decreases more effectively than we can. We also expect to continue to
face competition from new market entrants. We may be unable to continue to compete effectively with these existing or new competitors,
which could have a material adverse effect on our financial condition and results of operations.
If
we are unable to execute our plan to distribute SteriLumen’s Airocide products, we may not be able to generate revenues and your
investment could be materially adversely affected.
We
acquired the rights to manufacture and sell our Airocide products in February of 2021 and have not yet fully scaled to execute our plan
to sell and distribute SteriLumen’s Airocide products. The success of the Airocide business will depend on the execution of our
plan and the acceptance of Airocide products by the consumer and commercial markets. Achieving such acceptance will require significant
marketing investment. Once we execute our plan to sell and distribute the Airocide products, it may not be accepted by consumers at sufficient
levels to support our operations and build our business. If SteriLumen’s Airocide products are not accepted at sufficient levels,
our business could fail.
We
are subject to significant regulatory oversight and changes in applicable regulatory requirements could adversely affect our business.
We
may become subject to significant government regulation, by the EPA and, to a certain extent, by Congress, other federal agencies and
foreign, state and local authorities. Depending upon the circumstances, noncompliance with legislation or regulations promulgated by
these entities could result in the suspension or revocation of our licenses or registrations, the termination or loss of contracts or
the imposition of contractual damages, civil fines or criminal penalties any of which could have a material adverse effect on our business,
financial condition and results of operations. Furthermore, the adoption or modification of laws or regulations relating to UVC or air
purification or other areas of our business could limit or otherwise adversely affect the manner in which we currently conduct our business.
If we are required to comply with new regulations or legislation or new interpretations of existing regulations. This compliance could
cause us to incur additional expenses or alter our business model.
SteriLumen’s
Scientific Air business is highly dependent on a sole distributor and any disruption in their operations could have a material adverse
effect on our business, results of operations and financial condition.
Currently,
a sole distributor distributes Scientific Air products pursuant to an exclusive distribution agreement which, on a proforma basis, accounted
for approximately 19% of Scientific Air’s revenues for the twelve months ended December 31, 2021. Scientific Air’s revenues
were approximately 22% of the combined revenues of Scientifc Air and the Company for the twelve month period ended December 31, 2021.
Any number of factors relating to such distributor, including labor disruptions, catastrophic weather events, financial difficulties,
solvency problems, such distributor prioritizing the distribution of other products over ours or contractual disputes between us and
such distributor could lead to uncertainty in the distribution of a material amount of our Scientific Air products. While we are in the
process of identifying additional distributors, there can be no assurance that we will be able to do so in the near or foreseeable future.
If SteriLumen experiences distribution disruptions with respect to Scientific Air products, it may not be able to develop alternate sourcing
quickly and could cause it to alter production schedules or suspend production entirely. If any such disruptions occur it could have
a material adverse effect on our business, results of operations and financial condition.
SteriLumen’s
Disinfecting System business is highly dependent on its suppliers’ and any disruption in their operations could have a material
adverse effect on our business, results of operations and financial condition.
SteriLumen’s
Disinfecting System business will be dependent upon the continued ability of its suppliers to deliver systems, components, raw materials,
and finished disinfection products. Its UVC LEDs are manufactured in South Korea and then shipped to China or the United States for assembly
with all other components, which if manufactured in China, the finished products are shipped to Long Beach, California for warehousing
and distribution, otherwise the units are shipped from Mount Vernon. Any number of factors, including labor disruptions, catastrophic
weather events, contractual or other disputes with suppliers, and supplier financial difficulties or solvency problems could disrupt
its suppliers’ operations and lead to uncertainty in its supply chain or cause supply disruptions, which could, in turn, disrupt
its operations. If SteriLumen experiences supply disruptions, it may not be able to develop alternate sourcing quickly. Any disruption
of its production schedule caused by an unexpected shortage of systems, components, raw materials or parts even for a relatively short
period of time could cause it to alter production schedules or suspend production entirely. If any such disruptions occur it could have
a material adverse effect on our business, results of operations and financial condition.
SteriLumen’s
business is highly dependent on market perceptions of it and the safety and quality of its products.
Market
perceptions of SteriLumen’s business are very important to us, especially market perceptions of the safety and quality of SteriLumen’s
products. If any of its products or similar products that other companies distribute are subject to market withdrawal or recall or are
proven to be, or are claimed to be, harmful to end users, then this could have a material adverse effect on our business, results of
operations and financial condition. Also, because SteriLumen’s business is dependent on market perceptions, negative publicity
associated or perceived to be associated with its business, products or product pricing could have a material adverse impact on our business,
results of operations and financial condition.
Customers
may be hesitant in adopting UV light-based technologies, and our inability to overcome this hesitation could limit the market acceptance
of our products and our market share.
Our
UV light disinfection systems represent relatively new technologies in the market. Only a small percentage of professional medical institutions
or hospitality providers are immediately willing to conduct sanitation using our systems. Our future success will depend on our ability
to increase demand for our products by demonstrating to a broad spectrum of medical professional, dentists, hospitality industry, their
patients and customers, the potential performance advantages of our UV light systems over traditional methods of disinfection over competitive
UV light systems, and our inability to do so could have a material adverse effect on our business, financial condition, and results of
operations.
Conventional
germicidal UV light was historically considered as a human health hazard if improperly used and can lead to skin cancer and cataracts.
We may experience long sales cycles because healthcare facilities and hotels and other facilities may be slow to adopt new technologies
on a widespread basis and admit that such technologies can sanitize public space without damaging public health. As a result, we generally
are required to invest a significant amount of time and resources to educate general public about the benefits of our products in comparison
to competing products and technologies before completing a sale, if any. Factors that could inhibit adoption of UV technologies by healthcare
facilities or hospitality companies include the initial cost and concerns about the safety, efficacy, and reliability of our UV systems.
In addition, economic pressure, caused, for example, by an economic slowdown as a result of Coronavirus, changes in health care reimbursement
or by competitive factors in a specific market, could make businesses reluctant to purchase substantial capital equipment or invest in
new technologies. Customer acceptance will depend on the recommendations of governmental authorities, as well as other factors, including
the relative effectiveness, safety, reliability, and comfort of our systems as compared to other instruments and methods for performing
disinfecting procedures.
If
future data proves to be inconsistent with our research results or if competitors’ products present more favorable results our
revenues could decline and our business, financial condition, and results of operations could be materially and adversely affected.
Even
though our disinfecting devices are protected with patents, if new studies or comparative studies generate results that are not as favorable
as our research results, our revenues could decline. Additionally, if future studies indicate that our competitors’ products are
more effective or safer than ours, our revenues could decline. Furthermore, hospitals and businesses could choose not to purchase our
UV light sanitation systems until they receive additional published long-term clinical evidence and recommendations from prominent hospitals
and businesses that indicate our UV light sanitation systems are effective for disinfecting applications.
We
may face competition from other companies, many of which have substantially greater resources than we do. If we do not successfully develop
and commercialize enhanced or new products that remain competitive with products or alternative technologies developed by others, we
could lose revenue opportunities and customers and our ability to grow our business would be impaired.
A
number of competitors have substantially greater capital resources, larger customer bases, larger technical, sales and marketing forces
and stronger reputations with target customers than ours. We compete with a number of domestic and foreign companies that market traditional
chemical sanitation products, as well as companies that market UV technologies. The marketplace is highly fragmented and very competitive.
We expect that the rapid technological changes occurring in the health care industry could lead to the entry of new competitors, particularly
if UV disinfecting increases market acceptance. If we do not compete successfully, our revenue and market share could decline, which
would impact our ability to meet our operating cash flow requirements and our business, financial condition, and results of operations
could be adversely affected.
Our
long-term success depends upon our ability to (i) distinguish our products through improving our product performance and pricing, protecting
our intellectual property, improving our customer support, accurately timing the introduction of new products, and developing sustainable
distribution channels worldwide; and (ii) develop and successfully commercialize new products, new or improved technologies, and additional
applications for our UV light sanitation systems. We may not be able to distinguish our products and commercialize any new products,
new or improved technologies, or additional applications for our UV light disinfecting systems.
We
could incur problems in manufacturing our products.
In
order to grow our business, we must expand our manufacturing capabilities to produce the systems and accessories necessary to meet any
demand we may experience. We could encounter difficulties in increasing the production of our products, including problems involving
production capacity and yields, quality control and assurance, component supply, and shortages of qualified personnel. In addition, before
we can begin commercial manufacture of our products, we must ensure our manufacturing facilities, processes, and quality systems, and
the manufacture of our UV light sanitation systems, quality control, and documentation policies and procedures.From time to time, we
could expend significant resources in obtaining, maintaining, and addressing our compliance with various federal and requirements that
may be subject to changes. Our success will depend in part upon our ability to manufacture our products without FDA approval or compliance
with and other regulatory requirements.
We
have not experienced significant quality issues with components of our products supplied by third parties, however, we could in the future.
Our future success depends on our ability to manufacture our products on a timely basis with acceptable manufacturing costs, while at
the same time maintaining good quality control and complying with applicable regulatory requirements, and an inability to do so could
have a material adverse effect on our product sales, cash collections from customers, and our ability to meet operating cash flow requirements,
which could have a material adverse effect on our business, financial condition, and results of operations.
Adverse
publicity regarding our technology or products could negatively impact us.
Adverse
publicity regarding any of our products or similar products marketed or sold by others could negatively affect us. If any studies raise
or substantiate concerns regarding the efficacy or safety of our products or other concerns, our reputation could be harmed and demand
for our products could diminish, which could have a material adverse effect on growth in new customers and sales of our products, leading
to a decline in revenues, cash collections, and ultimately our ability to meet operating cash flow requirements.
Rapidly
changing standards and competing technologies could harm demand for our products, result in significant additional costs, and have a
material adverse effect on our business, financial condition, and results of operations.
The
markets in which our products compete are subject to rapid technological change, evolving industry standards, changes in the regulatory
environment, and frequent introductions of new devices and evolving sanitizing solutions and practices, specifically catalyzed by the
impact of the Coronavirus pandemic. Competing products could emerge that render our products uncompetitive or obsolete. We cannot guarantee
that we will successfully identify new product opportunities, identify new and innovative applications of our technology, or be financially
or otherwise capable of completing the research and development required to bring new products to market in a timely manner. An inability
to expand our product offerings or the application of our technology could limit our growth. In addition, we could incur higher manufacturing
costs if manufacturing processes or standards change, and we could need to replace, modify, design, or build and install equipment, all
of which would require additional capital expenditures.
We
could be unable to effectively manage and implement our growth strategies, which could have a material adverse effect on our business,
financial condition, and results of operations.
Our
growth strategy includes expanding our product line and applications by developing enhancements and transformational innovations, including
new solutions for various fields and industries. Expansion of our existing product line and entry into new applications divert the use
of our resources and systems, require additional resources that might not be available (or available on acceptable terms), may require
regulatory approvals, result in new or increasing competition, could require longer implementation times or greater start-up expenditures
than anticipated, and could otherwise fail to achieve the desired results in a timely fashion, if at all. These efforts could also require
that we successfully commercialize new technologies in a timely manner, price them competitively and cost-effectively, and manufacture
and deliver sufficient volumes of new products of appropriate quality on time. We could be unable to increase our sales and earnings
by expanding our product offerings in a cost-effective manner, and we could fail to accurately predict future customer needs and preferences
or to produce viable technologies. In addition, we could invest heavily in research and development of products that do not lead to significant
revenue. Even if we successfully innovate and develop new products and product enhancements, we could incur substantial costs in doing
so. In addition, promising new products could fail to reach the market or realize only limited commercial success because of efficacy
or safety concerns, failure to achieve positive clinical outcomes, or uncertainty over third-party reimbursement.
International
sales may comprise a significant portion of SteriLumen’s revenues and will be subject to risks associated with operating in domestic
and international markets.
International
sales may comprise a significant portion of SteriLumen’s revenue, and we intend to continue to pursue and expand our international
business activities. Political and economic conditions outside the United States could make it difficult for us to increase our international
revenue or to operate abroad. International operations are subject to many inherent risks, which could have a material adverse effect
on our revenues and operating cash flow, including among others:
|
• |
adverse
changes in tariffs and trade restrictions; |
|
• |
political,
social, and economic instability and increased security concerns; |
|
• |
fluctuations
in foreign currency exchange rates; |
|
• |
longer
collection periods and difficulties in collecting receivables from foreign entities; |
|
• |
exposure
to different legal standards; |
|
• |
transportation
delays and difficulties of managing international distribution channels; |
|
• |
reduced
protection for our intellectual property in some countries; |
|
• |
difficulties
in obtaining domestic and foreign export, import, and other governmental approvals, permits, and licenses, and compliance with foreign
laws; |
|
• |
the
imposition of governmental controls; |
|
• |
unexpected
changes in regulatory or certification requirements; |
|
• |
difficulties
in staffing and managing foreign operations; and |
|
• |
potentially
adverse tax consequences and the complexities of foreign value-added tax systems. |
We
believe that international sales may represent a significant portion of SteriLumen’s revenue, and we intend to expand its international
operations. In international markets where our sales are denominated in U.S. dollars, an increase in the relative value of the dollar
against the currency in such markets could indirectly increase the price of our products in those markets and result in a decrease in
sales. We do not currently engage in any transactions as a hedge against risks of loss due to foreign currency fluctuations. However,
we could do so in the future.
SteriLumen’s
collaborations with outside scientists and consultants may be subject to restriction and change.
SteriLumen
works with scientists at academic and other institutions, and consultants who assist it in its research, development, and design efforts.
These scientists and consultants have provided, and we expect that they will continue to provide, valuable advice on SteriLumen’s
programs. These scientists and consultants are not our or SteriLumen’s employees, may have other commitments that would limit their
future availability to SteriLumen and typically will not enter into non-compete agreements with SteriLumen. If a conflict of interest
arises between their work for SteriLumen and their work for another entity, SteriLumen may lose their services. In addition, SteriLumen
will be unable to prevent them from establishing competing businesses or developing competing products. For example, if a key scientist
acting as a principal investigator in any of SteriLumen’s clinical trials identifies a potential product or compound that is more
scientifically interesting to his or her professional interests, his or her availability to remain involved in its clinical trials could
be restricted or eliminated.
SteriLumen
has entered into or intends to enter into non-competition agreements with certain of SteriLumen’s employees. These agreements prohibit
its employees, if they cease working for it, from competing directly against it or working for its competitors for a limited period.
However, under current law, SteriLumen may be unable to enforce these agreements against certain of its employees and it may be difficult
for it to restrict their competitors from gaining the expertise its former employees gained while working for it. If SteriLumen cannot
enforce its employees’ non-compete agreements, it may be unable to prevent its competitors from benefiting from the expertise of
its former employees.
Risks
Related to MunnWorks’ Business
The
custom design decorative framed mirror supply market is highly competitive, and we may not be able to compete successfully.
MunnWorks
operates within the highly competitive custom design decorative framed mirror supply market, which is characterized by competition from
a number of other manufacturers. Competition is further intensified during economic downturns. MunnWorks competes with numerous large
national and regional companies for, among other things, customers, raw materials and skilled management and labor resources. Purchase
volumes have fluctuated substantially from time to time in the past, and we expect such fluctuations to occur from time to time in the
future. Some of its competitors have greater financial, marketing and other resources than it does and, therefore, may be able to adapt
to changes in customer preferences more quickly, devote more resources to the marketing and sale of their products, generate greater
national brand recognition or adopt more aggressive pricing policies than MunnWorks can.
In
addition, some of our competitors may resort to price competition to sustain or gain market share and manufacturing capacity utilization,
and MunnWorks may have to adjust the prices on some of its products to stay competitive, which could reduce its revenues. MunnWorks may
not ultimately succeed in competing with other manufacturers and distributors in its market, which may have a material adverse effect
on our business, financial condition or results of operations.
MunnWorks’
possible failure to develop new products or respond to changing consumer preferences and purchasing practices could have a material adverse
effect on our business, financial condition or results of operations.
The
custom design decorative framed mirror supply market is subject to changing consumer trends, demands and preferences. The uncertainties
associated with developing and introducing new products, such as gauging changing consumer preferences and successfully developing, manufacturing,
marketing and selling new products, could lead to, among other things, rejection of a new product line, reduced demand and price reductions
for our products. If MunnWorks’ products do not keep up with consumer trends, demands and preference, it could lose market share,
which could have a material adverse effect on our business, financial condition or results of operations.
Changes
to the buying strategies of MunnWorks’ customers could also affect its ability to compete. Further, the volatile and challenging
economic environment of recent years has caused shifts in trends, demands, preferences and purchasing practices and changes in the business
models and strategies of its customers. Shifts in consumer preferences, which may or may not be long-term, have altered the quantity,
type and prices of products demanded by the end-consumer and MunnWorks’ customers. If it does not timely and effectively identify
and respond to these changing consumer preferences and purchasing practices, its relationships with our customers could be harmed, the
demand for its products could be reduced and its market share could be negatively affected.
MunnWorks’
independent sales force may not be effective.
MunnWorks
hires independent sales representatives who have primary responsibility for contacting existing and potential customers and are paid
on a commission basis. While this sales model has proven successful in the past, to continue to be effective, sales representatives will
need to continue to be extremely knowledgeable about MunnWorks’ products. However, these independent sales representatives may
be selling products from different non-competitive sellers, which could prevent them from focusing on MunnWorks’ products and providing
the required information to the customers, which could have a material adverse effect on our business, results of operations and financial
condition.
MunnWorks’
business is highly dependent on its suppliers’ and any disruption in their operations could have a material adverse effect on our
business, results of operations and financial condition.
MunnWorks’
operations will be dependent upon the continued ability of its suppliers to deliver components, raw materials, and finished products.
Although many of its products are manufactured at our corporate headquarters in New York, many of its products are manufactured overseas.
Any number of factors, including labor disruptions, catastrophic weather events, contractual or other disputes with suppliers, and supplier
financial difficulties or solvency problems could disrupt its suppliers’ operations and lead to uncertainty in its supply chain
or cause supply disruptions, which could, in turn, disrupt its operations. If MunnWorks experiences supply disruptions, it may not be
able to develop alternate sourcing quickly. Any disruption of its production schedule caused by an unexpected shortage of systems, components,
raw materials or parts even for a relatively short period of time could cause it to alter production schedules or suspend production
entirely. If any such disruptions occur it could have a material adverse effect on our business, results of operations and financial
condition.
MunnWorks’
business is highly dependent on market perceptions of it and the quality of its products.
Market
perceptions of MunnWorks’ business are very important to us, especially market perceptions of the quality of MunnWorks’ products.
Because MunnWorks’ business is dependent on market perceptions, negative publicity associated or perceived to be associated with
its business, products or product pricing could have a material adverse impact on our business, results of operations and financial condition.
Risks
Related to Our Intellectual Property
If
the patents that we own or license, or our other intellectual property rights, do not adequately protect our technologies, we could lose
market share to our competitors and be unable to operate our business profitably.
Our
future success depends, in part, on our ability to obtain and maintain patent protection for our products and technology, to preserve
our trade secrets and to operate without infringing the intellectual property of others. We rely on patents to establish and maintain
proprietary rights in our technology and products. We currently possess a number of issued patents and patent applications with respect
to our products and technology. However, we cannot ensure that any additional patents will be issued, that the scope of any patent protection
will be effective in helping us address our competition, or that any of our patents will be held valid if subsequently challenged. It
is also possible that our competitors could independently develop similar or more desirable products, duplicate our products, or design
products that circumvent our patents. The laws of foreign countries may not protect our products or intellectual property rights to the
same extent as the laws of the United States. In addition, there have been recent changes in the patent laws and rules of the U.S. Patent
and Trademark Office (“USPTO”), and there could be future proposed changes that, if enacted, have a significant impact on
our ability to protect our technology and enforce our intellectual property rights. If we fail to protect our intellectual property rights
adequately, our competitive position could be adversely affected, and there could be a material adverse effect on sales, cash collections,
and our ability to meet operating cash flow requirements.
If
third parties claim that we infringe their intellectual property rights, we could incur liabilities and costs and have to redesign or
discontinue selling certain products, which could have a material adverse effect on our business, financial condition, and results of
operations.
We
face substantial uncertainty regarding the impact that other parties’ intellectual property positions will have on UV light applications.
From time to time, we expect to continue to receive, notices of claims of infringement, misappropriation, or misuse of other parties’
proprietary rights. Some of these claims could lead to litigation. We may not prevail in any future intellectual property infringement
litigation given the complex technical issues and inherent uncertainties in litigation. Any claims, with or without merit, could be time-consuming
and distracting to management, result in costly litigation, or cause product shipment delays. Adverse determinations in litigation could
subject us to significant liability and could result in the loss of proprietary rights. A successful lawsuit against us could also force
us to cease selling or redesign products that incorporate the infringed intellectual property. Additionally, we could be required to
seek a license from the holder of the intellectual property to use the infringed technology, and we may not be able to obtain a license
on acceptable terms, or at all.
Patent
terms are limited and we may not be able to effectively protect our products and business.
Patents
have a limited lifespan. In the U.S., the natural expiration of a patent is generally 20 years after it is filed. Although various extensions
may be available, the life of a patent, and the protection it affords, is limited. In addition, upon issuance in the U.S., the patent
term may be extended based on certain delays caused by the applicant(s) or the USPTO. Even if we obtain effective patent rights for all
our current patent applications, we may not have sufficient patent terms or regulatory exclusivity to protect our products, and our business
and results of operations would be adversely affected.
We
may be subject to claims challenging the inventorship of our patents and other intellectual property.
We
may be subject to claims that former employees, collaborators or other third parties have an interest in or right to compensation with
respect to our patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise
from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary
to defend against these and other claims challenging inventorship or claiming the right to compensation. If we fail in defending any
such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of,
or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are
successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other
employees. To the extent that our employees have not effectively waived the right to compensation with respect to inventions that they
helped create, they may be able to assert claims for compensation with respect to our future revenue may be successful. As a result,
we may receive less revenue from future products if such claims are successful which in turn could impact our future profitability.
Changes
in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
As
is the case with other equipment manufacturing companies, our success is heavily dependent on intellectual property, particularly patents.
Obtaining and enforcing patents in the biotechnology industry involves both technological and legal complexity. Therefore, obtaining
and enforcing patents is costly, time-consuming, and inherently uncertain. In addition, the U.S. has recently enacted and is currently
implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available
in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard
to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents,
once obtained. Depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing
patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and
patents that we might obtain in the future.
We
may not be able to protect our intellectual property rights throughout the world.
Filing,
prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our
intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S. In addition, the laws of
some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the U.S. Competitors
may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export
otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S. These
products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent
them from competing.
Many
companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The
legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets
and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for
us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings
to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts
and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our
patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits
that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce
our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual
property that we develop or license.
Risks
Relating to Ownership of Our Securities
The
public price of our Common Stock may be volatile, and could, following a sale decline significantly and rapidly.
The
offering price for the shares will be determined by negotiations between us and the underwriters and may not be indicative of prices
that will prevail in the open market following this offering. The market price of our common stock may decline below the initial offering
price, and you may not be able to sell your shares of our common stock at or above the price you paid in the offering, or at all. Following
this Offering, the public price of our common stock in the secondary market will be determined by private buy and sell transaction orders
collected from broker-dealers.
We
may not be able to maintain a listing of our Common Stock.
In
order for our common stock to continue to be listed on Nasdaq, we must meet certain financial and liquidity criteria to maintain such
listing. If we violate the maintenance requirements for continued listing of our common stock, our common stock may be delisted. In addition,
our board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing.
A delisting of our common stock from Nasdaq may materially impair our stockholders’ ability to buy and sell our common stock and
could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock. In addition, the
delisting of our common stock could significantly impair our ability to raise capital.
Our
directors and officers beneficially own more than 50% of the voting power of our voting stock as of December 31, 2021, and will be able
to exert a controlling influence over our business affairs and matters submitted to stockholders for approval.
Our
directors and officers have voting control over more than 50% of our voting stock (which excludes 158,959 shares underlying options and
warrants issued to the directors and officers, but does include 2,000 shares of the Company’s Super Voting Preferred Stock beneficially
owned by Max Munn, our Interim Chief Executive Officer, President and director , which is entitled to 1,000 votes per share (2,000,000
votes in aggregate) and votes with the common stock as a single class. As a result, our directors and officers will have control over
all matters submitted to our stockholders for approval, including the election of directors, amendments to our certificate of incorporation
and bylaws, the approval of any business combination and any other significant corporate transaction. These actions may be taken even
if they are opposed by other stockholders. This concentration of ownership may also have the effect of delaying or preventing a change
of control of our company or discouraging others from making tender offers for our shares, which could prevent our stockholders from
receiving a premium for their shares.
Our
directors and officers may have interests different from yours.
We
have not paid dividends on our Common Stock in the past and do not expect to pay dividends on our Common Stock in the future, and any
return on investment may be limited to the value of our stock.
We
have never paid cash dividends on our Common Stock and do not anticipate paying cash dividends on our Common Stock in the foreseeable
future. We currently intend to retain any future earnings to support the development 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
is limited by the terms of our Series A Perpetual Preferred Stock and may be limited by Delaware 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 a return on their investment.
The
elimination of personal liability against our directors and officers under Delaware law and the existence of indemnification rights held
by our directors, officers and employees may result in substantial expenses.
Our
Amended and Restated Certificate of Incorporation and our Bylaws eliminate the personal liability of our directors and officers to us
and our stockholders for damages for breach of fiduciary duty as a director or officer to the extent permissible under Delaware law.
Further, our amended and restated certificate of incorporation and our Bylaws and individual indemnification agreements we have entered
with each of our directors and executive officers provide that we are obligated to indemnify each of our directors or officers to the
fullest extent authorized by the Delaware law and, subject to certain conditions, advance the expenses incurred by any director or officer
in defending any action, suit or proceeding prior to its final disposition. Those indemnification obligations could expose us to substantial
expenditures to cover the cost of settlement or damage awards against our directors or officers, which we may be unable to afford. Further,
those provisions and resulting costs may discourage us or our stockholders from bringing a lawsuit against any of our current or former
directors or officers for breaches of their fiduciary duties, even if such actions might otherwise benefit our stockholders, indemnification
rights held by our directors, officers and employees may result in substantial expenses.
Our
certificate of incorporation will designate the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation
that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for
disputes with us.
Our
amended and restated certificate of incorporation specifies that, unless we consent in writing to the selection of an alternative forum,
the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for: (a) any derivative action or proceeding brought
on behalf of the Company, (b) any action asserting a claim of breach of a fiduciary duty owed by any director, officer, employee or agent
of the Company to the Company or the Company’s stockholders, (c) any action asserting a claim arising pursuant to any provision
of the Delaware General Corporation Law, the Company’s Certificate of Incorporation or the Bylaws, or (d) any action asserting
a claim governed by the internal affairs doctrine, in each case subject to said Court of Chancery having personal jurisdiction over the
indispensable parties named as defendants therein. Any person or entity purchasing or otherwise acquiring any interest in shares of our
capital stock shall be deemed to have notice of and to have consented to the provisions of our amended and restated certificate of incorporation
described above.
We
believe these provisions benefit us by providing increased consistency in the application of Delaware law by chancellors particularly
experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums
and protection against the burdens of multi-forum litigation. However, the provision may have the effect of discouraging lawsuits against
our directors, officers, employees and agents as it may limit any stockholder’s ability to bring a claim in a judicial forum that
such stockholder finds favorable for disputes with us or our directors, officers, employees or agents. The enforceability of similar
choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is
possible that, in connection with any applicable action brought against us, a court could find the choice of forum provisions contained
in our restated certificate of incorporation to be inapplicable or unenforceable in such action. If a court were to find the choice of
forum provision contained in our restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur
additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business, financial condition
or results of operations.
Our
revenues, operating results and cash flows may fluctuate in future periods and we may fail to meet investor expectations, which may cause
the price of our Common Stock to decline.
Variations
in our quarterly and year-end operating results are difficult to predict and our income and cash flows may fluctuate significantly from
period to period, which may impact our board of directors’ willingness or legal ability to declare a monthly dividend. If our operating
results fall below the expectations of investors or securities analysts, the price of our Common Stock could decline substantially. Specific
factors that may cause fluctuations in our operating results include:
|
• |
demand
and pricing for our products and services; |
|
• |
introduction
of competing products; |
|
• |
our
operating expenses which fluctuate due to growth of our business; and |
|
• |
variable
sales cycle and implementation periods for content and services. |
The
market price of our securities could be substantially affected by various factors.
The
market price of our Common Stock could be subject to wide fluctuations in response to numerous factors. The price of the our Common Stock
that will prevail in the market after this offering may be higher or lower than the offering price depending on many factors, some of
which are beyond our control and may not be directly related to our operating performance.
These
factors include, but are not limited to, the following:
|
• |
trading
prices of securities generally; |
|
• |
general
economic and financial market conditions; |
|
• |
government
action or regulation; |
|
• |
the
financial condition, performance and prospects of us and our competitors; |
|
• |
changes
in financial estimates or recommendations by securities analysts with respect to us or our competitors in our industry; |
|
• |
our
issuance of preferred equity or debt securities; and |
|
• |
actual
or anticipated variations in quarterly operating results of us and our competitors. |
As
a result of these and other factors, investors who purchase the Common Stock in this offering may experience a decrease, which could
be substantial and rapid, in the market price of the Common Stock, including decreases unrelated to our operating performance or prospects.
You
should consult your own independent tax advisor regarding any tax matters arising with respect to the securities offered in connection
with this offering.
Participation
in this offering could result in various tax-related consequences for investors. All prospective purchasers of the resold securities
are advised to consult their own independent tax advisors regarding the U.S. federal, state, local and non-U.S. tax consequences relevant
to the purchase, ownership and disposition of the resold securities in their particular situations.
We
have not paid dividends on our common stock in the past and do not expect to pay dividends on our common stock in the future, and any
return on investment may be limited to the value of our stock.
We
have never paid cash dividends on our common stock and do not anticipate paying cash dividends on our common stock in the foreseeable
future. We currently intend to use any future earnings to pay dividends on our Series A Preferred Stock and to support the development
of our business and do not anticipate paying cash dividends on our common stock 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 Delaware 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 a return on their
investment. Investors seeking cash dividends should not purchase our common stock.
We
will have broad discretion in using the proceeds of this offering and we may not effectively spend the proceeds.
We
will use the net proceeds of this offering for general corporate purposes, including investments and acquisitions. We have not allocated
any specific portion of the net proceeds to any particular purpose, and our management will have the discretion to allocate the proceeds
as it determines. We will have significant flexibility and broad discretion in applying the net proceeds of this offering, and we may
not apply these proceeds effectively. Our management might not be able to yield a significant return, if any, on any investment of these
net proceeds, and you will not have the opportunity to influence our decisions on how to use our net proceeds from this offering.
Provisions
of our Amended and Restated Certificate of Incorporation could delay or prevent the acquisition or sale of our business.
Our
Amended and Restated Certificate of Incorporation permits our Board of Directors to designate new series of preferred stock and issue
those shares without any vote or action by our stockholders. Such newly authorized and issued shares of preferred stock could contain
terms that grant special voting rights to the holders of such shares that make it more difficult to obtain stockholder approval for an
acquisition of our business or increase the cost of any such acquisition.
We
expect that we will need to raise additional capital, and raising additional funds by issuing additional equity securities or with additional
debt financing may cause dilution to shareholders or restrict our operations.
We
expect that we will need to raise additional capital in the future. We may raise additional funds through public or private equity or
debt offerings or other financings, as well as borrowings from banks or through the issuance of debt securities.
Any
new debt financing we enter into may involve covenants that restrict our operations more than our current outstanding debt. These restrictive
covenants could include limitations on additional borrowings and specific restrictions on the use of our assets, as well as prohibitions
or limitations on our ability to create liens, pay dividends, receive distributions from our subsidiaries, redeem or repurchase our stock
or make investments. These factors could hinder our access to capital markets and limit or delay our ability to carry out our capital
expenditure plan or pursue other opportunities beyond the current capital expenditure plan. Further, we may incur substantial costs in
pursuing any capital-raising transactions, including investment banking, legal and accounting fees. On the other hand, if we are unable
to obtain capital when needed, on reasonable terms and in amounts sufficient to fund our obligations, expenses, capital expenditure plan
and other strategic initiatives, we could be forced to suspend, delay or curtail these plans or initiatives or could default on our contractual
commitments. Any such outcome could negatively affect our business, performance, liquidity and prospects.
The
Series A Preferred Stock ranks junior to all of our indebtedness and other liabilities.
In
the event of our bankruptcy, liquidation, dissolution or winding-up of our affairs, our assets will be available to pay obligations on
the Series A Preferred Stock only after all of our indebtedness and other liabilities have been paid. The rights of holders of the Series
A Preferred Stock to participate in the distribution of our assets will rank junior to the prior claims of our current and future creditors
and any future series or class of preferred stock we may issue that ranks senior to the Series A Preferred Stock. Also, the Series A
Preferred Stock effectively ranks junior to all existing and future indebtedness and to the indebtedness and other liabilities of any
future subsidiaries. Our existing subsidiaries are, and future subsidiaries would be, separate legal entities and have no legal obligation
to pay any amounts to us in respect of dividends due on the Series A Preferred Stock.
We
have incurred and may in the future incur substantial amounts of debt and other obligations that will rank senior to the Series A Preferred
Stock. If we are forced to liquidate our assets to pay our creditors, we may not have sufficient assets to pay amounts due on any or
all of the Series A Preferred Stock then outstanding.
The
Company’s ability to pay dividends and to meet its debt obligations largely depends on the performance of its subsidiaries and
the ability to utilize the cash flows from those subsidiaries.
The
Company is a holding company for SteriLumen and MunnWorks and has no material assets other than its equity interests in those subsidiaries.
Therefore, the only current revenue source for future dividends on the Series A Preferred Stock is from its subsidiaries. SteriLumen
is an early-stage designer and marketer of disinfection systems with limited operating history spanning from December 2016. As a result
of the acquisition of the Akida assets, we expect that SteriLumen will have positive cash flow, but this cash flow combined with cash
flows from MunnWorks may not be sufficient to pay dividends on the Series A Preferred Stock. Our utilization of cash has been and will
continue to be highly dependent on SteriLumen’s product development programs and cash flow from Airocide and MunnWorks’ operations.
Our cash expenses will be highly dependent on the product development programs SteriLumen chooses to pursue, the progress of these product
development programs, the results of SteriLumen’s validation/marketing studies, the terms and conditions of SteriLumen’s
contracts with service providers and manufacturing contractors, and the terms of recruitment of facilities in our validation/marketing
studies.
In
addition, the subsidiaries and any joint ventures or other entities accounted for as equity method investments are separate and distinct
legal entities that are not obligated to pay dividends or make loans or distributions to the Company, whether to enable us to pay principal
and interest on our debt, our other obligations or dividends on our Common Stock or preferred stock (including the Series A Preferred
Stock offered hereby), and could be precluded from paying any such dividends or making any such loans or distributions under certain
circumstances, including, without limitation, as a result of legislation, regulation, court order, contractual restrictions or in times
of financial distress. The inability to access capital from our subsidiaries and entities accounted for as equity method investments
as well from the capital markets could have a material adverse effect on the Company’s cash flows and financial condition and,
on our ability, to pay dividends on the Series A Preferred Stock.
The
Series A Preferred Stock will be effectively subordinated to the obligations of our subsidiaries.
We
are a holding company and conduct substantially all of our operations through our subsidiaries. Our right to receive any assets of any
of our subsidiaries upon their liquidation, reorganization or otherwise, and thus the ability of a holder of our Series A Preferred Stock
to benefit indirectly from such distribution, will be subject to the prior claims of the subsidiaries’ creditors. Even if we were
a creditor of any of our subsidiaries, our rights as a creditor would be subordinate to any security interest in the assets of those
subsidiaries and any indebtedness of those subsidiaries senior to that held by us.
We
must adhere to prescribed legal requirements and we must also have sufficient cash in order to be able to pay dividends on the Preferred
Stock.
In
accordance with Section 170 of the Delaware General Corporation Law (“DGCL”), we may only declare and pay cash dividends
on the Series A Preferred Stock if we have either net profits during the fiscal year in which the dividend is declared and/or the preceding
fiscal year, or a “surplus”, meaning the excess, if any, of our net assets (total assets less total liabilities) over our
capital. If the capital of the Company, computed in accordance with Sections 154 and 244 of the DGCL, shall have been diminished by depreciation
in the value of its property, or by losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the
issued and outstanding stock of all classes having a preference upon the distribution of assets, the directors of the Company cannot
declare and pay out of such net profits any dividends upon any shares of any classes of its capital stock until the deficiency in the
amount of capital represented by the issued and outstanding stock of all classes having a preference upon the distribution of assets
shall have been repaired. We can provide no assurance that we will satisfy such requirements in any given year. Further, even if we have
the legal ability to declare a dividend, we may not have sufficient cash to pay dividends on the Series A Preferred Stock. Our ability
to pay dividends may be impaired if any of the risks described in this prospectus actually occur. Also, payment of our dividends depend
upon our financial condition and other factors as our board of directors may deem relevant from time to time. We cannot assure you that
our businesses will generate sufficient cash flow from operations or that future borrowings will be available to us in an amount sufficient
to enable us to pay dividends on the Series A Preferred Stock.
The
Series A Preferred Stock represents perpetual equity interests in us, and investors should not expect us to redeem the Series A Preferred
Stock on any such date that the Series A Preferred Stock becomes redeemable by us or on any particular date afterwards.
The
Series A Preferred Stock represents perpetual equity interests in us, and it has no maturity or mandatory redemption, is not redeemable
at the option of investors under any circumstances. As a result, unlike our indebtedness, the Series A Preferred Stock will not give
rise to a claim for payment of a principal amount at a particular date. As a result, holders of the Series A Preferred Stock may be required
to bear the financial risks of an investment in the Series A Preferred Stock for an indefinite period of time.
We
may redeem the Series A Preferred Stock on a date or dates determined in our sole discretion and the investor may not find a new investment
with a comparable dividend or interest rate.
The
Series A Preferred Stock will be a perpetual equity security. This means that it will have no maturity or mandatory redemption date and
will not be redeemable at the option of the holders. We may, at our option, after July 16, 2022, redeem the Series A Preferred Stock,
in whole or in part, at any time or from time to time as we may determine in our sole discretion, for cash at a redemption price equal
to $27.50 until July 16, 2026 and $25.00 thereafter. We may have an incentive to redeem the Series A Preferred Stock voluntarily if we
can do so without paying the premium or if market conditions allow us to issue other preferred stock or debt securities at a rate that
is lower than the dividend rate on the Series A Preferred Stock. If we redeem the Series A Preferred Stock, then from and after the redemption
date, dividends will cease to accrue on shares of Series A Preferred Stock, the shares of Series A Preferred Stock shall no longer be
deemed outstanding and all rights as a holder of those shares will terminate, except the right to receive the redemption price plus accumulated
and unpaid dividends, if any, payable upon redemption. If we choose to redeem the Series A Preferred Stock, you may not be able to reinvest
the redemption proceeds in a comparable security at an effective dividend or interest rate as high as the dividend payable on the Series
A Preferred Stock.
The
conversion feature may not adequately compensate you, and the conversion and redemption features of the Series A Preferred Stock may
make it more difficult for a party to take over our company and may discourage a party from taking over our company.
Upon
the occurrence of a Delisting Event or Change of Control, holders of the Series A Preferred Stock will have the right (unless, prior
to the Delisting Event Conversion Date or Change of Control Conversion Date, as applicable, we have provided or provide notice of our
election to redeem the Series A Preferred Stock) to direct the depositary to convert some or all of the Series A Preferred Stock into
our common stock (or equivalent value of alternative consideration), and under these circumstances we will also have a special optional
redemption right to redeem the Series A Preferred Stock. See “Description of Series A Preferred—Conversion Rights”
and “—Special Optional Redemption.” Upon such a conversion, the holders will be limited to a maximum number of
shares of our common stock equal to the Share Cap multiplied by the number of shares of Series A Preferred Stock converted. If the Common
Stock Price is less than $4.67 (which is approximately 50% of the closing sale price per share of our common stock on July 12, 2021),
subject to adjustment, the holders will receive a maximum of 5.353319 shares of our common stock per share of Series A Preferred
Stock, which may result in a holder receiving value that is less than the liquidation preference of the Series A Preferred Stock. In
addition, those features of the Series A Preferred Stock may have the effect of inhibiting a third party from making an acquisition proposal
for our company or of delaying, deferring or preventing a change of control of our company under circumstances that otherwise could provide
the holders of our common stock and Series A Preferred Stock with the opportunity to realize a premium over the then-current market price
or that stockholders may otherwise believe is in their best interests.
The
Series A Preferred Stock has not been rated.
We
have not sought to obtain a rating for the Series A Preferred Stock, and the Series A Preferred Stock may never be rated. It is possible,
however, that one or more rating agencies might independently determine to assign a rating to the Series A Preferred Stock or that we
may elect to obtain a rating of the Series A Preferred Stock in the future. In addition, we may elect to issue other securities for which
we may seek to obtain a rating. If any ratings are assigned to the Series A Preferred Stock in the future or if we issue other securities
with a rating, such ratings, if they are lower than market expectations or are subsequently lowered or withdrawn, could adversely affect
the market for or the market value of the Series A Preferred Stock. Ratings only reflect the views of the issuing rating agency or agencies
and such ratings could at any time be revised downward or withdrawn entirely at the discretion of the issuing rating agency. A rating
is not a recommendation to purchase, sell or hold any particular security, including the Series A Preferred Stock. Ratings do not reflect
market prices or suitability of a security for a particular investor and any future rating of the Series A Preferred Stock may not reflect
all risks related to us and our business, or the structure or market value of the Series A Preferred Stock.
If
Nasdaq delists the Series A Preferred Stock, investors’ ability to make trades in the Series A Preferred Stock could be limited.
Our
Series A Preferred Stock is traded on the Nasdaq Capital Market under the symbol “AUVIP.” In order to continue to be listed
on the Nasdaq Capital Market, we must meet and maintain certain financial, distribution, and share price levels. Generally, this means
having a minimum number of publicly held shares of Series A Preferred Stock (generally 1,000,000 shares), a minimum market value (generally
$5,000,000), a minimum net income from continuing operations (generally $750,000) and a minimum number of holders (generally 300 public
holders). If we are also unable to meet the listing standards for the Nasdaq Capital Market, we may apply to have our Series A Preferred
Stock quoted by OTC Markets. If we are unable to maintain listing for the Series A Preferred Stock on the Nasdaq Capital Market, the
ability to transfer or sell shares of the Series A Preferred Stock will be limited and the market value of the Series A Preferred Stock
will likely be materially adversely affected. Moreover, since the Series A Preferred Stock has no stated maturity date, investors may
be forced to hold shares of the Series A Preferred Stock indefinitely while receiving stated dividends thereon when, as and if authorized
by our board of directors and paid by us with no assurance as to ever receiving the liquidation value thereof.
The
market for our Series A Preferred Stock may not provide investors with adequate liquidity.
Liquidity
of the market for the Series A Preferred Stock depends on a number of factors, including prevailing interest rates, our financial condition
and operating results, the number of holders of the Series A Preferred Stock, the market for similar securities and the interest of securities
dealers in making a market in the Series A Preferred Stock. We cannot predict the extent to which investor interest in our Company will
maintain a trading market in our Series A Preferred Stock, or how liquid that market will be. If an active market is not maintained,
investors may have difficulty selling shares of our Series A Preferred Stock.
We
are allowed to issue shares of other series of preferred stock that rank above or equal to the Series A Preferred Stock as to dividend
payments and rights upon our liquidation, dissolution or winding up of our affairs without first obtaining the approval of the holders
of our Series A Preferred Stock. The issuance of additional shares of Series A Preferred Stock and/or additional series of preferred
stock could have the effect of reducing the amounts available to the Series A Preferred Stock upon our liquidation or dissolution or
the winding up of our affairs. It also may reduce dividend payments on the Series A Preferred Stock if we do not have sufficient funds
to pay dividends on all Series A Preferred Stock outstanding and other classes or series of stock with equal or senior priority with
respect to dividends. Future issuances and sales of senior or pari passu preferred stock, or the perception that such issuances and sales
could occur, may cause prevailing market prices for the Series A Preferred Stock and our Common Stock to decline and may adversely affect
our ability to raise additional capital in the financial markets at times and prices favorable to us.
Market
interest rates may materially and adversely affect the value of the Series A Preferred Stock.
One
of the factors that will influence the price of the Series A Preferred Stock is the dividend yield on the Series A Preferred Stock (as
a percentage of the market price of the Series A Preferred Stock) relative to market interest rates. Continued increase in market interest
rates may lead prospective purchasers of the Series A Preferred Stock to expect a higher dividend yield (and higher interest rates would
likely increase our borrowing costs and potentially decrease funds available for dividend payments). Thus, higher market interest rates
could cause the market price of the Series A Preferred Stock to materially decrease.
Holders
of the Series A Preferred Stock may be unable to use the dividends-received deduction and may not be eligible for the preferential tax
rates applicable to “qualified dividend income.”
Distributions
paid to corporate U.S. holders of the Series A Preferred Stock may be eligible for the dividends-received deduction, and distributions
paid to non-corporate U.S. holders of the Series A Preferred Stock may be subject to tax at the preferential tax rates applicable to
“qualified dividend income,” only if we have current or accumulated earnings and profits, as determined for U.S. federal
income tax purposes. Additionally, we may not have sufficient current earnings and profits during future fiscal years for the distributions
on the Series A Preferred Stock to qualify as dividends for U.S. federal income tax purposes. If the distributions fail to qualify as
dividends, U.S. holders would be unable to use the dividends-received deduction and may not be eligible for the preferential tax rates
applicable to “qualified dividend income.” If any distributions on the Series A Preferred Stock with respect to any
fiscal year are not eligible for the dividends-received deduction or preferential tax rates applicable to “qualified dividend income”
because of insufficient current or accumulated earnings and profits, it is possible that the market value of the Series A Preferred Stock
might decline.
A
holder of Series A Preferred Stock has essentially no voting rights.
The
holders of Series A Preferred Stock will not be entitled to vote on any matter that comes before our stockholders for a vote unless such
vote is required by the DGCL. This means that, unless it is required by Delaware law, you will not have the right to participate in any
decisions regarding or affecting our Company or your investment, including the election of directors or any extraordinary events, such
as a merger, acquisition or other similar transaction. Decisions on those matters could be made in a manner that materially and adversely
affects your interests. Our shares of the Super Voting Preferred Stock and our Common Stock are the only classes of our securities that
carry full voting rights. See “Description of the Securities--Series A Preferred Stock—Voting Rights.”
Future
issuances of preferred stock may reduce the value of the Series A Preferred Stock.
Upon
the completion of the offering described in this prospectus, we may sell additional shares of preferred stock on terms that may differ
from those described in this prospectus. Such shares could rank on parity with or senior to the Series A Preferred Stock offered hereby
as to dividends, voting or rights upon liquidation, winding up or dissolution. The creation and subsequent issuance of additional classes
of preferred stock on parity with the Series A Preferred Stock, could dilute the interests of the holders of Series A Preferred Stock
offered hereby. Any issuance of preferred stock that is senior to the Series A Preferred Stock would not only dilute the interests of
the holders of Series A Preferred Stock offered hereby, but also could affect our ability to pay distributions on, redeem or pay the
liquidation preference on the Series A Preferred Stock.
If
we are not paying full dividends on any future dividend parity stock, we will not be able to pay full dividends on the Series A Preferred
Stock.
When
dividends are not paid in full on outstanding shares of any class or series of our stock that ranks on a parity with the Series A Preferred
Stock in the payment of dividends (“dividend parity stock”) for a dividend period, all dividends declared with respect to
shares of Series A Preferred Stock and all shares of outstanding dividend parity stock for such dividend period shall be declared pro
rata so that the respective amounts of such dividends declared bear the same ratio to each other as all accrued but unpaid dividends
per share on the shares of Series A Preferred Stock and all shares of outstanding dividend parity stock for such dividend period bear
to each other. Therefore, if we are not paying full dividends on any outstanding shares of dividend parity stock, we will not be able
to pay full dividends on the Series A Preferred Stock.