ITEM 1A: RISK FACTORS
An investment in our common stock involves
a high degree of risk. You should carefully consider the risks described below, together with all of the other information
included in this Quarterly Report before making an investment decision. Our future operating results may vary substantially from
anticipated results due to a number of risks and uncertainties, many of which are beyond our control. The risks and uncertainties
described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently
believe are not material, may also become important factors that affect us. The following discussion highlights some of these risks
and uncertainties and the possible impact of these risks on future results of operations. If any of the following risks occur,
our business, financial condition or results of operations could be materially and adversely affected. In that case, the market
value of our stock could decline substantially and you could lose part or all of your investment.
Risks Related to Our Financial Position
and Need for Additional Capital
We have incurred significant losses
since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
Since the inception of NuGene, Inc. (our
wholly owned subsidiary) in December 2006 we have incurred significant operating losses. Our net losses were approximately $5.2
million for the fiscal year ended December 31, 2015, and $8.8 million for the nine months ended September 30, 2016. As of September
30, 2016, we had a deficit accumulated since inception of $15.3 million. We have invested a significant portion of our efforts
and financial resources in the development of our NuGene line of products. More recently, we have begun to also invest our efforts
and financial resources in the early development of our wound care/wound healing products.
We expect to continue to incur significant
operating losses for at least the next several years. To become and remain profitable we must succeed in commercializing and marketing
our NuGene line of products. We may never succeed in these activities and may never generate revenues that are significant or large
enough to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on
a quarterly or annual basis. Our failure to become and remain profitable could depress the market price of our common stock and
could impair our ability to raise capital, expand our business, or continue our operations. A decline in the market price of our
common stock could also cause you to lose all or a part of your investment.
Our financial statements have been
prepared assuming that our Company will continue as a going concern and we will need to obtain additional funding if we are to
continue operations.
The factors described elsewhere herein
raise substantial doubt about our ability to continue as a going concern. Our financial statements do not include any adjustments
that might result from this uncertainty. To date we have incurred significant cash losses that have materially impaired our liquidity
and working capital. We have been under severe liquidity restraints such that our prior CEO was required to personally guarantee
borrowings made by our Company from our bank. This has resulted in the substantial increase in balances outstanding and owing to
our suppliers that has put our relationships with them in jeopardy. We continue to attempt to procure the needed funding to maintain
our operations. Should we be successful, we will need to quickly reverse the historical trend of our operations through generating
significantly higher levels of revenue (at or about historical margins) and reducing our operating expenses. If we cannot generate
the revenues and gross margin at levels required to achieve profitability or obtain sufficient additional capital on acceptable
terms, we will need to substantially revise our business plan or cease operations. Should that happen, an investor could suffer
the loss of a significant portion or all of his investment in our Company.
We have a limited operating history
and investors will have no ability to gauge market acceptance for our products or the ability of management to execute on our business
plan.
We are an early-stage company with a limited
operating history and limited revenues derived from our operations. Our operations to date have been primarily focused on our formation,
the hiring of our management team, acquiring, licensing, and developing our technology and products, building and expanding our
sales force, marketing department and investor relations and commencing the commercial launch of our products.
It is difficult to predict future performance
and our ability to maintain operations is dependent upon a number of factors over which we have limited control. As a result, it
is difficult to predict our quarterly financial results and they are likely to fluctuate significantly. We are a relatively new
company with a limited operating history and our sales prospects are uncertain. We also have relatively limited experience selling
our products. Accordingly, we cannot predict with any certainty the timing or level of sales of our products in the future. If
our quarterly sales or operating results fall below the expectations of investors or securities analysts, the price of our common
stock could decline substantially. In addition to the other factors discussed under these “Risk Factors,” specific
factors that may cause fluctuations in our operating results include:
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Demand and pricing for our products, including any change in wholesaler purchasing patterns for
our products;
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Physician and patient acceptance of our products;
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Timing of new product offerings, acquisitions, licenses or other significant events by us, our
partners or our competitors;
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Regulatory approvals and legislative changes affecting our cosmeceutical products;
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Any interruption in the manufacturing or distribution of our products, including events affecting
our third-party suppliers and any failure to comply with manufacturing specifications;
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Changes in treatment practices of physicians or other providers that currently recommend our products;
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Significant product returns and rebates;
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Implementation of new or revised accounting or tax rules or policies; and
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The effect of competing technological and market developments.
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Because we have a limited operating
history, we are subject to all of the risks and uncertainties of a new business.
We initiated the rollout of the first generation
of NuGene products in 2013. We are subject to all of the risks and uncertainties normally associated with an early stage business,
including potential manufacturing issues, difficulties establishing our marketing and distribution operations, lack of name recognition,
lack of adequate capital, difficulties hiring and retaining qualified employees and difficulties in complying with all applicable
federal, state, and local regulatory and administrative requirements. As an early stage company, we expect to incur operating losses
until (if ever) we successfully release and market a line of products that will generate enough revenues and gross margin to become
profitable or thereafter maintain profitability. There is no assurance that we will be able to validate and market products that
will generate enough revenues for us to become profitable or thereafter maintain profitability. As a result, we cannot predict
when, if ever, it might achieve profitability and cannot be certain that it will be able to sustain profitability, if achieved.
Our lack of an operating history may make it difficult for you to evaluate our business prospects in connection with an investment
in our securities.
We need to raise additional capital
to continue our operations, which may not be available on commercially reasonable terms, or at all, and which materially may dilute
your investment
.
To attain profitability, we must increase
our revenues and manage our product, operating and administrative expenses, as to which each of which we can give no assurance.
Because we have been to date unable to generate sufficient revenues to pay our expenses and our existing sources of cash and cash
flows are otherwise insufficient to fund our activities, we must raise additional funds to continue our operations and to manage
our current short-term debt load. Further, our recent efforts to raise additional capital have been unsuccessful. We do not have
any arrangements in place for additional funds and no assurance can be given that required funds will become available on favorable
terms, or at all. Furthermore, if we issue equity or debt securities to raise additional funds, our existing stockholders may experience
dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders.
Our current cash and cash equivalents are insufficient to fund our operations through the end of our fiscal year in 2016. If we
are unsuccessful in obtaining additional funds on commercially reasonable terms or at all, and thereafter in achieving profitability,
we may be required to curtail significantly or cease our operations, which could result in the loss of all of your investment in
our stock.
Should we be able to obtain additional
financing and thereafter be successful in growing our revenues according to our operating plans, we may not be able to manage our
growth effectively, which could adversely affect our operations and financial performance
.
The ability to manage and operate our business
as we execute our growth strategy will require further substantial capital and effective planning. Additionally, we have not been
able to maintain adequate levels of capital to fund existing operations. Significant rapid growth on top of our current operations
could greatly strain our internal resources, leading to a much lower quality of customer service, reporting problems and delays
in meeting important deadlines resulting in substantial loss of market share and other problems that could adversely affect our
financial performance. Our efforts to grow could place a significant strain on our personnel, management systems, infrastructure,
liquidity, and other resources. If we do not manage our growth effectively, our operations could be adversely affected, resulting
in slower, no or negative growth, critical shortages of cash and a failure to achieve or sustain profitability.
Significant differences between actual
and estimated demand for our products could adversely affect us.
If we overestimate demand for our products,
we may be required to write off inventories and increase our reserves for product returns or liabilities to customers in future
periods. If we underestimate demand, we may not have sufficient inventory of products to ship to our customers. Our cosmeceutical
products have expiration dates that generally range from 24 to 36 months from the date of manufacture. We need to exercise judgment
in estimating these reserves. The actual amounts could be materially different from our estimates, and differences will need to
be accounted for in the period in which they become known. If we determine that the actual amounts exceed our reserve amounts,
we will record a charge to earnings to approximate the difference. A material reduction in earnings resulting from a charge could
have a material adverse effect on our net income, results of operations and financial condition.
If we raise additional funds through
collaboration, licensing, or other similar arrangements, it may be necessary to relinquish potentially valuable rights to our current
products, potential products, or proprietary technologies, or grant licenses on terms that are not favorable to us
.
If adequate funds are not available to
us, our ability to achieve profitability or to respond to competitive pressures would be significantly limited, and we may be required
to delay, significantly curtail or eliminate the sales of one or more of our current products and/or the development of one or
more of our potential products.
Risks Related to the Development and
Commercialization of Our Product Candidates
If our product candidates are found
to cause undesirable side effects we may need to delay or abandon our development and commercialization efforts.
Any undesirable side effects that might
be caused by our product candidates could interrupt, delay or halt the commercialization and marketing of the products. In addition,
if we start selling any of our product candidates and we or others later identify undesirable side effects caused by the product.
This could prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase the
costs and expenses of commercializing the product, which in turn could delay or prevent us from generating significant revenues
from its sale.
The commercial success of any product
candidates that we may develop will depend upon the degree of market acceptance by physicians, patients, and consumers.
Any products that we bring to the market
may not gain market acceptance by physicians, patients, and consumers. If these products do not achieve an adequate level of acceptance,
we may not generate significant product revenues and we may not become profitable. Physicians will not recommend our product candidates
until we can demonstrate the safety and efficacy of our product candidates as compared to other treatments. Even if the clinical
safety and efficacy of our product candidates are established, physicians may elect not to recommend these products, and consumers
may choose not to purchase our products. The degree of market acceptance of our product candidates will depend on a number of factors,
including:
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the willingness and ability of patients, the healthcare community, and consumers to adopt our products;
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the ability to manufacture our product candidates in sufficient quantities with acceptable quality
and to offer our product candidates for sale at competitive prices;
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the perception of patients, the healthcare community, and consumers regarding the safety, efficacy
and benefits of our product candidates compared to those of competing products or therapies;
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the convenience and ease of administration of our product candidates relative to existing treatment
methods; and
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marketing and distribution support for our product candidates.
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We face substantial competition in
the development of our product candidates which may result in others developing or commercializing products before or more successfully
than we do.
We are engaged in segments of the cosmeceuticals
industry that are characterized by intense competition and rapidly evolving technology. Many large companies, academic institutions,
and other public and private research organizations are pursuing the development of competing products. We face, and expect to
continue to face, intense and increasing competition as new products enter the market and advanced technologies become available.
Many of our potential competitors have significantly greater financial, technical and human resources than we have and may be better
equipped to discover, develop, manufacture, and commercialize product candidates.
Risks Related to Our Intellectual Property
If we are unable to protect our intellectual
property rights, our competitors may develop and market similar or identical products that may reduce demand for our products,
and we may be prevented from establishing collaborative relationships on favorable terms.
The following factors are important to
our success:
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receiving patent protection for our product candidates;
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maintaining our trade secrets;
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not infringing on the proprietary rights of others; and
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preventing others from infringing on our proprietary rights.
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We will be able to protect our proprietary
rights from unauthorized use by third parties only to the extent that our proprietary rights are covered by valid and enforceable
patents or are effectively maintained as trade secrets. We try to protect our proprietary position by filing U.S. and foreign patent
applications related to our proprietary technology, inventions and improvements that are important to the development of our business.
Our pending patent applications, those
we may file in the future, or those we may license from third parties, may not result in patents being issued. If patents do not
issue with claims encompassing our products, our competitors may develop and market similar or identical products that compete
with ours. Even if such patents are issued, they may not provide us with proprietary protection or competitive advantages against
competitors with similar technology. Failure to obtain effective patent protection for our technology and products may reduce demand
for our products and prevent us from establishing collaborative relationships on favorable terms.
We also rely on trade secrets, know-how
and technology, which are not protected by patents, to maintain our competitive position. We try to protect this information by
entering into confidentiality agreements with parties that have access to it, such as potential corporate partners, collaborators,
employees and consultants. Any of these parties may breach the agreements and disclose our confidential information or our competitors
may learn of the information in some other way. Furthermore, others may independently develop similar technologies or duplicate
any technology that we have developed. If any trade secret, know-how or other technology not protected by a patent were to be disclosed
to or independently developed by a competitor, our business and financial condition could be materially adversely affected.
The laws of many foreign countries do not
protect intellectual property rights to the same extent as do the laws of the United States. Accordingly, the fact that we have
obtained certain patent rights in the United States does not guarantee that we will be able to obtain the same or similar rights
elsewhere. Even if we are granted patents in foreign countries, we cannot guarantee that we will be able to enforce our rights
effectively.
If we are unable to obtain and maintain
protection for our intellectual property, the value of our technology and products may be adversely affected, which would materially
affect our business
.
Patents
. Our commercial success
will continue to depend in part on the patent rights we plan to obtain related to future products we may market. Our success also
depends on our and our licensors’, collaborators’, and suppliers’ ability to maintain these patent rights against
third-party challenges to their validity, scope, or enforceability of these patent rights.
Our patent position (and those of our licensors,
collaborators, and suppliers) is subject to the same uncertainty as other pharmaceutical and consumer product companies. Our patents
and patent applications (as well as those of our licensors, collaborators and suppliers) may not protect our technologies and products
because, among other things, our pending applications may not result in issued patents; we may develop additional proprietary technologies
that are not patentable; patents issued to us may not provide a basis for future commercially viable products; and patents issued
to us may not provide us with any competitive advantage, or may be challenged, circumvented, invalidated or rendered unenforceable
by third parties. For example, the USPTO or the courts may deny, narrow, or invalidate patent claims, particularly those that concern
biotechnology and pharmaceutical inventions. Inventors or third parties of whom we are unaware, may challenge the ownership of
patents and applications we own, license or benefit from through supply agreements with our collaborators and suppliers. We, our
licensors, collaborators, and suppliers may not be successful in securing or maintaining proprietary or patent protection for our
products, and protection that is secured may be challenged and possibly lost.
Trade Secrets and Proprietary Know-how
.
We, our licensors, collaborators, and suppliers also rely upon trade secrets, proprietary know-how, and other technological innovation,
particularly when patent protection is not appropriate or available. However trade secrets are difficult to protect, and we have
limited control over the protection of trade secrets used by our licensors, collaborators, and suppliers. Although we attempt to
protect our trade secrets by requiring our employees, consultants, advisors and current and prospective business partners to enter
into confidentiality agreements prohibiting them from disclosing or taking our proprietary information and technology, these agreements
may not provide meaningful protection for our trade secrets and proprietary know-how. If our employees or consultants breach these
agreements, we may not have adequate remedies for any of these breaches. Further, third parties that are not parties to confidentiality
agreements may obtain access to our trade secrets or know-how. Others may independently develop similar or equivalent trade secrets
or know-how. If our confidential or proprietary information is divulged to third parties, including our competitors, our competitive
position in the marketplace will be harmed and our ability to successfully penetrate our target markets could be severely compromised.
Trademarks
. Our trademarks will
continue to be important to our success and competitive position. We have received U.S. trademark registration for our corporate
name, NuGene
®
, and own or have rights to use our product and component names. We also have a license for the use
of Kathy Ireland
®
who acts as our brand ambassador. We also will need to pursue trademark registration for
any new trademarks that we select. We may not be able to secure any of our trademark registrations with the PTO or comparable foreign
authorities. If we do not adequately protect our rights in our various trademarks from infringement (and we are involved in two
separate ongoing disputes with respect to trademarks), any goodwill that has been developed in those marks would be lost or impaired.
We could also be forced to cease using any of our trademarks that are found to infringe upon or otherwise violate the trademark
or service mark rights of another company, and, as a result, we could lose all the goodwill that has been developed in those marks
and could be liable for damages caused by any infringement or violation.
We may be subject to claims that
we, or our employees, have inadvertently or otherwise used or disclosed alleged trade secrets or other proprietary information
of our employees’ former employers.
We employ individuals who were previously
employed at other personal care product or nutritional supplement companies, including our competitors or potential competitors.
To the extent that our employees are involved in research areas that are similar to those in which they were involved with their
former employers, we may be subject to claims that such employees have inadvertently or otherwise used or disclosed the alleged
trade secrets or other proprietary information of the former employers. Litigation may be necessary to defend against such claims.
Claims by other parties that we infringe
or have misappropriated their proprietary technology may result in liability for damages, royalties, or other payments, or stop
our development and commercialization efforts.
Competitors and other third parties may
initiate patent litigation against us in the United States or in foreign countries based on existing patents or patents that may
be granted in the future. Many of our competitors may have obtained patents covering products and processes generally related to
our products and processes, and they may assert these patents against us. Moreover, there can be no assurance that these competitors
have not sought or will not seek additional patents that may cover aspects of our technology. As a result, there is a greater likelihood
of a patent dispute than would be expected if our competitors were pursuing unrelated technologies.
While we conduct patent searches to determine
whether the technologies used in our products infringe patents held by third parties, numerous patent applications are currently
pending and may be filed in the future for technologies generally related to our technologies, including many patent applications
that remain confidential after filing. Due to these factors and the inherent uncertainty in conducting patent searches, there can
be no guarantee that we will not violate third-party patent rights that we have not yet identified.
There may be U.S. and foreign patents issued
to third parties that relate to aspects of our product candidates. There may also be patent applications filed by these or other
parties in the United States and various foreign jurisdictions that relate to some aspects of our product candidates, which, if
issued, could subject us to infringement actions. The owners or licensees of these and other patents may file one or more infringement
actions against us. In addition, a competitor may claim misappropriation of a trade secret by an employee hired from that competitor.
Any such infringement or misappropriation action could cause us to incur substantial costs defending the lawsuit and could distract
our management from our business, even if the allegations of infringement or misappropriation are unwarranted. A need to defend
multiple actions or claims could have a disproportionately greater impact. In addition, either in response to or in anticipation
of any such infringement or misappropriation claim, we may enter into commercial agreements with the owners or licensees of these
rights. The terms of these commercial agreements may include substantial payments, including substantial royalty payments on revenues
received by us in connection with the commercialization of our products.
Payments under such agreements could increase
our operating losses and reduce our resources available for development activities. Furthermore, a party making this type of claim
could secure a judgment that requires us to pay substantial damages, which would increase our operating losses and reduce our resources
available for development activities. A judgment could also include an injunction or other court order that could prevent us from
making, using, selling, offering for sale, or importing our products or prevent our customers from using our products. If a court
determined or if we independently concluded that any of our products or manufacturing processes violated third-party proprietary
rights, our clinical trials could be delayed and there can be no assurance that we would be able to reengineer the product or processes
to avoid those rights, or to obtain a license under those rights on commercially reasonable terms, if at all.
RISKS RELATED TO REGULATORY MATTERS
While we believe that that our principal
cosmeceutical products and product candidates do not require FDA approval as new drugs, the FDA could disagree and we may be required
to conduct clinical trials to establish efficacy and safety or cease to market these product
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Our cosmeceutical products are marketed
on the basis that they are generally recognized as safe and effective for their intended use and thus do not require new drug approval.
The FDA has not challenged this position. The FDA may at any time disagree with our position for a variety of reasons, including
new information about the particular product or its active ingredients, how the product is promoted, if another company obtains
FDA approval for a prescription drug with the same active ingredient, or based on a change of FDA regulatory policy. This could
require us to seek new drug approval for these products to remain on the market or to withdraw a product until required clinical
trials are performed and new drug approval is obtained.
If the active ingredients of the products
are finally determined by the FDA not to be generally recognized as safe and effective for over-the-counter, or OTC use, the FDA
may seek to apply those findings to prescription products as well, leading to potential objections to the continued marketing of
the products or a demand that marketing continue only on the basis of a new drug approval. Either of these outcomes could affect
the way our products are marketed or our ability to market them at all. Further, the FDA could decide that growth factors derived
from human adipose stem cells do not come within this policy and thus must seek new drug approval to remain on the market or must
be withdrawn until approval is obtained.
Our wound healing-wound care products under
development may not be approved by the FDA or foreign regulatory authorities, and any failure or delay associated with our product
development and clinical trials or obtaining regulatory approval of these products would increase our product development costs
and time to market. We face substantial risks of failure inherent in developing stem cell growth factor derived products that may
be determined by the FDA to fall under the classification as pharmaceutical products. The pharmaceutical industry is subject to
stringent regulation by many different agencies at the federal, state, and international levels. If determined to be pharmaceutical
products, then the product candidates will be required to satisfy rigorous standards of safety and efficacy before the FDA approves
them, and before any foreign regulatory authorities approve them for commercial use in any countries outside the U.S. where we
decide to market them. Even if a regulatory filing is accepted, the FDA or foreign regulatory authorities may request additional
information from us, including data from additional clinical trials, and, ultimately, may not grant marketing approval for some
of our products or may grant approval only under conditions that are less commercially attractive than anticipated. To the extent
that these products do not perform successfully in our planned pivotal clinical trials, we may need to develop alternative candidates.
Product development is generally a long, expensive, and uncertain process. Successful development of our new wound healing-wound
care product formulations, including our incisional and or burn cream will depend on many factors, including:
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Our ability to select key components, establish a stable formulation and optimize characteristics;
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Our ability to develop a formulation that demonstrates our intended safety and efficacy profile;
and
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Our ability to transfer from an early-stage company to commercial-scale operations and the costs
associated with commercial manufacturing.
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If we are unable to develop suitable clinical
formulations of our wound healing-wound care product candidates or are significantly delayed in doing so, our ability to commercialize
these products will be adversely affected. Once we have manufactured a formulation that we believe is suitable for pivotal clinical
testing, we will need to complete our clinical testing, and failure can occur at any stage of testing. These clinical tests must
comply with FDA and other applicable regulations. We may suffer significant setbacks in advanced clinical trials, even after showing
promising results in earlier trials. The results of later clinical trials may not replicate the results of prior clinical trials.
Based on results at any stage of clinical trials, we may decide to discontinue development of a product candidate. We, or the FDA,
may suspend clinical trials at any time if the patients participating in the trials are exposed to unacceptable health risks or
if the FDA finds deficiencies in our applications to conduct the clinical trials or in the conduct of our trials. Moreover, not
all products in clinical testing will receive timely, or any, regulatory approval. Even if clinical trials are completed as planned,
their results may not support our assumptions or our product claims. The clinical process may fail to demonstrate that our products
are safe for humans or effective for intended uses. In addition, these failures could cause us to abandon a product entirely. If
we fail to take any current or future product candidate from the development stage to market, we will have incurred significant
expenses without the possibility of generating revenues, and our business will be adversely affected.
We will be subject to ongoing regulatory
review of products currently under development that may be marketed in the future.
Any of our pharmaceutical products under
development will be subject to extensive regulation. These regulations will impact many aspects of our operations, including the
manufacture, labeling, packaging, adverse event reporting, storage, advertising, promotion, and record keeping related to the products.
The FDA also may require post-marketing testing and surveillance to monitor the effects of approved products or place conditions
on any approvals that could restrict the commercial applications of these products. In addition, the subsequent discovery of previously
unknown problems with a product may result in restrictions on the product, including withdrawal of the product from the market.
If we fail to comply with applicable regulatory requirements, we may be subject to fines, suspension, or withdrawal of regulatory
approvals, product recalls, seizure of products, injunctions against their distribution, disgorgement of money, operating restrictions,
and criminal prosecution.
In addition to FDA restrictions on marketing
of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain marketing practices
in the pharmaceutical industry in recent years. These laws include anti-kickback statutes and false claims statutes. Violations
of the federal anti-kickback statute are punishable by imprisonment, criminal fines, civil monetary penalties, and exclusion from
participation in federal healthcare programs. Although there are a number of statutory exemptions and regulatory safe harbors protecting
certain common activities from prosecution or other regulatory sanctions under the federal anti-kickback statute, the exemptions
and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing, arranging
for or recommending prescription or purchase may be subject to scrutiny if they do not qualify for a statutory exemption or safe
harbor. Federal false claims laws prohibit any person from knowingly making, or causing to be made, a false claim to the federal
government, or knowingly making, or causing to be made a false statement to have a false claim paid. The majority of states also
have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services
reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Sanctions under these
federal and state laws may include civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under
government programs, criminal fines, and imprisonment.
In addition, as part of the sales and marketing
process, pharmaceutical companies frequently provide samples of approved drugs to physicians. This practice is overseen by the
FDA and other governmental authorities under regulations that include, in particular, requirements concerning record keeping and
control procedures. Any failure to comply with these regulations may result in significant criminal and civil penalties as well
as damage to our credibility in the marketplace. Because of the breadth of these laws and the narrowness of the safe harbors, it
is possible that some of our business activities could be subject to challenge under one or more of these laws, which could have
a material adverse effect on our business, financial condition, and results of operations.
The regulatory status of our cosmeceutical
products could change, and we may be required to conduct clinical trials to establish efficacy and safety or cease to market these
products
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The Federal Food, Drug, and Cosmetic Act
does not recognize “cosmeceuticals” as a category of products. We use the term “cosmeceuticals” as a marketing
term to describe our non-prescription, cosmetic products. The FDA does not have a premarket approval system for cosmetic products
outside of new color additives, and we believe we are permitted to market our cosmeceutical products and have them manufactured
without submitting safety or efficacy data to the FDA. However, the FDA may in the future determine to regulate what we term as
cosmeceuticals or the ingredients included in our cosmeceuticals as drugs or biologics, rather than cosmetics. If any of our products
are deemed to be drugs or biologics, rather than cosmetics, we would be required to conduct clinical trials to demonstrate the
safety and efficacy of our cosmeceutical products in order to continue to market and sell them. In such event, we may not have
sufficient resources to conduct any required clinical trials and we may not be able to establish sufficient efficacy or safety
data to resume the sale of our cosmeceutical products. Any inquiries by the FDA or any foreign regulatory authorities into the
regulatory status of our cosmeceutical products and any related interruption in the marketing and sale of our cosmeceutical products
could severely damage our brands and image in the marketplace, including our relationships with physicians and their patients.
If our manufacturers do not comply
with U.S. and federal regulations, our supply of product could be disrupted or terminated
.
Our manufacturers must comply with U.S.
regulations and corresponding foreign standards, including the FDA’s current Good Manufacturing Practice regulations for
drug manufacturing and processing, or “cGMPs”, applicable to the manufacturing processes related to ingredients sold
to us for use in our products, and their facilities must be inspected and approved by the FDA and other regulatory agencies as
part of their business. We will have limited control over the FDA compliance of our third-party manufacturers. If any of our manufacturers
fail to meet or are found to be non-compliant with the cGMPs or any other FDA requirements or similar regulatory requirements outside
of the U.S., obtaining the required regulatory approvals, including from the FDA, to use alternative suppliers may be a lengthy
and uncertain process. A lengthy interruption in the manufacturing of one or more of our products as a result of non-compliance
could adversely affect our product inventories and supply of products available for sale which could reduce our sales, margins
and market share, as well as harm our overall business and financial results. Additionally, the Federal Drug and Cosmetic Act (“FDCA”)
may hold labelers/specification developers (brands selling a product) criminally and civilly liable for the violations, acts, and
omission of their manufacturers.
Under the FDCA, cosmetics (which we refer
to as cosmeceuticals) are defined as articles applied to the human body to cleanse, beautify, or alter the appearance. The manufacturing
of cosmetics is subject to the misbranding and adulteration sections of the FDCA applicable to cosmetics. Cosmetics are not subject
to premarket approval by the FDA but the product and ingredients must be tested to assure safety. If the product or ingredients
are not tested for safety, a specific warning is required. The FDA monitors compliance of cosmetic products through random inspections
of cosmetic manufacturers and distributors. The FDA utilizes an “intended use” doctrine to determine whether a product
is a drug or cosmetic by the labeling claims made for the product. If a cosmetic product is intended for a disease condition or
to affect the structure or any function of the human body, the FDA will regulate the product as a drug rather than as a cosmetic.
The product will then be subject to all drug requirements under the FDCA. The labeling of cosmetic products is subject to the requirements
of the FDCA, the Fair Packaging and Labeling Act and other FDA regulations.
We have only limited experience in regulatory
affairs, which may affect our ability or the time we require to obtain necessary regulatory approvals. We have only limited experience
in regulatory affairs, including the preparation and filing of applications to gain the regulatory approvals necessary for pharmaceutical
product candidates. Moreover, some of the products that are likely to result from our product development, licensing and acquisition
programs may be based on new technologies that have not been extensively tested in humans. As a result, we may experience a longer
than customary regulatory process in connection with obtaining regulatory approvals for any products that we develop, license or
acquire.
If we move forward with production
of an FDA regulated product, and we are found not to be in compliance with Good Manufacturing Practices, then our operations could
be harmed.
In the United States, FDA regulations on
Good Manufacturing Practices and Adverse Event Reporting requirements require us and our vendors to maintain good manufacturing
processes, including stringent vendor qualifications, ingredient identification, manufacturing controls and record keeping.
The ingredient identification requirement, which requires us to confirm the levels, identity, and potency of ingredients listed
on our product labels within a narrow range, is particularly burdensome and difficult for us with respect to products that contain
many different ingredients. We are also required to report serious adverse events associated with consumer use of our products.
Our operations could be harmed if regulatory authorities make determinations that we, or our vendors, are not in compliance with
these regulations or public reporting of adverse events harms our reputation for quality and safety. A finding of noncompliance
may result in administrative warnings, penalties, or actions impacting our ability to continue selling certain products.
In addition, compliance with these regulations has increased and may further increase the cost of manufacturing certain of our
products as we work with our vendors to assure they are qualified and in compliance.
RISKS RELATED TO OUR BUSINESS
Our products and product candidates
may not achieve or maintain widespread market acceptance.
We may not achieve or maintain widespread
market acceptance of our products or product candidates among physicians, patients, or healthcare providers. Our products’
success is highly dependent on physician and patient preference and market acceptance. We have a limited history of promoting our
cosmeceutical products. Our significant marketing efforts to date have been focused primarily on dermatologists and plastic surgeons.
We believe that market acceptance of our
products will depend on many factors including:
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The perceived advantages of our products over competing products;
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The effectiveness of our sales and marketing efforts;
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The convenience and ease of administration of our products;
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The safety and efficacy of our products and the prevalence and severity of any possible adverse
side effects;
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The availability and success of alternative treatments;
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Our product pricing and cost effectiveness;
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Publicity concerning our products, product candidates or competitive products;
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Whether or not patients routinely use our products and purchase additional product, and
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Our ability to respond to changes in physician, aestheticians, and patient preferences for the
treatment of dermatological conditions and the improvement of the appearance of skin.
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If our products fail to achieve or
maintain market acceptance or if new products or technologies are introduced by others that are more favorably received than our
products, are more cost effective or that otherwise render our products obsolete, we may experience a decline in the demand for
our products.
If we are unable to market and sell our
products successfully, our business, financial condition, results of operation and future growth would suffer. Our ability to compete
depends upon the success of our business development activities and our ability, and the ability of our collaborators, to innovate,
develop, and commercialize new products and product enhancements, as well as to identify new markets for our products.
Our business strategy requires us to develop
or acquire new and innovative applications of our products, identify new markets for our existing products, and develop or acquire
new technology. We are currently developing products for the treatment of burns and exploring several delivery technologies to
improve our existing products. However, our development efforts may not lead to new commercial products. To successfully expand
our product offerings, we must:
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Develop or acquire new products that either add to or significantly improve our current product
lines;
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Convince our target customers that any new cosmeceutical products or line extensions would be an
attractive revenue-generating addition to their practices;
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Protect our products with defensible intellectual property; and
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Satisfy and maintain all regulatory requirements for commercialization.
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The process of developing product candidates
involves a high degree of risk and may take several years. Product candidates we may acquire or license in the future that appear
promising in the early phases of development may fail to reach the market for several reasons, including:
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Pharmaceutical product candidates may fail to receive regulatory approvals required to bring the
products to market;
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Manufacturing costs or other factors may make our pharmaceutical and cosmeceutical product candidates
uneconomical;
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The proprietary rights of others and their competing products and technologies may prevent our
product candidates from being commercialized;
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Success of pharmaceutical product candidates in nonclinical and early clinical studies does not
ensure that later stage clinical trials will be successful;
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The length of time necessary to complete clinical trials and to submit an application for marketing
approval of pharmaceutical product candidates for a final decision by a regulatory authority varies significantly and may be difficult
to predict; and
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Developing pharmaceutical and cosmeceutical product candidates is very expensive and will have
a significant impact on our operating expenses.
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We may be unable to continue to develop
new products, enhancements to our existing products and other technologies in the near term, if at all, in part because new products
or enhancements to our existing products must meet regulatory standards and receive requisite regulatory approvals.
Our failure to introduce new products or
enhancements to our existing products could adversely affect our expected growth rate and adversely affect our overall business
and financial results.
Our marketed products and our products
under development could be rendered obsolete by technological or medical advances
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The development of medical advances to
treat the conditions that our products are designed to address may render our marketed products and our products under development
obsolete or uneconomical. The enhancement to the appearance of skin, the regeneration of hair growth and the treatment of burns,
acne or other skin disorders are the subjects of active research and development by many potential competitors, including major
pharmaceutical companies, specialized biotechnology firms, universities and other research institutions, as well as other major
cosmeceutical companies which develop wrinkle reduction or age defying skin and hair care products. While we intend to expand our
technological capabilities to remain competitive, research and development by others may render our technology or products obsolete
or noncompetitive or result in treatments superior to any therapy we develop.
Technological advances affecting costs
of production also could adversely affect our ability to sell products. Our products could become more expensive to produce, or
not competitive, which would decrease our revenues and adversely affect our results of operations and financial condition.
Our future success depends on our
ability to retain our chief executive officer and to attract, retain and motivate qualified personnel.
We are highly dependent on Steven Carlson,
our Chief Executive Officer. The loss of the services of Mr. Carlson might impede the achievement of our research, development,
and commercialization objectives. Replacing Mr. Carlson may be difficult and time-consuming because of the limited number of individuals
in our industry with the skills and experiences required to successfully develop and commercialize our products. We generally do
not maintain key person life insurance to cover the loss of any of our employees.
Recruiting and retaining qualified scientific
personnel, clinical personnel and sales and marketing personnel will also be critical to our success. We may not be able to attract
and retain these personnel on acceptable terms, if at all, given the competition for similar personnel. In addition, we rely on
consultants and advisors, including production, marketing, medical, and clinical advisors, to assist us in formulating our research
and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may
have commitments under consulting or advisory contracts with other entities that may limit their availability to us.
During the year ended December 31,
2015, the majority of our revenues were derived from two wholesale distributors. The loss of the distributors could have a material
negative effect on our financial condition.
During the year ended December 31, 2015,
we derived 31.1% and 15.7% of our revenues from two wholesale distributors. These two distributors purchase products from us on a
purchase order basis on negotiated terms of payment. The distributors are under no obligation to continue to purchase our products.
The loss of either of the distributors, a material reduction in their purchases or the cancellation of product orders or unexpected
returns of unsold products could decrease our revenues and impede our future growth prospects. We do not have long-term purchase
commitments with our distributors. We are actively seeking to expand our products’ distribution channels in order to reduce
the impact the loss of any one distributor would have on our Company, however we can give no assurance that we will be successful
in doing so.
If we breach any of our key license
or supply agreements, we could lose exclusivity rights or the agreements could be terminated
.
We have an international licensing agreement
with kiWW for all cosmetic products for a term of eight years. These rights are important to our business, and any breach of the
related agreements could result in a termination of the respective rights, which, in turn, would prevent us from marketing the
affected products or developing the affected product candidates. Our agreements with kiWW require milestone and royalty payments,
minimum revenue requirements or minimum annual royalty payments and other obligations. If we have insufficient demand for these
products or otherwise fail to meet the minimum purchase requirements or any of the other requirements set forth in these agreements,
we could lose the exclusive nature of our right to market products under the kiWW brand. Additionally, we are overdue in payments
owed to kiWW. Should we not be able to cure this breach of our payment obligations under the agreement within a mutually agreeable
timeframe, we face the possibility that the agreement could be terminated.
If we fail to comply with any of the requirements
under our key license and supply agreements, we may lose exclusive rights under these agreements or they may be terminated in their
entirety. As of the date of this prospectus, we remain overdue in payments owing to many of the counterparties to these agreements,
which increases the risk of such loss or termination. In that event, others could obtain rights to sell products that compete directly
with our products and our revenues and market share would correspondingly decrease. The loss of any rights under any of our license
and supply agreements would adversely affect our ability to sell our products and adversely affect our revenues and results of
operations.
We face risks due to our reliance
on third parties to perform many necessary commercial services for our products, including services related to the distribution,
storage, transportation, and regulatory monitoring of our products.
We rely on third parties to perform a variety
of functions related to the sale and distribution of our cosmeceutical products. These services include distribution, logistics
management, inventory storage and transportation, invoicing and collections, the key aspects of which are out of our direct control.
If any third-party service provider fails to comply with applicable laws and regulations, fails to meet expected deadlines or otherwise
does not carry out its contractual duties to us, our ability to deliver products to meet commercial demand would be significantly
impaired. In addition, we may retain one or more third parties to perform various regulatory monitoring services for our products,
including adverse event reporting, safety database management and other product maintenance services. If the quality or accuracy
of the data maintained by these regulatory service providers is insufficient, our ability to continue to market our approved products
could be jeopardized or we could be subject to regulatory sanctions.
If our competitors develop and market
products faster than we do or if the products of our competitors are considered more desirable than our products, revenues of our
existing or new products may be adversely affected
.
The dermatology market is highly competitive
and includes a number of established, large, and mid-sized pharmaceutical and cosmeceutical companies, as well as smaller emerging
companies and specialty pharmaceutical and cosmeceutical companies, whose activities are focused on our target markets and areas
of expertise. We face and will continue to face, competition for our products and in the commercialization, development, licensing
and discovery of our product candidates. This could negatively impact our ability to achieve significant market acceptance of our
products and product candidates. Furthermore, new developments including the development of other drug technologies, delivery methods
and improved formulations, occur in the pharmaceutical industry at a rapid pace. These developments may render our currently marketed
products and product candidates or technologies obsolete or noncompetitive.
Compared to us, many of our competitors
and potential competitors have substantially greater:
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Research and development resources, including personnel and technology;
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Favorable brand name awareness
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Clinical trial experience; and
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Manufacturing, distribution and sales and marketing experience.
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As a result of these factors, our competitors
may obtain regulatory approval of their products more rapidly than us. Our competitors may obtain patent protection or other intellectual
property rights that limit our ability to develop or commercialize our product candidates or technologies. Our competitors may
also develop pharmaceutical and cosmeceutical products that are more effective and less costly than ours and may also be more successful
than us in manufacturing and marketing their products.
Other competitors may invest significant
amounts in achieving production economies of scale
.
It is possible that our competitors may
be able to reduce their cost of production so that they can aggressively price their products and increase their greater market
share. Our competitors may also be able to attract and retain qualified personnel and to secure capital resources. Any of these
events could adversely affect our ability to compete and our results of operations could suffer.
Our products and product candidates
may cause undesirable side effects that could limit their use
.
Skin irritation is a reported side effect
of cosmeceutical products. Although these side effects generally are not severe, they may limit the use of our products, particularly
if physicians or patients perceive the risks to outweigh the benefits or the side effects of competitive products to be less significant.
If more severe side effects associated with any of our cosmeceutical products were to be reported or observed, we could be required
to suspend our marketing of the products, conduct additional safety tests, and potentially cease the sale of the products. In addition,
we face the potential for product liability claims from any patients who experience side effects, whether or not any action is
taken by a regulatory authority.
Undesirable side effects caused by our
product candidates could interrupt, delay or halt our development programs, including clinical trials, and could result in the
denial of any required regulatory approval by the FDA or other regulatory authorities.
We may face liability and indemnity
claims that could result in unexpected costs and damage to our reputation.
Our business exposes us to potential liability
risks that arise from the testing, manufacture and sale of our cosmeceutical products. Plaintiffs in the past have received substantial
damage awards against pharmaceutical companies based upon claims for injuries allegedly caused by the use of their products. Although
we currently maintain product liability insurance, there is no guarantee that any claims brought against us would be within our
existing or future insurance policy coverage or limits. Any judgment against us that is in excess of our policy limits would have
to be paid from our cash reserves, which would reduce our capital resources. Further, we may not have sufficient capital resources
to pay a judgment, in which case our creditors could levy against our assets. Also, it may be necessary for us to recall products
that do not meet approved specifications, which would result in adverse publicity, potentially significant costs in connection
with the recall and a loss of revenues. Any product liability claim or series of claims brought against us could harm our business
significantly, particularly if a claim results in adverse publicity or damage awards outside or in excess of our insurance policy
limits.
Failure to adequately comply with
information security policies or to safeguard against breaches of such policies could adversely affect our operations and could
damage our business, reputation, financial position, and results of operations
.
In the process of making sales using consumer
credit cards as a method of payment, we may handle and transfer such information as part of our business. These activities are
subject to laws and regulations, as well as industry standards, in the United States and other jurisdictions in which our products
and services are available. These requirements, which often differ materially and sometimes conflict among the many jurisdictions
in which we operate, are designed to protect the privacy of consumers’ personal information and to prevent that information
from being inappropriately used or disclosed. We maintain and review technical and operational safeguards designed to protect this
information and generally require others with whom we work to do so as well. However, despite those safeguards, it is possible
that hackers, employees acting contrary to our policies, third-party agents or others could improperly access relevant systems
or improperly obtain or disclose data about our consumers, or that we may be determined not to be in compliance with applicable
legal requirements and industry standards for data security, such as the Payment Card Industry guidelines. A breach or purported
breach of relevant security policies that compromises consumer data or determination of non-compliance with applicable legal requirements
or industry standards for data security could expose us to regulatory enforcement actions, card association or other monetary fines
or sanctions, or contractual liabilities, limit our ability to provide our products and services, subject us to legal action and
related costs and damage our business reputation, financial position, and results of operations.
Changes in economic conditions could
materially affect our ability to maintain or increase sales.
The cosmeceutical industry depends on consumer
discretionary spending. The United States in general or the specific markets in which we operate may suffer from depressed
economic activity, recessionary economic conditions, higher fuel or energy costs, low consumer confidence, high levels of unemployment,
reduced home values, increases in home foreclosures, investment losses, personal bankruptcies, reduced access to credit or other
economic factors that may affect consumers’ discretionary spending. Economic conditions may remain volatile and may depress
consumer confidence and discretionary spending in the future. Negative economic conditions, if and when they exist, might cause
consumers to make changes to their discretionary spending behavior, including spending currently made on our cosmeceutical line
of products. If such sales decrease, our profitability could decline as we spread fixed costs across a lower level of sales and
this could materially adversely affect our business, financial condition, or results of operations.
The cosmeceutical industry in which
we operate is highly competitive and increased competition could reduce our sales and profitability
.
We compete in different markets within
the cosmeceutical industry on the basis of the uniqueness of our product offerings, the quality of our products, customer service,
price, and distribution. Our markets are highly competitive. Our competitors vary in size and many may have greater
financial and marketing resources than we do. If we cannot maintain quality and pricing that are comparable or superior to
our competitors, we may not be able to grow our revenues and operating profits and we may lose market share. Competitive
conditions could result in our experiencing reduced revenues, gross margins, and operating results and could cause an investor
in our Company to lose a substantial amount or all of its investment in our Company.
The loss of suppliers or shortages
in ingredients could harm our business.
We acquire ingredients and products from
third-party suppliers and manufacturers. A loss of any of these suppliers and any difficulties in finding or transitioning to alternative
suppliers could harm our business. In addition, we obtain some of our products from sole suppliers that own or control the product
formulations, ingredients, or other intellectual property rights associated with such products. In the event we are unable to renew
these contracts, we may need to discontinue some products or develop substitute products, which could harm our revenue. In addition,
if we experience supply shortages or regulatory impediments with respect to the raw materials and ingredients we use in our products,
we may need to seek alternative supplies or suppliers and may experience difficulties in finding ingredients that are comparable
in quality and price. Some of our products incorporate products that may have limited supplies. If demand exceeds forecasts, we
may have difficulties in obtaining additional supplies to meet the excess demand. If we are unable to successfully respond to such
issues, our business could be harmed.
Risks Related to Our Common Stock
The recent public market for our
shares has been and may continue to be volatile. This volatility may affect the ability of our investors to sell their shares as
well as the price at which they sell their shares.
The market price for our shares may be
significantly affected by factors such as variations in the volume of trading activity, quarterly and yearly operating results,
general trends in the markets we serve, press releases announcing developments and changes in state or federal regulations affecting
us and our industry. Furthermore, in recent years the stock market has experienced extreme price and volume fluctuations that are
unrelated or disproportionate to the operating performance of the affected companies. Such broad market fluctuations may adversely
affect the market price of our common stock.
Because our stock price is volatile,
purchasers of our common stock could incur substantial losses.
Our stock price has been and may continue
to be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility
that has often been unrelated to the operating performance of particular companies. The market price for our common stock may be
influenced by many factors, including:
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results of clinical trials of our product candidates or those of our competitors;
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regulatory or legal developments in the United States and other countries;
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variations in our financial results or those of companies that are perceived to be similar to us;
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developments or disputes concerning patents or other proprietary rights;
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the recruitment or departure of key personnel;
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market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed
securities analysts’ reports or recommendations;
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general economic, industry and market conditions; and
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the other factors described in this “Risk Factors” section.
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The application of the “penny
stock” rules to our common stock could limit the trading and liquidity of the common stock, adversely affect the market price
of our common stock and increase your transaction costs to sell those shares
.
As long as the trading price of our common
stock is below $5 per share, and our common stock is not listed on a national securities exchange, the open-market trading of our
common stock will be subject to the “penny stock” rules, unless we otherwise qualify for an exemption from the “penny
stock” definition. The “penny stock” rules impose additional sales practice requirements on certain broker-dealers
who sell securities to persons other than established customers and accredited investors (generally those with assets, excluding
principal residence, in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 together with their spouse). These
regulations, if they apply, require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining
the penny stock market and the associated risks. Under these regulations, certain brokers who recommend such securities to persons
other than established customers or certain accredited investors must make a special written suitability determination regarding
such a purchaser and receive such purchaser’s written agreement to a transaction prior to sale. These regulations may have
the effect of limiting the trading activity of our common stock, reducing the liquidity of an investment in our common stock, and
increasing the transaction costs for sales and purchases of our common stock as compared to other securities. The stock market
in general and the market prices for penny stock companies in particular, have experienced volatility that often has been unrelated
to the operating performance of such companies. These broad market and industry fluctuations may adversely affect the price of
our stock, regardless of our operating performance. Stockholders should be aware that, according to SEC Release No. 34-29093,
the market for penny stocks has suffered in recent years from patterns of fraud and abuse. Such patterns include 1) control of
the market for the security by one or a few broker-dealers that are often related to the promoter or issuer; 2) manipulation of
prices through prearranged matching of purchases and sales and false and misleading press releases; 3) boiler room practices involving
high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; 4) excessive and undisclosed bid-ask
differential and markups by selling broker-dealers; and 5) the wholesale dumping of the same securities by promoters and broker-dealers
after prices have been manipulated to a desired level, along with the resulting inevitable collapse of those prices and with consequent
investor losses. The occurrence of these patterns or practices could increase the volatility of our share price.
We may not be able to attract the
attention of brokerage firms, which could have a material adverse impact on the market value of our common stock.
Security analysts of brokerage firms are
unlikely to provide coverage of our common stock since there is no incentive to brokerage firms to recommend the purchase of our
common stock. The absence of such coverage limits the likelihood that an active market will develop or be maintained for our common
stock. It will also likely make it more difficult to attract new investors at times when we require additional capital.
Future sales of our equity securities
could put downward selling pressure on our securities, and adversely affect the stock price.
There is a risk that this downward pressure
may make it impossible for an investor to sell his or her securities at any reasonable price, if at all. Future sales of substantial
amounts of our equity securities in the public market, or the perception that such sales could occur, could put downward selling
pressure on our securities, and adversely affect the market price of our common stock.
Our directors and principal stockholders
beneficially own or control a substantial portion of our outstanding common stock, which may limit the ability of our stockholders,
whether acting alone or together, to propose or direct the management on the overall direction of our Company
.
Additionally, this concentration of ownership
could discourage or prevent a potential takeover of our Company that might otherwise result in an investor receiving a premium
over the market price for his shares. A substantial portion of our outstanding shares of common stock is beneficially owned and
controlled by a group of insiders, including our officers and directors. Accordingly, our principal stockholders together with
our directors, Chief Executive Officer, and insider shareholders have the power to control the election of our directors and the
approval of actions for which the approval of our stockholders is required. If you acquire shares of our common stock, you may
have no effective voice in the management of our Company. Such concentrated control of our Company may adversely affect the
price of our common stock. Our principal stockholders may be able to control matters requiring approval by our stockholders, including
the election of directors, mergers or other business combinations. Such concentrated control may also make it difficult for our
stockholders to receive a premium for their shares of our common stock in the event we merge with a third party or enter into different
transactions that require stockholder approval. These provisions could also limit the price that investors might be willing to
pay in the future for shares of our common stock.
Our outstanding warrants may be exercised,
our convertible promissory notes may be converted, and our outstanding shares of preferred stock may be converted, in the future,
which would increase the number of shares in the public market and result in dilution to our stockholders.
We are currently authorized to issue
100,000,000 of our common stock. As of September 30, 2016 we had 40,334,673 shares of our common stock issued and
outstanding, excluding shares of common stock earned but unissued, issuable upon exercise of our outstanding warrants,
options, convertible promissory notes, and shares of common stock into which our issued shares of preferred stock may be
converted. To the extent the shares of common stock are issued, options and warrants are exercised, convertible promissory
notes are converted, or preferred stock is converted, holders of our common stock will experience dilution. In addition, in
the event of any future financing of equity securities or securities convertible into or exchangeable for, common stock,
holders of our common stock may experience dilution. As of September 30, 2016 outstanding warrants to purchase 4,679,234
shares of our common stock at a weighted average exercise price of approximately $0.78 per share. In addition, as of
September 30, 2016 we had outstanding options to purchase 4,352,619 shares of our common stock at a weighted average exercise
price of approximately $0.58 per share; and, our issued shares of preferred stock can be converted into 1,917,720 shares of
our common stock. In addition, we also had approximately $2,601,091 outstanding principal amount and interest of convertible
debt as of September 30, 2016 for which the conversion price varies depending on the average trading price of shares of our
common stock. Accordingly, if our stock price decreases, we could be required to issue a greater number of shares of
our common stock upon conversion of this debt than originally anticipated, which could lead to dilution of your investment in
our Company.
There is a limited trading market
for our common stock, and shareholders may have difficulty trading and obtaining quotations for our common stock.
Our common stock is quoted on the OTCQB
under the symbol “NUGN” and we have applied to list our common stock on the Nasdaq Capital Market. There has been limited
trading in our common stock. As a result, investors may find it difficult to dispose of, or to obtain accurate quotations of the
price of, our securities. A limited market may adversely affect the market price of our common stock and could also impair our
ability to raise capital by selling shares of capital stock and may impair our ability to acquire other companies or assets by
using common stock as consideration.
We have never paid any cash dividends
on our common stock and we do not anticipate paying any cash dividends in the foreseeable future.
We have paid no cash dividends on our common
stock to date. We currently intend to retain our future earnings, if any, to fund the development and growth of our business. In
addition, the terms of any future debt agreements may preclude us from paying dividends. As a result, we do not expect to pay any
cash dividends in the foreseeable future, and payment of cash dividends, if any, will depend on our financial condition, results
of operations, capital requirements and other factors and will be at the discretion of our board of directors. Furthermore, we
may in the future become subject to contractual restrictions on, or prohibitions against, the payment of dividends. Capital appreciation,
if any, of our common stock will be investors’ sole source of gain for the foreseeable future.
Our articles of incorporation allow
for our board to create series of preferred stock without further approval by our stockholders, which has and could further adversely
affect the rights of the holders of our common stock.
Our articles of incorporation authorize
the Board of Directors to issue up to 25,000,000 shares of “blank check” preferred stock. The preferred stock may be
issued in one or more series, the terms of which may be determined at the time of issuance by the Board of Directors without further
action by the stockholders. These terms may include preferences as to dividends and liquidation, conversion rights, redemption
rights and sinking fund provisions. We have issued 1,917,720 shares of Series A Preferred Stock to NuGene’s two founders,
both of whom also serve on our Board of Directors. The Series A Preferred Stock is initially convertible into common stock at a
ratio of one to one, has the right to elect a majority of the board of directors, and has in connection with any other vote of
shareholders three votes for every vote available to the common stock. These outstanding shares of Series A Preferred Stock diminish
and any future issuances of other series of preferred stock could further diminish the rights of holders of our common stock, and
therefore could reduce the value of such common stock. In addition, the Series A Preferred Stock could be used to restrict our
ability to merge with, or sell assets to, a third party. The Series A Preferred Stock makes it more difficult, and could delay,
discourage, prevent or make it more costly to acquire or effect a change-in-control, which in turn could prevent our stockholders
from recognizing a gain in the event that a favorable offer is extended and could materially and negatively affect the market price
of our common stock. This summary description of the Series A Preferred Stock is qualified in its entirety by reference to the
Certificate of Designations filed with Secretary of State of Nevada on December 24, 2014 and included in our Current Report on
Form 8-K filed with the SEC on January 6, 2015.
CORPORATE AND OTHER RISKS
We incur substantial costs as a result
of operating as a public company, and our management is required to devote substantial time to comply with public company regulations.
We are subject to the reporting requirements
of the Exchange Act, the Sarbanes-Oxley Act of 2002 as well as other federal and state laws. These requirements may place a strain
on our people, systems, and resources. The Exchange Act requires that we file annual, quarterly, and current reports with respect
to our business and financial condition. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures
and internal controls over financial reporting. In order to maintain and improve the effectiveness of our disclosure controls and
procedures and internal controls over financial reporting, significant resources and management oversight are required. This may
divert management’s attention from other business concerns, which could have a material adverse effect on our business, financial
condition, results of operations and cash flows.
Our Chief Executive Officer and our
Chief Financial Officer have limited experience in these roles in a public company.
To serve in the roles of officer and/or
director for a public company, an individual needs to be aware of responsibilities in addition to those shouldered by the leader
of a private company. Among such additional responsibilities, a senior executive officer must be able to communicate fairly
and effectively with the stakeholders of a public company, be aware of the controls required to be maintained by a public company
and act in accordance with the legal requirements incumbent upon such senior executives and directors. While our CEO has experience
in managerial positons in large public companies and led another company through a public offering, he does not have extensive
experience in operating a public company. Our CFO has never held a positon in a public company and he is not a trained financial
expert. The absence of such extensive experience (and training in the case of our CFO) could increase our exposure to untimely
compliance with applicable regulation that could result in possible added liability and cost to the material detriment of our operations
and financial interests. Our CFO is a medical doctor by training and has assumed the title and responsibility of a chief
financial officer but has not had any prior experience in the traditional services to be rendered but has rather relied on staff
and consultants in his acting in this capacity.
We do not have an Audit Committee
and we do not have a majority of independent persons serving on our Board of Directors
.
We do not have an independent Audit Committee.
An Audit Committee qualitatively enhances a company’s internal controls over financial reporting. Among its functions, independent
Audit Committees review the financial reporting, internal controls safeguarding Company assets, interact with auditors, may oversee
material financial decisions and provide a sounding board for individuals who believe that there are irregularities in a Company’s
accounting policies and procedures. Our Board of Directors consists of our two founders and one independent director. With
our lack of an independent Audit Committee and only one independent director, we run a greater risk that a significant error or
irregularity could occur that could be materially damaging to our shareholders.
For as long as we remain an “emerging
growth company” as defined in the JOBS Act, we may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies that are not “emerging growth companies.”
These exceptions provide for, but are not
limited to, relief from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, less extensive disclosure
obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements to
hold a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously
approved and an extended transition period for complying with new or revised accounting standards. We may take advantage of these
reporting exemptions until we are no longer an “emerging growth company.” We may remain an “emerging growth company”
for up to five years. To the extent we use exemptions from various reporting requirements under the JOBS Act, we may be unable
to realize our anticipated cost savings from those exemptions.
Pursuant to the JOBS Act, our independent
registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting
pursuant to Section 404 of the Sarbanes-Oxley Act for so long as we are characterized as an “emerging growth company.”
Section 404 of the Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal control
over financial reporting, starting with the second annual report that we file with the SEC as a public company, and generally requires
in the same report a report by our independent registered public accounting firm on the effectiveness of our internal control over
financial reporting. However, under the JOBS Act, our independent registered public accounting firm will not be required to attest
to the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act until
we are no longer an “emerging growth company”.
We are also currently able to take advantage
of certain of these exemptions as a smaller reporting company. 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.