LIQUIDITY AND CAPITAL RESOURCES
We have financed our operations primarily through private sales of equity
securities. As of September 30, 2004, we raised approximately $274,000 from the
sale of common stock and certain services for stock. Subsequent to September 30,
2004, we raised $200,000 in loans that were subsequently converted into to
stock.
Management expects to incur substantial expense in implementing its business
plan. The pace of this implementation will depend, in large part, on the ongoing
cash position. Management believes that the net proceeds of the offering,
together with our available cash, will be sufficient to meet our operating
expenses and capital requirements for at least twelve (12) months following
completion of this Prospectus. However, these expectations are based on certain
assumptions concerning the costs involved in purchase of equipment and hiring of
personnel for the establishment of the preliminary test site and the collection
of data from that site. These assumptions concern future events and
circumstances that management believes to be significant to our operations and
upon which its working capital requirements will depend. Some assumptions will
invariably not materialize and some unanticipated events and circumstances
occurring subsequent to the date of this Prospectus.
In addition, we require additional funding in order to achieve our operating
objectives. Such funding will be necessary for us to develop and expand the
"professional" and "direct-to-consumer" marketing strategies we have selected
for sale of our personal care products.
PLAN OF OPERATION
Upon the closing of the offering, we intend to commence scale-up, testing,
manufacturing and commercial sales of our personal care products and product
lines.
Upon completion of the preliminary laboratory studies and clinical studies, we
intend to market our products. Commencement and expansion of sales and marketing
activities will require funds to begin marketing initiatives, advertising and
public relations efforts and development of association alliances, as well as to
increase sales staff headcount and tradeshow attendance. In all likelihood,
additional financing will be required to conduct full-scale sales and marketing
activities.
Our plan assumes the completion of this offering in the first quarter of 2005
and includes the following activities over the next 12 months:
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(i) The establishment of pilot and commercial scale manufacturing
facilities for the specialized biomass to be used in the final
product including the purchasing and installing of equipment and
hiring of personnel The pilot scale process includes propagating the
engineered plants, harvesting the biomass and extracting and drying
the protein product. This process is expected to provide sufficient
material for dermatological studies and initial marketing and sales;
(ii) Expansion of a genetic database for personal care ingredients. These
data will be used to design formulations based on the variations in
human genetic sequences identified through analysis of the database.
Formulations are planned to be developed that are reflective of the
genetic makeup of the intended user, or population group represented
by the intended user;
(iii) Brief clinical studies with collaborating dermatologists or testing
laboratories will be undertaken to evaluate the performance of a
tropoelastin formulation;
(iv) Formulation and manufacturing of finished product using Contract
manufacturing facilities for production, blending, quality analysis
and finishing of our products. The Company will provide the dried
plant extract to be incorporated into the final finished product;
and
(v) Establish a sales and marketing organization to market, distribute,
and fulfill a proprietary line personal care products, and/or joint
venture with existing organizations that can distribute the product.
If we begin to accrue meaningful amounts of revenues from the sales of products
to third parties, we may need additional capital to finance its accounts
receivable. The amount of funds required to finance revenue growth will depend
upon the rate of sales growth, the timeliness of payments from customers, the
availability of receivables and inventory financing from third parties, and the
extent to which we permit (and our customers select) financing arrangements
other than payment upon delivery. The terms of the arrangements (including
payment timing) with any third-party finance company, and the frequency with
which such company allows, and its customers select, such arrangements, will
have a direct impact upon our working capital needs.
IMPACT OF INFLATION
To date inflationary factors have not had a significant effect on our
operations. We are not aware of any material trend, event or capital commitment,
which would potentially adversely affect liquidity.
OTHER:
Except for historical information contained herein, the matters set forth above
are forward-looking statements that involve certain risks and uncertainties that
could cause actual results to differ from those in the forward-looking
statements. Potential risks and uncertainties include such factors as the level
of business and consumer spending, the amount of sales of our products, the
competitive environment within our industry, the ability to continue to expand
our operations, the level of costs incurred in connection with our expansion
efforts, economic conditions and the financial strength of our customers and
suppliers.
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BUSINESS
HISTORY AND DEVELOPMENT
We were incorporated pursuant to the laws of Delaware on May 17, 2004 under the
name DermaPlus, Inc.
THE SCIENCE BEHIND OUR PRODUCTS
DermaPlus is a development stage skin care company that produces, designs and
synthesizes protein polymers and incorporates them into uniquely formulated
personal care products.
These protein polymers make up the Extracellular Matrix, a complex structural
entity which surrounds and supports cells that are found within human tissues.
The polymers include molecules such as elastin, laminin, keratin, fibrin and
collagen. Together they impart strength and elasticity to the skin, lung,
arteries, and other tissues. At present the Company synthesizes human
tropoelastin, the precursor to elastin, but anticipates producing other
Extracellular Matrix proteins in the future.
We intend to create anti-aging products that incorporate human tropoelastin
formulated specifically for users based on their genetic makeup. Unlike the
array of products on the market today that reduce the appearance of wrinkles
through sophisticated moisturizing and plumping, our products are the first to
provide human tropoelastin to the skin surface.
We believe that a fraction of human tropoelastin, when combined with carrier
agents and applied to the skin surface will penetrate the outer epidermal layer.
Once within the biochemical environment of the skin, the human-identical
tropoelastin is expected to become incorporated into the extracellular matrix
and increase the elastin content of the skin, reducing the appearance of
superficial wrinkles. We are currently conducting tests with contract
laboratories to establish the exact degree of tropoelastin absorption by skin.
We also intend to conduct safety and efficacy trials with human volunteers in
the future.
Many Extracellular Matrix proteins exist in the skin in more than one form,
reflecting the variable genetic makeup of human tissues. These combinations of
forms are unexpectedly complex and differ from tissue to tissue, with age and
from individual to individual. We have developed and continue to improve upon a
method of collecting data on the multiple forms (polymorphs) of human elastin
and is in the process of assembling a private database of tropoelastin genetic
sequences from human skin samples. This database will be used to guide the
manufacture of polymorphic tropoelastin preparations that match the genetic
characteristics of a selected or specified population group.
The personal care products containing these tropoelastin polymorphs will be the
first that can be specifically formulated for increased compatibility with the
skin of the user based on their genetic makeup. Benefits of this increased
compatibility include a lower chance of skin sensitivity and increased product
efficacy.
Currently, human tropoelastin and other Extracellular Matrix proteins are
synthesized by fermentation and available only in research quantities. When
produced through fermentation, they are far too scarce and expensive even to be
considered as an important ingredient in a personal care product. As far as we
are aware, no other similar materials are currently available in personal care
products. We have designed and contracted the construction of a proprietary gene
that can be incorporated into a green plant and cause the plant to synthesize
human tropoelastin as it grows. We believe that these plants can be grown
hydroponically in an enclosed facility, harvested and the human tropoelastin
extracted at a yield sufficient to provide the large volumes and low costs
necessary for use of this material in personal care products. We plan to
manufacture other Extracellular Matrix proteins using this method in the future.
We have a contractor currently assembling the engineered plants to be used in
the manufacturing process. We intend to scale up the tropoelastin manufacturing
processing in leased facilities.
MARKET OPPORTUNITY
The world market for wrinkle-reducing cosmeceutical products totaled $14.5
billion in 2003, an increase of 9.5% over the previous year. By 2008, this
global market is projected to reach $21.7 billion, based on a forecasted
compound annual growth rate (CAGR) of 8.4% from 2003 to 2008 (as reported by
Theta Reports Cosmeceuticals: Global Marketing & Breakthrough Therapies Report
No. 1246 June 2004).
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The general aging of populations is expected continue to drive the market. Our
patented processes for the design and production of personal care products
provides a competitive advantage in this market.
Another attractive market segment is US ethnic personal care markets. It has
become a major source of revenue with 1996 sales estimated at $970 million (C&E
News, April 12, 2000). Formulations designed for specific ethnic groups
currently have double-digit sales growth rates. DermaPlus plans to compete
directly in those segments.
BUSINESS STRATEGY
We intend to develop a cosmeceutical business based on customized personal care
ingredients identical to those in human skin. We intend to evaluate sales of our
products through trial marketing efforts conducted in-house and sales via
dermatologists and spas. As our independent cosmeceutical business grows, we
will evaluate how to best increase its profitability. Marketing efforts will be
bolstered by laboratory and clinical studies supporting product performance
claims.
Cosmeceutical skin-care products can be sold through the same channels that
currently sell cosmetics, allowing for the difference in markets between
cosmetics and cosmeceuticals. For example, health and natural food stores hold a
significant share of the anti-aging products retail market, followed by chain
drugstores and mass merchandisers, but they are not nearly as large in the
anti-aging cosmeceutical products category. The main cosmeceutical distribution
channels and some of their characteristics are:
Prestige Products. The most important distribution channel for prestige products
is the cosmetics departments of department stores. The balance is sold in
specialty shops, beauty salons, dispensing dermatologists, fitness centers and
personal care practitioners that all sell special brands of personal care
ingredients.
Interestingly, department stores, although they are a major purveyor of upscale
skin-care products, are not currently the major sellers of other anti-aging
products. The dermatology business is very competitive. The market in the
developed countries of the world is supplied by over one hundred companies. This
segment is a target for DermaPlus' personal care ingredients because high costs
will not deter those that are able to afford our more expensive, but also more
effective, products.
Mass Market. Mass retailers, such as drugstores, discount stores and
supermarkets, together have a large share. Chain drugstores are the leading mass
channel, although supermarkets and mass merchandisers are growing rapidly. As
part of the overall trend to devote more shelf space to skin-care products,
retailers are allocating more shelf space to cosmeceutical products and are
expanding their assortment. They often cross-merchandise cosmeceuticals in the
cosmetics and skin-care sections.
Direct Sales Market. Direct Sales comprises door-to-door, mail order, catalogue,
multilevel marketing and television ordering and infomercials. This is the other
segment that DermaPlus will pursue early on by negotiating agreements with one
or more multilevel marketing companies, and by selling proprietary ingredients
on a non-exclusive basis.
Mail order customers are reached through print and electronic advertising and
through web sites on the Internet. Multilevel marketing organizations, such as
NuSkin International, sell products that generally cannot be obtained in stores.
Television has rapidly growing consumer appeal and is ideally suited for
"concept" products, such as MatrixDesign's. We will actively explore the
opportunities of selling products with its ingredients to companies advertising
on television channels, such as QVC.
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Our marketing efforts will not be solely product - related. Since our personal
care ingredients, based on human proteins and biotechnology, is a new concept,
we will use the national media attention to focus on our story. We will also
increase industry awareness of our products through advertising and trade shows.
Alternatives approaches to developing these products include to contract for
proprietary manufacturing, introduce additional products related to existing
ones, explore new product areas, expand to other domestic markets and/or grow
internationally. Marketing is anticipated to be Direct To Consumer, as this is
the most effective method of making the customer aware of "the story" involving
elastin and other human polymers. Actual sales will be carried out through DTC
and selected third parties such as spas and dermatologists and multilevel
marketing organizations. Because these products can eventually be designed to
match the genetic profile of the intended customer, product design is intended
to be integrated with a marketing plan. The product will at some point in the
future literally contain a material design based on analysis of the intended
customer's elastin genetic profile. A marketing effort calculated to exploit
this novel factor would follow several steps:
(i) A target customer population in a specific area will be identified (Example
- Hispanic women aged 35 - 60 living in East Los Angeles);
(ii) Samples taken from a representative population of this group will be
analyzed for a characteristic pattern of elastin polymorphisms in the mRNA;
(iii) An elastin product closely matching or identical to the pattern
established by the mRNA analysis will be manufactured in plants and formulated
into a skin care product. This product will "be" the customer at the molecular
level;
(iv) A simultaneous marketing analysis of this group will be carried out to
identify preferences, buying patterns, pricing, advertising, sales locations;
(v) A marketing campaign aimed specifically at this customer group will be
planned and executed; and
(vi) Initial product launch and sales will be monitored and adjusted to maximize
the efficiency in expanded efforts to additional target population groups.
Competition. The US cosmetic skin-care market is highly segmented, with few
major national competitors. Only four companies; Estee Lauder, Procter & Gamble,
L'Oreal and Lever-Ponds have more than a 5% share of the market. Market shares
generally are divided on a producer and regional basis as well as by means of
distribution. In addition, there are a large number of in-house and toll
manufacturers that produce cosmetic ingredients. These ingredients are generally
inexpensive to manufacture, but often are ineffective.
Major competitors in each distribution channel are:
Prestige Sales. Cosmetic houses are the primary marketers of prestige
cosmeceutical product lines. These range from privately held independents, such
as Estee Lauder, to divisions of conglomerates, such as Elizabeth Arden, a
division of Unilever.
Direct Sales. Large personal care catalog companies, such as Avon and Mary Kay,
lead the group of alternative marketers. Niche marketers, which specialize in
anti-aging treatments, include CCA, Chantel Pharmaceuticals and University
Medical.
Mass Market. Pharmacia & Upjohn and Cosmair are leaders in the mass market.
Other large players are Unilever, Scott, Beiersdorff, Johnson & Johnson and
others, including private label companies. There are myriad mid to small size
cosmetic marketers and formulators.
The growing ethnic markets have attracted the attention of both specialized and
mainstream marketers. Whereas mainstream marketers, such as Cosmair and Procter
& Gamble, tend to target ethnic consumers through line extensions rather than
separate brands, smaller ethnic skin-care marketers formulate specific products
for Africans, Hispanics and Asians.
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Some of the more important activities in the developing cosmeceutical market
are:
o Clinique is now offering stop signs, an anti-aging serum containing
select botanical ingredients, vitamins and anti-oxidants available
at Neiman Marcus.
o Biotec is promoting Skin Life Formula Q10 which contains plant
collagen (Natto Gum) plant albumin, superphyco D and coenzyme Q10
(Source: Biotec, USA Research Technology and Beauty 33101 New Mexico
Ave, NW Washington, DC 20016, 877-364-9577).
o Princess Marcella Borghese is offering Spa Lift For Face with
bio-engineered involucrin-protein complex, which is claimed to mimic
the involucrin protein in skin cells (Mirabella, April, 1993 p.
112).
o Shiseido has established an Institute for Advanced Skin Research in
Tokyo, and OSI Pharmaceuticals, New York University and Pfizer
recently formed Anaderm, Inc. (Uniondale, NY) to apply modern drug
discovery tools in finding pharmacological agents for cosmetic use,
according to Arthur Bruskin, VP of drug discovery.
o Senetek PLC (Napa, CA) has developed Kinetin, a plant hormone that
retards aging in plants and delays age-related changes in cultured
human skin cells. Kinetin has shown good-to-excellent response in
partially reversing the clinical signs of photo-damaged facial skin.
o Kinetin is a key ingredient in skin care products sold by Osmotics
(Denver, CO) at upscale department stores and in products
distributed through dermatologists by ICN Pharmaceuticals (Costa
Mesa, CA) (GEN May 1, 2000 pp. 45).
Manufacturing Process. We are developing and testing a manufacturing process for
growing transgenic plants in water without soil. These plants will produce the
desired human biopolymers during the growth process. The initial planned
capacity will be sufficient to exceed expected demand.
We intend to transition to a contract grower to cultivate the plants from seed
supplied by us. The plant material containing the desired cosmeceutical would be
dried and then shipped to a manufacturer for formulation and bottling. We do not
currently have contracts with contract growing or formulation/bottling.
Intellectual Property and Proprietary Rights. We hold the exclusive rights to
two issued United States patents covering tropoelastin isomorphs as cosmetic
ingredients. Exclusive rights to these patents have been licensed to us. We will
receive assignments or excusive licenses to pending patents and believes that
the issued and pending patents will enable it to establish an advantage position
in personal care ingredients. We expect that future improvements and discoveries
will be covered by additional patent applications.
Government Regulation
The formulation, manufacturing, processing, packaging, labeling, advertising,
distribution and sale of personal care ingredients such as those being sold by
us are subject to regulation by a number of federal, state and foreign agencies,
principally, the Food and Drug Administration ("FDA") and the Federal Trade
Commission ("FTC"). Among other matters, such regulation is concerned with
health claims made with respect to a product that assert the healing or health
value of such product. Such agencies have a variety of remedies and processes
available to them, including initiating investigations, issuing warning letters
and cease and desist orders, requiring corrective labels or advertising,
requiring consumer redress (for example, by requiring that a company offer to
repurchase products previously sold to consumers), seeking injunctive relief or
product seizure, imposing civil penalties, or commencing criminal prosecution.
Federal and state agencies have in the past used these remedies in regulating
participants in the personal care industry, including the imposition by federal
agencies of civil penalties in the millions of dollars against a few industry
participants. In addition, increased sales and publicity of personal care
products may result in increased regulatory scrutiny of the industry. There can
be no assurance that the regulatory environment in which we operate will not
change or that such regulatory environment, or any specific action taken against
us, will not result in a material adverse effect on our business, financial
condition or results of operations.