Skinvisible (OTCBB: SKVI)

by: Publisher Friday, October 30th, 2009

Dear Members, We all know the World Health Organization has declared the H1N1 virus outbreak to be a pandemic. Here it is the last week of July, and flu season will be here a lot sooner than many of us have expected. If you are like me you are not wanting to just sit back and do nothing. You want to be proactive with your family and find a way to prevent the virus from affecting your family. We all remember the hype in the media from April and May. Most of the news coverage has let up in the United States for the Summer. We all know how things work. As soon as it gets serious here in the US, the media will pick up on the story again and make it the top item again. Is there anything we can do to protect our families and ourselves? Is there a company with an innovative product that is capable of helping in this effort? One product cannot do everthing, but there is a product that can help. It is from a well established fully reporting company that you can buy shares in. I want to introduce a company I had the honor to go out and visit last week at their headquarters in Las Vegas, Nevada. The company is Skinvisible (OTCBB: SKVI). Before I introduce to you the product we are speaking of, realize this company is not a one product start-up. The company has been around for years and has many successful products that are marketed around the world. This company is strong even if they did not have what appears to be one of the best products for stopping and killing the H1N1 Virus. DermSafe is the product. Let me tell you about DermSafe. This product is much like the hand sanitizers that you are used to. Just like with hand sanitizers, one application and you feel you kill virtually all of the H1N1 virus. What makes this product more important is that the killing continues and continues. Up to four hours after the application your hands are still killing the virus as you touch other surfaces and shake hands. Even if you wash your hands, the patented polymer keeps the power of DermSafe working. Skinvisible has developed an innovative polymer delivery vehicles and related compositions that hold active ingredients on the skin for extended periods of time when applied topically. The polymer delivery vehicles allow for normal skin respiration and perspiration. The polymer compositions wear off as part of the natural exfoliation process of the skin’s outer layer cells. Skinvisible’s process is formulated without the use of alcohol, silicones, waxes, or other organic solvents. Skinvisible has two U.S. Patents and has been granted patents in India, Australia, Japan and China.

Dear Members,

THE WORLD HEALTH ORGANIZATION DECLARES H1N1 A PHASE 6 PANDEMIC

We all know the World Health Organization has declared the H1N1 virus outbreak to be a Phase 6 Pandemic. Here it is the last week of July, and flu season will be here a lot sooner than many of us have expected. If you are like me you are not wanting to just sit back and do nothing. You want to be proactive with your family and find a way to prevent the virus from affecting your family. We all remember the hype in the media from April and May. Most of the news coverage has let up in the United States for the Summer. We all know how things work. As soon as it gets serious here in the US, the media will pick up on the story again and make it the top item again.

Is there anything we can do to protect our families and ourselves? Is there a company with an innovative product that is capable of helping in this effort?

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A COMPANY YOU CAN INVEST IN WITH A PRODUCT THAT CAN HELP FIGHT H1N1

The company is Skinvisible (OTCBB: SKVI)

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One product cannot do everthing, but there is a product that can help. It is from a well established fully reporting company that you can buy shares in. I want to introduce a company I had the honor to go out and visit last week at their headquarters in Las Vegas, Nevada. The company is Skinvisible (OTCBB: SKVI).

Before I introduce to you the product we are speaking of, realize this company is not a one product start-up. The company has been around for years and has many successful products that are marketed around the world. This company is strong even if they did not have what appears to be one of the best products for stopping and killing the H1N1 Virus.

DermSafe is the product.

Let me tell you about DermSafe. This product is much like the hand sanitizers that you are used to. Just like with hand sanitizers, one application and you feel you kill virtually all of the H1N1 virus. What makes this product more important is that the killing continues and continues. Up to four hours after the application your hands are still killing the virus as you touch other surfaces and shake hands. Even if you wash your hands, the patented polymer keeps the power of DermSafe working.

Skinvisible has developed an innovative polymer delivery vehicles and related compositions that hold active ingredients on the skin for extended periods of time when applied topically. The polymer delivery vehicles allow for normal skin respiration and perspiration. The polymer compositions wear off as part of the natural exfoliation process of the skin’s outer layer cells. Skinvisible’s process is formulated without the use of alcohol, silicones, waxes, or other organic solvents. Skinvisible has two U.S. Patents and has been granted patents in India, Australia, Japan and China.

When can you buy the product? The product is approved in Canada, and should soon be approved in the UK and Europe if the process goes as expected. China is also a market that is likely to be approved soon. The process there is underway as well. There have been some efforts to get it on a fast track approval for FDA approval. So far the FDA is not willing to let that happen. The company will certainly pursue normal channels for making the product available in the US. Skinvisible has much experience with this, so I think they will have eventual success. The opportunity here and now is all of the rest of the world. Should the FDA approval come at some point, it will be a bonus on top of the rest of the world. Do not look for that this year. For good reason the FDA is careful. The active ingredient in this product is well known and has been used in hospitals for years.

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THE CAPITAL STRUCTURE:


COMMON STOCK ONLY – NO PREFERRED ISSUES

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As your do your research and due diligence, I personally think you will see the opportunity here. Take note of the capital structure here. There are NO PREFERRED issues. The common shares the insiders have are the same shares you will buy. This is a very clean deal that has a great product.

I see the stock as serious undervalued based on everything else the company has to offer. When you factor in DermSafe, you can really see there is a lot of potential here.

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MY ESTIMATE

I am not going to give you a target price, but I will tell you this is very undervalued. Once DermSafe is on product shelves, we should see the stock do great revenue and as a result do multiples in pricing. That will happen this Fall, so get ready.

FYI, once a link is live that allows you to buy from a reputable Canadian Pharmacy web site, I will share that with you. I know many of us would love to not only have some shares but the product as well! I will keep you informed.

I would love to hear your comments.

John Pentony
Publisher, StockGuru

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StockGuru Profile for Skinvisible, Inc.

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Any discussion of Skinvisible needs to start with a discussion the H1N1 virus and Skinvisible’s product Derm Safe. Our profile has information on the entire company as you will find below. Note that this company can stand alone without DermSafe – and has for years. First the H1N1 problem:

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How Big is the H1N1 Problem?

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As of July 24, 2009 as we initiallypublish this profile, the World Health Organization ("WHO" estimates that as amny as TWO BILLION PEOPLE could become infected with H1N1 over the next two years. That is nearly ONE-THIRD of the world’s population.

Authorities in Britain say there were over 100,000 infections in England alone last week, while U.S. health officials estimate the United States has passed the 1 million case mark. Those figures dwarf WHO’s tally of 130,000 confirmed cases worldwide since the start of the outbreak last Spring.

The search for an effective inoculation has taken on a new urgency as WHO announced that almost 800 people have died from the disease in the past four months. This is more than the H5N1 bird flu strain has killed in six years.

What are the projected estimates for infection in the United States? This from the Center for Disease Control (“CDC”):

The CDC said Friday that – based on the experience of the 1957 flu pandemic – the number of Americans dying from swine flu over the next two years could range from 90,000 to several hundred thousand. That projection would drop if the vaccine campaign and other measures are successful, U.S. health officials said.

On Friday, July 24, the Associated Press released an interview with Keiji Fukuda, WHO’s Assistant Director-General for Health Security and Environment. Here are some of his comments:

“We haven’t seen widespread emergence of resistance to the drug right now,”; Fukuda said, but added “this is something we’re watching very carefully.”

It is inevitable that over a long enough period of time the swine flu virus will mutate, he said. “Unfortunately we can’t predict in what direction,” he said.

More of that interview can be found here:

http://news.aol.com/article/who-flu-chief-no-compromise-on-vaccine/586847?cid=14

Is DermSafe Effective in Killing H1N1 Virus?

In a word, YES. The killing action last for up to four hours.

A research and development company of patented skincare and medical dermatology products, previously announced that DermSafe, the Company’s hand sanitizing lotion, was proven effective in killing the H1N1 virus. The studies were conducted by Retroscreen Virology of London, England, U.K. demonstrating a greater than 99.99% inactivation/kill on the H1N1 influenza A virus. Most importantly, the killing action last up to four hours.

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A Comprehensive Look at Skinvisible:

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Like I said, this company can stand alone without DermSafe. The good news is that is not a reality. They do have this product. When you look at Skinvisible, you are look at a company that has been around since 1999. I personally visited their Las Vegas headquarters less than two weeks ago. They have been in the same offices for the past decade. I met their researchers and everyone responsible for the great success they have already generated.

Company Highlights:

  • Skinvisible has 6 patents approved including the US, India, Australia, China and Japan, 9 U.S. patents pending in addition to 34 PCTs internationally, with many more to be filed. Some of these PCT patents cover up to five products.
  • DermSafe, the Company’s hand sanitizing lotion, was proven effective with a greater than 99.99% inactivation/kill on the H1N1 influenza A virus
  • Skinvisible has licensed three of its prescription acne formulations
  • Skinvisible has licensed three over-the-counter products; two for $1 million each

Skinvisible has 25 different product formulation made with their patented technology targeting nine different indications

Revenue Source

Skinvisible has four sources of revenue:

  1. Licensing Fees
  2. Research and Development Fees
  3. Sales of Polymers
  4. Royalties from Licensed Polymers

Skinvisible’s Core Strengths

  1. Patents: Intellectual property Invisicare is protected internationally and new patents in progress
  2. Pipeline: Products available in ten key categories, with more than 25 formulations many with international patents pending; a cost-effective solution for companies seeking products to license
  3. The People: Specialized scientists, experienced Board of Directors, expert pharmaceutical & medical consultants, all focused on the Company’s success

Business Licensing Model

Skinvisible does not manufacture or sell products itself, instead the Company licenses out all of its product formulations made with Invisicare to pharmaceutical, medical and consumer goods companies. There is an upfront license fee for exclusive distribution for a specific territory (or worldwide), royalties and development fees if required. They supply the licensee with the formula and manufacturing instructions. They also work with companies with their own IP, products coming off patent, or looking for life cycle management for current products through new IP, line extensions or product enhancements.

Process for Combining Water Soluble and Insoluble Polymers

The patented Invisicare technology is used to produce a variety of prescription dermatology and over-the-counter skincare products along with hospital-related and consumer goods products that address a variety of medical conditions. Products in the pipeline are considered to be those which have been developed by Skinvisible in response to a variety of topical skin applications and product development opportunities identified both independently and in collaboration with established manufacturers and marketers.

Invisicare® Benefits

  • Displays superior skin adherence for extended time periods
  • Non-occlusive yet resists water wash-off, respiration and perspiration
  • Increased efficacy of active ingredients
  • Allows for lower use levels of actives with increased persistence of effect
  • Offers advantage of controlled and/or sustained time-release
  • Highly compatible with a variety of actives and bases
  • Easy to emulsify
  • Formulates well at a cream, lotion, or spray viscosity
  • Non-irritating emulsion dries quickly with no greasy after-feel
  • Non-occlusive film forms protective barrier against environmental irritants
  • Broad polymer selection to meet application requirements
  • Offers “Life Cycle” management to core products with potential for new patent
  • Simplified manufacturing process

Products Using Invisicare®

Products that successfully incorporate Invisicare® to date include antimicrobial hand sanitizer lotions, suncare products, skincare moisturizers, sunless tanning products as well as various dermatology products for various skin disorders. On an ongoing basis the Company is seeking to develop polymer formulations that can successfully be incorporated into other products.


Licensing of Invisicare

SKVI’s primary objective is to license Invisicare® to established brand manufacturers and marketers of prescription and over-the-counter products in the dermatological, medical, cosmetic, and skincare markets. With the exception of sales to one vendor, the Company’s policy is to only sell Invisicare to vendors that have executed a license agreement. Research and development is conducted in-house.

OVER-THE-COUNTER PRODUCTS LICENSED TO:

The company has signed an agreement with Panalab Internacional S.A. for their anti-acne product formulated with Adapalene (licensed territories – Argentina, Brazil and Chile).

The company signed an agreement with Embil Pharmaceutical Co. Ltd. for products formulated with the active ingredients Clindamycine HCL and Retinoic Acid (licensed territories countries in Eastern Europe and three in South East Asia.

SKINVISIBLE’S BLOCKBUSTER PRODUCT – DERMSAFE®

DermSafe Hand Sanitizer Lotion

Skinvisible’s DermSafe® is an antimicrobial hand sanitizer that has the unique ability to kill bacteria and kill/inactivate viruses on the hands for four hours or longer. DermSafe stays bound to the hands, even after frequent washings. This is considered to be a real plus for doctors and nurses as they move from patient to patient.

The Company intends to begin marketing Chlorhexidine Hand Sanitizer Lotion “DermSafe” in Canada in the third quarter of 2009. The Company expects to file for US FDA approval with a marketing partner in 2009 for this unique product that is needed immediately by the general public,

DermSafe is alcohol-free, and consequently eliminates fire, safety and skin drying issues associated with alcohol-based products. DermSafe also contains the patented technology Invisicare which allows the product to stay bound to the skin. The active ingredient, 4% chlorhexidine gluconate, has been safely used in pre-surgical scrubs worldwide for over 50 years.

Recent Developments

Effective in Killing H1N1 Virus:

The Company previously announced that DermSafe, their proprietary hand sanitizing lotion, was proven effective in killing the H1N1 virus. The studies were conducted by Retroscreen Virology of London, England demonstrating a greater than 99.99% inactivation/kill on the H1N1 influenza A virus.

The spread of this virus and the declaration of a pandemic by the World Health Organization (WHO) has increased Skinvisible’s efforts in the global licensing of DermSafe. On June 11, 2009, WHO raised their pandemic threat to a Phase 6 – “the virus is contagious, spreading easily from one person to another and from one country to another.” On the same date over 30,000 cases were confirmed in 74 countries. Less than one month later, the confirmed cases tripled in number to over 94,000, and the number continues to grow.

In the United States, the CDC estimates that over one million Americans currently have the flu virus, while Canadian health officials estimated that over 30% of Canadians or 10 million people will come down with this virus in the coming flu season. The British health minister stated that by the end of August, Britain could experience 100,000 new cases each day. In the southern hemisphere, where it is now winter, Argentina’s health minister reports that the number of deaths due to the H1N1 influenza A virus had reached 137, with a total of 3,056 officially confirmed cases. Many believe the actual toll to be much higher.

Markets for DermSafe:

In Canada DermSafe has received approval allowing the sale of DermSafe for personal use.

In the United States DermSafe requires approval by the Federal Drug Administration (FDA The FDA has opened a Pre-Investigational New Drug (Pre-IND) file for DermSafe. Globally: Skinvisible and select consultants are working with the appropriate governmental regulatory bodies to obtain marketing approvals and to acquire licensees. DermSafe is available for licensing both commercially in healthcare and food services as well as for personal use (retail) worldwide.

Skinvisible is working with potential licensees for DermSafe in the United States, Canada, China, Hong Kong, Singapore and other parts of Southeast Asia, Japan, the United Kingdom, Europe, Australia, Africa and Mexico.

In some countries the product requires little or no regulatory approval.


Products in the Pipeline

Products in the pipeline are considered to be those which have been developed by Skinvisible in response to a variety of topical skin applications and product development opportunities identified both independently and in collaboration with established manufacturers and marketers.

These products have been successfully tested in-house to determine “proof of concept” stability, proven active agent activity and sustained release) and are currently ready to be licensed to established pharmaceutical, OTC, cosmetic or skincare manufacturers for commercialization. Regulatory approvals may be required for some products.

Skinvisible’s Invisicare pipeline includes topical products for the following condition or use:

  • Acne
  • Topical Analgesics and First Aid
  • Anti-Aging
  • Anti-Fungal
  • Anti-Inflammatory
  • Antimicrobial Hand Sanitizing Lotions
  • Dermatitis/Moisturizers
  • Skin Cancer
  • UVA /UVB Sunscreens
  • Warts
  • Other: Scar Treatment/Long-Lasting Fragrances/ Wound Care/ Pre-Surgical Treatments/ Preventative Treatments

UVA/UVB Sunscreen

A key addition to the product portfolio in 2008 was a UVA/UVB sunscreen with Parsol 1789. Parsol 1789 is the most used UVA filter in sunscreens in the US and the only ingredient approved by the US FDA that is not proprietary. The Company’s studies indicate a minimum of eight hour photostability compared to the industry average of two hours. In addition, most sunscreens, even those that indicate they are water resistant, do not remain on the skin after swimming.

With Invisicare technology, sunscreens remain on the skin for 8 to 12 hours and resist wash-off and rub-off.

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Licensed Technology Invisicare® Polymer Delivery Vehicles

Skinvisible licenses its patented Invisicare formulations to established developers and manufacturers of dermatology, cosmetic, skincare, medical, consumer goods and surgical products, both in over-the-counter and prescription formats.

Invisicare Patents

Currently there are six patents approved including the US, Australia, India and this year Japan, nine U.S. patents pending. There are 34 patent application filed pursuant to international patent application with more to be filed. Some international patent applications reference up to five products.

  • New patents on dermatology and medical products will be generated on an ongoing basis
  • Every product formulated is protected by one or more patents.
  • Patent approvals are sought initially in the U.S. and subsequently internationally for all products developed.


Patent Protection

Pharmaceutical companies are pursuing new or improved revenue streams along with protecting their own intellectual properties. Invisicare allows companies to sell a patent-protected product that has been revitalized with new benefits, giving them a new story to help combat generic competitors. A prescription dermatology product can generate $100 plus million per year. Some can produce even $200 plus million – and that is why the Company believes the investment into a license with an Invisicare formulation is a very viable option for these companies. Worldwide patent protection submission for products formulated with Invisicare is ongoing.

Status of Research and Development for New Applications

The Company believes that the enhancement and extension of existing products and the development of new product categories have contributed significantly to our growth to date and are necessary for continued growth.

Management evaluates new ideas and seeks to develop new products and improvements to existing products to satisfy industry requirements and changing consumer preferences. The identification of trends in consumer preferences are used to generate new product ideas. Specific to the objective of generating new products, research and development toward developing additional applications with Invisicare continues. Various developmental stages are active for the following potential applications using Invisicare.

CORPORATE HIGHLIGHTS:

Year of Incorporation 1999
OTCBB Exchange SKVI
Industry Pharmaceutical
Operations based in Nevada, USA
Shares Outstanding 92.03 million
Insider Ownership 50%
Public Float 50%
Current Price $0.08 (as of July 24, 2009)
52 Wk. Hi/Lo $0.13/$0.03
Market Cap. $7.2 million
Fiscal Year End December 31
Employee Number 5

Management & Board of Directors


Terry Howlett President & Chief Executive
Officer
Mr. Howlett founded Skinvisible, Inc. in 1998. With over 30 years of entrepreneurial, business management and market initialization experience, he drives and directs the Company’s development and technology vision. He is adept at guiding emerging and publicly traded start-up companies through the stages of capital formation, strategic planning and business growth; specializing in venture capital financing. Mr. Howlett’s diversified background includes senior management, marketing, and sales positions with both established and start-up companies.


James A. Roszell Ph.D, Chemist
Dr. James Roszell is a doctoral chemist with over 35 years’ experience in product formulation, experimental design, analysis, and method validation. Since joining Skinvisible in 1998, he has been responsible for research and development of the Company’s patented technology, related polymer delivery vehicles, product formulations and compositions. Dr. Roszell is a joint contributor to Skinvisible’s Patent Number 6.756.059 and responsible for its four pending patents. Prior to joining Skinvisible, he worked as chemist for Supertech Products, Inc. in Florida where his responsibilities included ensuring compliance with OSHA, EPA\ and other standards and regulations, maintenance of quality control, research and development for new products. Dr. Roszell’s background includes work in chemical, pharmaceutical, environmental and clinical laboratory arenas. His invaluable chemical and scientific expertise are key factors in Skinvisible’s innovative technological achievements.


Doreen McMorran Vice President, Business
Development
Ms. McMorran brings to the Company almost 20 years of experience in the medical and pharmaceutical industry, specifically in the areas of strategic planning, sales and marketing. She has spent the last six years selling to international dermatology and skincare focused companies like Procter and Gamble, Johnson & Johnson, Stiefel, Galderma, Novartis and Graceway, to name a few. Ms. McMorran, who holds a Bachelor of Commerce (Honours) degree, spent six years in the pharmaceutical industry with Astra Pharma. Additionally she has held senior management level positions with a number of healthcare companies, focusing on business development, sales, marketing and operations.

Board of Directors:


Brian Piwek Independent Director
Mr. Piwek’s experience and expertise is in the international retail industry. He was president of Overwaitea Foods supermarket from 1991 until 1997. In 1997 Brian accepted the position as Co-CEO with A&P Canada (The Great Atlantic & Pacific Tea Company Inc.) and in 2000 was appointed Chairman, President and CEO of A&P Canada. In late 2002 he moved to the U.S. as President and Chief Executive Officer of A&P US (New York Stock Exchange symbol "GAP") where he began the turnaround of North America’s oldest retail food chain. Brian retired from A&P in July 2005. Brian has been recognized for his achievements throughout his career including "President of the Year" by the Jim Pattison Group for the outstanding financial performance of Overwaitea in 1993. Brian is an MBA graduate and has served on many voluntary boards.

Greg McCartney
Independent Director Mr. McCartney is past President and Chief Executive Officer of Genesis Bioventures a company he founded in 1997. He was previously owner and director of a private consulting firm specializing in financing and venture capital. Mr. McCartney has over 20 years of business experience working with both private and public companies in various manufacturing and technology-based industries.

About Invisicare: Invisicare is Skinvisible’s patented polymer delivery system that offers life-cycle management and unique enhancements for topically delivered products. It is a combination of hydrophilic and hydrophobic polymers that hold active ingredients on the skin for extended periods of time resisting both wash off and perspiration. Invisicare can control the release of actives, reduce irritation and can eliminate some costly manufacturing processes. It is non-occlusive and allows for normal skin respiration while protecting against environmental irritants. www.invisicare.com

About Skinvisible Pharmaceuticals, Inc.: Skinvisible Pharmaceuticals is a research-and-development company whose primary business objective is to license its proprietary formulations with Invisicare to pharmaceutical and cosmeceutical companies as well as assisting companies in enhancing their existing skin care products. Skinvisible receives a combination of research and development fees, upfront license fees, and ongoing royalties for the life of the Invisicare patent. Skinvisible’s value also lies in its ability to continually generate new IP on dermatology and medical products formulated with Invisicare. www.skinvisible.com

Forward Looking Statements: This profile contains ‘forward looking’ statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Such statements involve certain risks and uncertainties associated with an emerging company. Actual results could differ materially from those projected in the forward looking statements as a result of risk factors discussed in Skinvisible, Inc. reports on file with the U.S. Securities and Exchange Commission (including, but not limited to, a report on Form 10Q for the quarter ending March 30, 2009).

Pentony Enterprises LLC is STOCKGURU.COM, SHAREHOLDERVISION.COM and STREETRESEARCH.COM. 9555 Lebanon Road; Suite 103; Frisco, Texas 75035. (469) 252-3030. Disclosure: Pentony Enterprises LLC will be compensated 500,000 144 restricted common shares by the company for profile coverage for the period ending January 30, 2010. Pentony Enterprises is not a registered investment adviser or a broker/dealer. Pentony Enterprises LLC makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person, or that an investment in such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk.

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