What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2024-04-16 compared with 2023-03-30 · 172 added, 163 removed, 14 unchanged (96% of the section changed)

Company Overview

We, through our wholly owned subsidiary Skinvisible Pharmaceuticals Inc.,

are a pharmaceutical research and development (“R&D”) company that has developed and patented an innovative polymer delivery

system, Invisicare® and formulated over forty topical skin products, which we out-license globally.

We were incorporated in 1998,

and target an estimated $80 billion global skincare and dermatology market and a $30 billion global over-the-counter market as well as

other healthcare / medical and consumer goods markets.

With the research and development complete on forty products and numerous

patents issued (technology and product patents), we are ready to monetize our investment.

Our business model will continue to be to out-license

our patented prescription and over-the-counter (“OTC”) products featuring Invisicare to established manufacturers and marketers

of brands internationally and to maximize profits from the products we have already out-licensed.

The opportunity for us to license our products continues to be a viable

model as the need for pharmaceutical companies to access external R&D companies for new products due to their own down-sizing or elimination

of internal R&D departments.

The demand for our products is enhanced due to the granting of key US and international patents and the

completed development of a number of unique products.

We, through our wholly owned subsidiary

Skinvisible Pharmaceuticals Inc., are a pharmaceutical research and development (“R&D”) company that has developed and

patented an innovative polymer delivery system, Invisicare® and formulated over forty topical skin products, which we out-license

We were incorporated in 1998 and target an estimated $80 billion global skincare and dermatology market and a $30 billion global

over-the-counter market as well as other healthcare / medical and consumer goods markets.

The Company is also exploring new opportunities

in large medical markets outside of the dermatology market such as obesity and other potential markets where a topical or transdermal

solution would be a viable alternative.

With the research and development

complete on forty products and numerous patents issued (technology and product patents), we are ready to monetize our investment.

business model will continue to be to out-license our patented prescription and over-the-counter (“OTC”) products featuring

Invisicare to established manufacturers and marketers of brands internationally and to maximize profits from the products we have already

out-licensed.

The opportunity for us to license our

products continues to be a viable model as the need for pharmaceutical companies to access external R&D companies for new products

due to their own downsizing or elimination of internal R&D departments.

The demand for our products is enhanced due to the granting

of key US and international patents and the completed development of a number of unique products.

Our Flagship Product

Pivotal to our success is our patented polymer delivery system technology

Invisicare is a patented polymer delivery system that enhances the delivery of active ingredients for topically applied skin

care products.

Its patented technology has a unique formula and process for combining active ingredients with a delivery system that extends

the duration of time the product remains on the skin and active.

Invisicare is specifically formulated to carry water insoluble active

and certain cationic active ingredients in water-based products without the use of alcohol, silicones, waxes, or other organic solvents.

Products utilizing Invisicare have the proven ability to bond active ingredients to the skin for up to four hours and longer.

non-occlusive and allow normal skin respiration and perspiration while moisturizing and protecting against exposure from a wide variety

of environmental irritants.

When topically applied, these formulated products adhere to the skin's

outer layers, forming a protective bond, resisting wash-off, and delivering targeted levels of therapeutic or cosmetic skincare agents

They allow enhanced delivery performance for a variety of skincare agents resulting in improved efficacy, longer duration

of action, reduced irritation and lower dosage of active agent required.

The "invisible" polymer compositions wear off as part

of the natural exfoliation process of the skin's outer layer cells.

The advantage of products formulated with Invisicare is (1) Invisicare’s

ability to bind active ingredients (the drug) to the skin, forming a protective bond on the skin, for extended periods of time;

(2) Invisicare

can deliver targeted levels (high or low) of therapeutic or cosmetic ingredients to the skin in a controlled release;

(3) Invisicare can

help to reduce the irritation of some active ingredients due to how it controls the slower release of that active ingredient;

Invisicare science proves that it provides a protective skin barrier which helps retain the natural moisture content of the skin, while

still allowing it to breathe.

These benefits present an excellent opportunity for clear scientific advantages and marketing messages which

resonate with physicians and consumers.

We have positioned ourselves in the $80 billion

worldwide prescription and over-the-counter dermatology and skincare market.

Pivotal to our success is our patented

polymer delivery system technology Invisicare.

Invisicare is a patented polymer delivery system that enhances the delivery of active ingredients

for topically applied skin care products.

Its patented technology has a unique formula and process for combining active ingredients with

a delivery system that extends the duration of time the product remains on the skin and active.

Invisicare is specifically formulated

to carry water insoluble active and certain cationic active ingredients in water- based products without the use of alcohol, silicones,

waxes, or other organic solvents.

Products utilizing Invisicare have the proven ability to bond active ingredients to the skin for up

to four hours and longer.

They are non-occlusive and allow normal skin respiration and perspiration while moisturizing and protecting

against exposure from a wide variety of environmental irritants.

When topically applied, these formulated

products adhere to the skin's outer layers, forming a protective bond, resisting wash-off, and delivering targeted levels of therapeutic

or cosmetic skincare agents to the skin.

They allow enhanced delivery performance for a variety of skincare agents resulting in improved

efficacy, longer duration of action, reduced irritation and lower dosage of active agent required.

The "invisible" polymer compositions

wear off as part of the natural exfoliation process of the skin's outer layer cells.

The advantage of products

formulated with Invisicare is (1) Invisicare’s ability to bind active ingredients (the drug) to the skin, forming a protective

bond on the skin, for extended periods of time;

(2) Invisicare can deliver targeted levels (high or low) of therapeutic or cosmetic

ingredients to the skin in a controlled release;

(3) Invisicare can help to reduce the irritation of some active ingredients due to

how it controls the slower release of that active ingredient;

and (4) Invisicare science proves that it provides a protective skin

barrier which helps retain the natural moisture content of the skin, while still allowing it to breathe.

These benefits present an

excellent opportunity for clear scientific advantages and marketing messages which resonate with physicians and consumers.

We generate revenue by:

We develop topical prescription and over-the-counter products enhanced with Invisicare to license to pharmaceutical and consumer goods

companies around the world for an upfront fee and ongoing royalties;

• LICENSING :

We develop topical prescription

and over-the-counter products enhanced with Invisicare to license to pharmaceutical and consumer goods companies around the world for

an upfront fee and ongoing royalties.

• CO-DEVELOPMENT :

We assist pharmaceutical

clients in the early development of the most optimal formulation, which they then take forward into clinical testing;

We assist pharmaceutical clients

in the early development of the most optimal formulation, which they then take forward into clinical testing.

• LIFE CYCLE MANAGEMENT :

5 unchanged sentences

License Agreement with Quoin

On October 17, 2019, we entered an Exclusive License

Agreement with Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin”) pursuant to which we granted to Quoin a license

to certain patents for the development of products for commercial sale.

In exchange for the license, Quoin agreed to pay to us a license

fee of $1,000,000 (the “License Fee”) and a single digit royalty interest of all net sales on the licensed products subject

to adjustment in certain situations.

The agreement also requires that Quoin make certain milestone payments to us upon achieving regulatory

approval milestones for certain drug products.

The agreement was subject to termination,

if among other things, 50% of the license fee is not paid by December 31, 2019 and if the full License Fee is not paid by March 31, 2020.

No payments were made by Quoin and the agreement was terminated.

Both Parties subsequently determined that they continue to see the value

in a partnership and therefore on May 8, 2020 and again on July 31, 2020 the companies agreed to extend the Exclusive License Agreement

under the same terms to expire on December 31, 2020, and on January 27, 2021 the companies agreed to revise the milestone payments due

under the agreement and to extend the agreement indefinitely.

On June 14, 2021, the Company entered into an

amendment to change the terms of the license Fee as shown below.

As partial consideration for the rights

conveyed by Skinvisible under this Agreement, Licensee agrees to pay to Skinvisible a one-time, non-refundable, non-creditable license

issue fee of one million USD dollars (USD $1,000,000) (''License Fee'').

To date, Licensee has paid one million US dollars (USD $1,000,000).

Additionally, the milestones in the initial agreement

were changed as shown below:

(i) Successful

completion of Phase 2 testing:

(ii) Successful

completion of Phase 3 testing:

(iii) Regulatory

approval in either the US or EU, whichever happens first:

On June 6, 2022 we announced

that Quoin has received U.S.

FDA acceptance of its Investigational New Drug (IND) application for its licensed formulation which uses

our Invisicare proprietary drug delivery technology.

The topical formulation "QRX003" was developed to treat Nethertons Syndrome,

a debilitating hereditary disorder that affects the skin, hair and the immune system.

There currently is no cure or approved treatment

for Netherton Syndrome.

With the IND approved, the

clinical trial is underway.

We look forward to assisting Quoin in their success and potential FDA approval as well as potentially bringing

a treatment to patients suffering from Nethertons Syndrome.

Quoin is responsible for

obtaining all FDA and other regulatory body approvals necessary to market the products in the US and other countries.

Upon the successful

completion of various clinical and regulatory milestones, Skinvisible is entitled to receive a milestone payment of $5 million and ongoing

royalties from sales.

License Agreement with Ovation Science

On February 3, 2020, we entered into a License

Agreement with Ovation Science Inc.

pursuant to which Skinvisible granted to Ovation Science Inc.

a license for the manufacture and distribution

rights to its hand sanitizer product, DermSafe.

In exchange for the license, Ovation Science Inc.

agreed to pay to Skinvisible a royalty

percentage on all net sales on the licensed products subject to adjustment in certain situations plus a license fee payable in year 3

of the agreement if it chooses to continue the license.

On June 10, 2020, Ovation Science paid us the

fee otherwise due in year 3 and in exchange we extended the term of Ovation Science’s license to 6-years and granted Ovation additional

rights to its hand sanitizer products and assigned Canadian Identification Numbers 02310589 and 02355558, all DermSafe Trademarks, DermSafe

clinical data and the right to patent DermSafe where not currently patented.

In exchange for these rights, Ovation Science paid a $100,000

We completed the required assignments during the year ending December 31, 2020 and recognized $100,000 in revenue.

Market research indicates there is reasonably limited direct competition

for Invisicare and patented products in terms of performance capabilities for topically administered skin products.

Many companies are

seeking unique delivery systems to enhance their portfolio and purchasing companies that have delivery technology.

On October 17, 2019, we entered an Exclusive

License Agreement with Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin”) pursuant to which we granted Quoin a

license to certain patents for the development of products for commercial sale.

In exchange for the license, Quoin paid us a license fee

of one million USD dollars (USD

$1,000,000) (the “License Fee”)

and will additionally pay a single digit royalty interest of all net sales on the licensed products subject to adjustment in certain situations.

The agreement also requires that Quoin make a milestone payment of $5 million to us upon achieving the first to occur of either FDA or

European Union regulatory approval for one product licensed.

In addition, and upon the successful approval

in the US or European Union, whichever occurs first, Skinvisible is entitled to receive a single digit royalty percentage of Quoins net

sales revenues for any licensed product covered by the patent rights licensed under the License Agreement.

Plus, Quoin also agreed to

pay Skinvisible 25% of any revenues we receive as royalties in the event that we sublicense any licensed products to a third party.

On June 6, 2022, the Company announced

that its licensee Quoin and its product QRX003, was the first Invisicare delivery technology product to receive U.S.

FDA Acceptance of

Investigational New Drug Application and that Quoin was actively working towards obtaining necessary FDA and other regulatory approvals

for marketing the product in the United States and other countries.

On February 14, 2024, the Company

announced that there was significant progress in Quoin's clinical trials for product formulations containing Invisicare targeting Netherton

The trials focus on the innovative formulation "QRX003," powered by Skinvisible’s Invisicare® proprietary

drug delivery technology.

The updates include:

Initial Data and Clean Safety Profile:

The trials have demonstrated positive initial data

and a clean safety profile, leading to the implementation of an optimization plan.

• Optimization

Plan Implementation:

Quoin has increased the size of both clinical trials significantly and

adjusted dosing frequency to twice-daily from once-daily for both trials.

• Elimination

of Lower Dose:

In the blinded trial, a lower dose has been eliminated based on the positive

outcomes observed.

Quoin's press release highlights protocol

amendments aimed at enhancing the data set and potentially expediting regulatory approval.

We believe these protocol amendments could

ultimately result in the generation of a highly compelling data set, which could support regulatory filings and approval for QRX003 as

the first treatment for Netherton Syndrome.

On March 4, 2024

Quoin announced a further milestone:

it received FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical

We believe this announcement is important as:

to include teen patients in both Quoin’s open label and placebo-controlled studies

are expected to significantly expand the number of eligible subjects, potentially expedite

recruitment and lead to a more robust data set.

• This development represents the first ever inclusion

of non-adult subjects in Netherton Syndrome clinical studies conducted under an open Investigational New Drug Application.

• It is believed that the inclusion of this patient

population in Quoin’s studies will be a critical component of the development of a robust data set that could result in regulatory

approval with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments.

Market research indicates there is

reasonably limited direct competition for Invisicare and patented products in terms of performance capabilities for topically administered

skin products.

Many companies are seeking unique delivery systems to enhance their portfolio and purchasing companies that have delivery

Nevertheless, our current and potential

competitors may have longer operating histories, significantly greater resources and name recognition, and a larger base of customers

than we have.

Our competitors may also be able to adopt more aggressive pricing policies and devote greater resources to the development,

marketing and sale of their products and services than we can.

To be competitive, we must continue to invest significant resources in

sales and marketing.

We may not have sufficient resources to make these investments or to develop the technological advances necessary

to be competitive, which in turn will cause our business to suffer and restrict our profitability potential.

Government Regulation

Cosmetic and Skin Care Regulation

Depending upon product claims and formulation, skin care products may be

regulated as cosmetics, drugs, devices, or combination cosmetics and drugs.

The FDA has authority to regulate cosmetics marketed in the

United States under the FDCA and the Fair Packaging and Labeling Act (“FPLA”) and implementing regulations.

The Federal Trade

Commission (the “FTC”) regulates the advertising of cosmetics under the FTCA.

The FDCA prohibits the marketing of adulterated and misbranded cosmetics.

Cosmetic ingredients must also comply with the FDA’s ingredient, quality, and labeling requirements and the FTC’s requirements

pertaining to truthful and non-misleading advertising.

Cosmetic products and ingredients, with the exception of color additives, are not

required to have FDA premarket approval.

Manufacturers of cosmetics are also not required to register their establishments, file data

on ingredients, or report cosmetic-related injuries to the FDA.

We will be responsible for substantiating the safety and product claims

of the cosmetic products and ingredients before marketing.

The FDA or FTC may disagree with our characterization of one or more of the

skin care products as a cosmetic or the product claims.

This could result in a variety of enforcement actions which could require the

reformulation or relabeling of our products, the submission of information in support of the product claims or the safety and effectiveness

of our products, or more punitive action, all of which could have a material adverse effect on our business.

If the FDA determines we

have failed to comply with applicable requirements under the FDCA or FPLA, it can impose a variety of enforcement actions from public

warning letters, injunctions, consent decrees, and civil penalties to seizure of our products, total or partial shutdown of our production,

and criminal prosecutions.

If any of these events were to occur, it could materially adversely affect us.

If the FTC determines we have

failed to substantiate our claims, it can pursue a variety of actions including disgorgement of profits, injunction from further violative

conduct, and consent decrees.

Domestic State and Local Government Regulation

Some states and local governments in the United States regulate the labeling,

operation, sale, and distribution of our skin care products.

To the extent additional state or local laws apply, we intend to comply with

Depending upon product claims and

formulation, skin care products may be regulated as cosmetics, drugs, devices, or combination cosmetics and drugs.

The FDA has authority

to regulate cosmetics marketed in the United States under the FDCA and the Fair Packaging and Labeling Act (“FPLA”) and implementing

The Federal Trade Commission (the “FTC”) regulates the advertising of cosmetics under the FTCA.

The FDCA prohibits the marketing

of adulterated and misbranded cosmetics.

Cosmetic ingredients must also comply with the FDA’s ingredient, quality, and labeling

requirements and the FTC’s requirements pertaining to truthful and non-misleading advertising.

Cosmetic products and ingredients,

except for color additives, are not required to have FDA premarket approval.

Manufacturers of cosmetics are also not required to register

their establishments, file data on ingredients, or report cosmetic-related injuries to the FDA.

We will be responsible for

substantiating the safety and product claims of the cosmetic products and ingredients before marketing.

The FDA or FTC may disagree

with our characterization of one or more of the skin care products as a cosmetic or the product claims.

This could result in a

variety of enforcement actions which could require the reformulation or relabeling of our products, the submission of information in

support of the product claims or the safety and effectiveness of our products, or more punitive action, all of which could have a

material adverse effect on our business.

If the FDA determines we have failed to comply with applicable requirements under the FDCA

or FPLA, it can impose a variety of enforcement actions from public warning letters, injunctions, consent decrees, and civil

penalties to seizure of our products, total or partial shutdown of our production, and criminal prosecutions.

If any of these events

were to occur, it could materially adversely affect us.

If the FTC determines we have failed to substantiate our claims, it can

pursue a variety of actions including disgorgement of profits, injunction from further violative conduct, and consent decrees.

Domestic State and Local Government

Some states and local governments in the

United States regulate the labeling, operation, sale, and distribution of our skin care products.

To the extent additional state or local

laws apply, we intend to comply with them.

Foreign Government Regulation

In general, we will need to comply with the government regulations of each

individual country in which our products are to be distributed and sold.

These regulations vary in complexity and can be as stringent,

and on occasion even more stringent, than FDA regulations in the United States.

The level of complexity and stringency is not always precisely

understood today for each country, creating greater uncertainty for the international regulatory process.

Furthermore, government regulations

can change with little to no notice and may result in up-regulation of our product(s), thereby creating a greater regulatory burden for

We have not yet thoroughly explored the applicable laws and regulations that we will need to comply with in foreign jurisdictions.

As a result it is possible that we may not be permitted to sell our products in foreign markets or expand our business into one or more

foreign jurisdictions.

Environmental Laws

We are not subject to any significant or material environmental regulation

in the normal operation of our business.

Currently, we have two employees, including our CEO Terry Howlett.

We conduct our operations through our wholly-owned subsidiary, Skinvisible

Pharmaceuticals, Inc.

In general, we will need to comply

with the government regulations of each individual country in which our products are to be distributed and sold.

These regulations vary

in complexity and can be as stringent, and on occasion even more stringent, than FDA regulations in the United States.

The level of complexity

and stringency is not always precisely understood today for each country, creating greater uncertainty for the international regulatory

Furthermore, government regulations can change with little to no notice and may result in up-regulation of our product(s), thereby

creating a greater regulatory burden for us.

We have not yet thoroughly explored the applicable laws and regulations that we will need

to comply with in foreign jurisdictions.

As a result, it is possible that we may not be permitted to sell our products in foreign markets

or expand our business into one or more foreign jurisdictions.

Environmental

We are not subject to any significant

or material environmental regulation in the normal operation of our business.

Currently, we have two employees, including our Director

and CEO Terry Howlett.

We conduct our operations through our wholly owned subsidiary,

Skinvisible Pharmaceuticals, Inc.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business