Skinvisible, Inc. is a Nevada-based pharmaceutical R&D company specializing in polymer delivery systems for topical skin products, primarily licensing its patented Invisicare technology globally.

# Company Overview: Skinvisible, Inc.

## Business Focus
- Skinvisible, Inc. is a Nevada-incorporated pharmaceutical research and development (R&D) company.

## Core Technology
- Developed and patented **Invisicare®**, an innovative polymer delivery system.
  - Enhances delivery of active ingredients in topical skin products.
  - Extends the duration active ingredients remain on the skin (up to four hours or longer).
  - Capable of carrying water-insoluble and cationic active ingredients without organic solvents like alcohol or silicones.
  - Forms a protective, non-occlusive bond with the outer skin layer.
  - Allows normal respiration and perspiration.
  - Provides controlled release, reducing irritation, and helping retain skin moisture.
  - Wears off naturally through skin exfoliation.

## Product Formulation & Licensing
- Formulated over **forty topical skin products** utilizing Invisicare.
- Out-licenses these products globally to established manufacturers and marketers.
- Revenue model:
  - Licensing fees (upfront and ongoing royalties).
  - Co-development of formulations.
  - Lifecycle management through reformulation and line extensions.

## Market & Targets
- Addresses the **$80 billion** global skincare & dermatology market.
- Also targets the **$30 billion** global over-the-counter market.
- Exploring new large markets outside dermatology, including:
  - Obesity treatment.
  - Other healthcare/medical fields where topical transdermal solutions are viable.

## Business Strategy
- Monetize existing investments via licensing.
- Leverage patents and unique products developed.
- Provide solutions for pharmaceutical companies’ patent expirations and line extensions.
- Collaborate with established brands globally to expand product reach.

## Notable Agreements & Developments
- **Quoin Pharmaceuticals**:
  - Exclusive license for patents in development of products, including a drug candidate QRX003 for Netherton Syndrome.
  - Milestones:
    - FDA acceptance of investigational new drug application.
    - Clinical trials expansion and milestones.
    - International trial expansion in Saudi Arabia and the UK.
    - Pediatric clinical testing.
    - Expected regulatory filings based on trial data.
- **Ovation Science**:
  - License for DermSafe hand sanitizer.
  - License fee of $100,000, with ongoing royalties.
- **Patent filings**:
  - Filed provisional patents for transdermal delivery of obesity drugs and glucose-controlling agents, leveraging Invisicare technology.

## Operations
- Conducts business primarily through its wholly owned subsidiary, Skinvisible Pharmaceuticals, Inc.
- Current employees: Two (including CEO Terry Howlett).
- No real estate owned or leased.

## Financials (as of December 31, 2024)
- Revenue: **$20,000** (from licensing and product sales, same as 2023).
- Net Loss: **$565,654** (improved from a net loss of $2,382,440 in 2023).
- Assets: **$158,217**.
- Total current liabilities: **$3,719,687**.
- Working capital deficit: **$3,677,659**.
- Shareholders’ equity: **Negative $9,245,947**.
- Shares outstanding: **5,316,843** (as of April 10, 2025).
- No ongoing product sales; focus is on licensing and ongoing clinical and patent development.

## Summary
Skinvisible specializes in developing polymer-based delivery systems that improve topical and transdermal drug and skincare formulations. Its primary patent, Invisicare, provides scientific and marketing advantages, facilitating licensing of dermatological and medical products. It maintains a small team, with revenues mainly from licensing agreements and ongoing R&D activities, and has yet to achieve profitable operations.

Skinvisible Pharmaceuticals Inc. specializes in the research and development of pharmaceutical skin care products with an innovative delivery system, Invisicare®, targeting the large global skincare market.

# Skinvisible Pharmaceuticals Inc.

## Business model
The company operates through its wholly owned subsidiary, Skinvisible Pharmaceuticals Inc., which focuses on research and development of pharmaceutical products. Its primary technology is a patented polymer delivery system, Invisicare®, intended for topical skin products. The company targets an estimated $80 billion global skincare and dermatology market and a $30 billion over‑the‑counter market.

## Key offerings
- Invisicare®: A patented polymer delivery system that enhances permeation of active ingredients in topical skincare products. The system allows extended adherence to the skin without alcohol or organic solvents and claims to bond active ingredients to the skin for up to four hours or longer, promoting delivery while minimizing irritation.

## Revenue generation
1. Licensing: Development of patented topical prescription and over‑the‑counter products for licensing to pharmaceutical and consumer goods companies, with upfront fees and ongoing royalties.  
2. Co‑development: Assisting pharmaceutical clients in creating formulations to advance into clinical testing.  
3. Life cycle management: Reformulating existing products nearing patent expiration to incorporate Invisicare, extending product life.

## Key license agreements
- October 17, 2019: Exclusive License Agreement with Quoin Pharmaceuticals, Inc. for development of products based on the company’s patents, resulting in a $1,000,000 license fee and future royalties.

## Current operations
- As of December 31, 2023, the company has an accumulated deficit of $39,380,488 and has not generated sufficient revenues to cover expenses.

### Employee count
- Two employees, including Director and CEO Terry Howlett.

### Financial condition
- Outstanding secured notes payable: $433,600 (past due and in default).  
- Outstanding unsecured notes: $40,000 (past due and in default).  
- Anticipated additional operational capital needs for the next 12 months: $500,000.

## Market competition
The company competes with other pharmaceutical and skincare firms but believes demand for innovative delivery systems gives it a competitive advantage, with limited direct competition for Invisicare.

## Legal and regulatory environment
The company must comply with regulations for cosmetics and skin care, including the FDA and FTC, and with various international regulations as it expands into foreign markets.

## Conclusion
Skinvisible Pharmaceuticals owns a differentiated delivery technology with potential applications across prescription and over‑the‑counter skin products. It faces substantial financial challenges and a small employee base while depending on licensing and co‑development to generate revenue. Future product development and market penetration will determine the company’s viability.

SKINVISIBLE, INC.

10-K / April 14, 2025

10-K / April 16, 2024

10-K / April 14, 2025

Company Overview: Skinvisible, Inc.

Business Focus

Core Technology

Product Formulation & Licensing

Market & Targets

Business Strategy

Notable Agreements & Developments

Operations

Financials (as of December 31, 2024)

Summary