Effectively Treating Patients Everyday Confidential PluroGel® in

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• $8.6 Million Contract with U.S. Department of Defense
• EU Approval for Direct Sales
• Generating Royalty Revenue
Neal G. Koller || President & CEO
+ 1 (443) 994 - 0101 || NKoller@PluroGen.com
Dan Conley
+ 1 (908) 917 - 3537
Manufacturer of PluroGel® & ActiviGel™
||
||
Business Development
OnCallCFO@gmail.com
Effectively Treating Patients Everyday
Investment:
US DoD, Angel Groups, High-Net-Worth, UVA
●
UVA R&D over 30 years
$ Multi M
●
Direct Investment
$ 3.3
M
●
Department of Defense - Non Dilutive
$ 8.6
M
●
Raised to Date
$ 11.9 M
●
NOW - Series B Preferred
$ 3.0
Confidential
M
Effectively Treating Patients Everyday
Investment:
US DoD, Angel Groups, High-Net-Worth, UVA
●
UVA R&D over 30 years
$ Multi M
●
Direct Investment
$ 3.3
M
●
Department of Defense - Non Dilutive
$ 8.6
M
●
Raised to Date
$ 11.9 M
●
NOW - Series B Preferred
$ 3.0
Confidential
M
Effectively Treating Patients Everyday
Investment:
US DoD, Angel Groups, High-Net-Worth, UVA
●
UVA R&D over 30 years
$ Multi M
●
Direct Investment
$ 3.3
M
●
Department of Defense - Non Dilutive
$ 8.6
M
●
Raised to Date
$ 11.9 M
●
NOW - Series B Preferred
$ 3.0
Confidential
M
Effectively Treating Patients Everyday
Investment: US DoD, Angel Groups, High-Net-Worth, UVA
●
UVA R&D over 30 years
$ Multi M
●
Direct Investment
$ 3.3
M
●
Department of Defense - Non Dilutive
$ 8.6
M
●
Raised to Date
$ 11.9 M
●
NOW - Series B Preferred
$ 3.0
Confidential
M
Effectively Treating Patients Everyday
Investment: US DoD, Angel Groups, High-Net-Worth, UVA
●
UVA R&D over 30 years
$ Multi M
●
Direct Investment
$ 3.3
M
●
Department of Defense - Non Dilutive
$ 8.6
M
●
Raised to Date
$ 11.9 M
●
NOW - Series B Preferred
$ 3.0
Confidential
M
Effectively Treating Patients Everyday
Investment:
US DoD, Angel Groups, High-Net-Worth, UVA
●
UVA R&D over 30 years
$ Multi M
●
Direct Investment
$ 3.3
M
●
Department of Defense - Non Dilutive
$ 8.6
M
●
Raised to Date
$ 11.9 M
●
NOW - Series B Preferred
$ 3.0
Confidential
M
Effectively Treating Patients Everyday
Series $ 3.0 M - Use of Proceeds
•
$ 1.219 M - Sales & Marketing
•
$ 0.126 M - Inventory
•
$ 0.280 M - Regulatory & Medical Affairs
•
$ 0.595 M - Product Enhancements / Extensions Testing
•
$ 0.780 M - G & A (Salaries, Consulting, Legal, IP, Travel, Office, etc)
Confidential
Effectively Treating Patients Everyday
Valuation
●
Convertible Note Seed Round
No Valuation
●
Pre- Series A
$ 2.2
M
●
Post- Series A
$ 6.6
M
●
Pre-Series B (estimate)
$ 12.0 to 18.0
M
$ 1.0 M in Convertible Note
$ 2.0 M in Shares
Confidential
Effectively Treating Patients Everyday
Valuation
●
Convertible Note Seed Round
No Valuation
●
Pre- Series A
$ 2.2
M
●
Post- Series A
$ 6.6
M
●
Pre-Series B (estimate)
$ 12.0 to 18.0
M
$ 1.0 M in Convertible Note
$ 2.0 M in Shares
Confidential
Effectively Treating Patients Everyday
Valuation
●
Convertible Note Seed Round
No Valuation
●
Pre- Series A
$ 2.2
M
●
Post- Series A
$ 6.6
M
●
Pre-Series B (estimate)
$ 12.0 to 18.0
M
$ 1.0 M in Convertible Note
$ 2.0 M in Shares
Confidential
Effectively Treating Patients Everyday
Valuation
●
Convertible Note Seed Round
No Valuation
●
Pre- Series A
$ 2.2
M
●
Post- Series A
$ 6.6
M
●
Pre-Series B (estimate)
$ 12.0 to 18.0
M
$ 1.0 M in Convertible Note
$ 2.0 M in Shares
Confidential
Effectively Treating Patients Everyday
Valuation
●
Convertible Note Seed Round
No Valuation
●
Pre- Series A
$ 2.2
M
●
Post- Series A
$ 6.6
M
●
Pre-Series B (estimate)
$ 12.0 to 18.0
M
$ 1.0 M in Convertible Note
$ 2.0 M in Shares
Confidential
Effectively Treating Patients Everyday
Exit Plan
Targets
• Exit in 2 to 3 years
• Exit at 20X Revenue
Potential Suitors to Exit
• Already Partnered
• In Product Development
• In Discussion
Multiple Billion $$ Industries for Exit – Investor Advantage
• Pharma
• Medical Device
• Personal Skin Care
Confidential
Effectively Treating Patients Everyday
Exit Plan
Targets
• Exit in 2 to 3 years
• Exit at 20X Revenue
Potential Suitors to Exit
• Already Partnered
• In Product Development
• In Discussion
Multiple Billion $$ Industries for Exit – Investor Advantage
• Pharma
• Medical Device
• Personal Skin Care
Confidential
Effectively Treating Patients Everyday
Exit Plan
Targets
• Exit in 2 to 3 years
• Exit at 20X Revenue
Potential Suitors to Exit
• Already Partnered
• In Product Development
• In Discussion
Multiple Billion $$ Industries for Exit – Investor Advantage
• Pharma
• Medical Device
• Personal Skin Care
Confidential
Effectively Treating Patients Everyday
Exit Plan
Targets
• Exit in 2 to 3 years
• Exit at 20X Revenue
Potential Suitors to Exit
• Already Partnered
• In Product Development
• In Discussion
Multiple Billion $$ Industries for Exit – Investor Advantage
• Pharma
• Medical Device
• Personal Skin Care
Confidential
Effectively Treating Patients Everyday
Imagine …
How Painful and Costly
→
Typical Patients
60% Burn
Motor Cycle Accident
Wounds that Haven’t Healed in Months to Years
Confidential
Effectively Treating Patients Everyday
Imagine …
How Painful and Costly
→
Key Problems of Dressing Change
Time Consuming
Very Painful
Causes Tissue Damage
Confidential
Effectively Treating Patients Everyday
Imagine …
PluroGel® Solves The Big & Chronic Problems
→
PluroGel® is a New Material
Not the Standard Ointment or Cream Material or Hydrogel
→
PluroGel®
Simply Rinses Off Under Water
Thickens at Body Temperature to Protect
Reduces Tissue Damage
Improves Delivery of Actives
Confidential
Effectively Treating Patients Everyday
Imagine …
PluroGel® Solves The Big & Chronic Problems
→
PluroGel® is a New Material
Not the Standard Ointment or Cream Material or Hydrogel
→
PluroGel®
Simply Rinses Off Under Water
Thickens at Body Temperature to Protect
Reduces Tissue Damage
Improves Delivery of Actives
Confidential
Effectively Treating Patients Everyday
Imagine …
PluroGel® Solves The Big & Chronic Problems
→
PluroGel® is a New Material
Not the Standard Ointment or Cream Material or Hydrogel
→
PluroGel®
Simply Rinses Off Under Water
Thickens at Body Temperature to Protect
Reduces Tissue Damage
Improves Delivery of Actives
Confidential
Effectively Treating Patients Everyday
Why Wound & Burn Professionals Are Buying PluroGel®
Superior Outcomes after 9,500 Patients - Less Pain, More Gain
Unique Speedier Solution
Leapfrog Patient Benefits
1 Physical Properties
- Resolve Major Problems of Current Products
- No more tearing-away-to-look by Doctor
2 Bio-impact on Patient
- New Tools for Burn + Wound Clinics
3 Multi-function Properties
- Cost Reductions, Time Savings
4 Superior Scientific Data
- Better Patient Outcomes
& Clinical Data
Confidential
Effectively Treating Patients Everyday
Everyone Wants PluroGel® for Patients’ - Burn, Wound & Skin Care
- OTC
- Retail
Co-Branded
Italy
USA
Branded
gd || medical ag
Switzerland
UVA
OneMed Oy
Finland
MedTec-Con
Germany
Confidential
US
Dept. of
Defense
Product
Development
Effectively Treating Patients Everyday
PluroGel® Unique Triple Topical Antibiotic – WOUNDED WARRIOR
(Charlottesville, VA, 1 Sept. 2010) –
PLUROGEN SIGNS $ 8.6 MILLION CONTRACT WITH U.S. DEPT OF DEFENSE
• All costs for:
Regulatory Approval
Manufacturing Scale-up
• Product Purchase Contract Next
Confidential
Effectively Treating Patients Everyday
PluroGel® Single Topical Antibiotic
gd || medical ag
Switzerland
(Charlottesville, VA, 18 Aug. 2010) –
PLUROGEN RECEIVES EU APPROVAL
MedTec-Con
Germany
• Approval to Market:
OneMed Oy
Finland
PluroGel® with Silver Sulphadiazine
• Approval to Manufacture
PluroGel® with Silver Sulphadiazine
Italy
Confidential
Effectively Treating Patients Everyday
PluroGel® Concentrate Sold To:
EasyDerm UCS™
with PluroGel®
EasyDerm BFR™
with PluroGel®
Handy™
Surgical Cleansing Wipe
with PluroGel®
SailorDew™
with PluroGel®
PluroGel®
Concentrate
(55 gallon Drums)
Confidential
Effectively Treating Patients Everyday
PluroGel® Dermal Gel Sold To:
PluroGel®
Silver Sulfadiazine
PluroGel®
Dermal Barrier Gel
PluroGel®
Dermal Gel
(in 4-gallon Containers)
PluroGel®
Numbing Wound Gel
Confidential
PluroGel®
PNN
Triple Antibiotic
PluroGel®
Flavokine™
Botanical
Antibiotic
Gel
Effectively Treating Patients Everyday
PluroGel® in Development with:
PluroGel®
OTC Dual Antibiotic
PluroGel®
Dermal Gel
PluroGel®
OTC Hydrocortisone
&
Concentrate
PluroGel®
Facial Cleanser
Confidential
PluroGel®
Body Wash
Effectively Treating Patients Everyday
3 Multi-Billion Dollar Markets for PluroGel®
US
Global
Advanced Wound Care
$2.6 B
$5.2 B
Skin & Wound Cleansing Wipes
$ 3.0
$6.0 B
$ 60 B
$ 120 B
Markets
Retail Personal Skin Care Products
Multiple Categories
Enabling PluroGen Sales to $ 40 M in 2014
Confidential
Effectively Treating Patients Everyday
IP - Strong, Disruptive, Paradigm Shifting
Our Core PluroGel®
1 Issued Patent (5,635,540)
4 Patent Applications
Supporting Technologies
● Next Gen Nano-Silver Antimicrobial
1 Patent Application
● Natural Gel Anti-coagulant & Wound Healing
1 Patent Application
● Stem Cell Wound Healing (Fat-based)
6 Patents In Sight
● Substantial Trade Secrets and Know-how
Confidential
Effectively Treating Patients Everyday
PluroGen’s Experienced Management Team
Neal Koller
President & CEO
- 18 Years Senior Management Positions with Wyeth
- Built & Exited 3 Start-ups for Attractive Return
- Sold at 7x Revenue
- Sold at 50x Revenue
- Created 10x Enterprise Value
George Rodeheaver, PhD
Chief Science Officer, Co-founder
- Editor - Authoritative Wound Care Text
- Founder Wound Healing Society
Glenn Warden, MD
Chief Medical Officer
- Past President ABA
- Editor Emeritus – Burn Journal
John Bistline
Operations Manager
- 25 years in Manufacturing and R&D
Steve Coates
Regulatory Manufacturing Compliance
- 35 years Wyeth Regulatory Manufcaturing Compliance
Confidential
Effectively Treating Patients Everyday
PluroGen’s Senior Board
Neal Koller
Director, Secretary
George Rodeheaver, PhD
James Farinholt
- Chase Bank, Wheat
Chairman, Co-founder
Director
1st
Securities, Tall Oaks Capital
Adam Katz, MD
Director, Treasurer, Co-founder
- Global Luminary in Burn & Wound Care
- Founder – Adipose Stem Cell Society
Wendy Yarno
Director
- Chief Marketing Officer (retired) Merck (NYSE: MRK)
- Director St. Jude Medical (NYSE: STJ)
Confidential
Effectively Treating Patients Everyday
PluroGen at Inflection Point
● PluroGel® Branded
● PluroGel® Co-branded
4 Products launched
PluroGel® Single Antibiotic Approved
5 Product launched
PluroGel® Unique Triple Antibiotic
+ 9,500 Patients at UVA
1st Product trialed
+ Superior results
+ DoD Contract
4 In development
Confidential
Effectively Treating Patients Everyday
Based on Their Projections, Our All-in Projections
2009
2010
2011
2012
(Millions)
2013
2014
$ 0.012
$ 3.014
$ 10.748
$ 19.236
$ 32.294
$0.015
$ 0.027
$0.210
$ 1.338
$ 2.225
$0. 250
$ 2.363
$ 4.290
$ 5.876
$ 0.600
$3.000
$ 4.000
$ 1.000
Revenues
Branded Products
Co-Branded
Skin & Wound Cleansing
$ 0.008
Co-Branded OTC & Retail
US DoD Grant
Total Revenue
$ 0.008
$ 0.627
$ 6.291
$ 16.616
$ 25.864
$ 40.395
Gross Margin
$ 0.006
$ 0.022
$ 2.752
$ 10.340
$ 20.386
$ 33.101
Gross Margin %
75.0 %
79.8 %
83.6 %
82.0 %
82.0 %
81.9 %
Expenses
$ 0.476
$ 1.000
$ 8.055
$ 11.464
$ 11.825
$ 15.366
($ 0.471)
($ 0.379)
($ 2.369)
$ 2.833
$ 8.964
$ 16.927
$$ to re-invest
Confidential
Effectively Treating Patients Everyday
Creating Shareholder Value
•
Raising $3.0 M
•
$11.9 M Raised to Date ($ 8.6 M Non-dilutive)
•
$8.6 Million Contract with U.S. Department of Defense
•
EU Approval for Direct Sales
•
Generating Royalty Revenue
Neal G. Koller || President & CEO
+ 1 (443) 994 - 0101 || NKoller@PluroGen.com
Dan Conley
+ 1 (908) 917 - 3537
Confidential
||
||
Business Development
OnCallCFO@gmail.com
Effectively Treating Patients Everyday
PCCI Questions
Question 1 - Regulatory
Is PluroGen's triple antibiotic eligible for FDA's Fast Track,
Accelerated Approval, or Priority Review and which is the
best option in terms of speed to market?
Confidential
Effectively Treating Patients Everyday
PCCI Questions
Question – 2 Clinical
Can a product that is intended to be used initially in the
military (battlefield trauma) and eventually by the general
public (everyday trauma), go through clinical
trials only in military medical institutions or must civilians be
involved in the trials?
Confidential
Effectively Treating Patients Everyday
PCCI Questions
Question – 3 Financial
In today’s volatile financial environment, what is the best way
for a company like PluroGen to plan its exit strategy? What
exit strategy or strategies are viewed favorably by investors?
Confidential
Effectively Treating Patients Everyday
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