Fibrocell Science, Inc. (OTCBB: FCSC) is a cell therapy company focused on the development of a line of autologous tissue regeneration products for aesthetic, medical, and scientific applications. Using Fibrocell Science's patented process, a patient’s own fibroblast cells are harvested using a minimally invasive skin procedure, then processed, multiplied, purified, cryopreserved and re-injected as personalized therapy. Fibroblasts are cells that contribute to the production of collagen essential in the formation of connective tissue fibers. These matrix fibers are critical to the strength and elasticity of the skin.
2. Safe Harbor Provision
This presentation includes statements that are “forward-looking statements.” While
management has based any forward-looking statements contained in the presentation on its
current expectations, the information on which such expectations were based may change.
These forward-looking statements rely on a number of assumptions concerning future events
and are subject to a number of risks, uncertainties, and other factors, many of which are
outside of Fibrocell Science’s control, that could cause actual results to materially differ from
such statements. Such risks, uncertainties, and other factors include, but are not necessarily
limited to, those set forth under the caption “Item 1A. Risk Factors” in Fibrocell Science’s
most recent Form 10-K filing, as updated in “Item 1A. Risk Factors” in Fibrocell Science’s
most recent Form 10-Q filing. In addition, Fibrocell Science operates in a highly competitive
and rapidly changing environment, and new risks may arise. Accordingly, you should not
place any reliance on forward-looking statements as a prediction of actual results. Fibrocell
Science disclaims any intention to, and undertakes no obligation to, update or revise any
forward-looking statement. You are also urged to carefully review and consider the various
disclosures in Fibrocell Science’s most recent annual report on Form 10-K, our most recent
10-Q as well as other public filings with the SEC since the filing of Fibrocell Science’s annual
report.
2
3. Fibrocell Vision
Fibrocell Science: A unique autologous cellular therapeutic company with near term
promising revenue and a broad platform.
1. The first area of focus is aesthetics and dermatology, with an indication in
wrinkles/folds. Other possible indications: acne scarring, an unmet need, and
other areas i.e. fine lines and wrinkles around eyes/lips, décolletage and total
facial treatment
2. We will also pursue orphan indications for restrictive burn scars and vocal
cord scarring
3. Our long term vision is to biotransform autologous dermal fibroblasts to
“factor free” IPSC cells capable of differentiation into multiple cell types for
toxicological, research use, and therapeutics
3
4. Growing Market - Aesthetics
• Over 4.2 Million injectable procedures in 2010
• Market expansion through additional indications
• Demographic expansion
Source: American Society for Aesthetic Plastic Surgery, 2010 4
5. laViv – Personalized Dermal Technology
Innovative technology to isolate, purify and regenerate a patient’s own
fibroblast cells for re-injection
Fibroblast cells are part of the structural
framework of animal tissues and play a critical role
in wound healing by synthesizing extracellular
matrix proteins such as collagens
The regenerated cells are native to the recipient
and recognized by the body’s immune system as
“self”
Potential applications extend beyond the
dermatology field
5
6. Restoring the Equilibrium
• The first autologous cell therapy for use in aesthetics filed with the FDA
• Strict release testing on each clinical lot to ensure performance and safety,
including:
– Collagen content testing results must achieve specification for each
prepped injection, indicating cells are biologically active and produce
collagen
– Cell suspension must consist of at least 98% fibroblasts prior to
release
– Cells in suspension must achieve a viability level of at least 85%
Human Fibroblast Cell
Cytoskeleton in a Human Fibroblast Cell. Actin (Red), Microtubules 6
(Green), Nucleus (Blue). Image by Jiashan Wang
10. Widespread Press Coverage
Awarded a Beauty Breakthrough of the
Year Award by Allure Magazine
July issue of Vogue
October issue of Marie Claire
10
12. Patient Value Proposition
Younger demographics Desire to maintain youthful look
Not satisfied with current options Seeking more natural, soft look
Complement to existing regiments Longer lasting effect
Attraction to organic products Early patient surveys indicate strong
satisfaction
Women 25 - 35 Women 35+ Men 35+
Source: American Society for Aesthetic Plastic Surgery, 2010 12
13. Dermatologists Value Proposition
Only approved cell-based treatment
Patient retention
More frequent patient interactions
Personalized Skincare Cream
• Premium skin cream
• Contains patient’s own natural collagen
• Provided exclusively by your physician
13
14. laViv Potential
“That’s where I see the real home run. We should be able to inject laViv in small amounts all over to
up-regulate your fibroblasts and improve pigmentation, scarring, and sagginess–and not only on the
face but on hands, the arms and legs.” – Frederic Brandt, M.D., clinical investigator
Line Filling Other Aesthetic Applications*
Back of Hands Upper Chest / Neck
Full Face
Acne Scars
Nasolabial Folds
* Indication not approved 14
15. laViv - Skin Quality Characteristics
Percent of Patients with Improvement
Improvement in Improvement in
Skin Quality Characteristic Subject Self- Evaluator
Assessment Assessment
Total Score 93% 95%
Softness 56% 65%
Suppleness 47% 65%
Smoothness 63% 65%
Firmness 77% 67%
Thickness 47% 56%
Moistness 65% 65%
Even Appearance 77% 67%
Refreshed Appearance 77% 84%
Trial IT-R-007 (n=45)
16. laViv Treatment Process
Extraction
• A small sample of cells is removed from behind the ear from a small
skin punch biopsy with the use of local anesthetic
• The location is chosen due to limited exposure to the sun and to
avoid creating a visible scar
Purification & Culturing
• A proprietary manufacturing process expands fibroblasts from the
sample into tens of millions of new cells in 90 days
• Fibroblasts are tested by quality control and released by quality
assurance prior to shipment
• Cells are frozen for use in potentially multiple treatment sessions
16
16
25. Natrillaire™ Daily Moisturizing Cremè
First and Only Natural Personalized Skin Cream:
Expected launch in early 2012
Natrillaire Daily
Moisturizing Cremè
• Premium skin cream
• Contains your own
natural collagen
Skin Creams with
animal collagen or • Exclusively from your
non-personalized skincare physician
Premium human fibroblast
Skin growth media
Creams
25
26. Conventions and Scientific Association
Meetings
Association Meetings: Date/Location
American Society of Dermatologic November 3 – 6, 2011
Surgeons (ASDS) Washington, D.C.
American Society of Cosmetic December 1 – 4, 2011
Dermatology and Aesthetic Surgery Las Vegas, NV
(ASCDAS)
Orlando Dermatology Aesthetic and January 13,16, 2012
Clinical Conference Orlando, FL
American Academy of Cosmetic Surgery January 18-22, 2012
(AACS) Las Vegas, NV
American Society for Aesthetic Plastic May 3-8, 2012
Surgery (ASAPS) Vancouver, British Columbia
American Academy of Dermatology March 16-20, 2012
(AAD) San Diego, CA
27. Physician Training Programs Scheduled
In Target Markets :
• Dinner meetings in major markets beginning September through
December of 2011
• 10 – 15 attendees per meeting
• Expert moderated programs
27
28. Fibrocell Pipeline & Partner Opportunities
Numerous near-term indications to pursue
FDA-approved platform has significant partnership opportunities
In addition to Acne Scars, potential new indications include Total
Face, Restrictive Burn Scars, and Vocal Cord Scars
28
29. Acne Scarring Key Points
• Completed one Phase II/III study
Statistically significant efficacy results
Currently in discussions with the FDA
• Large market potential – estimated to be 3 million patients
• Opportunity to be the first medical treatment for Acne Scars
29
35. laViv Therapy
Acne Scar, Actual Result
Before Treatment 6 Months Post Treatment
Courtesy of Robert Weiss, MD, Margeret Weiss, MD, Karen Beasley MD, Gillish Munavalli, MD
35
36. laViv Therapy
Acne Scar, Actual Result
Before After
Courtesy of Gilly Munavalli, MDMD
36
37. Restrictive Burn Scars
Situation Patient Treated with Fibroblasts
• 63 year-old woman • Reviewed 5 months post second treatment
• Burned 10 years previously • Improvement on both sides of neck
• Full thickness burns • Stopped all analgesics
• Originally treated with skin grafts • Discarded cervical collar
• Scar tissue progressively became hardened, • Full range of motion and pain free
contracted and inflexible
• Constant pain with severe restriction and abduction
• Wearing cervical collar, taking strong analgesics
• Plastic surgeon reluctant to intervene
Feb. 1, 2006 August 11, 2006
Before Scar tissue now very soft &
treatment flexible, no longer palpable as a
Courtesy of Mark Palmer, MD
ridge, appearance much improved
37
40. laViv Therapy
Hypertrophic Burn Scar, Actual Result
Before Treatment 12 Months Post Treatment 14 Months Post Treatment
•Full range - Clench •Fine movement Fingers
Courtesy of Chris Inglefield, BsC 40
41. Vocal Cord Scars
Publication in the January edition of The Laryngoscope
“Cellular-based approaches using tissue engineering and
regenerative medicine techniques like Fibrocell’s autologous
fibroblasts are promising for the treatment of vocal scars.”
• Dinesh K. Dr. Chhetri, MD, Associate Professor, Division of Head
and Neck Surgery, David Geffen School of Medicine at UCLA
41
42. Long Range Potential
Fibroblast cells are present throughout the body
Potential alternative to stem cells
Ability to use in models for studying medical conditions, particularly where
no good animal models exist
James A. Byrne, PhD
Byrne (2008). Hum. Mol. Gen. 17:R37-R41
42
44. In Conclusion:
• Establish LAVIV in key U.S. markets
Recruiting/Training Physicians
Interest has been strong and encouraging
• First and only cell based therapy FDA approved
• Other possible aesthetic indications:
Total facial treatment, fine lines and wrinkles around eyes, lips, &
décolletage
• Acne Scarring offers a significant opportunity
• Restrictive Burn Scars and Vocal Cord Scarring are potential orphan
indications
Applied for Restrictive Burn Scars orphan status
Vocal Cord Scarring orphan drug application in progress
• Several important scientific publications this year
• UCLA – offers potential to be a stem cell alternative
• Launch in China expected 2012
44
45. Hypothetical Market Size
If each of the estimated
1.5 million current
Aesthetics Each 5% share of woman or
1.8% share of procedures =
women were treated for •Current indication approximately $150 - $225
one of the potential new •Potential new indications million annually
areas > $3 billion
market
Acne Scars 3 million patients each received
a treatment potential market is >
$5 billion
Restrictive
Burn Scars 25,000 patients = $100 - $150
million annually
45