Your SlideShare is downloading. ×
  • Like
Fibrocell Science, Inc. (OTCBB: FCSC)- UBS Investor Conference, September 2011
Upcoming SlideShare
Loading in...5

Thanks for flagging this SlideShare!

Oops! An error has occurred.


Now you can save presentations on your phone or tablet

Available for both IPhone and Android

Text the download link to your phone

Standard text messaging rates apply

Fibrocell Science, Inc. (OTCBB: FCSC)- UBS Investor Conference, September 2011


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. …

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.

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads


Total Views
On SlideShare
From Embeds
Number of Embeds



Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

    No notes for slide


  • 1. UBS Global Life Sciences Conference September 20, 2011
  • 2. Safe Harbor ProvisionThis presentation includes statements that are “forward-looking statements.” Whilemanagement has based any forward-looking statements contained in the presentation on itscurrent expectations, the information on which such expectations were based may change.These forward-looking statements rely on a number of assumptions concerning future eventsand are subject to a number of risks, uncertainties, and other factors, many of which areoutside of Fibrocell Science’s control, that could cause actual results to materially differ fromsuch statements. Such risks, uncertainties, and other factors include, but are not necessarilylimited to, those set forth under the caption “Item 1A. Risk Factors” in Fibrocell Science’smost recent Form 10-K filing, as updated in “Item 1A. Risk Factors” in Fibrocell Science’smost recent Form 10-Q filing. In addition, Fibrocell Science operates in a highly competitiveand rapidly changing environment, and new risks may arise. Accordingly, you should notplace any reliance on forward-looking statements as a prediction of actual results. FibrocellScience disclaims any intention to, and undertakes no obligation to, update or revise anyforward-looking statement. You are also urged to carefully review and consider the variousdisclosures in Fibrocell Science’s most recent annual report on Form 10-K, our most recent10-Q as well as other public filings with the SEC since the filing of Fibrocell Science’s annualreport. 2
  • 3. Fibrocell VisionFibrocell Science: A unique autologous cellular therapeutic company with near termpromising 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 expansionSource: 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 CellCytoskeleton in a Human Fibroblast Cell. Actin (Red), Microtubules 6(Green), Nucleus (Blue). Image by Jiashan Wang
  • 7. Beauty ThroughScience
  • 8. Consumers Want Natural, Revolutionary & Engaging GENUINE ENGAGING BEAUTIFUL Real Confident Timeless Pure Engaging Beautiful Natural Enduring Attractive Intelligent SOPHISTICATED VIBRANT GROUND-BREAKING Elegant Vibrant Revolutionary Exclusive Rejuvenate Innovative Luxurious Dramatic Transforming
  • 9. Widespread Press Coverage Awarded a Beauty Breakthrough of the Year Award by Allure Magazine July issue of Vogue October issue of Marie Claire 10
  • 10. laViv Market Growth Drivers Market Expansion • New Demographics • Additional Indications Patient Retention & Patient Referrals SatisfactionNovel, Personali zed Product +Organic, Natural , Long Lasting Effect 11
  • 11. 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
  • 12. 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
  • 13. 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
  • 14. 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)
  • 15. 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 1616
  • 16. Nasolabial Folds Photo Gallery
  • 17. IT-R-006 Clinical Trial Photos: R6109 Baseline 6 Months Post-Treatment 18
  • 18. IT-R-006 Clinical Trial Photos: R6109 Baseline 6 Months Post-Treatment 19
  • 19. IT-R-005 Clinical Trial Photos: R5120 Baseline 6 Months Post-Treatment 20
  • 20. IT-R-006 Clinical Trial Photos: R6421 Baseline 6 Months Post-Treatment 21
  • 21. IT-R-006 Clinical Trial Photos: R6421 Baseline 6 Months Post-Treatment 22
  • 22. IT-R-006 Clinical Trial Photos: R6421 Baseline 6 Months Post-Treatment 23
  • 23. IT-R-006 Clinical Trial Photos:R6136 Baseline 6 Months Post-Treatment 24
  • 24. Natrillaire™ Daily Moisturizing CremèFirst 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
  • 25. Conventions and Scientific Association MeetingsAssociation Meetings: Date/LocationAmerican Society of Dermatologic November 3 – 6, 2011Surgeons (ASDS) Washington, D.C.American Society of Cosmetic December 1 – 4, 2011Dermatology and Aesthetic Surgery Las Vegas, NV(ASCDAS)Orlando Dermatology Aesthetic and January 13,16, 2012Clinical Conference Orlando, FLAmerican Academy of Cosmetic Surgery January 18-22, 2012(AACS) Las Vegas, NVAmerican Society for Aesthetic Plastic May 3-8, 2012Surgery (ASAPS) Vancouver, British ColumbiaAmerican Academy of Dermatology March 16-20, 2012(AAD) San Diego, CA
  • 26. Physician Training Programs ScheduledIn Target Markets :• Dinner meetings in major markets beginning September through December of 2011• 10 – 15 attendees per meeting• Expert moderated programs 27
  • 27. 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
  • 28. 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
  • 29. Acne Scar Photo Gallery
  • 30. IT-A-008 Clinical Trial Photos:A8104 4 Months Post-Treatment 31
  • 31. IT-A-008 Clinical Trial Photos:A8117 4 Months Post-Treatment 32
  • 32. IT-A-008 Clinical Trial Photos:A8609 4 Months Post-Treatment 33
  • 33. IT-A-008 Clinical Trial Photos:A8110 4 Months Post-Treatment 34
  • 34. laViv Therapy Acne Scar, Actual Result Before Treatment 6 Months Post TreatmentCourtesy of Robert Weiss, MD, Margeret Weiss, MD, Karen Beasley MD, Gillish Munavalli, MD 35
  • 35. laViv Therapy Acne Scar, Actual Result Before AfterCourtesy of Gilly Munavalli, MDMD 36
  • 36. 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 aCourtesy of Mark Palmer, MD ridge, appearance much improved 37
  • 37. 38
  • 38. 39
  • 39. laViv Therapy Hypertrophic Burn Scar, Actual Result Before Treatment 12 Months Post Treatment 14 Months Post Treatment •Full range - Clench •Fine movement FingersCourtesy of Chris Inglefield, BsC 40
  • 40. 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
  • 41. 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
  • 42. iPSC - Cardiomyocytes 43
  • 43. 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
  • 44. Hypothetical Market SizeIf each of the estimated1.5 million current Aesthetics Each 5% share of woman or 1.8% share of procedures =women were treated for •Current indication approximately $150 - $225one of the potential new •Potential new indications million annuallyareas > $3 billionmarket 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