Biofrontera Ag · XETR:B8FK

Biofrontera — 19. MKK Conference 2015

16 slides from Biofrontera's conference presentation, May 2015

  1. Slide 1: Experts in dermatology

    Biofrontera I Experts in dermatology 19. MKK Conference I May 2015 Munich Company presentation I May 2015 I Page 1

  2. Slide 2: Disclaimer

    Biofrontera I Disclaimer These materials contain forward-looking statements based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements include statements regarding growth in

  3. Slide 3: Corporate Highlights

    Biofrontera I Corporate Highlights  Dermatology focused company  Ameluz® was approved in Europe in December 2011 for the treatment of actinic keratosis (AK)  Established proprietary salesforce and marketing channels across Europe – 2014 sales of EUR 3.1 MM  Main growth potential from expansion i

  4. Slide 4: Executive management team and board

    Biofrontera I Executive management team and board Prof. Hermann Lübbert, PhD, CEO, Founder  Founded Biofrontera in 1997  Extensive experience in academic research in the US and Europe  10 years in research management at Sandoz Pharma and Novartis Pharma Thomas Schaffer, CFO  25 years of experien

  5. Slide 5: Biofrontera's products

    Biofrontera I Biofrontera’s products  Ameluz®  BF-RhodoLED® Prescription drug Medical device  Approved for Actinic Keratosis (AK)  Photodynamic therapy lamp  In development for Basal Cell Carcinoma (BCC)  IP protection until 2027 Company presentation I May 2015 I Page 5

  6. Slide 6: Ameluz posology and mechanism

    Biofrontera I Ameluz® posology and mechanism 3 h incubation allows the 10-min illumination penetration of 5- activates PpIX and aminolevulinic acid produces reactive (ALA) into the cells of oxygen species the epidermis and its selectively in tumor metabolism to cells, thereby protoporphyrin IX elimi

  7. Slide 7: Non-melanoma skin cancer (NMSC) overview

    Biofrontera I Non-melanoma skin cancer (NMSC) overview  NMSCs are induced by UV-light or, rarely, HPV  Approximately 3,200 deaths in the US in 2011  AK affects 10% of the Caucasian population - if not treated, AK may progress to the more deadly squamous cell carcinoma (SCC)  Approximately 2.8 mi

  8. Slide 8: Local representatives

    Biofrontera I Local representatives Company Country Typical structure: Biofrontera Pharma Germany 1) Moderate upfront payments Spain 2) Transfer price in % of net sales price (~ 50% av.) Spirit / Biofrontera UK, Ireland 3) Ex-factory prices in the EU range from € 150 to € 250 Desitin Arzneimittel De

  9. Slide 9: Pipeline

    Biofrontera I Pipeline Product Indication Territory 2014 2015 2016 2017 Ameluz® Actinic keratosis EU Commercialization Ameluz® Actinic keratosis US Phase III Approval Commercialization Ameluz® Basal cell carcinoma EU Phase III Variation Commercialization Ameluz® Basal cell carcinoma US Phase III Var

  10. Slide 10: Complete Patient Clearance

    Biofrontera I Ameluz®: Most effective therapeutic option for AK treatment 100% PDT drugs 90% Meta-analysis of all AK treatment • Included 25 80% Complete Patient Clearance options available in Europe randomized, controlled 70% studies (5,562 patients). 60% • Measured total patient 50% clearance rate

  11. Slide 11: ALA-AK-CT007: Field therapy trial of AK with Ameluz and BF-RhodoLED

    Biofrontera I ALA-AK-CT007: Field therapy trial of AK with Ameluz® and BF-RhodoLED®  Placebo-controlled, multicenter study with 87 patients (DE)  First phase III study with PDT when field therapy was applied, despite field therapy recommendation in the dermatological guidelines  First phase III q

  12. Slide 12: Comparison Ameluz - Levulan

    Biofrontera I Comparison Ameluz® - Levulan® Ameluz®* Levulan®** Efficacy (3 months after last of 1 or 2 PDTs) ~ 90% ~ 65% Efficacy scalp ~ 82% ~ 50% P12m*CR ~ 60% ~ 31% Lamp red light blue light Application gel *** liquid Incubation 3 hr 12-18 hr Side effects see above extreme pain with long incubat

  13. Slide 13: US commercialization

    Biofrontera I US commercialization First steps made to prepare successful US commercialization, started to establish infrastructure  New legal entity in USA: Biofrontera Inc., Wilmington, DE  US medical advisory board formed, already held 2 very productive meetings  2 studies prepared by a renown

  14. Slide 14: Quarterly Revenue Development

    Biofrontera I Quarterly Revenue Development Strong revenue growth qoq plus one-time license payments following EU approval of Ameluz® Seasonality of business: Q4 remains to be strongest 1600 Tsd EUR 1400 1.375 1.247 1200 1.030 1.104 (prel.) 1000 775 779 800 712 634 650 751 567 566 600 483 400 200 0

  15. Slide 15: Summary

    Biofrontera I Summary  Dermatology focused company with best in class treatment for actinic keratosis  Ameluz® marketed in Europe for the treatment of actinic keratosis, expanding into field therapy and basal cell carcinoma indication  Established proprietary salesforce in Germany and Spain, and

  16. Slide 16: Biofrontera AG Hemmelrather Weg 201 D-51377 Leverkusen

    Biofrontera I Biofrontera AG Hemmelrather Weg 201 D-51377 Leverkusen Germany Phone: +49 (214) 876 32 -0 Fax: +49 (214) 876 32 -90 E-mail: [email protected] www.biofrontera.com Prof. Hermann Lübbert, PhD CEO [email protected] Thomas Schaffer CFO [email protected] Company presenta

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