Biofrontera I Experts in dermatology Company Presentation I April 2015 Company presentation I April 2015 I Page 1 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 market size, revenue potential, sources of future revenues, timing of regulatory submissions, receipt of regulatory approvals, results of clinical trials, timing of product introductions and commercialization, expansion in the US market, future fundraising efforts and plans for a market listing. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of Biofrontera AG, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. These risks include, without limitation, unanticipated delays or disruptions in clinical trials, potential need to expand, add or extend clinical trials, potentially unfavorable trial results, delays in regulatory submissions and approvals, potential denials of regulatory approval, changes in regulatory requirements, adverse events with patients, product liability, potential lack of demand, introduction of superior products by competitors, lack of adequate reimbursement, challenges in establishing distribution channels, potential manufacturing challenges, potential inability to manufacture products cost-effectively, costs and challenges of planned US expansion, failure to raise necessary funds on a timely basis, potential intellectual property infringement, potential inadequacy of our intellectual property portfolio, dependence on key employees and suppliers, dependence on the reliability and integrity of information technology systems, potential shareholder dilution, fluctuations in currency rates and potential inability to satisfy market listing requirements. Given these risks, uncertainties and other factors, recipients of these documents are cautioned not to place undue reliance on these forward-looking statements. Biofrontera AG disclaims any obligation to update these forward-looking statements to reflect future events or developments. Company presentation I April 2015 I Page 2 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 into basal cell carcinoma (BCC) indication – currently in Phase III trial Strong focus on US market opportunity for Ameluz® NDA filing with the FDA expected in Q2 2015 for the treatment of AK, with planned expansion to BCC Establishment of US organization started Multiple near-term catalysts Results from the ongoing Phase III trial in BCC indication Upcoming regulatory approvals in Europe and the US Long term potential supported by earlier stage pipeline and market-stage medical cosmetic line Listed on Prime Standard of the Frankfurt stock exchange and AIM Market in London; Ticker: B8F Company presentation I April 2015 I Page 3 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 experience in finance and venture capital Joined Biofrontera in 2013 Supervisory Board Jürgen Baumann (chairman) Prof. Dr. Bernd Wetzel (deputy chairman) Andreas Fritsch Dr. Ulrich Granzer Ulrike Kluge Fred Neimke Former board member of Schwarz Pharma (Marketing & Sales) Former head of research and development at Boehringer Ingelheim Head of Finance System GmbH & CoKG Former head of drug registration at Bayer, Knoll, and GSK Former head of business development at Schwarz Pharma Former board member of “Erste Versicherung“ in Vienna Company presentation I April 2015 I Page 4 Biofrontera I Biofrontera’s products Ameluz® Prescription drug Approved for Actinic Keratosis (AK) In development for Basal Cell Carcinoma (BCC) IP protection until 2027 BF-RhodoLED® Medical device Photodynamic therapy lamp Company presentation I April 2015 I Page 5 Biofrontera I Ameluz® posology and mechanism 3 h incubation allows penetration of 5aminolevulinic acid (ALA) into the cells of the epidermis and its metabolism to protoporphyrin IX (PpIX) preferentially in tumor cells the 10-min illumination activates PpIX and produces reactive oxygen species selectively in tumor cells, thereby eliminating these cells In Photodynamic Therapy (PDT) a pre-applied drug is activated by light Ameluz® PDT destroys the tumor tissue in a 1-time treatment without scar formation Ameluz® PDT causes strong skin rejuvenation due to enhanced collagen synthesis Company presentation I April 2015 I Page 6 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 million BCC cases annually in the US Actinic keratosis (AK) Basal cell carcinoma (BCC) Squamous cell carcinoma (SCC) Sources: http://www.skincancer.org/media-and-press/press-release-2013/nmsc http://www.skincancer.org/skin-cancer-information/actinic-keratosis http://www.skincancer.org/skin-cancer-information/skin-cancer-facts http://www.aad.org/media-resources/stats-and-facts/conditions/skin-cancer Company presentation I April 2015 I Page 7 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 quantification of anti-aging effect of PDT Ameluz® Placebo Complete patient clearance (ITT) 91% (50/55) 22% (7/32) Complete lesion clearance (ITT) 94% 33% Complete patient clearance after 1st PDT (ITT) 62% 9% Complete lesion clearance after 1st PDT (ITT) 84% 22% Ameluz® Placebo Very good or good 67% (32/48) 35% (9/26) Unsatisfactory or impaired 10% (5/48) 42% (11/26) Clinical end point Cosmetic outcome Company presentation I April 2015 I Page 8 Biofrontera I Local representatives Company Country Biofrontera Pharma Germany Spain Spirit / Biofrontera UK, Ireland Desitin Arzneimittel Denmark Typical structure: 1) Moderate upfront payments 2) Transfer price in % of net sales price (~ 50% av.) 3) Ex-factory prices in the EU range from € 150 to € 250 Norway Sweden Bipharma The Netherlands Belgium and Luxembourg Pelpharma Austria PHA FARMED Slovenia Perrigo Israel Louis Widmer Switzerland/Liechtenstein Company presentation I April 2015 I Page 9 Biofrontera I Pipeline Product Indication Territory Ameluz® Actinic keratosis EU Ameluz® Actinic keratosis US Ameluz® Basal cell carcinoma EU Ameluz® Basal cell carcinoma US BF-derm1 Severe chronic urticaria global BF-1 Migraine prophylaxis 2014 2015 2016 2017 Commercialization Phase III Phase III Approval Commercialization Commercialization Variation Phase III Variation Phase III Phase IIb global Phase I Company presentation I April 2015 I Page 10 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 incubation time field lesion Treatment area * all Ameluz® data are with LED lamps only ** all Levulan® data are with BLU-U only *** enhanced penetration and easier application Company presentation I April 2015 I Page 11 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 renowned market research company: Analysis of coding system including assessment of usability for Ameluz Analysis of treatment options for AK indication, patient and payers structures, medical and commercial considerations from physician’s viewpoint Hired CEO for US operations (starting 01 April): Monica L. Tamborini Active as COO and CFO since 1992 in biotech/pharma public and private companies Extensive experience in Management, Finance, Business Development , Quality Management & FDA interactions, and Government Contracts Previous positions include C-level positions at • DNAPrint Genomics Inc. • Pharm-Eco Laboratories Inc. Company presentation I April 2015 I Page 12 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 1.375 1400 1.247 1.104 1.030 1200 (prel.) 1000 800 751 712 634 650 775 567 600 779 566 483 400 200 0 Q1 12 Q1 13 Q1 14 Q1 15 Q2 12 Q2 13 Q2 14 Germany International Q3 12 Q3 13 Q3 14 Q4 12 Q4 13 Q4 14 Downpayments Company presentation I April 2015 I Page 13 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 marketing channels across Europe Belixos® medical cosmetic line for itching & redness sold through Amazon and pharmacies in Europe Currently three marketed products (cream, gel, liquid), next line expansion in Q2 2015 Strong focus is on the US market opportunity for Ameluz® Ongoing regulatory process in the US for the treatment of AK, with planned extension to BCC Multiple near-term catalysts Long-term potential from proprietary pipeline Phase II project: BF-derm1 for severe chronic urticaria Phase I project: BF-1 for migraine prophylaxis Company presentation I April 2015 I Page 14 Biofrontera I Biofrontera AG Hemmelrather Weg 201 D-51377 Leverkusen Germany Phone: Fax: E-mail: +49 (214) 876 32 -0 +49 (214) 876 32 -90 [email protected] www.biofrontera.com Prof. Hermann Lübbert, PhD CEO [email protected] Thomas Schaffer CFO [email protected] Company presentation I April 2015 I Page 15
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