Experts in dermatology

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