Biofrontera Ag · XETR:B8FK
Biofrontera — Investor Presentation (September 2020)
25 slides from Biofrontera's investor presentation, September 2020
Slide 1: Investor Presentation
INVESTOR PRESENTATION Prof. Dr. Hermann Lübbert, CEO September 2020
Slide 2: Forward-Looking Statements and Risks
DISCLAIMER FORWARD-LOOKING STATEMENTS AND RISKS This presentation contains forward-looking statements including, without limitation, statements containing the words “expects”, “future”,“potential” and words of similar import. Such forward looking statements are based on the currently held beliefs an
Slide 3: Biofrontera at-a-glance
COMPANY SUMMARY BIOFRONTERA AT-A-GLANCE HEADQUARTERS PRODUCTS SALES FORCE FINANCIAL STOCK MARKET PERFORMANCE Headquartered in Biofrontera’s Dedicated sales teams in Revenue growth from Listed on the Frankfurt Leverkusen, Germany Photodynamic Therapy the U.S., Germany, Spain EUR 4.1 million in 2015 t
Slide 4: Where do we want to be in 5 years?
GOALS WHERE DO WE WANT TO BE IN 5 YEARS? Revenue: between EUR 200 million and EUR 400 million in 2025 Ameluz® has become the PDT and XepiTM the topical antibiotic “standard of care” Market penetration gains achieved for PDT in the actinic keratosis and non- melanoma skin cancer market Acne indicatio
Slide 5: How do we want to achieve our goals?
CORPORATE STRATEGY HOW DO WE WANT TO ACHIEVE OUR GOALS? Biofrontera‘s strategy is to optimize the market potential and market positioning of its current product portfolio. Growth Core Markets R&D Licensing Opportunity With our two prescription We focus on our core Our research efforts for We seek li
Slide 6: Growth Milestones 2016 - 2020
TRACK RECORD GROWTH MILESTONES 2016 - 2020 Approved indication extensions for Ameluz® FDA approval of Ameluz® for the lesion- and field-directed treatment of AK on the face and scalp (May 2016) Treatment of basal cell carcinomas (BCC) in Europe (January 2017) Daylight-PDT for actinic keratosis
Slide 7: Ameluz is a gel formulation for topical use
PRODUCTS AMELUZ® IS A GEL FORMULATION FOR TOPICAL USE EU label* Basal Cell Carcinoma (BCC) Actinic Keratosis (AK) Field Cancerization EU/US US label** Daylight PDT Medical device in the EU; Lesion- and field-directed IP Approved for PDT with treatment of AK IP on nanoemulsion Ameluz® in the U.S. tec
Slide 8: AK: Before and after Ameluz PDT
ACTINIC KERATOSIS TREATMENT WITH PDT AK: BEFORE AND AFTER AMELUZ® PDT US dermatologists have traditionally preferred cryotherapy based on speed of treatment and good remuneration. Benefits of Ameluz® PDT vs. cryotherapy: • Higher efficacy with better clearance and recurrence rates • Serves medical n
Slide 9: Ameluz market potential for actinic keratosis
AK MARKET IN THE US AMELUZ® MARKET POTENTIAL FOR ACTINIC KERATOSIS The US is Biofrontera‘s largest market This 3% segment represents a $ 140M drug market 3% 13% cryotherapy Total AK population (US) topicals ~52,950,0001 PDT Treated AK patients ~12,961,0002 84% PDT Treated Patients 24%2 of AK patient
Slide 10: Competitive landscape in the US
AK MARKET IN THE US COMPETITIVE LANDSCAPE IN THE US Only PDT drug approved for field therapy. Better efficacy. More convenient application. Competitive advantages One competitor in the PDT market, approved for lesion-directed AK therapy only. (Levulan Kerastick® by Sun Pharma/Dusa Competition Pharma
Slide 11: Optimizing the market potential of Ameluz in the USA
PRODUCT STRATEGY OPTIMIZING THE MARKET POTENTIAL OF AMELUZ® IN THE USA Q2 Q2 Q3 Q4 2025 TBD 2021 2021 2022 2022 Product development Label expansion Label expansion Label expansion Label expansion Label expansion Approval of larger Approval for the Approval for the Indication: Indication: Indication:
Slide 12: Actinic keratosis market in the EU
AK MARKET IN THE EU ACTINIC KERATOSIS MARKET IN THE EU AK market by treatment option EU market 2.1 million** prescriptions for AK per year 7% size 7% One relevant competitor in the PDT market (Metvix®/Luxerm®) PDT • Two superiority claims in the Ameluz® EU label 86% competition • Ameluz® is the lead
Slide 13: Development Pipeline
RESEARCH & DEVELOPMENT DEVELOPMENT PIPELINE Clinical Phase Product Indication / comments Territory Submission Approval Status I II III Actinic keratosis (AK), Ameluz® EU/CH On market field cancerization Ameluz® AK, lesion- and field-directed US On market Ameluz® Basal cell carcin
Slide 14: Xepi is the first new topical antibiotic in over 10 years
PRODUCTS XEPI™ IS THE FIRST NEW TOPICAL ANTIBIOTIC TO ENTER THE US-MARKET IN OVER 10 YEARS Exclusive license from Ferrer Internacional SA Extended US-product portfolio through Xepi™ offers a brief five-day FDA approved in 2018 acquisition of Cutanea Life Sciences, Inc. in treatment course with only
Slide 15: Impetigo: Before and after Xepi treatment
ACTINIC KERATOSIS TREATMENT WITH PDT IMPETIGO: BEFORE AND AFTER XEPI™ TREATMENT XEPI™ Advantages* • Approved for impetigo due to Staphylococcus aureus or Streptococcus pyogenes, including antibiotic resistant strains such as MRSA • Approved for adults and pediatric patients 2 months of age and older
Slide 16: Xepi competitor generic mupirocin: market size and growth
TOPICAL ANTIBIOTICS MARKET IN THE US XEPI™ COMPETITOR GENERIC MUPIROCIN: MARKET SIZE AND GROWTH 12000 Mupirocin prescriptions in ´000 Mupirocin CAGR = 4% 358 10000 804 624 677 727 819 8000 TRx Volume in ´000 6000 10,613 9,522 9,361 9,851 8,501 8,988 4000 2000 0 ALTABAX BACTROBAN MUPIROCIN MUPIROCIN
Slide 17: Market potential of Xepi in dermatology alone
TOPICAL ANTIBIOTICS MARKET IN THE US MARKET POTENTIAL OF XEPITM IN DERMATOLOGY ALONE Generic Mupirocin: Utilization by specialty Dermatology XepiTM dermatology patients Pediatrics 10% 14% Mupirocin treated Nurse 100%1 dermatology patients Practitioner ~1,148,140 21% All Others 31% 63%2 Xepi™ eligibl
Slide 18: Optimizing Xepi market access
PRODUCT STRATEGY OPTIMIZING XEPITM MARKET ACCESS Reimbursement Payors Copay card Distribution Unrestricted access. Program redesigned – Independent Community effective April 1, 2020: Pharmacies (ICP) are MARKET Patient compliance Over 150 M lives covered • rebalances cost-sharing being added where A
Slide 19: Revenue growth 2012-2019
REVENUE REVENUE GROWTH 2012-2019 In EUR million +48% 31.3 • Lower H1 2020 product Germany Europe +98% sales negatively due to US pandemic compensated by 21.1 Development projects one-time payment from +114% Downpayments 16.1 licensing agreement 13.9 12.0 • 2020 forecast for sales revenue between EUR
Slide 20: Biofrontera Group financial results
FINANCIAL OVERVIEW BIOFRONTERA GROUP FINANCIAL RESULTS In million EUR (IFRS) 2014 2015 2016 2017 2018 2019 6M 2019 6M 2020 Total revenue 3.1 4.1 6.1 12.0 21.1 31.3 13.9 16.1 Product sales 3.1 4.1 5.0 10.6 21.0 30.6 13.7 9.7 thereof US revenues 0 0 1.2 6.3 14.9 23.3 10.2 6.3 Operating income (9.6) (1
Slide 21: Biofrontera shares
STOCK MARKETS BIOFRONTERA SHARES Key stock information Analyst coverage Listing Frankfurt Nasdaq Financial institution Analyst Rating Ticker symbol B8F BFRA Benchmark & Co Bruce Jackson buy Price per share (as of Sep 14, 2020) €3.67 $6.55 Lake Street Capital Thomas Flaten buy 1 ADS = 2 common shares
Slide 22: Share price performance 2016-2020
SHAREPRICE PERFORMANCE: B8F SHARE PRICE PERFORMANCE 2016-2020 June 2019 Tender offers by Deutsche Balaton and Maruho Co., Ltd. 800000 February 14, 2018 Price EUR 8.00/ EUR 7.20 8,00 € Nasdaq Listing 750000 Price EUR 4.80 700000 7,00 € May 11, 2016 FDA approval 650000 Price EUR 3.37 February 6, 2017
Slide 23: Shareholder structure
SHAREHOLDERS SHAREHOLDER STRUCTURE Shares outstanding: 44,849,365 Deutsche Shareholder structure: Free float Balaton Group • Two major investors, one institutional and one strategic, ~ 40% ~ 30% each holding just below 30% • About 40% free float, including institutional investors, Maruho Co., Ltd. f
Slide 24: Senior Leadership Team
LEADERSHIP SENIOR LEADERSHIP TEAM Prof. Hermann Lübbert, PhD Thomas Schaffer Erica Monaco, CPA Christopher Pearson Montserrat Foguet, PhD CEO & Founder CFO CFO USA CCO USA Senior VP Reg. Affairs and Production • 25 years of experience in • 15 years experience in • 22 years experience in sales, • Fou
Slide 25: Contact Details
CONTACT US CONTACT DETAILS Prof. Hermann Luebbert, PhD h.luebbert@biofrontera.com CEO & Founder Thomas Schaffer t.schaffer@biofrontera.com CFO Pamela Keck p.keck@biofrontera.com Head of Investor Relations Biofrontera AG Phone +49 (214) 876 32 -0 Hemmelrather Weg 201 Fax +49 (214) 876 32 -90 D-51377