Biofrontera AG · XETR:B8FK
Biofrontera — J.P. Morgan Health Care Conference 2020
18 slides from Biofrontera's conference presentation, January 2020
Slide 1: Corporate Presentation – J.P. Morgan Health Care Conference 2020
CORPORATE PRESENTATION J.P. Morgan Health Care Conference 2020 / San Francisco, CA Prof. Dr. Hermann Lübbert, CEO Thomas Schaffer, CFO January 2020
Slide 2: Disclaimer
DISCLAIMER 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 and assumptions of the management of Bi
Slide 3: Biofrontera at-a-glance
COMPANY SUMMARY BIOFRONTERA AT-A-GLANCE PRODUCTS FINANCIAL HEADQUARTER SALES FORCE STOCK MARKET PERFORMANCE Headquartered in Biofrontera’s PDT drug Dedicated sales teams in Strong revenue growth: Listed on the Frankfurt Leverkusen, Germany; Ameluz® is approved in the U.S., Germany, Spain doubling of
Slide 4: Non-melanoma skin cancer: sun damage has many faces
SUN DAMAGE HAS MANY FACES NON-MELANOMA SKIN CANCER Epidemiology 1 Progression 2,3,4 BCC: >4 million BCC treatments annually in the U.S. Recent data show that mild or even invisible AK has a higher AK: >58 million patients in the U.S., particularly the elderly chance of progression to SCC than
Slide 5: Ameluz is a gel formulation for topical use
PRODUCTS AMELUZ® IS A GEL FORMULATION FOR TOPICAL USE EU Approval* Basal Cell Carcinoma (BCC) Actinic Keratosis (AK) Field Cancerization EU/US US Approval** Daylight PDT Medical device in the EU; Lesion- and field-directed Approved for PDT with treatment of AK IP Ameluz® in the U.S. IP protection un
Slide 6: Meta-analysis of all AK treatment options available in Europe
COMPETITIVE ENVIRONMENT EU META-ANALYSIS OF ALL AK TREATMENT OPTIONS AVAILABLE IN EUROPE Significant superiority of Ameluz® over Metvix® was proven in phase III trials and is documented in the EMA approved Ameluz® SmPC (PI) PDT drugs 100% • European meta-analysis included Complete Patient Clearance
Slide 7: Ameluz vs. Levulan
COMPETITIVE ENVIRONMENT IN THE U.S. AMELUZ® VS. LEVULAN® FDA-approved prescribing information of both drugs Ameluz® / LED lamps (ITT)* Levulan® / Blu-U® (ITT)** Patient clearance: 3 months after last of 1 or 2 PDTs 84-91% 66-69% Patient clearance scalp 65-82% 50% Efficacy Patient clearance: 12 (Amel
Slide 8: Position Ameluz as the #1 PDT drug and expand the PDT market (EU)
AK MARKET IN THE EU POSITION AMELUZ® AS THE #1 PDT DRUG AND EXPAND THE PDT MARKET EU - Strategy Position Ameluz® as the #1 PDT drug (achieved in Germany and Spain) 7% Expand the PDT market through daylight PDT to compete 7% with topical drugs Estimated Average ex-factory price per tube of Amel
Slide 9: Position Ameluz as the #1 PDT drug and expand the PDT market (US)
AK MARKET IN THE U.S. POSITION AMELUZ® AS THE #1 PDT DRUG AND EXPAND THE PDT MARKET This 3% segment represents US - Strategy a $ 130M drug market Position Ameluz® as the #1 PDT drug 3% Expand PDT market by taking away market share from topicals and cryotherapy 13% List price per tube of Ameluz
Slide 10: Reimbursement of PDT with Ameluz
NEW CPT-CODES REIMBURSEMENT OF PDT WITH AMELUZ® CPT-codes (Jan 2019) Avg. payment to dermatologist in USD The Centers for Medicare and Medicaid Services Efficacy rates Avg. payment to dermatologist (CMS) have assigned new CPT-codes, which make PDT performed by other health care workers $126 the use
Slide 11: Xepi is the first new topical antibiotic in the US in over 10 years
PRODUCTS XEPI™ IS THE FIRST NEW TOPICAL ANTIBIOTIC TO ENTER THE US-MARKET IN OVER 10 YEARS Licensed from Ferrer Extended US-product portfolio through Xepi™ offers a brief five-day acquisition of Cutanea Life Sciences in FDA approved in 2018 treatment course with only March 2019. Topical antibiotic u
Slide 12: Xepi: topical antibiotics market in the U.S.
PRODUCT STRATEGY U.S. MARKET XEPI™: TOPICAL ANTIBIOTICS MARKET IN THE U.S. Short-term strategy: Estimated market size: 10.8 million prescriptions annually 1) Position Xepi™ (ozenoxacin) as the #1 choice for topical antibiotic prescribed by dermatologists Generic mupirocin (topical antibiotic) prescr
Slide 13: Development pipeline
RESEARCH & DEVELOPMENT DEVELOPMENT PIPELINE Biofrontera‘s strategy is to optimize the market potential and market positioning of Ameluz® before investing in the development of additional products. Clinical Phase Product Indication / comments Territory Pre-clinical Submitted Status I II III Actinic k
Slide 14: Product sales
REVENUE GROWTH PRODUCT SALES ~+48% In EUR thousands +98% +114% ~31,250 Guidance: EUR 28 – 31 mio Other Regions 21,107 USA Europe (ex. GER) 12,025 Germany 6,130 3,096 4,138 2014 2015 2016 2017 2018 2019 FRA: B8F | NASDAQ:BFRA | January 2020 14
Slide 15: Biofrontera shares
STOCK MARKETS BIOFRONTERA SHARES Key stock information Analyst coverage Listing Frankfurt Nasdaq Financial Institution Analyst Ticker Symbol B8F BFRA Benchmark & Co Bruce Jackson Price per Share (as of Jan 7, 2020) €4.85 US$ 10,34 Lake Street Capital Thomas Flaten 1 ADS = 2 common shares per share p
Slide 16: Shareholder structure
SHAREHOLDERS SHAREHOLDER STRUCTURE Deutsche Shares outstanding: 44,849,365 Free float Balaton Group ~ 40% Shareholder structure: ~ 30% • Two major investors, each holding about 30% • About 40% free float, including institutional investors and family offices in Europe and the U.S. Maruho Co., Ltd. ~
Slide 17: Investment opportunity
SUMMARY INVESTMENT OPPORTUNITY Our goal is to optimize the positioning and market potentials of Ameluz® and Xepi™, while becoming a leading specialty pharmaceutical company in dermatology. FINANCIAL PRODUCTS PIPELINE COMMERCIALIZATION STOCK MARKET PERFORMANCE Ameluz® : superior PDT Very low developm
Slide 18: Contact details
CONTACT US CONTACT DETAILS Prof. Hermann Lübbert, PhD [email protected] CEO & Founder Thomas Schaffer [email protected] CFO Pamela Keck [email protected] Head of IR Biofrontera AG Phone +49 (214) 876 32 -0 Hemmelrather Weg 201 Fax +49 (214) 876 32 -90 D-51377 Leverkusen Email
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