Experts in photodynamic therapy - Investor Presentation I September 2018 - Biofrontera
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Experts in photodynamic therapy
Investor Presentation I September 2018
FRA: B8F I NASDAQ:BFRA September 2018 I Page 1
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 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 and future capital needs. 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 which may prevent us from completing the development and commercialization of our products and
product candidates or have other material adverse effects on our business, 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
other factors referenced in this presentation. Given these risks, uncertainties and other factors, prospective investors 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.
FRA: B8F I NASDAQ:BFRA September 2018 I Page 2
Executive Management Team
Prof. Hermann Lübbert, PhD, CEO, CSO and Founder
▪ Founded Biofrontera in 1997
▪ Extensive experience in academic research in US and Europe
▪ 10 years in research management at Sandoz Pharma and Novartis Pharma
Christoph Dünwald, CCO
▪ 25 years of healthcare sales and marketing commercial expertise in USA,
Europe and Asia Pacific
▪ Previous employments at Bayer Healthcare and Allergan
Thomas Schaffer, CFO
▪ 25 years of experience in finance and venture capital
▪ CFO positions in small and multi-billion dollar businesses
FRA: B8F I NASDAQ:BFRA September 2018 I Page 3
At-A-Glance
Biofrontera is uniquely positioned to exploit the growing global market of photodynamic
therapy (PDT) for non-melanoma skin cancers and other dermatological conditions.
▪ German dermatology company with subsidiary in Boston area.
▪ Ameluz® is approved as a prescription drug in the US, EU, Switzerland and Israel.
▪ Dedicated sales and distribution teams in Germany, Spain, GB and the US.
▪ Listed on Nasdaq (ticker symbol: BFRA) and Prime Standard of the Frankfurt Stock Exchange
(ticker symbol: B8F).
FRA: B8F I NASDAQ:BFRA September 2018 I Page 4
Milestones – Biofrontera AG
EU
EU approval of Dedicated Ameluz® approval of
Ameluz® for sales team launch in daylight
treatment of AK in Spain the US PDT
December February November May October January March May
2011 2012 2014 2016 2016 2017 2018 2018
Start of product FDA EU Dedicated
sales in approval indication sales team
Germany expansion in the UK
to BCC
▪ Ameluz® available in US, EU, Switzerland and Israel
▪ Doubling of product sales in 2017 and H1 2018
▪ US revenue already represents >70% of total revenue as at June 30, 2018
FRA: B8F I NASDAQ:BFRA September 2018 I Page 5
NMSC: Sun Damage Has Many Faces
Epidemiology1 Progression2,3,4
BCC: >4 million BCC treatments annually in the US ▪ Clinical assessment of AK severity is not
AK: >58 million patients in the US, particularly the elderly population correlated to histopathological severity
SCC: second most dangerous skin cancer after melanoma ▪ SCC develops from AK. By definition, it is called
SCC: >1 million patients with an estimated 8,800 fatalities annually in the US SCC when neoplastic cells enter the dermis
SCC: incidence increased by 200% in last three decades
SCC: major cause of death for immunosuppressed people ▪ Recent data show that mild or even invisible AK
has a higher chance of progression to SCC than
Sources:
1) http://www.skincancer.org/skin-cancer-information severe (with strong hyperkeratosis) AK
2) Schmitz et al., J Eur Acad Dermatol Venereol. 2016 Aug;30(8):1303-7
3) Fernández-Figueras et al., J Eur Acad Dermatol Venereol. 2015 May;29(5):991-7 ▪ If an AK lesion progresses to SCC, it does so in
4) Fuchs & Marmur, Dermatol Surg. 2007 Sep;33(9):1099-101
about 2 years on average
Actinic keratosis (AK) Squamous cell carcinoma (SCC) Basal cell carcinoma (BCC)
FRA: B8F I NASDAQ:BFRA September 2018 I Page 6
Lead Products
▪ Ameluz®
Prescription Drug
▪ Approved in EU* for Basal Cell Carcinoma (BCC)
Actinic Keratosis (AK)
Field Cancerization
Daylight Therapy
▪ FDA approved** for Lesion- and field-directed AK
(since May 2016)
▪ IP protection until 2027 (granted in many parts of the world,
including EU and Japan, pending in the USA)
▪ BF-RhodoLED®
Medical Device
▪ Photodynamic Red LED Therapy Lamp
▪ Approved as medical device in the EU and approved in
combination with Ameluz® in the US
• Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) and of field cancerization in adults. Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due
to possible treatment-related morbidity and/or poor cosmetic outcome in adults. Full EU SmPC can be found at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002204/WC500120044.pdf
** Ameluz® gel, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® lamp, is indicated for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and
scalp. Full US prescribing information for Ameluz® and the U.S. User manual for BF-RhodoLED® can be found at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208081Orig1s000LBL.pdf
FRA: B8F I NASDAQ:BFRA September 2018 I Page 7
Ameluz®: Highly Effective Option for AK Treatment in the EU
100%
▪ European meta-analysis included
PDT drugs
90% Meta-analysis of all AK treatment 25 randomized, controlled studies
80% options available in Europe (5,562 patients)
Complete Patient Clearance
70%
Source: Vegter & Tolley, PlosOne 2014, June, Vol. 9, Issue 6 ▪ Clinical endpoint: total patient
clearance rates in mild to
60%
moderate AK on face or scalp
50%
▪ All included PDTs were performed
40%
with LED lamps
30%
▪ Significant superiority of Ameluz®
20% over Metvix® was proven in phase
10% III trial and is documented in the
EMA approved Ameluz® SmPC (PI)
0%
▪ The relative efficacy of different treatment options for mild to moderate actinic keratosis (including cryotherapy, topicals and PDT options)
was analyzed in a European meta-analysis (Vegter & Tolley 2014).
▪ Although this study was a meta-analysis of placebo-controlled trials, rather than a head-to-head comparison of treatments, we believe this
data shows significant support for Ameluz® PDT as the best available treatment for mild to moderate actinic keratosis on the face and scalp.
FRA: B8F I NASDAQ:BFRA September 2018 I Page 8
US Market: Ameluz® and Levulan® Comparison
Ameluz® / LED lamps with Levulan® / Blu-U® with 14-
3 hr exposure (ITT)* 18 hr exposure (ITT)**
Patient clearance: 3 months after last of 1 or 2 PDTs 84-91% 66-69%
Patient clearance scalp 65-82% 50%
Patient clearance: 12 (Ameluz) or 10-12 (Levulan)
53-69% 31%
months after last of 1 or 2 PDTs
Lesion clearance: 3 months after last of 1 or 2 PDTs 94-96% 72.1%/83.6%
Lesion clearance: 12 (Ameluz) or 10-12 (Levulan)
85-90% 83%
months after last of 1 or 2 PDTs
Formulation (easier and faster application of gel) gel liquid
Illumination time 10 min 16 min + 40 sec
Skin rejuvenation phase III data no phase III data
Approved treatment area field lesion
Treatment of superficial and nodular BCC high efficacy in phase III no data
*three phase III studies **two phase III studies and one open-label study *** 3 months
FRA: B8F I NASDAQ:BFRA September 2018 I Page 9
AK Markets in EU and US
2.1 million drug prescriptions Europe
▪ Dermatologists in Europe have favored topical prescriptions; we believe as a result of a
lack of reimbursement for procedures such as PDT (as opposed to self-applied drugs)
▪ Cryotherapy unpopular due to perceived poor efficacy, high recurrence rates and lack of
reimbursement
PDT Cryotherapy * Topicals ▪ We recently received approval to market Ameluz® for use in connection with daylight
* number of cryotherapies estimated
PDT, which we believe enables patients to obtain reimbursement more easily
since no reliable data available
▪ Average wholesale price per tube of Ameluz®: EUR 150
12.6 million treatments**
USA
▪ Most dermatologists in the US have preferred cryotherapy
▪ We believe new CPT codes and medical need of field therapy is now favoring PDT
▪ Although PDT represents only about 3% of the AK market, annual PDT drug sales are
PDT Cryotherapy Topicals
US$ ~135 million
** based on Biofrontera review of 2016 publicly
available information
▪ List price per tube of Ameluz®: US$ 270
FRA: B8F I NASDAQ:BFRA September 2018 I Page 10EU: Daylight PDT with Ameluz® launched
▪ Commercially more attractive for doctors and patients
▪ Almost pain-free
▪ Phase III: Statistical superiority in recurrence rates compared
to Metvix® after a single daylight PDT
3 months after PDT 12-month recurrence
Phase III
Ameluz® Metvix® Ameluz® Metvix® p-value
Lesion clearance 79.8% 76.5% 19.9% 31.6% PMilestones – Biofrontera Inc.
Addition of Addition of Employee
Randy Jeffrey Holm as growth to
FDA approval Wilhoite as VP Marketing & over 50
of Ameluz® COO Sales people
May October March August September November December
2016 2016 2017 2017 2017 2017 2017
Commercial Switch to Receipt of product-
product Third Party specific J-Code and
launch Logistic CPT-Code
(3PL) model
▪ Excellent coverage at national dermatology conferences
▪ Strong commercial infrastructure with licenses to sell pharmaceuticals in all US States
▪ Achieved a total of over US$ 16 million in revenue since launch until June 30, 2018
FRA: B8F I NASDAQ:BFRA September 2018 I Page 12US: Specific J-Code and Additional CPT-Codes effective Jan 2018
The Centers for Medicare and Medicaid Services (CMS) have assigned:
▪ Specific J-code J7345 for Ameluz®
▪ significantly simplifying billing and reimbursement process for dermatologists
▪ New CPT-codes for application of PDT
▪ for the first time, PDT is commercially more attractive for dermatologists than cryotherapy
Avg. payment to
CPT-code for
dermatologist
PDT previously (until Dec 31, 2017) $137
Previous PDT code as of Jan 2018 (PDT performed by other health care workers) $117
PDT without debridement, by qualified health care professional (corresponding to $193
USPI of Levulan)
PDT with debridement (i.e. targeted curettage, abrasion), by qualified health care $249
professional (USPI of Ameluz®)
Cryotherapy capped at >14 lesions $148
FRA: B8F I NASDAQ:BFRA September 2018 I Page 13Development Pipeline
Biofrontera‘s strategy is to first optimize the market potential and market positioning of
Ameluz® before investing in the development of additional products.
Product Indication / comments Territory Pre- Clinical Submitted Status
clinical
Ameluz® Actinic keratosis (AK), EU, CH, IL On market
field cancerization
Ameluz® AK, lesion- and field-directed US On market
Ameluz® Basal cell carcinoma EU On market
Ameluz® AK: Daylight PDT EU On market
Ameluz® AK: Trunk & extremities EU/US Phase III ongoing
Ameluz® Basal cell carcinoma US IND for Phase III accepted
Ameluz® Squamous cell carcinoma in situ EU/US Phase III in preparation
Ameluz® Acne EU/US Phase II in preparation
FRA: B8F I NASDAQ:BFRA September 2018 I Page 14Revenue Growth
EUR thousand
14000
12,025
12000
10000 +96%
8,969
8000
+79%
6,130 (+109%)
6000
5,006
4,138
4000
3,096
2000
0
2014 2015 2016 2017 6M - 2017 6M - 2018
Germany Europa (excl. GER) USA Other Regions
FRA: B8F I NASDAQ:BFRA September 2018 I Page 15Financial Overview
Biofrontera group financial results under IFRS (in million EUR)
6M 6M
2014 2015 2016 2017
2017 2018
Revenue 3.1 4.1 6.1 12.0 5.0 9.0
thereof US revenues 0 0 1.2 6.3 2.4 6.4
Operating Income (9.6) (10.2) (11.8) (13.9) (7.8) (7.3)
Cash & Cash Equivalents 8.5 4.0 15.1 11.1 15.4 26.3
Permanent loss carry forward 98.6 109.8 120.4 136.5 120.4 136.5
Debt 10.8 11.2 3.6 12.4** 12.4** 13.0**
**Long-term debt including €10 million drawdown from EIB loan
FRA: B8F I NASDAQ:BFRA September 2018 I Page 16Biofrontera‘s Proud Moment (Feb 15, 2018) FRA: B8F I NASDAQ:BFRA September 2018 I Page 17
Biofrontera Shares
Listing Frankfurt Nasdaq
Ticker Symbol B8F BFRA
Price per Share (as of September 17, 2018) €5.97 US$ 13.83
Nasdaq: 1 ADS represents 2 ordinary shares per share per ADS
52 Week High-Low €7.63 - €3.05 $17.98 - $11.25
Shares Outstanding 44,541,980
Market Cap (as of September 17, 2018) ~US$ 307 M
12-Month Share Price Development: B8F
FRA: B8F I NASDAQ:BFRA September 2018 I Page 18ADS – Seamless Trading on Both Markets
▪ US investors can buy ADSs through their brokers just like any other US security.
▪ Conversion of ADS into common shares and vice versa without delay.
▪ Fungibility of ADS/common shares for seamless trading on both NASDAQ and German stock exchange
to ensure maximum liquidity.
▪ ADS ticker symbol: BFRA
Full fungibility of shares and
ADS independent of the
US Investors market with seamless German Investors
exchange of common shares
into ADS and vice versa
Trading of ADS Trading of common
on NASDAQ Exchange shares on German
exchange i.e. Xetra or
Frankfurt Stock
1:2 Exchange
1 ADS represents
2 common shares
FRA: B8F I NASDAQ:BFRA September 2018 I Page 19Shareholder Structure
▪ Shares outstanding: 44,541,980
▪ Shareholder structure:
▪ renowned anchor and strategic investors
▪ about 53% freefloat
~20%
~53%
~20%
~3%
~2%~2%
Maruho WKT Zours / Deutsche Balaton AG
Universal-Investment-Gesellschaft mbH Semper Constantia
Biofrontera Management Freefloat
As of September 3, 2018
FRA: B8F I NASDAQ:BFRA September 2018 I Page 20Summary of Investment Opportunity
Ameluz® is the only topical PDT drug approved both in the EU and the US.
It is well positioned to expand the dermatological PDT markets on both continents.
▪ Very low development risk due to approved product
▪ Multi-billion $ market opportunity with actinic keratosis in the US alone
▪ Strong pipeline: Additional indications with similarly high market potentials possible (BCC, SCC in
situ, acne, others)
▪ Recent BCC and daylight approvals in Europe open up hospital and topical products markets
▪ Field therapy approval and higher reimbursement improve competitive advantage of PDT vs.
cryotherapy in the US
▪ BCC approval in the US will greatly increase Ameluz® market potential and allow better positioning
among PDT drugs, also in the AK market
FRA: B8F I NASDAQ:BFRA September 2018 I Page 21Glossary of Acronyms
▪ ADS: American Depositary Shares
▪ AK: Actinic Keratosis
▪ BCC: Basal Cell Carcinoma
▪ EU: European Union
▪ LED: Light Emitting Diode
▪ ITT: Intention-to-treat
▪ NMSC: Non-Melanoma Skin Cancer
▪ PDT: Photodynamic Therapy
▪ SCC: Squamous Cell Carcinoma
▪ SmPC: Summary of Product Characteristics
▪ U.S.: USA, United States of America
FRA: B8F I NASDAQ:BFRA September 2018 I Page 22Contact Us
Biofrontera AG
Hemmelrather Weg 201
D-51377 Leverkusen
Germany
Phone +49 (214) 876 32 -0
Fax +49 (214) 876 32 -90
Email ir@biofrontera.com
www.biofrontera.com
Prof. Hermann Lübbert, PhD CEO h.luebbert@biofrontera.com
Thomas Schaffer CFO t.schaffer@biofrontera.com
Christoph Dünwald CCO c.duenwald@biofrontera.com
Pamela Keck IR p.keck@biofrontera.com
FRA: B8F I NASDAQ:BFRA September 2018 I Page 23You can also read
