Experts in photodynamic therapy - Investor Presentation I April 2019 - Biofrontera
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Experts in photodynamic therapy
Investor Presentation I April 2019
FRA: B8F I NASDAQ: BFRA April 2019 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 April 2019 I Page 2
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.
▪ Headquartered in Leverkusen, Germany and wholly owned subsidiary in Boston, MA
▪ Biofrontera’s prescription drug Ameluz® is approved in the U.S., EU, Switzerland and Israel.
▪ Dedicated sales force in the U.S., Germany, Spain and the UK.
▪ Strong revenue growth: doubling of revenue year-over-year for the past 3 years.
▪ Listed on the Frankfurt Exchange (B8F) and Nasdaq (BFRA).
Corporate strategy
Optimizing the positioning and market potential of Ameluz® while becoming a leading specialty pharmaceutical
company in dermatology.
FRA: B8F I NASDAQ: BFRA April 2019 I Page 3
Milestones – Biofrontera AG
Dec 2011 Feb 2012 Nov 2014 May 2016 Oct 2016 Jan 2017 Nov 2017 Mar 2018 May 2018 Mar 2019
EU approval of Start of Dedicated FDA Ameluz® EU Receipt of EU Dedicated Acquisition
Ameluz® for product sales team approval of launch in indication product- approval of sales team of Cutanea
treatment of AK sales in in Spain Ameluz® the U.S. expansion specific J- daylight in the UK Life
Germany for to BCC Code and PDT Sciences
treatment improved Inc.
of AK CPT-Codes
▪ Strong U.S. commercial infrastructure now complemented by two additional FDA-approved products and additional sales force
through the acquisition of Cutanea Life Sciences, Inc..
▪ Addition of prescription drugs Aktipak™ for treatment of acne vulgaris and Xepi™ for treatment of impetigo in the U.S.
▪ High efficacy of Ameluz® is supported by favourable reimbursement in the U.S. through new CPT-codes for PDT.
▪ Approval of daylight PDT in combination with Ameluz® in March 2018 fueled the European PDT market.
FRA: B8F I NASDAQ: BFRA April 2019 I Page 4
Non-Melanoma Skin Cancer: Sun Damage Has Many Faces
Epidemiology1 Progression2,3,4
BCC: >4 million BCC treatments annually in the U.S. ▪ Clinical assessment of AK severity is not
AK: >58 million patients in the U.S., 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 U.S. 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 April 2019 I Page 5
Lead Products
Ameluz® - Prescription Drug
EU* approvals ▪ Basal Cell Carcinoma (BCC)
(since Dec 2011) ▪ Actinic Keratosis (AK)
▪ Field Cancerization
▪ Daylight PDT
FDA approvals**(since May 2016) Lesion- and field-directed AK
IP IP protection until 2027 (granted in many parts of the
world, including EU and Japan, pending in the USA)
BF-RhodoLED® - Medical Device$2(4Photodynamic Red LED Therapy Lamp
Approvals ▪ Medical device in the EU
▪ Approved in combination with Ameluz® in the U.S.
• 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 April 2019 I Page 6
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 April 2019 I Page 7
US Market: Ameluz® and Levulan® Comparison
Ameluz® / LED lamps Levulan® / Blu-U®
FDA-approved prescribing informations of both drugs
(ITT)* (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 (Ameluz) or 10-12 (Levulan)
53-69% 31%
months after last of 1 or 2 PDTs
Formulation (easier and faster application of gel) Gel (tube) Liquid (stick)
Convenience Illumination time 10 min 16 min + 40 sec
Incubation time 3 hrs 14-18 hrs
Skin rejuvenation Phase III data No phase III data
Indications and
Approved treatment area Field Lesion
potential
Superficial and nodular BCC High efficacy in phase III no data
*three phase III studies **two phase III studies and one open-label study
FRA: B8F I NASDAQ: BFRA April 2019 I Page 8
AK Market in the EU
Estimated market size: 2.1 million drug prescriptions for AK treatment
EU - Strategy
PDT Cryotherapy * 1) position Ameluz as the #1 PDT drug and
7% 7% 2) expand the PDT market through daylight PDT to compete with topical drugs
▪ Average wholesale price per tube of Ameluz®: EUR 150
▪ About 600,000 drug prescriptions annually for AK in Germany alone
▪ Dermatologists in Europe have favored topical prescriptions due to a lack of
Topicals reimbursement for procedures such as PDT
86%
▪ Recent approval to market Ameluz® for use in combination with daylight
PDT enables patients to obtain reimbursement more easily
▪ Cryotherapy is unpopular due to perceived poor efficacy, high recurrence
rates and lack of reimbursement
* Share of cryotherapy estimated since no reliable data available
FRA: B8F I NASDAQ: BFRA April 2019 I Page 9
EU: 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% PAK Market in the U.S.
Estimated market size: 12.6 million AK treatments*
PDT U.S. - Strategy
3%
1) position Ameluz® as the #1 PDT drug and
Topicals 2) take away market share from cryotherapy to expand the PDT market
13%
▪ List price per tube of Ameluz®: US$ 285
▪ 3% PDT treatments of the AK market represent annual PDT drug sales of
estimated US$ 130 million
Cryotherapy ▪ Most U.S. dermatologists have traditionally preferred cryotherapy due to
84% more favorable reimbursement
▪ New CPT codes and medical need of field therapy is now favoring PDT
* based on Biofrontera review of 2016 publicly available information
FRA: B8F I NASDAQ: BFRA April 2019 I Page 11Benefits of Photodynamic Therapy vs. Cryotherapy
Medical benefits of PDT:
▪ High efficacy with better clearance and recurrence rates
▪ Field treatment (selective killing of tumor cells) vs. spot treatment (no selectivity for tumor cells)
▪ Good esthetic result: no visible signs left after PDT vs. white spots or scars after cryotherapy
▪ General skin rejuvenating effect of PDT, as documented in phase III trials
As of January 1, 2018, PDT is financially more rewarding for doctors in the U.S. than cryotherapy.
FRA: B8F I NASDAQ: BFRA April 2019 I Page 12U.S.: Additional CPT-Codes
The Centers for Medicare and Medicaid Services (CMS) have assigned:
▪ New CPT-codes for application of PDT Financially more attractive for doctors
Avg. payment to
CPT-code (Jan 2019)
dermatologist
PDT performed by other health care workers $126
PDT without debridement, by qualified health care professional
$205
(corresponding to USPI of Levulan)
PDT with debridement (i.e. targeted curettage, abrasion), by qualified health
$261
care professional (USPI of Ameluz®)
Cryotherapy capped at >14 lesions $155
FRA: B8F I NASDAQ: BFRA April 2019 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 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/CH On market
Ameluz® AK: Trunk & extremities EU/US Phase III: analysis of results
Ameluz® Basal cell carcinoma US Phase III ongoing
Ameluz® Squamous cell carcinoma in situ EU/US Phase III in preparation
Ameluz® Acne US Phase II in preparation
FRA: B8F I NASDAQ: BFRA April 2019 I Page 14Acquisition of Cutanea Life Sciences, Inc. in March 2019
Investment Rationale
➢ Addition of two FDA-approved products already launched on the U.S. market
➢ Opportunity to integrate further expertise from Cutanea is expected to strengthen Biofrontera’s market position and serve as an
additional platform for organic growth
➢ The new products are complementary to Biofrontera’s core business and focused on the pursuit of similar customers within the
dermatology space.
➢ This acquisition represents a significant step towards our strategic goal of becoming a broader specialty pharmaceutical company in
dermatology in the U.S.
Transactional Highlights
▪ Initial purchase price of 1.00 US-Dollar. A purchase price equaling the Start-up Costs effectively paid shall be payable to Maruho by 2023.
▪ Maruho will provide an amount of up to USD $7.3 million as start-up funding (“Start-up Costs”).
▪ After 2023, profits from the sale of Cutanea products will be equally shared between Maruho and Biofrontera until 2030.
▪ All costs during a three-month transition period will be borne by Maruho.
▪ All rights and obligations related to R&D products and IP will remain with Maruho.
FRA: B8F I NASDAQ: BFRA April 2019 I Page 15Acquisition of Cutanea Life Sciences, Inc.
Products – Aktipak® for the treatment of acne vulgaris
Competitive advantages
▪ Stability, storage and lack of compounding requirement
▪ Advantageous side effect profile
Aktipak® is the only topical BPO/antibiotic treatment for acne vulgaris that delivers
proven efficacy in 8 weeks without concern of bacterial resistance, and
presented in the only portable, single use, convenient dispensing pack,
guaranteeing significantly greater shelf life than any other product in its class.
FRA: B8F I NASDAQ: BFRA April 2019 I Page 16Acquisition of Cutanea Life Sciences, Inc.
Products - Xepi™ for the treatment of impetigo
Competitive advantages
▪ Activity on and FDA-approval for resistant strains (MRSA)
▪ Advantageous side effect profiles
Xepi™ (ozenoxacin) Cream, 1%, is a safe and novel non-fluorinated
topical quinolone in a well-tolerated elegant cream formulation to treat
impetigo with no measurable absorption in patients as young as two
months, with short five-day BID treatment. Xepi™ provides a broad
spectrum antibacterial activity against Staph aureus and Strep
pyogenes and is the only FDA approved drug in its class with activity
against MRSA, offering healthcare professionals a viable choice by
which to exercise bacterial resistance stewardship.
FRA: B8F I NASDAQ: BFRA April 2019 I Page 17Revenue Growth
FY 2018
Revenue Guidance
19.0 - 22.0M
(prev. 16.0 - 20.0M)
EUR thousand
21,107*
22000
20000
Product
18000 sales
16000 +98%
14000 Product 12,025
12000 sales
10000
+114%
8000
6,130
6000
4,138
4000 3,096
2000
0
2014 2015 2016 2017 2018
Germany Europe (excl. GER) USA Other Regions
*Prelim. unaudited revenue FY 2018
FRA: B8F I NASDAQ: BFRA April 2019 I Page 18Financial Overview
Biofrontera group financial results under IFRS (in million EUR)
9M FY 2018
2014 2015 2016 2017 2018*
2018 Revenue Guidance
Total Revenue 3.1 4.1 6.1 12.0 21.1 19.0 - 22.0
(prev. 16.0 - 20.0)
Product Sales 3.1 4.1 5.0 10.6 21.0
thereof U.S .revenues 0 0 1.2 6.3 14.9
Operating Income (9.6) (10.2) (11.8) (13.9) (11.4)
Cash & Cash Equivalents 8.5 4.0 15.1 11.1 21.1
Permanent loss carry forward 98.6 109.8 120.4 136.5 158.8
Debt 10.8 11.2 3.6 12.4** 13.3**
*Prelim. unaudited revenue FY 2018
**Long-term debt including €10 million drawdown from EIB loan
FRA: B8F I NASDAQ: BFRA April 2019 I Page 19Biofrontera Shares
Listing Frankfurt Nasdaq
Ticker Symbol B8F BFRA
Price per Share (as of April 3, 2019) €6.30 US$ 13.53
1 ADS = 2 common shares per share per ADS
52 Week High-Low €6.50 - €4.78 $16.06 - $11.04
Shares Outstanding 44,632,674
Market Cap (as of April 3, 2019) ~US$ 300 M
YTD Share Price Development: B8F Analyst Coverage
Financial Institution Analyst
Benchmark & Co Bruce Jackson
Dawson James Robert Wasserman
Lake Street Capital Thomas Flaten
sc-consult GmbH Holger Steffen
FRA: B8F I NASDAQ: BFRA April 2019 I Page 20Shareholder Structure
▪ Shares outstanding: 44,632,674
▪ Shareholder structure:
▪ renowned anchor and strategic investors
▪ about 53% free float
~20%
~53%
~20%
~3%
~2% ~2%
Maruho WKT Zours / Deutsche Balaton AG
Universal-Investment-Gesellschaft mbH Liechtensteinische
Semper ConstantiaLandesbank AG
Biofrontera Management Free float
Freefloat
FRA: B8F I NASDAQ: BFRA April 2019 I Page 21ADS – Seamless Trading on Both Markets
▪ US investors can buy ADSs through their brokers just like any other U.S. 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
U.S. 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
stock exchange i.e.
Xetra or Frankfurt
1:2 Stock Exchange
1 ADS represents
2 common shares
FRA: B8F I NASDAQ: BFRA April 2019 I Page 22Summary of Investment Opportunity
Ameluz® is the only topical PDT drug approved both in the EU and the U.S.
Our goal is to optimize the positioning and market potential of Ameluz® while becoming a leading
specialty pharmaceutical company in dermatology.
▪ Very low development risk due to approved product.
▪ Multi-billion $ market opportunity with actinic keratosis in the U.S. alone.
▪ US-product portfolio with three FDA-approved prescription drugs.
▪ 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 U.S.
▪ BCC approval in the U.S. will greatly increase Ameluz® market potential and allow better positioning
among PDT drugs, also in the AK market.
FRA: B8F I NASDAQ: BFRA April 2019 I Page 23Executive Management Team
Prof. Hermann Lübbert, PhD, CEO, CSO and Founder
▪ Founded Biofrontera in 1997
▪ Extensive experience in academic research in the U.S. 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 the U.S.,
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 April 2019 I Page 24Glossary of Acronyms
▪ ADS: American Depositary Shares
▪ AK: Actinic Keratosis
▪ BCC: Basal Cell Carcinoma
▪ EIB: European Investment Bank
▪ EU: European Union
▪ LED: Light Emitting Diode
▪ ITT: Intention-to-treat
▪ PDT: Photodynamic Therapy
▪ SCC: Squamous Cell Carcinoma
▪ SmPC: Summary of Product Characteristics
▪ US: USA, United States of America
▪ USPI: United States Prescribing Information
FRA: B8F I NASDAQ: BFRA April 2019 I Page 25Contact 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 April 2019 I Page 26You can also read
