Experts in photodynamic therapy Investor Presentation I December 2018

Transcription

1 Experts in photodynamic therapy nvestor Presentation Page 1

2 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. Forwardlooking 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. Page 2

3 Executive 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 Page 3

4 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. Dermatology company with headquarter in Leverkusen, Germany and a wholly owned subsidiary in Boston, MA. Biofrontera s prescription drug Ameluz is approved and available in the U.S., EU, Switzerland and srael. Strong track record of executing our growth strategy. Corporate strategy: Optimizing the positioning and market potential of Ameluz by focusing on our sales efforts and adding further indications to the label. Strong revenue growth Listings n EUR million Total revenue FY 2015 FY 2016 FY M M FY 2018 Revenue Guidance (prev ) Ticker symbol Frankfurt: B8F Nasdaq: BFRA Price per share* 1 ADS = 2 common shares 5.41 per share US$ per ADS 52 week high-low $ $11.25 From product sales Shares outstanding 44,597,174 Market cap* ~US$ 267 M * as of Nov 21, 2018 Page 4

5 Milestones Biofrontera AG Dec 2011 Feb 2012 Nov 2014 May 2016 Oct 2016 Jan 2017 Nov 2017 Mar 2018 May 2018 EU approval of Ameluz for treatment of AK Start of product sales in Germany Dedicated sales team in Spain FDA approval of Ameluz for treatment of AK Ameluz launch in the U.S. EU indication expansion to BCC Receipt of productspecific J- Code and improved CPT-Codes EU approval of daylight PDT Dedicated sales team in the UK Dedicated sales teams in the U.S., Germany, Spain and the UK. Strong U.S. commercial infrastructure with 37 dedicated sales people covering 85% of the U.S. High efficacy of Ameluz is supported by favourable reimbursment in the U.S. through new J-code and CPT-codes for PDT. Approval of daylight PDT in combination with Ameluz in March 2018 fueled the European PDT market. Page 5

6 Non-Melanoma Skin Cancer: Sun Damage Has Many Faces Epidemiology 1 BCC: >4 million BCC treatments annually in the U.S. AK: >58 million patients in the U.S., particularly the elderly population SCC: second most dangerous skin cancer after melanoma SCC: >1 million patients with an estimated 8,800 fatalities annually in the U.S. SCC: incidence increased by 200% in last three decades SCC: major cause of death for immunosuppressed people Sources: 1) 2) Schmitz et al., J Eur Acad Dermatol Venereol Aug;30(8): ) Fernández-Figueras et al., J Eur Acad Dermatol Venereol May;29(5): ) Fuchs & Marmur, Dermatol Surg Sep;33(9): Progression 2,3,4 Clinical assessment of AK severity is not correlated to histopathological severity SCC develops from AK. By definition, it is called SCC when neoplastic cells enter the dermis Recent data show that mild or even invisible AK has a higher chance of progression to SCC than severe (with strong hyperkeratosis) AK f an AK lesion progresses to SCC, it does so in about 2 years on average Actinic keratosis (AK) Squamous cell carcinoma (SCC) Basal cell carcinoma (BCC) Page 6

7 Lead Products Ameluz - Prescription Drug EU* approvals (since Dec 2011) FDA approvals** (since May 2016) P Basal Cell Carcinoma (BCC) Actinic Keratosis (AK) Field Cancerization Daylight PDT Lesion- and field-directed AK P protection until 2027 (granted in many parts of the world, including EU and Japan, pending in the USA) BF-RhodoLED - Medical Device$249 Photodynamic 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 ** 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 Page 7

8 Complete Patient Clearance Ameluz : Highly Effective Option for AK Treatment in the EU 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Meta-analysis of all AK treatment options available in Europe Source: Vegter & Tolley, PlosOne 2014, June, Vol. 9, ssue 6 PDT drugs European meta-analysis included 25 randomized, controlled studies (5,562 patients) Clinical endpoint: total patient clearance rates in mild to moderate AK on face or scalp All included PDTs were performed with LED lamps Significant superiority of Ameluz over Metvix was proven in phase trial and is documented in the EMA approved Ameluz SmPC (P) 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. Page 8

9 US Market: Ameluz and Levulan Comparison The following comparison is based on the FDA-approved prescribing information of both drugs: Ameluz / LED lamps with 3 hr exposure (TT)* Levulan / Blu-U with hr exposure (TT)** 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 (Levulan) months after last of 1 or 2 PDTs 53-69% 31% Lesion clearance: 3 months after last of 1 or 2 PDTs 94-96% 72.1%/83.6% Lesion clearance: 12 (Ameluz) or (Levulan) months after last of 1 or 2 PDTs 85-90% 83% Formulation (easier and faster application of gel) gel liquid llumination time 10 min 16 min + 40 sec Skin rejuvenation phase data no phase data Approved treatment area field lesion Treatment of superficial and nodular BCC high efficacy in phase no data *three phase studies **two phase studies and one open-label study *** 3 months Page 9

10 AK Market in the EU Estimated market size: 2.1 million drug prescriptions for AK treatment PDT 5% Cryotherapy * 7% EU - Strategy 1) position Ameluz as the #1 PDT drug and 2) expand the PDT market through daylight PDT to compete with topical drugs Topicals 88% 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 reimbursement for procedures such as PDT 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 Page 10

11 EU: Daylight PDT with Ameluz launched Commercially more attractive for doctors and patients Almost pain-free Phase : Statistical superiority in recurrence rates compared to Metvix after a single daylight PDT Phase 3 months after PDT 12-month recurrence Ameluz Metvix Ameluz Metvix p-value Lesion clearance 79.8% 76.5% 19.9% 31.6% P<0.01 Olsen lesions 77.5% 74.1% 20.5% 34.4% P<0.01 Scalp 74.2% 67.5% 23.4% 43.7% P<0.01 Page 11

12 AK Market in the U.S. Estimated market size: 12.6 million AK treatments* Topicals 13% PDT 3% Cryotherapy 84% U.S. - Strategy 1) position Ameluz as the #1 PDT drug and 2) take away market share from cryotherapy to expand the PDT market List price per tube of Ameluz : US$ 285 3% PDT treatments of the AK market represent annual PDT drug sales of estimated US$ 135 million Most U.S. dermatologists have traditionally preferred cryotherapy due to 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 Page 12

13 Benefits 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 trials As of January 1, 2018, PDT is more financially rewarding for doctors in the U.S. than cryotherapy. Page 13

14 U.S.: 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 CPT-code for Avg. payment to 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 USP of Levulan) PDT with debridement (i.e. targeted curettage, abrasion), by qualified health care professional (USP of Ameluz ) $193 $249 Cryotherapy capped at >14 lesions $148 Page 14

15 Development 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 ndication / comments Territory Preclinical Clinical Submitted Status Ameluz Actinic keratosis (AK), field cancerization EU, CH, L On market 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 ongoing Ameluz Basal cell carcinoma US Phase ongoing Ameluz Squamous cell carcinoma in situ EU/US Phase in preparation Ameluz Acne EU/US Phase in preparation Page 15

16 Revenue Growth EUR thousand , ,096 4,138 6,130 Product sales +114% 12,025 Product sales +131% 7, M M Germany Europe (excl. GER) USA Other Regions Page 16

17 Financial Overview Biofrontera group financial results under FRS (in million EUR) M M 2018 Total Revenue Product Sales FY 2018 Revenue Guidance (prev ) thereof U.S.revenues Operating ncome (9.6) (10.2) (11.8) (13.9) (13.0) (11.4) Cash & Cash Equivalents Permanent loss carry forward Debt ** 12.8** 13.3 ** **Long-term debt including 10 million drawdown from EB loan Page 17

18 Biofrontera Shares Listing Frankfurt Nasdaq Ticker Symbol B8F BFRA Price per Share (as of Nov 21, 2018) 1 ADS = 2 common shares 5.41 per share US$ per ADS 52 Week High-Low $ $11.25 Shares Outstanding 44,597,174 Market Cap (as of October 17, 2018) ~US$ 267 M YTD Share Price Development: B8F Analyst Coverage Financial nstitution Benchmark & Co Dawson James Lake Street Capital sc-consult GmbH Analyst Bruce Jackson Robert Wasserman Thomas Flaten Holger Steffen Page 18

19 Shareholder Structure Shares outstanding: 44,597,174 Shareholder structure: renowned anchor and strategic investors about 53% freefloat ~20% ~53% ~20% ~3% ~2% ~2% Maruho Universal-nvestment-Gesellschaft mbh Biofrontera Management WKT Zours / Deutsche Balaton AG Semper Constantia Freefloat Page 19

20 ADS 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 U.S. nvestors Trading of ADS on NASDAQ Exchange Full fungibility of shares and ADS independent of the market with seamless exchange of common shares into ADS and vice versa 1:2 1 ADS represents 2 common shares German nvestors Trading of common shares on German stock exchange i.e. Xetra or Frankfurt Stock Exchange Page 20

21 Summary of nvestment Opportunity Ameluz is the only topical PDT drug approved both in the EU and the U.S. t 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 U.S. 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 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 Page 21

22 Glossary of Acronyms ADS: American Depositary Shares AK: Actinic Keratosis BCC: Basal Cell Carcinoma EU: European Union LED: Light Emitting Diode TT: ntention-to-treat PDT: Photodynamic Therapy SCC: Squamous Cell Carcinoma SmPC: Summary of Product Characteristics US: USA, United States of America Page 22

23 Contact Us Biofrontera AG Hemmelrather Weg 201 D Leverkusen Germany Phone +49 (214) Fax +49 (214) Prof. Hermann Lübbert, PhD CEO Thomas Schaffer CFO Christoph Dünwald CCO Pamela Keck R p.keck@biofrontera.com Page 23