Experts in photodynamic therapy Investor Presentation I September 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 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 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. German dermatology company with subsidiary in Boston area. Ameluz is approved as a prescription drug in the US, EU, Switzerland and srael. 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). Page 4

5 Milestones Biofrontera AG EU approval of Ameluz for treatment of AK Dedicated sales team in Spain Ameluz launch in the US EU approval of daylight PDT December 2011 February 2012 November 2014 May 2016 October 2016 January 2017 March 2018 May 2018 Start of product sales in Germany FDA approval EU indication expansion to BCC Dedicated sales team in the UK Ameluz available in US, EU, Switzerland and srael Doubling of product sales in 2017 and H US revenue already represents >70% of total revenue as at June 30, 2018 Page 5

6 NMSC: Sun Damage Has Many Faces Epidemiology 1 BCC: >4 million BCC treatments annually in the US AK: >58 million patients in the US, 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 US 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 Approved in EU* for FDA approved** for BF-RhodoLED Medical Device Photodynamic Red LED Therapy Lamp Basal Cell Carcinoma (BCC) Actinic Keratosis (AK) Field Cancerization Daylight Therapy Lesion- and field-directed AK (since May 2016) P protection until 2027 (granted in many parts of the world, including EU and Japan, pending in the USA) 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 ** 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 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 Markets in EU and US 2.1 million drug prescriptions PDT Cryotherapy * Topicals * number of cryotherapies estimated since no reliable data available 12.6 million treatments ** PDT Cryotherapy Topicals ** based on Biofrontera review of 2016 publicly available information 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 We recently received approval to market Ameluz for use in connection with daylight PDT, which we believe enables patients to obtain reimbursement more easily Average wholesale price per tube of Ameluz : EUR 150 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 US$ ~135 million List price per tube of Ameluz : US$ 270 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 Milestones Biofrontera nc. FDA approval of Ameluz Addition of Randy Wilhoite as COO Addition of Jeffrey Holm as VP Marketing & Sales Employee growth to over 50 people May 2016 October 2016 March 2017 August 2017 September 2017 November 2017 December 2017 Commercial product launch Switch to Third Party Logistic (3PL) model Receipt of productspecific J-Code and CPT-Code 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 Page 12

13 US: 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 13

14 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 On market Ameluz AK: Trunk & extremities EU/US Phase ongoing Ameluz Basal cell carcinoma US ND for Phase accepted Ameluz Squamous cell carcinoma in situ EU/US Phase in preparation Ameluz Acne EU/US Phase in preparation Page 14

15 Revenue Growth EUR thousand , ,096 4, % 6, % (+109%) 5,006 8, M M Germany Europa (excl. GER) USA Other Regions Page 15

16 Financial Overview Biofrontera group financial results under FRS (in million EUR) M 2017 Revenue thereof US revenues M 2018 Operating ncome (9.6) (10.2) (11.8) (13.9) (7.8) (7.3) Cash & Cash Equivalents Permanent loss carry forward Debt ** 12.4** 13.0** **Long-term debt including 10 million drawdown from EB loan Page 16

17 Biofrontera s Proud Moment (Feb 15, 2018) Page 17

18 Biofrontera Shares Listing Frankfurt Nasdaq Ticker Symbol B8F BFRA Price per Share (as of September 17, 2018) Nasdaq: 1 ADS represents 2 ordinary shares 5.97 per share US$ per ADS 52 Week High-Low $ $11.25 Shares Outstanding 44,541,980 Market Cap (as of September 17, 2018) ~US$ 307 M 12-Month Share Price Development: B8F Page 18

19 ADS 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 US 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 exchange i.e. Xetra or Frankfurt Stock Exchange Page 19

20 Shareholder Structure Shares outstanding: 44,541,980 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 As of September 3, 2018 Page 20

21 Summary of nvestment Opportunity Ameluz is the only topical PDT drug approved both in the EU and the US. 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 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 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 NMSC: Non-Melanoma Skin Cancer PDT: Photodynamic Therapy SCC: Squamous Cell Carcinoma SmPC: Summary of Product Characteristics U.S.: 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