Biofrontera AG. (incorporated and registered in Germany with registered number HRB 49717) Admission to trading on AIM. Nominated Adviser and Broker

Transkript

1 THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt about the contents of this document or as to what action you should take, you should immediately consult your stockbroker, bank manager, solicitor, accountant, legal or professional adviser or other independent financial adviser duly authorised for the purposes of the Financial Services and Markets Act 2000 (as amended) ( FSMA ) if you are in the United Kingdom or, if not, you should immediately consult another appropriately authorised independent financial adviser. This document comprises an AIM admission document and has been prepared in accordance with the AIM Rules for Companies. This document does not contain an offer of transferable securities to the public within the meaning of Section 85 of FSMA and is not a Prospectus for the purposes of the Prospectus Rules made under Section 73A of FSMA. Accordingly, this document has not been drawn up in accordance with the Prospectus Rules, nor has it been approved by the Financial Conduct Authority (the FCA ) pursuant to Section 85 of FSMA and a copy has not been delivered to the FCA under regulation 3.2 of the Prospectus Rules. Biofrontera AG (incorporated and registered in Germany with registered number HRB 49717) Admission to trading on AIM Nominated Adviser and Broker Application has been made for the entire issued share capital (the Shares ) of Biofrontera AG (the Company ) to be admitted to trading on AIM, the market of that name operated by London Stock Exchange plc ( London Stock Exchange ) ( AIM ). It is expected that admission to trading on AIM ( Admission ) will become effective and that dealings will commence on AIM in the shares on 3 June finncap Limited ( finncap ), which is authorised and regulated in the United Kingdom by the FCA, is acting as the Company s nominated adviser and broker for the purposes of the AIM Rules for Companies in connection with Admission. Its responsibilities as the Company s nominated adviser under the AIM Rules for Nominated Advisers are owed solely to the London Stock Exchange and are not owed to the Company or to any director of the Company ( Director ) or to any other person in respect of his decision to acquire shares in the Company in reliance on any part of this document. No representation or warranty, express or implied, is made by finncap as to any of the contents of this document and finncap has not authorised the contents of any part of this document (without limiting the statutory rights of any person to whom this document is issued). No liability whatsoever is accepted by finncap for the accuracy of any information or opinions contained in, or for the omission of any material information from this document for which the Company and the Directors are solely responsible. finncap will not be offering advice, and is not acting for, and will not otherwise be responsible for providing customer protections to recipients of this document in respect of the proposals described in this document. AIM is a market designed primarily for emerging or smaller companies to which a higher investment risk tends to be attached than to larger or more established companies. AIM securities are not admitted to the Official List of the United Kingdom Listing Authority (the UKLA ). A prospective investor should be aware of the risks of investing in such companies and should make the decision to invest only after careful consideration and, if appropriate, consultation with an independent financial adviser. Each AIM company is required pursuant to the AIM Rules for Companies to have a nominated adviser. The nominated adviser is required to make a declaration to the London Stock Exchange on admission in the form set out in Schedule Two to the AIM Rules for Nominated Advisers. Neither the UKLA nor the London Stock Exchange has examined or approved the contents of this document.

2 The Directors, whose names and functions appear on page 10 of this document, and the Company accept responsibility, both individually and collectively, for the information contained in this document and compliance with the AIM Rules for Companies. To the best of the knowledge and belief of the Directors and the Company (who have taken all reasonable care to ensure that such is the case), the information contained in this document is in accordance with the facts and does not omit anything likely to affect the import of such information. All of the Directors accept responsibility accordingly. The whole of this document should be read. The AIM Rules for Companies are less demanding than those of the Official List of the UKLA. An investment in the Company includes a significant degree of risk and potential investors should consider carefully the risk factors set out in Part II of this document. The information contained in this document has been prepared solely for the purpose of Admission and is not intended to inform or to be relied upon by any subsequent purchaser of shares in the Company and accordingly no duty of care is accepted in relation to them. No broker, dealer or other person has been authorised by the Company, the Directors or finncap to issue any advertisement or to give any information or make any representation in connection with the offering or sale of shares in the capital of the Company other than those contained in this document and if issued, given or made, the advertisement, information or representation must not be relied upon as having been authorised by the Company, the Directors or finncap. The Shares have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, (the Securities Act ) or with any securities regulatory authority of any state or other jurisdiction of the United States or under the applicable securities laws of Australia, Canada, the Republic of Ireland, the Republic of South Africa or Japan. Subject to certain exceptions, the Shares may not be offered, sold, taken up, delivered or transferred in, into or from the United States, Australia, Canada, the Republic of Ireland, the Republic of South Africa or Japan or to or for the account or benefit of any national, resident or citizen of Australia, Canada, the Republic of Ireland, the Republic of South Africa or Japan or any person located in the United States. This document does not constitute an offer to issue or sell, or the solicitation of an offer to subscribe for or purchase, any shares to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation in such jurisdiction. The distribution of this document in certain jurisdictions may be restricted by law and therefore persons into whose possession this document comes should inform themselves about and observe any such restriction. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction. Copies of this document will be available to the public free of charge during normal business hours on any day (Saturdays, Sundays and public holidays excepted) at the registered office of the Company at Hemmelrather Weg 201, Leverkusen, Germany, at the offices of finncap and on the Company s website FORWARD LOOKING STATEMENTS This document includes forward-looking statements which include all statements other than statements of historical facts, including, without limitation, those regarding the Company s financial position, business strategy, plans and objectives of management for future operations, or any statements preceded by, followed by or that include the words targets, believes, expects, aims, intends, will, may, anticipates, would, could or similar expressions or negatives thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Company s control that could cause the actual results, performance or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Company s present and future business strategies and the environment in which the Company will operate in the future. These forwardlooking statements speak only as at the date of this document. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based unless required to do so by applicable law or the AIM Rules for Companies. 2

3 CONTENTS Page ADMISSION STATISTICS 4 EXPECTED TIMETABLE OF PRINCIPAL EVENTS 5 DEFINITIONS 6 GLOSSARY OF TECHNICAL TERMS 9 DIRECTORS AND ADVISERS 10 PART I INFORMATION ON BIOFRONTERA AG 11 PART II RISK FACTORS 21 PART III PART IV PART V PART VI PART VII COURTESY ENGLISH TRANSLATION OF 2013 FINANCIAL STATEMENTS OF BIOFRONTERA AG 28 COURTESY ENGLISH TRANSLATION OF 2012 FINANCIAL STATEMENTS OF BIOFRONTERA AG 96 COURTESY ENGLISH TRANSLATION OF 2011 FINANCIAL STATEMENTS OF BIOFRONTERA AG 162 ORIGINAL GERMAN 2013 AUDITED FINANCIAL STATEMENTS OF BIOFRONTERA AG IN GERMAN 234 ORIGINAL GERMAN 2012 AUDITED FINANCIAL STATEMENTS OF BIOFRONTERA AG IN GERMAN 292 PART VIII ORIGINAL GERMAN 2011 AUDITED FINANCIAL STATEMENTS OF BIOFRONTERA AG IN GERMAN 351 PART IX ADDITIONAL INFORMATION 407 3

4 ADMISSION STATISTICS Number of Existing Shares 22,196,570 Approximate market capitalisation ISIN AIM symbol 69.3m DE B8F 4

5 EXPECTED TIMETABLE OF PRINCIPAL EVENTS Publication of this document 29 May 2014 Admission effective and dealings in Shares to commence on AIM 3 June 2014 Notes: Each of the times and dates set out above and mentioned elsewhere in this document may be subject to change of the absolute discretion of the Company and finncap without further notice. References to time in this document are to London time unless otherwise stated. 5

6 DEFINITIONS The following definitions apply throughout this document, unless the context otherwise requires: 2010 Stock Option Plan as defined in paragraph 5 of Part IX of this document Admission Admission Agreement AIM AIM Rules AIM Rules for Companies AIM Rules for Nominated Advisers applicable employee Articles BaFin Biofrontera Group or the Group certificated or in certificated form the admission of the Issued Share Capital to trading on AIM becoming effective in accordance with the AIM Rules the conditional agreement dated 29 May 2014 between the Company and finncap relating to, inter alia, Admission, details of which are set out at paragraph 14.1 of Part IX of this document the market of that name operated by the London Stock Exchange the AIM Rules for Companies the rules for companies relating to companies whose securities are admitted to trading on AIM, as published by the London Stock Exchange from time to time the rules relating to nominated advisers operating on AIM, as published by the London Stock Exchange from time to time as defined in the AIM Rules for Companies the articles of association of the Company in force on Admission, a summary of which is set out in paragraph 9 of Part IX of this document the Federal Financial Supervisory Authority of Germany the Company and its subsidiaries as at the date of this document a share or other security which is not in uncertificated form Clearstream Clearstream Banking S.A., a division of Clearstream International Luxembourg, and an international securities depository Companies Act the UK Companies Act 2006 (as amended from time to time) Company or Biofrontera Biofrontera AG, of Hemmelrather Weg 201, D Leverkusen, Germany, entered into the commercial register of the lower court of Cologne, Germany, register number HRB Corporate Governance Code Computershare Computershare Germany the UK Corporate Governance Code 2012, issued by the UK Financial Reporting Council, as amended from time to time Computershare Investor Services PLC Computershare Deutschland GmbH and Co K.G., Munich 6

7 CREST the relevant system (as defined in the CREST Regulations) in respect of which Euroclear UK & Ireland Limited is the operator (as defined in the CREST Regulations) in accordance with which securities may be held and transferred in uncertified form CREST Regulations the Uncertificated Securities Regulations 2001 (SI 2001/3755) including any modifications of them or any regulations in substitution for them made under Section 78 of the Companies Act Custodian Deed Poll Depositary Depositary Agreement Depositary Interest Directors or Board DTR Euro or finncap FCA means the custodian or custodians appointed by the Depositary the deed executed by the Depositary agreeing to hold Shares in trust and issue the Depositary Interests, details of which are set out in paragraph 14 of Part IX of this document Computershare, acting in its capacity as depositary pursuant to the Depositary Agreement the agreement entered into by the Company and the Depositary relating to the Depositary s appointment, details of which are set out in paragraph 14 of Part IX of this document a depositary interest issued by the Depositary, each representing one Share in uncertificated form the members of the Management Board and the Supervisory Board the Disclosure and Transparency Rules issued by the FCA (as amended from time to time) the single European currency finncap Ltd. nominated adviser and broker to the Company, incorporated in England and Wales with registered number the Financial Conduct Authority of the UK FSMA the Financial Services and Markets Act 2000 German Corporate Code German Stock Corporation Act German Securities Acquisition and Takeover Act (WpÜG) Germany IFRS the German Corporate Governance Code adopted on 26 February 2002, as amended on May the German Stock Corporation Act (Aktiengesetz, AktG) as currently in force the German Securities Acquisition and Takeover Act (Wertpapiererwerbs- und Übernahmegesetz WpÜG), as currently in force Federal Republic of Germany (Bundesrepublik Deutschland) International Financial Reporting Standards as adopted by the European Union 7

8 ISIN Issued Share Capital London Stock Exchange Management Board Official List Panel or Takeover Panel Pounds Sterling or Prospectus Rules relevant system Share or Shares Shareholders Substantial Shareholders subsidiary Supervisory Board Takeover Code UK or United Kingdom UKLA or UK Listing Authority uncertificated International Securities Identification Number the issued capital of the Company as it will be immediately following Admission London Stock Exchange plc the members of the management board of the Company, from time to time, currently comprising Thomas Schaffer and Hermann Lübbert the Official List of the UKLA the Panel of Takeovers and Mergers the official currency of the UK the rules published by the FCA under section 73A FSMA any computer based system and its related facilities and procedures that is provided by an operator and by means of which title to units of a security can be evidenced and transferred without a written instrument shares in the capital of the Company persons who are registered as holders of Shares from time to time those shareholders who will hold three per cent. or more of the Issued Share Capital as disclosed in paragraph 10 of Part IX of this document a subsidiary undertaking (as defined by section 1162 of the Companies Act) of the Company and subsidiaries shall be construed accordingly the members of the supervisory board of the Company from time to time, currently comprising Jürgen Baumann, Andreas Fritsch, Ulrich Granzer, Ulrike Kluge, Alfred Neimke and Bernd Wetzel The UK City Code on Takeovers and Mergers United Kingdom of Great Britain and Northern Ireland the FCA acting in its capacity as competent authority for the purposes of Part VI of the FSMA a Share recorded on the Company s register as being held in uncertificated form, and title to which, may be transferred by means of an electronic settlement system In this document, words denoting any gender include all genders and references to the singular shall include references to the plural, where applicable and vice versa. 8

9 GLOSSARY OF TECHNICAL TERMS Actinic keratosis Ameluz Basal Cell Carcinoma BF-RhodoLED Belixos (bio) colloid Biocolloid formulation CE certificate Chronic Neoplastic Damage Eczema Keratotic skin lesions LED Mahonia aquifolium Photodynamic Therapy or PDT Pruritus Psoriasis Squamous Cell Carcinoma dry or scaly patches of skin caused by damage from sun exposure Ameluz is Biofrontera s prescription drug approved by the European Medicines Agency for the treatment of mild and moderate actinic keratosis on the face and scalp a type of non-melanoma skin cancer Biofrontera s CE-certified red-light LED lamp for use in Photodynamic Therapy such as in combination with Ameluz Biofrontera s cosmetic product line a chemical system composed of a continuous medium/ continuous phase throughout which are distributed small particles, 1 to 1000mm in size (disperse phase), that do not settle out under the influence of gravity; the particles may be in an emulsion or in suspension. The term may be used to denote either the particles or the entire system formulation applied in the Belixos series to support rapid penetration of the upper skin layer a certificate required for certain product classes (e.g. medical devices) verifying the products meet EU safety, health or environmental requirements, and required for sales in the European Union long-term damage that promotes cell growth an inflammatory, relapsing, non-contagious and itchy skin disorder skin damage affecting the prominent cell type in the upper skin layer light emitting diodes a species of flowering plant in the family Berberidacae therapy involving the application to skin of lasers or other light sources combined with a light sensitive drug to destroy cancer cells a sensation that causes the desire or reflex to scratch a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales a type of non-melanoma skin cancer 9

10 DIRECTORS AND ADVISERS Directors Management Board Supervisory Board Hermann Lübbert, PhD (Chairman of the Management Board and Chief Executive Officer) Thomas Schaffer (Member of the Management Board and Chief Financial Officer) Jürgen Baumann (Chairman of the Supervisory Board) Andreas Fritsch Dr. Ulrich Granzer Ulrike Kluge Alfred Neimke Prof. Dr. rer. nat. Bernd Wetzel (vice Chairman of the Supervisory Board) Registered and Head Office Hemmelrather Weg 201 D Leverkusen Germany Telephone Company website on Admission Nominated Adviser and Broker Auditors to Company Reporting Accountant +49 (0) (Germany) finncap Ltd. 60 New Broad Street London EC2M 1JJ Warth & Klein Grant Thornton AG Rosenstraße Düsseldorf Germany Grant Thornton UK LLP 30 Finsbury Square London EC2P 2YU Legal advisers to the Company LLR LegerlotzLaschet as to German law Mevissenstraße Cologne Germany Legal advisers to the Company as to English law Legal advisers to the Nominated Adviser and Broker UK Depositary and Registrar to the Depositary Interests Memery Crystal LLP 44 Southampton Buildings London WC2A 1AP Gateley LLP 1 Paternoster Square London EC4M 7DX Computershare Investor Services plc The Pavillions Bridgwater Road Bristol BS99 6ZZ 10

11 PART I INFORMATION ON THE GROUP INTRODUCTION Biofrontera AG is a biopharmaceutical company specialising in the development of medical cosmetics and dermatological drugs for the care and treatment of skin and inflammatory diseases. Biofrontera s main product is Ameluz, a prescription drug approved for use in Europe for the treatment of mild to moderate actinic keratosis on the face and scalp in conjunction with photodynamic therapy. Biofrontera is the first small German pharmaceutical company to receive a centralized approval for a drug developed in-house. The Company is looking to further develop Ameluz for use with other medical conditions and is seeking regulatory approval to sell the product in other countries, in particular the USA. Actinic keratosis is a premalignant condition of thick, scaly or crusty patches of skin formed from chronic neoplastic damage of the upper layer of the skin caused by sunlight (UV emission). It occurs predominantly in fair skinned people in the later stages of their life on areas of the body which have frequently been exposed to sunlight without sufficient protection. Studies have shown that actinic keratosis occurs in 10% of the population in Europe and the US and 1% of the population in Japan and other Asian countries. It is considered as potentially pre-cancerous as it can propagate to squamous cell carcinoma. While it is possible for spontaneous regeneration of skin affected by actinic keratosis to occur, in almost all cases the skin remains damaged for many years. In addition, the Company also sells and distributes the Belixos cosmetic products, currently available in cream and liquid form which offer nurturing and regenerating effects for people suffering from pruritus, dry skin or chronic ailments such as eczema or psoriasis. In 2011 the Company set up its own sales team in Germany, which allowed Biofrontera to move from being an exclusively research-oriented business into a specialist dermatological pharmaceutical company. The Directors believe that the Company s origins mean it has a level of internal research and development expertise that is unusually high in the industry. The Company has entered into licensing agreements for sales and distribution rights of its products into other European countries. The strategy of Biofrontera Group is to establish itself as a pharmaceutical company leading in specialised dermatology products. GROUP STRUCTURE The Biofrontera Group consists of Biofrontera AG, the parent company, and four wholly owned subsidiaries Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, Biofrontera Development GmbH and Biofrontera Neuroscience GmbH. HISTORY The Company was set up in Lörrach as BioFrontera Laboratories GmbH in August 1997 with the aim of providing services to the pharmaceutical industry. In September 1997, the Company was relocated to Leverkusen and renamed BioFrontera Pharmaceuticals GmbH and commenced its current operations. On 24 August 2000 the company was converted into a stock corporation (AG). On 27 November 2003 the company was renamed to its current name Biofrontera AG. On 30 October 2006 the Company s entire share capital was listed on the Düsseldorf stock exchange. The Shares were subsequently listed on the General Standard of the Frankfurt Stock Exchange. Since the initial public offering, the Company has carried out several capital fund raises, the most recent one in February Details are specified in Part IX Additional Information, paragraph 2. 11

12 Up until 2010, the Company predominantly focused on research activities. On 2 September 2010, the Company submitted a centralised European marketing authorisation application for BF-200 ALA, its first self-developed drug now known as Ameluz. The application was approved in December This approval has aided the Company s transition from being fully research-oriented towards becoming an integrated pharmaceutical company specialising in dermatology products. In 2013 the Company secured a strategic investment from Maruho, the largest dermatology company in Japan with revenues in 2013 of over US$600m. The Directors believe that Maruho s support can be beneficial to the Company s future development, in particular as the Company and Maruho progress strategic discussions with regard to potential marketing partnerships in the US, the sale of Maruho products in the EU via Biofrontera sales channels and other development projects. In February 2014 the Company raised 15.5 million through the issue of new Shares to a number of investors including Maruho Deutschland GmbH. KEY PRODUCTS, MARKET OPPORTUNITIES AND COMPETITIVE LANDSCAPE Ameluz Product information Ameluz Gel (development name: BF-200 ALA) received centralised European approval for the treatment of mild and moderate actinic keratoses on the face and scalp in December Ameluz is applied to the skin in conjunction with photodynamic therapy; shining a specialised lamp onto the skin. During the treatment, the active substance 5-aminolevulinic acid (ALA) penetrates the affected cells, assisted by a nanoemulsion, where it is then converted into a second substance, particularly in neoplastic cells. This second substance, protoporphyrin IX, serves as a photosensitiser that can be stimulated by exposure to high intensity red light for minutes. When the molecules are stimulated in this way cytotoxic amounts of highly reactive oxygen are formed, which induces tumour cell death via oxidation processes. The Directors believe that an advantage of PDT in addition to the high healing rates is the cosmetic result achieved in large-surface applications of this form of treatment. In this regard, not only do the visible keratoses disappear, but patients report that healthy skin also looks better as a result of a stimulation of collagen synthesis. It is the Directors belief that scarring which can occur with other treatment options does not occur when using Ameluz. One of the patents on which Ameluz is based was acquired in 2004 from Applied Science and Technology AG ( ASAT ), based in Zug in Switzerland. Biofrontera was contractually obliged to pay a fee of EUR 1 million in respect of this patent within three months of the approval being issued and this payment was made in Biofrontera does not have to pay any turnover-related licensing payments for Ameluz and there are no further payment obligations outstanding relating to Ameluz. It has been evidenced in clinical trials that the type of PDT lamp that is used in treatment has an impact on the effectiveness of the treatment. Biofrontera decided to develop its own PDT lamp, BF- RhodoLED, which has key advantages over all previously available PDT lamps. This LED lamp was approved as a medical device in November 2012, which means it may be sold in all EU countries. In comparison to other PDT lamps, the BF-RhodoLED not only provides highly effective LED light at the optimum wavelength for use with Ameluz, but also enables the illumination to be adjusted to suit the individual patient. The medical staff administering the treatment can thus adjust the treatment to minimise any discomfort felt by patients during PDT. Market Opportunity and Competitive Landscape Currently sales of Ameluz are mainly in Germany as it was the first market in which the product was launched. The Biofrontera sales force comprises 10 employees who promote and market Ameluz and ensure dermatologists are informed about the properties of Ameluz and trained to perform PDT. Distribution to public pharmacies takes place via pharmaceutical wholesalers and hospital pharmacies 12

13 are supplied directly. In addition to regular sales force visits to dermatologists, Biofrontera has presented Ameluz at many major dermatological conferences in Germany since it was launched. Ameluz competes with the products Metvix and Alacare in particular. Ameluz enjoys more than 65 per cent. of the market of tube-based sales from wholesalers to public pharmacies in Germany (3), with the remaining per cent. of that market currently held by the competitors Metvix and Alacare. (1) It is the Directors belief that only a small proportion of suitable patients are currently being treated with proprietary medicinal products intended for use in PDT. The Directors expect growth in the overall market as PDT achieves the optimal healing rates and positive cosmetic results of all treatment options for actinic keratosis. However the Directors believe that better market penetration has so far been inhibited by the complexity of the treatment, the time required by medical practices to administer it and the lack of adequate remuneration for the medical practitioner. According to data collected by Biofrontera s sales force about 76,000 PDTs treating actinic keratosis are currently performed in Germany each year, although only a small proportion are carried out with approved drugs. The others use formulations prepared in pharmacies. These formulations are cheaper than Ameluz and competing products although they may incur significant liability risks for the medical practitioner according to a resolution passed by the Council of Ministers of the European Union in 2011 and based on an amendment to the 2012 Pharmacy Practice Regulation. Furthermore, according to the Management Board s assessment, which is based on the findings of the Research Institute Insight Health, approximately 482,000 units of other medications with significantly lower healing rates were used in These medications are often applied by the patient at home, and, while not giving rise to significant workloads at medical practices, may result in low patient compliance. The Company is attempting to achieve greater use of medicinal products in PDT and market expansion compared to other treatment alternatives, by means of targeted marketing and sales activities. Biofrontera has formed relationships with other pharmaceutical companies to enable distribution in several other European countries. The Company has currently concluded regional license agreements covering Spain, Denmark, Norway, Sweden, Benelux, Austria, Slovenia, the United Kingdom and Israel. The sales and distribution partners are specialists in their respective local markets and are familiar with the local conditions in each country, including the remuneration procedures of the local health insurance agencies. The distribution agreements provide that the regional distributors purchase Ameluz from the issuer at a price that is linked to the sales price in their own respective country. Exceptions to the foregoing are the United Kingdom and Slovenia, where Biofrontera distributes Ameluz directly through local wholesalers, while marketing activities are performed by local partners. In September 2012, licensing partner Desitin started marketing activities for Ameluz in Scandinavia. Thereafter, Bipharma commenced marketing activities in the Netherlands in October, followed by Spirit Healthcare in England, Scotland, and Wales and Pelpharma in Austria in November. In September 2013, Allergan began marketing activities in Spain. In November 2012, the BF-RhodoLED PDT lamp was approved as a medical device throughout Europe. The Company s own sales force as well as sales and distribution partners carry out sales and distribution of the PDT lamp along with sales of Ameluz. Sales of the PDT lamp are not intended as a separate business line but more to promote and enable PDT as a treatment and increase the dispense of Ameluz in medical practices that do not have a suitable lamp. The Directors believe that the total market for treating actinic keratosis will increase in the future and their objective is to increase Biofrontera s share in the overall market. Presently Ameluz PDT is the most efficient but not most frequently used treatment. In 2013, there were about 600,000 prescriptions for products to treat actinic keratosis. (1) Source: INSIGHT Health GmbH & Co KG, Auf der Lind 10, Waldem, Germany, an issuer of data based services for marketing- and supply-research, which provides in the area of market research and in particular the collection and preparation of data from various sources to the pharmaceuticals industry Insight Health 13

14 The Directors expect the overall market to increase as a result of both an increased number of actinic keratosis incidences and growing awareness of the disease. In approx % of patients, keratoses develop within 10 years into potentially fatal squamous cell carcinoma (Glogau et al., 2000). Actinic keratosis is thus considered to be an indication that should be treated to prevent this occuring. New, effective treatments are therefore becoming more important and the Directors believe this will create the potential to further increase global annual turnover. Additionally, the Directors believe that the market for Ameluz can be increased by expanding the indication spectrum to include basal cell carcinomas. For this indication, Ameluz is currently in a final clinical registration trial (phase III) which commenced in October The Company does not expect the approval process for this additional indication to be completed before the end of Q A major milestone for the company will be the approval for Ameluz and BF-RhodoLED in the USA. Currently, Levulan by Dusa Pharmaceuticals Inc. is the only approved PDT drug in the US for actinic keratosis only. Based on the advice of the Food and Drug Administration (FDA) Biofrontera is performing two phase I safety studies and one phase III study for the field treatment of actinic keratosis. The clinical parts of the two phase I studies have been completed without relevant safety issues. Patient recruitment in the phase III study was completed by the end of January 2014 and treatment of the last patient will be completed by the end of July. Based on the data used for European approval and the additional clinical trials, filing in the USA is expected in Q Further, in August 2013, actinic keratosis, for which Ameluz has been approved in Europe, was classified as an occupational illness on the basis of a decision issued by the Occupational Diseases Medical Experts Advisory Committee at the Federal Ministry of Labour and Social Affairs in Germany. The scientific justification for the classification as an occupational illness was published in the Federal Government s Joint Ministerial Gazette. The consequence of recognising actinic keratosis as an occupational illness is that patients are entitled to reimbursement of the treatment costs by professional associations. Similar to private health insurance agencies, medical benefits can then be deducted separately, rather than for a defined fee as is customary with the statutory health insurance agencies. The recognition as an occupational illness underlines and draws attention to the importance of actinic keratosis as a condition that should be treated effectively. The Board is of the opinion that Ameluz can benefit from this classification of actinic keratosis in the long term particularly as the cost of receiving Ameluz PDT treatment could be lessened through reimbursement by professional associations. KEY STRENGTHS OF AMELUZ The Directors believe that the overall market for PDT to treat actinic keratosis still has development potential and consequently sales of Ameluz can increase in this growing global market as envisaged by the Directors. Scarring or continued pigmentation changes, which can occur with other methods for treating actinic keratosis, do not, the Directors believe, exist when using Ameluz as the treatment considerably rejuvenates the skin. As the Company is the exclusive vendor and distributor of the BF-RhodoLED lamp (a photodynamic therapy lamp) sales synergies can be fully utilised. Clinical testing is now underway for the expansion of indications for Ameluz to the treatment of basal cell carcinoma. Any such expansion should significantly improve the market potential for the treatment. There may also be further potential indications. Belixos Product information Belixos consists of a combination of active ingredients extracted from plants in a biocolloid formulation. In October 2009, the Company introduced Belixos Cream to the market via an online 14

15 shop, as the first product in this range of active cosmetics. Since the establishment of the logistics infrastructure for Ameluz, German pharmacies have also been able to procure Belixos from their wholesalers. In February 2014, Belixos Liquid was launched as a treatment for itching scalps. Both Belixos products contain ingredients extracted from the plant Mahonia aquifolium. These ingredients are supplemented by additional plant extracts to create a combination of active ingredients that can spread very quickly and evenly in the upper layer of the skin, thanks to the composition of Belixos with its biocolloidal base. This gives the product a combination of effects, which can reduce the need for medical treatment and its side effects in people who suffer from itchiness or chronic ailments, including redness, scaling, or occasionally weeping eczema on the skin. Market Opportunity and Competitive Landscape The Company is currently only selling Belixos to the German market. In addition to sales through pharmacies, Belixos can also be obtained from the Company s online shop ( The Directors intend to develop the Belixos cosmetic range into a core business area that is not affected by the risks and time limits associated with business activities involving patent-protected pharmaceuticals. The marketing efforts for Belixos were greatly reduced whilst the Company focused launching Ameluz. The Company has now renewed its efforts and has expanded the Belixos range with Belixos Liquid. Further, an updated Belixos webpage and a dedicated Facebook site have been established to help promote the Belixos product. Other Products The Company currently has two other products in the clinical development stage, BF-derm1 and BF-1. These products do not currently generate any revenue. DIRECTORS AND SENIOR MANAGEMENT German companies typically have a two tiered board system consisting of a management board and a supervisory board. The management board is responsible for the day-to-day running of the business whilst the supervisory board supervises the management board, without any executive powers. The members of the Company s management and supervisory boards are listed below. Management Board Prof. Dr. rer. nat. Hermann Lübbert, CEO, aged 58 Prof. Dr. rer. nat. Hermann Lübbert is Chairman of the Management Board of Biofrontera AG and a Managing Director of all subsidiaries of Biofrontera AG. He studied biology in his home town of Cologne and received his doctorate there in Following eight years in academic research at the University of Cologne and the California Institute of Technology (USA), he gained experience in managing a global research organisation during 10 years at Sandoz and Novartis Pharma AG. Prof. Lübbert founded Biofrontera in 1997 and has been managing the Company ever since. He qualified as a university lecturer at the Swiss Federal Institute of Technology (ETH) Zurich and in addition to his engagement as Executive Director, holds a professorship for animal physiology at the Ruhr-University Bochum. Thomas Schaffer, CFO, aged 51 Mr. Thomas Schaffer began his professional career with various positions in the finance and controlling division at Siemens Semiconductor. He held the position of Vice President and CFO in the Security & Chipcard IC business area of Siemens and the subsequently formed Infineon Technologies AG. Following this, he spent four years as Managing Director and CFO of Infineon Ventures GmbH and 15

16 continued his career as Vice President and CFO of the Specialty DRAM Division of Qimonda AG, where he also took over management of Qimonda Solar GmbH, Dresden. With positions as CFO at Heptagon Oy, Finland/Switzerland, and Ubidyne Inc., Delaware, USA, he expanded his extensive international experience. Mr. Schaffer s broad expertise covers all areas relating to finance and accounting, and he has made a significant contribution to the strategic development of the companies for which he has previously worked. Since June 2013, Mr. Schaffer has held the position of CFO at Biofrontera AG and is a Managing Director of all subsidiaries of Biofrontera AG. Supervisory Board Jürgen Baumann, Monheim, Germany, Chairman of the Supervisory Board, aged 60 As an economics graduate, Mr. Baumann was formerly a member of the Management Board of Schwarz Pharma AG responsible for European operations with eight national subsidiaries and four production sites. Mr. Baumann has been Chairman of the Supervisory Board of Biofrontera since Up until October 2012, Mr. Jürgen Baumann was a member of the Supervisory Board of Riemser AG, Greifswald. Andreas Fritsch, Seefeld, Germany, aged 48 Mr. Fritsch (MBA) has been sales-director of Alfred Wieder AG since He was previously a team leader for major projects, real estate, renewable energy and special projects at HANNOVER Leasing, held teaching posts at the Sabel Academy Munich and the University of Applied Sciences Kempten and has extensive experience in credit ratings and accounting. Mr. Fritsch has been a member of the Supervisory Board of Biofrontera AG since May Mr. Fritsch is Managing Partner of Fritsch Consulting, Seefeld since December He was Managing Partner of Fritsch & Fritsch GbR, Seefeld untill December Mr. Fritsch was Managing Partner of Finance System GmbH & Co. KG, Munich until August 2013 and Managing Director of Patenthandel Portfoliofonds I Verwaltungs GmbH, Pullach, Pharma Invest I Verwaltungs GmbH, Pullach, Via Vadis Controlling GmbH, Munich until June Dr. Ulrich Granzer, Krailling, Germany, aged 53 Dr. Granzer is Managing Director of Granzer Regulatory Consulting & Services and was formerly director of regulatory affairs at GlaxoSmithKline plc., Knoll AG and Bayer AG. Dr. Granzer is a pharmacist and has been a member of the Supervisory Board of Biofrontera since Ulrike Kluge, Cologne, Germany, aged 57 Mrs. Kluge has more than 30 years experience in the pharmaceutical industry. She was Vice President of Corporate Development of Schwarz Pharma AG, Board member of the Japanese subsidiary Schwarz Pharma KK and previously headed various positions at Schering AG including the head of International Project Management Dermatology. With previous positions at Marion Merrell Dow, Inc., and Helopharm she began her career in the industry after completing her studies in oecotrophology and business administration, graduating with a degree (MSc) in oecotrophology. Mrs. Kluge has been Managing Director of klugeconcepts GmbH since Since May 2011 she has been working on the Supervisory Board of Biofrontera. Mrs. Ulrike Kluge was a member of the Advisory Board of Timm Techtransfer Office Hessen until 2012, and she was a member of the Advisory Board of Biocell GmbH, Wiehl, until Alfred Neimke, Vienna, Austria, aged 55 Mr. Neimke is a graduate in business administration (Diplom Kaufmann) and most recently served as a member of the Management Board of Sparkassen Versicherung AG, Vienna, working in the area of responsibility of asset management. Mr. Neimke was previously Chief Investment Officer Equities of 16

17 Sal. Oppenheim KAG, Cologne, and has been responsible for operations in Vienna, Frankfurt and Moscow. He was appointed to the Supervisory Board of Biofrontera during the Annual General Meeting in May Mr. Neimke is Managing Director of Kopernikus AG, Zurich. In addition, he was also Managing Director of Frene Consulting GesmbH, Vienna until 2011, and a member of the Management Board of S&R Biogas Energiesystem AG, Moosburg a.d. until Isar. Prof. Dr. rer. nat. Bernd Wetzel, Biberach/Riss, Germany, Vice Chairman, aged 69 Prof. Dr. Bernd Wetzel has almost 30 years of experience in the pharmaceutical industry at Boehringer Ingelheim. In 1997 he was appointed Head of Worldwide Research and Non-clinical Development. In 2003 he started consulting for biotechnology companies. Prof. Dr. Wetzel has been a member of the Supervisory Board of Biofrontera since 2006 and was elected as Vice Chairman in May Dr. Wetzel was a member of the supervisory board of Develogen AG, Göttingen, until October 2010, and a member of the supervisory board of Silence Therapeutics, London, until December In addition, he was an advisor to several biotech companies, to the Experimental Therapeutic Center in Singapore and to Techno Venture Management (TVM) in Munich. SUMMARY FINANCIALS The financial information set out below has been extracted from the Group s audited annual reports for the years ended 2011, 2012 and 2013 which are set out in Parts III, IV and V of this document. In order to make a proper assessment of the Group s business, investors should not rely solely on the summary information set out below but should read the Group s audited annual reports set out in Parts III, IV and V of this document. Audited Audited Audited Year ended Year ended Year ended 31 December 31 December 31 December (EUR 000) Sales revenues 3,115 3, Gross Profit 1,511 1, General administrative costs (5,462) (4,092) (3,043) Research and development costs (3,186) (1,384) (1,401) Financial result (1,232) (654) (1,921) Other operating income (expenses) ,651 Profit/loss before income taxes (8,067) (4,103) (4,644) Annual profit/loss (8,067) (4,118) (4,644) CORPORATE GOVERNANCE The Board recognises the importance of good corporate governance and intends, following Admission, to comply with the provisions of the German Corporate Governance Code (the Code ) as it already does. The Code contains recommendations and suggestions for managing and supervising German stock market listed companies. It is based on internationally and nationally recognised standards for good and responsible corporate governance. The Code can be viewed in English on the website Companies can choose to deviate from the recommendation of the Code however, the Management Board and the Supervisory Board must declare annually the extent to which the Company is in compliance, and any relevant deviation. 17

18 Internal provisions relating to corporate governance The Company currently has in place a number of sub-committees of the supervisory board, which are concerned with internal corporate governance. As at the date of this document, there is a personnel committee, an audit committee, a research and development committee, a business development committee and nomination committee. Further details of these committees (including as to membership) can be found in Part IX of this document. The Company has adopted a code for share dealings by directors and employees which is appropriate for an AIM company and which complies with Rule 21 of the AIM Rules for Companies on Restrictions on deals. REASONS FOR ADMISSION The Directors believe that Admission will assist Biofrontera in its development by raising its international profile in the life sciences arena; providing investment for the expansion of the Company s distribution and sales network; and increasing access to capital should further finance be required to expand the business in the future. CURRENT TRADING AND PROSPECTS FOR THE GROUP POST ADMISSION For the 2014 financial year, Biofrontera s turnover will still be subject to significant forecasting uncertainties relating primarily to the speed of market penetration. In Germany, as in 2013, the Board expects to achieve an increase in turnover compared with the previous year. It remains difficult to predict the increase in sales in other European countries, which means that revenues for the current financial year have a range of possible outcomes. Further progress in terms of turnover also depends on whether or not Biofrontera successfully concludes licensing agreements with distribution partners in other European countries. Contracts with US distributors and the associated down payments are not currently planned for In order to extend the range of indications, and to receive approval for the USA, Biofrontera will continue to invest heavily in R&D in Therefore, we expect our development costs to remain significant. LOCK-INS AND ORDERLY MARKET ARRANGEMENTS The Company has entered into a lock-in agreement with Maruho Deutschland GmbH dated 20 January 2014, in respect of 2,857,143 Shares registered in its name. Further details are set out in Part IX of this document. SHARE OPTIONS AND BONDS The Company has issued options and bonds under the 2010 Stock Option Plan, the Warrant Bond 2009/2017 and the Warrant Bond 2011/2016. As at the date of this document 658,150 options have been granted under the 2010 Stock Option Plan. Approximately 4,930,300 is outstanding under the Warrant Bond 2009/2017 and approximately 8,715,000 is outstanding under the Warrant Bond 2011/2016. Further information on each can be found in paragraphs 5 and 6 of Part IX of this document. If all conversion rights are executed in full this would result in a 16.5 per cent. dilution of the Issued Share Capital. DIVIDEND POLICY The objective of the Directors is to achieve capital growth for Shareholders through the continued expansion of the Group s sales and the growth of profits achieved from exploitation of the Ameluz and Belixos product ranges. Consequently, they do not anticipate that the Company will pay dividends to Shareholders in the short term nor can they predict the likely level or timescale for the declaration and payment of dividends by the Company. However, the Directors intend to recommend the payment of 18

19 dividends as soon as they believe that it is commercially prudent to do so and subject to the then availability of sufficient distributable reserves for such purpose. APPLICABILITY OF THE TAKEOVER CODE The Takeover Code is issued and administered by the Panel. The Takeover Code applies to takeovers and merger transactions, however effected, where the offeree company is, inter alia, a company whose registered office is in the UK, the Channel Islands or the Isle of Man and such company s shares are admitted to trading on a regulated market or multilateral trading facility or any stock exchange in the United Kingdom. The Company is incorporated and registered in Germany. For this reason, the Takeover Code does not apply to the Company and Shareholders will not be offered any protections under the Takeover Code. It is emphasised that, although the Shares will be traded on AIM, the Company will not be subject to takeover regulation in the United Kingdom. However, in accordance with the German Securities Acquisition and Takeover Act (WpÜG), anyone who reaches or exceeds a share of 30 per cent. of the company s voting rights in the regulated market is under an obligation to promptly disclose this fact, including the percentage of voting rights held, at the latest within seven calendar days, on the internet and also on an electronic financial news service and to subsequently make a public mandatory offer to all holders of company shares unless granted an exemption. For further details, please see Part IX. DISCLOSURE OF INTERESTS IN SHARES Under German law shareholders are not obliged to disclose their interests in a company in the same way as shareholders of certain public companies incorporated in the United Kingdom. In particular, the DTRs do not apply to the Company. Shareholders will however be subject to the provisions of the German Securities Trading Act. Please see Part IX for further information. TAXATION The attention of Shareholders is drawn to the further information regarding taxation set out in paragraphs 21 and 22 of Part IX. These details are, however, intended only as a general guide to the current tax position under UK and German taxation law and, if Shareholders are in any doubt as to their tax position, they should seek independent advice as to their own position. ADMISSION AND SETTLEMENT Application has been made to the London Stock Exchange for the Issued Share Capital to be admitted to trading on AIM. Admission is expected to take place at 8.00 a.m. on 3 June CREST To be traded on AIM, securities must be eligible for electronic settlement. CREST is a paperless settlement system enabling securities to be evidenced otherwise than by a certificate and transferred otherwise than by a written instrument in accordance with the CREST Regulations. CREST is a voluntary system. Depositary Arrangements With effect from Admission, it will be possible for CREST members to hold and transfer interests in Shares within CREST pursuant to a Depositary Interest arrangement established by the Company. The Shares will not themselves be admitted to CREST. Instead, pursuant to a method under which transactions in international securities may be settled through the CREST system, the Company has arranged for the Depositary to issue dematerialised depositary interests representing entitlements to Shares, known as Depositary Interests or DIs. The DIs will be independent securities constituted 19

20 under English law which may be held and transferred through the CREST system. DIs will have the same international security identification number (ISIN) as the underlying Shares. The agreement under which the Company has appointed the Depositary to provide the DI arrangements is summarised in paragraph 14 of Part IX of this document. The DIs will be created pursuant to, and issued on the terms of the Deed Poll executed by the Depositary in favour of the holders of the DIs from time to time. Prospective holders of DIs should note that they will have no rights in respect of the underlying Shares or the DIs representing them against Euroclear or its subsidiaries. In order for Shares to be dematerialised those Shares will be transferred to the Depositary or its Custodian or the Custodian s nominee and the Depositary will issue the corresponding DIs to participating CREST members. Each DI will be treated as one Share for the purposes of determining, for example, eligibility for any dividends. The Depositary will pass on to DI holders any stock or cash benefits received by it as holder of Shares on trust for such DI holder. DI holders will also be able to receive notices of meetings of holders of Shares and other notices issued by the Company to its Shareholders through the Custodian and Depositary. For more information concerning CREST and Clearstream Shareholders should contact their brokers or Euroclear at 33 Cannon Street, London EC4M 5SB or by telephone on +44 (0) Certificated Shares The right to receive written share certificates is excluded by the Company s Articles. The Shareholders can receive a co-owner participation evidenced by the deed deposited with Clearstream. RISK FACTORS Your attention is drawn to the Risk Factors set out in Part II of this document. FURTHER INFORMATION Your attention is drawn to Parts I, II and IX of this document which provide additional information on the Group. 20