Weichen stellen. Deutscher Biotechnologie-Report 2011

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1 Weichen stellen Deutscher Biotechnologie-Report 2011 German Biotechnology Report 2011

2 Impressum Dieses Werk ist urheberrechtlich geschützt. Alle Rechte, auch die der Übersetzung, des Nachdrucks und der Vervielfältigung des Buches oder Teilen daraus, sind vorbehalten. Kein Teil des Werkes darf ohne schriftliche Genehmigung von Ernst & Young GmbH in irgendeiner Form (Fotokopie, Mikrofilm, Datenträger oder einem anderen Verfahren) reproduziert oder unter Verwendung elektronischer Systeme verarbeitet, vervielfältigt oder verbreitet werden. Die Wiedergabe von Gebrauchs- und Handelsnamen sowie Warenbezeichnungen usw. in diesem Werk berechtigt auch ohne besondere Kennzeichnung nicht zu der Annahme, dass solche Namen im Sinne der Warenzeichen- und Markenschutz-Gesetzgebung als frei zu betrachten wären und daher von jedermann benutzt werden dürfen. Die Zahlenangaben und Informationen basieren auf Daten, die im Rahmen einer Primärdatenerhebung sowie Sekundärdatenrecherche von relevanten Unternehmen ermittelt wurden. Die in diesem Report wiedergegebenen qualitativen und quantitativen Einschätzungen wurden mit hoher Sorgfalt ermittelt, jedoch übernimmt der Herausgeber keine Haftung für die Richtigkeit und Vollständigkeit der Angaben. Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft Theodor-Heuss-Anlage 2, Mannheim April 2011 Layout und Produktion: magenta Kommunikation, Design und Neue Medien GmbH & Co. KG, Mannheim

3 Inhalt Vorwort 2 Executive Summary 4 1. Biotech-Industrie in Deutschland Ein Überblick 26 Weichen stellen 27 Kennzahlen Geschäftsstrategien 34 Weichen richtig stellen Produkte und Technologien 50 Die Pipeline der therapeutischen Produkte 51 Biotechnologieprodukte außerhalb des Therapiesektors 60 Technologieentwicklungen Transaktionen 64 Transaktionslandschaft im Überblick 65 Analyse: Allianzen deutscher Biotech-Unternehmen 72 Analyse: Allianzen europäischer Biotech-Unternehmen 77 Analyse: Akquisitionen deutscher Biotech-Unternehmen 80 Analyse: Transaktionsaktivitäten bei Big Pharma Finanzierung und Kapitalmarkt 94 Zahlen und Fakten im Überblick 95 Analyse: Finanzierung privater Biotech-Unternehmen 97 Analyse: Finanzierung börsennotierter Biotech-Unternehmen 120 Analyse: Marktkapitalisierung Biotech-Standort Deutschland 126 Weichenstellung für die Rahmenbedingungen der Biotech-Branche 127 Cluster und Life-Science-Netzwerke 132 Biotech Map of Germany Danksagung 136 Anhang 137 Methodik und Definitionen 138 Glossar 140 Verzeichnis der Tabellen und Abbildungen 142 Verzeichnis der Expertenbeiträge 144

4 Vorwort Preface Im Zuge der Verbesserung der allgemeinen Wirtschaftsdaten nach Überwindung der Finanz- und Wirtschaftskrise war die Hoffnung groß, dass auch die im letzten Jahr schwer angeschlagene Biotech-Industrie in Deutschland wieder neue Impulse erfahren würde. Insbesondere galt es zu beobachten, ob die damals propagierten Neuen Spielregeln (der Titel des letztjährigen Deutschen Biotechnologie-Reports) zur effizienteren Nutzung des knappen Kapitals greifen würden. Hier setzt der aktuelle Deutsche Biotechnologie-Report 2011 an, mit dem wir das erste Dutzend dieser Serie voll machen und Ihnen die 12. Ausgabe präsentieren. In der Rückschau auf das Jahr 2010 kann auf den ersten Blick klar erkannt werden, Dr. Siegfried Bialojan dass die Neuen Spielregeln in der Tat greifen. Unternehmen haben in vielen Fällen ihre Geschäftsmodelle angepasst, Kosteneffizienz gesteigert und auf der Suche nach frischem Kapital ein breites Spektrum an neuen Möglichkeiten ausfindig gemacht. Somit geht es jetzt um das richtige Weichen stellen für eine nachhaltige Zukunft. Die Zeichen für die Finanzierung zeigen auf den ersten Blick deutlich in Richtung Erholung, wenn die Weichen rechtzeitig richtig gestellt werden. Allerdings führt der Weg nicht zurück zu den klassischen Kapitalquellen, sondern hält vielfältige neue Alternativen bereit. Die Transaktionslandschaft bietet neue Weichenstellungen für Wertschöpfung. Geschäftsmodelle im Wandel erfordern auch geänderte Weichenstellungen bei der Besetzung der wichtigsten Managementfunktionen sowie der Definition ihrer Anforderungsprofile. Im globalen Vergleich hat Deutschland in der Biotechnologie allerdings noch einiges aufzuholen. Trotz unerwartet positiver Wirtschaftsdynamik bleibt die Biotechnologie noch ein Stück weit hinter den Entwicklungen in den USA zurück. Welche Erfolgsfaktoren und Kernkompetenzen sind auf globaler Ebene für die richtige Weichenstellung ausschlaggebend? Dieser Frage geht der parallel erscheinende globale Ernst & Young Biotechnologie-Report Beyond Borders 2011 nach, der in enger Zusammenarbeit mit dem European Life Science Center in Mannheim erstellt wurde. In the course of the improvement of key economic indicators and the ongoing recovery from the global financial crisis, hopes were high for Germany s biotech industry which had suffered very hard last year to regain its momentum. In particular, it was crucial to analyze whether the claimed Neue Spielregeln (New Rules) the title of last year s Ernst & Young German Biotech Report did effect raising of new capital and its use in the most efficient way. This is where the current Ernst & Young German Biotech Report 2011 steps in while completing the first full dozen of this series with its 12th edition. Looking back to the year 2010, clear signs indicate that the New Rules have indeed been successfully applied: companies adapted their business models, increased capital efficiency and broadened their scope of identifying alternative funding options. Right now, it is imperative to leverage the new momentum and Put Things on the Right Track the headline of the new report ( Weichen stellen ) for a sustainable future. At first glance, the financing situation of the companies points to recovery if the right course was set. However, this track does not lead back to classical funding but comes up with multiple alternatives. Transactions offer new tracks for generating value. Transforming business models request a different track setting as well, with respect to the management tasks required and the definition of specific job profiles. On an international level, Germany has to catch up quite a bit in the field of biotechnology. Despite enormous and to some extent unexpected dynamics in Germany s general economic recovery, the biotech sector still lags significantly behind other countries, including the United States. What are from a global perspective the major success factors and key competencies for setting the right course? This is the question addressed in the global Ernst & Young biotechnology report Beyond Borders 2011 which is published simultaneously in close collaboration with the European Life Science Center of Ernst & Young in Germany.

5 Viele Stellmöglichkeiten für die Weichen in der Biotechnologie sind auch bedingt durch entsprechende Entwicklungen in der Pharma- Industrie auf deren Weg vom Medikamentenhersteller zum Produzenten von Lösungen für Patientengesundheit. Diesen Prozess beschreibt unsere Pharma-Reportserie Progressions in klaren Schritten von Pharma 1.0 über 2.0 bis hin zum aktuellen Pharma 3.0. Ein wesentliches Element für die operative Umsetzung dieser Entwicklung ( Building pharma 3.0 der Titel des aktuelle Pharma- Reports) ist unter dem Begriff Radical Collaboration and Open Innovation zusammengefasst; hier finden sich neue Opportunitäten auch für Biotech-Unternehmen, die als Innovationsmotoren bereits langjährige Erfahrung mitbringen. Die Vernetzung zu einer umfassenden Gesundheitsbranche bezieht gleichermaßen auch die Medizintechnik mit ein mit Hightech-Apparaturen, bildgebender Diagnostik und Therapieansätzen. Unsere Medizintechnik-Reportserie Pulse of the Industry beleuchtet auch diesen Sektor aus einer globalen Perspektive. Das Zusammenwirken der Disziplinen der Life-Science-Industrie für eine optimale Patientenversorgung zu verstehen und darüber hinaus auch das erweiterte Health-Ökosystem mit Partnern aus den Bereichen Health IT, e-health und Telemedizin mitzuerfassen, wird zu einer unabdingbaren Kernkompetenz für den Aufbau eines patientenorientierten Gesundheitssystems der Zukunft. Die gedankliche Auseinandersetzung mit diesen Zusammenhängen, unzählige Gespräche mit allen Beteiligten sowie ein fundiertes Wissen der Fakten schaffen eine solide Basis für eine Beratungsexpertise, die wir unseren Kunden zur Verfügung stellen. Mit diesem Vorausblick hoffe ich, dass Ihnen die vorliegende Studie hilfreiche Anregungen liefert und würde mich freuen, wenn wir darüber hinaus den Dialog mit Ihnen fortsetzen dürften. Many of the track setting choices in the biotech industry are also a consequence of concurrent developments in the pharmaceutical industry on their way from a drug developer and marketer to a solution provider in the area of patient outcome. This process is described in our most recent pharma report series Progressions as a sequence of distinct steps starting from Pharma 1.0 over Pharma 2.0 to Pharma 3.0. One of the essential elements of Building pharma 3.0 the title of the most recent publication is Radical Collaboration and Open Innovation. This also encompasses new opportunities for biotech companies who bring in longstanding experience as an innovation engine. Building a complex health industry also integrates the medical devices sector with high tech apparatuses, medical imaging and therapeutic approaches. Pulse of the Industry the Ernst & Young series on the medical technology analyses this sector from a global perspective. To understand the interaction of all disciplines in the life science industry with the common goal of achieving optimal patient outcome and, in addition, to capture the extended health ecosystem including further sectors like Health IT, e-health and telemedicine, will become a major key competency to support building a patientoriented health system. Thinking and developing thought leadership along these lines, numerous discussions with all shareholders as well as sound knowledge of facts establish a solid basis for the consulting expertise we are offering to our clients. With this perspective, I hope this study will provide you with helpful food for thoughts and will be able to stimulate discussion. I would also be delighted if we could continue our dialogue on the topics raised in this report. Dr. Siegfried Bialojan Leiter European Life Science Center, Head European Life Science Center, Ernst & Young Mannheim, Germany Beyond Borders Global biotechno logy report 2011 Pulse of the industry Medical technology report 2010 Progressions Global pharmaceutical industry report 2011

6 Executive Summary 4 Weichen stellen Deutscher Biotechnologie-Report 2011

7 Weichen stellen Putting things on the right track Expanding knowledge on biotechnology in Germany Ernst & Young has been publishing a German Biotech report throughout the last twelve years. This report does attract a lot of interest in the life science industry in Germanspeaking countries and is frequently cited in publications by industry players of all kind. In order to make the information on the German biotech industry available to a broader international audience, we have decided to include for the first time this year an Executive Summary in English which includes the most important trends and developments as well as major charts of the German report. Readers are cordially invited to request more detailed information from the authors 1. Introduction Last year s report about Neue Spielregeln New Rules had been around changing business models, alternative funding and using capital most efficiently as well as discussing new value generating networks in form of new cluster developments in Germany. Those new rules were necessary based on an absolute low in venture capital financing with only about 80 million euro left for the whole biotech sector in Germany. The actual report, titled Weichen stellen Putting things on the right track is about following up on whether measures taken around the new rules would show effects and would indeed have put things on the right track throughout Defining events for the German biotech sector Key company figures number of companies, employees, revenues, R&D expenditures all with positive upward trends. Losses in the aggregated sector have been significantly reduced both through efforts by private and public companies. 17 new company foundations demonstrate positive basic atmosphere, whereas the majority of companies falling out the company statistics are based on mergers rather than insolvencies. German biotech companies have adapted their business model to sustain the funding crisis and to better leverage increased outsourcing and partnering opportunities with pharma companies. Availability of venture capital recovers significantly to reach 279 million euro more than three times as much as in 2009; however, this increase is associated with few very big financing rounds lead by two family offices (Struengmann / former owners of Hexal; Hopp / founder of SAP). Overall, still too few companies benefit from available VC sources; fundraising remains difficult. Alternative funding sources are becoming visible and more relevant. No IPOs in Germany since Capital market interest for biotech is weak; public company financing mostly through PIPEs and rights offerings to existing investors. Positive trend in transactions; alliances based on innovative technology platforms to generate products. M&A transactions within German biotech sector strengthen existing companies. Therapeutics development by German biotech companies strongly based on modern drug concepts (antibodies, proteins, RNA / DNA, cell-derived). Strong focus on highly attractive therapeutic areas (e. g. oncology). Major revenue sources are marketed products in the diagnostics, cell culture and research tool areas. Key company figures for biotech in Germany Despite worsening financing environment during the economic crisis, company number and other parameters have remained stable. In 2010, signs of recovery are visible with all criteria showing positive trends. Company numbers are stable with a slight overhang of new company foundations (17) over companies dropping out of the statistics. Similarly, number of employees is rising again. Both, private and public companies contribute to the overall positive feature. Whereas private companies have a stronger impact on revenue and concomitant R&D expenditure increases, public companies show a very robust result of their cost saving programs which helped them reducing the aggregate loss figure by 22 %. Table 1-2: Key metrics and financial data of the German biotech industry Key metrics Private companies Public companies Total industry / / /10 No. of companies % % < 1 % No. of employees 8,095 8,421 4 % 1,714 1,622-5 % 9,809 10,043 2 % Financial data (mil. ) Revenues % % 992 1,059 7 % R&D expenditures % % % Loss % % % Source: Ernst & Young, 2011 Weichen stellen Deutscher Biotechnologie-Report

8 Executive Summary Figure 2-1: Measures to increase business and capital efficiency (survey in Germany, 2010) Responses (multiple answers possible, n=153) Seeking alternative sources of capital Seeking synergies through strategic combinations Partnering earlier Pooling resources / facilities with other companies Seeking an M&A exit New business models Reducing projects in pipeline development Layoffs / downsizing facilities Increased outsourcing % 10 % 20 % 30 % 40 % 50 % 60 % 70 % 80 % 90 % 100 % Already implemented Very likely Likely Unlikely Very unlikely Source: Ernst & Young, 2011 Within the private companies, revenues mainly come from service and tool providers; whereas on the other hand, therapeutics developers are still heavily involved in the spending mode (R&D) with concomitant negative profit / loss balance. However, the overall positive feature must be treated with some caution since the aggregate numbers might mask the reality for individual companies, especially when average values derive from a heavily polarized situation, i. e. when a small number of very successful companies is combined with a broad mass of firms struggling with adverse environments. 2. Business Strategies Measures to improve business efficiency Since 2008, biotech companies in Germany and internationally were interviewed in an electronic survey about their measures to improve business as well as capital efficiency, especially to cope with the economic crisis. In the light of a pretty stable industry sector throughout the crisis (same number of companies), there had to be other means to avoid an expected major consolidation of the sector. The survey identified alternative capital sources and adaptation of business models as the key drivers. For German biotech companies the relevance of doing transactions with partners in the life science field, including alliances and M&A deals, has increased over time. In particular, going into early deals and leveraging synergies through strategic transactions has become an important business factor (see also Deal chapter). In terms of business model adaptation, the German biotech sector seemed to benefit from a broader differentiation with a higher share of service and tool provider models and fewer companies in the high risk therapeutics development mode. Structural measures against capital restraints e. g. stop / delay of projects, work force reduction and increased outsourcing have accumulated in the 2010 survey answers. Especially reducing workforce, which had not been the first choice for German companies due to more protective labor law regulations was increased in the actual survey. In general, there has been a continuous shift of measures over the last three years that were ticked as (very) likely earlier to now being already implemented. 6 Weichen stellen Deutscher Biotechnologie-Report 2011

9 Executive Summary Business models Business model discussions during the last decade especially when driven by venture capital investors were very much focusing on developing therapeutic products. Despite extreme risks, long time lines and high competition from pharmaceutical companies, this model was preferred and many biotech companies got pushed in this direction. The situation today changes the perspective on business models in several ways and Germany is in the middle of this discussion. The classical venture capital model has failed. There is a clear reduction of active VC investors, primarily due to the inability to raise new funds for high risk drug development; lacking track record, a more realistic view on time lines and the required long term breath are one argument against. Another driver of change is the increased need of pharmaceutical companies for innovation and their strong trend to partnering along the whole value chain. This has led to rethinking of business model development and also to refocusing on the prototypical biotech strength of setting up innovative technology platforms. Establishing novel and particularly powerful productgenerating technology platforms provides much broader commercialization choices to biotech companies and therefore greater flexibility to define business models (also adaptive to actual economic environments). Service model: Product-generating technology platforms in particular can be leveraged initially in a service type model, when VC financing in the very early stage is difficult to attract. This model explicitely meets pharma s increased tendency to outsource more and more parts of their value chain. Successful operation of this model will not only generate revenues to keep the company alive (especially in difficult funding times), but also establishes relationships to clients who provide technical due diligence of the platform and turn out to be good candidates for moving this model further onto the next level of value sharing partnering deals. Partnering model: Also the next level the Partnering Model has seen changes over time. Whereas the critical hurdle for entering Figure 2-3: Biotech business model pyramid Pharma transformation Access to innovation Creative partnering Option deals (e. g. Bayer / Micromet) Sell-buy-back (e. g. UCB / WILEX) Outsourcing external 30 % 50 % 70 % internal 70 % 50 % 30 % into a decent alliance used to be the clinical proof of concept (after phase II), entry points become more flexible. This is also connected to the pressure on pharma companies to increase their R&D output and to boost innovation. In order to make earlier transactions with higher risk profiles happen, new deal models came alive such as option deals. In this deal type, pharma pays an option fee to biotechs to hold an option for a ready-negotiated alliance until further data will become available. For biotechs, this means cash infusion at an early point in time. Although this solution can be considered as a pure emergency solution, it is a welcome alternative funding source in a cash-stripped sector. The partnering model is becoming more and more attractive for present investors, both from a value standpoint (partnering with a major pharma player will raise attention and interest) but from the money coming in as well. Inhouse product development and marketing: Finally, the original focus model of inhouse drug development and marketing of own therapeutics will be reserved only for a minor fraction of very successful companies, most probably after moving through the previous models. Product development and marketing Partnering model / product development Service model / technology and tool provider Source: Ernst & Young, 2011 Prototype examples in Germany: There have been many examples in Germany to demonstrate the characteristics of these models and even more to explain that companies might better consider to sequentially move through those steps on their way to success. Some of the paradigm companies are Evotec, MorphoSys, Phenex Pharmaceuticals etc. Leveraging outsourcing trend: The service model as such and companies adhering to it are growing due to the increased outsourcing trend in the industry. The same shift at pharma to a more pronounced extraprise has also initiated changes in another business field within biotech. Companies that have typically developed R&D tools and equipment which was sold to pharmas and others for their internal R&D activities have a chance to move on to become service providers if the same activities are outsourced. There are also some examples for this shift (e. g. CCS cell culture services; Miltenyi Biotec cell separation; Scienion microarrays). Weichen stellen Deutscher Biotechnologie-Report

10 Executive Summary Comparison of business model use in the international biotech sector Even though the discussion of business model developments is true globally, there are distinct differences in the quantitative distribution of various models between geographies and between Germany and other countries, in particular. In Germany, a significantly higher percentage (>20 %) of companies are pursuing the pure service model compared to the rest of Europe (9 %) and even more to the USA (7 %). Just complementary to this distribution, the pure partnering model dominates in the US (>35 %), followed by Europe (31 %) with Germany last with only about 15 % of companies. Reasons may be manyfold, one certainly being a different risk perception and willingness to accept risk compared to a preference for a more solid business (although with lower profits). On the other hand, German companies also have a specific focus on innovative technologies which is reflected in many early stage technology / product deals but might also explain the service preference to some extent. Finally, the relatively broad share of companies applying models that involve inhouse product development and marketing includes also many companies in the diagnostics, tool provider and other product businesses in the life science sector. Figure 2-4: Business models 2010 (international survey) Responses 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Germany (n = 153) Europe (rest, n = 257) USA (n = 186) Service / partnering / product development & marketing Partnering / product development & marketing Service / product development & marketing Service / partnering Product development & marketing Partnering Service Source: Ernst & Young, 2011 Role of CEOs in different business models Different business models require different capabilities on the management side. Service models mostly rely on customer relationship and service quality and require excellence in negotiating skills as well as technical expertise to drive technology leadership. Typical entrepreneurs (mostly founders of companies based on their own ideas) might run into conflicts when equity investors enter the company. In this case, the term exit comes into play. This will change the job profile of the CEO; often an outside individual is hired as a manager for a defined period with a defined job to complete (e. g. growth, exit). Depending on the company, this function might still require more entrepreneurial skills (e. g. technology platform with broad leveraging potential) or more project managing expertise (e. g. in a clinical portfolio company). Recently, project financing is discussed as a new model for VC investors to make money in the drug development field. In this case, the role of the CEO becomes even more shifted towards a pure project manager to coordinate a virtual service network while major entrepreneurial tasks reside with the investment firm. Again, also with respect to changing CEO roles it becomes clear that the life cycle of a biotech company is a very dynamic process with many changes according to business focus / model, status of the company, funding model etc. 8 Weichen stellen Deutscher Biotechnologie-Report 2011

11 Executive Summary 3. Product Development Pipeline growth flat The drug development pipeline of the German biotech sector revealed only very modest growth of 2.4 % (after 8 % in the year before) for drugs in preclinical and clinical development until registration. On the other hand, in the light of tough financing times and implemented cost cutting measures, even negative growth had been anticipated. There were no new market authorizations in 2010 from German biotech companies. Positive signals from the clinic With respect to the development value drivers, drug candidates in clinical phases I III, growth rate is 7.1 %. Especially, in phase II, the most critical value leap, a new all time maximum of 90 drug candidates was reached in new developments entered phase II, 5 of them biologics. Whereas phase III development is flat with only two additional compounds being added (one moving to registration), replenishment of the overall clinical development pool is secured through 11 new additions from preclinical studies. German pipeline dominated by biologics The greater than 50 % share of biologics in the German biotech therapeutics development pipeline continues to increase. Out of 344 compounds in preclinical and clinical development, 58.4 % are biologics (antibodies, therapeutic proteins, RNA / DNA molecules etc.). The share of biologics under investigation is highest in preclinical research with 61.9 %, which will drive future increase of biologics in the overall pipeline. The share of biologics in the German pipeline is significantly higher compared to the rest of Europe (approximately 50 %) and there are also major differences in their type. Germany has a broad focus on highly innovative biological drugs such as antibodies, recombinant proteins, cell-based therapies and RNA/DNA molecules. The remaining European biological pipeline is more biased Figure 3-1: Development pipeline by phase No. of compounds in studies Preclinical Phase I Phase II Phase III 2 3 Registration Source: Ernst & Young, 2011 Figure 3-5: Clinical development pipeline by active compound type, % 6 % Germany 8 % 13 % 6 % 11 % 18 % Europe (rest) Monoclonal antibodies Recombinant proteins RNA/DNA Peptides Cell-based Natural compounds Small molecules 50 % 4 % 7 % 5 % 13 % 16 % 5 % Source: Ernst & Young, 2011 Weichen stellen Deutscher Biotechnologie-Report

12 Executive Summary Figure 3-6: Clinical development pipeline by therapeutic area, % 8 % 4 % 7 % 6 % Table 3-2: Technologies of German biotech companies (selection) Segment Technology Description Company Screening UNIarray Systematic identification and application of autoantibody signatures Protein engineering Germany 8 % 10 % Anticalin technology Engineered lipocalins with transferred characteristics of antibodies Expression system CAP technology Proprietary cell line based on human amniocytes Library HuCAL Human combinatorial antibody library Drug delivery SMARTICLES Liposomal delivery technology with fully reversible surface charge 48 % 11 % 12 % Oncology Inflammation Cardiovascular Infectious disease Autoimmune Neurology Metabolic and endocrine Other Purification MACS Magnetically cell separation Europe (rest) 15 % 10 % Cell cultures Upcyte Controlled proliferation of primary cells 12 % Source: Ernst & Young, 2011 Protagen Pieris 5 % Cevec Pharmaceuticals MorphoSys novosom Miltenyi Biotec Medicyte 29 % 6 % Quelle: Ernst & Young, 2011 towards therapeutic peptides. German pipeline with focus on oncology Another major difference between the German biotech pipeline refers to the association of development drugs to therapeutic areas. German biotech companies clearly favor cancer (48 %) and inflammation (10 %) as major disease categories which together span more than 50 % of the whole pipeline. Europe is more diversified into cancer (29 %), infectious diseases (12 %), autoimmune diseases (10 %), neurological disorders (12 %) and metabolic diseases (11 %). Product development outside therapeutics This report has a strong focus on the therapeutic products in development. This is mainly due to the fact that there is sufficient data available from companies as well as public sources. Nevertheless, based on the number of biotech companies in Germany active in other subsectors and also on revenue shares, there are many other products marketed by German companies besides therapeutics. Unfortunately, no satisfying material is published to break this fraction further down into detailed categories. Amongst the most successful product categories manufactured by German biotech companies are the following: Diagnostics (molecular diagnostics, in vitro diagnostics, biomarkers, microbial diagnostics etc.) Tools (reference markers, custom-made nucleotides, peptides etc.) Cell culture equipment (media, factors etc.) In addition, many German companies develop technologies which have become an important source of income through service agreements and collaborations. Successful new technology platforms from German biotech companies were for example applied to screening, protein engineering, expression, drug delivery and purification processes or to library and cell culture systems. 10 Weichen stellen Deutscher Biotechnologie-Report 2011

13 Executive Summary 4. Transactions Relevance of transactions Collaboration with partners has always been a major aspect in the business activities of biotech companies. They have played a role in transforming academic ideas into commercial projects as well as in co-developing products together with pharma partners towards the market. In the context of actual changes towards the new health ecosystem, collaboration gains even more relevance. It is about sharing more activities along the value chain of drug development, sharing intellectual properties in an open innovation setting and also expanding the network to include non-traditional partners from other industries (e. g. IT). For biotech companies, transactions have also become one of the most important alternatives for funding further developments. Therefore, it is important to position the company in the right way to attract partners into lucrative alliances. Performing the analysis of transactions on the increasingly complex background of different business models and agreement schemes has become much more difficult. The availability of exact and comprehensive figures also varies between different deal types. Alliances according to the classical upfront-milestone-royalty scheme are more openly communicated as important news flow for involved companies; in contrast, license deals often show up as a press notice without figures and service deals on the other end of the spectrum are often kept confidential and undetected in available statistics. Alliances in Germany The total number of alliance agreements closed by German biotech companies has recovered from an all time low in 2009 to reach almost pre-crisis levels (2006 / 2007) of about 100 published deals. Also in terms of payments and published deal volumes (for therapeutic alliances), 2010 shows clear signs of recovery, even if the mega deals, both assigned to Cellzome (two deals with GSK in 2008 and 2010) are excluded. Aggregated (published) upfront Figure 4-2: Alliances of German biotech companies payments in annual comparison Sum (mil. ) Upfront payments Milestone payments Other and not specified payments Upfront payments (mega-deals, Cellzome / GSK) Milestone payments (mega-deals, Cellzome / GSK) and milestone payments add up to a total of 579 million euro compared to 290 million euro in 2009 and even in 2008 (109 million euro). For comparison: alliance numbers in the rest of Europe (526) and US (680) are slightly decreasing from a higher 2009 level Source: Ernst & Young, 2011 Figure 4-1: Alliances of German biotech companies in annual comparison No. of transactions Product- / asset purchase Service Licensing Cooperation Source: Ernst & Young, 2011 Weichen stellen Deutscher Biotechnologie-Report

14 Executive Summary Figure 4-5: Alliances of european biotech companies with published key data in annual comparison Sum (mil. ) Average (mil. ) Other partners Pharma partners Biotech partners Average other partners Average pharma partners Average biotech partners Source: Ernst & Young, 2011 M&A transactions in Germany There has been some attention in Germany to M&A deals, since half of the deals (total number of ten) did take place only between German biotech companies as merger partners: Applied Biosystems / GENEART WILEX / Heidelberg Pharma MorphoSys / Sloning BioTechnolgy Apogepha / Urotec This is important since most involved companies retained their assets, sites and employees in Germany. Alliance types with differentiated dynamics More detailed analysis of different types of alliances shows a clear shift towards outlicensing agreements (31 % to 39 %) at the expense of collaborations (42 % to 31 %). Likewise, this is observed in the rest of Europe as well as in the US. It can be speculated that out-licensing of assets is linked to financial constraints which force companies to partly sell their silver in order to afford further development of remaining internal projects. Whereas the fraction of service deals is relatively high (approximately 20 %) and stable in Germany, this deal segment increases in the US and the rest of Europe. Alliance deal volume associated with partner type In an analysis of the European alliances including the three major partner types pharmaceutical, biotech and other companies (e. g. CROs) it becomes clear that pharma-biotech deals cover the biggest part of the deal volume (almost 80 %) whereas biotech-biotech transactions and deals with other players contribute much less to the overall deal volume. The same analysis comes up with very consistent average deal volumes of 150 to 200 million euro for pharma-biotech deals, 80 million euro for biotech-biotech deals and only around 20 million euro for smaller alliances with other partners. 12 Weichen stellen Deutscher Biotechnologie-Report 2011

15 Executive Summary Alliances reflect therapeutic area focus As discussed in the product development chapter, German biotech companies have a different focus regarding therapeutic areas compared to the rest of Europe. This is also reflected in the association of therapeutic collaborations to disease areas. Transactions involving German biotech companies are heavily biased on oncology deals corresponding to development activities. However, the same dominance of infectious disease deals is not seen in the product development comparison; an explanation for this mismatch comes from a number of marketing agreements closed by MediGene around their Veregen antigenital wart virus treatment. Therapeutics alliances in Germany focus on early stage product developments based on innovative technologies Significant differences show up in a comparison of therapeutic alliances, categorized by development stages, between Germany, Europe and the US. Figure 4-7: German and European alliances by therapeutic focus, % 6 % 9 % 18 % Germany 30 % 30 % 2 % 5 % 4 % 30 % 6 % Oncology Infectious disease Neurology Metabolic and endocrine Inflammation Autoimmune Cardiovascular Other Europe (rest) 17 % 18 % 18 % Source: Ernst & Young, 2011 Figure 4-8: Alliances by stage of development of negotiated therapeutics, 2010 Germany Europe USA 21 % 28 % 27 % 27 % 40 % 23 % 56 % 5 % 7 % 27 % 39 % Research Early (preclinical to phase I) Late (phase II to registration) Approved/marketed Source: Ernst & Young, 2011 Weichen stellen Deutscher Biotechnologie-Report

16 Executive Summary Germany has by far the highest share of discovery related deals (56 %). This can only be explained by a stronger focus in Germany on product-generating technology platforms that make companies attractive to innovation-starved pharmas even at pretty early stages of product development. Examples are Priaxon s p53-directed platform partnered with Boehringer Ingelheim to discover novel cancer drugs or Kinaxo and their phosphoproteomics approach joining forces with Roche. German biotech companies thus match their business focus very well with the demands from their pharmaceutical partners. Overview on alliances involving German biotech companies Table 4-1 displays relevant characteristics of major alliances involving German biotech companies. As mentioned before the early stage aspect and the link to technology platforms become evident. Table 4-1: Alliances of German biotech companies, 2010 (selection) Company Cellzome Pieris DeveloGen (subsidiary of Evotec) Priaxon MediGene MorphoSys Partner GlaxoSmithKline Sanofi- Aventis MedImmune (subsidiary of AstraZeneca) Boehringer Ingelheim Astellas Pharma Europe Xencor Country UK France USA Germany UK USA Date March-10 September-28 December-15 January-1 July-19 June-27 Deal focus Technology / product Technology / product Technology / product Product Product Product Therapeutic stage Research Research Preclinical Research Marketed Phase I Potential value (mil. ) at least at least 10 Upfront payments (mil. ) yes 5.0 9,8 Milestones (mil. ) yes 20.0 yes Royalties yes yes yes yes 2 % yes Content Agreement about development of drugs using Cellzome s proprietary Episphere technology for epigenetic enzymes from four different classes Discovery and development of two drug candidates by using Pieris proprietary Anticalin technology in case of success expansion to four more targets Exclusive access to DeveloGens research program in the field of Regeneration of insulinproducing Betacells in diabetis research Worldwide collaboration to R&D into mdm2/p53- inhibitors for cancer treatment by using Priaxon s expertise in the area of small molecule drug discovery Sale of European marketing and distribution rights for the treatment Eligard with 2 % share of net sales for MediGene Worldwide license and collaboration agreement for clinical antibody program MOR208 (Xm Ab 5574) for treatment of B-cell tumors Source: Ernst & Young, Weichen stellen Deutscher Biotechnologie-Report 2011

17 Executive Summary Table 4-3: Mergers and acquisitions of German biotech companies, 2010 (selection) Company Country Buyer Country Type Date Potential value (mil. ) GENEART Germany Applied Biosystems Germany Biotech April-8 at least 67 ProBioGen Germany Minapharm Pharmaceuticals Egypt Pharma June Heidelberg Pharma Germany WILEX Germany Biotech November Sloning BioTechnology Germany MorphoSys Germany Biotech September DeveloGen Germany Evotec Germany Biotech July imagenes Germany Source BioScience UK Biotech December Oncogene Science USA WILEX Germany Biotech November Graffinity Pharmaceuticals Germany NovAliX France Biotech November-16 IEP Germany Cambrex USA other March-22 Urotec Germany APOGEPHA Arzneimittel Germany Pharma September-18 X-Zyme Germany Johnson Matthey UK other July-5 Source: Ernst & Young, 2011 The same display with major European therapeutic alliances presents more product related deals and a tendency to later development stages (see chapter 4). Acquisitions follow more conservative rules Just looking at the project status of the most advanced portfolio asset of acquired companies in the list of top European M&A transactions (see chapter 4) reveals a major difference compared to alliances. Most of the top acquisitions are driven by late stage development products which will enter the market in short time and without remaining major development risk. At least with respect to the top M&A deals, the rationale seems to be more buying short term revenue rather than getting access to innovation. M&A transactions involving technology platforms Nevertheless, there are also quite some technology acquisitions among European and especially again among the German acquisitions. As mentioned above, MorphoSys has acquired Sloning and its Slonomics platform which allows the establishment of highly precise protein libraries and complements ideally MorphoSys HUCAL antibody platform. This strategic consideration has already been proven through a most recent alliance agreement MorphoSys was able to close with Pfizer including the Sloning platform. WILEX, at least in parts, acquired a drug conjugation platform from Heidelberg Pharma in addition to prototype antibodies. Similarly, the acquisitions of GENEART by Life Technologies (Applied Biosystems) and ProBioGen by Minapharm included technology assets as deal drivers. Overall, the number of 11 M&A transactions in Germany is still very low compared to alliances. Obviously, life science companies still shy away from the risk of combining two businesses to create one stronger company. Also using M&A as a strategy to portfolio consolidation although often discussed is not really observable; the case of WILEX buying Heidelberg Pharma, both part of the dievini Hopp portfolio, might be an exception. Weichen stellen Deutscher Biotechnologie-Report

18 Executive Summary Pharma Buyers with big pockets Pharma companies have realized the innovation potential of biotech companies and are spending significant amounts of money to leverage these assets. In a global analysis we have correlated the cash situation of big pharma companies with their activity in acquiring biotech companies (aggregated 5 year activity) or entering into alliances with them. No correlation was found between cash position, number of alliances or acquisitions or money spent in either alliances or M&A deals. The clear outperformers amongst big pharma, Pfizer, Roche and Novartis, most recently joined by Sanofi-Aventis during their turnaround under the new management display distinct peaks in terms of M&A numbers. Looking at deal volumes, Roche is also in the fore with the Genentech takeover (31.8 billion euro), whereas two more peaks indicate major acquisitions of MedImmune by Astra Zeneca (11.4 billion euro) and Genzyme (expected to be closed by Sanofi- Aventis). Pfizer, in turn, although with a high number of deals altogether, has placed its financial bets more into mega mergers, e. g. Wyeth which was considered their biggest move into biotech. Johnson & Johnson, second richest life science company with cash position of over 16 billion euro is relatively weak in acquiring biotech companies, most probably due to its broader scope with focus also on medical devices. Big pharma companies are clearly more active in closing alliance deals with biotech companies. Again, Roche is the clear leader in terms of deal numbers, but also Novartis and Sanofi-Aventis keep their position as transaction leaders. Another big one joining is GSK, as active as Roche in deal numbers and even leading in terms of deal size, however, falling behind in the M&A statistics. On the lower end are companies that neither outperform as buyers nor alliance leaders; in particular, Astra Zeneca shows little activity despite enormous cash reserves after its single important takeover of MedImmune. Other rather pale dealmakers are Abbott, BMS and Eli Lilly and the Japanese pharma companies. Figure 4-14: Cash on hand of Big Pharma companies, 2009 Sum (mil. ) 20,000 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Pfizer Johnson & Johnson AstraZeneca Roche Merck & Co. GlaxoSmithKline Takeda Novartis Bristol-Myers-Squibb Eli Lilly Abbott Laboratories Sanofi-Aventis Daiichi Sankyo Bayer Cash on hand Source: Ernst & Young, Weichen stellen Deutscher Biotechnologie-Report 2011

19 Executive Summary Figure 4-15: Acquisitions by selected Big Pharma companies, Sum (mil. ) No. of acquisitions 35, , , , , , , Pfizer Johnson & Johnson AstraZeneca Roche Merck & Co. GlaxoSmithKline Takeda Novartis Bristol-Myers-Squibb Eli Lilly Abbott Laboratories Sanofi-Aventis Daiichi Sankyo Bayer 0 Total acquisition value No. of acquired companies Total acquisition value without mega-deals Biotech targets headquartered in the USA or Europe Source: Ernst & Young, 2011 Figure 4-16: Alliances by selected Big Pharma companies, 2010 Sum (mil. ) No. of alliances Pfizer Johnson & Johnson AstraZeneca Roche Merck & Co. GlaxoSmithKline Takeda Novartis Bristol-Myers-Squibb Eli Lilly Abbott Laboratories Sanofi-Aventis Daiichi Sankyo Bayer 0 Total value of alliances No. of alliances Biotech partners headquartered in the USA or Europe Source: Ernst & Young, 2011 Weichen stellen Deutscher Biotechnologie-Report

20 Executive Summary 5. Financing and capital market After two very bad years in terms of funding for the German biotech industry, 2010 shows signs of recovery. The total equity financing volume for public and private biotech companies combined reached 422 million euro, more than 200 % increase over With this amount the industry almost returned to funding levels before the crisis. Both, private (244 % up to 279 million euro) and public companies (165 % up to 143 million euro) could benefit from the recovery. Nevertheless, the biotech sector in Germany now in the fourth year in a row still had no IPOs in This gives cause for serious concerns regarding the exit perspectives of young biotech companies in the longer run. The funding situation in Europe is recovering more slowly from the all time low in Precrisis levels are still far away (53 % below 2007 funding volume). In addition, there is quite a diverging development between private and public companies. Venture capital (1014 million euro) for private companies reached the 1 billion euro precrisis mark; anyway, VC levels had never dropped dramatically (only 25 %) throughout the economic crisis. Still, the situation is much more severe for the public sector (1336 million euro); total 2010 figures were even 60 % below precrisis values. Faint light at the end of the tunnel raises some hope for returning capital market interest for the biotech sector based on 10 European IPOs in However, looking at the average volumes of 16.5 million euro indicates that those IPOs are still not offering real exit options for the investors. In the US, precrisis levels for venture capital as well as follow-on offerings at the stock markets had already recovered in 2009; so 2010 appeared flat. The only significant positive development was reported from stock markets, where 15 IPOs raised a total of 1097 million US dollar, a major leap after 6(!) million US dollar in 2008 and 697 million US dollar in The strong comeback of the US stock market interest in biotech is further confirmed by high IPO volumes of 73 million US dollar on average which indeed did provide exit options to investors. Figure 5-1: Capital raised by year, Germany Sum (mil. ) Follow-on and other financings of public companies IPO Venture Capital Figure 5-2: Capital raised by year, Europe Sum (mil. ) Follow-on and other financings of public companies IPO Venture Capital Source: Ernst & Young, Source: Ernst & Young, Weichen stellen Deutscher Biotechnologie-Report 2011

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