Biotechnology in Italy 2008, the financial perspective

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Hugh Nicholson
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1 Biotechnology in Italy 2008, the financial perspective Milan, 09/02/2009 Leonardo Vingiani Director of Assobiotec

2 Italian Biotech: a growing sector Enterprises 228 Employees R&D employees Total revenues mln R&D investment mln Total Equity + 56% EBIT + 213% Net Debt - 30% Source Blossom Associati - CrESIT

Breakdown of biotech companies by size 170 (75%) are small enterprises employing fewer than 50 employees with annual sales of less than 10 mln Small 75% Large 13% 28 (12%) are medium-sized, employing

3 Breakdown of biotech companies by size 170 (75%) are small enterprises employing fewer than 50 employees with annual sales of less than 10 mln Small 75% Large 13% 28 (12%) are medium-sized, employing less than 250, with annual sales of less than 50 mln Medium 12% Source Blossom Associati - CrESIT 30 (13%) are large enterprises, employing over 250, withannual sales exceed 50 mln 31 subsidiaries, or branches of multinationals, of which 18 belong to the Pharma- industry category

4 Breakdown of biotech companies by sector 168 (74%) health care - Red Red 74% Green 13% Bioinfo 5% White 9% 30 (13%) agriculture, animal husbandry and veterinary - Green 19 (9%) industrial and enviromenta - White 11 (5%) bioinformatics - Bioinfo Source Blossom Associati - CrESIT

Geographical distribution of biotech clusters and companies Almost all the regions (17) of our country host biotech companies at present only a few have attracted numerically and economically

5 Geographical distribution of biotech clusters and companies Almost all the regions (17) of our country host biotech companies at present only a few have attracted numerically and economically significant concentrations of companies Lombardy: 78 companies (35% of the total) Piedmont: 31 (12%) Tuscany: 22 (10%) Friuli Venezia Giulia: 16 (7%) Latium: 15 (6%) Emilia Romagna: 14 (6%) Sardinia: 13 (6%) Source: Italian Biotechnology Directory 2007

6 Biotech in Italy: R&D Geographical distribution of total R&D emploees Breakdown of R&D investments in biotech activities by area Lombardy 52% Latium 16% Red 86.28% Tuscany 9.5% Emilia 8.7% Piedmont 4.5% Campania 3.2% Friuli VG 2% Green 11.76% White 1.60% Bioinfo 0.36% Source Blossom Associati - CrESIT

7 Pharma sector 168 enterprises 126 Born Biotech 42 Pharma-Biotech 28 Biotech oriented 14 Pharma oriented 29 subsidiaris 18 Pharma-Biotech Employees R&D employees Total revenues mln R&D investment mln

8 Biotech in Italy: R&D The number of products under development has practically tripled in only two years, passing from 30 in March 2006 to 84 in March 2008 Of the 84 products under development, 8 have been given orphan drug designation (3 by EMEA and 5 by both EMEA and the FDA). These are mainly products for use in the field of oncology. The remaining products are for cardiovascular use. Italian biotech research, furthermore, can boast 63 products at a preclinical developmental phase and 99 molecules at a discovery phase, which altogether constitute a promising foundation for the sector in the coming years. Source Blossom Associati - Assobiotec

Italy has 84 products in clinical development PIPELINE PHASE I PHASE II

9 Breakdown of pipeline by phase In March 2008 Italy shows a good pipeline: PIPELINE DISCOVERY PRECLINIC CLINICAL Total % 26% 34% 100% Italy has 84 products in clinical development PIPELINE PHASE I PHASE II PHASE III % 42% 19% Source Blossom Associati - Assobiotec Total %

10 Clinical Pipeline (Italy, March 2008) ntineoplastics and immunomodulators Neurology Cardiovascular stroenterology and metabolic diseases Hematology and hemopoietic organs Dermatology Respiratory Urology and reproductive organs Bone/Muscles Hormones (sex hormones excluded) Systemic antimicrobials Sense organs Others % 3 are biopharmaceuticals

Analysis by biotechnological technologies Among the technologies most frequently found in the biotech sector, there is a strong predominance of the use of recombinant protein (16%), monoclonal

11 Analysis by biotechnological technologies Among the technologies most frequently found in the biotech sector, there is a strong predominance of the use of recombinant protein (16%), monoclonal antibodies (14%) and peptides (9%) However, a good 51% of the technologies utilised do not belong to any of the foregoing categories (i.e. other): a large part of these products concerns small molecules, clearly developed through biotechnological technologies

12 Key Strengths of Italian Biotech The combination of high quality research together with low costs makes the Italian biotech system highly competitive Excellent scientific community with strong international interactions Excellent quality of research, with several dedicated centers Strong product pipeline: tripled in the last 2 years

13 Key Strengths of Italian Biotech proximity between base research and clinical studies increasing commitment of national and local Government towards biotech good level of social acceptance of the biotech, especially in medical and industrial area

14 Key Strengths of Italian Biotech In the last 3 years ( ) 6 Italian biotech companies have been quoted on the most important Stock Exchanges Gentium BioXell Newron Pharmaceuticals Cosmo Pharmaceuticals DiaSorin MolMed (IPO June 2005, NASDAQ) (IPO June 2006, Swiss Stock Exchange) (IPO December 2006, Swiss Stock Exchange) (IPO March 2007, Swiss Stock Exchange) (IPO July 2007, Borsa Italiana) (IPO March 2008, Borsa Italiana)

15 Good expectation new regulation on tax credit on research in the last Financial Law an increasing collaboration between academy and companies a first step in the acknowledgement of the status of Young Innovative Companies the birth of events like BioInItaly to match foreign capitals with italian biotech projects

16 2009 Where International investors meet Italian biotech companies Milan, May 4 th 5 th, 2009 BioInItaly will bring together national and international venture capital and Italian companies from all sectors of the biotechnology industry. The event provide a unique opportunity for investors to monitor the pulse of the dynamic biotech sector in Italy. Investors will have an opportunity to discover some of the exciting developments in the Italian biotech sector in a single meeting. Join us!

17 Info For more information about italian enterprises

18 Thanks for your attention For more information: Assobiotec, Italian Association for the Development of Biotechnology Via Giovanni da Procida 11, Milan - Italy Ph ; Fax assobiotec@federchimica.it

Biotechnology in Italy

Italian Association for the Development of Biotechnology Biotechnology in Italy The Financial Perspective 2008 Blossom Associati - Assobiotec Report MANAGE INNOVATION Leadership Finance Management Companies