A Global Pharmaceutical Service Provider (GPSP)

Transcription

1 A Global Pharmaceutical Service Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York, 8 th February 2010

2 Disclaimer The documentation referred to into this presentation relates merely to the past and current activities of Pierrel S.p.A. (the"company )as available from public sources. The information contained herein therefore are not and must not be construed, under any circumstances, as a direct or indirect offer nor solicitation of the Company nor an invitation to subscribe for or purchase shares of the Company in the U.S.A., Canada, Japan, Australia or in any other country where the subject offer is not permitted in the absence of an authorization of the competent authorities (the"other Countries"). Under no circumstances and for no reasons, information included in this presentation can be copied or sent or otherwise reproduced, in whole or in part nor can this presentation and/or any other information contained herein be distributed to persons without the Company s prior consent. This report includes forward-looking statements covered by the Private Securities Litigation Reform Act of Because such statements deal with future events, they are subject to various risks and uncertainties and actual results for fiscal year 2009 and beyond could differ materially from the Company's current expectations. Forward-looking statements are identified by words such as "anticipates," "projects," "expects," "plans," "intends," "believes," "estimates," "targets," and other similar expressions that indicate trends and future events. Factors that A could Global cause the Pharmaceutical Company's results to differ Service materially from Provider those expressed (GPSP) in forward-looking statements include, without limitation, variation in demand and acceptance of the Company's products and services, the frequency, magnitude and timing of paper and other raw-material-price changes, general business and economic conditions beyond the Company's control, timing of the completion and integration of acquisitions, the consequences of competitive factors in the marketplace, cost-containment strategies, and the Company's success in attracting and retaining key personnel. Additional information concerning factors that could cause actual results to differ materially from those projected is contained in the Company's

3 Introduction Pierrel s.p.a. is a Public Company listed (PRL) on the Borsa Italiana stock market since May, 2006

4 From Manufacture to Market services Contract Pharmaceutical Organization (CPO) C Contract Research Research Organization CRO Two Services for One Mission.. Manufacturing Contract Manufacturing Organization CMO

5 CRO Division Exp. Revenues (pro forma) 2009: 40,5 mln EBITDA (pro forma) 2009: 2,8 mln Employees: 500 ❿ Revenues: 5,9 mln EBITDA: 0,2 mln Employees: 18 Countries: 1 Services: Phase II- III yrs Countries: 20 Services: Phase I, II, III, IV, late Phase and IMP 2009

6 Key Facts - 2 nd European Public Clinical CRO* 9 th Worldwide Public Clinical CRO* 24 th Worldwide Clinical CRO * *Source : Pharmaceutical Outsourcing 2008 report UBS Investment Bank

7 CRO division growing plan ACTIONS: Revenues: 5,9 mln EBITDA: 0,2 mln Employees: 18 Countries: 1 Services: Phase II- III Expected Revenues (pro forma) 2009: 40,5 mln EBITDA 2009 (pro forma): 2.9 mln Employees: 500 Countries: 20 Services: Phase I, II, III, IV, late Phase and IMP Increase the territorial coverage Leverage the therapeutic expertise Implement the new partnership business development model Near Future

8 Full Services from First In Man to drug approval and beyond NCEs Screening & Discovering Late Phase, PMS Non- Interventional POST DRUG APPROVAL Marketing Support: MAH PhV Scientific Advice & CME Events Labs & Animal Studies REGULATORY AGENCY MKT AUTHORIZATION IMP Preparation & Mng. NDA to Regulatory Authorities Not Provided Phase I Phase II- III studies DRUG MARKETING APPROVAL

9 Headquarters in Germany European HeadQuarters Oncology

10 Current international Operations Canada USA UK France Oncology Polska Pierrel Research Austria Europe and Germany Baltic States Russia Slovakia Hungary * The companies are going to be founded Spain, Switzerland PIERREL RESEARCH INTERNATIONA L*, Switzerland Italy IMP Contract Accounting Services* Romania, Bulgaria Balkan

11 By 2011, 65% of FDA-regulated clinical trials for the top biopharmaceutical companies will be conducted outside the US

12 The Global CRO Rooted in the local domain 493 million population 4,422,773 km2 27 Countries 27 different languages 27 different cultures 27 different medical cultures 27+1 authorities 27+1 regulations Coordination with US Challenge for service providers for the pharmaceutical industry

13 e-clinical Trial Fully Integrated and validated highly sophisticated technology Platform * * Developed in collaboration with Cineca, one of the most worldwide important computing centre

14 Some of Pierrel CRO clients

15 Preferred Provider To ALTANA Pharma AG Astellas Pharma Europe B.V. All kind of studies and services in gastro area Data management, Biostatistics, Programming LETI Pharma GmbH Merz Pharma GmbH All kind of studies and services All kind of studies Sanofi Aventis All kind of studies

16 Clinical Trials Metrics (Worldwide) By Therapeutic Area Projects (N=435) Sites (N=13.198) Patients (N= ) Immunology/Infectious Diseases Cardiology/Vascular Diseases Oncology Gastroenterology Pulmonary/Respiratory Diseases Pharmacology/Toxicology Endocrinology Neurology Nephrology/Urology Rheumatology Hematology Psychiatry/Psychology Dermatology/Plastic Surgery Obstetrics/Gynecology Musculoskeletal Dental/Maxillofacial Surgery Muscoloskeletal Ophthalmology Not Applicable Activity

17 Clinical Trials Metrics (Worldwide) By Type of Trial Projects (N=435) Sites (N=13.198) Patients (N= ) Phase I Phase II Phase III Phase IV Non Interventional Study (NIS) Medical Device Activity

18 Pierrel Contract Manufacturing better production for better drugs

19 50 years experience in CMO Since 1960 Pierrel is specialized in pharmaceuticals contract manufacturing The more recent production department was built in 2008 to international GMP standards, approved by EMEA and AIFA andfda(october2009)

20 Manufacturing Plant The top notch manufacturing site, located in Capua Italy, licensed by FDA and EMEA, via an aseptic production process. Pierrel in the last 3 years invested more than 50 Million $ to upgrading the plant at the most advanced worldwide standards.

21 PIERREL Insource Innovative Model Articaine case CRO Articaine significant advancement in the management of local anesthesia CMO Articaine Pierrel USA NDA filed Approved in Europe, Canada FDA approval expected 1-2Q 2010

22 Articaine differs from other local anesthetic agents used in dentistry. A growing market worth more than 200M$ o High and fast local anesthetic efficacy. o Effective in 95% of patients. Other anesthetics 75-85%. o Safety and Efficacy data available from Canada and Europe. o Very rare adverse local and systemic toxicity; o Preferred choice of European Dentists for all dental treatment of adults and children in patient with high risk; o Articaine is also administered frequently in nondental surgeries, such as in ophthalmology, orthopedic surgery and spinal anesthesia due to it s potency, predictability, efficacy and stability.

23 Leverage on Pierrel Know How and entrepreneurial spirit to implement Innovative models of partnerships Common Partnership Model Financial Sponsor BIOTECH/ Pharma CROs Innovative Partnership Model Biotech Projects Venture Capital

24 Conclusions Truly full service global company Fast growing company, thanks to its outstanding personnel, technology platform and its direct geographical presence in key locations Clear strategy plans, leveraging company know how and adoption of new collaboration models Solid platform for solid growth