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A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider...
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A Global Pharmaceutical Service Provider (GPSP)
UBS 20th Annual Global Healthcare Service Conference
New York , 8th February 2010
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 1995. 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.
A Global Pharmaceutical Service Provider (GPSP)
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 could cause the Company's results to differ materially from those expressed 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
Introduction
Pierrel s.p.a. is a Public Company
listed (PRL) on the “Borsa Italiana”
stock market since May, 2006stock market since May, 2006
From Manufacture to Market services
Contract Pharmaceutical Organization (CPO)
ContractTwo Services
Research
Contract
Research
Organization
CRO
Manufacturing
Contract
Manufacturing
OrganizationCMO
Two Services
for One
Mission ..
The Global CRO Rooted in the Local Domain
� Exp. Revenues
(pro forma) 2009:
40,5 € mln
� EBITDA
CRO Division
2005 2009
� Revenues: 5,9 € mln
� EBITDA: 0,2 € mln
� Employees: 18
� Countries: 1
� Services: Phase II- III
� EBITDA
(pro forma) 2009:
2,8 € mln
� Employees: 500
� Countries: 20
Services: Phase I, II, III, IV, late Phase and IMP
4 yrs
The Global CRO Rooted in the Local Domain
Key Facts - Pierrel Research
2nd European “Public” Clinical CRO*
9th Worldwide “Public” Clinical CRO*9th Worldwide “Public” Clinical CRO*
24th Worldwide Clinical CRO *
*Source : Pharmaceutical Outsourcing 2008 – report UBS Investment Bank
The Global CRO Rooted in the Local Domain
� Expected Revenues (pro forma) 2009: 40,5 € mln
� EBITDA 2009
ACTIONS:
� Increase the territorial coverage
� Leverage the therapeutic
CRO division growing plan
2005 2009
Near Future
� Revenues: 5,9 € mln
� EBITDA: 0,2 € mln
� Employees: 18
� Countries: 1
� Services: Phase II- III
� EBITDA 2009
(pro forma): 2.9 € mln
� Employees: 500
� Countries: 20
� Services: Phase I, II, III, IV, late Phase and IMP
therapeutic expertise
� Implement the new partnership business development model
The Global CRO Rooted in the Local Domain
NCEs Screening & Discovering
Labs & Animal Studies
Late Phase, PMS Non-
Interventional
Marketing Support:
Scientific Advice & CME Events
MAH PhV
REGULATORY AGENCY MKT
AUTHORIZATION
POST DRUG APPROVAL
Full Services from First In Man to drug approval and beyond
Studies
IMP Preparation & Mng.
Phase I
Pierrel Research
Not Provided
Phase II- III studies
NDA to Regulatory Authorities
AUTHORIZATION
DRUG MARKETING APPROVAL
The Global CRO Rooted in the Local Domain
Headquarters in Germany
European
HeadQuarters
Oncology
The Global CRO Rooted in the Local Domain
Pierrel Research Austria
Pierrel Research Europe and Germany
Pierrel Research Polska
Pierrel Research Baltic States Pierrel Research
Russia
Canada
Current international Operations
Pierrel Research Balkan
France
Spain
Pierrel Research UK
Pierrel Research Romania,
Pierrel Research Bulgaria
Pierrel Research Hungary
Pierrel Research Slovakia
Pierrel Research, Switzerland
Pierrel Research ItalyPIERREL
RESEARCH INTERNATIONAL*,
Switzerland
Pierrel Research IMP
Pierrel Research Oncology
Pierrel Research Contract Accounting Services*
* The companies are going to be founded
Pierrel Research
USA
The Global CRO Rooted in the Local Domain
By 2011, 65% of FDA-regulated clinical trials for the top biopharmaceutical companies will be conducted outside the US
The Global CRO Rooted in the Local Domain
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 cultures
• 27 different medical cultures
• 27+1 authorities
• 27+1 regulations
• Coordination with US
Challenge for service providers
for the pharmaceutical industry
The Global CRO Rooted in the Local Domain
e-Clinical Trial
Fully Integrated and validated highly sophisticated technology Platform *
* Developed in collaboration with Cineca, one of the most worldwide important computing centre
The Global CRO Rooted in the Local Domain
Some of Pierrel CRO clients
The Global CRO Rooted in the Local Domain
Preferred Provider To
� ALTANA Pharma AG All kind of studies and
services in gastro area
� Astellas Pharma Europe B.V. Data management,
Biostatistics,
ProgrammingProgramming
� LETI Pharma GmbH All kind of studies and
services
� Merz Pharma GmbH All kind of studies
� Sanofi Aventis All kind of studies
The Global CRO Rooted in the Local Domain
Clinical Trials Metrics (Worldwide)By Therapeutic Area
23
31
31
39
53
57
92
Endocrinology
Pharmacology/Toxicology
Pulmonary/Respiratory Diseases
Gastroenterology
Oncology
Cardiology/Vascular Diseases
Immunology/Infectious Diseases
Projects (N=435)
6498
2844
4977
15571
8408
48566
21599
Patients (N=136.063)
601
75
440
1427
858
4888
1782
Sites (N=13.198)
Activity 2007-2009
6
1
2
3
4
4
10
12
13
13
19
22
0 20 40 60 80 100
Not Applicable
Ophthalmology
Muscoloskeletal
Dental/Maxillofacial Surgery
Musculoskeletal
Obstetrics/Gynecology
Dermatology/Plastic Surgery
Psychiatry/Psychology
Hematology
Rheumatology
Nephrology/Urology
Neurology
282
43
3090
182
200
361
2400
4387
554
4175
7490
4436
0 20000 40000 60000
6
2
76
16
4
37
298
483
69
721
805
610
0 2000 4000 6000
The Global CRO Rooted in the Local Domain
Clinical Trials Metrics (Worldwide)By Type of Trial
77
66
Phase II
Phase I
Projects (N=435)
9278
5730
Patients (N=136.063)
1199
125
Sites (N=13.198)
Activity 2007-2009
12
53
46
181
0 50 100 150 200
Medical Device
Non Interventional Study (NIS)
Phase IV
Phase III
803
47910
26857
45485
0 20000 40000 60000
40
5648
2235
3951
0 2000 4000 6000
The Global CRO Rooted in the Local Domain
Pierrel Contract Manufacturingbetter production for better drugs
The Global CRO Rooted in the Local Domain
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
and FDA ( October 2009)
The Global CRO Rooted in the Local Domain
Manufacturing Plant
The top notch manufacturing site,
located in Capua – Italy, licensed by
FDA and EMEA, via an aseptic
production process.production process.
Pierrel in the last 3 years invested
more than 50 Million $ to
upgrading the plant at the most
advanced worldwide standards.
The Global CRO Rooted in the Local Domain
PIERREL Insource Innovative Model
Articaine case
Articaine Pierrel USA NDA filed
CROArticaine significant advancement in the management of local anesthesia
Articaine Pierrel USA NDA filed
Approved in Europe, Canada
FDA approval expected 1-2Q 2010
CMO
The Global CRO Rooted in the Local Domain
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.
Articaine differs from other local anesthetic agents used in dentistry.A growing market worth more than 200M$
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 non-
dental surgeries , such as in ophthalmology ,
orthopedic surgery and spinal anesthesia due to it’s
potency, predictability, efficacy and stability.
The Global CRO Rooted in the Local Domain
CROsFinancial Sponsor BIOTECH/Pharma
Leverage on Pierrel Know How and entrepreneurial spirit to implement Innovative models of partnerships
Common Partnership Model
Innovative Partnership Model
Venture Capital
BiotechProjects
The Global CRO Rooted in the Local Domain
Conclusions
• Truly full service global company
• Fast growing company , thanks to its outstanding personnel, technology platform and its direct 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