A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider...

24
A Global Pharmaceutical Service Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February 2010

Transcript of A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider...

Page 1: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

A Global Pharmaceutical Service Provider (GPSP)

UBS 20th Annual Global Healthcare Service Conference

New York , 8th February 2010

Page 2: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 3: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

Introduction

Pierrel s.p.a. is a Public Company

listed (PRL) on the “Borsa Italiana”

stock market since May, 2006stock market since May, 2006

Page 4: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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 ..

Page 5: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 6: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 7: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 8: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 9: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

The Global CRO Rooted in the Local Domain

Headquarters in Germany

European

HeadQuarters

Oncology

Page 10: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 11: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 12: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 13: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 14: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

The Global CRO Rooted in the Local Domain

Some of Pierrel CRO clients

Page 15: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 16: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 17: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 18: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

The Global CRO Rooted in the Local Domain

Pierrel Contract Manufacturingbetter production for better drugs

Page 19: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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)

Page 20: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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.

Page 21: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 22: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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.

Page 23: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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

Page 24: A Global PharmaceuticalService Provider (GPSP) UBS.pdf · A Global PharmaceuticalService Provider (GPSP) UBS 20 th Annual Global Healthcare Service Conference New York , 8 th February

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