Portfolio management and product development in Actavis. 8 May 2007 Sigurdur O. Olafsson Deputy CEO

Transcription

1 Portfolio management and product development in Actavis 8 May 2007 Sigurdur O. Olafsson Deputy CEO

2 Disclaimer Any statement contained in this presentation that refers to Actavis estimated or anticipated future results or future activities are forward-looking statements which reflect the Company s current analysis of existing trends, information and plans. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially depending on factors such as the availability of resources, the timing and effect of regulatory actions, the success of new products, the strength of competition, the success of research and development issues, unexpected contract breaches or terminations, exposure to product liability and other lawsuits, the effect of currency fluctuations and other factors. Actavis does not undertake the obligation to update or alter these forward-looking statements beyond its duties as an issuer of listed securities on the Iceland Stock Exchange.

3 Introduction Presentation overview Product selection and target outline Increasing efficiency in generic drug development Product launching strategies

4 A remarkable growth story Actavis in employees Present in 1 country EUR57 million in sales Actavis today 11,000 employees Present in close to 40 countries EUR1.6 billion in sales products on the market 355 projects in pipeline 24 billion tablets/capsules capacity and strong access to low-cost manufacturing

5 Creating shareholder value Revenue 1,600 M* Market value March EUR3 bn m 2.390m 1,379M 2.231m 452M 579M 57M 34m est EURmm EURmm

6 Well placed in key markets Serbia 2% Netherlands 3% Romania 5% Russia, Ukraine & CIS 6% Other 12% North America 31% Core segments: Own label sales: Central and Eastern Europe and Asia North America West Europe, Middle East and Africa Third party sales Nordic 7% United Kingdom 7% Turkey 7% Germany 8% Bulgaria (incl. Higia) 11% Well positioned in key Western European markets Breakdown of sales includes sales and distribution of finished goods Revenues in Bulgaria include the distribution business of Higia, acquired in 2005

7 Critical mass important Aim for top-5 in key markets Iceland #1 Norway #1 Sweden #2 Finland #5 USA #6 UK #2 Netherlands #4 Denmark #3 Malta #1 Germany #5 Russia #11 Serbia #3 Portugal #10 Turkey #7 Bulgaria #1 Sources: Bulgaria, Norway, Sweden, Denmark, Finland, Portugal, Turkey, Netherlands - IMS Dataview 2006; UK - IMS BGMA data at Tariff value price level; For volume, Actavis is #2; Russia Pharmaexpert 2006; Serbia IMS 2005 Data, USA IMS US IMS Prescription Audit - New and refilled prescriptions;

8 Actavis manufacturing sites Capacity of 24 billion tablets & capsules 20 manufacturing plants in 12 countries Plus one manufacturing plant in Norway for plasters

9 Local development sites and development capabilities North America Elizabeth, NJ SR, MR SOD Owings Mills, MD SSL Little Falls, NJ Conventional SOD Abrika Fort Lauderdale, FL Controlled release and other technically difficult products Europe Iceland SOD Both SR, MR and conventional products Malta conventional SOD Turkey Development unit mainly for the local market, conventional SOD Romania Oncological products India Lotus Labs Contract Research Organization Actavis Pharma Development API development Actavis Development unit concentrating on transfers Actavis API manufacturing and development

10 Product selection and target outline

11 Dynamic pipeline End of 2006 EU US ROW Total Development projects Molecules Ongoing registrations Early Development Full Development Biostudy / Stability Registration Total pipeline: 355 projects

12 Development project outline

13 Importance of a strong pipeline Short lifecycle of many generic products Older products have to be replaced with new products Pressure on prices Competitors Government initiatives for cost containment efforts Premium prices upon timely launch

14 Seven portfolio key segments

15 Portfolio process

16 Increasing efficiency in generic drug development

17 Growing presence in India Fully integrated Fully operational API research centre in Bangalore Over 60 employees DMF s a year Strong CRO business with over 200 bio-studies a year Analytical lab to support global stability studies Total of 620 employed in India

18 Actavis API objectives Cost Reduction APIs - significant costs component In-house API process development and production reducing cost IP and first to file Originators IP strategy is focused on the APIs (particle size, polymorphs, salts, etc) Counter these strategies Develop value added APIs - possible exclusivities Business continuity/risks Third-party API supply is subject to many risks; quality, supply shortage, patent infringement etc In house API supply does not eliminate these risks but enables us to identify and manage them much more efficiently

19 API Manufacturing India Current setup Actavis Alathur Acquired from Sanmar in February 2007 Located in Alathur 45 km from Chennai FDA approved and fully GMP compliant Currently best suited for small volume products Expansion plans Actavis is already expanding the Alathur API site Plan to reach 100 MT manufacturing capacity Contract manufacturing arrangement

20 Lotus - Platform for increased R&D output at lower cost Clinical research organization acquired May 2005 Clinical research work for Actavis Third party clients Operated and managed totally independent of Actavis finished form development Chinese wall Significant savings on clinical and BE studies Full control of quality and compliance High focus on GLP and GCP

21 Lotus cont d Audited by US FDA, EU and other authorities Approximately 400 employees Over 1000 BE studies in the last 5 years 120 studies for US FDA submission since 2004 Over 70 studies for EU since 2002 Over 200 beds Currently studies every month 8 LC MS/MS, 10 by year end 2007

22 Lotus cont d Increased focus on Phase I studies including first in man Drug- drug interaction studies BE studies on patients (Hormones and Oncology products) Phase III and IV capabilities New chemical entities Biosimilars Vaccine

23 Product launching strategies

24 Strong portfolio and pipeline management Around 650 products on the market 355 products under development and pending registration product and market launches 38 ANDA filings 2007 guidance Over 500 product and market launches ANDA filings expected in the US market

25 Launch management Timely selection of products for development Constant focus on meeting timelines Development Regulatory Sales & Marketing Supply chain Operations

26 Thank you