Title: 2005 Global Pharmaceuticals Conference New York, 24 May 2005
12005 Global Pharmaceuticals Conference New York,
24 May 2005
- Presented by Ivan Mijatovic
- CFO Vice-President of Management Board
www.pliva.com
2Disclaimer
- This presentation contains certain forward
looking statements based on PLIVAs current
beliefs and expectations about future events.
Such statements include descriptions of new
products expected to be introduced or which have
been introduced by Group companies and
anticipated customer demand for such products.
These statements are subject to numerous risks,
uncertainties and assumptions and are not
necessarily predictive of future results. Actual
results may differ materially from those
anticipated in the forward looking statements
depending on factors such as the progress of
clinical trials, product acceptance by
physicians, patient compliance, the outcome of
litigation, competition, regulatory actions,
fluctuations in currency, exchange and interest
rates, operating results, the effectiveness of
cost reduction measures, the effects of business
consolidation and restructuring and the impact of
any other factors not known to PLIVA or not
currently considered material by PLIVA.
3Generics PLIVAs Strategic Focus PLIVA to Exit
Proprietary Business
- Strategic review of core activities and strengths
shows greater value from focus on PLIVAs
generics business - Proceeds from proprietary divestments to be
reinvested in generics - SANCTURATM divested for total cash consideration
of up to USD 140m - USD 45m up front and up to USD 95m upon
achievement of commercial sales milestones - Removal of proprietary sales force yields
significant savings from Q3 - Divestment of remaining US proprietary operations
expected over next few months - Expected positive impact on 2005 earnings
4Generics PLIVAs Strategic Focus Where PLIVA
is Today
- 83 of PLIVAs revenue achieved on international
markets - Presence on 80 of global generics market through
focus on key markets - Proven capabilities in product development
- 1996 0 submissions
- 2000 22 submissions
- 2004 75 submissions/77 MAs
- Intensive CAPEX cycle completed
- 3 FDA approved and 2 MHRA approved manufacturing
sites post 2001 - Majority of production facilities in CEE
- Established infrastructure (QA/QC, Regulatory,
IT, Legal) supports future growth
1,130
600
424
5Generics PLIVAs Strategic Focus
- Further develop core competencies in generics
- Develop niche products including biosimilar
products, cytostatics, value-added generics, and
Paragraph IV - Build competitive manufacturing base
efficiencies through economies of scale and
improved utilization - Enhance and build leading position in selected
key generics markets - Develop strategic partnerships in order to
optimise portfolio potential
6Generics PLIVAs Strategic Focus Continuous
Generics Sales Growth
SALES in USDm
CAGR 29.3
Includes ROW
7PLIVAs RD in Generics Arena Core Competencies
Advantages
RD Product and API In house development
PRODUCTION
Vertical integration cost
competitive quality
MS Strong sales
network distribution channels
- 3 major centers of excellence with over 300
scientists covering chemistry, biotechnology,
formulation analytical work at a competitive
cost - Zagreb development for US and biosimilar
products, value added generics other complex
generic formulations - Krakow development for EU
- Brno development of cytostatics and other health
safety restricted products - Favorable regulatory and IP environment
- Standardization of regulatory files across CEE
facilitates prompt submission in EU - Launch in home CEE markets prior to patent
expiries in West
8Efficient New Product Development Teams
Increasing Number of Submissions Will Fuel
Growth
9Niche Generic Products Offer Long-term
ValueBiologicals Market Expected to Continuously
Grow
- Biologicals recorded sales of over USD 44bn in
2004 with annual growth from 15-25 - Biologicals represent up to 10 of total
pharmaceutical market - Seven of top ten hospital products represent
biologicals - 1/3 of drugs currently in RD are biological
drugs expected to dominate pipeline in long
term - More than 30 of sales in 2010-20 expected to
come from biologicals
10Niche Generic Products Offer Long-term ValueTwo
Advanced Biologicals Program
- Erythropoietin (EPO)
- Indication ANEMIA in dialysis patients for
chronic renal failure - Extensive clinical trials completed in Croatia in
2004 - Product launch expected in Croatia in 2005
- Advanced stage in preparations for WE clinical
program - Granulate Colony Stimulating Factor (GCSF)
- Indication NEUTROPENIA for chemotherapy
patients - CMC submitted to Drugs Institute
- 2 pilot clinical trials in progress
11Niche Generic Products Offer Long-term
ValueBiological Partnerships with Mayne and Barr
- Partnership with Mayne for EPO and G-CSF for
Western Europe, Middle East, North Africa and
Asia Pacific - Partnership with Barr for G-CSF for USA and
Canada - PLIVA is exclusive supplier to both partners
- EPO and G-CSF MAT Q3 2004 world-wide sales of USD
14.3bn (17) - Europe ROW USD 4.2bn (30)
- USA USD 10.1bn (13)
Global Erythropoietin Sales
Source Newport Horizon Global / IMS
12Niche Generic Products Offer Long-term
ValueCytostatics
- Challenging production process creates barriers
to entry - Specialised cGMP production facility in Brno,
Czech Republic - Facility FDA approved in September 2004
- In-house development co-operation with Dr.
Reddy Laboratories - Existing portfolio of 17 products
- Launches of new molecules including paclitaxel
(Poland) and carboplatin (Slovenia, USA) - Pipeline of 10 new products oral and injections
- 2004 worldwide sales of molecules in development
of USD 9.3bn - PLD-147, a novel oral cytostatic, in Phase I
clinical trials
13A Competitive Manufacturing Base
RD Product and API In house development
PRODUCTION
Vertical integration cost
competitive quality
MS Strong sales
network distribution channels
- Production concentrated in cost competitive
countries of CEE - Cost per employee in CEE over 60 lower than in
West - 5 sites provide flexible and quality services
while complying with cGMP requirements (3 FDA
approved, 2 MHRA approved) - Zagreb tablets, steriles, creams, API
- Krakow tablets, steriles
- Brno cytostatics
- West (Germany USA) tablets
- Consolidation of manufacturing sites from five to
four ongoing - Synergies within product supply process through
backward integration of API development and
production for targeted products - Outsourcing of low margin products to more cost
competitive countries
14Global Generics Marketing Sales Network
RD Product and API In house development
PRODUCTION
Vertical integration cost
competitive quality
MS Strong sales
network distribution channels
Baltic
Poland
Russia
Slovenia
Germany
Ukraine
UK
CIS
Czech Republic
China
Spain
Hungary
USA
Italy
Croatia
Strong business platform in eight key markets,
with presence in more than 30 countries world
wide. Total generic MS network of over 900
people across the globe.
15Well Positioned on Key PLIVA Markets in Generics
Business
- Increasing cost containment pressures on
healthcare systems world-wide favouring generics
use - 1 PLIVA market, US, represents close to half of
global generics market - Strong generic penetration of CEE, where PLIVA is
one of leading pharmaceutical companies - Well positioned top ten ranking on key EU
generics market
Source IMS World Review, 2005EGA PLIVA Estimate
16Strengthening Global Presence GenericsLong
Standing Experience in CEE
SALES in CEE (in USDm)
- Presence in key countries of Croatia, Poland,
Russia, Czech Republic, Hungary - PLIVA Key markets in 2004 USD 7bn
- CAGR 2004-10 7
- Top three ranking in Croatia and Poland
- Branded generics market supported by MS force of
over 600 - Over 600 products in CEE portfolio
- During 2004
- 243 approvals for 69 molecules
- 78 launches for 30 molecules
- Continuous new product development
- 621 pendings for 84 molecules
CAGR 10.5
17.6
Source IMS World Review 2004, PLIVA Estimate
17Strengthening Global Presence GenericsAggressive
Expansion in WE
SALES in WE (in USDm)
- Presence in key markets of Germany, UK, Spain
Italy - PLIVA Key markets in 2004 USD 12bn
- Well positioned in fast growing emerging generic
markets - Top ten generics ranking in Germany, Italy and
Spain - Full time MS force of over 250
- Over 750 products in WE portfolio
- During 2004
- 88 approvals for 24 molecules
- 99 new launches for 50 molecules
- Continuous new product development
- 340 pendings for 42 molecules
CAGR 145.0
19.9
Source IMS World Review 2004, PLIVA Estimate
18Strengthening Global Presence GenericsAggressive
Expansion in US
SALES in US (in USDm)
- US represents the largest generics market
- 2004 USD 19bn
- 35 molecules in portfolio
- Majority of top 15 generic products hold 1 or 2
market share - During 2004
- 11 approvals for 4 molecules
- 12 new launches for 3 molecules
- Continuous new product development
- 22 pendings for 8 molecules
CAGR 73.2
(3.2)
Source IMS World Review 2004, PLIVA Estimate
19PLIVA Looking Forward
- PLIVA will continuously improve its cost
competitiveness in key areas of Sales
Marketing, RD and Manufacturing - Development of a strong corporate product
portfolio - Strong organic growth of generics business with
more than 10 yoy - Increasing profitability over the next three
years
20Appendix
21Income Statement
22Operating Profit Breakdown in USDm
334.3
(126.7)
(31.0)
(23.6)
(76.1)
(6.3)
(11.0)
(1.0)
58.6
Revenue shown without FX Impact Net FX
Impact shown
23PLIVA Group FX Structure
- Appreciation of key currencies against USD
- HRK 6.4, EUR 5.0, PLN 24.5, CZK 14.9.
- Neutral FX impact (-1.5 USD 1.0m)
- Group revenue 4.6 (USD 13.2m) and Group costs
6.4 (USD 14.1m)
24Cash Flow StatementIn USDm
110.2
(20.3)
316.1
(3.9)
62.3
167.9
25Balance Sheet HighlightsIn USDm
Certain amounts as at 31 December 2004 have
been restated to conform with presentation in 2005
26PLIVA Ownership Structure 31 March 2005
27For additional information, please contact
Marija Mandic Executive Director Investor
Relations Corporate Communications Tel 1 385
1 6160 355 Tel 2 385 1 6120 909 Fax 385 1
6114 413 E-mail Marija.Mandic_at_pliva.com E-mail
ir_at_pliva.com
www.pliva.com