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2001-2004 Building Value
Milan, 9 May 2001
Milan, 9 May 2001
• Giovanni Recordati
Chairman and Chief Executive Officer
• Walter Bevilacqua
Vice President Corporate Development
• Avi Sartani
Vice President Pharmaceutical R&D
1
Giovanni Recordati
Chairman and Chief Executive Officer
2
KEY EVENTS IN 2000
•
•
•
•
Strong improvement in business
Expansion in France completed successfully
Zanidip® license for the USA
Pharmacia agreement: a strong basis for further growth
3
KEY TRENDS IN Q1 2001
•
•
•
•
Sales up 40.4%
Double digit organic growth continues
International sales over 60% of total sales
Strong increase in international sales of
lercanidipine
• Further increase in profitability
4
Walter Bevilacqua
Vice President Corporate Development
5
RESULTS Q1 2001
Q1 2000
Q1 2001
Change %
Net Sales
147.8
207.5
40.4%
Gross Profit
as % of sales
86.1
58.3%
121.6
58.6%
41.2%
R&D Expenses
as % of sales
17.6
11.9%
15.9
7.6%
(9.9)%
EBITDA
as % of sales
EBIT
as % of sales
26.3
17.8%
43.9
21.1%
66.7%
17.3
11.7%
28.5
13.7%
64.6%
Pretax Income
as % of sales
Net Income
as % of sales
21.1
14.3%
25.3
12.2%
20.2%
14.1
9.6%
16.2
7.8%
14.4%
(billion lira)
6
NET INCOME
Q1 2000
Q1 2001
Change %
Net Income
from Operations
10.7
16.5
54.2%
Non-recurring
Income / Expense, (Net)
3.4
(0.3)
n.s.
Net Income, Comprehensive
14.1
16.2
14.4%
(billion lira)
7
COMPOSITION OF SALES
Q1 2000
Q1 2001
Change %
PHARMACEUTICALS
108.8
73.6%
165.8
79.9%
52.5
ACTIVE INGREDIENTS
& INTERMEDIATES
39.0
26.4%
41.7
20.1%
6.7
TOTAL
147.8
100.0%
207.5
100.0%
40.4
ITALY
78.1
52.8%
81.5
39.3%
4.3
INTERNATIONAL
69.7
47.2%
126.0
60.7%
80.8
(billion lira)
8
COMPOSITION OF PHARMACEUTICAL SALES
(billion lira)
Q1 2000
Q1 2001
Change %
Pharmaceuticals Italy
73.8
67.8%
76.4
46.1%
3.6
Pharmaceuticals France
12.7
11.7%
47.4
28.6%
273.9
Pharmaceuticals Spain
8.5
7.8%
9.7
5.8%
14.3
International licensees
13.8
12.7%
32.3
19.5%
133.5
International pharmaceuticals
35.0
32.2%
89.4
53.9%
155.5
TOTAL PHARMACEUTICALS
108.8
100.0%
165.8
100.0%
52.5
9
SOURCES OF GROWTH
(% change, Q1 2001 over Q1 2000)
Price /
Volume Exchange
Total
Pharmaceuticals
12.9%
0.9%
+ 13.8%
Pharmaceutical Chemicals
7.4%
-0.7%
+ 6.7%
Organic Growth, total
11.4%
0.5%
+ 11.9%
Acquisitions
28.5%
Total Growth
39.9%
+ 28.5%
0.5%
+ 40.4%
10
EBITDA BY BUSINESS AREA
Q1 2000
Q1 2001
Change %
16.6
15.3%
33.8
20.4%
+ 103.7%
9.7
22.7%
10.1
21.9%
+ 3.4%
26.3
17.8%
43.9
21.1%
+ 66.7%
Operating depreciation
7.8
8.9
+ 14.3%
Goodwill amortization
1.2
6.5
+ 421.5%
17.3
11.7%
28.5
13.7%
+ 64.6%
(billion lira)
Pharmaceuticals
as % of sales
Pharmaceutical Chemicals
as % of sales*
Total
as % of sales
EBIT
as % of sales
* Including inter-company sales
11
CAPITAL EMPLOYED
2000
31 DEC
2001
31 MAR
Net Working Capital
for Operations
182.2
199.5
Net Non-current Assets
376.4
370.3
Reserves for Long - term
Liabilities
(43.1)
(42.9)
CAPITAL EMPLOYED
515.5
526.9
Net Debt
250.1
158.8
Shareholders’ Equity
265.4
368.1
FINANCING OF
CAPITAL EMPLOYED
515.5
526.9
0.94
0.43
(billion lira)
NET DEBT / EQUITY
RATIO
12
ZANIDIP® WORLDWIDE
SITUATION AND OUTLOOK
13
ZANIDIP® (LERCANIDIPINE)
A COMPARATIVE PRODUCT PROFILE
• Latest generation calcium-channel blocker
• Natural once a day
• Efficacy comparable to best competitors
• Excellent / superior tolerability and safety profile
14
ZANIDIP® (LERCANIDIPINE)
THE REFERENCE MARKET
• Hypertension is the largest indication worldwide - over
$30 billion
• Addressed by several classes of drugs
• CCBs are one of the largest, about $10 billion
• The leading brand is Norvasc® (amlodipine), sold by
Pfizer, about $3.4 billion
15
LERCANIDIPINE IN ITALY
MARKET SHARE AS A % OF NORVASC®
20%
Zanedip® as a
% of Norvasc®
10%
lercanidipine as
a % of
amlodipine
0%
1998
1999
2000
16
LERCANIDIPINE IN ITALY
MARKET SHARE AS A % OF OTHER CCBs
15%
(amlodipine
excluded)
10%
Zanedip® as a
% of other CCBs
5%
lercanidipine as
a % of other
CCBs
0%
1998
1999
2000
17
ROLL OUT HISTORY
1998
AUSTRIA
GREECE
ISRAEL
ITALY
LUXEMBOURG
NETHERLANDS*
SPAIN
UK
1999
BELGIUM
BRAZIL
LEBANON
2000
CHILE
CYPRUS
DENMARK
FINLAND
GERMANY
KOREA
KUWAIT
NORWAY
PAKISTAN
PHILIPPINES
SWEDEN
EXPECTED
2001
ARGENTINA
FRANCE
ECUADOR
HONG KONG
MEXICO
SINGAPORE
TAIWAN
TURKEY
VENEZUELA
VIETNAM
* Dec. 1997
18
ROLL OUT PLAN
Status Today:
LAUNCHED:
25 countries, representing approx. 29%
of world market (of which 15% in last
12 months)
APPROVED:
4 additional countries
FILED FOR
APPROVAL:
32 additional countries
LICENSED:
>40 additional countries
19
ROLL OUT PLAN
Key countries where regulatory development is ongoing:
AUSTRALIA (registered, launch late 2001 - early 2002)
CANADA
CHINA
USA
(filing expected 2H 2001)
JAPAN
(local phase III studies)
20
ROLL OUT PLAN
LICENSING / ROLL OUT TARGETS
ANNOUNCED FOR 2003
TO BE MET IN 2001
21
ZANIDIP® IN THE USA
FOREST LABORATORIES LICENSE AGREEMENT
22
THE HYPERTENSION MARKET IN THE USA
• Hypertension affects over 50 million people in the U.S.
• Market size exceeding 10 bn US$ in annual sales
• Calcium Channel Blockers account for well over one
third of the anti-hypertensive market…
• Norvasc® sales exceed $1.5 billion
Source: Recordati / Forest Laboratories
23
FOREST LABORATORIES: THE RIGHT PARTNER
• Annual sales exceeding 1.1 billion US$
• Sales force of over 1400 Reps
• Established presence in the cardiovascular market
• Tiazac® sales exceeding 150 ml US$ (5% market
share)
• Strong track record in European partnerships &
collaborations in FDA filings
Source: Forest Laboratories
24
TIAZAC® SALES DEVELOPMENT
(million USD)
158
130
140
120
5% market
share
85
100
80
60
40
25
20
0
1997
Source: Forest Laboratories
1998
1999
2000
Fiscal year ending March
25
Avi Sartani
Vice President Pharmaceutical R&D
26
DRIVERS FOR GROWTH
LICENSED-IN PRODUCTS
• Focus, determination, speed and willingness
to invest
• Multi-territorial presence
• Growing interest in the cardiovascular
therapeutic area
• A pipeline with the right balance between
potential and risks as well as time to market
27
FILLING THE PIPELINE:
LICENSING-IN ACTIVITIES
• At least 2 significant projects are in
advanced negotiations for products in the
cardiovascular area.
28
FILLING THE PIPELINE:
ONGOING R&D
• Lercanidipine:
- Consolidate its advantageous clinical profile
- Extend its patent life
29
FILLING THE PIPELINE:
ONGOING R&D
• Lercanidipine-ACEI fixed combination:
- New aggressive targets for blood pressure
control
- Combination of drugs needed for most patients
- Patient compliance
- Fixed combinations will play a significant role
in the future hypertension market.
30
FILLING THE PIPELINE:
ONGOING R&D
• Urology:
- Collaboration agreement with Pharmacia
- Lead optimization in the area of overactive
bladder is at an advanced stage
- Formulation activities are underway on a lead
compound for female sexual dysfunction
31
Giovanni Recordati
Chairman and Chief Executive Officer
32
Basis for 2001 - 2004 targets
• Current business
• Current products/late stage projects
• Current geography
®
• Zanidip in U.S., Japan not included
33
2001-2004 TARGETS
(billion lira)
2000
2001
2004
CAGR
2000-2004
Net Sales
689.1
825
1050
11.1%
Gross Profit
as % of sales
399.5
58.0%
483
58.5%
631
60.1%
12.1%
R&D
as % of sales
71.4
10.4%
70
8.5%
105
10.0%
10.1%
EBITDA
as % of sales
136.7
19.8%
173
21.0%
233
22.2%
14.3%
EBIT
as % of sales
90.3
13.1%
111
13.5%
171
16.3%
17.3%
34
EVOLUTION OF NET SALES & EBIT
(billion lira)
1100
980
1000
900
905
689
825
13.1%
13.5%
10.4%
11.0%
800
700
600
1050
18,0%
16,0%
16.3%
14,0%
15.2%
14.1%
12,0%
13.0%
12.1%
10,0%
500
8,0%
400
6,0%
300
4,0%
200
100
2,0%
0
0,0%
2000
2001
Net Sales
2002
EBIT
2003
2004
EBIT Prev. targets
35
RECORDATI IN 2004
2000
2004
CAGR
Net Sales
689
1050
11.1%
Pharmaceuticals
521
838
12.6%
Pharmaceutical Chemicals
168
212
6.0%
Italy
296
410
8.5%
Other Countries
393
640
12.9%
36
2001-2004 Building Value
Milan, 9 May 2001