Transcript www.recordati.it

2002-2005 The Next Step
Milan, 14 May 2002
2001 IMPORTANT EVENTS
• Lercanidipine:
successful launch in France
NDA filed in the USA
a new partner in Japan
• New product agreements:
pantoprazole, escitalopram, pitavastatin …
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KEY CONSOLIDATED DATA
(million euro)
EBIT
CAGR 41%
433.4
500
60
SALES
355.9
CAGR 23%
400
50
NET INCOME
CAGR 36%
271.8
40
300
214.9
192.3
30
EBIT
Net Income
200
20
100
10
0
0
1997
1998
1999
2000
1997
2001
Gross margin
80.7%
Pharmaceuticals
1998
1999
2000
2001
60%
25%
50%
20%
40%
15%
30%
10%
20%
19.3%
Pharmaceutical chemicals
EBITDA, EBITA, EBIT,
Net Profit
Gross % margin
EBITDA % margin
EBITA % margin
EBIT % margin
Net profit % margin
5%
10%
0%
0%
1997
1998
1999
2000
2001
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Pharmaceutical Net Sales
(million euro)
80.7%
349.6
400
Pharma as % of total
CAGR
30%
269.3
300
55%
63.7%
Int’l as % of pharma
188.5
200
122.5
200
140.4
150
19%
100
100
0
1997
1998
1999
2000
2001
50
0
1997
1998
Italy
1999
2000
2001
International
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EBITDA
€ 11.3 m
€ 14.5 m
€ 80.9 m
€ 17.6 m
1997
19.1%
9.2%
2001
Pharmaceuticals
23.2%
19.1%
Pharmaceutical
chemicals
As % of sales
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FIRST QUARTER COMPOSITION OF SALES
2001
2002
Change %
PHARMACEUTICALS
85.6
79.9%
107.6
83.2%
25.6%
PHARMACEUTICAL
CHEMICALS
21.5
20.1%
21.7
16.8%
1.1%
TOTAL
107.1
100.0%
129.3
100.0%
20.7%
ITALY
42.1
39.3%
52.0
40.2%
23.7%
INTERNATIONAL
65.0
60.7%
77.3
59.8%
18.8%
(million euro)
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SOURCES OF GROWTH
(% change, first quarter 2002 over
first quarter 2001)
Volume
Price /
Exchange
Total
PHARMACEUTICALS
16.6%
0.3%
16.9%
PHARMACEUTICAL
CHEMICALS
6.3%
(5.2)%
1.1%
14.6%
(0.9)%
13.7%
ORGANIC GROWTH, TOTAL
CHANGE OF CONSOLIDATION
PERIMETER
7.0%
TOTAL GROWTH
21.6%
7.0%
(0.9)%
20.7%
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FIRST QUARTER COMPOSITION OF
PHARMACEUTICAL SALES
(million euro)
Pharmaceuticals Italy
Pharmaceuticals France
2001
2002
Change %
39.4
49.3
46.1%
45.8%
24.9%
24.5
24.0
28.6%
22.3%
Pharmaceuticals Spain
5.0
International licensees
16.7
21.6
19.5%
20.1%
Sophartex
International pharmaceuticals
TOTAL PHARMACEUTICALS
5.8%
-
46.2
5.3
4.9%
7.4
6.9%
58.3
53.9%
54.2%
85.6
107.6
100.0%
100.0%
(2.1)%
5.6%
29.2%
-
26.3%
25.6%
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MAIN PRODUCTS
Breakdown of first quarter pharmaceutical sales
Zanidip 17%
(lercanidipine)
Other Products
20%
OTC 5%
Other revenue 10%
Elopram 7%
Main
Products
Tora-Dol 7%
Peptazol/
6%
Ulcotenal
Isocef 4%
Diezime 4%
Exomuc 4%
Urispas 2%
(flavoxate)
Lomexin 2%
(fenticonazole)
Hexa line 4%
(biclotimol)
Neo Codion 4%
Acequin/Acequide 2%
Amodex 2%
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RESULTS FIRST QUARTER
(million euro)
2001
2002
Change %
Net Sales
107.1
129.3
20.7%
Gross Profit
as % of sales
62.8
75.1
58.6%
58.1%
19.6%
31.6
37.6
29.5%
29.1%
8.2
10.0
7.6%
7.7%
21.7%
22.6
27.6
22.0%
Selling Expenses
as % of sales
R&D Expenses
as % of sales
EBITDA
as % of sales
EBIT
as % of sales
Net Income
as % of sales
21.1%
21.4%
14.7
18.4
19.0%
13.7%
14.2%
25.0%
8.3
9.9
7.8%
7.6%
18.1%
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FIRST QUARTER EBITDA BY BUSINESS AREA
(million euro)
2001
2002
Change %
PHARMACEUTICALS
17.4
23.0
20.4%
21.4%
31.6%
5.2
4.6
21.9%
18.9%
22.6
27.6
21.1%
21.4%
22.0%
OPERATING DEPRECIATION
4.5
5.5
20.4%
GOODWILL AMORTIZATION
3.4
3.7
11.3%
EBIT
14.7
18.4
13.7%
14.2%
as % of sales
PHARMACEUTICAL CHEMICALS
as % of sales*
TOTAL
as % of sales
as % of sales
(10.1)%
25.0%
* Including inter-company sales
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CAPITAL EMPLOYED
(million euro)
31 December 2001
185.1
76.4
31 March 2002
Net working
capital for
operations
Net non-current
assets
Capital employed: 261.5
79.2
180.3
Capital employed: 259.5
36.3
48.9
212.6
Net debt
223.2
Shareholders'
equity
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ZANIDIP® (LERCANIDIPINE)
• Latest generation calcium-channel blocker and first lipophilic DHP
CCB to be filed with the FDA.
• Natural once a day. Potent, long-lasting vasodilatory activity. Highly
vasoselective with gradual onset, smooth and uniform blood
pressure lowering activity.
• Efficacy as best in class. Significantly improved tolerability over
other DHP’s.
• Hypertension market well over $30 billion, CCB’s about $10 billion, of
which almost $7 billion in U.S.A. and Japan.
• Leader is Norvasc® (amlodipine) with over one third market share
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LERCANIDIPINE SALES - FIRST QUARTER
(million euro)
20
18.7
18
16
14.0
14
12
10.6
10
8
7.4
8.1
6.6
6
4
2
0
2001
Direct sales
2002
Sales to licensees
Total sales
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LERCANIDIPINE AS A % OF ALL CALCIUM CHANNEL BLOCKERS
% share of CCB market
IMS data - 1Q 2002 - bubble size represents $ market value of CCB’s
10
8
6
4
2
0
0
2
4
6
8
10 12 14 16 18
Argentina
Australia
Austria
Belgium
France
Germany
Holland
Italy
Korea
Spain
UK
Quarters from launch
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ROLL OUT STATUS AND PLAN
LAUNCHED
PLANNED 2002
LAUNCHES
APPROVED
FILED
34 countries
(approx. 1/3
of world market)
9 countries
20 countries
37 countries
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ROLL OUT IN MAJOR MARKETS
EUROPE FIVE
1998 ITALY, SPAIN, UK
2000 GERMANY
2001 FRANCE
USA
(filed 4Q 2001)
JAPAN
(local phase III studies, launch target 2005)
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PRODUCT PIPELINE
5 HT1A
ANTAGONIST
(overactive bladder/
urinary incontinence)
with Pharmacia
REC 2615
(female sexual
dysfunction)
PRECLINICAL TO PHASE I PHASE II
FENTICONAZOLE
(antifungal)
France
LERCANIDIPINE /
ACE-I COMBINATION
(hypertension)
LERCANIDIPINE
(hypertension)
LERCANIDIPINE
(hypertension)
2nd brand
Italy
37 countries 20 countries
incl. USA
LERCANIDIPINE
20 mg
Japan and
others
PHASE III PRE-FILING
PITAVASTATIN
(hypercholesterolemia)
Italy / Kowa
NITROGLYCERINE PATCH
(angina)
France
FILED
ESCITALOPRAM
(depression)
Italy / Lundbeck
VALGANCICLOVIR
(antiviral)
Italy / Roche
APPROVED
MARKETED
PANTOPRAZOLE
(antiulcer and other
indications)
Italy / Altana
NITROGLYCERINE PATCH
(angina) Italy
NITROGLYCERINE PATCH
(angina) Spain
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FILLING THE PIPELINE:
ONGOING R&D
• Lercanidipine:
- Advantageous clinical profile consolidates
- Patent life in extension, two new patents filed
- 20mg strength under registration
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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
- Currently in phase III
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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 for human trials in progress
on a lead compound for female sexual dysfunction
- “Satisfactory progress”
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Basis for 2002 - 2005 targets
• Current business
• Current products / late stage projects
• Current geography
• Zanidip® in U.S. included
- Pipeline buildup in 2002
- 2003 approval and launch
- Analysts’ estimates of peak sales in the U.S.
range from $ 100 million to $ 500 million
• Zanidip® in Japan not included
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BUSINESS SEGMENT DEVELOPMENT
2001
Pharmaceuticals
€350m
81%
Pharmaceutical chemicals
€83m
19%
2005
€550m
86%
€90m
14%
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2002-2005 TARGETS
(million euro)
2001
2002
2005
CAGR
2001-2005
Net Sales
433.4
502
640
10.2%
Gross Profit
as % of sales
251.3
58.0%
301
60.0%
400
62.5%
12.3%
R&D
as % of sales
30.9
7.1%
40
8.0%
65
10.2%
20.4%
EBIT
as % of sales
65.1
15.0%
84
16.7%
135
21.1%
20.0%
EPS (euro)
0.72
EPS CAGR to equal or exceed EBIT CAGR
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(million euro)
700
SALES and EBIT
Sales
600
500
400
EBIT
300
140
200
120
100
100
0
80
1997 1998 1999 2000 2001 2002 2003 2004 2005
60
40
20
0
1997 1998 1999 2000 2001 2002 2003 2004 2005
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Statements contained in this presentation, other than historical facts,
are “forward-looking statements” (as such term is defined in the Private
Securities Litigation Reform Act of 1995). These statements are based on
currently available information, on current best estimates, and on
assumptions believed to be reasonable. This information, these estimates
and assumptions may prove to be incomplete or erroneous, and involve
numerous risks and uncertainties, beyond the Company’s control. Hence,
actual results may differ materially from those expressed or implied by
such forward-looking statements.
All mentions and descriptions of Recordati products are intended solely
as information on the general nature of the company’s activities and are
not intended to indicate the advisability of administering any product in
any particular instance.
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