milan, 14 may 2002 2002-2005 the next step. 2001 important events lercanidipine:lercanidipine:...
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Milan, 14 May 2002
2002-2005 The Next Step
2001 IMPORTANT EVENTS2001 IMPORTANT EVENTS
• Lercanidipine:Lercanidipine:
successful launch in Francesuccessful launch in France
NDA filed in the USANDA filed in the USA
a new partner in Japana new partner in Japan
• New product agreements:New product agreements:
pantoprazole, escitalopram, pitavastatin …pantoprazole, escitalopram, pitavastatin …
11
KEY CONSOLIDATED DATAKEY CONSOLIDATED DATA
2
80.7% Pharmaceuticals
0
100
200
300
400
500
1997 1998 1999 2000 2001
19.3% Pharmaceutical chemicals
0
10
20
30
40
50
60
1997 1998 1999 2000 2001
EBIT
Net Income
0%
10%
20%
30%
40%
50%
60%
1997 1998 1999 2000 2001
0%
5%
10%
15%
20%
25%
Gross % margin
EBITDA % margin
EBITA % margin
EBIT % margin
Net profit % margin
SALESCAGR 23%
192.3214.9
271.8
355.9
433.4
Gross margin EBITDA, EBITA, EBIT,Net Profit
EBITCAGR 41%
NET INCOMECAGR 36%
(million euro)
Pharmaceutical Net SalesPharmaceutical Net Sales
0
100
200
300
400
1997 1998 1999 2000 2001
122.5 140.4
188.5
269.3
349.6
63.7%
80.7%
CAGR30%
(million euro)
3
0
50
100
150
200
1997 1998 1999 2000 2001
Italy International
Int’l as % of pharma
19%
55%
Pharma as % of total
EBITDAEBITDA
1997
2001 Pharmaceuticals
Pharmaceuticalchemicals
As % of sales
9.2%
19.1%
23.2%19.1%
€ 80.9 m€ 17.6 m
€ 14.5 m € 11.3 m
4
2002
77.359.8%
2001 Change %
FIRST QUARTER COMPOSITION OF SALESFIRST QUARTER COMPOSITION OF SALES
(million euro)
PHARMACEUTICALS 85.679.9%
18.8%
PHARMACEUTICAL CHEMICALS
TOTAL
ITALY
INTERNATIONAL
21.520.1%
107.1100.0%
42.139.3%
65.060.7%
107.683.2%
21.716.8%
129.3100.0%
52.040.2%
25.6%
1.1%
20.7%
23.7%
5
16.6%
21.6%
SOURCES OF GROWTHSOURCES OF GROWTH
PHARMACEUTICALS
TOTAL GROWTH
0.3%
(0.9)%
Total
20.7%
13.7%
(% change, first quarter 2002 over first quarter 2001)
Price /Exchange
7.0% 7.0%
PHARMACEUTICALCHEMICALS
ORGANIC GROWTH, TOTAL
6.3% (5.2)%
14.6% (0.9)%
CHANGE OF CONSOLIDATIONPERIMETER
16.9%
1.1%
Volume
6
20022001 Change %
49.3 45.8%
24.0 22.3%
21.6 20.1%
58.3 54.2%
107.6 100.0%
5.3 4.9%
39.4 46.1%
24.5 28.6%
16.7 19.5%
46.2 53.9%
85.6100.0%
5.0 5.8%
24.9%
(2.1)%
29.2%
26.3%
25.6%
5.6%
FIRST QUARTER COMPOSITION OF FIRST QUARTER COMPOSITION OF PHARMACEUTICAL SALESPHARMACEUTICAL SALES
Pharmaceuticals Italy
Pharmaceuticals France
International licensees
International pharmaceuticals
TOTAL PHARMACEUTICALS
Pharmaceuticals Spain
(million euro)
7
Sophartex - 7.4 6.9%
-
MAIN PRODUCTSMAIN PRODUCTSBreakdown of first quarter pharmaceutical sales
Zanidip 17%((lercanidipine))
Tora-Dol 7%
Elopram 7%
Isocef 4%
Hexa line 4% (biclotimol) Exomuc 4%
Neo Codion 4%
Peptazol/Ulcotenal
MainMainProductsProducts
Diezime 4%
Acequin/Acequide 2%
Urispas 2%(flavoxate)
Amodex 2%Lomexin 2%
(fenticonazole)
Other ProductsOther Products 20%20%
OTC 5%OTC 5%
Other revenueOther revenue 10% 10%
8
6%
107.1
62.858.6%
14.713.7%
8.37.8%
22.621.1%
2001
31.629.5%
129.3
75.158.1%
18.414.2%
9.97.6%
27.621.4%
2002
37.629.1%
20.7%
19.6%
25.0%
18.1%
22.0%
Change %
19.0%
RESULTS FIRST QUARTERRESULTS FIRST QUARTER
Net Sales
Gross Profitas % of sales
EBIT as % of sales
Net Incomeas % of sales
EBITDAas % of sales
(million euro)
Selling Expensesas % of sales
R&D Expensesas % of sales
8.27.6%
10.07.7% 21.7%
9
17.420.4%
14.713.7%
FIRST QUARTER EBITDA BY BUSINESS AREAFIRST QUARTER EBITDA BY BUSINESS AREA
PHARMACEUTICALSas % of sales
EBITas % of sales
23.021.4%
18.414.2%
Change %
25.0%
22.0%
(million euro)
* Including inter-company sales
2002
4.5 5.5 20.4%
PHARMACEUTICAL CHEMICALSas % of sales*
TOTALas % of sales
5.221.9%
4.618.9%
22.621.1%
27.621.4%
OPERATING DEPRECIATION
GOODWILL AMORTIZATION 3.73.4
31.6%
(10.1)%
11.3%
2001
10
CAPITAL EMPLOYEDCAPITAL EMPLOYED
Net workingcapital foroperations
Net non-currentassets
Net debt
Shareholders'equity
31 December 2001
223.2
36.3
212.6
48.9
76.4185.1
(million euro)
11
180.379.2
31 March 2002
Capital employed: 261.5 Capital employed: 259.5
ZANIDIPZANIDIP®® (LERCANIDIPINE) (LERCANIDIPINE)
• Latest generation calcium-channel blockerLatest generation calcium-channel blocker and first lipophilic DHP and first lipophilic DHP
CCB to be filed with the FDA.CCB to be filed with the FDA.
• Natural once a dayNatural once a day. Potent, long-lasting vasodilatory activity. Highly . Potent, long-lasting vasodilatory activity. Highly
vasoselective with gradual onset, smooth and uniform blood vasoselective with gradual onset, smooth and uniform blood
pressure lowering activity.pressure lowering activity.
• Efficacy as best in classEfficacy as best in class. Significantly . Significantly improved tolerabilityimproved tolerability over over
other DHP’s.other DHP’s.
• Hypertension market well over $30 billion, CCB’s about $10 billion, of Hypertension market well over $30 billion, CCB’s about $10 billion, of
which almost $7 billion in U.S.A. and Japan. which almost $7 billion in U.S.A. and Japan.
• Leader is NorvascLeader is Norvasc® ® (amlodipine) with over one third market share(amlodipine) with over one third market share
12
LERCANIDIPINE SALES - FIRST QUARTER LERCANIDIPINE SALES - FIRST QUARTER
0
2
4
6
8
10
12
14
16
18
20
2001 2002Direct salesDirect sales Sales to licenseesSales to licensees Total salesTotal sales
7.47.46.66.6
14.014.0
10.610.6
8.18.1
18.718.7
(million euro)
13
LERCANIDIPINE AS A % OF ALL CALCIUM CHANNEL BLOCKERSLERCANIDIPINE AS A % OF ALL CALCIUM CHANNEL BLOCKERS
0
2
4
6
8
10
0 2 4 6 8 10 12 14 16 18
Quarters from launch
% s
har
e o
f C
CB
mar
ket
Argentina
Australia
Austria
Belgium
France
Germany
Holland
Italy
Korea
Spain
UK
IMS data - 1Q 2002 - bubble size represents $ market value of CCB’sIMS data - 1Q 2002 - bubble size represents $ market value of CCB’s
14
ROLL OUT STATUS AND PLANROLL OUT STATUS AND PLAN
LAUNCHED
15
APPROVEDPLANNED 2002 LAUNCHES
FILED
34 countries34 countries(approx. 1/3(approx. 1/3
of world market)of world market) 9 countries9 countries
20 countries20 countries
37 countries37 countries
ROLL OUT IN MAJOR MARKETSROLL OUT IN MAJOR MARKETS
EUROPE FIVEEUROPE FIVE19981998 ITALY, SPAIN, UKITALY, SPAIN, UK20002000 GERMANYGERMANY20012001 FRANCEFRANCE
USA USA (filed 4Q 2001)(filed 4Q 2001)
JAPAN JAPAN (local phase III studies, launch target 2005)(local phase III studies, launch target 2005)
16
PRECLINICAL TO PHASE I PHASE II PRE-FILING FILED APPROVED
5 HT1AANTAGONIST(overactive bladder/urinary incontinence)with Pharmacia
REC 2615(female sexual dysfunction)
LERCANIDIPINE(hypertension)
PITAVASTATIN(hypercholesterolemia)
Italy / Kowa
NITROGLYCERINE PATCH(angina)
France
PANTOPRAZOLE(antiulcer and other
indications)Italy / Altana
NITROGLYCERINE PATCH(angina) Italy
PRODUCT PIPELINE PRODUCT PIPELINE
VALGANCICLOVIR (antiviral)Italy / Roche
LERCANIDIPINE /ACE-I COMBINATION(hypertension)
PHASE III MARKETED
ESCITALOPRAM(depression)Italy / Lundbeck
LERCANIDIPINE20 mg
37 countriesincl. USA
20 countriesJapan andothers
FENTICONAZOLE(antifungal)
France
LERCANIDIPINE(hypertension)
2nd brandItaly
17
NITROGLYCERINE PATCH(angina) Spain
FILLING THE PIPELINE:FILLING THE PIPELINE:ONGOING R&DONGOING R&D
• Lercanidipine:Lercanidipine:
-- Advantageous clinical profile consolidates Advantageous clinical profile consolidates
-- Patent life in extension, two new patents filed Patent life in extension, two new patents filed
-- 20mg strength under registration 20mg strength under registration
18
FILLING THE PIPELINE:FILLING THE PIPELINE:ONGOING R&DONGOING R&D
• Lercanidipine-ACEI fixed combination:Lercanidipine-ACEI fixed combination:
-- New aggressive targets for blood pressure New aggressive targets for blood pressure controlcontrol
-- Combination of drugs needed for most patients Combination of drugs needed for most patients
-- Patient compliance Patient compliance
-- Fixed combinations will play a significant role Fixed combinations will play a significant role in the future hypertension marketin the future hypertension market
-- Currently in phase III Currently in phase III
19
FILLING THE PIPELINE:FILLING THE PIPELINE:ONGOING R&DONGOING R&D
• Urology:Urology:
-- Collaboration agreement with Pharmacia Collaboration agreement with Pharmacia
-- Lead optimization in the area of overactive Lead optimization in the area of overactive bladder is at an advanced stagebladder is at an advanced stage
-- Formulation activities for human trials in progress Formulation activities for human trials in progress on a lead compound for female sexual dysfunctionon a lead compound for female sexual dysfunction
-- “Satisfactory progress” “Satisfactory progress”
20
Basis for 2002 - 2005 targetsBasis for 2002 - 2005 targets
• Current businessCurrent business
• Current products / late stage projectsCurrent products / late stage projects
• Current geographyCurrent geography
• ZanidipZanidip®® in U.S. included in U.S. included Pipeline buildup in 2002Pipeline buildup in 2002 2003 approval and launch2003 approval and launch Analysts’ estimates of peak sales in the U.S. range from $ Analysts’ estimates of peak sales in the U.S. range from $
100 million to $ 500 million100 million to $ 500 million
• ZanidipZanidip®® in Japan not included in Japan not included
21
BUSINESS SEGMENT DEVELOPMENTBUSINESS SEGMENT DEVELOPMENT
22
Pharmaceuticals
Pharmaceutical chemicals
2001
2005
€350m81%
€83m19%
€550m86%
€90m14%
2002-2005 TARGETS2002-2005 TARGETS
20022001
Net Sales
Gross Profitas%ofsales
EPS (euro)
433.4
251.358.0%
0.72
502
30160.0%
R&Das%ofsales
30.97.1%
408.0%
2005
40062.5%
6510.2%
CAGR2001-2005
10.2%
12.3%
20.4%
(million euro)
640
EBITas%ofsales
65.115.0%
8416.7%
13521.1% 20.0%
23
EPS CAGR to equal or exceed EBIT CAGR
SALES and EBITSALES and EBIT
24
0
100
200
300
400
500
600
700
1997 1998 1999 2000 2001 2002 2003 2004 2005
0
20
40
60
80
100
120
140
1997 1998 1999 2000 2001 2002 2003 2004 2005
Sales
EBIT
(million euro)
25
Statements contained in this presentation, other than historical facts,Statements contained in this presentation, other than historical facts,are “forward-looking statements” (as such term is defined in the Private are “forward-looking statements” (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based onSecurities Litigation Reform Act of 1995). These statements are based oncurrently available information, on current best estimates, and oncurrently available information, on current best estimates, and onassumptions believed to be reasonable. This information, these assumptions believed to be reasonable. This information, these estimatesestimatesand assumptions may prove to be incomplete or erroneous, and involve and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company’s control. numerous risks and uncertainties, beyond the Company’s control. Hence, actual results may differ materially from those expressed or Hence, actual results may differ materially from those expressed or implied by such forward-looking statements.implied by such forward-looking statements.All mentions and descriptions of Recordati products are intended solely All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company’s activities and are as information on the general nature of the company’s activities and are not intended to indicate the advisability of administering any product in not intended to indicate the advisability of administering any product in any particular instance.any particular instance.
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