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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
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Page 1: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

Milan, 14 May 2002

2002-2005 The Next Step

Page 2: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 3: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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)

Page 4: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 5: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 6: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 7: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 8: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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%

-

Page 9: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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%

Page 10: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 11: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 12: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 13: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 14: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 15: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 16: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 17: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 18: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 19: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 20: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 21: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 22: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 23: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

BUSINESS SEGMENT DEVELOPMENTBUSINESS SEGMENT DEVELOPMENT

22

Pharmaceuticals

Pharmaceutical chemicals

2001

2005

€350m81%

€83m19%

€550m86%

€90m14%

Page 24: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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

Page 25: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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)

Page 26: Milan, 14 May 2002 2002-2005 The Next Step. 2001 IMPORTANT EVENTS Lercanidipine:Lercanidipine: successful launch in France NDA filed in the USA a new.

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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