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0000950123-04-010455.txt : 200408310000950123-04-010455.hdr.sgml : 2004083120040831172701ACCESSION NUMBER:0000950123-04-010455CONFORMED SUBMISSION TYPE:425PUBLIC DOCUMENT COUNT:39FILED AS OF DATE:20040831DATE AS OF CHANGE:20040831

SUBJECT COMPANY:

COMPANY DATA:COMPANY CONFORMED NAME:AVENTISCENTRAL INDEX KEY:0000807198STANDARD INDUSTRIAL CLASSIFICATION:PHARMACEUTICAL PREPARATIONS [2834]IRS NUMBER:000000000STATE OF INCORPORATION:I0FISCAL YEAR END:1231

FILING VALUES:FORM TYPE:425SEC ACT:1934 ActSEC FILE NUMBER:001-10378FILM NUMBER:041009316

BUSINESS ADDRESS:STREET 1:67917 STRASBOURGSTREET 2:CEDEX 9CITY:STRASBOURG FRANCESTATE:I0ZIP:00000BUSINESS PHONE:3314768123

MAIL ADDRESS:STREET 1:67917 STRASBOURGSTREET 2:CEDEX 9CITY:STRASBOURG FRANCESTATE:I0ZIP:00000

FORMER COMPANY:FORMER CONFORMED NAME:RHONE POULENC S ADATE OF NAME CHANGE:19930512

FILED BY:

COMPANY DATA:COMPANY CONFORMED NAME:SANOFI-AVENTISCENTRAL INDEX KEY:0001121404STANDARD INDUSTRIAL CLASSIFICATION:PHARMACEUTICAL PREPARATIONS [2834]IRS NUMBER:133529324STATE OF INCORPORATION:I0FISCAL YEAR END:1231

FILING VALUES:FORM TYPE:425

BUSINESS ADDRESS:STREET 1:174 AVENUE DE FRANCECITY:PARISSTATE:I0ZIP:75013BUSINESS PHONE:33153774400

MAIL ADDRESS:STREET 1:174 AVENUE DE FRANCECITY:PARISSTATE:I0ZIP:75013

FORMER COMPANY:FORMER CONFORMED NAME:SANOFI SYNTHELABO SADATE OF NAME CHANGE:20010104

4251y01482be425.htmFILED PURSUANT TO RULE 425

FILED PURSUANT TO RULE 425

Filed by Sanofi-Aventis
Pursuant to Rule165 and Rule425(a) under the United States Securities Act of 1933,
as amended

Subject Company: Aventis
Commission File No.001-10378
Date: August31, 2004

On August31, 2004, during a conference call for financial analysts,institutional investors and journalists, representatives of Sanofi-Aventispresented the following slides, which were also made available on theSanofi-Aventis website.

In connection with the proposed acquisition of Aventis, Sanofi-Aventis(formerly known as Sanofi-Synthlabo) has filed with the United StatesSecurities and Exchange Commission (SEC), a registration statement on Form F-4(File no: 333-112314), which includes a prospectus and a prospectus supplementrelating to the revised offer, and related exchange offer materials, toregister the Sanofi-Aventis ordinary shares (including Sanofi-Aventis ordinaryshares represented by Sanofi-Aventis ADSs) to be issued in exchange for Aventisordinary shares held by holders located in the United States and for AventisADSs held by holders wherever located and has also filed with the SEC aStatement on ScheduleTO. Investors and holders of Aventis securities arestrongly advised to read the registration statement and the prospectus andprospectus supplement relating to the revised offer, the Statement on ScheduleTO, and any other relevant documents filed with the SEC, as well as anyamendments and supplements because they contain important information.Investors and holders of Aventis securities may obtain free copies of theregistration statement, the prospectus, the prospectus supplement relating tothe revised offer and related exchange offer materials, and the Statement onScheduleTO, as well as other relevant documents filed with the SEC, at theSECs web site at www.sec.gov. The prospectus, the prospectus supplementrelating to the revised offer and other transaction-related documents have beenmailed to Aventis securityholders eligible to participate in the U.S. offer andadditional copies may be obtained for free from MacKenzie Partners, Inc., theinformation agent for the U.S. offer, at the following address: 105, MadisonAvenue, New York, New York 10016; telephone 1-(212) 929-5500 (call collect) or1-(800) 322-2885 (toll-free call); e-mail [email protected].

* * * *

Conference call

2004 First Half Results

Acomplia in obesity

Important Information

In connection with the proposed acquisition of Aventis, Sanofi-Aventis (formerly Sanofi-Synthelabo) has filed a registration statementon Form F-4 (File no. 333-112314), including a prospectus and a prospectus supplement relating to the revised offer, and will fileadditional documents with the SEC. Investors are urged to read the registration statement, including the prospectus and theprospectus supplement relating to the revised offer, and any other relevant documents filed with the SEC, including allamendments and supplements, because they contain important information. Free copies of the registration statement, as wellas other relevant documents filed with the SEC, may be obtained at the SEC's web site at www.sec.gov. The prospectus and theprospectus supplement relating to the revised offer and other transaction-related documents are being mailed to Aventis securityholders eligible to participate in the U.S. offer and additional copies may be obtained for free from MacKenzie Partners, Inc., theinformation agent for the U.S. offer, at the following address: 105, Madison Avenue, New York, New York 10016; telephone: 1-(212)929-5500 (call collect) or 1-(800) 322-2885 (toll-free call); e-mail [email protected].

In France, holders of Aventis securities are requested, with respect to the offer, to refer to the prospectus supplement (noted'information complementaire), which has been granted visa number 04-384 by the AMF and which is available on the website of theAMF (www.amf-france.org) and without cost from: BNP Paribas Securities Services, GIS-Emetteurs, Service Logistique, Les Collinesde l'Arche, 75450 Paris Cedex 9 and to the recommendation statement (note d'information en reponse) which has been granted visanumber 04-510.

The public offer to holders of Aventis ordinary shares located in Germany (the "German Offer") is being made in accordance withapplicable German law and pursuant to an offer document/sales prospectus, which is available free of charge at BNP ParibasSecurities Services, Gruneburgweg 14, D-60322 Frankfurt am Main (Fax: 069 - 152 05 277) and on the website of the Company(www.sanofi-synthelabo.com). Any decision to tender Aventis ordinary shares in exchange for Sanofi-Aventis ordinary shares underthe German Offer must be taken exclusively with regard to the terms and conditions of the German Offer, as well as with regard to theinformation included in the offer document/sales prospectus, including any amendments thereto, issued in Germany.


The French Offer, the U.S. Offer and the German Offer are being made on substantially the same terms and completion of these offersis subject to the same conditions. It is intended that the subsequent offering periods in each of these three offers will expire at the sametime.

This communication does not constitute an offer to purchase or exchange or the solicitation of an offer to sell or exchange anysecurities of Aventis or an offer to sell or exchange or the solicitation of an offer to buy or exchange any securities of Sanofi-Aventis,nor shall there be any sale or exchange of securities in any jurisdiction (including the United States, Germany, Italy and Japan) inwhich such offer, solicitation or sale or exchange would be unlawful prior to the registration or qualification under the laws of suchjurisdiction. The distribution of this communication may, in some countries, be restricted by law or regulation. Accordingly, persons whocome into possession of this document should inform themselves of and observe these restrictions. The solicitation of offers to buySanofi-Aventis ordinary shares (including Sanofi-Aventis ordinary shares represented by Sanofi-Aventis ADSs) in the United States willonly be made pursuant to a prospectus and related offer materials that Sanofi-Aventis expects to send to holders of Aventis securities.The Sanofi-Aventis ordinary shares (including Sanofi-Aventis ordinary shares represented by Sanofi-Aventis ADSs) may not be sold,nor may offers to buy be accepted, in the United States prior to the time the registration statement becomes effective. No offering ofsecurities shall be made in the United States except by means of a prospectus meeting the requirements of Section 10 of the UnitedStates Securities Act of 1933, as amended.


Forward-Looking Statements. This communication contains statements that constitute forward-looking statements within the meaning ofthe U.S. Private Securities Litigation Reform Act of 1995. Forward-Looking statements are statements that are not historical facts. Thesestatements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives andexpectations with respect to future operations, products and services, and statements regarding future performance. Forward-lookingstatements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates" and similar expressions.Although Sanofi-Aventis' management believes that the expectations reflected in such forward-looking statements are reasonable,investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which aredifficult to predict and generally beyond the control of Sanofi-Aventis, that could cause actual results and developments to differ materiallyfrom those expressed in, or implied or projected by, the forward-looking information and statements. The following factors, among otherrisks and uncertainties that are described in our Form 20-F as filed with the SEC on April 2, 2004 and in the Reference Document filedwith the French Autorite des Marches Financiers on April 2, 2004, could cause actual results to differ materially from those described inthe forward-looking statements: the ability of Sanofi-Aventis to expand its presence profitably in the United States; the success of Sanofi-Aventis' research and development programs; the ability of Sanofi-Aventis to protect its intellectual property rights; and the risksassociated with reimbursement of health care costs and pricing reforms, particularly in the United States and Europe. Other than asrequired by applicable law, Sanofi-Aventis does not undertake any obligation to provide updates or to revise any forward-lookingstatements.

Investors and security holders may obtain a free copy of the Form 20-F filed with the SEC on April 2, 2004 and any other documents filedby Sanofi-Aventis with the SEC at www.sec.gov and may obtain the Reference Document filed with the AMF on April 2, 2004 (N 04-0391) and other documents filed with the AMF at www.amf-france.org. Free copies may also be obtained directly from Sanofi-Aventis onour web site at: www.sanofi-synthelabo.com.

Explanatory Notes

Unless otherwise stated, all figures in this communication are in French GAAP. In this communication, we refer to our historical salesas "reported" sales. In addition to reported sales, we also present and discuss two other non-GAAP indicators that we believe areuseful measurement tools to explain changes in our reported sales:

Comparable sales: When we refer to the change in our sales on a "comparable" basis, we mean that we exclude the impact ofexchange rate fluctuations and changes in Group structure (acquisitions and divestitures of entities and rights to products as well aschange in the consolidation percentage for consolidated entities). For any two periods, we exclude the impact of exchange rates byrecalculating sales for the earlier period on the basis of exchange rates used in the later period.

We exclude the impact of acquisitions by including sales for a portion of the prior period equal to the portion of the current periodduring which we owned the entity or product rights based on sales information we receive from the party from whom we make theacquisition. Similarly, we exclude sales in the relevant portion of the prior period when we have sold an entity or rights to a product. Fora change in the consolidation percentage of a consolidated entity, the prior period is recalculated on the basis of the consolidationmethod used for the current period.

Developed sales: When we refer to "developed sales" of a product, we mean consolidated sales, excluding sales of products to ouralliance partners, but including those that are made through our alliances and which are not included in our consolidated sales (withBristol-Myers Squibb on Plavix (r) /Iscover (r) (clopidogrel) and Aprovel (r) /Avapro (r) /Karvea (r) (irbesartan) and with Fujisawa onStilnox(r) / Myslee (r) (zolpidem). Our alliance partners provide us with information regarding their sales in order to allow us to calculatedeveloped sales. We believe that developed sales are a useful measurement tool because they demonstrate trends in the overallpresence of our products in the market.

Net Income Before Exceptional Items and Goodwill Amortization. Net income before exceptional items and goodwill amortizationis a non-GAAP financial measure that we define as net income excluding the effect of exceptional items and goodwill amortization, netof income tax and minority interests. We have included this non-GAAP financial measure in addition to the corresponding GAAPfinancial measure net income (which includes the effect of exceptional items and non-cash charges for goodwill amortization) becausewe consider this non-GAAP financial measure better reflects the underlying business performance of our operations. In addition, weuse this measure to assess our financial performance and to compare our financial performance across periods.

Earnings Per Share (EPS) Before Exceptional Items and Goodwill Amortization. EPS before exceptional items and goodwillamortization is a non-GAAP financial measure that we define as net income before exceptional items and goodwill amortization dividedby the basic number of shares outstanding calculated using the weighted average number of shares outstanding during the applicableaccounting period, adjusted on a time-weighted basis from the date of acquisition to reflect the number of Sanofi-Synthelabo sharesheld by the Group.

Explanatory Notes

Adjusted net income: Sanofi-Aventis believes that investor understanding of Sanofi-Aventis' performance will be enhanced bydisclosing "adjusted net income" for Sanofi-Aventis' core business. Sanofi-Aventis defines "adjusted net income", a non-GAAP financialmeasure, as net income as determined under French GAAP (which will include under the equity method Aventis's 50% interest in theearnings of Merial), excluding the impact of purchase accounting for the Aventis acquisition and acquisition-related integration andrestructuring costs. Sanofi-Aventis views adjusted net income as an operating performance measure and believes that the most directlycomparable French GAAP measure is net income.

Adjusted net income excludes the effects of purchase-accounting treatments under French GAAP related to the acquisition of Aventis.The purchase-accounting effects on net income will primarily relate to the one-time charge for purchased in-process research anddevelopment, the charges to cost of goods sold from the workdown of purchased inventory that was written up to fair value, the chargesrelated to the amortization of Aventis' goodwill and the charges related to the amortization of Aventis's definite-lived intangible assets.Sanofi-Aventis believes that excluding these non-cash charges will enhance an investor's understanding of Sanofi-Aventis' underlyingeconomic performance after the combination with Aventis because the excluded charges are not considered by management and theboard of directors of Sanofi-Aventis to reflect the combined entity's ongoing operating performance after the business combination.Rather, management and the board of directors of Sanofi-Aventis consider that each of the excluded fixed, non-cash charges reflects thedecision, in 2004, to acquire the businesses of Aventis.

Sanofi-Aventis also believes (subject to the material limitations discussed below) that disclosing "adjusted net income" will also enhancethe comparability of its ongoing operating performance. The elimination of the non-recurring items (the one-time charge for purchased in-process research and development and the charges to cost-of-goods sold resulting from the workdown of purchased inventory that waswritten up to fair value) will enhance comparability after the combination from one period to the other. The elimination of the amortizationof goodwill resulting from the acquisition of Aventis will also enhance comparability (1) across periods after the combination (because inApril 2005, Sanofi-Aventis will be required to publish its financial statements under IFRS, and it is presently expected that, under IFRS,goodwill will no longer be amortized) and (2) relative to its peers in the pharmaceutical industry (many of which, including Eli Lilly,Johnson & Johnson, Pfizer, Bristol Myers Squibb, Abbott, Wyeth, Merck & Co. and Schering Plough, report their results underU.S. GAAP, under which accounting principles goodwill is not amortized). Lastly, Sanofi-Aventis believes that the elimination of chargesrelated to the amortization of Aventis' definite-lived intangible assets will also enhance the comparability of its ongoing operatingperformance relative to its peers in the pharmaceutical industry that carry these intangible assets (principally patents and trademarks) atlow book values either because they are the result of in-house research and development that has already been expensed in prior

periods or because they were acquired through business combinations that were accounted as poolings-of-interest

Explanatory Notes

Management intends to use adjusted net income to manage and to evaluate Sanofi-Aventis' performance and believes it is appropriate todisclose this non-GAAP financial measure, as a supplement to its French GAAP reporting, to assist investors with their analysis of thefactors and trends affecting Sanofi-Aventis' business performance. Management intends to revise the format of its internal managementreporting to include this measure as a subtotal and will consider adjusting its segment information in accordance with SFAS 131 criteria totake into account this revised format. Management expects to use the measure as a component in setting incentive compensation targets,because it better measures the underlying operational performance of the business and excludes charges over which managers have nocontrol. Management also intends that, after the acquisition of Aventis, future earnings guidance for the combined entity will be given onthe basis of non-GAAP adjusted net income. As announced on January 26, 2004, management also intends to use adjusted net income tomanage and analyze dividend policy for the combined group. After the acquisition of Aventis, in general, and subject to any applicablelegal restrictions on distributions, Sanofi-Aventis intends to propose that its shareholders approve an annual dividend determined as apercentage of adjusted net income achieved in respect of the relevant year and management intends to manage and analyze dividendspaid as a ratio of non-GAAP adjusted net income, which it believes provides a consistent basis for comparison across periods.Accordingly, management believes that an investor's understanding of the evolution of Sanofi-Aventis' dividend policy will be enhanced bydisclosing non-GAAP adjusted net income.

Sanofi-Aventis reminds investors, however, that non-GAAP adjusted net income should not be considered in isolation from, or as asubstitute for, net income reported in accordance with French GAAP. In addition, Sanofi-Aventis strongly encourages investors andpotential investors, including holders of Aventis ordinary shares, not to rely on any single financial measure but to review its financialstatements, including the notes thereto, and its other publicly-filed reports carefully and in their entirety.


Jean-Claude LEROY

Senior Vice President,

Chief Financial Officer

Very strong consolidated sales growth *

Consolidated sales growth on acomparable basis : + 18.9%

Currency impact : - 4.5%

Of which

US Dollar : - 3.1%

Consolidated sales growth on areported basis : + 14.3%

* On a comparable basis H1 2002 H1 2003 H1 2004 Est 3680 3903 4460

+6.1%

(+14.4%*)

+14.3%

(+18.9%*)

Consolidated Sales

In million euros

H1 2002 H1 2003 H1 2004 Est 2974 3153 3660

Progression of 1.3 percentage point in

Gross Profit ratio

Progression of 1.3 percentage point inGross Profit ratio to 82,1%

Products mix and productivityimprovement

Increase of Plavix(r) and Avapro(r) USroyalties

At 2003 exchange rate, growth of 1.6percentage points in Gross Profit ratio to82,4%

+6.0%

+16.1%

80.8%

of Sales

82.1%

of Sales

80.8%

of Sales

Gross Profit

In million euros

Improvement of 3.3 percentage points in

Operating Margin

Research & Development: +13.4%

(+16.6% at 2003 exchange rate)

15.8% of sales

Phase III + Life Cycle Management

Financing of the entire cost of developingArixtra(r), idraparinux and other oligosaccharides

Selling & General Expenses: +12.6%

(+17.4% at 2003 exchange rate)

30.4% of Sales

Sales & marketing: +14.2%

Other Operating Incomes & Charges:+70 Eur m

vs. H1 2003

Share of Alliance profits received from BMS:

254 Eur m versus 153 Eur m in H1 2003

Share of Alliance profits paid to BMS:

115 Eur m versus 83 Eur m in H1 2003 H1 2002 H1 2003 H1 2004 Est 1233 1391 1733

+12.8%

+24.6%

33.5%

des

ventes

38.9%

des

ventes

35.6%

des

ventes

Operating profit

In million euros

A 2003 exchange rate, H1 2004 OperatingProfit : +34.9%

Operating Profit by region*

* 2 468 Eur m (excluding non-allocated expenditure: 735 Eur m)

A balanced geographic spread of

Operating Profit Europe U.S.A Autres pays CA 1012 1116 340

USA

1 116 m euros

+ 30,2%

Other Countries

340 m euros

+ 24,1%

45%

14%

Europe

1 012 m euros

+ 9,8%

41%

Net Profit*

In million euros

Improvement of 1.2 percentage point in

Net Margin

Financial Income: 22 m euros

(vs. 63 Eur m in H1 2003)

Net Financial Income:+18 Eur m (+30 Eur m in H1 2003)

Impact of hedging policy:

+29 Eur m (+53 Eur m in H1 2003)

Mark to market adjustment of stock optionplans 25 Eur m (20 Eur m in H1 2004)

Income tax rate: 34.0%

(vs. 33.1% in H1 2003)

In line with the tax rate for the full year2003

A 2003 exchange rate, H1 2004 NetProfit* : +31.2% H1 2002 H1 2003 H1 2004 Est 828 947 1136

+14.4%

+20.0%

22.5%

of Sales

25.5%

of Sales

24.3%

of Sales

* Consolidated Net Profit before exceptional items and goodwill amortization

EPS before exceptional itemsand goodwill amortization:

1,63 euro +21.6%

(at 2003 exchange rate: +32.8%)

EPS: 1.63 euro +21.6%

Strong EPS* growth Continues :+ 21,6%

* before exceptional items and goodwill amortization

Earning Per Share*

In euro H1 2002 H1 2003 H1 2004 Est 1.13 1.34 1.63

+18.6%

+21.6%

Consolidated Profit & Loss Account

* + 18,9% on a comparable basis, after eliminating the impact of changes

in Group structure and currency fluctuations

H1 2004 H1 2004 H1 2004 H1 2003 H1 2003 H1 2003 Var. in million euros Eur m % Sales % Sales Eur m % Sales % Sales NET SALES 4 460 100.0% 100.0% 3 903 100,0% 100,0% + 14.3%* Cost of goods sold (800) 17.9% 17.9% (750) 19,2% 19,2% + 6.7% GROSS PROFIT 3 660 82.1% 82.1% 3 153 80,8% 80,8% + 16.1% R&D expenses (704) 15.8% 15.8% (621) 15,9% 15,9% + 13.4% Selling and general expenses (1 356) 30.4% 30.4% (1 204) 30,8% 30,8% + 12.6% Other operating incomeand expenses 133 63 - OPERATING PROFIT 1 733 38.9% 38.9% 1 391 35,6% 35,6% + 24.6% Intangiblesamortization and provisions (65) (66) - 1.5% Net financial income / (expense) 22 63 - PROFIT BEFORE TAX ANDEXCEPTIONAL ITEMS 1 690 37.9% 37.9% 1 388 35.6% 35.6% + 21.8%

H1 2004 H1 2004 H1 2003 H1 2003 Var. in million euros Eur m % Sales Eur m % Sales PROFIT BEFORE TAX ANDEXCEPTIONAL ITEMS 1 690 37.9% 1 388 35.6% + 21.8% Exceptional items 9 1 - Income taxes (576) (458) + 25.8% Share in profits of equity associates 21 19 + 10.5% Goodwill amortization (4) (4) - Minority interests (2) (2) - NET PROFITATTRIBUTABLE TO THE GROUP 1 138 25.5% 944 24.2% + 20.6% EARNINGS PER SHARE (in euro) 1.63 1.34 + 21.6% Exceptional items and goodwillamortization attributable to the Group,net of tax (2) 3 NET PROFIT ATTRIBUTABLE TO THE GROUP BEFORE EXCEPTIONAL ITEMS AND GOODWILL AMORTIZATION 1 136 25.5% 947 24.3% + 20.0% EARNINGS* PER SHARE (in euro) 1.63 1.34 + 21.6%

Consolidated Profit & Loss Account (ctd)

* Before exceptional items and goodwill amortization

in million euros H1 2004 H1 2003 Operating cash flow 1 396 1 114 Change in working capital (630) (355) CASH FLOW PROVIDED BY OPERATING ACTIVITIES 766 759 Capital expenditure (201) (187) Proceeds from disposals 15 6 CASH FLOW USED IN INVESTING ACTIVITIES (186) (181) Changes in financial debts and others (of which impact of exchange rates variation) (47) (102) Dividends (667) (582) Net share purchase including share buy back programs 10 (684) FINANCING OPERATIONS (704) (1 368) NET CHANGE IN CASH (124) (790)

Simplified consolidated statement

of cash flows

in million euros 30/06/04 31/12/03 30/06/04 31/12/03 ASSETS LIABILITIES ANDSHAREHOLDERS' EQUITY LIABILITIES ANDSHAREHOLDERS' EQUITY Fixed assets 3 083 2 712 Shareholders' equity 6 834 6 323 Defered taxes 410 472 Minority interests 16 18 Inventories,receivables and others 3 846 3 187 Other long-term liabilities 806 763 Cash and deposits 3 218 3 378 Payables and others 2 578 2 277 Financial debts 323 368 TOTAL ASSETS 10 557 9 749 TOTAL LIABILITIESAND SHAREHOLDERS' EQUITY 10 557 9 749

Simplified consolidated

balance sheet

Net cash position on 30/06/2004 : 2 895 Eur m.

(including shares held for stock option plans for 577 Eur m.)

AcompliaTM in obesity

Gerard LE FUR

Senior Executive Vice President

Scientific Affairs

ACOMPLIA(tm) (rimonabant) in obesity

RIO-Europe study design

Treatment period : 2 years

Double-blind

Placebo n=305

Acomplia(tm) 5mg/day n=603


Placebo

D -28

D -1

? Inclusion (Randomisation 1/2/2)

D 728

Placebo run-in

Single-blind

Mild Hypocaloric diet : - 600 kcal/day

Patients with BMI ? 30kg/m2

or

Patients with BMI ? 27kg/m2 ifcomorbidity (hypertension and/ordyslipidemia)

Mean BW = 102.7 kg

Mean BMI = 36.6 kg/m2

Multicentre, randomised, double-blind, placebo-controlled,parallel-group study (5mg, 20mg once daily)

Analysis 1 year

ACOMPLIA(tm) (rimonabant) in obesity

RIO-Lipids study design

Treatment period : 1 year

Double-blind

Placebo n=334



Placebo

D - 28

D 1

? Inclusion (Randomisation 1/1/1)

D 364

Placebo run-in

Single-blind

Mild Hypocaloric diet : - 600 kcal/day

Patients with untreated dyslipidemiaand BMI between 27 and 40kg/m2

at inclusion:

Mean BW = 96kg

Mean BMI= 34kg/m2

Multicentre, randomised, double-blind, placebo-controlled,parallel-group study (5mg, 20mg once daily)

ACOMPLIA(tm) (rimonabant)

RIO-Europe and RIO-Lipids results (1/8) Placebo Acomplia 5 mg Acomplia 20 mg % decrease at 1-yr vs. baseline -0.212 -0.307 -0.535

Metabolic syndrome(1): Percent decrease at 1-year vs. baseline -ITT population

RIO-Europe

20mg vs placebo: p88cm

? Hypertension: ?130/?85mmHg

? Hypertriglyceridemia: ?150mg/dl

? Low HDL cholesterol: men


RIO-Europe and RIO-Lipids results (2/8)

Weight change (kg; mean+-SEM) by visit (week) and LOCF(1) -ITT population

RIO-Lipids

Donnees a completer

5mg vs placebo: p



Waist circumference change (cm; mean+-SEM) by visit (week)and LOCF(1) - ITT population

(1) LOCF: Last Observation Carried Forward

RIO-Lipids

RIO-Europe

5mg vs placebo: p=0.029

20mg vs placebo: p



HDL-cholesterol: Percent change (mean+-SEM) by visit (week)and LOCF(1) - ITT population

RIO-Lipids

Placebo

Acomplia(tm) 5mg

Acomplia(tm) 20mg

RIO-Europe

(1) LOCF: Last Observation Carried Forward

5mg vs placebo: p=0.025

20mg vs placebo: p



Triglycerides: Percent change (mean+-SEM) by visit (week) andLOCF(1) - ITT population

RIO-Lipids

Placebo

Acomplia(tm) 5mg

Acomplia(tm) 20mg

RIO-Europe

5mg vs placebo: ns

20mg vs placebo: p



Fasting insulin (IU/mL): Mean change from baseline (+-SEM)after 1 year - ITT population

placebo

n = 272

AcompliaTM

5 mg

n = 551

AcompliaTM

20 mg

n = 534

RIO-Europe

placebo

n = 305

AcompliaTM

5 mg

n = 307

AcompliaTM

20 mg

n = 309

RIO-Lipids

*

* p



Insulin (IU/mL) - OGTT test: Insulin 2 hr after 70g of glucose

Mean change from baseline (+-SEM) after 1 year - ITT population

* p



Cumulative study discontinuation rates

0

3

6

9

12

0.0

0.1

0.2

0.3

0.4

0.5

0

3

6

9

12

0.0

0.1

0.2

0.3

0.4

0.5

0

3

6

9

12

0

3

6

9

12

Cumulative Withdrawal rate

0.0

0.1

0.2

0.3

0.4

0.5

0.0

0.1

0.2

0.3

0.4

0.5

0

3

6

9

12

0.0

0.1

0.2

0.3

0.4

0.5

0

3

6

9

12

0

3

6

9

12

Cumulative Withdrawal rate

0.0

0.1

0.2

0.3

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RIO-Lipids

RIO-Europe

Placebo

Acomplia(tm) 5mg

Acomplia(tm) 20mg


RIO-Europe and RIO-Lipids 1year safety data

Overall summary (%) of subjects with treatment emergentadverse events (TEAEs)

ACOMPLIA(tm) (rimonabant) - The ten mostfrequently reported adverse events at 20mg

sanofi-aventis:

Towards a swift andeffective

integration

SANOFI-AVENTIS: events related

to the Aventis offer

August 11, 2004: Announcement of a public offer for 20% of the capitalof Aventis Pharma Limited India

Subsidiary 50.01% owned by Hoechst AG

August 12, 2004: Final results of the offers

95.47% (1) of the capital and 95.52% (1) of the voting rights of Aventis tendered

August 13, 2004: Reopening of the offers for 17 French trading days

Terms and conditions, consideration offered and financial analysis of the termsidentical to those of the improved offer (2)

August 20, 2004: Creation of sanofi-aventis

Settlement of the offer

Financing of the cash portion of the offer (14.8 billion euros):

Tranche A credit facility of 5 billion euros (3) used in full;

Tranche B credit facility of 5.5 billion euros (3) used in full;

commercial paper of 0.9 billion euros;

the balance from available cash.

(1) On a non-diluted basis

(2) Described in the prospectus supplement which received visa no. 04-384

(3) Which credit facility was signed on April24,2004

SANOFI-AVENTIS: events related to the Aventis offer

August 23, 2004: Announcements related to Hoechst AG

Announcement by sanofi-aventis of a mandatory public offer for the 1.91% of thecapital of Hoechst AG not held by sanofi-aventis

Announcement by Aventis of its intention to acquire the shares of the outstandingshareholders of Hoechst AG through a squeeze out transaction

August 30, 2004: Authorization from the Board of a study of a merger betweensanofi-aventis and Aventis

On the basis of an exchange ratio equivalent to that of the all share portion of theoffer, before adjustment (1.1739)

September 6, 2004: Expiration of the reopened offers

September 16, 2004: Result of the reopened offers

September 24, 2004: Scheduled settlement date

September 30, 2004: Dividend payment date

1.02 euro for newly-created shares

0.05 euro for existing shares

SANOFI-AVENTIS: towards a swift and effective

integration

June 21, 2004:

Announcement of the future Management Committee

July 2004:

Establishment of Integration Committee

August 30, 2004:

First meeting of the sanofi-aventis Board of Directors

September 2004:

Implementation of the new organizational structure begins, appointmentof country and support function heads

4th quarter of 2004:

2005 budget preparation for the new group

sanofi-aventis operational from the start of 2005

SANOFI-AVENTIS: a healthy outlook

Confirmation that deal will be accretive from 2004

Based on sanofi-aventis pro forma net adjusted income per share (1)

Confirmation of projected amount and timing

of synergies

1.6bn euros in 2006, of which 10% in 2004 and 60% in 2005

2005 guidance for the new group:

February 2005 analyst meeting

(1) See explanatory note

Questions

&

Answers

Conference call


Acomplia in obesity

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