SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULES 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the Month of January 2004
SANOFI-SYNTHELABO
(Exact name of registrant as specified in its charter)
174, avenue de France, 75013 Paris, FRANCE
(Address of principal executive offices)
(Indicate by check mark whether the registrant files or will file
annual reports under cover Form 20-F or Form 40-F.)
Form 20-F X Form 40-F
--- ---
(Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
Yes No X
--- ---
(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 82-_______________.
Sanofi~Synthelabo
Investor Relations Paris, January 22nd, 2004
CONTINUED STRONG CONSOLIDATED SALES GROWTH IN 2003:
15.6% ON A COMPARABLE BASIS
8.1% ON A REPORTED BASIS
VERY ROBUST GROWTH IN DEVELOPED SALES(1) IN 2003:
20.4% ON A COMPARABLE BASIS
Unless otherwise indicated, growth rates are on a comparable basis
>> In 2003, Sanofi-Synthelabo once again achieved very strong sales growth:
o Consolidated sales: up 15.6% (8.1% on a reported basis) to 8,048 million
euros
o Developed sales: up 20.4% to 10,560 million euros
>> Sales growth was particularly robust in the fourth quarter:
o Consolidated sales: up 17.0% (10.8% on a reported basis) to 2,108 million
euros
o Developed sales: up 28.7% to 2,919 million euros
>> In 2003, sales growth for Plavix(R), Avapro(R), Ambien(R) was strong with
particularly sound inventory levels(2) in the United States (close to 1.1
month(3) on average):
o Plavix(R): 39.9% developed sales growth, including 37.9% in the United
States and 37.9% in Europe
o Ambien(R): 10.4% consolidated sales growth, including 10.6% in the United
States
o Aprovel(R): 27.5% developed sales growth, including 30.0% in the United
States and 23.6% in Europe.
>> In 2003, sales of Eloxatin(R)were 824 million euros up 125.8%.
>> Accelerated growth of the business in the second half of 2003 confirms the
forecast of 2003 EPS(4) growth despite unfavorable currency effect.
------------
(1) Developed sales include Sanofi-Synthelabo consolidated sales and sales
generated under the agreements with Bristol-Myers Squibb on Plavix(R)/Iscover(R)
(clopidogrel) and Aprovel(R)/Avapro(R)/Karvea(R) (irbesartan), with Fujisawa on
Stilnox(R)/Myslee(R) (zolpidem), and with Organon on Arixtra(R) (fondaparinux)
(see explanatory note)
(2) Inventory level expressed in months' sales
(3) Internal estimates of inventories (wholesalers, hospitals, pharmacies...) as
of December 31st 2003
(4) Before exceptional items and goodwill amortization
2003 consolidated sales: up 15.6% on a comparable basis
Sanofi-Synthelabo generated 2003 consolidated sales of 8,048 million euros, a
rise of 15.6% on a comparable basis (8.1% on a reported basis). Currency
fluctuations had an unfavorable impact of 7.2 percentage points. Of this, over
half was due to the weakening of the US dollar, and the rest to the weakness of
some Latin American and Asian currencies. Changes in Group structure(5) had an
unfavorable impact of 0.3 of a percentage point.
Fourth-quarter consolidated sales amounted to 2,108 million euros, an increase
of 17.0% on a comparable basis (10.8% on a reported basis). During the quarter,
currency fluctuations had an unfavorable impact of 6.0 percentage points, and
changes in Group structure an unfavorable impact of 0.2 of a percentage point.
2003 Consolidated Sales by Geographical Region: Double-digit Growth in all 3
Zones on a comparable basis
===================-------------------------------------
2003 consolidated Change on a Change
In millions sales comparable basis on a reported
of euros basis
------------------------------------------------------------------------------
Europe 4,693 +10.4% +9.0%
United States 1,912 +32.9% +13.2%
Rest of the world 1,443 +13.1% -0.8%
------------------------------------------------------------------------------
Total 8,048 +15.6% +8.1%
----------------------===================-------------------------------------
- In Europe, 2003 consolidated sales totaled 4,693 million euros, an increase
of 10.4% on a comparable basis (9.0% on a reported basis). Fourth-quarter
consolidated sales growth achieved 13.2% on a comparable basis (11.0% on a
reported basis).
- In the United States, 2003 consolidated sales were 1,912 million euros, an
increase of 32.9% on a comparable basis. On a reported basis, growth was
13.2%, due to fluctuations in the dollar/euro exchange rate. Fourth-quarter
consolidated sales growth was 28.3% on a comparable basis (10.9% on a
reported basis).
- In the rest of the world, 2003 consolidated sales amounted to 1,443 million
euros, up 13.1% on a comparable basis but down 0.8% on a reported basis.
Fourth-quarter sales growth was 16.1% on a comparable basis (10.2% on a
reported basis).
------------
(5) Primarily, change from full consolidation to 51% proportionate consolidation
of Sanofi-Synthelabo Fujisawa (Taiwan) in May 2002
Consolidated sales by product: 26.9% growth for the top 10 products on a
comparable basis
2003 consolidated sales of the Group's top 10 products were 5,420 million euros,
an advance of 26.9% on a comparable basis (18.5% on a reported basis). This
represents 67.3% of the Group's consolidated sales, compared to 61.3% in 2002
(on a comparable basis). Fourth-quarter growth in sales of the top 10 products
was 23.1%.
=====================--------------------------------
In millions of euros 2003 Change on a Change on a
consolidated comparable reported
sales basis basis
--------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 1,345 +10.4% -5.5%
Plavix(R) 1,325 +37.4% +34.2%
Eloxatine(R) 824 +125.8% +111.8%
Aprovel(R) 683 +24.4% +21.5%
Fraxiparine(R) 319 +1.6% -1.5%
Depakine(R) 277 +7.4% +3.7%
Xatral(R) 222 +24.7% +22.0%
Solian(R) 148 +11.3% +9.6%
Cordarone(R) 146 -5.2% -9.9%
Tildiem(R) 131 -5.1% -7.1%
--------------------------------------------------------------------------------
Total 5,420 +26.9% +18.5%
---------------------------=====================--------------------------------
In 2003:
- Consolidated sales of Stilnox(R)/Ambien(R)/Myslee(R) were 1,345 million
euros, up 10.4% on a comparable basis.
In the United States, demand for Ambien(R) remained strong, with
prescriptions up 13.4%(6), coupled with a favorable price effect. Invoiced
sales of Ambien(R) grew only by 10.6% on a comparable basis due to the
reduction in inventory levels(7) of approximately 0.8 months(8) on the full
year.
In Japan, Myslee(R) became the class leader after two years from its
launch.
- Consolidated sales of Plavix(R)totaled 1,325 million euros, up 37.4% on a
comparable basis.
- Consolidated sales of Eloxatin(R) were 824 million euros, up 125.8% on a
comparable basis. This strong growth reflects the continuing success of
Eloxatin(R) in the United States, where sales reached 460 million euros.
Outside the United States, sales of the product increased by 37.4% on a
comparable basis to 364 million euros.
- Consolidated sales of Aprovel(R)reached 683 million euros, up 24.4% on a
comparable basis.
- Consolidated sales of Xatral(R)/Uroxatral(R) rose by 24.7% on a comparable
basis to 222 million euros. Uroxatral(R) was launched in the United States
at the start of November, and its progress is in line with our
expectations.
------------
(6) prescriptions IMS NPA+ 12/2003 retail + mail order + long term care
(7) Inventory level expressed in months' sales
(8) Internal estimates of inventories (wholesalers, hospitals, pharmacies...)
as of December 31st 2003
Apart from the top 10 products, the rest of the portfolio generated sales of
2,628 million euros in 2003, a decline of 2.4% on a comparable basis. Not
withstanding the fall in sales of Ticlid(R) (replaced by Plavix(R)) and the
virtual disappearance of sales of Corotrope(R)/Primacor(R) (since the
introduction of generics in the United States in May 2002), sales of the other
products in the portfolio rose 2.2%.
Pending additional indications, Arixtra(R), the sole synthetic product of its
therapeutic class, achieved consolidated sales of 19 million euros.
2003 Developed Sales(9): up 20.4% on a Comparable Basis
In 2003, developed sales, which represent the worldwide market presence of
Sanofi-Synthelabo products, reached 10,560 million euros, an increase of 20.4%
on a comparable basis. Fourth-quarter developed sales rose by 28.7% on a
comparable basis.
Developed Sales of Plavix(R)/Iscover(R) in 2003: Up 39.9% on a Comparable Basis
------------------------------------------------------
In millions of euros 2003 Change on a Q4 2003 Change on a
comparable comparable
basis basis
-----------------------------------------------------------------------------
Europe 1,056 +37.9% 305 +45.9%
United States 1,817 +37.9% 577 +73.3%
Rest of the world 352 +59.3% 103 +58.5%
-----------------------------------------------------------------------------
3,225 +39.9% 985 +62.3%
-----------------------------------------------------------------------------
2003 developed sales of Plavix(R)/Iscover(R)reached 3,225 million euros.
In the United States, demand for Plavix(R) again grew at a very strong pace in
2003, with prescriptions up 26.8%(10), coupled with a favorable price effect.
Invoiced sales of Plavix(R) advanced by 37.9% on a comparable basis.
------------
(9) Developed sales include Sanofi-Synthelabo consolidated sales and sales
generated under the agreements with Bristol-Myers Squibb on Plavix(R)/Iscover(R)
(clopidogrel) and Aprovel(R)/Avapro(R)/Karvea(R) (irbesartan), with Fujisawa on
Stilnox(R)/Myslee(R) (zolpidem), and with Organon on Arixtra(R) (fondaparinux)
(see explanatory note)
(10) prescriptions IMS NPA + 12/2003 retail + mail order + long term care
Developed Sales of Aprovel(R)/Avapro(R)/Karvea(R): Up 27.5% on a Comparable
Basis
------------------------------------------------------
In millions 2003 Change on a Q4 2003 Change on a
of euros comparable comparable
basis basis
-----------------------------------------------------------------------------
Europe 634 +23.6% 169 +19.9%
United States 407 +30.0% 121 +80.6%
Rest of the world 214 +35.4% 61 +27.1%
-----------------------------------------------------------------------------
1,255 +27.5% 351 +37.1%
-----------------------------------------------------------------------------
2003 developed sales of Aprovel(R)/Avapro(R)/Karvea(R)reached 1,255 million
euros. In the United States, demand for Avapro(R) again grew at a robust pace in
2003, with prescriptions up 14.9%(11), coupled with a favorable price effect.
Invoiced sales of Avapro(R) increased 30.0% on a comparable basis.
------------
(11) prescriptions IMS NPA+ 12/2003 retail + mail order + long term care
--------------------------------------------------------------------------------
2003 Fourth Quarter Detailed figures
--------------------------------------------------------------------------------
Fourth-Quarter Consolidated Sales by Geographical Region
===============------------------------------------------------------
Change on a Change on a
In millions of euros Q4 2003 Q4 2002 Q4 2002 comparable reported
Comparable Reported basis basis
-------------------------------------------------------------------------------------------
Europe 1,220 1,078 1,099 +13.2% +11.0%
United States 499 389 450 +28.3% +10.9%
Rest of the world 389 335 353 +16.1% +10.2%
-------------------------------------------------------------------------------------------
Total 2,108 1,802 1,902 +17.0% +10.8%
----------------------===============------------------------------------------------------
Fourth-Quarter Consolidated Sales of the Top 10 Products
===============------------------------------------------------------
Change on a Change on a
In millions of euros Q4 2003 Q4 2002 Q4 2002 comparable reported
Comparable Reported basis basis
-------------------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 350 316 361 +10.8% -3.0%
Plavix(R) 361 255 259 +41.6% +39.4%
Eloxatine(R) 224 146 159 +53.4% +40.9%
Aprovel(R) 177 150 153 +18.0% +15.7%
Fraxiparine(R) 80 81 83 -1.2% -3.6%
Depakine(R) 71 66 68 +7.6% +4.4%
Xatral(R) 66 49 49 +34.7% +34.7%
Solian(R) 40 32 33 +25.0% +21.2%
Cordarone(R) 36 39 40 -7.7% -10.0%
Tildiem(R) 32 33 34 -3.0% -5.9%
-------------------------------------------------------------------------------------------
Total 1,436 1,167 1,239 +23.1% +15.9%
-------------------------=============-----------------------------------------------------
Growth in Prescriptions of Plavix(R), Avapro(R) Ambien(R) in the United States
in the Fourth Quarter (Prescriptions IMS NPA+ fourth quarter retail + mail order
+ long term care) (excluding favorable price effect)
===================
Q4 growth in
prescriptions
-----------------------------------------
Plavix(R) +27.6%
Ambien(R) +12.8%
Avapro(R) +16.9%
-----------------------------------------
--------------------------------------------------------------------------------
2003 Detailed Sales Figures
--------------------------------------------------------------------------------
2003 Consolidated Sales by Geographical Region
==============-------------------------------------------------------
Change on a Change on a
In millions of euros 2003 2002 2002 comparable reported
Comparable Reported basis basis
---------------------------------------------------------------------
Europe 4,693 4,249 4,304 +10.4% +9.0%
United States 1,912 1,439 1,689 +32.9% +13.2%
Rest of the world 1,443 1,276 1,455 +13.1% -0.8%
-------------------------------------------------------------------------------------------
Total 8,048 6,964 7,448 +15.6% +8.1%
----------------------==============-------------------------------------------------------
2003 Consolidated Sales of the Top 10 Products
============-------------------------------------------------------------
In millions of euros Change on a Change on a
2002 comparable basis reported
Reported basis
2002
Comparable
2003
-------------------------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 1,345 1,218 1,424 +10.4% -5.5%
Plavix(R) 1,325 964 987 +37.4% +34.2%
Eloxatine(R) 824 365 389 +125.8% +111.8%
Aprovel(R) 683 549 562 +24.4% +21.5%
Fraxiparine(R) 319 314 324 +1.6% -1.5%
Depakine(R) 277 258 267 +7.4% +3.7%
Xatral(R) 222 178 182 +24.7% +22.0%
Solian(R) 148 133 135 +11.3% +9.6%
Cordarone(R) 146 154 162 -5.2% -9.9%
Tildiem(R) 131 138 141 -5.1% -7.1%
-------------------------------------------------------------------------------------------------
Total 5,420 4,271 4,572 +26.9% +18.5%
------------------------============-------------------------------------------------------------
Growth in Prescriptions of Plavix(R), Avapro(R) Ambien(R) in the United States
in 2003 (Prescriptions IMS NPA+ 12/2003 retail + mail order + long term care)
(excluding favorable price effect)
===================
2003 growth in
prescriptions
-----------------------------------------
Plavix(R) +26.8%
Ambien(R) +13.4%
Avapro(R) +14.9%
-----------------------------------------
Explanatory notes:
All figures in this press release are in French GAAP.
In this press release, we refer to our historical sales as "reported" sales.
In addition to reported sales, we also present and discuss two other non-GAAP
indicators that we believe are useful 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 of exchange rate fluctuations and
changes in Group structure (acquisitions and divestitures of entities and rights
to products as well as change in the consolidation percentage for consolidated
entities).
For any two periods, we exclude the impact of exchange rates by
recalculating 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 period during which we owned
the entity or product rights based on sales information we receive from the
party from whom we make the acquisition. Similarly, we exclude sales in the
relevant portion of the prior period when we have sold an entity or rights to a
product.
For a change in the consolidation percentage of a consolidated entity, the prior
period is recalculated on the basis of the consolidation method used for the
current period.
Reconciliation of 2002 reported-basis sales to 2002 comparable-basis sales
----------------------------------------------------------------------
In millions of euros
----------------------------------------------------------------------
2002 reported-basis sales 7,448
----------------------------------------------------------------------
Impact of changes in Group structure -24
----------------------------------------------------------------------
Impact of exchange rates -460
----------------------------------------------------------------------
2002 comparable-basis sales 6,964
----------------------------------------------------------------------
Developed sales When we refer to "developed sales" of a product, we mean
consolidated sales, excluding sales of products to our alliance partners, but
including those that are made through our alliances and which are not included
in our consolidated sales (with Bristol-Myers Squibb on Plavix (R) /Iscover (R)
(clopidogrel) and Aprovel (R) /Avapro (R) /Karvea (R) (irbesartan), with
Fujisawa on Stilnox (R) /Myslee (R) (zolpidem), and with Organon on Arixtra (R)
(fondaparinux)). Our alliance partners provide us with information regarding
their sales in order to allow us to calculate developed sales.
We believe that developed sales are useful measurement tool because they
demonstrate trends in the overall presence of our products in the market.
Reconciliation of 2003 consolidated sales to 2003 developed sales
-------------------------------------------------------------------------
In millions of euros
-------------------------------------------------------------------------
2003 consolidated sales 8,048
-------------------------------------------------------------------------
Non-consolidated sales of +1,900
Plavix(R)/Iscover(R) net of sales of product
to Bristol-Myers Squibb
-------------------------------------------------------------------------
Non-consolidated sales of +572
Aprovel(R)/Avapro(R)/Karvea(R)
-------------------------------------------------------------------------
Non-consolidated sales of +36
Stilnox(R)/Myslee(R)
-------------------------------------------------------------------------
Non-consolidated sales of Arixtra(R) +5
-------------------------------------------------------------------------
2003 developed sales 10,560
-------------------------------------------------------------------------
This release contains statements that constitute forward-looking statements
within the meaning of the U.S. Private Securities Litigation Reform Act of 1995.
These statements are based on management's current expectations or beliefs and
are subject to a number of factors and uncertainties that could cause actual
results to differ materially from those described in the forward-looking
statements. The following factors, among others that are described in our Form
20-F as filed with the US Securities and Exchange Commission on June 25, 2003
and in the Reference Document filed with the French Commission des Operations de
Bourse (now the Autorite des Marches Financiers) on April 23, 2003, could cause
actual results to differ materially from those described in the forward-looking
statements: the ability of Sanofi-Synthelabo to expand its presence profitably
in the United States; the success of Sanofi-Synthelabo's research and
development programs; the ability of Sanofi-Synthelabo to protect its
intellectual property rights; and the risks associated with reimbursement of
health care costs and pricing reforms, particularly in the United States and
France. Sanofi-Synthelabo does not undertake any obligation to provide updates
or to revise any forward-looking statements.
Investors and security holders may obtain a free copy of the Form 20-F and any
other documents filed by Sanofi-Synthelabo with the US Securities and Exchange
Commission at www.sec.gov as well as of the Reference Document filed with the
French Autorite des Marches Financiers at www.amf-france.org or directly from
Sanofi-Synthelabo on the web site www.sanofi-synthelabo.com.
------------------------------------------------------------------------------
Investor Relations Department:
Philippe Goupit Director of Investor Relations
Arnaud Delepine Investor Relations Europe
Sanjay Gupta Investor Relations US
Contacts:
E-mail: investor-relations@sanofi-synthelabo.com
Europe United States
Tel: +33 1 53 77 45 45 Tel: 00 1 212 551 42 93
Fax: +33 1 53 77 42 96 Fax: 00 1 212 551 49 92
REMINDER
On the occasion of the 2003 Full Year sales publication, a conference call for
financial analysts, institutional investors and journalists will be held on
Thursday, January 22nd, 2004 at 3.00 p.m. (Paris time). This conference call
will be in English.
In order to participate in the conference call, the following numbers are to be
dialed 10 minutes before it starts:
France: 00 33 (0) 1 70 70 81 98 code: 459621
United Kingdom: 00 44 (0) 207 984 75 82 code: 459621
USA: 00 1 718 354 11 58 code: 459621
A recorded version of the conference will be made available through Wednesday
February 11th, 2004 by dialing:
France: 00 33 (0) 1 70 70 82 10 code: 459621#
United Kingdom: 00 44 (0) 207 784 10 24 code: 459621#
USA: 00 1 718 354 11 12 code: 459621#
A live audio webcast of this conference will be made available at our internet
site (www.sanofi-synthelabo.com) and a recorded version will be archived through
Wednesday, February 11th, 2004.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Dated: January 22, 2004
SANOFI-SYNTHELABO
By: /s/ Marie-Helene Laimay
----------------------
Name: Marie-Helene Laimay
Title: Senior Vice President and
Chief Financial Officer