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 October 2003
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 LOGO]
~Investor Relations Paris, October 2003
ACCELERATION IN CONSOLIDATED SALES GROWTH DURING
THIRD QUARTER:
+16.4% ON A COMPARABLE BASIS
+9.2% on A REPORTED BASIS
CONSOLIDATED SALES GROWTH DURING THE FIRST NINE MONTHS:
+15.1% ON A COMPARABLE BASIS
+7.1% on A REPORTED BASIS
THIRD QUARTER 2003(1):
o Acceleration in sales growth:
- Consolidated sales: 2,037 million euros, up 16.4% (9.2% on a
reported basis).
- Developed sales: 2,718 million euros, up 22.0%.
o Very strong growth of Plavix(R)in Europe and the United States.
o Dynamic momentum for Aprovel(R)/Avapro(R)developed sales in the United
States and robust growth rate maintained in Europe.
o Success of Eloxatin(R) confirmed. Priority review granted in September 2003
by the Food and Drug Administration in the United States for the first line
treatment of metastatic colorectal cancer.
o Growth in prescriptions of Ambien(R) maintained in the United States
(13.9%(2) in the third quarter plus a favorable price effect). 6.3% decline
in consolidated US sales as a result of extraordinary high sales level on
the third quarter of 2002 in anticipation of the November 2002 price rise.
FIRST NINE MONTHS 2003 (1):
o Consolidated sales up 15.1% (7.1% on a reported basis) at 5,940 million
euros
o Developed sales up 17.4% at 7,631 million euros
2003 FULL-YEAR OUTLOOK:
o The third-quarter performance allows to confirm the full-year forecasts as
upgraded on September 2nd, 2003.
--------
(1) Unless otherwise indicated, growth rates are on a comparable basis
(2) Prescriptions IMS third quarter 2003 retail + mail order + long term care
Consolidated sales
------------------
Sanofi-Synthelabo generated consolidated sales of 5,940 million euros in the 9
months to end September 2003, an increase of 15.1% on a comparable basis and
7.1% on a reported basis. Currency fluctuations had an unfavorable impact of 7.5
percentage points to end September. 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(3) had an unfavorable impact of 0.5 of a
percentage point over the 9-month period.
Consolidated sales for the third quarter of 2003 were 2,037 million euros, a
rise of 16.4% on a comparable basis and 9.2% on a reported basis. During the
quarter, currency fluctuations had an unfavorable impact of 6.9 percentage
points and changes in Group structure an unfavorable impact of 0.3 of a
percentage point.
Consolidated sales by geographical region
-----------------------------------------
Consolidated Change on a Change on a
In millions 9-month sales comparable reported
of euros 2003 basis basis
------------------------------------------------------------------------------
Europe 3,473 +9.5% +8.2%
United States 1,413 +34.6% +14.0%
Rest of the world 1,054 +12.0% -4.0%
------------------------------------------------------------------------------
Total 5,940 +15.1% +7.1%
------------------------------------------------------------------------------
- In Europe, consolidated sales to end September were 3,473 million euros, up
9.5% on a comparable basis (8.2% on a reported basis), a higher growth rate
than that of the market (+7.4% IMS YTD retail to end August). The third
quarter saw an acceleration in comparable-basis sales growth to 13.0%
(11.6% on a reported basis), compared with 7.9% in the first half of 2003.
- In the United States, consolidated sales to end September reached 1,413
million euros, a rise of 34.6% on a comparable basis and 14.0% on a
reported basis; the difference was entirely due to fluctuations in the
dollar/euro exchange rate. This performance was due largely to the
continuing success of Eloxatin(R), which posted sales of 334 million euros
to end September. Third-quarter consolidated sales in the United States
rose by 26.3% on a comparable basis, despite a decline in sales of
Ambien(R) (down 6.3% on a comparable basis) due to unfavorable
comparatives.
- In the rest of the world, sustained growth in Asia and a recovery in Latin
American operations resulted in sales of 1,054 million euros to end
September, up 12.0% on a comparable basis but down 4.0% on a reported
basis. Third-quarter sales rose by 14.1% on a comparable basis and 1.7% on
a reported basis.
Consolidated sales by product
-----------------------------
Consolidated sales of the top 10 products to end September totaled 3,984 million
euros, an increase of 28.4% on a comparable basis and 19.5% on a reported basis.
The comparable-basis growth rate for the top 10 products during the third
quarter was 24.8%.
--------
(3) Primarily, change from full consolidation to 51% proportionate
consolidation of Sanofi-Synthelabo-Fujisawa (Taiwan) in May 2002
The top 10 products accounted for 67.1% of consolidated sales to end September,
compared with 60.1% on a comparable basis in the nine months to end September
2002.
In millions of euros Consolidated Change on a Change on a
9-month sales comparable reported
2003 basis basis
--------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 995 +10.3% -6.4%
Plavix(R) 964 +36.0% +32.4%
Eloxatin(R) 600 +174.0% +160.9%
Aprovel(R) 506 +26.8% +23.7%
Fraxiparine(R) 239 +2.6% -0.8%
Depakine(R) 206 +7.3% +3.5%
Xatral(R) 156 +20.9% +17.3%
Cordarone(R) 110 -4.3% -9.8%
Solian(R) 108 +6.9% +5.9%
Tildiem(R) 99 -5.7% -7.5%
--------------------------------------------------------------------------------
Total 3,984 +28.4% +19.5%
--------------------------------------------------------------------------------
During the first nine months of 2003:
- Consolidated sales of Stilnox(R)/Ambien(R)/Myslee(R) were 995 million
euros, up 10.3% on a comparable basis but down 6.4% on a reported basis.
This difference is related to the impact of movements in the dollar/euro
exchange rates, most of the product's sales being generated in the United
States (831 million euros to end September, up 10.5% on a comparable
basis). Third-quarter sales of Ambien(R) in the United States (315 million
euros) were in line with demand, which rose by 13.9% (prescriptions IMS
third quarter 2003 retail + mail order + long term care) with a favorable
price effect, but fell by 6.3% on a comparable basis as a result of
unfavorable comparatives. This was because the third quarter of 2002 saw a
build-up of Ambien(R) inventories held by American wholesalers in
anticipation of the November 2002 price rise. Inventory levels of Ambien(R)
in the United States at end September 2003 were similar to those at end
June 2003.
In Japan, consolidated sales of Myslee(R) were 36 million euros, up 38.5%
on a comparable basis.
- Consolidated sales of Plavix(R) came to 964 million euros, up 36.0% on a
comparable basis. Excluding sales of active ingredient and finished product
to Bristol-Myers Squibb, consolidated sales growth for Plavix(R) was 44.0%.
- Consolidated sales of Eloxatin(R) were 600 million euros, a rise of 174.0%
on a comparable basis. This very strong growth reflects the continuing
success of Eloxatin(R) in the United States, where sales reached 334
million euros. Outside the United States, sales of the product increased by
40.0% on a comparable basis to 266 million euros.
- Consolidated sales of Aprovel(R)were 506 million euros, up 26.8% on a
comparable basis.
Apart from the top 10 products, the rest of the portfolio generated sales of
1,956 million euros to end September 2003, a decline of 5.0% on a comparable
basis. Stripping out the fall in sales of Ticlid(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 by 1%.
Consolidated sales of Arixtra(R) remained low at 13 million euros. In July 2003,
files were submitted in the United States and Europe seeking approval for
Arixtra(R) as a curative treatment for thromboembolic events.
Developed sales(4)
------------------
In the nine months to end September, developed sales, which represent the
worldwide market presence of Sanofi-Synthelabo products, reached 7,631 million
euros, an increase of 17.4% on a comparable basis. Third-quarter developed sales
rose by 22.0 % on a comparable basis.
Developed sales of Plavix(R)/Iscover(R)
---------------------------------------
In millions of euros H1 2003 Change on a Q3 2003 Change on a 9 months Change on a
comparable basis comparable basis 2003 comparable basis
-----------------------------------------------------------------------------------------------------------------
Europe 476 +26.3% 275 +52.8% 751 +34.8%
United States 713 +15.6% 520 +41.3% 1,233 +25.2%
Rest of the world 157 +61.9% 92 +55.9% 249 +59.6%
-----------------------------------------------------------------------------------------------------------------
Total 1,346 +23.4% 887 +46.1% 2,233 +31.5%
-----------------------------------------------------------------------------------------------------------------
Developed sales of Plavix(R)(R)/Iscover(R)(R) to end September 2003 came to
2,233 million euros.
In the United States, third-quarter invoiced sales of Plavix(R) (520 million
euros) advanced by 41.3% on a comparable basis. Over the first 9 months of the
year, demand for Plavix(R) continued to grow at a strong pace, with
prescriptions up 26.5% (Prescriptions IMS YTD September 2003 retail + mail order
+ long term care), coupled with a favorable price effect.
Outside the United States, third-quarter sales growth was particularly buoyant,
reaching 52.8% in Europe and 55.9% in the rest of the world on a comparable
basis.
Developed sales of Aprovel(R)/Avapro(R)/Karvea(R)
-------------------------------------------------
In millions of euros H1 2003 Change on a Q3 2003 Change on a 9 months Change on a
comparable basis comparable basis 2003 comparable basis
-----------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------
Europe 306 +25.9% 159 +23.3% 465 +25.0%
United States 188 +0.5% 95 +61.0% 283 +15.0%
Rest of the world 97 +40.6% 56 +36.6% 153 +39.1%
-----------------------------------------------------------------------------------------------------------------
Total 591 +18.4% 310 +35.4% 901 +23.8%
-----------------------------------------------------------------------------------------------------------------
--------
(4) 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).
Developed sales of Aprovel(R)/Avapro(R)/Karvea(R) to end September 2003 were 901
million euros.
In the United States, third-quarter invoiced sales of Avapro(R) came to 95
million euros, an increase of 61.0% on a comparable basis. This growth rate
reflects invoiced sales in line with demand over the quarter plus favorable
comparatives, Bristol-Myers Squibb having initiated its inventory workdown of
Avapro(R) in the United States in the third quarter of 2002. Over the first 9
months of the year, volume growth in demand was 14.1% (Prescriptions IMS YTD
September 2003 retail + mail order + long term care); this was coupled with a
favorable price effect.
Outside the United States, third-quarter comparable-basis sales growth was 23.3%
in Europe and 36.6% in the rest of the world.
OUTLOOK FOR 2003:
The third-quarter performance allows to confirm the full-year forecasts as
upgraded on September 2nd, 2003:
o Growth in the region of 15% on a comparable basis in 2003 full-year sales.
o Growth of close to 20% in full-year 2003 EPS(5) expected at an average
annual rate of 1.10 dollars to one euro. The sensitivity of this growth
rate to fluctuations in the dollar is 1% for a 3-cent movement.
--------
(5) before exceptional items and goodwill amortization
Detailed figures for the third quarter of 2003
Third-quarter consolidated sales by geographical region
-------------------------------------------------------
In millions Change on a Change on a
of euros Q3 2003 Q3 2002 comparable Q3 2002 reported comparable basis reported basis
--------------------------------------------------------------------------------------------------------------------
Europe 1,153 1,020 1,033 +13.0% +11.6%
United States 529 419 483 +26.3% +9.5%
Rest of the world 355 311 349 +14.1% +1.7%
--------------------------------------------------------------------------------------------------------------------
Total 2,037 1,750 1,866 +16.4% +9.2%
--------------------------------------------------------------------------------------------------------------------
Third-quarter consolidated sales of the top 10 products
-------------------------------------------------------
Change on a Change on a
Q3 2003 Q3 2002 comparable Q3 2002 reported comparable basis reported basis
--------------------------------------------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 368 383 440 -3.9% -16.4%
Plavix(R) 352 227 232 +55.1% +51.7%
Eloxatin(R) 216 99 106 +118.2% +103.8%
Aprovel(R) 172 141 143 +22.0% +20.3%
Fraxiparine(R) 73 73 75 - -2.7%
Depakine(R) 69 62 64 +11.3% +7.8%
Xatral(R) 53 43 44 +23.3% +20.5%
Cordarone(R) 37 35 37 +5.7% -
Solian(R) 37 34 34 +8.8% +8.8%
Tildiem(R) 32 33 34 -3.0% -5.9%
--------------------------------------------------------------------------------------------------------------------
Total 1,410 1,130 1,208 +24.8% +16.7%
--------------------------------------------------------------------------------------------------------------------
Detailed figures for the first 9 months of 2003
9-month consolidated sales by geographical region
-------------------------------------------------
In millions 9 months 2003 9 months 2002 9 months 2002 Change on a Change on a
of euros comparable reported comparable basis reported basis
--------------------------------------------------------------------------------------------------------------------
Europe 3,473 3,171 3,209 +9.5% +8.2%
United States 1,413 1,050 1,239 +34.6% +14.0%
Rest of the world 1,054 941 1,098 +12.0% -4.0%
--------------------------------------------------------------------------------------------------------------------
Total 5,940 5,162 5,546 +15.1% +7.1%
--------------------------------------------------------------------------------------------------------------------
9-month consolidated sales of the top 10 products
-------------------------------------------------
In millions 9 months 2003 9 months 2002 9 months 2002 Change on a Change on a
of euros comparable reported comparable basis reported basis
---------------------------------------------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 995 902 1,063 +10.3% -6.4%
Plavix(R) 964 709 728 +36.0% +32.4%
Eloxatin(R) 600 219 230 +174.0% +160.9%
Aprovel(R) 506 399 409 +26.8% +23.7%
Fraxiparine(R) 239 233 241 +2.6% -0.8%
Depakine(R) 206 192 199 +7.3% +3.5%
Xatral(R) 156 129 133 +20.9% +17.3%
Cordarone(R) 110 115 122 -4.3% -9.8%
Solian(R) 108 101 102 +6.9% +5.9%
Tildiem(R) 99 105 107 -5.7% -7.5%
---------------------------------------------------------------------------------------------------------------------
Total 3,984 3,104 3,333 +28.4% +19.5%
---------------------------------------------------------------------------------------------------------------------
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.
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.
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 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 Commission des Operations de Bourse at www.cob.fr or directly from
Sanofi-Synthelabo on the web site www.sanofi-synthelabo.com.
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REMINDER
A conference call for financial analysts, institutional investors and
journalists will be held today Wednesday, October 22nd, 2003 at 3:30 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 78 code : 517790
United Kingdom : 00 44 (0) 207 019 95 04 code : 517790
USA : 00 1 718 354 11 52 code : 517790
A recorded version of the conference will be made available through Friday
October 31st, 2003 by dialing :
France : 00 33 (0) 1 70 70 82 10 code : 517790#
United Kingdom : 00 44 (0) 207 784 10 24 code : 517790#
USA : 00 1 718 354 11 12 code : 517790#
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
Friday, October 31st, 2003.
Investor Relations Department:
Philippe Goupit Director of Investor Relations
Arnaud Delepine Investor Relations Europe
Sanjay Gupta Investor Relations US
Isabelle Laurent Investor Relations
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
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: October 22, 2003
SANOFI-SYNTHELABO
By: /s/ Marie-Helene Laimay
-------------------------------
Name: Marie-Helene Laimay
Title: Senior Vice President and
Chief Financial Officer