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 July 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 if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(1):____
Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(7):____
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, July 23rd, 2003
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STRONG GROWTH IN CONSOLIDATED SALES
IN THE FIRST HALF OF 2003
+14.4% ON A COMPARABLE BASIS(1)
+6.1% ON A REPORTED BASIS
o Acceleration in sales growth in the second quarter on a comparable basis (1)
(+15.4%)
o Second-quarter invoiced US sales of Plavix(R)in line with demand
o Continuing success for Eloxatin(R)
o 2003 EPS(2) growth forecast confirmed
--------------------------------------------------------------------------------
Sanofi-Synthelabo generated consolidated sales of 3,903 million euros in the
first half of 2003, an increase of 14.4% on a comparable basis(1) and 6.1% on a
reported basis. Consolidated sales for the second quarter of 2003 were 1,944
million euros, a rise of 15.4% on a comparable basis(1) and 6.5% on a reported
basis.
Currency fluctuations had an unfavorable impact of 7.8 percentage points over
the half-year. Of this, half was due to the weakening of the US dollar (in the
first half of 2003, the euro appreciated against the dollar by an average of
over 20% relative to the first half of 2002), and the rest was due 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.
Consolidated sales by geographical region
-----------------------------------------
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Consolidated sales Change on a Change on a
In millions of euros H1 2003 comparable basis reported basis
-------------------------------------------------------------------------
Europe 2,320 +7.9% +6.6%
United States 884 +40.1% +16.9%
Rest of the world 699 +11.0% -6.7%
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Total 3,903 +14.4% +6.1%
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-------------------
(1) Comparable basis means constant Group structure and exchange rates (see
explanatory note)
(2) Before exceptional items and goodwill amortization
(3) Primarily, change from full consolidation to 51% proportionate consolidation
of Sanofi-Synthelabo-Fujisawa (Taiwan) in May 2002
- In Europe, first-half consolidated sales were 2,320 million euros, up 7.9%
on a comparable basis. Excluding sales of finished products to Bristol-Myers
Squibb, comparable-basis growth was 8.2% in the first half, a higher growth
rate than that of the market (7.3% IMS YTD retail to end May). In the second
quarter, consolidated sales advanced by 7.2% on a comparable basis (or 8.0%
excluding sales of finished products to Bristol-Myers Squibb).
- In the United States, first-half consolidated sales reached 884 million
euros, an increase of 40.1% on a comparable basis and 16.9% on a reported
basis, the difference being entirely due to fluctuations in the dollar/euro
exchange rate. This performance was due to the success of Eloxatin(R), which
generated sales of 213 million euros, and to the progress made by Ambien(R),
which posted 516 million euros in sales, an increase of 24.0% on a
comparable basis. Second-quarter consolidated sales in the United States
were 51.3% higher on a comparable basis.
- In the rest of the world, sustained growth in Asia and a recovery in Latin
American operations led to first-half sales of 699 million euros, up 11.0%
on a comparable basis but down 6.7% on a reported basis. The fall in
reported-basis figures was due to the weakness of some Latin American and
Asian currencies during the first half, and to the change to proportionate
consolidation of Sanofi-Synthelabo-Fujisawa (Taiwan). Second-quarter sales
rose by 12.6% on a comparable basis.
Consolidated sales by product
-----------------------------
First-half consolidated sales of the top 10 products totaled 2,574 million
euros, an increase of 30.4% on a comparable basis and 21.1% on a reported basis.
The comparable-basis growth rate for the top 10 products during the second
quarter (30.5%) was the same as for the first quarter (30.3%).
The top 10 products accounted for 65.9% of first-half consolidated sales,
compared with 57.9% on a comparable basis in the first half of 2002.
--------------------------------------------------------------------------------
In millions of euros Consolidated Change on a Change on a
sales comparable reported
H1 2003 basis basis
--------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 627 +20.8% +0.6%
Plavix(R) 612 +27.0% +23.4%
Eloxatin(R) 384 +220.0% +209.7%
Aprovel(R) 334 +29.5% +25.6%
Fraxiparine(R) 166 +3.8% +0.0%
Depakine(R) 137 +5.4% +1.5%
Xatral(R) 103 +19.8% +15.7%
Cordarone(R) 73 -8.8% -14.1%
Solian(R) 71 +6.0% +4.4%
Tildiem(R) 67 -6.9% -8.2%
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Total 2,574 +30.4% +21.1%
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During the first half of 2003:
- Consolidated sales of Stilnox(R)/Ambien(R)/Myslee(R) were 627 million
euros, a rise of 20.8% on a comparable basis and 0.6% on a reported basis.
This difference is related to the impact of movements in the dollar/euro
exchange rate, most of the product's sales being generated in the United
States. In the United States, the product recorded sales of 516 million
euros, up 24.0% on a comparable basis. In Japan, consolidated sales of
Myslee(R) reached 23 million euros growing by 23.7% on a comparable basis.
- Consolidated sales of Plavix(R) totaled 612 million euros, a rise of 27.0%
on a comparable basis. Without sales of active ingredient and finished
products to Bristol-Myers Squibb, consolidated sales growth for Plavix(R)
is 38.3%.
- Consolidated sales of Eloxatin(R) came to 384 million euros, up 220.0% on a
comparable basis. This very strong growth reflects the continuing success
of Eloxatin(R) in the United States, where it achieved sales of 213 million
euros. Outside the United States, sales advanced by 43.4% on a comparable
basis.
- Consolidated sales of Aprovel(R)were 334 million euros, a rise of 29.5% on
a comparable basis, underlining the success of this product, especially in
Europe.
- Consolidated sales of Arixtra(R) remained low at 8 million euros, due to
the current narrow range of indications. The program aimed at extending
indications for Arixtra(R) is on track.
Apart from the top 10 products, the rest of the portfolio generated sales of
1,329 million euros in the first half of 2003, a decline of 7.6% 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 were almost unchanged (- 0.4%).
Developed sales (4)
-------------------
First half developed sales, which represent the worldwide market presence of
Sanofi-Synthelabo products, reached 4,913 million euros, an increase of 15.0% on
a comparable basis. Second-quarter developed sales rose by 20.5% on a comparable
basis, thanks notably to a performance by Plavix(R) in the United States in line
with demand.
----------------
(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 Plavix(R)/Iscover(R)
---------------------------------------
----------------------------------------------------------------------------------------------------
In millions of euros Q1 2003 Change(5) Q2 2003 Change(5) H1 2003 Change(5)
----------------------------------------------------------------------------------------------------
Europe 233 +28.7% 243 +24.0% 476 +26.3%
United States 287 -14.1% 426 +50.5% 713 +15.6%
Rest of the world 73 +62.2% 84 +61.5% 157 +61.9%
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Total 593 +5.9% 753 +41.8% 1,346 +23.4%
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Developed sales of Plavix(R)/Iscover(R)amounted to 1,346 million euros in the
first half of 2003. In the United States:
- Second-quarter invoiced sales of Plavix (426 million euros) recorded a
strong rise of 50.5% on a comparable basis. This growth corresponds to
invoiced sales in line with demand, and also reflects a favorable
comparative base, since Bristol-Myers Squibb only began its inventory
workdown in the second quarter of 2002.
- Over the first half, demand for Plavix continues to grow at a sustained
pace, with prescriptions up 26.7% (Prescription IMS YTD June 2003 retail +
mail order + long term care), coupled with a favorable price effect.
- Given the very strong growth in prescriptions and the current level of
inventories held by American wholesalers, full-year invoiced sales should
be close to demand.
Outside the United States, second-quarter sales rose by 31.9 % on a comparable
basis.
Developed sales of Aprovel(R)/Avapro(R)/Karvea(R)
-------------------------------------------------
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In millions of euros Q1 2003 Change(5) Q2 2003 Change(5) H1 2003 Change(5)
----------------------------------------------------------------------------------------------------
Europe 146 +27.0% 160 +25.0% 306 +25.9%
United States 98 +3.2% 90 -2.2% 188 +0.5%
Rest of the world 46 +43.8% 51 +37.8% 97 +40.6%
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Total 290 +19.8% 301 +17.1% 591 +18.4%
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Developed sales of Aprovel(R)/Avapro(R)/Karvea(R)amounted to 591 million euros
in the first half of 2003.
In the United States, second-quarter sales of Avapro(R) reached 90 million
euros. Over the first half, prescriptions grew by 14.0% (Prescriptions IMS YTD
June 2003 retail + mail order + long term care), coupled with a favorable price
effect. Invoiced sales were in line with demand over the first half. The lack of
comparable-basis growth was due to an unfavorable comparative base, the
inventory workdown being implemented by Bristol-Myers Squibb from the second
half of 2002. Outside the United States, second-quarter sales rose by 27.9% on a
comparable basis.
----------------
(5) On a comparable basis
Recent events
- Announcement in June 2003 at the 39th annual conference of the ASCO
(American Society of Clinical Oncology) of major results with Oxaliplatine
(Eloxatin(R)), clearly demonstrating consistent superiority in the
treatment of colorectal cancer in all settings of the disease (early stage,
adjuvant treatment after surgery, metastatic settings).
- Approval in June 2003 by the US Food and Drug Administration of
Uroxatral(R)in the treatment of the signs and symptoms of benign prostatic
hypertrophy.
- Approval in June 2003 by the US Food and Drug Administration of Arixtra(R)
in the long-term prevention of deep venous thrombosis in patients
undergoing hip fracture surgery.
- Announcement in July 2003 at the 19th conference of the ISTH (International
Society on Thrombosis and Haemostasis) of favorable results with
Arixtra(R), demonstrating a significant reduction of the risk of deep
venous thrombosis in medical patients (ARTEMIS study) and benefits in
prevention of deep venous thrombosis after major abdominal surgery (PEGASUS
study).
Outlook
-------
Based on the strong activity during the first half of 2003, in a globally
tougher environment, the Group is able:
o to confirm the forecasts for growth in 2003 sales and earnings per share
before exceptional items and goodwill amortization as announced on February
18th, 2003: barring major adverse events, Sanofi-Synthelabo should achieve
in 2003:
- a similar level of comparable-basis consolidated sales growth to that
achieved in 2002;
- at an exchange rate of one euro per dollar, an increase in earnings
per share close to 20%, before exceptional items and goodwill
amortization, the sensitivity of this growth rate being 1% for a 3
cent movement in the dollar exchange rate.
o to anticipate for the first half of 2003, growth in earnings per share
before exceptional items and goodwill amortization, in line with the
full-year forecasts announced for 2003.
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Detailed figures for the first quarter of 2003
--------------------------------------------------------------------------------
First-quarter consolidated sales by geographical region
-------------------------------------------------------
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Consolidated sales Consolidated Consolidated Change on a Change
In millions of euros sales Q1 2003 sales Q1 2002 sales Q1 2002 comparable on a reported
(comparable) (reported) basis basis
--------------------------------------------------------------------------------------------------------------------
Europe 1,155 1,064 1,073 +8.6% +7.6%
United States 471 358 424 +31.6% +11.1%
Rest of the world 333 305 358 +9.2% -7.0%
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Total 1,959 1,727 1,855 +13.4% +5.6%
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First-quarter consolidated sales by product
-------------------------------------------
---------------------------------------------------------------------------------------------------------------------
Consolidated sales Consolidated Consolidated Change on a Change
In millions of euros sales Q1 2003 sales Q1 2002 sales Q1 2002 comparable on a reported
(comparable) (reported) basis basis
---------------------------------------------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 342 282 335 +21.3% +2.0%
Plavix(R) 289 230 236 +25.7% +22.5%
Eloxatin(R) 185 57 59 +224.6% +213.6%
Aprovel(R) 164 121 124 +35.5% +32.3%
Fraxiparine(R) 85 80 83 +6.3% +2.4%
Depakine(R) 68 65 67 +4.6% +1.5%
Xatral(R) 49 43 44 +14.0% +11.4%
Cordarone(R) 37 39 41 -5.1% -9.8%
Solian(R) 35 33 33 +6.1% +6.1%
Tildiem(R) 33 37 37 -10.8% -10.8%
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Total 1,285 986 1,059 +30.3% +21.3%
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Detailed figures for the second quarter of 2003
--------------------------------------------------------------------------------
Second-quarter consolidated sales by geographical region
--------------------------------------------------------
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Consolidated sales Consolidated Consolidated Change on a Change
In millions of euros sales Q2 2003 sales Q2 2002 sales Q2 2002 comparable on a reported
(comparable) (reported) basis basis
--------------------------------------------------------------------------------------------------------------------
Europe 1,165 1,087 1,103 +7.2% +5.6%
United States 413 273 332 +51.3% +24.4%
Rest of the world 366 325 391 +12.6% -6.4%
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Total 1,944 1,685 1,825 +15.4% +6.5%
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Second-quarter consolidated sales by product
--------------------------------------------
---------------------------------------------------------------------------------------------------------------------
Consolidated sales Consolidated Consolidated Change on a Change
In millions of euros sales Q2 2003 sales Q2 2002 sales Q2 2002 comparable on a reported
(comparable) (reported) basis basis
---------------------------------------------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 285 237 288 +20.3% -1.0%
Plavix(R) 323 252 260 +28.2% +24.2%
Eloxatin(R) 199 63 65 +215.9% +206.2%
Aprovel(R) 170 137 142 +24.1% +19.7%
Fraxiparine(R) 81 80 83 +1.3% -2.4%
Depakine(R) 69 65 68 +6.2% +1.5%
Xatral(R) 54 43 45 +25.6% +20.0%
Cordarone(R) 36 41 44 -12.2% -18.2%
Solian(R) 36 34 35 +5.9% +2.9%
Tildiem(R) 34 35 36 -2.9% -5.6%
---------------------------------------------------------------------------------------------------------------------
Total 1,289 988 1,066 +30.5% +20.9%
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--------------------------------------------------------------------------------
Detailed figures for the first half of 2003
--------------------------------------------------------------------------------
First-half consolidated sales by geographical region
---------------------------------------------------------------------------------------------------------------------
Consolidated sales Consolidated Consolidated Change on a Change
In millions of euros sales H1 2003 sales H1 2002 sales H1 2002 comparable on a reported
(comparable) (reported) basis basis
--------------------------------------------------------------------------------------------------------------------
Europe 2,320 2,151 2,176 +7.9% +6.6%
United States 884 631 756 +40.1% +16.9%
Rest of the world 699 630 749 +11.0% -6.7%
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Total 3,903 3,412 3, 680 +14.4% +6.1%
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First-half consolidated sales by product
----------------------------------------
---------------------------------------------------------------------------------------------------------------------
Consolidated sales Consolidated Consolidated Change on a Change
In millions of euros sales H1 2003 sales H1 2002 sales H1 2002 comparable on a reported
(comparable) (reported) basis basis
--------------------------------------------------------------------------------------------------------------------
Stilnox(R)/Ambien(R) 627 519 623 +20.8% +0.6%
Plavix(R) 612 482 496 +27.0% +23.4%
Eloxatin(R) 384 120 124 +220.0% +209.7%
Aprovel(R) 334 258 266 +29.5% +25.6%
Fraxiparine(R) 166 160 166 +3.8% +0.0%
Depakine(R) 137 130 135 +5.4% +1.5%
Xatral(R) 103 86 89 +19.8% +15.7%
Cordarone(R) 73 80 85 -8.8% -14.1%
Solian(R) 71 67 68 +6.0% +4.4%
Tildiem(R) 67 72 73 -6.9% -8.2%
--------------------------------------------------------------------------------------------------------------------
Total 2,574 1,974 2,125 +30.4% +21.1%
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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, 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.
Investors and security holders may obtain a free copy of documents filed by
Sanofi-Synthelabo with the US Securities and Exchange Commission at www.sec.gov,
or directly from Sanofi-Synthelabo on the web site www.sanofi-synthelabo.com.
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REMINDER
A conference call is arranged for financial analysts, institutional investors
and journalists, today on Wednesday July 23rd, 2003 at 9.30 a.m. Paris time. The
conference call will be in English.
To take part in the conference call, please call the following numbers 10
minutes before the presentation is due to start:
in France: 01 70 70 81 98 code: 163469
in the United Kingdom: 00 44 (0) 207 984 75 82 code: 163469
in the United States: 00 1 719 457 26 79 code: 163469
A recording of the conference call will be released at 11.30 a.m. Paris time,
and will be available until August 15, 2003, by calling the following numbers:
in France: 01 70 70 82 10 code: 163469 #
in the United Kingdom: 00 44 (0) 207 784 10 24 code: 163469 #
in the United States: 00 1 719 457 08 20 code: 163469 #
A live audio webcast of the conference call will be available on
www.sanofi-synthelabo.com, and a recording will be archived on this website from
11.30 a.m. the same day until August 15th, 2003.
--------------------------------------------------------------------------------
Investor Relations Department:
Philippe Goupit Director of Investor Relations
Isabelle Laurent 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
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: July 23, 2003
SANOFI-SYNTHELABO
By: /s/ Marie-Helene Laimay
-----------------------
Name: Marie-Helene Laimay
Title: Senior Vice President and
Chief Financial Officer