PARIS, Aug. 2 /PRNewswire-FirstCall/ -- The consolidated income statement for the first half of 2006 is provided in the appendices. 2006 first-half consolidated net income after minority interests was euro 2,381 million, compared with euro 1,087 million for the first half of 2005, after the impact of the accounting treatment of acquisitions (primarily the acquisition of Aventis) and restructuring costs (euro 1,583 million after tax in 2006 and euro 1,881 million in 2005).
In order to give a better representation of our underlying economic performance, we have decided to publish and explain an adjusted consolidated income statement(1) for the first half of 2006 and the second quarter of 2006, and to compare them with an adjusted consolidated income statement for the first half and second quarter of 2005 respectively. Adjusted net income for the first half of 2006 was euro 3,964 million, against euro 2,968 million for the first half of 2005.
Unless otherwise indicated, all sales figures in this press release are stated on a comparable basis(1).
SECOND QUARTER
- Net sales: euro 7,081 million, up 4.1% (5.9% on a reported basis).
Excluding the impact of the introduction of generics of 4 products(2) in
the United States, sales growth would have been 10.7%
- Strong performance by the Vaccines business: net sales up 59.1%
- Developed sales(1): up 5.9%
- Increase of 12.2% in R&D expenses
- Adjusted "Operating income - current" up 8.8% at euro 2,455 million
- Adjusted EPS of euro 1.33 (up 14.7%), or euro 1.34 (up 13.6%) excluding
selected items(3)
FIRST HALF
- Net sales: euro 14,116 million, up 4.5% (7.7% on a reported basis).
Excluding the impact of the introduction of generics of 4 products(2) in
the United States in the second half of 2005, sales growth would have
been 10.5%
- Strong performance by the Vaccines business: net sales up 44.4%
- Developed sales(1): up 6.4%
- Adjusted "Operating income - current" up 10.8% at euro 4,874 million
- Adjusted EPS of euro 2.95 (up 32.9%), or euro 2.60 (up 16.1%) excluding
selected items(3) (notably the gain on the disposal of Exubera(R))
FIRST LAUNCH OF ACOMPLIA(R) IN EUROPE: END JUNE IN THE UNITED KINGDOM
PLAVIX(R) US:
Settlement with Apotex fails to receive antitrust clearance from state attorneys
GUIDANCE FOR 2006 RAISED ON THE BASIS OF FIRST-HALF RESULTS
The Group expects adjusted EPS growth around 12%, barring major adverse events and subject to the conditions defined on page 12
(1) Refer to the Appendices for definitions of financial indicators
(2) Excluding net sales in the United States of Allegra(R), Amaryl(R),
Arava(R), DDAVP(R) (generics introduced in the second half of 2005)
(3) See Appendix 5
2006 second-quarter and first-half net sales
In the second quarter of 2006, sanofi-aventis recorded net sales of euro 7,081 million, a rise of 4.1%. Exchange rate movements had a favorable effect of 2.6 points, and changes in Group structure a negative effect of 0.8 of a point. After allowing for these impacts, reported-basis growth was 5.9%.
In the first half of 2006, sanofi-aventis recorded net sales of euro 14,116 million, a rise of 4.5%. Exchange rate movements (mainly dollar- related) had a favorable effect of 4.0 points, and changes in Group structure a negative effect of 0.8 of a point. After allowing for these impacts, reported-basis growth was 7.7%.
Net sales by business segment
Net sales reported by sanofi-aventis comprise net sales generated by the pharmaceuticals business and net sales generated by the human vaccines business.
Pharmaceuticals
Second-quarter net sales for the pharmaceuticals business, which were hit hard by the introduction of generics of Allegra(R) in the United States in September 2005 and the effect of healthcare system reforms in France and Germany, reached euro 6,513 million, an increase of 1.0%. Net sales of the top 15 products were euro 4,382 million, up 5.9%, representing 67.3% of pharmaceuticals net sales, against 64.2% for the same period in 2005.
First-half net sales for the pharmaceuticals business reached euro 13,036 million, an increase of 2.1%. Net sales of the top 15 products were euro 8,647 million, up 6.7%, representing 66.3% of pharmaceuticals net sales, against 63.5% for the same period in 2005.
Excluding the impact of generics of Allegra(R) and Amaryl(R) in the United States, the top 15 products would have achieved growth of 15.0% in the second quarter and 15.2% in the first half.
Change Change
million euro Q2 2006 on a on a
net comparable H1 2006 comparable
sales basis net sales basis
Lovenox(R) 614 +14.1% 1 238 +15.3%
Plavix(R) 565 +11.0% 1 145 +15.9%
Stilnox(R)/Ambien(R)/Ambien CR(TM) 467 +47.3% 908 +27.7%
Taxotere(R) 456 +10.9% 886 +11.0%
Eloxatin(R) 445 +17.4% 874 +16.2%
Lantus(R) 421 +39.9% 803 +40.9%
Copaxone(R) 271 +19.4% 534 +24.8%
Aprovel(R) 250 +8.7% 498 +12.2%
Tritace(R) 248 -2.7% 483 -0.4%
Allegra(R) 189 -58.3% 369 -57.4%
Amaryl(R) 119 -38.7% 240 -33.0%
Xatral(R) 92 +16.5% 186 +15.5%
Actonel(R) 91 +7.1% 180 +14.6%
Depakine(R) 76 -9.5% 154 -3.8%
Nasacort(R) 78 +1.3% 149 -1.3%
TOTAL TOP 15 4,382 +5.9% 8,647 +6.7%
TOTAL TOP 15 excl. impact of
Allegra(R) and Amaryl(R) in the
USA* 4,266 +15.0% 8,445 +15.2%
* Excluding net sales of Allegra(R) and Amaryl(R) in the United States
Second-quarter net sales of other pharmaceutical products amounted to euro 2,131 million, down 7.7%. There were two main reasons for the fall:
- Since the second half of 2005, DDAVP(R) (down 90% in the second quarter)
and Arava(R) (down 96% in the second quarter) have been affected by the
launch of generics in the United States; excluding the effect of these
generics(4), the drop in net sales of other pharmaceuticals would have
been 4.4%.
- Sales have been hit hard by healthcare system reforms in France and
Germany.
In the first half, net sales of other pharmaceutical products were down 5.8% at euro 4,389 million. Excluding the effect of generics of DDAVP(R) and Arava(R)5, the fall in net sales of other pharmaceuticals would have been 2.7%.
Human vaccines
Second-quarter net sales for the Human Vaccines business were up 59.1% at euro 568 million.
$150 million of sales of H5N1 vaccines were recorded in the United States in the second quarter under the contract signed with the U.S. Department of Health and Human Services.
Menactra(R), launched in the United States in March 2005, achieved net sales of euro 65 million. Net sales of Adacel(TM) (adult tetanus-diphtheria- whooping cough- booster), launched in the United States in July 2005, were euro 47 million, and were helped by an extension of the immunization recommendations issued by ACIP in the fourth quarter of 2005.
First-half net sales for the Human Vaccines business were up 44.4% at euro 1,080 million.
Change Change
euro million Q2 2006 on a on a
net comparable H1 2006 comparable
sales basis net sales basis
Polio/Whooping Cough/Hib Vaccines 135 +9.8% 320 +15.5%
Adult Booster Vaccines 97 +70.2% 178 +36.9%
Influenza Vaccines 152 +1069.2% 224 +229.4%
Travel Vaccines 57 +21.3% 124 +47.6%
Meningitis/Pneumonia Vaccines 87 +16.0% 151 +46.6%
Other vaccines 40 -4.8% 83 -3.5%
TOTAL 568 +59.1% 1,080 +44.4%
Sanofi Pasteur MSD, the joint venture with Merck & Co in Europe, generated sales of euro 143 million, a drop of 6.8% on a reported basis. Excluding Hexavac(R), sales of which were suspended by the EMEA in September 2005, Sanofi Pasteur MSD would have posted sales growth of 10.6% on a reported basis.
During the second quarter, two vaccines (from Merck & Co), which are to be marketed by Sanofi Pasteur MSD, were approved by the European authorities:
- Zostavax(R), a vaccine against herpes zoster (shingles) and herpes zoster related postherpetic neuralgia, was approved in May (frozen form); application for approval of a refrigerated form is to be submitted in the second half of 2006.
- Rotateq(R) was approved in June for the prevention of pediatric rotavirus gastroentiritis.
On July 28th, Gardasil(R) (a product from Merck & Co) obtained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for use in the prevention of cervical carcinoma, high grade cervical dysplasia (CIN2/3), high grade vulvar dysplastic lesions (VIN2/3) and external genital warts caused by Human Papillomavirus types 6, 11, 16 and 18.
(4) Excluding net sales of Arava(R) and DDAVP(R) in the United States
In the first half, Sanofi Pasteur MSD achieved sales of euro 287 million, up 1.9% on a reported basis. Excluding Hexavac(R), the sales growth of this joint venture would have reached 21.8% on a reported basis.
These sales are not consolidated by sanofi-aventis.
Net sales by geographical region
Change Change
euro million Q2 2006 on a on a
net comparable H1 2006 comparable
sales basis net sales basis
Europe 3,062 +0.2% 6,230 +2.7%
United States 2,494 +6.6% 4,841 +3.0%
Other countries 1,525 +8.2% 3,045 +10.8%
TOTAL 7,081 +4.1% 14,116 +4.5%
In Europe, net sales were up 0.2%, with growth adversely affected by healthcare system reforms in France and Germany.
First-half net sales growth in Europe was 2.7%.
In the United States, net sales were affected by competition from generics on 4 products(2), and increased by 6.6% in the quarter and by 3.0% in the first half.
Excluding the impact on net sales of these 4 products(2), growth would have been 30.1% in the second quarter and 22.9% in the first half.
Growth in Other Countries reached 8.2% in the second quarter, following a first quarter boosted by an exceptional season in influenza vaccines. Latin America and Asia continue to post strong growth.
In the first half, the region recorded strong growth, of 10.8%.
Developed sales(1)
Developed sales give an indication of the overall presence of sanofi-aventis products in the market. Second-quarter developed sales reached euro 8,159 million, an increase of 5.9%, while first-half developed sales were euro 16,101 million, a rise of 6.4%.
Developed sales of Plavix(R)/Iscover(R):
Change Change
euro million on a on a
comparable comparable
Q2 2006 basis H1 2006 basis
Europe 434 +10.7% 859 +13.3%
United States 804 +20.7% 1,517 +23.7%
Other countries 179 +20.9% 344 +20.3%
TOTAL 1,417 +17.5% 2,720 +19.8%
Second-quarter developed sales of Plavix(R) were up 17.5% at euro 1,417 million. In the United States, product sales were lifted by the launch late in 2005 of a new promotional campaign aimed at general practitioners, and by a stepping-up of product promotion in hospitals. Strong growth is continuing in prescriptions (TRx) at 13.2%5 in the second quarter and 13.7%6 in the first half.
In Europe, developed sales of Plavix reached euro 434 million, up 10.7%.
The launch of Plavix(R) in Japan as a treatment for the reduction of recurrence after ischemic cerebrovascular disorder went ahead as expected in early May.
On July 28, the CHPM has issued a positive opinion to extend Plavix(R) indication to patients suffering from ST-segment elevation acute myocardial infarction and who are eligible for thrombolytic therapy. The FDA is currently reviewing the dossier filed for this indication.
Developed sales of Aprovel(R)/Avapro(R)/Karvea(R):
Change Change
euro million on a on a
comparable comparable
Q2 2006 basis H1 2006 basis
Europe 222 +8.3% 435 +12.1%
United States 135 +8.0% 252 +19.4%
Other countries 93 +14.8% 177 +14.2%
TOTAL 450 +9.5% 864 +14.6%
Developed sales of Aprovel(R)/Avapro(R)/Karvea(R) were euro 450 million in the second quarter, up 9.5%.
Developed sales of the product in the United States were 8.0% higher in the second quarter. Over the period, growth in prescriptions was 4.1%(5) (TRx). In the first half, prescriptions of the product were up 5.16%.
(5) IMS NPA 3 channels-Q2 2006
(6) IMS NPA 3 channels-YTD end June 2006
Comments by product
Geographical split of consolidated net sales by product (TOP 15)
Change Change Change
Q2 2006 net sales on a on a Other on a
(euro million) Europe comparable USA comparable countries comparable
basis basis basis
Lovenox(R) 178 +8.5% 374 +18.0% 62 +8.8%
Plavix(R) 400 +8.1% 49 -5.8% 116 +33.3%
Stilnox(R)/Ambien(R)/
Ambien CR(TM) 24 -11.1% 423 +57.8% 20 -9.1%
Taxotere(R) 187 +23.0% 184 +1.7% 85 +9.0%
Eloxatin(R) 151 +11.9% 252 +17.2% 42 +44.8%
Lantus(R) 126 +20.0% 261 +48.3% 34 +70.0%
Copaxone(R) 70 +20.7% 186 +19.2% 15 +15.4%
Aprovel(R) 198 +5.3% - - 52 +23.8%
Tritace(R) 135 -10.6% 6 - 107 +3.9%
Allegra(R) 19 -9.5% 111 -69.4% 59 -14.5%
Amaryl(R) 47 -29.9% 5 -92.4% 67 +9.8%
Xatral(R) 57 -6.6% 23 +228.6% 12 +9.1%
Actonel(R) 63 +5.0% - - 28 +12.0%
Depakine(R) 51 -16.4% - - 25 +8.7%
Nasacort(R) 14 +16.7% 57 -1.7% 7 0.0%
Change Change Change
H1 2006 on a on a Other on a
(euro million) Europe comparable USA comparable countries comparable
basis basis basis
Lovenox(R) 351 +7.3% 765 +19.0% 122 +17.3%
Plavix(R) 811 +13.6% 110 +4.8% 224 +32.5%
Stilnox(R)/Ambien(R)/
Ambien CR(TM) 48 -11.1% 817 +32.8% 43 +2.4%
Taxotere(R) 362 +20.3% 360 +1.1% 164 +16.3%
Eloxatin(R) 296 +12.5% 496 +14.3% 82 +49.1%
Lantus(R) 255 +32.8% 485 +41.4% 63 +80.0%
Copaxone(R) 136 +22.5% 370 +27.1% 28 +7.7%
Aprovel(R) 398 +10.6% - - 100 +19.0%
Tritace(R) 270 -6.3% 10 +150.0% 203 +5.2%
Allegra(R) 33 +0.0% 194 -70.4% 142 -20.2%
Amaryl(R) 103 -19.5% 8 -93.1% 129 +13.2%
Xatral(R) 120 +2.6% 42 +82.6% 24 +14.3%
Actonel(R) 128 +14.3% - - 52 +15.6%
Depakine(R) 106 -9.4% - - 48 +11.6%
Nasacort(R) 24 +9.1% 110 -3.5% 15 0.0%
Net sales of Lovenox(R), the leading low molecular weight heparin on the market, reached euro 614 million in the second quarter, a rise of 14.1%. Growth of the product continues to be driven by its increasing use in medical prophylaxis.
In the first half, net sales of Lovenox(R) increased by 15.3%.
Net sales of Ambien(R)/Ambien CR(TM) in the United States surged by 57.8% in the quarter to euro 423 million, due to 8.7%(5) growth in prescriptions, a favorable price effect and the low level of net sales in the second quarter of 2005.
To end June, prescriptions of Ambien CR(TM) represented about 23% of prescriptions of Ambien(R) brand products. In Japan, developed sales of Myslee(R) reached euro 54 million, an increase of 12.8%.
Taxotere(R) again posted an excellent quarterly performance in Europe and in Other Countries. In the United States, despite a tough competitive environment, the product continues to gain market share in adjuvant and metastatic breast cancer treatment. In March 2006, Taxotere(R) was approved in the United States for advanced stage stomach cancer in association with the standard treatment (cisplatin and 5-fluorouracile), and received a positive opinion from the Committee for Human Medicinal Products (CHMP) in Europe in the same indication. The FDA and EMEA are currently reviewing filings for approval of Taxotere(R) as a neoadjuvant treatment for head and neck cancer.
Key trial results were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) in June this year regarding the use of Taxotere(R) (docetaxel) regimens in the treatment of non small cell lung cancer (NSCLC), head and neck cancer, and metastatic and adjuvant breast cancer:
- A meta-analysis performed on seven clinical trials in patients with
advanced NSCLC showed that patients receiving Taxotere(R) (docetaxel)
Injection Concentrate had better overall survival and less febrile
neutropenia than those treated with vinca-alkaloid (vinorelbine or
vindesine) regimens.
- An international multicenter phase III study has shown that patients
with advanced head and neck cancer who received a combination of
Taxotere(R), cisplatin, and 5-fluororuracil were 30% less likely to die
than patients who received the traditional therapy of cisplatin and
5-fluorouracil.
- The results of a phase III BCIRG 07 trial show no evidence of benefit
from the addition of carboplatin in women with HER2 positive metastatic
breast cancer (HER +ve MBC) treated with a combination of Taxotere(R)
and trastuzumab.
- First results of the BIG 2-98 trial in the adjuvant treatment of
patients with node positive early-stage breast cancer.
Eloxatin(R) posted net sales of euro 445 million in the second quarter, up 17.4%. Conversion to the ready to use solution is complete in France and the United States, and is in progress in various European countries.
Key results were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) in June this year from three studies evaluating Eloxatin(R) (oxaliplatin injection) in various gastrointestinal tumor types (colorectal, pancreatic and gastric cancers):
- Final analysis of the TREE study demonstrates that Eloxatin(R)-based
chemotherapy combined with bevacizumab provided significant improvement
in overall survival (OS) for patients with advanced colorectal cancer.
- The REAL 2 trial shows improved overall survival in advanced stomach
cancer with Eloxatin(R) -capecitabine combination.
- The ECOG 6201 study shows a non-statistically significant survival
increase when using fixed dose rate (FDR) gemcitabine (GEM) or a
combination of gemcitabine-Eloxatin(R) (oxaliplatin injection) (GemOx)
compared with the standard gemcitabine regimen in patients with locally
advanced or metastatic pancreatic cancer.
To further strengthen its portfolio in oncology, on July 3 sanofi-aventis announced it had signed an agreement with the Japanese pharmaceutical company Taiho giving sanofi-aventis the rights to develop and market an oral anticancer agent, S-1, a proprietary product from Taiho. Sanofi-aventis will lead the development and marketing of the product worldwide except in Japan and some other Asian countries. Taiho will be involved in the development of the product and will have the option of participating in the promotion of the product in any country in which sanofi-aventis markets it.
Lantus(R), the world's leading insulin brand, continues to record excellent performances, with net sales up 39.9% at euro 421 million in the second quarter. In the first half, net sales of the product reached euro 803 million, up 40.9%.
The results of a new study (APOLLO) were presented to the Annual Scientific Session of the American Diabetes Association (ADA) in June this year demonstrating that in patients with type 2 diabetes who had failed on oral therapy alone, the long-acting insulin Lantus(R) (insulin glargine, rDNA origin) administered once-daily in combination with oral antidiabetes drugs (OADs) is as effective and with less hypoglycemia than the short-acting insulin lispro in combination with OADs.
The results of another study were also presented to the ADA, demonstrating that a simple algorithm to adjust mealtime insulin based on pre-meal glucose patterns is just as effective as the more complex carbohydrate counting method - a standard technique that many diabetes patients find difficult to use. The new algorithm may provide patients with an easier method to dose their mealtime insulin therapy.
Adjusted consolidated income statement (unaudited)
The adjusted consolidated income statement (unaudited) is presented in Appendix 3.
Refer to Appendix 1 for a definition of "adjusted net income", and to Appendix 4 for a reconciliation of the consolidated income statement to the adjusted consolidated income statement.
Second quarter of 2006
Net sales generated by sanofi-aventis in the second quarter of 2006 were euro 7,081 million, up 5.9% on a reported basis.
Gross profit was euro 5,548 million, 5.3% higher than in the second quarter of 2005. The gross margin ratio was 78.4%, compared with 78.8% for the second quarter of 2005. The ratio of cost of sales to net sales was up 0.9 of a point at 26.7% as a result of the impact of generics of Allegra(R), Amaryl(R), Arava(R) and DDAVP(R) in the United States. This was partially offset by an 17.4% increase in other revenues (euro 358 million). The ratio of cost of sales to net sales in the second quarter 2006 was in line with the figure for the first quarter of 2006.
Research and development expenses continued their steady advance in the second quarter, and were up 12.2% on the second quarter of 2005 at euro 1,098 million. As in the first quarter, this rise reflects increasing Phase III clinical trials activity in pharmaceuticals and greater investment in R&D in the vaccines business. Research and development expenses represented 15.5% of net sales, compared with 14.6% in the second quarter of 2005.
Selling and general expenses were slightly lower than in the second quarter of 2005 at euro 2,011 million, representing 28.4 % of net sales. Selling expenses were higher in all the major geographical regions, except the United States where marketing of the 4 products(2) now subject to competition from generics has been discontinued. General expenses were virtually unchanged.
Operating income - current was 8.8% higher at euro 2,455 million and represented 34.7% of net sales, a 1-point improvement on the 2005 second- quarter figure.
Operating income was up 9.6% at euro 2,442 million.
Net financial expense came to euro 63 million, against euro 99 million in the second quarter of 2005. The fall in net financial expense was mainly attributable to a reduction in total debt due to the cash flow generated by the Group. Interest expense on debt totaled euro 85 million, compared to euro 109 million in the second quarter of 2005.
The share of profit from associates was euro 212 million, against euro 162 million in the second quarter of 2005. The rise in this item was due to strong growth in the Group's share of after-tax profits from the territories managed by BMS under the Plavix(R) and Avapro(R) alliance (euro 139 million, vs. euro 103 million in the second quarter of 2005), and to an increase in the contribution from Merial.
Minority interests amounted to euro 93 million, compared with euro 87 million in the second quarter of 2005. This line includes the share of pre-tax profits paid over to BMS from territories managed by sanofi-aventis (euro 88 million vs. euro 69 million in the second quarter of 2005).
Adjusted net income was 15.3% higher at euro 1,791 million.
Excluding selected items, adjusted net income was euro 1,797 million, up 14.5% on the 2005 second-quarter figure of euro 1,570 million (see Appendix 5).
Adjusted earnings per share (EPS) was euro 1.33, up 14.7% on the 2005 second-quarter figure of euro 1.16, based on an average number of shares outstanding of 1,346.0 million in the second quarter of 2006 and 1,335.8 million in the second quarter of 2005.
Excluding selected items, adjusted EPS was euro 1.34, 13.6% higher than the 2005 second-quarter figure of euro 1.18 (see Appendix 5).
First half of 2006
Net sales generated by sanofi-aventis in the first half of 2006 were euro 14,116 million, up 7.7% on a reported basis.
Gross profit was euro 11,005 million, 7.5% higher than in the first half of 2005. The gross margin ratio was 78.0%, compared with 78.1% for the first half of 2005. The ratio of cost of sales to net sales was up 0.5 of a point at 26.6% as a result of the impact of generics of Allegra(R), Amaryl(R), Arava(R) and DDAVP(R) in the United States. This was offset by an 18.1% increase in other revenues (euro 647 million), due primarily to fine performances from Plavix(R) and Avapro(R).
Research and development expenses were 12.7% higher than in the first half of 2005 at euro 2,144 million. This rise reflects increasing Phase III clinical trials activity in pharmaceuticals, especially on Rimonabant, SR58611, saredutant eplivanserin, biotinyl idraparinux and Plavix(R), and greater investment in R&D in the vaccines business. Research and development expenses represented 15.2% of net sales, compared with 14.5% in the first half of 2005.
Selling and general expenses were 2.8% higher than in the first half of 2005 at euro 4,061 million, representing 28.8 % of net sales. Selling expenses were higher, while general expenses were lower.
Other current operating income and expenses amounted to euro 140 million, against euro 69 million in the first half of 2005. This reflects an increase in the Group's share of profits from Actonel(R), and the income generated by the agreement with Prasco on the marketing of authorized generics in the United States.
Operating income - current was 10.8% higher at euro 4,874 million and represented 34.5% of net sales, a 0.9-point improvement on the 2005 first-half figure.
Other operating income and expenses were euro 520 million, compared with euro 7 million for the first half of 2005. This line includes gains on disposals of euro 553 million, of which euro 460 million was for Exubera(R) (euro 384 million after tax) and euro 45 million for the sale of the residual 30% interest in an Animal Nutrition business.
Operating income was up 23.2% at euro 5,393 million.
Net financial expense came to euro 93 million, against euro 205 million in the first half of 2005. The sharp fall in net financial expense was mainly attributable to a reduction in debt due to the cash flow generated by the Group. Interest expense on debt totaled euro 158 million, compared to euro 238 million in the first half of 2005.
Net financial expense figure was also helped by gains on financial instruments (euro 42 million, against euro 10 million in the first half of 2005).
Income tax expense came to euro 1,539 million, against euro 1,302 million for the first half of 2005, giving an effective tax rate of 29.0%, against 31.2% for the first half of 2005. Excluding the gain on Exubera(R), the Group's effective tax rate was 30.2% in the first half of 2006.
The share of profit from associates was euro 393 million, against euro 269 million in the first half of 2005. The rise in this item was due to strong growth in the Group's share of after-tax profits from the territories managed by BMS under the Plavix(R) and Avapro(R) alliance (euro 252 million, vs. euro 183 million in the first half of 2005), and to an increase in the contribution from Merial.
Minority interests amounted to euro 190 million, compared with euro 170 million in the first half of 2005. This line includes the share of pre-tax profits paid over to BMS from territories managed by sanofi-aventis (euro 182 million, vs. euro 138 million in the first half of 2005).
Adjusted net income was 33.6% higher at euro 3,964 million.
Excluding selected items, adjusted net income was euro 3,504 million, 17.3% higher than the 2005 first-half figure of euro 2,988 million (see Appendix 5).
Adjusted earnings per share (EPS) was euro 2.95, up 32.9% on the 2005 first-half figure of euro 2.22, based on an average number of shares outstanding of 1,345.2 million in the first half of 2006 and 1,335.1 million in the first half of 2005.
Excluding selected items, adjusted EPS was euro 2.60, 16.1% higher than the 2005 first-half figure of euro 2.24 (see Appendix 5).
Consolidated statement of cash flows and balance sheet for the six months ended June 30, 2006
Operating cash flow before changes in working capital came to euro 4,040 million in the first half of 2006, against euro 3,314 million in the first half of 2005.
Working capital needs increased by euro 1,076 million during the period, compared with a reduction of euro 82 million in the first half of 2005. Operating working capital needs rose at a slightly higher rate than net sales, and cash flow for the period was affected by outflows incurred on restructuring costs provided for in previous periods.
In addition, the usual time delay between recognition of income taxes for accounting purposes and payment of income taxes had a favorable effect on working capital needs in the first half of 2005.
Investing activities generated net cash of euro 75 million during the period. Acquisitions of property, plant and equipment and intangibles totaled euro 631 million. Acquisitions came to euro 497 million, primarily the 24.87% stake in Zentiva (euro 433 million). Disposals represent euro 1,203 million, the main divestment being the Exubera(R) rights (euro 1,072 million).
After the dividend payout of euro 2 billion, net cash generated during the first half of 2006 was euro 1.1 billion, enabling consolidated net debt to be cut from euro 9.9 billion at December 31, 2005 to euro 8.8 billion at June 30, 2006. Gearing stood at 19.5% at June 30, 2006, compared with 21.4% at December 31, 2005.
2006 FULL-YEAR OUTLOOK
Based on these good first-half results, and barring major adverse events, we expect 2006 full-year adjusted EPS growth around 12%:
- despite the full-year impact of the availability of generics of
Allegra(R), Amaryl(R), Arava(R) and DDAVP(R) in the United States;
- after taking account of the substantial launch costs of Plavix(R) in
Japan and Rimonabant(R);
- assuming selected items of euro 300 million, compared to after-tax
selected items of euro 168 million in 2005;
- based on an exchange rate of euro 1:$1.25, with sensitivity to the
euro/dollar exchange rate estimated at 0.6% of growth for a 1-cent
movement in the exchange rate.
About sanofi-aventis
Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY)
Forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect", "anticipates", "believes", "intends", "estimates", "plans" 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 are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Recent Events
May 9, 2006 Launch of Plavix(R) in Japan.
May 11, 2006 Online publication by The Lancet of a study
demonstrating that a Sanofi Pasteur H5N1 pandemic
influenza vaccine candidate with adjuvant generated a
significant immune response.
May 31, 2006 The Chairman, Jean-Francois Dehecq, indicated at the
Annual General Meeting that he would propose to the
Board of Directors that the office of Chairman of the
Board of Directors and the office of Chief Executive
Officer be separated, as provided for in the Bylaws of
sanofi-aventis, and that this would take effect from
January 1, 2007. He also indicated that he would
propose to the Board of Directors that Gerard Le Fur be
appointed as Chief Executive Officer. The annual
General Meeting also resolved to set an age limit of 70
for the Chairman of the Board of Directors.
June 3, 2006 The results of a meta-analysis showed benefits for
patients with advanced non small cell lung cancer
(NSCLC) receiving Taxotere(R) (docetaxel) regimens.
June 5, 2006 Presentation at the ASCO of key findings from three
studies evaluating Eloxatin(R) (oxaliplatin) in various
gastrointestinal tumor types (colorectal, pancreatic
and gastric cancers).
June 7, 2006 Announcement at the ASCO of the results of major
clinical trials regarding the use of Taxotere(R)
regimens in advanced non small cell lung cancer (NSCLC),
head and neck cancer and metastatic breast cancer, and
as an adjuvant breast cancer treatment.
June 10, 2006 Presentation to the ADA of the results of a new study
showing that a simple algorithm (combination of
Apidra(R) and Lantus(R)) to adjust mealtime insulin
based on pre-meal glucose patterns was just as
effective as the more complex carbohydrate counting
method.
June 13, 2006 Presentation to the ADA of the results of a new study
showing Lantus(R) to be as effective as and better
tolerated than the prandial insulin lispro in
initiating insulin therapy in type 2 diabetes.
June 21, 2006 Marketing approval obtained for Acomplia(R) in the
European Union.
June 25, 2006 Announcement of amendments to the settlement agreement
between sanofi-aventis, BMS and Apotex relating to
patent infringement litigation on Plavix(R) in response
to concerns raised by the FTC and state attorneys
general about the initial agreement.
June 29, 2006 Announcement of revision to prescribing information for
Ketek(R) in the United States
July 3, 2006 Announcement of the signature of an agreement with
Taiho on the development and marketing of S-1, an oral
anticancer agent.
July 27, 2006 Announcement by sanofi-aventis that the Antitrust
Division of the United States Department of Justice is
conducting a criminal investigation regarding the
proposed settlement of the PLAVIX litigation with
Apotex
July 28, 2006 Positive opinion obtained from the Committee for
Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMEA) to extend Plavix(R) indication
to patients suffering from ST-segment elevation acute
myocardial infarction and who are eligible for
thrombolytic therapy
July 28, 2006 Positive opinion obtained from the CHMP of the EMEA
for Gardasil(R) in the prevention of cervical carcinoma,
high grade cervical dysplasia (CIN2/3), high grade
vulvar dysplastic lesions(VIN2/3) and external genital
warts caused by HPV types 6, 11, 16 and 18.
July 28, 2006 Announcement by sanofi-aventis that Plavix(R)
litigation settlement fails to receive antitrust
clearance from states attorneys general
Financial Calendar
October 31, 2006 2006 third-quarter sales and results
February 13, 2007 2006 full-year results: Analyst/Investor meeting in
Paris
Contact: Jean-Marc Podvin, 33 1.53.77.42.23,
jean-marc.podvin@sanofi-aventis.com
Source: sanofi-aventis
CONTACT: Jean-Marc Podvin, +33-1-53-77-42-23,
jean-marc.podvin@sanofi-aventis.com