Strasbourg, France
August 2, 2001
- Strong performance by core
pharmaceutical business: Sales up 12.5% on activity basis, EPS
rise 30.2% U.S. records 17% activity growth in second quarter,
first half sales up 28% Strategic brands sales rise 35% in
second quarter, up 43% in first half
- Aventis upgrades earnings
projections for full year 2001
- Aventis is well positioned for
future growth: Aggressive life-cycle management to
significantly expand sales of blockbuster drugs New product
launches, approvals and promising pipeline products to fuel
future growth
-
Negotiations on Aventis CropScience divestment progress
Aventis today reported unaudited
consolidated group net sales of euro 11.646 billion (10.458
billion USD) for the first half of 2001. This compares with
sales of euro 11.091 billion (9.960 billion USD) in the first
half of 2000. Group net income rose to euro 730 million (656
million USD) compared to euro 337 million (303 million USD) in
the first half of 2000 (euro 632 million (568 million USD)
before exceptionals). Earnings per share (EPS) for the Aventis
group increased to euro 0.93 (0.84 USD) compared to euro 0.43
(0.39 USD) in the first half of 2000 (euro 0.81 (0.73 USD)
before exceptionals).
The group results still include non-core activities - namely
Aventis CropScience, Aventis Animal Nutrition and industrial
activities - which are going to be divested in order to focus on
the core pharmaceutical business, which comprises prescription
drugs, human vaccines and therapeutic proteins as well as the
50% interest in the animal health business Merial, a joint
venture with Merck & Co. and corporate activities. The pro forma
results for 2000, which present the core business retroactively,
are calculated before exceptional items.
Strong performance by Aventis core Pharma business in second
quarter:
Sales increase 12.5% on an activity growth basis and EPS rise
30.2%
During the first six months of
2001, net sales in the Aventis core pharmaceutical business rose
14.9%, excluding currency and structure effects (activity
growth) to euro 8.572 billion (7.698 billion USD) (+10% on a
reported basis). For the second quarter, core business net sales
posted an activity growth of 12.5% to euro 4.447 billion (3.993
billion USD) (+8.1% on a reported basis). EBITA for the Aventis
core business was euro 1.763 billion (1.583 billion USD) for the
first half of 2001, an increase of 30.2 % over the year-ago
period. During the second quarter, EBITA rose 26.7% percent to
euro 951 million (854 million USD) from euro 750 million (674
million USD) in 2000. Half-year net income for the core business
rose 43.9% to euro 697 million (626 million USD) from euro 484
million (435 million USD) in the first half of 2000, while
second-quarter net income grew 31.2% to euro 391 million (351
million USD) from euro 298 million (268 million USD) in the
year-ago period. Half-year EPS for the core business rose 42.8%
to euro 0.89 (0.80 USD) from euro 0.62 (0.56 USD) in the first
half of 2000, while second-quarter EPS increased 30.2% to euro
0.50 (0.45 USD) from euro 0.38 (0.34 USD).
Gross margin increased to 71.2% for the first six months of 2001
compared to 65.7% in the first half of 2000 and 68.4% for the
full year 2000. At the end of the first half, the EBITA margin
in the core business rose three percentage points to 20.6%
compared to the first half of 2000. This profitability
improvement was achieved despite higher spending on sales and
marketing for the successful launch of new products, such as the
diabetes drug Lantus(R) in the United States and the pre-launch
activities for the new antibiotic Ketek(R) in Europe.
Aventis upgrades earnings projections for full year 2001
"Strong performance within our core business has led us to
consistently exceed the growth objectives, which we had
established following the merger," said Patrick Langlois, Chief
Financial Officer of Aventis. "We anticipate now that, core
business activity sales growth will be around 13%, while EPS
will increase approximately 35% for this year on a basis of euro
1.50 . Having established a solid base for performance gives us
a great deal of confidence in our ability to deliver long-term
sustainable growth to our shareholders well beyond 2001."
"With most industrial divestitures already completed, and with
the anticipated divestment of Aventis CropScience and Aventis
Animal Nutrition under way by the end of this year, Aventis is
one step away from becoming a pure play pharmaceutical company,"
Langlois said.
U.S. sales grow 17% in second quarter and 28% in first half
Sales by Aventis Pharma in the United States rose 28% excluding
structural and currency effects
(activity growth) to euro 2.969 billion during the first six
months of 2001 (+25% on a reported basis). During the second
quarter, sales activity by Aventis Pharma in the United States
increased 17.4% to euro 1.600 billion (+16.2% on a reported
basis). The United States accounted for 34.6% of total Aventis
Pharma sales during the first half of 2001 compared to 30.5% in
the year-ago period and 33.2% for the full year 2000.
In Japan, the world's second-largest pharmaceutical market,
Aventis Pharma generated sales of euro 552 million during the
first half of 2001; an activity increase of 13.6% (+8.1% on a
reported basis). This favorable development is mainly
attributable to the introduction of allergy drug Allegra(R),
which was launched in Japan in November 2000 and has helped
Aventis to significantly strengthen its position as one of the
fastest-growing pharmaceutical companies in this important
market.
Strategic brands grow 35 % in second quarter and 43% in first
half
The prescription drugs business recorded sales of euro 7.413
billion in the first half of 2001, this is an activity growth of
15.7% (+9.4% on a reported basis). Sales activity of strategic
brands rose 34.8% in the second quarter of 2001 to euro 1.852
billion and 43.2% to euro 3.470 billion in the first half of
2001.
Strategic pharmaceutical brands, a group of 16 key
pharmaceutical products, accounted for 46.8% of total
prescription drugs sales during the first six months of 2001, up
from 34.9% in same period of 2000.
Among the main growth drivers
are:
Allegra(R)/Telfast(R)
(fexofenadine) generated a 53.6% increase in
half-year sales activity to euro 844 million (+ 60.7% on a
reported
basis), while second-quarter sales activity grew 43.4% to euro
460
million (+50.2% on a reported basis). In the United States,
sales
activity rose 37.5% to euro 680 million in the first half (+47%
on a
reported basis). Allegra(R) was a main growth driver in the
United
States, benefiting mainly from positive prescription trends. In
Japan,
the world's second-largest allergy market after the United
States,
sales of Allegra(R) have also been very strong since the
product's
launch in November 2000, rising to euro 82 million during the
first six
months of 2001.
On August 1, 2001, Aventis Pharmaceuticals, the U.S.
pharmaceutical
business of Aventis, filed a lawsuit against Barr Laboratories,
Inc.,
in U.S. District Court in New Jersey alleging infringement of
certain
U.S. patents related to fexofenadine HCl, which Aventis
Pharmaceuticals
markets in the U.S. under the brand name Allegra(R). Barr
Laboratories
had filed an Abbreviated New Drug Application (ANDA) with the
U.S. Food
and Drug Administration (FDA) seeking authorization to produce
and
market a generic version of fexofenadine HCl 60 mg capsules. In
the
U.S., Aventis holds multiple enforceable method of use,
formulation,
process and composition patents with respect to Allegra(R).
Under
applicable federal law, marketing of an FDA-approved generic
capsule
may not commence unless and until a decision favorable to Barr
Laboratories is rendered in the patent litigation or until 30
months
have elapsed, whichever comes first. On July 30, 2001, Aventis
Pharmaceuticals received notice that Barr Laboratories had filed
another ANDA with the FDA seeking authorisation to produce and
market a
generic version of fexofenadine HCl tablets. Aventis is
currently in
the process of analysing the situation. If a patent infringement
suit
is brought by Aventis against Barr relating to the ANDA for the
t
tablets, marketing of an FDA-approved generic tablet may not
commence
unless and until a decision favorable to Barr Laboratories is
rendered
in the litigation or until 30 months have elapsed, whichever is
first.
In addition, the tablet formulations are protected by regulatory
exclusivity until the first quarter of 2003.
-- Lovenox(R)/Clexane(R) (enoxaparin sodium) achieved sales of
euro 706
million for the first half of the year, an activity increase of
52.3%
(+58.9% on a reported basis). Second-quarter sales activity rose
36% to
euro 363 million (+41.8% on a reported basis). In the United
States,
sales activity grew 79.2% to euro 473 million in the first half
of the
year (+91.6% on a reported basis). Considered the standard
therapy for
the prevention and treatment of thrombosis as well as the
treatment of
unstable angina pectoris and myocardial infarction, Lovenox(R)
maintained its leading market position despite new competition
since it
has the broadest range of indications of any drug in its class.
-- Taxotere(R) (docetaxel), for the treatment of advanced breast
cancer
and non-small-cell lung cancer, posted first-half sales of euro
465
million, up 45.3% from the first half of 2000 (+49.3% on a
reported
basis). Second-quarter sales activity increased 36.2% to euro
254
million (+39.8% on a reported basis). In the United States,
sales of
Taxotere(R) rose 71.8% to euro 243 million (+83.7% on a reported
basis). Studies presented at the annual meeting of the American
Society
of Clinical Oncology in May underscored the continually growing
body of
clinical evidence for both the efficacy and safety of
Taxotere(R).
Aventis has a major clinical program in place to extend this
drug's
unique profile, and studies are underway to prove its safety and
efficacy for head and neck, prostate and gastric cancer in the
EU and
the United States.
-- Amaryl(R) (glimepiride), an oral treatment for type 2
diabetes,
achieved sales of euro 223 million in the first half of 2001, an
activity increase of 34.4% from the same period in 2000 (+34.7%
on a
reported basis), while second-quarter sales activity increased
23.3% to
euro 114 million (+22.6% on a reported basis). Results from a
number of
clinical trials presented at the recent American Diabetes
Association
meeting reaffirmed the safety and efficacy of Amaryl (R), which
offers
type 2 diabetes patients a once-daily oral therapy with 24-hour
glucose
control. Amaryl(R) is the first and only sulfonylurea with three
indications: monotherapy, in combination with insulin and in
combination with metformin.
-- Delix(R)/Tritace(R) (ramipril), an ACE inhibitor for the
treatment of
high blood pressure and congestive heart failure following
myocardial
infarction, achieved sales of euro 341 million in the first half
of
2001; this is an activity increase of 41.5% compared to the
year-ago
period (+39.8% on a reported basis). Second-quarter sales
activity grew
38.1% to euro 184 million (+36.7% on a reported basis).
Vaccines business posts 25% sales
growth in first half of 2001
Vaccine sales activity rose 24.6% to euro 615 million in the
first half of 2001 (+29.6% on a reported basis). Second-quarter
sales activity rose 22% to euro 298 million (27.1% on a reported
basis). North America was the largest contributor to the ongoing
strong performance with sales of euro 362 million in the first
half, this is an activity increase of 35.4%. Second-quarter
sales activity was up 26.3% to euro 179 million. Growth was
driven by the fully injectable polio vaccine IPOL(R), which
posted a 17.1% activity increase in sales to euro 128 million,
including non-consolidated sales in Europe through a
joint-venture with Merck & Co.
Therapeutic proteins recorded flat half-year sales of euro 561
million compared to euro 556 million in 2000. The business is
still affected by unresolved supply-chain problems for
Helixate(R), which is manufactured by a third party. Helixate(R)
is an enhanced recombinant product for the treatment of
hemophilia A that received regulatory approval in the U.S and EU
in mid- 2000.
In the first half of 2001, sales by the animal health business
Merial, a 50-50 joint venture with Merck & Co., which is
accounted for using the equity method, rose 10% to euro 944
million (+11.6% on a reported basis). Sales by Merial are not
consolidated in the Aventis core business sales.
Well positioned for future growth:
New products on the market and in the pipeline
Aventis is committed to expanding the range of indications,
formulations and combinations for its key drugs and aims to
maximize their potential through an aggressive life-cycle
management strategy, which is being applied to existing as well
as to upcoming products.
Actonel(R) (risedronate sodium), for the treatment and
prevention of postmenopausal osteoporosis and
corticosterorid-induced osteoporosis, was approved for use in
June in the EU for the reduction of hip fracture risk in women
with established postmenopausal osteoporosis. Also in June,
researchers reported studies that documented a sustained
five-year fracture-reduction benefit for postmenopausal women
with osteoporosis who received Actonel(R). This drug is being
co-developed and co-marketed by Aventis and Procter & Gamble
through the Alliance for Better Bone Health. It was launched in
the United States in mid-2000 and is currently approved in 47
countries, including most of western Europe. During the first
six months of 2001, Actonel(R) generated combined sales for
Aventis and Procter & Gamble of euro 122 million. Combined
second-quarter sales totaled euro 69 million.
Lantus(R) (insulin glargine), the new once-daily basal insulin
for the treatment of type 1 and type 2
diabetes, was launched in the United States in May 2001, quickly
achieving more than 10% share of new prescriptions in the
long-acting market segment since its launch. Total sales of
Lantus(R) were euro 24 million in the first six months of the
year. Launched in Germany in mid-2000, Lantus(R) has
successfully established a position as the reference treatment
for type 1 and type 2 diabetes by capturing more than 30% of the
basal insulin market in this country. Lantus(R) is the first and
only peakless basal insulin analogue to provide 24-hour blood
glucose control through one daily injection.
At its annual R&D meetings in May, Aventis announced that it has
more than 30 promising projects currently moving through
clinical development and that a number of important line
extensions are planned for its strategic brands. During the
first half of 2001, Aventis Pharma invested euro 1.397 billion
in research and development; this represents 16.3% of total
Aventis Pharma sales.
In July, Aventis received marketing approval from the European
Commission for Ketek(R) (telithromycin), a novel ketolide
antibiotic for respiratory infections, after having received a
positive opinion in April from the Committee for Proprietary
Medicinal Products (CPMP) for the treatment of
community-acquired pneumonia (CAP) as well as acute bacterial
exacerbation of chronic bronchitis, acute sinusitis and
tonsillitis/pharyngitis.
Aventis received an approvable letter in June from the U.S. Food
and Drug Administration (FDA) for
Ketek(R) for the community-acquired pneumonia (CAP), acute
bacterial exacerbations of chronic
bronchitis and acute bacterial sinusitis indications. An
approvable letter outlines conditions that Aventis must meet
before FDA will approve Ketek(R). The company will continue to
work closely with the agency on the specific data requirements
for approval.
Aventis and Pfizer Inc., which are cooperating to develop,
manufacture and market the inhalable insulin Exubera(TM), have
completed the phase III development program and have begun to
assemble the filings for the United States and Europe, currently
planned for submission later this year. Recognizing that
Exubera(TM) is a first-in-class product, with novel attributes
and expected rapid, extensive usage, the FDA and other
regulatory agencies are working closely with Aventis and Pfizer
to enable presentation of a comprehensive data package that
should maximize the full potential of Exubera(TM) in treating
patients with diabetes, and facilitate regulatory review. The
companies and the FDA are presently in active discussions of the
content and timing of the NDA; if additional data are required,
as now appears likely, the filing schedule would be revised.
In April, Aventis and Byk Gulden, a subsidiary of Altana,
announced that they are jointly developing the compound
ciclesonide for the treatment of asthma, a disease that affects
more than 20 million people alone in the United States. This
compound is being developed as an inhaled corticosteroid and is
planned to be submitted for U.S. regulatory approval in 2003.
Aventis and Asta Medica signed also in April an agreement
covering dexlipotam, which is currently in phase II development,
and other compounds being developed for the treatment and
prevention of the consequences of diabetes, diabetic late
complications and related metabolic diseases.
Negotiations
on Aventis CropScience divestment progress
After delivering strong performance during the first quarter,
Aventis CropScience, which is reported as a non-core activity,
continued to outperform the agricultural market trend during the
second quarter.
In a very competitive market, Aventis CropScience achieved
second-quarter sales of euro 1.205 billion, an activity increase
of 3.4 % from the second quarter of 2000 (+5.5% on a reported
basis). For the first half, sales activity rose 5.7% to euro
2.375 billion (+7.4% on a reported basis). This above-average
rise was attributable to the significant growth in all key
businesses of Aventis CropScience: Crop Protection sales
activity rose 4.4% in the first half, due mainly to the
contribution of the Brazilian, Canadian and French markets. The
herbicides Balance(R) and Puma(R) and the insecticide Regent(R)
led this sales growth. Overall the key growth drivers of Aventis
CropScience achieved a sales activity improvement of 49% in the
first half. The Environmental Science business improved its
sales activity by 17% in the first six months, mainly as a
result of performance in the United States, where sales grew 34%
on a reported basis. BioScience sales activity increased by 6%
in the same period, thanks to a recovery in the field
seeds area.
Half-year EBITA for Aventis CropScience rose 18.3% to euro 525
million compared to euro 444 million in the first half of 2000.
The EBITA margin was 22.1% compared to 20.1% in 2000. This
profitability increase was due mainly to an improved product
mix, the impact of product streamlining and a reduction in
operating costs.
Commenting on divestment process for Aventis CropScience, Horst
Waesche, member of the
Management Board of Aventis, said: "We are working closely with
our partners -- Schering and Bayer -- to prepare a formal
agreement, which should be finalized in the near future.
However, before such a binding agreement can be signed, the
required internal information and consultation procedures have
to be completed with the employee representative bodies."
Aventis is also in exclusive negotiations with CVC Capital
Partners Ltd. on the divestment of Aventis Animal Nutrition,
which contributed half-year sales of euro 285 million. A
possible closing is expected in the second half of 2001.
In December 2000, Aventis announced that it had agreed to sell
its 50% stake in Wacker-Chemie GmbH to the Wacker family in a
two-stage process to be completed in early 2002.
At the end of April, Allianz Capital Partners and Goldman Sachs
Funds acquired the 66.7% stake of Aventis in the industrial
gases group Messer Griesheim after the necessary approvals had
been obtained. The business was therefore deconsolidated in
April 2001.
Net debt of the Aventis group at the end of the first half was
at euro 11.469 billion compared to euro 13.133 billon at the end
of 2000. The reduction was mainly attributable to proceeds from
non-core divestments as well as the associated deconsolidation
of debt.
Aventis delivers euro 687 million cumulative synergies since its
formation
At the end of the first half of 2001, Aventis core businesses
have realized combined cumulative synergies of euro 466 million,
of which euro 424 million at Aventis Pharma and euro 42 million
at the corporate level. Aventis CropScience has achieved
synergies of euro 221 million since the beginning of 2000. As
announced, merger-related cash costs of around euro 2.45 billion
were booked in 1999 and 2000. No further merger-related one-time
costs are expected in 2001.
Aventis (NYSE: AVE) is dedicated to improving life through the
discovery and development of innovative pharmaceutical products.
In 2000, Aventis generated group sales of euro 22.3 billion and
employed around 92,500 people in its Pharma and Agriculture
businesses. Corporate headquarters are in Strasbourg, France.
For more information, please visit: http://www.aventis.com
Statements in this news release other than historical
information are forward-looking statements subject to risks and
uncertainties. Actual results could differ materially depending
on factors such as the availability of resources, the timing and
effects of regulatory actions, the strength of competition, the
outcome of litigation and the effectiveness of patent
protection. Additional information regarding risks and
uncertainties is set forth in the current Annual Report on Form
20-F of Aventis on file with the Securities and Exchange
Commission.
Provisional timing of third-quarter results: Beginning of
November 2001.
Company news release
N3702
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