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Bayer HealthCare Investor Day 2007:
Underlying EBITDA margin of the Bayer Group to exceed 22 percent by 2009 / Improved earnings forecast for Bayer HealthCare / Integration of Bayer Schering Pharma proceeding more quickly than planned / New research strategy adopted and pharmaceutical pipeline optimized / Current clinical studies confirm the potential of rivaroxaban / Nexavar® submitted in HCC / New drug to control bleeding during surgery inlicensed
Leverkusen, June 19, 2007 - In view of the improved earnings prospects for the
HealthCare business, the Bayer Group is raising its earnings guidance for 2007
and 2009. "We expect the underlying EBITDA margin for the Bayer Group as a
whole to exceed 20 percent this year, and we are aiming for a margin above 22
percent by 2009," said the chairman of the Board of Management, Werner Wenning,
on Tuesday at an investor conference in Leverkusen. "With this target, we are
headed toward a new order of magnitude for Bayer in terms of earnings and
underscoring our confidence in the earning power of our healthcare business,"
he explained. The company had previously expected to slightly improve upon the
prior-year margin (19.3 percent) in 2007 and begin generating a margin of about
22 percent, starting in 2009.
Bayer HealthCare's margin forecast for earnings before interest, taxes,
depreciation and amortization (EBITDA) before special items in 2007 is
increasing from previously 24 to now 25 percent. By 2009, the subgroup plans to
raise its underlying EBITDA margin to around 28 percent, compared to the
previously forecast 27 percent. "The strengths of all four divisions make Bayer
HealthCare a growth engine for the entire Bayer Group," explained Wenning,
adding: "Both the Schering acquisition and the strong performance of the
consumer health business are contributing to an increased profitability." The
Bayer Chairman confirmed the guidance published in March for the Bayer
CropScience and Bayer MaterialScience subgroups.
"The Schering takeover was a milestone in the further development of our
business portfolio, and we are proceeding faster than expected with the
integration," stated Wenning. "We are confident to achieve synergy effects of
more than EUR 800 million compared to the previously planned EUR 700 million by
2009. We also anticipate that we will achieve 80 percent of the synergies
already by the end of 2008." According to the Bayer CEO, the company plans to
further expand its HealthCare activities in order to strategically strengthen
the entire enterprise.
Pharmaceutical research concentrated on the most promising projects
"Our successful strategy for Bayer HealthCare ensures sustainable growth
through both the pharmaceutical specialties and consumer health businesses,"
said Arthur Higgins, Chairman of the Executive Committee of Bayer HealthCare.
"In the specialty pharmaceuticals field, the Schering acquisition was a key
step in the establishment of a leading international business. We recently
completed the strategic realignment of our development portfolio - a key
milestone in the integration process that will enable us to concentrate on the
most promising projects in the future," Higgins continued. The new pipeline
comprises 14 projects in Phase I, 17 projects in Phase II and 19 projects in
Phase III. A further 9 projects have already been submitted for marketing
authorization.
As a result of the evaluation, a total of 20 pipeline projects will have been
discontinued due to either strategic reasons or low prospects for success.
These projects include the cancer drug PTK/ZK, Leukine against Crohn's disease
and asoprisnil to combat benign uterine tumors. "We are adjusting our
pharmaceutical research and development budget for this year and in 2008 to
about 15 percent of the division's sales. We expect that the budget will be
between 15 and 17 percent in the years thereafter," Higgins said.
Bayer's drug discovery research will focus on four growth areas in the future:
Oncology, Cardiology, Women's Healthcare and Diagnostic Imaging. The clinical
development of new products and the further development of existing products
are to continue for all areas of the subgroup.
In order to ensure increased efficiency and optimal decision-making processes
in the future, a so-called "Proof of Concept" process has been established to
enable an accelerated procedure for making initial statements on the
effectiveness of new drugs in patients. In this way, the success prospects of a
new medicine can be evaluated more quickly and the development period can be
shortened overall. Higgins explained: "A key factor in our R&D strategy was to
increase productivity and strengthen our innovation capability."
Promising results for Nexavar® and rivaroxaban
"The outstanding Phase III results for our cancer drug Nexavar® and for the
thrombosis treatment rivaroxaban demonstrate the tremendous potential of these
products," said Dr. Kemal Malik, member of the Bayer Schering Pharma Management
Board responsible for Global Drug Development.
"Rivaroxaban showed impressive results in the recently completed RECORD3
study," Malik explained. In this Phase III trial for prevention of venous
thromboembolism (VTE) after knee replacement surgery, more than 2,500 patients
were examined as part of rivaroxaban's extensive development program. Key
RECORD3 results will be presented at the Congress of the International Society
on Thrombosis and Haemostasis (ISTH) in July 2007 in the "Late-Breaker Session"
- the congress program for important current presentations. "We aim to provide
an efficient prophylaxis for thrombosis for patients in the future and plan to
submit the full data for regulatory review before the end of this year in
Europe," Malik continued. It is planned to market the product under the trade
name Xarelto® following its approval by the regulatory authorities. Bayer
estimates the peak sales potential of this drug to exceed the amount of EUR 2
billion.
At the annual meeting of the American Society of Clinical Oncology (ASCO) held
in Chicago at the beginning of June, Bayer presented the results of a Phase III
study involving Nexavar® in the treatment of liver cancer. According to this
study, Nexavar® has demonstrated an increase in overall survival by 44 percent
over placebo in patients with advanced hepatocellular carcinoma. "Nexavar®
showed unprecedented efficacy in treating liver cancer, and this could be a
true breakthrough for patients suffering from this disease," said Malik. Liver
cancer is one of the most common cancer types worldwide. As there is currently
no approved treatment that can demonstrably increase overall survival in
patients suffering from this disease, Nexavar® has the potential to become the
therapeutic standard. The data in this indication has recently been submitted
for regulatory review in Europe and will be submitted in the U.S. still this
month.
Further clinical trials involving Nexavar® are ongoing in other indications as
well. Enrollment of approximately 900 patients has been completed in a Phase
III study in non-small cell lung cancer (NSCLC), and Bayer is targeting the
launch of this indication in 2009. Most recently, extensive Phase II studies
have been initiated to examine Nexavar's® potential in metastatic breast
cancer. Phase III studies in this indication could begin in 2009.
In the field of hematology, the pipeline has been strengthened by the
successful inlicensing of a late-stage hemostasis project. Bayer HealthCare has
acquired the commercialization rights outside the United States for recombinant
human thrombin (rThrombin) from U.S.-based ZymoGenetics. The two companies also
plan to jointly market the product designed for bleeding control during
surgery, in the United States. "This product is a clear strategic fit to our
growing specialized pharmaceuticals business," said Higgins.
Progress has also been reported in the further development of Kogenate. A
formulation based on liposomal technology could potentially prolong the
product's activity and thus reduce the number of infusions needed. This in turn
could contribute significantly to the success of preventive therapy for
hemophilia patients. The launch of a clinical Phase II trial is set for the end
of 2007, which makes this development candidate the only long-acting product in
advanced clinical development. This study will be the largest randomized,
double-blind clinical trial ever conducted in hemophilia. The European launch
is anticipated for 2011, followed a year later by introduction in the United
States.
11 projects expected to reach Phase III clinical development by 2009
"We expect our pipeline to produce 11 Phase III projects by the end of 2009,"
Malik highlighted. Promising results were reported for multiple sclerosis, as
the monoclonal antibody alemtuzumab has demonstrated in Phase II the best
treatment effect ever seen in a controlled trial. VEGF Trap-Eye could play an
important role in the treatment of serious eye diseases. It has shown positive
interim results in Phase II for the treatment of age-related macular
degeneration (AMD), the leading cause of strong visual impairment and blindness
in people over the age of 65 in the U.S. and Europe. Both compounds are
scheduled to enter Phase III studies in 2007.
"We can also report good progress from our early-stage pipeline and have
advanced eight projects into Phase II since December 2005," said Professor
Andreas Busch, member of the Bayer Schering Pharma Management Board responsible
for Global Drug Discovery. "We have set clear targets for productivity in our
drug discovery process: by the end of 2007, we aim to produce Proof of Concept
- in other words demonstrate their effectiveness in patients - for four
projects and transfer three drug candidates from research to clinical
development." As an example of the productivity of Bayer's research activities,
he described current achievements in the cardiology pipeline: three compounds
for various heart diseases have recently demonstrated efficacy in patients: BAY
58-2667 has been investigated in acute decompensated heart failure, BAY 63-2521
in patients with pulmonary hypertension, and BAY 68-4986 as a therapy for
stable angina pectoris.
Sustained growth through innovation
"Our new research and development strategy puts in place the foundation for the
successful future of our pharmaceuticals business," Higgins emphasized, adding:
"In addition to the marketing of new products, the further development of our
existing portfolio plays a crucial role in this context." For example, current
clinical studies are expanding the spectrum of applications for Betaferon® to
treat multiple sclerosis (MS) and creating the potential for further growth. In
the BENEFIT study, it was demonstrated that early treatment with Betaferon®
reduces patients' risk of permanent disability due to MS events by 40 percent
over three years compared to conventional treatment. The BEYOND trial is the
largest study ever conducted in MS patients, and has the goal of investigating
the efficacy and safety of the double-dose of Betaferon®. Filing of the BEYOND
data to support the launch of a high-dose version of Betaferon® in Europe and
in the United States is expected for the fourth quarter of this year.
Leading positions in Women's Healthcare and Diagnostic Imaging
Bayer is the world's leading supplier in Women's Healthcare. "We aim to further
expand this position," said Higgins. "We expect this business to grow by 7 to 8
percent annually in the medium term." The Yasmin® product family is the biggest
growth driver, Higgins stressed, explaining that Yasmin® is already the most
successful oral contraceptive worldwide and YAZ® builds on the success of the
active ingredient drospirenone. YAZ® is the only oral contraceptive approved in
the U.S. for three distinct indications (contraception, acne and treatment of
premenstrual dysphoria symptoms) and is the fastest growing brand in this
important market.
Bayer HealthCare is also the global leader in the area of Diagnostic Imaging.
To safeguard this position over the long term, the company is building on its
strong products and engaging in the exploration of innovative approaches in the
field of molecular imaging, the potential of which is being evaluated
particularly in oncology and in neurodegenerative diseases. One example is the
inlicensing of a development candidate from Avid Radiopharmaceuticals, Inc. for
early diagnosis of Alzheimer's disease. Molecular imaging is a promising new
method for the early diagnosis of a wide variety of diseases with the goal of
improving therapy decisions.
Consumer health: maximizing the value of key brands
"In consumer health, Bayer is building on the continued strengths of its three
divisions: Consumer Care, Animal Health and Diabetes Care," said Higgins. In
2006, all three businesses grew faster than the market. "We expect that our
attractive consumer health businesses will continue to exceed market growth by
about 2 percentage points."
"We are currently the number two global over-the-counter (OTC) consumer
healthcare company and will continue to outpace market growth and our main
competitors in the future", said Higgins. The Consumer Care Division is amongst
the fastest growing companies in this arena and achieved twice the average
market growth last year. 30 strong brands account for more than 80 percent of
sales; eight brands have sales over EUR 100 million each. The value of these
strong brands is the basis for future business success.
Through continued innovation and a focus on profitable segments, Bayer Animal
Health is also growing faster than the market. "Bayer Animal Health is a leader
with benchmark profitability," outlined Higgins. The strategy builds on
investment both in in-house R&D as well as in external partnerships. Numerous
development projects in the pipeline will support this business in the medium
to long term.
The Diabetes Care Division is also performing very positively. Meanwhile, Bayer
is among the fastest-growing companies in this area and made it into the top 3
worldwide in the first quarter of this year with net sales of EUR 226 million.
Higgins said: "We aim to further expand our leading position in the area of
diabetes diagnosis, management and monitoring."