Annual Business Review - Pt 1
AstraZeneca PLC
3 December 2001
ONE OF TWO
ASTRAZENECA'S COMMERCIAL STRENGTH
AND EXCELLENT PIPELINE TO DRIVE GROWTH AND ENSURE SUCCESS IN COMING YEARS
AstraZeneca today presents a business update to a meeting of analysts in
London.
Business performance over the past year has been robust and will deliver the
expected year-end targets. Investment made in sales and marketing has paid
dividends with the successful launches of Nexium and Symbicort. Established
products such as beta-blockers and respiratory treatments continue to grow
strongly with combined year on year sales of $2.7 billion, growing at 15 per
cent per annum. Key growth products Arimidex, Atacand, Casodex, Seroquel and
Zomig have now reached annualised sales of more than $2 billion (MAT Q3).
These performances demonstrate AstraZeneca's commercial strength in major
pharmaceutical markets, and provide a powerful commercial platform to deliver
the value of its promising portfolio of new medicines including Crestor,
Iressa and Exanta.
Commercial Strength
* Product portfolio addresses 60 per cent of the pharmaceutical market - a
segment forecast to be worth $292 billion in 2005
* Nexium launched in 38 countries (over 16 per cent weekly new prescription
market share in the US)
* Symbicort launched in 23 countries (23 per cent market share in units in
France after nine weeks)
* Sales force in the US ranked third in industry; sales force in the top
eight countries in Europe increased by more than 800 permanent representatives
* Leading positions in sales in Europe: Gastrointestinal (1), Oncology (1),
Respiratory (2), Cardiovascular (3)
* In Japan, AstraZeneca, with 15 per cent sales growth this year, is the
second fastest growing company and is expected to maintain double-digit
growth
Pipeline Progress
* AstraZeneca's statin, Crestor, on track for launch 2H 2002 with highly
competitive profile and impressive reduction in LDL-cholesterol
* Iressa - monotherapy indication for non small-cell lung cancer - NDA and
JNDA on track for submission by year-end 2001, EU filing Q2 2002; combination
filing Q2 2002 (EU/US)
* Exanta, the oral anticoagulant - major indications on track - filing for
first indication in prevention of venous thromboembolism (VTE) expected
Q3 2002 (EU)/ Q2 2003 (US); stroke prevention filing expected Q2 2003
(EU/US)
* Faslodex for second line treatment of breast cancer - launch planned for 1H
2002
* Casodex - approval for early prostate cancer in nine countries; sNDA on
track for submission by year-end 2001
* Pulmicort - product launch planned for Q1 2002 in Japan
* Arimidex - adjuvant breast cancer filing Q1 2002 (EU/US)
* Symbicort - chronic obstructive pulmonary disease (COPD) filing
Q1 2002 (EU)
* Line extensions and new indications underpin growth of all products
* R&D pipeline updated
Tom McKillop, Chief Executive Officer, said: 'Investment in building our
commercial strength over the last two to three years has made a significant
contribution to the outstanding success of this year's launches of Nexium and
Symbicort and to the continued good progress of growth products Arimidex,
Atacand, Casodex, Seroquel and Zomig.
'I am confident our excellent product portfolio and commercial strength will
drive growth and ensure the success of AstraZeneca in the coming years.'
To access the full presentations given today at AstraZeneca's Business Day or
to view a live web cast, please visit:
www.astrazeneca.com/Investors/Annual_Business_Review.htm
- Ends -
December 3, 2001
Further Enquiries:
Media:
Steve Brown, tel +44 (0)20 7304 5033
Emily Denney, tel +44 (0)20 7304 5034
Rachel Bloom-Baglin, tel +1 302 886 7858
Investors/Analysts:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel: +1 609 896 4148
Annual Business Review Highlights:
Portfolio Update - Managing the Portfolio to Create Value
John Patterson, Executive Vice President, Product, Strategy and Licensing,
reported the strength of AstraZeneca's current and future product portfolio,
designed to meet the needs of its customer base, which covers primary care
physicians and hospital and office-based specialists, including oncologists.
AstraZeneca's impressive portfolio of marketed and pipeline products
addresses 60 per cent of the total pharmaceutical market, a segment forecast
to be worth $292 billion in 2005, and has the potential to ensure the growth
and success of the company in the coming years.
The Primary Care Portfolio
The successful global introduction of Nexium for the treatment of
acid-related disorders will enable AstraZeneca to maintain its leading
position in the important and growing GI market. Supported by an active life
cycle management programme, Nexium will provide a long-term source of growth
in this key area. The ongoing development programme for Nexium will target a
new parenteral formulation and new indications for NSAID and COX2-induced
upper GI disorders and dyspepsia. The company is also investigating
innovative therapeutic areas for Nexium including extra-esophageal reflux
disease (EERD), also known as 'acid asthma.' To further differentiate Nexium
in the marketplace, additional comparative trials against its competitors are
planned.
The respiratory franchise, worth $1.5 billion, is currently growing at a rate
of 15 per cent per annum, driven by growth products, Symbicort, Rhinocort
Aqua and Pulmicort Respules. Symbicort, a flexible, adjustable, asthma
control medication, delivered in a single inhaler, is now successfully
winning market share in Europe from its main competitor, GlaxoSmithKline's
salmeterol/fluticasone combination product. Symbicort is the first and only
asthma medication that allows a patient to quickly gain and maintain control
of a variable disease with the same single inhaler. Indications for chronic
obstructive pulmonary disease (COPD) and single therapy, along with a pMDI
delivery device that will also be marketed in the US (filing in 2004), will
support Symbicort growth and will add value to the franchise.
AstraZeneca also has key pipeline products in several key cardiovascular (CV)
markets, which are forecast to show significant future growth. The lipid
market is worth $16.8 billion and is forecast to grow well over $20 billion
by 2005, fuelled by positive results from studies demonstrating the value of
lipid-lowering drugs in reducing cardiovascular events. AstraZeneca's planned
launch of Crestor, its highly effective cholesterol-lowering statin, in the
second half of 2002 will be supported by comparative clinical data which
demonstrate unsurpassed reductions in LDL-C. Exanta, which is currently in
phase III development, will be the first oral anticoagulant for 50 years to
enter the market, currently worth $2.8 billion and forecast to grow at 19
percent per annum. The current standard oral therapy, warfarin, is widely
prescribed but difficult to use, creating megabrand potential for a new,
oral, patient-friendly therapy. The first major primary care indication will
be for prevention of stroke in patients with atrial fibrillation, with
regulatory submissions in the US and EU planned for Q2 2003. In addition, AZ
242, a novel PPAR agonist currently in phase II development, will compete in
the oral antidiabetic market, worth $6.4 billion and forecast to grow to $15
billion by 2008. These exciting new opportunities will complement an existing
CV franchise which includes Atacand, a hypertension medication which will
grow with the reporting of studies in areas such as heart failure, elderly
hypertension and diabetic retinopathy, and the world's leading beta-blocker,
Seloken/Toprol-XL, currently growing in the US at a rate of over 30 percent
in total prescriptions and sales.
Specialist and Hospital Care Portfolio
The specialist and hospital franchise continues to feature established
products such as Diprivan, Merrem and a number of local anaesthetics, as well
as top growth products Zomig, for migraine, and Seroquel, the oral
anti-psychotic medication. Exanta will also be a key product in the hospital
setting with its first planned indication being in the prevention of venous
thromboembolism (VTE) in patients undergoing orthopaedic surgery. Later
indications for VTE treatment and secondary prevention post Acute Coronary
Syndrome (ACS) are on track for filings in 2003 and 2004.
Seroquel has differentiated itself from its competitors largely because of
its safety profile and excellent tolerability among patients. Sales for
Seroquel were $424 million in 2000, and increased by 83 per cent in the nine
months ending in September 2001. New formulations - sustained release and
granules - in addition to plans for a new indication in the common but
under-treated bi-polar disease, will fuel continued growth of Seroquel.
Oncology
Within the cancer market, there are four stages of disease at which products
are targeted: risk reduction, early stage, locally advanced and advanced
disease. At AstraZeneca, 30 years' oncology experience has resulted in the
development of medications that are effective in treating each stage of this
devastating disease. One such example is Nolvadex, the gold standard of
breast cancer treatment. To continue this tradition, AstraZeneca has
developed new products with the promise of improved efficacy and tolerability
to treat a variety of cancers across all stages.
Arimidex, the world's leading aromatase inhibitor, has shown improvements
over tamoxifen in advanced breast cancer and is currently being studied in
the adjuvant setting - a $2 billion opportunity. Comparative data with
tamoxifen, to be presented at the San Antonio Breast Cancer Conference on 10
December 2001, is eagerly awaited.
Casodex, the leading anti-androgen for the treatment of prostate cancer,
continues to grow at an impressive rate of 22 percent. Strong growth will
continue with Casodex's new indication for the treatment of early prostate
cancer, based on a study showing a 42 per cent risk reduction in progression
of the disease, when added to standard therapy. The early prostate cancer
indication has now been approved in nine countries, and an sNDA will be filed
in the US this month. As Prostate-Specific Antigen (PSA) testing becomes more
widespread, the market for treatment of early prostate cancer will increase.
New pipeline products include Iressa, Faslodex, and a number of promising
novel cancer compounds. Iressa, a drug which inhibits the effect of epidermal
growth factor (EGF) on the development of tumours, has shown exciting results
in non-small cell lung cancer, a frequently-occurring cancer associated with
smoking. The launch programme will begin in 2002. In the interim, AstraZeneca
has developed an expanded access programme that has already allowed more than
5,000 patients to be treated with Iressa, prior to approval. As development
progresses, Iressa is being studied as monotherapy and in combination with
other cancer agents, as well as in a number of other tumour types in which
EGF may play a role, including gastric, prostate, breast and colorectal
cancers. Faslodex, a second line treatment for advanced breast cancer, is
given as a monthly injection, which aids in compliance and removes the daily
reminder of the disease. Product launch in the US is scheduled in the first
half of 2002.
John Patterson commented, 'At AstraZeneca, we have an excellent commercial
portfolio that continues to be optimised by life cycle management, supported
by a strong flow of differentiated, commercially attractive, new medicines,
focused on areas of unmet medical need. This battery of marketed and pipeline
products will give our sales and marketing organisation the right
'ammunition' to grow the best portfolio into the best pharmaceutical
business.'
Succeeding in the European and Japanese Markets - Building a Strong Platform
for Growth
Bruno Angelici, Executive Vice President for the International Sales and
Marketing Organization, reported that AstraZeneca is achieving robust
performances in Europe and Japan, and is growing faster than the
pharmaceutical market as a whole.
In the European markets, Nexium has been launched in 14 countries, and market
share is increasing steadily on a monthly basis. Nexium is even performing
well where it faces generic competition. In Germany, Nexium continues to
recapture prescriptions from patients previously treated with generic
omeprazole, and boasts a market share of 11.9 per cent.
Symbicort has been launched in 15 countries in Europe, the first of which was
Sweden, where it has captured 40 per cent of market just 16 months after
launch. In total, Symbicort has captured more than nine per cent of the fixed
combination asthma market in 13 of these launch countries. Its rapid uptake
in countries like France (23 per cent market share in units after nine weeks)
and Italy (13. 1 percent after five weeks) is due to its differentiation from
GlaxoSmithKline's salmeterol/fluticasone combination product. Other growth
products in Europe include Atacand (+62 per cent), Casodex (+41 per cent),
Arimidex (+23 per cent), Seroquel (+230 per cent) and Zomig (+37 per cent).
In Japan, AstraZeneca is the second fastest growing company behind Pfizer.
The success here is being driven by the company's strong oncology market
position, where it is competing with Taiho for the number one position, and
the strong growth of Losec (Omepral). Omepral has benefited from a new
indication for long-term treatment, granted by the Ministry of Health to all
PPIs.
Opportunities for Growth
In Europe, AstraZeneca holds leading positions in sales in GI, oncology,
respiratory and CV therapy areas. Recent investments in the sales and
marketing organization have increased the sales force in the top eight
countries in Europe by more than 800 permanent representatives, and increased
AstraZeneca's share of voice in total details by five percent, out of the top
10 corporations.
Markets that demonstrate significant potential for the company include the
fixed combination asthma market in Europe and the lung cancer and statin
markets in Europe and Japan. Combined with the strength of the PPI market in
Japan, AstraZeneca should maintain double-digit rate growth in this country.
In the top seven markets in Europe, the fixed combination asthma market will
more than double in five years, from nearly $500 million to more than $1
billion. With the market growing at an annual rate of 23 per cent and
Symbicort's highly differentiated product profile, the company is well
positioned to win a significant share of this market within the next few
years. Iressa, with a profile that combines efficacy and improved
tolerability, is ideally suited to both the European and Japanese markets.
Finally, the statin market, worth $2.5 billion in the top seven European
markets, and worth $2.8 billion in Japan, are set for strong growth,
presenting tremendous opportunities for Crestor.
The GI franchise is strong and will remain strong. Although Losec will lose
market exclusivity, this will not happen simultaneously in all markets, but
instead, will be spread over many years. In fact, in countries where Nexium
has not yet been launched, Losec continues to show excellent growth: France
(22 per cent), Italy (55 per cent) and Japan (66 per cent). Nexium is
performing well across the world, with sales growth benefiting from a
continuous flow of publications demonstrating its clinical superiority over
all other PPIs. Nexium will also be launched in France, Italy, Belgium,
Greece and Spain within the next year.
Bruno Angelici commented, 'We believe AstraZeneca can achieve continuous and
robust growth over the next five years. This optimism is partly based on the
initial success of Nexium and Symbicort in Europe and our ongoing success in
Japan. However, we also have a rich pipeline waiting to be launched in
markets where we have built up significant marketing and sales muscle. With
this combination of competitive resources and assets, we feel confident we
can drive the business forward for many years to come.'
US Business Update-The Best Portfolio in the Best Hands
David Brennan, President and CEO of AstraZeneca in the US, and Executive Vice
President, North America, reported confidence in the ability of the US
business to deliver successful new product launches with Crestor and Iressa,
and underscored its commercial versatility to support a variety of product
launches in the future, while continuing to drive growth of key marketed
products in several therapeutic areas.
Within the US market, AstraZeneca is ranked fourth in sales, with audited
sales growth of 14 per cent. AstraZeneca's sales force is now the third
largest in the industry, and has generated an increase of 37 per cent in
details and increased the company's share of voice to 5.4 per cent (fourth
place in the industry). These investments, along with the careful
restructuring of the sales force, to allow for key overlaps among customer
groups, have contributed to the success of the US business, which includes:
* Nexium launch - Nexium is the fastest growing product in the PPI market
(over 16 per cent weekly new prescription market share). The
Direct-to-Consumer (DTC) campaign is a documented success with more than an
estimated 900,000 consumer-initiated doctor discussions
* Toprol-XL - has grown more than 30 per cent in new prescription market
share this year, and will continue to gain market share with the congestive
heart failure indication
* Seroquel - has now garnered a healthy 17 per cent share of new
prescriptions, Seroquel is the strongest growing product in its class
* Pulmicort Respules - in this smaller paediatric asthma market, Pulmicort
Respules has overtaken its competitors in new prescription market share
Building on the successes of the past year, the US is now well positioned to
bring Crestor and Iressa to market. David Brennan commented, 'We have seen
marketing success with our commercial engine with products of all sizes and
maturity. After this year's impressive achievement, we are poised and ready
to extend our accomplishments and to achieve even greater things in the
future. Any company in this industry would be thrilled to have a portfolio as
promising as ours. But in the right hands, the promise and the potential of
these products are assured. These products are in the right hands at
AstraZeneca.'
TRADE MARKS
The following brand names are trade marks of the AstraZeneca group of
companies:
Accolate Arimidex Atacand Atacand HCT Atacand Plus Bricanyl Casodex Crestor
Diprivan Exanta Faslodex Imdur Iressa Losec Marcaine Merrem Naropin Nexium
Nolvadex Omepral Oxis Plendil Prilosec Pulmicort Pulmicort Respules Rhinocort
Rhinocort Aqua Seloken Seroquel Symbicort Tenormin Toprol-XL Xylocaine
Zestril Zoladex Zomig Zomig Rapimelt Zomig ZMT
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
In order to utilise the 'Safe Harbor' provisions of the United States Private
Securities Litigation Reform Act of 1995, AstraZeneca is providing the
following cautionary statement. This news release contains forward-looking
statements with respect to the financial condition, results of operations and
businesses of AstraZeneca. By their nature, forward-looking statements and
forecasts involve risk and uncertainty because they relate to events and
depend on circumstances that will occur in the future. There are a number of
factors that could cause actual results and developments to differ materially
from that expressed or implied by these forward-looking statements. These
factors include, among other things, exchange rate fluctuations, the risk
that research and development will not yield new products that achieve
commercial success, the impact of competition, price controls and price
reductions, the risk of loss or expiration of patents or trade marks,
difficulties of obtaining and maintaining governmental approvals for
products, the risk of substantial product liability claims, exposure to
environmental liability and the risks related to the difficulty of completing
the integration of Astra's and Zeneca's large and complex businesses on a
timely basis and realising synergies.
More to follow.....
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