Basel, 17 October 2006
Roche’s
nine-month sales hit record high
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Group
•
Group sets new records for nine-month sales and growth, as sales for the period rise 17%* to 30.3 billion
Swiss francs
• Sales continue to accelerate in both divisions, surpassing the strong
growth recorded during the first half of 2006
Pharmaceuticals
•
Pharmaceutical sales reach 23.9 billion Swiss francs, an increase of 21%, or almost four times the global
market growth rate
• Market share rise from 4.4% to 4.7% — Roche moves into sixth place
among the world’s biggest drug makers (up from eighth place in 2005)
• Cancer medicines
deliver strong, 41% growth, reinforcing Roche’s leadership in oncology
• Sixteen approvals
in major markets, including worldwide marketing approvals for MabThera/Rituxan in rheumatoid arthritis,
for Herceptin in early breast cancer (EU) and for Avastin in non-small cell lung cancer (US)
•
Fifteen regulatory filings in major markets, including Mircera for the treatment of renal anemia and
Avastin for the treatment of lung and breast cancer
Diagnostics
•
Roche Diagnostics posts 5% rise in sales; growth accelerates in third quarter
• All business
areas help grow sales ahead of the global market in third quarter
• Shipment of insulin
pumps to US resumed following removal of import alert
Outlook
for 2006 reaffirmed
• Double-digit sales increases for the Roche Group and the
Pharmaceuticals Division; above-market growth in Diagnostics
• Target is for Core Earnings
per Share to grow ahead of sales
* Unless otherwise
stated, all growth
rates are based on local currencies.
Commenting
on the
Group’s performance in the first nine months of 2006, Roche Chairman and CEO Franz B. Humer said, ‘In
the third quarter Roche continued to grow well ahead of the market. Our oncology medicines and Tamiflu
remain the major growth drivers in the Pharmaceuticals Division. In Diagnostics, Diabetes Care is back
on growth track, with all other divisional business areas also contributing to increased sales. We are
very confident about achieving our ambitious goals for the full year – both in terms of sales and profits
and in terms of advancing our development programmes.’
Roche
Group
| 2006 | 2005 | % Change | % Change |
Sales from January to September1 | m CHF | mCHF | In CHF | In local currencies |
Pharmaceuticals Division | 23,912 | 19,434 | +23 | +21 |
Roche | 14,921 | 12,169 | +23 | +20 |
Genentech | 6,522 | 4,632 | +41 | +37 |
Chugai | 2,469 | 2,633 | -6 | -2 |
Diagnostics Division | 6,415 | 6,008 | +7 | +5 |
Roche Group | 30,327 | 25,442 | +19 | +17 |
1
See attachment to this release for details on quarterly sales growth.Roche posted
sales of 30.3 billion Swiss francs in the first nine months of 2006, an increase of 17% in local currencies
(19% in Swiss francs; 16% in US dollars) over the same period last year. The Group thus surpassed the
high growth rates reported for the first half-year. Nine-month sales in the Pharmaceuticals Division
increased 21% (23% in Swiss francs), or almost four times as fast as the global market. The Diagnostics
Division’s sales rose 5% (7% in Swiss francs), and in the third quarter the division extended its market
lead.
Outlook
Barring unforeseen events,
Roche expects full-year sales and income for 2006 to be up significantly from 2005. As announced at
the presentation of the 2006 interim results, sales in both the Pharmaceuticals and the Diagnostics
Division are expected to grow ahead of the market in local currencies. Roche anticipates double-digit
sales growth for the Pharmaceuticals Division and the Group as a whole. Roche’s target is for Core Earnings
per Share (EPS) to grow ahead of sales.
Pharmaceuticals
Division
Sales growth in the Pharmaceuticals
Division accelerated further during the first nine months of 2006, increasing to 21% in local currencies
(23% in Swiss francs; 20% in US dollars), or almost four times the global market rate (6%). Roche’s
market share rose from 4.4% to 4.7%, putting the Group in sixth place among the world’s biggest drug
makers – up from eighth place last year. Regional sales growth significantly outpaced the market average
in North America (27% vs 7%) and Europe (23% vs 5%). In Japan sales declined slightly (–2% vs –1%) due
to government-mandated price cuts. Continued strong demand for the division’s oncology products, ongoing
pandemic stockpiling of the influenza medicine Tamiflu and sales of the osteoporosis medicine Bonviva/Boniva
were the main factors driving robust growth during the period.
Oncology
— strong sales growth continues
With sales up 41%, the division’s oncology products
continued to deliver outstanding growth, reinforcing Roche’s position as the world’s leading provider
of cancer medicines.
Sales of MabThera/Rituxan, for non-Hodgkin’s lymphoma
(NHL), continued to grow strongly, advancing 15%. Growth is currently being driven by first-line use
in indolent and aggressive NHL. In July Roche received EU regulatory approval to market MabThera for
maintenance therapy in patients with relapsed or refractory follicular NHL giving these patients a better
chance to live disease-free for longer.
Sales of Herceptin, for HER2-positive
breast cancer, almost doubled compared with the first nine months of 2005. Data showing an impressive
survival benefit with Herceptin in early-stage breast cancer have been very well received by physicians
and have led to several fast-tracked regulatory and reimbursement approvals in the EU and other key
markets. Recently announced positive data from the phase III TAnDEM trial, investigating Herceptin in
combination with hormone therapy for metastatic breast cancer, have been filed with European regulatory
authorities in October.
Avastin, a cancer therapy with demonstrated survival
benefits in metastatic colorectal, breast and lung cancer, posted a 90% increase in sales. Moreover,
use of the medicine is expected to increase further now that reimbursement is widely in place in Europe
for the treatment of metastatic colorectal cancer (MCRC). To further expand the MCRC label for both
Avastin and Xeloda, two additional applications — based on data from the largest ever conducted first-line
MCRC study and supportive trial data from other studies — will be submitted simultaneously in the first
half of 2007. Following priority review, the world’s first angiogenesis inhibitor was approved by the
FDA in October for the treatment of non-small cell lung cancer (NSCLC); a filing for the same indication
was submitted to EU authorities in August. In addition, Avastin was filed with US and EU regulators
for the treatment of advanced breast cancer in May and July, respectively. In September the FDA requested
additional data analysis to support the filing in advanced breast cancer, though there are no concerns
about the drug’s efficacy or safety. Genentech will supply the requested data by mid-2007.
Xeloda
continues to post strong sales growth (22%), performing well in both the US and the EU. A filing for
approval of the drug to treat stomach cancer was submitted to EU regulators in July. Positive data from
a phase III trial have demonstrated the equivalent efficacy of an oral Xeloda-containing regimen compared
with an intravenous 5FU-containing regimen in first-line MCRC. Data from a phase III study in second-line
MCRC (comparing Xeloda/oxaliplatin vs 5FU/oxaliplatin) are expected in early 2007. The combined results
of these studies will be used for global filings in the first half of 2007.
Tarceva,
a novel, targeted drug that has been shown to extend the lives of patients with advanced NSCLC and pancreatic
cancer patients, remained on growth track in both the US and the EU with a sharp, 130% rise in sales.
A pivotal phase III trial (RADIANT) is under way to support expanded labelling for use in NSCLC in the
adjuvant setting. In September Roche requested a re-examination of the data supporting its filing for
Tarceva for the treatment of pancreatic cancer, after the EU’s Committee for Medicinal Products for
Human Use (CHMP) issued a negative opinion despite a statistically significant survival benefit with
the drug in this indication.
Anaemia — sales steady in
a highly competitive market
Combined sales of Roche’s NeoRecormon and Chugai’s
Epogin were stable overall. NeoRecormon grew 6% and retained its leadership position in its markets,
despite sustained pressure on pricing in the renal anemia and oncology segments. In Japan, where Epogin
remains the market leader for renal anemia, sales declined 12% due to government-mandated price cuts
and reimbursement changes, which resulted in a contraction of the overall anemia market. Roche filed
Mircera, the first continuous erythropoietin receptor activators (CERAs), with the US and European regulatory
authorities in April for the treatment of anemia associated with chronic kidney disease.
Transplantation
Sales
of CellCept, the world’s top-selling branded immunosuppressant for the prevention of organ transplant
rejection, rose 7% for the period, despite emerging generic competition in some Latin American markets.
Virology
— Tamiflu stockpiling sales continue to grow
Worldwide, sales of Tamiflu rose
to 1.6 billion Swiss francs, an increase of 88% over the same period last year. Growth was driven mainly
by pandemic stockpiling sales as some governments increased their population coverage. A Tamiflu supply
chain capable of producing 80 million treatments a year is now fully operational in the US. This addition
to the Roche network will bring total annual production capacity to 400 million treatment courses by
the end of 2006, ensuring that enough Tamiflu is available both for pandemic preparedness and for use
against seasonal influenza. Sales of Pegasys rose 2%, while Copegus sales continued to decline due to
generic erosion in the US.
Sales of the anti-HIV medicine Fuzeon advanced 22%.
Primary
care — Bonviva/Boniva gains market share
Sales of once-monthly oral Bonviva/Boniva
continued to increase, reaching 309 million Swiss francs in a highly competitive market. Boniva now
accounts for about 15% of new prescriptions in the US, and launches are ongoing across Europe and the
rest of the world. Data presented for the first time in September, at the Annual Meeting of the American
Society of Bone Mineral Research, show that patients on monthly Boniva tend to stay on their treatment
significantly longer than those taking weekly bisphosphonates. This raises the prospect of better treatment
outcomes.
Xenical, for weight loss, continued to post steady growth (7%).
Rheumatoid
arthritis — MabThera/Rituxan approved for autoimmune indication
Following US approval
in February, MabThera has also been approved in the EU for use in rheumatoid arthritis (RA) patients
with an inadequate response to “anti TNF” biologic therapies. MabThera/Rituxan is the first medicine
shown to be effective in preventing joint damage in this patient population.
Development
— important milestones achieved
In addition to receiving 16 approvals and filing
for 15 more indications in major markets, Roche again achieved a significant number of milestones in
developing new drugs and indications.
An international phase III study
(NO16966) involving 2,035 previously untreated metastatic colorectal cancer patients met both primary
endpoints. Results of the study showed that the chemotherapy combination Xeloda plus oxaliplatin (XELOX)
was as effective in terms of progression-free survival as infused 5-FU/leucovorin plus oxaliplatin (FOLFOX).
Secondly, the addition of Avastin to chemotherapy (FOLFOX and XELOX) significantly improved progression-free
survival compared with chemotherapy alone.
Data presented at this year’s
Congress of the European Society for Medical Oncology show that adding Herceptin to hormone therapy
significantly prolongs progression-free survival in patients with advanced hormone receptor-positive,
HER2-positive breast cancer, compared with hormone therapy alone.
The
results of three phase III maintenance therapy trials presented at the Congress of the European Renal
Association - European Dialysis and Transplant Association show that dialysis patients treated with
short-acting and frequently administered anti-anemia drugs can be switched directly to once-monthly
Mircera and maintain stable hemoglobin levels.
Genentech and its partner
Biogen Idec have announced that a phase II proof of concept study of MabThera/Rituxan for relapsing-remitting
multiple sclerosis has met its primary endpoint.
Roche has exercised
its option to license Ipsen’s glucagon-like peptide-1 (GLP-1) analogue for type 2 diabetes. A phase
II study to confirm the efficacy and safety of this compound in a sustained release formulation is scheduled
to start early in 2007.
Roche entered into several major new alliances
during the third quarter. In July Roche and Actelion signed an exclusive worldwide agreement to collaborate
on developing and commercialising Actelion’s selective S1P1 receptor agonist for multiple autoimmune
diseases. In October Roche and Plexxikon agreed to collaborate on a novel oral drug for several different
cancers, and an alliance with InterMune, also announced in October, has strengthened Roche’s research
activities targeting hepatitis C.
R873 in male erectile dysfunction has
been discontinued, as it did not meet Roche’s hurdles for medical differentiation. After clarification
of the regulatory framework for the class of integrin antagonists, R411 was discontinued in the development
of asthma. However, clinical development was started in multiple sclerosis. R1438 (DPPIV inhibitor)
in diabetes did not show enough clinical differentiation and, therefore, had been replaced by a back-up
compound which indicated the profile as requested.
Diagnostics
Division
Roche Diagnostics’ sales rose 5% in
local currencies (7% in Swiss francs; 4% in US dollars) in the first nine months of 2006. Following
gains of 3% and 5% in the first and second quarters, divisional sales accelerated to a third-quarter
increase of 6%. All five business areas contributed to growth, with Roche Applied Science and Roche
Near Patient Testing posting double-digit increases in sales.
Sales in
Iberia/Latin America and Eastern Europe advanced at double-digit rates, while growth in the Asia-Pacific
and Europe-Middle East-Africa (EMEA) regions was in the single-digits. Divisional sales in Japan continued
to outpace the market, and growth was also positive in the US. In October the FDA lifted its import
alert barring US importation of Accu-Chek insulin pumps from Disetronic Medical Systems AG (Burgdorf,
Switzerland). Pump shipments to the US market have already resumed.
Diabetes
Care — Accu-Chek Spirit launched in US
Fuelled by a third-quarter increase of 5%,
Roche Diabetes Care’s sales accelerated to a growth rate of 2% for the first nine months of the year.
Accu-Chek Aviva generated high sales volumes in the major EMEA markets and in the US and Canada, as
did Accu-Chek Active in Latin America and the Asia-Pacific region. The removal of the FDA’s import alert
will enable swift progress on providing worldwide access to Roche’s full insulin delivery portfolio.
Today, Accu-Chek Spirit is available in more than 30 countries. Outside the US, the Group’s insulin
delivery business posted 15% growth.
Centralized Diagnostics
— successful rollout of new cobas 6000 analyser series
Roche Centralized Diagnostics
recorded a 5% rise in overall sales, outpacing an average growth rate of 4% in this market segment.
The first configurations of the cobas 6000 analyser series, launched in June 2006, have begun contributing
to growth. Centralized Diagnostics’ immunochemistry business achieved strong growth, with sales advancing
by 13%, or nearly three times the market growth rate. The cardiac marker NT-proBNP showed a further
increase in sales and is on its way to becoming one of the business area’s top-selling reagents.
Molecular
Diagnostics — continued leadership
Roche Molecular Diagnostics increased its sales
by 4%, thus maintaining its leading market share in an increasingly competitive business. Its largest
segment, virology, grew 6%, helped by intensified marketing of the Cobas AmpliPrep/Cobas TaqMan systems
in the Eastern European and Asian markets. In the blood screening segment, Roche continued to increase
sales with ongoing roll out of its cobas s 201 system and multiplex HIV, HCV and HBV test in the EU.
These products are now available in all European countries.
Near
Patient Testing — new CoaguChek approval
Roche Near Patient Testing’s sales grew
11%. FDA approval of the CoaguChek XS system in the US and the successful introduction of the system
there and in many other countries strengthened Roche’s leadership in the coagulation monitoring market.
Blood gas and electrolyte testing products, the product portfolio for blood glucose testing in hospitals
and the rollout of the Cardiac proBNP assay all contributed to solid sales growth.
Applied
Science — strong demand for LightCycler and Genome Sequencer
Roche Applied Science
posted 12% sales growth. The LightCycler 480 instrument, the Genome Sequencer 20 system and products
for industrial use were the main contributors to this double-digit increase. The Genome Sequencer 20
system is being used in an increasing number of applications and contributed significantly to Applied
Science’s nine-month performance.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of
innovative products and services for the early detection, prevention, diagnosis and treatment of disease,
the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche
is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and
a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly
70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai. Additional information about the Roche
Group is available on the Internet (www.roche.com).
All
trademarks used or mentioned in this release are protected by law.
Annex
Additional
information
- Roche Pharma pipeline
- Date of
publication of full-year results for 2006: 7 February 2007 (tentative)
Disclaimer:
Cautionary statement regarding forward-looking statements
This
document contains certain forward-looking statements. These forward-looking statements may be identified
by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’,
‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions.
Various factors may cause actual results to differ materially in the future from those reflected in
forward-looking statements contained in this document, among others: (1) pricing and product initiatives
of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability
in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange
rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing
of new products or new uses of existing products, including without limitation negative results of clinical
trials or research projects, unexpected side-effects of pipeline or marketed products; (6) increased
government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate
protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees;
and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not
a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share
for 2006 or any subsequent period will necessarily match or exceed the historical published earnings
or earnings per share of Roche. |
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