Investor Update
Basel, 14 October 2004
Nine-month
sales show continued double-digit growth significantly above the market average
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Roche
Group
• Sales in core businesses up by 14%* to 21.9 billion Swiss francs
•
Outlook for full-year 2004: double digit rise* in Pharmaceuticals Division sales and high single-digit
sales growth* at Roche Diagnostics; significant market share gains; double-digit increase in operating
profit and substantially higher net income
• Sale of Roche Consumer Health to Bayer on
track
Roche Pharmaceuticals
• Strong
sales growth continues with 17%* gain, more than twice the global market average
• Anticancer
drug Avastin already among Roche’s leading products, with roughly 450 million Swiss francs in sales
in its first seven months on the market
• Development milestones:
- Tarceva:
filings for approval in advanced non-small cell lung cancer and positive clinical trial data in pancreatic
cancer
- Marketing applications filed for new osteoporosis medicine Bonviva/Boniva in
Switzerland, the European Union and the United States
Roche
Diagnostics
• Division extends global market lead as sales increase by 8%*, well
ahead of world market growth
• Molecular diagnostics, immunochemistry and diabetes care
the main growth drivers
• AmpliChip CYP450 becomes first chip-based test to be certified
and launched in Europe
* Unless otherwise stated, all percentage changes are period-over-period changes and are based on results in local currencies.
Commenting on the Group’s performance in the first nine months of 2004, Roche Chairman and CEO Franz B. Humer said, ‘Roche continued to post significant sales growth through the third quarter of this year. Nine-month sales revenues from the Group’s core businesses totalled 21.9 billion Swiss francs, an increase of 14% over the same period a year ago. The extremely successful launch of Avastin, the positive data from our clinical trials with Tarceva and the filings now under review by the EU and US authorities for Bonviva/Boniva put us in a very solid position for future growth. We expect full-year sales growth for 2004 to be in the double digits in the Pharmaceuticals Division and in the high single-digit range for Diagnostics. We also expect to see significant market share gains, a double-digit rise in operating profit and a substantial increase in net income. Moreover, Roche’s recent inclusion in the Dow Jones Sustainability Indexes underscores our efforts in the area of sustainable development.’
Roche Group
2004 | 2003 | % Change | % Change |
|
Sales from January to September | m CHF | mCHF | In CHF | In local currencies |
Pharmaceuticals Division | 16,132 | 14,192 | 14 | 17 |
Roche prescription | 10,523 | 9,584 | 10 | 12 |
Genentech prescription | 3,287 | 2,466 | 33 | 43 |
Chugai prescription | 2,322 | 2,142 | 8 | 7 |
Diagnostics Division | 5,763 | 5,382 | 7 | 8 |
Roche Group1 | 21,895 | 19,574 | 12 | 14 |
1) Continuing businesses (the Group’s core Pharmaceuticals and Diagnostics Divisions). Consumer Health (OTC) and the Vitamins and Fine Chemicals business are reported as discontinuing businesses.
Consumer Health (OTC) | 1,320 | 1,306 | 1 | 2 |
Vitamins and Fine Chemicals2 | - | 2,260 | -100 | -100 |
Roche Group (incl. discontinuing businesses) | 23,215 | 23,140 | 0 | 2 |
2) Consolidated for the period up to and including 30 September 2003.
Both
core businesses deliver significant sales growth
Sales by the Pharmaceuticals and
Diagnostics Divisions totalled 21.9 billion Swiss francs in the first nine months of 2004, a rise of
14% in local currencies (+12% in CHF) compared with the same period a year ago. Sales in both divisions
grew significantly faster than their respective markets. Total prescription drug sales advanced by 17%
(+14% in CHF) to 16.1 billion Swiss francs, with positive contributions to growth coming from all divisional
units (Roche +12%, Genentech +43%, Chugai +7%). Thanks to increasing sales and its steady market share
gains in recent quarters, Roche now ranks eighth among the world’s largest pharmaceutical companies.
In the Diagnostics Division, where sales rose by 8% (+7% in CHF) to 5.8 billion Swiss francs, growth
was driven primarily by the diabetes care, molecular diagnostics and immunochemistry businesses. The
sale of Roche Consumer Health to Bayer, announced in July, is on track.
Outlook:
further market share gains expected for full-year 2004
Barring unforeseen events,
Roche expects full-year sales growth for its Pharmaceuticals and Diagnostics Divisions to be in the
double digits and high single digits, respectively, in local currencies. This will translate into additional
market share gains for both divisions. Moreover, the Group anticipates a double-digit increase in operating
profit and a substantial rise in net income. The Pharmaceuticals Division expects to report an operating
profit margin (before exceptional items) for the full year of around 26% and expects the 2005 operating
profit margin (before exceptional items) to be broadly in line with 2004 — despite additional costs
for the launch and development of new products and the onset of generic competition for Rocephin in
the United States. The Diagnostics Division is on track to achieve an operating profit margin of around
23% before exceptional items in 2006. Roche also reaffirms that the Group’s operating profit margin
will be above 22% this year, two years earlier than originally anticipated.
Pharmaceuticals
Division
Sales grow well ahead
of the
market
The Pharmaceuticals Division posted strong gains in the first nine months
of 2004 as sales for the period rose by 17% (+14% in CHF). This was well above a global market growth
rate of roughly 7%. Sales in the third quarter were up by 17%, outpacing divisional sales growth for
the second quarter and overall market growth as well. North American sales increased by 24%, outperforming
the market (+8%) by a significant margin. Sales in Europe grew twice as fast as the market average,
while Chugai’s sales in Japan advanced at more than three times the market growth rate. In Latin America
sales grew by 13%, lagging slightly behind the overall growth rate as the region’s markets continued
their recovery. The division recorded sustained, solid growth in its most important therapeutic areas,
oncology (+31%), virology (+66%) and transplantation medicine (+13%). Overall sales of Rocephin were
up slightly.
Oncology: new and established products deliver
strong growth
MabThera/Rituxan, for non-Hodgkin’s lymphoma (NHL), continues to
deliver strong results (+31%) and is experiencing an acceleration of growth in Europe.
Avastin
generated a significant 452 million Swiss francs in sales in the first seven months following its approval
by the US Food and Drug Administration (FDA) for first-line use in metastatic colon cancer. A recommendation
for approval in the European Union is expected by the end of the year.
Herceptin,
which is prescribed for advanced breast cancer, once again posted strong growth in all key markets (+25%).
Sales of Xeloda (–1%), for breast and colorectal cancer, continued to be negatively impacted by high
wholesaler inventory levels in the United States. However, wholesaler inventories of the product are
starting to normalise, and US sales of Xeloda have recently begun to pick up again. In Europe and Japan
Xeloda posted solid growth rates of 30% and 219%, respectively. Kytril gained additional market share
in key markets as sales rose by a healthy 8%.
Marketing applications
for the new cancer drug Tarceva in advanced non-small cell lung cancer were filed with the European
and US regulatory authorities in August. Recently announced clinical trial data have also shown that
Tarceva confers a significant survival benefit in pancreatic cancer.
Virology:
hepatitis C combination therapy continues strong performance
The drug combination
Pegasys plus Copegus, for hepatitis C, reinforced its market lead as sales for the period doubled. Applications
for supplementary approval of Pegasys in hepatitis B have been submitted to many world regulatory agencies.
In addition, the FDA recently announced that it had granted priority review to the filing for Pegasys
in patients co-infected with hepatitis C and HIV.
Viracept sales declined
by 16% as a result of continued competitive pressure and the price reductions Roche has granted in least
developed and emerging market countries. Adoption of the anti-HIV medicine Fuzeon into treatment regimens
is steadily increasing, and nine-month sales of the product exceeded 120 million Swiss francs. In early
October Fuzeon was awarded the International Prix Galien, the highest accolade for pharmaceutical innovation.
Roche is the only company to have received the prize three times.
Transplantation
medicine: CellCept maintains its lead
With sales up by 12%, CellCept continues
to post double-digit growth and remains the cornerstone of immunosuppressive therapy. Inventory burn
off had an effect on US sales, however. Combined sales of Valcyte and Cymevene also increased again,
advancing by an impressive 21%.
Osteoporosis: applications
filed for Bonviva/Boniva
Applications for approval of once-monthly oral Bonviva/Boniva
for the treatment of postmenopausal osteoporosis have been filed with the authorities in Switzerland,
the European Union and the United States.
Anemia: development
of CERA on track
Combined sales of Roche’s anemia products NeoRecormon and Epogin
were up by 1%. NeoRecormon maintained its leadership position in all its markets despite continued competitive
pricing pressures in this therapeutic area. The development programme for CERA, Roche’s novel medicine
for the correction of anemia, is moving ahead as planned. Patients are currently being recruited into
phase III trials of the drug in renal anemia.
Primary care:
Tamiflu outperforms
Sales of Tamiflu rose by +107%, primarily as a result of cooperation
between Roche and various government agencies to create stockpiles of the medicine for use in the event
of an influenza pandemic.
Diagnostics
Division
Above-market sales growth
continues
The
Diagnostics Division reinforced its market lead in the first nine months of 2004 as sales grew by 8%
(+7% in CHF). The division’s molecular diagnostics, immunochemistry and diabetes care businesses were
major contributors to this above-market growth. Once again Roche Diagnostics posted double-digit gains
in Asia-Pacific, Latin America and Iberia. The division has continued to significantly expand its presence
in Asian markets through a variety of initiatives, including domestic production of Accu-Chek glucose
meters in China. In the EMEA region (Europe-Middle East-Africa), where Roche Diagnostics already enjoys
an above-average market share, sales grew at a high single-digit rate, significantly ahead of the market.
After taking account of the divestment of the hematology product line and the OPTI Systems and non-clinical
drugs of abuse testing businesses, US sales growth was also in the high single-digit range, well above
the growth rate for the market as a whole.
Diabetes Care:
new products with tremendous growth potential
Roche Diabetes Care extended its
market lead with a sales increase of 10%. Accu-Chek D-TRONplus, the first insulin pump to carry the
Accu-Chek name, was unveiled at this year’s European Association for the Study of Diabetes conference,
and a roll-out is now getting under way. Accu-Chek Pocket Compass 2.0, a software package for personal
digital assistants, is another product expected to stimulate steady growth. It is the first commercial
diabetes management software that allows users to download and combine data from both an insulin pump
and a blood glucose meter. The new possibilities this opens up for analysing data will benefit frequent
testers, in particular, enabling them to achieve even better glycemic control.
Near
Patient Testing: market lead strengthened
Roche Near Patient Testing reported sales
growth of 3%. In the primary care segment (compact systems for doctors’ offices), the Accutrend line
of cholesterol testing products posted especially strong double-digit sales growth. Sales of coagulation
monitoring products also continued to grow at a double-digit rate, despite mounting competition. The
global roll-out of Omni S, a multiparameter analyser for the hospital point-of-care segment, has been
successfully completed.
Centralized Diagnostics: moving
towards leadership in immunochemistry
With overall sales up by 6%, Roche Centralized
Diagnostics continued to grow faster than the market. Immunochemistry sales, which increased at an above-average
rate of more than 20%, were the major contributor to growth. The acquisition of new licenses for the
growing HIV assay segment and the launch of the Elecsys HIV combi assay in June have brought Roche a
major step closer to its goal of achieving market leadership in immunochemistry.
Molecular
Diagnostics: growth across the board
Sales growth at Roche Molecular Diagnostics
remained strong, at 13%. An agreement has been signed extending Roche’s exclusive blood screening contract
with the Japanese Red Cross for an additional four years. Sales of tests for Chlamydia and gonorrhea
were up sharply. Further progress was made towards obtaining reimbursement approval in Europe for the
Amplicor HPV test kit for human papillomavirus; the kit has already received CE (Conformité Européenne)
certification. Roche also consolidated its share of the fiercely competitive virology market by launching
Cobas TaqMan and Cobas TaqMan 48. With the launch of AmpliChip CYP450, Roche became the first company
to introduce a chip-based test for broad diagnostic use. In September the chip received the necessary
CE mark for use as an in-vitro diagnostic product in Europe.
Applied
Science: growth continues to outpace the market
Roche Applied Science continued
to experience healthy growth, with sales for the period advancing by 9%. Sales of LightCycler reagents
for automated PCR (polymerase chain reaction) testing were a major growth driver, as were product sales
to industrial customers. Preparations for the European launch of a new, improved LightCycler instrument
and an additional, modified LightCycler specifically for universities by the end of 2004 are moving
ahead on schedule.
Annex
Additional
information
- Annual Results 2004: 2 February 2005
Disclaimer
This
release 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 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 presentation 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; (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 or news coverage.
07.00h
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This release will posted on the Roche IR website.
Presentation
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14.00h
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Conference call will commence with presentations
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Officer
William M. Burns, Head of the Pharmaceuticals Division
Heino von
Prondzynski, Head of the Diagnostics Division
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