Investor Update
Basel, 26 April 2006
Roche
showed continued strong sales growth in the first quarter 2006 – sales up by 15%
Investor
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Roche
Group
• Group sales grew 15% in local currencies and 22% in Swiss francs to 9.8
billion Swiss francs
• Pharmaceutical sales up 19%, three times the global market growth
rate
• Outlook for 2006: Group poised for further strong year-on-year growth
Pharmaceuticals
Division
• Sales rose 19% in local currencies and 26% in Swiss francs
•
Sales of the division’s successful cancer medicines grew very strongly, advancing 52%*
•
Rheumatoid arthritis indication for MabThera/Rituxan launched in the US
• CERA in renal
anemia filed in the US
• Herceptin filed in major markets for treatment of early HER-2
positive breast cancer
• Tamiflu sales continue to grow strongly (+37%)
•
First filings for Avastin and Tarceva in Japan
• Positive phase III results from study
with Xeloda in stomach cancer
• New data confirm that adding Avastin to standard chemotherapy
doubles progression-free survival in advanced breast cancer patients
Diagnostics
Division
• Sales rose 3% in local currencies and 8% in Swiss francs
•
Immunochemistry portfolio generates solid double digit growth (+16%)
• Maturation of
Accu-Chek Advantage impacted Diabetes Care sales as anticipated — new Accu-Chek portfolio performing
well in the marketplace
• New sepsis test launched and automated blood screening system
cleared for marketing 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 quarter of 2006, Roche Chairman and CEO Franz B. Humer said: ‘Roche commenced the year with an outstanding quarter and all growth drivers continued last year’s strong performance. Sales growth was primarily driven by our novel cancer medicines with proven survival benefits, and Tamiflu was also a major contributor to growth. US approval of the first rheumatoid arthritis indication for MabThera/Rituxan and the progress we have made in developing Actemra are major milestones for our emerging autoimmune disease franchise. The molecular diagnostics business and immunochemistry portfolio continued to be the main growth drivers for our Diagnostics Division. We expect sales in this division to accelerate over the next several quarters.’
Roche Group
2006 | 2005 | % Change | % Change |
|
Sales from January to March1 | m CHF | mCHF | In CHF | In local currencies |
Pharmaceuticals Division | 7,739 | 6,155 | +26 | +19 |
Roche | 4,821 | 3,859 | +25 | +19 |
Genentech | 2,056 | 1,341 | +53 | +40 |
Chugai | 862 | 955 | -10 | -8 |
Diagnostics Division | 2,091 | 1,935 | +8 | +3 |
Roche Group | 9,830 | 8,090 | +22 | +15 |
1 See attachment to this release for details on quarterly sales growth.
Roche
posted
sales of 9.8 billion Swiss francs in the first quarter of 2006, an increase of 15% in local currencies
and 22% in Swiss francs (+11% in US dollars) over the same period last year. This continued the strong
double-digit growth reported for full-year 2005. First quarter sales in the Pharmaceuticals Division
increased 19% (+26% in Swiss francs). The Diagnostics Division maintained its leading market position
with sales growth of 3% (+8% in Swiss francs). 1
Positive
outlook for 2006
Barring unforeseen events, Roche expects full-year sales and income
for 2006 to be up significantly from 2005. The Group reaffirms the outlook announced at its annual media
conference: Sales in both the Pharmaceuticals and the Diagnostics Division are expected to grow ahead
of the market in local currencies, and we anticipate continued double-digit growth for the Pharmaceuticals
Division and the Group as a whole. Sales growth rates in the second half of the year are expected to
be comparable to those in the first half. Our target is for core earnings per share and non-voting equity
security to grow at least in line with sales.
Pharmaceuticals
Division
Key products continue
to deliver strong growth
In the first quarter of 2006 sales in the Pharmaceuticals
Division rose 19% in local currencies (+26% in Swiss francs), again growing three times as fast as the
market. Much of this growth came from the Group’s oncology portfolio, which showed again a significant
increase in sales for all its key products, including Herceptin, Avastin, MabThera, Tarceva and Xeloda.
Overall sales of the oncology portfolio showed an outstanding growth of 52%. Pandemic stockpiling by
governments of the anti-influenza drug Tamiflu was also a significant contributor to growth. Regional
pharmaceutical sales growth continues to far outpace market growth in North America (+24% vs. 5%) and
Europe (+24% vs. 7%). Japan experienced a sales decline (-8%), due to seasonal shifts in Tamiflu sales
and trade stock adjustments in anticipation of government price cuts, which became effective on 1 April.
Oncology – demand up strongly for whole portfolio
First-quarter
sales of Roche’s top-selling product, MabThera/Rituxan, for the treatment of non-Hodgkin's lymphoma
(NHL), were up by 16%. Sales showed particularly impressive growth in Europe/Rest of World
Worldwide sales of Herceptin, the only targeted
treatment approved for use in advanced HER2-positive breast cancer, have effectively doubled in the
first quarter 2006 compared with the same period last year. Strong growth was achieved in all major
markets. Based on exceptionally strong data on Herceptin’s benefits in early-stage HER2-positive breast
cancer, US and EU filings for this indication took place in February 2006. As a result of the impressive
data, Herceptin is already being used in some countries in the early-stage (adjuvant) setting.
Avastin,
a novel cancer therapy with demonstrated survival benefits in metastatic colorectal, breast and lung
cancer, also posted strong sales growth in the US and Europe (+141%). Avastin was just filed in the
US for the most common form of lung cancer. The first filing for Avastin in Japan has also been submitted
this month for the treatment of advanced colorectal cancer. Furthermore, regulatory filings in advanced
NSCLC in Europe and in advanced breast cancer in Europe and the US are on track for later this year.
Broadening the current label in metastatic colorectal cancer to include more chemotherapeutic options
is also planned in Europe.
Tarceva, a novel targeted drug that has been
shown to extend the lives of patients with advanced NSCLC and pancreatic cancer patients, achieved high
sales growth of 182%. Only 12 months after the launch in first countries, sales in Europe/RoW made up
already more than 30% of total sales while the roll-out in further markets is progressing on-track.
The filing for advanced NSCLC in Japan has just been submitted to the authorities this month. The EU
regulators are currently reviewing a filing for the treatment of advanced pancreatic cancer submitted
in October 2005.
Xeloda has achieved outstanding worldwide sales resulting
in a growth of 35%. All regions contributed to this strong increase, in particular the US (+40%) and
Europe/RoW (+34%). Sales were positively impacted by further growth in the area of post-surgical (adjuvant)
use in colon cancer patients, an indication approved and launched last year in the EU and US. Future
filings include stomach cancer and a combination therapy with Avastin in first-line metastatic colorectal
cancer.
Anemia – good growth maintained in Europe
Sales
of Roche’s NeoRecormon and Chugai’s Epogin, for the treatment of anemia, achieved a combined growth
of 3%, despite declining Epogin sales in Japan in anticipation of the bi-annual across-the-board price
cuts there. Sales of NeoRecormon were up 6% in Europe/RoW.
Transplantation
– CellCept remains leading immunosuppressant
The transplant portfolio achieved
further robust growth as sales rose 14% for the quarter. CellCept, the world’s top-selling branded immunosuppressant,
maintained strong double digit growth (+15%), driven by good performance especially in the US (+32%).
Virology – Tamiflu sales remain strong
Sales
of Tamiflu grew by 37% over last year, driven by pandemic deliveries. Japanese Tamiflu sales were down
from the first quarter of 2005 because the flu season 2005/2006 started earlier with already considerable
sales in the fourth quarter of 2005. More than 65 countries have already placed orders for pandemic
stocks of Tamiflu. Roche has continued to ramp up production capacity for Tamiflu and will be able to
produce 400 million treatment courses annually from the end of 2006 significantly exceeding orders that
have been received from governments to date. This has been achieved by using a collaborative network
of Roche's facilities and those of a number of independent companies. In March an additional sub-license
to manufacture oseltamivir, the active ingredient of Tamiflu, for China was granted to the HEC group.
Research into the most effective utilisation of Tamiflu against the H5N1 virus, both internally and
through collaborations with outside scientists and physicians and the WHO, continues.
Pegasys
sales increased slightly in the first quarter, against a background of declining prescriptions for hepatitis
C in the US and a number of European countries. In addition, US sales were affected by an adjustment
in wholesaler inventory levels following a price increase late last year. However, Pegasys still commands
a stable US market share of above 60% and remains the world’s leading treatment for chronic hepatitis
C. The National Institute for Clinical Excellence in the UK (NICE) has recommended Pegasys as first-line
choice for the treatment of chronic hepatitis B supporting the superior efficacy and cost effectiveness
of Pegasys compared to the previous standard of care. As anticipated, Copegus sales saw a marked decline,
mainly due to the emergence of generic competition in the US.
The HIV
medicine Fuzeon continues its consistent growth trend with sales increasing in the first quarter by
36%. Growth remains strongest in Europe/RoW (+60%).
Other
products – Bonviva rolling out in Europe
Sales of once monthly oral Bonviva/Boniva
for the treatment of postmenopausal osteoporosis reached 75 million Swiss francs. Sales came predominantly
from the US, with product launches set to continue in a number of European markets this year. In the
past quarter, Roche/GSK received FDA and EU approval for the quarterly Bonviva/Boniva injection, an
alternative formulation for women for whom oral bisphosphonates are not appropriate.
Xenical
performed well in the first quarter with sales growth of 16%. Sales were up both in the US (+24%) and
in Europe/RoW (+14%).
Overall Rocephin sales declined substantially
(-69%), in line with expectations. Following its US patent expiry in July 2005 sales declined by 96%
in the quarter, in Europe/RoW sales were 24% lower.
Major
development activities
In 2006 Roche already received four approvals in major indications
and submitted six major filings to regulatory authorities worldwide. In addition, the company’s late-stage
clinical development projects showed further progress with an impressive 45 phase III projects going
ahead as planned or have been successfully completed in the first quarter.
Autoimmune
diseases
A significant milestone for MabThera/Rituxan was achieved with the approval
in the US for its first rheumatoid arthritis indication. One treatment course comprising two infusions
offers lasting benefit to many rheumatoid arthritis patients who have had an unsatisfactory outcome
with current biological treatment options. Most patients in the trials who received additional courses
did so six months after the previous course. A regulatory filing was submitted to European authorities
in September 2005.
Since end 2005/early 2006, patient recruitment is
ongoing in the MabThera phase III programme for patients who have had an inadequate response or who
are intolerant to treatment with one or more disease-modifying antirheumatic drugs (DMARDs), including
two trials specifically studying the effect of further courses. Last month Genentech announced that
a next generation anti-CD20 humanised monoclonal antibody (ocrelizumab) phase II study in rheumatoid
arthritis met its primary endpoint and showed clinical activity in all dose levels studied. The development
of Actemra (formerly known as MRA) for rheumatoid arthritis is progressing well with more than 2,500
of the targeted 4,100 patients already recruited for the international phase III programme. The results
of a second Japanese phase III study confirmed earlier results in showing significant improvements in
slowing down joint damage. Chugai will submit a filing for Actemra to Japanese regulators shortly.
Oncology
The
development programme with Avastin is investigating the medicine in a broad range of cancers, including
renal cell carcinoma, pancreatic cancer, ovarian cancer and prostate cancer. Trials to expand the options
for combining Avastin with other chemotherapeutic agents for the treatment of metastatic colorectal
cancer, non-small cell lung cancer (NSCLC) and metastatic breast cancer are also ongoing. In addition,
preparations are underway to start phase III trials in the adjuvant indication of NSCLC and breast cancer,
and Genentech recently started recruiting into an adjuvant rectal cancer study. The result of the review
process regarding the adjuvant colon cancer study (AVANT) is expected in May. A Xeloda trial in advanced
gastric cancer has met its primary endpoint showing it to be at least as effective as current therapy.
This followed positive survival data seen in a Xeloda study in pancreatic cancer. The phase III programmes
of MabThera/Rituxan in Chronic Lymphocytic Leukaemia (CLL), Herceptin in gastric cancer, Xeloda in metastatic
colorectal cancer and adjuvant colon and breast cancer, and Tarceva in NSCLC and glioblastoma are on
track. In addition, Roche expects data on the use of Herceptin in combination with hormonal therapy
in metastatic breast cancer during 2006.
Anemia
The
first filing of CERA, the first Continuous Erythropoietin Receptor Activator for the treatment of anemia
in chronic kidney disease was submitted to the US authorities in April having completed the largest
development programme undertaken for this indication. The programme involved four phase III studies
which investigated the outcome of converting renal anaemia patients from existing erythropoeitin stimulating
agents to CERA at extended dosing intervals and two phase III studies which investigated the treatment
(correction) of anaemia in previously untreated patients in comparison to standard treatments. The European
filing for CERA is due to follow imminently. In the oncology setting, Roche has started recruiting patients
for an additional dose-optimisation study.
Strong R&D
pipeline
As of March 31, Roche has 59 new molecular entities (NME’s) and 53 additional
indications (AI) in its R&D pipeline (phase 0-3). During the first quarter of 2006, the following
changes in the pipeline occurred: Phase I - one project moved in and two projects were discontinued,
Phase II – two projects newly entered and two projects were discontinued, and Phase III – five projects
newly entered and one project received regulatory approval. There were no discontinuations in phase
III during the period. A complete overview of the Roche Pharma R&D pipeline is available on the
Internet.
Diagnostics
Division
Above market sales in Europe, Asia and
Latin America
The Diagnostics Division increased its sales by 3% in local currencies
(8% in Swiss francs) in the first quarter of 2006. The division’s molecular diagnostics business and
immunodiagnostics portfolio continued to be the main growth factors, with Applied Science and Near Patient
Testing also delivering solid performances. Double-digit sales gains were posted in Asia Pacific and
Iberia/Latin America, and above-market growth in the high single digits was recorded in the EMEA region
(Europe, Middle East and Africa). In the relatively flat market environment in Japan, Roche Diagnostics
continued to grow ahead of the market. In the US, revenues were down owing to erosion of Accu-Chek Advantage
sales.
Diabetes Care – new Accu-Chek generation gaining
momentum
Sales of Diabetes Care (-5%) were affected by the performance of the Accu-Chek
Advantage in the US. The recent launch of the successor product, Accu-Chek Aviva, has so far only partially
made up for declining US sales of the Advantage system. The launch of the integrated test strip system,
Accu-Chek Compact Plus, in the US and Canada will help to further expand Roche’s market leadership position
in this fast growing segment. High placements of Accu-Chek Aviva in North America, EMEA, and now also
in Japan, are contributing to regaining market share and compensating for the decline in Accu-Chek Advantage
sales. The Accu-Chek Smart Pix Device Reader has been launched globally. It allows people with diabetes
and Health Care Professionals to view blood glucose readings and insulin doses. With this, Accu-Chek
products further cover overall diabetes care management.
Centralized
Diagnostics –immunochemistry sales up strongly
Maintaining its leading market position
sales of Centralized Diagnostics grew by 7%. The immunochemistry business continued to be the main growth
driver, with Elecsys products posting an impressive 16% increase in sales. Continued rising demand for
the Elecsys proBNP cardiac assay was just one of the factors contributing to increased Elecsys sales.
In
2006 the business area is focused on rolling out its cobas 6000 series, the first of the next generation
of modular analytical systems for medium-sized laboratories.
Molecular
Diagnostics – new sepsis test available in Europe
This business area increased its sales
by 7%. The major focus for 2006 will be the EU launch and US FDA filing for the new automated cobas
s 201 modular blood screening system and more comprehensive cobas TaqScreen MPX test which simultaneously
detects HIV and hepatitis C and B viruses in donated blood. This test received the CE Mark (“Conformitée
Européenne”) in March. The LightCycler SeptiFast Test was launched in Europe in January and can rapidly
and reliably detect and identify 25 different sepsis-causing pathogens - including bacteria and fungi
- which cause approximately 90 percent of all sepsis cases. This new test opens up a whole new dimension
in the management of “blood poisoning” as rapid initiation of targeted treatment is crucial in this
condition.
Near Patient Testing – new coagulation monitoring
system on the market
Significant sales growth (+9%) was achieved by the Near Patient
Testing business. The newest coagulation monitoring system - CoaguChek XS - commenced its European roll-out
in January. This instrument allows more patients on long-term oral anticoagulation therapy to have access
to the advantages of self-monitoring and gives them information about their coagulation status directly
on the spot, virtually pain-free from one drop of blood. Sales of the Cardiac product line rebounded
in growth, primarily driven by the roll-out of Cardiac proBNP in the EMEA region, Latin America and
Asia Pacific.
Applied Science – remain strong player in
life science research
With sales advancing by 10%, Applied Science posted solid
growth. This is based on the introduction of the Light Cycler 480 which provided a very competitive
platform for high throughput real-time PCR applications in the research market. The introduction of
the innovative and fast Genome Sequencer 20 marked the entry into the attractive sequencing research
market. This system is the first product out of the strategic alliance with 454 Life Sciences and has
been very well accepted in all global markets.
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).
1 Europe/Rest of World: Europe and other countries excluding US and Japan
All trademarks used or mentioned in this release are protected by law.
Annex
Additional information
- Half-year results 2006: July 20 (tentative)
- Nine months sales 2006: October 17 (tentative)
07.00 CET (Central European Time) / 1:00 AM EDT (Eastern Daylight Time)
Release will be e-mailed and posted on the Roche IR website.
Presentation slides will be posted on the Roche IR website http://ir.roche.com.
14.00 - 15.30 CET / 8:00 - 9:30 AM EDT
Conference call will start with presentations by senior management followed by a Q&A session with live access to the speakers. Participants will be:
- Erich Hunziker, Deputy Head of the Corporate Executive Committee and CFO
- William M. Burns, CEO Division Roche Pharma
- Severin Schwan, CEO Division Roche Diagnostics
Dial in to the conference 10-15 min
prior to the scheduled start using the following numbers:
+41 (0) 91 610 56 00 (Europe
and ROW)
+1 (1) 866 291 41 66 (USA Toll Free)
+44 (0) 207 107 06 11
(UK)
Alternatively a live audio webcast can be accessed via http://ir.roche.com.
A
replay of the conference call will be available one hour after the conference call, for 48 hours. Access
is by dialing:
+41 91 612 43 30 (Europe and ROW) or
+1 (1) 866 416 25
58 (USA)
+44 207 108 62 33 (UK)
and will be asked to enter the ID 442
followed by the # sign
A replay of the webcast will be available on
demand at http://ir.roche.com.
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.